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Shih CA, Wu DC, Shie CB, Hsu PI. Dual Therapies Containing an Antibiotic Plus a Proton Pump Inhibitor or Vonoprazan for Helicobacter pylori Infection: A Systematic Review. Microorganisms 2025; 13:715. [PMID: 40284552 PMCID: PMC12029877 DOI: 10.3390/microorganisms13040715] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/22/2025] [Revised: 03/14/2025] [Accepted: 03/19/2025] [Indexed: 04/29/2025] Open
Abstract
Due to the increasing prevalence of antimicrobial resistance, the efficacy of standard triple therapy for Helicobacter pylori (H. pylori) infection has declined, with eradication rates now falling below 80% in most countries. Although bismuth quadruple therapy and concomitant therapy are advised in regions with high clarithromycin resistance, these treatments commonly cause frequent adverse events and require the use of two or three antibiotics. This review article evaluates the effectiveness of 14-day mono-antibiotic therapies for H. pylori infection through randomized controlled trials conducted from 1 October 2014 to 1 October 2024. The pooled eradication rates for 14-day high-dose amoxicillin/proton pump inhibitor (PPI) dual therapies were 86.1% (3335/3875; 95% confidence interval (CI): 85.1-87.2%) by intention-to-treat (ITT) analysis and 87.3% (3232/3702; 95% CI: 86.2-88.4%) by per-protocol (PP) analysis. For 14-day high-dose amoxicillin/vonoprazan dual therapies, the rates were 87.4% (1085/1241; 95% CI: 85.5-89.2%) by ITT and 93.0% (1044/1124; 95% CI: 91.5-94.5%) by PP. In the penicillin-allergic population, 14-day tetracycline/vonoprazan dual therapy showed eradication rates of 92.0% (138/150) by ITT and 95.1% (135/142) by PP. In conclusion, 14-day tetracycline/vonoprazan dual therapy presents an effective option for eradicating H. pylori in patients allergic to penicillin. For those without a penicillin allergy, first-line treatments can include 14-day mono-antibiotic regimens, such as high-dose amoxicillin/PPI dual, high-dose amoxicillin/vonoprazan dual, and tetracycline/vonoprazan dual therapies.
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Affiliation(s)
- Chih-An Shih
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital, Pingtung County 928004, Taiwan;
- Department of Nursing, Meiho University, Pingtung County 912009, Taiwan
| | - Deng-Chyang Wu
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung City 807377, Taiwan;
- Department of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung City 807378, Taiwan
| | - Chang-Bih Shie
- Division of Gastroenterology, Department of Internal Medicine, An Nan Hospital, China Medical University, Tainan City 709204, Taiwan
| | - Ping-I Hsu
- Division of Gastroenterology, Department of Internal Medicine, An Nan Hospital, China Medical University, Tainan City 709204, Taiwan
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Liu YX, Liu HN, Liu HQ, Yang YY, Cui HL, Fan LL, Sun WJ, Mei H, Wang XW, Yan G, Lan CH. Vonoprazan-Amoxicillin Dual Therapy Versus Drug Sensitivity-Based Individualized Therapy as a Rescue Regimen for Helicobacter pylori Infection: A Multicenter, Randomized Controlled Trial. Helicobacter 2025; 30:e70009. [PMID: 39996433 DOI: 10.1111/hel.70009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/31/2024] [Revised: 01/02/2025] [Accepted: 01/06/2025] [Indexed: 02/26/2025]
Abstract
OBJECTIVE Vonoprazan is a novel potassium-competitive acid blocker (P-CAB) that offers several advantages, such as fast onset time and strong acid inhibition, in the treatment of Helicobacter pylori infection. This study aims to evaluate the efficacy, adverse reactions, and compliance of the 14-day vonoprazan-amoxicillin dual therapy versus drug sensitivity-based individualized therapy in the retreatment of H. pylori infection. METHODS This multicenter, open-label, randomized, controlled non-inferiority study enrolled 240 adult patients who previously failed anti-H. pylori treatment. These patients were randomly assigned to receive the 14-day vonoprazan-amoxicillin dual therapy or drug sensitivity-based individualized therapy. The primary outcome was the eradication rate, and the secondary outcomes mainly included adverse events, patient compliance, antibiotic resistance rates, and risk factors that affected the eradication rate. RESULTS The intention-to-treat (ITT) and per-protocol (PP) analyses revealed that the eradication rates for the vonoprazan-amoxicillin dual therapy and drug sensitivity-based individualized therapy were comparably high, with rates of 87.50% and 83.33%, respectively. Furthermore, the vonoprazan-amoxicillin dual therapy fulfilled the criteria for the non-inferiority test, when compared to individualized therapy. The incidence of adverse reactions was significantly lower in the vonoprazan-amoxicillin dual therapy group. Both groups showed similarly good compliance and comparable rates of antibiotic resistance. The previous treatment with a clarithromycin-containing regimen was identified as an independent risk factor for clarithromycin resistance. CONCLUSION The 14-day vonoprazan-amoxicillin dual therapy exhibits high eradication rates and low incidence of adverse reactions in retreated patients, indicating its effectiveness and safety as a rescue regimen for patients with H. pylori infection.
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Affiliation(s)
- Yu-Xiang Liu
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University (Third Military Medical University), Chongqing, P. R. China
| | - Han-Ning Liu
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University (Third Military Medical University), Chongqing, P. R. China
| | - Heng-Qi Liu
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University (Third Military Medical University), Chongqing, P. R. China
| | - Ying-Ying Yang
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University (Third Military Medical University), Chongqing, P. R. China
| | - Hong-Li Cui
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University (Third Military Medical University), Chongqing, P. R. China
| | - Li-Lin Fan
- Department of Gastroenterology, West District Hospital of Chongqing, Chongqing, P. R. China
| | - Wen-Jing Sun
- Department of Gastroenterology, The 13th People's Hospital of Chongqing, Chongqing, P. R. China
| | - Hao Mei
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University (Third Military Medical University), Chongqing, P. R. China
| | - Xing-Wei Wang
- Department of Emergency Medicine, Daping Hospital, Army Medical University (Third Military Medical University), Chongqing, P. R. China
| | - Guo Yan
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University (Third Military Medical University), Chongqing, P. R. China
| | - Chun-Hui Lan
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University (Third Military Medical University), Chongqing, P. R. China
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Lin A, Lin Z, Liu Y, Chen S, Shao Y, Qiu F, Xiao Z, Xu Z, Chen L, Chen L, Lin W, Wang Y, Huang Z, Lin Z, Huang X. Ten-day versus 14-day vonoprazan-amoxicillin high-dose dual therapy for Helicobacter pylori eradication in China: A multicenter, open-label, randomized study. J Gastroenterol Hepatol 2024; 39:2645-2653. [PMID: 39582213 DOI: 10.1111/jgh.16761] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/12/2024] [Revised: 09/03/2024] [Accepted: 09/24/2024] [Indexed: 11/26/2024]
Abstract
BACKGROUND AND AIM Only a few studies have investigated the efficacy and safety of different durations of vonoprazan and amoxicillin (VA) high-dose dual therapy for the eradication of Helicobacter pylori. We aimed to compare the efficacy and safety of 10 days versus 14 days of VA high-dose dual therapy for H. pylori eradication. METHODS This study was conducted in 14 centers in China. A total of 250 patients infected with H. pylori were randomly assigned to Group VA-10 or VA-14. Both groups received the VA dual therapy (vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily). The primary endpoint was the H. pylori eradication rate. Secondary endpoints included adverse events and patient compliance. RESULTS Group VA-10 achieved eradication rates of 89.60%, 91.06%, and 91.67% as determined by the intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analysis, respectively. The eradication rates were similar to those in Group VA-14: 91.20%, 93.44%, and 93.39%. The difference and 90% confidence interval boundary -1.60% (-7.73% to 4.53%) in the ITT analysis, -2.39% (-8.00% to 3.23%) in the MITT analysis, and -1.72% (-7.29% to 3.85%) in the PP analysis were greater than the predefined noninferiority margin of -10%, establishing a noninferiority of Group VA-10 versus Group VA-14 (noninferiority P = 0.001 in ITT analysis, P < 0.001 in MITT analysis, and P < 0.001 in PP analysis, respectively). No significant differences were observed in adverse events between the two groups. CONCLUSIONS Ten-day VA dual therapy achieves comparable efficacy and safety to the 14-day regimen in Chinese population, providing patients with greater convenience and economic benefits.
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Affiliation(s)
- Aiping Lin
- Department of Gastroenterology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
| | - Zhihui Lin
- Department of Gastroenterology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
| | - Yijuan Liu
- Department of Gastroenterology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China
| | - Shuo Chen
- Department of Gastroenterology, Nanping People's Hospital, Nanping, China
| | - Yanfeng Shao
- Department of Gastroenterology, The Third People's Hospital of Fujian Province, Fuzhou, China
| | - Feng Qiu
- Department of Gastroenterology, Fujian Provincial Hospital North Brance Fujian Provincial Geriatric Hospitals, Fuzhou, China
| | - Zhongqin Xiao
- Department of Gastroenterology, Nanping Second Hospital, Nanping, China
| | - Zhangkun Xu
- Department of Gastroenterology, The General Hospital of Fujian Energy Group, Fuzhou, China
| | - Longqun Chen
- Department of Gastroenterology, Jinjiang Second Hospital (Jinjiang Anhai Hospital), Quanzhou, China
| | - Lianghuo Chen
- Department of Gastroenterology, Anxi Country Hospital, Quanzhou, China
| | - Weixing Lin
- Department of Gastroenterology, Fuding City Hospital, Ningde, China
| | - Yongfu Wang
- Department of Gastroenterology, Liancheng Hospital, Longyan, China
| | - Zhonghua Huang
- Department of Gastroenterology, Putian First Hospital, Putian, China
| | - Zhenqun Lin
- Department of Gastroenterology, Zhangzhou Municipal Hospital of TCM, Zhangzhou, China
| | - Xueping Huang
- Department of Gastroenterology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou, China
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Ye CG, Zhu XJ, Hu N, Wu BH, Fang J, Yang L. Efficacy and safety of high-dose dual therapy in eradicating Helicobacter pylori. Shijie Huaren Xiaohua Zazhi 2024; 32:665-670. [DOI: 10.11569/wcjd.v32.i9.665] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/25/2024] [Revised: 08/21/2024] [Accepted: 09/03/2024] [Indexed: 09/28/2024] Open
Abstract
BACKGROUND The infection rate of Helicobacter pylori (H. pylori) in China remains high, and high-dose dual therapy (HDDT) has been progressively applied in clinical practice and has achieved satisfactory treatment outcomes. This is related to the strong acid inhibition and the full effectiveness of antibiotics. However, there is limited research available on domestically procured drugs.
AIM To evaluate the efficacy and safety of high-dose dual therapy based on domestically procured drugs for eradicating H. pylori.
METHODS A total of 316 patients with newly diagnosed H. pylori infection were consecutively enrolled and randomly divided into two groups: HDDT group (esomeprazole enteric-coated capsules 20 mg qid and amoxicillin 750 mg qid for a total of 14 d) and bismuth-containing quadruple therapy (BQT) (esomeprazole enteric-coated capsules 20 mg bid, potassium citrate bismuth capsules 220 mg bid, amoxicillin 1000 mg bid, and furazolidone 100 mg bid for a total of 14 d). The primary observation index was the H. pylori eradication rate, and the secondary observation indexes were the safety of and patient compliance to the two treatment regimens.
RESULTS Intention-to-treat (ITT) analysis showed that the H. pylori eradication rates in the HDDT and BQT groups were 88.0% and 87.3%, respectively. Modified ITT (MITT) analysis showed H. pylori eradication rates of 91.4% and 92.0% in the two groups, and per-protocol (PP) analysis showed H. pylori eradication rates of 93.3% and 93.9% in the two groups, with no significant difference between the groups (P > 0.05). The incidence of adverse events in the HDDT group was significantly lower than that of the BQT group (P = 0.001). There was no significant difference in treatment compliance between the two groups (P > 0.05).
CONCLUSION HDDT based on domestically procured drugs has a similar eradication rate of H. pylori to BQT, but with a lower incidence of adverse events, making it a good treatment option worth considering in clinical practice.
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Affiliation(s)
- Chang-Gen Ye
- Department of Gastroenterology, Third People's Hospital of Jingdezhen City, Jingdezhen 333000, Jiangxi Province, China
| | - Xiao-Jia Zhu
- Department of Gastroenterology, Third People's Hospital of Jingdezhen City, Jingdezhen 333000, Jiangxi Province, China
| | - Na Hu
- Department of Gastroenterology, Third People's Hospital of Jingdezhen City, Jingdezhen 333000, Jiangxi Province, China
| | - Bai-Hui Wu
- Department of Gastroenterology, Third People's Hospital of Jingdezhen City, Jingdezhen 333000, Jiangxi Province, China
| | - Jun Fang
- Department of Gastroenterology, Third People's Hospital of Jingdezhen City, Jingdezhen 333000, Jiangxi Province, China
| | - Li Yang
- Department of Gastroenterology, Third People's Hospital of Jingdezhen City, Jingdezhen 333000, Jiangxi Province, China
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Reum Choe A, Tae CH, Choi M, Shim KN, Jung HK. Systematic Review and Meta-Analysis: Bismuth Enhances the Efficacy for Eradication of Helicobacter pylori. Helicobacter 2024; 29:e13141. [PMID: 39385325 DOI: 10.1111/hel.13141] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/20/2024] [Revised: 09/07/2024] [Accepted: 09/11/2024] [Indexed: 10/12/2024]
Abstract
BACKGROUND In the eradication of Helicobacter pylori, the efficacy of bismuth remains inconclusive. We aimed to compare the efficacy of bismuth on various H. pylori eradication regimens. METHODS Randomized controlled trials were collected to compare the efficacy of bismuth to nonbismuth regimens in H. pylori eradication. We pooled information to study eradication, adverse events, and drug compliance. In addition, subgroup analyses for eradication efficacy were performed according to high or low clarithromycin-resistance area, bismuth drug form, and amount of bismuth element. RESULTS Records for a total of 2506 patients in 15 trials from 13 randomized controlled studies were included. The eradication of H. pylori was superior when bismuth compared to nonbismuth regimen (odds ratio [OR] = 1.63, 95% confidence interval [CI], 1.33-2.00 in intention-to-treat [ITT]; OR = 2.05, 95% CI, 1.58-2.68 in per-protocol [PP] analyses), without significant difference in drug compliance or adverse events. Bismuth regimens in the high clarithromycin resistance area tend to enhance the eradication rate (OR = 1.66, 95% CI, 1.34-2.05 in ITT; OR = 2.22, 95% CI, 1.67-2.95 in PP analyses). Bismuth potassium citrate and bismuth subcitrate were more effective drug forms in regard to eradication rate. Bismuth at a dosage of < 500 mg/day was significantly higher for the eradication rate. CONCLUSIONS Bismuth to the H. pylori eradication regimens achieve a higher eradication rate, especially in the high clarithromycin resistance area. It could be an eradication option achieving sufficient resistance rates without increasing antibiotic resistance, side effects, or poor compliance.
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Affiliation(s)
- A Reum Choe
- Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea
| | - Chung Hyun Tae
- Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea
| | - Miyoung Choi
- Division of Health Technology Assessment Research, National Evidence-Based Healthcare Collaborating Agency, Seoul, Korea
| | - Ki-Nam Shim
- Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea
| | - Hye-Kyung Jung
- Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea
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Huang XP, Liu YJ, Lin SW, Shao YF, Qiu F, Qiu QW, Xu ZK, Chen JX, Chen LH, Lin ZQ, Dai WH, Zhang MQ, Jiang Q, Xiao ZQ, Cheng XX, Zhang XF, You WB, Chen W, Li LQ, Lin WX, Wang YF, Lai FJ, Chen LQ, Huang ZH, Zheng WQ, Wei JQ, Lin ZH. Vonoprazan-amoxicillin dual therapy for Helicobacter pylori eradication in Chinese population: A prospective, multicenter, randomized, two-stage study. World J Gastroenterol 2024; 30:3304-3313. [PMID: 39086752 PMCID: PMC11287422 DOI: 10.3748/wjg.v30.i27.3304] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/22/2024] [Revised: 06/12/2024] [Accepted: 06/25/2024] [Indexed: 07/11/2024] Open
Abstract
BACKGROUND The efficacy of Vonoprazan-amoxicillin dual therapy (VAT) in the treatment of Helicobacter pylori (H. pylori) is controversial. AIM To evaluate the efficacy of VAT in the Chinese population. METHODS This prospective, multicenter, randomized, open-label, and two-stage study was conducted at 23 centers in Fujian, China (May 2021-April 2022). H. pylori-infected patients were randomized to bismuth quadruple therapy (BQT), BQT-Vonoprazan (BQT-V), seven-day VAT (VAT-7), ten-day VAT (VAT-10), and fourteen-day VAT (VAT-14) groups. The primary endpoint was the H. pylori eradication rate. The secondary endpoint was the frequency of adverse events. This study was registered with the Chinese Clinical Trial Registry, ChiCTR2100045778. RESULTS In the first stage, VAT-7 and BQT-V groups were selected for early termination because less than 23 among 28 cases were eradicated. In the second stage, the eradication rates for BQT, VAT-10, and VA-14 were 80.2% [95% confidence interval (95%CI): 71.4%-86.8%], 93.2% (86.6%-96.7%), 92.2% (85.3%-96.0%) in the intention-to-treat (ITT) analysis, and 80.9% (95%CI: 71.7%-87.5%), 94.0% (87.5%-97.2%), and 93.9% (87.4%-97.2%) in the per-protocol analysis. The ITT analysis showed a higher eradication rate in the VAT-10 and VAT-14 groups than in the BQT group (P = 0.022 and P = 0.046, respectively). The incidence of adverse events in the VAT-10 and VAT-14 groups was lower than in the BQT group (25.27% and 13.73% vs 37.62%, respectively; P < 0.001). CONCLUSION VAT with a duration of 10 or 14 days achieves a higher eradication rate than the BQT, with a more tolerable safety profile in H. pylori-infected patients in Fujian.
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Affiliation(s)
- Xue-Ping Huang
- Department of Gastroenterology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou 350000, Fujian Province, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou 350001, Fujian Province, China
| | - Yi-Juan Liu
- Department of Gastroenterology, The First Affiliated Hospital of Fujian Medical University, Fuzhou 350000, Fujian Province, China
| | - Shao-Wei Lin
- School of Public Health, Fujian Medical University, Fuzhou 350000, Fujian Province, China
| | - Yan-Feng Shao
- Department of Gastroenterology, The Third People’s Hospital of Fujian Province, Fuzhou 350000, Fujian Province, China
| | - Feng Qiu
- Department of Gastroenterology, Fujian Provincial Hospital North Brance Fujian Provincial Geriatric Hospital, Fuzhou 350000, Fujian Province, China
| | - Qing-Wu Qiu
- Department of Gastroenterology, Xiaoao Hospital, Fuzhou 350000, Fujian Province, China
| | - Zhang-Kun Xu
- Department of Gastroenterology, The General Hospital of Fujian Energy Group, Fuzhou 350000, Fujian Province, China
| | - Jin-Xian Chen
- Department of Gastroenterology, The Second Hospital of Zhangzhou, Zhangzhou 363000, Fujian Province, China
| | - Liang-Huo Chen
- Department of Gastroenterology, Anxi Country Hospital, Quanzhou 362000, Fujian Province, China
| | - Zhen-Qun Lin
- Department of Gastroenterology, Zhangzhou Municipal Hospital of TCM, Zhangzhou 363000, Fujian Province, China
| | - Wen-Hua Dai
- Department of Gastroenterology, Zhangpu Hospital, Zhangzhou 363000, Fujian Province, China
| | - Ming-Qing Zhang
- Department of Gastroenterology, The Affiliated Dongnan Hospital of Xiamen University, Zhangzhou 363000, Fujian Province, China
| | - Qi Jiang
- Department of Gastroenterology, First Hospital of Nanping City, Nanping 353000, Fujian Province, China
| | - Zhong-Qin Xiao
- Department of Gastroenterology, Fujian Nanping Second Hospital, Nanping 353000, Fujian Province, China
| | - Xian-Xing Cheng
- Department of Gastroenterology, Wuyishan Municipal Hospital, Nanping 353000, Fujian Province, China
| | - Xiang-Fei Zhang
- Department of Gastroenterology, Fuzhou Changle District Hospital, Fuzhou 350000, Fujian Province, China
| | - Wen-Bin You
- Department of Gastroenterology, Changle City Second Hospital, Fuzhou 350000, Fujian Province, China
| | - Wei Chen
- Department of Gastroenterology, Changle City Second Hospital, Fuzhou 350000, Fujian Province, China
| | - Long-Qin Li
- Department of Gastroenterology, Jinjiang Municipal Hospital, Quanzhou 362000, Fujian Province, China
| | - Wei-Xing Lin
- Department of Gastroenterology, Fuding Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Ningde 352000, Fujian Province, China
| | - Yong-Fu Wang
- Department of Gastroenterology, Liancheng Hospital, Longyan 364000, Fujian Province, China
| | - Fu-Jin Lai
- Department of Gastroenterology, Xiapu County Hospital, Ningde 352000, Fujian Province, China
| | - Long-Qun Chen
- Department of Gastroenterology, Jinjiang Second Hospital, Quanzhou 362000, Fujian Province, China
| | - Zhong-Hua Huang
- Department of Gastroenterology, The First Hospital of Putian City, Putian 351100, Fujian Province, China
| | - Wen-Qi Zheng
- Department of Gastroenterology, Putian Fude Hospital, Putian 351100, Fujian Province, China
| | - Jin-Qi Wei
- Department of Gastroenterology, The 5th Affiliated Hospital of Sun Yat-sen University, Zhuhai 519000, Guangdong Province, China
| | - Zhi-Hui Lin
- Department of Gastroenterology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou 350000, Fujian Province, China
- Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou 350001, Fujian Province, China
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Qiu S, Huang Y, Chen J, Guo Y, Li M, Ding Z, Liang X, Lu H. Vonoprazan-Amoxicillin Dual Therapy With Different Amoxicillin Administration Regimens for Helicobacter pylori Treatment: A Randomized Controlled Trial. Helicobacter 2024; 29:e13118. [PMID: 39087868 DOI: 10.1111/hel.13118] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/06/2024] [Revised: 05/17/2024] [Accepted: 07/20/2024] [Indexed: 08/02/2024]
Abstract
BACKGROUND The effect of preprandial or postprandial administration of amoxicillin on the efficacy of vonoprazan-amoxicillin dual therapy (VA-dual therapy) for Helicobacter pylori treatment has not been studied. It is also unclear whether amoxicillin dosing four times daily is more effective than three times daily. We aimed to investigate the effect of different amoxicillin administration regimens on the efficacy of VA-dual therapy. MATERIALS AND METHODS H. pylori-infected subjects were randomly assigned to three groups in a 1:1:1 ratio to receive a 14-day dual therapy consisting of vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily before meals (BM-TID) or 1000 mg three times daily after meals (AM-TID) or 750 mg four times daily after meals (AM-QID). H. pylori eradication rates, adverse events rates, compliance, and antibiotic resistance were compared. RESULTS Between May 2021 to April 2023, 327 subjects were enrolled. The eradication rates of BM-TID, AM-TID, and AM-QID dual therapy were 88.1%, 89.9%, and 93.6% in intention-to-treat (ITT) analysis, 90.6%, 94.2%, and 99.0% in modified ITT (MITT) analysis, and 90.4%, 94.1%, and 99.0% in per-protocol (PP) analysis. Although there was non-inferiority between BM-TID and AM-TID, as well as between AM-TID and AM-QID, AM-QID was significantly more effective than BM-TID. There were no significant differences in adverse event rates, compliance, and antibiotic resistance among the three groups. CONCLUSIONS Postprandial administration and the increased frequency of administration of amoxicillin may contribute to a better efficacy of VA-dual therapy, especially for rescue therapy. All VA-dual therapy in our study could achieve good efficacy for first-line treatment. TRIAL REGISTRATION clinicaltrials.gov: NCT05901051.
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Affiliation(s)
- Shuhan Qiu
- NHC Key Laboratory of Digestive Diseases, Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Yu Huang
- NHC Key Laboratory of Digestive Diseases, Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Jinnan Chen
- NHC Key Laboratory of Digestive Diseases, Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Yixian Guo
- NHC Key Laboratory of Digestive Diseases, Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Meixuan Li
- NHC Key Laboratory of Digestive Diseases, Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Zhaohui Ding
- NHC Key Laboratory of Digestive Diseases, Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Xiao Liang
- NHC Key Laboratory of Digestive Diseases, Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Hong Lu
- NHC Key Laboratory of Digestive Diseases, Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
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Liu Z, Sun D, Kou L, Jia L, Hao J, Zhou J, Zheng W, Gao F, Chen X. Vonoprazan-amoxicillin dual therapy with different amoxicillin dosages for treatment-naive patients of Helicobacter pylori infection in China: a prospective, randomized controlled study. Eur J Gastroenterol Hepatol 2024; 36:712-719. [PMID: 38526917 DOI: 10.1097/meg.0000000000002760] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 03/27/2024]
Abstract
BACKGROUND The vonoprazan (VPZ)-amoxicillin (AMO) dual therapy (VA) demonstrates a satisfactory eradication rate for Helicobacter pylori (H. pylori ). However, the optimal dosage of AMO in this regimen remains uncertain. The objective of this study is to investigate the efficacy of different doses of AMO in the VA regimen for first-line treatment of H. pylori infection. METHODS A total of 192 treatment-naive H. pylori -infected patients were randomly assigned to one of three groups: low-dose VA (LD-VA: VPZ 20 mg b.i.d + AMO 750 mg t.i.d), moderate-dose VA (MD-VA:VPZ 20 mg b.i.d + AMO 1000 mg t.i.d), and high-dose VA (HD-VA: VPZ 20 mg b.i.d + AMO 1250 mg t.i.d). All groups received 14 days of treatment. The study evaluated and compared the eradication rates, adverse events (AEs), and patient compliance among the three groups. RESULTS Eradication rates for LD-VA, MD-VA, and HD-VA were 76.6% (49/64), 79.7% (51/64), and 84.4% (54/64), respectively, as determined by intention-to-treat analysis; 90.6% (48/53), 94.3% (50/53), and 98.1% (53/54) according to per-protocol analysis; 89.1% (49/55), 94.4% (51/54), and 96.4% (54/56) with modified intention-to-treat analysis (all P > 0.05). Although not statistically significant, numerically higher eradication rates were observed with the higher dose AMO VA regimen. There were no statistically significant differences in the incidence of AEs and compliance among the three VA regimens. CONCLUSION Fourteen-day VA regimens with AMO doses exceeding 2 g/day demonstrated satisfactory eradication rates. HD-VA therapy is potentially the most effective regimen. Large-sample clinical trials are required to further validate these findings.
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Affiliation(s)
- Zhu Liu
- Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin Institute of Digestive Disease, Tianjin Key Laboratory of Digestive Diseases, Tianjin
- Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan
| | - Dongjie Sun
- Department of Digestive Diseases, The Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China
| | - Luan Kou
- Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan
| | - Li Jia
- Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan
| | - Jiaorong Hao
- Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan
| | - Jihai Zhou
- Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan
| | - Wenwen Zheng
- Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan
| | - Fengyu Gao
- Department of Gastroenterology, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Jinan
| | - Xin Chen
- Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin Institute of Digestive Disease, Tianjin Key Laboratory of Digestive Diseases, Tianjin
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Valizadeh Toosi SM, Feyzi S, Kazemi A. Comparison of the Efficacy of 12-day Concomitant Quadruple Therapy versus 14-day High dose Dual Therapy as a First-line H. pylori Eradication Regimen. THE KOREAN JOURNAL OF GASTROENTEROLOGY = TAEHAN SOHWAGI HAKHOE CHI 2024; 83:150-156. [PMID: 38659251 DOI: 10.4166/kjg.2024.012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/29/2024] [Revised: 04/01/2024] [Accepted: 04/12/2024] [Indexed: 04/26/2024]
Abstract
Background/Aims Helicobacter pylori (H. pylori) is the most prevalent infection in the world and is strongly associated with gastric adenocarcinoma, lymphoma and gastric or duodenal ulcers. Different regimens have been used for H. pylori eradication. We aimed to compare the efficacy of two different regimens as first-line H. pylori eradication regimens, in an area with high antibiotic resistance. Methods In this RCT, we assigned 223 patients with H. pylori infection, who were naïve to treatment. They were randomly divided into two groups to receive either 12-day concomitant quadruple therapy (consisting of pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg every 12 hours) or 14-day high dose dual therapy (consisting of esomeprazole 40 mg and amoxicillin 1 g TDS). H. pylori eradication was assessed eight weeks after the end of treatment. Results H. pylori eradication rate by PP analysis for 12-day concomitant quadruple therapy and 14-day high dose dual therapy were 90.4% and 79.1%, respectively (p=0.02). According to ITT analysis, the eradication rates were 86.2% and 76.3%, respectively (p=0.06). Adverse drug reactions were 12.3% in high dose dual therapy and 36.8% in concomitant quadruple therapy (p<0.001). Conclusions Twelve-day concomitant therapy seems to be an acceptable regimen for first-line H. pylori eradication in Iran, a country with a high rate of antibiotic resistance. Although, high dose dual therapy did not result in an ideal eradication rate, but it had fewer drug side effects than the 12-day concomitant regimen.
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Affiliation(s)
- Seyed Mohammad Valizadeh Toosi
- Gut and Liver Research Center, Non-communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran
| | - Sahar Feyzi
- Medicine faculty, Mazandaran University of Medical Sciences, Sari, Iran
| | - Arash Kazemi
- Gut and Liver Research Center, Non-communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran
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Yan TL, Wang JH, He XJ, Zhu YB, Lu LJ, Wang YJ, Wang ZW, Gao JG, Xu CF, Ma H, Luan SM, Li L, Chen Y. Ten-Day Vonoprazan-Amoxicillin Dual Therapy vs Standard 14-Day Bismuth-Based Quadruple Therapy for First-Line Helicobacter pylori Eradication: A Multicenter Randomized Clinical Trial. Am J Gastroenterol 2024; 119:655-661. [PMID: 37975609 PMCID: PMC10984633 DOI: 10.14309/ajg.0000000000002592] [Citation(s) in RCA: 7] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/23/2023] [Accepted: 10/02/2023] [Indexed: 11/19/2023]
Abstract
INTRODUCTION Whether 10-day short-course vonoprazan-amoxicillin dual therapy (VA-dual) is noninferior to the standard 14-day bismuth-based quadruple therapy (B-quadruple) against Helicobacter pylori eradication has not been determined. This trial aimed to compare the eradication rate, adverse events, and compliance of 10-day VA-dual regimen with standard 14-day B-quadruple regimen as first-line H. pylori treatment. METHODS This prospective randomized clinical trial was performed at 3 institutions in eastern China. A total of 314 treatment-naive, H. pylori -infected patients were randomly assigned in a 1:1 ratio to either 10-day VA-dual group or 14-day B-quadruple group. Eradication success was determined by 13 C-urea breath test at least 4 weeks after treatment. Eradication rates, adverse events, and compliance were compared between groups. RESULTS Eradication rates of VA-dual and B-quadruple groups were 86.0% and 89.2% ( P = 0.389), respectively, by intention-to-treat (ITT) analysis; 88.2% and 91.5% ( P = 0.338), respectively, by modified ITT analysis; and 90.8% and 91.3% ( P = 0.884), respectively, by per-protocol (PP) analysis. The efficacy of the VA-dual remained noninferior to B-quadruple therapy in all ITT, modified ITT, and PP analyses. The incidence of adverse events in the VA-dual group was significantly lower compared with that in the B-quadruple group ( P < 0.001). Poor compliance contributed to eradication failure in the VA-dual group ( P < 0.001), while not in the B-quadruple group ( P = 0.110). DISCUSSION The 10-day VA-dual therapy provided satisfactory eradication rates of >90% (PP analysis) and lower rates of adverse events compared with standard 14-day B-quadruple therapy as first-line H. pylori therapy. TRAIL REGISTRATION NUMBER ChiCTR2300070100.
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Affiliation(s)
- Tian-Lian Yan
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China;
| | - Jing-Hua Wang
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China;
| | - Xin-Jue He
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China;
| | - Ya-Bi Zhu
- Department of Gastroenterology, Lishui People's Hospital, Lishui, China;
| | - Lin-Jie Lu
- Department of Gastroenterology, Haining People's Hospital, Haining, China.
| | - Yan-Jiao Wang
- Department of Gastroenterology, Lishui People's Hospital, Lishui, China;
| | - Zi-Wei Wang
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China;
| | - Jian-Guo Gao
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China;
| | - Cheng-Fu Xu
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China;
| | - Han Ma
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China;
| | - Shuang-Mei Luan
- Department of Gastroenterology, Lishui People's Hospital, Lishui, China;
| | - Lan Li
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China;
| | - Yi Chen
- Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China;
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Wang H, Kong QZ, Li YY, Yang XY, Zuo XL. High-dose dual therapy versus bismuth-containing quadruple therapy for the eradication of Helicobacter pylori: A systematic review and meta-analysis. J Dig Dis 2024; 25:163-175. [PMID: 38577962 DOI: 10.1111/1751-2980.13263] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/23/2023] [Revised: 02/01/2024] [Accepted: 03/06/2024] [Indexed: 04/06/2024]
Abstract
OBJECTIVE To update evidence-based data comparing the efficacy and safety of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) in eradicating Helicobacter pylori infection through meta-analysis. METHODS Multiple databases were systematically searched for randomized controlled trials (RCTs) published up to May 18, 2023. Dichotomous data were evaluated using risk ratio (RR) and 95% confidence interval (CI). Subgroup analysis, sensitivity analysis, risk of bias assessment, and quality of evidence evaluation were performed. RESULTS Twenty RCTs containing 7891 subjects were included in the analysis. There was no statistically significant difference in H. pylori eradication rate between HDDT and BQT in the intention-to-treat (ITT) analysis (86.31% vs 84.88%; RR 1.02, 95% CI 1.00-1.04, P = 0.12). In the per-protocol (PP) analysis, the eradication rates for HDDT and BQT were 90.27% and 89.94%, respectively (RR 1.01, 95% CI 0.99-1.03, P = 0.44). Adverse events were significantly lower with HDDT than with BQT (RR 0.44, 95% CI 0.38-0.51, P < 0.00001). Patient adherence was significantly different between the two groups (RR 1.01, 95% CI 1.00-1.03, P = 0.02). Subgroup analysis based on antibiotic combinations within the BQT group showed a significantly higher eradication rate for HDDT than for BQT only when BQT used amoxicillin combined with clarithromycin (P = 0.0009). CONCLUSIONS HDDT showed comparable efficacy with BQT for H. pylori eradication, with fewer adverse effects and higher compliance. Due to regional differences, antibiotic resistance rates, and combined BQT antibiotics, more studies are needed for further validation and optimization of HDDT.
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Affiliation(s)
- Hui Wang
- Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China
| | - Qing Zhou Kong
- Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China
| | - Yue Yue Li
- Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China
- Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
| | - Xiao Yun Yang
- Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China
- Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
| | - Xiu Li Zuo
- Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China
- Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
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Tirgar Fakheri S, Shokri-Afra H, Graham DY, Bari Z, Fakheri H. A pilot study evaluating high dose esomeprazole, bismuth subcitrate and amoxicillin for eradicating Helicobacter pylori infection in Iran. Helicobacter 2024; 29:e13061. [PMID: 38411303 DOI: 10.1111/hel.13061] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/20/2023] [Revised: 02/04/2024] [Accepted: 02/14/2024] [Indexed: 02/28/2024]
Abstract
BACKGROUND Helicobacter pylori (H. pylori) is strongly associated with peptic ulcer disease and gastric cancer. We evaluated two triple therapy regimens comprising esomeprazole, high dose bismuth, and different doses of amoxicillin for first-line H. pylori eradication. MATERIALS AND METHODS Two hundred patients with dyspepsia and naive H. pylori infection were randomly assigned into two groups (n = 100). Both groups were treated for 14 days similarly with esomeprazole (40 mg, twice daily) and bismuth subcitrate (240 mg, three times daily), but the dose of amoxicillin was varied between Groups A (750 mg) and B (1000 mg) three times daily. Treatment compliance and side effect were evaluated following the therapies and after 8 weeks, a negative test of stool H. pylori antigen confirmed eradication. RESULTS The two groups were comparable with respect to sex and age. According to intention to treat analysis, eradication rates were 80% (95% CI: 77.2%-82.8%) and 90% (95% CI: 84.1%-95.9%) in A and B groups, respectively (p = 0.22). Per-protocol eradication rates were 87% (95% CI: 80.4%-93.6%) and 92.8% (95% CI: 87.7%-97.9%), respectively (p = 0.23). Severe adverse effects were 3% and 2%, respectively (p = 0.34). CONCLUSION High dose esomeprazole, amoxicillin and bismuth achieved 92.8% cure rates per protocol in a country with a high background rate of resistance. Additional studies are needed to ascertain whether this therapy can be further improved. Until then, it can be recommended as a first-line H. pylori eradication in north of Iran.
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Affiliation(s)
- Sepehr Tirgar Fakheri
- Gut and Liver Research Center, Non-communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran
| | - Hajar Shokri-Afra
- Gut and Liver Research Center, Non-communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran
| | - David Y Graham
- Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA
| | - Zohreh Bari
- Gut and Liver Research Center, Non-communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran
| | - Hafez Fakheri
- Gut and Liver Research Center, Non-communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran
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Cheng J, Fan C, Huang K, Zhai L, Wang H, Xie D, Cai Y, Li Z, Bai Q, Wang P, Ding H. Efficacy and safety of high-dose ilaprazole-amoxicillin dual therapy for Helicobacter pylori eradication: a prospective, single-center, randomized trial. Front Pharmacol 2023; 14:1272744. [PMID: 38026958 PMCID: PMC10661892 DOI: 10.3389/fphar.2023.1272744] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/04/2023] [Accepted: 10/27/2023] [Indexed: 12/01/2023] Open
Abstract
Background: Until now, there have been no randomized controlled trials directly evaluating the efficacy of high-dose ilaprazole-amoxicillin dual therapy (HT) in comparison to other standard treatments for H. pylori (Helicobacter pylori) infection. This study aimed to compare the effectiveness and safety of HT with bismuth quadruple therapy (BQT) as an initial treatment for H. pylori. Methods: This single-center, prospective, randomized clinical controlled trial recruited 225 consecutive patients. They were assigned to either HT group (ilaprazole, 10 mg, twice daily; amoxicillin 1,000 mg, three times daily) or BQT group (compound bismuth aluminate granules, 2.6 g, three times daily; ilaprazole, 5 mg, twice daily; amoxicillin, 1,000 mg, twice daily; clarithromycin, 500 mg, twice daily) for 14 days. The 13C-urea breath test assessed eradication success 4 weeks after treatment. The primary outcome focused on the eradication rate, with secondary outcomes including safety and compliance. Results: From February 2023 to March 2023, 228 subjects were screened, and 225 were randomized. The HT and BQT groups showed eradication rates of 76.3% and 61.3% (p = 0.015) both by intention-to-treat (ITT) analysis and per-protocol (PP) analysis. HT was associated with fewer adverse events than BQT (27.2% vs. 81.8%, p = 0.002). The most commonly reported adverse events was bitter taste of mouth (3.5% vs. 60.4%, p < 0.001). There was no significant difference in compliance between the two groups (89.5% vs. 92.8%, p = 0.264). Conclusion: The 14-day HT treatment demonstrates better efficacy in H. pylori eradication treatment and improved safety and compliance compared to BQT. The results provide supporting evidence for 14-day HT can be potentially considered as a first-line regimen for empirical treatment. Clinical Trial Registration: https://www.chictr.org.cn/showproj.html?proj=186562, identifier ChiCTR2200066284.
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Affiliation(s)
- Jianping Cheng
- Department of Gastroenterology and Oncology, Civil Aviation General Hospital, Beijing, China
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Su NY, Shi Q, Mei H, Hu J, Liu YX, Liu HN, Liu HQ, Guo Y, Wang XW, Lan CH. Efficacy and safety of vonoprazan-based dual therapy and esomeprazole-based dual therapy in eradicating primary Helicobacter pylori infection: A propensity score matching analysis. Helicobacter 2023; 28:e13003. [PMID: 37565458 DOI: 10.1111/hel.13003] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/16/2023] [Revised: 05/25/2023] [Accepted: 06/14/2023] [Indexed: 08/12/2023]
Abstract
BACKGROUND According to the Maastricht VI/Florence consensus report, potassium-competitive acid blockers (P-CAB) may improve Helicobacter pylori eradication treatment. MATERIALS AND METHODS A total of 213 H. pylori treatment-naive patients aged between 18 and 70 years were treated with two regimens. The two regimens are VDT: 20 mg vonoprazan twice a day and 1 g amoxicillin three times daily and EDT: 20 mg esomeprazole four times a day and 750 mg amoxicillin four times daily. 13 C-urea breath tests were used to evaluate eradication rate 4-6 weeks after treatment. Based on propensity score matching (PSM), this retrospective study analyzed the eradication rates, adverse events (AEs), compliance, and antibiotic resistance rates in VDT and EDT groups. RESULTS On intention-to-treat (ITT) analysis, the eradication rate in VDT group (89.0%; 95% CI 81.7-96.3) was non-inferior to that in EDT group (87.7%; 95% CI 80.1-95.3; p = 0.796). The corresponding per-protocol (PP) eradication rates were 94.1% (95% CI 88.4-99.8) and 92.8% (95% CI 86.7-98.9; p = 1.000), respectively. There were no significant between-group differences with respect to compliance or incidence of AEs. CONCLUSIONS The efficacy and safety of 14-day VDT and EDT were comparable. Therefore, 14-day VDT or EDT may be recommended for the first-line treatment of H. pylori infection.
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Affiliation(s)
- Na-Yun Su
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University, Third Military Medical University, Chongqing, China
| | - Qing Shi
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University, Third Military Medical University, Chongqing, China
| | - Hao Mei
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University, Third Military Medical University, Chongqing, China
| | - Jie Hu
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University, Third Military Medical University, Chongqing, China
| | - Yu-Xiang Liu
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University, Third Military Medical University, Chongqing, China
| | - Han-Ning Liu
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University, Third Military Medical University, Chongqing, China
| | - Heng-Qi Liu
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University, Third Military Medical University, Chongqing, China
| | - Yan Guo
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University, Third Military Medical University, Chongqing, China
| | - Xing-Wei Wang
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University, Third Military Medical University, Chongqing, China
| | - Chun-Hui Lan
- Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University, Third Military Medical University, Chongqing, China
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15
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Chen S, Shen W, Liu Y, Dong Q, Shi Y. Efficacy and safety of triple therapy containing berberine, amoxicillin, and vonoprazan for Helicobacter pylori initial treatment: A randomized controlled trial. Chin Med J (Engl) 2023; 136:1690-1698. [PMID: 37469024 DOI: 10.1097/cm9.0000000000002696] [Citation(s) in RCA: 12] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/18/2022] [Indexed: 07/21/2023] Open
Abstract
BACKGROUND With the development of traditional Chinese medicine research, berberine has shown good efficacy and safety in the eradication of Helicobacter pylori (H. pylori). The present study aimed to evaluate the efficacy and safety of triple therapy containing berberine, amoxicillin, and vonoprazan for the initial treatment of H. pylori. METHODS This study was a single-center, open-label, parallel, randomized controlled clinical trial. Patients with H. pylori infection were randomly (1:1:1) assigned to receive berberine triple therapy (berberine 500 mg, amoxicillin 1000 mg, vonoprazan 20 mg, A group), vonoprazan quadruple therapy (vonoprazan 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, colloidal bismuth tartrate 220 mg, B group), or rabeprazole quadruple therapy (rabeprazole 10 mg, amoxicillin 1000 mg, clarithromycin 500 mg, colloidal bismuth tartrate 220 mg, C group). The drugs were taken twice daily for 14 days. The main outcome was the H. pylori eradication rate. The secondary outcomes were symptom improvement rate, patient compliance, and incidence of adverse events. Furthermore, factors affecting the eradication rate of H. pylori were further analyzed. RESULTS A total of 300 H. pylori-infected patients were included in this study, and 263 patients completed the study. An intention-to-treat (ITT) analysis showed that the eradication rates of H. pylori in berberine triple therapy, vonoprazan quadruple therapy, and rabeprazole quadruple therapy were 70.0% (70/100), 77.0% (77/100), and 69.0% (69/100), respectively. The per-protocol (PP) analysis showed that the eradication rates of H. pylori in these three groups were 81.4% (70/86), 86.5% (77/89), and 78.4% (69/88), respectively. Both ITT analysis and PP analysis showed that the H. pylori eradication rate did not significantly differ among the three groups (P >0.05). In addition, the symptom improvement rate, overall adverse reaction rate, and patient compliance were similar among the three groups (P >0.05). CONCLUSIONS The efficacy of berberine triple therapy for H. pylori initial treatment was comparable to that of vonoprazan quadruple therapy and rabeprazole quadruple therapy, and it was well tolerated. It could be used as one choice of H. pylori initial treatment.
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Affiliation(s)
- Shasha Chen
- Postgraduate Department, Xi'an Medical University, Xi'an, Shaanxi 710021, China
| | - Weina Shen
- Postgraduate Department, Xi'an Medical University, Xi'an, Shaanxi 710021, China
| | - Yuhuan Liu
- Postgraduate Department, Xi'an Medical University, Xi'an, Shaanxi 710021, China
| | - Qiang Dong
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Medical University, Xi'an, Shaanxi 710032, China
| | - Yongquan Shi
- Postgraduate Department, Xi'an Medical University, Xi'an, Shaanxi 710021, China
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Medical University, Xi'an, Shaanxi 710032, China
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Wang Y, Li Y, Gong Y, Dong Y, Sun J, Chen M. Antibiotic resistance characteristics and risk factors analysis of Helicobacter pylori strains isolated from patients in Liaoning Province, an area in North China. PeerJ 2023; 11:e15268. [PMID: 37214095 PMCID: PMC10198150 DOI: 10.7717/peerj.15268] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2022] [Accepted: 03/29/2023] [Indexed: 05/24/2023] Open
Abstract
Background The prevalence of Helicobacter pylori (H. pylori) keeps rising while the eradication rate continues to decline due to the increasing antibiotic resistance. Regional variations of antimicrobial resistance to H. pylori have been recommended by guidelines in recent years. This study aims to investigate the antibiotic resistance rate of H. pylori and its association with infected subjects' characteristics in Liaoning Province, an area in north China. Methods Gastric tissues from 178 H. pylori positive participants without previous antibiotic use within four weeks were collected for H. pylori culture. Antibiotic susceptibility to furazolidone (AOZ), tetracycline (TC), levofloxacin (LFX), metronidazole (MET), clarithromycin (CLA), and amoxicillin (AMX) were examined with the agar dilution method. Associations between H. pylori resistance and patient characteristics were further analysed. Results No resistance was observed in AOZ or TC. For LFX, MET, CLA, and AMX, the overall resistance rates were 41.10%, 79.14%, 71.78%, and 22.09% respectively. There were significant differences between resistance to CLA and MALToma (P = 0.021), and between resistance to MET and age (P < 0.001). Conclusions The primary resistant rates of LEX, MET, CLA, and AMX were relatively high in Liaoning. Treatment effectiveness improvement could be achieved by prior antimicrobial susceptibility tests before antibiotic prescription.
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Affiliation(s)
- Yanmeng Wang
- Gastroenterology, The First Hospital of China Medical University, Shenyang, Liaoning, China
| | - Yiling Li
- Gastroenterology, The First Hospital of China Medical University, Shenyang, Liaoning, China
| | - Yuehua Gong
- Key Laboratory of GI Cancer Etiology and Prevention, The First Hospital of China Medical University, Shenyang, Liaoning, China
| | - Yuzhen Dong
- Gastroenterology, The First Hospital of China Medical University, Shenyang, Liaoning, China
| | - Jing Sun
- Gastroenterology, The First Hospital of China Medical University, Shenyang, Liaoning, China
| | - Moye Chen
- Gastroenterology, The First Hospital of China Medical University, Shenyang, Liaoning, China
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Liu DN, Wang QY, Li PY, Wu DH, Pan J, Chen ZY, Li YQ, Han XY, Lan C, Tang J, Tan Y, Mo CY, Yang WZ, Han JL, Huang XX. Comparing high-dose dual therapy with bismuth-containing quadruple therapy for the initial eradication of Helicobacter pylori infection on Hainan Island: a randomized, multicenter clinical trial. Clin Res Hepatol Gastroenterol 2023; 47:102125. [PMID: 37062356 DOI: 10.1016/j.clinre.2023.102125] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/27/2023] [Revised: 04/06/2023] [Accepted: 04/14/2023] [Indexed: 04/18/2023]
Abstract
BACKGROUND Traditional bismuth-containing quadruple therapy, as a first-line eradication treatment for Helicobacter pylori (H. pylori), has several disadvantages, including drug side effects, low medication adherence, and high costs. Trials of high-dose dual treatment have demonstrated its advantages, which include good safety and adherence profiles. In this study, we investigated the efficacy, safety, and compliance of a high-dose dual therapy when compared with bismuth-based quadruple treatment for the initial eradication of H. pylori infection on Hainan Island, China. METHODS We randomized 846 H. pylori-infected patients into two groups. A bismuth-containing quadruple therapy group was administered the following: esomeprazole 20 mg, amoxicillin 1000 mg, and clarithromycin 500 mg twice daily, and colloidal bismuth pectin in suspension 150 mg three times/day for 2 weeks. A high-dose dual therapy group was administered the following: esomeprazole 20 mg four times/day and amoxicillin 1000 mg three times/day for 2 weeks. Patients were given a 13C urea breath test at 4 weeks at treatment end. Adverse effects and compliance were evaluated at follow-up visits. RESULTS Eradication rates in the high-dose dual therapy group were: 90.3% (381/422, 95% confidence interval [CI]: 87.1%-92.9%) in intention-to-treat (ITT) and 93.6% (381/407, 95% CI: 90.8%-95.8%) in per-protocol (PP) analyses. Eradication rates were 87.3% in ITT (370/424, 95% CI: 83.7%-90.3%) and 91.8% in PP analyses (370/403, 95% CI: 88.7%-94.3%) for quadruple therapy, with no statistical differences (P = 0.164 in ITT and P = 0.324 in PP analyses). Adverse effects were 13.5% (55/407) in the dual group and 17.4% (70/403) in the quadruple group (P = 0.129). Compliance was 92.4% (376/407) in the dual group and 86.6% (349/403) in the quadruple group (P = 0.007). CONCLUSIONS High-dose dual therapy had high eradication rates comparable with bismuth-based quadruple treatment, with no differences in adverse effects, however higher adherence rates were recorded.
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Affiliation(s)
- Dan-Ni Liu
- Department of Gastroenterology, Central South University Xiangya School of Medicine Affiliated Haikou Hospital, Haikou, China
| | - Qiu-Yan Wang
- Department of Gastroenterology, Tongji Wenchang Hospital of Huazhong University of Science and Technology, Wenchang, China
| | - Pei-Yuan Li
- Department of Gastroenterology, Tongji Wenchang Hospital of Huazhong University of Science and Technology, Wenchang, China
| | - Dong-Han Wu
- Department of Gastroenterology, Sanya Municipal People's Hospital, Sanya, China
| | - Jing Pan
- Department of Gastroenterology, Central South University Xiangya School of Medicine Affiliated Haikou Hospital, Haikou, China
| | - Zheng-Yi Chen
- Department of Gastroenterology, Central South University Xiangya School of Medicine Affiliated Haikou Hospital, Haikou, China
| | - Yan-Qiang Li
- Department of Gastroenterology, Wanning Municipal People's Hospital, Wanning, China
| | - Xiang-Yang Han
- Department of Gastroenterology, Hainan Provincial People's Hospital, Haikou, China
| | - Cheng Lan
- Department of Gastroenterology, Hainan Provincial People's Hospital, Haikou, China
| | - Jing Tang
- Department of Gastroenterology, The First Affiliated Hospital of Hainan Medical College, Haikou, China
| | - Yan Tan
- Department of Gastroenterology, The First Affiliated Hospital of Hainan Medical College, Haikou, China
| | - Cui-Yi Mo
- Department of Gastroenterology, Qionghai Municipal People's Hospital, Qionghai, China
| | - Wei-Zhong Yang
- Department of Gastroenterology, The Second Affiliated Hospital of Hainan Medical College, Haikou, China
| | - Jun-Ling Han
- Department of Gastroenterology, 928th Hospital of Joint service support force of the Chinese People's Liberation Army, Haikou, China
| | - Xiao-Xi Huang
- Department of Gastroenterology, Central South University Xiangya School of Medicine Affiliated Haikou Hospital, Haikou, China.
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Guan JL, Han YY, Wang MR, Xia SH, Li JY, Zhang MY, Zhao K, Feng LN, Zhang Y, Dong RN, Liao JZ, Li PY. Impact of body size on efficacy of high-dose dual therapy for Helicobacter pylori eradication. Helicobacter 2023; 28:e12953. [PMID: 36738099 DOI: 10.1111/hel.12953] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/12/2022] [Revised: 01/11/2023] [Accepted: 01/15/2023] [Indexed: 02/05/2023]
Abstract
BACKGROUND High-dose dual therapy (HDDT) is an emerging and promising therapeutic regime for Helicobacter pylori (H. pylori) eradication. However, the pharmacokinetics of the components of HDDT, amoxicillin and proton pump inhibitor, are likely to be affected by body size. In this study, we aimed to find out the impact of body size on the efficacy of HDDT. METHODS We collected the medical data of 385 treatment-naive patients infected with H. pylori who received HDDT (esomeprazole 20 mg and amoxicillin 750 mg four times daily) for 14 days from July 2020 to December 2021. The associations among the eradication efficacy, adverse events, and variables (sex, age, height, body weight, body mass index (BMI), body surface area (BSA), smoking, drinking, etc.) were analyzed respectively in our study. Among these factors, continuous variables were classified into categorical variables using the cut-off values which were calculated by receiver operating characteristic analysis. RESULTS The eradication rate of HDDT was 89.9%. There were 55 (14.3%) patients who occurred adverse events during the treatment. Patients with height <170.5 cm, body weight <60.5 kg, BMI <20.55 kg/m2 , BSA <1.69 m2 had a higher eradication rate (92.1% vs. 84.0%, 93.1% vs. 86.8%, 96.0% vs. 87.8%, 93.4% vs. 84.8%, all p < .05). The multivariate analysis showed that BSA ≥1.69 m2 (OR 2.53, 95% CI: 1.28-4.99, p = .007) was the only independent predictor of eradication failure. CONCLUSION HDDT could achieve better eradication efficacy in patients with small BSA. Clinicians should be aware of the impact of BSA on the H. pylori eradication rate and pay more attention to patients with large BSA.
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Affiliation(s)
- Jia-Lun Guan
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ying-Ying Han
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Mu-Ru Wang
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Su-Hong Xia
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ji-Yan Li
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ming-Yu Zhang
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Kai Zhao
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Li-Na Feng
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Yu Zhang
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ruo-Nan Dong
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Jia-Zhi Liao
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Pei-Yuan Li
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.,Department of Gastroenterology, Wenchang People's Hospital, Wenchang, China
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Yang Q, He C, Hu Y, Hong J, Zhu Z, Xie Y, Shu X, Lu N, Zhu Y. 14-day pantoprazole- and amoxicillin-containing high-dose dual therapy for Helicobacter pylori eradication in elderly patients: A prospective, randomized controlled trial. Front Pharmacol 2023; 14:1096103. [PMID: 36817141 PMCID: PMC9931190 DOI: 10.3389/fphar.2023.1096103] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/11/2022] [Accepted: 01/23/2023] [Indexed: 02/04/2023] Open
Abstract
Background: Currently, the management of Helicobacter pylori (H. pylori) infection in elderly patients is controversial. We investigated whether high-dose dual therapy would serve as the first-line therapy in elderly patients. Methods: This was a single-center, randomized study of 150 elderly patients with H. pylori infection who were randomly assigned to 14-day therapy with pantoprazole 40 mg 3 times daily and either amoxicillin 1,000 mg 3 times daily or amoxicillin 1,000 mg twice daily, clarithromycin 500 mg twice daily and bismuth 220 mg twice daily. H. pylori eradication was evaluated by a 13C-urea breath test 4 weeks after the completion of treatment. Results: Successful eradication was achieved in 89.3% of the high-dose dual therapy (HT) group in the intention-to-treat (ITT) analysis, 91.7% in the modified intention-to-treat (mITT) analysis, and 93.0% for per-protocol (PP) analysis which was similar to the bismuth-containing quadruple therapy (BQT) group (86.6%, 87.8%, and 90.3%, respectively). There were no significant difference between the HT group and the BQT group in the ITT analysis (p = 0.484), mITT analysis (p = 0.458), or PP analysis (p = 0.403). HT was associated with fewer side effects (10.6% of patients) than BQT (26.6%) (p = 0.026). Conclusion: In this trial, we found that 14-day HT had a similar eradication rate to BQT but fewer side effects, which may be better for elderly patients.
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Affiliation(s)
| | | | | | | | | | | | | | - Nonghua Lu
- Department of Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital of Nanchang University, Nanchang, China
| | - Yin Zhu
- Department of Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital of Nanchang University, Nanchang, China
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Yun JW, Wang C, Yu Y, Xu HM, Gou LZ, Li XL, Yi GR, Lin YM, Han TY, Zhang DK. High-dose amoxicillin-proton pump inhibitor dual therapy as first-line treatment for Helicobacter pylori infection in Northwest China: A prospective, randomised controlled trial. Br J Clin Pharmacol 2023; 89:232-241. [PMID: 35947524 DOI: 10.1111/bcp.15488] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/07/2022] [Revised: 07/20/2022] [Accepted: 08/04/2022] [Indexed: 11/30/2022] Open
Abstract
AIMS We aimed to assess the eradication efficacy and factors that influencing it of high-dose dual therapy (HDDT) in Gansu region, Northwest China. METHODS A total of 216 treatment-naive patients with Helicobacter pylori infection were randomly assigned to two groups for the 14-day eradication treatment: the HDDT group (amoxicillin 750 mg q.i.d. and esomeprazole 40 mg t.i.d.) and the amoxicillin and clarithromycin-containing bismuth quadruple therapy group (ACBQT: esomeprazole 20 mg, bismuth potassium citrate 2 g, amoxicillin 1 g, and clarithromycin 500 mg; b.i.d.). The eradication rates, adverse effects and patient compliance of these two groups were compared. Eradication efficacy was determined by 13 C urea breath test (13 C UBT) 4-8 weeks after finishing treatment. Antibiotic resistance was determined by the Epsilometer testing (E-test) method. RESULTS The eradication rates for the HDDT and ACBQT groups were 71.0% and 74.7% (P = .552) by per-protocol analysis, and 65.7% and 68.5% (P = .664) by intention-to-treat analysis. The overall adverse event rates in the HDDT and ACBQT groups were 2.0% and 43.4% (P < .001), respectively. The resistance rates to amoxicillin, clarithromycin, tetracycline, levofloxacin and metronidazole were 15.2%, 42.0%, 5.4%, 35.7% and 83.0%, respectively. Amoxicillin resistance and delta over baseline (DOB) of 13 C UBT ≥ 20 before treatment significantly reduced the eradication rate in 112 participants with H. pylori cultured. CONCLUSION The HDDT as first-line treatment for H. pylori was unsatisfactory in Gansu. Amoxicillin resistance and DOB of 13 C UBT ≥ 20 before treatment were significantly correlated with H. pylori eradication failure.
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Affiliation(s)
- Jian-Wei Yun
- Department of Gastroenterology, The Second Hospital of Lanzhou University, Lanzhou, China.,Key Laboratory of digestive diseases, The Second Hospital of Lanzhou University, Lanzhou, China
| | - Cui Wang
- Quality Control Department, Gansu Provincial People's Hospital, Lanzhou, China
| | - Yi Yu
- Department of Gastroenterology, The Second Hospital of Lanzhou University, Lanzhou, China
| | - Hui-Mei Xu
- Department of Gastroenterology, The Second Hospital of Lanzhou University, Lanzhou, China.,Key Laboratory of digestive diseases, The Second Hospital of Lanzhou University, Lanzhou, China
| | - Ling-Zhu Gou
- Department of Gastroenterology, The Second Hospital of Lanzhou University, Lanzhou, China.,Key Laboratory of digestive diseases, The Second Hospital of Lanzhou University, Lanzhou, China
| | - Xiao-Li Li
- Department of Gastroenterology, The Second Hospital of Lanzhou University, Lanzhou, China.,Key Laboratory of digestive diseases, The Second Hospital of Lanzhou University, Lanzhou, China
| | - Gui-Rong Yi
- Department of Gastroenterology, The Second Hospital of Lanzhou University, Lanzhou, China
| | - Yi-Ming Lin
- Department of Gastroenterology, The Second Hospital of Lanzhou University, Lanzhou, China
| | - Ti-Yun Han
- Key Laboratory of digestive diseases, The Second Hospital of Lanzhou University, Lanzhou, China
| | - De-Kui Zhang
- Department of Gastroenterology, The Second Hospital of Lanzhou University, Lanzhou, China.,Key Laboratory of digestive diseases, The Second Hospital of Lanzhou University, Lanzhou, China
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21
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Ten-Day Vonoprazan-Amoxicillin Dual Therapy as a First-Line Treatment of Helicobacter pylori Infection Compared With Bismuth-Containing Quadruple Therapy. Am J Gastroenterol 2022; 118:627-634. [PMID: 36729890 DOI: 10.14309/ajg.0000000000002086] [Citation(s) in RCA: 40] [Impact Index Per Article: 13.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/23/2022] [Accepted: 11/02/2022] [Indexed: 02/03/2023]
Abstract
INTRODUCTION No study has investigated the efficacy and safety of vonoprazan-amoxicillin dual therapy compared with bismuth quadruple therapy (B-quadruple). This study aimed to evaluate the efficacy and safety of 10-day vonoprazan-amoxicillin dual therapy as a first-line treatment of Helicobacter pylori infection compared with B-quadruple and to explore the optimal dosage of amoxicillin in the dual therapy. METHODS A total of 375 treatment-naive, H. pylori-infected subjects were randomly assigned in a 1:1:1 ratio into 3 regimen groups including VHA-dual (vonoprazan 20 mg twice/day + amoxicillin 750 mg 4 times/day), VA-dual (vonoprazan 20 mg + amoxicillin 1,000 mg twice/day), and B-quadruple (esomeprazole 20 mg + bismuth 200 mg + amoxicillin 1,000 mg + clarithromycin 500 mg twice/day). Eradication rates, adverse events (AEs), and compliance were compared between 3 groups. RESULTS The eradication rates of B-quadruple, VHA-dual, and VA-dual were 90.9%, 93.4%, and 85.1%, respectively, by per-protocol analysis; 89.4%, 92.7%, and 84.4%, respectively, by modified intention-to-treat analysis; 88.0%, 91.2%, and 82.4%, respectively, by intention-to-treat analysis. The efficacy of the VHA-dual group was not inferior to the B-quadruple group (P < 0.001), but VA-dual did not reach a noninferiority margin of -10%. The AEs rates of the B-quadruple group were significantly higher than those of the VHA-dual (P = 0.012) and VA-dual (P = 0.001) groups. There was no significant difference in medication compliance among 3 treatment groups (P = 0.995). CONCLUSIONS The 10-day VHA-dual therapy provided satisfactory eradication rates of >90%, lower AEs rates, and similar adherence compared with B-quadruple therapy as a first-line therapy for H. pylori infection. However, the efficacy of VA-dual therapy was not acceptable.
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22
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Shen C, Li C, Lv M, Dai X, Gao C, Li L, Zhang Q, Pan W, Liu C, Han S, Zhang Y, Ding S, Deng H, Yao Y, Xu J, Wei M, Shi H, Yuan P, Yang X, Jian Y, Shan J, Liu Y, Chen Z, Deng X, Liu F, Deng L, Zhong X, Li H, He S, Chen L, Liu G, Xu H, Zhong Y, Shi H, Ren J. The prospective multiple-centre randomized controlled clinical study of high-dose amoxicillin-proton pump inhibitor dual therapy for H. pylori infection in Sichuan areas. Ann Med 2022; 54:426-435. [PMID: 35098820 PMCID: PMC8812792 DOI: 10.1080/07853890.2022.2031269] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023] Open
Abstract
OBJECTIVES To evaluate the safety and efficacy of high-dose amoxicillin-proton pump inhibitor dual therapy, and to provide a new eradication regimen as a first-line option for patients with H. pylori infection. METHODS A total of 971 H. pylori positive patients who received initial treatment were recruited from March to August 2020, and randomly divided into treatment group and control group. The treatment group received of 20 mg esomeprazole four times daily and 750 mg amoxicillin four times daily for 14 days. Control group received of 220 mg bismuth potassium citrate twice daily, 20 mg esomeprazole twice daily, 1000 mg amoxicillin twice daily and 250 mg clarithromycin capsule twice daily for 14 days. Four weeks after the end of treatment, the urea breath test was reviewed to detect whether H. pylori was eradicated. RESULTS There were no statistical differences in age, gender, the total clinical symptom scores before and after initial treatment, the compliance, and the degree of remission of symptoms before and after initial treatment between the two groups. The eradication rates of H. pylori between dual therapy and quadruple therapy were 88.31% and 85.26% (p=.158) by intention-to-treat (ITT) analysis, 88.66% and 85.44% (p=.186) by modified intention-to-treat (mITT) analysis, and 91.63% and 90.60% (p=.116) by PP analysis, respectively. Adverse events in dual therapy group were significantly lower than quadruple therapy group (13.3% vs. 28.2% (p<.01)). CONCLUSIONS For the initial treatment of H. pylori infection, the high-dose dual therapy regimen has the same efficacy as the bismuth-containing quadruple therapy regimen, good compliance, less adverse reactions and high safety, so it can be recommended as the empirical first-line treatment regimen for the eradication of H. pylori (KY2019173).
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Affiliation(s)
- Cheng Shen
- Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Changping Li
- Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Muhan Lv
- Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Xiaosong Dai
- Sichuan Provincial People's Hospital, Chengdu, China
| | - Caiping Gao
- Sichuan Provincial People's Hospital, Chengdu, China
| | - Liangping Li
- Sichuan Provincial People's Hospital, Chengdu, China
| | - Qin Zhang
- First People's Hospital of Liangshan Yi Autonomous Prefecture, Xichang, China
| | - Wen Pan
- Sichuan University West China Hospital Tibet People's Government in Chengdu Office Branch, Chengdu, China
| | - Chao Liu
- Sichuan University West China Hospital Tibet People's Government in Chengdu Office Branch, Chengdu, China
| | - Sijing Han
- Chengdu Medical College Second Affiliated Hospital, Chengdu, China
| | - Yang Zhang
- Chengdu Medical College Second Affiliated Hospital, Chengdu, China
| | | | - Hong Deng
- People's Hospital of Deyang City, Deyang, China
| | - Yong Yao
- Suining Central Hospital, Suining, China
| | - Jianyu Xu
- Suining Central Hospital, Suining, China
| | | | - Haiyan Shi
- Bazhong Central Hospital, Bazhong, China
| | - Peijie Yuan
- The Fourth People's Hospital of GuangYuan, GuangYuan, China
| | - Xiaoyan Yang
- Chengdu Second People's Hospital, Chengdu, China
| | - Yi Jian
- Chengdu Second People's Hospital, Chengdu, China
| | - Jing Shan
- Chengdu Third People's Hospital, Chengdu, China
| | - Yan Liu
- Chengdu Fifth People's Hospital, Chengdu, China
| | - Zonghua Chen
- The Second People's Hospital of Yibin, West China Hospital of Sichuan University, Yibin, China
| | | | - Fei Liu
- Leshan City Geriatric Hospital, Leshan, China
| | - Lijuan Deng
- Leshan Sichuan Armed Police General Hospital, Leshan, China
| | - Xianfei Zhong
- Leshan Sichuan Armed Police General Hospital, Leshan, China
| | - Hong Li
- Pengzhou People's Hospital, Chengdu, China
| | - Shaoya He
- Sichuan Anyue County People's Hospital, Ziyang, China
| | - Li Chen
- Sichuan Anyue County People's Hospital, Ziyang, China
| | - Gang Liu
- Zigong Third People's Hospital, Zigong, China
| | - Hairong Xu
- Zigong Third People's Hospital, Zigong, China
| | - Yuquan Zhong
- First Peoples Hospital of Neijiang, Neijiang, China
| | - Hua Shi
- The First People's Hospital of Ziyang, Ziyang, China
| | - Jiangang Ren
- Wuhou District Third People's Hospital, Chengdu, China
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Hu Y, Zhu Y, Lu NH. The management of Helicobacter pylori infection and prevention and control of gastric cancer in China. Front Cell Infect Microbiol 2022; 12:1049279. [PMID: 36530421 PMCID: PMC9751207 DOI: 10.3389/fcimb.2022.1049279] [Citation(s) in RCA: 13] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2022] [Accepted: 11/14/2022] [Indexed: 12/04/2022] Open
Abstract
Helicobacter pylori (H. pylori) infection, a type-1 carcinogen, was closely associated with gastric cancer (GC). Successfully eradicating H. pylori infection could reduce the incidence of GC. China was a country with high incidence of GC and high prevalence of H. pylori infection. Nearly half of worldwide GC new cases and deaths attributed to H. pylori infection occurred in China. H. pylori prevalence varied over time with the improvement of socioeconomic status and sanitary conditions. The knowledge of antibiotic resistance rate in time was important to guide the clinical choice of antibiotics use in the regimens. With the publication of five Chinese consensus reports on the management of H. pylori infection and the effort of public preach of H. pylori-related knowledge, the standardization of H. pylori diagnosis and treatment by clinicians was improved. Bismuth-containing quadruple therapy was widely applied in clinical practice of H. pylori eradication because of high efficacy and safety. High-dose Proton Pump Inhibitor-amoxicillin dual therapy or vonoprazan-amoxicillin dual therapy showed comparable efficacy and lower side effects than bismuth-containing quadruple therapy, which were the alternative choice. The diagnosis rate of early GC was low and distinguishing Chinese GC risk population for the further endoscopy screening was important. Efforts have been done to establish prediction models to stratify GC risk in the Chinese GC risk population. We reviewed the current situation of the management of H. pylori infection and prevention and control of GC in China here.
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Affiliation(s)
- Yi Hu
- Department Of Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China,JiangXi Clinical Research Center for Gastroenterology, Nanchang, Jiangxi, China
| | - Yin Zhu
- Department Of Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China,JiangXi Clinical Research Center for Gastroenterology, Nanchang, Jiangxi, China,*Correspondence: Nong-Hua Lu, ; Yin Zhu,
| | - Nong-Hua Lu
- Department Of Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China,JiangXi Clinical Research Center for Gastroenterology, Nanchang, Jiangxi, China,*Correspondence: Nong-Hua Lu, ; Yin Zhu,
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Chen XX, Chen YX, Bi HX, Zhao X, Zhang LF, Liu JY, Shi YQ. Efficacy and safety of triple therapy containing berberine hydrochloride, amoxicillin, and rabeprazole in the eradication of Helicobacter pylori. J Dig Dis 2022; 23:568-576. [PMID: 36415112 PMCID: PMC10107123 DOI: 10.1111/1751-2980.13146] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/31/2022] [Revised: 11/02/2022] [Accepted: 11/21/2022] [Indexed: 11/24/2022]
Abstract
OBJECTIVE To estimate the effectiveness and safety of triple therapy containing berberine, amoxicillin, and rabeprazole in the eradication of Helicobacter pylori (H. pylori). METHODS This prospective, randomized controlled, open-label, noninferiority trial included treatment-naive patients with H. pylori infection who were randomly allocated at a ratio of 1:1 into the berberine triple therapy group (berberine hydrochloride 300 mg thrice daily, amoxicillin 1 g twice daily, and rabeprazole 10 mg twice daily) or standard bismuth-containing quadruple therapy group (amoxicillin 1 g twice daily, rabeprazole 10 mg twice daily, clarithromycin 500 mg twice daily, and bismuth tartrate 200 mg twice daily) for 14 days. Negative 13 C/14 C-urea breath test at 4 weeks after completion of the therapy was regarded as successful eradication. RESULTS Altogether 262 and 262 patients received berberine triple therapy and bismuth-containing quadruple therapy, respectively. Both intention-to-treat (79.8% vs 80.9%, P = 0.742) and per-protocol analyses (83.6% and 85.1%, P = 0.636) showed comparable eradication rate between the two groups, indicating a noninferior eradication rate (the lower limit of the 95% confidence interval over -10% [-7.9% and -7.87%, respectively]). Adverse events more commonly occurred in the bismuth-containing quadruple-therapy group (8.8% vs 16.0%, P = 0.012), while patient compliance and symptom improvement of the two regimens were comparable. CONCLUSION Triple therapy containing berberine, amoxicillin and rabeprazole is noninferior to bismuth-containing quadruple therapy in the initial treatment for H. pylori eradication.
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Affiliation(s)
- Xing Xing Chen
- Xi'an Medical University, Xi'an, Shaanxi Province, China.,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi'an, Shaanxi Province, China.,The Second Affiliated Hospital of Xi'an Medical College, Xi'an, Shaanxi Province, China
| | - Yu Xin Chen
- Xi'an Medical University, Xi'an, Shaanxi Province, China.,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi'an, Shaanxi Province, China
| | - Han Xin Bi
- Xi'an Medical University, Xi'an, Shaanxi Province, China.,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi'an, Shaanxi Province, China
| | - Xin Zhao
- Xi'an Medical University, Xi'an, Shaanxi Province, China.,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi'an, Shaanxi Province, China
| | - Li Feng Zhang
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi'an, Shaanxi Province, China
| | - Jun Ye Liu
- Department of Radiation Protective Medicine, Air Force Medical University, Xi'an, Shaanxi Province, China
| | - Yong Quan Shi
- Xi'an Medical University, Xi'an, Shaanxi Province, China.,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi'an, Shaanxi Province, China
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25
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Han Y, Long H, Lin Y, He Q, Chen W, Ding X, Zhou L, An P, Wang F, Zhang Z, Hu Y, Li P. Optimized dual therapy for treatment-naive patients of Helicobacter pylori infection: A large-scale prospective, multicenter, open-label, randomized controlled study. Helicobacter 2022; 27:e12922. [PMID: 35939559 PMCID: PMC9541209 DOI: 10.1111/hel.12922] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/16/2022] [Revised: 07/09/2022] [Accepted: 07/13/2022] [Indexed: 12/19/2022]
Abstract
BACKGROUND The efficacy and safety of high-dose amoxicillin (AMX) and proton pump inhibitors (PPI) dual therapy raises much more attention in recent years. Comparative studies among the dual therapies are required to explore more suitable regimens. This study compared the efficacy, adverse events, and patient compliance of three different high-dose dual regimens in treatment-naive patients of Helicobacter pylori (H. pylori) infection. MATERIALS AND METHODS The study was a prospective, multicenter, open-label, randomized controlled trial, including H. pylori-infected treatment-naive patients at 12 tertiary hospitals in China. The eligible subjects received high-dose AMX and esomeprazole (ESO) dual therapy of different regimens. They were randomly assigned to group A (ESO 20 mg plus AMX 750 mg, Qid for 14 days), group B (ESO 40 mg Bid plus AMX 1 g Tid for 14 days), or group C (ESO 20 mg plus AMX 1 g, Tid for 14 days). The eradication rates, adverse events, and patient compliance of the three groups were compared. RESULTS Between April 2021 and January 2022, a total of 1080 subjects were screened and 945 were randomized. The eradication rates in groups A, B, and C were 88.6% (95% CI 84.5%-91.9%), 84.4% (95% CI 80.0%-88.3%), and 86.7% (95% CI 82.4%-90.2%; p = .315), respectively, based on intention-to-treat analysis; 90.3% (95% CI 86.4%-93.3%), 85.5% (95% CI 81.1%-89.2%), and 87.8% (95% CI 83.6%-91.2%; p = .197), respectively, according to modified intention-to-treat analysis; and 90.4% (95% CI 86.5%-93.5%), 85.8% (95% CI 81.4%-89.5%), and 88.3% (95% CI 84.1%-91.7%; p = .202) in per-protocol analysis. History of antibiotics use in 2 years reduced eradication effect in group B (ESO 40 mg Bid, AMX 1 g Tid). The modified intention-to-treat eradication rates were 81.4% vs 90.0% among those with or without a history of antibiotics use in group B (p = .031). The adverse event rates were 13.7%, 12.7%, and 12.1% in groups A, B, and C, respectively (p = .834). Patient compliance of the three groups was similar. CONCLUSIONS Two optimized AMX and PPI dual regimens (ESO 40 mg Bid or 20 mg Tid plus AMX 1 g Tid for 14 days) had similar efficacy, safety and compliance as compared with classical dual regimen (ESO 20 mg plus AMX 750 mg Qid for 14 days) in H. pylori-infected treatment-naive patients.
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Affiliation(s)
- Ying‐Ying Han
- Division of GastroenterologyTongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhanChina
| | - Hui Long
- Department of GastroenterologyTianyou Hospital Affiliated to Wuhan University of Science and TechnologyWuhanChina
| | - Ya Lin
- Department of GastroenterologyWenchang People's HospitalWenchangChina
| | - Qiong He
- Department of GastroenterologyWuhan Red Cross HospitalWuhanChina
| | - Wei‐Gang Chen
- Department of GastroenterologyThe First Affiliated Hospital of Shihezi University Medical CollegeShiheziChina
| | - Xiang‐Wu Ding
- Department of GastroenterologyWuhan Fourth HospitalWuhanChina
| | - Lin Zhou
- Department of GastroenterologySuizhou Central HospitalSuizhouChina
| | - Ping An
- Department of GastroenterologyRenmin Hospital of Wuhan UniversityWuhanChina
| | - Fen Wang
- Department of GastroenterologyThe Third Xiangya Hospital, Central South UniversityChangshaChina
| | - Zhen‐Yu Zhang
- Department of GastroenterologyNanjing First Hospital, Nanjing Medical UniversityNanjingChina
| | - Yun‐Lian Hu
- Department of GastroenterologyHubei Provincial Hospital of Traditional Chinese MedicineWuhanChina
| | - Pei‐Yuan Li
- Division of GastroenterologyTongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhanChina,Department of GastroenterologyWenchang People's HospitalWenchangChina
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26
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Jiang Z, Qian X, Wang Z, Dong Y, Pan Y, Zhang Z, Wang S. Antibiotic resistance of Helicobacter pylori isolated from patients in Nanjing, China: A cross-section study from 2018 to 2021. Front Cell Infect Microbiol 2022; 12:970630. [PMID: 36159644 PMCID: PMC9493266 DOI: 10.3389/fcimb.2022.970630] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/16/2022] [Accepted: 08/24/2022] [Indexed: 12/02/2022] Open
Abstract
The increasing antibiotic resistance of Helicobacter pylori infection is a globally urging problem. To investigate the H. pylori resistance situation in Nanjing, China, we enrolled patients in Nanjing First Hospital from January 2018 to May 2021. H. pylori strains were isolated from patients who had at least one positive 13C-urea breath or rapid urease result. Subsequently, we performed antibiotic susceptibility tests on the isolated strains to clarithromycin, metronidazole, levofloxacin, amoxicillin, furazolidone and tetracycline. ARMS-PCR was conducted to determine H. pylori clarithromycin resistance gene mutation. Our results demonstrated that the primary resistance rates of metronidazole, clarithromycin, levofloxacin, amoxicillin, furazolidone and tetracycline were 67.19% (1417/2109), 35.99% (759/2109), 24.23% (511/2109), 0.76% (16/2109), 0.28% (6/2109) and 0.09% (2/2109), respectively. The resistance rates of metronidazole, clarithromycin and levofloxacin elevated significantly after treatment and the three antibiotics composed the majority of multi-resistance patterns. However, the resistance rates of amoxicillin, furazolidone and tetracycline were still in low levels after treatment. ARMS-PCR showed a rather good consistency with antibiotic susceptibility test in detecting clarithromycin resistance, with a kappa value of 0.79. Overall, this study revealed the latest complex situation of antibiotic resistance of H. pylori infection in Nanjing and offered suggestions on clinical medication for curing H. pylori.
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Affiliation(s)
- Zongdan Jiang
- Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
| | - Xuetian Qian
- Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
| | - Zhi Wang
- Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
| | - Yunfan Dong
- Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
| | - Yuqin Pan
- General Clinical Research Center, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
| | - Zhenyu Zhang
- Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
- *Correspondence: Zhenyu Zhang, ; Shukui Wang,
| | - Shukui Wang
- General Clinical Research Center, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
- *Correspondence: Zhenyu Zhang, ; Shukui Wang,
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27
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Hu Y, Xu X, Ouyang YB, He C, Li NS, Xie C, Peng C, Zhu ZH, Xie Y, Shu X, Lu NH, Zhu Y. Optimization of vonoprazan-amoxicillin dual therapy for eradicating Helicobacter pyloriinfection in China: A prospective, randomized clinical pilot study. Helicobacter 2022; 27:e12896. [PMID: 35466521 DOI: 10.1111/hel.12896] [Citation(s) in RCA: 36] [Impact Index Per Article: 12.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/17/2022] [Revised: 03/29/2022] [Accepted: 04/07/2022] [Indexed: 12/20/2022]
Abstract
BACKGROUND Vonoprazan-amoxicillin (VA) dual therapy has been shown to achieve acceptable cure rates for treatment of Helicobacter pylori(H. pylori) in Japan. Its effectiveness in other regions is unknown. We aimed to explore the efficacy of VA dual therapy as first-line treatment for H. pyloriinfection in China. METHODS This was a single center, prospective, randomized clinical pilot study conducted in China. Treatment naive H. pyloriinfected patients were randomized to receive either low- or high-dose amoxicillin-vonoprazan consisting of amoxicillin 1 g either b.i.d. or t.i.d plus VPZ 20 mg b.i.d for 7 or 10 days. 13 C-urea breath tests were used to access the cure rate at least 4 weeks after treatment. RESULTS Three hundred and twenty-three patients were assessed, and 119 subjects were randomized. The eradication rates of b.i.d. amoxicillin for 7 and 10 days, t.i.d. amoxicillin for 7 and 10 days were 66.7% (16/24), 89.2% (33/37), 81.0% (17/21), and 81.1% (30/37) (p = .191) by intention-to-treat analysis, respectively, and 72.7% (16/22), 89.2% (33/37), 81.0% (17/21), and 81.1% (30/37) (p = .454) by per-protocol analysis, respectively. CONCLUSION Neither 7- or 10-day VA dual therapy with b.i.d. or t.i.d. amoxicillin provides satisfied efficacy as the first-line treatment for H. pyloriinfection in China. Further optimization is needed.
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Affiliation(s)
- Yi Hu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Xin Xu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Yao-Bin Ouyang
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Cong He
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Nian-Shuang Li
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Chuan Xie
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Chao Peng
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Zhen-Hua Zhu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Yong Xie
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Xu Shu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Nong-Hua Lu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
| | - Yin Zhu
- Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China
- JiangXi Clinical Research Center for Gastroenterology, Nanchang, China
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28
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Bi H, Chen X, Chen Y, Zhao X, Wang S, Wang J, Lyu T, Han S, Lin T, Li M, Yuan D, Liu J, Shi Y. Efficacy and safety of high-dose esomeprazole-amoxicillin dual therapy for Helicobacter pylori rescue treatment: a multicenter, prospective, randomized, controlled trial. Chin Med J (Engl) 2022; 135:1707-1715. [PMID: 36193978 PMCID: PMC9509165 DOI: 10.1097/cm9.0000000000002289] [Citation(s) in RCA: 23] [Impact Index Per Article: 7.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/04/2023] Open
Abstract
BACKGROUND High-dose dual therapy (HDDT) with proton pump inhibitors (PPIs) and amoxicillin has attracted widespread attention due to its favorable efficacy in eradicating Helicobacter pylori (H. pylori). This study aimed to compare the efficacy and safety of high-dose PPI-amoxicillin dual therapy and bismuth-containing quadruple therapy for H. pylori rescue treatment. METHODS This was a prospective, randomized, multicenter, non-inferiority trial. Patients recruited from eight centers who had failed previous treatment were randomly (1:1) allocated to two eradication groups: HDDT (esomeprazole 40 mg and amoxicillin 1000 mg three times daily; the HDDT group) and bismuth-containing quadruple therapy (esomeprazole 40 mg, bismuth potassium citrate 220 mg, and furazolidone 100 mg twice daily, combined with tetracycline 500 mg three times daily; the tetracycline, furazolidone, esomeprazole, and bismuth [TFEB] group) for 14 days. The primary endpoint was the H. pylori eradication rate. The secondary endpoints were adverse effects, symptom improvement rates, and patient compliance. RESULTS A total of 658 patients who met the criteria were enrolled in this study. The HDDT group achieved eradication rates of 75.4% (248/329), 81.0% (248/306), and 81.3% (248/305) asdetermined by the intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analyses, respectively. The eradication rates were similar to those in the TFEB group: 78.1% (257/329), 84.2% (257/305), and 85.1% (257/302). The lower 95% confidence interval boundary (-9.19% in the ITT analysis, - 9.21% in the MITT analysis, and -9.73% in the PP analysis) was greater than the predefined non-inferiority margin of -10%, establishing a non-inferiority of the HDDT group vs. the TFEB group. The incidence of adverse events in the HDDT group was significantly lower than that in the TFEB group (11.1% vs. 26.8%, P < 0.001). Symptom improvement rates and patients' compliance were similar between the two groups. CONCLUSIONS Fourteen-day HDDT is non-inferior to bismuth-containing quadruple therapy, with fewer adverse effects and good treatment compliance, suggesting HDDT as an alternative for H. pylori rescue treatment in the local region. TRIAL REGISTRATION Clinicaltrials.gov, NCT04678492.
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Affiliation(s)
- Hanxin Bi
- Xi’an Medical University, Xi’an, Shaanxi 710021, China,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi’an, Shaanxi 710032, China
| | - Xingxing Chen
- Xi’an Medical University, Xi’an, Shaanxi 710021, China,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi’an, Shaanxi 710032, China
| | - Yuxin Chen
- Xi’an Medical University, Xi’an, Shaanxi 710021, China,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi’an, Shaanxi 710032, China
| | - Xin Zhao
- Xi’an Medical University, Xi’an, Shaanxi 710021, China,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi’an, Shaanxi 710032, China
| | - Shasha Wang
- Department of Gastroenterology, Xianyang Central Hospital, Xianyang, Shaanxi 712000, China
| | - Jiehong Wang
- Department of Gastroenterology, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi 712000, China
| | - Ting Lyu
- Department of Gastroenterology, Shaanxi Nuclear Industry 215 Hospital, Xianyang, Shaanxi 712000, China
| | - Shuang Han
- Department of Gastroenterology, Xi’an Red Cross Hospital, Xi’an, Shaanxi 710054, China
| | - Tao Lin
- Department of Gastroenterology, Xi’an Daxing Hospital, Xi’an, Shaanxi 710082, China
| | - Mingquan Li
- Department of Gastroenterology, Yan’an People's Hospital, Yan’an, Shaanxi 716000, China
| | - Donghong Yuan
- Department of Gastroenterology, Yan’an University Affiliated Hospital, Yan’an, Shaanxi 716000, China
| | - Junye Liu
- Department of Radiation Protective Medicine, Air Force Medical University, Xi’an, Shaanxi 710032, China
| | - Yongquan Shi
- Xi’an Medical University, Xi’an, Shaanxi 710021, China,State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi’an, Shaanxi 710032, China
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29
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Chen J, Li P, Huang Y, Guo Y, Ding Z, Lu H. Primary Antibiotic Resistance of Helicobacter pylori in Different Regions of China: A Systematic Review and Meta-Analysis. Pathogens 2022; 11:pathogens11070786. [PMID: 35890031 PMCID: PMC9316315 DOI: 10.3390/pathogens11070786] [Citation(s) in RCA: 31] [Impact Index Per Article: 10.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/12/2022] [Revised: 06/29/2022] [Accepted: 07/04/2022] [Indexed: 01/30/2023] Open
Abstract
Aim: Understanding the prevalence of antibiotic resistance can provide reliable information for selecting treatment options. The goal of this meta-analysis was to observe the primary antibiotic resistance of Helicobacter pylori (H. pylori) in different regions and time periods of China. Method: We searched PubMed, EMBASE, Chinese Biomedical databases and the China National Knowledge Infrastructure from inception to 20 February 2022. Data on the prevalence of H. pylori primary resistance at various time points were included. A random-effect model was established to calculate the pooled antibiotic resistance. Results: In total, 2150 articles were searched, with 70 meeting the inclusion criteria. The resistance to clarithromycin, metronidazole, levofloxacin amoxicillin, tetracycline and furazolidone in 2016–2020 were 34% (95% CI: 30–39%), 78% (95% CI: 73–84%), 35% (95% CI: 30–40%), 3% (95% CI: 1–5%), 2% (95%CI: 1–4%) and 1% (95% CI: 0–4%), respectively. Clarithromycin showed regional difference, as the resistance was higher in northern (37%, 95% CI: 32–41%) and western China (35%, 95% CI: 17–54%) than that in southern (24%, 95% CI: 17–32%) and eastern China (24%, 95% CI: 20–28%). Conclusion: The resistance of H. pylori to clarithromycin and metronidazole was high and increased over time, whereas resistance to levofloxacin, amoxicillin, tetracycline and furazolidone remained stable.
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Affiliation(s)
- Jinnan Chen
- Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Key Laboratory of Gastroenterology &Hepatology NHC Key Laboratory of Digestive Diseases, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200120, China; (J.C.); (Y.H.); (Y.G.); (Z.D.)
| | - Puheng Li
- School of Mathematical Sciences, Peking University, Beijing 100091, China;
| | - Yu Huang
- Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Key Laboratory of Gastroenterology &Hepatology NHC Key Laboratory of Digestive Diseases, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200120, China; (J.C.); (Y.H.); (Y.G.); (Z.D.)
| | - Yixian Guo
- Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Key Laboratory of Gastroenterology &Hepatology NHC Key Laboratory of Digestive Diseases, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200120, China; (J.C.); (Y.H.); (Y.G.); (Z.D.)
| | - Zhaohui Ding
- Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Key Laboratory of Gastroenterology &Hepatology NHC Key Laboratory of Digestive Diseases, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200120, China; (J.C.); (Y.H.); (Y.G.); (Z.D.)
| | - Hong Lu
- Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Key Laboratory of Gastroenterology &Hepatology NHC Key Laboratory of Digestive Diseases, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200120, China; (J.C.); (Y.H.); (Y.G.); (Z.D.)
- Correspondence: ; Tel.: +8621-58752345
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30
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Sjomina O, Lielause A, Rūdule A, Vangravs R, Paršutins S, Poļaka I, Daugule I, Stonāns I, Park JY, Leja M. Randomised clinical trial: comparison of efficacy and adverse effects of a standard triple clarithromycin-containing regimen with high-dose amoxicillin and bismuth therapy in Helicobacter pylori eradication. Eur J Cancer Prev 2022; 31:333-338. [PMID: 35471812 DOI: 10.1097/cej.0000000000000718] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
BACKGROUND The clarithromycin-based triple therapy is the most prescribed Helicobacter pylori eradication regimen in Europe; it causes adverse effects in a significant proportion of subjects, leading to discontinuation. Alternative therapies are required because of increasing clarithromycin resistance or to decrease the adverse effects. AIMS We compared the efficacy and spectrum of adverse effects of clarithromycin-based triple therapy with the high-dose amoxicillin/bismuth regimen. METHODS A randomised clinical trial enrolled healthy individuals aged 40-64 years. H. pylori was assessed with a 13C-urea breath test. In total 579 H. pylori-positive subjects were randomly allocated in two groups: group 1: clarithromycin 500 mg, amoxicillin 1000 mg, esomeprazole 40 mg, all twice daily; group 2: bismuth subcitrate 240 mg twice daily, amoxicillin 1000 mg three times daily, esomeprazole 40 mg twice daily. Regimens were administered for 14 days.Information on treatment completion and adverse effects were collected via a telephone interview at 21-28 days after medication delivery. The efficacy was assessed by UBT 6 months after the treatment. RESULTS We analysed 483 subjects for adverse effects (248 vs. 235 respectively). Furthermore, 316 subjects were analysed for efficacy. In per-protocol analysis, a higher efficacy was seen in group 1 (88.4 vs. 77.0%; P < 0.001); no difference was observed in compliance (90.3 and 91.2%). Therapy-related adverse effects were more common in group 1 (56.9 vs. 40.0%; P < 0.01). In intention-to-treat analysis no statistical difference in efficacy was revealed. CONCLUSIONS Bismuth-based high-dose amoxicillin therapy showed a lower efficacy but was less frequently associated with adverse effects. Further research is required to examine the high-dose amoxicillin and bismuth-containing regimens in various populations to maximise eradication efficacy.
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Affiliation(s)
- Olga Sjomina
- Institute of Clinical and Preventive Medicine
- Faculty of Medicine, University of Latvia, Riga, Latvia
| | - Alise Lielause
- Institute of Clinical and Preventive Medicine
- Faculty of Medicine, University of Latvia, Riga, Latvia
| | - Aiga Rūdule
- Institute of Clinical and Preventive Medicine
| | | | | | | | - Ilva Daugule
- Institute of Clinical and Preventive Medicine
- Faculty of Medicine, University of Latvia, Riga, Latvia
| | | | - Jin Young Park
- International Agency for Research on Cancer, Lyon, France
| | - Mārcis Leja
- Institute of Clinical and Preventive Medicine
- Faculty of Medicine, University of Latvia, Riga, Latvia
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31
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Shao QQ, Yu XC, Yu M, Ma J, Zhao JB, Yuan L, Qi YB, Hu RB, Wei PR, Xiao W, Lan L, Jia BL, Zhang LZ, Ding SZ. Rabeprazole plus amoxicillin dual therapy is equally effective to bismuth-containing quadruple therapy for Helicobacter pylori eradication in central China: A single-center, prospective, open-label, randomized-controlled trial. Helicobacter 2022; 27:e12876. [PMID: 35150597 DOI: 10.1111/hel.12876] [Citation(s) in RCA: 14] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/30/2021] [Revised: 01/10/2022] [Accepted: 01/16/2022] [Indexed: 12/11/2022]
Abstract
BACKGROUND Antibiotic resistance emerges as a major issue for Helicobacter pylori (H. pylori) treatment. High-dose dual therapy has recently shown encouraging results in H. pylori eradication, but it has yet to be validated in this H. pylori highly infected area; it is also not known if this concept can be extended to antibiotics other than amoxicillin, and factors that affect the eradication. We investigate if rabeprazole plus amoxicillin or furazolidone regimens could be a first-line therapy for H. pylori eradication, and factors that affect the curing rate. METHODS This is a single-center, prospective, open-label, randomized-controlled trial. Naive patients (n=292) were randomly treated with bismuth-containing quadruple therapy (BQT), rabeprazole plus amoxicillin (RADT), or furazolidone (RFDT) groups. RADT and FADT use three times daily regimens. H. pylori diagnosis and eradication were determined and confirmed by 13 C-urea breath test. RESULTS In per-protocol (PP) analysis, H. pylori eradication rate was 91.2% in BQT group, 89.6% in RADT, and 51.0% in RFDT group. In intention-to-treat (ITT) analysis, infection was eradicated in 86.7% of patients in BQT group, 85.8% in RADT, and 48.1% in RFDT groups, respectively. Noninferiority was confirmed between BQT and RADT groups. The incidence of side effects in BQT group was significantly higher than that in RADT group. Successful eradication was associated with lower body surface area (BSA) and low body mass index (BMI) in BQT group. Smoking and high BSA index reduced H. pylori eradication rate in RADT group. CONCLUSIONS Rabeprazole-amoxicillin dual therapy is equally effective to the bismuth-containing quadruple therapy for H. pylori eradication with fewer side effects and saves use of one antibiotic per each treatment. Successful eradication is also associated with low BSA and non-smoking condition, which deserves future stratified analysis for refinement and optimization.
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Affiliation(s)
- Qiao-Qiao Shao
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Xue-Chun Yu
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Miao Yu
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Jing Ma
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Jun-Bo Zhao
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Lin Yuan
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Ya-Bin Qi
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Ruo-Bing Hu
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Pei-Ru Wei
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Wei Xiao
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Ling Lan
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Bai-Ling Jia
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
| | - Lian-Zhong Zhang
- Department of Ultrasound Imaging, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, China
| | - Song-Ze Ding
- Department of Gastroenterology and Hepatology, People's Hospital of Zhengzhou University and Henan Provincial People's Hospital, Zhengzhou, China
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Guan JL, Hu YL, An P, He Q, Long H, Zhou L, Chen ZF, Xiong JG, Wu SS, Ding XW, Luo HS, Li PY. Comparison of high-dose dual therapy with bismuth-containing quadruple therapy in Helicobacter pylori-infected treatment-naive patients: An open-label, multicenter, randomized controlled trial. Pharmacotherapy 2022; 42:224-232. [PMID: 35075679 DOI: 10.1002/phar.2662] [Citation(s) in RCA: 29] [Impact Index Per Article: 9.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/12/2021] [Revised: 10/21/2021] [Accepted: 11/23/2021] [Indexed: 12/13/2022]
Abstract
OBJECTIVE Bismuth-containing quadruple therapy for Helicobacter pylori (H. pylori) eradication has a relatively high rate of side effects and high cost, thus the option of a high-dose dual therapy with a high eradication rate and fewer adverse events is a consideration. However, studies of dual therapy are still scarce and are mostly single-center studies with limited generalizability. Large-scale, multicenter studies are required. Our study investigated and compared the effectiveness, adverse events, patient compliance, and costs of high-dose dual therapy with those of bismuth-containing quadruple therapy in H. pylori-infected treatment-naive patients in a prospective, multicenter, open-label, randomized controlled trial. METHOD Treatment-naive patients infected with H. pylori were randomly assigned to receive high-dose dual therapy (esomeprazole 20 mg 4 times daily and amoxicillin 1000 mg 3 times daily, for 14 days) or bismuth-containing quadruple therapy (esomeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 220 mg, all twice daily for 14 days). The effectiveness, adverse events, patient compliance, and costs of both groups were compared. RESULTS A total of 700 patients were enrolled. The high-dose dual therapy group (N = 350) achieved eradication rates of 89.4% (intention-to-treat), 90.4% (modified intention-to-treat), and 90.6% (per-protocol), which were similar to rates in the bismuth-containing quadruple therapy group (N = 350), 84.6%, 88.0%, and 88.2%, respectively (p > 0.05). The high-dose dual therapy group had a lower rate of adverse events (12.9% vs. 28.1%, p < 0.001) and lower costs (¥590.2 vs. ¥723.22) compared with the quadruple therapy group, respectively. The compliance of both groups was satisfactory (97.7% high-dose dual vs. 96.8% quadruple, p > 0.05). CONCLUSION High-dose dual therapy for H. pylori eradication had similar efficacy and compliance, fewer adverse events, and lower costs than bismuth-containing quadruple therapy for treatment-naive patients.
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Affiliation(s)
- Jia-Lun Guan
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Yun-Lian Hu
- Department of Gastroenterology, Hubei University of Chinese Medicine, Wuhan, China
| | - Ping An
- Department of Gastroenterology, Wuhan University People's Hospital, Wuhan, China
| | - Qiong He
- Department of Gastroenterology, Wuhan Red Cross Hospital, Wuhan, China
| | - Hui Long
- Department of Gastroenterology, Tianyou Hospital Affiliated to Wuhan University of Science and Technology, Wuhan, China
| | - Lin Zhou
- Department of Gastroenterology, Suizhou Central Hospital, Wuhan, China
| | - Zhi-Fen Chen
- Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, China
| | - Jian-Guang Xiong
- Department of Gastroenterology, Xianning Central Hospital, Wuhan, China
| | - Shi-Sheng Wu
- Department of Gastroenterology, The Second Hospital of Huangshi, Wuhan, China
| | - Xiang-Wu Ding
- Department of Gastroenterology, Wuhan Puai Hospital, Wuhan, China
| | - He-Sheng Luo
- Department of Gastroenterology, Wuhan University People's Hospital, Wuhan, China
| | - Pei-Yuan Li
- Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.,Department of Gastroenterology, Wenchang People's Hospital, Hainan, China
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Wang J, Cao Y, He W, Li X. Efficacy and safety of bismuth quadruple regimens containing tetracycline or furazolidone for initial eradication of Helicobacter pylori. Medicine (Baltimore) 2021; 100:e28323. [PMID: 34941132 PMCID: PMC8701960 DOI: 10.1097/md.0000000000028323] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/02/2021] [Accepted: 11/27/2021] [Indexed: 01/05/2023] Open
Abstract
Helicobacter pylori (H pylori) infection can cause chronic gastritis, peptic ulcer, and even gastric cancer, so effective eradication is critical.This study compared the efficacy and safety of bismuth quadruple regimens including either tetracycline or furazolidone for initial eradication.Patients newly diagnosed with H pylori infection from January 2020 to January 2021 were randomly assigned to receive either the tetracycline-containing regimen (n = 116) or furazolidone-containing regimen (n = 168). Both regimens included 1 proton pump inhibitor (rabeprazole 20 mg, or esomeprazole 20 mg, or eprazole 5 mg), colloidal pectin bismuth 300 mg, and amoxicillin 1000 mg in addition to tetracycline 1.0 g or furazolidone 0.1 g. All drugs were administered twice daily for 12 consecutive days. The 14C urea breath test was used for diagnosis, and re-test negativity at one-month follow-up was considered successful eradication. Adverse events were recorded during follow-up by telephone interview.In total, 109 patients in the tetracycline group and 157 in the furazolidone group were re-examined at 1 month. In the tetracycline group, 101 patients tested negative at follow-up, yielding an eradication rate of 92.7% according to per-protocol analysis and 87.1% by intention-to-treat analysis. In the furazolidone group, 141 patients tested negative, yielding eradication rates of 89.8% by PP and 83.9% by ITT. Eradication rates did not differ significantly between regimens (per-protocol: χ2 = 0.637, P = .517; intention-to-treat: χ2 = 0.537, P = .501). However, total adverse events incidence was significantly lower in the tetracycline group (20.2% vs 37.6%; χ2 = 9.193, P = .003).Both bismuth quadruple regimens produce high initial eradication, but the tetracycline regimen appears safer.
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Cao Y, Zhang J, Liu Y, Zhang L, Wang L, Wang J, Qi Y, Lv H, Liu J, Huo L, Wei X, Shi Y. The efficacy and safety of different bismuth agents in Helicobacter pylori first-line eradication: A multicenter, randomized, controlled clinical trial. Medicine (Baltimore) 2021; 100:e27923. [PMID: 34918639 PMCID: PMC8678011 DOI: 10.1097/md.0000000000027923] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/04/2021] [Revised: 06/30/2021] [Accepted: 11/02/2021] [Indexed: 01/05/2023] Open
Abstract
BACKGROUND The aim of this study was to evaluate the efficacy and safety of bismuth pectin capsules and bismuth pectin granules in the first-line quadruple treatment of Helicobacter pylori (H. pylori). METHODS This study was a multicenter, randomized, open-labelled controlled clinical trial. Patients with a H. pylori infection were randomized into 4 groups (1:1:1:1) and treated with a 14-day bismuth-containing quadruple therapy. The 4 groups received either bismuth potassium citrate capsules (220 mg), colloidal bismuth pectin capsules (200 mg), bismuth pectin granules (150 mg), or bismuth pectin granules (300 mg). The primary outcome was the eradication rate of H. pylori. The secondary outcomes included symptom improvement, patient compliance, and incidence of adverse events. This study was registered at ClinicalTrials.gov (NCT04209933). RESULTS A total of 240 patients were included in this study, and 211 patients completed the follow-up. An intention-to-treat analysis showed that the H. pylori eradication rates of the 4 groups were 73.3%, 76.7%, 75.0%, and 71.7%, respectively. The per-protocol analysis showed that the H. pylori eradication rates of the 4 groups were 86.3%, 82.1%, 83.3%, and 86.0%. There was no significant difference among the 4 groups in the H. pylori eradication rate (P > .05). There were also no significant differences in the symptom improvement rate, overall adverse reaction rate, or patient compliance among the 4 groups. CONCLUSIONS Bismuth pectin capsules and bismuth pectin granules had similar efficacy and safety for H. pylori eradication compared to bismuth potassium citrate. These data suggest that bismuth pectin can be an alternative to bismuth potassium citrate to eradicate H. pylori when using bismuth-containing quadruple therapy.
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Affiliation(s)
- Yaping Cao
- Xi’an Medical University, Xi’an, Shaanxi Province, China
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi’an, Shaanxi Province, China
| | - Jian Zhang
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi’an, Shaanxi Province, China
- Department of Gastroenterology, The Air Force Hospital of Northern Theatre of PLA, Shenyang, Liaoning Province, China
| | - Yuan Liu
- Department of Emergency, Xin’an Central Hospital, Xi’an, Shaanxi Province, China
| | - Lifeng Zhang
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi’an, Shaanxi Province, China
| | - Lu Wang
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi’an, Shaanxi Province, China
| | - Jie Wang
- Xi’an Medical University, Xi’an, Shaanxi Province, China
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi’an, Shaanxi Province, China
| | - Ying Qi
- Xi’an Medical University, Xi’an, Shaanxi Province, China
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi’an, Shaanxi Province, China
| | - Huanhuan Lv
- Xi’an Medical University, Xi’an, Shaanxi Province, China
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi’an, Shaanxi Province, China
| | - Juan Liu
- Xi’an Medical University, Xi’an, Shaanxi Province, China
| | - Lijuan Huo
- First Hospital of Shanxi Medical University, Taiyuan, Shanxi Province, China
| | - Xiaoguo Wei
- Gansu Provincial Hospital, Lanzhou, Gansu Province, China
| | - Yongquan Shi
- Xi’an Medical University, Xi’an, Shaanxi Province, China
- State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi’an, Shaanxi Province, China
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Zhao Y, Yang Y, Aruna, Xiao J, Song J, Huang T, Li S, Kou J, Huang L, Ji D, Xiong S, Peng W, Xu S, Cheng B. Saccharomyces boulardii Combined With Quadruple Therapy for Helicobacter pylori Eradication Decreased the Duration and Severity of Diarrhea: A Multi-Center Prospective Randomized Controlled Trial. Front Med (Lausanne) 2021; 8:776955. [PMID: 34869495 PMCID: PMC8637152 DOI: 10.3389/fmed.2021.776955] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2021] [Accepted: 10/04/2021] [Indexed: 12/27/2022] Open
Abstract
Background: Whether probiotics helped the Helicobacter pylori (H. pylori) eradication was still highly controversial. The non-bacterial Saccharomyces boulardii (S. boulardii) has demonstrated its efficacy in the treatment of antibiotic-associated and infectious diarrhea. We aimed to evaluate the effects of S. boulardii combined with quadruple therapy for H. pylori eradication and associated side effects. Methods: Three hundred and sixty H. pylori-infected patients were recruited in this multicenter, randomized controlled trial. The patients who underwent H. pylori eradication treatment were randomized in a ratio of 1:1 into two separate groups that received standard quadruple therapy (Group A) and quadruple therapy plus S. boulardii sachets (Group B) for 14 days. The everyday medication and side-effect records were collected for compliance and adverse effect analysis. All patients accepted 13C/14C-urea breath tests 4 weeks after the therapy completion. Results:Saccharomyces boulardii and quadruple therapy-combined intervention significantly reduced the incidences of overall side effects (27.8 vs. 38.5%, p = 0.034) and diarrhea (11.2 vs. 21.2%, p = 0.012) in Group B compared with quadruple therapy alone in Group A, especially reduced the diarrhea duration (5.0 days vs. 7.7 days, p = 0.032) and incidence of severe diarrhea (4.7 vs. 10.1%, p = 0.040). Intention-to-treat (ITT) analysis and per-protocol (PP) analysis both indicated no statistical differences of eradication rate between Groups A and B (ITT: 82.7 vs. 85.8%, p = 0.426; PP: 89.7 vs. 94.2%, p = 0.146). The joint use of S. boulardii and quadruple therapy markedly improved the overall pre-eradication alimentary symptoms (hazard ratio (HR): 2.507, 95% CI: 1.449–4.338) recovery. Conclusion:Saccharomyces boulardii ameliorated H. pylori eradication-induced antibiotic-associated side effects especially reduced the incidence of severe diarrhea and the duration of diarrhea. However, there was no significant effect of S. boulardii on the rate of H. pylori eradication. Trial Registration: The protocol had retrospectively registered at ClinicalTrails.gov, Unique identifier: NCT03688828, date of registration: September 27, 2018; https://clinicaltrials.gov/show/NCT03688828
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Affiliation(s)
- Yuchong Zhao
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Yilei Yang
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Aruna
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Jun Xiao
- Department of Gastroenterology and Hepatology, Zhongnan Hospital of Wuhan University, Wuhan, China
| | - Jun Song
- Department of Gastroenterology and Hepatology, Union Hospital (West District), Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Tizheng Huang
- Department of Gastroenterology and Hepatology, Hubei Aerospace Hospital, Xiaogan, China
| | - Shuyu Li
- Department of Gastroenterology and Hepatology, The Third People's Hospital of Hubei Province, Wuhan, China
| | - Jiguang Kou
- Department of Gastroenterology and Hepatology, The Central Hospital of Xiaogan, Xiaogan, China
| | - Lu Huang
- Department of Gastroenterology and Hepatology, The First People's Hospital of Xiaogan, Xiaogan, China
| | - Dexiong Ji
- Department of Gastroenterology and Hepatology, Anlu People's Hospital, Anlu, China
| | - Si Xiong
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Wang Peng
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Sanping Xu
- Department of Gastroenterology and Hepatology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Bin Cheng
- Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
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Huang Q, Shi Z, Cheng H, Ye H, Zhang X. Efficacy and Safety of Modified Dual Therapy as the First-line Regimen for the Treatment of Helicobacter pylori Infection: A Meta-Analysis of Randomized Controlled Trials. J Clin Gastroenterol 2021; 55:856-864. [PMID: 33074949 PMCID: PMC8513521 DOI: 10.1097/mcg.0000000000001448] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/08/2020] [Accepted: 09/12/2020] [Indexed: 01/30/2023]
Abstract
BACKGROUND In an era of antibiotic resistance, modified dual therapy has been paid much attention because of simple drug composition and low resistance of amoxicillin. However, its eradication rate as a first-line regimen remains controversial. This study is to evaluate the efficacy and safety of modified dual therapy for the initial treatment of Helicobacter pylori (H. pylori) infection compared with mainstream first-line therapies. METHODS PubMed, the Cochrane Library, and Embase were searched for randomized clinical trials evaluating the efficacy and safety of modified dual therapy as the initial treatment for H. pylori eradication compared with guideline-recommended first-line therapies. A meta-analysis was conducted using Review Manager 5.3 and dichotomous data were estimated by the risk ratio (RR) with the 95% confidence interval (CI). We also performed subgroup analysis according to control groups and studies with antibiotic susceptibility tests. RESULTS Eight studies including 1672 patients with H. pylori infection met the selection criteria and were assessed. The meta-analysis demonstrated that modified dual therapy achieved similar efficacy [85.83% vs. 86.77%, RR 0.99 (95% CI, 0.95-1.03), intention-to-treat analysis; 89.53% vs. 90.45%, RR 0.99 (95% CI, 0.96-1.02), per-protocol analysis] and compliance [95.77% vs. 95.56%, RR 1.00 (95% CI, 0.98-1.02)] compared with recommended first-line regimens. In addition, there were no significant differences in comparing the eradication rate of modified dual therapy with clarithromycin triple therapy, bismuth quadruple therapy, and concomitant therapy, respectively. Subgroup analysis based on the studies with antibiotic susceptibility tests also confirmed a similar efficacy. However, modified dual therapy showed fewer adverse effects [8.70% vs. 22.38%, RR 0.39 (95% CI, 0.28-0.54)], with a significant difference (P<0.00001). CONCLUSION Modified dual therapy achieved equal efficacy and compliance compared with recommended first-line regimens for H. pylori infection, and generally modified dual therapy showed fewer side effects.
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Affiliation(s)
- Qiuyue Huang
- Department of Integrated Traditional Chinese and Western Medicine, Peking University First Hospital
- Institute of Integrated Traditional Chinese and Western Medicine, Peking University
| | - Zongming Shi
- Department of Integrated Traditional Chinese and Western Medicine, Peking University First Hospital
- Institute of Integrated Traditional Chinese and Western Medicine, Peking University
| | - Hong Cheng
- Department of Gastroenterology, Peking University First Hospital, Beijing, China
| | - Hui Ye
- Department of Integrated Traditional Chinese and Western Medicine, Peking University First Hospital
- Institute of Integrated Traditional Chinese and Western Medicine, Peking University
| | - Xuezhi Zhang
- Department of Integrated Traditional Chinese and Western Medicine, Peking University First Hospital
- Institute of Integrated Traditional Chinese and Western Medicine, Peking University
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Liu C, Wang Y, Shi J, Zhang C, Nie J, Li S, Zheng T. The status and progress of first-line treatment against Helicobacter pylori infection: a review. Therap Adv Gastroenterol 2021; 14:1756284821989177. [PMID: 34262609 PMCID: PMC8243100 DOI: 10.1177/1756284821989177] [Citation(s) in RCA: 17] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/15/2020] [Accepted: 12/30/2020] [Indexed: 02/04/2023] Open
Abstract
Helicobacter pylori (HP) is a major causative agent of chronic gastritis and peptic ulcer. HP is also engaged in the development of gastric cancer and gastric mucosa-associated lymphoid tissue lymphoma. It is an important pathogenic factor in various other systemic diseases, such as vitamin B12 deficiency, iron deficiency, and idiopathic thrombocytopenia. The current consensus is that unless there is a special reason, eradication therapy should be implemented whenever HP infection is found, and it is ideally successful the first time. International guidelines recommend that under certain conditions, treatment should be personalized based on drug susceptibility testing. However, drug susceptibility testing is often not available because it is expensive, time-consuming, and difficult to obtain living tissue. Each region has separately formulated guidelines or consensuses on empirical therapy. Owing to an increasing drug resistance rate in various places, the eradication rate of proton pump inhibitor (PPI) triple therapy and sequential therapy has been affected. These regimens are rarely used; the PPI triple especially has been abandoned in most areas. Currently, radical treatment regimens for HP involve bismuth-containing quadruple therapy and concomitant therapy. However, quadruple therapy has its own limitations, such as complex drug administration. To improve the effectiveness, safety, and compliance, many clinical studies have proposed useful modified regimens, which mainly include the modified bismuth-containing quadruple regimen, high-dose dual therapy, and vonoprazan-containing regimens. Studies have shown that these emerging regimens have acceptable eradication rates and safety, and are expected to become first-line treatments in empirical therapy. However, the problem of decline in the eradication rate caused by drug resistance has not been fundamentally solved. This review not only summarizes the effectiveness of mainstream regimens in the first-line treatment of HP infection with the currently increasing antibiotic resistance rates, but also summarizes the effectiveness and safety of various emerging treatment regimens.
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Affiliation(s)
- Caiqi Liu
- Harbin Medical University, Harbin, China
| | - Yuan Wang
- Harbin Medical University, Harbin, China
| | - Jiaqi Shi
- Harbin Medical University, Harbin, China
| | | | | | - Shun Li
- Harbin Medical University, Harbin, China
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Graham DY, Lu H, Shiotani A. Vonoprazan-containing Helicobacter pylori triple therapies contribution to global antimicrobial resistance. J Gastroenterol Hepatol 2021; 36:1159-1163. [PMID: 32918832 DOI: 10.1111/jgh.15252] [Citation(s) in RCA: 45] [Impact Index Per Article: 11.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/27/2020] [Revised: 08/31/2020] [Accepted: 09/06/2020] [Indexed: 12/13/2022]
Abstract
Amoxicillin and proton pump inhibitor dual Helicobacter pylori therapy has proved not to be reliably highly effective primarily because of traditional proton pump inhibitors' inability to maintain a high intragastric pH. Clarithromycin and proton pump inhibitor H. pylori dual therapy failed in part because clarithromycin resistance emerged during therapy causing treatment failures. The combination of amoxicillin, clarithromycin, and proton pump inhibitor was subsequently undermined by increasing clarithromycin resistance. Although vonoprazan appeared to restore the effectiveness of triple therapy, the improvement was almost entirely to improved effectiveness of amoxicillin dual therapy component and resulted in the majority (>85% currently in Japan) of those receiving vonoprazan-amoxicillin plus a second antibiotic (e.g. clarithromycin, metronidazole, fluoroquinolone, or rifabutin) receiving no benefit from the second antibiotic. The results in somewhere between 2800 and 5600 kg of unnecessary clarithromycin per one million H. pylori treatment courses per year in Japan. The only contribution of the second antibiotic is to increase global antimicrobial resistance. There are now sufficient data to prove that optimized vonoprazan-amoxicillin dual therapy can reliably achieve cure rates ≥95%. This manuscript discusses use of the principles of antimicrobial stewardship to develop potassium-competitive acid blocker-containing H. pylori therapies that will reliably achieve high H. pylori cure rates with minimal or no use of excess antibiotics. Such therapies are urgently needed so that use of vonoprazan triple therapies can be curtailed while also improving overall H. pylori cure rates.
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Affiliation(s)
- David Y Graham
- Department of Medicine, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, Texas, USA
| | - Hong Lu
- GI Division, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - Akiko Shiotani
- Department of Internal Medicine, Kawasaki Medical School, Okayama, Japan
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Pih GY, Choi KD, Gong EJ, Na HK, Ahn JY, Lee JH, Jung KW, Kim DH, Song HJ, Lee GH, Jung HY. Modified bismuth quadruple therapy with low-dose metronidazole as first-line therapy for Helicobacter pylori infection. Helicobacter 2021; 26:e12759. [PMID: 33113240 DOI: 10.1111/hel.12759] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/06/2020] [Revised: 08/30/2020] [Accepted: 09/02/2020] [Indexed: 12/12/2022]
Abstract
BACKGROUND Bismuth-containing quadruple therapy is an effective alternative first-line therapy for Helicobacter pylori infection. We evaluated the efficacy and safety of a modified twice-a-day bismuth quadruple regimen (BQT-2) with low-dose (1000 mg total) metronidazole as first-line therapy for the eradication of H pylori. MATERIALS AND METHODS In this prospective pilot study, patients diagnosed with H pylori infection and naïve to eradication therapy were included. The modified BQT-2 therapy consisted of rabeprazole 20 mg, amoxicillin 1 g, metronidazole 500 mg, and tripotassium dicitrato bismuthate 600 mg (elemental bismuth 240 mg) twice daily, given 30 minutes before morning and evening meals for 14 days. H pylori eradication was assessed by 13 C-urea breath test conducted at least 4 weeks after therapy completion. RESULTS In 66 patients who received the modified BQT-2 regimen, the compliance rate was 100% and the H pylori eradication rate was 77.3%. H pylori was successfully cultured in 50 (75.8%) patients. The resistance rates to metronidazole and clarithromycin were 30.0% and 22.0%, respectively. Eradication rates were not significantly different according to the resistance to metronidazole (metronidazole-susceptible: 74.3% [26/35], metronidazole-resistant: 73.3% [11/15]; P > .99). Most of the adverse events were mild, with 20 (30%) patients developing nausea, epigastric soreness, loose stool, asthenia, skin rash, dizziness, taste perversion, headache, or dyspepsia. CONCLUSIONS Twice-a-day modified BQT-2 regimen with low-dose metronidazole was suboptimal as an alternative first-line therapy for eradicating H pylori, despite high patient compliance.
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Affiliation(s)
- Gyu Young Pih
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Kee Don Choi
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Eun Jeong Gong
- Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea
| | - Hee Kyong Na
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Ji Yong Ahn
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Jeong Hoon Lee
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Kee Wook Jung
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Do Hoon Kim
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Ho June Song
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Gin Hyug Lee
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Hwoon-Yong Jung
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
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Yun J, Wu Z, Qi G, Han T, Zhang D. The high-dose amoxicillin-proton pump inhibitor dual therapy in eradication of Helicobacter pylori infection. Expert Rev Gastroenterol Hepatol 2021; 15:149-157. [PMID: 32960107 DOI: 10.1080/17474124.2021.1826306] [Citation(s) in RCA: 18] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
INTRODUCTION More attention has been paid to the eradication therapy of Helicobactor pylori with the enhancement of health awareness of patients. However, the increasing antibiotic resistance of H. pylori, due to the wide use and abuse of antibiotics, has become a critical factor affecting the efficacy of eradication. To effectively improve the eradication rate of H. pylori, high-dose amoxicillin-proton pump inhibitor (PPI) dual therapy has recently become one of the hot issues. AREAS COVERED The authors review the schemes and efficacy of high-dose amoxicillin-PPI dual therapies in eradication of H. pylori infection. The review indicates that the H. pylori eradication rate of the dual therapy is overall comparable to or better than that of bismuth-containing quadruple therapy or standard triple therapy. It is more effective to administer both amoxicillin and PPI 3-4 times daily for 14 days in the high-dose amoxicillin-PPI dual therapy, and esomeprazole seems to be superior to other PPIs. EXPERT OPINION The high-dose amoxicillin-PPI dual therapy is currently a promising H. pylori eradication regimen in clinical practice, deserving further verification and discussion. Much more attention should be paid to the influence of CYP2C19 polymorphisms and virulence genotyping on H. pylori eradication, and the homogeneity and objectivity of the comparison among different studies.
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Affiliation(s)
- Jianwei Yun
- Department of Gastroenterology, The Second Hospital of Lanzhou University , Lanzhou, China.,Key Laboratory of Digestive Diseases, The Second Hospital of Lanzhou University , Lanzhou, China
| | - Zhiping Wu
- Department of Gastroenterology, The Second Hospital of Lanzhou University , Lanzhou, China
| | - Guoqing Qi
- Department of Gastroenterology, The Second Hospital of Lanzhou University , Lanzhou, China
| | - Tiyun Han
- Key Laboratory of Digestive Diseases, The Second Hospital of Lanzhou University , Lanzhou, China
| | - Dekui Zhang
- Department of Gastroenterology, The Second Hospital of Lanzhou University , Lanzhou, China.,Key Laboratory of Digestive Diseases, The Second Hospital of Lanzhou University , Lanzhou, China
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Hu CT. High-dose dual therapy versus bismuth-containing quadruple therapy for the treatment of Helicobacter pylori infection – A review of the strengths, weaknesses, and proposed solutions. Tzu Chi Med J 2021; 34:303-309. [PMID: 35912055 PMCID: PMC9333101 DOI: 10.4103/tcmj.tcmj_185_21] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/28/2021] [Revised: 07/19/2021] [Accepted: 08/17/2021] [Indexed: 11/04/2022] Open
Abstract
Helicobacter pylori is the principal cause of peptic ulcers, gastric cancer, and mucosa-associated lymphoid tissue lymphoma. The first treatment to H. pylori infection is dual therapy (a bismuth compound plus metronidazole). On the launch of omeprazole in 1988, dual therapy became omeprazole and amoxicillin (low dose). The poor H. pylori eradication rates by either bismuth-based or low-dose dual therapy drove more combinations of antibiotics were needed. Antibiotic resistance, especially clarithromycin and metronidazole, has made bismuth-containing quadruple therapy (BCQT) a savior for first-line and second-line treatments. However, its complicated dosing regimen commonly causes more adverse events and poor drug compliance. Thus, high-dose dual therapy (HDDT) has been re-arising. This article reviews the strengths and weaknesses of HDDT versus BCQT with proposed solutions.
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14-Day High-Dose Amoxicillin- and Metronidazole-Containing Triple Therapy With or Without Bismuth as First-Line Helicobacter pylori Treatment. Dig Dis Sci 2020; 65:3639-3646. [PMID: 32020360 DOI: 10.1007/s10620-020-06115-7] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/15/2019] [Accepted: 01/27/2020] [Indexed: 02/07/2023]
Abstract
BACKGROUND Amoxicillin, metronidazole, proton pump inhibitor, bismuth quadruple therapy had been shown to reliably achieve high eradication rates. The role of individual components remains undefined. AIM To identify the additional benefit/role of bismuth in amoxicillin, metronidazole, proton pump inhibitor, bismuth quadruple therapy for Helicobacter pylori (H. pylori) treatment. METHODS This was a non-inferiority factorial design trial. Treatment-naive H. pylori-infected subjects were randomly (1:1) assigned to receive 14-day amoxicillin- and metronidazole-containing triple therapy consisting of esomeprazole 20 mg twice a day, amoxicillin 1 g, and metronidazole 400 mg both thrice daily with or without 220 mg bismuth twice a day. Six weeks after treatment, H. pylori eradication was assessed by 13C-urea breath test. Antimicrobial susceptibility was assessed by the twofold agar dilution method. RESULTS From July 2018 to June 2019, a total of two hundred and sixteen subjects were randomized. Both therapies achieved high eradication rates. Per-protocol with bismuth = 97.9% (94/96, 95% CI 95.1-100%) and without bismuth = 94.7% (90/95, 95% CI 90.3-99.1%) (P = 0.43). Intent-to-treat analysis = 90.7% (98/108, 95% CI 85.2-96.2%) versus 88.9% (96/108, 95% CI 82.8-95.0%) with and without bismuth (P = 0.65). The two regimens were not inferior by intent-to-treat or per-protocol analyses. Metronidazole resistance did not affect the efficacy of either therapy. CONCLUSION Neither the presence nor absence of bismuth or metronidazole resistance reduced the effectiveness of triple therapy containing esomeprazole 20 mg twice a day, amoxicillin 1 g, and metronidazole 400 mg thrice daily in this population. The clinical trial was registered with ClinicalTrials.gov, NCT03557437.
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Georgopoulos S, Papastergiou V. An update on current and advancing pharmacotherapy options for the treatment of H. pylori infection. Expert Opin Pharmacother 2020; 22:729-741. [PMID: 33131337 DOI: 10.1080/14656566.2020.1845649] [Citation(s) in RCA: 28] [Impact Index Per Article: 5.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
Introduction: Eradication of Helicobacter pylori (H. pylori) becomes more challenging due to increasing antimicrobial resistance. Consequently, the performance of clarithromycin-containing triple therapies is now declining to unacceptable levels and should be abandoned unless a prior susceptibility test precludes clarithromycin resistance.Areas covered: This review summarizes updated evidence concerning new and advancing pharmacotherapy options for H. pylori eradication.Expert opinion: Due to the declining efficacy of legacy triple therapies, most guidelines recommend bismuth quadruple therapy as the best initial empiric treatment. Concomitant, sequential and hybrid therapies are remarkable bismuth-free quadruple options, provided that dual clarithromycin-metronidazole resistance is low. Levofloxacin-, rifabutin-, furazolidone- and sitafloxacin-containing regimens remain useful, particularly as salvage options. To eradicate H. pylori in line with the rules of antibiotic stewardship, susceptibility-guided treatment appears as the ideal approach. However, the feasibility and cost-effectiveness of universal pre-treatment susceptibility testing warrants further evaluation. Molecular testing methods promise convenient characterization of H. pylori antibiotic susceptibility. High-dose dual therapy (proton-pump-inhibitor plus amoxicillin) and vonoprazan, a more potent acid inhibitor that likely enhances the activity of amoxicillin, are promising alternatives that could decrease misuse of antibiotics. Addition of certain probiotics could somewhat increase the performance of H. pylori eradication regimens, while improving tolerability.
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Affiliation(s)
- Sotirios Georgopoulos
- Department of Gastroenterology, Athens Medical P. Faliron General Hospital, Athens, Greece
| | - Vasilios Papastergiou
- Department of Gastroenterology, "Konstantopoulion-Patision" General Hospital, Athens, Greece
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Management of Helicobacter pylori. Curr Opin Gastroenterol 2020; 36:518-524. [PMID: 32868505 DOI: 10.1097/mog.0000000000000678] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/10/2022]
Abstract
PURPOSE OF REVIEW Gastroenterologists and many general internists and primary care physicians confront questions regarding the management of Helicobacter pylori on a daily basis. The subject remains of global interest and continue to generate debate and research. Using the search terms 'pylori and treatment' or 'pylori and management' we identified over 1000 relevant articles in PubMed published over the time period 1 January 2019 to 30 April 2020. We have selected the most highly clinically relevant of these to review here. RECENT FINDINGS Clinical evidence grows regarding the benefits of H. pylori eradication on gastric cancer prevention. High rates of resistance to clarithromycin and levofloxacin, correlating with treatment failure in regimens utilizing these drugs, has stimulated interest in alternative regimens as well as the need for susceptibility testing of individual patients and populations. Although many aspects of H. pylori management are well established, implementation of appropriate testing and treatment pathways remains suboptimal throughout healthcare settings. SUMMARY Increased emphasis on measuring H. pylori-related clinical outcomes in practice is needed to identify implementation gaps, and to suggest means to best apply the knowledge gained on H. pylori for the prevention of gastric symptoms and disease.
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Gao W, Ye H, Deng X, Wang C, Xu Y, Li Y, Zhang X, Cheng H. Rabeprazole-amoxicillin dual therapy as first-line treatment for H pylori eradication in special patients: A retrospective, real-life study. Helicobacter 2020; 25:e12717. [PMID: 32548932 PMCID: PMC7540066 DOI: 10.1111/hel.12717] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/30/2020] [Revised: 05/28/2020] [Accepted: 05/29/2020] [Indexed: 01/06/2023]
Abstract
BACKGROUND The currently recommended quadruple regimens for Helicobacter pylori infection might not be appropriate for every patient, especially in elderly patients or those with multiple comorbidities. OBJECTIVE To evaluate the efficacy and safety of rabeprazole-amoxicillin dual therapy in H pylori-positive elderly patients or those with multiple comorbidities. METHODS From November 2013 to May 2017, the clinical data of H pylori-positive patients ≥60 years old or with multiple comorbidities were collected and reviewed. All patients were given rabeprazole 10 mg three times a day and amoxicillin 1000 mg thrice a day (RA dual therapy) for 14 days as first-line treatment. H pylori eradication was evaluated by 13 C-urea breath test 6 weeks after treatment. Adverse effects were recorded. RESULTS A total of 198 patients were enrolled, including 116 elderly patients and 82 patients with multiple comorbidities. Successful eradication was achieved in 90.9% (180/198, 95% CI: 86.1%-94.2%) patients. Adverse effects, which were mainly mild (referring to skin rash, abdominal pain, and diarrhea), occurred in 22 patients (22/198, 11.1%) and resolved spontaneously. CONCLUSION Dual therapy composed of rabeprazole and amoxicillin as a first-line treatment appears to be effective and safe for H pylori infection in elderly patients or those with multiple comorbidities. Additional studies are needed to optimize the regimen.
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Affiliation(s)
- Wen Gao
- GI DepartmentPeking University First HospitalBeijingChina
| | - Hui Ye
- TCM and Integrative Medicine DepartmentPeking University First HospitalBeijingChina
| | - Xin Deng
- TCM and Integrative Medicine DepartmentPeking University First HospitalBeijingChina
| | - Chi Wang
- GI DepartmentPeking University First HospitalBeijingChina
| | - Ying Xu
- GI DepartmentPeking University First HospitalBeijingChina
| | - Yixuan Li
- GI DepartmentPeking University First HospitalBeijingChina
| | - Xuezhi Zhang
- TCM and Integrative Medicine DepartmentPeking University First HospitalBeijingChina
| | - Hong Cheng
- GI DepartmentPeking University First HospitalBeijingChina
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Tang X, Chen X, Shen Y, Yang T, Hu R, Debowski AW, Stubbs KA, Benghezal M, Marshall BJ, Li H, Tang H. Primary antibiotic resistance of Helicobacter pylori among a Chinese Tibetan population. Future Microbiol 2020; 15:1353-1361. [PMID: 32900223 DOI: 10.2217/fmb-2020-0206] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023] Open
Abstract
Aim: To evaluate the primary antibiotic resistance in Helicobacter pylori strains isolated from a Chinese Tibetan population. Methods & materials: Gastric biopsies from 400 H. pylori treatment-naive Tibetan patients were collected for H. pylori isolation. Susceptibility to amoxicillin (AML)/clarithromycin (CLR)/levofloxacin (LEV)/metronidazole (MTZ)/tetracycline (TET)/rifampicin (RIF)/furazolidone (FZD) was determined by E-test or a disk diffusion assay. Results: Biopsies from 117 patients were H. pylori culture positive (29.3%). The primary resistance rates to MTZ, CLR, LEV, RIF, AML, TET and FZD were 90.6, 44.4, 28.2, 69.2, 7.7, 0.8 and 0.8%, respectively. Interestingly, 42.7% of the strains had simultaneous resistance to CLR and MTZ. Conclusion: Among Tibetan strains, primary resistance rates were high for CLR/MTZ/LEV, whereas primary resistance rates to AML/TET/FZD were low. The high resistance to RIF is a concerning finding.
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Affiliation(s)
- Xiaoqiong Tang
- West China Marshall Research Center for Infectious Diseases, Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, 610041, China
| | - Xiaohong Chen
- Department of Digestive Medicine, Hospital of Chengdu Office of People's Government of Tibetan Autonomous Region, Chengdu, 610041, China
| | - Yalin Shen
- West China Marshall Research Center for Infectious Diseases, Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, 610041, China
| | - Tiankuo Yang
- West China Marshall Research Center for Infectious Diseases, Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, 610041, China
| | - Renwei Hu
- Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, 610041, China
| | - Aleksandra W Debowski
- Helicobacter pylori Research Laboratory, School of Biomedical Sciences, Marshall Centre for Infectious Disease Research & Training, University of Western Australia, Nedlands, Perth, 6009, Australia.,School of Molecular Sciences, University of Western Australia, Crawley, Perth, 6009, Australia
| | - Keith A Stubbs
- School of Molecular Sciences, University of Western Australia, Crawley, Perth, 6009, Australia
| | - Mohammed Benghezal
- West China Marshall Research Center for Infectious Diseases, Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, 610041, China
| | - Barry J Marshall
- Helicobacter pylori Research Laboratory, School of Biomedical Sciences, Marshall Centre for Infectious Disease Research & Training, University of Western Australia, Nedlands, Perth, 6009, Australia
| | - Hong Li
- West China Marshall Research Center for Infectious Diseases, Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, 610041, China
| | - Hong Tang
- West China Marshall Research Center for Infectious Diseases, Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, 610041, China
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Feng XY, Zhang Y, Deng B. Progress in research of high-dose dual therapy as an eradication protocol for Helicobacter pylori infection. Shijie Huaren Xiaohua Zazhi 2020; 28:847-851. [DOI: 10.11569/wcjd.v28.i17.847] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Affiliation(s)
- Xin-Yi Feng
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou 225000, Jiangsu Province, China
| | - Yun Zhang
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou 225000, Jiangsu Province, China
| | - Bin Deng
- Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou 225000, Jiangsu Province, China
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Bang CS, Lim H, Jeong HM, Shin WG, Choi JH, Soh JS, Kang HS, Yang YJ, Hong JT, Shin SP, Suk KT, Lee JJ, Baik GH, Kim DJ. Amoxicillin or tetracycline in bismuth-containing quadruple therapy as first-line treatment for Helicobacter pylori infection. Gut Microbes 2020; 11:1314-1323. [PMID: 32362221 PMCID: PMC7524369 DOI: 10.1080/19490976.2020.1754118] [Citation(s) in RCA: 25] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/03/2020] [Revised: 03/17/2020] [Accepted: 03/30/2020] [Indexed: 02/08/2023] Open
Abstract
AIM To compare the efficacy and safety between modified quadruple- and bismuth-containing quadruple therapy as first-line eradication regimen for Helicobacter pylori infection. METHODS This study was a multicenter, randomized-controlled, non-inferiority trial. Subjects endoscopically diagnosed with H. pylori infection were randomly allocated to receive modified quadruple- (rabeprazole 20 mg bid, amoxicillin 1 g bid, metronidazole 500 mg tid, bismuth subcitrate 300 mg qid [elemental bismuth 480 mg]; PAMB) or bismuth-containing quadruple therapy (rabeprazole 20 mg bid, bismuth subcitrate 300 mg qid, metronidazole 500 mg tid, tetracycline 500 mg qid; PBMT) for 14 days. Rates of eradication success and adverse events were investigated. Antibiotic resistance was determined using the agar dilution and DNA sequencing of the clarithromycin resistance point mutations in the 23 S rRNA gene of H. pylori. RESULTS In total, 233 participants were randomized, 27 were lost to follow-up, and four violated the protocol. Both regimens showed an acceptable eradication rate in the intention-to-treat (PAMB: 87.2% vs. PBMT: 82.8%, P = .37), modified intention-to-treat (96.2% vs. 96%, P > .99), and per-protocol (96.2% vs. 96.9%, P > .99) analyses. Non-inferiority in the eradication success between PAMB and PBMT was confirmed. The amoxicillin-, metronidazole-, tetracycline-, clarithromycin-, and levofloxacin-resistance rates were 8.3, 40, 9.4, 23.5, and 42.2%, respectively. Antimicrobial resistance did not significantly affect the efficacy of either therapy. Overall compliance was 98.1%. Adverse events were not significantly different between the two therapies. CONCLUSION Modified quadruple therapy comprising rabeprazole, amoxicillin, metronidazole, and bismuth is an effective first-line treatment for the H. pylori infection in regions with high clarithromycin and metronidazole resistance.
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Affiliation(s)
- Chang Seok Bang
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
- Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Korea
- Institute of New Frontier Research, Hallym University College of Medicine, Chuncheon, Korea
| | - Hyun Lim
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
- Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Korea
| | - Hae Min Jeong
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
- Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Korea
| | - Woon Geon Shin
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
- Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Korea
| | - Jae Ho Choi
- Institute of New Frontier Research, Hallym University College of Medicine, Chuncheon, Korea
| | - Jae Seung Soh
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
- Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Korea
| | - Ho Suk Kang
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
- Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Korea
| | - Young Joo Yang
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
- Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Korea
| | - Ji Taek Hong
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
- Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Korea
| | - Suk Pyo Shin
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
- Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Korea
| | - Ki Tae Suk
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
- Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Korea
| | - Jae Jun Lee
- Institute of New Frontier Research, Hallym University College of Medicine, Chuncheon, Korea
- Department of Anesthesiology and Pain Medicine, Hallym University College of Medicine, Chuncheon, Korea
| | - Gwang Ho Baik
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
- Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Korea
| | - Dong Joon Kim
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
- Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Korea
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O'Connor A, Furuta T, Gisbert JP, O'Morain C. Review - Treatment of Helicobacter pylori infection 2020. Helicobacter 2020; 25 Suppl 1:e12743. [PMID: 32918350 DOI: 10.1111/hel.12743] [Citation(s) in RCA: 25] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
This review summarizes important studies regarding Helicobacter pylori therapy published from April 2019 to April 2020. The main themes that emerge involve studies assessing antibiotic resistance, and there is also growing momentum behind the utility of vonoprazan as an alternative to proton pump inhibitor (PPI) therapy and also bismuth-based regimens as a first-line regimen. Antibiotic resistance is rising wherever it is being assessed, and clarithromycin resistance in particular has reached a point where it may no longer be a viable therapy without previous testing in many regions of the world. The evidence for the efficacy of a bismuth-based quadruple therapy as a first-line therapy is now very clearly established, and there is substantial evidence that it is the best performing first-line therapy. The utility of vonoprazan as an alternative to PPI therapy, especially in resistant and difficult-to-treat groups, has also been considered in great detail this year, and it may offer an opportunity in the near future to reduce the problem of antibiotic resistance.
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Affiliation(s)
- Anthony O'Connor
- Department of Gastroenterology, Tallaght University Hospital/Trinity College, Dublin, Ireland
| | - Takahisa Furuta
- The Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan
| | - Javier P Gisbert
- Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
| | - Colm O'Morain
- Department of Gastroenterology, Tallaght University Hospital/Trinity College, Dublin, Ireland
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50
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Gao CP, Zhang D, Zhang T, Wang JX, Han SX, Graham DY, Lu H. PPI-amoxicillin dual therapy for Helicobacter pylori infection: An update based on a systematic review and meta-analysis. Helicobacter 2020; 25:e12692. [PMID: 32314468 DOI: 10.1111/hel.12692] [Citation(s) in RCA: 68] [Impact Index Per Article: 13.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/12/2019] [Revised: 02/27/2020] [Accepted: 03/03/2020] [Indexed: 01/30/2023]
Abstract
BACKGROUND AND AIMS The efficacy of PPI-amoxicillin dual therapy (high-dose dual therapy) in the eradication of Helicobacter pylori is controversial. We aimed to investigate whether PPI-amoxicillin dual therapy is effective. METHODS We searched several publication databases for randomized controlled trials (RCTs) that compared PPI-amoxicillin dual therapy with controls up to March 2019. Meta-analyses of eradication rates were performed using random-effects models. RESULTS Data from twelve RCTs including 2249 patients suggested that PPI-amoxicillin dual therapy and the current mainstream guidelines-recommended therapies achieved similar efficacy (83.2% vs 85.3%, risk ratio [RR]: 1.00, 95% CI 0.97-1.03, intention-to-treat analysis), (87.5% vs 90.1%, RR: 0.98, 95% CI 0.95-1.02, per-protocol analysis), and compliance (94.3% vs 93.5%, RR: 1.11, 95% CI 0.78-1.59), but side effects were less likely in the dual therapy (12.9% vs 28.0%, RR: 0.53, 95% CI 0.37-0.76). Further subgroup analyses showed that the seven RCTs (1302 patients) that reported antimicrobial susceptibility test results also showed that PPI-amoxicillin dual therapy and the current guidelines-recommended therapies achieved similar efficacy, and PPI-amoxicillin dual therapy was as effective for rescue therapy (RR: 0.97, 95% CI 0.89-1.05) as for first-line treatment (RR: 0.97, 95% CI 0.93-1.02). CONCLUSIONS Compared with the current mainstream guidelines-recommended therapies, PPI-amoxicillin dual therapy has the same efficacy and compliance, and generally PPI-amoxicillin dual therapy causes fewer side effects.
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Affiliation(s)
- Cai-Ping Gao
- Department of Gastroenterology, Sichuan Academy of Science & Sichuan Provincial People's Hospital, University of Electronic Science and Technology, Chengdu, China
| | - Di Zhang
- Department of Gastroenterology, Sichuan Academy of Science & Sichuan Provincial People's Hospital, University of Electronic Science and Technology, Chengdu, China
| | - Ting Zhang
- Department of Gastroenterology, Sichuan Academy of Science & Sichuan Provincial People's Hospital, University of Electronic Science and Technology, Chengdu, China
| | - Jin-Xia Wang
- Department of Gastroenterology, Sichuan Academy of Science & Sichuan Provincial People's Hospital, University of Electronic Science and Technology, Chengdu, China
| | - Sheng-Xi Han
- Department of Gastroenterology, Sichuan Academy of Science & Sichuan Provincial People's Hospital, University of Electronic Science and Technology, Chengdu, China
| | - David Y Graham
- Department of Medicine, Michael E DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, Texas
| | - Hong Lu
- Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.,Clinical Research Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China
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