Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. May 6, 2024; 12(13): 2201-2209
Published online May 6, 2024. doi: 10.12998/wjcc.v12.i13.2201
Yiwei Xiaoyu granules for treatment of chronic atrophic gastritis with deficiency syndrome of the spleen and stomach
Wan-Qun Chen, Qing-Feng Fan, Yuan-Jun He, Fei Li, Xin Wu, Yan-Ping Li, Xiao-Jun Yang
Wan-Qun Chen, Qing-Feng Fan, Yuan-Jun He, Fei Li, Xin Wu, Yan-Ping Li, Xiao-Jun Yang, Department of Gastroenterology, Chongqing Hospital of Traditional Chinese Medicine, Chongqing 400000, China
Co-corresponding authors: Yan-Ping Li and Xiao-Jun Yang.
Author contributions: The authors declare that this work was done by the authors named in this article and all liabilities pertaining to claims relating to the content of this article will be borne by them; Yang XJ and Li YP contributed equally to this work; Yang XJ, Li YP and Chen WQ conceptualized and designed the research; Fan QF, He YJ, Li F and Wu X screened patients and acquired clinical data; Fan QF and He YJ collected gastric specimen and performed laboratory analysis; Yang XJ and Li YP performed Data analysis; Chen WQ wrote the paper. All the authors have read and approved the final manuscript. Chen WQ proposed, designed and conducted serum function analysis, performed data analysis and prepared the first draft of the manuscript. Both Yang XJ and Li YP have played important and indispensable roles in the experimental design, data interpretation and manuscript preparation as the co-corresponding authors. Yang XJ applied for and obtained the funds for this research project. Yang XJ conceptualized, designed, and supervised the whole process of the project. Yang XJ searched the literature, revised and submitted the early version of the manuscript with the focus on the preventive effect of Yiwei Xiaoyu granules on chronic atrophic gastritis. Li YP was instrumental and responsible for data re-analysis and re-interpretation, figure plotting, comprehensive literature search, preparation and submission of the current version of the manuscript with a new focus on a double-blind, randomized, controlled trial. This collaboration between Yang XJ and Li YP is crucial for the publication of this manuscript and other manuscripts still in preparation.
Supported by the National Natural Science Foundation of China, No. 81904175; Chongqing Health Planning Commission Project, No. ZY201802063, No. 2019ZY013111, and No. 2022QNXM061; Chongqing Performance Incentive Project, No. jxyn2021-1-1; and Chongqing Technology Innovation and Application Development Special Key Project, No. CSTB2022TIAD-KPX0187.
Institutional review board statement: The protocol received approval from the Ethics Review Board of Chongqing Hospital of Traditional Chinese Medicine (No. 2019-ky-24).
Clinical trial registration statement: This study was registered on the Chinese clinical trial registry website (http://www.chictr.org.cn/index.aspx, ChiCTR1900026455).
Informed consent statement: All study participants provided informed written consent prior to study.
Conflict-of-interest statement: There was no conflict of interest associated with this work.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at [yxj20220606@163.com].
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Xiao-Jun Yang, PhD, Doctor, Department of Gastroenterology, Chongqing Hospital of Traditional Chinese Medicine, No. 6 Panxi Seven Branch Road, Jiangbei District, Chongqing 400000, China. yxj20220606@163.com
Received: January 11, 2024
Revised: March 3, 2024
Accepted: April 1, 2024
Published online: May 6, 2024
Processing time: 104 Days and 19.1 Hours
Abstract
BACKGROUND

The Correa sequence, initiated by Helicobacter pylori (H. pylori), commonly progresses to gastric cancer through the stage of chronic atrophic gastritis (CAG). Although eradication of H. pylori only reduces the risk of gastric cancer, it does not eliminate the risk for neoplastic progression. Yiwei Xiaoyu granules (YWXY) are a commonly used composite preparation in Chinese clinics. However, the pursuit of excellence in clinical trials and the establishment of standardized animal experiments are still needed to contribute to full understanding and application of traditional Chinese medicine in the treatment of CAG.

AIM

To demonstrate the effectiveness of YWXY in patients with CAG and spleen-stomach deficiency syndrome (DSSS), by alleviating histological scores, improving response rates for pathological lesions, and achieving clinical efficacy in relieving DSSS symptoms.

METHODS

We designed a double-blind, randomized, controlled trial. The study enrolled seventy-two H. pylori-negative patients (mean age, 52.3 years; 38 men) who were randomly allocated to either the treatment group or control group in a 1:1 ratio, and treated with 15 g YWXY or 0.36 g Weifuchun (WFC) tablet combined with the respective dummy for 24 wk. The pre-randomization phase resulted in the exclusion of 72 patients: 50 participants did not meet the inclusion criteria, 12 participants declined to participate, and 10 participants were excluded for various other reasons. Seven visits were conducted during the study, and histopathological examination with target endoscopic biopsy of narrow-band imaging was requested before the first and seventh visits. We also evaluated endoscopic performance scores, total symptom scores, serum pepsinogen and gastrin-17.

RESULTS

Six patients did not complete the trial procedures. Treatment with YWXY improved the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) stage, compared with WFC (P < 0.05). YWXY provided better relief from symptoms of DSSS and better improvement in serum gastric function, compared with WFC (P < 0.05).

CONCLUSION

YWXY compared with WFC significantly reduced the risk of mild or moderate atrophic disease, according to OLGIM stage, significantly relieved symptoms of DSSS, and improved serum gastric function.

Keywords: Chronic atrophic gastritis; Yiwei Xiaoyu granules; Randomized clinical trial; Weifuchun tablet; Traditional Chinese medicine; Helicobacter pylori

Core Tip: Despite the successful eradication of Helicobacter pylori (H. pylori), which has been shown to reduce the risk of gastric cancer (GC), patients with chronic atrophic gastritis (CAG) still remain susceptible to disease progression leading to GC. Our findings suggest that treatment with Yiwei Xiaoyu granules for CAG patients without H. pylori improved the stage of Operative Link on Gastric Intestinal Metaplasia Assessment, provided better clinical symptoms relief and better improvement in serum gastric function levels compared to Weifuchun tablet. However, the total sample size of this study is limited and prolong follow-up hasn’t been carried out.