Wang HP, Qin XY, Xu BW, Lu TC, Gao RK, Lin M, Li J. Chinese herbal medicine for colorectal cancer: An overview of systematic reviews and evidence map. World J Gastrointest Oncol 2026; 18(7): 120031 [DOI: 10.4251/wjgo.120031]
Corresponding Author of This Article
Jie Li, MD, PhD, Professor, Department of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixiange Street, Xicheng District, Beijing 100053, China. qfm2020jieli@yeah.net
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Oncology
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Wang HP, Qin XY, Xu BW, Lu TC, Gao RK, Lin M, Li J. Chinese herbal medicine for colorectal cancer: An overview of systematic reviews and evidence map. World J Gastrointest Oncol 2026; 18(7): 120031 [DOI: 10.4251/wjgo.120031]
He-Ping Wang, Xiao-Yan Qin, Rui-Ke Gao, Jie Li, Department of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China
Xiao-Yan Qin, Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China
Bo-Wen Xu, Department of Oncology, Hunan Cancer Hospital, Changsha 100053, Hunan Province, China
Tai-Cheng Lu, Department of Oncology, Beijing Hospital of Traditional Chinese Medicine, Beijing 100010, China
Ming Lin, Department of Oncology, Sanming Integrated Medicine Hospital, Sanming 365000, Fujian Province, China
Author contributions: Wang HP, Qin XY and Xu BW were involved in the conception and design; Wang HP, Qin XY and Xu BW registered the protocol and performed the search, screen, inclusion, and quality assessment of the included studies; Wang HP, Qin XY and Xu BW contributed to draft the first version of this manuscript; Lu TC, Gao RK and Lin M provided critical revisions; Li J and Gao RK revised the manuscript; Li J, as the corresponding author, supervised the entire research project, including conceptualization, methodology design, and supervision of the manuscript drafting. All authors have read and approved the final manuscript. Wang HP and Qin XY contributed equally to this work as co-first authors.
Supported by China Academy of Chinese Medical Sciences (CACMS) Innovation Fund/Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences, No. CI2023C012YL; Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine, No ZYYCXTD-C-202205; Health Research Project of Hunan Provincial Health Commission, No. 20257728; High-Level Talent Support Program of Hunan Cancer Hospital, No. 20250731-1046; and Hunan Provincial Natural Science Foundation of China, No. 2026JJ82680.
Conflict-of-interest statement: The authors declare that they have no known competing financial interests.
PRISMA 2009 Checklist statement: The authors have read the PRISMA 2009 Checklist, and the manuscript was prepared and revised according to the PRISMA 2009 Checklist.
Corresponding author: Jie Li, MD, PhD, Professor, Department of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixiange Street, Xicheng District, Beijing 100053, China. qfm2020jieli@yeah.net
Received: February 13, 2026 Revised: March 8, 2026 Accepted: April 21, 2026 Published online: July 15, 2026 Processing time: 151 Days and 0.7 Hours
Abstract
BACKGROUND
Colorectal cancer (CRC) accounts for second place of new cases in China. Chinese herbal medicine (CHM) is widely used as an integrative treatment for CRC. However, evidence on the efficacy of CHM for CRC remains unclear.
AIM
To evaluate quality of previous systematic reviews (SRs) and summarise evidence on CHM treatment for CRC.
METHODS
All available online academic databases were systematically searched from the time of their foundation to October 2025, and eligible systematic reviews investigating therapeutic effectiveness and safety of CHM in the treatment of CRC patients were incorporated into this study. Their reporting, methodological and evidence quality were evaluated using the PRISMA, AMSTAR-2, and GRADE.
RESULTS
Ninety-seven SRs were included in this study. Thirty of the included SRs were assessed as high in reporting quality, 67 as moderate; 12 SRs were assessed as moderate in methodological quality, 27 as low quality, 58 as critically low quality. Seven pieces of evidence assessed as moderate quality by GRADE approach, 40 as low quality, and 46 as very low quality. Moderate-quality evidence showed that orally administered CHM plus XELOX increased the objective response rate (ORR) by 44%. Compound Kushen Injection plus FOLFOX increased ORR by 26% and Karnofsky Performance Status (KPS) improvement rate by 24%. Aidi Injection plus FOLFOX4 chemotherapy increased ORR by 22%, disease control rate by 10% and KPS improvement rate by 30%.
CONCLUSION
Orally administered CHM and CHM injections combined with chemotherapy have promising effects on tumor response and performance status of patients with advanced CRC.
Core Tip: Previous studies have reported the potential effects of Chinese herbal medicine (CHM) for colorectal cancer (CRC) treatment, but in the absence of quality evaluation. This study comprehensively assessed the quality of reporting, methodology, and evidence of previously published systematic reviews (SRs). Evidence with moderate certainty showed that orally administered CHM and CHM injections combined with chemotherapy have promising effects on tumor response and performance status of patients with advanced CRC. This study presents an evidence map for better understanding. Most of the included SRs had unsatisfactory methodological quality, and SRs should be well designed and focus on more specific populations and interventions.
Citation: Wang HP, Qin XY, Xu BW, Lu TC, Gao RK, Lin M, Li J. Chinese herbal medicine for colorectal cancer: An overview of systematic reviews and evidence map. World J Gastrointest Oncol 2026; 18(7): 120031
The disease burden of colorectal cancer (CRC) is gradually increasing with lifestyle becoming more westernized, diets becoming richer, and living standards getting higher due economic growth. In 2022, CRC was the second highest newly diagnosed (more than 500000) and fourth highest cause of death (nearly 240000) in China[1]. The development of a national healthcare system has led to the decline of the mortality rates of cancers with traditionally high incidence rates and poor prognosis; however, the mortality rate of CRC is still increasing[2]. The global economic cost of CRC from 2020 to 2050 is estimated at $2.75 trillion[3]. The proportion of patients diagnosed with advanced CRC and the mortality rate have increased, making CRC a key focus for prevention and treatment in the future[4].
However, existing conventional therapies cannot resolve all clinical problems associated with CRC treatment, such as drug resistance and adverse reactions, aggravation of uncomfortable symptoms, and the decline in quality of life (QoL). Complementary and alternative medicines have been proven essential in cancer treatment[5]. Chinese herbal medicine (CHM), a traditional Chinese medicine, is broadly employed in clinical practice, while also providing important support for the research, development and innovation of new drugs[6]. Recent studies have shown that CHM plays an active role in preventing and treating CRC recurrence and metastasis, reducing toxicity and side effects, and improving QoL and patient survival[7-10].
With the increasing clinical research on CHM for the treatment of CRC, a considerable number of systematic reviews (SRs) and meta-analyses have evaluated its efficacy and safety. These SRs focused on specific areas, such as the role of adjunctive therapy to chemotherapy[11], the role of interventions in chemotherapy-related myelosuppression[12], gastrointestinal reactions[13], chemotherapy-induced peripheral neuropathy (CIPN), and hand-foot syndrome (HFS)[14]. Consequently, their findings provide a good entry point for CHM interventions for CRC. An overview of the pieces of evidence on CHM for CRC palliative care in the SRs show that CHM significantly improved the QoL. However, in the existing literature, the efficacy of CHM in prolonging patient survival and alleviating chemotherapy- and/or radiotherapy-related adverse effects remains controversial, and the methodological quality of existing SRs has not been satisfactory[15]. Despite advancements in research, the therapeutic benefits of CHM as a primary or adjuvant treatment for CRC, including its effectiveness at different disease stages and treatment periods, remain inconclusive. The reporting and methodological qualities of existing SRs have also not been thoroughly evaluated. Further, most of them failed to appraise the quality of the overall evidence and did not draw any clear conclusions. Currently, overviews of SRs are progressively being employed as a method for integrating evidence. They provide broader coverage than individual SRs and provide evidence on the application of the same intervention across different clinical conditions[16,17].
This work aimed to integrate evidence on the clinical efficacy of CHM for CRC based on currently available SRs, evaluate the reporting and methodological quality of these SRs, assess the quality of evidence reported in these SRs, provide an evidence map, and identify evidence gaps for further work.
MATERIALS AND METHODS
The present study was registered in the PROSPERO database (No. CRD42022311266).
Eligibility criteria
Type of studies: The current overview analysis encompassed SRs irrespective of the presence of meta-analytic synthesis, which appraised the clinical therapeutic efficacy of CHM treatment for CRC.
Types of participants: This overview includes participants diagnosed with CRC based on etiological or serological tests. Patients with postoperative CRC, those who underwent adjuvant chemotherapy, and those with advanced or metastatic CRC were included.
Types of intervention and control: SRs pertaining to CHM intervention strategies were incorporated into this overview. The CHM interventions considered in study included CHM formulas, patented medicines, and injections. Topical CHM use was excluded. As this study focused on herbal medicine, studies of animal-origin interventions (such as cinobufotalin) were excluded. Chemotherapy, chemotherapy combined with targeted drugs (e.g., cetuximab or bevacizumab), standard medication, and placebo were included as control groups.
Types of outcomes: Clinical efficacy outcomes included survival outcomes, including overall survival (OS), recurrence-free survival (RFS), progression-free survival; tumour response outcomes, including objective response rate (ORR) and disease control rate (DCR) reported using RECIST or WHO criteria; QoL; performance status; and other clinical efficacy-related outcomes reported in the included SRs. Laboratory results unrelated to clinical efficacy (such as tumour markers, blood cell counts, and serum cytokines) were excluded from this study. As the focus of this study was on clinical efficacy and RECIST is based on imaging results[18], tumour markers and blood cell counts were not selected as references. Cytokines are important prognostic indicators in anticancer immunotherapy[19,20], but the SRs included in our study did not address herbal combination immunotherapy interventions for CRC, and thus cytokines were not included. The safety outcomes included the adverse events (AEs) that occurred during treatment.
Search strategy
The electronic databases PubMed, EMBASE, CENTRAL, CNKI, Wanfang, and Chinese Scientific Journal (VIP) were searched from their inception to October 2025. English and Chinese languages were used in this study. The grey literature of dissertation and conference papers were searched in the CNKI, Wanfang, and VIP databases.
A search strategy was developed using a combination of controlled MeSH, EMTREE, and text terms. The full search strategy is presented in Supplementary material.
Screening and selection
All identified search records were managed in EndNote 20 for subsequent literature screening and reference management. Two reviewers independently evaluated titles and abstracts. The full-text manuscripts were further examined to determine their eligibility for inclusion. The screening of studies and assessment of eligibility were carried out independently by two reviewers. For cases of repeated publications of a single study, the most recent publications or publications reporting more complete outcomes were included. The complete steps of literature screening and study selection were comprehensively depicted in the PRISMA flow diagram[21].
Data extraction
Data extraction was performed on the enrolled SRs, with the following information collected: (1) Identification details (first author, publication year); (2) Numbers of included randomized controlled trial (RCT) and participants; (3) Intervention of treatment group and control group; and (4) Stage or status of the participants; and (5) Outcomes details.
Quality assessment
The methodological rigor and reporting completeness of enrolled SRs were appraised with the aid of the PRISMA checklist and AMSTAR-2 framework[22,23]. The PRISMA-2009 checklist has 27 items, with each item counting for 1 point. The total points are interpreted as follows: 0-10, low quality of reporting; 11-22, moderate quality of reporting; and 23-27, high quality of reporting[24]. The AMSTAR-2 tool has 16 domains, seven of which are critical domains. Flaws in the critical and noncritical domains reflect the methodological quality of the SRs. The methodological quality was classified as high, moderate, low, or critically low. Quality assessment was assessed by two independent reviewers. In the event of disagreement, a third reviewer arbitrated to reach a consensus. The reporting and methodological quality are presented in bar charts.
Evidence assessment
The GRADE was used to assess the quality of the synthesized evidence of the included SRs[25]. Multi-dimensional systematic appraisal covering five core domains (risk of bias, inconsistency, indirectness, imprecision, publication bias) enabled the evidence base to be graded into high, moderate, low, and very low.
Quality of evidence
When more than one SR evaluated similar outcomes with similar PICO components, the evidence reported by the largest and most recent meta-analyses were included[26]. If neither criterion was met by a single review, priority was given to the review with the largest sample size. We further assessed all the meta-analyses to determine whether the most recent were the largest. To provide precise and reliable evidence, we performed separate analyses of the following stages or statuses: Postoperative CRC, adjuvant chemotherapy for CRC, advanced or metastatic CRC, and unrestricted stage or status. We performed a subgroup analysis of different treatment regimens for each stage or status if adequate information was provided in the included SRs. Bubble plots were used to present the synthesized evidence reported by the included SRs and display information on five dimensions: Population, quality of evidence, sample size, intervention, and outcomes. Each bubble represents one synthesized evidence, and the details are as follows: (1) Patient stage or status (“postoperative CRC”, “combined with adjuvant chemotherapy”, “advanced stage CRC”, “unrestricted stage or status”) was on the X-axis; (2) Quality of evidence (“moderate”, “low”, “very low”) was on the Y-axis; (3) The color represented different clinical outcomes; (4) Size represented the number of included patients; and (5) The tags on the bubbles represented interventions.
RESULTS
Included studies
The entire literature screening workflow was depicted in Figure 1. Ninety-seven SRs were included in this study. Details of the included SRs are listed in Supplementary Table 1. Three SRs explored both clinical efficacy and safety outcomes of CHM for postoperative CRC patients; 10 assessed CHM combined with adjuvant chemotherapy; 31 evaluated CHM for advanced-stage CRC; 4 evaluated CHM for reducing chemotherapy-induced AEs; and 49 did not restrict the stage of CRC or status of the patients. Thirty-two SRs evaluated the efficacy of orally administered CHM. Thirty-eight SRs evaluated injections of CHM, which included 13 Compound Kushen Injections (CKI), nine Aidi Injections (ADI), five Brucea Javanica Oil Emulsion Injections (BJOEI), four Kangai Injections (KAI), four Shenqi Fuzheng Injections (SFI), two Kanglaite Injections (KLTI), and one Xiaoaiping Injection (XAPI). The treatments for the control groups included usual care and chemotherapy; the FOLFOX regimen, FOLFIRI, XELOX, oxaliplatin-based chemotherapy, and first-line chemotherapy regimens were reported in 13, 2, 1, 7, and 4 SRs, respectively.
Figure 1 Process of study selection.
CRC: Colorectal cancer.
Quality of SRs
Comprehensive appraisal was conducted on methodological rigor and reporting completeness of enrolled SRs. Among the 97 included studies, 30 were categorized with high reporting quality, and the remaining 67 were assigned moderate quality ratings. Twelve, 27, and 58 SRs had moderate, low, and critically low quality, respectively. The main reasons for the downgrading of reporting quality were the absence of registration and written protocols, shortage of a full electronic search strategy, and lack of additional analyses (such as subgroup analysis and sensitivity analyses). Similarly, the absence of registration, non-comprehensive search strategy, and absence of a list of excluded studies and justifications contributed to unsatisfactory methodological quality. The details of the reporting and methodological quality of the included SRs are shown in Figure 2 and Supplementary Tables 2 and 3.
Figure 2 Systematic reviews quality assessment chart.
A: Bar chart of reporting quality of included systematic reviews (SRs) assessed by PRISMA; B: Bar chart of methodological quality of included SRs assessed by AMSTAR-2.
Postoperative administration of CHM for inducing complications
Three SRs reported the postoperative administration of CHM: One SR included 40 RCTs reporting the recovery of gastrointestinal function in CRC[27], another SR of 6 RCTs reported the recovery of gastrointestinal function in RCT[28], and the other included 15 RCTs reporting the efficacy and safety of CHM for low anterior resection syndrome (LARS) in patients with postoperative rectal cancer (RC)[29].
Recovery of gastrointestinal function: Two SRs provided results on the time to first recovery of bowel sounds, the time to first flatus, and the time to first bowel movement[27,30]. The findings indicated that oral CHM administration in postoperative CRC patients resulted in a 10.16-hour reduction in the time to first recovery of bowel sounds [MD = -10.16, 95% confidence interval (CI): -12.90 to -7.42], time to first anal flatus by 12.17 hours (MD = -12.17, 95%CI: -14.11 to -10.24), and time to first defecation by 15.41 hours (MD = -15.41, 95%CI: -18.06 to -12.76)[27]. CHM enema interventions for postoperative RC shortened first bowel sound recovery time by 16.59 hours (MD = -16.59, 95%CI: -19.05 to -14.14), time to first anal flatus by 12.30 hours (MD = -12.30, 95%CI: -13.07 to -11.52), and time to first defaecation by 14.17 hours (MD = -14.17, 95%CI: -17.17 to -11.18)[30] (Figure 3 and Table 1).
Effective rate and recurrence rate of LARS: One SR appraised the clinical efficacy of CHM therapy for patients with LARS[29]. Integrated meta-analytic data demonstrated that compared with individuals under isolated routine care, CHM administration was associated with a 38% increase in treatment efficacy [risk ratio (RR) = 1.38, 95%CI: 1.20-1.59] and an 80% decline in recurrence incidence (RR = 0.20, 95%CI: 0.05-0.87). Compared with usual care, CHM plus usual care achieved a 26% higher effective rate for LARS (RR = 1.26, 95%CI: 1.11-1.42) and a 40% lower recurrence rate (RR = 0.60, 95%CI: 0.18-2.03) (Figure 3 and Supplementary Table 4).
Safety outcomes: Both SRs reported AEs in the included RCTs. One SR revealed that patients receiving CHM had a significantly lower incidence of nausea, vomiting, and abdominal distension compared with the control group [odds ratio (OR) = 0.30, 95%CI: 0.21-0.42][27], Another SR reported that no serious AEs occurred, and the incidence of AEs in patients administered CHM was relatively low[30]. In contrast, another SR reported no obvious statistical differences existed in the AE occurrence rate when comparing the two therapeutic regimens[29].
Administration of CHM combined with adjuvant chemotherapy
Outcomes of long-term survival: Five SRs reported RFS and OS rates, and the results of the two largest and most recent SRs have been presented[31,32]. Results of meta-analyses showed that patients administrated with CHM plus adjuvant chemotherapy had lower RFS rates by 61% (RR = 0.39, 95%CI: 0.27-0.57) at 1 year, 60% (RR = 0.40, 95%CI: 0.29-0.54) at 2 years, and 48% (RR = 0.52, 95%CI: 0.43-0.61) at 3 years than those who received adjuvant chemotherapy alone[31]. No statistically significant differences were detected in the 1-year, 2-year, and 3-year overall survival rates (1-year: RR = 0.98, 95%CI: 0.89-1.08; 2-year: RR = 1.11, 95%CI: 0.72-1.73; 3-year: RR = 1.02, 95%CI: 0.56-1.86) between patients receiving CHM combined with adjuvant chemotherapy and those treated with adjuvant chemotherapy alone. However, patients administered CHM in addition to adjuvant chemotherapy may have a higher 5-year survival rate (RR = 1.72, 95%CI: 1.18-2.49)[32]. One SR reported RFS outcomes, and a meta-analysis of three RCTs showed that CHM may prolong RFS by 9.76 months (MD = 9.76, 95%CI: 5.71-13.82)[33] (Figure 3, Table 2 and Supplementary Table 4).
Table 2 Summary of findings of evidence in adjuvant chemotherapy combined with Chinese herbal medicine.
Performance status: Seven SRs reported the outcomes of performance status, and the results of the two most recent SRs are presented[34,35]. A meta-analysis of 12 RCTs showed that patients administered CHM had a 64% lower Karnofsky Performance Status (KPS) improvement rate (RR = 0.36, 95%CI: 0.26-0.51), and a meta-analysis of four RCTs showed that compared to FOLFOX chemotherapy alone, oral administration of CHM using the Yiqi Jianpi method combined with the FOLFOX regimen could improved the KPS score (SMD = 1.45, 95%CI: 1.00-1.89) relative to FOLFOX chemotherapy alone[35] (Figure 3, Table 2 and Supplementary Table 4).
Safety outcomes: Safety outcomes were reported in seven SRs. The incidence of myelosuppression, anemia, leukopenia, neutropenia, erythrocytopenia, thrombocytopenia, nausea and vomiting, diarrhea, hepatic dysfunction, renal dysfunction, and CIPN during adjuvant chemotherapy were reported, and results of four SRs are presented. Compared with patients treated with adjuvant chemotherapy alone, those receiving the combination of CHM and adjuvant chemotherapy showed a significantly lower incidence of multiple chemotherapy-related AEs. Specifically, the combined regimen achieved a 39% reduction in myelosuppression risk (RR = 0.61, 95%CI: 0.46-0.79)[36], 25% lower anemia occurrence (RR = 0.75, 95%CI: 0.63-0.89)[36], 33% decreased leukopenia incidence (RR = 0.67, 95%CI: 0.61-0.75)[36], 40% declined neutropenia risk (RR = 0.60, 95%CI: 0.46-0.79)[36], and 29% lower thrombocytopenia incidence (RR = 0.75, 95%CI: 0.63-0.89)[36]. Additionally, CHM combination treatment was linked to a 45% lower incidence of nausea and vomiting (RR = 0.55, 95%CI: 0.46-0.66)[34], 62% lower diarrhea incidence (RR = 0.38, 95%CI: 0.29-0.49)[34], 48% decreased hepatic dysfunction (RR = 0.52, 95%CI: 0.32-0.86)[35], 59% diminished renal dysfunction (RR = 0.41, 95%CI: 0.18-0.96)[35], and 31% mitigated risk of CIPN (RR = 0.69, 95%CI: 0.58-0.62)[37].
Administration of CHM combined with chemotherapy in advanced CRC
Nine SRs reported the efficacy and safety of oral administration of CHM for advanced CRC, other six SRs reported CHM without restriction of administration type, results of five of these 15 SRs were represented[38-42]. Five SRs reported the efficacy of CKI for advanced CRC, and the results of the largest and newly published SRs are presented[43]. Three SRs reported the efficacy of ADI for advanced CRC, and the results of two newly published SRs have been presented[28,44]. Two studies have reported the efficacy of the BJOEI for advanced CRC, and the results of the largest and newly published SR have been reported[45]. The efficacy and safety of SFI, KLTI, KAI, and XAPI were separately reported by four individual SRs, the results of these four are presented[46-49].
Long-term survival outcomes: Eight SRs were used to evaluate the survival outcomes of patients with advanced CRC receiving CHM. Pooled results showed that orally-administered CHM could increase 1-, 2-, and 3-year survival rates for stages III-IV CRC (OR = 3.10, 95%CI: 2.10-4.57; OR = 2.38, 95%CI: 1.53-3.70; OR = 2.32, 95%CI: 1.35-3.98)[50], and in CRC of stage IV or Duke’s D (RR = 1.27, 95%CI: 1.07-1.52; RR = 1.19, 95%CI: 0.85-1.68; RR = 1.68, 95%CI: 0.57-4.96)[40] (Figure 3, Table 3 and Supplementary Table 4).
Table 3 Summary of findings of evidence in administration of Chinese herbal medicine for advanced colorectal cancer.
Oral administration of CHM: Meta-analytic data covering 38 eligible RCTs revealed that chemotherapy combined with oral CHM was associated with a 30% higher ORR (RR = 1.30, 95%CI: 1.14-1.49) and a 12% higher DCR (RR = 1.12, 95%CI: 1.06-1.17) compared with chemotherapy alone[40]. Another meta-analysis of 12 RCTs showed that oral administration of CHM plus FOLFOX4 chemotherapy yielded a 25% higher ORR than chemotherapy with the FOLFOX-4 regimen (RR = 1.25, 95%CI: 1.06-1.47)[41] (Figure 3, Table 3 and Supplementary Table 4).
CKI: Meta-analytic data covering 31 eligible RCTs revealed that patients who received CKI plus oxaliplatin-based chemotherapy had a 40% higher ORR (RR = 1.40, 95%CI: 1.29-1.51) and a 12% higher DCR (RR = 1.12, 95%CI: 1.08-1.16) than those who received oxaliplatin-based chemotherapy alone[43]. Another meta-analysis of 8 RCTs showed that patients who received CKI plus FOLFOX had a 26% higher ORR (RR = 1.26, 95%CI: 1.12-1.43) and a 6% higher DCR (RR = 1.06, 95%CI: 1.01-1.12) than those who received FOLFOX chemotherapy alone[51] (Figure 3 and Table 3).
ADI: Compared with chemotherapy with the FOLFOX4 regimen, ADI combined with FOLFOX4 increased ORR by 22% (RR = 1.22, 95%CI: 1.11-1.34) and DCR by 10% (RR = 1.10, 95%CI: 1.05-1.16)[28]. Relative to FOLFIRI chemotherapy monotherapy, the combination of ADI and FOLFIRI achieved a 14% increase in DCR (RR = 1.14, 95%CI: 1.02-1.28), whereas no prominent statistical differences concerning ORR were found among the compared groups (RR = 1.16, 95%CI: 0.96-1.41)[44] (Figure 3 and Table 3).
BJOEI: Meta-analytic data covering 6 eligible RCTs revealed that BJOEI plus FOLFOX improved ORR by 45% (RR = 1.45, 95%CI: 1.22-1.72) relative to FOLFOX chemotherapy alone; BJOEI plus FOLFIRI therapy brought about a 30% rise in ORR (RR = 1.30, 95%CI: 1.17-1.45) relative to FOLFIRI chemotherapy alone; and BJOEI plus capecitabine therapy brought about a 8% rise in ORR (RR = 1.08, 95%CI: 1.01-1.15) relative to maintenance chemotherapy of capecitabine alone[45] (Figure 3, Table 3 and Supplementary Table 4).
Other injections: Data from a meta-analysis of 12 RCTs demonstrated that the ORR was significantly higher in patients treated with SFI in combination with oxaliplatin-based chemotherapy (RR = 1.35, 95%CI: 1.18-1.55), relative to those receiving oxaliplatin-based chemotherapy alone[48]. Another meta-analysis enrolling 5 RCTs, no statistically significant between-group difference in ORR was identified between patients administered FOLFOX chemotherapy as monotherapy and those receiving a KLTI-FOLFOX combination regimen (RR = 1.11, 95%CI: 0.82-1.49)[46]. Upon integrated meta-analytic evaluation of 22 RCTs, KAI combined with chemotherapy was associated with a 32% elevation in ORR (RR = 1.32, 95%CI: 1.22-1.43) over single-agent chemotherapy protocols[47]. Another meta-analysis of four RCTs indicated that the combination of XAPI and oxaliplatin-based chemotherapy was associated with superior ORR (OR = 2.09, 95%CI: 1.25-3.50)[49] (Figure 3, Table 3 and Supplementary Table 4).
Performance status
Oral administration of CHM: A meta-analysis of 24 RCTs indicated that compared to those who received chemotherapy alone, chemotherapy plus oral administration of CHM increased the KPS score by 6.23 points (MD = 6.23, 95%CI: 4.75-7.70) and had a higher KPS improvement rate of 103% than chemotherapy alone (RR = 2.03, 95%CI: 1.69-2.45)[40]. Another meta-analysis of 16 RCTs showed that oral administration of CHM plus chemotherapy increased the KPS improvement rate by 46% (RR = 1.46, 95%CI: 1.35-1.58) relative to chemotherapy alone[52]. A meta-analysis of nine RCTs showed that oral administration of CHM plus chemotherapy with the FOLFOX4 regimen increased the KPS improvement rate by 84% (RR = 1.84, 95%CI: 1.54-2.19) relative to FOLFOX-4 alone[41] (Figure 3, Table 3 and Supplementary Table 4).
CKI: A meta-analysis enrolling 16 RCTs demonstrated that the combination of CKI and oxaliplatin-based chemotherapy was associated with a 24% increase in the KPS improvement rate (RR = 1.24, 95%CI: 1.14-1.36), compared with oxaliplatin-based chemotherapy alone[43] (Figure 3 and Table 3).
ADI: A meta-analysis including 3 RCTs demonstrated that CHM combined with chemotherapy was associated with prominent improvements in physical performance status. This strategy yielded a 31% higher KPS improvement rate (RR = 1.31, 95%CI: 1.13-1.53) and a 5.61-point rise in KPS score values (MD = 5.61, 95%CI: 4.68-6.55) relative to chemotherapy alone[45] (Figure 3, Table 3 and Supplementary Table 4).
BJOEI: A meta-analysis of four RCTs showed that chemotherapy plus BJOEI with a 5.61-point rise in KPS scores (MD = 5.61, 95%CI: 4.68-6.55) relative to chemotherapy alone[45] (Figure 3 and Supplementary Table 4).
Other injections: A meta-analysis including 7 RCTs indicated that SFI combined with oxaliplatin-based chemotherapy may yield a 26% increase in the KPS improvement rate, compared with oxaliplatin-based chemotherapy alone (RR = 1.26, 95%CI: 1.13-1.40)[48]. Another meta-analysis encompassing 17 RCTs demonstrated that XAPI adjuvant chemotherapy was associated with a 48% higher KPS improvement rate (RR = 1.48; 95%CI: 1.36-1.60) relative to chemotherapy alone[47]. A meta-analysis of three RCTs also showed that XAPI combined with oxaliplatin-based chemotherapy achieved a better KPS improvement rate (OR = 3.71, 95%CI: 1.92-7.17) than oxaliplatin-based chemotherapy[49] (Figure 3, Table 3 and Supplementary Table 4).
Safety outcomes: Safety outcomes of CHM for advanced CRC were reported in 24 included SRs. Meta-analysis results demonstrated that oral CHM integrated with chemotherapy contributed to markedly reduced occurrence of diverse chemotherapy-associated adverse events compared with solitary chemotherapy, including a 24% reduction in leukopenia (RR = 0.76, 95%CI: 0.67-0.86), 34% reduction in thrombocytopenia (RR = 0.66, 95%CI: 0.54-0.81), 30% reduction in anemia (RR = 0.70, 95%CI: 0.61-0.80), 31% reduction in nausea and vomiting (RR = 0.69, 95%CI: 0.61-0.78), 34% reduction in diarrhea (RR = 0.66, 95%CI: 0.57-0.75), 46% reduction in hepatic dysfunction (RR = 0.54, 95%CI: 0.43-0.68), and 30% reduction in CIPN (RR = 0.70, 95%CI: 0.59-0.83)[40]. Compared with maintenance chemotherapy with capecitabine, CHM plus capecitabine lowered the incidence of leukopenia by 34% (RR = 0.66, 95%CI: 0.49-0.89), 49% lower incidence of nausea and vomiting (RR = 0.51, 95%CI: 0.36-0.72), 51% reduced diarrhea occurrence (RR = 0.49, 95%CI: 0.35-0.68), HFS by 45% (RR = 0.55, 95%CI: 0.38-0.79)[39]. Oral administration of CHM plus chemotherapy with the FOLFOX-4 regimen alleviated grade 3 and 4 chemotherapy-related AEs for neutropenia by 67% (RR = 0.33, 95%CI: 0.18-0.60), nausea and vomiting by 66% (RR = 0.34, 95%CI: 0.17-0.67), and CIPN by 61% (RR = 0.39, 95%CI: 0.15-1.00) relative to FOLFOX-4 alone[41]. The safety outcomes of CHM injections are presented in Supplementary Table 5.
Administration of CHM in reducing AEs caused by chemotherapy
Five SRs focused on the effectiveness of CHM in reducing chemotherapy-induced AEs. Two SRs evaluated the effectiveness of CHM in reducing CIPN and HFS[14]; one evaluated the effectiveness of CHM in reducing leukopenia and neutropenia[12]; one evaluated gastrointestinal toxicity[13]; and one evaluated general AEs[53].
Leukopenia and neutropenia: The pooled analysis results demonstrated that CHM combined with chemotherapy was associated with a 31% reduction in the incidence of leukopenia (RR = 0.69, 95%CI: 0.59-0.82) and a 29% reduction in neutropenia incidence (RR = 0.71, 95%CI: 0.55-0.90), respectively. Furthermore, the incidence rates of grade 3/4 leukopenia (RR = 0.52, 95%CI: 0.35-0.77) and grade 3/4 neutropenia (RR = 0.42, 95%CI: 0.27-0.64) were also significantly decreased with the combination regimen[12].
Gastrointestinal AEs: Meta-analysis showed that the administration of CHM plus chemotherapy significantly reduced the incidence of overall gastrointestinal AEs by 22% (RR = 0.78, 95%CI: 0.72-0.84) , with corresponding reductions of 26% for nausea and vomiting (RR = 0.74, 95%CI: 0.66-0.82), 36% for diarrhea (RR = 0.64, 95%CI: 0.44-0.93), 35% for oral mucositis (RR = 0.65, 95%CI: 0.48-0.88), and 64% for abdominal distension (RR = 0.36, 95%CI: 0.18-0.73)[13].
CIPN and HFS: Meta-analysis showed that the administration of CHM plus chemotherapy significantly reduced the incidence of all-grade CIPN by 22% (RR = 0.78, 95%CI: 0.66-0.91) and grade 3/4 CIPN by 58% (RR = 0.42, 95%CI: 0.23-0.77). The subgroup analysis showed that CHM plus FOLFOX chemotherapy reduced the incidence of all-grade CIPN by 30% (RR = 0.70, 95%CI: 0.52-0.96) and grade 3/4 CIPN by 67% (RR = 0.33, 95%CI: 0.16-0.70). No significant differences were observed for all grade CIPN (RR = 0.92, 95%CI: 0.81-1.05) and grade 3/4 CIPN (RR = 0.66, 95%CI: 0.18-2.47) for CHM plus XELOX and all grade CIPN (RR = 0.91, 95%CI: 0.57-1.45) and grade 3/4 CIPN for CHM plus SOX regimen (RR = 0.67, 95%CI: 0.11-3.92)[14].
Administration of CHM for CRC with unrestricted stage or status
The overview included 36 SRs that did not restrict the clinical stage or status of included participants. Thirteen SRs evaluated the efficacy of orally administered CHM[54-66], four SRs evaluated the effectiveness of ADI[67-70], four SRs of SFi[71-73], six SRs of CKI[74-79], three SRs of KAI[80-82], three SRs of BJOEI[83-85], one of KLTI[86], one of Astragalus injection[87], and one of Quxie capsule[88], the other 11 SRs did not restrict the stage of disease, status of the patient, or the mode of administration of CHM. The SR results of these SRs are presented in Figure 3, Table 4 and Supplementary Table 4.
Table 4 Summary of findings of evidence in administration of Chinese herbal medicine for colorectal cancer of unrestricted stage or status.
We evaluated the quality of synthesized evidence reported in the included SRs. Among the 93 evidence items assessed, 7 reached moderate grade, 40 were of low quality, and 46 were identified as very low quality evidence. The primary reasons for evidence quality downgrading included the suboptimal risk of bias profiles of the RCTs included in the underlying meta-analyses, limited sample sizes, and significant clinical heterogeneity across studies. Detailed information for evidence graded as moderate and low quality is summarized in Tables 1, 2, 3, and 4, data for very low-quality evidence is provided in Supplementary Table 4, and a bubble plot of the synthesized evidence is presented in Figure 3.
DISCUSSION
Ninety-seven SRs were included in this study. Thirty and 67 had high and moderate reporting quality, respectively. Twelve, 27, and 58 had moderate, low, and critically low methodological quality. The main reasons for the downgrading of reporting and methodological quality were the lack of registration, full search strategy, additional analysis, list of excluded studies, and justification. We assessed 93 pieces of synthesized evidence: 7 had moderate quality, 40 had low quality, and 46 had very low quality. Synthesized evidence of moderate certainty showed that orally administered CHM plus XELOX increased the ORR in patients with advanced CRC by 44% relative to XELOX alone. Further, CKI plus FOLFOX increased the ORR by 26% and KPS improvement rate by 24% relative to FOLFOX alone. ADI plus FOLFOX4 chemotherapy increased ORR by 22%, DCR by 10%, and KPS improvement rate by 30%. In summary, this study recommends that patients with advanced CRC undergoing chemotherapy should be treated with orally administered CHM based on syndrome differentiation and treatment, and it is advisable to consider combining CHM injections with chemotherapy.
This study had some limitations. First, some CHM interventions lack standardization, which makes it difficult to control for clinical heterogeneity. The limited information provided by the included SRs cannot provide reliable explanations to reduce clinical heterogeneity, resulting in poor-quality of synthesized evidence. Second, the general requirements of journals for SR reviewers included the submission of the PRISMA checklist; most of the included SRs had moderate to high compliance with the PRISMA statement. In contrast, most of the included SRs simply reported the required items in the manuscript but did not adhere to the guidelines for rigorous SRs. Therefore, only 12 SRs had moderate methodological quality. Third, some SRs failed to state conflicts of interest, especially those evaluating the application of CHM injections. Fourth, this study did not evaluate the cost-effectiveness of CHM for treating CRC, which is a crucial indicator in clinical decision-making. In addition, some articles focused on laboratory indicators, including cellular immune function and tumour markers, which have limited relevance to clinical efficacy and were not included in the analysis.
Nevertheless, there are multiple notable advantages associated with our investigation. This work integrated all available systematic reviews concerning CHM intervention efficacy in CRC populations, and pioneered the comprehensive quality assessment of such studies. Reporting, methodological, and evidence quality were evaluated to assess the reliability of prior SRs and summarize the existing evidence. We presented information based on five dimensions of evidence in a single plot, which enabled us to gain a more intuitive understanding of the clinical efficacy of CHM for the treatment of CRC. We performed a comprehensive evaluation of SRs that included patients with CRC who received different treatments and had different statuses or stages, and the quality of evidence was assessed according to the PICO criteria to minimize the influence of clinical heterogeneity.
Our study found that some SRs simply concluded that CHM or CHM injections combined with chemotherapy (or chemotherapy of FOLFOX/XELOX/FOLFIRI) are effective for treating CRC, but such a conclusion is of little to no value. Comparing the effects of different drugs in combination with chemotherapy is an area that should be focused on to guide clinical diagnosis and treatment more accurately. In contrast, more than half of the articles had outcome metrics in the range of tumour remission rates, KPS, and AE, with a large number of replicated studies, most of which confused the difference between KPS as a measure of performance status and QoL, which should be more accurately assessed using the QLQ-C30 or FACT-C scale. We call on researchers to report more rigorously on SR. While the quality of the evidence is still relatively low, we believe that high-quality evidence will emerge with more focused meta-analyses.
CONCLUSION
Our results suggest that orally administered CHM and injections of CKI and ADI combined with chemotherapy have a promising effects on ORR and performance status of patients with advanced CRC. The unsatisfactory methodological quality and quality of the synthesized evidence prevented us from arriving at a definite conclusion regarding other stages of CRC. Rigorous SRs and RCTs are required in the future.
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