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Acupuncture plus Chinese Herbal Medicine for Irritable Bowel Syndrome with Diarrhea: A Systematic Review and Meta-Analysis.

ABSTRACT: Purpose:To comprehensively evaluate the efficacy and safety of acupuncture combined with Chinese herbal medicine (CHM) in treating irritable bowel syndrome with diarrhea (IBS-D). Methods:Relevant randomized controlled trials (RCTs) were systemically retrieved from electronic databases from inception to March 2018, including the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Biological Medical Database (CBM, SinoMed), China Science and Technology Journal Database (VIP), and Wan Fang Data. Meanwhile, pooled estimates, including the 95% confidence interval (CI), were calculated for primary and secondary outcomes of IBS-D patients. Besides, quality of relevant articles was evaluated using the Cochrane Collaboration's risk of bias tool, and the Review Manager 5.3 and Stata12.0 softwares were employed for analyses. Results:A total of 21 RCTs related to IBS-D were included into this meta-analysis. Specifically, the pooled results indicated that (1) acupuncture combined with CHM might result in more favorable improvements compared with the control group (relative risk [RR] 1.29; 95% CI 1.24-1.35; P =0.03); (2) the combined method could markedly enhance the clinical efficacy in the meantime of remarkably reducing the scores of abdominal pain (standardized mean difference [SMD] -0.45; 95% CI -0.72, -0.17; P = 0.002), abdominal distention/discomfort (SMD -0.36; 95% CI -0.71, -0.01; P = 0.04), diarrhea (SMD -0.97; 95% CI -1.18, -0.75; P < 0.00001), diet condition (SMD -0.73; 95% CI -0.93, -0.52; P<0.00001), physical strength (SMD -1.25; 95% CI -2.32, -0.19; P = 0.02), and sleep quality (SMD -1.02; 95% CI -1.26, -0.77; P < 0.00001) compared with those in the matched groups treated with western medicine, or western medicine combined with CHM. Additionally, a metaregression analysis was constructed according to the name of prescription, acupuncture type, treatment course and publication year, and subgroup analyses stratified based on the names of prescriptions and acupoints location were also carried out, so as to explore the potential heterogeneities; and (3) IBS-D patients treated with the combined method only developed inconspicuous adverse events; more importantly, the combined treatment had displayed promising long-term efficacy. Conclusions:Findings in this study indicate that acupuncture combined with CHM is suggestive of an effective and safe treatment approach for IBS-D patients, which may serve as a promising method to treat IBS-D in practical application. However, more large-scale, multicenter, long-term, and high-quality RCTs are required in the future, given the small size, low quality, and high risk of the studies identified in this meta-analysis.

SUBMITTER: Yan J

PROVIDER: S-EPMC6487118 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Acupuncture plus Chinese Herbal Medicine for Irritable Bowel Syndrome with Diarrhea: A Systematic Review and Meta-Analysis.

Yan Jing J Miao Zhi-Wei ZW Lu Jun J Ge Fei F Yu Li-Hua LH Shang Wen-Bin WB Liu Li-Na LN Sun Zhi-Guang ZG

Evidence-based complementary and alternative medicine : eCAM 20190414

<h4>Purpose</h4>To comprehensively evaluate the efficacy and safety of acupuncture combined with Chinese herbal medicine (CHM) in treating irritable bowel syndrome with diarrhea (IBS-D).<h4>Methods</h4>Relevant randomized controlled trials (RCTs) were systemically retrieved from electronic databases from inception to March 2018, including the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Biological Medical Databa ...[more]

PMID: 31110553

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Project description:Objective. To evaluate the clinical effectiveness and safety of acupuncture therapy in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) or functional diarrhea (FD) in adults. Method. Five electronic databases-PubMed, EMBASE, CNKI, VIP, and Wanfang-were searched, respectively, until June 8, 2020. The literature of clinical randomized controlled trials of acupuncture for the treatment of IBS-D or FD in adults were collected. Meta-analysis was conducted by Using Stata 16.0 software, the quality of the included studies was assessed by the RevMan ROB summary and graph, and the results were graded by GRADE. Result. Thirty-one studies with 3234 patients were included. Most of the studies were evaluated as low risk of bias related to selection bias, attrition bias, and reporting bias. Nevertheless, seven studies showed the high risk of bias due to incomplete outcome data. GRADE's assessments were either moderate certainty or low certainty. Compared with loperamide, acupuncture showed more effectiveness in weekly defecation (SMD = -0.29, 95% CI [-0.49, -0.08]), but no significant improvement in the result of the Bristol stool form (SMD = -0.28, 95% CI [-0.68, 0.12]). In terms of the drop-off rate, although the acupuncture group was higher than the bacillus licheniformis plus beanxit group (RR = 2.57, 95% CI [0.24, 27.65]), loperamide group (RR = 1.11, 95% CI [0.57, 2.15]), and trimebutine maleate group (RR = 1.19, 95% CI [0.31, 4.53]), respectively, it was lower than the dicetel group (RR = 0.83, 95% CI [0.56, 1.23]) and affected the overall trend (RR = 0.93, 95% CI [0.67, 1.29]). Besides, acupuncture produced more significant effect than dicetel related to the total symptom score (SMD = -1.17, 95% CI [-1.42, -0.93]), IBS quality of life (SMD = 2.37, 95% CI [1.94, 2.80]), recurrence rate (RR = 0.43, 95% CI [0.28, 0.66]), and IBS Symptom Severity Scale (SMD = -0.75, 95% CI [-1.04, -0.47]). Compared to dicetel (RR = 1.25, 95% CI [1.18, 1.32]) and trimebutine maleate (RR = 1.35, 95% CI [1.13, 1.61]), acupuncture also showed more effective at total efficiency. The more adverse effect occurred in the acupuncture group when comparing with the dicetel group (RR = 11.86, 95% CI [1.58, 89.07]) and loperamide group (RR = 4.42, 95% CI [0.57, 33.97]), but most of the adverse reactions were mild hypodermic hemorrhage. Conclusion. Acupuncture treatment can improve the clinical effectiveness of IBS-D or FD, with great safety, but the above conclusions need to be further verified through the higher quality of evidence.

Project description:BackgroundIrritable bowel syndrome with diarrhea (IBS-D) is a chronic functional gastrointestinal disorder that has a significant impact on quality of life, work productivity, and healthcare resources. External therapy of traditional Chinese medicine (TCM) has positive effects on IBS-D and is simple, convenient, and low-cost. This study aimed to systematically evaluate the efficacy and safety of external therapy of TCM for IBS-D.MethodsThis study was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. The PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals (VIP), Wan Fang, and Chinese Biomedical (CBM) databases were electronically searched to collect randomized controlled trials comparing external therapy of TCM with Western medicine for IBS-D from inception to 31 December 2021. Two authors independently screened, extracted, and assessed the selected studies. The Jadad scale and Cochrane Collaboration Risk of Bias tool were used to evaluate study quality. The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE). The meta-analysis was performed using the Review Manager software (version 5.3).ResultsTwenty-one studies involving 1,862 subjects were included. Acupuncture and moxibustion were the most commonly used external therapies. The meta-analysis showed that based on total effective rate with moderate certainty of evidence (n = 21 studies, n = 1,862 participants, RR = 1.25, 95% CI [1.2, 1.31], I2 = 0%, P < 0.00001), clinical cure rate with low certainty of evidence (n = 17 studies, n = 1,502 participants, RR = 1.66, 95% CI [1.4, 1.96], I2 = 1%, P < 0.00001), recurrence rate with very low certainty of evidence (n = 5 studies, n = 260 participants, RR = 0.44, 95% CI [0.34, 0.58], I2 = 0%, P < 0.00001), total symptom score (MD = -4.9, 95% CI [-7.34, -2.47]), and IBS severity scoring system score (IBS-SSS) with moderate certainty of evidence (MD = -52.72, 95% CI [-63.9, -41.53]), the experimental group had significant advantages compared with the control group. The sensitivity analysis further confirmed the robustness of the primary outcomes. The improvement in quality of life associated with IBS (IBS-QOL) was superior in the experimental group compared to the control group, and the difference was statistically significant; however, the clinical heterogeneity was strong. The inverted funnel plot of the included studies indicated a potential publication bias.ConclusionExternal therapy of TCM for IBS-D alleviated abdominal symptoms, improved clinical effectiveness, and reduced recurrence with great safety. However, because of the limitations of publication bias in trials, more rigorous studies with a clinical design are necessary for further verification of the outcomes.Systematic review registration[https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42020222993].

Project description:ObjectiveThe fragility index (FI), which is the minimum number of changes in status from "event" to "non-event" resulting in a loss of statistical significance, serves as a significant supplementary indicator for clinical physicians in interpreting clinical trial results and aids in understanding the outcomes of randomized controlled trials (RCTs). In this systematic literature survey, we evaluated the FI for RCTs evaluating Chinese herbal medicine (CHM) for irritable bowel syndrome (IBS), and explored potential associations between study characteristics and the robustness of RCTs.MethodsA comprehensive search was conducted in four databases in Chinese and four databases in English from their inception to January 1, 2023. RCTs encompassed 1:1 ratio into two parallel arms and reported at least one binary outcome that demonstrated statistical significance were included. FI was calculated by the iterative reduction of a target outcome event in the treatment group and concomitant subtraction of a non-target event from that group, until positive significance (defined as P < 0.05 by Fisher's exact test) is lost. The lower the FI (minimum 1) of a trial outcome, the more fragile the positive result of the outcome was. Linear regression models were adopted to explore influence factors of the value of FI.ResultsA total of 30 trials from 2 4118 potentially relevant citations were finally included. The median FI of total trials included was 1.5 (interquartile range [IQR], 1-5), and half of the trials (n = 15) had a FI equal to 1. In 12 trials (40%), the total number of participants lost to follow-up surpassed the respective FI. The study also identified that increased FI was significantly associated with no TCM syndrome differentiation for inclusion criteria of the patients, larger total sample size, low risk of bias, and larger numbers of events.ConclusionsThe majority of CHM IBS RCTs with positive results were found to be fragile. Ensuring adequate sample size, scientifically rigorous study design, proper control of confounding factors, and a quality control calibration for consistency of TCM diagnostic results among clinicians should be addressed to increase the robustness of the RCTs. We recommend reporting the FI as one of the components of sensitivity analysis in future RCTs to facilitate the assessment of the fragility of trials.

Project description:ObjectivesEvidence-based treatment guidelines have been unable to provide evidence-based guidance on the effects of acupuncture for irritable bowel syndrome (IBS) because the only previous systematic review included only small, heterogeneous, and methodologically unsound trials. We conducted a new systematic review and meta-analysis of randomized controlled trials (RCTs) to estimate the effects of acupuncture for treating IBS.MethodsMEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, Cumulative Index to Nursing and Allied Health, and the Chinese databases Sino-Med, CNKI, and VIP were searched through November 2011. Eligible RCTs compared acupuncture with sham acupuncture, other active treatments, or no (specific) treatment, and evaluated acupuncture as an adjuvant to another treatment. Our outcomes were overall IBS symptom severity and health-related quality of life. Dichotomous data were pooled to provide a relative risk (RR) of substantial improvement after treatment, and continuous data were pooled to provide a standardized mean difference (SMD) in post-treatment scores between groups.ResultsA total of 17 RCTs (N=1,806) were included. We found no evidence of an improvement with acupuncture relative to sham acupuncture on symptom severity (SMD=-0.11, 95% confidence interval (95% CI): -0.35 to 0.13; 4 RCTs) or quality of life (SMD=-0.03, 95% CI: -0.27 to 0.22; 3 RCTs). Because of the homogeneity of the results of the sham-controlled trials, results were unaffected by restriction to the four sham-controlled RCTs that used adequate randomization, blinding, and had few withdrawals/dropouts. Among RCTs that did not use a placebo control, acupuncture was more effective than pharmacological therapy (RR of symptom improvement=1.28, 95% CI: 1.12 to 1.45; 5 RCTs) and no (specific) treatment (RR = 2.11, 95% CI: 1.18 to 3.79; 2 RCTs). There was no difference between acupuncture and Bifidobacterium (RR=1.07, 95% CI: 0.90 to 1.27; 2 RCTs) or between acupuncture and psychotherapy (RR=1.05, 95% CI: 0.87 to 1.26; 1 RCT). Acupuncture as an adjuvant to another Chinese medicine treatment was statistically significantly better than the other treatment alone, in trials with a high risk of bias (RR=1.17, 95% CI: 1.02 to 1.33; 4 RCTs).ConclusionsSham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control on IBS symptom severity or IBS-related quality of life. In comparative effectiveness Chinese trials, patients reported greater benefits from acupuncture than from pharmacological therapies. Future trials may help clarify whether or not these reportedly greater benefits of acupuncture relative to pharmacological therapies are due entirely to patients' preferences for acupuncture or patients' greater expectations of improvement on acupuncture relative to drugs.

Project description:Background: Irritable bowel syndrome (IBS) is a common disorder with abdominal pain and bowel habits changes. Herbal medicines (HMs) are frequently used in the treatment of IBS. Therefore, several systematic reviews (SRs) have been conducted to assess the efficacy and safety of HM in IBS patients. This study aimed to investigate the methodology and quality of evidence of SRs, and to describe the current state of research and evidence for the treatment of IBS with HM. Methods: SRs published up to January 2022 were searched using six electronic databases. SRs and/or meta-analyses on the use of HMs for IBS were included. The effects of placebo, conventional medicine (CM), and probiotics were compared with those of HMs. Two investigators independently extracted the data and assessed methodological quality using the Measure Tool to Assessment System Reviews 2 (AMSTAR 2). Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) was used to evaluate the quality of evidence for each main finding. Results: Eighteen SRs were included in this overview. Among them, eight SRs reported only specific subtypes of IBS: six SRs reported patients with diarrhea-predominant IBS, and two SRs reported patients with constipation-predominant IBS. In terms of total efficacy, HM was more effective than placebo, CM, or probiotics. HM showed a more significant effect than CM in relieving independent IBS symptom score (abdominal pain score, diarrhea score, abdominal distension score, stool frequency score, etc.) and recurrence rate. The rate of adverse events was significantly lower with HM compared to CM, and no serious adverse events were reported with HM treatment. According to AMSTAR 2, the methodological quality of the included SRs was extremely low. Furthermore, the quality of evidence for total efficacy was considered low or very low according to the GRADE tool. Conclusion: HM can be considered as an effective and safe treatment for IBS. However, the methodological quality of the included SRs and the quality of evidence was generally low. Therefore, well-designed randomized controlled trials are needed in the future so that a high-quality SR can be used to better assess the safety and efficacy of HM in the treatment of IBS. Systematic Review Registration: https://osf.io/nt6wz, identifier 10.17605/OSF.IO/NT6WZ.

Dataset Information

Acupuncture plus Chinese Herbal Medicine for Irritable Bowel Syndrome with Diarrhea: A Systematic Review and Meta-Analysis.

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Acupuncture plus Chinese Herbal Medicine for Irritable Bowel Syndrome with Diarrhea: A Systematic Review and Meta-Analysis.

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