Efficacy and safety of Modified Tongxie Yaofang in diarrhea-predominant irritable bowel syndrome management: A meta-analysis of randomized, positive medicine-controlled trials

Abstract

ObjectiveTo systematically evaluate the efficacy and safety of Modified Tongxie Yaofang (M-TXYF) for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).MethodElectronic databases including PubMed, Springer Link, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature (CBM), Wanfang, and Chinese Scientific Journals Database (VIP) were conducted from their inception through May 11, 2017 without language restrictions. Primary and secondary outcomes were estimated by 95% confidence intervals (CI). RevMan 5.3 and the Cochrane Collaboration’s risk of bias tool were analyzed for this meta-analysis.ResultsTwenty-three literatures with a total of 1972 patients were included for the meta-analysis. The overall risk of bias evaluation was low. The pooled odds ratio showed that M-TXYF was significantly superior to routine pharmacotherapies (RP) in clinical therapeutic efficacy (OR 4.04, 95% CI 3.09, 5.27, P < 0.00001, therapeutic gain = 17.6%, number needed to treat (NNT) = 5.7). Moreover, compared with RP, M-TXYF showed that it can significantly reduce the scores of abdominal pain (standardized mean difference (SMD) -1.27; 95% CI -1.99, -0.56; P = 0.0005), abdominal distention (SMD -0.37; 95% CI -0.73, -0.01; P = 0.09), diarrhea (SMD -1.10; 95% CI -1.95, -0.25; P = 0.01), and frequency of defecation (SMD -1.42; 95% CI -2.19, -0.65; P = 0.0003). The differences of the adverse events between experiment and control groups had no statistical significance.ConclusionThis meta-analysis indicated that M-TXYF could be a promising Chinese herbal formula in treating IBS-D. However, considering the lack of higher quality of randomized controlled trials (RCTs), highly believable evidences should be required.

Review article: an analysis of safety profiles of treatments for diarrhoea‐predominant irritable bowel syndrome

“…The Chinese herbal medicine Tongxie Yaofang was evaluated in a meta‐analysis of 23 randomised clinical studies in patients with IBS‐D (n = 1972) . Patients with IBS‐D receiving Tongxie Yaofang were significantly more likely to experience improvement of clinical symptoms vs other treatments (90.3% vs 72.7%, respectively; odds ratio, 4.0; 95% CI, 3.1‐5.3 [ie, pinaverium bromide alone or in combination with a probiotic or montmorillonite powder, glutamine, loperamide, miyarisan, or trimebutine maleate]) . The number needed to treat for Tongxie Yaofang was 5.7 .…”

“…Patients with IBS‐D receiving Tongxie Yaofang were significantly more likely to experience improvement of clinical symptoms vs other treatments (90.3% vs 72.7%, respectively; odds ratio, 4.0; 95% CI, 3.1‐5.3 [ie, pinaverium bromide alone or in combination with a probiotic or montmorillonite powder, glutamine, loperamide, miyarisan, or trimebutine maleate]) . The number needed to treat for Tongxie Yaofang was 5.7 . Safety was evaluated in 12 studies included in the meta‐analysis; AEs reported with Tongxie Yaofang included nausea (n = 3 in two studies), compared with 16 AEs reported across the other treatments .…”

“…The number needed to treat for Tongxie Yaofang was 5.7 . Safety was evaluated in 12 studies included in the meta‐analysis; AEs reported with Tongxie Yaofang included nausea (n = 3 in two studies), compared with 16 AEs reported across the other treatments . A number needed to harm for Tongxie Yaofang was not reported …”

“…The number needed to treat is one such piece of information that healthcare providers can use to select appropriate therapies. In this review, a wide range of numbers needed to treat for medications used to treat IBS‐D were reported (Table ) and may be related to the primary endpoint of the studies and other methodologic considerations (patient population).…”

“…Chinese herbal medicine Tongxie Yaofang was evaluated in a meta-analysis of 23 randomised clinical studies in patients with IBS-D (n = 1972). 87 number needed to treat = 4). 88 A separate meta-analysis of seven randomised, controlled studies (n = 634) showed a similar benefit in IBS symptoms for peppermint oil compared with placebo (number needed to treat = 4).…”