Si-Ni-San For The Treatment Of Gastrointestinal Disorders: Systematic Review And Meta-analysis

Objective: Functional dyspepsia (FD), Duodenogastric reflux (DGR) andirritable bowel syndrome (IBS) are the most common gastrointestinal disorderswith unmet need. Hereby we conducted a systematic review and meta-analysisof the classic formula Si-Ni-San for the treatment of these three gut problems.Methods:We seached database PUBMED, CNKI and WANFANG up to1January2013for randomized, controlled clinical trials (RCTs). Key wordsincluded ‘functional dyspepsia’,‘duodenogastric reflux’, or ‘irritable bowelsyndrome’ in combination with ‘Si-Ni-San’. Inclusion crtiteria were clinicalstudies of Si-Ni-San in the treatment of FD, DGR and IBS. Jadad scale was usedto assess the methodological qualities. Random effect model was selected in thepool analysis of therapeutic efficacy to adjust for heterogeneity and funnel plotsgenerated to explore publication bias. For discrete data, odds ratios (OR) and95%confifence interval (95%CI) were automatically calculated.Results: After screening238potential articles from the electronic databases, weeventually included61RCTs for analysis. In30RCTs of FD, Si-Ni-San (n=1641)versus conventional medicine (n=1347) showed a significant difference (oddsratios=3.81,95%CI=3.06-4.73, p<0.0001) with marginal heterogeneity (I2= 0%). In15RCTs of DGR, Si-Ni-San (n=792) versus conventional medicine(n=645) exhibited a significant difference versus conventional medicine (oddsratios=3.83,95%CI=2.71-5.41, p<0.0001) with marginal heterogeneity (I2=0%). In16RCTs of IBS, Si-Ni-San (n=766) versus conventional medicine(n=657) demonstrated a significant difference versus conventional medicine(odds ratios=4.81,95%CI=3.57-6.47, p<0.0001) with marginal heterogeneity(I2=0%). Most of the included RCTs had Jadad score less than4.Conclusions: Si-Ni-San displays consistent therapeutic efficacy in treatingcommon digestive diseases. Different gastrointestinal diseases areintercorrelated with similar mechanism such as “stagnation of Liver qi”(Gan QiYu Jie). High quality clinical trials of Chinese herbal medicine are needed tovalidate the beneficial effect and mechanistic insight.