Efficacy and safety of Si-Jun-Zi-Tang-based therapies for functional (non-ulcer) dyspepsia: a meta-analysis of randomized controlled trials

Yaping Wang,Bin Liu,Zhiling Yu,Xiuqiong Fu,Tiejun Tong

doi:10.1186/s12906-020-03176-z

Abstract

BackgroundThe traditional Chinese medicine formula Si-Jun-Zi-Tang (SJZT) has a long history of application in the treatment of functional dyspepsia (non-ulcer dyspepsia, FD)-like symptoms. SJZT-based therapies have been claimed to be beneficial in managing FD. This study aimed to assess the efficacy and safety of SJZT-based therapies in treating FD by meta-analysis.MethodsSystematic searches for RCTs were conducted in seven databases (up to February 2019) without language restrictions. Data were analyzed using Cochrane RevMan software version 5.3.0 and Stata software version 13.1, and reported as relative risk (RR) or odds ratio (OR) with 95% confidence intervals (CIs). The primary outcome was response rate and the secondary outcomes were gastric emptying, quality of life, adverse effects and relapse rate. The quality of evidence was evaluated according to criteria from the Cochrane risk of bias.ResultsA total of 341 potentially relevant publications were identified, and 12 RCTs were eligible for inclusion. For the response rate, there was a statically significant benefit in favor of SJZT-based therapies (RR = 1.23; 95% CI 1.17 to 1.30). However, the benefit was limited to modified SJZT (MSJZT). The relapse rate of FD patients received SJZT-based therapies was lower than that of patients who received conventional medicines (OR = 0.23; 95% CI 0.10 to 0.51). No SJZT-based therapies-related adverse effect was reported.ConclusionSJZT-based prescriptions may be effective in treating FD and no serious side-effects were identified, but the effect on response rate appeared to be limited to MSJZT. The results should be interpreted with caution as all the included studies were considered at a high risk of bias. Standardized, large-scale and strictly designed RCTs are needed to further validate the benefits of SJZT-based therapies for FD management.Trial registrationSystematic review registration: [PROSPERO registration: CRD42019139136].

Highlights

The traditional Chinese medicine formula Si-Jun-Zi-Tang (SJZT) has a long history of application in the treatment of functional dyspepsia-like symptoms
According to the Rome IV criteria, Functional (non-ulcer) dyspepsia (FD) is characterized by the presence of one or more symptoms, such as postprandial fullness, early satiation, epigastric pain and epigastric burning, none of which can be explained by an organic disease [1]
We used the Chinese words 四君子汤 (Si-Jun-Zi-Tang) and 功能性消化不良 for the search in Chinese Biomedical Database (CBM), Wanfang, China Science and Technology Journal Database (VIP) and China National Knowledge Infrastructure (CNKI)

Summary

Introduction

The traditional Chinese medicine formula Si-Jun-Zi-Tang (SJZT) has a long history of application in the treatment of functional dyspepsia (non-ulcer dyspepsia, FD)-like symptoms. Many therapies have been proposed for FD, including Helicobacter pylorieradication therapy [8], acid-suppression therapy [9], prokinetic agents [10], antidepressants [11], psychological therapy [12], and placebo [10]. These therapies are unsatisfactory in efficacy and some of them have serious side effects [13,14,15,16]

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