Efficacy and safety of the Shugan Jieyu capsule as a complementary treatment for functional dyspepsia: A systematic review and meta-analysis.

BACKGROUND

To evaluate the efficacy and safety of the Shugan Jieyu capsule as a complementary treatment for functional dyspepsia (FD).

METHODS

Seven electronic databases were searched for randomized controlled trials (RCTs) on Shugan Jieyu capsule treatment for FD with a scientifically rigorous search strategy. The quality of the literature was assessed using the Risk of Bias 2 tool, a meta-analysis was performed with RevMan v5.3 and Stata 12.0.

RESULTS

Thirty-two RCTs containing 3582 participants were included in the meta-analysis. The combination of the Shugan Jieyu capsule with Western medications (WM) was more efficacious than treatment with WM alone (relative risk [RR] = 1.29, 95% confidence interval [CI]: [1.23, 1.35], P < .00001) and had comparable safety (RR = 1.0, 95% CI: [0.68, 1.47], P = .99). This combination also reduced the rate of disease recurrence (RR = 0.24, 95% CI: [0.14, 0.40], P < .00001) and patients' gastrointestinal symptom scores (standardized mean difference [SMD] = -1.59, 95% CI: [-2.00, -1.18], P < .00001).

CONCLUSION

While current evidence suggests SG as a complementary therapy may enhance FD treatment efficacy without increasing safety risks, these findings are constrained by the low methodological quality of included studies and exclusive derivation from Chinese populations. Definitive conclusions require future high-quality, multicenter RCTs with standardized outcome measures and diverse ethnic cohorts.