ABSTRACT
OBJECTIVE: To systematically evaluate therapeutic efficacy and safety of Compound muni ziqi granules in the adjuvant treatment of chloasma, and to provide evidence-based reference for clinical treatment. METHODS; Retrieved from Chinese Journal Full-text Database (CJFD), China Scientific Journal Database (CSJD), Wanfang database, Medline and Embase, randomized controlled trials (RCTs) about therapeutic efficacy (total response rate, cure rate, the decrease level of E2, FSH and LH in serum) and safety of Compound muni ziqi granules alone or combined with routine drug (trial group) vs. routine drug (control group) in the treatment of chloasma were collected. Meta-analysis was conducted by using Rev Man 5. 3 statistical software after data extraction of clinical studies meeting inclusion criteria and quality evaluation with Cochrane systematic evaluator manual 5. 1. 0. RESULTS: Totally 12 RCTs were enrolled, involving 1 100 patients. Results of Meta-analysis showed that total response rate [OR=2. 84, 95％CI(2. 20, 3. 67), P<0. 001], cure rate [OR=2. 11, 95％CI(1. 59, 2. 79),P<0. 001],decrease level of Ez [OR=-98. 64, 95％ CI (-110. 84, -86. 44), P <0. 001], decrease level of FSH [OR=-1. 85, 95％CI(-2. 58,-1. 11),P<0. 001] and decrease level of LH [OR= - 5. 85, 95％ CI (-6. 83, -4. 87), P<0. 001] in trial group were significantly better than control group, with statistical significance. In trial group, a few patients suffered from the increase of menstruation, the decrease of menstruation, temporary pigmentation and transient burnout; but all symptoms did not affect the treatment. CONCLUSIONS: Compound muni ziqi granules show definite clinical efficacy and good response rate in the adjuvant treatment of chloasma with mild ADR.