Chinese Herbal Medicine Guizhi Fuling Formula for Treatment of Uterine Fibroids: A Systematic Review of Randomized Clinical Trials.

PURPOSE: Guizhi Fuling Formula is widely applied for treatment of uterine fibroids in China. The formula consists of five herbs: Ramulus Cinnamomi, Poria, Semen Persicae, Radix Paeoniae Rubra or Radix Paeoniae Alba, and Cortex Moutan. Many clinical trials have been published. This review aims at assessing the efficacy and safety of Guizhi Fuling formula for uterine fibroids. METHODS: PubMed, Cochrane CENTRAL, EMBASE, and four Chinese databases were searched till May 2013. We included randomized trials testing Guizhi Fuling Formula for uterine fibroids, compared with no intervention, placebo, medication, or other Chinese patent medicines approved by the State Food and Drug Administration of China. Authors extracted data and assessed the quality independently. We applied RevMan 5.2.0 software to analyse data of included randomized trials. RESULTS: A total of 38 randomized trials were identified with involving 3816 participants. The methodological quality of the included trials was generally poor in terms of risk of bias. Meta-analyses demonstrated that Guizhi Fuling formula plus mifepristone was more effective than mifepristone alone in reducing the volume of fibroids (in total volume of multiple fibroids subgroup, mean difference (MD):−19.41 cm3, 95%CI −28.68 to −10.14; in average volume of multiple fibroids subgroup, MD:−1.00 cm3, 95%CI −1.23 to −0.76; in average volume of maximum fibroids subgroup, MD:−3.35 cm3, 95%CI −4.84 to −1.87, I2=93%, random effects model). Guizhi Fuling Formula significantly improved dysmenorrhoea either used alone (relative risk (RR) 2.27, 95% CI 1.04 to 4.97) or in combination with mifepristone (RR 2.35, 95%CI 1.15 to 4.82). No serious adverse events were reported.CONCLUSION: Guizhi Fuling Formula may have additional benefit based on mifepristone in reducing volume of fibroids. However, due to high risk of bias of the trials, we could not draw confirmative conclusions on the benefit. Further well-designed clinical trials are warranted.