title: Chinese herbal medicine Guizhi Fuling Formula for treatment of uterine fibroids: a systematic review of randomised clinical trials.
abstract: BACKGROUND
  Guizhi Fuling Formula is widely applied for uterine fibroids in China. Many clinical trials are reported. This study assessed the efficacy and safety of Guizhi Fuling Formula for the treatment of uterine fibroids.
  
  
  METHODS
  PubMed, Cochrane CENTRAL, EMBASE, and four Chinese databases were searched through May 2013. We included randomised controlled trials (RCTs) that tested Guizhi Fuling Formula for uterine fibroids, compared with no intervention, placebo, pharmaceutical 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 randomised trials.
  
  
  RESULTS
  A total of 38 RCTs involving 3816 participants were identified. The methodological quality of the included trials was generally poor. Meta-analyses demonstrated that Guizhi Fuling Formula plus mifepristone were more effective than mifepristone alone in reducing the volume of fibroids (in total volume of multiple fibroids, MD -19.41 cm(3), 95% CI -28.68 to -10.14; in average volume of multiple fibroids, MD -1.00 cm(3), 95% CI -1.23 to -0.76; in average volume of maximum fibroids, MD -3.35 cm(3), 95% CI -4.84 to -1.87, I(2) = 93%, random effects model). Guizhi Fuling Formula significantly improved symptoms of dysmenorrhea either when it was used alone (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.
  
  
  CONCLUSIONS
  Guizhi Fuling Formula appears to have additional benefit based on mifepristone treatment in reducing volume of fibroids. However, due to high risk of bias of the trials, we could not draw confirmative conclusions on its benefit. Future clinical trials should be well-designed and avoid the issues that are identified in this study.
authors.forename: Ni-Ni
authors.initials: NN
authors.lastname: Chen
authors.forename: Mei
authors.initials: M
authors.lastname: Han
authors.forename: Hong
authors.initials: H
authors.lastname: Yang
authors.forename: Guo-Yan
authors.initials: GY
authors.lastname: Yang
authors.forename: Yu-Yi
authors.initials: YY
authors.lastname: Wang
authors.forename: Xiao-Ke
authors.initials: XK
authors.lastname: Wu
authors.affiliation: Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, No, 11 Bei San Huan Dong Lu, Beijing, Chaoyang District, China. jianping_l@hotmail.com.
authors.forename: Jian-Ping
authors.initials: JP
authors.lastname: Liu
mesh_terms: D015982:Bias; D002681:China; D000529:Complementary Therapies / Q000009:adverse effects; D004359:Drug Therapy, Combination / Q000009:adverse effects; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D004412:Dysmenorrhea / Q000188:drug therapy; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000188:drug therapy* / Q000473:pathology; D015735:Mifepristone / Q000627:therapeutic use; D008517:Phytotherapy / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic
chemical_list: D004365:Drugs, Chinese Herbal; C525079:guizhi-fuling; D015735:Mifepristone