title: The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial.
abstract: Although Traditional Chinese Medicine (TCM) has been widely used in clinical settings, a major challenge that remains in TCM is to evaluate its efficacy scientifically. This randomized controlled trial aims to evaluate the efficacy and safety of berberine in the treatment of patients with polycystic ovary syndrome. In order to improve the transparency and research quality of this clinical trial, we prepared this statistical analysis plan (SAP).
  
  
  
  The trial design, primary and secondary outcomes, and safety outcomes were declared to reduce selection biases in data analysis and result reporting. We specified detailed methods for data management and statistical analyses. Statistics in corresponding tables, listings, and graphs were outlined.
  
  
  
  The SAP provided more detailed information than trial protocol on data management and statistical analysis methods. Any post hoc analyses could be identified via referring to this SAP, and the possible selection bias and performance bias will be reduced in the trial.
  
  
  
  This study is registered at ClinicalTrials.gov, NCT01138930 , registered on 7 June 2010.
authors: Center for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
authors: Ying
authors: Y
authors: Zhang
authors: Center for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
authors: Jin
authors: J
authors: Sun
authors: Center for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
authors: Yun-Jiao
authors: YJ
authors: Zhang
authors: Center for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
authors: Qian-Yun
authors: QY
authors: Chai
authors: Center for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
authors: Kang
authors: K
authors: Zhang
authors: Department of Obstetrics and Gynecology, First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, 150040, China.
authors: Hong-Li
authors: HL
authors: Ma
authors: Department of Obstetrics and Gynecology, First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, 150040, China. xiaokewu2002@vip.sina.com.
authors: Xiao-Ke
authors: XK
authors: Wu
authors: Center for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China. Jianping_l@hotmail.com.
authors: Jian-Ping
authors: JP
authors: Liu
mesh_terms: D000293:Adolescent; D000328:Adult; D001599:Berberine / Q000009:adverse effects / Q000627:therapeutic use*; D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007333:Insulin Resistance; D015233:Models, Statistical; D011085:Polycystic Ovary Syndrome / Q000175:diagnosis / Q000188:drug therapy*; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal; D001599:Berberine
keywords: Berberine; Polycystic ovary syndrome; Randomized controlled trial; Statistical analysis plan; Traditional Chinese medicine