title: [Quality assessment of randomized controlled trials on wenxin granule for treatment of atrial fibrillation].
abstract: OBJECTIVE
  To investigate the statement on randomized controlled trials on Wenxin granule for treatment of atrial fibrillation and to judge whether those trials could offer high quality evidence or not, thus improve design level and quality.
  
  
  METHODS
  RCTs were searched from home and abroad about atrial fibrillation treated with Wenxin granule, which reported before October, 2010. Jadad scale and CONSORT statement were used.
  
  
  RESULTS
  There were 66 RCTs retrieved that met inclusion criteria. Using Jadad rating scale, only 2 literatures gain score 4 and 1 literature gains score 3, 54 literatures gain score 2, 7 literatures gain score 1, 2 literatures gain score 0. Only 2 literatures described random number table as the method of grouping. None of the RCTs was reported the allocation concealment. Only 1 literature was used blinding. Fifty-nine literatures were mentioned the lost to follow-up conditions. According to the CONSORT standards, only six literatures (9.1%) mentioned the method of generating the random sequence. Four literatures (6.1%) were quasi-random. Nineteen literatures (28.8%) had inclusion criteria. Six literatures (9.1%) had the follow-up record. Fifty one literatures (77.3%) described the adverse events. None had the estimation of the sample size, intention-to-treat analysis and stratified analysis. None had the ethical approval or informed consent.
  
  
  CONCLUSIONS
  The quality of clinical trials of Wenxin granule in treating atrial fibrillation needs to be improved.
authors: Institute of Basic Research In Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. liuweimin68@yahoo.com.cn
authors: Weimin
authors: W
authors: Liu
authors: Rui
authors: R
authors: Jiang
authors: Shasha
authors: S
authors: Ding
authors: Wei
authors: W
authors: Fu
authors: Shuqin
authors: S
authors: Wang
authors: Xue
authors: X
authors: Li
authors: Jing
authors: J
authors: Kang
authors: Dongning
authors: D
authors: Wu
authors: Bo
authors: B
authors: Liu
authors: Wenchao
authors: W
authors: Mao
authors: Liyun
authors: L
authors: He
authors: Baoyan
authors: B
authors: Liu
mesh_terms: D001281:Atrial Fibrillation / Q000188:drug therapy*; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D006801:Humans; D016032:Randomized Controlled Trials as Topic
chemical_list: D004365:Drugs, Chinese Herbal