title: Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials.
abstract: BACKGROUND
  Insomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD) is a well known classic Chinese herbal prescription for insomnia and has been treating people's insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia.
  
  
  METHODS
  A systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs) involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions.
  
  
  RESULTS
  Twelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information.
  
  
  CONCLUSIONS
  Despite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well-designed RCTs are needed.
authors: The Center of Neurology and Rehabilitation, The Second Affiliated Hospital of Wenzhou Medical College, Wenzhou, 325027, China.
authors: Cheng-long
authors: CL
authors: Xie
authors: Yong
authors: Y
authors: Gu
authors: Wen-Wen
authors: WW
authors: Wang
authors: Lin
authors: L
authors: Lu
authors: Deng-lei
authors: DL
authors: Fu
authors: Ai-ju
authors: AJ
authors: Liu
authors: Hui-qin
authors: HQ
authors: Li
authors: Ji-huang
authors: JH
authors: Li
authors: Yan
authors: Y
authors: Lin
authors: Wen-jie
authors: WJ
authors: Tang
authors: Guo-qing
authors: GQ
authors: Zheng
mesh_terms: D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008517:Phytotherapy; D012107:Research Design / Q000592:standards; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; C530157:suanzaoren