Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials

BMC Complementary and Alternative Medicine

Guo-qing Zheng³  Wen-jie Tang¹  Yan Lin³  Ji-huang Li³  Hui-qin Li³  Ai-ju Liu³  Deng-lei Fu³  Lin Lu³  Wen-Wen Wang³  Yong Gu²  Cheng-long Xie³ 

[1] Department of Psychology, School of Environmental Science and Public Health, Wenzhou Medical College, Wenzhou, 325000, China;School of Chinese Medicine, University of Hong Kong, Hong Kong, SAR, China;The Center of Neurology and Rehabilitation, The Second Affiliated Hospital of Wenzhou Medical College, Wenzhou, 325027, China

关键词: Systematic review;    Suanzaoren decoction;    Insomnia;   

Others  :  1231157
DOI  :  10.1186/1472-6882-13-18

 received in 2012-10-22, accepted in 2013-01-03,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Xie et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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