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Efficacy of Huadananshen mistura on insomnia: a randomized, double-blind, placebo-controlled, and multi-center clinical trial

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Journal of Traditional Chinese medicine 2013年第4期33卷 423-427页

作者： Huafang Li Xiaoli Yan Ting Li Jian Xu Qiaochu Wang Yifeng Xu Department of Psychiatry Shanghai Mental Health Center Shanghai Jiao Tong University School of Medicine Department of Insomnia Shanghai Chinese Medicine Hospital

OBJECTIVE: To evaluate the effect of Huadananshen mistura in clinical treatment of Chinese patients with insomnia. METHODS: In this randomized, double-blind, placebo-controlled, multi-center study, 244 patients with insomnia were randomly assigned to a placebo group, a low-dose (10 mL/day), or a high-dose (20 mL/day) mistura group. Efficacy was assessed by using the sleep dysfunction rating scale (SDRS) and Clinical Global Impression-Improvement (CGI-I) scores. Safety and tolerability assessments included emergent adverse events, laboratory tests, and electrocardiograms. RESULTS: Total SDRS scores decreased in all three groups, and there were significant differences between the placebo group and the lowand high-dose mistura groups (P=0.000). CGI-I ratings in the lowand high-dose mistura groups were sig-nificantly better than that of the placebo group (P= 0.000). Incidences of rebound insomnia were similar in all three groups (placebo group: 6.94% , low-dose mistura group: 12.99% , and high-dose mistura group: 10.96% ; P=0.475). The efficacy of Huadananshen mistura in the lowor high-dose group was significantly better than that of the placebo group (P=0.000), but with no significant difference found between the lowand high-dose mistura groups (P=0.887). The rates of adverse events were similar in the three groups (placebo 2.44% , low-dose mistura 0%, and high-dose mistura 5%; P=0.088). CONCLUSION: Huadananshen mistura is an effective and generally well-tolerated hypnotic medicine for the treatment of Chinese patients with insomnia.

关键词： sleep initiation and maintenance disorders medicine Chinese traditional Randomized controlled trials Double-blind method Huadananshen mistura

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