落花安神口服液治疗失眠症疗效的随机双盲安慰剂对照临床试验

Efficacy of Luohua Anshen Oral Liquid on insomnia: A randomized, double-blind, placeb-controlled clinical trial

目的:为观察落花安神口服液对失眠症的临床疗效和安全性。方法:64例失眠症患者随机分为安慰剂(A)组33例,落花安神口服液(B)组31例。通过治疗前后测Spiegel量表及失眠症中医症状症候量表检测有效性。安全性检测包括不良事件报道及Tess量表检查。结果:与治疗前相比,治疗后A组和B组Spiegel量表及中医症状症候量表评分均有所下降(P<0.05,P<0.01)。A组总有效率33.3%,B组总有效率77.4%,差异显著(P<0.05);未发现明显不良反应。结论:落花安神合剂治疗失眠症安全、有效。

Objective: To evaluate the efficacy and safety of Luohua Anshen Oral Liquid on insomnia. Methods: Sixtyfour patients with insomnia were randomly divided into the placebo group(A) and the Luohua Anshen Oral Liquid group(B), 33 and 31 patients per each group respectively. Efficacy was assessed by Spiegel scale and insomnia TCM syndrome scale. Safety assessments included emergent adverse events reports and Tess scale. Results: After the treatment, total scores of Spiegel scale and insomnia TCM syndrome scale decreased and significant differences between two groups were found(P<0.05, P<0.01).The total effective rate were 33.3% and 77.4% in group A and B respectively with significant differences(P<0.05). No obvious adverse reaction was found. Conclusion: Luohua Anshen Oral Liquid could be seen as an effective and safe treatment method for insomnia.