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  • Title: Efficacy of huadananshen mistura on insomnia: a randomized, double-blind, placebo-controlled, and multi-center clinical trial.
    Author: Li H, Yan X, Li T, Xu J, Wang Q, Xu Y.
    Journal: J Tradit Chin Med; 2013 Aug; 33(4):423-7. PubMed ID: 24187859.
    Abstract:
    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 low- and high-dose mistura (P = 0.000). CGI-I ratings in the low- and high-dose mistura groups were significantly 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 low- or high-dose group was significantly better than that of the placebo group (P = 0.000), but with no significant difference found between the low- and 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.
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