Efficacy and Safety of a Traditional Chinese Medicine Formula, Suanzaorentang, on Primary Insomnia: A Double-Blind Randomized Placebo-Controlled Study
Publication in refereed journal

摘要Despite widely used as one of the commonest over-the-counter treatments of insomnia, the efficacy and safety of suanzaorentang, a composite Traditional Chinese Medicine (TCM) formulae, are poorly understood. We aimed to evaluate the efficacy and safety of suanzaorentang on primary insomnia over a period of four weeks with both subjective and objective sleep measurements. A randomized, double-blind, placebo-controlled trial (RCT) involving 162 primary insomniac subjects (mean age 46.5 years, range 21 to 64 years; female: 68.5%) treated at 2 university affiliated sleep centers in Hong Kong. Among 162 subjects, 86% (n=139) completed the whole trial. Participants received either four weeks Chinese herbal formula (suanzaorentang group) or placebo by block randomization. After 4-week treatment, the treatment group showed more improvement in subjective sleep quality in the perceived depth of sleep (Visual analog scale, mean differences (95%CI) = -16.0 (-22.1 to -9.9) v.s. -7.1 (-13.3 to -1.0), p<0.05) and refreshing sleep (mean differences (95%CI) = -12.0 (-18.2 to -5.8) v.s. -2.2 (-8.9 to 4.5), p<0.05) than placebo group. However, the two groups did not have any differences over the objective measures and the Insomnia Severity Index total scores. No difference in overall adverse events was found between groups. The study showed that 4-weeks treatment of suanzaorentang improved perceived sleep quality but not subjective sleep difficulty or objective sleep parameters. In particular, suanzaorentang had good safety profile and tolerability.
著者Wing YK, Chung KF, Lam SP, Zhang Jihui, Yu MWM, Cheng KF, Fong CYS, Leung PC
期刊名稱Journal of Sleep Medicine and Disorders

上次更新時間 2018-27-02 於 17:00