Improving sleep quality in climacteric women with insomnia: A randomized, head-to-head trial between Jia-Wei-Shiau-Yau San (JWSYS) and Suan-Zao-Ren Tang (SZRT)

BackgroundJia-Wei-Shiau-Yau San (JWSYS) was reported to reduce various menopausal-related symptoms, and Suan-Zao-Ren Tang (SZRT) is a frequently prescribed Chinese herbal formula for insomnia. We performed a double-blind, randomized trial to compare the efficacy of SZRT with that of JWSYS for insomnia in climacteric women.MethodsA total of 60 subjects 40-60 years of age with a history of insomnia at least 1 month were recruited from the Taipei City Hospital. The participants were instructed to take 4 g 3 times per day of either SZRT (n = 30) or JWSYS (n = 30) for a period of 4 weeks. The primary outcome measures were the mean component scores of the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome parameter was the global score on the World Health Organization Quality of Life questionnaire - Taiwan brief version.ResultsOf the initial 60 intent-to-treat participants, 54 completed the 4-week study. The mean domain and individual scores of PSQI decreased significantly under both treatments, reflecting improved daytime vitality and concentration ability. Mixed model analysis showed that SZRT was more effective in improving habitual sleep efficiency and prolonging sleep duration, while JWSYS was more effective in improving sense of well-being. Both formulas were associated with good compliance and safety. Serum cholesterol decreased slightly after 4 weeks of SZRT treatment.ConclusionSZRT appears to be more effective than JWSYS for improving sleep efficiency and duration, but the latter seems to be more effective in improving well-being. The potential effect of SZRT on serum total cholesterol level deserves further study.