Suan Zao Ren Tang as an Original Treatment for Sleep Difficulty
in Climacteric Women: A Prospective Clinical Observation
Chia-Hao Yeh, Christof K. Arnold, Yen-Hui Chen, and Jung-Nein Lai
Little scientific evidence supports the efficacy of herbal medicines in the treatment of women with sleep difficulty during the climacteric period. The purpose of this study is to evaluate the efficacy and safety of Suan Zao Ren Tang (SZRT) in reducing the impact of sleep disturbance on climacteric women, as measured by Pittsburg sleep quality index (PSQI) and the World Health Organization quality of life (WHOQOL). Sixty-seven climacteric women with sleep difficulty intending to treat received SZRT at a rate of 4.0 g, thrice daily for four weeks (MRS < 16, n = 34; MRS ≥ 16, n = 33). After taking into account potential confounding factors, the mean PSQI total scores had fallen from 13.0 (±2.9) to 9.0 (±3.2) (95% confidence interval −4.93, −3.10). Further analyses showed that SZRT produced superior benefit of daytime dysfunction in women with severe menopausal symptoms (MRS ≥ 16). There were three of the withdrawals involved treatment-related adverse events (stomachache, diarrhea, and dizziness). Excluding women with a past history of stomachache, diarrhea, or dizziness, four weeks of therapy with SZRT appears to be a relatively safe and effective short-term therapeutic option in improving daytime function of climacteric women with poor sleep quality.
Copyright © 2011 Chia-Hao Yeh et al. This is an open access article distributed
under the Creative Commons Attribution License.
1. Herbal Formula
2. Preparation of the Herbs
3. Recruitment of Subjects
4. Eligibility Criteria
5. Ineligibility Criteria
6. Study Design and Procedure
8. Safety Assessment
9. Statistical Analysis
1. Study Population
2. Safety and Adverse Effects
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