Traditional Chinese medicine lifestyle intervention for chronic insomnia: raw data from a multicenter, parallel, open randomized controlled clinical trial.zip

Background: Traditional Chinese Medicine (TCM) lifestyle interventions are believed to assist in improving sleep. However, large-scale clinical trials confirming their effectiveness and safety are lacking. Therefore a multicenter, parallel, randomized controlled trial was conducted in China. Methods: The music therapy combined with TCM group listened to music combined with sleeping drinks and sleeping pillows which were made of TCM. Music therapy alone group only listened to music. The primary outcome was the change from baseline in the Pittsburgh Sleep Quality Index (PSQI) at weeks 4, 8, and 12. Secondary outcomes were the change from baseline in the Fatigue Scale-14 (FS-14), Hyperarousal Scale (HAS), and Insomnia Severity Index Scale (ISI) total scores at weeks 4, 8, and 12. Both groups intervened for 12 weeks. Generalized estimating equations were used for statistics, and the Full analysis set(FAS)was used to analyze the data along with the Per Protocol Set (PPS). Results: After 12 weeks of treatment, significant improvements were observed in the TCM intervention combined with the music group for both primary and secondary outcomes, but the treatment advantage only became apparent at weeks 8 and 12. In terms of safety analysis, there were no serious adverse effects. Conclusion: TCM interventions to assist in the treatment of chronic insomnia are effective and safe.背景：传统中医（Traditional Chinese Medicine，TCM）生活方式干预被认为可辅助改善睡眠，但目前缺乏验证其有效性与安全性的大规模临床试验。为此，我国开展了一项多中心、平行组随机对照临床试验。 方法：音乐联合中医干预组聆听音乐，并服用由中药材制成的助眠饮品与助眠枕；单纯音乐治疗组仅聆听音乐。主要结局指标为第4、8、12周时匹兹堡睡眠质量指数（Pittsburgh Sleep Quality Index，PSQI）较基线的变化值；次要结局指标为第4、8、12周时疲劳量表-14（Fatigue Scale-14，FS-14）、过度觉醒量表（Hyperarousal Scale，HAS）及失眠严重指数量表（Insomnia Severity Index Scale，ISI）总分较基线的变化值。两组均接受为期12周的干预。统计分析采用广义估计方程，数据分析同时采用全分析集（Full analysis set，FAS）与符合方案集（Per Protocol Set，PPS）。 结果：干预12周后，中医联合音乐干预组的主要及次要结局指标均获得显著改善，但该治疗优势仅在第8周和第12周时显现。安全性分析结果显示，未发生严重不良事件。 结论：中医辅助治疗慢性失眠的方案安全有效。