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

<strong>Background:</strong> 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. <strong>Methods:</strong> 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). <strong>Results</strong>: 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. <strong>Conclusion</strong>: TCM interventions to assist in the treatment of chronic insomnia are effective and safe.