Purpose: Insomnia is a common problem with significant psychological and general health comorbidities and is often resistant to treatment. Specific aims included: 1. To determine the efficacy of acupuncture on self-report and objective measures of sleep. 2. To determine the impact of acupuncture on daytime manifestations of insomnia. 3. To explore the impact of acupuncture on physiologic measures of hyperarousal. Methods: 47 subjects were randomized to receive verum-vssham acupuncture in a protocol based on TCM principles. Verum treatment involved 15 needles with mild manual stimulation over 30 minutes. Park Sham Needles were used for the sham protocol. Subjects were seen twice weekly for 4 weeks then weekly for 4 weeks. Self-report measures included sleep quality, fatigue, anxiety, and depression. Objective outcomes included polysomnography, wrist-actigraphy, and psychophysiologic testing of HRV. Assessments were obtained at baseline, end-of-intervention, and 3-months post-treatment. Intention-totreat analysis was used. Results: Four subjects dropped out. Significant improvement was seen in both groups over time on self-report measures of insomnia and secondary symptoms, but there was no between group difference. The key objective measure, sleep-efficiency on polysomnography, did not improve in either group. Physiologic measures of hyperarousal, including EEG delta power on polysomnography, and HRV, improved over time, but there were no significant group differences. On secondary analysis there was no correlation between primary sleep measures and physiologic measures of hyperarousal. Nor was there a difference in physiologic measures of hyperarousal between responders and nonresponders to the intervention, independent of group assignment. Conclusion: Based on TCM literature, acupuncture shows promise for insomnia. In this trial, acupuncture was no more effective than placebo. Subjects in both groups showed improvement in self-report measures of insomnia as well as secondary symptoms. The primary weakness of this study was small sample size. While this trial is considered negative, acupuncture for insomnia merits further study.
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