A Randomized Controlled Trial Of Auricular Acupuncture Combined With Eszopiclone In The Treatment Of Primary Insomnia

Objective:To evaluate the clinical efficacy and safety of auricular acupuncture combined eszopiclone 3mg for treatment of insomnia.Method:This was a randomized controlled trial with 106 subjects who reported insomnia defined as sleep latency of at least 30 minutes, wakefulness after sleep onset at least 40 minutes, total sleep time less than or equal to 6 hours, or sleep efficiency less than 80% per night for at least 3 nights per week over the previous month. Patients were randomly assigned to auricular acupuncture combined eszopiclone 3 mg (group A) or placebo auricular acupuncture combined eszopiclone 3 mg (group B) for 4 weeks. The different groups were given different auricular points and needles. Sleep data form actiwatch which including sleep onset latency, wakefulness after sleep onset, total sleep time, sleep efficiency, number of awakenings were collected at baseline and end of treatment. The scores of Pittsburgh Sleep Quality Index, Insomnia Severity Index Scale, Epworth Sleeping Scale, Flinders Fatigue Scale were collected at baseline, end of treatment, and 12-week follow-up. Safety and compliance were assessed at clinic visits.Results:After 4-week treatment, patients of group A or group B both reported improvements in sleep onset latency, wakefulness after sleep onset, total sleep time, sleep efficiency, number of awakenings, the scores of Pittsburgh Sleep Quality Index, the scores of Insomnia Severity Index Scale, the scores of Epworth Sleeping Scale and the scores of Flinders Fatigue Scale to baseline (P< 0.01). This objective sleep evaluation from actiwatch and subjective evaluation from scales above showed no statistically difference between group A and group B (P> 0.05). The adverse events of group A occurred less than group B (P> 0.05).Conclusion:In this study, auricular acupuncture combined eszopiclone provided significant improvements in sleep onset latency, sleep maintenance, sleep duration, sleep quality, and daytime function. However, limited to sample size, the existing research evidence did not show better efficacy for auricular acupuncture combined eszopiclone for treatment of insomnia to placebo auricular acupuncture combined eszopiclone. Further conclusions still need to expand the sample content to be confirmed. In addition, this experiment can observe whether auricular acupuncture can really reduce the side effects of drugs.