Background Few high-quality, large-scale, controlled trials comparing the effectiveness and safety of acupuncture,auricular acupuncture and combined acupuncture treatment for insomnia are available.
Objective To carry out a randomised, assessor-blinded, waitlist-controlled trial to test the superiority of combination treatment.
Methods After in-person and polysomnography screening, 224 subjects (mean age 53.4 years; 75.4% female) with DSM-5 insomnia disorder, who were free from major psychiatric disorders and with sleep-diary-derived sleep efficiency averaged over 1 week of <85%, were randomised to acupuncture alone, acupuncture plus auricular acupuncture (combination treatment), or a waitlist in a 3:3:1 ratio. Standardised acupuncture and combination treatment were provided three times weekly for 3 weeks. The primary outcome was sleep-diary-derived sleep efficiency. Secondary outcomes included wrist actigraphy and self-reported scales on insomnia, anxiety and depression, fatigue, sleepiness and functioning. Assessments were conducted at baseline, 1 week, 4 weeks and 13 weeks after treatment. Participants on the waitlist were re-randomised to receive acupuncture or combination treatment after the second post-baseline assessment.
Results There was no significant difference between acupuncture and combination treatment in the primary outcome and most secondary outcomes at all time points. However, both treatments were better than waitlist in reducing insomnia, anxiety/depressive symptoms and fatigue, and improving function. Within-group improvements were maintained at 13 weeks after treatment. Of 260 adverse events, 243 were mild (93.5%). Discontinuation due to adverse events was 2.1% and 3.1% for acupuncture and combination treatment, respectively.
Conclusions Limited by short-term treatment and follow-up, the attempt to augment acupuncture by auricular acupuncture was not supported. Acupuncture and combination treatment were safe and had mild hypnotic effects, which lasted for at least 13 weeks.
Trialregistration number NCT01891097; Results.
- Auricular Acupuncture
- Randomized controlled trial
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Contributors K-FC and W-FY designed the study and drafted the manuscript. W-FY, BY-MY and FC-YL were responsible for data collection and analysis. K-FC and W-FY interpreted the results. Z-JZ, RM-KN and G-CY reviewed the manuscript. All authors declare that they made substantial contributions to the study, including drafting or revising the work; read and approved the final version of the manuscript accepted for publication, and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding Health and Health Services Research Fund (HHSRF #10111301), Food and Health Bureau, Hong Kong SAR.
Competing interests None.
Patient consent Obtained.
Ethics approval Institutional review board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster.
Provenance and peer review Not commissioned; externally peer reviewed.
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