Efficacy and Safety of Electroacupuncture for Insomnia Disorder: A Multicenter, Randomized, Assessor-Blinded, Controlled Trial

Abstract

Purpose

To evaluate the efficacy and safety of electroacupuncture in treating insomnia.

Patients and Methods

In a multicenter, randomized, assessor-blinded, controlled trial, 150 patients with DSM-5-diagnosed insomnia with Insomnia Severity Index (ISI) scores ≥ 15 were randomly assigned to three different groups that underwent 10 sessions of electroacupuncture, sham-electroacupuncture, or usual care for 4 weeks from October 2015 to June 2016 at four Korean medicine hospitals, Republic of Korea. The primary outcome included the ISI score at Week 4; the secondary outcomes included evaluations of Pittsburgh Sleep Quality Index (PSQI), sleep diary, Hospital Anxiety and Depression Scale (HADS), EuroQoL five dimension (EQ-5D), Patient Global Impression of Change (PGIC), and salivary melatonin and cortisol levels. Assessments were performed at baseline (Week 0) and at Weeks 2, 4, 8, and 12.

Results

Compared with the usual care group, electroacupuncture group showed a greater improvement in ISI, PSQI, sleep diary-derived variables and HADS and EQ-5D scores at Week 4. The effects mostly persisted until Week 12. There were no significant differences between electroacupuncture and sham-electroacupuncture groups at Week 4 in all outcome measures, except sleep diary-derived sleep efficiency. However, the ISI score showed a significant difference between these groups at Weeks 8 and 12. Treatment success as per PGIC was significantly and borderline higher for electroacupuncture compared with usual care and sham-electroacupuncture, respectively. No significant changes in salivary melatonin and cortisol levels before and after treatment were observed in all groups. No serious adverse events were reported. Blinding was maintained in the sham-electroacupuncture group.

Conclusion

Ten sessions of electroacupuncture can improve the sleep quality of patients with insomnia without serious adverse effects. Thus, it can be recommended as an effective, safe, and well-tolerated intervention.

Keywords:

• electroacupuncture
• insomnia
• sleep initiation and maintenance disorders
• randomized controlled trial

Data Sharing Statement

The data that support the findings of this study are available from the corresponding author (Joo-Hee Kim) upon reasonable request. Additionally, the individual-deidentified participant data are available after contacting the corresponding author via email. The data will be available immediately following publication without an end date.

Acknowledgments

This work was supported by the Korea Institute of Oriental Medicine (K16122 and KSN1522120).

Disclosure

The authors declare that they have no conflicts of interest.