Effect of electroacupuncture versus cognitive behavioral therapy for perimenopausal insomnia: a non-inferiority, randomized controlled trial

BACKGROUND AND PURPOSE: Perimenopausal insomnia (PMI) significantly compromises the quality of life and daily functioning. Electroacupuncture (EA) is an effective non-pharmacological therapy for insomnia, but its efficacy compared to cognitive behavioral therapy for insomnia (CBT-I) is not well-established. This trial aimed to test the non-inferiority of EA compared with CBT-I for PMI. MATERIALS AND METHODS: In this two-arm, non-inferiority randomized controlled trial, 160 women were randomly assigned to EA or CBT-I groups (n = 80 each). CBT-I was used as an active comparator to establish whether EA preserves clinical efficacy within a pre-specified margin. The primary outcome was a mean change in the Insomnia Severity Index (ISI) score from baseline to week 8. A non-inferiority margin of -4 points on the ISI was predefined. RESULTS: At week 20, 92% (147/160) of the study participants completed follow-up, with retention rates of 95% (76/80) in the EA group and 89% (71/80) in the CBT-I group. EA demonstrated non-inferiority to CBT-I in the reduction of ISI score from baseline. The mean decrease in ISI was 6.80 (95% CI [confidence interval], 5.84 to 7.77) for EA and 9.16 (95% CI, 8.14 to 10.17) for CBT-I. The between-group difference of -2.36 (95% CI, -3.77 to -0.94) was within the non-inferiority margin. Serious adverse events were not reported. CONCLUSION: EA effectively improves sleep quality in women with PMI and is non-inferior to CBT-I. Therefore, EA is a viable treatment option for PMI.