Comparative Effects of Two Acupuncture Protocols in the Management of Chronic Insomnia: A Randomized Controlled Trial.

BACKGROUND

Chronic Insomnia Disorder (CID) significantly impairs both sleep quality and daytime functioning. However, current treatments have limited efficacy in improving daytime function and are often associated with side effects. This highlights the urgent need for effective and safe therapeutic approaches that can target both nocturnal and daytime symptoms.

OBJECTIVE

To evaluate the clinical efficacy and safety of acupuncture in improving sleep quality and daytime functioning in patients with chronic insomnia, and to optimize its treatment protocol.

METHODS

This study was a single-blind, randomised, controlled trial. The treatment group received acupuncture at HT7, BL15, LR3 and BL18, while the control group was treated at GV20, EX-HN22, BL62 and KI6. Each group underwent 10 sessions administered three times per week. The Insomnia Severity Index (ISI) served as the primary evaluation index for sleep efficacy, while the Pittsburgh Sleep Quality Index (PSQI) and polysomnography (PSG) were secondary indexes for sleep quality. The Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), Fatigue Severity Scale (FSS), and Epworth Sleepiness Scale (ESS) were used to evaluate daytime functional impairment.

RESULTS

Totally 76 patients were included in this study and randomly assigned to the treatment group (n=38) and the control group (n=38). Both groups showed significant improvements in sleep quality and daytime functioning. The treatment group exhibited a mean ISI reduction of 7.58 points versus 5.71 points in the control group; however, this difference was not statistically significant. PSG data revealed similar improvements in total sleep time, sleep efficiency, and REM sleep percentage across groups. Notably, the treatment group demonstrated significantly greater reductions in BAI and BDI scores (p<0.05), while improvements in FSS and ESS scores were comparable.

CONCLUSION

Acupuncture is an effective and safe treatment to improve sleep as well as daytime functioning for chronic insomnia. The protocol using HT7, BL15, LR3 and BL18 may offer added benefits for reducing anxiety and depressive symptoms.

CLINICAL TRIAL REGISTRATION

This study was registered with the China Clinical Trial Registry (CCTR), registration ID: ChiCTR2200066102.