Comparative effectiveness of different acupuncture courses for chronic insomnia disorder: a randomized controlled trial

Why clinicians should know about it

• Picked for Complementary and Alternative Medicine (top studies of the week, 6 September 2026): RCT comparing 4-, 6-, 8‑week acupuncture for insomnia

Abstract

BACKGROUND: Acupuncture is effective for chronic insomnia disorder (CID), but the favorable treatment duration remains uncertain, and direct evidence comparing different treatment courses is limited. This study compared the effectiveness of 4-, 6-, and 8-week acupuncture courses to determine whether extending treatment provides additional clinical benefit. METHODS: In this three-arm randomized controlled trial, 201 patients with CID were randomly assigned (1:1:1) to receive 4, 6, or 8 weeks of acupuncture (n = 67 per group), administered three times weekly using the same acupoints. The primary outcome was the the Insomnia Severity Index (ISI) score at treatment completion. Secondary outcomes included clinical remission (ISI < 8), and a minimal clinically important difference (ISI-MCID reduction ≥6), as well as scores on the Pittsburgh Sleep Quality Index (PSQI), Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), and Fatigue Severity Scale (FSS), hypnotic medication use, and safety. Outcomes were assessed at baseline, treatment completion, and 1 and 3 months after treatment. Longitudinal continuous outcomes were analyzed using linear mixed-effects models under the intention-to-treat principle. RESULTS: A total of 201 patients (157 women [78.1%], 44 men [21.9%]) were included in the intention-to-treat analysis. ISI scores decreased from baseline to post-treatment in the 4-, 6-, and 8-week groups, with mean changes of -7.4 points (95% CI, -9.0 to -5.8; P < .001), -9.7 points (95% CI, -11.4 to -8.0; P < .001), and -10.0 points (95% CI, -11.7 to -8.3; P < .001), respectively. Compared with the 4-week group, the 6- and 8-week groups showed greater improvements in ISI scores, with adjusted mean differences of -2.7 points (95% CI, -4.8 to -0.6; P = .008) and -2.8 points (95% CI, -4.9 to -0.6; P = .006), respectively. The additional improvement with the 8-week course versus the 6-week course was limited, with an adjusted mean difference of 0.0 points (95% CI, -2.2 to 2.1; P > .99). Clinical remission and MCID were more frequent in the 6-week group than in the 4-week group (P = .003 and P = .010, respectively). Sleep quality also generally favored the 6-week course over the 4-week course, with an adjusted mean difference of -1.9 points (95% CI, -3.6 to -0.2; P = .02). Between-group differences in depressive and anxiety symptoms were observed mainly between the 8- and 4-week groups. However, these secondary findings should be interpreted cautiously. No significant between-group differences were observed in fatigue or hypnotic medication use. No serious adverse events were reported. CONCLUSION: Six- and 8-week acupuncture courses produced greater improvements in insomnia severity than a 4-week course in patients with CID. Extending treatment from 6 to 8 weeks provided limited additional benefit for core sleep outcomes. These findings may inform clinical decisions regarding acupuncture treatment duration for CID. TRIAL REGISTRATION: https://www.chictr.org.cn [ChiCTR2300073711].

Abstract as published, via PubMed.