Efficacy of Acupuncture for Insomnia After Chemotherapy in Breast Cancer: A Randomized Sham-Controlled Trial

Post-chemotherapy insomnia is a prevalent complication among breast cancer patients. No relevant sham-controlled studies have employed polysomnography to objectively verify acupuncture treatment effects. This single-blind randomized controlled trial assessed the short-term therapeutic effect and safety of acupuncture for insomnia occurring after breast cancer chemotherapy.

This single-center study recruited 76 patients diagnosed with stage I-III breast cancer. All participants completed chemotherapy treatment, fulfilled ICSD-3 chronic insomnia diagnostic standards, and conformed to the TCM syndrome of Yin deficiency with excessive fire. Subjects were allocated into acupuncture group and sham acupuncture group at a 1:1 ratio with sealed opaque envelope randomization. The research spanned 9 months, including 5 weeks of biweekly intervention with 10 treatment sessions, alongside follow-up visits conducted at one week and one month after treatment termination. Clinical assessments were carried out at baseline, treatment completion, 1-week and 1-month follow-up. The primary outcome was Insomnia Severity Index score. Secondary outcomes contained PSQI, polysomnographic parameters, BAI, BDI, BFI-C and TCMSRS. All 76 randomized participants (38 cases per group) were analyzed based on intention-to-treat approach via MMRM statistical model.

Baseline clinical features showed no statistical difference between two groups (all p > 0.05). Significant group-time interaction was detected in ISI assessment (F = 2.80, p = 0.047). The acupuncture group exhibited more favorable symptom improvement compared with sham group. Between-group mean differences reached -1.61 (95% CI: -2.71 to -0.50, p = 0.005) after treatment, -1.75 (95% CI: -3.15 to -0.35, p = 0.015) at 1-week follow-up, and -1.77 (95% CI: -3.22 to -0.32, p = 0.017) at 1-month follow-up. Remarkable group-time interaction was also observed in PSQI (F = 4.67, p = 0.005), with acupuncture group presenting better sleep improvement at post-treatment, with mean difference of -1.18 (95% CI: -2.01 to -0.36, p = 0.006). Statistically significant interactive results were obtained in BFI-C (F = 4.07, p = 0.010), and acupuncture brought obvious fatigue relief with mean difference of -1.95 (95% CI: -3.22 to -0.68, p = 0.003). TCMSRS also showed notable interaction effect (F = 5.85, p = 0.001), and intergroup difference stood at -1.47 (95% CI: -2.34 to -0.60, p = 0.001) at 1-month follow-up. BDI scores presented significant group-time interaction (F = 3.00, p = 0.039), yet no evident pairwise difference was found in post-hoc comparison. No interactive variation existed in BAI evaluation (F = 1.69, p = 0.176). Polysomnography results demonstrated distinct advantages of acupuncture intervention. Between-group comparisons showed the treatment group obtained elevated sleep efficiency by 10.54% (95% CI: 0.75 to 20.33, p = 0.036) and increased N3 sleep proportion by 8.26% (95% CI: 3.09 to 13.43, p = 0.003). Wake after sleep onset time decreased by 32.00 minutes (95% CI: -57.50 to -0.50, p = 0.046). No severe adverse events emerged throughout the study.

Acupuncture improved insomnia severity, sleep quality, PSG-measured sleep architecture (increased sleep efficiency and N3, reduced WASO), fatigue, and TCM pattern symptoms in breast cancer patients with post-chemotherapy insomnia and the Yin deficiency with excessive fire syndrome; however, the between-group difference for the primary outcome did not reach the minimal clinically important difference; therefore, a clinically meaningful advantage over sham cannot be concluded from the current data.

China Clinical Trial Registry, https://www.chictr.org.cn/; registration number: ChiCTR2400082110.