Efficacy and Safety of Acupuncture Combined with Estazolam for Insomnia in Hemodialysis Patients: A Single-Center, Randomized Controlled Trial

Objective: To evaluate the efficacy and safety of acupuncture combined with estazolam for hemodialysis patients with insomnia. Methods: This prospective, randomized controlled trial was conducted from August 15, 2022 to February 22, 2024. By the random number table method, 110 end-stage renal-disease undergoing hemodialysis patients with insomnia were randomly divided into 2 groups to receive 1 mg/d of estazolam (control group, 55 cases) or acupuncture combined with 1 mg/d of estazolam (intervention group, 55 cases) for 4 weeks, and followed up for another 4 weeks. All patients received their standard treatments and common medications. The Pittsburgh Sleep Quality Index (PSQI), Hamilton Anxiety Scale (HAMA), and Chinese Medicine Syndrome Score of Insomnia (CMSSI) were the primary outcomes measured at baseline and at 2, 4, and 8 weeks, as well as clinical effectiveness before and after treatment; the second outcomes were the sleep stucture parameters assessed before and after treatment. Adverse effects were also assessed. Results: At 2, 4, and 8 weeks post-treatment, the scores of PSQI, HAMA, and CMSSI in the intervention group were lower than those in the control group (all P<0.01). At 4 weeks, the intervention group also had a significantly higher clinical effective rate than that in the control group (81.82% vs. 41.82%, P<0.01). Meanwhile, at 4 weeks post-treatment, the intervention group showed shorter sleep latency and wake time after sleep onset, higher sleep efficiency, total time in bed, sleep scores, deep sleep duration, deep sleep proportion, rapid eye movement (REM) duration and proportion, and lower light sleep proportion compared with control group (P<0.05 or P<0.01). After 4 weeks of follow-up, the intervention group still maintained higher sleep scores, deep sleep duration, deep sleep proportion, REM duration and proportion, as well as a lower light sleep proportion (P<0.05 or P<0.01). No major unfavorable adverse events were reported in both groups. Conclusion: Acupuncture combined with estazolam was superior to estazolam alone in improving clinical efficacy and sleep quality in hemodialysis patients with insomnia, with good safety and long-term efficacy. (Registration No. ChiCTR2200061967)