Efficacy and safety of Tongdutiaoshen acupuncture on insomnia in maintenance hemodialysis patients: A randomized clinical trial protocol

BACKGROUND: Patients undergoing maintenance hemodialysis (MHD) experience insomnia frequently. Poor sleep quality impairs the quality of life and adversely affects long-term outcomes. Currently, the treatment of insomnia in patients undergoing MHD is mainly based on medication, although it has severe side effects and poor compliance in patients. Therefore, developing complementary and alternative therapies with higher efficacies is important. This study explores the clinical efficacy and safety of Tongdutiaoshen acupuncture in treating insomnia in patients with MHD. METHODS: This randomized controlled trial (RCT) will be performed at Beijing Luhe Hospital, affiliated with Capital Medical University in China. We will strictly adhere to the Standards for Reporting Interventions in Clinical Trials of Acupuncture (2010). A total of 110 MHD patients with insomnia will be randomly allocated in a 1:1 ratio to the drug control (DC) or Tongdutiaoshen acupuncture (TA) group. Patients in the control group will be administered estazolam tablets (1 mg/day) for four weeks, followed by a 4-week follow-up period. Based on the background therapy provided for the DC group, the TA group will be administered the interventional cohort three times a week for four weeks in a row, followed by a 4-week follow-up period. The primary endpoints will include the Pittsburgh Sleep Quality Index (PSQI), Hamilton Anxiety Scale (HAM-A), TCM Insomnia Syndrome Score, and clinical response rate, which will be evaluated on days 0, 14, 28, and 56. Secondary endpoints will include sleep data monitoring and related laboratory indices, which will be evaluated on days 0, 28, and 56, respectively. DISCUSSION: This study is designed based on a rigorous methodology to evaluate the efficacy and safety of Tongdutiaoshen acupuncture for insomnia in patients undergoing hemodialysis. The findings of this trial will be published in peer-reviewed journals as reliable evidence. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2200061967. Registered on July 07, 2022.