Wang Pei, Wang Zheng, Li Zhong-Xin, Ma Si-Hui, Li Yan, Li Huan, Yang Chao, Yu Man, Wang Jiao, An Yan-Chen, Li Min
Center of Traditional Chinese Medicine, Beijing Luhe Hospital Affiliated to Capital Medical University, No.82, Xinhua South Street, Tongzhou Distract, Beijing, 101149, China.
Kidney Center, Beijing Luhe Hospital Affiliated to Capital Medical University, No.82, Xinhua South Street, Tongzhou Distract, Beijing, 101149, China.
Contemp Clin Trials Commun. 2023 Aug 1;35:101196. doi: 10.1016/j.conctc.2023.101196. eCollection 2023 Oct.
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 acupuncture in treating insomnia in patients with MHD.
This randomized controlled trial (RCT) will be performed at Beijing 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 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.
This study is designed based on a rigorous methodology to evaluate the efficacy and safety of acupuncture for insomnia in patients undergoing hemodialysis. The findings of this trial will be published in peer-reviewed journals as reliable evidence.
Chinese Clinical Trial Registry ChiCTR2200061967. Registered on July 07, 2022.
维持性血液透析（MHD）患者经常出现失眠。睡眠质量差会损害生活质量，并对长期预后产生不利影响。目前，MHD患者失眠的治疗主要基于药物，但药物有严重的副作用且患者依从性差。因此，开发疗效更高的补充和替代疗法很重要。本研究探讨针刺治疗MHD患者失眠的临床疗效和安全性。
本随机对照试验（RCT）将在中国首都医科大学附属北京医院进行。我们将严格遵循《针刺临床试验干预措施报告标准（2010）》。总共110名患有失眠的MHD患者将按1:1的比例随机分配到药物对照组（DC）或针刺治疗组（TA）。对照组患者将服用艾司唑仑片（1毫克/天），持续四周，随后进行4周的随访期。基于为DC组提供的背景治疗，TA组将连续四周每周接受三次干预治疗，随后进行4周的随访期。主要终点将包括匹兹堡睡眠质量指数（PSQI）、汉密尔顿焦虑量表（HAM - A）、中医失眠症候评分和临床有效率，将在第0、14、28和56天进行评估。次要终点将包括睡眠数据监测和相关实验室指标，分别在第0、28和56天进行评估。
本研究基于严格的方法设计，以评估针刺治疗血液透析患者失眠的疗效和安全性。本试验的结果将作为可靠证据发表在同行评审期刊上。
中国临床试验注册中心ChiCTR2200061967。于2022年7月7日注册。
