Wu Yuchi, Yang Lihong, Li Lingli, Wu Xiuqing, Zhong Zhicong, He Zhiren, Ma Hongyan, Wang Lixin, Lu Zhaoyu, Cai Cun, Zhao Daixin, Meng Xiangxin, Qi Airong, Yang Aicheng, Su Guobin, Guo Xinfeng, Liu Xusheng, Zou Chuan, Lin Qizhan
Hemodialysis Department, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, People's Republic of China.
Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.
Trials. 2018 Mar 7;19(1):171. doi: 10.1186/s13063-018-2546-2.
Patients on maintenance hemodialysis (MHD) frequently complain of insomnia. Poor sleep quality impairs their quality of life and adversely affects long-term outcome. Previously we applied auricular acupressure therapy (AAT) for MHD patients with insomnia and yielded favorable results. AAT probably improves sleep quality by stimulating the vagus nerve and inhibiting sympathetic overactivity. However, the efficacy of AAT for insomnia in this population is still lacking. The proposed randomized controlled trial (RCT) will evaluate the efficacy and safety of AAT for improvement of sleep quality in MHD patients with insomnia.
METHODS/DESIGN: The proposed study is a multi-center, double-blind (participants and assessors), parallel-group RCT. A total of 112 participants with insomnia will be recruited from six hemodialysis centers in Guangzhou, China, and randomly allocated in a 1:1 ratio to receive auricular acupressure on either active points (AA group) or control points (points irrelevant to insomnia management, SAA group). The treatment will last for 8 weeks prior to a follow-up period of 12 weeks. Evaluation by blinded assessors at baseline, at 8 weeks (end of treatment) as well as at 4-week, 8-week and 12-week follow-ups (after intervention) will include Pittsburgh Sleep Quality Index (PSQI) scores and average weekly dose of hypnotics. The primary endpoint is clinical response rate (percentage of participants who reach a reduction of PSQI global score ≥ 3 in each group) at 8 weeks from baseline. Secondary endpoints include the changes in PSQI scores over time from baseline, as well as the changes in weekly dose of hypnotics.
This paper describes the rationale and design of a double-blind RCT that aims to determine the efficacy and safety of AAT for insomnia of hemodialysis patients. If successful, this project will provide evidence of the efficacy and safety of AAT for insomnia of hemodialysis patients.
ClinicalTrials.gov , Identifier: NCT03015766 . Registered on 22 December 2016.
维持性血液透析（MHD）患者经常抱怨失眠。睡眠质量差会损害他们的生活质量，并对长期预后产生不利影响。此前我们对患有失眠的MHD患者应用耳穴按压疗法（AAT），取得了良好效果。AAT可能通过刺激迷走神经和抑制交感神经过度活动来改善睡眠质量。然而，AAT对该人群失眠的疗效仍缺乏研究。拟进行的随机对照试验（RCT）将评估AAT改善MHD失眠患者睡眠质量的疗效和安全性。
方法/设计：拟进行的研究是一项多中心、双盲（参与者和评估者）、平行组RCT。将从中国广州的六个血液透析中心招募总共112名失眠患者，并以1:1的比例随机分配，分别接受在有效穴位上进行耳穴按压（AA组）或对照穴位（与失眠治疗无关的穴位，SAA组）。治疗将持续8周，随后有12周的随访期。由盲法评估者在基线、8周（治疗结束时）以及4周、8周和12周随访（干预后）时进行的评估将包括匹兹堡睡眠质量指数（PSQI）评分和催眠药的平均每周剂量。主要终点是从基线起8周时的临床缓解率（每组中PSQI总分降低≥3分的参与者百分比）。次要终点包括从基线起PSQI评分随时间的变化，以及催眠药每周剂量的变化。
本文描述了一项双盲RCT的基本原理和设计，旨在确定AAT治疗血液透析患者失眠的疗效和安全性。如果成功，该项目将为AAT治疗血液透析患者失眠的疗效和安全性提供证据。
ClinicalTrials.gov，标识符：NCT03015766。于2016年12月22日注册。
