International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China.
Beijing Changping Hospital of Integrated Chinese and Western Medicine, Beijing, 102208, China.
Trials. 2021 Nov 4;22(1):771. doi: 10.1186/s13063-021-05732-5.
Constipation is known as a common adverse effect of antipsychotics. Advice for its management remains inadequate. This study is designed to investigate the efficacy and safety of electro-acupuncture (EA) for antipsychotic-related constipation.
This is a single-centric, parallel-group, randomized controlled trial with blinded participants, outcome assessor, and statistician. One hundred twelve participants will be randomly assigned into the EA group or sham acupuncture (SA) group in a 1:1 ratio. The study will last for 22 weeks for each participant, including a 2-week baseline assessment period, an 8-week treatment period, and a follow-up for 12 weeks. The primary outcome is the change of mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8 from baseline. Secondary outcomes include the change from baseline of mean weekly CSBMs during the follow-up period, mean weekly spontaneous bowel movements (SBMs), overall CSBM response rate, scores on Bristol Stool Form Scale (BSFS), straining level, Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of life questionnaire (PAC-QOL), and Brief Psychiatric Rating Scale (BPRS). Adverse events and medicine use will be recorded as well.
The study is designed based on a rigorous methodology to evaluate the efficacy and safety of EA for antipsychotic-related constipation. The finding will be published in peer-reviewed journals as reliable evidence.
ClinicalTrials.gov ChiCTR2000032582. Registered May 3, 2020, with the Chinese Clinical Trial Registry.
便秘是抗精神病药物的常见不良反应。针对其管理的建议仍然不足。本研究旨在调查电针（EA）治疗抗精神病药相关便秘的疗效和安全性。
这是一项单中心、平行组、随机对照试验，参与者、结果评估者和统计学家均设盲。112 名参与者将以 1:1 的比例随机分配到 EA 组或假针刺（SA）组。每位参与者的研究持续时间为 22 周，包括 2 周的基线评估期、8 周的治疗期和 12 周的随访期。主要结局是从基线到第 1 周到第 8 周每周平均完全自发性排便次数（CSBMs）的变化。次要结局包括随访期间每周平均 CSBMs 从基线的变化、每周平均自发性排便次数（SBMs）、整体 CSBM 反应率、Bristol 粪便形态量表（BSFS）评分、用力程度、便秘症状患者评估量表（PAC-SYM）、便秘患者生活质量问卷（PAC-QOL）和简明精神病评定量表（BPRS）评分的变化。还将记录不良事件和药物使用情况。
该研究基于严格的方法学设计，旨在评估 EA 治疗抗精神病药相关便秘的疗效和安全性。研究结果将发表在同行评议的期刊上，作为可靠的证据。
ClinicalTrials.gov ChiCTR2000032582。2020 年 5 月 3 日在中国临床试验注册中心注册。
