Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial

Abstract Background 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. Methods This is a single-centric, pa...

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Autores principales:	Fang-Ting Yu, Di-He Long, Guang-Xia Shi, Li-Qiong Wang, Jian-Feng Tu, Li-Li Gang, Fu-Quan Liu, Yang Wang, Xiao Cui, Si Bao, Yu Yu, Wei Wei, Shi-Yan Yan, Jing-Wen Yang, Cun-Zhi Liu
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Electro-acupuncture Antipsychotic-related constipation Randomized controlled trial Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/9b8c40d81a1c4199b45fb284b68a05bf
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spelling	oai:doaj.org-article:9b8c40d81a1c4199b45fb284b68a05bf2021-11-08T11:03:17ZEvaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial10.1186/s13063-021-05732-51745-6215https://doaj.org/article/9b8c40d81a1c4199b45fb284b68a05bf2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05732-5https://doaj.org/toc/1745-6215Abstract Background 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov ChiCTR2000032582. Registered May 3, 2020, with the Chinese Clinical Trial Registry.Fang-Ting YuDi-He LongGuang-Xia ShiLi-Qiong WangJian-Feng TuLi-Li GangFu-Quan LiuYang WangXiao CuiSi BaoYu YuWei WeiShi-Yan YanJing-Wen YangCun-Zhi LiuBMCarticleElectro-acupunctureAntipsychotic-related constipationRandomized controlled trialMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Electro-acupuncture Antipsychotic-related constipation Randomized controlled trial Medicine (General) R5-920
spellingShingle	Electro-acupuncture Antipsychotic-related constipation Randomized controlled trial Medicine (General) R5-920 Fang-Ting Yu Di-He Long Guang-Xia Shi Li-Qiong Wang Jian-Feng Tu Li-Li Gang Fu-Quan Liu Yang Wang Xiao Cui Si Bao Yu Yu Wei Wei Shi-Yan Yan Jing-Wen Yang Cun-Zhi Liu Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial
description	Abstract Background 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov ChiCTR2000032582. Registered May 3, 2020, with the Chinese Clinical Trial Registry.
format	article
author	Fang-Ting Yu Di-He Long Guang-Xia Shi Li-Qiong Wang Jian-Feng Tu Li-Li Gang Fu-Quan Liu Yang Wang Xiao Cui Si Bao Yu Yu Wei Wei Shi-Yan Yan Jing-Wen Yang Cun-Zhi Liu
author_facet	Fang-Ting Yu Di-He Long Guang-Xia Shi Li-Qiong Wang Jian-Feng Tu Li-Li Gang Fu-Quan Liu Yang Wang Xiao Cui Si Bao Yu Yu Wei Wei Shi-Yan Yan Jing-Wen Yang Cun-Zhi Liu
author_sort	Fang-Ting Yu
title	Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial
title_short	Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial
title_full	Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial
title_fullStr	Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial
title_full_unstemmed	Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial
title_sort	evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/9b8c40d81a1c4199b45fb284b68a05bf
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Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trial

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