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...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2021-11-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05732-5 |
| _version_ | 1818821251836149760 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-18T23:05:13Z |
| format | Article |
| id | doaj.art-9b8c40d81a1c4199b45fb284b68a05bf |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-18T23:05:13Z |
| publishDate | 2021-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-9b8c40d81a1c4199b45fb284b68a05bf2022-12-21T20:48:28ZengBMCTrials1745-62152021-11-012211910.1186/s13063-021-05732-5Evaluating the efficacy and safety of electro-acupuncture in patients with antipsychotic-related constipation: protocol for a randomized controlled trialFang-Ting Yu0Di-He Long1Guang-Xia Shi2Li-Qiong Wang3Jian-Feng Tu4Li-Li Gang5Fu-Quan Liu6Yang Wang7Xiao Cui8Si Bao9Yu Yu10Wei Wei11Shi-Yan Yan12Jing-Wen Yang13Cun-Zhi Liu14International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineBeijing Changping Hospital of Integrated Chinese and Western MedicineInternational Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineInternational Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineInternational Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineBeijing Changping Hospital of Integrated Chinese and Western MedicineBeijing Changping Hospital of Integrated Chinese and Western MedicineBeijing Changping Hospital of Integrated Chinese and Western MedicineBeijing Changping Hospital of Integrated Chinese and Western MedicineBeijing Changping Hospital of Integrated Chinese and Western MedicineBeijing Changping Hospital of Integrated Chinese and Western MedicineBeijing Changping Hospital of Integrated Chinese and Western MedicineInternational Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineInternational Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineInternational Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineAbstract 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.https://doi.org/10.1186/s13063-021-05732-5Electro-acupunctureAntipsychotic-related constipationRandomized controlled trial |
| spellingShingle | 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 Trials Electro-acupuncture Antipsychotic-related constipation Randomized controlled trial |
| title | 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_short | 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 |
| topic | Electro-acupuncture Antipsychotic-related constipation Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-021-05732-5 |
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