Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial
Abstract Background Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and...
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doaj-462bbf2b75e44ab6be7c83cde36333222020-11-25T03:14:11ZengBMCBMC Complementary and Alternative Medicine1472-68822017-03-011711910.1186/s12906-017-1692-5Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trialWing-Fai Yeung0Ka-Fai Chung1Zhang-Jin Zhang2Wai-Chi Chan3Shi-Ping Zhang4Roger Man-Kin Ng5Connie Lai-Wah Chan6Lai-Ming Ho7Yee-Man Yu8Li-Xing Lao9The Hong Kong Polytechnic UniversityDepartment of Psychiatry, University of Hong KongSchool of Chinese Medicine, University of Hong KongDepartment of Psychiatry, University of Hong KongSchool of Chinese Medicine, Hong Kong Baptist UniversityDepartment of Psychiatry, Kowloon HospitalDepartment of Psychiatry, United Christian HospitalSchool of Public Health, University of Hong KongThe Hong Kong Polytechnic UniversitySchool of Chinese Medicine, University of Hong KongAbstract Background Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and safety. The purpose of the study is to evaluate the efficacy of using electroacupuncture as an adjunct treatment to gradual tapering of benzodiazepine doses in complete benzodiazepine cessation in long-term benzodiazepine users. Methods/Design The study protocol of a randomized, assessor- and subject-blinded, controlled trial is presented. One hundred and forty-four patients with histories of using benzodiazepines in ≥50% of days for more than 3 months will be randomly assigned in a 1:1 ratio to receive either electroacupuncture or placebo electroacupuncture combined with gradual benzodiazepine tapering schedule. Both experimental and placebo treatments will be delivered twice per week for 4 weeks. Major assessments will be conducted at baseline, week 6 and week 16 post-randomization. Primary outcome is the cessation rate of benzodiazepine use. Secondary outcomes include the percentage change in the doses of benzodiazepine usage and the severity of withdrawal symptoms experienced based on the Benzodiazepine Withdrawal Symptom Questionnaire, insomnia as measured by the Insomnia Severity Index, and anxiety and depressive symptoms as evaluated by the Hospital Anxiety and Depression Scale. Adverse events will also be measured at each study visit. Discussion Results of this study will provide high quality evidence of the efficacy and safety of electroacupuncture as an adjunct treatment for benzodiazepine tapering in long-term users. Trial registration ClinicalTrials.gov NCT02475538 .http://link.springer.com/article/10.1186/s12906-017-1692-5Benzodiazepine discontinuationWithdrawalAcupunctureShamRCT |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Wing-Fai Yeung Ka-Fai Chung Zhang-Jin Zhang Wai-Chi Chan Shi-Ping Zhang Roger Man-Kin Ng Connie Lai-Wah Chan Lai-Ming Ho Yee-Man Yu Li-Xing Lao |
spellingShingle |
Wing-Fai Yeung Ka-Fai Chung Zhang-Jin Zhang Wai-Chi Chan Shi-Ping Zhang Roger Man-Kin Ng Connie Lai-Wah Chan Lai-Ming Ho Yee-Man Yu Li-Xing Lao Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial BMC Complementary and Alternative Medicine Benzodiazepine discontinuation Withdrawal Acupuncture Sham RCT |
author_facet |
Wing-Fai Yeung Ka-Fai Chung Zhang-Jin Zhang Wai-Chi Chan Shi-Ping Zhang Roger Man-Kin Ng Connie Lai-Wah Chan Lai-Ming Ho Yee-Man Yu Li-Xing Lao |
author_sort |
Wing-Fai Yeung |
title |
Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial |
title_short |
Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial |
title_full |
Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial |
title_fullStr |
Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial |
title_full_unstemmed |
Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial |
title_sort |
electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial |
publisher |
BMC |
series |
BMC Complementary and Alternative Medicine |
issn |
1472-6882 |
publishDate |
2017-03-01 |
description |
Abstract Background Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and safety. The purpose of the study is to evaluate the efficacy of using electroacupuncture as an adjunct treatment to gradual tapering of benzodiazepine doses in complete benzodiazepine cessation in long-term benzodiazepine users. Methods/Design The study protocol of a randomized, assessor- and subject-blinded, controlled trial is presented. One hundred and forty-four patients with histories of using benzodiazepines in ≥50% of days for more than 3 months will be randomly assigned in a 1:1 ratio to receive either electroacupuncture or placebo electroacupuncture combined with gradual benzodiazepine tapering schedule. Both experimental and placebo treatments will be delivered twice per week for 4 weeks. Major assessments will be conducted at baseline, week 6 and week 16 post-randomization. Primary outcome is the cessation rate of benzodiazepine use. Secondary outcomes include the percentage change in the doses of benzodiazepine usage and the severity of withdrawal symptoms experienced based on the Benzodiazepine Withdrawal Symptom Questionnaire, insomnia as measured by the Insomnia Severity Index, and anxiety and depressive symptoms as evaluated by the Hospital Anxiety and Depression Scale. Adverse events will also be measured at each study visit. Discussion Results of this study will provide high quality evidence of the efficacy and safety of electroacupuncture as an adjunct treatment for benzodiazepine tapering in long-term users. Trial registration ClinicalTrials.gov NCT02475538 . |
topic |
Benzodiazepine discontinuation Withdrawal Acupuncture Sham RCT |
url |
http://link.springer.com/article/10.1186/s12906-017-1692-5 |
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