Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial

BMC Complementary and Alternative Medicine

Study Protocol

Roger Man-Kin Ng¹  Connie Lai-Wah Chan²  Ka-Fai Chung³  Wai-Chi Chan³  Shi-Ping Zhang⁴  Li-Xing Lao⁵  Zhang-Jin Zhang⁵  Lai-Ming Ho⁶  Wing-Fai Yeung⁷  Yee-Man Yu⁷ 

[1] Department of Psychiatry, Kowloon Hospital, 147A Argyle Street, Kowloon, Hong Kong SAR, China;Department of Psychiatry, United Christian Hospital, 130 Hip Wo Street, Kwun Tong, Kowloon, Hong Kong SAR, China;Department of Psychiatry, University of Hong Kong, Pokfulam, Hong Kong SAR, China;School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong SAR, China;School of Chinese Medicine, University of Hong Kong, Pokfulam, Hong Kong SAR, China;School of Public Health, University of Hong Kong, Pokfulam, Hong Kong SAR, China;The Hong Kong Polytechnic University, Hunghom, Kowloon, Hong Kong SAR, China;

关键词: Benzodiazepine discontinuation;    Withdrawal;    Acupuncture;    Sham;    RCT;   

DOI  :  10.1186/s12906-017-1692-5

 received in 2016-12-15, accepted in 2017-03-16,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundConventional 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/DesignThe 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.DiscussionResults 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 registrationClinicalTrials.govNCT02475538.

【 授权许可】

CC BY   
© The Author(s). 2017