Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial
| Autor: | Wai Chi Chan, Yee Man Yu, Lixing Lao, Connie Lai Wah Chan, Lai-Ming Ho, Ka Fai Chung, Roger Man Kin Ng, Shi Ping Zhang, Zhang-Jin Zhang, Wing Fai Yeung |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty Electroacupuncture medicine.drug_class medicine.medical_treatment Anxiety Hospital Anxiety and Depression Scale Placebo law.invention 03 medical and health sciences Benzodiazepines Study Protocol 0302 clinical medicine Randomized controlled trial Clinical Protocols Sham law Sleep Initiation and Maintenance Disorders Surveys and Questionnaires Acupuncture Medicine Humans 030212 general & internal medicine Adverse effect Benzodiazepine business.industry Benzodiazepine discontinuation lcsh:Other systems of medicine General Medicine Middle Aged lcsh:RZ201-999 Substance Withdrawal Syndrome Treatment Outcome Complementary and alternative medicine Anesthesia Withdrawal Physical therapy Female medicine.symptom business 030217 neurology & neurosurgery RCT |
| Zdroj: | BMC Complementary and Alternative Medicine BMC Complementary and Alternative Medicine, Vol 17, Iss 1, Pp 1-9 (2017) |
| ISSN: | 1472-6882 |
| Popis: | 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. Electronic supplementary material The online version of this article (doi:10.1186/s12906-017-1692-5) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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