Electroacupuncture for Tapering Off Long-term Benzodiazepine Use: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 3
- 主要终点
- The proportion of participants who successfully discontinued benzodiazepines
研究概览
简要总结
This study aims to examine the efficacy of electroacupuncture for tapering benzodiazepines in long-term users. All eligible subjects will be randomized in a ratio of 1:1 to (1) Electroacupuncture combined with gradual tapering; and (2) Placebo acupuncture combined with gradual tapering.
详细描述
Recent randomized controlled studies support that acupuncture has beneficial effects for insomnia. Primary insomnia patients receiving electroacupuncture showed an increase in sleep diary-derived sleep efficiency from an average of 69.8% at baseline to 81.2% at 1-week post-treatment. A similar result was found in patients with residual insomnia associated with major depressive disorder.
Acupuncture is efficacious in alleviating anxiety and insomnia symptoms; hence, it may help to reduce the impacts of withdrawal symptoms during benzodiazepine tapering. However, there has been no randomized controlled trial to examine the efficacy and safety of acupuncture on benzodiazepine discontinuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged ≥ 18 years
- •taking benzodiazepines (World Health Organization Anatomical, Therapeutic and Chemical classification system codes N05BA, N05CD, N05CF, and M03BX07)) on more than 50% of days for at least 3 months and during their prospective 2-week record prior to baseline
- •willing to withdraw their benzodiazepine use during the study,
排除标准
- •any relapse of psychiatric disorder in the past year that required intervention,
- •Hospital Anxiety and Depression Scale depression or anxiety as a tool (subscore ≥ 8) which indicates subjects with possible depression or anxiety
- •have any unstable psychiatric conditions or serious physical illnesses which are judged by the investigator to render unsuitable or unsafe;
- •have valvular heart defects or bleeding disorders, taking anticoagulant drugs, or are fitted with any implanted electrical device such as pacemaker, defibrillator, or brain stimulation,
- •have received any acupuncture during the previous 6 months prior to baseline,
- •are pregnant, breast-feeding or of childbearing potential but not using adequate contraception,
- •have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe and
- •significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (a score ≥ 3)
结局指标
主要结局
The proportion of participants who successfully discontinued benzodiazepines
时间窗: up to 12-week post-treatment
次要结局
- The percentage of equivalent dose of benzodiazepines reduced(First week of treatment (week 1), second week of treatment (week 2), third week of treatment (week 3), fourth week of treatment (week 4), 2-week post-treatment (week 6) and 12-week post-treatment (week 16))
- Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ)(First week of treatment (week 1), second week of treatment (week 2), third week of treatment (week 3), fourth week of treatment (week 4), 2-week post-treatment (week 6) and 12-week post-treatment (week 16))
- Insomnia Severity Index (ISI)(second week of treatment (week 2), fourth week of treatment (week 4), 2-week post-treatment (week 6) and 12-week post-treatment (week 16))
- Hospital Anxiety and Depression Scale (HADS)(second week of treatment (week 2), fourth week of treatment (week 4), 2-week post-treatment (week 6) and 12-week post-treatment (week 16))
研究者
Dr. YEUNG Wing-Fai
Assistant Professor
The Hong Kong Polytechnic University