OBJECTIVE To undertake a double blinded randomised placebo-controlled trial to assess the efficacy of vigabatrin, a GABA-transaminase inhibitor, as a benzodiazepine sparing agent in the management of acute alcohol withdrawal syndrome in a residential setting. METHODS We enrolled 120 patients with alcohol use disorder who were randomly assigned to either treatment with vigabatrin (2g/day for 4 days) or placebo. The primary outcome was defined as the number of participants in each treatment arm needing diazepam for withdrawal management. A secondary outcome prespecified was the total dose of diazepam received by participants in each treatment arm. Participants were recruited on admission to a residential withdrawal unit at St Vincent's Hospital Melbourne from December 2014 to April 2019. RESULTS No significant difference was observed in the number of participants requiring benzodiazepines during their residential withdrawal stay with 44 participants (78.6%) in placebo arm requiring at least one dose of diazepam compared to 38 (66.7%) in vigabatrin arm (p = .156). An 18.1% difference was observed between the proportion of participants who received a total dose of >100mg of diazepam during their residential withdrawal stay in placebo arm (32.1%), compared to vigabatrin arm (14.0%, p = .022). There were higher rates of reported adverse events in placebo arm with nine (15.0%) participants reporting adverse events compared with two (3.3%) participants in vigabatrin arm (p = .027). CONCLUSION Vigabatrin significantly reduced the number of participants requiring >100mg diazepam over the course of their alcohol withdrawal and was associated with a reduction in adverse effects when compared to placebo.

中文翻译：

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Vigabatrin 在急性酒精戒断管理中的安慰剂对照随机试验。

目的 进行一项双盲随机安慰剂对照试验，以评估氨己烯酸（一种 GABA 转氨酶抑制剂）作为苯二氮卓类保留剂在住宅环境中治疗急性酒精戒断综合征的疗效。方法 我们招募了 120 名酒精使用障碍患者，他们被随机分配接受氨己烯酸（2 克/天，持续 4 天）或安慰剂治疗。主要结果定义为每个治疗组中需要地西泮进行戒断管理的参与者人数。预先指定的次要结果是每个治疗组的参与者接受的地西泮总剂量。参与者是在 2014 年 12 月至 2019 年 4 月入住墨尔本圣文森特医院的住院撤离病房时招募的。结果 在停药期间需要苯二氮卓类药物的参与者人数没有观察到显着差异，安慰剂组有 44 名参与者 (78.6%) 需要至少一剂地西泮，而氨己烯酸组有 38 名 (66.7%)（p = .156 ). 安慰剂组 (32.1%) 与氨己烯酸组 (14.0%, p = .022) 相比，在停药期间接受总剂量 >100mg 地西泮的参与者比例有 18.1% 的差异。安慰剂组报告的不良事件发生率更高，有 9 名 (15.0%) 参与者报告了不良事件，而氨己烯酸组则有 2 名 (3.3%) 参与者报告不良事件 (p = .027)。结论 Vigabatrin 显着减少了需要 >