Liu Jia, Wang Lu-Ning
Department of Neurology, Xuanwu Hospital, Capital Medical University, Changchun Street 45, Beijing, China, 100053.
Cochrane Database Syst Rev. 2015 Apr 3(4):CD008502. doi: 10.1002/14651858.CD008502.pub4.
The treatment baclofen shows potential for rapidly reducing symptoms of severe alcohol withdrawal syndrome (AWS) in people with alcoholism. Treatment with baclofen is easy to manage and rarely produces euphoria or other pleasant effects, or craving for the drug. This is an updated version of the original Cochrane review published in Issue 2, 2013.
To assess the efficacy and safety of baclofen for people with AWS.
We searched the Cochrane Drugs and Alcohol Group Specialised Register (searched 13 January 2015), the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 1), MEDLINE (1966 to January 2015), EMBASE (1980 to January 2015), and CINAHL (1982 to January 2015). We also searched registers of ongoing trials, including ClinicalTrials.gov, the ISRCTN registry, and the European Clinical Trials Database. At the same time, we handsearched the references quoted in the identified trials, and sought information from researchers, pharmaceutical companies, and relevant trial authors about unpublished or uncompleted trials. We placed no restrictions on language.
We included all randomised controlled clinical trials (RCTs) evaluating baclofen versus placebo or any other treatment for people with AWS. We excluded uncontrolled, non-randomised, or quasi-randomised trials. We included both parallel group and cross-over studies.
Two review authors independently assessed references retrieved for possible inclusion. Any disagreements were resolved by an independent party. We contacted study authors for additional information where needed. We collected adverse effects information from the trials.
Two RCTs with a total of 81 participants were eligible according to the inclusion criteria. One study suggested that both baclofen and diazepam significantly decreased the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) score, without any significant difference between the two interventions. The other study showed no significant difference in CIWA-Ar score between baclofen and placebo, but a significantly decreased dependence on high-dose benzodiazepines with baclofen compared to placebo. Only one study reported on the safety of baclofen, without any side effects.
AUTHORS' CONCLUSIONS: The evidence for recommending baclofen for AWS is insufficient. We therefore need more well-designed RCTs to prove its efficacy and safety.
巴氯芬治疗对于快速减轻酒精中毒患者的严重酒精戒断综合征（AWS）症状显示出潜力。巴氯芬治疗易于管理，很少产生欣快感或其他愉悦效果，也不会引起对药物的渴望。这是2013年第2期发表的原始Cochrane系统评价的更新版本。
评估巴氯芬治疗AWS患者的疗效和安全性。
我们检索了Cochrane药物与酒精小组专业注册库（检索时间为2015年1月13日）、Cochrane对照试验中央注册库（CENTRAL；2015年第1期）、MEDLINE（1966年至2015年1月）、EMBASE（1980年至2015年1月）和CINAHL（1982年至2015年1月）。我们还检索了正在进行的试验注册库，包括ClinicalTrials.gov、ISRCTN注册库和欧洲临床试验数据库。同时，我们手工检索了已识别试验中引用的参考文献，并向研究人员、制药公司和相关试验作者寻求未发表或未完成试验的信息。我们没有对语言设置限制。
我们纳入了所有评估巴氯芬与安慰剂或其他治疗方法对比治疗AWS患者的随机对照临床试验（RCT）。我们排除了非对照、非随机或半随机试验。我们纳入了平行组研究和交叉研究。
两位综述作者独立评估检索到的可能纳入的参考文献。如有分歧，由独立第三方解决。必要时，我们联系研究作者获取更多信息。我们从试验中收集不良反应信息。
根据纳入标准，两项共81名参与者的RCT符合要求。一项研究表明，巴氯芬和地西泮均显著降低了修订版酒精戒断临床研究所评估量表（CIWA-Ar）评分，两种干预措施之间无显著差异。另一项研究表明，巴氯芬与安慰剂在CIWA-Ar评分上无显著差异，但与安慰剂相比，巴氯芬显著降低了对高剂量苯二氮䓬类药物的依赖。只有一项研究报告了巴氯芬的安全性，未发现任何副作用。
推荐巴氯芬用于治疗AWS的证据不足。因此，我们需要更多设计良好的RCT来证明其疗效和安全性。
