Optimal Dose of Baclofen for the Treatment of Alcohol Use Disorder: A Systematic Review and Dose-Response Meta-analysis.

IF 7.4 2区医学 Q1 CLINICAL NEUROLOGY

CNS drugs Pub Date : 2025-05-10 DOI:10.1007/s40263-025-01188-2

Kazumasa Kotake, Ryuhei So, Nozomu Hashimoto, Eriya Imai, Takao Kaneko, Masahiro Banno, Yuki Furukawa

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引用次数: 0

Abstract

Background and objectives: Baclofen, a traditional treatment for spasticity, is gaining interest for its use in alcohol use disorder (AUD). To assist clinicians in using baclofen for effective and safe treatment of AUD, we investigated the optimal target dosage of baclofen through a systematic review and dose-response meta-analysis.

Methods: We searched Cochrane, EMBASE, MEDLINE via PubMed, PsycINFO, ClinicalTrials.gov, and the International Clinical Trials Registry Platform for randomized controlled trials on 1 and 2 April 2024. Inclusion criteria were patients aged ≥ 18 years diagnosed with AUD according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV, DSM-IV-TR, or International Classification of Diseases (ICD)-10, and treated with baclofen monotherapy. Continuous outcomes-percent days abstinent, drinks per drinking day, heavy drinking days (HDDs), craving, and anxiety-were analyzed as mean or standardized mean differences. Binary outcomes-relapse and dropout, including due to adverse events-were analyzed as odds ratios. Each outcome was assessed using the Cochrane Risk of Bias 2.0 tool. A one-stage random-effects dose-response meta-analysis was performed using restricted cubic splines with fixed knots at 10%, 50%, and 90% percentiles.

Results: A total of 14 trials (1344 patients) were included. Increasing the dose of baclofen up to 50-60 mg/day was associated with a higher percent days abstinent and reduced craving. However, a higher baclofen dose increases the risk of dropout due to adverse events. Commonly observed adverse events were drowsiness, sedation, somnolence and fatigue. Baclofen up to 50-60 mg/day did not significantly affect drinks per drinking day, HDDs, anxiety, relapse or dropout. Doses > 60 mg/day lacked reliable evaluation due to limited data and study heterogeneity.

Conclusions: Baclofen up to 50-60 mg/day may increase percent days abstinent and reduce craving, but may increase dropout due to adverse events. Clinicians should carefully consider individual patient factors when prescribing baclofen to patients with AUD.

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巴氯芬治疗酒精使用障碍的最佳剂量：系统评价和剂量-反应荟萃分析

背景和目的：巴氯芬是一种治疗痉挛的传统药物，因其在酒精使用障碍（AUD）中的应用而引起人们的兴趣。为了帮助临床医生有效、安全地使用巴氯芬治疗AUD，我们通过系统评价和剂量-反应荟萃分析探讨了巴氯芬的最佳目标剂量。方法：我们于2024年4月1日和2日通过PubMed、PsycINFO、ClinicalTrials.gov和国际临床试验注册平台检索Cochrane、EMBASE、MEDLINE和随机对照试验。纳入标准：根据精神障碍诊断与统计手册(DSM)-IV、DSM-IV- tr或国际疾病分类(ICD)-10诊断为AUD的患者，年龄≥18岁，接受巴氯芬单药治疗。连续结果-戒酒天数百分比，每个饮酒日的饮酒量，重度饮酒日（hdd），渴望和焦虑-被分析为平均或标准化平均差异。二元结果——复发和退出，包括不良事件——以比值比进行分析。使用Cochrane风险偏倚2.0工具评估每个结果。采用10%、50%和90%百分位固定结的受限三次样条进行一期随机效应剂量-反应荟萃分析。结果：共纳入14项试验（1344例患者）。增加巴氯芬的剂量至50-60毫克/天与更高百分比的戒断天数和减少渴望有关。然而，较高的巴氯芬剂量会增加因不良事件而退出的风险。常见的不良反应是嗜睡、镇静、嗜睡和疲劳。巴氯芬达到50-60毫克/天对每天饮酒量、hdd、焦虑、复发或退出没有显著影响。由于有限的数据和研究异质性，剂量bb0 ~ 60mg /天缺乏可靠的评估。结论：巴氯芬高达50- 60mg /天可增加戒断天数百分比并减少渴望，但可能由于不良事件而增加退出。临床医生在给AUD患者开巴氯芬处方时应仔细考虑个体患者因素。

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来源期刊

CNS drugs 医学-精神病学

CiteScore

12.00

自引率

3.30%

发文量

审稿时长

6-12 weeks

期刊介绍： CNS Drugs promotes rational pharmacotherapy within the disciplines of clinical psychiatry and neurology. The Journal includes: - Overviews of contentious or emerging issues. - Comprehensive narrative reviews that provide an authoritative source of information on pharmacological approaches to managing neurological and psychiatric illnesses. - Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. - Adis Drug Reviews of the properties and place in therapy of both newer and established drugs in neurology and psychiatry. - Original research articles reporting the results of well-designed studies with a strong link to clinical practice, such as clinical pharmacodynamic and pharmacokinetic studies, clinical trials, meta-analyses, outcomes research, and pharmacoeconomic and pharmacoepidemiological studies. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in CNS Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.