Efficacy of Acamprosate for Alcohol Dependence in a Family Medicine Setting in the United States: A Randomized, Double-Blind, Placebo-Controlled Study
Efficacy of Acamprosate for Alcohol Dependence in a Family Medicine Setting in the United States: A Randomized, Double-Blind, Placebo-Controlled Study
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DOI：
10.1111/acer.12010
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发表时间：
2013-04-01
影响因子：
3.2
通讯作者：
Garbutt, James C.
中科院分区：
文献类型：
--
作者：
Berger, Lisa;Fisher, Michael;Garbutt, James C.
背景
已发现阿坎酸相对于安慰剂治疗，能提高完全戒酒率，并增加戒酒天数百分比（PDA）。由于美国大多数阿坎酸临床试验是在酒精及其他药物专科诊所进行的，因此有必要在综合医疗环境中检验阿坎酸的疗效。本研究在家庭医学环境中，对阿坎酸与安慰剂在治疗酒精依赖患者的主要研究结果（PDA）方面的疗效进行了测试。次要研究结果包括重度饮酒天数百分比（%HDD）和γ - 谷氨酰转移酶水平（正常或偏高）。
方法
在两个家庭医学环境（北卡罗来纳州和威斯康星州）进行了一项阿坎酸的随机、双盲、安慰剂对照、平行组设计研究。主要通过广告招募了100名志愿者，参与者被分配在12周内每日3次口服666毫克（2片）阿坎酸（1998毫克/天）或匹配的安慰剂。所有参与者同时接受家庭/初级保健医生进行的5次简短行为干预。
结果
在PDA或次要结果方面，未发现阿坎酸有显著的治疗效果。在PDA和%HDD上发现了显著的治疗目标与时间的交互作用。与减少饮酒量相比，最初以戒酒为目标的参与者在PDA方面随时间推移平均有所改善，并且从基线到治疗结束时的%HDD更低。
结论
在初级保健环境中对主要通过广告招募的酒精依赖个体进行的这项临床试验中，未发现阿坎酸相对于安慰剂有效的证据。无论用药情况如何，饮酒结果都有显著改善。戒酒目标与饮酒结果的改善显著相关，这表明有此目标的酒精依赖患者在家庭医学环境中接受咨询可能效果特别好。
Background Acamprosate has been found to enhance rates of complete abstinence and to increase percent days abstinent (PDA) from alcohol relative to placebo treatment. As most U.S. clinical trials of acamprosate have been conducted in alcohol and other drug specialty clinics, there is a need to examine the efficacy of acamprosate in generalist settings. This study tested the efficacy of acamprosate versus placebo on the primary study outcome of PDA in the treatment of alcohol-dependent patients in a family medicine setting. Secondary study outcomes included percent heavy drinking days (%HDD) and gamma glutamyltransferase level (normal or high). Methods A randomized, double-blind, placebo-controlled, parallel group design of acamprosate was conducted in 2 family medicine settings (North Carolina and Wisconsin). One hundred volunteers were recruited primarily by advertisement, and participants were assigned to 666mg (2pills) oral acamprosate 3 times daily (1,998mg/d) or matching placebo over a 12-week period. All participants concomitantly received 5 sessions of a brief behavioral intervention from a family/primary care physician. Results No significant treatment effect of acamprosate was found on PDA or the secondary outcomes. Significant treatment goal by time interaction effects was found on PDA and %HDD. Participants who had an initial goal of abstinence versus a reduction in alcohol use improved on average over time in PDA and had less %HDD from baseline to the end of treatment. Conclusions This clinical trial did not find evidence of efficacy for acamprosate compared to placebo among alcohol-dependent individuals recruited primarily by advertisement as studied in a primary care setting. Drinking outcomes significantly improved regardless of medication condition. A goal of abstinence was significantly associated with improved drinking outcomes, suggesting that alcohol-dependent patients with such a goal may do particularly well with counseling in a family medicine setting.