From the Addictions Program, Centre for Addiction and Mental Health, Toronto, Ontario, Canada; and Addictions Unit, McGill University Health Centre, Montreal, Canada.
J Addict Med. 2009 Jun;3(2):74-82. doi: 10.1097/ADM.0b013e318182d890.
: The Combined Pharmacotherapies and Behavior Interventions Study (COMBINE) reported no significant difference between acamprosate and placebo in the treatment of alcohol dependence. To evaluate the impact of COMBINE, we performed a meta-analysis of acamprosate placebo-controlled trials with the inclusion of data from COMBINE. As a secondary analysis, we added the COMBINE data to a recently published meta-analysis of naltrexone placebo-controlled trials.
: A structured literature search of major databases was performed from January 1990 to August 2007 for acamprosate placebo-controlled randomized trials. Mean differences in cumulative abstinent days (CAD) and abstinence rates (AR) from eligible studies were statistically combined to calculate point estimates and 95% CI for differences in CAD and AR.
: Ten and 16 studies evaluating CAD and AR, respectively were suitable for statistical pooling. The findings revealed that acamprosate was superior to placebo in the mean number of CAD (P < 0.001) and AR (pooled AR = 1.58; P < 0.001). The pooled AR for naltrexone was also significant indicating a relative benefit over placebo (AR = 1.27; P < 0.001). The COMBINE trial results contributed a weight of less than 15% to the final pooled statistical outcomes for both agents.
: The current study confirmed that acamprosate and naltrexone are both effective agents for the treatment of patients with alcohol dependence. Systematic reviews with meta-analyses of randomized controlled trials and randomized controlled trials with adequate sample sizes are in the same (highest) level of evidence. Therefore, clinicians should use both these sources of information as their foundation for selecting optimal therapy for patients with alcohol dependence.
联合药物治疗和行为干预研究（COMBINE）报告显示，在治疗酒精依赖方面，卡尼汀与安慰剂之间没有显著差异。为了评估 COMBINE 的影响，我们对卡尼汀安慰剂对照试验进行了荟萃分析，并纳入了 COMBINE 的数据。作为二次分析，我们将 COMBINE 数据添加到最近发表的纳曲酮安慰剂对照试验的荟萃分析中。
从 1990 年 1 月至 2007 年 8 月，对主要数据库进行了结构化文献检索，以查找卡尼汀安慰剂对照随机试验。从合格研究中统计合并累积戒断天数（CAD）和戒断率（AR）的均值差异，以计算 CAD 和 AR 差异的点估计值和 95%CI。
有 10 项和 16 项研究分别评估了 CAD 和 AR，适合进行统计学汇总。结果表明，卡尼汀在 CAD 的平均数量上优于安慰剂（P<0.001）和 AR（汇总 AR=1.58；P<0.001）。纳曲酮的汇总 AR 也具有统计学意义，表明其相对安慰剂有优势（AR=1.27；P<0.001）。COMBINE 试验结果对这两种药物的最终汇总统计结果的权重不足 15%。
本研究证实，卡尼汀和纳曲酮都是治疗酒精依赖患者的有效药物。系统评价和荟萃分析随机对照试验以及具有足够样本量的随机对照试验处于相同（最高）证据水平。因此，临床医生应该将这两种信息来源作为为患者选择最佳治疗方法的基础。
