A systematic review 1 included 11 randomized controlled trials with a total of 1 527 patients. Disulfiram treatment was compared with placebo, none or other abstinence-supportive treatments. Overall, 6 studies reported of a significant better effect on abstinence for patients treated with disulfiram. Six of 9 studies measuring secondary outcomes reported that patients treated with disulfiram had significantly more days until relapse and fewer drinking days, respectively. The quality of the included studies was moderate. Valid results were found regarding the effect of disulfiram versus placebo over 12 months and unsupervised disulfiram versus other or no treatment. Supervised treatment with disulfiram has some effect on short-term abstinence and days until relapse as well as number of drinking days when compared with placebo, none, or other treatments.
A randomized, open label, multicentre naturalistic study 2 included 243 voluntary treatment-seeking alcohol-dependent adult outpatients. First, they received a 12-week continuously supervised medication, followed by targeted medication (TM) up to 52 weeks in addition to a 67-week follow-up period; altogether 119 weeks (2.5 years). Subjects were randomized 1:1:1 to receive supervised naltrexone (NTX), acamprosate (ACA) or disulfiram (DIS), 50, 1998, or 200 mg, respectively, per day, plus a brief manual-based cognitive-behavioural intervention. The patients were met at week, and then after 3, 6, and 12 months. All three study groups showed marked reduction in drinking, from baseline to the end of the study. During the continuous medication phase, treatment with DIS was more effective in reducing heavy drinking days (HDD) and average weekly alcohol consumption, and increasing time to the first drink, as well as the number of abstinent days. During the TM period, there were no significant differences between the groups in time to first HDD and days to first drinking, but the abstinence days were significantly more frequent in the DIS group than ACA and NTX. There were no differences between the NTX and ACA groups in either phase of the study of drinking outcomes.
A meta-analysis 3 assessed the efficacy and safety of disulfiram in RCTs in supporting abstinence. Overall, the 22 included studies showed a higher success rate of disulfiram compared to controls Hedges'g 0.58 (95% CI 0.35 to 0.82). When comparing blind and open-label RCTs, only open-label trials showed a significant superiority over controls g 0.70 (95% CI 0.46 to 0.93). RCTs with blind designs showed no efficacy of disulfiram compared to controls. Disulfiram was also more effective than the control condition when compared to naltrexone g 0.77, 95% CI 0.52 to 1.02, to acamprosate g 0.76, 95% CI 0.04 to 1.48, and to the no disulfiram groups g 0.43, 95% CI 0.17 to 0.69. There was hihg heterogeneity and 89 % of the study population were male subjects.
Comment: The quality of evidence is downgraded by study limitations (open-labelled studies).
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