Randomised controlled trials (RCTs) were eligible if they investigated disulfiram in various doses with or without a control group and/or investigated disulfiram against placebo, no treatment, or other medical or behavioral treatments. Patients had to be aged 15 years or older and be diagnosed with an alcohol use disorder. Alcohol use disorders were defined as an intake of alcohol above 20g/day for women and above 30g/day for men and included hazardous and harmful use as well as the alcohol dependency syndrome. The primary outcome was continuous intake below 20g/day for women and 30g/day for men, including abstinence at follow-up. Included studies had to have used an intention-to-treat analysis. Studies which combined disulfiram with other treatments were excluded.
Most studies were of male patients with alcohol dependence according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) or International Statistical Classification of Diseases and Related Health Problems (ICD) classification systems. Patients in some studies were undergoing detoxification at study onset. In a few studies, some patients were expected to have been abstinent before enrolment. Baseline alcohol consumption ranged from six to seven units (each of 12g) per day, to nine to 11 units (each of 10g) per day. Studies were published from 1979 to 2010 in India, Denmark, USA, Austria, Finland and Italy.
Disulfiram doses were mostly 200 or 250mg per day, although doses of 1mg (considered as placebo) or 800mg per day were also used. Comparators included placebo, no treatment, acamprosate, topiramate, naltrexone, riboflavine, and G-hydroxybutyrate. In most studies patients also received (voluntary) cognitive therapy, psychotherapy, or alcohol counselling. The median compliance rate was 85% (range 19 to 100), and the median follow-up rate was 93% (range 18 to 100). Outcome definitions varied across trials.
Two reviewers independently selected studies for inclusion.