Florez 2011.

Methods	Randomised controlled open study
Participants	182 participants; mean age 47.7 years; 85% male; 87% only elementary school education; 62% married; 46% employed; 74% reporting more than 700 ethanol grams per week; OCDS score 18 on average Inclusion criteria: meeting ICD‐10 criteria for alcohol dependence; having an ethanol intake, during the past six months before detoxification, of at least 210 g/wk for men and 140 g/wk for women, assessed with the EuropASI and the Alcohol Timeline Followback; expressing a desire to stop drinking alcohol Exclusion criteria: younger than 18 or older than 65 years of age; current diagnosis of dependence or abuse of other substances except nicotine assessed with the EuropASI and a urine drug screen; current psychiatric diagnosis other than personality disorders assessed with the EuropASI; any clinically significant medical condition that in the opinion of the researchers would adversely affect safety or study participation assessed with the EuropASI; inability to give full informed consent; clinical history of mental retardation; pregnancy or breast‐feeding; not having a significant other to provide accurate daily alcohol‐related information to researchers
Interventions	(1) Topiramate, 91 participants; (2) naltrexone, 91 participants Drug dose: topiramate up to 200 to 400 mg/d; naltrexone 50 mg/d All participants received weekly psychological therapy based on BRENDA model (Volpicelli 2001) Setting: outpatient Duration: six months. Country of origin: Spain
Outcomes	Efficacy was defined according to the following categories: Abstinence: no alcohol intake reported during previous three months. No problems reported (problems defined as a score of four or more on any of the EuropASI scales) Moderate drinking without problems: reported drinking of less than 40 g of ethanol per day for men and less than 30 g for women, with no more than two days on which heavier drinking was reported. No problems reported Moderate drinking with problems: same as previous but problems reported Heavy drinking without problems: reported drinking greater than moderate drinking on three or more occasions per quarter. No problems reported Heavy drinking with problems: same as previous but problems reported The following variables were also used: number of heavy drinking days; percentage of days abstinent during previous three months; total drinking days during previous three months; days to first drink; drinks per drinking day Participants in groups three, four and five and dropouts were considered relapsed
Notes	All participants were detoxified before starting treatment with naltrexone or topiramate
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation stated. No further information available from the study
Allocation concealment (selection bias)	High risk	Unblinded study
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data on all participants analysed on an intent–to‐treat basis. Dropouts assumed to have resumed heavy drinking on the day after their last contact
Blinding of participants and personnel (performance bias) all outcomes	High risk	Unblinded study
Blinding of outcome assessment (detection bias) subjective	High risk	Unblinded study
Blinding of outcome assessment (detection bias) objective	Low risk	Outcome measurement not likely to be influenced by lack of blinding