Paparrigopoulos 2010.
Methods | Randomised controlled open study | |
Participants | 120 participants; mean age 46.8 years; 74.2% male; 90% Caucasian; 31% with more than 12 years of education; 57% married; 248 gr/d alcohol consumption on average Inclusion criteria: age 18 to 70 years; alcohol dependence; absence of serious physical illness; absence of another preexisting or co‐existing major psychiatric disorder on DSM‐IV Axis I; absence of abuse of another drug; participants with affective or anxiety symptoms were not excluded from the study if concurrent with an alcohol‐abusing period; however, individuals who fulfilled a DSM‐IV diagnosis of depressive or anxiety disorder were excluded from the study if such symptoms had been recorded before onset of alcoholism or during periods of abstinence |
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Interventions | (1) Tiagabine, 60 participants; (2) no pharmacological treatment, 60 participants Drug dose: tiagabine up to 15 to 20 mg/d Participants were involved in short‐term psychotherapy (four to six weeks) of cognitive‐behavioural orientation consisting of both individual sessions (twice a week) and family interventions (once every two weeks) Setting: inpatient for four to six weeks, then outpatient Duration: six months. Country of origin: Greece |
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Outcomes | Retention in treatment; abstinence from alcohol; MCV and liver enzymes; alcohol craving; mood and functioning; side effects | |
Notes | All participants underwent a detoxification protocol that included vitamin replacement and administration of diazepam. Tiagabine was added to the last part of the detoxification period | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details provided |
Allocation concealment (selection bias) | High risk | Unblinded study |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No details provided |
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 |