De Wildt 2002.
Methods | Multisite RCT (14 sites). | |
Participants | 248 Dutch patients meeting DSM‐IV criteria for alcohol dependence or abuse. | |
Interventions | 1. Acamprosate + MET (n= 86) 2. Acamprosate + CBT (n= 78) 3. Acamprosate (n= 77). |
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Outcomes |
Physiological primary: GGT. Non‐physiological primary: Number abstinent, number relapsed, time to first relapse, number of abstinent days, rate of continuous abstinence. Secondary: None. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Sealed envelope randomisation with balancing by blocks of 15 was used to obtain equal numbers of patients per treatment group from each centre." |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgment. |
Blinding (performance bias and detection bias) Patients and providers | Low risk | No blinding, but most outcomes were physiological and also used to validate self‐reports, and not likely to be influenced by lack of blinding. |
Blinding (performance bias and detection bias) Assessors | Low risk | Insufficient information to know whether assessors were blinded. But most outcomes were physiological and also used to validate self‐reports, and not likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 30% attrition at 6 months follow‐up. Balanced drop‐out and reasons for drop‐out stated. ITT completed. |
Selective reporting (reporting bias) | Low risk | The published report included all expected outcomes based on the study hypotheses. |
Other bias | High risk | 23% of patients consulted some other professional for alcohol‐related problems during the treatment. Blood samples were drawn to check on self‐report. There were no differences between groups at baseline. |