Butterworth 1971a.
Methods | Randomized, double‐blind, comparative trial | |
Participants | 39 people with alcohol dependence (all men; mean age: information not available) with a significant degree of anxious‐depressive symptomatology. Inclusion criteria:
Exclusion criteria:
Participants with bipolar disorder: information not available |
|
Interventions | Drugs:
Psychotherapy: information not available Scheduled duration of treatment: 3 weeks Site: Alcoholism Treatment Service of East Louisiana State Hospital, Mandeville, LA, USA Setting: inpatients Route of administration: orally Starting dose: information not available Pattern of dose reduction: information not available |
|
Outcomes | Depression:
Alcohol dependence: data not available Dropouts Adverse effects |
|
Notes |
Baseline characteristics of participants Depression:
Alcohol dependence:
Other psychiatric comorbidity: information not available Other substance‐use disorders: information not available Other characteristics of study Other pharmacological treatment: other concomitant therapy not allowed Funding source: medications were supplied by Laboratories of Pfizer Inc. Declaration of interest: information not available |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random allocation stated. No further details provided. |
Allocation concealment (selection bias) | Unclear risk | Method of concealment not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind stated. Medications prepared to appear identical. Evaluations conducted by 2 independent investigators and the results pooled. |
Blinding of outcome assessment (detection bias) objective | Low risk | No information on blinding of outcome assessors. |
Blinding of outcome assessment (detection bias) subjective | Unclear risk | No information on blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | High risk | No information on dropouts provided. Methods applied to account for missing data not described. Intention‐to‐treat approach not reported. |
Selective reporting (reporting bias) | High risk | No information on dropouts provided. Methods applied to account for missing data not described. Intention‐to‐treat approach not reported. |