Lôo 1988.
Methods | Randomized, double‐blind, comparative trial | |
Participants | 129 people with alcohol dependence with depression or dysthymic disorder (111 men and 18 women; mean age: approximately 38 years) Inclusion criteria:
Exclusion criteria:
Participants with bipolar disorder: information not available |
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Interventions | Drugs:
Psychotherapy: information not available Scheduled duration of treatment: 4‐8 weeks (depending on the centre concerned) Sites: 7 centres, in France Setting: unclear Route of administration: orally Starting dose: tianeptine = 37.5 mg/day; amitriptyline = 75.0 mg/day Pattern of dose reduction: information not available |
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Outcomes | Depression:
Alcohol dependence: data not available Anxiety:
Dropouts Adverse effects |
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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 offered: other pharmacological treatments were allowed. Funding source: information not available Declarations of interest: information not available Other information In the original study, the duration of the trial was 4‐8 weeks depending on the centre concerned. In the present meta‐analysis, only data of 4 weeks were analyzed. Before the onset of the trial, participants received a pretreatment with a placebo for 3‐10 days to screen out placebo‐responder participants. After this period, participants received tianeptine or amitriptyline. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to permit judgement. |
Allocation concealment (selection bias) | Unclear risk | Method of concealment not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind stated. Medication and placebo prepared to appear identical. No specific reference made to blinding of participants and personnel. |
Blinding of outcome assessment (detection bias) objective | Low risk | No information on the blinding of outcome assessors. |
Blinding of outcome assessment (detection bias) subjective | Unclear risk | No information on the blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Intention‐to‐treat analysis not used. However, the numbers of dropouts were low (10/64, 12/65) and were not unbalanced between groups. |
Selective reporting (reporting bias) | High risk | Several data were missing (final MADRS score for amitriptyline, adverse effects, and alcohol consumption). |