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. 2018 Apr 24;2018(4):CD008581. doi: 10.1002/14651858.CD008581.pub2

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:
  • DSM‐III diagnoses of alcohol dependence or alcohol abuse and depression or dysthymia

  • MADRS score ≥ 20


Exclusion criteria:
  • persistent alcohol intoxication at time of trial

  • presence of psychotic traits

  • recent antidepressant or neuroleptic treatment

  • serious somatic illness

  • pregnancy or absence of contraception in a woman of childbearing potential


Participants with bipolar disorder: information not available
Interventions Drugs:
  • tianeptine (37.5 mg/day; 64 participants; 57 men and 7 women; age (mean ± SD): 37.9 ± 1.0 years)

  • amitriptyline (75.0 mg/day; 65 participants; 54 men and 11 women)


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
Outcomes Depression:
  • final MADRS score (obtained from a figure)

  • final SCL‐90 (obtained from a figure)

  • response


Alcohol dependence: data not available
Anxiety:
  • final HRSA score (obtained from a figure)


Dropouts
Adverse effects
Notes Baseline characteristics of participants
Depression:
  • primary depression (rate of participants): 100%

  • duration: information not available

  • MADRS score (mean ± SD): tianeptine = 30.0 ± 0.8; amitriptyline = 29.3 ± 0.8


Alcohol dependence:
  • duration: information not available

  • severity: information not available

  • being actively drinking: participants were withdrawn from alcohol 2‐5 weeks before inclusion


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.
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).