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

Liappas 2005 arm A.

Methods Randomized, single‐blind, comparative trial
Participants 30 people with alcohol dependence of an original group constituted by 60 participants (41 men and 19 women; mean age: 47 years)
Inclusion criteria:
  • current DSM‐IV diagnosis of alcohol abuse or alcohol dependence

  • aged 18‐70 years


Exclusion criteria:
  • DSM‐IV diagnosis of primary depression; secondary depression was not an exclusion criterion

  • serious physical illness

  • other pre‐ or coexisting major psychiatric disorder, i.e. any psychotic disorder and bipolar disorder

  • other drug abuse, excluding nicotine


Participants with bipolar disorder were excluded.
Interventions Treatment:
  • mirtazapine (30‐60 mg/day, in 1‐2 divided doses per day; 20 participants; 13 men and 7 women) and psychotherapy

  • only psychotherapy (10 participants)


Psychotherapy: cognitive behavioural psychotherapy administered in individual sessions and family interventions, twice a week
Scheduled duration of treatment: 3 weeks
Site: Drug and Alcohol Addiction Clinic, Athens University Psychiatric Clinic, Eginition Hospital, Athens, Greece
Setting: inpatients for 1 week, then residential treatment
Route of administration: orally
Starting dose: information not available
Pattern of dose reduction: information not available
Outcomes Depression:
  • final HRSD score


Alcohol dependence: no information available
Anxiety:
  • final HRSA score


Global assessment:
  • final GAS score


Dropouts
Adverse effects: data not available
Notes Baseline characteristics of participants
Depression:
  • primary depression (rate of participants): 0%

  • duration: information not available

  • HRSD score (mean ± SD): mirtazepine = 37.9 ± 7.8; controls = 39


Alcohol dependence:
  • drinks per drinking days (mean ± SD): mirtazepine = 27.6 ± 18.5; controls = 22.1,

  • duration (mean ± SD): mirtazepine = 15 years; controls = 14 years,

  • being actively drinking: participants were detoxicated before treatment,

  • length of abstinence: 1 week


Anxiety:
  • HRSA score (mean ± SD): mirtazapine = 33.2 ± 12.6; controls = 33.


Other psychiatric comorbidity: participants with other mental disorders were excluded.
Other substance‐use disorders: participants with substance use disorders were excluded.
Other characteristics of study
Other pharmacological treatment offered: other pharmacological treatments were not allowed.
Funding source: information not available
Declarations of interest: information not available
Other information
In the original study, 60 participants were included into 4 groups:
  • only psychotherapy (20 participants)

  • mirtazapine plus psychotherapy (20 participants)

  • venlafaxine plus psychotherapy (20 participants)


Participants but not clinicians were blind to group status
In the present meta‐analysis, we divided the control group (only psychotherapy) into 2 smaller groups, and compared these 2 smaller groups to the 2 antidepressants, using 3 subgroups:
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer random sequence generation was used ("At the end of the first week, individuals were randomly/electronically allocated to one of the three groups").
Allocation concealment (selection bias) Low risk Computer sequence of allocation used.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Single‐blind study ("Patients but not clinicians were blind to group status").
Blinding of outcome assessment (detection bias) objective Low risk Single‐blind study ("Patients but not clinicians were blind to group status").
Blinding of outcome assessment (detection bias) subjective High risk Single‐blind study ("Patients but not clinicians were blind to group status").
Incomplete outcome data (attrition bias) 
 All outcomes High risk Dropouts were not included in the analysis due to missing data.
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement.