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. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Ginsberg 1998.

Study characteristics
Methods Design: parallel
Duration: 4 weeks
Assessment: baseline and post‐intervention
Country: Belgium
Participants Pain condition: fibromyalgia
Population: people with fibromyalgia
Minimum pain intensity: no
Inclusion criteria
  • Aged between 18 and 75

  • Fibromyalgia meeting the ACR 1990 criteria

  • History of widespread pain for at least 3 months

  • Pain in at least 11 of 18 specific tender points


Exclusion criteria
  • Physical health comorbidities


Total participants randomised: 100
Age in years (mean): 39.8
Gender: 85/100 were female
Pain duration in months (mean): 34.7
Interventions Placebo
  • n = 50

  • Inert

  • Matched dosing


Pirlindole 150 mg
  • n = 50

  • Reversible MAOI

  • Fixed dose

Outcomes Pain intensity
Mood
AEs
Withdrawal
Missing data methods NR
Funding source NR
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation methods not specified
Allocation concealment (selection bias) Unclear risk Allocation procedures not specified
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk States double‐blind, but no information regarding study drugs' appearance
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Self‐reported outcomes from participants, but unsure of blinding
Incomplete outcome data (attrition bias)
All outcomes High risk Completer analysis only. Unclear with number randomised, completer analysis and no clear explanation of when and who withdrew.
Attrition
Total: 39/100 (39.0%)
Placebo: 22/44 (50.0%)
Pirlindole 150 mg: 17/45 (37.8%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias identified