Skip to main content
. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

29060/433.

Study characteristics
Methods Design: parallel
Duration: 8 weeks
Assessment: baseline and post‐intervention
Country: Belgium
Participants Pain condition: fibromyalgia
Population: people with fibromyalgia and depressive symptoms
Minimum pain intensity: ≥ 4 on 0‐10 VAS
Inclusion criteria
  • Fibromyalgia meeting ACR criteria

  • ≥ 4 on 0‐10 pain intensity VAS

  • Concomitant depressive symptoms


Exclusion criteria
  • Physical health comorbidities

  • Psychiatric disorders


Total participants randomised: 52
Age in years (mean): 45
Gender: 12/45 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 26


Paroxetine 20 mg
  • n = 26

  • SSRI

  • Fixed dose

Outcomes AEs
SAEs
Withdrawal
Missing data methods ITT but no method reported
Funding source Pharamaceutical: GlaxoSmithKline
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 No information given regarding blinding procedures
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Self‐reported outcomes from participants but unsure of blinding measures
Incomplete outcome data (attrition bias)
All outcomes High risk Use ITT for primary outcome but don't report imputation method. Completer‐only analysis for the secondary outcomes
Attrition
Total: 13/52 (25.0%)
Placebo: 5/26 (19.2%)
Paroxetine 20 mg: 8/26 (30.8%)
Selective reporting (reporting bias) High risk State a number of measures that they will collect but don't report findings for (Abnormal Involuntary Movement Scale, fatigue VAS). No protocol, no publication
Other bias High risk Not published ‐ just a scientific summary on GSK registry. Trial ran in 1995 but only posted in 2005