29060/433.
Study characteristics | ||
Methods | Design: parallel Duration: 8 weeks Assessment: baseline and post‐intervention Country: Belgium |
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Participants | Pain condition: fibromyalgia Population: people with fibromyalgia and depressive symptoms Minimum pain intensity: ≥ 4 on 0‐10 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 52 Age in years (mean): 45 Gender: 12/45 were female Pain duration in years (mean, SD): NR |
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Interventions | Placebo
Paroxetine 20 mg
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Outcomes | AEs SAEs Withdrawal |
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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 |