Arnold 2002.

Study characteristics
Methods	Design: parallel Duration: 12 weeks Assessment: baseline and post‐intervention Country: USA
Participants	Pain condition: fibromyalgia Population: women with fibromyalgia Minimum pain intensity: no Inclusion criteria Aged over 18 and meeting the ACR 1990 criteria for fibromyalgia Exclusion criteria Evidence of traumatic injury, inflammatory rheumatic disease, or infectious or endocrine‐related arthropathy; clinically unstable medical illness; a history of seizure, head trauma, or stroke; a lifetime history of hypomania, mania, psychosis, or dementia; alcohol or substance dependence during the past 6 months; a substantial risk of suicide; any current Axis I diagnosis; or a score of  ≥ 10 on the 17‐item Hamilton Depression Rating Scale. Received monoamine oxidase inhibitors, tricyclics, lithium, SSRIs, or other antidepressants within 2 weeks before randomisation; received investigational medications within 3 months before randomisation; or previously received fluoxetine for fibromyalgia Total participants randomised: 60 Age in years (mean, SD): 46 (11) Gender: 46/46 were female Pain duration: average duration of fibromyalgia was 11 (9) years
Interventions	Fluoxetine SSRI Flexibly dosed depending upon tolerance and improvement: starting dose 20 mg/day, maximum dose 80 mg/day Mean dose was 45 mg/day Placebo Inert Identical capsules to fluoxetine, with matched titration process
Outcomes	Pain intensity Quality of life Depression Physical function Withdrawal
Missing data methods	LOCF
Funding source	Pharmaceutical: Eli Lilly
Conflicts of interest	NR, but authors in other papers have declared conflicts of interest regarding involvement with Eli Lilly
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not enough information ‐ just says that participants were 'randomly assigned'
Allocation concealment (selection bias)	Unclear risk	No information given
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Identical capsules and titration process
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias) All outcomes	High risk	High attrition and used LOCF Attrition: Total: 23/60 (38.3%) Placebo: 12/30 (40.0%) Fluoxetine 10‐ 30 mg: 11/30 (36.7%)
Selective reporting (reporting bias)	Unclear risk	No protocol or trial registration found
Other bias	Low risk	No other sources of bias were identified