Arnold 2002.
| Methods |
Study setting: Single center study in US Study design: Parallel Study duration: (1) duration wash‐out not reported, (2) 12 weeks titration and maintenance, (3) no follow‐up |
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| Participants |
Inclusion criteria: At least 18 years of age and met the ACR criteria (1990) Exclusion criteria: Evidence of traumatic injury, inflammatory rheumatic disease, or infectious or endocrine‐related arthropathy; unstable medical illness; a lifetime history of hypomania, mania, psychosis or dementia; alcohol or substance dependence during the past months; substantial risk of suicide; any current Axis I disorder; a score >= 10 on the Hamilton Depression Rating Scale (0‐17); received any antidepressants within 2 weeks before randomisation; received investigational medications within 3 months before randomisation; previously received fluoxetine for fibromyalgia Fluoxetine: N = 30; Mean age 46 years; 100% women; 90% white; Pain baseline 6.1 (SD 1.9); FIQ total baseline 42 (SD 14) Placebo: N = 30; Mean age 46 years; 100% women; 97% white; Pain baseline 6.0 (SD 1.9); FIQ total baseline 44 (SD 14) |
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| Interventions |
Fluoxetine 10‐80 mg p.o. 1/d for 12 weeks. Starting dose of 20 mg. After 2 weeks, the dose could be in 10‐ to 20‐mg increments every 2 weeks to a maximum of 80 mg/d Placebo p.o. 1/d for 12 weeks Rescue medication: Subjects were allowed to continue acetaminophen or NSAID on their usual schedule Co‐therapies allowed or prohibited: No information provided |
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| Outcomes |
At least 30% pain reduction: Calculated by imputation method (>= 25% pain reduction scores reported) Global improvement: >= 25% improvement in FIQ total score Fatigue: FIQ subscale VAS 0‐10 Sleep problems: Not assessed Depression: FIQ subscale VAS 0‐10 Drop out due to adverse: Reported Serious adverse events: Not reported Pain: FIQ subscale VAS 0‐10 Disease‐related quality of life: FIQ total score VAS 0‐80 Physical functioning: FIQ subscale 0‐10 Anxiety: FIQ subscale VAS 0‐10 Tenderness: Myalgic score |
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| Notes | High attrition rate (38.3%) Dropouts for any reasons: fluoxetine: 11/30 (36.6%), placebo: 12/30 (40%) The reasons for withdrawal were an adverse effect or event (n = 12), including nervousness, headache, insomnia, nausea, gastrointestinal reflux, increased appetite, decreased appetite or weight loss, fatigue, sedation, anorgasmia, weakness, decreased coordination, decreased concentration, migraine, worsening pain, herniated lumber disc, fall with muscle strain, ear pain, or diagnosis of breast cancer; lack of efficacy (n = 5); loss to follow‐up (n = 4); or for other reasons that were not related to medication (n = 2). There were no significant differences between the treatment groups in the incidence of these events Funding: Supported by an investor initiated grant by Eli‐Lilly |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "All medication were in identical capsules" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | ITT by LOCF |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information about the protocol to permit judgment |
| Group similarity at baseline (selection bias) | Low risk | No significant differences between the two groups in demographic and clinical variables |