Russell 1991.
| Methods | Randomised, double‐blind, placebo‐controlled, parallel‐group Probably single centre, USA 2‐week washout, 6 weeks parallel double‐blind group phase followed by 24‐week open trial No imputation described and some analyses based on 32 participants Analgesics and NSAIDs discontinued 2 weeks before randomisation No stated minimum pain intensity. Measured pain intensity at baseline 6.5/10 |
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| Participants |
Ibuprofen: N = 17 Placebo: N = 14 No group‐level data. Overall mean age 47 years (SEM 1.2), 89% women; 20% Hispanic; pain baseline 6.2 (SEM 0.2), duration of symptoms or FM diagnosis not reported Inclusion criteria:Russell 1986 (almost all met Yunus 1981, and ACR 1990 criteria) Exclusion criteria: other rheumatic diseases, chronic infections, untreated endocrine disorders, unstable seizure diathesis, psychiatric disorders, or active peptic ulceration |
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| Interventions | Ibuprofen 600 mg four times a day Placebo |
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| Outcomes |
Pain: NRS 0‐10 PGIC much or very much improved: not assessed Fatigue: FIQ single item (VAS 0‐10): not assessed Sleep: not assessed Quality of life: HAQ ‐ 24 questions each scored 0‐3 Adverse events (AEs): physical examination, electrocardiograms (ECGs), and laboratory analysis. Further details of assessment of adverse symptoms not reported Depression: HADS and HAS Anxiety: not assessed Disability: not assessed Cognitive disturbances: not assessed Sexual function: not assessed Tenderness: mean tender point threshold (kg/cm²) |
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| Notes | Oxford Quality Score R = 1 DB = 2 W = 1 Total = 4/5 No conflicts of interest reported Funding source ‐ Upjohn |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details reported |
| Allocation concealment (selection bias) | Unclear risk | No details reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details reported |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participant‐reported outcomes; participants were adequately blinded to intervention. Blinding of outcome assessors of safety not adequately described |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Completer analysis (63/78 ‐ 19% attrition) |
| Selective reporting (reporting bias) | Low risk | Most secondary outcomes reported |
| Group similarity at baseline | Unclear risk | No details reported |
| Sample size bias | High risk | Fewer than 50 participants per treatment arm |