Goldenberg 1986.
Methods | Randomised, double‐blind, placebo‐controlled, parallel‐group Probably single centre in USA Duration of screening and washout not reported, 6‐week parallel group phase No obvious imputation for withdrawals if participants completed 2 visits No NSAID or other drug for 3 days before initial visit Minimum pain intensity 4/10 or higher |
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Participants |
Naproxen: N = 19 Placebo: N = 19 No demographic information for separate groups. Overall mean age 44 years (range 21‐69), 95% women, 87% white Pain baseline (extracted from figure): 7.6 Mean years of chronic pain 3.5 (0.5‐20) years Inclusion criteria: modified Yunus 1981 Exclusion criteria: history of peptic ulcer disease or cardiac arrhythmias, or if they were taking medications that could not be stopped |
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Interventions |
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Outcomes |
Pain: 0‐10 cm PGIC much or very much improved: 0‐10 cm Fatigue: 0‐10 cm Sleep problems: 0‐10 cm Adverse events (AEs): no information provided Health‐related quality of life: not assessed Psychological distress: not assessed |
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Notes | Oxford Quality Score R = 1 DB = 1 W = 1 Total = 3/5 No conflicts of interest reported Funding source ‐ Arthritis Foundation, and Syntex |
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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, though both "blinded" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participant reported, or all participants evaluated in a blinded manner by one assessor |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Over 90% of participants reported data, and no imputation mentioned |
Selective reporting (reporting bias) | Low risk | All important outcomes reported |
Group similarity at baseline | Unclear risk | No information |
Sample size bias | High risk | Fewer than 50 participants per treatment arm |