Kravitz 1994.
| Methods | Randomised, double‐blind, placebo‐controlled, parallel‐group Probably single centre in USA Diagnostic criteria of Yunus 1981 1 week screening and washout, 1 week parallel‐group phase Single missing data point imputation, but all were completers Placebo ibuprofen for 1 week before baseline visit No minimum pain intensity |
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| Participants |
Ibuprofen: N = 15 Placebo: N = 16 No important demographic differences noted. Overall mean age 48 years (SD 11), 92% women, 90% White Inclusion criteria: modified Yunus 1981 Exclusion criteria: pregnant or child‐bearing potential, nursing, allergy or sensitivity to study drugs, peptic ulcer or bleeding, alcohol or drug abuse, major depression, suicidal ideation, psychosis or schizophrenia, fibromyalgia of secondary cause. Previous psychiatric illness not an exclusion if participant not currently ill |
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| Interventions | Ibuprofen 600 mg four times a day Placebo |
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| Outcomes |
Pain: 0‐100 mm PGIC much or very much improved: 7‐point scale Fatigue: not assessed Sleep problems: not assessed Adverse events (AEs): no information provided Health‐related quality of life: not assessed Psychological distress: HRDS, BDI, HARS |
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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. Not mentioned that placebo identical |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participant‐reported for major outcome. Not mentioned if other measures evaluated in a blinded manner by one assessor |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All important outcomes reported |
| Selective reporting (reporting bias) | Low risk | All important outcomes reported |
| Group similarity at baseline | Low risk | No important demographic differences between groups |
| Sample size bias | High risk | Fewer than 50 participants per treatment arm |