Mahagna 2016.
Methods | Randomised, double‐blind, placebo‐controlled, parallel‐group 2 medical centres in Israel Duration of screening and washout not reported, 6 weeks parallel group phase LOCF imputation for withdrawals No NSAID or coxib for 2 weeks before enrolment No stated minimum pain intensity |
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Participants |
Etoricoxib: N = 32; 100% female; race not reported; mean age 49.8 (SD 13.2) years; pain baseline 6.4 ± 1.7 on BPI; years since diagnosis 3.5 (SD 6.2) years Placebo: N = 32; 100% female; race not reported; mean age 51.0 (SD 9.7) years; pain baseline 6.4 ± 1.8 on BPI; years since diagnosis 5.2 (SD 6.6) years Inclusion criteria: ACR 1990 criteria Exclusion criteria: confirmed pregnancy or breast feeding, with active or previous coronary artery disease, congestive heart failure, coexisting neoplastic conditions (not including basal cell carcinoma), coexisting rheumatic conditions, active or previous gastrointestinal bleeding, renal failure, comorbid conditions causing significant disability and those with uncontrolled hypertension |
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Interventions | Etoricoxib 90 mg fixed dose Placebo |
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Outcomes |
Pain: Brief Pain inventory NRS 0‐10; 30% and 50% and more pain relief rates reported PGIC much or very much improved: not assessed Fatigue: FIQ VAS 0‐10 subscale scores not reported Sleep problems: FIQ VAS 0‐10 subscale scores not reported Adverse events (AEs): "Assessment of adverse effects was conducted by actively addressing this issue with each patient at each encounter." Health‐related quality of life: FIQ total score 0‐100 Psychological distress: SF‐36 mental health summary score (50‐0) |
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Notes | Oxford Quality Score R = 1 DB = 1 W = 1 Total = 3/5 No conflicts of interest reported Funding source ‐ MSD |
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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 | Most secondary outcomes not reported |
Selective reporting (reporting bias) | Low risk | Pain baseline scores reported |
Group similarity at baseline | Low risk | Similar at baseline |
Sample size bias | High risk | Fewer than 50 participants per treatment arm |