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. 2017 Mar 27;2017(3):CD012332. doi: 10.1002/14651858.CD012332.pub2

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
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
Interventions Etoricoxib 90 mg fixed dose
Placebo
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)
Notes Oxford Quality Score
R = 1
DB = 1
W = 1
Total = 3/5
No conflicts of interest reported
Funding source ‐ MSD
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