Li 2013.
| Study characteristics | ||
| Methods | Design: RCT Sample size: 179 participants (90 in etoricoxib group, 89 in indomethacin group) Analysis: ITT Withdrawals: 1 (0.5%) lost to follow‐up in the etoricoxib group, 0 in the indomethacin group | |
| Participants | 179 participants (90 in etoricoxib group, 89 in indomethacin group) Participant characteristics Mean age: 52 ± 15 years (etoricoxib group); 53 ± 14 years (indomethacin group) Male: 85 (96%) (etoricoxib group), 81 (91%) (indomethacin group) Mean disease duration: not described Mean number of affected joints: monoarticular: 75 (83%) participants (etoricoxib group), 73 (82%) participants (indomethacin group); polyarticular: 14 (17%) participants (etoricoxib group), 27 (18%) participants (indomethacin group) Affected joints: MTP 46 (52%) (etoricoxib group 53%, indomethacin group 60%); intertarsal joint 6 (8%) (etoricoxib group 6%, indomethacin group 8%); ankle 21 (27%) (etoricoxib group 19%, indomethacin group 24%); knee 10 (13%) (etoricoxib group 2%, indomethacin group 3%); wrist 3 (4%) (etoricoxib group 4%, indomethacin group 5%); elbow 1 (1%) (etoricoxib group 1%, indomethacin group 1%); other 2 (3%) (etoricoxib group 4% indomethacin group 5%) Inclusion criteria: adults with acute gout attack (< 48 hours from onset), diagnosed according to American College of Rheumatology classification criteria, and with total score of 5 (of a max possible score of 10) on 3 symptom questions for pain (0‐ to 4‐point Likert scale), tenderness (0‐ to 3‐point scale), and swelling (0‐ to 3‐point scale); eligible participants also had at least 1 blood count, blood chemistry, and urinalysis performed 1 year before randomisation without abnormalities that would contraindicate the use of any study medication Exclusion criteria: concurrent medical/arthritic disease that could confound evaluation of benefit or that contraindicated use of study medication; history contraindicating use of indomethacin; polyarticular gout involving > 4 joints; history of cancer during previous 5 years or history of cerebrovascular events, myocardial infarction, or coronary bypass in the previous year; received corticosteroids within 1 month before randomisation; received anticoagulants, ticlopidine, clopidogrel, or digoxin; use of NSAIDs 48 hours before baseline assessments or analgesics, including aspirin, within 6 hours before baseline assessments or during the trial |
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| Interventions |
Group 1: 1 tablet of etoricoxib 120 mg or placebo from bottle A once daily in the morning for 5 days Group 2: 1 capsule of indomethacin 75 mg or placebo from bottle B twice daily (morning and evening) for 5 days |
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| Outcomes | Outcomes evaluated at prespecified time intervals: baseline, 4 hours after initial dose on day 1, 4 hours after daily dose on days 2 and 5 Primary outcome • Patients' assessment of pain in the affected joint from baseline, as reported by patients on a 0‐ to 4‐point (0 = no pain, 4 = extreme pain) Likert scale Secondary outcome • Investigators' assessment of tenderness of the study joint on a 4‐point Likert scale (0 = no pain, 1 = patient states there is pain, 2 = patient winces, 3 = patient withdraws) • Investigators' assessment of swelling of study joint on a 4‐point Likert scale (0 = no swelling to 3 = bulging beyond joint margins) • Patients' and investigators' global assessment of response to therapy on a 5‐point Likert scale (0 = excellent, 4 = poor) • Proportion of participants who discontinued treatment because of lack of efficacy • AEs |
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| Notes |
Funding: Merck Sharp & Dohme, a subsidiary of Merck & Company, Inc. Adverse events Group 1: etoricoxib Total AEs: 13/89 Serious AEs: 0/89 Nature of total adverse events: gastric dilation, diarrhoea, stomachache, dizziness, chills, fever, leg swelling Group 2: indomethacin Total AEs: 19/89 Serious AEs: 1/89 Nature of total adverse events: abdominal distension, stomach upset, stomachache, digestive tract upset, nausea, cough, somnolence, right‐hand numbness, dizziness, leg swelling Nature of serious adverse events: 16‐day duration of gouty arthritis in a formerly unaffected joint |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated allocation schedule |
| Allocation concealment (selection bias) | Low risk | Study sponsor who provided the computer‐generated allocation schedule was blinded to group allocations |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "patients took one tablet of etoricoxib or placebo from bottle A once daily and one tablet of indomethacin or placebo from bottle B twice daily" |
| Blinding of outcome assessment for self‐reported outcomes (detection bias) | Low risk | Participants blinded |
| Blinding of outcome assessment for assessor‐reported outcomes (detection bias) | Low risk | Outcome assessors blinded to treatment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 withdrawal in the etoricoxib group due to loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported |
| Other bias | Low risk | None apparent |