Man 2007.
Study characteristics | ||
Methods |
Design: RCT Sample size: not described Analysis: ITT Withdrawals: 0 |
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Participants | 90 participants (46 in indomethacin group, 44 in prednisolone group) Participant characteristics Mean age: 66 years (indomethacin group); 64 years (prednisolone group) Male: 74/90 (82%) Mean disease duration: not described Mean number of affected joints: monoarthritis: 45 (98%) participants (indomethacin group), 41 (93%) participants (prednisolone group); > 1 joint involved: 1 (2%) participant (indomethacin group), 3 (7%) participants (prednisolone group) Affected joints: not described Inclusion criteria: clinical diagnosis of acute arthritis suggestive of gout, defined as presence of pain and warmth in a joint; presented within 3 days of onset of pain and also had ≥ 1 of the following: metatarsal‐phalangeal joint involvement or knee/ankle joint involvement and aspirate containing crystals or typical gouty arthritis with either gouty tophi present or previous joint aspiration confirming the diagnosis of gout Exclusion criteria: clinical suspicion of sepsis/other joint disease; if follow‐up was deemed to be impossible, comorbidity that would interfere with assessment; concurrent presence of dementia/confusion/active GI symptoms/renal insufficiency with serum creatinine level > 200 mol/L/bleeding disorder/treatment with warfarin; allergy to study drugs; joint aspirate that excluded the diagnosis of gout |
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Interventions |
Group 1: prednisolone: intramuscular placebo, oral prednisolone 30 mg, paracetamol 1 g, and placebo indomethacin, followed by prednisolone 30 mg for 5 days, paracetamol 1 g every 4 hours as required, and placebo indomethacin 50 mg 3 times daily for 2 days and 25 mg 3 times daily for 3 days Group 2: indomethacin: intramuscular diclofenac 75 mg, oral indomethacin 50 mg, paracetamol 1 g, and placebo prednisolone, followed by indomethacin 50 mg 3 times daily for 2 days and 25 mg 3 times daily for 3 days; and paracetamol 1 g every 4 hours as required and placebo prednisolone for 5 days |
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Outcomes | Outcomes evaluated at prespecified time intervals: by telephone interview at 24 hours or physical review if in hospital and review after 5 and 14 days. Pain scores and AEs were recorded every 30 minutes for 2 hours after drug administration Participants in the indomethacin group received diclofenac 75 mg intramuscularly in addition to indomethacin 50 mg orally; those in the prednisolone group received prednisone 30 mg orally and intramuscular placebo Primary outcomes • Pain as reported by participants on a 10‐cm VAS (0 = absence of pain to 10 = the most severe pain the participant had ever experienced) • AEs: quote: "patients were asked to select in the trial diary one or more of five categories of side‐effects: none; gastric pain, abdominal pain, or both; itch, dizziness, or both; dyspnoea, palpitations, or both; other" Secondary outcomes • Time to complete resolution of pain, stiffness, and joint swelling • Supplementary paracetamol • Treatment failure defined as non‐resolution of symptoms or recurrence of symptoms at day 14 • Relapse rate |
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Notes | With regards to pain scores, quote: "patients were aware of their previous scores at all stages of recording" Funding: no funding received Adverse events Group 1: prednisolone Total adverse events: 12/44 Nature of events: rash, dizziness, drowsiness, dry mouth, nausea Group 2: indomethacin Total adverse events: 29/46 Nature of events: epigastric pain, nausea, diarrhoea, vomiting, indigestion, dizziness, drowsiness |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random sequence |
Allocation concealment (selection bias) | Low risk | Allocation concealed in sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both participants and study personnel blinded Quote: "...preparations and identical placebos were all pre packed..." |
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 |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals in the present study |
Selective reporting (reporting bias) | Unclear risk | Secondary endpoints not reported in the prespecified way |
Other bias | Low risk | None apparent |