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. 2021 Dec 9;2021(12):CD010120. doi: 10.1002/14651858.CD010120.pub3

Man 2007.

Study characteristics
Methods Design: RCT
Sample size: not described
Analysis: ITT
Withdrawals: 0
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
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
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
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
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