Siegmeth 1976.
| Study characteristics | ||
| Methods | Design: RCT Sample size: not described Analysis: not described Withdrawals: 0 | |
| Participants | 46 participants (23 in each group) Participant characteristics Mean age: 59.9 (range 36 to 78) years Male: 100% Mean disease duration: 4.8 years (ketoprofen group); 5.6 years (phenylbutazone group) Mean number of affected joints: not described Affected joints: not described Inclusion criteria: acute gout defined as (1) hyperuricaemia 7 mg%; (2a) crystal identification; (2b) typical history of a podagra; (2c) at least 2 arthritis episodes during maximally 2 weeks before the trial; (2d) presence of tophi. For the diagnosis of acute gout, the following were needed: 1 and 2a, or 1 and 2 out of 3 criteria (2b, 2c, 2d) Exclusion criteria: chronic gout and kidney disease, GI disorder, hepatic disorder, haematological disorder | |
| Interventions | Group 1: ketoprofen 2 intramuscular injections 50 mg each day for 7 days Group 2: phenylbutazone 2 intramuscular injections 300 mg each day for 7 days | |
| Outcomes | Outcomes evaluated at days 1 and 7
Primary outcome
• Pain as rated on an ordinal scale (0 to 3 scale; 0 = absent, 1 = moderate, 2 = strong, 3 = very strong)
Secondary outcomes
• Sleep deprivation • Inflammation defined as redness and swelling as rated on an ordinal scale (0 to 3 scale; 0 = absent, 1 = moderate, 2 = strong, 3 = very strong) • Uric acid concentrations • Tolerance |
|
| Notes |
Funding: not reported Adverse events Ketoprofen appears to be slightly better tolerated with respect to systemic and local side effects compared to phenylbutazone |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described; stated only that both study drugs were provided by intramuscular injection |
| Blinding of outcome assessment for self‐reported outcomes (detection bias) | Unclear risk | Not reported |
| Blinding of outcome assessment for assessor‐reported outcomes (detection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | Low risk | None apparent |