Burdeinyi 1992.
Methods |
Study design: open‐label, randomised controlled trial with 4 arms of therapy (MTX, parenteral gold, sulfasalazine/salazopiridazine, NSAIDs (considered as placebo)) Duration of study: 12 months Run‐in period: none Location: Russia Number of study centres: not reported Study setting: outpatient Withdrawals: 49 ‐ method of handling missing data not described Dates of study: not reported |
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Participants |
Randomised: n = 126
Completed: n = 77
Baseline characteristics Mean age (reported only for the 77 completers), dispersion measure not reported:
Sex (reported only for the 77 completers), dispersion measure not reported:
Mean disease duration (reported only for the 77 completers), dispersion measure not reported:
Severity of condition: not reported Diagnostic criteria: rheumatologist‐diagnosed PsA Inclusion criteria: adults with clinically active PsA; no further criteria reported Exclusion criteria: not reported |
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Interventions |
Group 1: intramuscular gold injections equivalent to 34 mg elemental gold every week Group 2: sulfasalazine/salazopiridazine 0.5 g daily and increasing to 1 g twice a day Group 3: methotrexate 2.5 mg every 12 hours to a total weekly dose of 10 mg (unclear if this was per oral or parenteral) Group 4: controls (considered as placebo) ‐ NSAIDs (mainly diclofenac or indomethacin ‐ doses not reported) ‐ no placebo tablets Concomitant medications: after enrolment, all participants received intra‐articular corticosteroid injections. NSAIDs (mainly diclofenac or indomethacin) for all participants and intra‐articular corticosteroids at the discretion of the trial clinician. The last intra‐articular injection was no later than 4 weeks before the last examination, and NSAID dose was changed no later than 2 weeks before the last examination Excluded medications: not reported |
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Outcomes |
Time points: 12 months Major:
Minor:
N.B. Efficacy of treatment was based on pain scores, severity of morning stiffness, duration of morning stiffness, fatigability, Ritchie Articular Index, swollen joint count, tender joint count, compression force, and ESR. These outcomes were compared to baseline for the individual, and were subsequently combined and reported as the 'treatment effectiveness index'. This was a composite outcome designed by study authors that was not cited as a validated outcome measure. Individual variables were not reported. Study authors could not be contacted to provide individual data for individual outcomes |
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Notes |
Clinical trials registration: not reported Funding: not reported Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The study involved 126 patients with clinically active psoriatic arthritis, who were randomised into 4 groups" Specific details regarding the randomisation process were not reported |
Allocation concealment (selection bias) | Unclear risk | No explanation of allocation concealment procedures was provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Placebo controls were not used, hence it is possible that participants and personnel were aware of the treatment assignment |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No explanation regarding blinding of outcome assessors was provided |
Incomplete outcome data (attrition bias) All outcomes | High risk | Losses to follow‐up were recorded with reasons; however, incomplete efficacy data do not appear to be included in the final analysis |
Selective reporting (reporting bias) | Unclear risk | The primary outcome of Treatment effectiveness index was selectively reported; this is a composite index of several component scores (such as the Ritchie articular index) Components were not reported |
Other bias | Unclear risk | Differences in baseline characteristics and co‐intervention use were reported Compliance with therapy was not clearly documented The overall impact of this on study results is unclear |