Skip to main content
. 2019 Jan 18;2019(1):CD012722. doi: 10.1002/14651858.CD012722.pub2

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
Participants Randomised: n = 126
  • Placebo ‐ n = 41

  • Methotrexate ‐ n = 31

  • Gold ‐ n = 30

  • Sulfasalazine ‐ n = 24


Completed: n = 77
  • Placebo ‐ n = 31

  • Methotrexate ‐ n = 16

  • Gold ‐ n = 15

  • Sulfasalazine ‐ n = 15


Baseline characteristics
Mean age (reported only for the 77 completers), dispersion measure not reported:
  • Placebo ‐ 41.5 years

  • Methotrexate ‐ 39.7 years

  • Gold ‐ 30.4 years

  • Sulfasalazine ‐ 40.6 years


Sex (reported only for the 77 completers), dispersion measure not reported:
  • Placebo ‐ 12 males, 9 females

  • Methotrexate ‐ 8 males, 8 females

  • Gold ‐ 3 males, 12 females

  • Sulfasalazine ‐ 7 males, 8 females


Mean disease duration (reported only for the 77 completers), dispersion measure not reported:
  • Placebo ‐ 4.2 years

  • Methotrexate ‐ 6.4 years

  • Gold ‐ 4.1 years

  • Sulfasalazine ‐ 6.2 years


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
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
Outcomes Time points: 12 months
Major:
  • Withdrawals due to adverse events ‐ measured as events/no events, with events indicating harm


Minor:
  • Total adverse events ‐ measured as events/no events, with events indicating harm


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
Notes Clinical trials registration: not reported
Funding: not reported
Declarations of interest: not reported
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