| Methods |
Allocation: randomized
Blinding: First phase double blind, 2nd open label
Design: parallel study
Sample size at entry 304: auranofin 152; placebo 152
Analysis: completers, 60.5% follow‐up (auranofin 106, placebo 78) |
| Participants |
Country: USA, multicentre (K=14)
Patients with active RA on NSAIDs
Age: median 53 yrs
Duration of disease: median 4 yrs
Females: 69%
RF: not reported
Concomitant use of steroids: 13.5%
Concomitant use of other DMARDS: none
Previous use of DMARDS: none |
| Interventions |
Auranofin 6 mg/day vs identical placebo
Treatment duration: 26 wk. |
| Outcomes |
Tender joint count
Swollen joint count
Physician global efficacy: 4 pt scale 4=worse
ESR
Xray results reported in text of review |
| Notes |
Wenger 1983 reports final analysis of data from Katz et al 1982 Wenger results included
Quality score: 3
Allocation concealment: unclear
Only blinded phase included
Reported: end of trial results. No SDs included
Converted global efficacy to 4 point scale and combined groups = worse with therapeutic failure. Mean & SD calculated. Numbers of ADRs not requiring withdrawal not reported except for diarrhea. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
