| Methods |
Allocation: Randomized (subgrouped by 'general' or 'nodule' groups)
Blinding: double blind
Design: parallel study, two doses vs placebo
Sample size at entry: penicillamine 600 mg/day n=34; 1200 mg/day n= 44; control 12mg/day n= 43
Analysis: completers |
| Participants |
Country: UK, 5 centres
Patients with active RA
Age: mean 53.4 y (sd 9.6)
Duration of disease: mean 8.7y (sd 7.6)
Females: 68%
RF: 100%
Concomitant use of steroids: 62%
Concomitant use of other DMARDS: none
Previous use of DMARDS: excluded from study |
| Interventions |
Synthetic d‐penicillamine: 600 mg/day, or 1200 mg/day or control with 12 mg/day
Treatment duration: 24 wks |
| Outcomes |
Pain (scale 0 to 4, 4 = very severe)
ESR |
| Notes |
Quality score: 4
Allocation concealment: B
Reported: baseline & mean differences using combined results for all subgroups
Baseline pain score: mean & sd calculated from table 1. Baseline sd imputed to end of trial result
Reported: change in ESR, calculated end of trial score, imputed sd from CV = 0.7 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
