| Methods |
Allocation: randomized (blocks of 4 within each centre, size of block unknown to investigator)
Blinding: double blind
Design: parallel study
Sample size at entry: 132. auranofin 67; placebo 65
Analysis: Completers, 81.8% follow‐up
(auranofin 57, placebo 51) |
| Participants |
Country: 5 Nordic countries (K=11)
Patients with active RA (early disease, < 2 yr)
Age: mean 57 yr. (SD 9.5)
Duration of disease: mean 11 mo. (SD 6)
Females: 63%
RF: 66%
Concomitant use of steroids: Intra‐articular steroids allowed
Concomitant use of other DMARDS: none
Previous use of DMARDS: no gold salts, penicillamine, or levamisole. No antimalarials in past 1 mo.
All patients on NSAIDs |
| Interventions |
Auranofin 6 mg/day vs indentical placebo
Treatment duration: 24 months. |
| Outcomes |
Tender joints: Ritchie index
Swollen joint count
Pain: 100 mm VAS, 100=worst possible pain
Function: Stanford Health Assessment Questionnaire & Keitel function test
Patient assessment: 100 mm VAS, 100=perfect health
Physician assessment: 100 mm VAS, 100=worst possible deterioration
ESR
X‐ray: Larsen index, 32 joints, 6 point scale, 5=mutilating changes |
| Notes |
Johnsen 1989 reports 3, 6, 12 & 18 mo results from Borg et al 1988 2 yr. trial.
Quality score: 4
Allocation concealment: unclear
Report: baseline medians with 1st‐3rd quartiles. Results reported as % change from baseline median values and quartiles. End of trial results calculated. Medians were imputed as means. End of trial SD = baseline (1st ‐ 3rd quartile)/2
6 mo.withdrawal data estimated from graphs
ADR data reported at 24 months only. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
