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. 2000 Apr 24;2000(2):CD002048. doi: 10.1002/14651858.CD002048

Lewis 1984.

Methods Allocation: randomized 
 Blinding: double blind for tablet therapy but not injections. Blind assessments. 
 Design: parallel study, 3 groups 
 Sample size at entry 90: Auranofin 30; placebo 30, GSTM 30. 
 Analysis: completers
Participants Country: UK 
 Patients with active RA 
 Age: median 52.17 yrs (sd 16.7) 
 Duration of disease: median 5 yrs (sd 13.00) 
 Females: 69% 
 RF: 88.9% 
 Concomitant use of steriods: none 
 Concomitant use of DMARDS: none 
 Previous of DMARDS: not in past 6 mo.
Interventions Auranofin 6mg/day or matching placebo or GSTM 50 mg IM/wk 
 Treatment duration: 6 mos
Outcomes ESR 
 Disease activity index (combining other measures)
Notes Quality score: 4 
 Allocation concealment: unclear 
 Except for ESR no OMERACT end of trial results reported 
 Six outcome measures were combined to derive a disease activity index. 
 Reported ESR changes, imputed baseline SD to end of trial 
 Withdrawals and dropouts reported @ 24 wks. ADRs not requiring withdrawal not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear