Intra-articular steroids: confounder of clinical trials.
The effect of intra-articular (i-a) steroid injection on ESR and C-reactive protein (CRP) in rheumatoid arthritis (RA) was investigated. One week following injection of 1 or 2 knees there was a significant fall in ESR (p less than 0.0001) and CRP (p less than 0.01) in a cohort of 20 RA patients. The mean drop for both ESR and CRP was 46%. This effect lasted over a variable period up to 6 months. A survey of 50 published drug efficacy studies in RA revealed that, while 44 used ESR and 20 CRP as efficacy measures, 37 neither excluded nor recorded i-a steroid injections during the study. Steroid injections were excluded in 8 studies and recorded in 5, being used as an outcome measure in 2 of these. It is recommended that the frequency with which i-a injections are used in drug efficacy studies is reported and that they are avoided in the 3 months preceding an outcome measurement if ESR or CRP are being used as outcome measures.
Taylor
H G
HG
Staffordshire Rheumatology Centre, Haywood Hospital, Stoke-on-Trent, UK.
Fowler
P D
PD
David
M J
MJ
Dawes
P T
PT
D000368:Aged; D001172:Arthritis, Rheumatoid / Q000097:blood / Q000188:drug therapy*; D001799:Blood Sedimentation / Q000187:drug effects; D002097:C-Reactive Protein / Q000378:metabolism; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007270:Injections, Intra-Articular; D008297:Male; D010865:Pilot Projects; D013256:Steroids / Q000008:administration & dosage / Q000627:therapeutic use*
D013256:Steroids; D002097:C-Reactive Protein