Randomised controlled trial
Randomised, blinded, placebo controlled trial of doxycycline for
chronic seronegative arthritis
M Smiejaa, D W MacPhersona, W Keanb, M L Schmuckd, C H Goldsmithc, W Buchananb, L E Hartb, J B Mahonya
a Department of
Pathology and Molecular Medicine, McMaster University, Hamilton, Canada, b Department of Medicine, McMaster University, c Department of Clinical Epidemiology and
Biostatistics, McMaster University, d Education
Services, McMaster University
Correspondence to: Dr M Smieja, Laboratory Medicine L424, St Joseph's Hospital, 50 Charlton Avenue East, Hamilton ON L8N 4A6, Canada smiejam{at}mcmaster.ca
Accepted for publication 8 June 2001
OBJECTIVE
To determine
whether long term doxycycline improves symptoms in patients with
chronic seronegative or reactive arthritis.
METHODSA randomised,
triple blind, controlled clinical trial of three months' treatment
with doxycycline or placebo of patients with chronic reactive or
seronegative arthritis was conducted. The primary study end points
were three month pain and functional status measured by a self
administered Arthritis Impact Measurement Scales version 2 (AIMS2)
quality of life questionnaire. Secondary end points were pain and
functional status at 6-12 months, three month rheumatologist assessed
joint count, pain, and arthritis activity, and treatment efficacy in
those with previous exposure to chlamydia.
RESULTSOf 60 patients randomly allocated to receive doxycycline or placebo, results
from 37 were evaluable at three months. Groups were well balanced for
major prognostic variables. Doxycycline had no detectable effect at
three months on pain change scores (mean difference 1.5, 95% CI 
1.2
to 4.2, p=0.25) or composite functional change scores (mean difference
0.8, 95% CI 5.6 to 7.1, p=0.81). Furthermore, there were no
differences in secondary study end points, and no apparent treatment
effect in patients with previous chlamydia infection.
CONCLUSIONThree
months' treatment with doxycycline did not improve pain or functional
status in patients with chronic reactive or seronegative arthritis.
© 2001 by Annals of the Rheumatic Diseases
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