Primary Sjogren's syndrome is a systemic autoimmune exocrinopathy char
acterized by a lymphoplasmacytic infiltrate and destruction of salivar
y and lacrimal glandular tissues. There is no widely accepted or effec
tive systemic therapy for this disorder. The purpose of this 6-month r
andomized, double-blinded, placebo-controlled study was to examine the
effects of prednisone (30 mg, alternate days), piroxicam (20 mg, dail
y), or placebo on the salivary, lacrimal and immunologic alterations o
f primary Sjogren's syndrome. Eight patients were enrolled in each gro
up. Salivary and lacrimal function were assessed at entry and at the c
ompletion of treatment. Labial minor salivary gland tissue was obtaine
d at these times and examined for intensity of infiltration (focus sco
res) and for the relative proportion of glandular elements. Serologic
and subjective evaluations were done as well, and patients were monito
red for therapy-related side effects. Neither active treatment led to
significant improvement in salivary or lacrimal function, although pre
dnisone improved salivary flow in selected patients and was associated
with positive subjective responses. Prednisone also significantly dec
reased the serum total protein, IgG, IgA, and sedimentation rate and i
ncreased the white cell count. There were no significant alterations i
n either focus scores or the percentage of glandular component tissues
of minor glands with either active treatment. This study demonstrated
that 6 months of prednisone or piroxicam at the doses utilized failed
to improve the histological or functional parameters of salivary and
lacrimal glands in primary Sjogren's syndrome.