The aim of the study was to compare the efficacy and the effects on the muc
osa of the gastrointestinal tract (CIT) of nabumetone and diclofenac retard
in patients with osteoarthritis (OA), An open, multicentre, randomised, co
mparative, endoscopy-blind parallel group study included 201 patients with
nabumetone and 193 patients with diclofenac retard suffering from moderate
to severe OA of the knee or hip joint. Twelve clinical efficacy variables w
ere assessed and a portion of the population underwent gastroduodenoscopy.
All patients exhibited significant improvement in pain severity and pain re
lief (p<0.001 and p<0.0001, respectively) but there were no differences bet
ween the groups for all the efficacy variables. Eleven per cent of patients
on nabumetone and 19% on diclofenac experienced GIT side-effects. Sixty-ni
ne patients with nabumetone and 61 with diclofenac underwent gastroduodenos
copy. The differences in the mucosal grade for the oesophagus, stomach and
duodenum at baseline were not significant. In the oesophagus there were sig
nificantly less changes after treatment with nabumetone (p = 0.007) than wi
th diclofenac; there were similar findings in the stomach (p<0.001) but the
difference in the duodenum was not significant. This study indicates that
nabumetone and diclofenac retard have similar efficacy in the treatment of
OA, but nabumetone has significantly fewer GIT side-effects.