Aim: To compare the efficacy of cimetidine and tripotassium dicitrato
bismuthate (TDB) in arthritic patients who had developed gastric (GU)
or duodenal (DU) ulceration while taking non-steroidal anti-inflammato
ry drugs (NSAIDs). Methods: Eighty-six rheumatoid arthritis (RA) patie
nts affected by endoscopically proven DU (n = 44) or GU (n = 42), and
on chronic NSAID therapy which was not suspended during anti-ulcer the
rapy, were randomized to cimetidine (400 mg t.d.s.) or TDB (120 mg q.d
.s.). A repeat endoscopy was planned after 4 weeks (and 8 weeks, in ca
se of failed healing). The patients who were unhealed after 8 weeks of
therapy were allocated to the alternative anti-ulcer drug for a furth
er 8 weeks without interrupting the anti-inflammatory therapy. Results
: At week 4 of therapy, 14/24 (58%) DU and 9/20 (45%) GU patients trea
ted with cimetidine were healed, compared with 12/20 (60%) and 10/22 (
45%) TDB-treated patients (N.S.). At week 8 of therapy, the DU healing
rates were 15/24 (63%) with cimetidine and 14/20 (70%) for TDB. The c
orresponding GU healing rates were 12/20 (60%) with cimetidine and 13/
22 (60%) for TDB (N.S.), At week 16, complete healing with cimetidine
was observed in 67% of DU and 57% of GU patients unhealed with TDB: th
e corresponding figures in the patients crossed to TDB were 83% for DU
and 63% for GU patients (N.S. vs. cimetidine). Conclusions: No statis
tically significant difference was found between the healing activitie
s of cimetidine and TDB in rheumatoid arthritis patients with peptic u
lcer who did not interrupt their NSAID treatment for arthritis. This t
rial showed that the continued consumption of NSAIDs appears to slow t
he ulcer healing process, especially in GU patients.