269 patients with various rheumatic disorders who had been treated with non-steroidal anti-inflammatory drugs (
NSAID) for at least three weeks, were enrolled in this randomised double-blind multicenter trial. Entry criteria were both the presence of an
ulcer in gastric and/or duodenal mucosa (> 3 mm and < 20 mm in diameter) as well as dyspeptic symptoms. The patients had been treated with 150 mg
nizatidine nocte (n = 86), 2 x 150 mg/d (n = 93) and 2 x 300 mg/d (n = 90)
nizatidine. All patients continued to take their original
NSAID-medication. The three
nizatidine-groups had been well matched with respect to important patient characteristics. After 8 weeks of treatment more than 90% of gastric and
duodenal ulcers had been healed under all three
nizatidine-dosages. There was a tendency for higher healing rates in case of
gastric ulcers after 4 weeks following the higher dose of
nizatidine. Erosions in stomach and duodenum as well as
esophagitis had been improved to a similar degree with all
nizatidine doses. The same holds with respect to improvement of clinical symptoms such as epigastric
pain,
heartburn etc. Consumption of additional
antacids was similar in all three groups. In the subsequent prophylactic trial 237/221 patients had been followed for 3/6 months. 116/107 received in addition to their continued antirheumatic medication
nizatidine 150 mg nocte and 121/114 patients 2 x 150 mg
nizatidine daily. The cumulative relapse rates within 6 months averaged 5.5% in the low and 1.8% in the high dose group (n.s.).(ABSTRACT TRUNCATED AT 250 WORDS)