Ranitidine in the Therapy of NSAID-Induced Gastroduodenal Lesions: Results of a Randomized, Placebo-Controlled, Double-Blind Study in Patients with Rheumatic Diseases

Abstract

Forty-six patients with rheumatic diseases suffering from dyspepsia and endo-scopically proven gastroduodenal lesions entered a double-blind placebo-controlled study with 150 mg ranitidine twice daily for 4-8 weeks. The patients had to have been treated for at least 3 months with the non-steroidal anti-inflammatory drugs (NSAID) diclofenac, indomethacin, or piroxicam before entering the study. During the trial all patients had to continue taking NSAIDs. At entry patients in the placebo group (n = 23) had a total of 33 gastrointestinal lesions of grade 1 to 3. In the ranitidine group (n = 23) a total of 28 gastrointestinal lesions had been found. After 4 weeks of treatment the number of lesions had been reduced to 20 in the placebo group and to 5 in the ranitidine group (p <0.05). The total damage score at entry, which averaged 2.0 with placebo and 1.8 with ranitidine, had been reduced to 1.3 (placebo) and 0.3 (ranitidine) (p <0.05). Ranitidine administration was accompanied by the disappearance of epigastric pain, epigastric distress, and epigastric burning in almost 80% of the patients. Ranitidine does not adversely influence the anti-arthritic activity of NSAIDs. Our results underline the efficacy of ranitidine in the treatment of NSAID-induced gastroduodenal muclsal lesions in patients with rheumatic diseases.