Abstract
A double-blind placebo-controlled study was conducted to examine whether the gastrointestinal signs and lesions induced by non-steroidal antirheumatics (NSAID) could be successfully treated with the prostaglandin E1 analogue misoprostol despite continued NSAID treatment. A concomitant treatment with 2 .times. 400 .mu.g misoprostol daily was carried out four weeks in 67 rheumatoid arthritis patients in whom upper abdominal complaints were due to NSAID treatment. Assessment of the severity of the gastro-intestinal signs and symptoms as well as of the oesophago-gastroscopic findings was done at the beginning of the study and after two and four weeks. Within four weeks the improvement of the score of upper abdominal pain was significantly greater in the misoprostol-treated patients than in the placebo-treated patients (M = 84.1%, P = 30.9%; p = 0.0001). The same applies to other gastrointestinal symptoms and signs (M = 86.3%, P = 29%; p = 0.0046), endoscopic gastric lesions (M = 76.7%, P = 34.4%; p = 0.029) and duodenal lesions (M = 79%, P = 13%; p = 0.051). In 87.1% of the patients tereated with misoprostol (placebo group 37.1%) an improvement of the gastrointestinal signs and symptoms was achieved (p = 0.001). Already after two weeks the misoprostol group showed a greater reduction of the score of gastric lesions (m = 46.9%, P = 20.8%; p = 0.05) and of the duodenal lesions (M = 68%, P = 6.2%; p = 0.0051), as well as a greater frequency of improvement of gastrointestinal signs and symptoms (M = 80.7%, P = 41.7%; p = 0.001). Mild diarrhoea was seen in both treatment groups once each. In one patient of the placebo group treatment was discontinued due to the occurrence of tarry stools. The results of the study show that necessary antirheumatic therapy can be continued despite associated gastrointestinal complaints provided misoprostol is given at the same time.

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