The effects of omeprazole on healing and appearance of small gastric and duodenal lesions during dosing with diclofenac in healthy subjects

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are associated w ith gastrointestinal mucosal damage. Omeprazole prevents the formation, and accelerates the healing, of NSAID-induced ulcers. Aim: To test whether omeprazole accelerates healing of standardized gastrod uodenal lesions in the presence of diclofenac. Methods: In a double-blind, double-dummy, placebo-controlled, crossover stu dy, 12 healthy volunteers received consecutive, 2-week courses of omeprazol e (40 mg o.d.) and placebo, in random order, with an intervening, 4-week wa shout period; diclofenac (50 mg t.d.s.), was given for the second week of e ach course. Five endoscopies were performed, one at the outset and the othe rs before and after each course of diclofenac. Biopsies were taken from the endoscopically normal mucosa of the corpus, antrum and duodenum and also f rom any new mucosal lesion that developed after diclofenac. The sites of bi opsies taken before each course of diclofenac were evaluated endoscopically after each course to assess the extent of healing according to a predeterm ined healing score scale. Results: The healing scores observed after administration of placebo/diclof enac (median=0; range 0-6) and after omeprazole/diclofenac (median=0; range 0-6; P=0.17) did not differ. Small gastroduodenal lesions developed de nov o in six subjects during placebo/diclofenac and in seven during omeprazole/ diclofenac. Focal chemical gastropathy was observed only in close proximity to macroscopic lesions. Conclusions: In healthy subjects, omeprazole does not accelerate the healin g of pre-existing mucosal lesions or prevent the development of small diclo fenac-induced mucosal lesions.