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Background & Aims: Prostaglandin production in the normal gastrointestinal tract, believed to be critical for mucosal integrity, is mediated by cyclooxygenase (COX)-1, whereas prostaglandin production at inflammatory sites seems to occur via induction of COX-2. We hypothesized that COX-2-specific inhibition with rofecoxib (25 mg once daily) in the treatment of patients with osteoarthritis would cause fewer gastroduodenal ulcers than an equally effective dose of ibuprofen (800 mg 3 times a day), a nonspecific COX inhibitor. Methods: A total of 742 osteoarthritis patients without ulcers on baseline endoscopy were randomly assigned to receive rofecoxib (25 or 50 mg once daily), ibuprofen (800 mg 3 times daily), or placebo. Endoscopy was repeated at 6, 12, and 24 weeks. At 16 weeks, by study design, 95% of the placebo group and 5% of the other groups were discontinued. Results: The cumulative incidence of gastroduodenal ulcers >=3 mm with rofecoxib (25 or 50 mg once daily) was significantly (P < 0.001) lower than with ibuprofen and was statistically equivalent to placebo at week 12 (placebo, 9.9%; 25 mg rofecoxib, 4.1%; 50 mg rofecoxib, 7.3%; and ibuprofen, 27.7%). At 24 weeks, ulcer rates were 25 mg rofecoxib, 9.6%; 50 mg rofecoxib, 14.7%; and ibuprofen, 45.8% (P < 0.001, ibuprofen vs. 25 and 50 mg rofecoxib). Conclusions: Rofecoxib, at doses 2-4 times the dose demonstrated to relieve symptoms of osteoarthritis, caused significantly less gastroduodenal ulceration than ibuprofen, with ulcer rates comparable to placebo. GASTROENTEROLOGY 1999;117:776-783

Hemorrhoids are a frequently occurring disorder widely believed to be caused by chronic constipation. In the present study, the epidemiology of hemorrhoids was evaluated and compared with the epidemiology of constipation. The analysis was based on 4 data sources: from the United States, the National Health Interview Survey, the National Hospital Discharge Survey, and the National Disease and Therapeutic Index; from England and Wales, the Morbidity Statistics from General Practice. Results showed that 10 million people in the United States complained of hemorrhoids, corresponding to a prevalence rate of 4.4%. In both sexes, a peak in prevalence was noted from age 45–65 yr, with a subsequent decrease after age 65 yr. The development of hemorrhoids before age 20 yr was unusual. Whites were affected more frequently than blacks, and increased prevalence rates were associated with higher socioeconomic status. This was in contrast to the epidemiology of constipation, which demonstrated an exponential increase in prevalence after age 65 yr and was more common in blacks and in families with low incomes or low social status. The data presented illustrate differences in the epidemiologic behavior of hemorrhoids and constipation, calling the presumption of causality between constipation and hemorrhoids into question.