Prospective multicentre study of risk factors associated with delayed healing of recurrent duodenal ulcers (RUDER)

Accepted for publication 9 February 1993 Abstract Risk factors for delayed duodenal ulcer healing during treatment with ranitidine (300 mg daily) were examined in a multicentre German study of 1923 patients with endoscopicaily proved, recurrent-duodenal ulceration. Healing rates, per protocol, were 39-5% at two weeks, 70-9% at four weeks, and 93-2% at eight weeks. Prospective testing of five, predefined risk factors indicated that smoking (p=0-0039) was associated with a decreased healing rate at two weeks. Frequent prior recurrence (p=0464), a heavy physical workload (p=0-145), and' psychological stress (p=0062) were not associated with a decreased healing rate and there were too few patients at risk to aliow assessment of the effect of regular NSAID intake. Exploratory analysis identified prior slow healing, a large ulcer, multiple ulcers, and prior ulcer complications, in addition to smoking, as markers of slow healing. In the absence ofthese risk factors, the mean healing time was 3*3 weeks (95% confidence interval 3-0, 3.5), rising to 3*7 weeks (3.5, 3.9) for one, 4*4 weeks (4.1, 4.7) for two, and 5-1 weeks (4.5, 5.6) for three to five risk factors. Delayed duodenal ulcer healing is associated with multiple factors whose effect is cumulative; for patients with two or more of five easily identified risk factors, more than four weeks' treatment with a histamine H2 receptor antagonist is required to achieve ulcer healing. (Gut 1993; 34: 1319-1326)