A multicenter, randomized, double-blind clinical trial examining the effect of oral human recombinant epidermal growth factor on the healing of duodenal ulcers

Background: Our aim was to study the efficacy of oral human recombinant epi dermal growth factor (EGF) in the treatment of duodenal ulcers, on the basi s of its repairing actions in the gastrointestinal tract. Methods: A placeb o-controlled, multicenter, randomized, and double-blind study was conducted . Treatment groups were A) placebo solution, B) Ia mug/ml of human recombin ant (hr)-EGF, and C) 50 mug/ml of hr-EGF, three times daily during 6 weeks. Patients, 15-65 years old, with a duodenal ulcer >4 mm, who gave their wri tten informed consent to participate were eligible. Exclusion criteria were gastric ulcer and more than one duodenal deer, ulcer-related complications , and previous treatment with oral EGF or other specific anti-ulcer drugs i n the previous 2 weeks. The main outcome variable was ulcer healing, evalua ted by endoscopy after the 2nd, 4th, and 6th week. Results: One hundred and three patients were included. The groups were comparable with regard to ag e, sex, toxic habits, antecedents of ulcerous disease, initial size and dep th or the ulcer, initial symptoms. and positivity for Helicobacter pylori. The ulcers were healed in a larger proportion of patients treated with hr-E GF at the highest dose (70.6% in group C versus 40.0% and 35.3% in placebo and low-dose groups, respectively (P=0.007)). The difference was significan t from week 4 on. Groups A and B did not differ. Eighty-eight percent of gr oup C patients were cured or improved versus 57% and 56% in groups A and B, respectively. No adverse reactions were reported. Conclusions: Oral hr-EGF was effective in the treatment of duodenal ulcer at a 50-mug/ml dose every 8 h but not at 10 mug/ml.