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 epidermal growth factor (EGF) in the treatment of duodenal ulcers, on the basis of its repairing actions in the gastrointestinal tract. METHODS: A placebo-controlled, multicenter, randomized, and double-blind study was conducted. Treatment groups were A) placebo solution, B) 10 microg/ml of human recombinant (hr)-EGF, and C) 50 microg/ml of hr-EGF, three times daily during 6 weeks. Patients, 15-65 years old, with a duodenal ulcer >4 mm, who gave their written informed consent to participate were eligible. Exclusion criteria were gastric ulcer and more than one duodenal ulcer, ulcer-related complications, and previous treatment with oral EGF or other specific anti-ulcer drugs in the previous 2 weeks. The main outcome variable was ulcer healing, evaluated by endoscopy after the 2nd, 4th, and 6th week. RESULTS: One hundred and three patients were included. The groups were comparable with regard to age, sex, toxic habits, antecedents of ulcerous disease, initial size and depth or the ulcer, initial symptoms, and positivity for Helicobacter pylori. The ulcers were healed in a larger proportion of patients treated with hr-EGF 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 significant from week 4 on. Groups A and B did not differ. Eighty-eight percent of group 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-microg/ml dose every 8 h but not at 10 microg/ml.

Oral human recombinant epidermal growth factor in the treatment of patients with duodenal ulcer.

The epidermal growth factor has been shown to be mucoprotective and to accelerate healing of gastroduodenal ulcers in animals. A prospective, positively controlled clinical trial was conducted. Seventy five patients with duodenal ulcer were randomly distributed in three groups to receive oral human recombinant epidermal growth factor in 1% carboxymethyl cellulose at two different doses (450 mg or 600 mg/day), or cimetidine. Treatment was administered up to a maximum of 6 weeks. The most important assessment criteria was the proportion of patients healed after 2, 4 and 6 weeks of treatment determined by endoscopy. Treatment with both doses of epidermal growth factor showed a long-term healing effect in 76.5% at 6 weeks vs 92.5% with cimetidine (p = N.S.). The evolution of the clinical symptoms was similar in the three groups. Adverse reactions were not detected in any of the patients included in this study. To our knowledge, this is the first report on the oral use of epidermal growth factor in humans.

[Influence of colloidal bismuth subcitrate, metronidazole, and amoxycillin on Helicobacter pylori and gastroduodenal ulcer healing]. / Influencia del subcitrato de bismuto coloidal, metronidazol y amoxicilina sobre el Helicobacter pylori y sobre la cicatrización de la úlcera gastro-duodenal.

In many works performed in different countries, including Cuba, the microorganism Helicobacter pylori (Hp) is involved in the etiopathogenesis and relapse of gastroduodenal ulcer (GDU). In a previous work, we saw that under treatment of Colloidal bismuth subcitrate (CBS) or Metronidazole (M) alone during 4 weeks, the percentage of Hp clearance obtained was very low. So, we decided to extend the treatment with a unique drug up to 6 weeks or to make a combination of drugs during 4 weeks. 114 patients with GDU endoscopic diagnosis and Hp positive by urease test antral biopsy were located in 5 schedules of treatment: 1) CBS 480 mg daily during 6 weeks; 2)M 1 g daily during 6 weeks; 3) CBS 480 mg daily plus M 750 mg daily during 4 weeks; 4) CBS 480 mg daily plus Amoxycillin (A) 1500 mg daily during 4 weeks and 5) M 750 mg daily plus Amoxycillin 1500 daily during 4 weeks. Endoscopy and urease test were repeated at the end of treatment. Healing of ulcer was obtained in 83.3%; 36.4%; 89.2%; 91.9% and 54.6% respectively. Hp clearance was reached in 55.6%; 27.3%; 67.6%; 70.3% and 27.3% respectively. So, the schedules of treatment less effective (concerning both healing and Hp clearance) were M during 6 weeks and M plus A during 4 weeks. It has been reported that Hp strains may become resistant to nitroimidazolics in the course of treatment and that this resistance could be diminished by the coadministration of CBS. We recommend in GDU-Hp positive a treatment with CBS during 6 weeks or the combination of CBS, which action is basically local, with an antibiotic such as M (no more than two weeks) or Amoxycillin during 4 weeks.

[Fibroesophagogastroduodenoscopy in the gastroenterology institute (experience in 8,000 cases)]. / La fibroesofagogastroduodenoscopia en el instituto de gastroenterologia (experiencia en 8.000 casos).

The results of 8,000 fiber-optic endoscopic procedures performed at the Gastrenterologic Institut during a 5 year period are analyzed in this paper. This extensive was possible not only because the method is simple and innocous due to the flexibility and high technology of these apparatue, but also because the Cuban Public Health System made feasible the exploration without expenses for all the patients needing it. Thirty-two percent of the explorations in an ever greater scale in the search for gastric cancer in its early stages. Chronic inflammation of the upper digestive tract comprised 47% of the abnormal endoscopies. Peptic ulcers were found in 18% of the 3.979 positive gastroduodenoscopies. Esophagogastric cancer was found in 14% of the 4.888 pathologic esophagastroscopies. The results reported and the low morbidity encountered (only 2 significant accidents in over 8,000 procedures) have motivated the Ministry to use this method in all first class hospitals and in several second class ones throughout the country.

[Emergency fibroendoscopy. Basic exploration in the diagnosis of upper digestive bleeding (experience in 200 cases)]. / La fibroendoscopia de urgencia. Exploración fundamental en el diagnóstico de los sangramientos digestivos altos (experiencia en 200 casos).

Prognosis in upper gastrointestinal hemorrage (UGIH) depends mostly upon an early diagnosis. The addition of an around the clock endoscopist on duty in the hospital was decided upon to provide inmediate evaluation of all UGIH. The team performed 200 endoscopies, many within the first 12 hours and all of them before 24 hours of bleeding. Endoscopy was unsuccessful in 5 out of 205 attempts. The usefulness of the method was demonstrated as in 94.55% of the patients the cause of the bleeding was established. Peptic ulcers was the cause in 51.5% of the patients and acute inflammatory disease in 14.5%. Esophageal varices were found in 10%, but it is important that we observed 12 patients with non-bleeding varices in which the bleeding was in relation to associated pathologies.