Omeprazole in the treatment of patients with severe reflux oesophagitis not responding to H2-receptor antagonists and ineligible for surgery

In 42 patients (25 men, 17 women, mean age 62 years) with severe erosive or ulcerative oesophagitis not responding to H2-receptor antagonist treatment over at least 3 months and ineligible for surgery, omeprazole was administered at an initial dose of 40 mg/day, subsequently reduced to 20 mg after healing of the lesions. Patients had monthly clinical, endoscopic, histological and laboratory assessment over the healing period, then were reevaluated 3-monthly over one year, then 6-monthly, during the maintenance treatment. Stages of oesophagitis were based on the Savary-Miller classification, modified for stage I (erosions must be present). With 40 mg omeprazole, healing was observed in 71%, 83% and 90% of the patients after 1, 2 and 3 months of treatment, respectively. After one month of treatment, a complete healing was less frequently observed in patients with stage IV oesophagitis pre-trial (55%) than in the patients with stages I, II and III pre-trial (90%) (p less than 0.05). Ninety per cent of the patients healed at one month were asymptomatic whereas 50% of the patients with incomplete healing still had symptoms, most often dysphagia, rarely heartburn. Maintenance treatment with 20 mg was sufficient in most patients, with a probability of remaining healed of 69% from 9 to 24 months after starting this dosage. In 9 patients with Barrett's oesophagus, the lengths of the circumferential metaplasia were found to be reduced after one year of treatment compared to pre-trial lengths (p less than 0.005). There was no further significant reduction of length after 2 years of treatment. Fasting gastrin was increased in most of the patients, although great inter-patient variability was observed; 50% of the patients had levels not exceeding 5 times the upper limit of normal. There was no consistent increase of enterochromaffin-like cell density in 29 patients investigated up to nearly 2 years of omeprazole administration. The treatment was well tolerated. By inducing a profound and sustained inhibition of acid secretion, as confirmed by pH monitoring, omeprazole promotes healing of the lesions of severe oesophagitis and prevents recurrence of lesions and symptoms. Omeprazole is therefore a valuable treatment for patients ineligible for surgery, particularly in the elderly.