Although the pathogenic role of gastroesophageal reflux in Barrett's esophagus is widely accepted, the pattern of gastric and esophageal pH profile of patients with Barrett's esophagus is not well documented. Moreover, the observation that a columnar-lined esophagus can also develop after gastrectomy implies that chronic irritation of the lower esophagus by duodenal juice can be as harmful as acid reflux. To test this hypothesis, we simultaneously monitored gastric and esophageal pH in 19 patients with endoscopically and histologically proven Barrett's esophagus, in 35 with slight-to-moderate esophagitis and in 10 healthy subjects. The gastroesophageal reflux pattern in both Barrett's esophagus and esophagitis was characterized by mainly acid refluxes. Esophageal acid exposure (% time pH < 4) was 39.4 in patients with Barrett's esophagus, 14.6 in patients with esophagitis (P < 0.05), and 3.1 in healthy subjects (P < 0.05). Seven of 19 patients with Barrett's esophagus and 7 of 35 with esophagitis had evidence of alkaline reflux too; but pure alkaline refluxes accounted for only 1.9% of total time in Barrett's esophagus and 0.3% in esophagitis patients. In conclusion, these results confirm the high prevalence and severity of acid reflux in patients with Barrett's esophagus and show that the reflux of pure alkaline material into the esophagus is a rare event in both Barrett's esophagus and esophagitis patients.
A multicenter study that involved 15 Italian institutions was carried out to compare the efficacy and safety of famotidine 40 mg at bedtime, famotidine 20 mg b.i.d., famotidine 40 mg b.i.d., and ranitidine 150 mg b.i.d. in promoting the healing of acute duodenal ulcer. Two hundred and twenty-four patients with endoscopically proven duodenal ulcer were randomly allocated into four treatment groups. Efficacy results for the four groups were similar at weeks 2, 4, and 8 of therapy. At week 8, the percentage of patients healed in each group was as follows: 92% in the famotidine 40-mg bedtime group, 97% with 20 mg b.i.d., 93% with 40 mg b.i.d., and 90% with ranitidine 150 mg b.i.d. Day pain and night pain were markedly reduced in all four groups, antacid consumption fell considerably, and therapy was generally well tolerated. The adverse experiences evaluated by the investigator as possibly, probably, or definitely related to test medication were rare and moderate.
One hundred patients were entered into a double-blind, double-dummy comparison of tripotassium dicitrate bismuthate (TDB) versus ranitidine, to evaluate short-term healing rates, and successfully healed patients were then entered into a follow-up phase to observe relapse rates. At 4 weeks 84% of patients treated with TDB and 68% of those treated with ranitidine had healed. At 8 weeks these figures had risen to 96% and 90%, respectively (p = NS). After a year's follow-up study 84% of patients healed initially with ranitidine had relapsed, whereas in the case of patients healed initially with TDB the relapse rate was 67% (p less than 0.05). The results confirm that in the short term, TDB is as effective as ranitidine, whereas the significantly better protection against relapse offered by TDB compared with ranitidine underlines the importance of restoring mucosal defence, an approach that to date has been somewhat overlooked.
A multicentre study involving 9 Italian institutions was carried out to compare the efficacy and safety of ranitidine 150 mg b.i.d. and ranitidine 300 mg nocte in the treatment of reflux oesophagitis. 117 patients with histologically proven oesophagitis were randomly allocated to two comparable treatment groups. Efficacy and reliability were evaluated by clinical and laboratory tests at the beginning of the study, and at 3 and 6 weeks; endoscopy and biopsies were performed at the beginning and at 6 weeks. Treatment with ranitidine for 6 weeks led to total disappearance of gastro-oesophageal reflux symptoms in 60% of patients, with percentages of partial improvement varying between 85% and 95% of cases. Improvement in the results of endoscopic examination was 85%, of which 55% were cured. Microscopic examination revealed an improvement of 36% and 44%, with a cure rate of 18% and 26% respectively. With regard neither to the regression of symptoms nor to the macroscopic and microscopic inflammation of the oesophageal mucosa did statistical examination show significant differences in the therapeutic efficacy of ranitidine 150 mg b.i.d. or 300 mg nocte for treatment of reflux oesophagitis.
