Prevention of peptic ulcer and dyspeptic symptoms with omeprazole in patients receiving continuous non-steroidal anti-inflammatory drug therapy. A Nordic multicentre study.

BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs) are known to cause gastroduodenal lesions and dyspeptic symptoms. METHODS: Patients with a history of dyspepsia or uncomplicated peptic ulcer disease and with a need for continuous NSAID treatment were randomized to receive either 20 mg omeprazole once daily or placebo. Gastroduodenal ulcers, erosions, and dyspeptic symptoms were evaluated after 1 and 3 months. RESULTS: During a 3-month study period 4.7% (4 of 85) of omeprazole-treated patients developed peptic ulcer, compared with 16.7% (15 of 90) of patients treated with placebo. This prophylactic effect of omeprazole was sustained independently of previous peptic ulcer history or Helicobacter pylori status. Development of dyspeptic symptoms requiring active treatment, either alone or in combination with ulcer(s) or erosions, occurred in 15.3% (15 of 85) of patients treated with omeprazole and 35.6% of those who received placebo. CONCLUSIONS: Omeprazole, 20 mg once daily, provides effective prophylactic therapy in patients at risk of developing NSAID-associated peptic ulcers or dyspeptic symptoms.

Sucralfate versus placebo in reflux esophagitis. A double-blind multicenter study.

The healing capacity and symptom relief were studied in 138 patients with symptomatic endoscopically verified reflux esophagitis treated with sucralfate (n = 69) or placebo (n = 69), 1 g four times daily (granules suspended in half a glass of water), for at most up to 12 weeks. The reflux esophagitis (modified Savary-Miller scale) was distributed with 71 patients having grade 1, 39 patients having grade 2 or 3, and 28 patients having grade 4. All patients were told to follow the antireflux regimen. Antacid tablets were supplied, to be used only for the relief of severe pain, and were counted. The esophageal lesions were completely healed in 42% (sucralfate) and 35% (placebo) after 6 weeks of treatment (NS). Corresponding cumulative healing rates at 12 weeks of treatment were 54% and 41% (NS), respectively. The symptom improvement, however, was significantly better in the sucralfate group after 3 weeks of treatment. The results indicate a symptomatic benefit of sucralfate in reflux esophagitis.