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Abstract
Objectives: The effect of omeprazole and H2-blockers in patients with ulcerlike and refluxlike dyspepsia is mainly studied in endoscoped patients. In general practice most patients are treated without endoscopy. We studied the effect of omeprazole versus H2-blockers and placebo in patients consulting the general practitioner because of dyspeptic complaints in which, based on symptom clusters, ulcerlike or refluxlike symptoms were predominant.
Methods: Patients with ulcerlike or refluxlike dyspepsia according to a symptom-based classification were randomised to treatment with omeprazole 20 mg in the morning versus cimetidine 400 mg twice daily (n=469), if the patients had a verified medical history of peptic ulcer disease or reflux oesophagitis, or to a treatment with omeprazole 20 mg in the morning versus placebo (n=548), if no such history was present. The endpoint was a total relief of symptoms after two weeks of treatment.
Results: In both groups treatment success was obtained in 50% of the patients treated with omeprazole versus 35% (p=0.002) of those treated with cimetidine, and 36% (p=0.009) of those treated with placebo, respectively.
Conclusions: The response rates indicate that patient selection based on symptom clusters is insufficient for predicting the response to acid suppression, and that aspects other than acid-related factors contribute to symptom presentation. The lack of difference in the response to omeprazole treatment in the two groups indicates that recurrence of dyspeptic symptoms in patients with previous peptic ulcer disease or reflux oesophagitis does not necessarily reflect a relapse of the disease.