Objective To assess the efficacy of omeprazole in patients presenting with troublesome reflux symptoms.
Design Randomized, double-blind, parallel-group, placebo-controlled comparison.
Setting Primary care.
Subjects Patients were recruited using a symptom-based questionnaire for diagnosis of gastro-oesophageal reflux disease.
Interventions After endoscopy, patients without endoscopic oesophagitis were randomized to omeprazole 20 mg (Ome20), omeprazole 10 mg (Ome10) or placebo once daily for 4 weeks (n=261) and those with oesophagitis (except circumferential/ulcerative) were randomized to receive either Ome20 or Ome10 once daily for 4 weeks (n=277).
Patients not symptom-free at 4 weeks received open treatment with Ome20 once daily for a further 4 weeks.
Those symptom-free at 4-8 weeks were followed up for 6 months off treatment, to see whether their symptoms recurred.
Main outcome measure Complete upper GI symptom relief during week 4 on Ome20 or Ome10 in patients with or without endoscopic oesophagitis.
Results Forty one percent of all patients on Ome20 and 35% on Ome10 reported complete relief from upper GI symptoms during week 4, whilst 73% of the patients on Ome20 and 62% on Ome10 obtained sufficient control.
Complete relief during week 4 was reported by 19% of endoscopy-negative patients on placebo, and sufficient control by 35%. Endoscopic healing at 4 weeks occurred in 76% of oesophagitis patients on Ome20 and in 56% on Ome10. (...)
Mots-clés Pascal : Reflux gastrooesophagien, Symptomatologie, Diagnostic, Soin santé primaire, Questionnaire, Traitement, Chimiothérapie, Antisécrétoire, Oméprazole, Optimisation, Dosage, Etude comparative, Homme, Appareil digestif pathologie, Oesophage pathologie
Mots-clés Pascal anglais : Gastroesophageal reflux, Symptomatology, Diagnosis, Primary health care, Questionnaire, Treatment, Chemotherapy, Antisecretory agent, Omeprazole, Optimization, Assay, Comparative study, Human, Digestive diseases, Esophageal disease
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0177513
Code Inist : 002B13A03. Création : 11/09/1998.