Gastro-oesophageal reflux disease in primary care: an international study of different treatment strategies with omeprazole

Abstract

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. After 6 months off treatment, 90% of patients with oesophagitis and 75% of endoscopy-negative patients reported symptomatic relapse. CONCLUSION: Both 10 mg and 20 mg of omeprazole gave effective relief of symptoms, although 20 mg gave superior healing in patients with oesophagitis. After cessation of treatment, symptomatic relapse was rapid and frequent in both endoscopy-positive and endoscopy-negative patients.