REFLUX SYMPTOM RELIEF WITH OMEPRAZOLE IN PATIENTS WITHOUT UNEQUIVOCALESOPHAGITIS

Background: As many as 50 % of patients with reflux symptoms have no e ndoscopic evidence of oesophagitis. This multicentre study was designe d to assess symptom relief after omeprazole 20 mg once daily in patien ts with symptoms typical of gastro-oesophageal reflux disease but with out endoscopic evidence of oesophagitis. Methods: Patients (n = 209) w ere randomized in a double-blind study to receive either omeprazole 20 mg once daily (n = 98) or placebo (n = 111) for 4 weeks. Symptoms wer e assessed at clinic visits and using daily diary cards, with patient- completed questionnaires providing additional data on symptoms and on psychological disturbance. Results: On completion, symptom relief favo ured omeprazole: 57% of patients on omeprazole were free of heartburn (vs. 19% on placebo), 75% were free of regurgitation (47%) and 43% wer e completely asymptomatic (14%), each with P < 0.0001. Fewer patients in the omeprazole group required alginate/antacid relief medication (P < 0.05). Symptom relief (time to first heartburn-free day) was more r apid with omeprazole (2 vs. 5 days on placebo; P < 0.01). A greater re duction in anxiety occurred in the omeprazole group (P < 0.05). Conclu sion: Omeprazole 20 mg once daily is effective in providing relief of the symptoms typical of gastrooesophageal reflux disease in patients w ith essentially normal oesophageal mucosa.