TREATING THE SYMPTOMS OF GASTROESOPHAGEAL REFLUX DISEASE - A DOUBLE-BLIND COMPARISON OF OMEPRAZOLE AND CISAPRIDE

Citation
Jp. Galmiche et al., TREATING THE SYMPTOMS OF GASTROESOPHAGEAL REFLUX DISEASE - A DOUBLE-BLIND COMPARISON OF OMEPRAZOLE AND CISAPRIDE, Alimentary pharmacology & therapeutics, 11(4), 1997, pp. 765-773
Citations number
45
Categorie Soggetti
Pharmacology & Pharmacy","Gastroenterology & Hepatology
ISSN journal
02692813
Volume
11
Issue
4
Year of publication
1997
Pages
765 - 773
Database
ISI
SICI code
0269-2813(1997)11:4<765:TTSOGR>2.0.ZU;2-4
Abstract
Background: Few studies have specifically addressed the management of the symptoms of gastro-oesophageal reflux disease, and there are no co mparative data in this respect for acid pump inhibitors and prokinetic agents. Methods: Following endoscopy 424 patients presenting with hea rtburn as the predominant symptom of gastrooesophageal reflux disease were randomized to treatment with omeprazole 20 or 10 mg once daily, o r cisapride 10 mg four times daily, in a double-blind, double-dummy, p arallel group, multicentre study. Symptoms and quality of life were as sessed at 4 weeks. Patients still experiencing heartburn continued the rapy for a further 4 weeks and the assessments were repeated. Results: At 4 weeks, heartburn was resolved in 65% (95% CI: 57-73%), 56% (48-6 4%) and 41% (32%-49%) of patients treated, respectively, with omeprazo le 20 mg and 10 mg once daily, and cisapride. Both omeprazole doses we re significantly more effective than cisapride (P < 0.01). The same or der of efficacy was observed regardless of the presence of erosive oes ophagitis. Regurgitation and epigastric pain also improved to a greate r degree with omeprazole than with cisapride. Quality of life was impr oved in all treatment groups, and the improvement in the reflux dimens ion of the Gastrointestinal Symptom Rating Scale (GSRS) score was sign ificantly different between groups (P = 0.002). Conclusions: Omeprazol e 20 or 10 mg once daily is significantly more effective than cisaprid e in the resolution of heartburn, regardless of the presence of erosiv e oesophagitis, and this is accompanied by an improvement in patient q uality of life.