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
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.