Background: This randomized, double-blind, multicentre study compared lanso
prazole with placebo for symptomatic relief of patients with non-erosive ga
strooesophageal reflux disease (GERD).
Methods: 214 patients with symptomatic, non-erosive GERD (moderate to sever
e daytime and/or night-time heartburn greater than half the days over the p
ast 6 months and during the 7- to 10-day pre-treatment period) were randomi
zed to either lansoprazole 15 mg or lansoprazole 30 mg, or placebo o.d. for
8 weeks.
Results: Daily diary data indicated that on the first treatment day a stati
stically significantly smaller percentage of lansoprazole patients reported
daytime and night-time heartburn and antacid usage, compared with placebo
patients. Lansoprazole patients also reported statistically significant les
s severe daytime and night-time heartburn on the first treatment day. Durin
g 0-4, 4-8, and 0-8 weeks of therapy, a statistically significant smaller p
ercentage of days and nights with heartburn, less severe daytime and nightt
ime heartburn, and less antacid usage were observed in the lansoprazole gro
up compared to the placebo group. The percentages of patients with adverse
reactions were similar in the lansoprazole and placebo groups.
Conclusions: The results of this study demonstrate that lansoprazole is an
appropriate therapy for patients with symptomatic non-erosive GERD.