Randomised clinical trial: sodium alginate oral suspension is non-inferior to
omeprazole in the treatment of patients with non-erosive gastroesophageal
disease.
Author(s): Chiu CT(1), Hsu CM, Wang CC, Chang JJ, Sung CM, Lin CJ, Chen LW, Su MY, Chen TH.
Affiliation(s): Author information:
(1)Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital at
Linkou, Chang Gung University College of Medicine, Taoyuan, Taiwan.
Publication date & source: 2013, Aliment Pharmacol Ther. , 38(9):1054-64
BACKGROUND: The burden of gastroesophageal reflux disease (GERD) is increasing in
the Asia area and the majority of GERD patients have non-erosive reflux disease
(NERD).
AIM: To evaluate the efficacy and safety of sodium alginate suspension compared
to omeprazole in adult subjects with NERD.
METHODS: In this 4-week, double-blind, parallel study, 195 NERD subjects were
randomised to one of two treatment groups: sodium alginate suspension 20 mL three
times a day and omeprazole 20 mg once daily. The primary efficacy endpoint was
the percentage of patients achieving adequate heartburn or regurgitation relief
at day 28 assessed by patient diary. The secondary efficacy endpoints included
percentage of patients achieving adequate heartburn or regurgitation relief,
change from baseline of the Reflux Disease Questionnaire total score at day 14
and 28 from baseline, and patients' overall satisfaction.
RESULTS: In this study, 183 subjects were included in the intent-to-treat
population, and 172 subjects were included in the per-protocol population.
Non-inferiority of sodium alginate to omeprazole was demonstrated in the
intent-to-treat population [difference, 2.7% (53.3% vs. 50.5%, P = 0.175), 95%
lower confidence interval -11.9%, above the preset margin of -19%]. All of the
secondary efficacy endpoints were comparable between two groups. The incidence of
adverse event was relatively low and there was no difference between the two
groups (5.4% vs. 5.5% for sodium alginate vs. omeprazole). No severe adverse
event was noted in this study.
CONCLUSION: The study showed that sodium alginate was as effective as omeprazole
for symptomatic relief in patients with non-erosive reflux disease
(Clinicaltrials.gov NCT01338077).
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