Gastroeophageal reflux is a condition in which
the acidified liquid content of the stomach backs up into the esophagus. The
antiacid magaldrate and prokinetic domperidone are two drugs clinically used
for the treatment of gastroesophageal reflux symptoms. However, the evidence of a superior effectiveness of this combination in comparison with individual drugs is lacking. A
double-blind, randomized and comparative clinical trial study was designed to
characterize the efficacy and safety of a fixed dose combination
of magaldrate (800 mg)/domperidone (10 mg) against domperidone
alone (10 mg), in patients with gastroesophageal reflux symptoms. One hundred
patients with gastroesophageal reflux diagnosed by Carlsson scale were
randomized to receive a chewable tablet of a fixed dose of magaldrate/domperidone
combination or domperidone alone four times each day during a month. Magaldrate/domperidone
combination showed a superior efficacy to decrease global esophageal (pyrosis,
regurgitation, dysphagia, hiccup, gastroparesis, sialorrhea, globus pharyngeus
and nausea) and extraesophageal (chronic cough, hoarseness, asthmatiform
syndrome, laryngitis, pharyngitis, halitosis and chest pain) reflux symptoms
than domperidone alone. In addition, magaldrate/domperidone combination
improved in a statistically manner the quality of life of patients with
gastroesophageal reflux respect to monotherapy, and more patients
perceived the combination as a better treatment. Both treatments were well
tolerated. Data suggest that oral magaldrate/domperidone mixture could be a
better option in the treatment of gastroesophageal reflux symptoms than only
domperidone.