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A double-blind, randomized clinical trial was performed to explore efficacy and safety of lansoprazole plus metoclopramide vs. ranitidine plus metoclopramide to diminish GERD symptoms on the basis of Infant Gastroesophageal Questionnaire Revised version (I-GERQ-R) scores in 120 neonates with GERD resistant to monotherapy and conservative therapy.
In neonates with gastroesophageal
reflux disease (GERD), both lansoprazole plus metoclopramide and ranitidine plus metoclopramide displayed
vital responses after one week and one month of therapy. However, the response
rate was considerably better in the lansoprazole plus metoclopramide therapy
compared with the ranitidine plus metoclopramide therapy.
A double-blind, randomized clinical
trial was performed to explore efficacy and safety of lansoprazole plus
metoclopramide vs. ranitidine plus metoclopramide to diminish GERD symptoms on
the basis of Infant Gastroesophageal
Questionnaire Revised version (I-GERQ-R) scores in 120 neonates with GERD
resistant to monotherapy and conservative therapy.
The enrolled neonates were randomly allocated to either oral lansoprazole plus metoclopramide arm or oral ranitidine plus metoclopramide arm. After one week and one month, the alterations of signs symptoms and signs were recorded. In the end, 54 participants in each arm completed the trial and their data were assessed.
The
major endpoint was an alteration in the total number of GERD-linked signs and
symptoms from baseline to the therapy end. The secondary endpoints were
complications in either group after administration of lansoprazole,
metoclopramide, and ranitidine.
After one week and one month, the response
rate of subjects treated with
lansoprazole plus metoclopramide was considerably greater in comparison with
the subjects treated with ranitidine plus metoclopramide. During the
intervention, no treatment-emergent side effects were found in either arm. The
combination of acid suppressants with
metoclopramide caused a greater response rate when compared to monotherapy
utilized prior to the intervention.
In GERD patients, the response rate
is considerably elevated in lansoprazole
plus metoclopramide-treated patients compared with the ranitidine plus
metoclopramide-treated patients.
International Journal of Pediatrics
The Safety and Efficacy of Lansoprazole plus Metoclopramide among Neonates with Gastroesophageal Reflux Disease Resistant to Conservative Therapy and Monotherapy: A Clinical Trial
Peymaneh Alizadeh Taheri et al.
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