Non-erosive Reflux Disease Clinical Trial
Official title:
Comparing Omeprazole With Fluoxetine for Treatment of Non Erosive Reflux Disease and Its Subgroups: a Double-blind Placebo-controlled Clinical Trial
Gastro-esophageal reflux disease (GERD) is highly prevalent, affecting up to 20% of the
adult population in North America. Up to 70% of GERD patients have non-erosive reflux
disease (NERD), a term used to describe symptoms suggestive of GERD in patients with no
endoscopic evidence of erosive esophagitis. NERD represents a heterogeneous group of
patients whom are sub classified according to 24 hours-PH monitoring results and also
symptom-acid association analysis(Symptom Index,SI).
Treatment of NERD can be a challenge for clinicians. According to the many studies , the
pooled rate for symptomatic response after a period of proton pomp inhibitor(PPIs)therapy as
the most frequently used drug, in NERD patients is lower than for erosive esophagitis
patients. It is also shown that acid exposure is much lower in NERD patients than those with
erosive esophagitis and NERD patients are less likely to exhibit a strong association
between heartburn symptoms and acid reflux events than patients with erosive oesophagitis.
Furthermore, beside the high economic burden, there are concerns about the adverse effects
of long time administration of PPIs.
Several hypothesis has been proposed to describe low response rate of NERD patients to PPIs.
One of the most acceptable theories is that patients with anxiety or depression and
psychological problems are at an increased risk of developing reflux symptoms. On the other
hand, pain modulators such as sertraline, a selective serotonin reuptake inhibitor(SSRI),
and other antidepressants have been shown to improve symptoms in patients with functional
gastrointestinal disorders like non cardiac chest pain.
According to the above-mentioned tips, the investigators hypothesize that antidepressants
like fluoxetine, as an SSRI, may have beneficial effects in improving symptoms of NERD
patients.
The purpose of this study is to compare the effect of omeprazole with fluoxetine and placebo
for treatment of NERD patients and its subgroups who all experience reflux symptoms and have
normal endoscopic findings.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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