Comparing Omeprazole With Fluoxetine for Treatment of Non Erosive Reflux Disease and Its Subgroups: a Double-blind Placebo-controlled Clinical Trial

Summary

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.

Conditions

• Non-erosive Reflux Disease

Interventions

DRUG

Fluoxetine

20 mg , oral , daily 30 mins before breakfast, for 6 weeks

DRUG

Omeprazole

20 mg , oral , daily 30 mins before breakfast, for 6 weeks

DRUG

placebo

oral , daily 30 mins before breakfast, for 6 weeks

DRUG

Omeprazole

20 mg , oral , daily 30 mins before breakfast, for 6 weeks

DRUG

Fluoxetine

20 mg , oral , daily 30 mins before breakfast, for 6 weeks

DRUG

placebo

oral , daily 30 mins before breakfast, for 6 weeks

Sponsors & Collaborators

• Tehran University of Medical Sciences

  lead OTHER

Principal Investigators

• Seyed Amir Mirbagheri, MD · Department of Internal Medicine, Faculty of medicine, Tehran university of medical sciences

• Mohammad Reza Ostovaneh, MD,MPH · Tehran University of Medical Sciences

• Arash Etemadi, MD, PhD · Tehran University of Medical Sciences

• Yasin Farrokhi Khajeh Pasha, MD, MPH · Tehran University of Medical Sciences

• Behtash Saeidi, MD · Tehran University of Medical Sciences

• Kaveh Hajifathalian, MD · Tehran University of Medical Sciences

• Akbar Fotouhi, MD, PhD · Tehran University of Medical Sciences

• Seyed Mahmoud Eshagh hosseini, MD · Tehran University of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2011-08-31

Completion

2011-08-31

Countries

• Iran

Study Locations