Abstract
Purpose: Functional heart burn is a challenging clinical entity. Rome III criteria confirmed the clinical state. The subjects of collective, nonerosive reflux disease (NERD) with negative diagnostic studies, including histopathology and lower esophageal sphincter dysfunction, fall into the category of Functional Heart Burn (FHB) after a proton pump inhibition (PPI) challenge test. Therapeutic modalities are not yet established. Melatonin, a natural neurohormone related to serotonin, inhibits gastric acid secretion, alters nitric oxide function at gastroesophageal junction, and helps heal esophageal erosions. This study evaluates the possible role of melatonin in FHB.Methods: Sixty patients (n=60), ages 21-42 years (mean of 33), with Rome III proven FHB, were randomized into three groups. All patients underwent initial PPI challenge for 4 weeks, followed by panendoscopy with biopsies of antrum, body, distal and proximal esophagus. H. pylori, eosinophilic esophagitis (EoE) and mast cells were evaluated. All patients underwent pH monitoring (RESTEC pH monitoring). Group A (n=20) placebo at bedtime, Group B (n=20) Nortryptaline 25 mg orally at bed time, and Group C (n=20) over-the-counter(OTC)melatonin 6 mg at bed time for 3 months. All groups received omperazole 20 mg before breakfast and also underwent lifestyle modification. Pre- and post GERD-HQRL scores were analyzed. Exclusion: active ulcers, EOE, achalasia, esophageal stricture, infections of esophagus, scleroderma, H. pylori gastritis, and drugs affecting motility. Results: Patients in Melatonin group had a significantly higher percentage of relief (15/20=75%; Pearson's Chi-square=12.2, p=0.002) in heart burn score than those in Nortryptaline (4/20=20%) and Placebo (9/20=45%) groups. Melatonin group also had relatively better quality of life, less day time somnolence, and better tolerability compared to the other two groups. Side Effects: Melatonin- 5(25%)distension, 4(20%) diarrhea, and 4(20%) day time somnolence; Nortryptiline- 7(35%) constipation, 9(45%) somnolence, 11(55%) dry mouth, and 2(10%) dizziness; Placebo- 5(25%) constipation, 11(55%) daytime somnolence, and 6(30%) abdominal distension. Conclusion: OTC Melatonin improves functional heart burn and GERDHQRL score, is generally well tolerated, and offers a significant cost benefit. A larger trial is needed to validate.
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