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Background: Melatonin is a safe and effective treatment for patients with functional pain and gastrointestinal disorders. Objective: To evaluate the efficacy and safety of melatonin for 3 months in patients with functional heartburn. Methods: In the randomized, placebo-controlled pilot study, patients with functional heartburn were treated with omeprazole 20 mg before breakfast and randomized to receive either melatonin 6 mg (n = 20), nortripty line 25 mg (n = 20), or placebo (n = 20) at bedtime for 3 months. Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQOL) scores were assessed at baseline and at the end of the study. Results: Melatonin improved GERD-HRQOL scores compared with nortriptyline (P = 0.0015) and placebo (P

The effect of melatonin in functional heartburn: A randomized, placebo-controlled clinical trial