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Wade, A.G., Ford, I., Crawford, G., McConnachie, A., Nir, T., Laudon, M., et al. (2010) Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: A randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety. BMC Medicine, 8, 51.

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

  AUTHORS: Patrick P. Basu, Hemanth Hempole, Nitya Krishnaswamy, Niraj J. Shah, Mark M. Aloysius

  KEYWORDS: Melatonin; Functional Heartburn; Nortriptyline; HRQOL

  JOURNAL NAME: Open Journal of Gastroenterology, Vol.4 No.2, February 8, 2014

  ABSTRACT: 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