Key result
Melatonin 6 mg significantly increased the percentage of patients reporting improvement in heartburn symptoms compared to placebo (75% vs 45%, P < 0.0001) in patients with functional heartburn.
Why the study?
Does melatonin improve GERD-HRQOL scores in patients with functional heartburn?
RCT (n=60)
Randomized
No
Does melatonin improve GERD-HRQOL scores in patients with functional heartburn?
Absolute Event Rate: 75% vs 45%
p-value: p=<0.0001
Melatonin may be an effective treatment for improving quality of life in patients with functional heartburn.
Melatonin improves heartburn symptoms in functional heartburn; supports adjunctive use and extends options beyond PPIs pending HRQOL confirmation.
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
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Basu et al. (2014) conducted an RCT in Functional heartburn (n=60). Melatonin vs. Placebo or Nortriptyline 25 mg was evaluated on Improvement in heartburn symptoms (GERD-HRQOL) (p=<0.0001). Melatonin 6 mg significantly increased the percentage of patients reporting improvement in heartburn symptoms compared to placebo (75% vs 45%, P < 0.0001) in patients with functional heartburn.
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