Therapeutic effect of melatonin in patients with functional dyspepsia

J Clin Gastroenterol. 2007 Mar;41(3):270-4. doi: 10.1097/MCG.0b013e318031457a.


Background and goal: Melatonin may inhibit reactive oxygen species-related pathogenesis in the alimentary tract by neutralizing free radicals. In the present study we assessed the potential protective action of melatonin in ulcerlike dyspepsia.

Study: Sixty patients aged 19 to 39 years with the diagnosis of functional dyspepsia according to the Rome Criteria II and no Helicobacter pylori infection were involved in the study. Melatonin, at a dose of 5 mg (n=30), or placebo (n=30) were taken in the evening for a period of 12 weeks. At this time, patients were on an equivalent diet and were only to take an alkaline drug in case of the abdominal pain.

Results: After 12 weeks, the dyspeptic symptoms completely subsided in 17 patients in the melatonin-treatment group (56.6%). In other 9 individuals (30.0%) a partial improvement in health was achieved, especially in the frequency and intensity of nocturnal pain. After placebo, the majority of patients (93.3%) did not experience any improvement in symptoms. Multivariate analysis indicated that melatonin (odds ratio 95.86, 95% confidence interval 3.72-2469.37, P<0.01) correlated independently with significantly improved patients health. H. pylori past infection decreased positive effect of melatonin in ulcerlike dyspepsia.

Conclusions: Melatonin can be considered as an auxiliary drug in the treatment of ulcerlike dyspepsia.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abdominal Pain / etiology
  • Adult
  • Antioxidants / therapeutic use*
  • Cross-Over Studies
  • Double-Blind Method
  • Dyspepsia / complications
  • Dyspepsia / drug therapy*
  • Female
  • Humans
  • Male
  • Melatonin / therapeutic use*


  • Antioxidants
  • Melatonin