Therapeutic Potential of Melatonin in Functional Dyspepsia
Abstract
Melatonin has demonstrated potential therapeutic benefits across a range of functional gastrointestinal disorders, including irritable bowel syndrome and heartburn, due to its effects on motility regulation, visceral sensitivity, and gut-brain signaling. To assess its efficacy specifically in functional dyspepsia (FD), we conducted a meta-analysis of three randomized controlled trials (RCTs) involving a total of 148 patients (74 in each of the melatonin and placebo groups). The primary outcome was symptom improvement following melatonin supplementation. The fixed-effect model revealed a statistically significant benefit (odds ratio [OR], 4.96; 95% confidence interval [CI], 2.19-11.27; p<0.001), whereas the random-effects model showed a non-significant trend toward improvement (OR, 4.59; 95% CI, 0.82-25.80). These findings indicate that melatonin may be a promising adjunctive treatment for FD. However, the small number of RCTs and the age of the included studies limit definitive conclusions; large‑scale, recent trials are needed to define the optimal target population.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 148 participants or records.
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