Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of Gastroesophageal Reflux Disease Symptoms: A Clinical Trial.
Study Goal
The researchers aimed to determine whether adding sublingual melatonin to omeprazole improves treatment efficacy for gastroesophageal reflux disease symptoms compared to omeprazole alone.
Results Summary
The study found that melatonin combined with omeprazole significantly reduced heartburn, epigastric pain, and gastroesophageal reflux disease symptoms compared to placebo, with no serious adverse events reported. Quality of life scores were also significantly higher in the melatonin group.
Population
78 patients with gastroesophageal reflux disease (72 completed the trial) exhibiting heartburn, regurgitation, and a score ≤32 on the FSSG scale.
Effective Dosage
3 mg/day sublingual melatonin + 20 mg/day omeprazole.
Duration
4 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
omeprazole 20 mg/d plus sublingual melatonin (3 mg/d) | decrease | heartburn | patients with gastro gastroesophageal reflux disease | - | declined significantly | #1 |
omeprazole 20 mg/d plus sublingual melatonin (3 mg/d) | decrease | epigastric pain | patients with gastro gastroesophageal reflux disease | - | declined significantly | #2 |
omeprazole 20 mg/d plus sublingual melatonin (3 mg/d) | decrease | Frequency Scale for the Symptoms of gastroesophageal reflux disease score | patients with gastro gastroesophageal reflux disease | - | declined significantly | #3 |
omeprazole 20 mg/d plus sublingual melatonin (3 mg/d) | increase | quality of life score | patients with gastro gastroesophageal reflux disease | - | was significantly higher | #4 |
omeprazole 20 mg/d plus sublingual melatonin (3 mg/d) | no change | adverse events | patients with gastro gastroesophageal reflux disease | - | were similarly observed | #5 |
BACKGROUND/AIMS: Proton pump inhibitors are frequently used to treat gastroesophageal reflux disease, but their effect is restricted. The present study aimed to investigate whether the addition of sublingual melatonin to omeprazole was effective in the treatment of gastro gastroesophageal reflux disease symptoms. MATERIALS AND METHODS: This was a randomized double-blind clinical trial. A total of 78 patients with gastro gastroesophageal reflux disease were randomly allocated to either omeprazole 20 mg/d plus sublingual melatonin (3 mg/d) or omeprazole 20 mg/d plus placebo for 4 weeks. The selected patients had histories of heartburn and regurgitation and a score ≤32 on the Frequency Scale for the Symptoms of gastroesophageal reflux disease (FSSG). The outcome measures for the assessment of treatment efficacy were heartburn, epigastric pain and the Frequency Scale for the Symptoms of gastroesophageal reflux disease score. Safety and quality of life were evaluated in the patients as the secondary outcomes too. RESULTS: Seventy-two out of 78 eligible patients completed this trial (35 in the melatonin group and 37 in the placebo group). Heartburn, epigastric pain, and Frequency Scale for the Symptoms of gastroesophageal reflux disease score declined significantly in the melatonin group compared to the placebo group (P = .04, P = .03, and P = .0001, respectively). Moreover, the quality of life score was significantly higher in the melatonin group compared with the placebo group (P = .0001). Adverse events were similarly observed in the 2 groups (P = .55), and there were no serious adverse events. CONCLUSION: The combination of sublingual melatonin (3 mg/day) with omeprazole (20 mg/day) may be more effective than omeprazole (20 mg/day) alone in the treatment of gastroesophageal reflux disease.