The value of melatonin supplementation in postmenopausal women with Helicobacter pylori-associated dyspepsia.
Study Goal
The researchers aimed to assess the role of melatonin in treating chronic dyspepsia in postmenopausal women with H. pylori infection and evaluate its impact on symptom resolution.
Results Summary
Melatonin supplementation (1 mg morning and 3 mg at bedtime) significantly improved dyspeptic symptom resolution (84.3% vs. 43.7% in the placebo group) and was associated with lower baseline melatonin levels in affected women. H. pylori eradication rates were similar between melatonin and placebo groups.
Population
Postmenopausal women with H. pylori-associated chronic dyspepsia.
Effective Dosage
1 mg in the morning and 3 mg at bedtime.
Duration
6 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
- | no change | serum level of female hormone | 152 subjects including 30 healthy women (Group I), 60 women with asymptomatic H.pylori infection (Group II), and 64 women with H. pylori infection with chronic dyspepsia (Group III) | no significant differences | No significant differences were found | #1 |
- | no change | Serum melatonin levels | Group I (12.5 ± 2.72 pg/ml) and Group II (10.5 ± 3.73 pg/ml) | p > 0,05 | were similar | #2 |
- | decrease | Serum melatonin level | Group III (5.72 ± 1.42 pg/ml) | p < 0.001 | was significantly lower | #3 |
14-day antibacterial treatment with pantoprazole, amoxicillin and levofloxacin | increase | Eradication of H.pylori | 75.0% women in Group IIIa | 75.0% | was obtained | #4 |
14-day antibacterial treatment with pantoprazole, amoxicillin and levofloxacin | increase | Eradication of H.pylori | 84.3% in Group IIIb | 84.3% | was obtained | #5 |
placebo | increase | dyspeptic symptoms | 43.7% patients in Group IIIa | 43.7% | resolved | #6 |
melatonin 1 mg/morning and 3 mg/at bedtime | increase | dyspeptic symptoms | 84.3% in Group IIIb | 84.3% | resolved | #7 |
Melatonin supplementation | increase | H. pylori-associated dyspepsia | postmenopausal women with lower levels of this hormone | - | is useful in treating | #8 |
BACKGROUND: Dyspeptic syndrome is particularly common in postmenopausal women in the form of epigastric pain. The aim of the study was to assess the role of melatonin in chronic dyspepsia in this group of women, and examine the role of Helicobacter infection. METHODS: The study comprised 152 subjects including 30 healthy women (Group I), 60 women with asymptomatic H.pylori infection (Group II), and 64 women with H. pylori infection with chronic dyspepsia (Group III). Endoscopic examination was performed, as well as histological assessment of gastric end duodenal mucosa, urease breath test (UBT-13C), and immunoenzymatic assessment of serum 17-β-estradiol, follicle stimulating hormone and melatonin, and urinary 6-sulfatoxymelatonin. In Group III, 14-day antibacterial treatment was introduced with pantoprazole, amoxicillin and levofloxacin followed a six-month treatment with placebo in 32 women (Group IIIa), and melatonin 1 mg/morning and 3 mg/at bedtime in the other 32 women (Group IIIb). RESULTS: No significant differences were found between serum level of female hormone. Serum melatonin levels were similar between Group I (12.5 ± 2.72 pg/ml) and Group II (10.5 ± 3.73 pg/ml; p > 0,05). The level was significantly lower in Group III (5.72 ± 1.42 pg/ml; p < 0.001). Eradication of H.pylori was obtained in 75.0% women in Group IIIa, and in 84.3% in Group IIIb (p > 0.05). After six months, dyspeptic symptoms resolved in 43.7% patients in Group IIIa and 84.3% in Group IIIb (p < 0.001). CONCLUSION: Melatonin supplementation is useful in treating H. pylori-associated dyspepsia, particularly in postmenopausal women with lower levels of this hormone. TRIAL REGISTRATION: NCT04352062, date of registration: 15.04.2020.