Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Background: The aim of the study was to assess the role of melatonin in chronic dyspepsia in this group of women, with consideration 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 H. pylori infected with chronic dyspepsia(group III). Endoscopic examination, histological assessment of gastric end duodenal mucosa, urease breath test(UBT-13C), and serum levels of 17-β-estradiol, follicle stimulating hormone, melatonin and urinary concentration of 6-sulfatoxymelatonin were determined by immunoenzymatic method. In group III - 14-day antibacterial treatment was introduced with pantoprazole, amoxicillin and levofloxacin. Afterward, in 32 women was administered placebo(group IIIa), and in 32 women (group IIIb) melatonin at a dose 1 m/morning and 3 mg/at bedtime, for six months.
Background:Dyspeptic syndrome in the form of epigastric pain are particularly frequent in postmenopausal women. The aim of the study was to assess the role of melatonin in chronic dyspepsia in this group of women, with consideration 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 H. pylori infected with chronic dyspepsia(group III). Endoscopic examination, histological assessment of gastric end duodenal mucosa, urease breath test(UBT-13C), and serum levels of 17-β-estradiol, follicle stimulating hormone, melatonin and urinary concentration of 6-sulfatoxymelatonin were determined by immunoenzymatic method. In group III - 14-day antibacterial treatment was introduced with pantoprazole, amoxicillin and levofloxacin. Afterward, in 32 women was administered placebo(group IIIa), and in 32 women (group IIIb) melatonin at a dose 1 m/morning and 3 mg/at bedtime, for six months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Melatonin ( 5-Methoxy-N-Acetyltryptamine) at dose 1mg/morning and 3mg/at bedtime (period 6 months) |
|
| Placebo | Placebo Comparator | 1 tablet twice daily (period 6 months) |
|
| Helicobacter pylori infected group | Other | Pantoprazole 2 x 40mg (twice daily) Amoxicyllin 2 x 1000mg (twice daily) Lovofloxacin 2 x 500mg (twice daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 10 point Visual Analogue Scale (VAS) of Dyspeptic symptoms | scale that access severity of Dyspeptic symptoms such as: epigastric pain of hunger nature and pain in the epigastric region at night (intensity measured from 1 to 10 points) | 6 months |
Not provided
Not provided
Inclusion Criteria:
Patients with
Exclusion Criteria:
Patients with
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cezary Chojnacki, MD.PhD. | Department of Clinical Nutrition and Gastroenterological Diagnostics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Nutrition and Gastroenterological Diagnostics Medical University of Lodz | Lodz | 90-647 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12914663 | Background | Heinemann LA, Potthoff P, Schneider HP. International versions of the Menopause Rating Scale (MRS). Health Qual Life Outcomes. 2003 Jul 30;1:28. doi: 10.1186/1477-7525-1-28. | |
| 33243209 | Derived | Chojnacki C, Medrek-Socha M, Konrad P, Chojnacki J, Blonska A. The value of melatonin supplementation in postmenopausal women with Helicobacter pylori-associated dyspepsia. BMC Womens Health. 2020 Nov 26;20(1):262. doi: 10.1186/s12905-020-01117-z. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008550 | Melatonin |
| D000077402 | Pantoprazole |
| D000658 | Amoxicillin |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Pantoprazole 40mg | Drug | pantoprazole 2 x 40mg |
|
|
| Amoxicillin | Drug | Amoxicillin 2 x 1000mg |
|
|
| Levofloxacin 500mg | Drug | Levofloxacin 2 x 500mg |
|
|
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |