The effect of melatonin on endometrial histology in patients with endometrial proliferative disorders: Double blind randomized randomized clinical trial

Abstract

Endometrial hyperplasia represents a range of morphological and biological changes in the endometrial glands and stroma, which range from an exacerbation of the physiological condition to carcinoma. In recent years, several laboratory studies have been conducted to evaluate the role of melatonin in the regulation of endometrial cell proliferation, and on the other hand, the evidence obtained has shown the inhibitory role of melatonin administration in various gynecological cancers. Therefore, the aim of this study is to investigate the effect of melatonin on endometrial histology in patients with endometrial proliferative disorders. Method: In this double-blind randomized clinical trial, patients referred to Tabriz Alzahra Hospital with complaints of abnormal vaginal bleeding and diagnosis of endometrial proliferative disorders or atypical hyperplasia were included in the study. Patients were randomly divided into two control and intervention groups. Patients in the control group received routine treatment of megestrol acetate with a dose of 80 mg daily, and patients in the intervention group received megestrol acetate 80 mg + melatonin 5 mg daily before going to bed for three months. The demographic information of the patients, including age, gravidity, parity, and body mass index, were matched in the two groups. Patients were followed up for 3 months and endometrial biopsy was performed after completion of treatment. Endometrial tissue was compared in two groups after treatment. Results: Out of a total of 40 patients who were initially included in the study, a total of 37 patients were included in the final analysis. In general, 18 of the 19 patients in the intervention group (94.7%) had normal biopsy results, and 12 of the 18 patients in the control group (66.6%) had a normal biopsy, and this difference was statistically significant.