Efficacy of Ormeloxifene vs Norethisterone in the Management of Perimenopausal DUB

Abstract

Background: Disorders of menstruation are the most common reason for a gynaecological consultation among women of reproductive age group. Dysfunctional Uterine Bleeding is defined as abnormal uterine bleeding in the absence of organic, systemic or iatrogenic causes. It can be managed both medically and surgically. In medical management, several drugs have been used. However there is lack of studies suggesting the most appropriate drug. The objective of our study is to compare the treatment efficacy of Norethisterone acetate (a progesterone derivative) versus Ormeloxifene (selective estrogen receptor modulator) in the treatment of DUB. Methodology: Total of 100 perimenopausal women with DUB were enrolled in our prospective study. They were randomly assigned into group A and group B. Group A was treated with 60mg Ormeloxifene two times a week for 3 months followed by once a week for another 3months. Group B was treated with Norethisterone 5 mg two times a day from Day5 to Day26 for 6 months. Primary outcome parameters noted were reduction in menstrual blood loss that was measured by fall in Pictorial Blood Loss Assessment Chart (PBAC) score, increase in haemoglobin, and decrease in endometrial thickness at the end of study. Results: In our study, the reduction in mean PBAC score with Ormeloxifene was significantly more than that seen with norethisterone after 6 months of therapy. There was a significant  increase in hemoglobin level and reduction in endometrial thickness with Ormeloxifene compared to  norethisterone. Patients were more compliant to Ormeloxifene because of better tolerance and convenient dosage schedule. Conclusion: In our study Ormeloxifene was found to be more effective than Norethisterone in reducing blood loss, improving haemoglobin level and reducing endometrial thickness in DUB patients.