Norethisterone Versus Ormeloxifene in the Treatment of Perimenopausal Dub

Abstract

BACKGROUND Dysfunctional Uterine Bleeding is defined as abnormal uterine bleeding in the absence of organic disease. Regarding the medical management of DUB, several drugs have been used, however there is lack of studies suggesting the most appropriate drug. The objective of the study was to compare the two drugs, Norethisterone a progesterone derivative and Ormeloxifene, a selective oestrogen receptor modulator in terms of effectiveness and safety. MATERIALS AND METHODS Women attending Gynaec OPD s with DUB were chosen for the study. Sample size was hundred which was divided in 2 groups. Ormeloxifene 60mg twice weekly for 12 weeks followed by once a week for another 12 weeks was given in group A. Group B women received norethisterone 5mg twice a day from day 5 to day 26 of a cycle for 6 months. Primary outcome parameters noted were reduction in menstrual blood loss as measured by fall in PBAC (Pictorial Blood Loss Assessment Chart) score, increase in haemoglobin, and decrease in endometrial thickness at the end of the study. RESULTS Ormeloxifene showed a better reduction in mean PBAC score (225 to 75) compared to norethisterone (234 to 110) at 6 months (p<0.01). Similarly, group A (Ormeloxifene) showed statistically significant increase in haemoglobin concentration (7.2 g% to 10.5 g% vs. 7.6 g% to 9.9 g%, (p<0.05) and reduction in endometrial thickness from 11.8mm to 6.6mm vs. 11.2mm to 8.1mm, p<0.05, respectively, in comparison to Group B (Norethisterone). None of the cases reported any major side effects in the study. CONCLUSION Ormeloxifene is superior to norethisterone in reducing menstrual blood loss, as well as improving perimenopausal symptoms and thus in the treatment of perimenopausal DUB.