Comparative evaluation of the effectiveness of ormeloxifene v/s norethisterone in perimenopausal abnormal uterine bleeding

Background: Menstrual disorders are the second most common gynecological conditions resulting in hospital referral’s and OPD. The objective of this study was to compare the efficacy and safety of these two drugs ormeloxifene and norethisterone which is rapidly emerging as a safe and effective agent for AUB (abnormal uterine bleeding). Methods: 300 women presenting with AUB randomly allocated 2 equal groups, Group I, which received 60 mg Ormeloxifene twice a week for 12 weeks followed by once a week for next 12 weeks and Group II, which received 5 mg Norethisterone twice daily for 21 days for 6 cycles. The primary outcome were reduction in menstrual blood loss [measured by fall in PBAC (Pictorial Blood Loss Assessment Chart) score and subjective assessment] and rise in hemoglobin level. Results: The reduction in Mean PBAC score with ormeloxifene was significantly more than with norethisterone at 6 months. Rise in hemoglobin concentration was more with Ormeloxifene group. No major side effects were reported in any group. Conclusion: Both drugs are effective in treating peri-menopausal AUB, but ormeloxifene is superior to norethisterone in reducing menstrual blood loss, as well as improving peri-menopausal symptoms. Clinical significance: Better and effective medical management will reduces need for hysterectomies and its long term complications.