Reduced Dose of Ormeloxifene in Dysfuncitonal Uterine Bleeding-Safety and Effectiveness

Abstract

AIM OF THE STUDYTo evaluate the effectiveness and safety of reduced dose of Ormeloxifene in the management of Dysfunctional Uterine Bleeding (DUB). Long term medical management for DUB, which is ideal and cost-effective is not yet available. Once it is available, it can revolutionise the management of DUB in developing countries. If Ormeloxifene is proved to be effective long-term at lower doses with minimal side effects, it can prevent the major number of blood transfusions and hysterectomies, which are common especially in the lower socioeconomic group of patients who cannot afford costly conservative measures. MATERIAL AND METHODSOut of 240 eligible patients with DUB, recruited from Gynaec OPD of CKM Hospital, Warangal, only 160 women consented to participate, out of which half of the patients were given the standard dose of Ormeloxifene that is 60mg twice a week for 3 months and once a week for 3 months (Group A). Half of the patients were given reduced dose of Ormeloxifene that is 30mg twice a week for all 6 months (Group B); 54 women from each group who completed the 6 months treatment and came regularly for followup were included in the present study. Both groups were matched for age and parity.Pre-treatment PBAC (Pictorial Blood Loss Assessment Chart) scores were done for all cases and mean PBAC scores were calculated. Same was done at follow-up visits at 1 month, 3 months and 6 months. Side effects were looked for and TVS was done for Endometrial Thickness (ET)/Ovarian cysts. Haemoglobin estimation was done at the end of the study. Effectiveness was taken as reduction of mean PBAC score at the end of 6 months. CONCLUSIONMean PBAC scores at the end of 6 months, in each group showed a reduction of 86.64% of blood loss in group A (standard dose of Ormeloxifene) and 87.69% of blood loss in group B (reduced dose of Ormeloxifene). The reduction in both groups was similar. When the reduction in group A and group B was compared, the difference was not statistically significant [P = 0.33]. Hence, the lower dose schedule followed in group B can be recommended for management of DUB. This could make long term usage of Ormeloxifene more feasible when proved safe by larger randomised double blind studies.