Abstract
Introduction: Dysfunctional Uterine Bleeding (DUB) is an abnormal uterine bleeding, in the absence of any organic, systemic or iatrogenic cause. Pharmacological treatment options available are combined oral contraceptive pills, progestogens, danazol, gonadotrophin releasing hormone (GnRH) agonists, SERMs, prostaglandin synthetase inhibitor, anti-fibrinolytics and ethamsylate. The purpose of the study was to evaluate the efficacy and safety of Ormeloxifene and compare it to combined oral contraceptive pills (OCPs) in dysfunctional uterine bleeding. Method: Hundred women aged 20-50 years presenting with DUB were randomly allocated to two groups of 50 each. Group A were given Ormeloxifene tablet 60 mg twice a week for 12 weeks, followed by 60 mg once a week for 12 weeks. Group B were given OCPs containing 30 microgram Ethinyloestradiol and 150 microgram Levonorgestrel from day 1 to day 21st of the menstrual cycle for 6 cycles. The outcome was studied by assessment of menstrual blood loss by Pictorial Blood loss Assessment Chart (PBAC) score, Hb level in g/dl, endometrial thickness in mm, patient’s level of satisfaction and any drug side effects at the end of 6 months. Results: The reduction in mean PBAC score with Ormeloxifene (330 to 2.8) was significantly more than with oral contraceptive pills (317 to 74) at 6 months (P<0.001). In both the groups mean hemoglobin level increased but rise in Hb in group A (1.5 g/dl) was more as compared to the rise in Hb in group B (1.2 g/dl). The mean endometrial thickness decreased in both the groups but the decrease in group A (9.6 mm to 8.4 mm) was not statistically significant as compared to the decrease in group B (9.8 mm to 6.4 mm). The side effects were minimal in both the groups. 22% patients with Ormeloxifene and 10% with oral contraceptive pills were highly satisfied with their treatment. Conclusion: Ormeloxifene is effective in control of DUB and can be used as an alternative to OCP for treatment of DUB with possibly minimal side effects and better dosage compliance.
Highlights
Dysfunctional Uterine Bleeding (DUB) is an abnormal uterine bleeding, in the absence of any organic, systemic or iatrogenic cause
Significant improvement was observed in cases with Dysmenorrhea, regularity of menstrual cycle, amount of flow, and duration of bleeding whereas the mean cycle length was 27.78±2.26 after 6 months in the post-treatment group A and 27.38±1.59 after 6 months in the post treatment group B. (Table 3)
It was observed that Ormeloxifene and COC’s are both effective for the treatment of DUB as evident by control of menorrhagia, increased haemoglobin concentration and reduced endometrial thickness as well as patient’s satisfaction level
Summary
Dysfunctional Uterine Bleeding (DUB) is an abnormal uterine bleeding, in the absence of any organic, systemic or iatrogenic cause. The purpose of the study was to evaluate the efficacy and safety of Ormeloxifene and compare it to combined oral contraceptive pills (OCPs) in dysfunctional uterine bleeding. Results: The reduction in mean PBAC score with Ormeloxifene (330 to 2.8) was significantly more than with oral contraceptive pills (317 to 74) at 6 months (P
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