Comparative study between ormeloxifene and oral contraceptive pills in the treatment of dysfunctional uterine bleeding

Authors

  • Jimitkumar Jamanadas Chhatrala Department of Obstetrics & Gynecology, SBKS Medical Institute and Research Centre, Pipariya, Wagodia, Vadodara, Gujarat, India
  • Rutwa Chawada Department of Obstetrics & Gynecology, SBKS Medical Institute and Research Centre, Pipariya, Wagodia, Vadodara, Gujarat, India
  • H. B. Saini Department of Obstetrics & Gynecology, SBKS Medical Institute and Research Centre, Pipariya, Wagodia, Vadodara, Gujarat, India

Keywords:

Dysfunctional uterine bleeding, Oral contraceptive pills, Ormeloxifene, Selective estrogen receptor modulator

Abstract

Background: Dysfunctional uterine bleeding is the most common cause of abnormal uterine bleeding. It can cause anemia, reduces the quality of life and increases healthcare costs. The present study was carried out to study the efficacy of ormeloxifene and compare it to combined oral contraceptive pills in the treatment of dysfunctional uterine bleeding.

Methods: 140 patients with dysfunctional uterine bleeding were selected randomly and divided into 2 groups of 70 each. Group A was given ormeloxifene tablet 60 mg twice a week for 12 weeks followed by 60 mg once a week for next 12 weeks. Group B was given low dose oral contraceptive pills containing 30 μg of ethinyl estradiol and 150 μg levonorgestrel from day 1 of the menstrual cycle to day 21 for 6 consecutive cycles. Follow up for six months on every cycle was done to assess the symptoms in the form of amount of bleeding (which was assessed by pictorial blood loss assessment chart score), recurrence of symptoms and also the side effects of each drug. Patient’s improvement was assessed by performing blood hemoglobin level. Patient’s level of satisfaction was judged by general health, limitation of social activity, sexual life and patient’s wish to continue treatment with the same drug.

Results: The reduction in mean pictorial blood loss assessment score with ormeloxifene (174 to 75) was significantly more than with oral contraceptive pills (171 to 106) at 6 months (P <0.05). In both the groups hemoglobin level increased but it was slightly more seen in patients treated with ormeloxifene  as compared to oral contraceptive pills (7.0 gm% to 10.1 gm% vs. 7.2 gm% to 9.5 gm%, P >0.05). Recurrence of symptoms was 11% with ormeloxifene and 24% with oral contraceptive pills. The side effects were minimal in both the groups. 68.6% patients with ormeloxifene and 47.2% with oral contraceptive pills were highly satisfied with their treatment.

Conclusions: Ormeloxifene is more effective, with convenient dose schedule, well tolerated, with better compliance and shows less recurrence rate in treatment of dysfunctional uterine bleeding than oral contraceptive pills.

References

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Published

2017-02-06

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Original Research Articles