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

Jimitkumar Jamanadas Chhatrala, Rutwa Chawada, H. B. Saini

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.

Keywords


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

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References


Dutta DC. Abnormal menstrual bleeding. In: Hiralal Konar, eds. Textbook of Gynecology: 6th ed. New Delhi, India: Jaypee Brothers Medical Publishers; 2014: 180.

Frick KD, Clark MA, Steinwachs DM, Langenberg P, Stovall D, Munro MG, et al. Financial and quality-of-life burden of dysfunctional uterine bleeding among women agreeing to obtain surgical treatment. Womens Health Issues. 2009;19:70-8.

Coulter A, Kelland J, Peto V, Rees MCP. Treating menorrhagia in primary care. An overview of drug trials and a survey of prescribing practice. Int J Tech Assess Health Care. 1995;11:456-71.

Winsor SHM, Fisher S, Hahn PM, Reid RL. Retrospective evaluation of the long term outcomes following conservative management of menorrhagia in ovulatory women. J Soc Obstet Gynecol Can. 1999;2:155-63.

Bhattacharyya TK, Banerji A. Efficacy of a selective estrogen receptor modulator: ‘ormeloxifene’ in management of dysfunctional uterine bleeding. South Asian Federat Obstet Gynaecol. 2010;2:207-11.

Shelly W, Draper MW, Krishnan V, Wong M, Jaffe RB. Selective estrogen receptor modulators: an update on recent clinical findings. Obstet Gynecol Surv. 2008;63:163-81.

Singh MM. Centchroman, a selective estrogen receptor modulator, as a contraceptive and for the management of hormone-related clinical disorders. Med Res Rev. 2001;21:302-7.

Osborne CK, Zhao H, Fuqua SA. Selective estrogen receptor modulators: structure, function, and clinical use. J Clin Oncol. 2000;18:3172-86.

Higham JM, O’Brien PMS, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990;97:734-9.

Khare VE, Ghosh GO, Patil PO, Nagar NI. Ormeloxifene HCl vs. combined oral contraceptive pill in treatment of dub. JEMDS. 2014;4:1026-33.

Mandal DE, Parmanik SU, Surana SI, Hazra AB, Mandal SA, Maity TA. Comparative study of low-dose oral contraceptive pill and ormeloxifene in the treatment of dysfunctional uterine bleeding. Int J Health Allied Sci. 2014;4:225-31.