Efficacy of ormeloxifene in comparison to oral contraceptive pills in medical management of dysfunctional uterine bleeding
Background: Menstrual disorders are the most common gynecological condition resulting in hospital referrals. Dysfunctional Uterine Bleeding is an abnormal uterine bleeding, in the absence of any organic, systemic or iatrogenic cause. Among women in reproductive age, one in 20 consults her general practitioner each year with menorrhagia. This condition can be managed both medically and surgically. Pharmacological treatment options available for DUB are combined oral contraceptive pills, progestogens, danazol, gonadotrophin releasing hormone (GnRH) agonists, prostaglandin synthetase inhibitor, anti-fibrinolytics and ethamsylate. Role of ormeloxifene in dysfunctional uterine bleeding (DUB) is still in an exploring level.The purpose of the study was to evaluate the efficacy of ormeloxifene in the treatment of DUB and compare the effects of ormeloxifene with combined oral contraceptive pills for the control of DUB.
Methods: Sixty women presenting with DUB were randomly allocated to 2 equal groups, 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 low dose combined oral contraceptive pills (OCP) containing 30 microgram ethinyloestradiol and 150 microgram levonorgestrel from day 1 to day 21st of the menstrual cycle for 6 cycles. The various parameters studied were reduction in menstrual blood loss which was measured by fall in pictorial blood loss assessment chart (PBAC) score, rise in haemoglobin (Hb) level and reduction in endometrial thickness, any drug side effects, compliance with the drug, dosage schedule and effect on quality of life after each month and at the end of trial period of 6 months. Patient’s level of satisfaction was assessed by improvement in Hb concentration, sense of wellbeing as well as overall general health, quality of life, sexual life and comfort with the continuation of the same drug.
Results: Mean blood loss (PBAC score) following treatment showed significant reduction in both the groups, however this reduction was comparatively high in ormeloxifene treated group. The various parameters to assess the subjective and clinical improvement at the end 3 and 6 months post treatment showed significant improvement in both the treatment groups; however ormeloxifene group showed significantly better improvement in comparison to OCP group. Mean endometrial thickness also showed reduction in both the groups but more significant reduction was observed in ormeloxifene group as compared to OCP group following 6 months of treatment. Symptomatic relief and subjective feelings in relation to improvement of menstrual abnormalities, any undesirable side effects, about dosage compliance and any thought of discontinuing the drug by the patients indicated excellent control of menorrhagia in both the study group, which accounted for 86.66% in ormeloxifene group and 80% of individuals in OCP group.
Conclusions: ORM 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.
Mitan LAP, Slap GB. Dysfunctional uterine bleeding. 2004. Available at www.sh.Isuhsc.edu/fa
mmed/outpatient-manuel/dub.114-/2015. Accessed on 9 July 2016.
Konar H. Abnormal menstrual bleeding. D. C Dutta’s Textbook of Gynaecology. 6th edition. New Delhi: Jaypee Brothers Medical Publishers; 2014: 180.
Masand D, Gupta S, Patel J. To observe effect of Ormeloxifene in medical management of dysfunctional uterine bleeding. Journal of Evolution of Medical and Dental Sciences. 2015;4:587-97.
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. STOP-DUB Research Group. Womens Health Issues. 2009;19(1):70-8.
Ely JW, Kennedy CM, Clark EC, Bowdler NC. Abnorml uterine bleeding: A management algorithm. J Am Board Fam Med. 2006;19:590-602.
ACOG Practice bulletin. Management of an-ovulatory bleeding. Int J of Gynecol Obstet. 2001;72:263-71.
Chhatrala JJ, Chawada R, Saini HB. Comparative study between ormeloxifene and oral contraceptive pills in the treatment of dysfunctional uterine bleeding. Int J Reprod Contracept Obstet Gynecol. 2015;4:366-9.
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;21:302-47.
Osborne CK, Zhao H, Fuqua SA. Selective oestrogen receptor modulators, structure, function and clinical use. J Clinical Oncol. 2000;18:3172-86.
Agarwal N, Singh S, Singh S, Agarwal M, Manocha P. Comparative evaluation of the efficacy and safety of ormeloxifene and norethisterone in dysfunctional uterine bleeding. Int J Reprod Contracept Obstet Gynecol. 2013;2(2):194-8.
Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. British J Obstet Gynaecol. 1990;97:734-9.
Nicholson WK, Ellison SA, Grason H, Powe NR. Patterns of ambulatory care use for gynaecological conditions: a national study. Am J Obstet Gynecol. 2001;184:523-30.
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.
Mandal D, Parmanik S, Surana S, Hazra A, Mandal S, Maity TK. Comparative study of low dose oral contraceptive pills and Ormeloxifene in the treatment of dysfunctional uterine bleeding. Int J Health Allied Sci. 2014;3:225-31.
Jacob KJ, Mini, Deepak AV. A comparative study on the effectiveness of ormeloxifene versus norethisterone in the management of peri-menopausal dysfunctional uterine bleeding. IAIM. 2015;2(7):87-92.
Grover S, Chabra A, Bindu S. A study of ormeloxifene in case of dysfunctional uterine bleeding. Int J Med and Dent Sci. 2013;2(2):162-9.