Shanmuga Sundhari, A V (2022) Comparative Evaluation of Efficacy of Ormeloxifene and Norethisterone in Abnormal Uterine Bleeding. Masters thesis, Madras Medical College, Chennai.
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Abstract
BACKGROUND: Abnormal uterine bleeding is the most common menstrual disorder among women in all age groups and accounts for 20% of gynaec OPD. It is characterized by heavy, prolonged flow with or without breakthrough bleeding. It is most often the result of endocrinological dysfunction which responds well to conservative treatment. It causes adverse effects which includes Anaemia, reduced quality of life and increased healthcare costs. ❖ The medical treatment of AUB comprises of Combined Oral Contraceptive pills, Progestogens, Danazol, Gonadotrophin releasing hormone agonists, Anti-fibrinolytics, Ethamsylate, Prostaglandin synthetase inhibitor and Levonorgestrel-releasing intrauterine device. ❖ Ormeloxifene, a third generation Selective Estrogen Receptor Modulator (SERM) is widely used non-steroidal oral contraceptive. This drug was developed at Central Drug Institute, Luckno in 1967. It acts on estrogen receptors as agonist and antagonist in different tissues. It has anti-estrogenic action on endometrium and breast and estrogenic action vagina, bones, liver, cardiovascular and central nervous system. Unlike progesterone, Ormeloxifene does not produce breakthrough bleeding, spotting, breast engorgement, weight gain. AIMS AND OBJECTIVES: To compare and evaluate the efficacy of ormiloxifene and norethisterone in dysfunctional uterine bleeding. MATERIALS AND METHODS: Over 120 women presenting with abnormal uterine bleeding without any organic, systemic or iatrogenic cause will be recruited in this study. They will be allocated in to two groups A and B, 60 in each group using proper randomization method. General examination will be done to assess the Anemia. Pelvic examination will be done to rule out pregnancy, fibroid, adenomyosis or any other pelvic pathology. Baseline Investigations will be done for Hb%, Total count, Differential count, bleeding time, clotting time, platelet count, thyroid profile to rule out any bleeding disorders and subclinical hypothyroidism. Ultrasound examination will be done for endometrial thickness and to rule out other pathology. ❖ Group A will be administered with Ormeloxifene tablet 60mg twice a week for 12 weeks followed by 60mg once a week for next 12 weeks. Group B will be administered with Norethisterone tablet 5mg twice a day for 21 days followed by 7 days withdrawal for 6 cycles. ❖ Both groups will be followed up at 1, 3, 6 months. All subjects will be asked to maintain a menstrual diary recording the episodes of bleeding, the days of bleeding, number of sanitary pads used, and degree of soiling of used pads, number and size of clots passed, presence of menstrual cramps and any other symptoms they experienced. The pictorial blood loss assessment chart (PBAC) scoring will be done on each visit to assess menstrual blood loss. This PBAC method correlates well with the alkaline hematin test. A PBAC score ≥ 100 indicates a menstrual loss of ≥ 80ml and will be considered diagnostic for menorrhagia. ❖ The outcome parameters are amount of menstrual blood loss (assessed by fall in PBAC score), amount of hemoglobin concentration, endometrial thickness using ultrasound to be measured at each visit. RESULTS: It was found that Ormiloxifene prove to be the better drug when compared to Norethisterone in terms improvement in PBAC score (70.11 for ormiloxifene group which is significantly more than norethisterone group of 018.5) with p-value of < 0.05 and the Same holds true for reduction in endometrial thickness and hemoglobin improvement with Ormiloxifene. Patient compliance is better with ormiloxifene. Ormiloxifene induced amenorrhea provide symptomatic relieve to the patients. Overall side-effects associated with norethisterone, a steroidal drug is avoided with ormiloxifene as it is non-steroidal drug. CONCLUSION: Ormeloxifene is a new modality and is found to be a better option in reducing menorrhagia in DUB in respect to a greater success rate, better compliance and cost effectiveness.
| Item Type: | Thesis (Masters) |
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| Additional Information: | 221916892 |
| Uncontrolled Keywords: | Abnormal uterine bleeding, Ormiloxifene, Norethisterone, PBAC score. |
| Subjects: | MEDICAL > Obstetrics and Gynaecology > MEDICAL > Obstetrics and Gynaecology |
| Depositing User: | Subramani R |
| Date Deposited: | 17 Apr 2022 07:25 |
| Last Modified: | 29 Nov 2023 03:30 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/19311 |
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