To Observe Effect of Ormiloxifene in Medical Management of Dysfu N Ctional Uterine Bleeding

Abstract

OBJECTIVE:To evaluate the efficacy and safety of ormeloxifene in the medical management of dysfunctional uterine bleeding. DESIGN AND SETTING: A descriptive observational study was conducted on women with dysfunctional uterine bleeding, who attended to out -patient department of Obstetrics & Gynaecology in a National Institute Of Medical Science Medical College, shobha nagar, Jaipur (Rajsthan). MATERIAL AND METHOD: 54 patients with dysfunctional uterine bleeding were recruited for the study. Ormeloxifene 60 mg twice a week for 3 months from first day of periods and once a week for next 3 months was given. Mean blood loss (MBL) was assessed using pictorial blood loss assessment chart (PBAC). And subjectively by a visual analog scale (VAS).Ultrasonography (USG) for endometrial thickness and blood hemoglobin levels were done as baseline and at 1, 3 and 6 months of treatment. Side-effects of the drug were recorded. Changes in PBAC scoring, endometrial thickness (ET) and hemoglobin levels (Hb) were analyzed by student's paired 't' tests using SPSS 17.0 version. p value ≤ 0.05 was taken as significant. RESULT: The mean pretreatment MBL (PBAC score) was 343.13 (140-765), which reduced to 222.22 (80-398) at 1 months and 90.0 (0-340) at 3 months with treatment.By end of 6 months, the mean PBAC score was 68.84 (0-320). There was a significant reduction in MBL in patients on ormeloxifene (p-value ≤ 0.001).The rise in haemoglobin and decrease in ET,in women on ormeloxifene was also satistically significant(p value<o.oo1).Out of 54 patients,46 womens with menorrhagia were recruited in study. Three (6.52%) patients had no response, four (8.7%) patients were lost to follow-up. During the one year study period, 1(2.17) of the patients underwent hysterectomy.The most common side effect reorted was amenorrhea (28.26%). CONCLUSION: Ormeloxifene is very effective in improving all the parameters of blood loss in abnormal uterine bleeding including the no. of days of bleeding, no. of pads soiled and the passage of clots. Ormeloxifene has a good patient acceptability and compliance due to its minimal side effects, low cost and simple dosage schedule.

Efficacy of ormeloxifene in comparison to oral contraceptive pills in medical management of dysfunctional uterine bleeding

“…Many drugs have been recommended for treatment of DUB including antifibrinolytics, medroxyprogesterone acetate, NSAIDs, oral contraceptive pills, progestins, levo-norgestrel containing IUCD, GnRH analogues, danazol and a few studies have also recommended use of ormeloxifene. 1,3,5,11,14,15 In the present study, reduction in menorrhagia represented by decrease in post-treatment PBAC score was significantly observed in both the treatment groups, however, ormeloxifene treatment showed better results in comparison to OCP.…”

“…At the end of 6 months post treatment with ormeloxifene showed better results on reduction of ET in comparison to OCP therapy and these findings are in agreement with the earlier studies. 3,11 Though in the present study, the level of satisfaction among the patients was observed in both the treatment groups, however ormeloxifene therapy was reported to be comparatively more effective. The side effects were minimal and tolerable in both the groups indicated the safety and tolerance of both the drugs among all the patients.…”

“…It is a major cause for referral to gynaecological outpatient clinics and account for one of the major cause for hysterectomies with added risk of surgical and anaesthetic complications. 3,4 Many articles have reviewed the management of DUB and often include use of algorithms to manage it in stepwise manner, starting from medical therapy to minimally invasive surgeries to hysterectomy. 1,5,6 Pharmacological interventions can be hormonal or nonhormonal.…”

“…The ACOG recommends to start the treatment with medical therapy failing which resort to surgical treatment. 3,6 Oral contraceptive pills (OCP) are commonly used for treatment of DUB in adolescent and reproductive age group but having oestrogen as a component it is contraindicated in patients with hypertension, current or past history of venous thromboembolism, ischemic heart disease, history of cerebrovascular accident, complicated valvular heart disease, smokers, patients with severe migraine headache, focal neurological signs, breast cancer, diabetes with retinopathy and neuropathy, liver disease etc. 7 Ormeloxifene is a third generation selective oestrogen receptor modulator (SERM), which acts selectively on oestrogen receptors on bones, vagina, liver, cardiovascular and central nervous system and as antagonist on endometrium and breast.…”

“…3,7,11,[15][16][17] The mean endometrial thickness was also significantly reduced in both the study groups following therapy. At the end of 6 months post treatment with ormeloxifene showed better results on reduction of ET in comparison to OCP therapy and these findings are in agreement with the earlier studies.…”