English

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.