Comparison of effectiveness of ormeloxifene with norethisterone in abnormal uterine bleeding

Abstract

Introduction: Abnormal uterine bleeding is defined as ‘‘bleeding from the uterine corpus that
is abnormal in volume, regularity, and/or timing’’Menorrhagia is socially embarrassing,
physically incapacitating condition and has great financial drain. About 10-15 % of women
experience episodes of abnormal uterine bleeding at sometime during the reproductive years
of their life. Its common during extremes of reproductive life, following pregnancy and during
lactation.
Material and Methods: The present study was undertaken to evaluate and compare the effect
of ormeloxifene as compared to norethisterone on PBAC score , hemoglobin and endometrial
thickness and any side effect arising out of their use. The present study was carried out in 70
women of age 25 to 40 years with complain of heavy and prolonged menstrual bleeding
attending out patient and in patient department of Obstetrics and Gynaecology at VALASMC,
Etah . The cases were randomly allocated to two groups. Group 1- included 31 cases who
received ormeloxifene 60 mg twice a week for 12 weeks followed by 60 mg once a week for
next 12 weeks & Group 2- included 32 cases who received 5 mg norethisterone twice daily for
21 days for 6 consecutive cycle.
Results: After six months of Ormeloxifene treatment , mean hemoglobin increased from 8.1
gm/dl to 10.2 gm/dl. This increase was statistically significant (P< 0.0001. With
Norethisterone, mean hemoglobin increased from 8.2 gm/dl to 9.6 gm/dl after six months of
treatment. This increase was statistically significant (P< 0.0001). After three months of
treatment with Ormeloxifene, mean endometrial thickness was decreased from 8.9 mm to 7.1
mm. This decrease was statistically significant (P< 0.0001). With Norethisterone, mean
endometrial thickness was decreased from 9.1 mm to 8.1 mm after three months of treatment.
This decrease was statistically significant (P< 0.0001). After six months of Ormeloxifene
treatment, mean endometrial thickness was decreased from 8.9 mm to 6.1 mm. This decrease
was statistically significant (P< 0.0001). After six months of Norethisterone treatment, mean
endometrial thickness was decreased from 9.1 mm to 7.2 mm. This decrease was statistically
significant (P< 0.0001) Conclusion: Thus it was concluded from the present study that both drugs were effective in treating abnormal uterine bleeding. . In the study Ormeloxifene was found to be effective than Norethisterone in reducing blood loss, improving Haemoglobin level and reducing endometrial thickness for treating AUB patients. Also compliance of the patients was good because drug was well tolerated, convenient dosage schedule for treatment of AUB.It can be used in any age group and is oncologically protective to the breast and endometrium