Ormeloxifene versus Tranexamic acid in dysfunctional uterine bleeding comparative evaluation

Abstract

Background: Dysfunctional Uterine bleeding (DUB) is the most common cause of abnormal uterine bleeding (AUB). Medical therapy being the first line of management, an ideal drug should be able to block the estrogenic effects on the Endometrium without interfering with its beneficial effects on other tissues. Both Ormeloxifene - a selective estrogen receptor modulator (SERM) and Tranexamic acid-an anti fibrinolytic inhibitor is important in the treatment of DUB. The aim of this study is to assess the efficacy and safety of Ormeloxifene v/s Tranexamic acid in the treatment of DUB.Methods: This is a prospective double blind study conducted for 2 years in 200 women presenting with DUB attending to the Gynaecology outpatient department (OPD) of Narayana Medical College and Hospital, Nellore, AP, India. Two hundred women presenting with DUB were recruited into this study (after fulfilling inclusion and exclusion criteria) with informed consent and randomly divided into two equal groups (Group-A and Group-B) after obtaining college ethical committee approval.Results: The reduction in the mean pictorial blood loss assessment chart (PBAC) score with Ormeloxifene (from 278 to 97.6) was significantly more than that of Tranexamic acid (from 261 to 134.5) at six months (p <0.0001). The rise in Hemoglobin concentration (8.4g% to 11.15g% vs. 8.5 to 9.7gm%; p <0.008) and reduction in Endometrial thickness (from 10.57mm to 6.5mm v/s 9.96mm to 7.24mm p <0.0001) were also significantly more with Ormeloxifene than with Tranexamic acid. Relief from dysmenorrhoea and subjective improvement were also found to be considerable with Ormeloxifene.Conclusions: Both Ormeloxifene and Tranexamic acid can be considered for DUB treatment but Ormeloxifene is found to be superior to Tranexamic acid in various aspects.

Ormeloxifene in acute heavy menstrual bleeding in menopausal transition

“…In our study, 60% (39/65) of women had high PBAC score (>300) during recruitment but studies conducted by Nisha et al, 25 (80%,40/46) and Soniya et al, 26 (85.7%, 42/49) reported higher score compared to the current findings of the study. Ormeloxifene offered the net reduction of mean endometrial thickness of 4.1mm in our study equivalent to the result of Archana and Ritika 27 among 75 women, 4 mm in study by Hymavathi et al 23 whereas it was lesser i.e. 2.4mm and 2.7mm in studies by Jacob et al, 14 and Gandotra et al 18 The result of rise in mean hemoglobin level (mean) after 6months of ormeloxifene was 1.1gm/dl in our study comparing 1.3gm/dl, 1.4gm/dl and 1.3gm/dl in studies performed by Jacob et al, 14 Nikita et al, 18 Biswas et al, 28 respectively.…”

“…3 Ormeloxifene was found superior and safer medical therapeutic option in HMB. 12,19 Ormeloxifene was compared with oral contraceptives and progestins regarding risk of deep vein thrombosis, cardiovascular disease, obesity in the age group and better control of bleeding compared with tranexamic acid as well as reduced the need of surgical intervention from studies of Jacob and coworkers 14 (ormeloxifene vs. norethisterone), Godha et al, 21 (ormeloxifene vs. Medroxyprogesterone acetate), Dhananjay BS et al, 22 (ormeloxifene vs. LNG-IUS), Hymavathi K et al, 23 (Ormeloxifene vs. tranexamic acid), Arunadevi and Minnalkodi 24 (ormeloxifene vs. OCP).…”

Comparative Study of Desogestrel- Containing Oral Contraceptive and Levonorgestrel- Containing Oral Contraceptive in Dysfunctional Uterine Bleeding

“…PBAC scoring for a given cycle was done by adding up the scores obtained on each day of menstruation, thereby assessing MBL (Mandal et al, 2014). A PBAC score greater than 100 signi ies that menstrual blood loss is greater than 80ml (Srivaths et al, 2015;Rani et al, 2016;Hymavathi et al, 2018). This scoring system is not equivalent but is proportional to MBL (Magnay et al, 2018).…”