A Randomized controlled trial evaluating role of Ulipristal acetate versus leuprolide acetate in management of fibroid- Redefining role of each!
Journal Title: International Journal of Surgery Science - Year 2018, Vol 2, Issue 2
Abstract
Introduction: Ulipristal acetate is a selective progesterone-receptor modulator that acts on progesterone receptors in myometrial and endometrial tissue and inhibits ovulation without causing large effects on estradiol levels or antiglucocorticoid activity. Gonadotropin-releasing hormone (GnRH) agonists can be used as bridging or presurgical treatments and create an artificial menopausal state, resulting in reversible reduction of uterine and fibroid volume and aiding in the correction of anemia. Methodology: This was a randomized controlled trial study conducted at a tertiary care hospital situated in an urban area. A total number of 30 patients with symptomatic fibroids were enrolled in this study. The patients were divided into two groups (Group A and B) of 15 patients each according to whether they received either Ulipristal acetate 5 mg OD orally daily or leuprolide injection 3.75 mg once in a month. The primary outcome was evaluated in terms of change in size of fibroid, reduction in pain, resolution of menorrhagia and improvement in quality of life. Result: A total number of 30 patients with symptomatic fibroids were enrolled in this study. Results were tabulated and analyzed using SPSS 16.0 version software. Microsoft word and excel were used for generating charts and graphs. P value <0.05 is considered statistically significant. Demographic profile of both the groups were comparable no statistically significant difference was noted. Symptomatic relief provided by both the drugs are comparable, ulipristal had an edge over leuprolide when fibroid was > 5 cm in size although the difference was not statistically significant. Adverse effects were more common with leuprolide when compared with ulipristal (p value>0.05). Time taken to control the symptoms is less with ulipristal though not statistically significant. Conclusion: We conclude from this study that both these drugs can be used for treatment of symptomatic fibroids. Ulipristal acetate should be preferred over leuprolide depot when the fibroid size is found to be more than 5 cm. Key message: Further original clinical studies of large sample size to identify the optimal indications for UPA in patients with symptomatic fibroid.
Authors and Affiliations
Dr. Surendra, Dr. Vinu Choudhary
Keywords
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