Author Interviews, NEJM, OBGYNE, Surgical Research / 29.07.2020
NEJM Study Compares Treatments for Uterine Fibroids
MedicalResearch.com Interview with:
Jane Daniels PhD
Professor of Clinical Trials, Faculty of Medicine & Health Sciences
School of Medicine
University of Nottingham
MedicalResearch.com: What is the background for this study? MedicalResearch.com: What are the main findings?
[caption id="attachment_54976" align="alignleft" width="200"]
One example of a large fibroid-Wikipedia image[/caption]
Response: Uterine fibroids are the most common non-cancerous tumour in women of childbearing age. They are associated with heavy bleeding, lower chances of having children and reduced quality of life. Traditional surgical options were either to remove the fibroids (myomectomy) or completely remove the womb. A newer approach, known as uterine artery embolization, involves blocking the blood supply to the fibroids in the womb.
Fibroids may be associated with infertility and problems during pregnancy, including miscarriage and preterm birth. As more women are having children at a later age, fibroids are becoming more of an issue for them and safe and effective fertility sparing treatments are needed.
Both treatments improve quality of life, but myomectomy will provide greater benefit to women on average.
MedicalResearch.com: What should readers take away from your report?
Response: This study is the largest to date comparing women treated with either myomectomy or uterine-artery embolization for their fibroids. It was completed in hospitals across the UK, and included a substantial number of women of African-Caribbean ethnicity, who are more likely have bothersome fibroids, so we can be confident that the findings are important and relevant.
Women, including those desiring a future pregnancy, should be provided with the evidence generated by the FEMME trial to enable to make a fully informed decision regarding their fibroid treatment.
One example of a large fibroid-Wikipedia image[/caption]
Response: Uterine fibroids are the most common non-cancerous tumour in women of childbearing age. They are associated with heavy bleeding, lower chances of having children and reduced quality of life. Traditional surgical options were either to remove the fibroids (myomectomy) or completely remove the womb. A newer approach, known as uterine artery embolization, involves blocking the blood supply to the fibroids in the womb.
Fibroids may be associated with infertility and problems during pregnancy, including miscarriage and preterm birth. As more women are having children at a later age, fibroids are becoming more of an issue for them and safe and effective fertility sparing treatments are needed.
Both treatments improve quality of life, but myomectomy will provide greater benefit to women on average.
MedicalResearch.com: What should readers take away from your report?
Response: This study is the largest to date comparing women treated with either myomectomy or uterine-artery embolization for their fibroids. It was completed in hospitals across the UK, and included a substantial number of women of African-Caribbean ethnicity, who are more likely have bothersome fibroids, so we can be confident that the findings are important and relevant.
Women, including those desiring a future pregnancy, should be provided with the evidence generated by the FEMME trial to enable to make a fully informed decision regarding their fibroid treatment.
Dr. Al-Hendy[/caption]
MedicalResearch.com: What is the background for this approval?
Uterine fibroids, commonly referred to as uterine leiomyomas, are the most common type of non-cancerous tumor known to impact women of reproductive age (30-50 years old). In fact, studies show that uterine fibroids can occur in up to 70 percent of European American women and over 80 percent of African American women by age 50. As a result of uterine fibroids, women can experience a range of symptoms, the most common being heavy menstrual bleeding (i.e. prolonged and/or frequent bleeding), which can lead to other health effects such as anemia, fatigue, pelvic pain, urinary frequency etc.
Uterine fibroid treatment recommendations have historically been based on the size and location of the fibroid(s). When treating larger and more complicated fibroids, healthcare providers have typically believed that surgery is their best course of action, which has made uterine fibroids the leading reason for the hysterectomies performed in the U.S. The FDA approval of ORIAHNN was based on improving care for uterine fibroid sufferers who have had a negative impact on their quality of life due to disruptive symptoms. What makes the approval of ORIAHNN so exciting, is that women now have an oral therapy to directly address heavy menstrual bleeding due to uterine fibroids.
Dr. Travers[/caption]
Colm Travers, M.D., MSPH
Assistant Professor
Department of Pediatrics
University of Alabama at Birmingham
MedicalResearch.com: What is the background for this study?
Response: It is known that black mothers are much more likely to deliver preterm and low birth weight infants. The purpose of this study was to determine whether racial/ethnic disparities in care practices and outcomes were decreasing or increasing among extremely preterm infants.
These are infants born from 22 to 27 weeks of gestation who have a high risk of death and major illnesses. 
Marco Taglietti, M.D.
President and Chief Executive Officer
SCYNEXIS Inc
Dr. Taglietti discusses SCYNEXIS’ announcement of positive results from its second Phase 3 study investigating the safety and efficacy of oral ibrexafungerp as a treatment for vaginal yeast infection.
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Dr. Kaufman[/caption]
Gregory Kaufman, M.D.
Senior Vice President
Global Clinical and Medical Affairs
Specialty at Lupin
MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by trichomoniasis? How common is this infection?
Response: The Phase 3 trial evaluated the effectiveness and safety of a single oral dose of Solosec® (secnidazole) 2g oral granules for the treatment of trichomoniasis in adult women. Top-line results were positive and showed that Solosec was generally well-tolerated.
Trichomoniasis is the most common non-viral sexually transmitted infection (STI) in the U.S., and is caused by a protozoan parasite called Trichomonas vaginalis.
