Tag: dysmenorrhoea

Many Hysterectomies Could be Avoided

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Adenomyosis, a cause of painful menstrual cramps and heavy bleeding, is more common than generally appreciated, and many hysterectomies could be avoided with alternative treatment, suggests a review of the literature published in JAMA Network.

Adenomyosis is a gynaecologic condition characterised by ectopic endometrial tissue within the uterine myometrium. Up to a third of all women have adenomyosis, which should be considered in the differential diagnosis of abnormal uterine bleeding and/or pelvic pain, the researchers noted. It is considered a common uterine condition, but often goes undiagnosed until it results in a hysterectomy.

However, the findings suggest that surgery may be preventable for some women. The researchers identified a range of medical therapies and uterine-sparing procedures that can alleviate symptoms without resorting to hysterectomy.

“Many women come to me and say the only solution they’ve ever been offered is a hysterectomy. Other low-cost, low-risk options such as medical management or less invasive options have existed for more than 20 years,” said lead author Kimberly A Kho, MD.

Modern ultrasound and MRI imaging, combined with a pelvic examination, can often spot the condition, she added. Dr Kho and colleagues encouraged greater awareness of this condition – along with endometriosis – including among school nurses, who are frequently the first contact for young women who begin menstruating. Society may inaccurately teach women that heavy bleeding and pain during periods are normal, but these symptoms can worsen if left untreated, leading to lower quality of life, pain in sexual intercourse, and fertility problems.
“Physicians often consider adenomyosis to be a condition of women in their 40s and 50s because that’s when they have their uteruses removed and receive a diagnosis, but it develops much earlier,” said Dr Kho. “Improved clinical awareness is needed to ensure appropriate patient care and encourage additional studies to improve the understanding of adenomyosis.”

Though there are no FDA-approved therapies specifically indicated for treating adenomyosis, the condition can still be managed by using medications developed for contraception, or for symptoms such as fibroids or endometriosis. The authors noted the need for further research, including what ages and ethnicities are most commonly affected, and what could be learned from the condition about uterine cancers.

Source: UT Southwestern Medical Center

Relugolix Combination Therapy is Promising for Fibroid Symptom Relief

A pair of clinical trials showed that combination therapy with relugolix reduced heavy bleeding and pain from uterine fibroids without the risk of side effects from low oestrogen levels.

Relugolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, currently approved for men with advanced prostate cancer.  Uterine fibroids are common in women, and a quarter of those who are affected by them experience symptoms such as heavy menstrual bleeding and pain.

Injectable long-acting GnRH agonists are effective treatments for uterine fibroids, but cause BMD loss and thus are not generally eligible for long term use.  
In the two trials done in North and South America, Africa, and Europe, 71% and 73% of patients, respectively, who received relugolix together with estradiol and norethindrone acetate had significantly lower blood loss, compared with 19% and 15% in the placebo group.
Similar bone mineral density (BMD) measures were seen in the placebo and relugolix combination therapy groups; but MD decreased among patients who received relugolix monotherapy.

“For the first time, we have an oral treatment that can effectively and safely improve the symptoms of uterine fibroids, particularly heavy menstrual bleeding,” Ayman Al-Hendy, MD, PhD, of the University of Chicago Medicine, stated in an interview. and added that relugolix may be a viable, long-term alternative to the current surgical treatments available for fibroids patients.

“The goal of this program from the beginning was to develop an effective and long-term treatment as a viable alternative to hysterectomy,” Dr Al-Hendy said. “Any patient with uterine fibroids would be a good candidate for this non-surgical treatment.”

Lauren Schiff, MD, associate professor of minimally invasive gynecologic surgery at the school of medicine at the University of North Carolina at Chapel Hill, said that relugolix seems to be a good option for non-surgical treatment of fibroids.

Dr Schiff, who was not involved with the study, said that understanding bone mineral density (BMD) is key for using relugolix past six months. “If the bone density safety measure is maintained for long-term use, then this would be really ideal medication,” she told MedPage Today.

The trial’s primary endpoint was less than 80 ml blood loss, and >50% reduction in total blood loss from trial start. The investigators assessed several secondary outcomes, including amenorrhea, volume of menstrual blood loss, distress, pain, anaemia, fibroid volume, and uterine volume.

Around 388 participants were randomised in the first trial, and 382 in the second.

Around three-quarters of patients who received relugolix combination therapy reached the primary endpoint, with the treatment effects appearing similar baseline characteristics.

Amenorrhea over the last 35 days of the trial occurred in 52% and 50% of participants who received relugolix combination therapy in each trial, respectively. Pain was also reduced in the treatment groups.

Patients who received the combination therapy also had improvements in pain, distress from bleeding and pelvic discomfort, anaemia, and experienced reduced uterine volume. However, significant shrinkage in fibroid volume was not observed.

The prevalence of side effects was similar in the relugolix combination therapy group and the placebo cohort, with hot flashes being the most commonly reported side effect in the trial.

Strict assessment criteria for patients meant generalisability was limited. Additionally, study duration was only six months. The researchers plan to release data from a 28-week extension study, as well as a 52-week randomised-withdrawal trial, and these may shed more light on safety and efficacy in the long term.

Source: MedPage Today

Journal information: Al-Hendy A, et al “Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy” N Engl Med 2021; DOI: 10.1056/NEJMoa2008283.