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Depression in women with endometriosis linked to chronic pain

Depression in women with endometriosis linked to chronic pain

By I.Soussis MD
The complex relationship between endometriosis and depression in women is largely determined by chronic pelvic pain, a systematic review has found.

According to the researchers, raising awareness among physicians on the nature of this relationship, which “is arguably more complex than a direct cause-effect relationship,” is essential to finding the best course of treatment and improving the quality of life of women with endometriosis.

The review study, “Depressive symptoms among women with endometriosis: a systematic review and meta-analysis,” was published in the American Journal of Obstetrics & Gynecology.

Endometriosis, a chronic disease caused by the abnormal growth of endometrium outside the uterus, is estimated to affect approximately 10 percent of women of reproductive age.

The disorder is mainly associated with infertility and chronic pelvic pain, but patients may also experience painful sexual intercourse (dyspareunia), painful or irregular menstrual cycles (dysmenorrhea), painful bowel movements (dyschezia), psychological issues, and overall low quality of life.

Symptoms of depression are significantly more common among individuals with chronic pain. Therefore, “an association between endometriosis and depression may be reasonably expected,” the researchers say. However, so far, no study explored this potential relationship thoroughly.

In this review study, the authors established two goals: first, to determine if there is a link between endometriosis and depression; and second, to assess whether depression is more common in women with chronic pelvic pain associated with endometriosis than in women with endometriosis but without pelvic pain and women with pelvic pain but without endometriosis.

The review included studies published over the past 30 years focused on comparing the clinical outcomes of women with and without endometriosis, or, among those with endometriosis, women with and without chronic pelvic pain.

A meta-analysis from 24 studies involving a total of 99,614 women revealed that those with endometriosis had significantly higher levels of depression than those not affected by the disease. This effect was even stronger when the researchers performed the same type of analysis on 11 studies (1,070 women) comparing between healthy women and those with endometriosis.

Further analysis showed that women with endometriosis who also experienced chronic pelvic pain had higher levels of depression than those who did not report pain.

However, no significant differences were found between women with endometriosis and chronic pain and those with chronic pain not affected by the disease.

“The findings of our multiple meta-analyses provide converging evidence that chronic pain, rather than endometriosis itself, is the main determinant of depressive symptoms,” the researchers wrote. “Screening for psychiatric symptoms among women with endometriosis has therefore been advocated, and our findings would suggest to particularly direct it to those with chronic pain.”

“Future studies into possible modulators of the association will hopefully provide further insights about how to improve the quality of life of women with endometriosis and/or pelvic pain,” they concluded.

 

My opinion

In our effort to provide personalized care in patients with endometriosis, the impact of chronic pelvic pain on the quality of life should be taken into consideration. Such patients might benefit from psychological assessment and possibly treatment for depression.

Read more:

https://www.ncbi.nlm.nih.gov/m/pubmed/30419199/

image credit https://www.medicalnewstoday.com/articles/301822.php

Endometriosis and endometrial cancer have common genetic causes

Endometriosis and endometrial cancer have common genetic causes

By I. Soussis MD

Both endometriosis and endometrial cancer have a genetic component. Genome-wide association studies (GWAS) identifying single nucleotide polymorphisms (SNPs) -differences in a single DNA building block, called a nucleotide-  associated with either disease.

Endometriosis and endometrial cancer may be linked, as suggested by the fact that higher levels of estrogen increase the risk for both diseases, which, in turn, is lessened with treatments such as contraceptive pills and hormonal therapies.

Moreover, both disorders correlate with greater risk for uterine fibroids and ovarian cancer. Further suggesting the link, cancer-related genetic changes, including dysregulation of genes, have been reported in endometriosis.

The new study, “Genetic overlap between endometriosis and endometrial cancer: evidence from cross‐disease genetic correlation and GWAS meta‐analyses,” appeared in the journal Cancer Medicine.

Epidemiological studies have led to conflicting data regarding this potential association, which may have been due to small sample sizes, underdiagnosis and misdiagnosis of endometriosis, and inability to adjust for variables such as oral contraceptives, the scientists said.

As such, they conducted a GWAS, using separate datasets for endometriosis and endometrial cancer to study the extent of a common genetic cause for both diseases. 

The team subsequently combined the datasets in a meta‐analysis – a statistical study that combines the results of various studies — to find genetic loci, or specific spots in chromosomes, potentially associated with risk for both disorders.

In total, the datasets for endometriosis included 3,194 cases and 5,330 controls, while those for endometrial cancer had 2,057 cases and 3,866 controls. Results of the meta‐analysis were compared with those from a dataset including 4,402 endometrial cancer cases and 28,758 controls.

The results revealed the presence of weak to moderate, but significant, genetic overlap between the  diseases, as well as significant SNP pleiotropy, which refers to disease-associated SNPs correlating with variation in gene expression and/or DNA methylation -the addition of a methyl chemical group to DNA, regulating gene expression- in both disorders.

Thirteen distinct loci were associated with the diseases, with one locus -SNP rs2475335- located within the PTPRD gene, associated at a significant level. PTPRD is a commonly inactivated gene across different types of cancer. Deletions and mutations in this gene have been detected in numerous tumor types, including endometrial cancer. The PTPRD protein regulates the activation of STAT3, a transcription factor -proteins that control gene expression- previously implicated in both endometriosis and endometrial cancer.

The other identified risk loci contain candidate genes such as SKAP1, associated with ovarian cancer, potentially relevant as causes and/or treatment targets of endometriosis and endometrial cancer, the investigators said.

“Our genetic study indicates that endometriosis and endometrial cancer have a moderate, but significant, shared genetic etiology,” the researchers said. Studies are now needed to better understand how the identified risk loci affect both diseases, the team stated.

“Our genetic correlation analysis supports recent large epidemiological studies indicating an increased risk of endometrial cancer in women previously diagnosed with endometriosis,” according to the researchers.

Sources/image credit:

https://endometriosisnews.com/2018/11/13/endometriosis-endometrial-cancer-have-genetic-link-study-reports/?utm_source=END+E-mail+List&utm_campaign=5f76824be2-RSS_MONDAY_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_5a9732e593-5f76824be2-72512137

https://onlinelibrary.wiley.com/doi/full/10.1002/cam4.1445

 

Endometriosis can also affect adolescents

Endometriosis can also affect adolescents

By I.Soussis MD

Although endometriosis is commonly characterized as a disease affecting adult women of reproductive age, a review article compiled by an international panel of experts and published in Best Practice & Research Clinical Obstetrics and Gynaecology highlighted that it can also affect adolescents and younger women.

In addition, the authors reported that many women may experience their first symptoms in their teen years, but that they may not be recognized as indicative of endometriosis until later in their lives.

Risk factors for endometriosis in adolescents and young women include:

  • congenital abnormalities of the Müllerian duct  (due to increased incidents of retrograde menstruation),
  • first-degree relative with endometriosis, which accounts for approximately 50% of the risk for developing the disease,
  • early onset of menses,
  • prolonged menstruation (> 5 days),
  • short menstrual cycle interval (< 28 days), and
  • early-onset dysmenorrhea.

Studies have also reported associations between endometriosis and exposure to passive smoke during childhood and elevated levels of 2,4-dihydroxybenzophenone (found in sunscreens).

Other risk factors include premature birth, low body mass index, high caffeine or alcohol intake, and acne.

Consumption of soy formula as an infant has been observed to double the risk of endometriosis compared to that in women who were not exposed to dietary soy isoflavones as infants, reported the authors.

Potential protective factors identified:

  • use of oral contraceptives (OCs)
  • regular exercise
  • onset of menses after age 14
  • increased intake of omega-3 fatty acids

Black and Hispanic race compared to white or Asian race may also offer some degree of protection.

Symptoms and signs in adolescents:

Endometriosis lesions often have a different appearance in adolescents than in adults when visualized on laparoscopy: ovarian endometriomas and deep endometrial lesions are more the norm compared to powder-burn lesions seen in adult women.

Ovarian endometriomas are typically filled with “syrup-like chocolate material” and are surrounded by duplicated ovarian parenchyma. They have fibrotic walls and adhesions on the surface, according to the authors and are lined by endometrial epithelium, stroma, and glands. They are typically visualized in the rectovaginal septum, rectum, rectosigmoid colon, bladder, ureter, uterine ligaments, and vagina.

As in adults, the lesions should be staged from minimal disease (Stage 1) to severe disease (Stage 4), based on their size, location, and the types seen, and the extent of adhesions.

Distinguishing primary dysmenorrhea from endometriosis:

Many teens present with dysmenorrhea, which in light of the new information about the development of endometriosis in adolescents and young women should be evaluated to rule out endometriosis.

In adolescents with endometriosis, dysmenorrhea tends to be the first symptom of the disease and increases in severity over time. The pain is both cyclic and acyclic and interferes with school attendance, social activities, and exercise. Teens who are sexually active often report dyspareunia and gastrointestinal distress.

The clinical diagnosis can be verified with pelvic ultrasound and magnetic resonance imaging (MRI), but laparoscopy is the only way to obtain a definitive diagnosis.

The disease is unlikely to resolve spontaneously and is typically treated with nonsteroidal anti-inflammatory drugs, oral contraceptives, and progestin-only contraceptives. Laparoscopy and surgery may be an option for adolescents who fail to respond to medical therapy.

Source/image credit:

http://www.contemporaryobgyn.net/endometriosis/endometriosis-can-affect-adolescents-well-adult-women

 

Is medical cannabis effective as a treatment for endometriosis?

Is medical cannabis effective as a treatment for endometriosis?

By. I.Soussis MD

Studies show that medical cannabis has a positive effect on symptoms of endometriosis and may even stop its proliferation, according to Moshe Hod, a Tel Aviv University medical school professor of obstetrics and gynecology and president of the European Association of Perinatal Medicine. Moshe Hod is also head of Gynica, an Israeli startup specializing in cannabis-based solutions in the field of women’s health.

According to Gynica, the female reproductive system contains the most endocannabinoid receptors in the human body, after the brain.

Gynica is the first company that will carry out research and development at the newly licensed Lumir Lab.

Israel is extending its reputation as a world leader in medical cannabis research with the establishment of Lumir Lab (a cannabinoid research lab) at the campus of the Hebrew University of Jerusalem. Cannabinoids is one of the active ingredients unique to the cannabis plant.

The lab is headed by Czech analytic chemist Lumír Ondřej Hanuš, one of the world’s leading cannabinoids researchers.

Gynica and the Lumir Lab will collaborate on a treatment for endometriosis, a disease common in women that is defined by abnormal extrauteral growths of uterine endometrial tissue and associated with severe pain. Partly because how the abnormal growths become associated with pain is poorly understood, the pain is difficult to alleviate without resorting to hormones or surgery.

Recent studies showed that sensory and sympathetic nerve fibers sprout branches to innervate the abnormal growths. This situation, together with the knowledge that the endocannabinoid system is involved in uterine function and dysfunction and that exogenous cannabinoids were once used to alleviate endometriosis-associated pain, suggests that the endocannabinoid system is involved in both endometriosis and its associated pain.

Approximately 180 million women suffer from endometriosis worldwide.

“More research is needed in order to understand the mechanisms of action and identify which active cannabinoids most effectively eliminate endometriotic lesions, prevent recurrence and reduce pain with no negative impact on the ovulation cycle” professor Moshe Hod said.

“Currently, the vast majority of the cannabis products available in various markets have no scientific basis, which prevents the medical community from supporting the legitimacy of treatments based on cannabis,” said Hod. “We aim to provide tools and solutions that are not currently available.”

Israel has one of the world’s most progressive regulatory frameworks for medical cannabis.

Sources:

https://www.israel21c.org/endometriosis-latest-target-for-medical-cannabis-research/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2972363/

Image credit: https://www.health.harvard.edu/diseases-and-conditions/endometriosis2

 

Surgery improves pregnancy odds for women with colorectal endometriosis

Surgery improves pregnancy odds for women with colorectal endometriosis

By I Soussis MD

Secondary analysis of results from a French trial investigating the effects of surgical management of colorectal endometriosis found that the intervention effectively improved postoperative fertility rates, including the ability to conceive naturally. 

The study is one of the first to evaluate the impact of first-line surgery on pregnancy rates in this population.

First-line assisted reproductive technology (ART) is the recommended strategy for improving pregnancy rates in women with endometriosis, but is a subject of controversy in the gynecological community due to a lack of high-quality data comparing it to surgical management. 

In addition, the European Society of Human Reproduction and Embryology (ESHRE) has reported that there was no evidence that surgical management of deep endometriosis would improve pregnancy rates prior to ART.

The study population consisted of 55 women from the ENDORE (Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum) randomized trial conducted between March 2011 and August 2013 who wished to conceive. 

ENDORE was an unblinded, parallel-arms, controlled trial designed to determine if conservative rectal surgery was superior to segmental resection in women with colorectal endometriosis.

All of the women had deep endometriosis reaching into the rectum up to 15 cm from the anus with lesions measuring more than 20 mm in length. The endometrial lesions at minimum involved the muscular layer in depth and up to half of the rectal circumference. Twenty-five subjects underwent a conservative surgical procedure (shaving or disc excision) and 30 had radical rectal surgery (segmental resection). The surgeries were all performed by the same gynecologist. Subjects were followed for 50 to 79 months.

Of 36 patients who wanted to become pregnant after surgery, 23 (63%) had tried unsuccessfully prior to surgery for more than a year (the infertile group). After surgery, 29 patients became pregnant (81%), and some had more than one pregnancy, for a total of 37 pregnancies. Odds of postoperative conception improved over time.

 

Probability of Pregnancy After Surgery

At 12 months At 24 months At 36 months At 48 months
33.4% (95% CI: 20.6-51.3%) 60.6% (95% CI: 44.8-76.8%) 77% (95% CI: 61.5-89.6%) 86.8% (95% CI: 72.8-95.8%)

Overall, 17 women became pregnant naturally and 12 used ART (in vitro fertilization, intrauterine insemination, or oocyte donation). Looking specifically at the 23 infertile women, three-quarters (17) were able to conceive, and half of the pregnancies occurred naturally.

In total, 24 of the 37 pregnancies occurred as a result of natural conception, and subjects who were advised by their physicians to try to conceive naturally got pregnant significantly earlier than subjects who were referred for ART (P= 0.008).

Although the study had a small sample size, was subject to possible ascertainment bias  and preoperative and postoperative fertility assessments were not performed for all women, the trial was prospective with long-term follow up. 

It showed that fertility and the ability to conceive naturally can be restored by first-line surgery in women who are infertile due to colorectal endometriosis, perhaps in part due to the ability of women with endometriosis-related severe dyspareunia to engage in regular sexual intercourse postoperatively.

The authors stopped short of recommending that surgery for infertility be recommended over ART until more studies are performed. They suggested that in the interim “Physicians should ultimately offer patients a balanced perspective of the potential benefits and potential harms of alternative options.”

Read more: 

https://academic.oup.com/humrep/article/33/9/1669/5059386?searchresult=1

Source: http://www.contemporaryobgyn.net/endometriosis/does-surgery-improve-pregnancy-odds-women-colorectal-endometriosis?rememberme=1&elq_mid=3948&elq_cid=550575&GUID=337689F9-99FE-489C-A600-B32594ED6E4B

 

Citrus fruits consumption reduces the risk of endometriosis, study suggests

Citrus fruits consumption reduces the risk of endometriosis, study suggests

By I Soussis MD, Fertility Specialist

Fruit intake, in particular citrus fruits such as oranges and grapefruit, may protect women from endometriosis, a study published at Human Reproduction suggests.

Endometriosis is a hormone-dependent disorder characterized by the growth of endometrial tissue in sites outside the uterus. Although the cause remains unclear, it is known that genetics, immune response, and environmental factors contribute to its progression.

Studies have proposed that diet may also play a role in endometriosis, as it can affect the inflammatory process and change steroid hormones’ activity.

In the study “Fruit and vegetable consumption and risk of endometriosis,” the researchers evaluated whether the consumption of fruits and vegetables could influence the incidence of endometriosis.

The team reviewed the clinical records of 70,835 premenopausal women who were enrolled in the Nurses’ Health Study II (NHS II) and followed between 1991 and 2013. During this time, 2,609 cases of endometriosis were surgically confirmed, 313 of which were associated with infertility.

In general, increased consumption of fruits was found to be linked to a reduced risk of endometriosis.

Women consuming more than one serving of citrus fruits per day had a 22% lower endometriosis risk, compared to women consuming less than 1 serving per week. No association was observed between total vegetable intake and endometriosis risk.

However, women consuming more than 1 serving per day of cruciferous vegetables (broccoli, cauliflower, cabbage and Brussels sprouts) had a 13% higher risk of endometriosis compared to those consuming less than1 serving per week.

Altogether, the results suggested that “higher intake of fruits, particularly citrus fruits, is associated with a lower risk of endometriosis,” the researchers stated.

This could in part be explained by the effects of the compound beta-cryptoxanthin present in these fruits and may increase the protective effect of retinol (vitamin A).

Diets rich in fruits and vegetables include higher levels of pro-vitamin A nutrients (alpha-carotene, beta-carotene, beta-cryptoxanthin) and women with endometriosis have been reported to have lower intake of vitamin A than women without endometriosis.

In contrast, “consumption of some vegetables increased endometriosis risk, which may indicate a role of gastrointestinal symptoms in both the presentation and exacerbation of endometriosis-related pain,” the researchers stated.

Additional studies could further evaluate the impact of dietary patterns and different combinations of food on the manifestation and development of endometriosis.

 

Read more: https://academic.oup.com/humrep/article-abstract/33/4/715/4833874?redirectedFrom=fulltext

 

Mutations in cancer-related genes may be origin of endometriosis, study suggests

Mutations in cancer-related genes may be origin of endometriosis, study suggests

By I. Soussis MD

Endometriosis development is linked to the occurrence of genetic mutations affecting cancer-related genes, a recent study suggests.

The study, “Clonal Expansion and Diversification of Cancer-Associated Mutations in Endometriosis and Normal Endometrium,” was published at the journal Cell Reports. Endometriosis is considered a benign gynecologic disease that is characterized by overgrowth of endometrial tissue outside of the uterus. While it remains unclear what causes the uncontrolled proliferation of endometrium cells, genetics has been pointed to as an important risk factor.

Genetic studies have identified several spots on the genetic code that could be involved in the development of the disease. Also, mutations in cancer-related genes identified in ovarian endometriosis have been proposed as the precursors of some types of ovarian cancer.

 In this study, Japanese researchers analyzed the genetic landscape of 13 endometriosis lesion samples and 11 normal uterine samples using whole-exome sequencing. With this approach they identified 4,192 genetic variants in all samples (both endometriosis and healthy), which were mostly affecting cancer-associated genes including KRASPIK3CAFBXW7PPP2R1A, and PIK3R1.

Although the mutated genes were recurrently the same between the two types of samples, the team found that the frequency of the mutations varied significantly. The mutations in cancer-associated genes were much more frequent among endometriosis tissue samples than in uterine healthy tissue.

This finding suggested that endometrial glands were had accumulated more genetic mutations throughout time.

“The identified mutations can be the genomic footprints” that can help trace the “cell lineage [transformation] from ‘‘normal’’ uterine endometrial epithelium [cells lining the outer surface of the organ] to endometriosis and on to certain subtypes of ovarian cancer,” the researchers stated.

To further validate their findings the team performed a new sequencing analysis focused on 84 specific genes previously identified. They analyzed 94 ovarian endometriotic tissue samples collected from 45 women, and 71 normal uterine endometrial samples from 29 subjects with benign gynecologic diseases.

This new analysis confirmed that KRAS and PIK3CA were the most frequently mutated among the targeted genes, and their frequency was higher in endometriosis cases.

To better understand the genetic changes that were occurring, the researchers analyzed 109 isolated endometrial glands collected from the uteri of three endometriosis patients, located at endometriosis lesions sites or unaffected sections.

Interestingly, each gland within the normal uterus of the same woman had different genetic profiles, which goes in accordance with “the sporadic and spontaneous (…) origins during menstrual glandular proliferation cycles,” they said.

This analysis revealed that PIK3CA was the most frequently mutated gene across the single endometrial glands, and other less-frequent mutations in cancer-associated genes, including KRAS and ARID1A, also were present.

The team believes that these findings further support a century-old retrograde hypothesis proposed by John Sampson suggesting that the “origin of endometriosis [is] at genomic level.”

 

Source: https://endometriosisnews.com/2018/08/30/mutations-in-cancer-related-genes-may-promote-endometriosis/?utm_source=END+E-mail+List&utm_campaign=ef14358ef4-RSS_MONDAY_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_5a9732e593-ef14358ef4-72512137

 

 

 

Acupuncture found to be effective adjunctive treatment for endometriosis-related pain

Acupuncture found to be effective adjunctive treatment for endometriosis-related pain

By I.Soussis MD, Fertility Specialist

Endometriosis, Pain Management Meta-analysis of 3 studies of acupuncture for relief of endometriosis-related pain found positive results for reduction in pain intensity, according to research published in the Journal of Pain Research. This alternative and complementary therapy has been proven to be safe, with a low side-effect profile.

Swedish researchers performed a literature search for clinical trials, case reports, and observational studies with abstracts written in English using the keywords “acupuncture and endometriosis.” 

They retrieved 3 articles involving a total of 99 women with diagnosed endometriosis (stages I-IV) aged 13 to 40. All of the studies entailed acupuncture sessions during which 7 to 12 needles were inserted per subject and left in for 15 to 25 minutes. 

The needles were placed in the lower back,/pelvic area, lower abdominal area, feet, and/or hands. Depth of stimulation with the needles ranged from intracutaneous to subcutaneous to intramuscular, and the stimulation was primarily manual in nature. 

The number of treatments varied from 9 to 16 and occurred once or twice a week, and treatments were given in a hospital, acupuncturist’s office, or patient’s home. All of the studies reported a decrease in rated pain intensity, but differed in terms of research design, needle stimulation techniques, and the instruments used to evaluate the outcomes.

Two of the studies were prospective, randomized, single-blind, placebo/sham trials and the other was a retrospective observational case series study (n=2). The Visual Analog Scale, Numeric Rating Scale, and Verbal Rating Scale were used to measure patient-rated pain intensity. Subjects were permitted to continue using their standard analgesic in 2 studies.

The results indicated that no matter the specific technique used, acupuncture effectively and safely reduced pain intensity compared to baseline. One study found that acupuncture also reduced pain-related disability, and 2 studies found reduced analgesic intake and perceived stress. Likewise, 2 studies found that the therapy improved health-related quality of life, and social activity and attendance in school were increased after acupuncture treatment in the observational study.

 

Although acupuncture has been used for many years to relieve pain and has been noted to have few serious side effects, its use remains controversial due to a lack of understanding of its mechanism of action. 

The authors reported that “the pain-alleviating effects induced by acupuncture have been attributed to different physiological and psychological processes such as activation of endogenous descending pain inhibitory systems, deactivation of brain areas transmitting sensations of pain-related unpleasantness, interaction between nocioceptive impulses and somato-visceral reflexes, and as a method that induces the expectation of symptom relief.” 

They noted that currently available therapies for pain management in endometriosis patients are often ineffective or accompanied by adverse effects, and there is need for nonpharmacological interventions such as acupuncture. 

Source: http://www.contemporaryobgyn.net/endometriosis/acupuncture-found-be-effective-adjunctive-treatment-endometriosis-related-pain?rememberme=1&elq_mid=2570&elq_cid=607376

 

Endometriosis drug approved by the FDA to reduce pain

Endometriosis drug approved by the FDA to reduce pain

By I. Soussis MD,MSc, FRCOG, Fertility Specialist

The Food and Drug Administration announced the approval of the commercial version of the drug elagolix for the treatment of endometriosis pain.

This is the first time in over a decade that an oral treatment specifically designed for endometriosis pain has been approved.

Endometriosis is a condition affecting around 1 in 10 women (around 170 million women worldwide).

The condition is characterized by an abnormal growth of endometrium, which is the tissue that normally lines the inside of the uterus.

This tissue growth causes pain in the pelvis, lower back, and abdomen. Other symptoms include heavy periods or bleeding in-between periods, extremely painful menstrual cramps, pain during intercourse, and infertility.

There is currently no cure for the condition, but surgery is often recommended to remove the tissue, which relieves the symptoms for a while. Birth control pills are often prescribed to slow down the growth of abnormal tissue, and nonsteroidal anti-inflammatory drugs such as ibuprofen help ease the pain.

Now, the Food and Drug Administration (FDA) has approved a new drug to ease the pain of women living with moderate to severe endometriosis.

Elagolix is “the first and only oral gonadotropin-releasing hormone antagonist” designed specifically for endometriosis.

The drug -which will be marketed under the brand name Orilissa- is the first of its kind to have been approved by the FDA in more than a decade.

The drug was approved based on the results of two studies that formed the largest phase 3 clinical trial program to have ever been conducted on endometriosis.

In total, the studies examined the effects of elagolix on almost 1,700 women who had moderate to severe endometriosis pain.

In the two studies, the women were administered either 150 milligrams of elagolix once daily or 200 milligrams twice daily.

Compared with the women who received placebo, those who received the treatment reported a significant reduction in three types of pain: nonmenstrual pelvic pain, menstrual pelvic pain, and pain during intercourse.

These results were noted at 3 months and 6 months from the beginning of the treatment.

The FDA approved the following recommended dosage and duration of use: the drug can be taken for up to 24 months in a dosage of 150 milligrams per day, or up to 6 months if the dose is 200 milligrams twice per day.

However, the clinical trials also revealed a range of side effects. The most common ones were hot flashes, night sweats, headache, nausea, trouble sleeping, anxiety, joint pain, depression, and mood swings.

First study author Dr. Hugh S. Taylor,  the chair of the Department of Obstetrics, Gynecology and Reproductive Sciences at the Yale School of Medicine in New Haven, CT said “Endometriosis is often characterized by chronic pelvic pain that can impact women’s daily activities. Women with endometriosis may undergo multiple medical treatments and surgical procedures seeking pain relief and this [FDA] approval gives physicians another option for treatment based on a woman’s specific type and severity of endometriosis pain.”

My opinion:

Although endometriosis is a very common disease new drugs specifically designed for endometriosis are far and few between. This is an important development that will improve quality of life in women with endometriosis. 

It would be of interest to see if the same drug could be used as a part of the IVF antagonist protocol thus simplifying the treatment. Until now, all the antagonists used are injectable preparations. Our aim is to simplify protocols and reduce the number of injections. 

Read more: https://www.prnewswire.com/news-releases/abbvie-receives-us-fda-approval-of-orilissa-elagolix-for-the-management-of-moderate-to-severe-pain-associated-with-endometriosis-300685204.html

 

Fatigue is a common symptom of endometriosis

Fatigue is a common symptom of endometriosis

By I.Soussis MD,MSc,FRCOG, Fertility Specialist

Women with endometriosis experience debilitating fatigue more than twice as often as those who don’t have the condition, yet fatigue isn’t discussed or researched widely enough in these patients, a recent study concluded.

The international study found that high levels of fatigue experienced by women with endometriosis are independent of other factors, such as insomnia, pain, depression, occupational stress, weight, and motherhood.

The study “Fatigue – a symptom in endometriosis,” was published in the journal Human Reproduction.

Fatigue is a known symptom of endometriosis that affects the daily activities and quality of life of women living with the condition. But scientists and physicians lack large population studies investigating the frequency of fatigue in women with the disease.

Researchers designed a multicenter study that recruited 1,120 women (560 with endometriosis and 560 without it), at hospitals and private practices in Switzerland, Germany, and Austria between 2010 and 2016.

Participants responded to a questionnaire focused on several factors associating quality of life with endometriosis, as well as family and medical histories, mental disorders, and lifestyle. Fatigue and insomnia were classified at five different levels, with 1 being “never” and 5 being “very often.”

Responses showed that frequent fatigue was experienced by more than half of the women with endometriosis (50.7 percent) but by only a minority of women who didn’t have endometriosis (22.4 percent).

The study also found a link between fatigue in endometriosis and insomnia (women with endometriosis had a seven-fold increase in insomnia compared with healthy women), depression (a four-fold increase), pain (a two-fold increase), and occupational stress (nearly a 1.5-fold increase). However, no correlation was seen between the above symptoms and age, disease stage, and time since diagnosis.

Endometriosis leads to inflammation and an activation of the immune system, which may help to explain the link between endometriosis and fatigue, researchers said.

Proteins that are produced when the immune system is activated are known to be involved in fatigue symptoms. Also, chronic exposure to high stress can lead to fatigue, and researchers said this could be an additional explanation.

“These findings suggest that endometriosis has an effect on fatigue that is independent of other factors and that cannot be attributed to symptoms of the disease,” Brigitte Leeners, the study’s lead researcher and deputy head of the Department of Reproductive Endocrinology at the University Hospital Zurich, in Switzerland, said.

“We believe that in order to improve the quality of life for women with this condition, investigating and addressing fatigue should become a routine part of medical care, and doctors should investigate and address this problem when they are discussing with their patients the best ways to manage and treat the disease”. It would also help these women if steps were taken to reduce insomnia, pain, depression and occupational stress,” she added.

 

Read more: https://academic.oup.com/humrep/advance-article/doi/10.1093/humrep/dey115/5040620

Image credit: https://endometriosisnews.com/2018/03/16/endometriosis-causes-chronic-fatigue-more-than-feeling-tired/

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