TREATMENT ENDOMETRIOSIS

Medical cannabis treatment for endometriosis in clinical trial

Medical cannabis treatment for endometriosis in clinical trial

Israeli researchers have already started pre-clinical studies to examine the impact of medical cannabis in the treatment of endometriosis, which affects one in 10 women of childbearing age.

The research is led by Gynica, a company licensed by the Israeli Health Ministry to develop cannabis-based products for women, in cooperation with Lumir Lab, a cannabis research facility in the Biotechnology Park, Hadassah Ein Karem Jerusalem.

Endometriosis affects some 176 million women worldwide. In women with endometriosis, the uterine lining grows outside the uterus, in the fallopian tubes, ovaries and other areas of the abdominal cavity and in the pelvis. These women suffer from severe pain before and during menstruation, bleeding and pain during and after intercourse, dyspepsia and frequent or painful urination.

Anecdotal evidence has shown that women who smoke cannabis find relief from their pain, said Dr. Sari Sagiv, VP of research and development at Gynica. The researchers set out to find out what compounds or combination of compounds of cannabis can potentially address the problem.

Endometriosis is a complicated disease,” she said, as it has a number of factors working together that need to be addressed.

I believe cannabis has enough compounds that can affect a number of factors” of the disease, she said, including reducing pain, inflammation and the risk of recurrence.

The researchers have already tested a variety of cannabis compounds of endometriosis cells in vitro to see how they react to the compounds.

We are trying single or a combination of compounds on these cells” to find out if there is an impact and what it is, she explained. “We have already seen that there are different parts of the compounds that have a lot of impact.”

The researchers are now whittling the compounds down to a “lead candidate,” with which they will start clinical trials.

We already have an indication of what can be a lead candidate to deal with a number of factors that can cure endometriosis, not just address the pain. But she declined to reveal additional details until a patent has been filed. We want to start clinical trials in the third quarter of the year,” Sagiv said.

In parallel with the research process being conducted at Lumir Lab, Gynica is collaborating with Canadian company Strainprint, a firm that specializes in data collection and analysis of the effects of cannabis on various diseases. The companies are working on setting up the world’s largest data collection platform to analyze the effects of cannabis on women.

Lumir Lab is run by Prof. Lumir Hanush, a leading cannabis researcher, who is responsible for some of the most important discoveries made in the field of cannabis active substances. Gynica is led by Prof. Moshe Hod, a gynecologist and president of the European Association of Obstetricians. The firm does R&D specializing in cannabinoids based in the field of gynecology.

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

Source: https://www.timesofisrael.com/israeli-researchers-probe-how-cannabis-can-treat-endometriosis/

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

 

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