Does resurfacing laser treatment for post-menopausal vaginal symptoms work?
|CTVnews 13 Oct 2021 at 14:26|
TORONTO -- A type of laser resurfacing treatment popularly used for skin rejuvenation has increasingly been marketed as an alternative treatment for vaginal atrophy, a condition that typically affects women after menopause.
Fractional carbon dioxide laser is a minimally-invasive procedure typically used to help improve facial skin tone, fine lines, treat minor scars or sun damage, but some manufacturers say the procedure provides highly effective results for a range of gynecological issues as well.
The U.S. Food and Drug Administration previously issued a warning over using these devices as a therapy for vaginal conditions, and suggests the therapy works no better than a fake treatment. But Health Canada has approved at least one such device for that specific use. So do these devices work?
Fractional CO2 laser therapy is a safe and effective non-hormonal alternative for the treatment of post-menopausal vaginal symptoms.
Genitourinary syndrome of menopause (GSM), also known as vaginal atrophy or vulvovaginal atrophy (VVA), is characterized by vaginal dryness, irritation, itching, burning, urinary incontinence, painful urination, and pain or discomfort during sexual intercourse. It is often a result of decreased estrogen levels in vaginal tissues. An estimated 40 to 60 per cent of postmenopausal women experience these symptoms, which can negatively disrupt their quality of life. Women undergoing breast cancer treatment can also experience vaginal atrophy symptoms.
The physical, psychosocial, and economic effects of vaginal symptoms of menopause are substantive, although not life-threatening, scientists wrote in a new Australian study published this week by The Journal of the American Medical Association (JAMA).
Fractional CO2 laser therapy typically involves inserting a probe inside the vagina to destroy or reshape vaginal tissue aimed at stimulating collagen and tightening the tissue in the region. In the U.S. the FDA has cleared or approved these types of energy-emitting devices for removing abnormal or precancerous cervical and vaginal tissue and genital warts, but the regulator says it has not evaluated the safety and effectiveness of these devices for vaginal rejuvenation.
In addition to the deceptive health claims being made with respect to these uses, the vaginal rejuvenation procedures have serious risks, the FDA wrote in July, 2018.
The deceptive marketing of a dangerous procedure with no proven benefit, including to women whove been treated for cancer, is egregious. In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.
Health Canada had yet to respond to a queryfrom CTVNews.ca at the time of publication. On its website , it says it regulates laser devices under three separate regulatory acts that ensure that laser systems sold in Canada are safe and effective when used for their licenced medical purposes by trained professionals.
Results from the Australian JAMA study analyzing the procedures effectiveness for women with post-menopausal gynecological symptoms add to questions around its efficacy. The paper concluded that after 12 months, the severity of the symptoms were not statistically significant compared to those who underwent a sham treatment. Quality of life and quality of sex also did not change meaningfully between the two groups, researchers said. Vaginal wall biopsies were also analyzed, with no significant difference in histology between the groups either.
Researchers also noted that because there is no demonstrable difference versus sham treatment, it cannot be considered to be cost-effective due to the steep price of the treatment.
In the study, women underwent three treatments a month apart, in line with recommended practice, with the sham treatment performed at minimal energy settings that had no effect on the tissue. A topical anesthetic cream was applied to all patients to reduce any differences in pain perception, while other visual and auditory considerations were also made to ensure they were identical between the two groups.
This clinical trial, among the largest of its kind on this subject, involved 90 women with post-menopausal symptoms. It was double-blinded, randomized, and importantly, sham-controlled, with patients followed for a year. It adds to previous studies that also suggested no significant difference.
To be sure, there is at least one study published in January 2018 showing more positive results. Other positive studies lacked control groups, randomization and/or had much shorter follow-up period, however, raising some concerns over the quality of the results, according to a discussion on this topic published in The Journal of Urology in December 2017.
The JAMA study published this week noted that medical devices are often adopted into clinical practice with a lower level of evidence than pharmaceutical products, with rapid dissemination before stringent evaluation and pointed to the FDAs warning in 2018. The paper acknowledged some limitations to its study, including the fact that it did not evaluate the risk of complications, although no safety issues were identified.
The British Menopause Society told the BBC that this study was notable in that it was not industry funded and among the biggest randomized trials of its kind, adding that the therapy should only be offered in clinical trials to gather more evidence.
While the treatment has gained popularity as a non-hormonal alternative to treat post-menopausal vaginal symptoms, the latest study adds to ongoing doubts as to whether this expensive procedure works.