Laser treatments that claim to rejuvenate vaginal tissue and alleviate women's symptoms of menopause are useless and no better than sham treatment, a clinical trial involving nearly 80 Australian women has found.
"The treatment of laser for postmenopausal vaginal symptoms just wasn't effective," says gynecologist Jason Abbott of the University of New South Wales; he is the senior author of the study which didn't find any benefit in any outcomes.
"Based on our study, we hope that women don't go for commercial laser treatment for postmenopausal symptoms."
Around half of women experience unpleasant symptoms with menopause when their estrogen levels drop in middle age. This includes hot flushes, night sweats, vaginal dryness, low libido and mood swings, which understandingly leaves some women feeling irritable or looking for symptom relief.
Some observational data suggested that laser treatments, which are approved for treating skin conditions such as acne, scarring, or genital warts, might also have some effect on the sometimes painful vaginal symptoms that accompany menopause.
But studies were short, open to bias, had no imitation treatment for comparison, and involved very small numbers of women, so experts warned to approach the use of costly laser treatments with caution.
Like cosmetics though, medical devices aren't necessarily subjected to the same rigorous testing by national regulatory authorities as medications and drugs are, which means they may be marketed to clinicians and consumers alike without sound evidence backing their claims.
In 2018, the US Food and Drug Administration moved to crack down on laser devices marketed for "vaginal rejuvenation", after it found numerous cases of women who had developed vaginal burns, scarring, and recurring pain after having undergone such laser treatments.
"We are deeply concerned women are being harmed," physician and former FDA commissioner Scott Gottlieb, said at the time.
"These products have serious risks and don't have adequate evidence to support their use for these purposes" Gottlieb said, adding that the "deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions."
The results from this latest randomized, double-blind, placebo-controlled trial – considered the gold standard for evaluating whether or not medical interventions work – add weight to those statements.
Nearly 80 women were involved in the trial. These women had sought medical care for their troublesome symptoms, including vaginal burning, itching, or dryness, and 50 percent of them had had hormone treatment for previous breast cancer, which can bring on early menopause.
Half the women received three sessions of laser treatment, while the other 42 women were given a sham treatment where the device was powered down to almost zero.
After 12 months, there was no difference in women's overall symptoms or most severe symptoms in either group. Their quality of life was much the same, there were no substantial differences in vaginal health noted in clinical assessments, and even tissue analyses showed little change after either treatment.
"No matter which way you look at it, there wasn't any difference between whether you had the actual laser or whether you had this placebo treatment," says Abbott.
While it may be frustrating for people who have already tried tropical lubricants or moisturizers to alleviate vaginal pain to hear that laser therapy would be little help, the study provides solid evidence against sinking money into it.
"It's really important for women to be made aware when it's quite an expensive treatment that it isn't different to having no treatment at all," Abbott adds.
Some women in the study did see improvements in their symptoms, of up to 20 percent. But because women who received laser therapy and those who didn't both reported some symptom relief, Abbott puts the changes down to the placebo effect, which he and colleagues plan to investigate further.
"The placebo effect can have a very profound arrangement on the way that someone perceives their symptoms," he says.
The study was published in the Journal of the American Medical Association.