Laser treatment said to rejuvenate vaginal tissue ‘no better than placebo’

14 Oct 2021

Fractional CO₂ laser treatments to cut symptoms of menopause might not work at all, suggest new trials by UNSW, Sydney.

Vaginal laser therapy treatments claim to reduce negative tissue symptoms of menopause – experienced by about half of all women – by up to 100 per cent. But results from a new trial shows they might not work at all, say researchers at the University of New South Wales (UNSW), Sydney, Australia.

Fractional carbon dioxide lasers are a commercial form of treatment for various skin conditions, such as acne, deep wrinkles and scarring. While the lasers are commonly associated with facial skin treatments, they are also promoted as an effective way to treat painful vaginal symptoms that can happen after menopause.

According to its proponents, the CO₂ laser removes the outer layers of damaged skin and encourages the growth of new, healthy skin, which are said to reduce – or even completely remove – the negative vaginal symptoms.

But a new UNSW Sydney-led trial, the results of which are published this week in Journal of the American Medical Association, compared the results of the laser to results from a placebo treatment – and surprisingly, it found there was no difference between the two.

“The treatment of laser for postmenopausal vaginal symptoms was not effective,” commented gynaecologist Jason Abbott, a professor at UNSW Sydney. “Based on our study, we hope that women do not go for commercial laser treatment for postmenopausal symptoms.”

About half of women experience changes to their vaginas after menopause, caused by a drop in oestrogen. These changes can also happen to women who have been treated for breast cancer. Some of the more common symptoms including pain during sex, vaginal dryness, itchiness or irritation, and urinary tract symptoms.

“These symptoms aren’t life-threatening, but they can be uncomfortable and decrease quality of life,” said Prof. Abbott, who is also the director of the GRACE Unit at the Royal Hospital for Women and medical director of the charity Endometriosis Australia.

The researchers recruited 78 women with postmenopausal vaginal symptoms to test the laser’s effectiveness. The women were randomly split into two groups: half were given the laser treatment, while the other half were given a placebo treatment. The study was double-blind.

Conclusion: no difference

After 12 months, the research team compared outcomes – both self-reported changes as well as changes reported by an assessing doctor or independent pathologist – and found there was no difference between the two groups. “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,” said Prof. Abbott. “It’s really important for women to be made aware when it’s quite an expensive treatment that [vaginal laser treatment] is not different to having no treatment at all.”

Medications have to go through rigorous testing before they gain Therapeutic Goods Approval (TGA), which is needed for use in Australia, but devices and procedures do not require this, commented Dr Fiona Li, lead author of the study and PhD candidate at UNSW Medicine & Health.

The university’s statement about the survey results asked, “Why have fractional CO₂ lasers for vaginal symptoms been on the market for so long if they’re not effective?”, and suggested the explanation, “Until now, many studies have shown that they are effective – in fact, initial studies suggested the symptoms might reduce by up to 100 per cent. But many of these studies used less scientifically sound test methods or smaller sample sizes.”

Prof. Abbott added, “All of the studies up until now have been pushed with a great deal of fervour and enthusiasm, but it's very important that we go back to science and put things into a very rigorous methodology.”

Dr Li, who is also an obstetrics and gynaecology resident at the Royal Hospital for Women, hopes the findings highlight the importance of researching new technologies before they come onto the market, said, “Patients don't always know that these treatments don't need to have a strong evidence backing before they’re rolled out and recommended from clinicians.”

Surprisingly, many women participating in the study did see some improvements: on average, the participants showed a 20 per cent improvement in their symptoms. But these improvements happened to both the laser and placebo groups. Prof. Abbott says this highlights the power of the placebo effect. “The placebo effect can have a very profound arrangement on the way that someone perceives their symptoms,” he said.

To further investigate this, the UNSW team is next offering the laser treatment to the women who received a placebo treatment in this study. They hope to learn more about the power of placebo by studying how these women respond to the change when they know they are getting the actual laser treatment. The team hopes to see the results in a year’s time, depending on Covid-19 interruptions.