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12 October 2021

This laser is supposed to rejuvenate vaginal tissue. But scientists say it鈥檚 no better than a placebo

Vaginal laser therapy treatments claim to reduce negative vaginal symptoms of menopause 鈥� experienced by about half of all women 鈥� by up to 100 per cent. A new trial shows they might not work at all.

Have you heard of a fractional carbon dioxide (CO2) laser?

These 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, they are also promoted as an effective way to treat painful vaginal symptoms that can happen after menopause.

According to its advertisers, the CO2 laser removes the outer layers of damaged skin and encourages the growth of new, healthy skin, which are said to reduce 鈥� or even get completely rid of 鈥� the negative vaginal symptoms.

But a new UNSW Sydney-led trial, the results of which are published today in , compared the results of the laser to results from a placebo treatment 鈥� and surprisingly, it found there was no difference between the two.

鈥淭he treatment of laser for postmenopausal vaginal symptoms just wasn't effective,鈥� says gynaecologist , a professor at UNSW Sydney.

鈥淏ased on our study, we hope that women don't go for commercial laser treatment for postmenopausal symptoms.鈥�

About half of women experience changes to their vagina 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.

鈥淭hese symptoms aren鈥檛 life-threatening, but they can be pretty uncomfortable and decrease your quality of life,鈥� says Prof Abbott, who is also the director of the Gynaecological Research and Clinical Evaluation (GRACE) Unit at 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鈥檚 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 鈥� meaning that not only did the participants not know which group they were in, but neither did the researchers and clinicians. Double-blind studies are considered the most scientifically robust research method.

After 12 months, the research team compared outcomes 鈥� both self-reported changes as well as changes reported by an assessing doctor or independent pathologist 鈥� and found there wasn't any difference between the two groups.

鈥淣o matter which way you look at it, there wasn鈥檛 any difference between whether you had the actual laser or whether you had this placebo treatment,鈥� says Prof. Abbott.

鈥淚t'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.鈥�

Debunking past studies

So why have fractional CO2 lasers for vaginal symptoms been on the market for so long if they鈥檙e not effective?

Well, up until now, many studies have shown that they are effective 鈥� 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.

鈥淎ll 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,鈥� says Prof. Abbott.

Lead author of the study Dr Fiona Li, PhD candidate at UNSW Medicine & Health, says she hopes the findings highlight the importance of researching new technologies before they come onto the market.

鈥淢edications have to go through rigorous testing before they're TGA approved in Australia, but devices and procedures don鈥檛 need to be,鈥� says Dr Li, who is also an obstetrics and gynaecology resident at the Royal Hospital for Women.

鈥淧atients don't always know that these treatments don't need to have a strong evidence backing before they鈥檙e rolled out and recommended from clinicians.鈥�

Finding solutions that work

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.

鈥淭he placebo effect can have a very profound arrangement on the way that someone perceives their symptoms,鈥� he says.

鈥淲e're very keen to try and better understand how that happens and how the placebo effect works.鈥�

To further investigate this, the team are 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 hope to see the results in a year鈥檚 time, depending on COVID-19 interruptions.

In the meantime, women who are experiencing these vaginal symptoms may find relief in topical lubricants or moisturisers. But as everyone鈥檚 experience is different, the best port of call would be your GP.

鈥淭he most important thing is to have a chat with your doctor to explore all the options and consider what is the best treatment for you,鈥� says Dr Li.

鈥淚n the future we're looking into new areas where we might be able to find other treatments to help women.鈥�

Abstract

Abstract
Importance Postmenopausal vaginal symptoms are common and frequently detrimental to a woman鈥檚 quality of life. Fractional carbon dioxide vaginal laser is increasingly offered as a treatment, but the efficacy remains unproven.

Objective
To determine the efficacy of fractional carbon dioxide laser for treatment of vaginal symptoms associated with menopause.

Design, Setting, and Participants
A double-blind, randomized, sham-controlled trial with 12-month follow-up was undertaken at a single tertiary referral hospital in Sydney, Australia. Enrollment commenced on September 19, 2016, with final follow-up on June 30, 2020. Participants were postmenopausal women with vaginal symptoms substantive enough to seek medical treatment. Of 232 participants approached, 85 were randomized.

Interventions
Three treatments using a fractional microablative carbon dioxide laser system performed 4 to 8 weeks apart, with 43 women randomized to the laser group and 42 to the sham group.

Main Outcomes and Measures
The co鈥損rimary outcomes were symptom severity assessed using a visual analog scale (VAS; range, 0-100; 0 indicates no symptoms and 100 indicates the most severe symptoms) and the Vulvovaginal Symptom Questionnaire (VSQ; range, 0-20; 0 indicates no symptoms and 20 indicates the most severe symptoms) at 12 months. The minimal clinically important difference was specified as a 50% decrease in both VAS and VSQ severity scores. There were 5 prespecified secondary outcomes, including quality of life (range, 0-100; higher scores indicate better quality of life), the Vaginal Health Index Score (range, 5-25; higher scores indicate better health), and vaginal histology (premenopausal or postmenopausal status).

Results
Of 85 randomized participants (mean [SD] age, 57 [8] years), 78 (91.7%) completed the 12-month follow-up. From baseline to 12 months, there was no significant difference between the carbon dioxide laser group and the sham group in change in symptom severity (VAS score for overall vaginal symptoms: 鈥�17.2 vs 鈥�26.6; difference, 9.4 [95% CI, 鈥�28.6 to 47.5]; VAS score for the most severe symptom: 鈥�24.5 vs 鈥�20.4; difference 鈥�4.1 [95% CI, 鈥�32.5 to 24.3]; VSQ score: 鈥�3.1 vs 鈥�1.6; difference, 鈥�1.5 [95% CI, 鈥�5.9 to 3.0]). There were no significant differences between the laser and sham group in the mean quality of life score (6.3 vs 1.4; difference, 4.8 [95% CI, 鈥�3.9 to 13.5]) and Vaginal Health Index Score (0.9 vs 1.3; difference, 鈥�0.4 [95% CI, 鈥�4.3 to 3.6]) or in histological comparisons between laser and sham treatment groups. There were 16 adverse events in the laser group and 17 in the sham group, including vaginal pain/discomfort (44% vs 68%), spotting, discharge, and lower urinary tract symptoms. No severe adverse events were reported in either group.

Conclusions and Relevance
Among women with postmenopausal vaginal symptoms, treatment with fractional carbon dioxide laser vs sham treatment did not significantly improve vaginal symptoms after 12 months.

Reference

Li, F. G. et al. Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms: A Randomized Clinical Trial. JAMA 326, 1381-1389, doi:10.1001/jama.2021.14892 (2021).