Postmenopausal trial finds no difference between placebo and laser treatment

Monday, 18 October, 2021

Postmenopausal trial finds no difference between placebo and laser treatment

Fractional carbon dioxide (CO2) lasers — commonly associated with facial skin — are also promoted as an effective way to treat painful vaginal symptoms that can happen after menopause.

But a new UNSW Sydney-led trial 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 just wasn’t effective,” said gynaecologist Jason Abbott, a professor at UNSW Sydney.

“Based on our study, we hope that women don’t go for commercial laser treatment for postmenopausal symptoms.”

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 include pain during sex, vaginal dryness, itchiness or irritation, and urinary tract symptoms.

“These symptoms aren’t life-threatening, but they can be pretty uncomfortable and decrease your quality of life,” said Professor 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’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 — 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 — both self-reported changes as well as changes reported by an assessing doctor or independent pathologist — and found there wasn’t any difference between the two groups. The findings of the study have been published in JAMA: The Journal of the American Medical Association.

“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,” Professor Abbott said.

“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.”

Debunking past studies

So why have fractional CO2 lasers for vaginal symptoms been on the market for so long if they’re not effective? Well, up until now, many studies have shown that they are effective — in fact, initial studies suggested the symptoms might reduce by up to 100%.

But many of these studies used less scientifically sound test methods or smaller sample sizes, according to UNSW.

“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,” Professor Abbott said.

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.

“Medications have to go through rigorous testing before they’re TGA approved in Australia, but devices and procedures don’t need to be,” said Dr Li, who is also an obstetrics and gynaecology resident at the Royal Hospital for Women.

“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.”

Solutions that work

Surprisingly, many women participating in the study did see some improvements: on average, the participants showed a 20% improvement in their symptoms. But these improvements happened to both the laser and placebo groups.

Professor Abbott said 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.

“We’re very keen to try and better understand how that happens and how the placebo effect works.”

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’s 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’s experience is different, the best port of call would be your GP.

“The 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,” Dr Li said.

“In the future we’re looking into new areas where we might be able to find other treatments to help women.”

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