A potentially risky laser treatment offered to menopausal women to rejuvenate the vagina is no better than sham or fake therapy, researchers say.
They tested it in a trial to see if it might ease vaginal dryness and painful sex linked to going through the change.
According to the National Institute for Health and Care Excellence, the therapy should only be used for research purposes.
However, some private clinics in the UK and the US continue to provide it.
A probe is inserted into the vagina to heat and change or remodel the surrounding tissue during laser rejuvenation.
Clinics claim that intentionally injuring the tissue to kickstart the body’s healing process can increase natural lubrication and restore sexual gratification.
According to officials, the non-surgical treatment can be completed in a lunch hour but is not completely risk-free.
The US regulator has already said it is “deeply concerned” women can be harmed by the procedure.
Some people who have had it have suffered from vaginal burns and scarring.
The study, described in the Journal of the American Medical Association, is one of the largest to independently examine the therapy using the “gold standard” clinical trial design.
This type of research has been requested by NICE in order to determine whether the therapy is safe and beneficial enough to be recommended for wider use in the NHS.
The Australian researchers, who were not funded by the industry, randomly assigned 85 women to either the laser treatment or a placebo procedure, in which the probe was inserted but the required “dose” of laser energy was not delivered.
There were no serious side effects reported, but there was no discernible difference in symptom improvement between the two groups during the year of follow-up.
An accompanying editorial in JAMA compared the laser-therapy situation to the recent vaginal-mesh scare, in which some women were injured by a procedure that was later halted due to safety concerns.
“The widespread clinical use of vaginal laser therapy, followed by burgeoning reports of adverse events and FDA [US Food and Drug Administration] warnings, brought an unfortunate sense of deja vu,” said the authors, Drs Marisa Adelman and Ingrid Nygaard of the University of Utah School of Medicine. Following a rush to market vaginal mesh products for the treatment of pelvic organ prolapse prior to the completion of rigorous randomised trials, these products are no longer available in the United States.” Although marketing prior to the availability of evidence demonstrating efficacy and safety may result in short-term profits for companies and clinicians, this approach closes any window of opportunity to actually learn which individuals, if any, benefit from the treatment, as well as those at increased risk of harms.”
“This is the type of study we have been waiting for,” said Tim Hillard, a consultant gynaecologist in Dorset and past-president of the British Menopause Society. It is one of the largest randomised trials and is not supported by industry.
“It really emphasises the importance of doctors only offering this therapy in clinical trials to gather more evidence.”
Mr Hillard stated that new treatments for menopausal symptoms were desperately needed and worth researching.
“Symptoms such as vaginal dryness, itching, discomfort, or pain during intercourse are very common and can be very distressing for women,” he says.
“It can be difficult to discuss them.
“Many women put up with it and don’t seek help – but there are treatments that may help and specialists who can advise.”
Managing the menopause
- Most women will reach menopause between the ages of 45 and 55
- Symptoms can begin months or even years before periods stop entirely and continue for years after
- Hot flushes, night sweats, vaginal dryness, mood changes and difficulty sleeping are common
- Doctors may do a blood test to measure hormone levels and can refer patients to a menopause specialist
- Hormone-replacement therapy or vaginal oestrogen creams and lubricants may help