For women with postmenopausal vaginal symptoms, fractional carbon dioxide laser versus sham treatment fails to significantly improve vaginal symptoms after 12 months, according to the results of a randomized controlled trial in JAMA.
“With the widespread marketing and uptake of laser for a variety of gynecological conditions, we wanted to test the very high levels of published improvement in menopausal symptoms,” said principal investigator Jason Abbott, PhD, a professor of gynecology at the University of New South Wales (UNSW) in Sydney, Australia.
The rationale for improvement in menopause via laser is reasonable, according to Abbott. “We also considered that only a double-blind, sham controlled trial would be valuable,” he said. “Importantly, those treated with breast cancer, where topical oestrogens are relatively contraindicated, are a specific patient population we wanted to include.”
The study was conducted at a single tertiary referral hospital in Sydney. Enrollment started in September 2016, with final follow-up in June 2020.
Participants were postmenopausal women with vaginal symptoms severe enough to seek medical treatment. A total of 85 women with a mean age 57.8 years were randomized for treatment: 43 women for laser and 42 women for sham.
Sessions of 3 treatments of a fractional microablative carbon dioxide laser system (DEKA) were performed and spaced 4 to 8 weeks apart.
Overall, 91.7% of the women completed their 12-month follow-up.
From baseline to 12 months, there were no significant differences between the laser group and the sham group in change in symptom severity, change in the most severe symptom, and change in the Vulvovaginal Symptom Questionnaire (VSQ).
There were also no significant differences between the 2 groups in the mean quality of life score, the Vaginal Health Index Score, and for histological comparisons.
“I am not surprised by the placebo response in the sham intervention group,” Abbott told Contemporary OB/GYN®. “This is a constant in most studies, and its absence should raise alarm bells.”
The fact there was so little response in the laser arm “truly demonstrates that the very high response rates initially reported from non-randomized studies were most definitely falsely elevated, with success substantially overstated,” Abbott, a clinical academic at the Royal Hospital for Women in Sydney, said. “Perhaps the most surprising finding was that vaginal skin in postmenopausal women does not always have to be histologically 'postmenopausal.’ This is an area worthy of more study.”
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.
Based on the current study results, “vaginal laser treatments really should only be offered in a research and not a commercial setting,” Abbott said. “Women need to be informed that the benefit is not scientifically validated.”
The study used the same laser settings as those reported in the initial data sets and on the same clinical symptoms, clinician assessment, and histological assessments.
“We are now reviewing the vaginal histology of our study patients in considerably more detail,” said Abbott, “We are also researching the minimal clinically important difference that women desire from laser.”
Because laser treatment is a quality of life and not a quantity of life procedure, “how much or little improvement are women prepared to accept?” Abbott pondered. “And how much or little are they willing to pay for that improvement?”