New Study shows Vaginal Laser Therapy Ineffective for Menopause Symptoms
Vaginal rejuvenation is a sham.
Finally we have a quality study to evaluate “laser therapy” for genitourinary syndrome of menopause (GUSM), a treatment that is often advertised as the cringeworthy “vaginal rejuvenation.” Until now the studies have all been low quality and designed in a way that could make the laser therapy appear more effective than it really is. Think “Glamour Shots,” but for medical research.
And what did this new study show? Therapy with fractional carbon dioxide laser for vaginal symptoms of menopause is as effective as a sham procedure. Meaning, it does nothing.
You can find the study here.
Let’s take a deeper dive.
What is GUSM?
Up to 80% of people with ovaries will eventually develop genitourinary syndrome of menopause or GUSM. Those who are affected can develop some or all or the following: vaginal dryness, vaginal itching. loss of lubrication, pain with sexual activity, and recurrent bladder infections.
The main driver of GUSM is the decrease in estrogen, which has many downstream effects on the vagina, vulva, bladder, and urethra. For example, estrogen causes the cells that line the vagina to fill with glycogen, which is a storage sugar. This physically makes the cells plump, so they are more robust, so it protects against friction-related discomfort. When these cells are shed from the vaginal walls, they become part of the vaginal discharge and as the cells break down they release this storage sugar to feed the good bacteria. It’s the vaginal circle of life. Without the glycogen, the vaginal microbiome changes, which can affect lubrication, lead to a change in odor, and contribute to bladder infections. Estrogen also positively impacts the connective tissue, increases how quickly the cells in the vaginal wall are replaced, and increases blood flow to the region. So there are many pathways by which the drop in estrogen with menopause can negatively affect these tissues.
The gold standard treatment for GUSM is vaginal estrogen. However, vaginal DHEA (dehydroepiandrosterone), a hormone that the body converts into estrogen and testosterone, is also effective. Vaginal moisturizers can help as well, although they tend to be more effective when there is only one symptom and unlike estrogen, they won’t help prevent bladder infections. Good therapy for people who cannot use vaginal estrogen is lacking.
What is Laser therapy for GUSM and Why Did Some People Think It Worked?
The laser is a fractional carbon dioxide laser device. These lasers are approved for other indications, but in the vagina the claim is they injure a small portion of the surface of the vagina (a fraction, if you will) and this sets off a cascade of events that increases blood flow and restores the tissues so they appear as if they have been treated with estrogen.
When I first heard about this several years ago I was perplexed. This hypothesis did not seem biologically plausible. How could trauma and increased blood flow actually increase glycogen in the vaginal cells? The effects of estrogen are lost within 4-6 weeks of stopping therapy, yet the laser was supposed to provide benefit for months and months? How was this possible given how quickly the vaginal epithelium (the lining of the vagina) is replaced? I’ve done a lot of vaginal surgery over the years and used the carbon dioxide laser a lot. When removing genital warts with the laser we aim to cause very little tissue injury, meaning I’ve seen a lot of people with minor tissue trauma and not one experienced any post-operative “vaginal rejuvenation.” How could something that is advertised as even less traumatic to the tissues than removing warts have such a profound impact?
However, I am always willing to be won over by good science. So when I first heard about the laser for GUSM, I looked up the studies. The problem? There were all low quality. Initially the studies were retrospective, meaning researchers asked women who had the laser if they thought it helped. This is not how one decides if a brand new therapy is safe and effective. In addition, the results were always amazing! Sometimes close to 100% effective. That’s a big red flag.
As an aside, medications do not get approved based on retrospective studies, so we shouldn’t be using lasers on vaginas for based on retrospective studies either.
Even though quality data didn’t exist, many providers began offering the therapy. It’s about $2,000-3,000 and not covered by health insurance, so it’s cash, in case you are wondering. One woman told me there were posters for it all over her gynecologist’s office and while she sat undressed waiting for her exam she began to worry about her vagina being old and sad, whereas she did not have those concerns before she entered the exam room.
And in no time at laser therapy for “vaginal rejuvenation” was all over Instagram.
Eventually three small clinical trials trickled in. None of these studies compared the laser to sham therapy (sham therapy is what we call a placebo when it’s a device that is is being tested), they compared the laser with vaginal estrogen. In addition, the studies were not blinded, so the women and the researchers knew which therapies they were getting. This last point about the patients knowing which therapy they were receiving is critical, as the placebo or sham response rate tends to be higher with new technologies. These studies could have easily maximized the potential upside of a placebo effect, meaning make the laser look better than it really was. To me, these are the kind of studies that are done when there is a concern your therapy might not hold up to a sham study.
It is important to remember the lack of quality, high volume studies with laser therapy isn’t just about wasting money by foisting an ineffective therapy on people. It also means we literally have no reliable safety data. This last point is very important as the FDA has received reports of injuries from these devices, releasing a report about it in 2018. You can read that report here.
I’ve seen injuries after laser vaginal rejuvenation and I know several colleagues who have as well. And while this last point is admittedly anecdotal, it is the kind of anecdote that should create the impetus for a high quality safety study. If no one is studying this therapy in the right way we not only have no idea who we are helping or not, but no idea who we may be hurting. Is this one injury for every 100 treatments, every thousand, or every ten thousand? It matters. A lot. And it matter seven more if we don’t know how many people we are helping.
I feel it’s important to point out that I am not the only one who has been skeptical of vaginal laser therapy–it is not recommended by the American College of Obstetricians and Gynecologists (ACOG).
How are Doctors Using Lasers for GUSM if they Are not Approved for this Indication?
The fractional carbon dioxide lasers are not approved for treating GUSM, but they are approved for other medical conditions. If a device is approved for one indication, providers are free to use them for anything they want. And yes, that is problematic.
Tell Me About This New Study
Researchers in Australia enrolled 85 women with GUSM, half of them received three treatments with the laser and the other half received three sham therapy sessions. The women were blinded so they didn’t know which therapy they had received. The women were then followed for 12 months to assess outcomes. Approximately half of the participants had vaginal biopsies before therapy and 6 months after the first treatment. A few patients were lost to follow up, so by one year there was data on 38 women who had received the laser and 40 women who received the sham therapy.
This study was not funded by a company that makes any of the lasers, which is important to mention.
What were the findings? There were no differences between the groups in any metric evaluated. No change in pain, sexual activity, quality of sex, or quality of life. Also, no differences in the biopsy specimens, 9% of people who had laser therapy and 12.5% who had the sham treatment had an improvement in how the tissues looked under the microscope.
What You Should Know
We have a very long history in gynecology of under tested medications and therapies gaming the system in some way or another with women paying the price. Diethylstilbestrol (DES, birth defects and cancer), the Dalkon Shield (pelvic infections and death), and some of the vaginal mesh surgeries (chronic pain) for starters, so we need to be very cautious with new interventions. And yet despite the absence of quality data on the effectiveness and safety of laser therapies for vaginal menopause symptoms, many doctors are promoting the laser as if it is the fountain of youth for the vagina. Literally. I mean what else does “vaginal rejuvenation” imply?
And it is not just gynecologists offering these unapproved, untested vaginal laser therapies. Dermatologists, urologists, and even emergency medicine doctors (with have concierge medical practices on the side or as their primary source of income) offer this treatment.
I was skeptical before this data existed and this new study has only confirmed that I was right to be concerned. It is true that not everyone can use vaginal hormones for GUSM and that lubricants and moisturizers don’t always help these people, but the answer is not to offer untested, expensive, potentially harmful procedures under the guise of “vaginal rejuvenation.”
Now we have a sham controlled trial with the fractional carbon dioxide laser telling us the treatment is a sham. This procedure should not be offered outside of a well-designed, sham controlled clinical trial. And in my opinion, the FDA needs to step in and warn providers against using the fractional carbon dioxide laser for treatment of menopause-related symptoms.
People with vaginas deserve quality care, not inadequately studied, expensive interventions.