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Serious potential harms and financial conflicts missing in recap of study on vaginal laser surgery for menopausal symptoms

Getting relief from sexual dysfunction and incontinence caused by menopause

Our Review Summary

This news release summarizes an observational study on the benefits of CO2 ablative laser treatments for reducing menopausal symptoms like vaginal dryness/itching/burning, painful intercourse, frequent urinating, or incontinence in 94 post-menopausal women. While the release makes the claim that the study “demonstrated that this type of laser surgery was particularly effective in reducing the intensity of dyspareunia (painful sex) and dryness,” it was an observational study which cannot show cause-and-effect.

The release notes that this intervention is a subject of debate among experts, and that more studies are needed to confirm the long term efficacy and safety of this approach.

It falls short in several areas: it neglects to mention that the FDA warns against using lasers for menopause symptoms, excludes any data from the study, and omits disclosure of significant financial conflicts of interest among study authors and the organization that distributed the release, the North American Menopause Society.

 

Why This Matters

It’s estimated that around half of post-menopausal women have at least one of the aforementioned constellation of symptoms that some doctors label “genitourinary symptoms of menopause,” or GSM, and others see as normal (but problematic) symptoms of a low estrogen state.

Some women respond well to symptomatic treatment, others may choose hormone replacement, and some struggle to find relief. It’s important to point out that many women seek no treatment at all.

For women interested in treatment, finding reliable information can be problematic. Thorough and thoughtful news releases and news coverage should, at the very least, provide:  good data balancing the benefits and potential harms, give a sense of safety and efficacy in comparison to other existing treatments, seek out independent experts not involved in the highlighted study, as well as fully disclose if that study could be biased by conflicts of interest.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The cost of CO2 laser therapy is not mentioned.

Much of the CO2 laser treatment in the US is applied to skin — often for wrinkles, scars, discolorations, or people who want to look younger. According to WebMD such “laser skin resurfacing” cost an average of $2,330 in 2016.

However, it’s unclear if vaginal laser therapy would be comparable in terms of duration, equipment involved, or cost.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The release does not offer data to support this statement:

This type of laser surgery was particularly effective in reducing the intensity of dyspareunia (painful sex) and dryness. It further demonstrated that four or five laser therapies may be superior in lowering GSM symptoms compared with three in both short- and long-term follow-up.

Readers might correctly guess the improvements reported come from patient questionnaires, but would have no sense of the scale or significance of these benefits.

Without supporting evidence they’d also be left wondering which GSM symptoms improved, by how much, and for how long.

It also appears that the results after three treatments is very similar to four or five treatments without any evaluation of the side effects.  Most importantly, since the study was not controlled and subjects were not randomized, there are multiple confounding factors that could have been responsible for the beneficial results.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

Not mentioned and extremely relevant based on this June, 2018 publication by the FDA:

FDA warns against use of Energy-based devices to perform vaginal ‘rejuvenation or vaginal cosmetic procedures

This includes “procedures intended to treat vaginal conditions and symptoms related to menopause, urinary incontinence, or sexual function”

Side effects listed include: “vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.”

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The release does well to point out this is a “small, retrospective, non-sham-controlled study” and that “there is ongoing debate regarding the safety and effectiveness of vaginal laser surgery.”

Several key limitations of the study were excluded. The release claims that the study “demonstrated that this type of laser surgery was particularly effective in reducing the intensity of dyspareunia (painful sex) and dryness.”  It should have more directly stated that as an observational study, it cannot show cause-and-effect.

In addition, the study could not exclude the possibility that some of the positive outcomes reported by the subjects were due to a placebo effect.

Does the news release commit disease-mongering?

Satisfactory

The release tells us that “painful sex, dryness, itching/burning, urinary frequency, and incontinence” are symptoms and signs associated with menopause. We’re also told that “collectively” these represent genitourinary syndrome of menopause (GSM) which the gynecologic literature variably describes as either a “condition” or a “constellation of symptoms” associated with low estrogen levels in women. (See this helpful essay from Harvard Women’s Health Watch.)

Some readers might be left wondering: “So is GSM a disease? Do I need to have all the symptoms to qualify? Aren’t many of these symptoms part of ‘normal’ menopause? Or, is having such symptoms abnormal and should therefore be treated?”

We wish the news release had made it clear that these symptoms can represent normal aspects of aging that many women choose to manage with non-pharmacologic and non-surgical approaches.

We’ll give this the benefit of the doubt and rate this satisfactory since it’s debatable whether or not this news release disease mongers.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

Funding for the study is not included.

Also relevant for readers, but not mentioned, is that two of the authors have financial ties to the company that produces the laser tested in this study. Both authors have been expert witnesses for the laser company, suggesting a higher degree of approval of the therapy and potential for bias in the way the study is done.

Equally relevant is that the National Menopause Society (NAMS)  — which authored the news release — receives corporate support from about a dozen biotechnology companies, many that sell treatments targeted at GSM.  Also, about three-fourths of the NAMS board have disclosed relationships with industry.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The news release names some of the many treatments available for managing menopause symptoms through this quote from the executive director of NAMS:

Until more data are available, all treatment options, including lubricants, vaginal moisturizers, and FDA-approved vaginal and systemic hormone therapies, should be discussed with women who suffer from GSM to determine the best treatment option for them.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

It’s mentioned that vaginal laser surgery represents “one of the newer and more hotly contested approaches” to menopause symptoms.

So we’ll give this a satisfactory mark, but it would have helped readers to give them a ballpark sense of how widely the surgery is being used in North America.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The news release doesn’t say what’s new about the study.  Lasers have been used for vaginal atrophy for at least 5 years. It’s not clear from the release how long CO2 lasers have been used for genitourinary symptoms.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

The release is unjustified in claiming that this observational study demonstrates effectiveness. It made the claim in the following paragraph:

The results of this small, retrospective, non-sham-controlled study demonstrated that this type of laser surgery was particularly effective in reducing the intensity of dyspareunia (painful sex) and dryness. It further demonstrated that four or five laser therapies may be superior in lowering the intensity of GSM symptoms compared with three laser therapies in both short- and long-term follow-up.

The last paragraph of the release somewhat moderates the hearty endorsement of the therapy.

Total Score: 3 of 10 Satisfactory

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