The Journal of Obstetrics and Gynecology published a study in September 2023 that investigated whether treating with vaginal estrogen for vulvovaginal symptoms of menopause posed a safety risk to breast cancer survivors, particularly the risk of breast cancer recurrence. The conclusion, that they found NO increase in risk and therefore the use of vaginal estrogen appears to be safe in breast cancer survivors, regardless of whether they had estrogen receptor positive (ER+) versus estrogen receptor negative (ER-) breast cancer.1

In the United States, breast cancer is the #2 cancer affecting women and will likely affect 1 in 8 women within their lifetime.2 Of women diagnosed and treated systemically for breast cancer, an estimated 70% of them will develop vulvovaginal symptoms of menopause which presents with symptoms such as genital dryness/burning/irritation, lack of vaginal lubrication, pain with intercourse, urinary urgency, pain with urination, and recurrent urinary tract infections.3 The root cause of these symptoms is the lack of estrogen. Up until present day, the use of Vaginal Estrogen for treatment of vulvovaginal symptoms has been contraindicated in women with a history of breast cancer. Many physicians believe it to be a major contraindication, and so this treatment has been uncommon in this patient population. Only an estimated 5 in 100 women with a history of breast cancer were treated with vaginal estrogen for vulvovaginal symptoms of menopause, and 4 in 100 women who had a history of ER+ breast cancer were treated.

The findings of this recent study is good news for patients with a history of breast cancer. Both women and their healthcare providers can feel more confident when deciding whether the benefits of treatment with vaginal estrogen outweigh the overall risks. The quality of the study is more good news for healthcare providers, because 1) the study looked at a substantial patient group of more than 42,000 breast cancer survivors and 2) the study followed these women for up to 5 years.

While this study is robust and encouraging, there was likely variability in what was considered treatment with vaginal estrogen and dosages/formulations varied. At Fowler Gyn International, treatment for chronic vulvovaginal conditions associated with altered vaginal microflora may use doses of vaginal estrogen that are higher than the doses commonly prescribed by gynecologists. If you are one of the many proud breast cancer survivors and still fear the use of any estrogen supplementation, the FGI Approach also offers effective non-estrogen treatment for vulvovaginal conditions. Inquire here thru Talk-to-Doc!

References:
1. Agrawal P, Singh SM, Able C, Dumas K, Kohn J, Kohn TP, Clifton M. Safety of Vaginal Estrogen Therapy for Genitourinary Syndrome of Menopause in Women With a History of Breast Cancer. Obstet Gynecol. 2023 Sep 1;142(3):660-668. doi: 10.1097/AOG.0000000000005294. Epub 2023 Aug 3. PMID: 37535961.
2. American Cancer Society: information posted on their website.
3. Kim HK, Kang SY, Chung YJ, Kim JH, Kim MR. The Recent Review of the Genitourinary Syndrome of Menopause. J Menopausal Med. 2015 Aug;21(2):65-71. doi: 10.6118/jmm.2015.21.2.65. Epub 2015 Aug 28. PMID: 26357643; PMCID: PMC4561742.

As recent as ten years ago, many docs did’t know the term “vulvodynia.” The condition has been around since the first report of symptoms consistent with the condition published in the medical literature in the 1870’s. That’s 150 years ago. Most docs had not heard of vulodynia even by the turn of the century in 2000. Today nearly all gynecologists know the term vulvodynia and understand the symptoms. But there is nobody I know of,  except myself, claims to have a treatment that consistently works.  I 1997 all the vulvovaginal experts in the world who were gathered at Beveno, Italy for the ISSVD XIV World Conference scoffed at me for suggesting external irritants had anything to do with vulvodynia. Today, avoidance of external irritants is the first thing knowable vulvologists teach their patients. There are many names for vulvodynia, all of which make no sense because none of them are etiology based. Because I believe I have discovered the etiology of vulvodynia, I have divided the vulvodynia patients into two diagnostic groups; EIV stands for External Irritant Vulvodynia and AFV stands for Altered Vaginal Microflora Vulvodynia. I find vast majority are AFV patients. It’s easy to know the distinction because, AFV patients have Altered Vaginal Microflora on Vaginal Fluid Analysis. I presents these findings at the ISSVD  World Congress XVII in Queenstown New, Zealand in 2006. All but four of the worlds vulvovaginal experts scoffed at me.  EIV have normal flora. It’s an objective finding. However, once the vestibule gets sensitized by the irritant vaginal secretions in AFV, they act just like EIV patients because external irritants exacerbate their symptoms as well.

So now you understand, all vulvodynia starts from irritation of the vestibule which is made of different embryologic tissue called Endoderm compared to the tissues lining the vagina above bing Ectoderm and lining the ‘more exterior’ vulva below also derived from Ectoderm. In some patients, the irritation at the vestibule level triggers pelvic muscle tightness called Levator Ani Syndrome or Pelvis Floor Spasm or Pelvic Floor Tension Myalgia. This is why you hear of some docs prescribing PT. This is miss-guided because it will usually make the symptoms worse for several months then the symptoms will get perhaps 30-40% better. It’s expensive. If the vulvodynia is treated correctly so that the burning resolves, the pelvic floor muscle tightness goes away with no more trigger factor. I believe most docs that are experiencing success with vulvodynia patients, are treating those of the EIV type. EIV will completely resolve with just avoidance of irritants, it doesn’t matter what else from the long list of treatments available. See my Blog of Jan 2023.  AVF patients usually respond between 30-50% from just avoidance of external irritants alone. But this large group will not be cured unless they have treatment to fix the altered vaginal microflora. This is where The Fowler Gyn Approach stands above and beyond what else is out there.

The most unique feature is the use of advanced diagnostic testing with qualitative Vaginal Fluid Analysis testing (VFA Test). Other gynecologists continue to use the century old technique of Wet Preparations. Fowler Gyn International Laboratory is CLIA certified and utilizes reagents, staining and quantification techniques with analysis under phase contrast microscopy. It appears that Dr. Fowler is the only gynecologist in the US that has CLIA certified laboratory dedicated to the complex analysis of vaginal constituents. Moreover, Dr Fowler discovered the etiology  of a set of related chronic vulvovaginal conditions; vulvodynia, chronic vaginal bacterial infections, recurrent yeast infections, urinary frequency & urgency w/o bladder cause, recurrent UTI’s w/o bladder cause. For instance, the rest of the world believes that vulvodynia is a nerve condition involving the skin of the vulva. Dr. Fowler discovered vulvodynia and the rest of these conditions have a common underlying etiology known as vaginal dysbiosis. He has developed and perfected treatment protocols over several decades which required numerous patient-years observation. There has not been another medical practice in the country posting the number of testimonies as shown for the Fowler Gyn Approach. Its’ quite clear that the exceptionally high response rate has led to more social media buzz than virtually any other vulvovaginal physician in the country.

Based on your age, hormone profile and results of the VFA test, Dr. Fowler selects the proper place in the algorithm of mixed bio-identical hormone doses that you should start with. There are 42 different doses in the FGI algorithm. It takes 4 months to allow the majority of the response that will be induced by a particular dosage. The progress is measured by the change in the six VFA parameters.

Dr. Fowler has found that each woman has a narrow band-width to which they respond. There is no response with too little hormone and there is no response if too much hormone is given. Women with these conditions are different than the general population of women in that their vaginal mucosa only responds to the higher echelon of hormone levels and it must be the proper ratio of bio-identical hormones and it must be formulated in a base that will not cause any reaction. If any of these three things is wrong, the treatment will fail. The base is the medium through which the hormone is delivered. These are all vaginal preparations; the treatments are NOT given orally.

Women who have these conditions should look at it this way. You have a vagina like that of a jet engine compared to and automobile engine. As long as the jet gets it’s high octane Jet A fuel then the engine produces amazing horsepower. If it receives the lower octane fuel of Mogas, it sputters and spurts. In real terms, the vagina shrinks in caliber and length, the mucosa becomes dry, and an altered vaginal microflora pattern develops. This micro-environment is conducive to the growth of aberrant bacteria and yeast.  The vaginal secretions change from being soothing to an irritant. These secretions may have a new odor and plentiful enough to cause a new discharge. These secretions work their way down the vagina and onto the vestibule at the opening of the vagina. The vestibule is about 1/2” wide and made of endoderm. It is the endoderm that gets sensitized and causes burning, stinging or rawness. This tissue is flanked on both sides by ectoderm of the vagina and the ectoderm of the vulva. The ectoderm is more resilient and generally does not get sensitized.

The VRT treatment is aimed  at getting the flora to change back to normal, then the secretions are no longer irritating and the variable symptoms of burning, rawness, stinging, itching and/or urinary frequency/urgency resolve. Symptoms which are a direct result of the altered flora such as dryness, odor and discharge also resolve.

Based on the VFA test results and your hormone profile(HP), the FGI Approach uses two to six vaginal ingredients, collectively known as the Vaginal Rejuvenate Therapy (VRT) for therapy.

The considerations in the HP are as follows: your age, proximity to menopause, factors that influence your endogenous estrogen production such as lifestyle stress, exercise and body weight, whether you still have sexual arousal wetness and a q-tip assay for vaginal moisture which you can preform.

While the rest of the medical world still believes that vulvodynia is a condition limited to the vulvar skin and nerves, the FGI Approach recognizes that it is secondary to the underlying etiology. Specifically, the conditions of vulvodynia, chronic bacterial infections from Gardernella Vaginalis which is an indicator of possible BV or one of the the other 30+ bad bacteria, recurrent yeast, chronic vaginal odor or discharge, or urinary frequency/urgency without a blabber cause, are all caused by altered vaginal microflora or in some cases of vulvodynia, by exposure to external irritants.

The vaginal secretions in cases of altered vaginal microflora change from neutral to an irritant. This does not hurt the tough Ectoderm of the vagina but just up inside the opening of the vagina, the lining of the vagina changes to Endoderm, a rim about 1/2” wide, flanked on both sides by Ectoderm. The Endoderm is of different embryologic origin than the Ectoderm. In fact this is the only area in the human body, including men and women, where Endoderm is exposed to the outside environment. It is the Endoderm that is prone to getting irritated by stimulants and becoming inflamed. It is the inflamed Endoderm that stimulates the underlying nerves of the vulva. You see everybody else in the world as far as Dr. Fowler can determine, treats Vulvodynia in particular as a condition of the skin and the nerves. Now you see that’s not; the skin and nerve irritation are secondary to the underlying cause of altered vaginal microflora and/or external irritant exposure.

These conditions require two-six vaginal medications to correct, known as Vaginal Rejuvenate Therapy.

The etiology of chronic vaginal burning pain, a condition come to be known as Vulvodynia, eluded physicians for over a century. Hope for relief from the pain was dismal. Internet stories abound of women having their lives ruined due to inability to concentrate at work, engage in intercourse, exercise or enjoy social functions. That all changed when a Mayo Gynecologist,  R Stuart Fowler, M.D. discovered the underlying etiology. There proved to be two types. The most common etiology is altered vaginal microflora where the vaginal secretions turn from a neutral to an irritant. Dr. Fowler created the designation, Altered Flora Vulvodynia, AVF. The second much less common etiology arises from irritants in common hygienic products, designated External Irritant Vulvodynia or EIV. This resolves with the change in products that  get in contact with the vulva. It took years for Dr. Fowler to develop a way to correct the underlying vaginal microflora of women with AFV. It proved difficult because each woman requires an individualized approach. Although it’s one approach that fits all, it’s not one treatment fits all. Now Dr. Fowler has 42 protocols for women with Altered Flora Vulvodynia. Each woman goes into the algorithm based on her Hormone Profile (HP) and results of the VFA Test. The VFA test is a quantitative analysis of the constituents of the vagina. During treatment, this test also provides objective evidence of how close the flora is approaching normal. This treatment has proved a success in thousands of women. Unlike the dozens of “bandaid” therapy available for vulvodynia patients, the Fowler Gyn International approach provides a cure for both underlying etiologies of vulvodynia.

There is trick to getting Vulvodynia to totally resolve. One must have a treatment formula that will allow the vulvar skin, particularity located in the vestibule, to totally turn over several times under perfect non-irritated conditions. It seems all gynecologists in the world have been taught and believe, except for the experts at FGI, that vulvodynia is a condition of the vulvar skin and nerves. In truth, that’s secondary to the real etiology. But the vulvar skin, especially the vestibule is where the pain emanates from. Treating the skin and/or the nerves is only bandaid therapy covering over where the stimulus acts. However, to have an effective treatment, it must protect the vulvar skin from irritants until the skin has turned over 5-6 times. In the forth thru sixth time when the skin turns over, the cells lying next to the nerves are no longer irritated and no longer stimulate the nerves.

The vulvar/vestibular skin is constantly turning over. The newly forming cells start at the bottom of the skin known as the basement membrane and gradually push their way to the top layer as they maturate. When they reach the top, they detach and break away to join the vaginal secretions, making room for newer cells growing up from below. It takes roughly one month for new cells to get all the way to the top layer, meaning the vestibular skin you have now will be totally replaced in 4 weeks!

The turnover or shedding of maturated cells provides vaginal secretions with a high nutrient content for lactobacilli. The turnover varies from a few in number to a larger number of cells over a given time frame. This exposes more or less immature cells to external/internal stimulants. This is why as FGI treatment proceeds, symptomatically it is common to have a few good days followed by some bad days, then a good week or two followed by a few bad weeks and so forth. The more new cells exposed to irritants, the more sensitive the vestibule feels. After approximately 4-6 turnovers, the sensitized skin cells are fully replaced by non-sensitized cells which no longer stimulate the nerves and then the symptoms finally resolve for good, until another “vaginal insult” occurs. However, the longer the vulvar skin does not get influenced by external irritants or vaginal insults, the more reserve the skin develops. After 1 year of being asymptomatic, the vulvar skin can withstand normal insults like exposure to harsh hair shampoo, saliva, perspiration, fragrance, vigorous intercourse, brief hormonal changes, etc. Once most FGI clients are out 3-5 years, they often nearly forget their horrible years with vulvodynia. Unfortunately, most women do get occasional extreme exposure to irritant or significant hormonal change which causes a relapse every 5-10 years or so. Fortunately, the experts at FGI know how to adjust their protocol based on VFA testing and the condition remits quite quickly again for years more symptom free living.