By Stephanie A. Prendergast, MPT, , Cofounder, PHRC Los Angeles
It is common knowledge amongst medical professionals and researchers that it takes an average of 17 years for research evidence to reach clinical practice. In 2002 an event occurred that changed healthcare overnight for menopausal women, affecting over 50 million people at the time. Twenty years later, tremendous confusion still exists amongst medical providers and patients about the safety of Hormone Therapy (HT). Women are fearful of HT and suffering unnecessarily. Researchers, medical providers, and advocacy groups are working hard to set the record straight.
What is Menopause and why is Hormone Therapy important?
Menopause is defined as a 12 month cessation of menses, the average age of menopause is around 52. However, the symptoms and consequences of hormonal deficiencies begin as early as 35 and will continue throughout a woman’s lifespan if left untreated.
Statistics and Facts
- 6,000 US women enter menopause daily
- 50 million women are currently menopausal in the US
- 80% of OBGYN residents admit to being ill-prepared to discuss menopause
- Less than 13% of PCPs asked their patients about menopause
- 84% of menopausal women struggle with genital, sexual and urinary discomfort that will not resolve on its own;less than 25% seek help
- Bloomberg cites – $150B in global productivity loss because of 1 million women leaving the workforce every year due to menopausal symptoms
What is the Women’s Health Initiative (WHI)?
The Women’s Health Initiative (WHI) is the largest, randomized longitudinal study to date designed to investigate strategies for the prevention and control of common chronic diseases in postmenopausal women, including cardiovascular disease, cancer, and osteoporotic fractures. This initiative was no small undertaking, it consisted of observational and study and clinical trials with over 161,000 women enrolled at 40 different clinics nationally.
While the WHI includes multiple studies, this blog focuses on the Postmenopausal Estrogen/Progestin Intervention (PEPI) trial of estrogen alone and estrogen in combination with three different progestins.
The Breakdown and What You Need To Know
- Study Design: randomized controlled primary prevention trial
- 16,608 postmenopausal women with an intact uterus were recruited for the estrogen and progestin arm
- 10,739 women post-hysterectomy were recruited for the estrogen-only arm
- Age of women included ranges from 50 – 79 years
- The study was intended to last longer than it did. The study was discontinued after 5.2 years because the groups receiving estrogen and progesterone showed a slight increased risk in breast cancer and heart disease.
Overnight, Hormone Therapy Was Abandoned
Before the actual study was published, the media learned about the discontinuation of the study and immediately headlines evoked fear and hysteria amongst medical providers and patients. The results were distorted and misinterpreted and all of a sudden patients on HT believed they would get breast cancer and heart disease. Insurance companies and doctors contacted patients and told them this was in fact true and to immediately stop HT. Just like that, 75% of prescriptions for HT were thrown away.
In the months and years following this news in July of 2002, researchers and clinicians tried to clarify the misinformation. Researchers part of the study tried to re-explain the same data with the right intent. They did not succeed in educating the majority of the country about what actually happened. One example is listed below, a free article available on PubMed.
- This paper is a re-evaluation of the studies based on the graphic analysis of the the tabulated data from the WHI study above
- In contrast to the conclusions reached by the WHI treatment of postmenopausal women with estrogen and progestin does not increase the risk of cardiovascular disease, invansive breats cancer, stroke, or venous thromboembolism.
- There is disagreement with the claim that an increased risk of stroke existed in women treated with estrogen alone.
The Facts: What We Know Now
The WHI was a tremendous effort to close the gender gap on the amount of research conducted on women vs white men. There were a number of significant flaws in the study that was halted. The authors themselves have since repudiated their own results, and numerous studies have been released showing the benefits of HT when used in a safe manner, but yet there is confusion and suffering.
In 2002 the majority of menopausal women in the US were using HT. Today, the number is estimated to be less than 7%.
What Went Wrong
The information below is a summary from the lecture The Truth About Hormone Therapy, sponsored by the Let’s Talk Menopause patient advocacy group and featuring North American Menopause Society leaders.
Three main trends caused the negative outcomes in the study mentioned above. First, it is important to note that in the study the increased risk of breast cancer and heart disease was not statistically significant, but also, we now know why there was even a slight risk at all and these risks can be mitigated in clinical practice today.
- The amount and consistent use of progesterone
In this study, daily synthetic progestin was prescribed to women in high doses. Progestin levels vary throughout the month, we now know supplementation should be closer to a woman’s normal cyclical pattern. Women with a uterus need to balance systemic estrogen therapy with a progestin to protect the uterine lining from hyperplasia. Synthetic progestins can be replaced with micronized progesterone which is safe and well tolerated.
- Failure to recognize the impact of age and when to start HT
Systemic estrogen reduces the symptoms of hot flashes, which tend to start as estrogen declines and before a woman is technically in menopause based on the definition (cessation of menses for 12 consecutive months). The study was blinded, meaning women in the study did not know if they were receiving HT or a placebo. Women under the age of 50 were excluded because the estrogen therapy would eliminate their symptoms and they would know they were receiving the actual treatment, therefore ‘unblinding’ them.
The median age of participants in the study was 65. 21% of women in the study were over the age of 70 and had never taken HT prior.
Recent studies show that HT is safe and best utilized at the onset of menopausal symptoms. The estrogen component will reduce hot flashes, which are not just an unpleasant symptom but actually an inflammatory event associated with cardiovascular disease. Early usage also helps with insomnia, mood issues, cognitive decline, and prevents bone loss. Experts agree HT should be started within the first three years of menopause to protect bone health, which significantly declines without HT in the first 5 years of menopause.
The risk of cardiovascular disease only occurred in women who started HT for the first time after 10 years in menopause.
- Body Mass Index (BMI) deviations from the regular population
Higher Body Mass Index is linked to higher risk for heart disease in all people. The women in this study had BMIs higher than average BMI for women in the US at the time. Despite this and the age concerns mentioned above, 23 women per 10,000 had heart disease incidence, which was not statistically significant.
Why does this matter?
Menopause is more than just hot flashes. Hormone Therapy is a safe an effective way to reduce bothersome symptoms (hot flashes, insomnia, mood changes, cognitive decline, bone loss) and also prevent cardiovascular disease, breast cancer, bone fractures, and the Genitourinary Syndrome of Menopause.
GSM was recently defined in 2014 as it’s own subset of menopause, and because it so closely affects or work as pelvic floor physical therapists we will be covering this in more detail in future posts. However, to get there we have to start here.
Conclusion
Despite current confusion, the experts do agree about HT. The North American Menopause Society, the American Society for Reproductive Medicine, the Endocrine Society and the International Society for the Study of Women’s Sexual Health take the position that HT is safe, especially for recently menopausal women. Grassroots advocacy groups such as Let’s Talk Menopause and My Menopause Matters are trying to help the information get out there. After all, this controversy is exceeding the 17 year rule of medicine changing by clinical practice, and women continue to suffer.
Additional Resources
The Experts Do Agree About Hormone Therapy
The Truth About Hormone Therapy
References
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Are you unable to come see us in person in the Bay Area, Southern California or New England? We offer virtual physical therapy appointments too!
Virtual sessions are available with PHRC pelvic floor physical therapists via our video platform, Zoom, or via phone. For more information and to schedule, please visit our digital healthcare page.
In addition to virtual consultation with our physical therapists, we also offer integrative health services with Jandra Mueller, DPT, MS. Jandra is a pelvic floor physical therapist who also has her Master’s degree in Integrative Health and Nutrition. She offers services such as hormone testing via the DUTCH test, comprehensive stool testing for gastrointestinal health concerns, and integrative health coaching and meal planning. For more information about her services and to schedule, please visit our Integrative Health website page.
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FAQ
What are pelvic floor muscles?
The pelvic floor muscles are a group of muscles that run from the coccyx to the pubic bone. They are part of the core, helping to support our entire body as well as providing support for the bowel, bladder and uterus. These muscles help us maintain bowel and bladder control and are involved in sexual pleasure and orgasm. The technical name of the pelvic floor muscles is the Levator Ani muscle group. The pudendal nerve, the levator ani nerve, and branches from the S2 – S4 nerve roots innervate the pelvic floor muscles. They are under voluntary and autonomic control, which is a unique feature only they possess compared to other muscle groups.
What is pelvic floor physical therapy?
Pelvic floor physical therapy is a specialized area of physical therapy. Currently, physical therapists need advanced post-graduate education to be able to help people with pelvic floor dysfunction because pelvic floor disorders are not yet being taught in standard physical therapy curricula. The Pelvic Health and Rehabilitation Center provides extensive training for our staff because we recognize the limitations of physical therapy education in this unique area.
What happens at pelvic floor therapy?
During an evaluation for pelvic floor dysfunction the physical therapist will take a detailed history. Following the history the physical therapist will leave the room to allow the patient to change and drape themselves. The physical therapist will return to the room and using gloved hands will perform an external and internal manual assessment of the pelvic floor and girdle muscles. The physical therapist will once again leave the room and allow the patient to dress. Following the manual examination there may also be an examination of strength, motor control, and overall biomechanics and neuromuscular control. The physical therapist will then communicate the findings to the patient and together with their patient they establish an assessment, short term and long term goals and a treatment plan. Typically people with pelvic floor dysfunction are seen one time per week for one hour for varying amounts of time based on the severity and chronicity of the disease. A home exercise program will be established and the physical therapist will help coordinate other providers on the treatment team. Typically patients are seen for 3 months to a year.
What is pudendal neuralgia and how is it treated?
Pudendal Neuralgia is a clinical diagnosis that means pain in the sensory distribution of the pudendal nerve. The pudendal nerve is a mixed nerve that exits the S2 – S4 sacral nerve roots, we have a right and left pudendal nerve and each side has three main trunks: the dorsal branch, the perineal branch, and the inferior rectal branch. The branches supply sensation to the clitoris/penis, labia/scrotum, perineum, anus, the distal ⅓ of the urethra and rectum, and the vulva and vestibule. The nerve branches also control the pelvic floor muscles. The pudendal nerve follows a tortuous path through the pelvic floor and girdle, leaving it vulnerable to compression and tension injuries at various points along its path.
Pudendal Neuralgia occurs when the nerve is unable to slide, glide and move normally and as a result, people experience pain in some or all of the above-mentioned areas. Pelvic floor physical therapy plays a crucial role in identifying the mechanical impairments that are affecting the nerve. The physical therapy treatment plan is designed to restore normal neural function. Patients with pudendal neuralgia require pelvic floor physical therapy and may also benefit from medical management that includes pharmaceuticals and procedures such as pudendal nerve blocks or botox injections.
What is interstitial cystitis and how is it treated?
Interstitial Cystitis is a clinical diagnosis characterized by irritative bladder symptoms such as urinary urgency, frequency, and hesitancy in the absence of infection. Research has shown the majority of patients who meet the clinical definition have pelvic floor dysfunction and myalgia. Therefore, the American Urologic Association recommends pelvic floor physical therapy as first-line treatment for Interstitial Cystitis. Patients will benefit from pelvic floor physical therapy and may also benefit from pharmacologic management or medical procedures such as bladder instillations.
Who is the Pelvic Health and Rehabilitation Team?
The Pelvic Health and Rehabilitation Center was founded by Elizabeth Akincilar and Stephanie Prendergast in 2006, they have been treating people with pelvic floor disorders since 2001. They were trained and mentored by a medical doctor and quickly became experts in treating pelvic floor disorders. They began creating courses and sharing their knowledge around the world. They expanded to 11 locations in the United States and developed a residency style training program for their employees with ongoing weekly mentoring. The physical therapists who work at PHRC have undergone more training than the majority of pelvic floor physical therapists and as a result offer efficient and high quality care.
How many years of experience do we have?
Stephanie and Liz have 24 years of experience and help each and every team member become an expert in the field through their training and mentoring program.
Why PHRC versus anyone else?
PHRC is unique because of the specific focus on pelvic floor disorders and the leadership at our company. We are constantly lecturing, teaching, and staying ahead of the curve with our connections to medical experts and emerging experts. As a result, we are able to efficiently and effectively help our patients restore their pelvic health.
Do we treat men for pelvic floor therapy?
The Pelvic Health and Rehabilitation Center is unique in that the Cofounders have always treated people of all genders and therefore have trained the team members and staff the same way. Many pelvic floor physical therapists focus solely on people with vulvas, this is not the case here.
Do I need pelvic floor therapy forever?
The majority of people with pelvic floor dysfunction will undergo pelvic floor physical therapy for a set amount of time based on their goals. Every 6 -8 weeks goals will be re-established based on the physical improvements and remaining physical impairments. Most patients will achieve their goals in 3 – 6 months. If there are complicating medical or untreated comorbidities some patients will be in therapy longer.