Understanding the differences between Compounded Bioidentical hormones and “Big Pharma” bioidentical hormones

One should realize that Big Pharma does make bioidentical hormones, ex: estradiol tablet, transdermal estradiol patches and gels, progesterone capsules are all bioidentical. The chemical make-up is the same as the estradiol and progesterone made by the ovary. These products have multiple doses, allowing for tailored dosing for each individual woman.  Big Pharma bioidentical products are FDA approved. There dosing is always consistent if it is created by the same manufacturer meaning that Brand names will always be the dosing that is stated but generics can be 25% higher or lower than brand products.  But, if one uses the same generic product made by the same manufacturer, then the dosing will be consistent.

Compounded hormones can also be tailored specially for the patient and many times women like to put there hormones all together into one cream which is more convenient and sometimes less expensive. Compounded hormones can also be placed in creams or oral capsules that are anti-allergenic and don’t have harmful preservatives or compounds in them:  cleaner drugs, without fillers in them. The only issue is that compounded hormones are not FDA approved because they do not contain the FDA package warnings and not all compounded pharmacies meet the new FDA sterilization guidelines leading to sterility issues.  Minimal government regulation and monitoring exists, so each pharmacy could potential create a different dosing and depending on the pharmacy overdosing/underdosing could potentially occur.  Patients must realize that the FDA package warnings that are placed in Big Pharma bioidentical hormones also relate to compounded bioidenticals. Thus, American College of Obstetrics and Gynecology does not approve of compounded hormones unless there is a documented medical issue with prescribing Big Pharma medication, ex: the patch doesn’t stick or the gels are too expensive.

The GOOD NEWS is that there is regulation of these pharmacies. The practice of compounding is regulated by state boards of pharmacy. … FDA has oversight for the integrity and safety of the drugs (called Active Pharmaceutical Ingredients, or APIs, by FDA) used in compounded preparations. Thus, the drug that is used in the cream is FDA regulated. The state board of pharmacy has created further oversight of compounding pharmacies. Compounding pharmacies must meet compliance with PCAB Pharmacy Compounding Accreditation Standards. PCAB is a service of Accreditation Commission for Health Care (ACHC) and is a third-party accreditation organization that has developed the highest national standards that providers are measured against in order to illustrate their ability to effectively deliver quality compounded medications to consumers. PCAB performs on-site visits with industry-expert surveyors who audit specific areas of performance. PCAB Accreditation also requires annual validation to ensure continued compliance with all applicable standards, similar to FDA regulation.  Furthermore, in Jan 2020 there will be new FDA sterilization guidelines for all compounding pharmacies too meet.

Bottom Line: compounded bioidentical hormones are similar to Big Pharma Bioidentical Hormones

Definition:

1.   The word “bioidentical hormones” means that the hormones in            the medication are the same chemical make-up as the hormones made by the ovary.            

  2.   Big Pharma Hormones: estradiol tablet, Estrogel, Divigel, estradiol  patches, femring, estring, estrace/estradiol 

The Dreadful UTI

Over the past few months, many perimenopausal and menopausal women have come in to the office with the complaint of a UTI or recurrent UTI’s. They don’t understand why NOW! Why are they suddenly occurring when they did not before? This stimulated me to write up an informational email on why UTI’s increase as we age.

Why do Urinary Tract Infections (UTI) increase during the perimenopausal and menopausal years? The answer is simple. It is because estrogen decreases. As the tissue becomes devoid of estrogen many changes occur! I will list for you the changes that occur when you add estrogen (E2) to your body or when you have the Mona Lisa Touch Procedure (MLT).

1.        E2 or MLT normalizes the vaginal flora

2.        E2 or MLT returns the vagina to its normal PH

3.        E2 or MLT increases the collagen in your vagina and bladder thus, making the tissue thicker, tighter but also stretchier. (I recommend both in order to obtain maximum thickness, tightness and stretch)

4.        E2 or MLT increases the top layer of cells and bringing them closer together.

5.       E2 or MLT increases anti-bacterial substances which will thus, decrease infection

So obviously a great way to prevent or decrease urinary tract infections is to use systemic or vaginal estrogen or obtain the Mona Lisa Touch Procedure. Sometimes both are needed.

Menopause and Hormones

This article brings you the most up to date information on issues that are important to all of us women.

To all of my patients: You may not be having menopausal symptoms as of yet but I am sure you know someone close to you who is!

Over the years there have been misconceptions about hormones, mostly the fear of breast cancer. Over the last years many studies have been done that have not been recognized by the press and public.

Last year the International Menopause Society came together and created a new consensus statement. This statement reveals the many BENEFITS of Hormones when they are started during the EARLY menopausal years. Like other recent articles this new consensus statement is not being blown up by the press.

The statement reemphasis that Hormone Replacement Therapy is the most effective treatment for menopausal symptoms (per hundreds of studies). It also enforces that early use during the perimenopausal and early menopausal years are BENEFICIAL and SAFE for the cardiovascular system, brain, and bones.”Increasing data indicate benefits for primary prevention of osteoporotic fractures and coronary artery disease and a reduction in all-cause mortality for women who initiate MHT around the time of menopause.”

Concerning breast cancer risk from hormones, the guidelines cite the increased risk for breast cancer attributable to hormones as less than 1 per 1000 women per year of use, which is a risk similar to or LOWER than the contribution of factors such as a sedentary lifestyle, obesity, and alcohol consumption (1-2 drinks a week).

The statement is even recommending that patients who are genetically predisposed to breast cancer can use hormones if needed because it will not increase their risk, per a large observational study.

Estrogen and Progesterone Benefits:

  • Improves quality of life
  • Improves sleep
  • Improves moods: increase neurotransmitters such as norephinephrine, serotonin, GABA, and endorphins. Without hormones the level of these neurotransmitters decrease
  • Improves Facial skin: increases skin thickening and tightening
  • Improves Libido
  • Improves the vaginal tissue
  • Improves Memory: early use before complete loss may decrease dementia risks
  • AND NO WEIGHT GAIN, you could actually lose weight because you feel better and have more energy

What Each Hormone Does to Us

Now, since we all know how Safe Hormones are, who needs them and when do the symptoms start? Symptoms of hormone loss can start in the late 30’s. Many women in their 40’s start to develop heavy painful sometimes erratic menses, insomnia, anxiety, irritability and decreased libido. Then as the years move on, other symptoms such as hot flashes, night sweats, brain fog, poor memory, palpitations and vaginal dryness occur. Some women only get a few of these symptoms; others get all of them, Ugh!

Estrogen controls : hot flashes, night sweats, feeling warm all the time, poor memory or concentration, anomia (cannot name things), vaginal dryness, pain with intercourse, skin and nail thinning, hair loss, wrinkles, palpitations

Progesterone controls: Insomnia, heavy erratic menses, anxiety, feeling overwhelmed.

Testosterone controls: libido (with the help of estrogen), improves orgasm, muscle mass/strength, confidence.

I can fix all of these symptoms with bioidentical hormones. These hormones will be dosed for each individual. Depending on your symptoms and lab levels you may only need progesterone or you may need both estrogen and progesterone or all three.

PLEASE STOP SUFFERING and START LIVING

Updated Guidelines for Hormone Therapy Use

Hormone therapy remains the most effective treatment for hot flashes and other troublesome menopause symptoms, regardless of a woman’s age

CLEVELAND, Ohio (June 20, 2017)–A new position statement on the use of hormone therapy (HT) for menopausal and postmenopausal women from The North American Menopause Society (NAMS) has been published online today in the Society’s journal, Menopause. “The use of hormone therapy continues to be one of the most controversial and debated topics,” says Dr. JoAnn V. Pinkerton, NAMS executive director. “The goal of this updated version of the Society’s position statement is to provide excellent, evidence-based, current clinical recommendations to menopause practitioners for the improvement of care for women depending on them to help relieve menopause symptoms.” The statement also reviews the effects of HT on various health conditions, such as cardiovascular disease and breast cancer, at different stages of a woman’s life.

What’s new in the 2017 position statement? The statement expands on and solidifies NAMS’s previous position on several critical areas of confusion regarding HT:

  • The risks of HT differ for different women, depending on type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is needed. Treatment should be individualized using the best available evidence to maximize benefits and minimize risks, with periodic reevaluation for the benefits and risks of HT continuation.
  • For women aged younger than 60 years or who are within 10 years of menopause onset and have no contraindications, the benefit-risk ratio appears favorable for treatment of bothersome hot flashes and for those at elevated risk of bone loss or fracture. Longer duration may be more favorable for estrogen-alone therapy than for estrogen-progestogen therapy, based on the Women’s Health Initiative randomized, controlled trials.
  • For women who initiate HT more than 10 or 20 years from menopause onset or when aged 60 years or older, the benefit-risk ratio appears less favorable than for younger women because of greater absolute risks of coronary heart disease, stroke, venous thromboembolism, and dementia.
  • Hormone therapy does not need to be routinely discontinued in women aged older than 60 or 65 years and can be considered for continuation beyond age 65 years for persistent hot flashes, quality-of-life issues, or prevention of osteoporosis after appropriate evaluation and counseling of benefits and risks.
  • Vaginal estrogen (and systemic if required) or other nonestrogen therapies may be used at any age for prevention or treatment of the genitourinary syndrome of menopause.

“NAMS discovered through its review of the literature that the previous position that hormone therapy should be prescribed only for the ‘lowest dose for the shortest period of time’ may be inadequate or even harmful for some women,” says Dr. Pinkerton. “NAMS has clarified this position to the more fitting concept of the ‘appropriate dose, duration, regimen, and route of administration’ that provides the most benefit with the minimal amount of risk. In addition, women older than 65 years old will be relieved to know that they don’t have to stop using hormone therapy for their bothersome hot flashes just because of their age. The data simply do not support it, but individualized evaluation and discussion is recommended.”

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NAMS has developed a patient education piece, “Deciding About Hormone Therapy Use,” part of its MenoNote series available on its website. This valuable handout simplifies the data in the new position statement for women trying to make decisions about using HT.

Stop and Prevent Wrinkles with Estrogen and Pelleve

Okay Girls, here is what we know about stopping wrinkles!  Don’t let your estrogen decline, use Retin A and stimulate the collagen with Pelleve (my preference) or laser resurfacing or micro-needling.  As Dr. Diane Madfes said at the American Academy of Dermatology, “Estrogen supplementation and collagen stimulation are both effective in preserving the integrity of a women’s skin as the levels of the hormone decrease.”

After a few years of declining estrogen levels, we lose 50% of our Type 3 collagen. This is because estrogen maintains the receptor that promotes collagen formation. Without estrogen, we cannot stimulate collagen anymore.

Estrogen not only stimulates collagen but it exerts a plethora of antiaging, skin-preserving effects. Estrogen protects against oxidative damage. The hormone also protects skin’s water-binding qualities by promoting mucopolysaccharides, sebum production, barrier function, and hyaluronic acid. It may even play a role in protecting against ultraviolet light. Estrogen also helps with healing.

All these add up to rapid skin aging after estrogen levels drop.

“The visible effects of aging on women’s skin are not so much related to her chronological age as to the years after menopause,” Dr. Madfes said – a finding that is particularly illustrated in young women with surgical menopause and those with breast cancer who take tamoxifen. The observation seems to suggest that early intervention with estrogen might help prevent at least some of the signs of aging.

So why not use estrogen on your face, you can! So if you don’t want to use systemic estrogen that increases your estrogen levels, then just use low doses on your face.

Come and make an appointment today to discuss YOUR FACE.

Vaginal Lubricants

Creating a blog about vaginal lubricants seemed like a simple project but after researching the subject I was amazed by what I found. First of all READ THE LABELS! If you care about what you place into your body, you should be just as concerned about what you place onto your vagina.

What to avoid:

  • Avoid Petroleum based products.
  • Avoid products on the market that have irritants in them such as: glycerin, propene glycol and parabens.
  • Avoid water based products that don’t have a natural ph of 3.5 to 4.5.
  • Avoid products that have a high osmolality, the goal is 350 to 1200 mOsm/kg.

Irritants, non-natural ph values and high osmolality can cause increased bacterial infections in the vagina and can cause cell death.

For a list of products naming their osmolality and PH values, (for example the popular product KY Jelly has high osmolality and parabens), see:

Onward to a summary of differnt types of lubricants:

Water Based Lube

Water based lubes are the most common lube types to find. Many prefer them, as they are easy to clean off clothes and bedding as well as safe to use with barriers and condoms. They are often the most gentle lube types and are available in many different formulas like gels, creams, and liquids. They are compatable with any sex toy.

What to look for:

  • First ingredient is water or aloe, if glycerin is present AVOID!
  • It can feel cool to the skin and may get a little sticky after a while.
  • Most commonly used.
  • Offers the most variety, including flavors, warming, stimulating and natural.

Silicone Based Lube

Silicone is a natural element that is hypoallergenic by nature. It lasts longer than water-based lube so there is less need to reapply during sex. If you are looking to enjoy some playtime in water, like shower or bath, silicone lube is the way to go. IMPORTANT: Most silicone based lube is not compatable with latex condoms.

What to look for:

  • Ingredients that end in “ol” or “cone” like, dimethicone or dimethiconol. Also ingredients like cyclopentasiloxane.
  • Never feels sticky.
  • Creates long lasting glide.
  • Great to use in the water (tub, shower, pool).
  • DO NOT USE with Silicone devices.
  • Hydrates, protects and traps moisture in the skin.

Hybrid Based Lube

Hybrid lubes are a mixture of water and silicone based and often have creamy textures comparable to the body’s natural fluids. However, because they still do contain silicone, they ARE NOT to be used with condoms, barriers and silicone devices.

What to look for:

  • Water-based lubricant with silicone ingredient such as, dimethicone. It is usually visually white or creamy looking.
  • Feels slippery, but think enough to feel sensation.
  • A unique water-based lube that does not feel sticky.
  • Leaves skin feeling silky smooth when dry.
  • Often hydrates, protects and traps moisture in the skin.
  • Not recommended for use with most silicone devices.

Plant Based Lube

These can be gel or liquid and contain a blend of plant-based derivatives instead of silicone polymers.

What to look for:

  • Provides smooth glide and feels very silky.
  • Some may contain a natural form of glycerin that is derived from vegetable oil or plant based cellulose.
  • May contain aloe for its healing and moisturizing properties.
  • Many formulas are certified organic, which appeals to many customers.
  • Most formulas are compatible with all toy materials. Be sure to check your device label prior to lube use.

Now for MY OPINION, unless you are playing with toys or using condoms just open your pantry and use the most natural products out there: OLIVE OIL or COCONUT OIL. Both are edible and inexpensive.

Neither one increases bacterial count, kills cells or irritates the skin. Coconut oil has been studied to be antibacterial and antifungal. Both are moisturizing, and olive oil can even be used for those trying for pregnancy.

So in closing, pay attention to the ingredients of the various lubricants on the market.

New Guidelines On Menopause from the National Institute for Health and Care Excellence

Guidelines from the National Institute For Health and Care Excellence (NICE) offer a unique perspective of diagnosis and management of menopause, designed to help women stop suffering in silence.

The safety of hormone replacement therapy (HRT) depends largely on the age of the patient. For most women the risks are few and the POTENTIAL BENEFITS ARE MANY when HRT is given for clear indications and therapy is initiated within a few years of menopause.

Here are a few key statements on hormone therapy:

Combined HRT may be associated with 5 additional breast cancer instances per 1,000 women greater than age 50 after 7.5 years of use. Overall mortality is not increased. There is in fact, a GREATLY DECREASED RISK ASSOCIATED WITH ESTROGEN ALONE. Risk returns to baseline after stopping HRT, suggesting HRT acts as a PROMOTOR rather than an INITIATOR.

CVD (Cardiovascular Disease) risk is not increased when starting therapy in women less than age 60.

DVT/PE (Deep Vein Thrombosis/Pulmonry Embolism) background risk with oral estrogens, which is 1.7 per 1,000 women greater than age 50 after 7.5 years of use by women greater than age 50. Greater risk is in the first 12 months of use. RISK WITH TRANSDERMAL ESTROGEN IS NO GREATER THAN GENERAL POPULATION RISK.

For the full article see: Contemporary OB/GYN September 2017 Issue