ALTERNATIVES TO DRUGS MADE WITH CONJUGATED EQUINE ESTROGENS

by JANE ALLIN

As part of of the The Horse Fund's campaign against the manufacture and use of the Premarin family of drugs – Premarin, Prempro and Duavee – we have compiled a list of alternatives to drugs made with pregnant mare's urine (conjugated equine estrogens).

We encourage you to go online to further acquaint yourself with the effectiveness and safety of these compounds. There is a wealth of information out there, but beware of false claims and err on the side of caution.

And, as always, please consult with your doctor before you use these or any other alternatives for the relief of menopausal symptoms.

LIFESTYLE CHANGES

Probably the simplest and most natural approach to the treatment of menopause is to adopt a healthy lifestyle in regard to diet, exercise and stress management. Not only will this help alleviate symptoms but the benefits will ensure that you remain healthy now and in the future.

  1. Nutrition: It should go without saying, avoid refined and processed foods, choose more whole foods, fresh fruit, vegetables and complex carbohydrates. Avoid high fat dairy products and meats and supplement these items with healthy fats such as olive oil, nuts, seeds and lean cuts of meat or fish. Additionally, practice portion control and avoid empty calorie foods.

  2. Exercise: Exercise is vital to keeping symptoms in check. Exercise directly affects hormonal activities in the body by raising the level of endorphins, for example, to maintain emotional stability and suppress anxiety. Moreover, the benefits are unsurpassed: maintenance of muscle and joint strength, increased metabolism, reduced weight, improved cardiovascular health, increased cognitive function, maintenance of bone integrity, and the list goes on.

  3. Stress Management: It is a well known fact that stress induces more severe hot flashes. There are many stress-reduction techniques available to manage the burden of everyday anxiety – rest, relaxation, varied leisure activities, and most importantly self-affirming thoughts to maintain self-image and confidence.

  4. Lifestyle Solutions: Common sense solutions that include dressing in layers, lowering room temperatures, consuming cool drinks, and avoiding alcohol and caffeine. For those women who are overweight, weight loss can also help.

DIETARY PHYTOESTROGENS

Dietary phytoestrogens are naturally occurring substances (e.g. Isoflavins) found in fruits, vegetables, and whole grains such as soybeans, alfalfa sprouts, and oilseeds (such as flaxseed).

There is some evidence that they have a weak estrogen-like effect that may reduce the intensity and frequency of hot flashes.  However an authoritative review of placebo-controlled studies of plant-based estrogens found no convincing evidence that they were helpful in curbing menopausal hot flushes.

One exception was genistein, a substance in soy, which the researchers said warranted further study (http://goo.gl/mivG1p).

Eating natural foods that contain these compounds is safe but there are also non-prescription supplements on the market for which there is no long-term safety data.

PRESCRIPTION DRUGS

There is also convincing evidence that some prescription drugs such as SSRIs, SNRIs, Gabapentin, Clonadine (Catapres) and Pristiq, which are not licensed for treating menopausal symptoms do in fact alleviate hot flashes and night sweats. These are powerful drugs yet in severe cases some doctors may be willing to prescribe one of these treatments, with the patient’s consent.

Megace and Megace ES are synthetic female hormones belonging to the progesterone group used for stimulating appetite and treating breast cancer. The mechanism of appetite stimulation or suppression of cancer is not clearly understood and was FDA approved in 1993.

HERBAL MEDICINES

Herbal medicines are readily available however caution is advised since they can contain powerful ingredients that may contraindicate other prescription drugs and/or may have adverse effects on certain individuals.

Some examples include: Black Cohosh for hot flashes and sweating, Kava to reduce anxiety, Ginko to decrease the risk of onset of dementia and St. John’s Wort as an anti-depressant. No substantiated medical studies are available for these medicines and most do not have to comply with the stringent safety, quality and manufacturing regulations that govern conventional medicines.

IN THE NEWS

As time progresses many women – and doctors – are looking for safer and more humane alternatives to conventional HRT.

In 2010 a non-hormonal supplement called Amberen, manufactured by Lunada Biomedical, was touted as the next cure-all for relief of menopausal symptoms. Claiming to have a double-blind, placebo-controlled clinical study to back its effectiveness, it contains 100% natural ingredients, all on the FDA’s approved Generally Recognized As Safe (GRAS) list. To date there are mixed reviews on its effectiveness – some it works for, some it doesn’t.

Osphena – touted as the new female Viagra – was FDA approved in 2013 for the treatment of painful sex due to vaginal atrophy associated with menopause.

Osphena is a SERM (selective estrogen receptor modulator) that acts as an estrogen agonist/antagonist – the same class of drugs as bazedoxifene. However it carries with it risky side effects: stimulation of the lining of the uterus that can lead to uterine cancer, increased risk of blood clots, hot flashes and drug interactions.

Moreover in early June 2013 the U.S. Food and Drug Administration approved the drug “Brisdelle” (paroxetine) for the treatment of hot flashes due to menopause. 

Brisdelle contains the selective serotonin reuptake inhibitor paroxetine mesylate, making it unique from all other FDA-approved treatment for hot flashes which contain the hormones estrogen or progestin. 

Brisdelle, manufactured by Noven Pharmaceuticals, is the first non-hormonal treatment to be approved by the FDA for hot flashes associated with menopause.

BUYER BEWARE

1.  Bio-identical Hormones

The term Bioidentical Hormone Replacement Therapy (BHRT) or “natural hormone therapy” is poorly defined and without a precise medical definition.

Bio-identical hormones are synthesized in the lab from plant sources and as the term implies are pharmaceuticals that closely mimic natural hormones produced in the body since they possess the same molecular structure as endogenous hormones.

There are two classifications of bioidentical hormones; (1) FDA-approved and; (2) compounded in pharmacies based on hormone levels measured in saliva and blood tests (not FDA approved).

The terminology is confusing and the FDA considers “BHRT” to be a marketing term. The lack of distinction between FDA-approved bioidentical hormones (often referred to as synthetics) and compounded bioidentical hormones has resulted in considerable misunderstanding regarding exactly what BHRT is.

The vast majority of advocates of BHRT are referring to the compounded versions where hormones are custom-mixed by a pharmacist – unapproved drugs.

In addition to estrogen and progesterone, these compounded drugs may contain other hormones such as testosterone, DHEA and adrenal hormones extracted from animal glands. [1]

Often promoted as being safer than conventional HRT derived from pregnant mare’s urine, are these claims of a safer alternative justified?

This includes both FDA-approved and compounded hormones. A Harvard Women’s Health Watch article illustrates that there is much evidence to suggest they are not. [2]

  • In contrast to mainstream thought, compounded BHRT hormones are drugs – just not approved.

  • As much as it may seem that these hormones are safer than the Premarin® family of drugs, there is no solid evidence to prove this. Some of these drugs have been approved by the FDA because data collected from trials has proven their effectiveness in relieving menopausal symptoms and reducing the risk of osteoporosis. However there have been no long-term studies like the WHI performed to assess their safety profile.

  • FDA-approved bioidenticals come with black box warnings analogous to those for conventional HRT. Because compounding pharmacies are not required to detail the risks of their bioidenticals (i.e. they are not approved) they may therefore create the illusion of being safer than commercially marketed drugs.

  • Overall, FDA-approved and compounded bioidenticals contain the same hormones. The difference between the two is the accuracy of preparation. Where FDA-approved versions are measured precisely under rigid control, compounded bioidenticals lack these specifications. Random testing has shown that the indicated potency of compounded hormones varies substantially.

  • Blood and saliva tests to measure a woman’s hormones is only a snapshot in time and are not particularly useful for setting hormone levels which can fluctuate from hour to hour. In menopausal women hormones levels are particularly unstable without a “normal” concentration. Accordingly dosage may be inappropriate for treating symptoms.

2. FDA-Approved Hormone Therapy

Contrary to popular belief the FDA has yet to approve any “true” generic as a substitute for Premarin® and its daughter products (i.e. Prempro®, Premphase®). In other words no prescription drugs used to treat menopausal symptoms, other than the Premarin family, contain pregnant mare’s urine.

Currently the vast majority of FDA-approved HRT prescription drugs are synthetic bioidenticals often referred to as “Synthetics” (i.e. hormones identical on a molecular level to endogenous hormones that are synthesized in the lab from natural plant sources) - these are not the versions produced at a compounding pharmacy which are not FDA approved.

What’s important however is that these drugs carry with them the same risks and warnings associated with drugs derived from conjugate estrogen estrogens, whether that be estrogen alone or combined with progestin.

In pre- and postmenopausal women, estrogens can increase the risk of cancer of the ovaries, stroke, dementia, and serious blood clots in the legs.

Estrogen, when used with a progestin, can increase the risk of heart disease (such as heart attacks), stroke, serious blood clots in the lungs/legs, dementia, and cancer of the breast/ovaries.

If you are concerned about these risks, there are basically three categories of FDA- approved synthetic bioidentical HRT products on the market as shown below along with their common brand names.

PRODUCTBRAND NAME
Estradiol / Norethindrone (Estrogen/Progestin Combinations):Activella, Jevantique
Synthetic Conjugated Estrogens, Estradiol, Esterified Estrogens:Estrace, Cenestin, Climara, Dinigel, Enjuvia, Estrogel, Minivelle, Ogen, Vivelle-Dot, Evamist, Menostar, Menest, Femring, Vagifem
Esterified Estrogens / Methyltestosterone (Estrogen/Androgen Combination):Menogen, Estratest, Covaryx, Essian, Syntest D.S., Syntest H.S.

CONSULT YOUR DOCTOR

In any case, it is important to separate fact from fiction and be astutely aware of the consequences of clinically unproven medications. Apart from the unmistakable benefits of lifestyle changes, before considering any of the alternatives listed please consult your doctor.
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[1], [2] http://www.health.harvard.edu/newsletters/Harvard_Womens_Health_Watch/2011/September/bioidentical-hormones-help-or-hype

TELL PHYSICIANS ABOUT PREMARIN

Be sure to notify physicians in your area who may prescribe any of the Premarin family of drugs about how they are made, and the potential impact on lives of horses and women.

Print and and send our Dear Physician Letter.  See link below.

Last Updated: March 20, 2014

 

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