Category Archives: Evidence Based Medicine

What about compounded hormones?

Posted on by

This excerpt comes from an article entitled What are bioidentical hormones? first printed in the August 2006 issue of the Harvard Women’s Health Watch

…

Much of the confusion about bioidentical hormones comes from the mistaken notion that they must be custom-mixed at a compounding pharmacy. But custom compounding is necessary only when a clinician wants to prescribe hormones in combinations, doses, or preparations (such as lozenges or suppositories) not routinely available — or to order hormones not approved for women, such as testosterone and DHEA. Compounding pharmacies use some of the same ingredients that are made into FDA-approved products, but their products are not FDA-approved or regulated.

One size doesn’t fit all in women’s health. Compounded hormones can certainly help to individualize treatment, but if you’re considering them, be aware of the following:

•Compounded drugs are mixed to order, so there are no tests of their safety, effectiveness, or dosing consistency.

•There is no proof that compounded hormones have fewer side effects or are more effective than FDA-approved hormone preparations.

•Some clinicians who prescribe compounded hormones order saliva tests to monitor hormone levels. Most experts say these tests are of little use because there’s no evidence that hormone levels in saliva correlate with response to treatment in postmenopausal women.

•There is no scientific evidence that the compounded preparations Biest and Triest, which are largely estriol, are safer or more effective than other bioidentical and FDA-approved formulations. Some proponents claim that estriol decreases breast cancer risk and doesn’t increase endometrial cancer risk. Both claims are unproven.

•Heath insurers don’t always cover compounded drugs.

This doesn’t mean that you shouldn’t consider compounded hormones. Just realize that, in a real sense, you’re going to be an experiment of one. Unless your clinician has considerable experience with bioidentical hormones and a particular compounding pharmacy, you’re better off with a prescription for commercially available hormones, many of which are bioidentical.

See the whole article at http://www.health.harvard.edu/womens-health/what-are-bioidentical-hormones

HCS: We do have doctors in Singapore who have “considerable experience with bioidentical hormones” but their ability to help us is being curtailed.

 

Three Drugs I Would Not Take

Posted on by

Dr Christiane Northrup looks at hormone replacement in the last section of this blog post – the rest of the post is useful too.

In Western Medicine, drugs are created to treat symptoms as opposed to the root cause of the condition. If you only suppress your symptoms, instead of also addressing the cause, your body will often protest by developing so-called “side effects” to medication or even by developing another dis-ease. This is how our bodies talk to us. But, there is nothing “side” about these effects—they are the direct result of the drugs.

Many of the most popular drugs being prescribed for millions have significant side effects that just don’t outweigh the risks. There are three drugs, which are frequently prescribed to women, that fall into this category—and which I personally would not take.

Statins for Heart Health

Statin drugs are prescribed to lower cholesterol. And the myth is that lowering cholesterol is the key to preventing heart disease. But the latest research has shown that things are far more complex than that. The truth is that statins deplete the body’s CoEnzyme Q10 (CoQ10)—a vital nutrient for producing energy in the cells.1 Of all the organs, the heart requires the most energy and CoQ10 to function properly. So why take a medication for heart health that depletes a vital nutrient shown to support the heart—as well as every cell in your body?

Low levels of CoQ10 have also been linked to depression and dementia, as well as muscle weakness, fatigue, pain, and nerve damage—all of which are also known side effects of statins.2 And because your body makes less CoQ10 as you age, taking any medication that lowers CoQ10 is not advisable. Further, fat—and fat in the form of cholesterol—has been vilified as the enemy of a health heart. Actually, sugar is the real culprit, not fat, because sugar causes inflammation. And this inflammation taxes the cardiovascular system and the entire body.

If you want to protect your heart, start by reducing inflammation. This means a healthy diet and supplements that are high in antioxidants. Taking vitamin E has been shown to keep blood platelets slippery (so fewer blood clots) and reduce inflammation.3(See The Wisdom of Menopause for a complete list of heart-healthy supplements and foods.)

Heart health also has an emotional component. If you want to truly heal your heart—or protect it at midlife—you need courage to look closely at any source of emotional pain, and then heal this brokenness with compassion, faith in the Divine, and emotional release. You were meant to have an open heart—to give and receive love, and to live joyfully.

Bisphosphonates for Bone Loss

Your body is constantly renewing itself. Older or damaged cells are eliminated by the body, so that newer, healthier cells can take their place. Your bones go through this cycle, too. If you have decreased bone mass, that means that your body is breaking down bone faster than it is creating new bone.

The most popular treatment is a biphosphonate, such as Actonel, Boniva, or Fosomax. These medications prevent bone breakdown and therefore bone loss. Although this sounds like a good idea, these drugs interfere with the natural cycle of breakdown and restoration.4 The result is older, porous, brittle bone—and brittle bone means an increased likelihood of fractures.5

Bisphosphonates have significant side effects, too, including back pain, joint pain, stomach pain, nausea, vomiting, heartburn, and constipation.6 And some women have suffered osteonecrosis of the jaw—death of bone tissue—a condition that is not treatable7 We’re also seeing atypical fractures of the femur that don’t heal! All because of dense bone that doesn’t remodel and allow in a good blood supply. Many dentists are also seeing an increasing need for root canal surgery because of these drugs.

In about 50 percent of women prescribed a biphosphonate will stop treatment because of these side effects.

Even with these side effects, bisphosphonates may offer some benefit for women over 70 who already have osteoporosis. But I want you to protect your bones much earlier than that! And that means promoting bone health naturally. Be sure to get plenty of calcium, magnesium, and vitamin D. (Studies suggest that to keep your vitamin D levels in the optimal range requires 5,000 IU/day!) I also suggest eating an alkaline diet, getting plenty of weight-bearing exercise, and considering bioidentical hormones or plant hormones (phytoestrogens) that have estrogenic effects.

Premarin, Prempro, and All Other Synthetic Hormones

I’ve been talking about bioidentical hormones for nearly three decades. And it still surprises me when women — and doctors — don’t know the difference between bioidentical hormones and synthetic ones. Bioidentical hormones are created to be an exact match in molecular structure to a woman’s body. That is what makes them “bioidentical.” In contrast, non-bioidentical estrogen, such as the estrogen in Premarin, is bioidentical only if your native food is hay. That’s because it is made from the urine of pregnant horses. Hence the name Pre (pregnant) Mar (mares) in (urine). Progestin is a synthetic form of progesterone that is derived from bioidentical progesterone. The reason for this is that you can’t patent a bioidentical hormone that naturally occurs in nature. And so—to make progesterone marketable—it was changed into a compound not native to the female human body.

For about two decades, Premarin (just estrogen) and Prempro (Premarin plus Provera, a synthetic form of progesterone) were the gold standard for many doctors. And the one-pill-fits-all-women approach was the only option women were given. Then, in 2002, the Women’s Health Initiative Studies showed that women who supplemented with synthetic estrogen or Progestin had more incidences of breast cancer, heart attack, stroke, and blood clots than those who were given a placebo. Once thought to confer heart health and other benefits, women suddenly became wary of these drugs. 9

The best approach for hormone therapy is one that is unique to you. Women can have their levels of estrogen, progesterone, DHEA, testosterone, and other hormones tested. Or simply pay attention to how you feel — which I find is a far more accurate way to assess hormone balance than testing your levels. The results (and how you feel) allow you and your doctor to customize a treatment plan that is right for you. Start with the lowest dose possible and see how you do. Better yet, change your diet to a low sugar, organic food approach. Add a natural herbal remedy such as Pueraria mirifica,maca, black cohosh, ground golden flaxseed, or chasteberry. And if that doesn’t work, then try the bioidenticals.

Remember that hormone therapy can take a few trials and errors. It’s a work in progress — just like you are at menopause.

You aren’t destined to wind up on various preventative medications. My mom is in her late 80s and she isn’t on any medication! Neither is my doctor friend Gladys who likes to say “93 and prescription free.” Before you take any medications regularly, make sure you are informed about all the risks and benefits. Does the drug cause nutritional deficiencies? Are you increasing your risk of cancer or heart disease? If so, seek out some alternatives that won’t put your health at risk.

References

  1. Langsjoen, P.H., & Langsjoen, A.M. (2003) The clinical use of HMG CoA-reductase inhibitors and the associated depletion or coenzyme Q10. A review of animal and human publications. Biofactors, 18 (1-4), 101-111.
  2. Scott, R.S., et al. (1991). Simvastatin and side effects N Z Med J, 104, 493-495. Laise, E. (Nov 2003). The Lipitor dilemma. Smart Money: The Wall Street Journal Magazine of Personal Business, 12(11), 90-96. Golumb, B.A., et al. (2007) Physician response to patient reports of adverse drug effects: Implications for patient-tergeted adverse effect surveillance. Drug Safety, 30, 669-675. King, D.S., et al. (2003). Cognitive impairment associated with atorvastatin and simvastatin. Pharmacology, 23, 1663-1667.
  3. Stampfer, M.J., et al. (1993). Vitamin E consumption and the risk of coronary artery disease in women. New Engl J Med, 328 20), 1444-1449.
  4. Odvina, C.V., et al. (2004). Severely suppressed bone turnover: A potential complication of alendronate therapy. J Clin Endocrinol Metab, 90, 1294-1301.
  5. Parker-Pope, T. (July, 15 2008) Drugs to buil bones may weaken them. New York Times, available online www.nytimes.com/2008/07/15/health/15well.html?partner=rssnyt&emc=rss
  6. National Osteoporosis Foundation, http://nof.org/articles/22
  7. Ruggiero, S.L. et al. (2004). Ostenecrosisof the jaws associated witht the use of bisphosphonates: A review of 63 cases. J Oral Maxillofacial Surg. 62, 527-534.
  8. Neviaser, A.S., et al. (2008). Low-energy femoral shaft fractures associated with alendronate use. J Orthop Trauma, 22, 346-350.
  9. Writing Group for the Women’s Health Initiative Investigators (2002). Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal

http://www.drnorthrup.com/three-drugs-that-i-would-not-take/#sthash.0GZ1dslc.dpuf

Women Empowerment: Dispelling Medical Myths

Posted on by

Dr Helene B Leonetti invites us to share this excellent article, posted 16 June 2014. (Bolding by HCS)

The last fifty years have seen great changes in medicine, and being a part of the journey since 1961, I would like to offer a perspective.  Women’s’ health has been in the forefront of my practice, and there are two issues about which I would like to focus: thyroid health, and hormone replacement therapy.

As we get more and more aware of epigenetics and how everything impacts everything else, we can now almost smugly agree that the dietary, environmental, hormonal, increased toxic load, and emotional connection to thyroid function is real.  Yet, the paltry testing and interpretation of those tests have not changed in these last 50 years.  It is a given that women experience far more thyroid disease than men: perhaps 10:1.  And yet, we continue to measure TSH and occasionally free T4 to assess the health of this power organ located interestingly in the area of the fifth chakra.  The testing so essential includes free T3, reverse T3, TPO and thyroglobulin antibodies, ferritin, iodine, vitamin B12, and vitamin D (25 hydroxyvitamin D).  And the old values of TSH (0.5-5.5 now in some labs lowering the range to 0.4-4.5) is still absurdly too large a spectrum, the higher the number, the more underactive the thyroid.  Those of us practicing functional more integrative medicine desire the range more closely to 0.3-2.0;  yet the endocrine world has yet to adopt these more appropriate levels.  And even with the ideal TSH without looking at antibodies, and the other aforementioned levels, some 2-3 of every ten women I evaluate have abnormal findings.  

Adrenal dysfunction measured in saliva is closely aligned with thyroid function and it, too should be evaluated, because one cannot replace thyroid without addressing adrenal fatigue, which is beyond the scope of this writing. We know that heavy metal intoxication, chronic candida from environmental mold, pesticides, gluten sensitivity all impact thyroid health.  Interestingly, the more physiological T4/T3 preparation, known as Armour thyroid, was replaced with Synthroid (T4 alone) with the expectation that the body would know how to take the inactive T4 and convert it to the active T3.  Our bodies are magnificent and magical and if left to their own devices could do this, providing we give the necessary cofactors to assist liver detoxification and conversion to the active form.  But since we still do not accept the vital role of ingredients provided by pure untainted food and nutrients, we cannot put all the pieces together, and continue the band aid approach to therapy.  The important role of compounding pharmacies comes into play here, as Armour thyroid has gone through some struggles with availability and quality, and so many physicians are choosing to have thyroid compounded from porcine thyroid powder under strict regulations, without fillers and additives, often harmful for patients with multiple chemical sensitivities.

Which is my Segway (sic) into hormone replacement for women.  One must remember history so as not to repeat it, said Santayana.  Back in the 1960s an infamous book written by then president of the American College of Obstetrics and Gynecology, Robert Wilson, MD, titled ‘Forever Feminine’ extolled the benefits of Premarin (pregnant mares’ urine) an estrogen which became not only the largest selling hormone, but drug in the industry.  This well publicized book by the Wyeth Company who sold Premarin was read by millions of women who flocked to their doctors requesting the miracle hormone that would prevent them from becoming dried up sexless hags, aging with little ability to attract a loving partner.  

This drug which was produced by torturing magnificent mares and their fouls (that story told most eloquently by PETA (People for the Ethical Treatment of Animals) became so profitable and ingested by hundreds of thousands of women, and because it was ordered as estrogen alone, approximately four per cent of women developed uterine cancer.   Back to the drawing board, our astute forefathers realized that if a woman still had an intact uterus, she required the other important hormone, progesterone, to balance the stimulatory effects of the estrogen.  Thus was born MPA (medroxyprogesterone acetate) a synthetic progestogen patentable (operative word here) and it was cleverly marketed as Prempro.  The issue here is that synthetic progesterone has many side effects (see the PDR) and many women began complaining, such that many albeit unnecessary hysterectomies were performed so that women needed only to take estrogen.

This is where the medieval solution to this problem originated and continues to his day. We now know that synthetic progestin is actually more carcinogenic than estrogen, and to the credit of the pharmaceutical industry, a more bio identical progesterone capsule, named Prometrium, has been added to the tool kit of my colleagues.  And if estrogen, and a more gentle plant based form which we now have in pills, patches, sprays, gels were always ordered with the more  balancing natural progesterone, I may not be writing this.  But this is not the case.  Despite the fact that God gave women two major hormones, estrogen and progesterone, and to a lesser amount, testosterone, most physicians stay stuck in the 1970s thinking that if there is no uterus, there is no need for progesterone, especially since we are most familiar with the synthetic version.

My final observation: my profession continues to denigrate bio identical hormones, compounded specifically by pharmacists trained to do so, claiming they can be dangerous, tainted, and found to be dose erratic, according to some critics.  Yet for 25 years I have measured hormones in the saliva, and along with a comprehensive thyroid panel, AND most importantly, my patient’s story, I have been able to formulate small, appropriate doses of these hormones, preferably administered through the skin or in the vagina, thus avoiding first pass through the liver and avoiding cytokines and clotting factors which can be affected by estrogen pills.  And the one size fits all hormones provided by the pharmaceutical industry cannot come close to addressing each patient’s unique biochemistry.  

It is time that we release our egos and righteous indignation about whether we are in the conventional or alternative camps of medical practice.  We are here to serve our patients, and when we integrate the best of both worlds, those whom we serve benefit.  I just had back surgery: not angel dust or acupuncture, though I certainly gave those attention: this is a metaphor for how we need us all.

Helene B Leonetti, MD

www.helenebleonettimd.com

Combined hormone replacement therapy and risk of breast cancer in a French cohort study of 3175 women.

Posted on by

French study shows that when bioidentical hormones are used there is no increased risk of breast cancer

de Lignières B, de Vathaire F, Fournier S, Urbinelli R, Allaert F, Le MG, Kuttenn F

Abstract

The largest-to-date randomized trial (Women’s Health Initiative) comparing the effects of hormone replacement therapy (HRT) and a placebo concluded that the continuous use of an oral combination of conjugated equine estrogens (CEE) and medroxy-progesterone acetate (MPA) increases the risk of breast cancer. This conclusion may not apply to women taking other estrogen and progestin formulations, as suggested by discrepancies in the findings of in vitro studies, epidemiological surveys and, mostly, in vivo studies of human breast epithelial cell proliferation showing opposite effects of HRT combining CEE plus MPA or estradiol plus progesterone. To evaluate the risk of breast cancer associated with the use of the latter combination, commonly prescribed in France, a cohort including 3175 postmenopausal women was followed for a mean of 8.9 years (28 367 woman-years). In total, 1739 (55%) of these women were users of one type of estrogen replacement with systemic effect during at least 12 months, any time after the menopause, and were classified as HRT users. Among them, 83% were receiving exclusively or mostly a combination of a transdermal estradiol gel and a progestin other than MPA. Some 105 cases of breast cancer occurred during the follow-up period, corresponding to a mean of 37 new cases per 10 000 women/year. Using multivariate analysis adjusted for the calendar period of treatment, date of birth and age at menopause, we were unable to detect an increase in the relative risk (RR) of breast cancer (RR 0.98, 95% confidence interval (CI): 0.65-1.5) in the HRT users. The RR of breast cancer per year of use of HRT was 1.005 (95% CI 0.97-1.05). These results do not justify early interruption of such a type of HRT, which is beneficial for quality of life, prevention of bone loss and cardiovascular risk profile, without the activation of coagulation and inflammatory protein synthesis measured in users of oral estrogens.

http://www.ncbi.nlm.nih.gov/pubmed/12626212

 

The Truth About Hormone Therapy – Erika Schwartz, Kent Holtorf and David Brownstein

Posted on by

The Wall Street Journal March 16, 2009

An interesting study of “how special interests, a confused medical establishment, and opportunists can combine to complicate the issue and deny patients access to safe and effective treatments”.

Evidence?  (bolding by HCS)

There are 25 years of scientific research with hundreds of studies in the U.S. and Europe that have demonstrated that bioidentical hormones, estradiol and micronized progesterone, are equally or more effective than synthetics — and safer. Yet mainstream medicine has buried its head in the sand and refused to take these studies seriously.

The article concludes:

Sadly, seven years after the WHI study finding Premarin/Provera unsafe, the hormone-replacement debate can be summed up in three words: confusion, ignorance, misinformation. Meanwhile, millions of women have embraced bioidenticals, leaving their conventional physicians looking stubborn and foolish.

The medical establishment must stop kowtowing to drug companies and start serving women’s best interests — and that involves widely prescribing bioidentical hormones. This will lead to healthier, happier women and, in the long run, help reduce America’s skyrocketing health-care costs.

YES . . . PLEASE!

See:  http://www.wsj.com/articles/SB123717056802137143

Natural (Bioidentical) vs. Synthetic Hormone Replacement Therapy – Drs Jacob Teitelbaum & Kent Holtorf

Posted on by

The Safety of Bioidentical Hormones — the Data vs. the Hype
Jacob Teitelbaum, MD   

From the Townsend Letter June 2007

As a friend of mine used to say, “If things don’t make sense, follow the money trail.” Because the sale of non-bioidentical estrogen and progesterone makes so much money for drug companies, I suspect that those companies find their profits very threatened by the use of safer or bioidentical hormones. As has frequently been the case when natural products threaten pharmaceutical sales, there appears to be a major public relations misinformation campaign. Although I am not privy to what goes on in the pharmaceutical “back rooms,” my impression is that they feel that if consumers can be confused and frightened enough by misinformation, profits can be protected. My impression (as a physician without a financial stake in either side) is that bioidentical hormones are far safer and effective than synthetic progesterone and pregnant horse urine (Premarin). Historically, unfortunately, when there is big money to be made, there has been no problem getting big-name doctors to tout the health benefits of infant formula over breast milk and even of smoking! It’s sad when information put out by actresses, like Suzanne Somers in her recent book Ageless (on bioidentical hormones), is more accurate than information put out by prominent physicians! But this is what happens when money talks.

To help supply more accurate information on the subject, I’d like to offer readers an excellent review article by Dr. Kent Holtorf. Kent is a superb physician and a friend of mine whom I greatly respect. I think that after reading this article, it will be clear to you that bioidentical hormones are the way to go.

Natural (Bioidentical) vs. Synthetic Hormone Replacement Therapy
by Kent Holtorf, MD

Below is a review of the medical literature demonstrating how natural hormones are superior to their synthetic counterparts. [Evidence? HCS]The conclusion is clear that bioidentical hormones are a safe alternative to Premarin and medroxyprogesterone acetate (MPA), marketed as Provera. The natural bioidentical hormones are very different from their synthetic versions, often having completely opposite physical and cellular effects. Thus, it is critical that women be given the information that these natural hormones do not have the negative side effects of the synthetic hormones and in no way pertain to the conclusions reached by the Women’s Health Initiative (WHI) study. Natural hormones are a safe and more conservative approach to hormone replacement therapy that does not carry the risks associated with Premarin and Provera.

Read in full at: http://www.townsendletter.com/June2007/painfree0607.htm

Estriol & hot flashes: How the right forms of estrogen may help fight cancer, MS and more – Dr Jonathan Wright

Posted on by

Reprinted From “Nutrition and Healing”

An interesting article about estriol – “the forgotten estrogen”.

Food for thought?

“At a convention last fall, I listened to a European professor report her estrogen research findings. When I asked her about her thoughts on conventional hormone replacement therapy (the kind that caused so much trouble last year, which uses horse estrogen called Premarin), she laughed, and said that no one in Europe would even think of prescribing it. She noted the safety of estriol, and pointed out that although “estrogen” prescriptions are used much less frequently in Europe than North America, when estrogen is prescribed, it’s almost always estriol. “We’re not horses!” she said.”

Read the whole article at http://www.tahomaclinicblog.com/estriol-hot-flashes/

Meet the doctor big pharma can’t shut up

Posted on by

Dr David Healy does not consider himself a radical. He prescribes antidepressants and other prescription drugs to his patients. He runs a national university school of psychological medicine. “I’m fairly conservative. I’m a very mainstream doctor, really,” he said. But as New York Times reporter Benedict Carey pointed out in a 2005 story, the Irishman living on an island off the coast of Wales “has achieved a rare kind of scientific celebrity: he is internationally known as a scholar and pariah.”

Do you remember the reports that the pilot who crashed the German Wings plane into the Alps, killing all 150 people on board, was on anti depressant drugs?

[David] Healy’s status as an outcast arises from his grave concern that blockbuster drugs like Prozac and other antidepressants can lead to suicide, murder and unforeseen mental health problems. In the 1990s, he began to publish academic journal papers providing evidence that antidepressants could increase the risk of suicide. Although many colleagues denied the link, by 2004 American and British drug regulators issued strong warnings supporting Healy’s and other’s claims.

http://www.alternet.org/meet-doctor-big-pharma-cant-shut

 

 

Treating thyroid patients like children – Dr Malcolm Kendrick

Posted on by

This is a very refreshing article by a well known UK doctor.  Such were the truths it revealed that many of the (at the time of writing) 264 replies came within the first two days after it was posted on his blog. Patients were virtually screaming (forgive the pun) with joy that at last somebody had recognised how they feel.

We do have some doctors in Singapore who recognise how we feel when T3 is missing but it seems that their hands are becoming increasingly tied with regard to helping us deal with it.

Some extracts from the article are posted here with permission but please read the whole article – Dr Kendrick speaks for so many of us. If only he could speak to the Ministry of Health!

Dr Kendrick admits:

To be honest, until about a year ago I had no real idea what T3 was either, but I have learned quite a lot since.

He certainly has. This paragraph really caught our attention (bolding by HCS):

The lab tests, especially for TSH, are far from 100% reliable, to say the very least. In fact the man who developed the test in the UK, at Amersham International in Wales, has told me that the test is virtually worthless in many cases (especially continuous testing when patients are taking thyroid hormone replacement).

And yet more good sense, which echoes what many of us at Hormone Choice Singapore have experienced (bolding by HCS):

Far more telling, from my point of view, is the fact that hundreds, indeed thousands of patients report that, although their blood tests were normal, they felt terrible, and that they have felt so much better when they have been given ‘excess’ T4 and/T3, or NDT (natural desiccated thyroid). Whilst there is no doubt that some of them are, to quote a medical colleague, ‘not tightly wrapped.’ I have spoken to many, many, people who are calm, rational and reasonable, and their stories are compelling. A hellish existence that was ‘cured’ by Dr Skinner and his like. I refuse to believe that all of these patients are ‘somatising’ fruitcakes.

Read the whole article at:

http://drmalcolmkendrick.org/2015/05/01/treating-thyroid-patients-like-children/

And comments at:

http://drmalcolmkendrick.org/2015/05/01/treating-thyroid-patients-like-children/#comments