Why Doesn’t My Endocrinologist Know All Of This?

Historically, relying on a consensus statement to treat or not to treat a particular patient has been shown to result in poor care and, as such, society consensus statements and practice guidelines are considered to be worst level of evidence in support of a particular therapy or treatment. A number of organizations, including the World Health Organization and others, have ranked the strength and accuracy of various types of evidence used in the medical decision process. In all scoring systems, the highest strength of evidence is randomized control trials and meta-analyses, with lower scores for other types of evidence. All grading systems place consensus statements and expert opinion by respected authorities (societies) as the poorest level of evidence, because historically they have failed to adopt new concepts and treatments based on new knowledge or new-found understanding demonstrated in the medical literature (1-6).

For instance, a recent study published in the 2009 Journal of the American Medical Association studied the evidence supporting the practice guidelines and consensus statements published by the American College of Cardiology and the American Heart Association. It was found that only 11% of the recommendations, practice guidelines and consensus statements were based on quality evidence and over half were based on poor quality evidence that was little more than the panel’s opinion. The review also found that even the strongest (Class 1) recommendations, which are considered medical dogma, cited as a legal standards and often go unquestioned as medical fact, were only supported by high quality evidence 19% of the time and not revised based on new evidence (6).

Similarly, the Endocrine Society, the American Association of Clinical Endocrinologists and the American Thyroid Association also have a long history of guidelines and recommendations that are not supported by the medical literature and fail to adjust or abandon recommendations when new understanding and knowledge contradicts their recommendations. A case in point is the recommendation by these societies that a normal TSH adequately rules out thyroid dysfunction, despite massive amounts of literature that demonstrate this not to be the case (see Diagnosis of Hypothyroidism) or that T4 only replacement is adequate for most patients. A doctor who simply follows outdated society treatment guidelines that relies on a simple laboratory test and ignores the clinical aspects of a patient is not practicing evidence-based medicine. (1-7). Such doctors may be adequate as lab technicians, but as doctors and clinicians they fall short (1-7). This method of practice is consistently rebuked as improper and poor medicine, but has become the standard used by a large percentage of endocrinologists and physicians who feel medicine can be related to simply reading “normal” or “abnormal” in a laboratory column.

Discussing the lack of scientific basis of most medical society’s consensus statements and treatment guidelines in Internal Medicine News, Dr. Diana Petritti states, “Expert opinion and consensus statements can be quite misleading when used as the basis for a practice. Expert opinions imply that there is something that the experts know that clinician doesn’t know. I don’t think it’s always appreciated that it’s only opinion. There is a tendency to make guidelines and recommendations seem authoritative. I believe that physicians think that there is a great deal more behind authoritative recommendations than there might be when you lift the lid of the box and see what’s underneath(8).”

There has been significant concern by health care organizations and medical experts that physicians are placing too much reliance on consensus statements and failing to learn of new information presented in medical journals. Thus, they lack the ability to translate this new information into treatments for their patients. The concern is that doctors fail to practice evidence-based medicine, erroneously relying on what they have previously been taught and on “expert” societies instead of changing treatment philosophies based on new information as it becomes available. This is especially true for endocrinological conditions, where physicians are very resistant to changing old concepts of diagnosis and treatment — despite overwhelming evidence to the contrary — because it is not what they were taught in medical school and endocrinology residency.

This concern is particularly clear in an article published in the New England Journal of Medicine entitled “Clinical Research to Clinical Practice: Lost in Translation” (9). The article was written by Claude Lenfant, M.D., Director of National Heart, Lung and Blood Institute, and it is well supported. He states that there is great concern that doctors continue to rely on what they learned 20 years before and are uninformed about scientific findings. According to Dr. Lenfant, medical researchers, along with public officials and political leaders, are increasingly concerned about physicians’ inability to translate research findings in their medical practice to benefit their patients. He says that very few physicians learn about new discoveries from reading medical journals or by attending scientific conferences; thus, they lack the ability to translate new knowledge in the field into enhanced treatments for their patients. He states that a review of past medical discoveries reveals how excruciatingly slow the medical establishment is to adopt novel concepts, noting that even simple methods to improve medical quality are often met with fierce resistance. “Given the ever-growing sophistication of our scientific knowledge and the additional new discoveries that are likely in the future, many of us harbor an uneasy, but quite realistic suspicion that this gap between what we know about disease and what we do to prevent and treat them will become even wider. And it is not just recent research results that are not finding their way into clinical practice; there is plenty of evidence that ‘old’ research outcome have been lost in translation as well (1).”

Dr. Lenfant discusses the fact that the proper practice of medicine involves the combination of medical knowledge, intuition and judgment and that physicians’ knowledge is lacking because they don’t keep up with the medical literature. He states that there is often a difference of opinion among physicians and reviewing entities, but that judgment and knowledge of the research pertaining to the patient’s condition is central to the responsible practice of medicine. “Enormous amounts of new knowledge are barreling down the information highway, but they are not arriving at the doorsteps of our patients. (9).”

These thoughts are echoed by physicians who have researched this issue as well, such as William Shankle, M.D., Professor, University of California, Irvine. He states, “Most doctors are practicing 10 to 20 years behind the available medical literature and continue to practice what they learned in medical school….There is a breakdown in the transfer of information from the research to the overwhelming majority of practicing physicians. Doctors do not seek to implement new treatments that are supported in the literature or change treatments that are not (10).”

This view is echoed by the Dean of Stanford University School of Medicine who states that in the absence of translational medicine the delivery of medical care would remain stagnant and uninformed by the tremendous progress taking place in science and medicine (11).

This concern has also received significant publicity in the mainstream media. An example is an article by Sidney Smith, M.D., former president of the American Heart Association, published in 2003 in the Wall Street Journal entitled “Too Many Patients Never Reap the Benefits of Great Research.” Dr. Smith is very critical of physicians for not seeking out available information and applying that information to their patients, arguing that doctors feel the best medicine is what they’ve been doing and thinking for years. They discount new research, Dr. Smith says, because it is not what they have been taught or practiced, and they refuse to admit that what they have been doing or thinking for many years is not the best medicine. He states, “A large part of the problem is the real resistance of physicians…; many of these independent-minded souls don’t like being told that science knows best, and the way they’ve always done things is second-rate (12).” The National Center for Policy Analysis also expresses concern for the lack of ability of physicians to translate medical therapies into practice (13).

A review published in The Annals of Internal Medicine found that there is clearly a problem of physicians not seeking to advance their knowledge by reviewing the current literature, believing proper care is what they learned in medical school or residency and not basing their treatments on the most current research. The review found that the longer a physician is in practice, the more inappropriate and substandard the care (14). Thus, it is not a surprise that the scientific evidence as expressed in the literature is often opposite to what is continually repeated as dogma by most physicians and those considered to be “experts.”

Another example is a study published in the Journal of the American Medical Informatics Association (15). In reviewing the study, the National Institute of Medicine reports that there is an unacceptable lag between the discovery of new treatment modalities and their acceptance into routine care: “The lag between the discovery of more effective forms of treatment and their incorporation into routine patient care averages 17 years.” (16) In response to this unacceptable lag, the Business and Professions Code passed an amendment relating to the healing arts. This amendment — CA Assembly Bill 592; An Act to Amend Section 2234.1 of the Business and Professions Code — states: Since the National Institute of Medicine has reported that it can take up to 17 years for a new best practice to reach the average physician and surgeon, it is prudent to give attention to new developments not only in general medical care but in the actual treatment of specific diseases, particularly those that are not yet broadly recognized [such as the concept of tissue hypothyroidism, chronic fatigue syndrome and fibromyalgia] (17).

The Principals of Medical Ethics adopted by the American Medical Association in 1980 states that a physician shall continue to study, apply, and advance scientific knowledge, make relevant information available to patients, colleagues, and the public (18). This has, unfortunately, been replaced with a goal of providing merely “adequate” care. The current insurance reimbursement system in the United States fosters this thinking, as the worst physicians are financially rewarded by insurance companies. While it is true that the best physicians are continually fighting to provide cutting edge treatments and superior care that the insurance companies deem not medically necessary, even these physicians eventually get worn down and are forced to capitulate to the current system that promotes substandard care.

This was clearly demonstrated in a study published in the March 2006 edition of The New England Journal of Medicine entitled “Who is at Greater Risk for Receiving Poor-Quality Health Care.” The study found that the majority of individuals received substandard, poor-quality care, and that there was no significant difference among different income levels or whether or not the individual was covered by insurance. It used to be the case that only those in low socioeconomic classes without insurance received poor-quality care. But insurance company restrictions on treatments and diagnostic procedures have made the same poor care afforded to those of low socioeconomic status the new standard-of-care for society at large (19). An example of this is a physician’s failing to spend the time to adequately assess a potential hypothyroid patient and instead simply does a TSH test.

Most physicians will satisfy their required amount of continuing medical education (CME) by going to a conference a year, usually at a highly desirable location that has skiing, golf, boating, etc. Physicians are rarely monitored as to whether or not they actually showed up for the lectures or went skiing instead. One must also understand that the majority of conferences organized by medical societies are in fact sponsored by pharmaceutical companies. These payments by pharmaceutical companies are called unrestricted grants, so that the society has free reign to do what they want with the money and thus can claim there is no influence of lecture content by the companies. The problem, however, is that if the society wants to continue getting these “unrestricted” grants, they must think twice about providing content that the sponsoring pharmaceutical company might disapprove of. Consequently, ground breaking research that goes against the status quo and does not support the drug industry receives little attention.

Evidence-based medicine involves the synthesis of all available data when comparing therapeutic options for patients. Evidence-based medicine does not mean that data should be ignored until a randomized control trial of a particular size and duration is completed. A physician who tries to avoid the need of being a physician and is fine with just being a technician or health care provider will adamantly defend the “one-size fits all” method of diagnosis and treatment. But the best doctors who truly practice evidence-based medicine and not merely the perception of such will not rely on consensus statements to best provide their patients. Instead of relying on old dogma, the best physicians will seek out and translate both basic science results and clinical outcomes to decide on the safest, most efficacious treatment for their patients. Further, the best physicians will continually assess the current available data to decide which therapies are likely to carry the greatest benefits for patients and involve the lowest risks.

References

 

From The Doctor’s Desk: The Moral of the Story? Hormone Balance Key To Reducing Breast Cancer Potential.

I have four kids that range in age from four to eleven. One of my favorite things to do is read them a great story. So today, let’s talk about some very important stories and the moral each one presents.

The story about breast cancer potential has more characters than just estrogen and progesterone as we discussed in my last post. There are other hormones that are integral characters in that story also. As you will learn in this post, the moral to the breast cancer story is balance — balance between all the hormones in your body.

The Story On Dehydroepiandrosterone (DHEA) — Say That One Three Times Fast!

DHEA, a testosterone precursor, is a hormone produced by the adrenal glands and plays a part in breast protection. DHEA plays an important role in supporting the immune system. DHEA stimulates the production of good T-helper lymphocytes-1 and their associated good cytokines: interferon, Interleukin-2 and Tumor Necrosis Factor-beta. This is in contrast to the bad T-helper lymphocytes-2 and their bad cytokines. DHEA levels typically decline as we age. The decrease in DHEA levels are inversely correlated with increasing age-related disease. The strength of this correlation is yet to be determined, but the decline in immune system due to low DHEA is clear. So where does that leave DHEA? Individuals with low DHEA levels have more disease, and in this case, more breast cancer. The moral of this story? Low DHEA = a compromised immune system = breast cancer vulnerability.

The Story On Melatonin — The Sandman Hormone.

Melatonin is the hormone that regulates your sleep cycle. It is produced from the pineal gland in the brain. Low melatonin levels have been linked to breast cancer through the additional benefits of melatonin. Melatonin boosts the immune system, decreases estrogen and progesterone production, and acts as an anti-oxidant. Bench studies (non-human studies) have shown significant increase risks of breast cancer with low melatonin levels. Can you guess what happens as we age? Yes, you guessed it. Our melatonin levels fall. Ever talk to a post-menopausal woman? Most women of that age have sleep-related complaints. The moral of this story? Low melatonin = a compromised immune system = breast cancer vulnerability.

The Story on Thyroid — The Energy Hormone.

How about the thyroid hormone?  The breast cancer link reaches to all hormones and everything seems to involve the thyroid these days! T4 (or better known as synthroid, levoxy, levothryoixine) is one of the most prescribed medicines today. But T4 is a very weak thyroid hormone. In fact, the body is looking for T3, a result of T4 to T3 conversion. The problem is that many individuals don’t convert T4 to T3 well. (Very often I see patients who have been on synthroid for years without symptomatic improvement even though their “levels” are said to be “good”.  I digress. That’s a subject for another post. Let’s get back to the breast cancer link.) Low T4 and T3 levels result in low sex hormone binding globulin levels (SHBG). SHBG is how some hormones are transported. When SHBG levels drop, the free availability of the hormone it transports goes up. In this case, the levels of free estradiol go up. Remember the negative breast implications of estrogen dominance from last weeks post (link)? The moral of this story? Low thyroid = low SHBG = high estradiol = estrogen dominance = breast cancer vulnerability.

The Story On Insulin — The Sugar Storer

Finally, Insulin. Insulin’s primary role is in the storage of glucose. However, due to the large percentage of simple or refined sugars in our diet, insulin resistance has become a major epidemic, and, yes, insulin resistance increases the risk of breast cancer. How, you ask? High simple sugars leads to insulin resistance and PCOS (Polycystic Ovarian Syndrome). As a result, estrogen dominance and excess testosterone are produced which leads to weight gain. Remember that fat cells produce even more estrogen and estrogen stimulates breast cell growth (link). Young women will start their cycles at an earlier age and thus will increase their lifetime exposure to estrogen without appropriate progesterone balance. And to make matters worse, traditional therapy with birth control pills for these young women increases the breast cancer risk even further. The moral of this story? Insulin resistance = estrogen dominance = breast cancer vulnerability.

Change The Ending Of The Story.

Just because any of these hormone deficiencies might produce in you symptoms which you recognize in this post doesn’t mean that you are going to have breast cancer. However, the sooner you seek hormone balance, the quicker you are going to lower your breast cancer vulnerability/potential. As you can see, the hormonal symphony is what is important. Balance! When your hormones are balanced, the result is a symphony, and in turn, your body is in tune and makes beautiful music. But when your hormones are not balanced, then…well, you know the ending of that story.

Confession #2: Who Knew I Had So Much In Common With Oprah?

During my journey back to good health, I have discovered there are many others taking the journey with me. Oprah and I go way back. Just kidding. Oprah and I do have two things in common: we were both born in southern states (she in Mississippi, me in Louisiana), and we both have a condition called hypothyroidism. And, it turns out, we are on the same journey.

You may have heard about hypothyroidism on recent episodes of Oprah (you can watch episodes on her website). Oprah has sought treatment for her hypothyroidism with bioidentical hormones, just like me. My condition was diagnosed in December of 2007 and I have been treated with bioidentical thyroid since that time. Because we have the same condition, I thought I would share with you some of the symptoms I experienced.

I had symptoms but didn’t even know they were symptoms. That’s one of the main reasons I am bearing my soul to you. I want you to know what I didn’t. If you have symptoms, my guess is you probably don’t know you have symptoms either.

Hair falling out. I have long hair (bra strap length). And when your long hair falls out, it just seems normal. In fact, when Dr. Goodyear asked me if my hair was falling out, I said no. After I began treatment with bioidentical thyroid, my hair stopped falling out. It was shocking. If you are pulling handfuls of hair out each time you wash, it might not be normal. I had handfuls while blow drying as well.

Lack of energy. I have two young children, ages 10 and 4. My four-year-old didn’t sleep through the night on a regular basis until she was 2 ½. (No, I don’t need parenting classes. She had chronic ear infections and difficulty cutting teeth.) I assumed that my chronic exhaustion was due to my chronic lack of sleep. And I assumed that when I did get a couple of good nights of sleep and still felt tired, that I just needed more time to get “back to normal.” That never happened. Even after she began sleeping through the night, I remained chronically tired. I finally agreed with my husband that something just wasn’t right.

Weight gain/depression. For me, this was the worst symptom of all. Even on a diet, I gained weight. What’s up with that? Humiliation. Guilt. Frustration. I made great efforts to eat right and exercise but with no results. (Oprah’s battle with this is well-documented!) This led me, frustrated, back to the pantry to eat myself to happiness. After diagnosis and treatment, I learned that with hypothyroidism your body chemistry is working against you. You will gain weight…spontaneously, but because of your abnormal body chemistry, not because you overate.

Cold feet. No, not the scared to do something kind of cold feet. For me, socks every night was a must. Even in the summer.

Dry skin. I am the original oily-skinned girl. Shiny nose at noon. You know my type! My skin became dry but I didn’t notice it. My aesthetician made a comment to me following a facial about how my skin had changed. It was her comment that made me realize that my skin had become dry (as had my hair).

Fuzzy thinking/poor memory. I found myself unable to remember a list of a few items at the grocery store. I had to write EVERYTHING down. And I mean everything. Couldn’t even remember to return a phone call. (Anyone reading this who I forgot to call, now you know why! So sorry!) I couldn’t even concentrate to make the grocery list and counted on my husband to do that with me.

After Dr. Goodyear diagnosed me, I began taking bioidentical thyroid made by our local compounding pharmacist. Bioidentical thyroid takes a little longer to produce results than the synthetic variety. But my patience was rewarded with a return to normal thyroid levels. Within two weeks, my hair stopped falling out. Within three months, I could tell a substantial difference in my energy level and my ability to think clearly. Now, after 15 months of therapy, I am working again. It would have been impossible for me to have a normal job 15 months ago.

If you have questions about hypothyroidism and its symptoms, please send your comments.

Related articles by Zemanta

• Oprah on her battle with weight (cnn.com)
• Oprah Can Blame Her Thyroid. Can You? (usnews.com)
• Confession #1 (seasonswc.com)

Hormone Symphony

Have you ever heard a great symphony play under a great conductor in a great symphony hall? I have. The music is beautiful.

Of course, it doesn’t matter how good the conductor is or how good the acoustics are—if the orchestra is not good. If the symphony’s tempo is off, or the pitch, or the key, or the volume, then it doesn’t even matter who wrote the music. Beethoven, Mozart, or Bach will just sound like noise to the audience.

Symphony comes from a Greek word meaning “agreement or concord of sound.”

Your hormones are like a symphony. When everything works together, then and only then can you appreciate the beauty of the music.

When your hormones are out of balance, your body will experience symptoms that wreck the music—hot flashes, mood swings, weight gain. Like a symphony, your hormonal balance is more complicated than any individual part. It is not just about your estrogen and thyroid as many would have you believe. Your hormonal symphony requires the balance of all hormones: all estrogen types, progesterone, testosterone, DHEA, cortisol, thyroid, and melatonin. One hormone out of balance can start a ripple effect that results in total hormonal imbalance.

When your hormones are not balanced, your body feels like a bad symphony, just making noise. However, when all hormones are balanced, your body can make beautiful music. If we reduce your diagnosis to estrogen problems or thyroid problems only, we will miss the mark. When we evaluate and treat your hormones as a whole system, your body can be a symphony.

Who needs Hormones?

Who needs hormones? The answer is: not everyone. Some need hormones, and some don’t. Additionally, a need for hormone therapy is not unique to women. Men can benefit from hormone therapy as well.

If you have symptoms of hormone imbalances, then hormone replacement therapy may be right for you. However, a “one size fits all approach” is never appropriate. Each individual’s hormone needs are as unique as his or her thumb print.

Hormone testing will help determine the specific hormone imbalances and direct treatment.

What symptoms indicate hormone imbalance?

The symptoms of low estrogen include…

• hot flashes
• night sweats
• vaginal dryness
• urinary frequency
• depressed feeling
• sleeping difficulty
• no interest in sex
• no periods

The symptoms of low testosterone include…

• fatigue
• lack of drive
• lack of initiative
• less assertive
• decline in sense of well being
• general depressed moods
• irritable
• lack of self-confidence
• difficulty in setting goals
• decline in mental sharpness
• no stamina/endurance
• loss of muscle mass, strength, or tone
• increased body fat around waist
• elevated cholesterol
• decreased libido
• decreased sexual ability
• sleep apnea

The symptoms of low thyroid include…

• general fatigue or afternoon fatigue
• elevated cholesterol
• difficulty losing weight
• cold hands and feet
• sensitivity to cold
• difficulty thinking clearly
• difficulty concentrating
• poor short term memory
• depressed moods
• hair loss
• constipation
• dry, itchy skin
• fluid retention
• recurrent headaches
• restless sleep
• tingling or numbness in hands and feet
• decreased sweating
• infertility or recurrent miscarriages
• recurrent infections
• muscles aches
• joint pain
• thinning of eyebrows and eyelashes
• enlargement of tongue and teeth indentations
• decreased body hair
• hoarse voice
• slow heart rate
• low blood pressure
• low body temperature
• sleep apnea

The symptoms of high estrogen/low progesterone include…

• premenstrual breast tenderness
• premenstrual mood swings
• premenstrual fluid retention and/or weight gain
• migraine headaches
• severe menstrual cramps
• heavy periods with clotting
• irregular menstrual cycles
• uterine fibroids
• fibrocystic breasts
• endometriosis
• history of infertility
• history of miscarriages
• joint pain
• muscle pain
• decreased libido
• anxiety and/or panic attacks

What are bioidentical hormones?

One of the most frequent questions we here is: “Hey! What is the difference between bioidentical hormones and synthetic hormones like premarin, prempro, premphase, and provera?”

I’m glad you asked! Synthetic hormones include conjugated equine (that’s horse in English) estrogens and progestins. (My wife is not a horse, and I’m pretty sure you aren’t either!)

The key difference between bioidentical and synthetic hormones is molecular structure. In an effort to fully replicate the function of the hormones produced by your body and to minimize the side effects, the molecular structure of the hormones must be identical to those produced in your body.

Synthetic hormones are similar but not identical. These structural differences lead to metabolism by-products that increase the frequency and intensity of unwanted side effects.

Bioidentical hormones are structurally and chemically identical to the hormones your body produces.

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You may have heard that there are not many studies about bioidentical hormones. Certainly, there have not been as many studies of bioidentical hormones as synthetic hormones. But, here’s why.

Pharmaceutical companies fund research for synthetic hormones through profitable patents and mass production. Bioidentical hormones cannot be patented, and thus there are limited funds for research. There are some European studies of bioidentical hormones, but they are small in number and limited in scope.

Related articles by Zemanta and Seasons

• Bioidentical hormones: What does the scientific evidence say?
• The Bioidentical Hormone Debate (www.postgradmed.com)
• Abstract: Are Bioidentical Hormones (Estradiol, Estriol, and Progesterone) Safer or More Efficacious than Commonly Used Synthetic Versions in Hormone Replacement Therapy? (holtorfmed.com)
• Study: Hormone therapy caused breast cancer for thousands (cnn.com)