Testosterone 101

Testosterone is a sex hormone that plays an important role in the body. In men, it’s thought to regulate sex drive (libido), bone mass, fat distribution, muscle mass and strength, and the production of red blood cells and sperm. A small amount of circulating testosterone is converted to estradiol, a form of estrogen Both men and women have this hormone. But in the male, there is 7 to 10 times more circulating in the body.

This results in male characteristics much more different than a female such as increased bone mass, how fat is distributed throughout the body, as well as increased muscle mass, strength as well as higher production of red blood cells. Of course, men also produce sperm. Testosterone works in unison with other hormones, to feed your energy levels, calibrate your moods, and trigger your desire for, and your ability to have, sex.

Low t levels (take the quiz – add low T quiz) can disrupt these processes and spoil your quality of life.

Over the years, our clinicians are seeing patients who are overly fatigued, depressed, physically weak, and overweight. These are very common symptoms of Low Testosterone. A drop in T count can occur at any time, not just in mid-life or during old age. Male hormone imbalances can be brought by stress, acute illness, poor nutrition, and a host of other conditions. Testosterone therapy is the jumpstart men can take advantage of to make important changes in lifestyle that will restore their vitality, quality of life, and health.

A Critical Review of a Recent Observational Study and Media Attention on Testosterone and Heart Attack Risk

After a recent article on testosterone use was published in the Journal of the American Medical Association (JAMA), there has been an opportunity for law firms to capitalize on the suggested correlation between testosterone use and increased heart attack risk.

However, the observational study behind the article suggesting such correlation has received significant criticism on the basis of flawed study designs and serious analysis errors. Dr. Neal Rouzier, BHRT pioneer and expert, has written a critical review of the study’s resulting article from JAMA and television advertisements for various law firms.

You might have been alarmed by the recent television commercials from law firms soliciting patients that have taken testosterone and suffered a heart attack. Unfortunately, these campaigns have been influenced by a recent negative observational study of weak power and poor design and that has also been severely criticized by many medical experts in urology and endocrinology.

In spite of the worrisome television hype, patients and doctors should not be led astray or fear using testosterone solely based on the hysteria created by attorneys.

In contrast to this recent negative study, there are over 40 years of well-designed, randomized controlled trials and observational studies that all support the safety and efficacy of testosterone administration (I have provided references to some of those trials and studies below).

The most recent negative study of concern, which reported an association between the use of testosterone therapy and increased risk of death and heart attacks, appeared in the Journal of the American Medical Association (JAMA). Regardless of the study’s criticism, legal zealots have latched on to the negative conclusions as a basis for lawsuits including anyone that might have suffered a heart attack while taking testosterone.

The negative conclusions from this study have also reached the media, making patients concerned about their testosterone prescriptions. Because patients are unaware of the research from more than 40 years of supportive trials and studies, these patients now question if they should discontinue their testosterone medication.

-Why the JAMA Study Should Be Ignored-

In spite of this fear that has been instilled in the public by certain attorney groups, the public does not have enough experience or information to make informed decisions concerning the use of testosterone. I wish to explain and elaborate on why this study should be ignored and that no one should stop taking testosterone or fear taking it.

Physicians should not cease prescribing testosterone and patients should not stop using testosterone based on this one weak study, the results of which goes against a plethora of data showing safety and efficacy. I base my therapy on a composite of many studies over several decades of research and not on one rogue study that, in the opinion of medical experts, should be discarded.

It helps to understand the difference between a randomized controlled study (RCTs) and an observational study. In an RCT, subjects are screened to remove those that have other medical problems or issues that might adversely influence the data and results. To simplify understanding of RCTs, there is a treated group and a placebo group that are specifically tested by eliminating any patients that may have risk factors that would skew any results.

Observational studies, on the other hand, are not as powerful, accurate, or reliable as RCTs. In observational studies, careful selection does not take place, and reports (which may or may not be RCTs) are selectively reviewed without any regard to avoiding biases and errors. Reviewers pick and choose from the studies without randomization or control from other influencing factors, which can add inaccuracy and bias to any study. There was significant inaccuracy and error in this recent JAMA study.

Gross Data Mismanagement Calls for Corrective Action A post by three professional medical societies, along with an international group of 130 scientists and physicians, has petitioned JAMA to retract this recent article (JAMA 2013; 310:1829-36).

In a letter addressed to JAMA editors, the newly formed Androgen Study Group cites “gross data mismanagement thereby rendering the article no longer credible.” The article was one of two studies that prompted the FDA to issue a safety bulletin on the use of testosterone products. However, this warning from the FDA is only an advisory as the FDA has cautioned both patients and physicians not to stop testosterone therapy based on just one study, particularly when this study’s design flaws incorrectly led to negative results.

This article has already undergone two published corrections.

The first was published in January due to misreporting of primary results. A second correction published in March revealed what the group called “major errors” in the article’s text and figures.

In other words, the statistical analysis utilized was inappropriate and other statistical methods actually show opposite results with beneficial connotations. Furthermore, the numbers used for the statistical analysis were different from the numbers published in their tables. The raw numbers in their tables actually proved protection against myocardial infarction (heart attack), not the increased risk that they published. It is not until their data is plugged into a complex analytical scheme that it shows harm, hence the insistence for JAMA to retract the article. The petition was signed by the International Society for Sexual Medicine, the Sexual Medicine Society of North America, and the International Society for the Study of the Aging Male, along with more than 125 scientists and physicians (of which I am one).

“This is an extraordinary event,” said Abraham Morgentaler, MD, of Harvard University who is chairman of the Androgen Study Group. “In my 25 years in academic medicine, I have never witnessed anything like this response to a journal article.”

He adds that the call for retraction of an article is exceedingly rare. “To have several professional societies and so many of the most accomplished experts in the field unite in this action indicates the seriousness of the article’s errors, and the magnitude of damage this article has caused to the public’s perception of testosterone therapy.”

A Critical Review of a Recent Observational Study and Media Attention on Testosterone and Heart Attack Risk

After a recent article on testosterone use was published in the Journal of the American Medical Association (JAMA), there has been an opportunity for law firms to capitalize on the suggested correlation between testosterone use and increased heart attack risk. However, the observational study behind the article suggesting such correlation has received significant criticism on the basis of flawed study designs and serious analysis errors. Dr. Neal Rouzier, BHRT pioneer and expert, has written a critical review of the study’s resulting article from JAMA and television advertisements for various law firms.

You might have been alarmed by the recent television commercials from law firms soliciting patients that have taken testosterone and suffered a heart attack. Unfortunately, these campaigns have been influenced by a recent negative observational study of weak power and poor design and that has also been severely criticized by many medical experts in urology and endocrinology.

In spite of the worrisome television hype, patients and doctors should not be led astray or fear using testosterone solely based on the hysteria created by attorneys.

In contrast to this recent negative study, there are over 40 years of well-designed, randomized controlled trials and observational studies that all support the safety and efficacy of testosterone administration (I have provided references to some of those trials and studies below). The most recent negative study of concern, which reported an association between the use of testosterone therapy and increased risk of death and heart attacks, appeared in the Journal of the American Medical Association (JAMA). Regardless of the study’s criticism, legal zealots have latched on to the negative conclusions as a basis for lawsuits including anyone that might have suffered a heart attack while taking testosterone.

The negative conclusions from this study have also reached the media, making patients concerned about their testosterone prescriptions. Because patients are unaware of the research from more than 40 years of supportive trials and studies, these patients now question if they should discontinue their testosterone medication.

No. We understand that things change. If you currently are on TRT or were in the last 6 months, you can be seen and usually not have to have any new labs drawn. However, you will need to be seen for a new patient visit but this appointment is usually scheduled quickly so you do not have a further lapse in treatment.

Optimal Men’s Center is a concierge-style clinic, without the concierge price tag! As stated above, we do take most insurances and typically you will just have a copay for the in-office injections. However, with the numerous forms of insurance policies out there, we can discuss things in person. If you have a deductible and high deductible plans, we can provide a bill that can be submitted and, based on your policy and the services you receive, you may see some reimbursement. Please understand that any reimbursement for treatment is between you and your insurance provider.

We will only treat patients after testing confirms there is a need for medical treatment. If levels are not on the lower ranges, if there is a medical issue that precludes treatment, or a person is seeking medical treatment for non-medical reasons, Optimal Men’s Center will not be able to treat the individual.

Remember that by avoiding insurance directly allows us to provide cutting edge, highly effective treatment with no strings attached.

We will only treat patients after testing confirms there is a need for medical treatment. If levels are not on the lower ranges, if there is a medical issue that precludes treatment, or a person is seeking medical treatment for non-medical reasons, Optimal Men’s Center will not be able to treat the individual.

Properly prescribed, finely-tuned treatment eliminates side effects for the majority of men. Potential side effects occur when the dosing of one or more components of treatment is sub-optimal or excessive. When side effects do occur they are typically mild and can usually be easily addressed with a slight adjustment to the treatment plan. Most patients that have side effects keep it to themselves. Remember that we are available at any time you have questions.

Some side effects can include:
Increased body temperature (think higher metabolism too!)
Acne – most commonly on shoulders
Irritability or agitation

Yes. But, there is much more to evaluating a man’s hormone status than a simple total testosterone reading. Some men have a fair amount of testosterone but not enough of it is actually bio-available for the body to use. Assessing the “free” or “bioavailable” portion of the hormone is critical, and in our experience, rarely evaluated by doctors who do not specialize in BHRT.

Not necessarily. Most of our patients come into the office for injections because it is usually much cheaper due to insurance payments. Some patients do elect to self-administer subcutaneous (very shallow) or intramuscular (slightly deeper) injections with small-gauge needles…but there are other alternatives. Some patients choose to use creams that absorb through the skin. Some patients are good candidates to have small “pellets” implanted into an area of fatty tissue – an alternative to injections and creams.

Many providers of TRT will tell you that…it depends, knowing that they want you on this for life so they can continue to make money treating you. However, there is evidence to the contrary.

Typically, TRT is administered in cycles with other medications that are used to help keep the natural (endogenous) production of testosterone at its maximum level. When TRT is delivered this way along with accompanying medications it allows the body a chance to rehabilitate itself and naturally increase its own (endogenous) T production. Also, it is absolutely imperative that TRT is used in combination with a proper diet and exercise plan. Research has shown that excess belly fat is a major culprit for low T levels; since it triggers estrogen production as well as insulin resistance which can drastically hurt the body’s levels of endogenous T production.

Several studies have shown that TRT promotes fat loss and encourages muscle building, thanks to its powerful impact on muscle protein synthesis. Often when men with Low T lose significant body fat and gain muscle mass, the testicles will begin to produce more of their own T once again. If other lifestyle factors are reversed such as continued improvement in sleep quality and normalized sleep schedule, continued/persistent weight loss maintenance, reduction in stress, and discontinuation of any medications [such as narcotics or certain medications like for seizures (not usually recommended on the second)] are also quite helpful. IF these modifications to lifestyle and weight loss are tenaciously followed, lifelong TRT may not be necessary.

There is no one-size-fits-all solution for those men with low testosterone, but our team of clinicians will work with each and every patient on an individual basis to assist in establishing a regimen of bio-identical hormone replacement therapy that is right for them.

As with many medical interventions, particularly those requiring prescription medications, there are risks. Hormone replacement is a sophisticated medical intervention and requires expertise to perform both effectively and safely. Optimal Men’s Center urges anyone considering hormone treatment to seek an expert trained properly in Bio-identical Hormone Replacement Therapy (BHRT). If you are not sure, ask. This is not a game to be played with your body or your health.

Many doctors shy away from HRT. Some even discourage it in general. From our experience, this is a consequence of a lack of knowledge combined with fear of the unknown.

A clinician with proper training, repetition, and ultimately expertise with this specific intervention – gained through thousands of patient contacts and years of follow-up – can confidently offer effective, safe HRT. This is what you will find with the clinicians at Optimal Men’s Center.

The risk with prostate health concerns men are those with preexisting prostate cancer. For those patients, there is some concern that testosterone may encourage the growth of abnormal cells, although a direct correlation has not been firmly established. See this study regarding TRT for patients who actually had prostate cancer and had decreased PSA levels.

As for cardiovascular (CV) concerns, with appropriate dosing and consistent monitoring, there are both short and long-term benefits as it pertains to such CV events like heart attacks and strokes. Many studies show these advantages. However, we do understand that every patient is unique and needs close observation.

Proper nutrition and exercise are absolutely essential for optimal health. Sometimes specific nutrients or other supplemental measures can make a big difference. However, there are often greater obstacles that will bring guys in for a visit. We will make a thorough assessment and then discuss the options so each patient can make an informed decision about how they would like to address their health needs. There are numerous supplements that can assist men in their drive for feeling Optimal.

However, when it comes to supplements that are supposed to increase a man’s testosterone, we have yet to see even one that works more than a few months (we have done labs to disprove the manufacturer claims). There are a few that can increase mild conversion to Free Testosterone but if you have low Total Testosterone to start off with, you will not gain much Free T to be of any significance. Unfortunately, men who have Low-T are notoriously targeted by supplement companies with promises that are just too good to be true.

Our patients’ hormone deficiencies are treated with bio-identical hormones that are engineered to work with how the body functions. We treat our patients to bring their hormone levels back to where they are safely determined best. Men who abuse steroids are people that will sacrifice safety in order to develop excessive hormone levels, which is a very dangerous way to achieve an increase in muscle mass. This is not sustainable and will cause significant health issues down the road.

Not at all. Such oral medications like Viagra and Cialis work great for many men, but they are not effective for others. Sometimes just changing the route of administration that we use such as sublingual (under the tongue (troches or dissolvable) meds or Trimix (microinjections), we are able to find satisfying solutions for over 90% of our patients.

Dr. Morgentaler went on to say, “Lost in the media frenzy that followed this article’s publication is the fact that substantial evidence accumulated over 30 years has repeatedly shown that higher testosterone levels are associated with better cardiovascular outcomes. In the interests of medical science and the public good, JAMA should do the right thing and retract the article.”

“Many of my patients stopped taking testosterone because of the JAMA article, even those who had experienced substantial benefits. And now we find out it was all based on nothing but sloppy science. We are talking about real consequences on individuals’ health and quality of life,” states Dr. Morgentaler. The Androgen Study Group says it is dedicated to the education and accurate reporting on the science of testosterone deficiency and treatment in men. It was organized specifically to respond to the “recent unwarranted, unscientific attacks” on testosterone therapy in medical and public media.

TESTOSTERONE
ESTRADIOL
THYROID
CORTISOL
DHEA
BLOOD SUGAR HORMONES
If Abnormal FBS (fasting blood sugar), further testing may include:
A1C (3 Month Blood Sugar Average) and/or
FASTING INSULIN LEVEL

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