“Truth is universal. Perception of truth is not.” Anonymous
The recent outcry about testosterone therapy increasing cardiovascular disease and myocardial infarction (heart attack) is causing a tremendous amount of confusion for my patients and for men all over the country. The lawyers have grabbed onto two recent studies and have helped to create panic. In this article I will break down the problems with the flawed JAMA study and the PLOS One study that started the whole problem.
There are four key problems with the JAMA study.
- It was a retrospective, observational study that simply looks at clinical treatments of patients. It does not randomize patients into groups. It simply observes and measures two groups, a control group and a treatment group. This type of study has its strengths, but often has multiple variables that are unaccounted for when assessing the data.
- Only 60% of the subjects had follow up blood work! The other 40% were discounted and we have no idea what their testosterone levels were. This is a major flaw in the study and when attempting to statistically prove something.
- Of the men whose testosterone levels were measured, the levels rose from a 175.5 ng/dL to a 332.2 ng/dL. This is an important point. Cardiovascular benefit from testosterone does not even start until you reach levels of at least 500 ng/dL and research has supported this over the years. (For my male patients, I use a replacement range of around 600 ng/dL to 1100 ng/dL.) They were observing a “treatment” group who never reached optimal levels in the first place and had low levels of testosterone that are associated with cardiovascular disease. This is like studying dehydration in people and determining that when you only give 10 drops of water to a dehydrated person, and they are still thirsty and have problems associated with dehyration, that it was the 10 drops of water that caused their problems!
- They used synthetic versions of testosterone that deliver testosterone in suboptimal ways. Of the study participants, 1.1% received testosterone gel, 63.3% received patches, and 35.7% received injections. These are all inferior delivery methods of testosterone, particularly when they are not employed correctly by the doctor and then not used correctly by the patient. In over eight years of studying and working with testosterone replacement for men, it is clear that compliance is a key determining factor on whether levels of testosterone remain consistent and in the range. First, the patient must actually use the methods consistently and this study does not know that for sure because they are taking the patient’s word for it. Also, gels, patches, and injections can provide varying amounts of testosterone from almost little reaction to an over-abundance of hormone.
What About This Good Study?
Only four short weeks earlier before the JAMA study came out, another observational study came out that did not get as much sensational media coverage. This was a different larger observational study that showed that testosterone therapy decreased factors associated with cardiovascular disease! This study found that men treated with testosterone showed cardiovascular improvements as indicated by:
- Increased HDL (removes cholesterol buildup from arterial walls)
- Reduced LDL (bad cholesterol)
- Reduced triglycerides (carb associated lipids)
- Reduced glucose (blood sugar)
- Reduced C-reactive protein (an inflammatory marker)
- Reduced liver enzymes
- Reduced blood pressure
- Reduced hemoglobin A1c (diabetes and cardiovascular disease marker)
The Other Flawed Study
The PLOS One study concluded that among the over 55,000 subjects studied who were given a testosterone prescription, MI (heart attack) was two times more likely than the control group in the first 90 days after the prescription was given.
The PLOS One study by Finkle has its own issues also.
- The study did not account for measurements such as ekg, exercise tolerance, muscle to fat ratio, the type of testosterone therapy used, dosing, and what other interfering medications the subjects were taking.
- The study did not take into account prior blood tests that examine higher risk factors for MI (heart attack) such as an elevated hemoglobin and hematocrit, red blood cell count, platelet aggregation (clotting), HDL (good) cholesterol levels, and even a simple blood pressure reading. The treatment group could have been much less fit and have far more variables that lead to an increased chance of MI as compared to the control group.
- The comparison group, or “control” group, were men taking PDE5 medications such as Viagra and Cialis. This medications are known to improve cardiovascular outcomes because they dilate blood vessels and therefore lower blood pressure. This simply is not a statistically fair control group and will alter any statistical analysis. It is like studying the amount of water people drink and their level of urination. The treatment group are people who only drink one glass of water a day and they have known urinary retention problems, and the control group are normal people who drink 8 glasses of water daily. The treatment group urinates once a day and the control group urinates 5 times a day. And then concluding that one glass of water CAUSES a 5 fold increase in urinary retention!
- The control group was three times as large at over 167,000 people as compared to the treatment group on the testosterone therapy at over 55,000.
- The MI events in testosterone users was 10 in 1000 versus 5 in 1000 in the control group. But the control group was 3 times as large and was given a PDE5 medication like Viagra that is now known to be helpful in treating cardiovascular disease.
Testosterone therapy, prescribed and administered by a competent physician, can examine risk factors and properly monitor outcomes in an individual patient. I routinely check blood work that demonstrates possible increased risk for cardiovascular disease. Any man who has a known cardiovascular risk profile will almost always be additionally monitored by his own internist and/or cardiologist. The key here is prudence and common sense.
In my book, The Hormone Zone, I also discuss the benefits of testosterone therapy and improvements in cardiovascular disease outcomes. The studies supporting this for the past two decades are too numerous to list here and too numerous to discount over one or two studies that happened to make it to the front page of the lame-stream media and directly into the hands of lawyers. I utilize almost solely bioidentical subcutaneous testosterone pellets for men, which provide a consistent flow of testosterone for up to six months. This maintains levels of testosterone in an optimal range, reducing the risks associated with peak and trough levels and allowing men to experience the health benefits and quality of life that consistent bioidentical testosterone can provide.
Fear not my friends! The sky is not falling here…
To Your Health!
Dr. John A. Robinson
“America’s Natural Health Expert”