Testosterone therapy is often used in men aged between 65 and 70 years, and even when it translates into significant benefits to the patient, it also produces a series of serious risks, five different studies published in both the Journal of American Medicine and JAMA Internal Medicine found.
According to the results of the investigation, this particular therapy improves bone density and anemia in patients, while the results also showed how it could produce an increase of coronary arteries plaque buildup. The investigation also proved that this therapy does not help in the cognitive functions of the patients, as it supposedly helped memory and thinking in aged men.
One of the five studies published in JAMA Internal Medicine shows that testosterone therapy lowers the risks of cardiovascular diseases in men with 40 or more years in a period of three years.
Specialists recommend this treatment for men who have a lower presence of the male hormone in their blood system. Among the symptoms of low testosterone in men, are low libido, fatigue, body and facial hair loss, and decreased muscle mass. This therapy is usually implemented through gels, injections or mouth patches.
A group of investigators from the Perelman School of Medicine at the University of Pennsylvania’s designed a series of tests they dubbed the Testosterone Trials. These trials consisted of different studies among 12 academic specialized medical centers from across the United States.
This investigation comes as a direct response to a call the Institute of Medicine did back in 2003 when they suggested a more rigorous study regarding the positive and adverse effects the therapy has among aged male patients in the country.
The National Institute of Health and AbbVie (formerly Solvay and Abbott Laboratories) were two of the organizations that supported the research that has been presenting results since February of 2016. AbbVie is one of the pharmaceutical companies that produce testosterone therapy components.
These Testosterone Trials included the participation of almost 800 men who had 65 years or more and didn’t have the usual amount of the hormone in their bloodstream. The investigators randomly divided the participants into two groups of the same number. One of the groups was assigned with a testosterone gel for over year, while the other was granted with a placebo.
After this division, the researchers proceeded to measure all the health consequences each participant was experiencing during time periods of three months, six months, nine months and at the very end of the investigation. After the research had ended, the investigators followed several cases for another year, to have a more specific body of results.
In this issue, Susan S. Ellenberg, lead biostatistician on the study and a professor at the University of Pennsylvania, explain how this mechanism worked during the investigation. She said that “people could be in only one trial, or they could be in multiple trials, but it was all sub-studies under one big umbrella trial.”
Ellenberg also said that this does not mean that all the 800 participants were part of the different sub-studies as she qualified the testosterone trials as “single trial” and “a single randomization.”
The first trial conducted was the Cognition Trial, and it was the only one in which all the participants were involved. According to the final results, cognitive functions like memory or improved thinking processes were not enhanced during the time of the therapy (which was implemented with testosterone gel).
The second trial was the Bone Trial, and it was demonstrated how the use of the testosterone gel helped on the improvement of bone density and bone strength in the aged men studied.
In the Cardiovascular trial, results showed how this therapy is not exclusively positive for the patients. The results found more plaque buildup in the coronary arteries of men that underwent the treatment. However, the number of men that suffered from cardiovascular diseases like heart attacks was similar in both studied groups (those with placebo and those with testosterone gel).
The last trial was the Anemia Trial, and it showed how this therapy is efficient when correcting the condition caused by an iron deficiency in the blood system.
“There had been suggestions previously that testosterone might be efficacious in (these four) areas. It turns out it was efficacious in some but not in others,” said Dr. Peter Snyder, senior author and a professor of medicine at the University of Pennsylvania.
According to Dr. Ellenberg, these results are not enough to determine if the testosterone therapy is entirely positive for patients to use, as further investigations are needed to get to that answer.
“I think this will help men and their physicians decide whether this is a reasonable treatment for them,” she said. “The importance of the studies will depend on the individual needs of patients because they all address different issues.”