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Study seems to be incomplete

Posted by Omegamic on 01 Feb 2014 at 17:12 GMT

I just read this report. As with some other studies that 'showed' that testosterone therapy might increase risk of heart related problems, there was no data included regarding the level of fitness of the test subjects.

The doubling of risk for men over 65, quoted without allowing for level of fitness, makes the report useless.

Here is my reasoning.

Given:

a) Men over 65 have been living with increasingly lower testosterone levels for nearly 25 years

b) A lot of men over 65 live fairly sedentary lives.

While a) and b) are related, the relationship is not as strong. The on-set of sedentary behavior in seniors has many other causes. However, the significance of sedentary behavior is paramount to fitness levels. Testosterone therapy will increase the desire of the patient to get active as they rapidly begin to feel more vigorous. If they were sedentary before the beginning of the therapy, the suddenly increased physical activity may precipitate dangerous levels stress to the cardiovascular system since fitness does not return quickly to people over 65.

Due to this apparent oversight I am forced to conclude that this study is incomplete. Without that data it is impossible to tell if the increased rate of heart related problems was strictly caused by the testosterone, or from the secondary effect of increased physical activity.

In my opinion it is premature of the research team to have released this report without that correlation included, as the treatment of the two scenarios is completely different. In the likely event that the heart problems are as a result of a sudden increase in physical activity, the wise treatment would be to include counseling on how to increase physical fitness at a suitable rate or include an appropriate fitness program a part of the testosterone therapy.

Most who will read the news articles related to this report will not bother to read the report, and if they do they are likely not qualified to realize the importance of the missing data. They will make uninformed decisions that will have negative effects on others.

No competing interests declared.

RE: Study seems to be incomplete

Lawley replied to Omegamic on 03 Feb 2014 at 03:39 GMT

This is a valid observation and has significant clinical implications. As with events subsequent to the publication of the Women's Health Initiative (WHI) in 2002 incomplete data and premature conclusions can create a domino effect which adversely impact on the health of the very patients who may benefit most.
This same phenomenon of increased CV events was seen when Viagra was released.
When initiating any form of medication "the benefits must outweigh the risks" and this includes a complete evaluation of the fitness of men prior to the prescribing of testosterone.
It may well be that the subjects of this study were in good physical shape, however without this data testosterone's chequered history may well be prolonged.

Competing interests declared: Pharmacist, pharmaceutical industry

RE: Study seems to be incomplete

Vegasdealer replied to Omegamic on 03 Feb 2014 at 12:57 GMT

Just started TT 30 days ago and had testicular at age 47 now 65 and some what fit and your observation seems to make sense to a lay person from what I read.
Thank you for your input.

No competing interests declared.

RE: Study seems to be incomplete

augiegalindo replied to Omegamic on 03 Feb 2014 at 17:38 GMT

Your observation is spot on. Correlative data, patient fitness level, and even more importantly quality of care with regard to how their TRT was managed are glaring omissions. This was a far better review that the recent JAMA article was, yet it is no substitute for a quality prospective study. Until data is brought forth from a long-term placebo-controlled study using a representative (not high-risk) cohort, with management and re-evaluation for TRT patients, recommendations against TRT will be highly presumptive at best. As a TRT clinician I am fully ready to admit my bias, but the quality of data here does not match the media weight it carries.

Competing interests declared: I am a clinician specializing in TRT.