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Hormone Replacement for Men? Perhaps

Rating

4 Star

Hormone Replacement for Men? Perhaps

Our Review Summary

We wish there were more stories like this one which take a broad view of the evidence on a given treatment and aren’t simply reactions to a press release about a new study. This column on testosterone therapy rightly emphasizes the limited and conflicting data to support this treatment and the uncertain potential for harm. The comparison to hormone replacement in women provides a useful reminder of the limitations of observational studies.

With that being said, there were some gaps in the coverage. The first relates to the cost of treatment, which can be quite high but isn’t mentioned. The second relates to the potential for a conflict of interest with one of the experts quoted in the piece. Both issues are important to the overall content of the story and discussion of them would have provided readers with a better understanding of the controversy 

 

Why This Matters

There is evidence that some men suffer from a real problem with testosterone deficiency, and that testosterone replacement can be helpful for these men.  However, it is difficult to distinguish pathological deficiency from the normal drop in testosterone that occurs in most men with age. And there is very little good evidence that testosterone therapy fixes the problems, such as fatigue, lack of libido, and sexual dysfunction, which most men who take testosterone think it will help them with. 

Despite this lack of evidence, there is an increasingly sophisticated effort to market testosterone patches and creams to a broad group of men who may have low testosterone levels, or, as the drug industry puts it, "low T." (Click here to take the "low T" quiz, which, as the Pharmalot blog notes, instructs you to "talk to your doctor about your symptoms" even if you have none.) These promotions imply that any number of nonspecific symptoms can be attributed to low testosterone levels. And they specifically tell the public to ask for testing that probably isn’t required and won’t lead to effective treatment. Meanwhile, men who take testosterone will be exposed to uncertain but potentially serious risks, and pay significantly for the privilege.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Given the controversies about the benefit of testosterone replacement treatment in andropausal men, the costs of care are an important consideration. Testosterone replacement therapies can range from $10 to $300 a month not including testing and physician visits.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

This story notes that testosterone has inconsistent effects on sexual function, the primary reason men seek out this type of treatment. Other potential benefits of testosterone therapy are listed as improved muscle mass, increased bone density, decreased body fat and total cholesterol, and improved blood sugar metabolism.  

As with the harms, this story never provides statistical data on how often these benefits occur and how big a benefit can be expected. However, we’re not sure these numbers with would have been helpful, since the benefits are reflected in some fairly arcane scales (e.g. the "libido scale," "subjective vitality scale," etc.) that would be difficult to describe in a relatively brief piece like this. Does a 20% increase in the libido scale number mean anything to anyone other than researchers? We think the piece satisfies the spirit of the criterion and offers enough detail for a satisfactory grade.   

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

The story notes that a recent study was halted because of an unexpectedly high rate of cardiac problems in the testosterone group. It also mentions the possibility that testosterone therapy can result in thickening of the blood and may increase the risk of prostate cancer.

The story isn’t precise about how often these harms occur, and it also didn’t mention some of the "minor" side effects associated with testosterone use, including acne, hair loss on the scalp, hair growth on the face, increased breast size, and testicular atrophy.

A close one here. Overall, we felt the story called appropriate attention to the harms and did not try to minimize them — enough to earn a satisfactory.    

Does the story seem to grasp the quality of the evidence?

Satisfactory

The point of this article is to call attention to the conflicting evidence on testosterone therapy, a goal which it  achieves in the process of satisfying this criterion. Some high points include:

  • Citing previous experience with hormone replacement for menopause, a strategy which was supported by observational evidence but failed to produce a clear benefit when tested in an appropriately designed clinical trial. The comparison to testosterone therapy is apt.
  • Quoting an expert who emphasized the small size and short duration of current studies of testosterone therapy.
  • Noting that even the most rigorous study currently underway will not be able to tell us whether testosterone therapy is safe for long-term use.   

We wish the story had been a bit more thorough in its discussion of a large European study that found that "limited physical vigor" and sexual symptoms were linked to low levels of testosterone. Elsewhere in the story we learn about the perils of relying too heavily on observational studies to guide treatment decisions. The article should have noted that this was an observational study which could not establish whether low testosterone or some other factor was responsible for these individuals’ symptoms.

Does the story commit disease-mongering?

Satisfactory

The concept of male "andropause" bears many of the hallmarks of disease-mongering. Low testosterone is common in aging men and has never been conclusively shown to cause the symptoms — such as low sexual desire and erectile dysfunction — that are typically attributed to it. So offering treatment for this "condition" can be seen as an unwarranted medicalization of the normal aging process.

This article edges toward the line when it suggests that men being treated in one study had experienced "a decrease in energy, mood, vitality and sexuality as result of low testosterone levels." The evidence linking these symptoms to low testosterone levels comes from observational studies that cannot prove cause and effect.  And many studies show that such non-specific symptoms can be caused by chronic diseases, such heart disease and diabetes, which are also common in aging men with low testosterone. These chronic diseases can also cause testosterone levels to decrease. This doesn’t mean that low testosterone is responsible for the symptoms, or that testosterone therapy will alleviate them. 

This questionable assertion notwithstanding, the article overall does a good job of presenting conflicting evidence on the subject. Elsewhere in the story it is noted that sexual performance and desire are not reliably linked to testosterone levels. And the story notes that any parallel to menopause — a comparison often made by supporters of testosterone therapy — is tenuous at best, since the hormone decline experienced by men is far more gradual and the symptoms are less disruptive.    

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

Although one source, Dr. Abraham Morgentaler, is identified as the author of a book which promotes testosterone therapy, the story does not disclose, as indicated in these recent CME conference materials, that Dr. Morgentaler also receives grant funding and is on the speaker’s bureau of companies which manufacture testosterone products. To avoid the appearance of any potential conflict, the story should have alerted readers to these relationships.

Does the story compare the new approach with existing alternatives?

Not Applicable

The article could have mentioned  lifestyle changes, such as getting more exercise and quitting smoking, that may improve libido, combat fatigue, and increase sexual function. But since there’s not much evidence that these or other approaches are effective, we don’t think the article should be dinged for failing to mention them. We’ll rule it Not Applicable in this case.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The study notes that testosterone therapy is available in the U.S. as an intramuscular injection, a skin patch or gel, pellets inserted under the skin, and in oral preparations.  

Does the story establish the true novelty of the approach?

Satisfactory

The article does not try to oversell the novelty of testosterone replacement therapy.

Does the story appear to rely solely or largely on a news release?

Satisfactory

This article is clearly not based on a news release.

Total Score: 7 of 9 Satisfactory

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