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Study: Testosterone therapy may be overprescribed in US

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American physicians may be applying too liberal of a standard for diagnosing late-onset hypogonadism, sometimes called "male menopause," and prescribing testosterone therapy in older men, according to a British study published in the New England Journal of Medicine. U.S. prescriptions for male testosterone therapy has increased 400 percent since 1999, according to researchers.

British researchers have named 32 symptoms associated with late-onset hypogonadism or “male menopause” caused by a reduction in testosterone production in ageing men.

Unlike female menopause which affects all women, male menopause affects only about 2 percent of elderly men. Hypogonadism is often linked to poor general health and obesity.

The findings should offer valuable guidance to physicians prescribing male testosterone therapy, a practice that has increased by 400 percent in the United States since 1999 but no where else, say researchers from the University of Manchester, Imperial College London and other partnering institutions. Their study is published in the New England Journal of Medicine.

Expert insight about testosterone replacement therapy: "Testosterone replacement therapy may stimulate growth of the prostate. If early prostate cancer is present, testosterone may stimulate the cancer’s growth. Therefore, men who have prostate cancer should not take testosterone replacement therapy. It is important for all men considering testosterone replacement therapy to undergo prostate screening before starting this therapy." -- Cleveland Clinic

The researchers tapped colleagues at eight European health centers to recruit 3,369 men between the ages of 40 and 79. They measured the participants’ testosterone levels and asked them detailed questions about their sexual, physical and psychological health.

Only nine of the 32 identified symptoms for late-onset hypogonadism were associated with low testosterone levels. The major symptoms associated with low testosterone levels were  decreased frequency of morning erection, decreased frequency of sexual thoughts or sex drive, and erectile dysfunction. All three sexual symptoms must be present along with low testosterone levels in order to diagnose late-onset hypogonadism, said the research team.

“Our findings have for the first time identified the key symptoms of late-onset hypogonadism and suggest that testosterone treatment may only be useful in a relatively small number of cases where androgen deficiency is suspected, since many candidate symptoms of classic hypogonadism were not associated with decreased testosterone levels in older men,” said lead author Fred Wu, University of Manchester School of Biomedicine.

The research is pary of the European Male Ageing Study which is funded by the EU. The study also identified the thresholds of testosterone below which certain symptoms become increasingly prevalent. Documentation of levels of testosterone below these thresholds is required to confirm the diagnosis of hypogonadism in symptomatic elderly men, according to the study.

Subscribe to comments feed Comments (10 posted):

Aeron Haworth on 06/16/2010 15:30:01
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Aspects of this article are not accurate. The researchers investigated 32 symptoms that are often associated with what has been termed 'late-onset hypogonadism' ('male menopause') and found that three sexual symptoms (the ones you name) were associated with low testosterone levels in older men. Six other symptoms - three physical and three psychological - also had an association with low testosterone levels, though the correlation was much weaker. The remaining 23 symptoms had no association, or an inverse relationship, with low testosterone levels in older men. The researchers argue that their findings suggest that all three sexual symptoms (along with verified low testosterone levels) should be present in patients before a diagnosis of male menopause can be considered. This, as you say, appears to be relevant in about 2% of cases.

Your article also confuses what is hypogonadism and what is termed 'late-onset hypogonadism'. Hypogonadism has established symptoms and can occur at any age. This research was concerned with the symptoms of late-onset hypogonadism (male menopause) which has not been thoroughly investigated before.

Hypogonadism (low production of testosterone) already has established diagnostic tests. Late-onset hypogonadism (low testosterone production due to ageing) does not. Indeed, some scientists/physicians have questioned whether it exists at all, while others argue it is common among older men and should be treated with testosterone replacement. This study, published in a highly respected, peer-reviewed journal, will hopefully help this debate.

Finally, the study was funded by the European Union and is part of the European Male Ageing Study.

Given that this is a contentious issue, particularly in the US, it is important that the facts of this study are properly reported. Please visit the University of Manchester website for the original press release. The full study can be obtained by contacting me at aeron.haworth@manchester.ac.uk
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Kathlyn Stone on 06/16/2010 16:05:25
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Hi Aeron,
Here's the study, now available on the NEJM web site: http://content.nejm.org/cgi/content/full/NEJMoa0911101
Your points, when carefully evaluated, do not demonstrate any inaccuracy on my part. I focused on the key findings of the study whereas your criticism seems more to do with the political sensitivities surrounding the issue. I'm glad you contributed those thoughts but I wish you would have done so without complaining of "inaccuracies." I clarified that the EU funds the European Male Ageing Study, for what that's worth. Kathlyn Stone
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Aeron Haworth on 06/16/2010 16:33:27
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Hi Kathlyn,

As I'm sure you're aware, I wrote the press release for this study. I am not a scientist but my job is to relay complex findings to a lay audience (such as myself).

I thank you for posting my comments. However, I still think your article has some inaccuracies. It was a very complex paper to follow and I was picked up on various issues in my initial draft.

The main point of contention with your copy is that your article does not distinguish between hypogonadism (a recognised condition) and late-onset hypogonadism (male menopause), which is what this paper addresses.

If you replaced 'hypogonadism' with 'late-onset hypogonadism' within the article, we would be pretty much there.

My background is journalism, not science, but I am sure of my facts on this issue. I can ask one of the researchers to comment/contact you but I feel sure of my facts (at least in lay terms) in what I have written.

Reuters has picked this up and done a very good job (as far as I can see). Take a look and see if I may have a few points for you to consider.

Thanks for covering the story anyway.

Aeron
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m3 zero on 06/17/2010 01:08:36
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This one is explained very clearly.I would like to know about normal levels of testosterone at different ages, how men's health is affected by decreased testosterone levels, and whether testosterone therapy might increase the risk of prostate cancer.
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Kathlyn Stone on 06/17/2010 07:51:31
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Aeron: 'late-onset hypogonadism'
Done.
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LeonRover on 06/17/2010 08:37:57
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This study has developed some cut-off levels for hypogonadism in an population of aging European males.

Is it Aeron's contention that the cut-off levels here are different from those in males from younger age groups, and that the only difference is that of frequency of occurrence?

From a casual reading, it seems that there is no association between the "sexual symptoms" and proposed "psychological symptoms? Is this the case?

If so, a possible conclusion is, testosterone supplementation would only be of value in cases of hypogonadism, whether of early or late onset.

As far as administration of the substance exogenously, surely there is no presumption of danger or safety, when

1) the substance is bioidentical to the endogenous substance, namely hydroxyandrost-4-en-3-one, lacking those esters and other chains beloved of companies with patents.
2) administration is once or twice daily, in conformity with a healthy circadian rhythm
3) is not in supra-physiological amounts.
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AL Norton on 06/18/2010 22:41:12
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there are politcal sensitivities in medicine? No!
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Deckenlapme Kinderzimmer on 06/19/2010 03:42:09
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This is been most frequent successful treatment. Testosterone replacement therapy may stimulate growth of the prostate. If early prostate cancer is present, testosterone may stimulate the cancer’s growth. This is most problematic for the people who is undergoing this.
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4gb sd on 06/25/2010 23:16:19
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I had read this and it is so impressive. This one is explained very clearly.I would like to know about normal levels of testosterone at different ages.Great researches done here.
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mbt trainers on 06/28/2010 04:53:10
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Your article is nice. But you haven't included side effects. Some of the side effects of Testosterone Injections include:
1.Liver Problems
2.Increased Red Blood Cells
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