Taken from my column in The Times 22.4.2013
HRT may have fallen from grace but, if a recent trip to the States is anything go by, the male equivalent, testosterone replacement therapy (TRT), is very much in the ascendancy. And we are starting to feel the impact here with the number of NHS prescriptions for the hormone rising fast, much to the concern of some specialists.
TRT isn’t new, but it is being marketed as never before thanks to a new range of testosterone products, particularly skin gels (even available in under-arm “roll-ons”). I have just returned from a conference in Miami and it was difficult to turn the TV on without seeing an advert featuring a grizzled middle-aged male model enjoying life with his glamorous wife after applying testosterone.
The buzz phrase in the States is “Low T” and you would be forgiven for thinking that it is the answer to any middle-aged man’s concerns. The adverts direct men to websites featuring a “screening” questionnaire (see below). And the questions are pretty banal – what middle-aged man doesn’t lack energy, feel grumpy or complain that they are not as good at sports as they used to be?
Most worrying of all is that a significant proportion of men taking TRT in the States haven’t even had their testosterone level checked. They are prescribed the hormone purely on the basis of their answers to the questionnaire, meaning many are taking the drug inappropriately and risking other health problems as a result.
What is particularly frustrating for specialists here in the UK is that the pendulum has rapidly swung from one extreme to the other. There is little doubt that testosterone deficiency has been under appreciated and under treated in the past but now, thanks to the marketing power of big pharma, we are likely to follow America and end up over-using it.
And that matters because if it prescribed properly, t men who need it, the effects can be transformational for everything from energy levels and wellbeing, to sexual performance. There is even evidence that it can reduce the likelihood of an early death in men with conditions like heart disease.
But used inappropriately to artificially boost levels in men who have normal levels can have the opposite effect by increasing the risk of an early heart attack (as confirmed by a recent study from the States) and possibly a range of other problems like stroke and cancer of the prostate.
Lots of middle-aged and older men do have lower than ideal levels of testosterone but for many it is simply a marker of their general health. If you are overweight, diabetic, a heavy drinker, if you take lots of opiate-based painkillers (such as codeine), or are just generally unwell then your testosterone level will fall. It does drop with age too but a fit middle-aged man won’t have a level much below what he would have had in his thirties. Replacing missing testosterone may help some of these men but it is no panacea for the afflictions of middle-age, or years of physical neglect.
TRT should only be used in men with proven deficiency confirmed by blood tests. Normal ranges vary from lab-to-lab but experts I have quizzed suggest that levels below 6 nmol/l confirm a problem. Men below 9 nmol/l probably have an issue, while those between 9 and 11 nmol/l might have one if they also have symptoms like low libido or difficulties with erections (see below). 12 or above and you need to look elsewhere to explain your symptoms.
And the test must be conducted properly. Testosterone levels vary throughout the day and the gold standard is to have the blood taken at 9am having fasted for at least eight hours before. And if the result comes back as low, it should be repeated to confirm there is a problem.
My next step would be to refer to a specialist because it is important that men are given the right type and dose of testosterone and are carefully monitored. The idea is to raise the level into the middle of the normal range and this requires skill and experience.
So if, like many Americans, you are taking the hormone on the basis of a screening questionnaire in the hope that it will turn the clock back, and you haven’t been formally tested then I would urge you to reconsider. And if you are going to the States, look out for the Low T ads and be grateful we don’t have direct consumer advertising for prescription-only medicines here in the UK. Yet.
You can hear me debating the pros and cons of TRT with UK experts by visiting the Inside Health page of bbc.co.uk/radio4
Edited to add: I have had lots of emails asking for specific advice on individual cases / interpret readings etc (see below) but really can’t give definitive answers on a blog. Medicine by email has its limitations, so please direct any clinical queries to your own GP / specialist. Thank you.
The androgen deficiency in the ageing male (ADAM) questionnaire is a popular screening tool in the States – albeit controversial here in the UK
1. Has your sex drive diminished?
2. Do you lack energy?
3. Have you lost strength or endurance?
4. Have you lost height?
5. Have you noticed a decreased “enjoyment of life”?
6. Are you sad or grumpy?
7. Are your erections less strong?
8. Have you noticed a recent deterioration in your ability to play sport?
9. Do you fall asleep after dinner?
10. Has there been a recent drop off in your performance at work?
If you answer yes to any of the first seven, or if you answer yes to more than three in total, you MAY have low testosterone.
UPDATE 3/2017- this is a report from Medscape of a new and worrying finding. Visit www.medscape.com for full report:
LOS ANGELES, CA — In a randomized trial of 138 older men with age-related low testosterone levels, those who received testosterone gel (AndroGel, AbbVie) for a year to attain youthful testosterone levels had a 20% greater buildup of noncalcified plaque in their coronary arteries than those who received a placebo gel.
These findings from the Cardiovascular Trial—one of the seven National Institutes of Health (NIH) Testosterone Trials (T Trials) examining different clinical outcomes in older men with age-related low testosterone levels who receive testosterone or placebo—were published in the February 21, 2017 issue of the Journal of the American Medical Association.
The men had a mean age of 71 and a high prevalence of cardiovascular risk factors, and half had severe atherosclerosis.
The findings “should at least strike some caution in people, to not be too laissez- faire” about testosterone therapy in similar men, Dr Matthew J Budoff (Los Angeles Biomedical Research Institute at Harbor-University of California, Los Angeles Medical Center) told heartwire from Medscape.
“Plaque progression is bad; there’s no mechanism by which this could be helpful,” he continued. When treating men with low testosterone, “I would be more cautious in patients who have already had a cardiovascular event or have significant atherosclerosis [and] tell these men that either we should forgo testosterone or use a much lower dose.”
The study dose aimed to give 70-year-old men the testosterone levels of 30-year-old men, which may not be warranted. “Maybe once you’re 70, you don’t have to be 40 again,” Budoff observed. “It didn’t work out so well for women either in the hormone-replacement trial.”
Perhaps “more modest doses of androgen or . . . forgoing it depending on their risk should be considered,” he added. “Certainly a larger trial needs to be done with heart attack and stroke, but until we have more data I just think this should raise some caution.”
An editorialist goes even further, saying the findings are “unprecedented ” and “ominous.” Dr David J Handelsman (University of Sydney, Australia) writes that “the coronary luminal narrowing observed over 12 months in this study is an unprecedented drug effect and appears ominous in signifying accelerated atherosclerosis and is perhaps a harbinger of increased cardiac ischemic events.”
Effect of Testosterone on Coronary Plaque
The trial aimed to test the hypothesis that testosterone therapy would slow the progression of noncalcified coronary artery plaque volume in older men with age-related low testosterone.
Since this was a 1-year study and it takes longer to see changes in calcified plaque, the researchers examined “noncalcified plaque, which represents the more active plaque in the coronaries” and is associated with myocardial ischemia and subsequent cardiovascular adverse events, Budoff explained.
Secondary outcomes included total plaque volume and coronary artery calcium score.
The researchers analyzed data from 138 men (73 men in the testosterone group and 65 in the placebo group) at nine sites who had coronary artery plaque volume assessed by coronary computed tomographic angiography (CCTA) at baseline and 12 months.
The men were 65 or older, with average serum testosterone below 275 ng/mL, and subjective complaints and objective evidence of sexual dysfunction, physical dysfunction, and/or reduced vitality.
Most were obese (mean body-mass index [BMI] 30), hypertensive (66%), or former smokers (66%), and close to a third had type 2 diabetes (30%). The men had an average coronary artery calcium score of 250 Agatston units, which is “pretty high but not an outrageous number; you would expect a 70-year-old man to have some coronary calcium,” according to Budoff.
The men in the treatment group received an initial 5-g/day dose of testosterone gel, which was adjusted (based on regular testosterone determinations) to try to keep serum testosterone levels in the normal range for young men (280–873 ng/dL).