Mixed Results from Testosterone Therapy Study

[Jinzang]

You'll probably see this reported in the news. From the press release at the NIH website:

In older men with low testosterone, one year of testosterone treatment improved bone density and corrected anemia of both known and unknown causes, but also increased the volume of coronary artery plaque, according to results reported from the Testosterone Trials (T Trials). Testosterone treatment had no effect on memory or other cognitive function.

The T Trials were conducted at 12 sites across the country in 790 men age 65 and older with low levels of testosterone and symptoms to which low testosterone might contribute. Participants were randomly assigned to receive testosterone gel or a placebo gel applied to the skin daily. Serum testosterone concentration was measured at one, two, three, six, nine and 12 months. The men were also closely monitored for prostate and cardiovascular problems. In addition to low testosterone, the presence of complaints such as low sexual function, difficulty in walking or low vitality was required for eligibility to participate in the trials.

“The results on diverse outcomes indicate the potential trade-offs between benefits and risks of testosterone treatment in older men,” said Evan Hadley, M.D., director of NIA’s Division of Geriatrics and Clinical Gerontology. “However, clarifying the effects of testosterone on many major clinical outcomes such as cardiovascular events, fractures, and disability will require longer, larger scale trials. The results also illustrate that decisions about testosterone treatment need to be individualized, taking into account each patient’s balance of risks for the various conditions that testosterone treatment could affect.”

 

[FeelingLost]

Interesting press release. Subing to this thread to catch others comments,
thanks Jinzang.

I am pretty new here and have no clue how many forum members on a TRT protocol are in their 60's
I am and one of our mods is also.

For my situation my PCP has offered two paths TRT or Antidepressants.
I tried the later for 30 days and hated being drugged to the point of not caring.

 

[Vince]

I do have my lipid panel done through ClevelandHeartLabs, here's my latest results.
https://www.excelmale.com/forum/showthread.php?8541-My-Latest-Cleveland-Heart-Clinic-Labs

 

[Jinzang]

I am in my 60's also. I've been on TRT for a little over a year. I believe my problems were brought on by the stress of my brother's death as well as losing my job. At first I tried to solve them trough diet and exercise, then after a little investigation found out that my symptoms lined up pretty closely to the symptoms of low T, so I went on TRT.

 

[FeelingLost]

So I read the press release again and the associated pages linked in the PR.
My take on what I read was this sample was quite small.

Trials were conducted at 12 sites across the country in 790 men age 65 and older with low levels of testosterone and symptoms to which low testosterone might contribute.

Of the 790 men approx 50% were give a placebo, they did not really say 50% so I am guessing it's 50% and if so that means only 395 men were treated.
There was no talk of the T lvls measured in these men. Did the gel work for all of them? Did they have a target T lvl they had hoped to get to. Was that target >300, 500, 800 ng/dL There was nothing posted about free T lvls.

Sorry the retired rocket scientist in me is coming out. I am all about the details and this report has very few. Still a good read.

 

[Leesto]

I am pretty new here and have no clue how many forum members on a TRT protocol are in their 60's
I am and one of our mods is also.

I am in my 60's. Before TRT I had the classic low-T symptoms. Also had metabolic syndrome with HbA1C as high as 13.5 and BP running around 200/110. My lifetime prognosis wasn't good. Got on diabetes meds and bp meds and got some statistical benefits but did not feel better.

I started the Ketogenic diet and TRT about 8 months after getting on the other meds. I then started Gene's N.O. stack a few months into TRT. After a while I was able to reduce the BP and diabetes meds. Now I am on half the meds and my BP this morning was 127/81 and HbA1C sits at 5.9. More importantly I feel good! I'm gaining muscle and losing fat. I have my youthful energy back. Aches and pains have subsided. I want to work out instead of feeling like it is drudgery.

I can't say for sure how much improvement came from TRT, how much form the ketogenic diet, and how much from the N.O. stack, but I'm sticking with all three!

 

[madman]

By the time one reaches their 60s I would say a majority already have some degree of arterial plaque build up/vascular stiffness whether due to poor diet/genetics/inflammation/stress/lack of exercise/pollutants/medications. The list of many factors goes on. Where any of these factors considered pre treatment with testosterone in theses older men? VASCULAR health is a big factor in overall heart/circulatory/lung/brain function and regardless of how healthy one chooses to live AGING in and of itself contributes to decreased function so we will never be at peak functioning like in our younger years.

Poor vascular health is also one of the major contributors to ED hence why some will always struggle in this area even when being treated with trt/PDE5 inhibitors!

 

[r3d3]

I was similarly disappointed in the below article links published on this - no mention of study participant hormone levels, fitness profiles, treatment types(amounts, frequency,HCG,AI,etc) or goals(regaining energy or psychological aspects vs libido for example) summarizing to re-enforce existing medical opinion and mischaracterization of those interested in TRT for legitimate reasons, things I've already experienced and been disappointed by in seeking help from local doctors and endos. Would like to see further analysis on the problems of this study/report from doctors who regularly perscribe and follow their patients health on TRT.

cnn.com/2017/02/21/health/testosterone-therapy-study/


arstechnica.com/science/2017/02/testosterone-pills-wont-beef-up-your-brain-but-could-harm-your-heart/


jamanetwork.com/journals/jama/article-abstract/2603909

 

[Jinzang]

Yesterday's post was put together quickly and didn't have a link to the studies themselves, which I prefer to do. So here's a link to the more concerning of the studies, on TRT and arterial plaque increase. The full text of the article is available, thanks JAMA. I'll refrain from comment, except to say it doesn't seem a badly designed or conducted study. Here are a few excerpts from the paper:

Double-blinded, placebo-controlled trial at 9 academic medical centers in the United States. The participants were 170 of 788 men aged 65 years or older with an average of 2 serum testosterone levels lower than 275 ng/dL (82 men assigned to placebo, 88 to testosterone) and symptoms suggestive of hypogonadism.

Of 170 men who were enrolled, 138 (73 receiving testosterone treatment and 65 receiving placebo) completed the study and were available for the primary analysis. Among the 138 men, the mean (SD) age was 71.2 (5.7) years, and 81% were white. At baseline, 70 men (50.7%) had a coronary artery calcification score higher than 300 Agatston units, reflecting severe atherosclerosis. For the primary outcome, testosterone treatment compared with placebo was associated with a significantly greater increase in noncalcified plaque volume from baseline to 12 months (from median values of 204 mm[SUP]3[/SUP] to 232 mm[SUP]3[/SUP] vs 317 mm[SUP]3[/SUP] to 325 mm[SUP]3[/SUP], respectively.

Testosterone was administered as a 1% gel in a pump bottle (AndroGel). Placebo gel was similar. The dose was initially 5 g/d and was adjusted, if necessary, on the basis of testosterone levels measured at a central laboratory (Quest Clinical Trials) at months 1, 2, 3, 6, and 9, to try to keep the serum concentration within the normal range for young men (280-873 ng/dL).

The sample size for this trial was initially estimated to be 400 men in the protocol of October 2010 but was later reduced to 140 men when the primary outcome was changed from total to noncalcified plaque volume, because the latter has a smaller standard deviation.

At baseline, noncalcified plaque volume showed considerable variability, and the median in the testosterone group (204 mm[SUP]3[/SUP] [interquartile range, 60 to 420 mm[SUP]3[/SUP]]) was somewhat lower than that in the placebo group (317 mm[SUP]3[/SUP] [interquartile range, 168 to 589 mm[SUP]3[/SUP]])

Exploratory analyses of the individual components of noncalcified plaque showed that testosterone treatment was associated with a significantly greater increase in fibrous plaque volume.

The change in noncalcified coronary artery plaque volume in men in the testosterone group was not associated with changes in levels of total testosterone (r = −0.04; P = .74), free testosterone (r = −0.006; P = .96), or estradiol (r = −0.08; P = .50).

 

[FeelingLost]

I wonder if Aged Garlic Extract or a Statin could be used to reduce this noncalcified plaque brought on by TRT?
Thanks for the extra info Jinzang.
I'm still not convinced or willing to stop my TRT experiment on the slight chance it could increase my chance of a heart attack.

 

[Vince]

I wonder how they measured the noncalcified plaque. I know you can measure calcified plaque with a CT scan. I believe you can measure non calcified plaque with MRI scan on the carotid arteries. Did it mention in the article how the plaque was measured?

 

[user_joe]

I'd like to think there wasn't an agenda here, and they were just clueless. Gels seems to work for maybe 20% of people. They are also literally saying 300 tt is within range. Worthless data.

 

[Jinzang]

Yes, the article explains how plaque was measured and how they distinguished the different kinds of plaque. It was a little over my head, as I am not familiar with these tests.

If anyone has severe atherosclerosis (And half the men in this study did. They were also obese.) I would suggest following the program in Prevent and Reverse Heart Disease, which is a pretty drastic dietary change, but proven to work.

 

[Cooper]

I'd like to think there wasn't an agenda here, and they were just clueless. Gels seems to work for maybe 20% of people. They are also literally saying 300 tt is within range. Worthless data.

Gels only work for maybe 20% of people?? What are you getting that from? Is that factual or just another injection person to quickly dismissing gels - which work very well for many men.

 

[user_joe]

Gels only work for maybe 20% of people?? What are you getting that from? Is that factual or just another injection person to quickly dismissing gels - which work very well for many men.

Its anecdotal. Do a poll and see for yourself. The majority of accounts I read report eventually switching to objections.

 

[madman]

I wonder if Aged Garlic Extract or a Statin could be used to reduce this noncalcified plaque brought on by TRT?
Thanks for the extra info Jinzang.
I'm still not convinced or willing to stop my TRT experiment on the slight chance it could increase my chance of a heart attack.

http://www.ctvnews.ca/health/long-t...tosterone-replacement-therapy-study-1.2893711

 

[Jinzang]

I wouldn't make too much of this study. The study itself says that they're not certain of the clinical significance of these findings. At most it suggests men with severe arteriosclerosis should not start TRT. I think a heart healthy diet and regular exercise would outweigh any negative side effects of TRT.

 

[FeelingLost]

I wouldn't make too much of this study. The study itself says that they're not certain of the clinical significance of these findings. At most it suggests men with severe arteriosclerosis should not start TRT. I think a heart healthy diet and regular exercise would outweigh any negative side effects of TRT.

Yeah, I don't. It is hard to trust anything that you read these days.
I am not sure if it's an age thing or a symptom of my low T but I see conspiracy theories everywhere these days. It is a major contributor of my anxiety.

I do like madman's study up in Canada with 38,000 men followed. That beats the heck out of <400.

 

[madman]

View attachment jamainternal_Cheetham_2017_oi_160129 (1).pdf February 17,2017

 

[Mountain Man]

By the time one reaches their 60s I would say a majority already have some degree of arterial plaque build up/vascular stiffness whether due to poor diet/genetics/inflammation/stress/lack of exercise/pollutants/medications. The list of many factors goes on. Where any of these factors considered pre treatment with testosterone in theses older men? VASCULAR health is a big factor in overall heart/circulatory/lung/brain function and regardless of how healthy one chooses to live AGING in and of itself contributes to decreased function so we will never be at peak functioning like in our younger years.

Poor vascular health is also one of the major contributors to ED hence why some will always struggle in this area even when being treated with trt/PDE5 inhibitors!

I'm 63 and have worked out my entire life. I was a]very frustrated for the pas 15-20 years or so when orthopedic problems came along and training hard yielded virtually no results. I convinced my pcp to give me a referral to Abraham Motgantaler's clinic in Boston when my total T came in around 400. It was less when I was tested in Boston at 372.Testosterone has been hovering at 1000 for the 9 months I've been on TRT. Have been using cialis for approx 10 years

Morgantaler has been very vocal about flawed research. I think the moral of the story is to stay in touch with your prescriber, get bloodwork, work out hard and get some cardio 3-4 times per week. I think sitting back and assuming TRT will do all the work is a big mistake. Older guys going on TRT are often train wrecks or very out of shape to begin with. This can skew the results.