Dr.Scally, question on long term trt

Discussion in 'Men's Health Forum' started by supwiz, Apr 7, 2006.

  1. #1

    supwiz Member

    Dr. Scally, With all the medical info. on the benefits of healthy levels of testosterone(usually patients on testosterone), and a person can't restore their natural production thru proper therapy or doesn't want to try, is there really any harm on being on reasonable amounts of trt ongoing? I'm talking mid fifties with no desire to procreate anymore or having to have daily sex. I don't consider shrunken testes, receding hairline, an occational pimple to be problems. I'm asking about serious health concerns being caused by reasonable dose lifetime trt keeping testosterone in a normal to high normal range. I'm glad your on the forum-your reputation in this area is second to none. Thanx, Greg B.
  2. #2
    Michael Scally MD

    Michael Scally MD Doctor of Medicine

    The question opens up a 'bag of worms' regarding a patient's wishes. I understand your agreeing to certain side effects, etc. to be on TRT. But if thereis a cause for the hypogonadisn it first needs to be determined, if possible. When you state, "... a person can't restore their natural production thru proper therapy or doesn't want to try ..." I have to assume that the patient has no prior significant medical history - diagnosis PADAM or Andropause.

    TRT in Brief

    Frank hypogonadism is a clinical condition in which low levels of serum testosterone are found in association with specific signs and symptoms, including diminished libido and sense of vitality, erectile dysfunction, reduced muscle mass and bone density, depression, and anemia. It is associated with specific morbidity and mortality risks.

    When relative hypogonadism occurs in an older man, the condition is often called andropause, or androgen deficiency of the aging male. The difference is whether or not a serum T level is compared to the same age or that of a younger age. BTW the same approach is taken for BMD. There we use comparison to a younger population. At this time there are no long term studies on the morbidity and mortality for TRT. The most controversial topic in the ongoing discussion of TRT is the issue of risk.

    Testosterone supplementation in the United States has increased more than 500 percent in prescription sales of testosterone products since 1993. IMS Health (www.imshealth.com/ims/portal), which tracks prescription drug sales, has said the market for testosterone products in general jumped from $49 million in 1997 to $200+/2000, 250+ million/2001, and 400+/2002 The first testosterone gel on the market, androgel, launched by the Belgian pharmaceutical company Solvay S.A. in 2000, posted about $196 million in U.S. sales last year, a 52 percent jump from 2001.

    Coronary Artery Disease - Data supporting a causal relation between higher testosterone levels and heart disease is sparse. Several studies suggest that higher testosterone levels may actually have a favorable effect on the risk of cardiovascular disease. Studies of TRT have not demonstrated an increased incidence of cardiovascular disease or events such as myocardial infarction, stroke, or angina.

    Lipid Profile - Available data regarding the relation of TRT to lipid profiles are inconsistent. Supraphysiologic doses of androgens, particularly oral nonaromatizable androgenic steroids lower high-density lipoprotein (HDL) levels. Numerous controlled studies using physiologic replacement doses of testosterone have shown no change, or minimal reduction, in HDL, often with a reduction in total cholesterol.
    The limited information available suggest a neutral effect of TRT within the physiologic range is not associated with worsening of the lipid profile

    Polycythemia - Men with hypogonadism have lower hemoglobin levels than age-matched controls, and TRT can restore their hemoglobin levels to the normal range. Injections appear to be associated with a greater risk of erythrocytosis than topical preparations. the H/H/ level should be monitored in men receiving TRT. Treatment may include the withholding of testosterone, therapeutic phlebotomy, or blood donation, may be instituted if erythrocytosis develops.

    Benign Prostatic Hyperplasia - The development of BPH requires the presence of androgens and that the marked reduction in serum testosterone caused by chemical or surgical castration causes reduced prostate volume. Studies have failed to demonstrate exacerbation of voiding symptoms attributable to BPH during testosterone supplementation.

    Prostate volume, as determined by ultrasonography, does increase significantly during testosterone-replacement therapy.Urine flow rates, postvoiding residual urine volumes, and prostate voiding symptoms did not change significantly in these studies. This is explained by the poor correlation between prostate volume and urinary symptoms. Individual men with hypogonadism may occasionally have increased voiding symptoms with TRT.

    Prostate Cancer - There is no scientific peer-reviewed literature that definitely establishes a link between the administration of testosterone and the increasing the risk or development of prostate cancer. There is no compelling evidence that testosterone has a causative role in prostate cancer or to suggest men with higher testosterone levels are at greater risk of prostate cancer or that treating hypogonadism with exogenous androgens increases this risk. Just remember the incidence of prostate cancer rises with aging which is associated with declining testosterone levels. Prostate cancer becomes more prevalent exactly at the time of a man's life when testosterone levels decline.

    Over 200,000 men are given a diagnosis of prostate cancer each year and most are first detected by a rise in the PSA level unrelated to testosterone therapy.

    Interestingly the underlying prevalence of occult prostate cancer in men with low testosterone levels appears to be substantial. A history of prostate cancer has been considered an absolute contraindication to testosterone-replacement therapy which is now under active debate for men who are deemed cured.

    PSA The 2002 U.S. Preventative Services Task Force recommendations on the screening for prostatic cancer concludes that the evidence is insufficient to recommend for or against routine screening for prostate cancer using prostate-specific androgens (PSA) testing or digital rectal examination (DRE), "Screening is associated with important harms including frequent false-positive results and unnecessary anxiety, biopsies, and potential complications of treatment of some cases of cancer that have never affected a patient's health. The USPSTF concludes that evidence is insufficient to determine whether the benefits outweigh the harms for a screened population."

    PSA values used to trigger prostate biopsy include an increase of 1.5 ng per milliliter within two years or a total increase of 2.0 ng per milliliter over any period. These recommendations have been based on observational population studies in untreated men.

    Hepatic Effects - The use of oral preparations of testosterone has been reported to lead to hepatotoxic effects and neoplasia, including benign and malignant tumors. Intramuscular injections and transdermal preparations do not appear to be associated with hepatic dysfunction. Routine monitoring with liver-function tests is probably unnecessary but caution usually is better.

    Sleep Apnea - Testosterone-replacement therapy has been associated with exacerbation of sleep apnea or with the development of sleep apnea.

    gynecomastia - A small number of men receiving testosterone-replacement therapy report breast tenderness and swelling.

    ASIH Probably the most bothersome since this may cause problems in discontinuing TRT. Testicular size and consistency often diminish, fertility will be greatly decreased because of down-regulation of gonadotropins.

    Skin - Transdermal TRT is associated with a variety of skin reactions, mainly erythema or pruritus, which are more common with patches than with gel preparations. Intramuscular injections of testosterone can cause local pain, soreness, bruising, erythema, swelling, nodules, or furuncles. Acne, oily skin, increased body hair, and flushing have also been observed but are generally considered only a minor inconvenience. There isnt any data indicating acceleration of male-pattern baldness with TRT but seems reasonable it might.

    Fluid retention is uncommon and generally mild, but testosterone-replacement therapy should be used cautiously in men with congestive heart failure or renal insufficiency.

    Hypertension has rarely been reported.

    There is no universal agreement regarding target levels of replacement therapy, although many experienced clinicians aim for the mid- to upper-normal range in order to optimize the response to treatment. Treatment to raise levels above the physiologic range is discouraged, although it should be recognized that peak serum testosterone levels generally do rise transiently above the upper limit of normal with standard injection-therapy dosages.

    If the patient reports an adequate clinical response to testosterone supplementation, there is no need for dosage adjustment, even if levels are in the low-normal range. If the clinical response is suboptimal and testosterone levels are no higher than the low-normal range, the testosterone dosage should be increased. If the maximal recommended dose of transdermal therapy has been prescribed without the achievement of adequate serum testosterone levels, consideration should be given to changing to intramuscular-injection therapy. For men receiving injection therapy, clinicians must interpret the results of blood tests on the basis of the interval since the most recent injection, recognizing that peak serum levels are obtained 2 to 5 days after injection and that the levels often return to base line by 10 to 14 days after injection. If the hematocrit rises above the reference range, consideration should be given to temporarily withholding testosterone-replacement therapy, reducing the dosage, or performing phlebotomy. Subsequent monitoring visits are performed at three-to-six-month intervals for the first year and yearly thereafter. At each visit there should be an assessment of the symptomatic response to treatment.


    These are free dowbnloadable files on the 'Net.

    Rhoden EL, Morgentaler A., Risks of testosterone-replacement therapy and recommendations for monitoring, N Engl J Med. 2004 Jan 29;350(5):482-92.

    Screening for prostate cancer: recommendation and rationale. (2002). Ann Intern Med, 137(11), 915-916.

  3. #3

    supwiz Member

    Thank you Dr. Scally for a brillient response! I feel we can't know enough when it comes to such a powerful balance in the body of hormone levels. It's a honor to have you on our forum!

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