only for experttuttor PICO As evidence base research nursing
Running head: TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALE OLDER 1
TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALE OLDER 8
TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALE OLDER THAN 39 YEARS OLD WITH LOW TESTOSTERONE SYNDROME
Introduction
Testosterone is a hormone found in humans, with much high levels in males than females, mainly produced by the testicles. It may perhaps be said that it is testosterone levels in a body of a person that distinguish men from women. It provides men their distinctive large muscles, deep voices, and body and facial hair, differentiating them from the women. It stimulates the genitals growth at puberty, occupies a function in production of sperm, fuels libido, and adds to usual erections. It as well fosters the construction of red blood cells, aids cognition, and boosts mood. In due course, the testicular “machinery” that builds testosterone increasingly becomes lesser efficient, and levels of testosterone begin to fall, by around 1% a year, commencing in the 40s. As men get above 39 years and beyond, they could begin to have low testosterone signs and symptoms for instance lower sex drive and vitality sense, erectile dysfunction, decrease energy, reduced bone density and muscle mass, and anemia.
The normal levels in blood range between 280 ng/dl to 1,100 ng/dl. When the testosterone levels fall below 280 ng/dl, the patient is diagnosed with hypogonadism. They are three type of hypogonadism:
-Primary hypogonadism: testicular origin. Low serum testosterone levels with high levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH)
-Secondary hypogonadism: hypothalamic-pituitary origin.low serum testosterone levels with low levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH)
-Mixed hypogonadism: a combination of both, which is increasingly common in the aging male population. low serum testosterone levels with normal levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH)
Hypogonadism can be diagnosed in the absence of low testosterone syndrome if the patient shown asymptomatic low serum testosterone levels. (Bouloux, 2005)
Significance of the topic to nursing practice
As the population ages there will be an equivalent increase in the number of elderly and middle aged men dealing with hypogonadism symptoms. As a result nurses must be conscious of the prospective benefits and threats of testosterone replacement therapy, variety of treatment options accessible and the support and monitoring that these patients need.
When Low testosterone syndrome is diagnosed?
Low testosterone syndrome is diagnosed when the labs results shown a low serum testosterone level less than 290 ng/dl accompanied with physical symptoms like lack of energy, decreased libido and sex drive, loss of muscle mass, lack of focus and concentration, notable increased in belly fat, depression and the complementary blood labs work shown imbalance in the lipid panel, insulin resistance, glucose intolerance, high glucose levels or anemia. All this signs and symptoms can be accompanied as well with a sudden change in cardiac rhythm, high blood pressure, and palpitations.
Treatment
Testosterone replacement therapy(TRT) is used for treatment of adult males for conditions connected with an absence or deficiency of endogenous testosterone (hypogonadism) (Szeinbach, Seoane-Vazquez & Summers, 2012) Intra muscular injections vs topical testosterone gel and patches treatment are the two known types of testosterone replacement therapies. Every different route has own benefits, risks and side effects of each, make them different at all, qualifying each ones for different approaches.
Purpose of the Evidence Base Practice project
In this evidence base practice project we propose to phrase clinical questions according to the PICO (Patient, Intervention, Comparator and Outcome) format for evaluation of the research based evidence and development of the recommendations for effectiveness of the weekly IM cypionate testosterone injection versus testosterone topical gel in males 39 years old and older diagnosed with lower testosterone syndrome for keeping the testosterone levels within normal ranges between 280 ng/dl to 1,100 ng/dl with a sustaining increased libido and muscle mass. The purpose of the testosterone drug class review is to provide evidence informed
recommendations for the use of these therapies for treatment of patients 39 years and beyond diagnosed with low testosterone syndrome. This review will be useful for healthcare providers who prescribe testosterone replacement therapy or manage individuals that receive this intervention.
Application to: Efficiency of TRT treatment for 39 years old and older with low testosterone syndrome diagnosis.
Primary Research Question
What is the present research evidence for the safety and efficacy of intra muscular injections vs topical testosterone gel treatment in adult men with testosterone deficiency?
PICO Statement
Participants/population:This review will evaluate studies that consist of men aged 39 years or older diagnosed with testosterone deficiency or men who have been diagnosed with hypogonadism and are obtaining with hypogonadism and are obtaining testosterone replacement therapy.
Intervention(s), exposure(s): This review will consider studies that evaluate effectiveness of intra muscular vs topical replacement therapy.
Comparator(s)/control: Will compare the effects of intra muscular injections vs topical testosterone gel treatment used by men aged 39 years or older diagnosed with low testosterone syndrome.
Outcomes:
1-Efficacy: Keep the serum testosterone levels within normal ranges between 280 ng/dl to 1,100ng/dl with a sustaining increased of libido and muscle mass.
2-Safety: Cardiovascular death, quality of life, stroke, myocardial infarction, erythrocytosis, severe unfavorable events, newly diagnosed illness (heart disease, diabetes, prostate cancer), site or skin reactions
Literature summary table for quantitative studies
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Author/Title/Year in APA Reference Citation |
Purpose |
Sample/ Population |
Data Collection Method |
Major Findings/Conclusions |
|
|
1. Assess Retrospectively the efficacy and safety of long-term (≥ 2 years therapy) testosterone undecanoate depot (TUD)therapy in the clinical setting 2. Retrospecti vely compare TUD with T pellet implants (TI) therapy. |
Data Retrospective were assembled for 179 hypogonadal men treated with testosterone undecanoate depot for ≥ 2 years from 1998-2011, from the Waikato Hospital Endocrine Database |
Retrospective data were collected |
In general, 72% of trough TT levels were in the range of normal for TUD therapy in comparison with 53% of trough TT levels through TI therapy. |
|
To compare Testosterone Replacement Therapy Medications for Treatment of men with Hypogonadism |
Research studies of men with hypogonadism |
Six electronic databases were searched |
An evaluation of all testosterone medications disclosed that the mainly cost-efficient medicat ions of TRT were injectable formulations, specifically depo-testosterone and Delatestryl.
|
|
Pastuszak A.W, Mittakanti H, Liu J.S, Gomez L, Lipshultz L.I, Khera M..J Androl. (2015) Comparison of the Effects of Testosterone Gels, Injections, and Pellets on Serum Hormones, Erythrocytosis, Lipids, and Prostate-Specific Antigen, Sex Med.; 3(3): 165–173.
|
To evaluate the lasting effects of injectable, topical, and implantable pellet testosterone formulations for men treated for hypogonadism . |
Men treated for hypogonadism with a single testosterone formulation |
Retrospective review of hypogonadal men treated with a single testosterone formulation |
All testosterone formulations raised serum testosterone and calculated free T . More significant increases in estradiol occur with injectable testosterone and testosterone gels. Changes in hemoglobin and hematocrit are most significant with injectable testosterone , and effects on lipids are uneven and conflicting. |
Zitzmann M, Mattern A, Hanisch J, Gooren L, Jones H, Maggi M. (2013) IPASS: a study on the tolerability and effectiveness of injectable testosterone undecanoate for the treatment of male hypogonadism in a worldwide sample of 1,438 men. J Sex Med. 2013 Feb;10(2):579-88. doi: 10.1111/j.1743-6109.2012.02853.
|
Assessment of effectiveness and safety of injectable long-acting testosterone undecanoate (TU) in daily clinical practice of hypogonadal men. |
Enrolled 1,493 hypogonadal men |
An international, multicenter, one-arm, prospective observational study in 23 countries. |
In this major international sample of hypogonadal men, injectable long-acting TU was effectual and well tolerated. |
Literature summary table for qualitative studies
|
Author/Title/Year in APA Reference Citation |
Problem |
Purpose |
Sample/Population |
Data Collection Method |
Major Findings/Conclusions |
Annotations |
Borst S.E, Yarrow J.F (Jun 15, 2015) Injection of testosterone may be safer and more effective than transdermal administration for combating loss of muscle and bone in older men. Am J Physiol Endocrinol Metab.; 308(12):E1035-42. doi: 10.1152/ajpendo.00111.2015.
|
The musculoskeletal effects of testosterone are not proven |
1) To evaluate the musculoskeletal advantages of TRT and 2) To evaluate the cardiovascular (CV) perils of TRT. |
Older men with hypogonadism treated with TRT |
Randomized controlled trials (RCTs) addressing the effects of TRT on 1-RM muscle strength |
Oral TRT add to CV risk and propose that the IM TRT risk profile of CV may be better than that for transdermal or oral TRT. |
The musculoskeletal testosterone effects are dose-dependent and higher doses of T are administered typically by intra-muscular (i.m.) injection than with transdermal preparations. Research available data suggests that i.m. injection might be both the most safest and effective form of TRT. |
|
Ullah, M Iftekhar; Riche, Daniel M; Koch, Christian A, (2014)Transdermal testosterone replacement therapy in men. PubMed
|
Complexity of testosterone replacement therapy with regard to best treatment option for an individual patient |
To evaluate General indications of transdermal testosterone replacement therapy, available formulations, dosage, application sites, and recommended titration schedule. |
Research reported in recent articles for Older men with hypogonadism treated with TRT |
Evaluations of Recent articles on advances in testosterone replacement therapy |
Transdermal TRT can restore testosterone in men with hypogonadism and reinstate a balanced concentration of testosterone in the blood. Also Transdermal TRT has acceptance of improved patient when compared to forms of injectable testosterone |
Transdermal TRT has an additional positive adverse effect profile in comparison to buccal formulations of testosterone. |
References
Bouloux P. Testim (2005) 1% testosterone gel for the treatment of male hypogonadism Clin Ther.;27(3):286–298
Szeinbach SL, Seoane-Vazquez E, Summers KH. (2012)Development of a men’s Preference for Testosterone Replacement Therapy (P-TRT) instrument. Patient Prefer Adherence.;6:631–641
Conaglen. H.M, Paul R.G, Yarndley T, Kamp J, Elston M.S, Conaglen J.V., (Feb 2014) Retrospective investigation of testosterone undecanoate depot for the long-term treatment of male hypogonadism in clinical practice., J Sex Med.;11(2):574-82. doi: 10.1111/jsm.12401
Luthy, K. E., Williams, C., Freeborn, D. S., & Cook, A. (2017) Comparison of Testosterone Replacement Therapy Medications in the Treatment of Hypogonadism, The Journal for Nurse Practitioners. doi:10.1016
Pastuszak A.W, Mittakanti H, Liu J.S, Gomez L, Lipshultz L.I, Khera M..J Androl. (2015) Comparison of the
Effects of Testosterone Gels, Injections, and Pellets on Serum Hormones, Erythrocytosis, Lipids, and
Prostate-Specific Antigen, Sex Med.; 3(3): 165–173.
Zitzmann M, Mattern A, Hanisch J, Gooren L, Jones H, Maggi M. (2013) IPASS: a study on the tolerability
and effectiveness of injectable testosterone undecanoate for the treatment of male hypogonadism in a
worldwide sample of 1,438 men. J Sex Med. 2013 Feb;10(2):579-88. doi: 10.1111/j.1743-
6109.2012.02853
Borst S.E, Yarrow J.F (Jun 15, 2015) Injection of testosterone may be safer and more effective than transdermal
administration for combating loss of muscle and bone in older men. Am J Physiol Endocrinol Metab.;
308(12):E1035-42. doi: 10.1152/ajpendo.00111.2015.
Ullah, M Iftekhar; Riche, Daniel M; Koch, Christian A, (2014) Transdermal testosterone replacement therapy in