How to manage low testosterone level in men: a guide for primary care

Ahmed Al-Sharefi; Scott Wilkes; Channa N Jayasena; Richard Quinton

doi:10.3399/bjgp20X710729

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How to manage low testosterone level in men: a guide for primary care
Geoffrey Hackett, Professor Mike Kirby, David Ralph, Sudarshan Ramachandran, Rowland Rees, T Hugh Jones, Jonny Coxon, Adrian Heald and Patrick Wright

Published on: 03 July 2020
How to manage low testosterone level in men: a guide for primary care
George Castle

Published on: 27 June 2020

Published on: (3 July 2020)

How to manage low testosterone level in men: a guide for primary care
Geoffrey Hackett, Consultant in Urology, Aston University
Other Contributors:
Professor Mike Kirby, Physician, University of Hertfordshire

David Ralph, Consultant Urologist, UCH London

Sudarshan Ramachandran, Professor of Metabolic Medicine, Keele University

Rowland Rees, Urologist, University Hospital Southampton

T Hugh Jones, Consultant Endocrinologist, University of Sheffield

Jonny Coxon, Gender physician / President BSSM, British Society for sexual Medicine

Adrian Heald, Consultant in Diabetes, University of Manchester

Patrick Wright, GP, BSSM
We write on behalf of the British Society for Sexual Medicine to express our concerns over the above “clinical intelligence” or “guide” for general practitioners on male hypogonadism and the accompanying management algorithm. We are concerned that this terminology made lead to GPs interpreting the article as being a peer reviewed guideline rather than personal opinion. Unfortunately, the authors state that there are UK guidelines in place for erectile dysfunction, referencing a guideline of fertility and a NHS clinical knowledge summary Aug 2019, which comes with a disclaimer that it is NOT a NICE guideline. In fact, this NHS CKS states that is almost exclusively based on the comprehensive peer reviewed BSSM guidelines 2018,¹ omitted by the authors, who chose to reference Australian guidelines instead. The guidelines of the American Urology Association state that “patients need to be informed that low testosterone is an independent risk factor for cardiovascular disease”.²

Whilst we could dissect many points in the article that are not referenced and represent personal opinion, we believe that the findings from 2 pivotal trials should lead the authors reconsider their advice. Firstly, the recent T4DM RCT³ involving 1007 obese men with hypogonadism studied for 2 years, presented at American Diabetes Association 2020, clearly showed that TRT reduces progressi...
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We write on behalf of the British Society for Sexual Medicine to express our concerns over the above “clinical intelligence” or “guide” for general practitioners on male hypogonadism and the accompanying management algorithm. We are concerned that this terminology made lead to GPs interpreting the article as being a peer reviewed guideline rather than personal opinion. Unfortunately, the authors state that there are UK guidelines in place for erectile dysfunction, referencing a guideline of fertility and a NHS clinical knowledge summary Aug 2019, which comes with a disclaimer that it is NOT a NICE guideline. In fact, this NHS CKS states that is almost exclusively based on the comprehensive peer reviewed BSSM guidelines 2018,¹ omitted by the authors, who chose to reference Australian guidelines instead. The guidelines of the American Urology Association state that “patients need to be informed that low testosterone is an independent risk factor for cardiovascular disease”.²

Whilst we could dissect many points in the article that are not referenced and represent personal opinion, we believe that the findings from 2 pivotal trials should lead the authors reconsider their advice. Firstly, the recent T4DM RCT³ involving 1007 obese men with hypogonadism studied for 2 years, presented at American Diabetes Association 2020, clearly showed that TRT reduces progression to type 2 diabetes by over 40% compared with intensive lifestyle intervention. In fact, 2 years of free weightwatcher intervention with one to one support, despite moderate weight loss, resulted in worsening of physical symptoms. Based on NHS diabetes figures, the T4DM study results suggests that, with their cut-off of 14 nmol/l for total testosterone and BMI of over 30 kg/m^2, over 1 million men in the UK could potentially be prevented from progressing to type 2 diabetes. In the T4DM study, TRT v lifestyle advice and placebo, resulted in significantly greater loss of visceral fat, increase in muscle mass and symptomatic benefit. This paper is likely to change clinical practice. We acknowledge the findings of this were not available at the time that this paper went to press.

The second, and most important study to date is the T trial⁴ of 780 hypogonadal men using testosterone gel v placebo over 12 months. This showed conclusively that TRT significantly improved sexual function, depression, mood, walking distance, anaemia, and bone mineral density. Both these large RCTs included men almost exclusively classified as “functional hypogonadism” and provide the highest level of evidence. Apart from bariatric surgery, multiple meta-analyses have shown lifestyle interventions alone in male hypogonadism do not improve clinical symptoms.⁵ Quinton et al. comment that the management of non-gonadal illness “should not usually involve testosterone” is not supported by a large body of evidence. Distressing clinical symptoms bring the patient to the doctor, not a desire for body sculpture as suggested by the authors.

We would invite the authors to address these issues of clinical evidence as we feel that this “guide” will cause great confusion for many general practitioners.

References
1. Hackett G, Kirby M, Edwards D et al. British Society for Sexual Medicine guidelines on adult testosterone deficiency, with statements for UK practice. J Sex Med 2017; 14:1504-23.
2. Mulhall JP, Trost LW, Brannigan RE et al. Evaluation and Management of Testosterone Deficiency: AUA Guideline. J Urol 2018; 200(2):423–432. doi:10.1016/j.juro.2018.03.115
3. Wittert G, Atlantis E, Bracken AC et al. Effect of Testosterone treatment on Type 2 diabetes Incidence in high risk men enrolled in a Lifestyle programme: 2-year Randomised placebo-controlled study: presentation 274-OR. American Diabetes Association June 2020.
4. Snyder PJ, Bhasin S, Cunningham GR et al. Effects of Testosterone Treatment in Older Men. N Engl J Med 2016; 374(7):611-24.
5. Giagulli VA, Castellana M, Lisco G Triggiani V. Critical evaluation of different available guidelines for late‐onset hypogonadism. Andrology. 27 June 2020 https://doi.org/10.1111/andr.12850.

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Competing Interests: None declared.
Published on: (27 June 2020)

How to manage low testosterone level in men: a guide for primary care
George Castle, Foundation Doctor, York Teaching Hospital NHS Trust
Al-Sharefi et al¹ correctly identify that there is currently some debate about the correct monitoring of testosterone replacement therapy in primary care.

In comparison to the many drug monitoring activities carried out to high standards in General Practice, such as rheumatological DMARD immunosuppressives, or therapies linked to the QOF domains like levothyroxine, there may be under-performance in the monitoring of testosterone replacement therapy (TRT). As is the case for many long-term conditions in primary care, practice nurses and clinical pharmacists could become more involved in this.

In a preliminary study² that we performed in two typical practices in the East of England, it was clear that patients were not consistently receiving the recommended annual monitoring, in particular PSA testing and digital rectal examination (DRE).

There are multiple reasons for this, including the disparity between the different international guidelines and the absence of a UK consensus. The patients are often unaware, as the leaflets inside their medication do not highlight monitoring requirements. When patients are discharged from endocrinology or urology clinics for follow-up by general practitioners, the communication of explicit guidance on the requisite monitoring would be helpful to both doctor and patient.

Further work is needed to set agree...
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Al-Sharefi et al¹ correctly identify that there is currently some debate about the correct monitoring of testosterone replacement therapy in primary care.

In comparison to the many drug monitoring activities carried out to high standards in General Practice, such as rheumatological DMARD immunosuppressives, or therapies linked to the QOF domains like levothyroxine, there may be under-performance in the monitoring of testosterone replacement therapy (TRT). As is the case for many long-term conditions in primary care, practice nurses and clinical pharmacists could become more involved in this.

In a preliminary study² that we performed in two typical practices in the East of England, it was clear that patients were not consistently receiving the recommended annual monitoring, in particular PSA testing and digital rectal examination (DRE).

There are multiple reasons for this, including the disparity between the different international guidelines and the absence of a UK consensus. The patients are often unaware, as the leaflets inside their medication do not highlight monitoring requirements. When patients are discharged from endocrinology or urology clinics for follow-up by general practitioners, the communication of explicit guidance on the requisite monitoring would be helpful to both doctor and patient.

Further work is needed to set agreed UK GP guidelines for the monitoring of testosterone replacement therapy, including DRE guidance, plus education on the risks of TRT; and the organising of regular practice audit is desirable to ensure that regular reviews in primary care are taking place.

References
1. Al-Sharefi A, Wilkes S, Jayasena CN, Quinton R. How to manage low testosterone level in men: a guide for primary care. Br J Gen Pract 2020; 70 (696): 364-365.
2. Castle G, Stammers J. Testosterone Prescribing in UK General Practice: Are patients being monitored correctly for associated risks whilst on treatment? Basic & Clinical Pharmacology & Toxicology 2020 May 30. doi.org/10.1111/bcpt.13448.

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Competing Interests: None declared.