Assessment and Management of Low Testosterone in Men
Assessment and Management of Low Testosterone in Men
Objective To document current practices in the approach to low testosterone in older men. Given that recommendations are based on low-level evidence, we hypothesized that there would be a wide variability in clinical practice patterns.
Design Members of all major endocrine and andrological societies were invited to participate in a Web-based survey of the diagnostic work-up and management of a hypothetical index case of a 61-year old overweight man presenting with symptoms suggestive of androgen deficiency, without evidence of hypothalamic-pituitary-gonadal (HPT) axis disease.
Results Nine hundred and forty-three respondents (91·2% adult endocrinologists) from Northern America (63·7%), Europe (12·7%), Oceania (8·2%), Latin America and Caribbean (7·6%), and the Middle East, Asia, or Africa (7·8%) completed the survey. Response rates among participating societies ranged from 4·1–20·0%. There was a wide variability in clinical practice patterns, especially regarding biochemical diagnosis of androgen deficiency, exclusion of HPT axis pathology, and monitoring for prostate cancer. In a man with suggestive symptoms, 42·4% of participants would offer testosterone treatment below a serum total testosterone of 10·4 nmol/l (300 ng/dl). A total of 46·0% of participants were, over the last five years, 'less inclined' to prescribe testosterone to men with nonspecific symptoms and borderline testosterone levels, compared to 'no change' (29·3%) or 'more inclined' (24·7%), P < 0·001.
Conclusions This large-scale international survey shows a wide variability in the management of lowered testosterone in older men, with deviations from current clinical practice guidelines, and a temporal trend towards increasing reluctance to prescribe testosterone to men without classical hypogonadism. These findings highlight the need for better evidence to guide clinicians regarding testosterone therapy.
Classical hypogonadism due to structural disease of the hypothalamic-pituitary-testicular (HPT) axis is a clearly defined disease state that generally requires and responds well to testosterone replacement. By contrast, the approach to so-called late onset hypogonadism (LOH), a constellation of symptoms compatible with androgen deficiency and lowered testosterone levels but without recognizable HPT pathology, remains controversial. This is because the diagnosis of androgen deficiency in older men is difficult. Symptoms of androgen deficiency are nonspecific and overlap with comorbidities. Moreover, reference ranges for testosterone levels for older men remain uncertain. In addition, there are currently no randomized controlled clinical trials that provide evidence regarding clinically meaningful end points to demonstrate efficacy, and safety, of testosterone therapy in such men.
Several clinical practice recommendations exist on the diagnostic assessment and management of androgen deficiency. Given the lack of robust evidence, it is inevitable that all 32 recommendations made in the current testosterone therapy guidelines of the Endocrine Society (TES) are based on very low or low quality evidence. Compared to other TES guidelines, they have the third-lowest evidence backing, and only hirsutism and androgen therapy in women have less.
The limited evidence leaves considerable room for physician's choice and it is not known to what extent current clinical practices are in line with, or deviate from published guidelines.
The objectives of this study were therefore first, to document current practice in the assessment and management of low testosterone in men; second, to compare practice patterns with current clinical practice guidelines; and third, to assess international differences.
Abstract and Introduction
Abstract
Objective To document current practices in the approach to low testosterone in older men. Given that recommendations are based on low-level evidence, we hypothesized that there would be a wide variability in clinical practice patterns.
Design Members of all major endocrine and andrological societies were invited to participate in a Web-based survey of the diagnostic work-up and management of a hypothetical index case of a 61-year old overweight man presenting with symptoms suggestive of androgen deficiency, without evidence of hypothalamic-pituitary-gonadal (HPT) axis disease.
Results Nine hundred and forty-three respondents (91·2% adult endocrinologists) from Northern America (63·7%), Europe (12·7%), Oceania (8·2%), Latin America and Caribbean (7·6%), and the Middle East, Asia, or Africa (7·8%) completed the survey. Response rates among participating societies ranged from 4·1–20·0%. There was a wide variability in clinical practice patterns, especially regarding biochemical diagnosis of androgen deficiency, exclusion of HPT axis pathology, and monitoring for prostate cancer. In a man with suggestive symptoms, 42·4% of participants would offer testosterone treatment below a serum total testosterone of 10·4 nmol/l (300 ng/dl). A total of 46·0% of participants were, over the last five years, 'less inclined' to prescribe testosterone to men with nonspecific symptoms and borderline testosterone levels, compared to 'no change' (29·3%) or 'more inclined' (24·7%), P < 0·001.
Conclusions This large-scale international survey shows a wide variability in the management of lowered testosterone in older men, with deviations from current clinical practice guidelines, and a temporal trend towards increasing reluctance to prescribe testosterone to men without classical hypogonadism. These findings highlight the need for better evidence to guide clinicians regarding testosterone therapy.
Introduction
Classical hypogonadism due to structural disease of the hypothalamic-pituitary-testicular (HPT) axis is a clearly defined disease state that generally requires and responds well to testosterone replacement. By contrast, the approach to so-called late onset hypogonadism (LOH), a constellation of symptoms compatible with androgen deficiency and lowered testosterone levels but without recognizable HPT pathology, remains controversial. This is because the diagnosis of androgen deficiency in older men is difficult. Symptoms of androgen deficiency are nonspecific and overlap with comorbidities. Moreover, reference ranges for testosterone levels for older men remain uncertain. In addition, there are currently no randomized controlled clinical trials that provide evidence regarding clinically meaningful end points to demonstrate efficacy, and safety, of testosterone therapy in such men.
Several clinical practice recommendations exist on the diagnostic assessment and management of androgen deficiency. Given the lack of robust evidence, it is inevitable that all 32 recommendations made in the current testosterone therapy guidelines of the Endocrine Society (TES) are based on very low or low quality evidence. Compared to other TES guidelines, they have the third-lowest evidence backing, and only hirsutism and androgen therapy in women have less.
The limited evidence leaves considerable room for physician's choice and it is not known to what extent current clinical practices are in line with, or deviate from published guidelines.
The objectives of this study were therefore first, to document current practice in the assessment and management of low testosterone in men; second, to compare practice patterns with current clinical practice guidelines; and third, to assess international differences.