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The Endocrine Society Presents Clinical Practice Guidelines for Use of Growth Hormone in Adults and for Evaluation and Treatment of Androgen Deficiency in Men

Posted on: Saturday, 24 June 2006, 06:00 CDT

BOSTON, June 24 /PRNewswire/ -- The Endocrine Society will hold a media round table today 10:00 a.m. to discuss new clinical practice guidelines on the use of growth hormone therapy for adults, as well as guidelines for treating androgen deficiency in men.

The Society's clinical guidelines were developed in the last year by special task forces on endocrine-related topics and recently published in the May and June editions of The Journal of Clinical Endocrinology and Metabolism (JCE&M). Importantly, the Society itself funds its guidelines, rather than seeking corporate sponsorship. For this and future guidelines, it has structured a rigorous and innovative guideline development process. A task force of experts in the particular field creates each guideline. The task force relies on evidence-based reviews of the literature to provide support for its recommendations.

In addition, The Hormone Foundation, the patient education affiliate of the Society, has developed a separate set of patient-focused guidelines on both subjects. The new patient guide has also been published in a tear-out format in JCE&M and Endocrine News and is available on the Foundation's Web site so that physicians and the public can easily download and copy it for distribution to patients (http://www.hormone.org/).

"The Endocrine Society has a responsibility to set the standards and expectations for practitioners on who, when and how to use growth hormone and androgens in adult patients," said Dr. Robert Vigersky, chair of the Clinical Guidelines Subcommittee for The Endocrine Society. "These guidelines provide recommendations for all medical practitioners to help detect signs and symptoms early and treat each condition as effectively and safely as possible for."

Growth Hormone therapy

Growth Hormone Deficiency (GHD) in adults must be accurately diagnosed before any therapy is considered, according to the guidelines. GHD in adults is sometimes a carry-over condition from childhood but may also be caused by structural lesions or trauma or may exist for no identifiable reason, known as "idiopathic."

"Growth Hormone (GH) therapy offers benefits in body composition, exercise capacity, skeletal integrity and qualify of life measures in those who are GH deficient," according to the guidelines. These guidelines do not apply to those who wish to take growth hormone to prevent aging or improve strength and/or athletic performance.

Among the guidelines for Growth Hormone Deficiency*: -- Patients with childhood onset GHD who are appropriate candidates for GH therapy should be retested for GHD as adults. -- Adults with evidence of structural hypothalamic, surgery or irradiation to these areas, or other pituitary hormone deficiencies, should be considered for evaluation of acquitted GHD. -- GH treatment is most likely to benefit those patients who have more severe clinical and biochemical abnormalities and should be encouraged in such patients. -- GH treatment should not be considered for patients who have an active malignancy. -- GH treatment should be individualized rather than weight based. -- GH dosing should take age, sex and estrogen status into consideration.

"There has been a concern that GH therapy ... could lead to tumor recurrence or the development of malignancies. However, an increase in the recurrence rates of either intracranial or extracranial tumors has not been demonstrated," according to the guidelines.

However, the guidelines note that there are no published reports of long- term observational studies in patients with (growth hormone deficiency) treated with hormones with respect to the development of malignancies, and said that periodic monitoring will be necessary for adverse effects and physiologic benefit.

Androgen Deficiency in Men

According to the guidelines, signs and symptoms of androgen deficiency include incomplete sexual development, reduced sexual desire, decreased spontaneous erections, breast discomfort, loss of body hair, very small or shrinking testes, inability to father children, reduced muscle bulk and strength and host flashes or sweats.

Among the guidelines for Androgens in Men*: -- Androgen deficiency should be diagnosed only in men with consistent symptoms and signs and unequivocally low serum testosterone levels. -- Measurement of morning total testosterone levels should be used as initial diagnostic test. -- Testosterone therapy should be given to men who have low testosterone levels to induce and maintain secondary sex characteristics and to improve sexual function, sense of well-being, muscle mass and strength and bone mineral density. -- Offering testosterone therapy to all older men with low testosterone levels as a general policy is not recommended. However, it may be used on an individualized basis in those older men with low testosterone levels on more than one occasion and significant symptoms of androgen deficiency, after appropriate discussion of the uncertainties of the risks and benefits of testosterone therapy in older men. -- Testosterone should not be used in men with prostate cancer or in those with an elevated PSA level or abnormal prostate examination without thorough urologic evaluation.

*Clinical guidelines review process and recommendations are independent of industry influence.

Founded in 1916, The Endocrine Society is the world's oldest, largest, and most active organization devoted to research on hormones, and the clinical practice of endocrinology. Today, The Endocrine Society's membership consists of over 13,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society, and the field of endocrinology, visit our web site at http://www.endo-society.org/ .

The Endocrine Society

CONTACT: For a complete press schedule, to speak with a presenter or toobtain a free press registration form, Meghan Norville for The EndocrineSociety, +1-410-821-8220, cell: +1-443-852-1600,meghann@imrecommunications.com

Web site: http://www.endo-society.org/http://www.hormone.org/

Source: PRNewswire

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