Sermorelin Therapy—Antiage or Rage?

Interview With Allison Novins, ND, and Tom Perls, MD
Mark Swanson, ND

This month’s Expert Report focuses on antiaging medicine and interviews Allison Novins, ND, director of the Snohomish Naturopathic Clinic, Snohomish, Washington. She is a naturopathic specialist in this growing area of healthcare for baby boomers 50 years and older. Many seek her care for effective treatments to help them age less and grow older more gracefully. Our specific antiaging topic of discussion is sermorelin acetate therapy, a growing and popular treatment alternative to human growth hormone (hGH) for antiaging. Her clinical experience and naturopathic perspectives on growth hormone and the ways and rationale for increasing it in adults will be welcome information to help learn a little more about this treatment.

Sermorelin is used to aid in the diagnosis and treatment of prepubertal children with idiopathic growth hormone deficiency.1 Its off-label use may include adult age-related growth hormone insufficiency. The Food and Drug Administration does not regulate its prescription use, so it is up to the discretion of the practitioner on how to use it. A quick search online will find clinics and websites marketing sermorelin therapy for achieving a fountain of youthful and robust health that can turn back the aging diseases clock. Dr Novins’ website outlines sermorelin therapy somewhat more conservatively as an antiaging clinic service, with the following highlight: In short, the stimulation of hGH with Sermorelin helps us maintain a healthful body composition and helps us avoid some diseases commonly associated with aging.”2

Of course, an important question many clinicians and patients may ask is whether sermorelin actually works, and is it safe? Therefore, an equally important component of this interview would be to request references on the best supportive evidence-based research. Preferably, these should be human clinical studies on the results of sermorelin therapy relating to direct cellular and organ effects, insulinlike growth factor 1
(IGF-1 [somatomedin C]) and hGH levels, health benefit outcomes, and long-term safety. While offering up a plethora of health benefits, it is not unexpected that antiaging therapies, especially those that market and target increasing hGH, are not without their harshest critics. One of the more outspoken and published opponents of hGH for antiaging is Tom Perls, MD, from Boston University School of Medicine (Boston, Massachusetts). His 2005 study3 on hGH published in JAMA was cited by Dr Novins as being one of the best evidence-based studies and rationale for using sermorelin vs hGH. For clarification, I wanted to give Dr Perls an opportunity to respond. He welcomed the chance and gives a directed response at the end of the interview.

Dr Novins, what are your educational background, professional affiliations, and current position?

Dr Novins: I am a graduate of Bastyr University [Seattle, Washington]. I have a naturopathic practice in Snohomish, Washington. I am a current member of the WANP [Washington Association of Naturopathic Physicians] and AANP [American Association of Naturopathic Physicians].

What is your specialty and the focus of your practice?

Dr Novins: The focus of my practice is helping patients age gracefully. I help patients determine what they can do now that will have a positive impact on their health 10 years from now. I do quite a bit of bioidentical hormone replacement therapy, along with nutrition and lifestyle counseling.

What is sermorelin? How does it work, and what is its primary clinical indication?

Dr Novins: Sermorelin is also known as GRF 1-29 NH2. It stands for growth hormone–releasing factor, with the numbers indicating the amino acid chain that is responsible for the effect of sermorelin. Sermorelin works by promoting the secretion of human growth hormone (hGH) from the pituitary gland. Sermorelin is not the same as hGH; it stimulates the production of hGH in the body. Research has conclusively shown that hGH secretion drops off significantly as we age. Sermorelin is therefore indicated for any patient with a lower hGH level.

How is it being used in your naturopathic practice?

Dr Novins: The age-related drop in hGH production can contribute to weight gain, especially in the trunk, reduced muscle mass, reduced bone mineral content, insomnia, and mental changes in how we view our wellness. When these metabolic changes occur (increased weight gain, decreased muscle mass, etc), we increase our risk for heart disease, insulin resistance, diabetes, metabolic syndrome, and other disorders that are common causes of death after age 50.

Is it considered a natural bioidentical hormone?

Dr Novins: Sermorelin is not a hormone; it is merely 2 amino acids that speak the correct language to the pituitary gland. These amino acids are a truncated analogue of growth hormone–releasing factor, so they cannot be considered truly bioidentical. However, the amino acids that make up sermorelin are naturally occurring.

Who are the ideal candidates for sermorelin treatments?

Dr Novins: Patients who are displaying signs of aging and have a low IGF-1 level become candidates for sermorelin treatment.

What are the expected long-term health benefits of sermorelin therapy?

Dr Novins: Long-term health benefits that have been reported include increased skin elasticity and texture, increased energy and emotional stability, improved bone density, increased muscle mass and strength, less fat tissue, improved memory, improved sexual function, improved cardiovascular strength and lower blood pressure, higher HDL
[high-density lipoprotein cholesterol] and lower LDL [low-density lipoprotein cholesterol], and improved immunity.

Are there any contraindications or safety concerns?

Dr Novins: As with any peptide, local or systemic allergic reaction can occur. By stimulating the pituitary instead of giving the end hormone, we avoid the risk of overdosing.

How is it administered, and for how long? What is a typical patient dose instruction?

Dr Novins: Sermorelin injections are given nightly before bed in the subcutaneous tissue. A patient’s individual dose depends on his/her body mass index (BMI). Men: 200 µg/d for BMI of 18.5 to 24.9 or 400 µg/d for BMI of 25 to 29.9 and over. Women: 300 µg/d for BMI of 18.5 to 24.9 or 400 to 500 µg/d for BMI of 25 to 29.9 and over. The duration of treatment is ongoing and as determined by patient and provider.

In your practice, can most adult patients over age 50 who simply want to feel more youthful and energetic, improve their muscle and body composition, and hopefully “age less” be prescribed sermorelin injections to self-administer at home?

Dr Novins: Any patient can be prescribed sermorelin injections to self-administer at home; the necessity is determined by the IGF-1 blood levels and the symptom picture. The effectiveness can be tracked using IGF-1 blood work.

What biochemical improvements are seen on laboratory tests following sermorelin treatment? Does it result in more youthful hormone patterns? Can it improve the biomarkers of metabolic syndrome?

Dr Novins: Biochemical markers that have been seen to improve include bone mass, IGF-1
levels, blood pressure, and a higher HDL and a lower LDL cholesterol. Patients also enjoy improved hormone levels. Considering that sermorelin use reduces truncal obesity and fat to muscle ratio, it follows that it is a significant aid in reducing metabolic syndrome.

Why do you recommend the coadministration of vitamin B12 injections with sermorelin?

Dr Novins: Sermorelin comes in a powder form and must be reconstituted prior to injection. Since B12 supports the energy pathways in the body to ward off depression, anxiety, and fatigue, we find it is a valuable additive.

Dr Swanson’s comment: Dr Novins’ website lists vitamin B injections as a clinic service, available on a walk-in basis without appointment to nonpatients.

What are the best evidence-based published studies supporting the efficacy of sermorelin therapy as a better alternative to recombinant hGH for growth hormone therapy in aging?

Dr Novins: The studies by Perls et al3 and Shalet4 that point out the dangers of hGH and highlight the hGH-releasing factor alternative are enlightening.

Dr Swanson’s comment: These 2 articles are review and commentary, not clinical studies. They make no mention of sermorelin or highlight hGH-releasing factor as an alternative to hGH in adults as used in antiaging therapies.

Have there been any published human clinical trials using sermorelin as a growth hormone secretagogue to promote pituitary growth hormone release during aging?

Dr Novins: Yes, there have been human studies. One such study is by RusselI-Aulet et al.5

Dr Swanson’s comment: This study is not a clinical trial using sermorelin in adults.

Is the age-related decline in IGF-1 levels generally more pronounced in an overweight (abdominal/truncal) insulin-resistant adult patient (>55 years) compared with a similar-aged normal-weight healthy adult without insulin resistance?

Dr Novins:A study published by Rasmussen et al6 suggests that lower IGF-1 levels are found in obese people. Ultimately, however, the research remains inconclusive, a fact that is mentioned in the article, and which the authors suggest is due to differences in methodology.

Can you provide any additional published clinical study citations that show sermorelin has attenuated and reversed the age-related drop in IGF-1 and/or hGH in adults?

Dr Novins: Claims have been made that sermorelin increases IGF-1, but I do not have any citations to offer.

Dr Swanson with Dr Perls’ response: I then invited Dr Perls to comment on the subject and his article.3

Note: Dr Perls had not seen the full content of the interview, except for the specific question and answer herein that lists his article as a reference.

Dr Perls, what is your current position?

Dr Perls: I am an associate professor of medicine and geriatrics at Boston University School of Medicine.

Our Expert Report interview topic is on the use of sermorelin, a growth hormone–releasing factor secretagogue used as an alternative to hGH in aging adults, primarily as an antiaging therapy. Your article3 was sited herein as a best evidence-based reference supporting the rationale for using sermorelin vs hGH. For clarification of the topic and content of your published articles, I wanted to give you an opportunity to respond and to indicate whether increasing IGF-1 and hGH levels in adults would likely result in any of the plethora of health benefits being attributed to sermorelin, which seem to be the same as those claimed for hGH but without the risks.

Dr Perls: On the contrary, my articles3,7,8 completely, for many reasons, condemn the use of hGH for antiaging and age-related declines in IGF-1. As the 2008 JAMA article7 points out, some antiaging or age management doctors try to claim they are providing hGH for adult growth hormone deficiency syndrome (AGHDS) and are therefore providing it legally. But this is not the same as age-related declines in IGF-1 or hGH. AGHDS is a very rare (3 per 10 000 people) syndrome that usually is due to a cancer involving the anterior pituitary or treatment of the cancer with radiation and/or surgery, resulting in the gland’s inability to produce appropriate amounts of hGH. Furthermore, a stimulation test is required to prove this diagnosis in addition to demonstrating a pathology involving the anterior pituitary. These antiaging and age management doctors nearly never perform these tests because they know the test results would not support their provision of the hormone. Claiming that a person has AGHDS without results from these tests supporting the diagnosis is, to me, irresponsible and deceptive and ultimately would lead to illegal distribution of hGH.

Of course, you know that hGH has its effect by stimulating the liver to produce IGF-1 and a number of other growth factors. So, studies of benefits of risks of hGH might approximate those of IGF-1. To make claims about benefits and risks of IGF-1, one should study IGF-1. For hGH, my articles and the studies they cite all show that the risks far outweigh the benefits. Any claims of increased lean muscle mass are due to increased water retention. Weight loss has been in the 1% to 3% range; people who can stick to a calorie-reducing diet would benefit far more!

This idea of IGF-1 being somehow more physiologic and safe is ridiculous. Bottom line: people should not be messing with their hormones unless they have an endocrinopathy that can be proven and has been demonstrated to require treatment. Otherwise, the risks far outweigh the benefit.

Dr Swanson’s closing comment: I would like to thank Dr Allison Novins and Dr Tom Perls for contributing their expertise and making this issue of The Expert Report an especially thought-provoking exchange of viewpoints. Clearly, good reliable evidence-based studies are needed to determine the metabolic fate, outcome expectations, and long-term efficacy and safety of sermorelin. In this case, there is a striking lack of these studies and very little documentation from physicians’ clinical presentations. One such study that was planned to begin to answer these questions was announced in 2008 by Society for Applied Research in Aging founder and coinvestigator Richard Walker, PhD. This study, which was to be evidence-based, peer-reviewed, and published, is described as “an effort to gather the greatest amount of data possible so as to make it the most reliable predictions about Sermorelin as a clinical intervention in aging….”9 Dr Walker10 is sermorelin’s chief architect and proponent for its use in adult antiaging. So far, the status of the study remains unknown, and it has not been published.


Mark Swanson, ND writes The Expert Report column, which is featured monthly in NDNR. Doctor Swanson is the Chief Medical Officer at Pure Encapsulation, Inc. and for more than 20 years has been the company’s Senior Medical Advisor. He is a former Associate Editor for the American Journal of Naturopathic Medicine, National Product Director, and consultant to the nutritional supplement industry. He is a pioneer graduate of Bastyr University, 1984. Dr. Swanson maintains his private practice specializing in functional-naturopathic medicine in Sequim, Wa. Contact: info@drswanson.com
References

Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-157.

Snohomish Naturopathic Clinic. Sermorelin for anti-aging. http://www.snohomishnaturopathic.com/sermorelin_for_anti-aging.asp. Accessed March 28, 2012.

Perls TT, Reisman NR, Olshansky SJ. Provision or distribution of growth hormone for “antiaging”: clinical and legal issues. JAMA. 2005;294(16):2086-2090.

Shalet SM. Growth hormone outgrows growth. Clin Endocrinol (Oxf). 2004;61(1):1-9.

Russell-Aulet M, Dimaraki EV, Jaffe CA, DeMott-Friberg R, Barkan AL. Aging-related growth hormone (GH) decrease is a selective hypothalamic GH-releasing hormone pulse amplitude mediated phenomenon. J Gerontol A Biol Sci Med Sci. 2001;56(2):M124-M129.

Rasmussen MH, Juul A, Hilsted J. Effect of weight loss on free insulin-like growth factor-I in obese women with hyposomatotropism. Obesity (Silver Spring). 2007;15(4):879-886.

Olshansky SJ, Perls TT. New developments in illegal provision of growth hormone for “anti-aging” and bodybuilding. JAMA. 2008;229(23):2792-2794.

Perls TT. Growth hormone and anabolic steroids: athletes are the tip of the iceberg. Drug Test Anal. 2009;1(9-10):419-425.

Investigation of Sermorelin as a clinical intervention in aging [press release]. Palm Harbor, FL: PRWeb.com; January 23, 2008. http://www.prweb.com/releases/2008/01/prweb642821.htm. Accessed March 28, 2012.

Walker RF. Sermorelin: a better approach to management of adult-onset growth hormone insufficiency? Clin Interv Aging. 2006;1(4):307-308.

Recommended Posts