The Expert Report
Interview With Michaël Friedman, ND
Mark Swanson, ND
My special guest for this issue of The Expert Report is Michaël Friedman, ND, clinician, teacher, mentor, specialist in functional-integrative endocrinology, passionate herbalist, and founder of the Association for the Advancement of Restorative Medicine (AARM). He is also the author of Fundamentals of Naturopathic Endocrinology1 and is a leading expert on the clinical use of sustained-release triiodothyronine with botanical medicines to treat patients with low body temperature and restore normal body temperature and to improve the quality of life in patients diagnosed as having Wilson temperature syndrome (WTS).2 He also devotes much of his time to speaking with clinicians across the globe on this unique specialty and healing art.
About the Guest
Dr Friedman, what are your education and current position?
Dr Friedman: I graduated from the Canadian College of Naturopathic Medicine [Toronto, Ontario]. Currently, I am the founder and executive director of the Association for the Advancement of Restorative Medicine.3 A large part of my education honestly has not come from books or clinical studies but by working with herbs and studying with a traditional Shuar healer from the Amazon.
Restorative Medicine and the AARM
What is restorative medicine?
Dr Friedman: Restorative medicine is a cross-disciplinary approach for “restoring” function. It is not simply treating symptoms and palliating medical conditions. Its modalities include high therapeutic doses of herbs, nutrition, and bioidentical hormone replacement therapies. It also encourages lifestyle modalities. The ultimate goal, when possible, is that the treatment can eventually be weaned off, whether it is herbs or hormones.
What are the mission and vision of the AARM?
Dr Friedman: AARM is a nonprofit medical association to support cross-disciplinary collaboration between medical and naturopathic doctors. It was formed to provide education, clinical research, and cutting-edge protocols, which empower physicians to more effectively treat their patients and build their practices. We currently have over 650 members that are MDs, NDs, and DOs. Our board of directors and peer-review medical group is very diverse, ranging from folkloric herbalists to physicians. AARM recognizes and is grateful that plant knowledge comes vastly from the wisdom of our ancestors and traditional cultures. It also promotes the normalization of low body temperatures with the use of the T3 [triiodothyronine] protocol and/or herbal and nutritional protocols in people with or without normal thyroid blood tests. We are launching our first pilot issue of our medical journal this August. Our vision is that this journal will be indexed in MEDLINE-PubMed4 in 2015.
How does restorative medicine differ from functional medicine and the core functional therapeutics of naturopathic medicine?
Dr Friedman: I believe they are very similar in that they seek to identify and address the root causes of disease and in line with the core functional therapeutics. The restorative medicine goal is to help restore health to the body such that the body can maintain that state of good health on its own after the treatments are discontinued. We are an umbrella under which many types of healers unite. Our focus has been traditionally on the hormone system, focusing on T3 (triiodothyronine). Along with the science, we believe in the art of medicine.
Thyroid Frustration
Why do patients often say they feel little or no improvement on their thyroid medication, despite having a normal thyroid function panel?
Dr Friedman: Feeling well on thyroid medicine has a lot to do with delivering steady thyroid stimulation to the cells, sufficient to generate normal body temperatures. Many of the studies that have been done did not use sustained-release T3 or use body temperature as an end point. My opinion is that there are a great number of patients on T4 [thyroxine] monotherapy, to the satisfaction of blood tests, that still do not feel well and that most of them would feel much better if their temperatures were normalized by adding to or replacing their T4 with sustained-release T3 or pure T3 on its own.
Wilson Temperature Syndrome
I would like to focus the remaining part of the interview on Wilson temperature syndrome, which many NDs treat, and most get asked about. For disclosure, are you financially or professionally affiliated with Dr Denis Wilson, founder of WTS?
Dr Friedman: Denis Wilson and I are co-owners of Restorative Formulations and WTSmed supplements [Montpelier, Vermont]. No other financial relationships.
Wilson temperature syndrome is all about restoring normal body temperature. Does it follow the Broda Barnes basal body temperature guide? What temperature range is considered normal (oral) body temperature? And what do patients with WTS average?
Dr Friedman: Broda Barnes5 focused more on measuring the temperature upon waking as a measure of basal metabolic rate. With WTS, it’s felt that it’s a more specific indication of a problem if the temperature is low during the active part of the day, when it’s supposed to be its highest. Measuring the temperature during the day also helps patients correlate their symptoms with their temperatures. We consider it normal for the oral body temperature to average 98.6°F during the active part of the day. Most patients with WTS have daytime oral temperatures averaging below 98.0°F. Many people with symptoms consistent with slow metabolism will feel better when their temperatures are normalized to 98.6°F. However, some people will feel fine with temperatures of 98.2°F. We don’t recommend treating temperatures so much as patients.
How does your normal temperature differ from other normal temperature values from research studies?
Dr Friedman: The patients that respond well to normalization of their body temperatures with T3 are routinely assessed to be “healthy” by mainstream medicine. I do know that a 1992 JAMA study6 involved 148 healthy subjects that found that at 8 am the average temperature was 97.6°F. This study merely documented average temperatures but did not establish its relationship to health and wellness. We theorize that increasing exposure to toxins and other metabolic stress factors over the past 50 years may be linked to reduced gradually declining body temperatures, being clinically relevant in WTS patients, and may help explain the surprisingly high prevalence.
Dr Swanson’s comment: The mean oral temperature in the JAMA study6 was 98.2°F, and the upper limit of the normal temperature range was 99.2°F. Maximum and mean temperatures varied with time of day, men and women had comparable thermal variability, and women had slightly higher temperatures than men. Temperatures varied diurnally, with 6 AM being the lowest and 4 to 6 PM the highest.
Would WTS low body temperatures and WTS likely persist, despite moving to a warmer climate, wearing more insulating clothing, exercising, etc?
Dr Friedman: I have treated WTS patients in hot climates too. They don’t seem any better off there vs a colder climate.
Sustained-release Triiodothyronine
Treatment of patients with WTS uses compounded sustained-release triiodothyronine. How can clinicians be assured the compounded triiodothyronine is delivering an adequate sustained-release period and will have the same release consistency with each dose preparation?
Dr Friedman: The E4M (METHOCEL hydroxypropyl methylcellulose and methylcellulose polymers) that most compounding pharmacists use has a lot of data to demonstrate its sustained-release curve. The sustained-release action can be over 12 hours, depending on the ratio of E4M to medicine being delivered. The more E4M that is used, the longer the time release. It’s best for pharmacists to titrate their formulas, adjusting the E4M:medicine ratio in large numbers of patients to gain confidence that the dosing is lasting 12 hours. Patients can often feel when a dose is running out.
Dr Swanson’s comment:The data handbook on E4M in sustained-release applications refers to the large-scale production and pharmacokinetics of tablets only.7,8 Compounded sustained-release triiodothyronine does not require it to be a standardized recipe. In my phone survey with compounding pharmacies, none knew of any pharmacokinetics data on sustained-release triiodothyronine. None estimated that E4M compounded capsules of sustained-release triiodothyronine had to have a sustained release of 12 hours; most said likely 6 to 8 hours. None knew for sure. All agreed that if the same prescription being filled was by different pharmacies it would likely result in variations between some preparations. One said that their compounded sustained-release triiodothyronine was a proprietary tablet. Therefore, the subjective response of the patient to treatment currently guides the acceptance of the sustained-release performance of triiodothyronine. The best advice is to inquire with the compounding pharmacy before prescribing and to instruct patients not to change compounding pharmacies unless they notify the physician first.
The primary treatment objective for WTS is to restore a normal body temperature, without any further need for triiodothyronine. Do people relapse?
Dr Friedman: Some people will relapse, especially when under continued stress. Some people do benefit from being on a little T3 indefinitely.
If a patient with normal body temperature feels cold all the time and complains of fatigue or other low thyroid–like symptoms, is he or she ever a candidate for having WTS?
Dr Friedman: No.
Evaluation Insights
Does the WTS protocol induce a period of controllable hyperthyroidism? What are the precautions and contraindications to treatment?
Dr Friedman: No, I would not call it a state of hyperthyroidism. Patients with hyperthyroid have temperatures over 99°F typically and also produce over 600 µg of T3 a day. Our dosages are never that high. The contraindications to T3 therapy include uncontrolled Addison’s disease, low cortisol, angina, high blood pressure, or arrhythmias. Precautions would include ruling out these contraindications and evaluating the patients’ cardiovascular conditions to see if they can tolerate T3 therapy. If a patient can run around the block and not feel very bad from the increased heart rate, that’s usually a good indication that they can tolerate the T3 therapy well. Herbal cardiac and adrenal support can also be very helpful for patients undergoing T3 therapy. It’s also important to use well-made sustained-release T3 in a way that makes pharmacological sense (according to protocol).
What is the laboratory thyroid hormone evaluation protocol for WTS? Are there other assessment markers?
Dr Friedman: I don’t think there is or will be any more direct test than the body temperature. There’s nothing more accurate than assessing metabolism by the temperature of the body. There are no blood tests to test for this condition. I always will order lab tests to rule out other causes of fatigue such as TSH [thyrotropin level], WBC [white blood cell count], etc. I never treat someone if they have low body temperature and no symptoms.
Is WTS linked to a higher inflammatory burden, increasing cardiovascular risks? Would you also screen for inflammation markers with WTS?
Dr Friedman: No, I don’t know why there would be inflammation. However, low metabolism can be a burden on the heart, and many people with low body temperature do have heart palpitations, which resolve after body temperature is corrected. There is one case in which a hypothyroid patient was able to cancel heart surgery once the patient was administered T4.
Evidence-based Research
To finally “prove the case” for WTS against its harshest critics (such as the American Thyroid Association9 and The Endocrine Society10), what is the best evidence-based research supporting the existence of WTS and its treatment outcomes and safety?
Dr Friedman: Broda Barnes found that low body temperature has an effect on how people feel. Dr Wilson did not discover that. Broda Barnes thought that low body temperature can be increased but not reversed with indefinite use of Armour thyroid. Dr Wilson noticed after treating 5000 patients with T3 that, after a certain set of cycling, the body was able to reset itself, so that patients no longer needed T3 after therapy was discontinued. There have been no research studies done that I know of that low body temperature affects how people feel. However, clinically this has been seen. I think a study on this would be great.
Studies demonstrating that low body temperature can be reset in a subset of patients with low body temperature have not been performed as of yet. However, clinically this has been noted by some practicing physicians who have used the WTS protocol. This would be a great study to do.
Our srT3 [sustained-release triiodothyronine] cycling protocol is one modality that can reverse this condition. Clinically, this has been seen, but no study has been done on this. WTS from many doctors’ perspectives, including Dr Wilson and myself, is that WTS can be treated clinically in many ways, whether it’s herbal, nutritional, avoiding food allergies, and detoxification, etc, or even regular-release T3. The only reason for the sustained-release option is to make it more tolerable in the subset of patients who complain of cardiac stimulatory effects of regular T3. Using Armour is fine as well; however, I have never seen it reset a patient’s body temperature after it was discontinued.
Studies have been done on the use of T3 as an effective tool in euthyroid, in depression,11-14 bipolar,15 and fibromyalgia (FM),16 with all patients showing positive quality-of-life parameters. In Dr Lowe’s FM studies,16-19 75% of patients improved with T3 treatment. Although Dr Lowe criticized Dr Wilson’s work, the concept that (despite normal TSH) the use of T3 in fibromyalgia is very similar to WTS. The only difference is the end point is not body temperature, and no cycling was done. This research can be extrapolated to be very similar with WTS. Patients with normal TSH but who don’t feel well do respond to T3. The only difference that WTS brings in is that the body temperature is included in the diagnoses. Just because temperature was not assessed in the T3 studies doesn’t mean that all these patients had lower temperatures before treatment was initiated.
Dr Swanson’s comment:The late Dr John Lowe hypothesized that patients with fibromyalgia have a peripheral hypometabolism of thyroid hormone within cells. His research reported that most patients with fibromyalgia had low body temperature also.17 Thus, theoretically under a WTS protocol with triiodothyronine, a successful FM treatment could be given in the shorter term and then weaned off once the body temperature is reset. This was not the case in any of Dr Lowe’s patients. They improved only when a thyroxine-triiodothyronine combination or triiodothyronine was given indefinitely.If weaned off, relapse always occurred.18,19
Dr Swanson’s Closing Comment
Thank you, Dr Friedman, for this expert “temperature gauge” perspective on Wilson temperature syndrome and restorative medicine. A large number of clinicians who practice the WTS protocol use your guidance for helping their patients achieve successful outcomes. Many have passionately embraced it as a bold, insightful, and brilliant treatment that addresses a condition with a frustratingly difficult-to-treat history. It is also anticipated that well-designed, published independent evidence-based research will emerge on WTS protocols to further advance its science and knowledge, including clinical trials and case studies. May I suggest that the AARM3 make a call for scientific papers on this subject at the 10th Annual International Restorative Medicine Conference, to be held in San Diego, California, from September 13 to 16, 2012?
Dr Friedman: Yes. Physician certification at the conference will include the T3 protocol. It will be taught by Dr Denis Wilson, endocrinologist Edwin Cunningham, MD (who has used T3 for over 45 years in clinical practice), and myself. There will be over 50 classes to choose from in simultaneous tracks.
Dr. Swanson: A major naturopathic physicians professional liability insurer has recently clarified their WTS malpractice coverage, stating: “Coverage would be excluded for the use of compounded T3 because the FDA has not approved use of this treatment as safe and effective in the treatment of Wilson’s Temperature Syndrome. Until the FDA approves this specifically for the treatment of this condition, we would exclude this treatment under the [ ] policy”. (20)
Mark Swanson, ND, writes “The Expert Report” column, which is featured in NDNR. Dr. Swanson has over 25 years experience as chief medical advisor, research and technical consultant, and products formulations expert to leading practitioner brand supplement manufacturers. He is a former associate editor for the American Journal of Naturopathic Medicine, national product director, and published researcher. He is a pioneer graduate of Bastyr University, 1984. Dr. Swanson has his private practice specializing in Preventics Care and Functional Medicine, in Sequim, Washington. Contact: [email protected]
References
1. Friedman M. Fundamentals of Naturopathic Endocrinology. Kingston, Ontario, Canada: Quarry Press; 2001.
2. Wilson’s temperature syndrome. http://www.wilsonssyndrome.com. Accessed June 16, 2012.
3. Association for the Advancement of Restorative Medicine. http://www.restorativemedicine.org. Accessed June 16, 2012.
4. PubMed. http://www.ncbi.nlm.nih.gov/pubmed. Accessed June 16, 2012.
5. Broda O. Barnes, M.D., Research Foundation Inc. http://www.brodabarnes.org. Accessed June 16, 2012.
6. Mackowiak PA, Wasserman SS, Levine MM. A critical appraisal of 98.6°F, the upper limit of the normal body temperature, and other legacies of Carl Reinhold August Wunderlich. JAMA. 1992;268(12):1578-1580.
7. Dow. METHOCEL cellulose ethers: technical handbook. http://www.dow.com/PublishedLiterature/dh_004f/0901b8038004fa1b.pdf. Accessed June 16, 2012.
8. Dow. Methycellulose. http://www.dow.com/dowwolff/en/industrial_solutions/polymers/methylcellulose/index.htm. Accessed June 16, 2012.
9. American Thyroid Association. http://www.thyroid.org. Accessed June 16, 2012.
10. The Endocrine Society. http://www.endo-society.org. Accessed June 16, 2012.
11. Abraham G, Milev R, Stuart Lawson J. T3 augmentation of SSRI resistant depression. J Affect Disord. 2006;91(2-3):211-215.
12. Cooper R, Lerer B. The use of thyroid hormones in the treatment of depression. Harefuah. 2010;149(8):529-534, 549-550.
13. Joffe RT. Hormone treatment of depression. Dialogues Clin Neurosci. 2011;13(1):127-138.
14. Kelly TF, Lieberman DZ. Long term augmentation with T3 in refractory major depression. J Affect Disord. 2009;115(1-2):230-233.
15. Kelly T, Lieberman DZ. The use of triiodothyronine as an augmentation agent in treatment-resistant bipolar II and bipolar disorder NOS. J Affect Disord. 2009;116(3):222-226.
16. Lowe JC, Garrison RL, Reichman AJ, Yellin J, Thompson M, Kaufman D. Effectiveness and safety of T3 (triiodothyronine) therapy for euthyroid fibromyalgia: a double-blind placebo-controlled response-driven crossover study. Clin Bull Myofascial Ther. 1997;2:31-58.
17. Lowe JC, Honeyman G, Yellin J. Lower resting metabolic rate and basal body temperature of fibromyalgia patients compared to matched healthy controls. Thyroid Sci. 2006;1(8):1-18.
18. Swanson M. The “Lowe” down on thyroid: the Expert Report interview with Dr John Lowe. NDNR. March 2012. https://ndnr.com/web-articles/anxietydepressionmental-health/the-lowedown-on-thyroid. Accessed June 18, 2012.
19. Lowe JC. The Metabolic Treatment of Fibromyalgia. Boulder, CO: McDowell Publishing Co; 2000.
20. Letter on file.
