This month I had a patient who is hypothyroid, as a result of Hashimotos thyroiditis, ask me to give her compounded combination t3/t4 thyroid hormone therapy during fertility treatments and pregnancy. She was a new patient to me and came to me because I am a holistic doctor and believer of a mind-body approach to the practice of medicine. I will not discuss what we ended up doing in her case, but in this blog I hope to impress upon you, the reader, what a physician like me thinks about in the process of deciding with the patient what will be the best thyroid treatment for her. I will present the latest guidelines of care from the published data, and the ethics that guide our integrity as physicians.
Looking at the actual guidelines for thyroid replacements:
The American thyroid Association (ATA) guidelines does not recommend combination therapy (T3 +T4) for the treatment of hypothyroidism, due to lack of long term data and conflicting results obtained from published data in short term studies. Levothyroxine therapy is effective at treating hypothyroidism in most circumstances and should be the initial therapy used to treat the condition. The endocrine society and ATA allows for combination therapy trials in unique circumstances.
The use of desiccated thyroid, which also has higher T3 content ratio per dose, is also not recommended for thyroid replacement in hypothyroidism, and particularly not during pregnancy since adequate T4 is necessary for the developing brain, and not having enough could be deleterious.
The ATA guidelines for treat of hypothyroidism recommend against use of compounded thyroid therapy due to safety, potency, stability of products and the fact that no data exists that shows superiority over existing therapies. However there are noted exceptions to its use including allergies to existent therapies that cannot be overcome with liquid pure preparations of thyroid hormone. It is clear that well made compounded products may be incredibly beneficial to individual patients, but there is no large data on these to guide us. A major concern is that of lack of FDA oversight over compounded medicines which creates for me as a physician a major potential problem in truly knowing reliability and safety of the product. If compounded preparations are used it is best that they be obtained from compounding pharmacies which are accredited by the Compounding Pharmacy Accreditation Board, which provides at least better oversight on the purity of products and is better than no oversight at all.
Ethical guidelines for physicians:
Physicians must show Benefecence (to help heal and treat while minimizing harm) and Non-Maleficence (the obligation to not introduce harm or prescribe a therapy that has no therapeutic benefit).
Physicians must be honest and give patients best therapy first and foremost. This means that patients need to be given and offered first medicine for which data is ample and reliably known to help and not cause harm when used correctly.
My particular perspective:
Physicians work long and hard to get through medical school, internships, residency and fellowships. Physicians need to deal with a lot of red-tape with government demands and shorter time to spend with their patients. Most importantly, for me and other physicians, we do not want to have our licenses to practice medicine taken away, after all this effort, for prescribing non-standard therapy and potentially causing harm when many other therapies are available and extensive long-term data for these exists. This is why I always begin treatment of thyroid deficiency with levothyroxine. What happens next is defined by the patients response to the therapy in combination with their laboratory test and the understanding and trust involved in the patient-physician relationship.
While holistic care takes patients’ autonomy for their care and wishes for their treatment as needs to be respected, it is important that patients understand that sometimes the therapies that they request may not be reasonable at that particular time, may be actually dangerous for them, and that the process of engaging in these non-standard therapies places their physicians in a potentially medico-legal conundrum. So if non-standard therapy is ultimately used, the patients need to acknowledge potential risks and sign informed consents documenting that they are choosing to use therapy for which risks and uncertainty exist.
When I do decide with patients to explore combination therapies by adding T3 to T4 or use of desiccated thyroid, these are considered trials or considered an N of 1 treatment. The typical patient for whom I try these non-standard therapies are those that have had a total thyroidectomy or their thyroid destroyed by radioactive iodine treatment (for thyrotoxicosis) or severe thyroiditis, and do not feel well on levothyroxine monotherapy alone. I think long and hard for the outcome expected for that particular patient. Even if it is good for a particular individual, this does not mean that it is good therapy for all. Pregnancy is a special time, a lot is at risk, and for me this is a particularly worrisome time to use non-standard therapies.
For patients that want to use or try desiccated thyroid it is important that they understand that desiccated thyroid, which comes from pigs, is not natural to humans. Armour and other desiccated thyroid hormone preparations have too much T3 (an unnatural large amount) and the T3 blood levels, when taken orally, are short lasting on the body. Further a once a day dosage makes no sense, if this drug is taken, small doses twice or three times per day are needed when using combinations with T3 in them. Patients need to understand that they may experience hyperthyroidism (too much thyroid effect on the body) leading to heart arrhythmias such as atrial fibrillation, bone loss, and other effects. We actually have no long-term data of use on these agents. Lastly while some patients may feel better in these preparations that may not necessarily translate into better long-term health outcome measures such as quality of life or mortality.
Reference: Jonklaas J, Bianco AC, Bauer AJ, Burman KD,Cappola AR, Celi FS, Cooper DS, Kim BW, Peeters RP, Rosenthal MS, Swaka AM Guidelines for the treatment of hypothyroidism. Thyroid 2014; 24:1670-1751.
I also thank my colleague Dr. M. S. Rosenthal for hearing me out on this complex case.