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Clinical Ethics Considerations In Levothyroxine Treatment

Love your Body – – Robin Nielsen – Natural Hormone Solutions

11.What are the ethical obligations of clinicians in treating hypothyroidism?


Clinical ethical principles in levothyroxine treatment for hypothyroidism revolve around two core ethical principles in medicine: the Principles of Beneficence and Non-Maleficence, which guide the risk/benefit analysis in clinical practice, and protect clinicians from deviating from practice to satisfy inappropriate patient demands. Additional ethical obligations revolve around the professional virtues of competence and intellectual honesty.


Discussion of the clinical ethics literature

Clinical ethics is a field of practice that refers to the bedside ethical issues and dilemmas that arise in the everyday delivery of patient care. Among the four core medical ethical principles introduced and codified in the 1970s in most developed countries, the relevant ethical principle in the treatment of hypothyroidism is the Principle of Beneficence, which guides health care providers to maximize clinical benefits and minimize clinical harms and the Principle of Non-Maleficence, the obligation to not intentionally introduce harms to patients or to not intentionally initiate a therapy that is known to have no therapeutic benefit. The Principle of Non-Maleficence also directs practitioners to warn third parties of imminent harms, if the patient appears to be a threat to an identifiable third party or the public this is also a legal standard, codified in health law doctrine.

The Wonders Of Hormone Reset Programs With Robin Nielsen

May 3, 2022

On this weeks episode of TheGirlfriend Doctor, we had a conversation with my very goodfriend/colleague of many years, Robin Nielsen. Robin is a hormoneexpert, Certified Clinical Nutritionist, and Board Certified inHolistic Health. Robin has been helping women with menopausalhealth for many years now and she gives us her secrets to maintaina healthy and thriving life!

Robin discusses the importanceon not only focusing on sex hormones because theyre minisculecompared to the other main hormones, which are cortisol andinsulin. She explains why that these are the main hormones womenshould focus on because they are the main factors that eithercontribute or deprive our gene expression. These factorsessentially control the trajectory of our success.

We also talk about her differentprograms made to help deal with the issues that come with menopauselike weight gain, mood destabilization, and more. Robin emphasizesthat ladies need to not only attend the hormone reset program butmaintain it after its done. Consistency is key when it comes torepairing our molecular integrity, and our lifestyle choices arethe formula. This talk is too interesting to not tune in, solisten, learn, and grow!


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Synthetic Combination Therapy And The Rationale For Its Use

13a.Do genetic variants in thyroid hormone pathway genes affect the serum or tissue levels of thyroid hormones in healthy euthyroid individuals or hypothyroid patients taking replacement therapy?

Summary statement

Specific polymorphisms in the deiodinases are consistently associated with very small changes in serum thyroid hormone levels. Insufficient data exist to draw any conclusion about the clinically relevant effects of deiodinase or transporter polymorphisms on tissue thyroid hormone levels.

Mechanistic background

Twin and family studies have shown that between 26% and 65% of the variation in serum thyroid function tests is due to genetic factors . Genetic variants can be divided into two broad classes, based on their frequency and their functional effects on the target gene. Polymorphisms are common genetic variants that occur frequently in the population and generally have only very modest effects on gene function. In contrast, mutations are rare genetic variants with major effects on gene function leading to monogenic disorders such as RTH, RTH , or the Allan-Herndon-Dudley syndrome due to mutations in the TH transporter MCT8 . While no patients have been identified with functionally important deiodinase mutations, seven patients with mutations in SECISBP2, a gene critical for the synthesis of selenocysteine containing proteins including the deiodinases, have been identified. Affected individuals have a mild phenotype but do exhibit decreased serum T3 levels .

Recommended Reading: How To Get Hormones Balanced

Thyroid Hormone Analogs And Euthyroid Patients

23.Should thyroid hormone analog therapy be used in euthyroid individuals with nonhypothyroid-related medical conditions based on current evidence?


Although preclinical data suggest that the concept of thyromimetic use for treatment of nonhypothyroid-related medical conditions may be promising, we recommend against the use of such drugs outside of the research setting, due to concerns about the lack of clear benefit or excessive side effects of currently available preparations.

Strong recommendation. Low-quality evidence.

Mechanistic background

How To Balance Your Hormones With Food

  • Yes, what we eat does matter in fact its essential to feeling fabulous. Thats because its the information we give our body to functionor dysfunction. So choose function for hormone balance, and eat good quality proteins, fats and vegetables with a dollop of starchy carbohydrate at every meal three times a day.
  • Be sure to eat plenty of vegetables every day to help build muscle and bone and have enough minerals and fiber to run all of your bodys processes.

Recommended Reading: How To Get Rid Of Hormonal Acne Scars

Two Big Hormones To Get Balanced First

Hi beauties, welcome to Hormone Breakthrough Wednesday. This is Robin Nielsen and Im so excited to be here with you today. I love Hormone Breakthrough Wednesdays because they give us an opportunity just to take a quick break and kind of refocus on whats important. Were all about becoming the CEO, the chief executive officer of our own health. Its really, really important that we once in a while show up to take that next step on behalf of ourselves so we can really learn more and more about our bodies. So today I want to share a little bit about two big hormones. And you know, we pay a lot of attention to our sex hormones. You know, when we talk about hormones in general, were thinking about estrogen, progesterone, testosterone, were thinking about the, the, um, the sex hormones and actually they are considered minor hormones.

They regulate so many different things including digestion. They play a really key role in digestion. If your adrenals arent happy, nobodys happy. They really have a big impact on your thyroid function. Cortisol is one of your major hormones. Thats one of the two hormones Im going to talk about today. And it has a rhythm. Cortisol has a rhythm. The rhythm is supposed to start out kind of at its highest point right here. Its highest point when you wake up in the morning or if you know, I dont know, 30 minutes to an hour after you wake up in the morning and then it kind of goes downhill like this throughout the day.

Are Your Hormones Wrecking Your Sex Drive With Robin Nielsen

In this episode Robin Neilsen and I jam on the hidden hormone deal breakers that may be wreaking havoc on your sex drive, what to look out for if you have a low sex drive, and how to be the Goddess of your goddess of your own health, as you hold the keys to your health and wellbeing and sexuality.

Robin is a Functional Nutritionist, Board Certified in Holistic Nutrition with over 13 years of clinical experience. She specializes in hormone balance and helping women grow younger no matter their age.

She is Founder and CEO of Insulite Health, the worlds most comprehensive company offering natural support to women with PCOS empowering them to take charge of their bodies, their health, and their lives.

As co-founder of Sexy Younger You!, she has launched 3 Summits and Programs and interviewed over 150 of the worlds leading health experts on the top strategies for aging well and balancing hormones. Robin is past president of the National Association of Women Business Owners, Silicon Valley, the National Association of Nutrition Professionals and her wellness retreats have been featured on the CBS program Eye on the Bay.

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Use Of Levothyroxine In Euthyroid Individuals

10a.Is there a role for the use of levothyroxine to treat biochemically euthyroid patients with symptoms that overlap with those of hypothyroidism?


We strongly recommend against the use of levothyroxine treatment in patients who have nonspecific symptoms and normal biochemical indices of thyroid function because no role exists for use of levothyroxine in this situation.

Strong recommendation. High-quality evidence.

Discussion of the clinical literature

10b.Is there a role for the use of levothyroxine to treat euthyroid patients with depression?


We recommend against the routine use of levothyroxine for the treatment of euthyroid individuals with depression due to a paucity of controlled data examining treatment efficacy in this setting.

Weak recommendation. Low-quality evidence.

Discussion of the clinical literature

Depression is seen in some overtly hypothyroid patients and usually resolves with treatment . On the other hand, depression is not more common in patients with SCH , and when it does co-exist with mild hypothyroidism, LT4 therapy does not improve it .

10c.Is there a role for the use of levothyroxine to treat euthyroid patients with obesity?


We recommend against the treatment of obesity with levothyroxine in euthyroid individuals due to a lack of treatment efficacy for this condition

Strong recommendation. Moderate quality evidence.

Discussion of the clinical literature

Discussion of the clinical literature

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Summary And Future Perspectives

Mouse models with disrupted co-regulator function overall demonstrate that co-activators and co-repressors play a role in the regulation of transcription by TRs not only in the presence or absence of TH respectively, but are also essential for the normal signaling by TR isoforms under a range of TH concentrations. Removal of co-repressor or co-activator function produces a shift in the dynamics of cofactor recruitment and balance of transcriptional activation vs repression that underlies TR actions. Lack of co-repressor recruitment results in a higher percentage of the receptors that are available to bind T3 and co-activators, thus increasing TR sensitivity and transcriptional response to the hormone. At the same time, co-activator removal not only precludes binding of other components of co-activator complex necessary for maximal transcriptional activation, but also leads to enhanced recruitment of co-repressors, thus locking TRs in the repressive mode.

Studies using animal models have also confirmed that co-regulator specificity does exist in vivo, with NCoR and Src1 being the preferred co-repressor and co-activator for TR isoforms. SMRT and Src2 appear to be a second-tier co-regulator and can only minimally, if at all, compensate for the absence of NCoR and Src1 in the context of TH signaling. In fact, the role of SMRT and Src2 only becomes apparent in the compound knockout models, such as Src1//Src2/ , L-NCoRID/Smrt/ , and NCoRID/Src1/ .

Levothyroxine And Other Nonhypothyroid Medical Conditions

5a.What is the appropriate management of perceived allergy to the constituents of levothyroxine or intolerance to levothyroxine?


Perceived allergy or intolerance to levothyroxine can be managed by changing the dose or product, including consideration of gel capsules, and possibly by treating concomitant iron-deficiency anemia. In selected cases, a consultation with an allergist may be appropriate.

Weak recommendation. Low-quality evidence.

Discussion of the clinical literature

5b.How do co-existent medical conditions affect the management of levothyroxine replacement therapy?


We recommend considering patients’ underlying medical conditions in order to establish realistic treatment goals and avoid exacerbation of underlying comorbidities.

Weak recommendation. Low-quality evidence.

Discussion of the clinical literature

Renal and liver disease

There are no adjustments in LT4 dosing that are required in cases of cirrhosis or renal failure. Nephrotic syndrome, with its large urinary protein losses that include the thyroid hormone transport proteins TBG, transthyretine and albumin, can be a cause of increased LT4 requirements due to excessive urinary thyroid hormone losses .

Cardiac disease
Gastrointestinal disease

See recommendation 3c for discussion of gastritis, celiac disease, and intestinal by-pass surgery

5c.How do co-existent psychosocial, behavioral, and mental health conditions affect the management of levothyroxine therapy?

Recommended Reading: What Is Thyroid Hormone Replacement

Choice Of Levothyroxine Product

2a.Is there a clinical rationale for prescribing brand-name levothyroxine preparations in preference to generic levothyroxine?


Prescription of brand name levothyroxine, or alternatively maintenance of the same generic preparation , is advised. Switches between levothyroxine products could potentially result in variations in the administered dose and should generally be avoided for that reason .

Weak recommendation. Low-quality evidence

Strong recommendation. Low-quality evidence

Strong recommendation. Moderate-quality evidence

Discussion of the clinical literature

Blakesley et al. , in a study funded by Abbott Laboratories, studied the FDA-recommended pharmacokinetic process of comparing LT4 products. Even when correction was made for endogenous serum T4 levels in healthy individuals, enabling the detection of differences in the administered dose of 25% and 33%, they could not distinguish acute LT4 doses that differed by 12.5%, leaving open the precise sensitivity of this method to exclude clinically meaningful differences in bioavailability between products considered equivalent.

2b.Are there situations in which therapy with levothyroxine dissolved in glycerin and supplied in gelatin capsules may have advantages over standard levothyroxine?

Discussion of the clinical literature

There is the theoretical possibility that gel capsules or liquid LT4 would be useful in patients with allergies to any of the excipients in solid LT4 tablets.

Low Triiodothyronine Concentrations In Hospitalized Patients


22a.In hospitalized adult patients exhibiting the nonthyroidal illness syndrome, should thyroid hormone replacement be instituted with levothyroxine?


We recommend against the use of levothyroxine as a form of therapy for hospitalized patients experiencing critical illness exhibiting the nonthyroidal illness syndrome. The few randomized controlled trials comparing levothyroxine therapy to no treatment have not shown significant clinical benefit, and have raised safety concerns that limit support for this approach.

Strong recommendation. Moderate quality evidence.

22b.In hospitalized adult patients exhibiting the nonthyroidal illness syndrome, should thyroid hormone replacement be instituted with liothyronine?


We recommend against the use of liothyronine as a form of therapy for hospitalized patients experiencing critical illness exhibiting the nonthyroidal illness syndrome. Although low doses of liothyronine have not been linked to harm in clinical trials, data showing any significant clinical benefit are also lacking.

Weak recommendation. Moderate quality evidence.

Mechanistic background

Discussion of the clinical literature

Randomized controlled data are limited with regards to this clinical question. Review of 10 recent review articles indicates that a large majority of experts do not advocate the initiation of LT3 therapy in this clinical setting .

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Levothyroxine Therapy And Endpoints During Therapy

1a.Is levothyroxine monotherapy considered to be the standard of care for hypothyroidism?


Levothyroxine is recommended as the preparation of choice for the treatment of hypothyroidism due to its efficacy in resolving the symptoms of hypothyroidism, long-term experience of its benefits, favorable side effect profile, ease of administration, good intestinal absorption, long serum half-life, and low cost.

Strong recommendation. Moderate quality evidence.

Ncor In Adipose Tissue: Adipocyte

Adipocyte-specific deletion of NCoR has shown that this CoR represses PPARG signaling pathway in adipocytes . Adipocyte-specific NCoR knockout mice fed high-fat diet demonstrate phenotypic resemblance to animals treated with PPARG agonists, which includes obesity, improved whole-body glucose tolerance, and changes in adipocyte morphology and function, diminished macrophage infiltration, and inflammation. Indeed, PPARG target genes were upregulated in adipose tissue of NCoR knockout animals, and these mice were refractory to further PPARG-stimulation with rosiglitazone, in agreement with the notion that deletion of NCoR increases sensitivity to endogenous PPARG ligands.

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Levothyroxine Therapy In Specific Subpopulations

6a.How should levothyroxine therapy be managed in the elderly with hypothyroidism?


In general, levothyroxine should be initiated with low doses, and the dose titrated slowly based on serum thyrotropin measurements. It should be recognized that normal serum thyrotropin ranges are higher in older populations , and that higher serum thyrotropin targets may be appropriate.

Strong recommendation. Moderate quality evidence.

Discussion of the clinical literature

In elderly persons who are without known heart disease or without major risk factors for heart disease, LT4 therapy can be initiated at the full dose , although the method of starting with a low dose and increasing it slowly is still preferred by some experts . The final LT4 dose that normalizes the serum TSH is generally lower in the elderly compared to younger persons , related to decreases in T4 turnover with age, in turn caused by decreases in lean body mass . However, other factors in the elderly, such as decreased thyroid hormone absorption concomitant drug use, which is more common in the elderly and other comorbidities may serve to negate the effects of decreased T4 metabolism, leading to an LT4 dose that is closer to what would be predicted in a younger person.

6b.How should levothyroxine therapy be managed in pregnant women with hypothyroidism?

Discussion of the clinical literature

6c.How should levothyroxine therapy be managed in infants and children with overt hypothyroidism?

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