People with hypothyroidism who choose dried thyroid extract (DTE) over levothyroxine alone perceive that it works better, but patients may not be aware of the risks, new research suggests.Those were some of the findings from the qualitative analyzes of nearly 700 online posts from three popular online hypothyroid forums, which found that 75% of patients felt they did better with DTE than standard levothyroxine therapy (LT4). .

The results were due to be presented at the Endocrine Society annual meeting in late March, but the meeting was canceled due to the COVID-19 pandemic. They were subsequently published online April 3 in Medicine by Freddy J.K. Toloza, MD, a postdoctoral researcher at the University of Arkansas for Medical Sciences, Little Rock, and a research collaborator at the Mayo Clinic, Rochester, Minnesota, and colleagues.Made from dried pork thyroid glands, DTE is not approved by the U.S. Food and Drug Administration because it predates the agency, but it was protected and is legally sold by prescription under the names of Nature Thyroid, Thyroid USP and Armor Thyroid.

DTE is currently used in 10-29% of hypothyroid patients, despite concerns about the risk of side effects associated with hyperthyroidism.

"Current guidelines (American Thyroid Association) strongly suggest the use of levothyroxine over DTE as thyroid replacement therapy. We agree with this recommendation due to concerns about the side effects of DTE," Toloza told Medscape Medical News."However, additional research needs to be done to understand if this recommendation applies to all hypothyroid patients," he added, and for those patients taking DTE, more research is required to determine who is at risk for side effects and the methods to prevent them. .Toloza said hypothyroid patients taking DTE frequently described the lack of individualized treatments and the feeling of not being heard as problems influencing their choice.

"These findings reinforce the need for patient-centered approaches in current clinical practice. Physicians must listen carefully to their patients and consider their individual needs and the context of each patient," he noted.A select group of patients improves in combination with T4 / T3When asked to comment, endocrinologist Rachel Pessah-Pollack, MD, of New York University Langone Health, told Medscape Medical News: "Animal-derived desiccated thyroid hormone contains both T4 and T3. We generally do not recommend use this because it can vary in concentration, which means that the actual preparation is not physiological. "Pessah-Pollack, co-author of the 2012 American Thyroid Association and American Association of Clinical Endocrinologists Joint Clinical Practice Guidelines on Hypothyroidism, added that one of the main concerns about the use of DTE is the risk of iatrogenic hyperthyroidism, which could lead to atrial fibrillation and fractures

"That is one of the main factors that drives many professional societies to really use caution with regard to DTE. That is also the reason why large societies recommend not using DTE based on the evidence to date." , He said.

However, the whole question of "combination therapy" in hypothyroidism is debatable. Doctors may also prescribe a "combination" of synthetic levothyroxine (LT4) and treatment with triiodothyronine (LT3); This, along with the use of DTE products, has been a topic of debate for many years.

The current guidelines (2014) of the American Thyroid Association do not specifically rule out the use of synthetic LT4 / LT3 therapy, but "recommend only against routine use of combination therapy." And while they do not expressly endorse the use of DTE, they did delete a statement that "should not be used."

"There is definitely a select group of patients who do better on T4 / T3 combination therapy, and we are still trying to delineate who that population is," Pessah-Pollack told Medscape Medical News.

"As long as these patients are closely monitored and aware of the risk of hyperthyroidism and their levels are followed to ensure that they are not hyperthyroid, in selected cases this is appropriate."

"But the first line is to ensure that a good evaluation is done Clearly, this helps us understand that we do need more studies in this area, well-designed and blinded studies to really help us get to the bottom of this controversy."

Those taking DTE cite improved symptoms, well-beingToloza and colleagues analyzed 673 posts from three online forums, Medscape's parent company WebMD, PatientLikeMe, and Drugs.com, selected from an initial 1235 post because they included more comprehensive information.

Approximately half (51%, n = 257) of the patients had primary hypothyroidism / Hashimoto's thyroiditis, 25% (n = 126) had postsurgical hypothyroidism, and 16% (n = 81) had postablation hypothyroidism. Among the 172 publications in which DTE dose information was available, the mean dose was 84.1 mg / day. The duration of treatment varied widely, from 2 weeks to 45 years.

Among the publications describing the source of the DTE prescription, initial interest was primarily patient-driven in 54% (n = 88), while 46% (n = 74) said a physician fueled their interest in try the DTE. (Type of clinician not reported.)

Among the publications that mentioned the source of DTE, local pharmacies were the most common (63%, n = 75), followed by pharmacies outside the United States (31%, n = 37) and online (6%, n = 7).

Previous thyroid treatments were mentioned in 300 publications, of which 93% mentioned monotherapy with LT4.

Among the reasons for switching to DTE, there were no improvements in clinical symptoms (47%, n = 75), development of side effects (24%, n = 38), no change in general well-being (22%, n = 36). ), and without changes in laboratory work (7%, n = 12).

The perceived benefits of DTE included an improvement in clinical symptoms (56%, n = 155), a change in general well-being (34%, n = 94), the possibility of reaching a previous state of health (7%, n = 19) and a low cost compared to the previous treatment (3%, n = 8).

Specific symptoms reporting improvement included fatigue (28%, n = 43), weight gain (17%, n = 26), and neurocognitive symptoms (5%, n = 8). The average time to notice the benefits with DTE was approximately 30 days, but it varied widely from 2 days to 4 months.

Most publications (77%, n = 99) stated that DTE was more effective than their previous therapy, while 13% (n = 17) described it as equally effective and 10% (n = 13) said it was less effective.

DTE side effects were described in 20% (n = 136), including weight loss (15%), fatigue (11%), palpitations (11%), heat intolerance (11%), sleep disorders (10%), high blood pressure (7%) and hair loss (5%).

"Doctors think they know how you feel"A qualitative analysis of the publications yielded five main themes: experience with previous therapies before starting DTE, perceived effectiveness and benefits of DTE, side effects of DTE, need for individualized therapy for hypothyroidism, and barriers to obtaining DTE.

One patient posted, "Synthroid (levothyroxine) did not help and gives me negative side effects my endocrinologist attributed all side effects to everything except Synthroid."

Another wrote: "(The armor) changed my life I'm glad I found a medication that makes me feel normal again everyone has improved; the mood, the skin (no itching), no pain head, goiter is depressed. "

Others cited the lower cost of armor compared to Synthroid.

However, some expressed negative experiences with DTE, such as: "My doctor hoped this medication would help with brain fog, energy, and tiredness. I experienced the opposite."

And some were unable to obtain it. One wrote: "Doctors think they know how you feel and don't even tell you about Armor. I asked my doctor and they said there weren't enough studies to show its effectiveness."

Better evaluation, more data neededPessah-Pollack noted that the study data does not address whether the patients' initially prescribed doses of levothyroxine were optimal, noting that changes are sometimes needed, such as during pregnancy, after weight gain, or if the patient is taking other certain medications.

"It is unclear from the symptoms reported by the patient whether they actually had an evaluation of their thyroid levels to ensure that their thyroid hormone dose was correct before switching to T4 / T3 replacement There are many factors that they should be taken before deciding that the drug itself is not working. "

What is urgently needed, he said, are "well-designed, blinded studies that look at this controversy."

"Here, we don't know why patients feel better We need to do additional work that includes validated symptom questionnaires and comparing the thyroid levels of patients on armored thyroid with those on levothyroxine monotherapy."

Toloza agrees: "It cannot be said that DTE works better for the user due to the limitations and nature of the data used in our study."

"However, our findings are in line with previously published research, which has shown that a subset of patients may prefer ETD to levothyroxine and have greater satisfaction with this treatment. However, the reason behind this has not yet been established. understands well, "and should be further investigated.

Pessah-Pollack has reported being an advisor to Boehringer Ingelheim-Eli Lilly and Radius Health, and moderator for Sanofi.

Medicine Published online April 3, 2020. Summary

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. (tagsToTranslate) hypothyroidism (t) thyroid disorder (t) goiter (t) hyperthyroidism (t) chronic lymphocytic thyroiditis (t) adverse effects (t) side effects (t) patient safety (t) thyroid (t) Endocrine Society

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