Is there a role for Natural Desiccated Thyroid in the treatment of levothyroxine unresponsive hypothyroidism?

[helvella]

Newly published paper. Conclusion: Significant benefit and, as ever, more research needed.

No-one can ever again legitimately say "There is no evidence..."

Note: Paper by authors from from Wales, England, Mexico and Denmark.

Int J Clin Pract

. 2021 Oct 9;e14967.

doi: 10.1111/ijcp.14967. Online ahead of print.

Is there a role for Natural Desiccated Thyroid in the treatment of levothyroxine unresponsive hypothyroidism? Results from a Consecutive Case Series

Adrian H Heald 1 2 , Lakdasa Premawardhana 3 , Peter Taylor 3 , Onyebuchi Okosieme 3 , Tasneem Bangi 2 , Holly Devine 2 , Mark Livingston 4 , Ahmed Javed 2 , Gabriela Y C Moreno 5 , Torquil Watt 6 , Mike Stedman 7 , Colin Dayan 3 , Dyfrig A Hughes 8

Affiliations

• PMID: 34626513

• DOI: 10.1111/ijcp.14967

Abstract

Introduction: Some levothyroxine unresponsive individuals with hypothyroidism are prescribed a Natural Desiccated Thyroid (NDT) preparation such as Armour Thyroid® or ERFA Thyroid® . These contain a mixture of levothyroxine and liothyronine in a fixed ratio. We evaluated the response to NDT in individuals at a single endocrine centre in terms of how the change from levothyroxine to NDT impacted on their lives in relation to quality of life (QOL) and thyroid symptoms.

Methods: The ThyPRO39 (thyroid symptomatology) and EQ-5D-5L-related QoL)/EQ5D5L (generic QOL) questionnaires were administered to 31 consecutive patients who had been initiated on NDT, before initiating treatment/6 months later.

Results: There were 28 women and 3 men. The dose range of NDT was 60mg-180mg daily. Age range was 26-77 years with length of time since diagnosis with hypothyroidism ranging from 2-40 years. One person discontinued the NDT because of lack of response; 2 because of cardiac symptoms. EQ-5D-5L utility increased from a mean (SD) of 0.214 (0.338) at baseline, to 0.606 (0.248) after 6 months; corresponding to a difference of 0.392 (95% CI 0.241-0.542), t=6.82, p<0.001. EQ-VAS scores increased from 33.4 (17.2) to 71.1 (17.5), a difference of 37.7 (95%CI 25.2-50.2), t=-4.9, p<0.001. ThyPRO scores showed consistent fall across all domains with the composite QoL-impact Score improving from 68.3 (95%CI 60.9-75.7) to 25.2 (95%CI 18.7-31.7), a difference of 43.1 (95%CI 33. -53.2) (t=5.6, p<0.001).

Conclusion: Significant symptomatic benefit and improvement in QOL was experienced by people with a history of levothyroxine unresponsive hypothyroidism treated with NDT, suggesting the need for further evaluation of NDT in this context.

Keywords: NDT; free T3; free T4; levothyroxine; liothyronine; quality of life.

pubmed.ncbi.nlm.nih.gov/346...

As so often, full paper is behind a paywall.

onlinelibrary.wiley.com/doi...

[shaws Administrator]

Thanks for posting helvella and the information will be welcomed by those who still suffer due to the fact that those (BTA etc) who withdrew this product - without notice or any scientific evidence that they should do so - just goes to show how ignorant they really are and that hypo patients were completely ignored especially those who were well upon it, suddenly had no source in the UK and searching desperately abroad to see if they could do so. They are still doing so today.

Why did the BTA et al remove this important, and first replacement from 1892 and with no regard to those people who had recovered their health and the anguish suffered by them that they could no longer get it prescribed. We know its safety was proven from 1892 onwards and it saved many, many lives.

I do hope it can be restored for patients. We are all different, of course in what our body decides what is best for us - the patients.

[LindaC in reply to shaws]

👏💚💛

[Hidden]

Is it explained what "levothyroxine unresponsive hypothyroidism" means? Is it about the patient´s subjective experince (feeling that levo is not working despite normal FT4 and FT3 levels), or low FT4 levels and/or FT3 levels? So, would it imply impaired conversion?

[helvella Administrator in reply to Hidden]

Afraid I don’t have access to the full paper but that is an important question.

[diogenes Remembering in reply to helvella]

I'll see if my colleagues can access and will send on if they can. I look at this as a definite and severe questioning of T4-therapy is all. As you may remember I strongly believe that DTE (NDT) has in it not just a ratio of T3/T4, but both are largely bound on to thyroglobulin, and intestinal removal of the bound T4/3 acts as a slow release format, reducing a T3 spike. All that is needed now is for proper NDT uptake dynamics to be done and the FT4/3 changes monitored over time preferably in volunteers to begin with..

[helvella Administrator in reply to diogenes]

That would be great- thank you.

Proper assessment of NDT uptake dynamics would appear to be a simple enough affair. Obviously, funding is an obstacle but technically is there any difficulty?

[diogenes Remembering in reply to helvella]

None whatever. One could easily compare NDT (T3) dynamics against T3 itself in volunteers.

[Hidden in reply to diogenes]

Which would explain why some patients feel that NDT is a "smoother ride" compared to synthetic T3.

[helvella Administrator in reply to Hidden]

That makes lots of sense but has difficulties explaining why some people feel the effects of NDT very, very quickly.

[TSH110 in reply to helvella]

I do it was virtually immediate with me. I felt effects within 24 hours. I react very rapidly to medications and I have a gene for it apparently.

[C70rol in reply to helvella]

I had a grandmother who was given Armour in 1920, as were other patients in the same position,, as that was the only treatment available at that time. The drug companies weren’t formed at that point in time. Wasn’t it something like 1960-1970’s that the drug companies took ‘charge’? And yet a GP told me that NDT had not been around long enough to be trusted!

I’m third generation NDT!

[helvella Administrator in reply to C70rol]

Armour were selling dried thyroids in London in 1894.

And Burroughs, Wellcome had thyroid tabloids in 1893.

Possibly the fact that desiccated thyroid (as Thyroid BP) was added to the British Pharmacopoeia in 1932 affected which products were available?

helvella - Historical Context of Thyroid Treatment in the UK

Extracts of possible interest mostly from The Chemist and Druggist. These documents are currently still being developed.

Pre-1900 document

dropbox.com/s/h9mul6hdfqfew...

1900-1949 document

dropbox.com/s/a2wd7agpfcrcj...

1950-1999 document

dropbox.com/s/barcg7h4uj2nm...

2000 onwards

dropbox.com/s/dwgrmoxqj24el...

helvella - History of Thyroid Hormone Medicines in the UK

A collection of (hopefully) quite interesting information about thyroid hormone medicines, companies, brand names/trade marks, and much else.

dropbox.com/s/cag4qidukqeb8...

[C70rol in reply to helvella]

Wow ,thanks for that full history. I shall copy that . It does worry me that some docs make up so many excuses as to why they won’t prescribe it !!!

[helvella Administrator in reply to C70rol]

What has always got me is the fact that the doctors appear never to have fought against restrictions on their ability to practice as they see fit.

We see blood test requests rejected on specious/spurious grounds.

We see denial of their ability to prescribe specific medicines.

We see them forced into 28-day prescribing.

Of course, they might have fought, but failed. And it is quite clear there are doctors who absolutely agree that these restrictions are wrong. But, from the patient point of view, they appear to have been easy to roll over and push into obedience. After all, we patients can't be expected to know the history which resulted in the current situation. We just see that we don't get the blood test we think we need, cannot be prescribed the medicine we think we need, and have to get a new prescription every month. Without any acceptable explanation.

[Gingernut44 in reply to C70rol]

I hope you told him/her that was total hogwash.

[Me1157 in reply to helvella]

Yes there is! Speaking from experience of being on both at different times for a number of years. I am a poor T4 converter....When I was on amour NDT- I usually felt an energy boost not long after taking it. I used to take mine first thing in the morning. I had less brain fog and felt more like myself and weight was easier to lose. I went thro phases ups & downs with NDT too, but I did much better on it than levo. I think it's because the NDT is not always as stable as it should be. There's been less recalls ( I was told with the 1 grain doses than 2 grain doses). So, I used to have my US Dr perscribe 2 x1 grain tablets daily. Instead of 1x 2 grain tablet daily.

[shaws Administrator in reply to Hidden]

When I was given levothyroxine, all it did for me was give me intense palpitations and cardiologist was considering putting an implant in my heart to 'see what was going on' as he was puzzled by he overnight recordings of severe palpitation on levo only.. When T3 was added palps ceased and I didn't need an implant. I then went onto T3 only and am still on it and am well and no symptoms..

[Hidden in reply to shaws]

I am a bit curious: how to you handle doctors? My experience has been (and I have a below range TSH on levo) that doctors are always trying to interfere. Even if I haven´t consulted them about my thyroid. But as soon they ask if I´m on any drugs, and I say levo, they will immediately want to order labs. When they see my TSH (0.05) they immediately try to make me lower levo...it´s like a low TSH is a red flag to them. I imagine it must be even more difficult when on something most doctors consider unconventional and even experimental? Or do you avoid doctors at all?

[shaws Administrator in reply to Hidden]

Their assumption is that 'with too low a TSH that we've become hyPERactive.

They are very poorly trained and assume that if our TSH goes below 1 they instantly seem to believe that we're on too high a dose and might have a heart attack and they may be blamed.

A doctor phoned me:-

Mrs G your TSH is too low, your T3 too high and T4 too low.

"Yes doctor that's because I do not take levothyroxine so T4 will be low and as I take liothyronine (T3) it will be high and TSH low.

Dr's response was "but T3 converts to T4." No Dr. it's the other way around, T4 converts to T3..

[Hidden in reply to shaws]

OMG, it´s even worse than I thought...!

[Zephyrbear in reply to shaws]

I had that exact same conversation with an endo! Makes you wonder what they do teach them in medical school, especially after they decide to specialise in endocrinology… 🤷‍♀️

[shaws Administrator in reply to Hidden]

A doctor phoned me to say:-

Your TSH is too low: your T3 is too high and T4 too low.

"yes doctor". I take T3 only, so TSH will be low and T3 high. As I take no T4 it will be low".!

GP - but T3 converts to T4.

No doctor that is not right.

T4 is supposed to convert to T3.

[amala57]

Thanks for posting this.My life would be intolerable without NDT.

I dread not being able to get hold of it.

I wish they would license it in the UK.

My GP would prescribe it for me if it was licensed.

[SlowDragon Administrator in reply to amala57]

2,200 prescriptions for Armour on NHS in England last year

openprescribing.net/analyse...

Less for Erfa - only 355

openprescribing.net/analyse...

[amala57 in reply to SlowDragon]

I've asked my GP several times. She won't take "the risk".

[shaws Administrator in reply to amala57]

She might if she's aware of how many prescriptions were given last year:-

2,200 prescriptions for Armour on NHS in England last year

Of course she's wary of losing her job through the rumours but surely she could double-check with whomsoever employs her.

I doubt she's aware it was the very first replacement in 1892 and it saved lives from then on - with no blood tests at all and just the skill of the doctor knowing clinical symptoms and gradual doses until hypo patient's clinical symptoms resolve. There were no blood tests in 1892 just the skill of the doctors.

[amala57 in reply to shaws]

Next time I see her I will present her with this info. I don't hold out much hope. Worth trying again. Thanks

[Hidden in reply to amala57]

But I suppose she’ll “take the risk” of prescribing ‘black box’ drugs such as Gabapentin and some antidepressants - not to mention HRT and many other drugs which can have catastrophic side effects.

The myth that T3 will cause osteoporosis or heart disease should be well and truly debunked.

[amala57 in reply to Hidden]

Yes indeed. The last doctor I saw gave me 100 high strength codine & paracetamol tablets! (I haven't taken any yet).The system is stacked against us.

Again, women (mainly), being ignored. 😒

[TSH110 in reply to SlowDragon]

Does that mean they are free to the patient? It is very interesting but my area is zero ☹️

[helvella Administrator in reply to TSH110]

In general, that is exactly what it means. Exactly the same basis as levothyroxine. So long as those who need to, in England, have acquired exemption certificates.

[TSH110 in reply to helvella]

I wonder if it’s worth a pop if no one in the area has been successful does that imply it’s effectively banned? Perhaps just making a noise is worth doing.

[helvella Administrator in reply to TSH110]

We need to think about things like GPs moving around. If one who is familiar with NDT moves to an area where none is prescribed, that could result in its use spreading.

Even if they have to play the game and submit requests through CCGs, etc., it might in time happen.

But perhaps the biggest boost would be a bona fide UK licensed product at a sensible price?

[TSH110 in reply to helvella]

Yes that would be really good, do you think it will happen? The demand must be there but is any attempt underway to set such a product in train? I hope so, as the tide is turning with papers like this coming out.

I might try my GP say I’ve been taking it for seven years with no ill effects and feel considerably better than I ever did on Levothyroxine when I was at the the surgery for all sorts of problems such as severe vitamin D deficiency. Plus I have DIO2 poor conversion gene combination and thyroid hormone resistance genes which might explain my low T3 on T4 monotherapy, which was recognised by the endocrinology department, but they chose to do nothing to help me when they could have trialled T3, leaving me suffering hell for two years.

I didn’t ask to get this horrible disorder and why should I have to pay for my medication and buy it on the internet when I had a medical exemption certificate up to 60 and it can be prescribed on the NHS. They should do it too protect patients like me who could be conned out of a considerable amount of money or be sold anything posing as NDT.

I think she’s German or Scandinavian so might have a more open mind to it.

I had assumed they were private prescriptions requiring payment for the NDT. Thanks for the clarification

[helvella Administrator in reply to TSH110]

No - I really don't expect it to happen.

Initially any move would, I suspect, be more likely to use thyroid powder from existing manufacturers:

bioiberica.com/en

biofac.dk/products/thyroid-...

And, other than this specific paper having a heavy UK contingent among the authors, I'd have put the UK towards the end of the queue of countries likely to take up the challenge of creating a new product. (Maybe the need for France to change their law would put them even further back?)

I agree there is plenty of justification for getting it prescribed.

[Gingernut44 in reply to TSH110]

Mine too, zero for Armour and Erfa ☹️

[TSH110 in reply to Gingernut44]

I might try asking & see what happens.

[Gingernut44 in reply to TSH110]

Don’t hold your breath 😊

[TSH110 in reply to Gingernut44]

No I don’t think I’ll get anywhere but they should know we want it, not Levothyroxine.

[Gingernut44 in reply to TSH110]

👍 Good luck

[TSH110]

Great news & thanks for posting

[Miffie]

A fabulous piece thank you. I saw an endo in Kernow CCG who advised he was very happy for me to continue to self source ndt. I may suggest an NHS script is in order now I have this added to open prescribing info.

[diogenes Remembering]

Have obtained the paper and have sent to Lyn Mynott for those interested.

[Gingernut44 in reply to diogenes]

Many thanks for all your help and work to help us

[diogenes Remembering]

Have obtained the paper and sent to Lyn Mynott for those interested

[tattybogle]

Wondering if this is any help in birkie and waveylines search for an NHS endo willing to prescribe NDT ... ie. are some of the authors of this paper are practicing UK endo's ? might be worth checking them out.

but whatever , it's probably a good paper for anyone on NDT to have up your sleeve . I haven't had time to read it again properly. it's behind a paywall , but diogenes ( bless 'im ) sent a copy to LynnMynott.