I don't really know if this is something that will set a precedent? But seems positive

[shambles]

Clinical Trial to Compare Natural Desiccated Thyroid to Levothyroxine

thyroid.about.com/od/t3trea...

[Hidden]

Ooo!! Very interesting! Thanks for the link!

Louise

x

[Issy]

bet they dont choose people who dont do well on T4 though.... so they will find "no benefit" unless they happen to have thousands of people oin the trial.

[Moggie]

Great news that another trial is being orchestrated, just a shame it isnt here in Britian.

Dont know if it will change much though as docs over here can be presented with cold, hard facts regarding NDT and how usless T4 is to some thyroid sufferers but they still will not listen. In fact I think over the last year it has gotten worse with more GP's totally refusing to accept anything other than T4 actually works.

Dont mean to sound so cynical and put a dampener on it (and I hope to god I'm wrong) but getting our medics over here to beleive in the benefits of NDT when they dont even believe in the benefits of T3 is just to much to ask from a institution that is narrow minded and totally unreceptive to anything other than T4.

Moggie x

[shaws Administrator]

That is really good news but, as Issy says, hope they choose people who complain about T3=4.

I particularly liked the phrase:-

This trial is also important because there is a strong bias among conventional endocrinologists against prescribing natural desiccated thyroid drugs, but it is not based on research, but rather, their own opinions and preferences. Some endocrinologists, in fact, have even said that natural thyroid drugs like Armour are only taken by the "fringe", despite the fact that more than two million prescriptions for these drugs are written each year in the United States alone, and more around the world.

[RedApple Administrator]

Oh gosh, this seems like really good news but... Who are the people behind it... which way are they hoping it will go? Can we trust those conducting this trial to understand what they're doing. If they don't dose the desiccated patients correctly, it could end up being the ultimate proof that desiccated doesn't work.

[helvella Administrator]

The fundamental fact that someone, somewhere is doing a proper trial is excellent.

It is quite extraordinary that the doctors both have US Navy email addresses. I would like to understand why they have a particular interest. But perhaps I should not be surprised. We would not expect a trial to be run by a pharmaceutical company for lots of reasons. Academic and practising endos seem to generally be antagonistic. So the US Navy might be one of the few organisations with clout and, somewhere, the budget to achieve this.

I can't help wondering if there is a specific Navy issue - such as supporting many wives left back at home for the duration of long voyages/assignments, or even on-board issues?

The recruitment is, sadly, a mere 180. Wouldn't be surprised if they have 1800 volunteers already sending emails in - and many more to come.

I have a few observations:

A while before it starts, a year to go through the process, and what, another year to publication? At best we will get the paper into public as our Christmas present for 2014.

The trial does a crossover. Unfortunately we have seen that taking desiccated thyroid can require careful dose adjustment, and/or split dosing, which could be a problem.

I would have liked to see assessment every week rather than at each four month change.

I wonder whether anyone will refuse to go through the crossover if they have experienced a big improvement and simply don't want (or are scared of) returning to their original medicines?

I wonder which make of desiccated thyroid they will use? And what conversion factor?

On thing I agree with - the doctors are referring to Desiccated Thyroid Extract and do not use the Natural Desiccated Thyroid terminology. I always have disagreed with the "Natural" in there - it is a bit like saying that patients with breathing difficulties are given Natural Oxygen cylinders to help. And it serves to make Desiccated Thyroid sound rather as if it is not properly standardised and tested. Which at one time did seem to be an issue.

The link to the actual clinical trial is here:

clinicaltrials.gov/ct2/show...

An awfully long time to hold our breath... (With ordinary or Natural Oxygen.)

Rod

[foxglove in reply to helvella]

Hi Rod ,

Agree with your comment about the word "natural". Clever of you to illustrate it by quoting "Natural Oxygen"

Good when reason and logic creeps into replies!

[helvella Administrator in reply to helvella]

Aha!

It will switch between Armour Thyroid and Synthroid.

[helvella Administrator in reply to helvella]

Back in 2003 the same doctors did a comparison between levothyroxine only and combined liothyronine and levothyroxine.

The paper from that is here:

ncbi.nlm.nih.gov/pubmed/146...

And seems very disappointing. It drew the response shown here:

jama.jamanetwork.com/articl...

And their reply.

[Glynisrose]

I think it will depend mostly on the size of the group studied. Personally I think there should be at least 50 - 100 people in the groups, or how can they extrapolate it across the rest of sufferers?

There are other factors too, such as when starting to take NDT you need to start on a low dose and raise it gradually, will they do that? Or will they just exchange the levo dosage for NDT and then say that the majority of people can't tolerate it?

Scary!!

[helvella Administrator in reply to Glynisrose]

On the trial site it says:

Estimated Enrollment: 180

[ejh1]

Am very pleased to see that their primary outcome measures are symptoms and the biochemical measures are relegated to secondary endpoints. The study doesn't close out until May 2014 (assuming sufficient recruitment) and so we may expect a congress abstract shortly after this if there is a suitable one around then, or maybe even a press release. It looks like a US government funded study, and they can be rather slow with their trial reports, so I would expect to have to wait until 2015 to have a full primary paper.

Emma

[nobodysdriving]

Someone please remind me since how long Levo has totally substituted NDT??

is it 40 years? or longer?

What I wanted to say is:

in the medical history it is VERY WELL KNOWN that when something is discovered which seems to be cheap and effective it is rolled out at one hundred miles and hour, people 'become blind' to anything else and think this new discovery is going to change the world for the better!

they happily carry on with the new discovery thinking everyone is better off because of this new fantastic tool/medicine to only then find out 20-30 years later that it was not as good as it seemed and perhaps should be used with more caution!

an example:

CTG machines in obstetrics: cardiotocograph to monitor continuosly a baby's heart-rate when he/she is in his/her mother's womb.

this machine was started being used on ALL women since the 70s, this machine was going to save every baby's life!

NOT!

it was then discovered 20 years later (or it started getting more well known) that the CTG is not as good as it seems and MANY women would end up with a caesaren section and/or other horrible interventions with NO CHANGE IN BABY'S OUTCOME

fast forward 40 years later: NOW and in the UK if you use a CTG machine on a 'low risk' woman you are a 'BAD practitioner'!! (totally the opposite to 40 years earlier where all women had to have one in use in labour or you 'were bad')

I can see this happening with so many 'medical interventions' and I am sure this will happen with levothyroxine too, that it will not be used across the board regardless as it is now.

Call me 'optimistic' but I think it's only obvious that this will have to happen

Maybe this is the beginning of a turning point?

[Glynisrose]

We can only hope that doctors will rebel against the 'evidence based' medicine that stops them from interacting with the patient. Personally I think that todays doctors just see the £ signs and go for it, not realising, or caring that patients depend on their attitude as well as judgement!!

Innovation is good, but it should not mean that tried and trusted methods should be thrown out the window. Every time a doctor points out to me that NDT has no consistency in quality I point out that it was LEVOTHYROXINE that was withdrawn on 2 occasions for this very reason and there has never been a recall for NDT for inconsistency or for it not being effective!!

[helvella Administrator in reply to Glynisrose]

There have been several recalls of Armour Thyroid over the years. Including one in which it was losing potency so ending up sub-potent.

RLC claim never to have had a desiccated thyroid recall.

[maryfran33]

My concern about this proposed study is the fact that the TSH will be used as the "guideline". No mention of free T4 or free T3??

Mary

[Glynisrose]

As I said, NDT has never been recalled due to its manufacture and the only recalls I know about are the ones where Armour was wrongle labelled. However several makes of levothyroxine have now been tested and some withdrawn from the market.

[Hidden]

For what it's worth, apparently this trial is open only to USDOD (Armed Forces) employees; they are not recruiting candidates from the general public.

[Hidden in reply to Hidden]

Hi Hollyann

I read it that they COULDN'T take part if they were in the armed forces, it's under the list of exclusions.

Louise

x

[Hidden in reply to Hidden]

Yes, that was misleading for me too, but it only means that if you're scheduled to ship out, you can't be included. In fact, the doctors involved are only able to work with members of the DOD, so it is worded in a slightly silly way ("If you are in the military" - when all their recruits will be in the military).

When I went back to reread it, that bit appears immediately after 'exclusions' but isn't actually bulleted.

[Hidden in reply to Hidden]

From an email:

"Subject: RE: clinical trial on hypothyroidism

We are grateful for your interest. Unfortunately we are only including the Dept Of Defense eligible subjects to enroll in this study since we are not allowed to see other patients. If you request your physician he can always start the desiccated thyroid extract since this drug is available in the pharmacies with best regards Dr Shakir"

[Hidden in reply to Hidden]

Ahhh! Bit confusing! lol!

Louise

x