Hi
My daughter wants to change over from levo to NDT and was thinking of getting Armour. I know there are several other NDT's' apart from Armour, can anyone advise which one is the best to take. I realise what works for one may not work for another but would just appreciate some feedback.
Many thanks browny
The best is the one that suits you, so it is individual to the person.
I tried a few but not Armour. I liked best Naturethroid, which is hypoallergenic.
thyroiduk.org.uk/tuk/treatm...
Hi shaws
Many thanks for your reply, my daughter is prone to allergies so Naturethroid may be the one to try first.
RLC labs also do another besides Naturethroid, now called WP thyroid (it used to be Westhroid) - both are hypo-allergenic.
Hi
Yes I have read about WP thyroid but she will have to purchase without a prescription
and this one seems to be more expensive
All the readily available ones are identified here:
thyroiduk.org.uk/tuk/treatm...
Look for Non-UK Desiccated Thyroid (aka NDT)
Might be worth considering Westhroid P and, if successful, see if Nature-Throid is equally as tolerable. At least she would be less likely to find a problem with an ingredient confusing the trialling of desiccated thyroid.
Rod
Hi
Thanks Rod, she is on 175mcg levo, can she just stop it then start the NDT and at what dose should she start at.
Thankyou
I do not take desiccated thyroid so anything I said would be theoretical. Trouble is, different people react differently. Be careful and thoughtful - don't simply jump.
Hope someone with actual experience can answer usefully.
Hi, rod. I am on Armour Thyroid for a few yrs, and would like to switch to WP, because it has much less additives. Would you know, where I can obtain it from, since I live in the US?
Thank you,
Galiarich
Hope she finds one that works for her. Some people cannot tolerate anything with T4 in it, so she has other options if the NDT doesn't work for her.. Jane x
Many thanks Jane,
Dr Skinner (RIP) was going to add T3 when she was due to see him in January but she thinks her G.P. won't prescribe it so she thinks buying NDT the best option at the moment.
It is possible to buy T3 if she wants to. My daughter finds T3 alone suits her best. Jane x
I know this is an option, I think because she had been on the T4 she thought she should go for the NDT with the T4 and T3 in it, but really the levo has not done anything for her at all. Its quite difficult to decide what to do as her G.P. did not diagnose Hypo as her TSH was 3.4 but we all know the TSH tests are useless, but Dr. Skinner diagnosed her from her typical symptoms, low temp. thick tongue and a host of other symptoms.
RIP? Has Dr Skinner passed away?
Sorry Debs, I have just read this, yes, Dr. Skinner has passed away, 2 weeks ago. It was announced in the posts on this site. Poor man, there are so many tributes to him in the post section. Such a lovely caring man such a loss to everyone. My daughter was a patients of his so she is now panicking, this is why I posted the question as we have to look at what to do now.
Can you PM me if you get an answer as our GP will not prescribe Erfa & the pharmacy I use won't dispense without a prescription. Nightmare, he will be such a loss to our community.... RIP X
Hi Debs, We are looking at buying them from abroad, a member has kindly sent a list of companies you can purchase all the different NDT
from, and some do not need a prescription. I will try and PM you the list if this will help.
Let me know.
yes please that would be great. Thanks 
Hi
Just PM you the list but let me know if its come through O.K. as I'm not sure I have done it right.
Hi
Did you get the PM with web sites and I just had a thought your daughter may get another specialist to prescribe Efra, may daughter is in a different position as her G.P. did not diagnose hypo so another specialist may not prescribe for her.
Thanks for your resonse, yes I have got the info now. It is such a worry isn't it? How old is your daughter? Hope you find a solution. Debs x
Sorry,i havnt got any advice but am actually askingif u could kindly PM me that list of companies that sell NDT?I am trying to get my iron and adrenals sorted firt but later plan to try ndt;self-med as have no other option.Its a worry buying online;i mean knowing its its a legitimate company.Goodluck with your daughter.
Would you mind PM'ing me that list too? Anna
Hi Browny I would be very grateful if you would pm me a list of where I can get NDT without prescription too. I have a subclinical hypo - tried lexo but had reaction and Gps answer to increase dose !!!!!. Done loads of reading about NDT and read so many comments on this site which have made me feel I could benefit from trying it. Cannot find any GPs willing to prescribe and cheapest specialist I have found charges over £200 to see you and then charges for tests and a prescription. Many thanks
Hi My daughter takes Erfa NDT prescribed by doctor Skinner which we buy ourselves as our GP although supportive cannot prescribe for us. She has done much better on it than on Thyroxine altough her TSH is now suppressed which makes my GP jumpy but which I understand is common with this type of drug. Hope she gets better on a change of meds my daughter described being onThyroxine as slowly being poisoned every day..........! Good luck Debs x
Many thanks Debs for your reply glad to hear your daughter is doing well on Erfa, was she originally diagnosed by your G.P. or by Dr. Skinner.
My Daughters G.P. kept saying she had CFS but Dr. Skinner diagnosed Hypo but she has not had any improvement with Levo.
Best Wishes
She was diagnosed by GP after 3 years of illness but she became Hyper as she has graves disease & collapsed at College, they did emergency bloods & we got her diagnosis. Sadly after her RAI treatment she very quickly became hypo & was started on Levothyroxine with disasterous effect. She now is a patient of Dr Skinner & is on a Gluten free diet which helps her loads, she takes sublingual iron & ferritin as she does better when her Iron bloods sit in the top end of the range. Make sure if your daughter takes a contraceptive pill to take it well away from the iron & Erfa as it can have a negative effect when combined.
One of the best things we found about Erfa is that patients with auto immune disease often have absorption problems in the gut & Erfa is dissolved in the cheek which means they get more of the actual dose than a purely oral drug. Hope this helps, my daughter is 23, she was daignosed at 19. Debs x
Do go slowly. Here's why: I persuaded my consultant to give me Armour a few wks ago. Was on Levo 100mcg. Still on Levo 50mcg plus armour 30mg (half a grain) per day which is how he started me. I break the grain into two and take it morning & lunchtime. I chew it to break up cellulose (see Stop The Thyroid Madness website for lots of info). However my iron was very low (not that consultant bothered to check it) so I've had to bump that up before I can go any further (consultant never explained any of this - he was clueless and wanted me to go back on Levo when I ran into problems). Again, see that site for info on why iron levels and adrenal levels need to be optimal before trying NDT. Otherwise you can end up with it 'pooling' (not getting into the cells), causing reverse T3 to build up, and ultimately ending up worse/more hypo, or with seriously struggling adrenals due to the new increase in metabolism from T3. Get her iron and adrenals tested and if necessary, build up iron over few weeks, then try it. If all ok, build up slowly (some say increase by 15mg (quarter grain of NDT every 2 wks, but it's much slower for me, else I get very shaky and hypo/struggling adrenal symptoms). Am increasing in another couple of weeks as am slowly feeling better with iron supplements (Bluebonnet brand is good - see above site for necessary dosage over a few weeks to build up, but then reduce - iron can be toxic at high doses long term). Good luck.
Many thanks ribbon for your reply, my daughter is on iron tablets, her G.P. prescribed one but
Dr. Skinner doubled the dose. I do think she may have adrenal issues, she has just gone to the surgery to have her thyroid bloods taken and
Dr. Skinner bless him requested a cortisol test as well, I have just said to her lets wait and see what the results say before deciding on the next course of action. She is panicking because she only has 2 weeks left of levo and of course the G.P. will not prescribe. Even though she has not had any improvement with the levo she does not want to be without anything.
I would stop the T4 and up the armour if I were you.. you're getting mucho t4 and not a lot of T3.. there are 3 reasons to go from Levo to NDT
1. you don't convert very well and need a bit of direct T3 - so why bother with more T4? Dr Peatfield's book says stop taking Levo completely 2 days before you start NDT and My endo said the same when I changed over.
2. You are allergic to the lactose in T4 - same again, why keep taking it
3. You just don't get on with it.. - same again, why keep taking it?
it seems very odd indeed
The main problem with natural thyroid extract is not only its inconsistency batch to batch of the ratio of T4 to T3 in it, but that if you take it alone, the T4/T3 ratio may not be optimum for you. In a sense its not a controlled product and even from one manufacturer the T4/T3 content may fluctuate somewhat. Therefore if you can't achieve your individually optimum T4 and T3 levels by natural thyroid alone, you would have to supplement it by T4 or T3 to achieve those levels. Personally I worry about taking "naked" T3 in any form as it is a potent hormone and can have swift unpleasant (and dangerous) effects in some people. We take T4 alone at the moment to let the body change it to the potent T3 as it requires it. This isn't optimal either and TSH can be suppressed to get the right level of FT3. In an ideal world I'd recommend slow release T4 and T3 capsules, to give a patient the right amount AND ratio of FT4 to FT3 typical for them in good health. A problem with the pills that nowadays give instant uptake is that for a short while after taking them you are overdosed (once or more times a day). This has to be true otherwise you would be underdosed the rest of the day as the hormones get used up. Whether this daily temporary overdosing has longterm consequences I do not know, but nor does anyone else. But on balance I'd rather be overdosed on T4 than T3 to give me a good QoL if I had no alternative. Good daily QoL outweighs potential problems later in life, but T3 may bring forward the problems sooner.
With all due respect -I don't understand 'the batch ' variance statement. this was put out by a certain body who wanted NDT's not to be used -it is not fact! but Myth. Each batch of NDT is carefully assessed for it's content of T4/T3 and is measured so that it is the same in each tablet.....hope that puts that one to bed!
I prefer Erfa to Armour, it has a very slightly more T3 to T4 ratio but only tiny... they're both good.. May people like Naturethroid because there are no fillers.. things like Lactose are used to make the tablets stick together and some people are sensitive to it.. Erfa and Armour could have differing amounts of a filler so if you're sensitive to one of them, one will suit you better than the other...
these are the reputable brands and their T4 to T3 content for dosage - remember that T3 is 3 x stronger than T4 so if you're on 125mg of T4 you need about 1 3/4 grains - 2 grains
Brand of (Natural)
Desiccated Thyroid USPDoseLevothyroxine (T4) contentLiothyronine (T3) content
NP Thyroid
(Acella Pharmaceuticals)
npthyroid.com 1 grain = 60mg 38 mcg 9 mcg
Armour Thyroid
(Forest Pharmaceuticals)
1 grain = 60mg 38 mcg 9 mcg
Thyroid
(Erfa Canada Inc)
1 grain = 60mg 35 mcg 8 mcg
Nature-Throid
(RLC Labs, Inc)
1 grain = 65mg 38 mcg 9 mcg
Westhroid-P
(RLC Labs, Inc)
1 grain = 65mg 38 mcg 9 mcg
HealthXchange
1 grain = 60mg 38 mcg 9 mcg
Erfa has a similar composition to the 'old' Armour formula that so many people liked before they changed it to the current one. I my self found Armour did not work after they changed their formula -the main change in the formula as I understand it was a change in fillers.....lol
Hi
Many thanks for your rely, we were looking into the Naturethroid because of it not having any fillers in it but I looked at Stop the thyroid madness and it lists 8 other ingredients in it so I am a bit confused.
Browny, please look on Thyroid UK main website for the lists of ingredients in each of the desiccated thyroid products. If you are looking for the one with the 'least' ingredients, then that would be Westhroid-Pure (also called WP-Thyroid) which is made by the same company (RCL labs) that make Nature-throid.
Here's the link... scroll down and click on the purple bar that says
*Non-UK - Desiccated Thyroid
Diogenes, its a myth that there is no consistency of NDT from batch to batch, it is tested the same way any other medication is tested. Stop levo about 3 days before starting NDT, start on a low dose, 25 mcg ish and raise after two to three weeks depending how you feel. The major differences are in what fillers are used in the tablets.
Many thanks, yes I thought it would be best to start really low. Some people say reduce the levo as you introduce the NDT but I agree I think to stop a few days the begin the NDT.
I transferred from levo to a NDt successfully several years ago. You don't need to stop the levo for a while and then go across to a NDt BUT you do need to make a conversion of an equivalent dose of the NDT that takes int account the T3 content ( which is 5xs the potency of levo ) as well as the T4 content- I think if I remember the equivalent charts are on the stop the madness website. If not am sure Thyroid UK have guidelines on how to convert your dose from T4 to a T4/T3 (NDT) -if not come back to me as there is another website support group that definitely does.
Many thanks for your reply, I have seen the conversion on Thyroid UK but would be interested to see the one on the other support group, PM if you can.
Best wishes browny
Hello,
I didn't put my point clearly enough, sorry. It isn't the actual weight of T4 and T3 that's important, it is the consistency of bioavailabilty from product to product. That is, how the particular formulation computes the rate of takeup of the hormones. Even within a product, bioavailability of T4 in T4 tablets can vary and it is this that controls the effect of the medication as well as uptake interference from food.. Also, one should be aware that feeling well on thyroid medication is not necessarily the same as being well. For example, you can feel a million dollars when overdosing on T4 (or T3 or both), but in the medium term it isn't good for you. In the early days in the 70's people used to ask for 400 ug T4 and get it, because it made them buzz. We know better now. This is my worry with T3 + T4 medication: on taking it it goes straight to your brain rather like a drug and can give you a "high" temporarily because there aren't any binding proteins in the brain to mitigate its effect.. T3 is potent and has a short lifetime, so medication can make you "bounce about" up and down much more than T4, which only falls by about 8% per day after taking a pill. Caution and care are the watchwords here. Medics aren't being entirely bullheaded in this respect: for some people T3 is too active as a medication and can cause real problems. It isn't the short term that should be considered; the long term is just as important.
I also find that as I am currently on nearly 5 grains of Erfa that this is best spread across the day -so I take some very early in the morning (to counteract my slight adrenal problem) some when I wake up -a top up at lunch and a very small amount before I sleep as it helps deep restorative sleep. It is true that if you take too much T3 FOR YOU (excuse the capitals -but what is one person's medicine is another persons poison -in other words we all have different needs) then you will end up with hyper signs and symptoms In my experience what docs find difficult is getting the balance of meds just right -a wise doctor allows their patient some leeway to alter this themselves ( up or down) to get the balance just right -it is an art rather than an exact science! .
Hi diogenes,
i have pondered whether to reply or not but feel I must as am perturbed by the idea that t3 is any more of a 'drug' than other hormones that are prescribed. Surely all hormones medications can be dangerous if taken without knowledge?
I started on the standard levo and tried really hard to make it work for several years -the reality is that it is not so wonderful for quite a number of people -for me it left me poorly and only a little improved and requiring additional medicines with dubious potential long term effects.. All medication should be treated with great respect. T3 is like most medications -if it is administered without care and knowledge then like most medications can cause harm. However some of us need T3 as we do not convert (Levothyroine ) T4 into T3 -which of course is the usable form that the body needs - or we absorb it poorly into our systems.
The problem I have found around either T3 on its own or T4/T3 NDT's is that the vast majority of doctors are not educated on the use of these meds and on their effective applications -this leads to distrust and mis-information. I believe that if doctors were much better equipped/trained on the application of these meds then many more patients would benefit from them -improving their health. On T4 ( levothyroxine) I needed pain killers, blood pressure tablets, laxatives, water retention tablets, indigestion meds, eye drops, skin emollients/excema cream and antidepressants. Yet my bloods which measure T4 and TSH only looked 'fine' Clearly I wasn't!!!
On Erfa -I no longer require any other meds -my blood pressure has returned to normal, I no longer suffer with water retention, I am no longer in pain, my eyes are not dry, my bowels are regular, skin is no longer dry and the excema went away and am no longer depressed -Erfa with it's T4/T3 combination helps me and saves my GP a fortune in additional medication. I do not have sudden hits or highs as you describe but experience an even steady constant level as I was before I became poorly with hypothyroidism. I am capable of making small adjustments to to my meds as my body would if it had the ability to increase or lower the hormones due to weather changes, level of activity etc... My GP is happy for me to do so. .However I had to take the initiative and sort this out and then show my GP that it benefited me -not the other way round. If I hadn't done this I would still be on levothyroxine and getting more and more poorly.
If more GP's were up to speed on it's use then patients would not have to resort to having to sort it out for themselves. This is what leads to self medication -and it's a great shame but it is also true that many a poorly patient who has educated themselves up has become well on T3 or T4/T3 regime in spite of the GP not because of them.
Glynisrose,
I think you made a mistake in what you have written:
25 mcg ish looks as if it applies to the 'NDT' - but if it does, it does not make sense.
Rod
Medics do not care about how their patients feel, this is the problem and the reason why many choose to self medicate. I agree that new patients should be cautious but NEVER believe all a doctor tells you, he is only going to follow his interests not yours!! PLUS I have to say that blood tests are not worth the paper they are written on!! TSH is useless if like me, you have no thyroid!!
I'm quoting from a website that seems to know what it is talking about. Po ssibly the manufacturers have changed their testing schedules, but if not, then the situation below still holds.
Batch Variations in Desiccated Thyroid Preparations
Although the USP (United States Pharmacopeia) specifies the standard concentration for T4 and T3 in thyroid gland preparations, the reality is that there is a wide variation in the concentrations of the thyroid hormones in desiccated thyroid extract available in the market.
For every 65 mg of desiccated thyroid, the USP specifies that 38 micrograms of T3 and 9 micrograms of T4 be present. However, a survey of different desiccated thyroid extract brands shows that T3 concentrations may vary from 8 micrograms to 59 micrograms while T4 is usually found in the 8 – 18 microgram range.
This variation does not only occur between different brands of desiccated thyroid. It can also be found within the same batch of the same brand.
This variation is caused by the manufacturers’ insistence on standardizing their desiccated thyroid preparations by iodine content and not by thyroid hormone content. Since there are other sources of iodine in desiccated thyroid besides T3 and T4, there will always be variations in the contents of desiccated thyroid pills.
In a way, the standardization of desiccated thyroid by iodine content represents the old method of treating hypothyroidism by increasing iodine levels.
Currently, endocrinologists prefer simply treating hypothyroidism with thyroid hormone replacements.
A New Understanding of the Relationship between T3 and T4
Since desiccated thyroid was first used, doctors have come to a better understanding of the relationship between thyroid hormones and thyroid problems.
For example, in the 1960s, researchers demonstrated that most of the T3 found in the body is produced from T4. This means that to increase the levels of T4 and T3, only T4 replacement is needed in most cases.
In addition, by the 1970s, clinicians could very well measure the levels of T3, T4 and TSH or thyroid-stimulating hormone, the pituitary hormone that controls the release of T3 and T4. Therefore, it was possible to confirm that T4 replacement alone was enough to normalize the levels of T3 and TSH.
In contrast, results showed that desiccated thyroid caused abnormally high levels of T3 in the body for up to 4 hours after ingestion.
Desiccated thyroid triggers a high level of T3 in the body in two ways:
The T4:T3 ratio is higher in desiccated thyroid than in human thyroid gland. In humans, the ratio is 11:1 but in desiccated thyroid, the ratio is 4:1. This means that for the same amount of T4 replaced, desiccated thyroid supplies almost three times the amount of T3 as human thyroid gland
Some of the T4 in desiccated thyroid is still converted to T3
The abnormally high levels of T3 triggered by desiccated thyroid can severely suppress TSH.
When this happens it can become difficult for the body to self-regulate the amounts of T3 and T4 produced by the thyroid gland.
The high levels of T3 and the suppression of TSH can quickly lead to hyperthyroidism. This is the reason why some patients placed on desiccated thyroid complain of insomnia, anxiety, tremors and heat sensitivity.
In contrast, T4 replacement drugs, such as the different levothyroxine brands, produce far less fluctuations in thyroid hormone levels compared to desiccated thyroid and even combinations of T4 and T3.
Unless things have changed in test schedules and the way the hormones are measured, variability in AVAILABLE T3/T4 batch to batch, product to product isn't a myth. I wouldn't be against strictly controlled NDT in slow release form, supplemented with whatever extra T3 or T4 would restore the individual back to their natural set points for good health.
DON'T BELIEVE THIS - IT's written by the makers of Levo.....and it's not science.. Unfortunately most of our GPs have read it...
Here are the actual studies - Please don't fall for this rubbish.. it's never been true, EVER
Studies using 'Armour Thyroid' per se in three of 12 studies.
1.Krenning, E.P., Docter, R., Visser, T.J., et al.: Replacement therapy with L-thyroxine: serum thyroid hormone and thyrotropin levels in hypothyroid patients changing from desiccated thyroid to pure thyroxine substitution therapy. Neth. J. Med., 28(1):1-5, 1981.
2.Singh, S.P., Feldman, E.B., and Carter, A.C.: Desiccated thyroid and levothyroxine in hypothyroidism: comparison in replacement therapy. N.Y. State J. Med., 72(9):1045-1048, 1972.
3.Sawin, C.T., Hershman, J.M., Fernandez-Garcia, R., et al.: A comparison of thyroxine and desiccated thyroid in patients with primary hypothyroidism. Metabolism, 27(10):1518-1525, 1978.
Nine further studies reporting “direct comparison” of the two forms of treatment i.e. natural -v- synthetic thyroxine only.
4.LeBoff, M.S., Kaplan, M.M., Silva, J.E., et al.: Bioavailability of thyroid hormones from oral replacement preparations. Metabolism, 31(9):900-905, 1982.
5.Lavietes, P.H.. and Epstein, F.H.: Thyroid therapy of myxedema: A comparison of various agents with a note on the composition of thyroid secretion in man. Ann. Intern. Med., 60:79-87, 1964.
6.Gorowski, T., Pucilowska, J., and Wernic, K.: Comparative effects of desiccated thyroid gland and sodium salt of L-thyroxine in the treatment of hypothyroidism.Pol. Tyg. Lek., 44(32-33):768-770, 1989.
7.Felt, V. and Nedvidkova, J.: Comparison of treatment with L-thyroxine and a dried thyroidgland preparation in patients with hypothyroidism. Vnitr. Lek., 28 (11):1067-1073, 1982
8.Wartofsky, L.: Combined levotriiodothyronine and levothyroxine therapy for hypothyroidism: are we a step closer to the magic formula? Thyroid, 14(4):247- 248, 2004
9.Kosowicz, J., Horst-Sikorska, W., Lacka, K., et al.: Outcome of treating hypothyroidism with thyreoideum. Pol. Tyg. Lek, 48(27-28):599-602, 1993.
10.Warszawie, C.M.K.P.: Treatment of hypothyroidism with L-thyroxine. Pol. Tyg. Lek, 48(27-28):605-608, 1993.
11.McGavack, T.H. and Reckendorf, H.K.: Therapeutic activity of desiccated thyroid substance, sodium Lthyroxine and D, L-triiodothyronine: a comparative study. Am. J. Med., 20:774-777, 1956
12.Baisier, W.V., Hertoghe, J., and Eeckhaut, W.:Thyroidinsufficiency: is thyroxine the only valuable Drug? J. Nutr. Environ. Med., 11:159-166, 2001.
Studies that Established the Clinical Benefits of NDT
13.Gautam Das, Shweta Anand & Parijat De. Does synthetic thyroid extract work for everybody? Endocrine Abstracts (2007) P316 (abstract below)
14.Alan R. Gaby, MD. “Sub-laboratory” Hypothyroidism and the Empirical use of Armour® Thyroid. (Altern Med Rev 2004;9(2):157-179)
15.Lowe, J.C.: Natural desiccated thyroid: Guttler’s false claim about It. Thyroid Science 4(9):C1-6, 2009
16.Novak, Edmund A. M.D.; Holthaus, Joseph M. M.D.; Ogborn, Richard O. M.D: Clinical Study of Levo-Thyroxine and Aged Desiccated Thyroid in Euthyroid Subjects: American Journal of the Medical Sciences: March 1964
17.Thompson, W.O., McLellan, L.L., Thompson, P.K., et al.: The rates of utilization of thyroxine and of desiccated thyroid in man: the relation between the iodine in desiccated thyroid and thyroxine. Arch. Intern. Med., 1932.
18.Boothby, W. M., Sandiford, I., Sandiford, K., et al.: Abstract of Communication to the XIIth International Physiol. Congress held at Stockholm, Aug. 3-6, 1926. Skandinav. Archiv. 1926, xlix, 99. Metabolism studies showing the effect of desiccated thyroid and thyroxin on a patient with myxedema.
19.Thompson, W.O., Nadler, S.B., Taylor, S. G., III, and Thompson, P. K.: The calorigenic action of various thyroid derivatives. J. Clin. Invest. (Proc.), 13:690, 1934.
20.Foster, G. L., Palmer, W. W., and Leland, J. P.: A comparison of the calorigenic potencies of l-thyroxine, dl-thyroxine, and thyroid gland, with a note on the thyroxine content of the acid-soluble fraction of the peptic digest of thyroid protein. J. Biol. Chem., 115:467, 1936
21.Thompson, W. O., Thompson, P. K., Brailey, A. G., et al.: The calorigenetic action of thyroxin at different levels of basal metabolism in myxedema. J. Clin. Invest., 7(3): 437–463, 1929.
22.Sturnick, M.I. and Falcon-Lesses, M.: A comparison of the effect of desiccated thyroid and sodium levothyroxine on the serum protein-bound iodine. New Engl. J. Med., 264:609, 1961.
23.Sisson, J.C.: Principles of, and pitfalls in, thyroid function tests. J. Nuclear Med., 6:853-901, 1965.
24.Robertson, J.D. and Kirkpatrick, H.F.W.: Changes in basal metabolism, serum protein-bound iodine and cholesterol during treatment of hypothyroidism with oral thyroid and l-thyroxine sodium. Brit. Med. J., March 22, 1:624, 1952.
25.Gilman, A.G. and Murad, F.: Thyroid and antithyroid drugs. In The Pharmacologic Basis of Therapeutics, (ed 5). Edited by L.S. Goodman and a. Gilman, New York, MacMilIan, 1975, p.1398.
26.Means, J.H., DeGroot, L.J., and Stanbury, J.B.: The Thyroid and Its Diseases, 3rd edition. New York, McGraw-Hill, 1963, p. 334.
27.Werner, S.C.: Treatment of hypothyroidism. In The Thyroid, 3rd edition. Edited by S.C. Werner and S.H. Ingbar, New York, Harper and Row, 1971, p.834.
28.Daughaday, W.H.: The adenohypophysis. In Textbook of Endocrinology, 5th edition. Edited by R.H. Williams, Philadelphia, Saunders, 1974, p.60.
29.Lowe, J.C.: Stability, effectiveness, and safety of desiccated thyroid vs levothyroxine: rebuttal to the British Thyroid Association. Thyroid Science, 4(3):C-1-12, 2009.
30.Frederick L. Benoit.ieutenant Commander, MC, MC, USN: Treatment of Riedel's Thyroiditis With Desiccated Thyroid.Endocrine Clinic and Medical Service, U.S. Naval Hospital,Oakland..Submitted July 14, 1964.
31.Beverley Strisower, A.B.,John W Gofman, MD., Elmer Galioni, MD.,Joshua H Rubinger, M.D.,Georgfe W O’Brien M.D. and Alexander Simon, M.D. “Effect of Long-Term Administration of Desiccated Thyroid on Serum Lipoprotein and Cholesterol Levels”.The Journal of Clinical Endocrinology & Metabolism January 1, 1955 vol. 15 no. 1 73-80
32.George S. Serif and Alan K Brevik.: " Effects of Butyl-4-hydroxy-3,5-diiodobenzoate on the Conversion of p-carotene to Vitamin A in the Rat." The Journal of Biological Chemistry. Vol. 235, No. 8, August 1960
Therapeutic Equivalence of NDT, T4, and T3
35.McGavack, T. R. and Reckendorf, H. K.: Therapeutic activity of desiccated thyroid substance, sodium Ithyroxine and d,1 triiodothyronine: A comparative study. Amer. J. Med., 20: 774, 1956.
36.Singh, S.P., Feldman, E.B., and Carter, A.C.: Desiccated thyroid and levothyroxine in hypothyroidism: comparison in replacement therapy. N.Y. State J. Med., 72(9):1045-1048, 1972.
37.Lavietes, P.H. and Epstein, F.H.: Thyroid therapy of myxedema: A comparison of various agents with a note on the composition of thyroid secretion in man. Ann. Intern. Med., 60:79-87, 1964.
38.Haynes, R.C., Jr.: Thyroid and antithyroid drugs. In Goodman and Gilman’s The Pharmacological Basis of Therapeutics, 8th edition. New York, Pergamon
Wow Redditch you know your stuff
Well I had to read up because My GP was telling me that my bloods were "normal" and my symptoms were "in my head" when I couldn't stay up for more than 3 hours! I knew that it wasn't in my head.. so all I could do was read every book and every paper.. Dr Barry Durrant Peatfield saved my life. I'm back at work, symptom free and self medicating.. they know NOTHING.. you have to do it yourself and listen to your body.. I have been on NDT for a year and it has changed my life...
Thanks Redditch, did your G.P. say you were in the so called range. My daughter has just got her results TSH 0.05 range 0.35 - 4.5
T4 24 top of range 22. T3 requested but either surgery not received it yet or lab has not done it. G.P has requested to see her. She is on 175mcg levo prescribed by Dr. Skinner but she has not felt any improvement. Dr. S was going to add T3 but unfortunately that will not happen now.
MY GP and the next one and the Next one were all useless.. they know less than nothing.. Your daughter should take her temperature.. if TSH is low like that.. it could be lack of conversion or it could be pituitary issues.. temperature is key.. If she's cold then come back to me via private message for more like adrenals quiz etc
Sorry to be awkward, but the simple question is, either the producers of NDT have changed from the recommended (and legally enforceable) US Pharmacopeia method and measure their T4/T3 content correctly nowadays and normalize it before selling, or they haven't. Can you get info from the individual NDT manufacturers who supply you about how they do this nowadays, that is, a clear statement of proper control by legitimate methods and not just iodine measurement. It's in everyone's interests to know exactly what they are getting and how consistent it is. The manufacturers would in any case have to normalize each batch of NDT by synthetic T4 or T3 as required, simply because each batch of natural material will have a different T4/T3 content and ratio by sheer random chance (not least by the varying quality of the raw material). BTW a silent majority of people on T4 do get along reasonably (maybe not perfectly) well and have a good QoL. Its the significant minority who write in here who don't, and aren't being treated properly because of the "one size fits all diagnostic activity" of TSH measurement and decisions therefrom. I'm not knocking NDT so long as it is properly controlled for the benefit of those who use it, but one must consider the caveats and make absolutely sure that you are taking controlled products with consistent content.
As I understand, the USA manufacturers of desiccated thyroid tablets simply use Thyroid USP from American Labs. Therefore the standardisation would be done by them rather than RLC, Forrest or whoever. (There might be exceptions.)
I'd be happy to be corrected if anyone knows better!
But doesn't bioavailability depend to some extent on the formulation of the tablet, or is that what you are saying (brain clearly not 100% yet!)? For example, Nature Throid and Armour may contain the same amounts of Thyroid USP (which is standardised) yet patients find they need more of one brand than they do of the other to be well because of the formulation of the tablets themselves. I think this is why some people recommend chewing their NDT. Apparently it breaks down the cellulose to some extent making it easier to absorb the hormones. I have no proof as to the validity of the science here.
So if the standardisation applies to the the Thyroid USP and there is no standardisation of the actual NDT products themselves then there will be differences in the effects of different brands of NDT. I suppose this is why people find that one brand suits them better than another. But that applies to a lot of different medications; levothyroxine included. How many recalls of levothyroxine have there been in the last 2 years because of this sort of issue? Too many!
Apologies if I have completely misunderstood your point. I think it's bed time 
Indeed it is bioavailability that matters, ultimately.
But all we really have at present is assay of T4 and T3 content.
I suggest that if the T4 and T3 content is stable and known, then the bioavailability might, with luck and a following wind, be fairly consistent within a particular formulation. Mind, I suggest that there is no reason to assume consistency between different dosages within a formulation.
The biggest levothyroxine recall/withdrawal from market I know about is that of the USA's number two brand Levoxyl. And that despite it having been reformulated quite a number of years ago to address issues of dissolution failure. And being lactose-free (a common cry when people discuss why some fail to deliver).
Rod
Diogenes... THERE IS NO VARIATION in DOSE or AMOUNT of T3 or T4 in batch or between tablets of NDT
The Makers of Levothyroxine spread this rumour
YOU CAN'T MAKE PATENT MONEY ON A BIT OF PIG
YOU CAN MAKE LOADS OF MONEY ON A DRUG PATENT
The makers of NDT can't compete financially with the drug companies who spread these rumours which is why NDT (the drug of choice until 1958) was taken out of the BNF
IT'S RUBBISH
THEY never did have any issues.. It isn't true......
It's just rather strange then that the website I got the information from was progressivehealth.com/consi... which was actually advocating natural products against synthroid. Coming from such a source, I thought that this was balanced, weighing up the pros and cons from a manufacturer not connected with the T4 producers. Also your reference list is very old, right at the time when natural products were not properly controlled, so you have to produce an article which states categorically that T4/T3 content (not iodine only) is and always has been correctly measured and shows the evidence direct. Mere assertion won't do . I'm only saying this because I want people to be better, but I don't want them to be fooled by inadequate products. Note that the natural product makers are no more moral than anyone else. They are businessmen who want to sell you things and it's up to you to make sure that what they sell is what it says on the tin.
may be they just picked up on the same mythology it's very commonly bandied about even my endo told me and I had to send her all my research to prove it was rubbish..
Re your point about old research they don't need to re-prove what they've proved... there is no more variation in NDT than there is in Levo... end of
The Natural products have always been controlled
T3 was unavailable last year for months because THEY had a control issue...
Honestly, this is a myth
You are holding recent OPINION over dated RESEARCH
If you want recent.... but this again is someone's opinion rather than proper research....
google.co.uk/search?q=5+myt...
Or if that link doesn't work just google the 5 myths of hyperthyroidism Dr Richard Shames
See Myth 3 and follow the links there.. that is more recent research for you
Consider the money made here.... any site which is advocating "natural" products presumably sells vitamins and stuff or gets commission from links..
If you're on Levothyroxine you may NEVER get better. so you will ALWAYS buy vitamins.. you are a money pot for these guys
If you take NDT.. you MAY, like ME, get rid of your antibodies and get BETTER which means..
No more scrips for Levo and no more sales of all those natural supplements
I am sorry but all they care about is the money stream. It's disgusting.. but it's a fact
No I'm not quoting unsupported opinion, the variable content of NDT is documented in the American Society of Health-System Pharmacists “Big Red Book” where the actual measurements were quoted. They should of all people be independent and free from bias. So either that's out of date because things have changed (and they must have been unsatisfactory all the time up to the publication of the article in the Red Book) or they haven't. None of the articles you quote say categorically that NDT is controlled and how it is controlled and show the numerical peer reviewed evidence - they simply put down Synthroid as equally variable. This isn't science, it's unsupported assertion, and it's this attitude I want to abolish in all producers of all products for health, wherever they come from. People MUST know what they are taking, and manufacturers MUST state how they measured what is in their product and its consistency. Otherwise we're not talking about a proper treatment but a confidence trick played on consumers by amoral producers.
Diogenes what you need to know is that Armour and Erfa (both are NDTs ) are regulated by their countries medical commissions -that is America and Canada -they HAVE to pass strict quality controls -fact! this means that EACH tablet contains the same amount of T3 & T4. the reality is that there have been more drug recalls on Levothyroxine then NDTs due to the content being erractic
I think you are being taken in my propaganda -the companies that produce synthetic T4 make an absolute fortune every year t-they are not going to let companies selling NDT pinch their market because people get well on NDT's Think about the companies that sell tobacco and how hard they have fought over the years and now how hard they are opposing e cigarettes.......they don't want to loose their enormous profits. It's more about that then optimal treatment for patients. Disgusting but true.
Sorry, I must disagree with you given no satisfactory answer to my question. It isn't that the tablets do not pass strict quality controls. The argument and my query is the BASIS in strict scientific measurement as what methods are used to get those controls working and the recorded results. If it's based on the present internet available US Pharmacopeia it's frankly nonsense - that method does not measure T4 and T3, it only measures iodine and apparently has not been updated for decades. I want to know in plain language how the NDT manufacturers get their results and control their product. So far, I've got no answers. I want all users to know what they are taking, according to credible measurements by an accredited robust method. As to the T4 synthetics making fortunes - well all I can say is that there are a multitude of generic manufacturers (not Synthroid nor Eltroxin) making very modest money out of T4 products that cost pennies. My wife has been taking many examples of these for 45 years. One was a lab in Barnstaple. I don't think the NDT producers make products that cost pennies - rather expensive I see them! So I do not think the NDT producers have any greater haloes than the synthetics - they are all out to get you to buy their products. If they work for you then fine, but don't let's imagine that in any of these areas we're dealing with angels.
.....maybe you should contact the medical commissioners in Canada? As i know for a fact that in Canada Erfa is a registered medicine and is therefore put through the same strict procedures as other registered medicines. So if you are saying that the Canadian processes are not good enough then they are not good enough for other medicines that are registered in Canada.!!! i am not a scientist so I doubt that what I can provide for you will sate your desire for scientific empirical evidence -but am sure the Canadian authorities will oblige you if you would like to contact them
From my point of view levothyroxine and its other makes are concerned they did not work for me -and that CAN be evidenced by my medical records. my own NHs GP's agree that Levo does not work for me. they also agree that it is actually cheaper to give me Erfa than the gammut of other meds that goes with taking Levothyroxine. So it's actually cost effective! That's not taking into consideration that on Erfa I actually feel well -and am well -that has been medically checked so is not just an illusion of my brain being fooled by the alleged 'hit' of T3. So all I can say to you -that in my case the medical evidence shows that NDT does indeed give a better and greater improvement in my health than Levo. Fact.
As far as who is trying to 'out' who in the pharmaceutical world of selling -then you have already summered it up well -the biggest giants get the biggest cut and give the largest hype as they have the money to do so.....all fairs in love and war they would argue -however is it fair on patients? Surely this is the point of medical commisioners -to ensure we don't get taken in by hype -either positive or slating to denigrate another product on the 'otherside'? Medical research is often used by the pharma's to support this 'hype' and hence the big pharma's keenness to fund specific projects. One has only to look at margarine versus butter research over the years, publicity and counter argument -and how it swung from one extreme to the other to see how the propaganda wheels turn spouting the latest current medical evidence to see what a nonsense it all is. Call me a cynic!
From a patients point of view surely it is good practice to have a range of product available for use -after all we patients sadly do not fit into one tight mold -much is still not known about hypothyroidism and it's process despite it being discovered and treated well over a hundred years ago. Medicine is a science but it is also an art -as a patient I feel the art is somewhat lost.
There's a lot in what you say BUT I still don't have the answers and I'll contact the Canadians to find out what they do. It well might be that they alone do a satisfactory job in controlling their product. If so, then all NDT takers ought to take ERFA if it's the only properly controlled product. What I believe is that there are lots of alternatives for people to use - some happy on T4, some on T4/T3 some on NDT (BUT ONLY IF IT'S CONTROLLED PROPERLY BY GOOD METHODS). A well controlled plethora of available substances has no worries for me. I do NOT want people taking tablets of dubious control. Personally I think my wife would have been better off on a judicious T4/T3 mix than T4 alone, because for 45 years her TSH was not detectable and still isn't and we don't care and nor does our GP. With that mix she might have had a detectable TSH, and no atrial fibrillation which she now has spasmodically. But only having T4 available she had to exchange immediate daily good QoL for potential problems later. I think in all cases there are benefits and risks - it's the balance that each person takes that counts, so long as they do it with open eyes and good information.
I hope you find the answers and that you let us all know what you find out. I would find it worrying if a registered medicine does not meet satisfactory criteria/ control -if those drugs don't then nothing does. It would mean the whole business needs to be reviewed not just for NDT but all registered drugs.
Re the TSh -am afraid mine is negligible on meds whether levo or synthetic T3/4 or NDT. The risk of arterial fibrillation were less than all the other risks that I was putting my body under with medicating less or using less effective products for me.
One thing I have learnt is the importance of vitamins -and I do supplement well -I was a great skeptic of B12 -but have to admit since supplementing well -I feel so much better and notice that I need less Erfa- interesting -and probably another area of much needed research. . Am assuming that it might mean the uptake in my cells of my thyroid hormones med is better with the B12? Pity little is actually known about this area in hypothyroidism
It's always good to have someone who questions what is out there -all is often not how it seems. Recently I heard about a drugs company who held back on research data over trials of potential products -I find this shocking but I guess it happens a lot. And it leaves me wondering how much research stats are manipulated and managed -maybe this depends on who is funding it? As an anayst am sure you know much more about this than me.
Diogenes, if you have access to the 'Big Red Book' can you look and see what references they sight and what the date of the references are? Your question regarding the possible variable bioavailability is an interesting one and I am also curious. I don't know if or how, they test for that. I think the standard for T4 and T3 is plus or minus 10% but I don't have a citation to back that up. I think all they test for is the amount of T4 and T3 and the dissolution rate. If would be informative to actually get the accurate answers. I will try and pursue this from my end with a couple of contacts I have but with your credentials I'm sure you will get better access to the information. They did use the amount of iodine (roughly 1 or 2 per cent) for a number of years but I'm pretty sure they switched to assaying T4 and T3 in the 1960s or 1970s or so after they developed the appropriate tests. PR
Hello,
The only reference I can find in the Red Book is an old one dating back from 1980.
Hormonal Content of Thyroid Replacement Preparations
Robert W. Rees-Jones, MD; Arturo R. Rolla, MD; P. Reed Larsen, MD
JAMA. 1980;243(6):549-550. doi:10.1001/jama.1980.03300320041023.
I'm sure things must have moved on from then, but the present day existence of the outdated iodine measurement protocol for NDT T4 and T3 determination is still in the US Pharmacopeia. Providers of NDT tablets in the US can designate them NOT for human diagnostic use, knowing cynically that they will be used for just that purpose. Maybe, because of the loophole they don't use proper determination methods and still rely on the Pharmacopeia, because hey it doesn't matter as (ha! ha!) it isn't going to be used on humans is it? Some of my correspondents have implied that somehow I'm against NDT. I certainly am, if the product isn't properly controlled for T4/3 content. If well controlled, I still have problems but they are dose-related vis a vis the vigour and short life of T3 rather than anything else. But if people taking NDT take the utmost caution in dosing themselves so as not to give periodic T3 "storm" then that's up to them. The human body is extremely tough and can withstand some deviation from ideality. Long term effects of suboptimal dosing is where I have uncertainty. What I want to see is some lab/organization routinely taking samples/batches of the popular NDT's, subjecting them to proper independent analysis, and broadcasting the results continuously on the net. That way everyone knows what's happening and can take action accordingly. Then no producer can hide.
Diogenes, three things I find interesting in that reference. 1. In 1980 the synthetics only had 50% market share and 2."At present, both generic thyroid and levothyroxine preparations are available, and their use has been encouraged by recent changes in prescription regulations." I've never read about the changes in prescription regulations, I wonder what the changes were? 3. "Since the Food and Drug Administration still accepts the United States Pharmacopeia standard based on organic iodine content for this medication, there is no specification of the precise hormonal content of these tablets." I was wrong, I thought by this time they had moved to specifications for the amount of T4 and T3. I will have to pursue this some more and try to find out when the standard changed.
I agree that just like in the TFT's it would be good to have standardization and ongoing testing to make sure the standards are met.
There is still great disagreement about the bioequivalence standards for Levo Thyroxine Sodium. This is from 2005, the full PDF is available free.
ncbi.nlm.nih.gov/pmc/articl...
I wonder if that has been resolved in the last 7 years.
I did find a letter online supposedly from the Medical Director at Erfa which said,
"Dear Mrs Roland,
Obviously the “big red book” doesn’t mention which kind of desiccated thyroid nor when this was true. The truth is that this was true 100 years ago when desiccated thyroid was discovered since then things have changed in the manufacturing process. In each Erfa 60 mg tablet embossed “ECI 60”, there is 36 mcg. of T4 and 8 mcg. of T3 . A 10% variation is accepted through the manufacturing process but we rarely exceed 5%.
Thyroid is a medication approved by Health Canada and is subject to inspection and standards as all the other medication in Canada. Thyroid medication was previously owned by Pfizer Canada and we did not change the formulation since then. As most of the medication, we follow the USP standards and consistency is preserved from batch to batch. Although the accepted difference in dosage between batch to batch is around 10%, we rarely exceed 5% variation which is in my opinion an excellent result. We also never had any recalls of the product contrarily to many levothyroxine products.
I hope this helps.
Sincerely,
Henri Knafo, MD, MSc, BSc
Medical Director
Erfa Canada Inc
This is inline with my understanding but I cannot validate the authenticity of the letter. Someone would have to write Erfa and get a response. He also does not mention testing for bioavailability, so that question is still up in the air.
There were undoubtedly NDT products produced in the 1900s that were substandard. Armour was always considered the Cadillac. I have about 24 years experience taking NDT, my sister has about 44 years experience taking NDT, Syn T4 and Syn T3, the synthetics didn't work, and my mother started Armour about in the 1920s, she just was never given enough Armour to be effective. Neither my sister nor I have ever gotten a T3 buzz, we just feel "normal". This is the experience of the majority of people that take it. I have read of some cases where people do get a reaction, jittery heart and so forth, but these are by far the minority of situations. Science does not have all the answers in the thyroid arena, it doesn't even know all the right questions to ask. There is no question that many people do just fine on Syn T4, there also is no question that a lot of us do not do fine on it, and so far no one has done the science to really find out why. Maybe someday. Hopefully with minds like yours that keep asking questions and demanding accountability, that will force science forward and maybe some day we will get more answers. Respectfully, PR
I may have sent this to the wrong person. If so I'm sending it again. Apologies if already received.What is urgently needed for those who prefer to use NDT as their therapeutic substance is an outside-manufacturer Quality Assurance Scheme (NDT-QAS) that mimics in its aims the QAS schemes for monitoring the competence of individual labs in measuring FT4 and FT3 in designated blood samples or controls. The patient-led thyroid groups should organize a lab that will, by accredited methods, routinely measure the T4 and T3 content of various manufacturers (to begin with the most used) batch by batch, and within-batch through the permitted lifetime of a batch until expiry date. These results will prove accuracy, reliability and robustness and would then be put on the net for all interested parties to see (and act upon where necessary). I think NDT users do themselves a great disservice by simply accepting what manufacturers tell them. An independent checking service would avoid all that. Perhaps in the US you could organize such a service.
Hi ribbon, she is in fact coeliac so Armour is a no no then, thanks for letting me know. If you cannot get the Erfa or Westhyroid I now have a list of online suppliers so if you want it let me know and I will PM you.
Redditch, I'm with you. I had zero improvement on Levo or on Levo combined with T3. NDT is helping, with slow increments. Maybe save your energy giving your hard won knowledge and experience to those of us who value and need it. I'm learning from your posts. Thanks.
What is urgently needed for those who prefer to use NDT as their therapeutic substance is an outside-manufacturer Quality Assurance Scheme (NDT-QAS) that mimics in its aims the QAS schemes for monitoring the competence of individual labs in measuring FT4 and FT3 in designated blood samples or controls. The patient-led thyroid groups should organize a lab that will, by accredited methods, routinely measure the T4 and T3 content of various manufacturers (to begin with the most used) batch by batch, and within-batch through the permitted lifetime of a batch until expiry date. These results will prove accuracy, reliability and robustness and would then be put on the net for all interested parties to see (and act upon where necessary). I think NDT users do themselves a great disservice by simply accepting what manufacturers tell them. An independent checking service would avoid all that. Perhaps in the US you could organize such a service.
Diogenes, while I agree that it would be nice to have independent verification of NDT products, I disagree with the priority. First and foremost what is 'urgently needed' for all thyroid patients is the ability to get a timely and accurate diagnosis and then adequate treatment. I lost 12 years of my life and ended up financially devastated and starting over in my mid forties, and yet I consider myself lucky. We are routinely subjected to an inferior standard of treatment that leaves many of us sick, makes us sicker, destroys our relationships with our loved ones, destroys our careers and destroys our lives. This happens not because we lack medications that will give us our lives back but because of the arrogance, ignorance and incompetence of allopathic medicine and their practice of highly selective evidence based medicine. Changing the inferior standard of treatment has to be the most important priority. We need to stop needlessly damaging people in the name of scientific dogma. There has been and is good science being done on understanding the endocrine system, you have contributed to this, but it is highly limited at best in regards to a complete and thorough understanding of the system and all the biochemical interactions that take place and all the problems that can arise. The science that is applied to a patient in a doctor's office is pitiful. Our lives depend on the lottery of the thyroid function tests which are fraught with problems, as you are well aware, and if we win that lottery then we are only given one choice of medicine and if we have problems with it we are told it is all in our heads. This is an absolutely insane standard of treatment and fixing it is what is 'urgently needed'. PR
Unfortunately, re-educating the thyroidologists and forcing heads round (I could fill this website with examples of influential, and grossly wrong, [and sometimes dishonest] published "research") will take longer than either of us is likely to live - certainly me. In that vacuum, at least you NDT users should be sure of what you are taking. If it came out right - ie tightly properly controlled production of NDT - then you have a firm riposte to the opponents as regards control of product and open information. Content of product is another matter, but you would have disarmed them as regards quality considerations. This would be a parallel to what has to be done with the synthetics. In this, I'm not advocating NDT or dismissing it. I'm trying to get you to establish in effect your own regulatory system for your own purposes and for your own good so as everyone can know what they are taking and how good and consistent it is.
diogenes,
An interesting approach. I wonder how much it would cost to achieve this? Could you put forward a rational outline for such a scheme? I guess that virtually all UK users take Erfa, RLC products or Armour (with just a few taking NP Thyroid, or one of the Thai products or something else).
Mind, we would still have the problem endemic to thyroid medications - that assay of content can be so far away from availability. Clearly highlighted by the Teva withdrawal and with possible echoes in other patient experiences.
Also, is there any way of accessing the Thyroid USP standard itself? Even in summary form? Have looked but cannot find a suitable source.
Rod
Hello,
My schema would work as follows. First it depends on being able to fully dissolve the NDT tablets without harming the contents. Then I take the "all is well"approach because that's the cheapest. If all is not well, more work is needed. I would obtain the current batches of say three popular rival NDT producers. Initially I would take 3 dose levels from each of the batches. I would then measure by immunoassay each NDT tablet in triplicate for total T4 and T3. I would compare the results from each company against each other for the same nominally stated dose and also compare for each company the stated T4/3 dose with that actually obtained.
This gives me three results - 1) do the nominally stated T4/3 doses always agree with the immunoassay results 2) with different nominal dose levels, do the immunoassay measurements give the same fractional differences in doses as stated by the individual manufacturer 3) do the equal stated nominal doses at a given level agree from each manufacturer. That would be a start. With three manufacturers you would have 3(Man) x 3 (dose levels) x 3 (triplicate measurements at each dose level) x 2 (T4 and T3 measured). = 54 measurements. The difference between any immunoassay result and manufacturer's claim at any level should not exceed +/- 10%. If accuracy and consistency is obtained, then all one need do is in the future check consistency and robustness of T4/3 level to batch age through to expiry.
Regarding the Thyroid USP standard, I've directly asked the Canadian authorities to tell me by which analytical method their regulations demand validation of ERFA NDT. This is classified a drug in Canada, whereas the US Pharmacopeia online still requires the inadequate total iodine estimation which tells you nothing about T4/3 content.
I 've gone a little into prices for T4 and T3 tests. US prices are about equivalent to £20/test for total T4 and about £40/test for total T3. I think a UK labs prices could be 70% of those. Thus by US prices my schema would cost 27 x 20 + 27 x 40 = £1520 but perhaps in the UK about £1K to perform. I think you could get such a deal for an ongoing programme.
Diogenes, I called American Laboratories Inc to request the product specification sheets and learned that they won't talk to me. In order to get the spec sheets you have to be listed with the FDA as a manufacturer and have the appropriate drug license which ALI has to have a copy of on file before they supply info. Ridiculous! However, after getting passed to a supervisor I was able to learn that there is a monograph in the USP Vol 32 which details the testing standards for USP desiccated powder, and for several hundred dollars I can buy my own copy. Thru other sources I was able to learn that the documentation that comes with the powder lists inorganic and organic iodine and the amount of T4 and T3, I believe by weight. We need to find a current copy of that monograph, that will give us the current testing standards. PR
Yes, they act like limpets! I'll see if I can access the USP vol 32 story online, but Sherlock Holmes isn't in it! Why oh why do organisations hold everything so closely to their chests? Something to hide or mere obfuscation?
Thanks PR4NOW and diogenes.
It reminds of all the products that claim conformance to BS1234 or some other standards and we poor saps can't even find out what the standard covers! I can understand high fees for the fullest level of details including precise techniques to be used. But summary information should be readily available - at least to all customers/patients.
Rod
Here is the copy of the US procedure for assaying T4 and T3 in NDT.
USP Reference standards 11—
USP Levothyroxine RS.
USP Liothyronine RS.
Identification— The retention times of the peaks for liothyronine and levothyroxine in the chromatogram of the Assay preparation correspond to those in the chromatogram of the Standard preparation, as obtained in the Assay.
Microbial enumeration tests 61 and Tests for specified microorganisms 62— It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
Loss on drying 731— Dry it in vacuum at 60 for 4 hours: it loses not more than 6.0% of its weight.
Limit of inorganic iodides—
Extracting solution— Prepare a 1 in 100 solution of sulfuric acid in water.
Reference solution— Dissolve an accurately weighed quantity of potassium iodide in water to obtain a stock solution containing 0.131 mg, equivalent to 0.100 mg of iodide, per mL. Transfer 1.0 mL of this stock solution into a 100-mL volumetric flask, dilute with Extracting solution to volume, and mix. Each mL of the Reference solution contains 1.0 µg of iodide. [NOTE—Prepare this solution on the day of use.]
Test solution— Transfer 1.00 g, or proportionately less if the iodine content is greater than 0.2%, of Thyroid to a beaker, add 100.0 mL of Extracting solution, and sonicate for 5 minutes.
Electrode system— Use an iodide-specific, ion-indicating electrode and a silver-silver chloride reference electrode connected to a pH meter capable of measuring potentials with a minimum reproducibility of ±1 mV (see pH 791).
Procedure— Transfer the Reference solution to a beaker containing a magnetic stirring bar. Rinse and dry the electrodes, insert in the solution, stir for 5 minutes or until the reading stabilizes, and read the potential, in mV. Repeat this process using the Test solution. The requirements of the test are met if the Test solution has a higher potential, in mV, than the Reference solution: the limit is 0.01%.
Assay—
Mobile phase— Prepare a degassed and filtered mixture of water, acetonitrile, and phosphoric acid (650:350:5). Make adjustments if necessary (see System Suitability under Chromatography 621).
Reducing buffer solution— Freshly prepare a solution in 0.11 M sodium chloride that is 0.04 M with respect to tris(hydroxymethyl)aminomethane and 0.05 M with respect to methimazole. Adjust, if necessary, with 6 N hydrochloric acid or 0.1 N sodium hydroxide to a pH of 8.4 ± 0.05.
Proteolytic enzyme— Freshly prepare a solution containing 15 mg of bacterial protease* in each 5 mL of Reducing buffer solution.
Enzyme deactivating solution— Prepare a 1 in 100 mixture of phosphoric acid in acetonitrile.
Standard preparation— [NOTE—Protect solutions from light.] Transfer accurately weighed quantities of about 9 mg of USP Liothyronine RS and about 38 mg of USP Levothyroxine RS to a 100-mL volumetric flask, add 50 mL of a mixture of water, acetonitrile, and ammonium hydroxide (500:500:1), and swirl to dissolve. Dilute with a mixture of water and acetonitrile (1:1) to volume, and mix (stock solution). On the day of use, pipet 5 mL of the freshly prepared stock solution into a 250-mL volumetric flask, dilute with Reducing buffer solution to volume, and mix to obtain a solution having known concentrations of about 1.8 µg of liothyronine per mL and about 7.6 µg of levothyroxine per mL. Pipet 5 mL of this solution into a screw-capped 16- × 125-mm culture tube. Pipet 2 mL of Enzyme deactivating solution into the tube, place the cap on the tube, and shake the mixture vigorously.
Assay preparation— Transfer an accurately weighed portion of finely powdered Thyroid, equivalent to about 38 µg of levothyroxine, to a screw-capped 16- × 125-mm culture tube that previously has been flushed with nitrogen. Taking precautions to avoid unnecessary exposure to air, pipet 5 mL of Proteolytic enzyme into the tube. Allow nitrogen to flow gently over the mixture for 5 minutes. Place the cap on the tube, mix to disperse the contents, and place in a covered water bath maintained at a temperature of 37 ± 1 for 28 hours. Protect the contents of the tubes from light. Examine occasionally, and mix as necessary to ensure dispersion. At the end of the incubation period, pipet 2 mL of Enzyme deactivating solution into the tube, place the cap on the tube, mix vigorously, and centrifuge at about 2000 rpm for 5 minutes. Filter the supernatant through a 0.45-µm porosity filter, discarding the first 1 mL of the filtrate.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 230-nm detector and a 4.6- × 25-cm column that contains packing L1. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the tailing factors for the liothyronine and levothyroxine peaks are not more than 1.8, and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 200 µL) of the Assay preparation, and the Standard preparation, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in µg, of liothyronine (C15H12I3NO4) and levothyroxine (C15H11I4NO4) in the portion of Thyroid taken by the formula:
7C(rU / rS)
in which C is the concentration, in µg per mL, of the corresponding USP Reference Standard in the Standard preparation, and rU and rS are the peak responses for the corresponding analytes obtained from the Assay preparation and the Standard preparation, respectively.
Diogenes, do you have a link to where you found this? I am not that familiar with the USP Online site and was unable to find the reference on it. A link would give me a better idea where they hid it for future reference. PR
HelloI
I looked at both the sites you gave me. The first is the old USP just measuring the iodine content of NDT pills. But the second (the usp32 Chinese site) seems to be the real McCoy and is more uptodate. It quotes the USP source as:
USP32–NF27 Page 3735
Pharmacopeial Forum: Volume No. 28(3) Page 789. Here the T4 and T3 are properly measured, as is the iodine content as iodate. It looks genuine to me.
Diogenes, take a look at these two links please. This may be an older version, vol 29. These sites are in China so make sure your firewall and antivirus are up to date and don't click on any ads. The copies seem accurate.
pharmacopeia.cn/v29240/usp2...
pharmacopeia.cn/v29240/usp2...
I get the general idea of what they are talking about but this is beyond my training. PR
Diogenes, this may be out of Vol 32. This appears to be an unofficial site so make sure your firewall and anti-virus are up to date and don't click on any of the ads. PR
uspbpep.com/usp32/pub/data/...
uspbpep.com/usp32/pub/data/...
These sites are registered in shanghai, china but they seem to be good copies of the material.
Hello,
I have looked carefully at this site and contents. I am now content that the USP requirements and techniques displayed in the modern day USP 32 are adequate for the accurate determination of T4 and T3 content in thyroid extract. This is welcome news because users can now be assured that modern proper techniques have been employed and have supplanted the older inadequate method. When this came about I do not know, but it must have been post 1980. So you and Helvella and interested others can officially put it about that those products that conform to the procedures described in USP 32 do adequately control their T4/T3 content. I still think an independent check regime on manufacturers' thoroughness in production would be valuable to all NDT users. But at least users can believe in well controlled products by an accepted method of standardisation.
Yes, I did mean to say start on a low dose and build up, don't understand when you say that 25 mcg is not correct, it is if you read the leaflet that comes with NDT!!
No-one anywhere takes 25 micrograms of desiccated thyroid.
The smallest dosage tablet I know of is the 15 milligram Armour tablet.
What confuses is that desiccated thyroid tends to be in grains so 15, 30, 60, etc. (or 16, 32, 65, etc.) when expressed in milligrams so the combination of the number 25 and the unit microgram looks very odd to me.
Rod, thanks, I never understood why 1 grain was equal to either 60 or 65. Sometimes its the little things that drive you nuts. PR
I think that 65 mg is very close to a grain. But someone, somewhere thought that 60 mg gave a simpler measurement for halving, quartering, and even doubling! So we end up with two different numbers...
Interestingly, this is also why some companies produce Aspirin in 325 mg tablets - that is, 5 grains. (I don't think any UK products do this - but I could be wrong.)
And 130 mg morphine. And various other multiples of 65 (or 60) that give some otherwise very odd looking numbers.
Rod
I did not specify but only said 25mcg because that is the equivalent levo.
Hi Browny,
I took WP Thyroid for 4 months, with good effect, then swapped to Thyro-Gold and had a bad reaction. I was surprised, as I thought it would be better. I can't recommend anything other than WP, but intend to stick with that one in future.
Mel
I gave up relying on the efficacy of endocrinology testing, which doesn't pick up on secondary hypothyroidism from my pituitary adenoma. My nails are growing properly, my skin's healing, I can eat 1200 calories a day without ballooning, I don't crash every afternoon, & my morning temperature is up by half a degree from 35.1. As I'm not relying on blood tests, I started with 1/4 grain for two weeks, then 1/2. I 1/2 grains is too much & 1 grain feels right
I thought Thyro-Gold was the only NDT available without prescription. It took a long time to arrive, & I couldn't get the dosage right as it's not easy to measure loose powder from a capsule. If I took too little, I was back to being a doormouse, & regained most of the weight in a month that weight I'd lost after 4 months on WP. If I took too much, it was worse than taking 1 1/2 WP ~ my skin burned & I couldn't sleep. I asked twice about the dosage, but no response.
Other people seem to be fine taking it, so I'd read up on other people's response.
Mel
I hope I have as much success with WP Thyroid as you have.
I said to my husband this morning that my nails are shocking, were a few years ago they were so nice.
It is always nice to hear a success story so thanks for letting me know it has helped you.
Do you now get it prescribed or do you buy it.
Which thyroid hormone is best for us?
Best NDT?
Best NDT?
Which NDT is better for someone with High Blood Pressure.
which labs to pay most attention to when on NDT...?
