Just published - the study we knew was being done, and there were many comments then.
Their findings are here. Comments welcomed.
Introduction: Levothyroxine is the third most commonly prescribed medication in the UK, with an annual cost to the NHS of £52 million. Due to the fluctuating nature of thyroid function, guidelines for hypothyroidism management recommend that an elevated Thyroid Stimulating Hormone (TSH) should be confirmed with repeat testing, prior to commencing treatment. International research has demonstrated that levothyroxine is routinely prescribed contrary to such guidance and frequently for those with normal thyroid function. The goal of this research is to determine the acceptability of de-prescribing levothyroxine.
Methods: Patients registered with five general practices in North-East England were invited to participate. All were taking levothyroxine for at least six months and never had a documented TSH >10mU/L. Those with a history of thyroid cancer, thyroidectomy or pituitary disease were excluded. Participants discontinued levothyroxine for a six-week period. All completed a ThyPRO-39 quality of life questionnaire prior to intervention and again at the end of the study period, along with assessment of free T4, TSH & TPO antibodies at six weeks. The primary outcome was the proportion of patients who remain euthyroid, off levothyroxine, at 6 weeks.
Results: 102 participants were enrolled. 94 (92.2%) completed 6 weeks of levothyroxine withdrawal, with 8 patients restarting early, primarily due to symptoms. 60.8% of those completing the discontinuation period were either euthyroid or had TSH in the subclinical hypothyroidism range (4.4-10mU/L). 50% of those with subclinical hypothyroidism chose not to restart treatment at trial conclusion, with higher TPO-Ab levels positively predicting those who recommenced. 65.7% of the whole cohort reported feeling either “the same” or “better” at the end of the study period.
Conclusion: Most patients prescribed levothyroxine for presumed primary hypothyroidism do not develop overt hypothyroidism 6 weeks after discontinuation of medication, highlighting the potential for de-prescribing levothyroxine in select patients, without impacting patient well-being.
All completed a ThyPRO-39 quality of life questionnaire prior to intervention and again at the end of the study period, along with assessment of free T4, TSH & TPO antibodies at six weeks. The primary outcome was the proportion of patients who remain euthyroid, off levothyroxine, at 6 weeks.
And would need retesting several more times over coming year(s)
Just testing once at 6 weeks is inadequate
And no testing of Ft3, vitamin D, folate, B12, ferritin, cholesterol or GFR
60.8% of those completing the discontinuation period were either euthyroid or had TSH in the subclinical hypothyroidism range (4.4-10mU/L). 50% of those with subclinical hypothyroidism chose not to restart treatment at trial conclusion,
It doesn’t say what % of the 60.8% were classed as “sub clinical” ……
TSH over 4 is likely to result in increasing cholesterol and reduced kidney function, reducing levels of vitamins etc etc
Exactly, symptoms can take years to slowly develop, they don't all appear within 6 weeks.
Scientific papers shouldn't come to conclusions based on how the patients "reported feeling the same or better"... That's not quantifiable. I want to see blood pressure, LDL, triglycerides, eGFR, iron panel etc comparisons before making bold conclusions that can have serious long-term consequences.
....highlighting the potential for de-prescribing levothyroxine in select patients, without impacting patient well-being.
Exactly how does one determine how a patient will react?
The very fact that 8 patients didn't even make it to 8 weeks (and likely took many months to recover) demonstrates they have harmed these people. I know for a fact I would be in this group as have previously stopped Levo and suffered enormously as a result.
There must be more to it than this? More than ‘feeling’, it’s not science!
The study excluded those with pituitary problems - did they test everyone to see if they had pituitary problems? No, these patients would be overt and already diagnosed. Again, it’s not science. Actually, it’s abysmal !
if push comes to shove , i would be willing for them to change that so the levo prescription is free, but i continued to pay for 'other / unrelated / occasional' prescriptions like everyone else has to. (however 'unrelated' could be a bit hard to define)
and while they are at it , they could deal with this idiocy of routine 28 day prescribing for levo. i currently get 2 mths which is ok, but i much preferred 3 monthly ..and it would incur less expense all round .
The ‘doctor/researcher’ to whom you refer has other papers to his name which are even worse. He certainly is no scientist. It’s worrying seeing really good researchers/doctors having their name associated with his. In my view this must be damaging for their careers (never mind us).
Talk about the ‘expected’ final result being the basis for the research = thoroughly dodgy research. In that everyone who is anyone, is already aware of his reputation, knows exactly what the conclusions of this ‘research’ would be.
Certainly many local patients know this guys views. This result is hardly surprising coming from his reputation. If he had any dignity he should have left it well alone.
Don’t quote me on this but I think when I started with Levothyroxine (four years ago) it was the most often prescribed drug. Very soon after, it became the second most prescribed drug. Now it’s the third most prescribed drug. Mmmmm, seems like his dastardly plan is working. Get as many people either off thyroid meds or at least get them reduced. He must think himself a big friend of the government by apparently cutting costs. However this has enormously far reaching costs to individuals, families, businesses, communities, the NHS itself and the GDP.
International research has demonstrated that levothyroxine is routinely prescribed contrary to such guidance and frequently for those with normal thyroid function.
I note the use of International. Maybe in USA this happens but in the UK it can be a challenge to get treatment
a little story about about saving the NHS some money.
various symptoms . feeling extremely unwell :
seen by 2 GP's and a Nurse practitioner so .... 3 appts .
sent for:
kidney ultrasound.
referred to gastro consultant ,
sent for endoscopy ... and colonoscopy.
CT scan with contrast.
repeat visit to gastro for results ( all perfectly fine)
total cost ... no idea ,presumably 'loads'
fourth GP appt (by chance with elderly semi retired GP ~ experienced in looking at actual thyroid symptoms ) ... who thought i was overmedicated based on her careful physical observations during 10 minute appt.
took thyroid bloods ..(no one else had though to do so as previous routine annual test was 10 mths previous and looked ok/ normal for me )
reduced Levo dose by 25mcg .."et viola" ... i got better.
total cost 1x 10 minute appt + TSH/fT4 test (minus 25mcg levo / day ongoing) ie. 'peanuts'
difference ... better GP understanding/ experience of thyroid symptoms
that's how to save money .... give GP's better understanding of thyroid hormone action.
unlike this little experiment, which ..... (when put into practice on a large scale , as i have no doubt it will be) ........will cost the NHS a lot more than it saves in the long run.
If doctors had a better understanding of thyroid hormone action the 52 million would likely increase -
the realisation should be that doctors need T3/T4 blood test readings and in turn T3 and T4 thyroid hormone replacements readily available in primary care with which to restore a patients thyroidal balance, health and well being as was the system before cost cutting exercises were implemented.
The 52 million could be reduced considering the numbers involved in sourcing thyroid hormone replacement - and hope the NHS actively challenges the market prices being such a major player - especially since they left themselves badly exposed over T3 prices in the past 20 years.
Optimally medicated hypothyroidism in primary care , as was the system, would stop referrals to hospitals for all sorts of other tests and consults which generally end up as a waste of everybody's time and money.
the levo bill would probably go up , i agree .... but multiple other costs would probably go down. eg, my little gastro escapade would presumably have cost enough to have paid for 'levo for life' for several other patients .
also , had i been diagnosed (& treated appropriately with an early option of a little added T3 perhaps) earlier than i was , rather than struggling and going downhill for 4 years , they may well have saved the cost of referring me for a programme of 'pragmatic rehabilitation' ,consisting of hour long face to face appts once a month for 18months ..... and some other counselling a few yrs later .
Yes - I just amended my post - sorry - I hadn't finished when I posted as was getting upset thinking of my own situation with the NHS some years ago - as I came away with the addition of PTSD - with my counselling being this forum followed by self medicating the most appropriate thyroid hormone replacement for me.
similar here ......this forum has been the most effective (and cost effective ! ) form of counselling i have ever had. It fixed the low self esteem that NHS gaslighting had given me , thanks everyone xxx
Typical nasty nonsense from Simon Pearce. Full of bias and he is knowledgable enough to know this.
Patients who never had TSH > 10 from five general practices were invited to take part. Only those who had some doubts would take part. Bias 1.
"60.8% of those completing the discontinuation period were either euthyroid or had TSH in the subclinical hypothyroidism range (4.4-10mU/L)". Another way of saying 60.8% had a TSH < 10. Using the term 'euthyroid' Bias 2. Not pointing out that 39.2% now had a TSH > 10. Bias 3.
"65.7% of the whole cohort reported feeling either “the same” or “better” at the end of the study period" not separating out "the same" from "better" Bias 4.
"50% of those with subclinical hypothyroidism chose not to restart treatment at trial conclusion" No details on how many were "subclinical", nor does this percentage include the eight pateints who dropped out because of symptoms. Bias 5.
"Most patients prescribed levothyroxine for presumed primary hypothyroidism do not develop overt hypothyroidism 6 weeks after discontinuation of medication" Overt meaning TSH > 10. This cohort were selected because they never had TSH > 10. Bais 6.
The study raises other questions, not least how effective levothyroxine monotherapy is in patients with hypothyroid signs and symptoms and a TSH < 10. It ducks the issue that many studies show that even a mildly elevated TSH is associated with cardiovascular harm and reduced lifespan. It also ignores the harm of an elevated TSH in pregnancy. The short duration of the trial is also a problem, six weeks is long enough for most of the levothyroxine to leave the circulation (pharmacokinetics) but many effects of hypothyrodism take much longer to surface (pharmacodynamics).
Yes I have definitely noticed a rise in research papers referring to subclinical hypo being very important in the development of CVD. I recently looked at the cost of private angiograms, with the likely addition of stents, nothing less than £11,000. Can you imagine (because that’s only your starter) how costs mount. The drug bill - I have a regime of 9 other ‘heart drugs’ excluding my levothyroxine and so far No T3 to be seen. Wonderful papers on Heart and Thyroid connections.
I live in Simon Pearce’s land of care. Local Cardiologists know nothing of the wonderful thyroid research available and no-one calls him out.
He is a menace to hypothyroid patients and he is a menace to the tax paying public.
"Patients registered with five general practices in North-East England were invited to participate".I'd be interested to know how many patients declined to participate... I suspect that the patients taking part were more likely to have been started on levo by GP following random blood tests, rather than those that experienced significant symptoms before seeing their GP and being started on levo. I can't see many people that have struggled with symptoms before being treated, and then have gone through the slog of finding a somewhat effective dose would willingly take part in this study?? The number of people that told them to get lost is likely far more telling than any data they present....
also ... absolutely no data to show how well those who chose to participate were treated whilst on levo ....ie , if they were under / overtreated, or had dose yanked about by a GP with all the subtlety of a sledgehammer as we often see on here without waiting for doses to properly settle in , not checking for any other issues which may have an impact on how well they felt while on levo such as B12 etc etc etc , and felt crap on levo as a result of these issues ..... these participants might well report feeling 'the same' even if 6 wks without levo also left them feeling crap.
an honest trial would have only looked at those whose care/ monitoring was truly optimal.
p.s i seem to remember he had to extend the recruitment period for this 'study' to get enough participants . 'get lost' figures would indeed be more interesting.
Just came across this on X (Twitter) liebertpub.com/doi/10.1089/... . It references a study that helvella has already posted about healthunlocked.com/thyroidu... . They do seem to be a bit relentless in trying to deprescribe. I have noticed that these 'studies' that recommend deprescribing are always behind a paywall.
Of course the main problem is reliance on TSH testing rather than putting the effort (and skill) into making a clinical diagnosis. We should bear in mind that a much higher percentage of patients are prescribed levothyroxine in the USA than elsewhere. So, whilst there is some over-prescribing we shouldn't extrapolate American studies to the UK population.
Nonetheless so called 'subclinical hypothyroidism' carries substantial risk. This study jamanetwork.com/journals/ja... finds that those with 'subclinical hypothyroidism' are 90% more likely to die during the study duration of 7.3 years. I don't know of a drug that is as cheap and safe that can halve your risk of dying. it appears that dropping dead is an acceptable consequence of deprescribing.
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Factors Contributing to High Levothyroxine Doses in Primary Hypothyroidism
