There has been a lot of questioning of high-dose thiamine treatment here lately. We would all like to see a large randomized controlled double-blind trial. The proponents of this treatment, Dr. Costantini and his associates, have been begging for funding for years without success. So we have to make do with lesser evidence. Here is an informal survey result:
" After just one day and over a hundred responses, I counted 49 Yes (helps) and just 9 No’s (hoax)."
In the comments below, HIkoi counted 47 positive responses and 19 negative. For reasons set forth in the comments below, the negative results are likely underrepresented, so we can only guess at the actual percentage of those who try it who receive benefit. With that said, it is unquestionable that many have received and continue to receive benefit from this treatment.
As regards evaluating evidence, a discussion of standards of proof is in order. For the FDA to grant a monopoly for an expensive new drug that must be used under medical supervision and will reap insurance payments, two large expensive phase 3 trials are required. Such drugs often come with the possibility of causing serious adverse events, which are defined as any untoward medical occurrence that at any dose: en.wikipedia.org/wiki/Serio...
1.Results in death
2.Is life-threatening
3.Requires inpatient hospitalization or causes prolongation of existing hospitalization
4.Results in persistent or significant disability/incapacity
5.May have caused a congenital anomaly/birth defect
6.Requires intervention to prevent permanent impairment or damage
High-dose thiamine for the treatment Parkinson's is inexpensive and is low risk, particularly when taken by mouth: en.wikipedia.org/wiki/Thiamine
"Thiamine supplements are generally well tolerated. Allergic reactions, including anaphylaxis, may occur when repeated doses are given by injection." Here is a report of someone who experienced toxicity after taking 10 grams daily for over 2 weeks. Adverse symptoms resolved 2 days after cessation: jamanetwork.com/journals/ja...
As far as I know, the adverse effects that have occurred in Parkinson's treatment have resolved upon discontinuation. The benefits can be substantial:
Patients and Methods: Starting in June 2012, we have recruited 50 patients with PD ...All the patients were assessed at baseline with the Unified Parkinson's Disease Rating Scale (UPDRS) ... and began treatment with 100 mg of thiamine administered intramuscularly twice a week, without any change to personal therapy. All the patients were re-evaluated after 1 month and then every 3 months during treatment.
Results: Thiamine treatment led to significant improvement of motor and nonmotor symptoms: mean UPDRS scores (parts I–IV) improved from 38.55 to 18.16 (p = 2.4 × 10−14, ... within 3 months and remained stable over time; motor UPDRS part III score improved from 22.01 to 9.92 (p = 3.1 × 10−22). Some patients with a milder phenotype had complete clinical recovery. .. Follow-up duration ranged from 95 to 831 days" [Confidence intervals omitted for readability]
Yes this is not a controlled study, but I have never seen improvement this good with placebo. With P values expressed as 10−14, to 10−22, this means 14 to 22 zeros to the right of the decimal point - unheard of good P values.
With this risk-benefit profile do we really want to require the same standards of proof as for new drug approval? Of course not, in my opinion. Each of you is free to decide as you like.
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Marco is still pursuing other avenues with the aim of finding funding for a rigorous study. This is not connected to his work as an environmental scientist, but he’s really committed to completing what his friend Dr Costantini discovered and started to explore before his untimely death. I’m putting my profits from book sales into the go fund me page to fund a B1 research project but sadly it will hardly scratch the surface. It is a gesture anyway.
The problem is those who didn't benefit were likely not to have participated. Those who are "bought in" would have been more keen to respond. It's a skewed population. There was no way to ensure a response from all who tried B1
Nor was there any sort of control over other symptomatic adjustments (ie also changing levadopa, as Royprop was constantly doing at one stage.)
I can't see there ever being a trial. Not only has the amount of funding raised so far (after more than 3 years) been hopelessly inadequate, as Daphne pointed out, but team Constantini's methodology was unscientific and unlikely to inspire interest from any serious research
And there is a tendency to treat all positive responses to B1 as substantial and equivalent. This further illustrates the weakness of team Constantini's presentation. PB cited one of their published "research " papers. Take the next 50 PD patients who walk through the door, give them all a standard twice weekly 100mg im injection and observe progress over the next 3 months. All respond positively with significant substantial updrs score improvements.
How does that square with this forums experience? You and I, Jimcaster, jeeves and several others got no benefit. PB himself primarily improved his constipation, and Daphne I think sense of smell and mood. Very very few reporting a positive response, report updrs results like team Constantini's 50 walk ins.
And where in team Constantini's 50 successes is the dose adjustment, overshoots and other black art tuning that Daphne refers to in her post on this thread?
"an error has occurred".
There's no harm trying B1 and enthusiastically reporting positive experiences. What's frustrating is the paranoid whinging about an alleged establishment conspiracy to suppress the hidden truth about B1, when no trials are needed either to promote it or enjoy its benefits, and the main trial sponsor has such questionable methodology and claimed results
There isn't going to be a trial. Chill and enjoy whatever benefits you perceive if you are lucky enough to get some benefits
Just to clarify, ‘Daphne’/I lost all my rigidity and bradykinesia too. I also haven’t increased my levodopa dosage in seven years. It remains at 200mg a day. Perhaps I’m just lucky.However, I do not push B1. If people aren’t interested, that’s fine by me. It’s not easy finding the right dose, and I quite understand why people don’t want to bother. There are however many people who do want to try the protocol and for them I am happy to be a sounding board for their questions.
I appreciate you do not push B1, and recognise the value of the resource you offer. Like Marc, I think people should try B1 and like him I have done so. Moreover whilst you offer your support for a trial, you are not one of the pharma-bashing whiners promoting daft conspiracy theories.I believe a cure, or as near as we can get to a cure, is much much much more likely to come from conventional research and pharmaceutical development than it is from some amateur neuro researcher on a forum uncovering the magic supplement, or stack of supplements, that cure PD, and bashing them is at best irrelevant whining.
Again, I appreciate that doesn't apply to you and I am pleased that you get a worthwhile benefit from B1
WTP, does it not seem logical to me to diminish the positive experiences of the members of this forum considering them unreliable or minor and immediately after citing the negative experience of other posters as certain proof that the b1 don’t work, are they perhaps as reliable as the others?. I didn't know you tried the b1, so you don't use it anymore?
"... those who didn't benefit were likely not to have participated." rings true to me, plus the likelihood some of the benefits, after initially reporting positive results, were short lived (and without follow-up reports) we don't really know what % have benefitted.
I do feel 80% is too high. I believe if 80% of the people on this forum are benefiting substantially, it would be yelled from the rooftops -- every day. It's not popular, but I'm going to stay with 20% and qualify that even further by pointing out we don't know by how much (benefit.) Dr. C hurt his credibility by saying 100% benefited.
I also agree everyone should try B1 and should spend time tinkering with the dose.
I have experimented 1 to 4 g per day for nearly 2 years, injected 1 mL twice a week for the better part of a year, used sublingual for months and currently take 1500 mg/day HCL along with 50 mg of allithiamine 'just in case,' but zip, nada.
I feel it should be recognized that Daphne doesn't push B1, but instead acts as a resource and should be appreciated for organizing (writing a book) what is known about B1.
I have received clear benefit - constipation relief is no small thing. My bathroom duties are now quick and efficient, better than even before Parkinson's. I am not the shouting from the rooftop type - I post and comment as I deem appropriate. What exactly would you have people who have benefited do differently?
I do not think it is fair to pull an arbitrary number like 20 percent out of the air. It is fair to say we do not know the correct percentage of those who have benefited, but there have been at least 47 PWP who say that they have.
pb, I wouldn't want or expect you to do anything differently. I am sorry if you read that into my comment. I am truly glad it has benefited so many. My guess of 20% was just that - a guess.
Surely, you recognize such a survey does not account for all the variables? 47 out of how many, for example. It is unknowable because we don't how many people saw the survey but did not participate.
I am jealous. I wish it relieved me of constipation.
I have been taking magnesium for eons, long before I started high dose thiamine. I find magnesium helps by increasing moisture content whereas thiamine helps by increasing peristalsis.
You have made a colorful editorial comment about dose adjustment which mischaracterizes a straightforward process - if symptoms of overdose arise, quit and resume at a lower dosage.
And those who didn’t bother to continue HDT or scared to reach the recommended high dose or to eventually find the right dose maybe among those didn’t contribute to this post.
Thank you for posting.I laugh when people say B1 success could be down to a placebo. A typical experience…
You start off all excited with positive expectations and nothing happens. You up the dose, get impatient and up the dose again. You’ve gone too far and your symptoms worsen. You take a break and restart one dose lower. Hey presto! At last! Your symptoms improve….
And they think this could be placebo! It wouldn’t be so hard to find the right dose if it was placebo!
Even more funny that those are cynical to B1, they have been using Thiamine themselves for several years.! I don’t understand if HDT has no effects on them why they bother to take it regularly!!
I be one of those (who take it regularly.) I continue to take it for the same reason I take everything else, none of which I can say has benefitted me, it may be of benefit. Not a silly reason all and all.
Many of this forum members including myself stopped the HDT for sometime and clearly noticed that their symptoms returned. That didn’t happen with stopping other supplements . I think that confirms something.
There were 145 responses. Credit to you for combing through all of them and counting. I did a search on the word "no " and only found 4 no votes, so that method proved to be inadequate.
If we take your numbers as correct that is still a 70% success rate which is pretty good.
Why are we tabulating the % that benefit from the number who responded to the survey when the number who read the survey and who tried b1 but did not respond to the survey is unknowable, but is the only figure that tells us what % benefit.
Could not agree more !! Very good results as far as I am concerned. I have been using B1 for three years. Have not noticed any aggravation of my symptoms. Takeaway bit les medicine than was prescribed
The story of HDT is based only on word of mouth until the Dap1948 book came out and it is very simple.
An Italian neurologist, Antonio Costantini, who worked in a clinic where there were hospitalized Parkinson's patients casually observes that B1 improves the symptoms of PD and studies without initially disclosing it.
Treated patients having had improvements tell others ranging from Dr C getting improvements as well.
Word of mouth runs fast until it reaches social media, with ups and downs, so the information comes out of Italy and so it has reached the whole world.
The point is that this is only possible if there are results. When it ceases to give results it will stop, but today we always hear of someone who has improvements with the b1 who happy, wants to tell others about it. By now HDT has been around the world and tens of thousands of people use it daily to improve their quality of life.
The pharmaceutical promoters are committed to discrediting HDT and I honestly do not understand why since it is not a cure and does not decrease the use of drugs such as levodopa with which b1 is synergistic, but you know, they attack with blind stupidity any effective message that does not come from their side.
So, in my opinion, a survey or research that can determine the effectiveness of b1 is no longer necessary, because the results obtained from its use and the word of mouth it generates after years are already the solid confirmation that it works.
In fact Marc, HUCP is a forum for patients, not a scientific magazine. Our experiences have an approximate value and if they are positive they carry on word of mouth in general. For the accuracy you require, a scientific pharmacological approach is required, i.e. a test in a very controlled context. They are two different precisions in different contexts and one cannot be used to invalidate the other or vice versa. If word of mouth continues it is because there is some result, this is the precision we get here and no further, if you want more, a more controlled context is needed but it is not up to us sick to take care of it. On my door there is no written "Ministry of Health, we have a great responsibility for the health of all citizens" and then what?
If you have read my comments, you would know I've experimented with every form of B1 over years proving I don't require scientific pharmacological approach - which is separate my pointing out the survey of forum readers is a poor way to figure out what percent benefit.
Of course Marc, but what level of scientific precision do you give to your experience as well as mine? We have three levels of precision here: ours based on poorly controlled personal experience, Dr C's clinical experience based on medical practice (Medical practice is not an exact science but is based on several sciences: anatomy, biology, pharmacology, etc.) and the third based on pharmacological science, the so-called missing double blind. Now mixing the three levels and Fight each other against each other is not a good idea; it is journalist crap and pretty much what we see here on HU.
But a scientist or organization that wants to find a cure for PD should take into account the experiences of these people here and deepen instead of running after mice….or not?
I've been using it since November of 2018. I've tried decreasing my dose and even stopping entirely (wondering if I really need it and if it's really what is helping me so dramatically), but my symptoms always come roaring back with a vengeance. I definitely can't do without it. I just get really tired of posting over and over and over again that it helps me only to be met with skepticism or arguments. For those who don't want to try it, don't try it. No one is trying to sell anyone anything. I just don't get the resistance that it's always met with. If you try it for 6 months and have no improvement, what have you lost?
My gut feeling (pun kinda' intended) is that the non-responders have malabsorption issues or imbalances of other nutrients (my gut health is so strongly tied to my symptoms), or that it has something to do with the origins of an individual's PD.
Thank you for reporting your results, 1LW, again! Nothing works for everybody, even the gold standard treatment for PwP doesn't work for everybody. With pretty much all things PD, it comes down to trial and error. B1 happens to have a very good safety profile that makes trialing it very low risk compared to any prescription meds for PD. There is no risk of withdrawal side effects if you stop cold turkey other than your old symptoms returning.
If it works, that's great and just stick with it. If it doesn't help, just move on to the next drug or supplement. All there is for PwP is trying to improve your quality of life, so if something does that for you, congratulations and enjoy it!
I don't think anyone is annoyed with you on that topic. The annoyance seems to be when people say it is a placebo effect or what if it is a placebo effect? Even if it is a placebo effect, so what? It is working for many people and they are not going to stop taking it as long as it is working. All there is with this disease and many others is attempts to improve your quality of life and you can only know what helps by trialing the available options. Under those circumstances, having a very good safety profile is highly desirable and B1, fortunately, has that plus on its side. B1 has other health benefits so that is another plus in its favor.
I understand that some people don't want to take it because of no PD/B1 studies and that is their choice to make. Some people feel it doesn't do anything for them and they should say so if they want to. You did and to me that was a good reality check for all of the members. Nothing works for everyone. The bottom line is to improve quality of life and that is a good goal to work toward in any incurable disease imo.
The annoyance seems to be when people say it is a placebo effect or what if it is a placebo effect? Even if it is a placebo effect, so what? It is working for many people and they are not going to stop taking it as long as it is working.
How can people possibly be annoyed by this discussion if it doesnt matter either way? Should those of us interested in having that discussion be forced to have it elsewhere becuase individuals that are 100% convinced it 'works' cant handle opposing views? Really? Arent the people here adults?
Its actually quite important to some of us that the placebos be separated out.
I appreciate opposing views because we all need a realistic understanding of the pros and cons of the various options out there. What bothers me is when people try to discourage others from trying something just because it didn't work for them personally.
I agree. If it works then that’s good news. One strange feature of this phenomenon is another phenomenon: curiously, a few members of our community have told me privately that B1 did little for them but they didn’t feel that they wanted to admit this publicly, such was the direction of travel on the forum. Strange but true.
Boy, the goalposts really do move around for thiamine, don't they?
The reason thiamine attracted so much attention on this forum is not because some people said it 'helped', and it's not because AC published a handful of non-placebo controlled trials that showed improvements. We know this, because if those factors were enough for the level of attention we've seen, we'd have just as many threads about NAC or melatonin, or any number of other things that have shown promise in open label trials.
It's because, for a while through the conduits royprop and chartists, and more lately through you (PB) and daphne, the following claims and representations were made by the proponents (i have copied these remarks from highdosethiamine.org).
Yet when benchmarking the success or otherwise of the treatment, we are now relying on an informal survey asking people if it 'helps'? Why aren't we asking people if it does what the proponents promised it would do?
My emphasis below.
1. The progression of the disease has been halted.
2. We observed that the right dose of thiamine can lead to an improvement of the symptoms between 50 and 80-90%, but in order to push towards the complete regression of the symptoms, the correct dose of l-dopa should be coupled to power the dopaminergic motor circuits. L-dopa then shall no longer lead to DYSKINESIA if used together with the high-dose thiamine.
3. High-dose thiamine does not eliminate the primary cause of the disease but blocks all damages inflicted by the disease.
4. The question then, if you take carbidopa/levodopa (as Sinemet) will the thiamine still prevent late stage development of problems like dyskinesia?
Answer : Certainly. Yes. (Kevo note: not maybe, not probably, but certainly)
5. Once a person has established the correct dose of thiamine/B-1 and is stable, including a good response to the Pull Test and a good reduction of symptoms, this person will never need to increase their other PD medications such as Levodopa / Sinemet or other drugs. There is a possibility that these standard drugs may be reduced especially if they have side effects.
6. Furthermore, suppose that for any reason the patient cannot or does not want to take any kind of classical treatment for Parkinson's disease; the right dose of thiamine can give him, at any stage of the disease, an improvement that can range from 30 to 70%, while at the same time abolishing the progression of the disease!
7. We do not have any patients who do not respond to treatment with thiamine.
If a drug manufacturer made the above claims about a new drug that then delivered as inconsistent results as thiamine does, there would be a town square lynching here.
Regarding your last sentence, there is a sordid history of a variety of drug manufacturers cheating on measures of efficacy and covering up really awful problems with their medications, for example, selling an ineffective drug that increased suicidal behavior among children. I documented this at some length with proper references here: When Good Doctors Prescribe Bad Medicine:
Regarding the rest, I never claimed thiamine would do all those things set forth above. My claim is that it is a good risk/benefit proposition. As far as I know it has not caused any serious adverse events and has helped at least 47 of us.
Regarding the rest, I never claimed thiamine would do all those things set forth above.
But you link to that site on a regular basis. The claims i copied above are not supplemental to the core 'protocol', they are central to the protocol. They are very bold claims, in some cases are made repeatedly and they are made unambiguously. As i said above, they are the reasons for the hype. If those claims hadnt been published then repeatedly posted on this site (mostly by Roy), we wouldnt be having this discussion.
These claims are tantamount to a cure. People are now saying "no one ever said it was a cure", but the picture the proponents painted was much closer to a cure - no more progression, no more med increases, no more MCs, broad releif across both motor and non motor, works in 100% of patients - than it was something that "helps". It sure sounds like a cure to me.
If you tell people they are getting the cure, id expect them to react accordingly for at least a little while.
Ive tried both solgar 500 and the 100mg sublingual with no observable benefit. Never had a persistent problem with constipation though.
For the record, i am totally open to the idea that it has a legitimate (non placebo) benefit in some PWPs, and i said that in parkie's thread too.
not caused any serious adverse events
But we will never know if it does, because anytime someone has an AE they are told it cant be the thiamine because thiamine doesnt do that. Either that or the resident experts simply ignore it, as happened in this recent thread:
The book gets a plug as does a dosing thread. Not much more than that is said about it, but i have serious doubts that those that track all of the 'improvements' reported here also added those reported side effects to a similar list.
Roy's UDPRS deteriorated 10 points in 2 years (cant find the ref as his account deletion makes it difficult). Twice as fast as average. If we are expected to be open minded enough as to accept that all of the good things happening in peoples' lives are the result of thiamine supplementation, and that everyone's PD is different, then surely it should be open to us to conclude that the HDT protocol actually accelerated his disease progression? Maybe he took too much of it?
I think we arent that far apart on this. I agree that it 'helps' in some PWPs. What i probably should have said a bit earlier is that i am attempting to explain why it is controversial and why there is a large enthusiasm gap.
I link to the site because it has dosing instructions straight from the source.
You have condensed and highlighted exaggerated claims made at the site without any note of mitigating statements such as this intro:
"Clinical observation of patients suffering from a number of autoimmune and neurodegenerative diseases ... suggests that the HDT protocol can be a powerful aid to classic therapy, enhancing benefits for the patient while also reducing collateral/side effects of traditional drugs." [Emphasis added]
I will add a note that not everyone benefits when I link to it.
I copied answers from their FAQ. This wasnt a press conference where they were expected to answer questions in a live setting, it was a written response to questions where they had the opportunity to consider and edit their answers. Theyre professionals, arent they? They wrote those answers, not me. They chose the terms used.
If you are now saying that the responses in the FAQ shouldnt really be taken seriously becuase they are all subject to a caveat that doesnt even appear in the FAQ document (i didnt realise that when reading the FAQ, we were expected to comb the site for disclaimers that may serve to invalidate the FAQ) then i think you are being incredibly generous towards them and i am left wondering should we ever take seriously anything they say about anything.
I think you are missing the point Gio. Roy posted that over 2 years, his updrs score got worse. His PD measurably progressed from a score of 27 to 37. 10 points. 5 points per year.3 points per year is normal
Roy posted that although he was taking B1, over the last 2 years his PD, as measured by updrs, had progressed twice as fast as normal progression
That doesn't fit with Dr C's claims that those treated with B1 do not progress
I'll tell you right away that I have to have dinner (Bresaola della Valtellina, a little protein in the evening).
So where is the mistake?
It's Roy who's unreliable or HDT isn't working.
Because you can’t say Roy and the others here on the forum are unreliable when they talk about improvements with HDT and become trustworthy when reporting bad things.
Either one or the other according to Aristotelian logic, or we are on a gradual scale of values where it needs more precise study and where no one is wrong at all.
Research and discovery continue.
PS:Personally Dr. C never told me that the disease would not progress, he preferred the positive version that is, that I would be fine, it is different!
But Roy has skin cancer, not leukemia. And that started, and so did any treatment for it, AFTER the 2nd updrs of 37. So he progressed 10 points during 2 years when he was not on chemo
Maybe the excessive doses of B1 caused the cancer? Roy tended to do things BIG
Moreover, in the 6 years since diagnosis before the first score of 27 his PD had progressed by 4 points pa on average (6x4 is 24)
Now Roy becomes reliable for you? But in several previous posts he said he was unreliable. You even opened a thread about him to disavow him when he left. It does not work this way. This is not the correct way of representing the facts.
why? don't you remember the thread you wrote ad personam about Roy when he was already gone? You've been writing about him for a whole day. Here too you denigrate what he did and quote "Maybe the excessive doses of B1 caused the cancer? Roy tended to do things BIG". short memory or lack of empathy?
also this here explains to us in your opinion on the reliability of Roy:
GioI know English isn't your first language but I think you are deploying your primary forum tactic of throwing up a smoke screen to attempt to distract from uncomfortable rational criticism of any aspect of B1.
Observing that Roy repeatedly posted that he was having to make very substantial adjustments to his was dopa as well as B1 treatment is not saying he is unreliable.
Observing that the tantrum he threw melodramatically leaving the forum because the moderators asked him to stop using language which was unnecessary and offensive, meant he was behaving like a sulky baby was not questioning his reliability either. Just his maturity.
This smoke screen tactic is making you look a little desperate
And you insist on the lack of esteem and as usual you are rather autobiographical.Without Roy you would not have even heard of it, he had many defects but who has not? He also had over 300 followers.
Seeing the number of words you are dedicating to prove your thesis, I would say that the smoke comes from you. I have already clarified my point from the first two posts by answering MBA and for me it was closed there.
I asked you very simply before, where is the mistake?
It is people like Roy who are not reliable in reporting or it is Dr C's clinical studies that are wrong.
As much as you try to say that clinical studies have no value in terms of drug science they were performed with a more rigorous methodology than a forum opinion poll, they certainly do not have the accuracy of a large double-blind drug study. but I'm not at the level of being totally discredited by the narrative based on a Roy post.
So why not survey dopamine agonists and discredit the research based on the negative opinions. Why not do it on vaccines or levodopa.
You must be familiar with the real scene from which the data derive to analyze them, you cannot move them from their original context and you must know the logic of gradual scales to understand:
the more you increase the precision the result changes, if you use a more precise methodology you will have a result different but this does not discredit the less precise result.
I see after years that there are positive reports in the use of thiamine, but to what extent? It always depends on the precision of the method, even the gold standard of double blind is difficult to use on a substance that is fundamental for the body and is contained in foods such as b1.
Until now no research has disproved the dr C that I know of, only you are desperately trying to do it using as proof the negative posts of this forum.
Sorry but you insist on making the same mistake: a trial is a context, a single opinion on the forum is another context it is this transferring data from one real condition to another that is wrong.
There is also a theory I heard from Doctor C about how it can happen, about the different suffering condition of the lesional cells. According to him, in theory, some of the cells still alive are suffering and some dying and will be revitalized by the thiamine. but for today I have already given, another time.Bye
Surely if thiamine is sufficiently potent that it protects neurons in a fashion that few if any other known treatments can, and that overdoses cause a worsening of symptoms, then sustained overdose could cause an acceleration of the neurodegeneration?
But didn't you say it was all a placebo effect? indeed no ... you said that for some it was a placebo and for someone else it was therapeutic. I had never heard that a substance could have both a placebo and a therapeutic effect.
You practically invalidated all the science behind the double-blind method with one sentence.
I just got done reading the original thread and it was long, but interesting. I had not previously seen it as it was posted during the period when I was gone from HU. Thank you!
You state."We would all like to see a large randomized controlled double-blind trial."
As this thread has established, this is not true. Most of us cannot imagine a bigger waste of money. B1 is authorised and available today and you can and do legally use it. I would far rather the money was used on research for a potential pharmaceutical (or other medical treatment) like the dopamine pump being developed at Lille University, or inhibikase ikt148009
The invalidity of your claim for 80% success has been addressed already. It was an invalid population. I would guess most of the thousands using this forum have tried B1. A large handful are advocates. Maybe 1 or 2 percent?
You then list adverse events which drug trials screen for, as though these are the risks people subject themselves to taking any medication. But not with B1. The implication being taking any licensed pharmaceutical product exposes you to those risks, but B1 is a safe alternative
Words fail me
As for the trial you want, you report Dr C's preliminary trial
50 patients
100% success
Wait for it...
Thiamine treatment led to significant improvement of motor and nonmotor symptoms: mean UPDRS scores (parts I–IV) improved from 38.55 to 18.16 (p = 2.4 × 10−14, ... within 3 months and remained stable over time; motor UPDRS part III score improved from 22.01 to 9.92 (p = 3.1 × 10−22).
OK. So you get your trial. The previous result is the primary outcome we are looking for statistically significant evidence of. Not "I think it helped my constipation, and my friend thought it helped his mood"
Let's do a quick trial based on responders to this thread. Starting with you PB, did you experience an improvement in updrs I-IV of 20 points (38 to 18)?
Did you experience an improvement in updrs motor scores of 12 (22 to 10)?
So, if those were the primary outcomes we were looking for, in a proper rigorous trial to demonstrate efficacy for an fda license, to confirm the research backed claims made by Dr C and repeated by you at the start of this thread, what do you think the reported trial outcome would be?
Let's ask the same question of Daphne and everyone else supporting a request for a "proper" double blind placebo controlled on this thread. Yes Gio - that includes you, but the answer needs to be 2 updrs scores not pages of arty Italian meta physics.
Its a pretty direct, specific, measurable claim Dr C was making. And yet even enthusiasts couldn't match those results at 50% success never mind his published claimed 100%. There is a word to describe that sort of claim
And we haven't looked at establishing the false claim which makes B1 attractive to most - "no progression"
You are going to need a minimum 2 year trial duration to establish that.
And finally you referenced my use of "black art" to describe dose adjustment. Perhaps you could publish your proposed trial methodology to achieve "dose adjustment" with double blinding
All of this would have been considered by MJFF. Their response is therefore no surprise
For your interest, here is a copy of Colangeli's post regarding what they were told by MJFF:
Dear all,
I unfortunately have to share some sad news with you all.
As you all know we submitted to the Michael J Fox Foundation a project proposal for a clinical trial involving the High Dose Thiamine treatment. Although the pre-proposal was invited for further development (stage 1) unfortunately the proposal has been rejected by the reviewers at stage 2.
The reviewers expressed various concerns and a general skepticism about the impact that thiamine with the protocol developed by Dr. Costantini can actually have on PD. The three reviewers although contradicting each other on specific sections of the review, generally implied that the research is not groundbreaking and novel enough, not very trustworthy, same goes for our design (based on dose titration aka giving each patient its efficient dosage or else no improvements can be seen whereas they would have preferred a one size fits all type of dosage) and the lack of experience and reputation of us as Investigators. Reviewers also pointed out that our estimates concerning the recruitment of patients were far too optimistic (200 patients from two of the largest hospitals in Italy in 12 months), one highlighted that the budget we estimated for the clinical trial was too low to be true and in general said that our proposal is unrealistic and the expected results would not be very relevant to the PD community.
I am very sorry but this is their verdict and we can only accept it even though I personally feel this is a missed opportunity for many PD patients.
It seems that the foundation had many of the same observations that some of us here do. Big surprise.
It would be interesting to see the full original text of the reply, which is presumably in english. I don't suppose anyone here has access to it. But as you say Kevo, their conclusions match ours, and Dr C's teams surprise can only reflect their naievity as to what a drug licensing clinical trial entails
Bah! little old for a big surprise. Perhaps that is why MJFF have not yet opened any decisive doors on the road to healing, despite the great availability of resources. What matters is the result, , this alone distinguishes an naive from a professional.
It’s cheap and people can’t show-off with a bottle of Solgar B1 but they simply can wear their Coronet Duo Red Light while Jetskinng in the ocean somewhere in Southern France or Mediterranean and share their selfies .😂😂😂
No Kia. The real problem is that the users of B1 aren't happy with it being freely available, inexpensive, risk free, and effective. They want to persuade someone to spend a couple of million pounds on research whose methodology they reject, to reassure them they're not daft and it does work really. They huddle together to raise funds for this vital enterprise and after 3 years, from their vast user base desperate for independent validation, they have raised less money than a primary school raffle on a Tuscan hamlet.And they all believe in father Christmas and the Tooth fairy , and a magic fairy land where a good doctor tries his magic on the next 50 people he sees, and they all improve, by on average 20 updrs points in 3 months and stay that way forever, although outside never never land, cos they haven't got the magic fairy dust, nobody can get anywhere close to those results (apart from Gio, who no longer has any symptoms of parkinson's disease at all). Sad😞
WTP, Out of thousands of scientific papers about PD, if just a tiny fraction of their “methodologies “ were correct then we weren’t debating about B1 here and perhaps we weren’t members of this forum in the first place because we didn’t need to. There are hundreds of variables involved. When you say “ They” there are loads of other “They”s that don’t care about the methodology and they want better quality of life and that has been given to them by the help of HDT.
It is sad that HDT doesn’t work for everyone as many other medications including Ldopa.
If enough funds not raised for the HDT research, that doesn’t undermine the huge efficacy of Thiamine.
Ah now "Kia Let's break this down"? You wouldn't understand it as you don't understand the difference between pills and intramuscular injections used in the pilot study of Dr C. You take the data out of context and you already have your story written a priori like a journalist of the "gazette of propaganda"
Of course I do. To finally find out the mechanism of action for this miraculous molecule (B1) on PD that has made life of thousands of people easier and free of pain and to see different potentials of Thiamine.
Who knows if they carry out a research on Thiamine and come up with a new molecule with better outcome. Or at least they will say don’t expect more from Thiamine and be happy with B1 as it is and enjoy the benefits.
See, I think this is the confusion. It reminds me a bit of BREXIT.I asked if you wanted a trial, which was what PB said at the start of this thread, everyone wanted. You have interpreted that as a research programme to discover mechanism of action and possibly develop enhanced molecules.
I don't think PB, Daphne, or team Constantini meant that. Heaven only knows what Gio thinks he wants.
I think PB et all meant a clinical trial to demonstrate efficacy (I think safety is probably a given). I think they wanted product testing, not product development or pure research, to establish that the FDA would licence B1 as a treatment for Parkinson’s disease , on the basis it was shown to be safe, tolerable and effective to the standard required of a new pharmaceutical.
So first we need to clear up what "you" (the B1 trial advocates want)
In my opinion B1 hcl intramuscular should be prescribed by a doctor, the problem was few will do so without a double-blind drug study, rightly. We've discussed it before, but you don't seem to remember it.
IMO To date, the problem is overcome by new research on the bioavailability of b1 in different form than hcl in pills.
The double-blind study was requested by the scientific medical community for validation when this clinical pilot study was presented at the Milan conference on PD that I had previously reported to you. Simple, isn't it?
Yes I agree with a proper clinical trial and like I said eventually assessing its mechanism of action if qualify for that stage and to find out B1 potentials.
So, a trial of efficacy to the same standard as any pharmaceutical. IM injection only as I think Gio is saying?
(nobody is going to investigate the mechanism of action during the clinical trial. For pharmaceuticals that will have been done at the pre-clinical stage.)
Are we testing for any relief for any symptom, PB style, or disease modification? Disease progression? (say like exanatide)
To recap. 2 questions
IM only?
Symptom relief or disease modification?
You can confer with Daphne and PB, and Gio if you can understand him. I think it needs to be just the one hymn sheet you all sing off if you want to be taken seriously
Initial application, on a small scale, of a study protocol, in order to verify if the project is adequate, establish its feasibility or obtain information that allows to determine the size of the final study sample.
1) CLINICAL STUDY:
Strictly controlled and ethically designed experiment, in which the participating subjects are assigned to different intervention modalities simultaneously (in the same time frame), randomly and at the same time supervised simultaneously.
The random distribution is the best method to determine that the groups formed are comparable in all characteristics except the intervention they receive.
The clinical study is the most rigorous epidemiological method for proving hypotheses.
By extension, a clinical study is sometimes defined as any clinical development process for a drug.
The Law on Drugs and the Royal Decree 561/1993 define the clinical study as: any experimental evaluation of a substance or drug, through its administration or application to human beings, aimed at each of the following purposes:
Highlight their own pharmaco-dynamic effects or collect data related to its absorption, metabolism and elimination in the human body;
Establish its effectiveness for a specific therapeutic, prophylactic or diagnostic indication;
Know the profile of his adverse reactions and establish their safety.
An experimental evaluation will always be considered that study in which the subjects are randomly assigned to one or another therapeutic intervention group, or even if the process of habitual medical prescription is directly or indirectly affected.
An experimental evaluation will always be considered that study in which an unauthorized substance is used as a pharmaceutical specialty but also when a pharmaceutical specialty is used in conditions of use other than those authorized.
2) OPEN CLINICAL STUDY:
Confused term, used to indicate that a clinical study does not possess any specific methodological characteristics.
An open clinical study is a clinical study with no control group, as opposed to a controlled clinical study.
It can also be a no-masking clinical study, as opposed to a single-blind or double-blind clinical study.
3) SINGLE BLIND CLINICAL STUDY:
study in which the subject, but not the operator, ignores which of the two possible treatments he receives.
4) DOUBLE BLIND CLINICAL STUDY:
Study in which the subject and the observer ignore the treatment administered.
5) TRIPLE BLIND CLINICAL STUDY:
Study in which the participating subject, the observer investigator and the investigator who analyzes the data ignore the treatment received.
It occurs when the clinical variables examined are mild, that is, they can be interpreted in different ways.
6) CROSSED CLINICAL STUDY:
Clinical study in which each individual receives each of the treatments under study consecutively.
7) CLINICAL STUDY OF n = 1:
Study in which the entire population is limited to one patient and in which the order of administration of the comparative treatments is determined randomly.
15) PILOT STUDY:
Initial application, on a small scale, of a study protocol, in order to verify if the project is adequate, establish its feasibility or obtain information that allows to determine the size of the final study sample.
I said eventually and after a successful clinical trial and if that qualifies then be checked for the mechanism of action.It can be assessed for symptoms relief and/or disease modification and /or slowing down progression.
To choose the way of delivery like oral, intramuscular or sublingual, etc… it’s to the researchers and pharmacologists to decide.
KiaYou don't seem to understand. With everyone wanting a different sort of trial, instead of having one costly trial for which the fund raising has been hopelessly inadequate, you have half a dozen such trials.
If the objective is to "prove it works" by matching the trial requirements of a new drug, or a repurposed drug, then you are going to have to do phase 1,2 & 3 trials. Phase 3 will have to be multicentre double blind placebo controlled over at least 2 years for disease modifying, with probably 300+ trial subjects.
$5 million maybe?
And you are going to have to sort out a standard dose (possibly expressed as units of B1 per kg of body mass.. But you can't do a blind trial which black art adjusts dosage to patient response. Tolerability and safety, in an already unrestricted supplement probably don't need to be demonstrated, but you are going to have to do a phase 2 to determine dosage
WTP,I have a question for you. You wrote a torrent of words against Dr C's pilot study, saying it's impossible to achieve those results. You went so far as to ask forum members to demonstrate, with their experience, that they got the study score, not without belittling it initially.
But how can you discredit Dr C's pilot study when you haven't even read it?
Yes, you haven't even read it, otherwise you would have understood that in the study were used thiamine hcl 100 mg intramuscular injections 2xweek for everyone , while here on the forum they mainly use pills with variable doses and are not in the least comparable experience.
Only when you asked me, who am the only one here who uses thiamina hcl for injections, did you realize this.
What was your answer?
"Ok bye" and you changed the subject of your narrative always to continue to discredit.
bah!
As a self-styled pharmaceutical research expert you are very superficial and do not even read what you criticize.
You don't understand the difference between a pilot study and a forum survey, and explain to Kia how to do a phase 3 study?
You are much more like a propaganda journalist who arrives a version of the story already written by his editor with no respect for the truth and for other people. Among other things, you are quite autobiographical in your judgments, which, as any intelligent person knows, is a frequent risk when judging others.
OK.I don't think there is a clear consensus as to the nature or the objectives of the B1 trial "we all hope for", but it doesn't really matter. It's not going to happen and these groundhog day discussions achieve nothing.
I don't think so. It doesn't apply to aspirin, paracetemol, ibuprofin, loratadine, loperamide or other over the counter medications which are "authorised".
Like all of those medications, its freely available and inexpensive.
Hello park_bear, Regarding vitamin b1. I had searched vitamin b1 parasites before, and there was a study. Perhaps the 47% and 19 or 9 % findings here at this website relate to what was found in a study. "The results revealed that 6% of the control group were biochemically deficient in vitamin B1 compared with a percentage incidence of 42% among the parasitized subjects." pubmed.ncbi.nlm.nih.gov/272...
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The Effect of Curcumin on Idiopathic Parkinson Disease: A Clinical and Skin Biopsy Study
The Effect of Curcumin on Idiopathic Parkinson Disease: A Clinical and Skin Biopsy Study
