USA: National Institutes of Health (NIH) intramural ME/CFS study

[Sid]

If you follow the forums, every now and then you will have people who share their daily symptoms or their most worrisome symptoms. Shaking and fine motor skills is not typically ME. I question whether seizures is part of ME. I am not doctor but I do not think so. Someone mentioned one sided numbness, which is not typical of ME.

I didn't say those symptoms are part of ME. I was questioning the notion that someone couldn't have epilepsy AND ME. If someone has had ME for 30 years and they develop Parkinson's disease later on, I think we need to be careful not to attribute all their symptoms to this "real disease" that's now been identified.

 

[Sean]

Having ME does not make one immune to getting other diseases, and vice-versa.

 

[Mithriel]

Shaking and fine motor skills is not typically ME. I question whether seizures is part of ME. I am not doctor but I do not think so. Someone mentioned one sided numbness, which is not typical of ME.

These things are actually quite common in ME. The neurological symptoms were sidelined when CFS was invented but intention tremor and difficulty using hands were not unusual in my local ME group in the 80s.

I had absence seizures during my teenage years and read that it was nt uncommon in teenagers in an ME publication when I was finally diagnosed.

Temporary and one sided paralysis are found too. It is like vision problems now being found because someone has finally looked.

As for PEM, I have never heard of another illness where walking causes swollen lymph glands.

 

[DokaGirl]

I have hypothyroidism and ME.

The hypothyroidism preceded ME by over a decade.

Not that I qualify for the 5 year limit, but I would likely be excluded from the study re the hypothyroidism.

(It would be interesting to see what percentage of people with ME have hypothyroidism.)


The neurological signs - invisible tremors - yes; poor fine motor control - yes ("Zip-loc" bags are very difficult to open and close) vision problems - yes; and the ground comes up abruptly to meet my left foot, especially when I'm more tired (foot drop?)

 

[DokaGirl]

The misdiagnoses, and hence about 30 percent weeded out in the first week, re-emphasizes lack of medical training for one thing. Another is the poor medical care for these people who may have gone the full five years with something more readily treatable. Appalling, but not surprising any more.

 

[wigglethemouse]

Another interesting aspect - all of the 19 participants had a clear doctor documented infectious trigger, a requirement for entering the study. And 6 of the 19 turn out to have a rare disease found. Food for thought

 

[wigglethemouse]

For anyone that is thinking of participating in the study a comment was left on the article from a participant offering to provide advice and providing a few more details. Also, the first "week" is in fact two weeks, with 10 full days of testing.

Sanna
March 23, 2019 at 8:53 pm - Reply

I was the 14th or 15th patient-participant in the first study visit, was adjudicated, and will be returning (as what looks like the 7th patient) for an abbreviated second study visit after the conference. I have to say, I was so surprised and impressed with my experience there. It was very rough, but Dr. Nath and his team (especially Dr. Walitt) made me feel cared for and safe throughout my 14-day stay with them. They did all they could to make me comfortable, while continuing the research protocol. It is a medical experience like no other.

I am endlessly thankful to Dr. Nath and his team for doing this research. I am confident that there will be findings from this research that will move us forward, and I am looking forward to find out what they will share with us during the conference and once the study is complete.

I am also always glad to answer anybody’s questions from a patient-participant’s perspective.

Sanna
March 23, 2019 at 9:00 pm - Reply

@Tina: It was not just ‘one’ rare disorder but different issues they found that had not been identified prior by other doctors that were identified as likely being responsible for the symptoms of some patients. (Based on my conversations with the team while participating in the study.)

Sanna
March 24, 2019 at 12:18 am - Reply

From a study participant: the first week actually was 10 full days of testing, and I was admitted for 14 days total (the article said one week). The second study visit is supposed to be even slightly longer. So, all together both studies would mean being admitted to the Clinical Center for about 4 weeks total.

Sanna
March 24, 2019 at 4:30 am - Reply

Cort, I’m happy to share anything anyone is interested in. However, unfortunately my PEM state would not allow me to stay in the metabolic chamber on my own, and I would likely be crashed from the testing before the CPET, so I am only doing a very abbreviated second study visit.

 

[Alvin]

He mentions one patient having Parkinson's. Its symptoms and presentation are completely different. Don't see why that would preclude someone from having ME or how it could account for ME symptoms. He also mentions head injuries with LOC and strokes. Again, the head injury could just be the precipitating event that triggered ME. People with stroke don't have our symptoms. So what if that one person had major depression? Why can't a person with ME or any other condition develop depression? Having one illness doesn't immunise you from getting others. I am very skeptical about this research project and any project led by randomly assembled grifters working for govt $ who don't have a background in this. Perhaps there is something useful to be gleaned from whittling down the cohort to those who have no other comorbidities. But then again out here in the real world comorbidities are the rule not the exception.

Hi Sid, I agree with most of what you say except I do not share your skepticism. I think it is important for all patients to be appropriately assessed and investigated.

I agree with both of you comorbidity is not uncommon. But being a waste basket diagnosis is a real problem, without a biomarker we will have people misdiagnosed as having ME. For study purposes they would want only ME but if they dismissed people who had ME plus something else then those patients are going to suffer needlessly with more then one disease and i doubt NIH is following up with those people they may have misled

If you follow the forums, every now and then you will have people who share their daily symptoms or their most worrisome symptoms. Shaking and fine motor skills is not typically ME. I question whether seizures is part of ME. I am not doctor but I do not think so. Someone mentioned one sided numbness, which is not typical of ME.

I have motor control issues but i do not have Parkinsons, i was thoroughly tested for it and still see a world class Parkinsons neurologist annually since thats who diagnosed my ME and i was advised to maintain a paper trail forever.
I used to get what i called exhaustion spells where i looked like i was having seizures for 10-60 minutes, i think from going beyond PEM threshold and forcing myself to keep going. Also my motor control is still taxing today and i have times of difficult motor control still and i freeze though its a brain function freeze not the motor freeze Parkinson patients get even if it looks the same to an observer.
Though i could try some Levodopa
I have bottles of it kicking around, i have to dispose of the unused ones regularly for a relative who has Parkinsons which i never get around to.

We are gathered here because we have received a ME diagnosis or because we suspect we have the disease. Many have received very very poor care, and many have given up seeing doctors because of the trauma and hostility they have encountered in health care. This diagnosis relies on symptomatology and disease presentation. This is a problem. We are in desperate need of biomarkers and diagnostics tests.

Amen

 

[Wonko]

We really do sound very similar in some respects, although from the sounds of it you've had much more testing and possibly treatment options than I was offered.

 

[Alvin]

We really do sound very similar in some respects

Indeed

although from the sounds of it you've had much more testing and possibly treatment options than I was offered.

I'm so sorry to hear this

The testing took herculean pressure on my part over several decades with more then a little bit of luck. More then a few doctors hate my guts because i would not listen to them and refuted their shoehorning with simple logic. Its the easiest way to make enemies in the medical profession...
The second easiest is when their treatments don't work

Ironically the skills i learned at navigating our medical system is whats needed by so many today, even in mainstream diseases there are so many specialists who are average or worse that to get excellent care you need to barrel through doctors.

 

[DokaGirl]

I'm unclear on what case definition the trial applicants have been assessed under before they get to the NIH.

Not the CCC when they see the NIH researchers, but what have their doctors at home used?

Or is that not stipulated for the trial?

Maybe their GPs could use whatever case definition, and then the NIH uses the CCC to see if these trial applicants fit?

If their doctors are using more vague definitions, that could explain the large number misdiagnosed.

Which is educational in itself for the NIH researchers, the patients and their GPs.



Re the almost 30% misdiagnoses for the participants in the trial, this digs an even deeper hole for very vague definitions like the Oxford criteria.

 

[Alvin]

Re the almost 30% misdiagnoses for the participants in the trial, this digs an even deeper hole for very vague definitions like the Oxford criteria.

I consider Oxford and Fukuda dead. The only reason they still come up is that they are wrong so can be used for obfuscating malfeasance.

 

[dreampop]

This is very intersting, and it must be somethign Nath addresses, imo, before the study has concluded. Because that could honestly be 5 years from now.

It is of immediate need and value to know rare diseases that commonly present as ME/CFS and - I'm assuming - disclosing this information won't negate any objective findings on ME/CFS from the inhouse study. We shouldn't be waiting on that.


There are a few other considerations about his comments.

The first consideration is that most people probably haven't had good work-ups. Head to toe in specialities. So, that is one reason to not be surprised at this finding.

The second consideration is that something that disqualifies you from the study may not in fact disqualify you from having ME/CFS, but when performing a study are confounding and so must be removed.

A simple thought experiment of this is you may have Crohn's and ME/CFS, upon enlisting in this study, you discover the Crohn's. Does that condition disqualify you from the study? What if it is treated and you still have highly unusual ME/CFS symptoms?

The same may be true of rare diseases and neurologic symptoms. So, if 50% of the patients are rejected from the study, it may not be true that 50% of the patients don't have ME/CFS.

Nath has been clear he wants as isolated ME/CFS as possible. OFC he may rule out interesting things and a lot of legit ME/CFS and not rule out perhaps sub 1 year self limiting post viral fatigue. That is where a little trust comes to them (trust they have not afforded with the BPS staffers).

One final thing. There was a comment from some HR content, be it the article or comment section, wish I could find it right now, where someone who saw Nath years before when he was at Hopkins. This person had ME/CFS but wanted answers. Apparently, Nath diagnosed them with something the patient and the patient's neurologist thought didn't fit the symptoms at all. Nath's conclusion was it wasn't me/cfs but this other neurologist thing. But the patient and the patient's doctor disagreed. So, things may be even more complicated than they look.

Again, most important thing I think is for the NIH to release all the infortmation available as early as possible

 

[Patient4Life]

It seems PEM is a very wooly thing.

PEM is not unique to ME.

This would mean PEM is not unique to ME after all, and CCC is not that good at identifying ME.

If PEM is not unique to ME or ME/CFS, it can still only worsen the symptoms-set unique to a disease.

So, unless other diseases also have all the following: unrefreshing sleep, cognitive dysfunction, orthostatic intolerance and others listed under the SEID and CCC criteria, it would be pretty hard for someone with another disease to get to a diagnosis with those criteria.

Do EDS, MS, Lupus, etc. have those same symptoms listed under SEID and CCC? I don't think so. Do they have PEM? Perhaps. EDS is said to have PEM but it will not worsen symptoms EDS patients don't even have and I am not certain EDS has even the core symptoms of SEID. Dr. Davis now believe an MS type (relapsing/remitting?) also have ME/CFS. Lupus does not have the same symptom set listed under SEID or CCC criteria. And, EDS patients have had LIFELONG fatigue. CCC and SEID state the fatigue must be new.

I think people had been misdiagnosed as having ME/CFS by a doctor using Fukuda or they diagnosed themselves, perhaps a doctor saying they had Chronic Fatigue and the patient thinking they have Chronic Fatigue Syndrome.

 

[Patient4Life]

Maybe their GPs could use whatever case definition, and then the NIH uses the CCC to see if these trial applicants fit?

If their doctors are using more vague definitions, that could explain the large number misdiagnosed.

I think this is what happened.

 

[wigglethemouse]

So, unless other diseases also have all the following: unrefreshing sleep, cognitive dysfunction, orthostatic intolerance and others listed under the SEID and CCC criteria, it would be pretty hard for someone with another disease to get to a diagnosis with those criteria.

I wondered the same thing but the more I look the more I see parallels in other diseases. Myasthenia Gravis for example (or Congenital Myasthenic Syndromes - the genetic version of MG in simple terms).
Hall mark is muscle weakness after exertion. Studies have shown
Orthostatic intolerance
Sleep Disturbance
Cognitive Dysfunction

For those with paralysis or seizures I often wonder about MELAS

I'm not trying to argue, just point out similarities I have seen in a few other diseases. I've no idea how one would get tested for the diseases I've mentioned. CMS requires genetic testing for example. Many people diagnosed with MG have seronegative testing for acetylcholine antibodies, so even if you get testing for MG the doc may say, nope, test is negative.

Again, most important thing I think is for the NIH to release all the infortmation available as early as possible

I too agree this is very important. I'm hoping as well, somehow, that the ME/CFS doctors coalition will look at this area and publish case reports as they continue to grow so that knowledge of other diseases to test for that may mimic ME/CFS is well documented, so others may benefit.

 

[Patient4Life]

Myasthenia Gravis for example

But, I don't see anything about OI, Sleep disturbance, or cognitive dysfunction worsening after exertion, in MG especially 24-72 hours later. Just because you might have a symptom that gets worse after exertion in a disease does not mean that all your symptoms get worse especially days later.

Also, I don't see chronic fatigue or fatigue in MG, just muscle weakness and muscle fatigue.

 

[Forbin]

Quite a few people with autoimmune disorders have shown up during the filtering out process. Nath suggested that could be an interesting cohort to study on its own.

Now that I look at it again, it is not completely clear that they are screening out everyone with an autoimmune disorder, but they might be. I wonder how stringent they are in this regard. For instance, scalp psoriasis is no doubt autoimmune in nature, but it can be relatively mild in some cases, and, of course, limited to the scalp.

 

[obeat]

I'm unclear on what case definition the trial applicants have been assessed under before they get to the NIH.

Not the CCC when they see the NIH researchers, but what have their doctors at home used?

Or is that not stipulated for the trial?

Maybe their GPs could use whatever case definition, and then the NIH uses the CCC to see if these trial applicants fit?

If their doctors are using more vague definitions, that could explain the large number misdiagnosed.

Which is educational in itself for the NIH researchers, the patients and their GPs.



Re the almost 30% misdiagnoses for the participants in the trial, this digs an even deeper hole for very vague definitions like the Oxford criteria.

@Keela Too @adambeyoncelowe Are you aware of this thread? 30% misdiagnosis rate is important information for NICE.

 

[Milo]

Re:using vague definition, 99.9% of the doctors diagnosing are not able to explain what different definitions there are for ME and CFS.