If you are in Rochester, MN., Long Island, NY, or Boston, go sign up and make them aware of how extensive this disease has spread.
Posted by David95928 (Member # 3521) on :
It seems to me that this should be viewed with suspicion and skepticism.
The inclusion criteria would seem to limit it to chronic lymies with persitent arthritis. Given the wide range of symptoms, I suspect these folks are actually in a minority and not representative of the clinical population.
If, by some miracle, one meets their criteria for illness, the treatment offered is Rocephin. No mention of how long or how much. In my opinion, Rocephin alone rarely gives chronic lymies stable remissions.
So, by participating, we run the risk of playing into the games that NIH plays with the Steerites and if treated at all it will be ineffectively. Forget it.
Posted by Aniek (Member # 5374) on :
The inclusion criteria does not limit to people with Lyme arthritis. There is a Lyme Arthritis Control group, which is seperate from a group of people who are suspected or diagnosed with either Chronic Lyme or Post Lyme.
The study probably wants to compare patients with and without the arthritis symptoms.
Not all NIH funded studies are bad. The Columbia study we are all waiting on from Dr. F is funded by the NIH.
Posted by ldfighter (Member # 9405) on :
I had a different concern - that like the Klempner and Krupp studies, they're taking people with ANY persistent signs or symptoms without specifying which ones, or specifying how severe the symptoms have to be. Can the symptoms be mild? How mild?
AND - then they're excluding anyone with "serious pre-existing or concurrent chronic medical or psychiatric illnesses other than Lyme disease".
Problem is that these "concurrent illnesses" may reflect chronic Lyme infection, such as a patient with depression or ocd due to Lyme encephalopathy. Would that patient be excluded from the study? If so, that would skew the results away from finding abnormalities - because the most encephalopathic patients will be excluded.
Looks to me like they're creating a patient sample that gets rid of the most severely ill patients (and includes patients with even one mild ongoing symptom, if I'm reading this right), then "looking" for neuropsych, immunologic and other abnormalities which they'll be less likely to find.
It's silly to do neuropsych testing across the board on anyone who tests positive for Lyme and has ANY symptoms at all - and the NIH must know this. Fallon knows this, and that's why he restricted his study population to those with cognitive symptoms.
(This was one of the major criticisms of the Krupp study which found no cognitive benefit to IV abx. The study patients had only mild cognitive deficits to begin with, so you wouldn't expect them to improve that much. The study did find benefits from abx in terms of fatigue, which is how the patients were selected. But guess which of these two findings got the most attention?)
What makes Lyme so hard to research this way is that it does so many different things to the body, not to mention all the different strains. Lumping everyone together into a heterogenous group, and then excluding anyone with something that could be diagnosed as another medical or psychiatric illness - to me this looks like a way of trying to minimize abnormalities at the group level.
Instead of their CLD vs. chronic lyme arthritis populations, why not compare chronic lyme encephalopathy, chronic lyme arthritis, chronic lyme neuropathy, etc. as distinct groups? They want to say it's all just "the aches and pains of daily living" as it says in the guidelines. Just a guess.
Posted by ldfighter (Member # 9405) on :
Also curious that they're doing MRI but not SPECT scans, which are more often abnormal in chronic lyme.
Posted by Aniek (Member # 5374) on :
I think criticism should wait until we know who is actually doing the study. The NIH is probably just providing the funds. It could be an ILADS member, or it could be a Wormie.
Designing studies are so difficult, and we don't know what it is they are really trying to get at. If they didn't exclude people with symptoms that could be from other illnesses, then the results would be criticized for being non-Lymies.
Plus, abx clearly won't work if they do have another condition causing the symptoms. So it would hurt us if they included people who had Lyme and non-Lyme related Parkinsons, because how would the researchers judge what symptoms are from what.