Apparently Dr. F (who's on our side, I thought) published a report on October 10th, 2007 indicating that IV ABX was NOT effective against Lyme Disease.
The details are: Fallon BA, Keilp JG, Corbera KM, et al. A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy. Neurology. 2007 Oct 10; [Epub ahead of print].
Still working on insurance appeal and wondering if anyone has any information to combat this. Thanks for any help.
Cathy
Posted by Keebler (Member # 12673) on :
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The research team says short term IV of a single drug is not enough. Nothing new there. LLMDs have said that for years.
But it had to be shown in some fancy study so that they can go on now to more complex studies.
Sad, but true, that research comes with many constraints.
In the eyes of most doctors, 10 weeks is long-term. In the eyes of borrelia researchers, 10 weeks is a minor irritation for the spirochetes.
And, heaven help them if they were to have considered the cyst form of lyme and actually treated that, too.
Combination - rotation - treatment for longer courses have been what the LLMDs have said all along.
Also, note that coinfections were not considered here. Or, gasp, liver protection or probiotics.
I don't think the funding was available for the best research project(s).
It had to be short course of a single drug (because that is apparently all the powers that be can wrap their heads around) or nothing at all, most likely.
Bottom line for the study: " . . .Treatment strategies that result in sustained cognitive improvement are needed."
But here's how I see the the REAL bottom line: Research studies simply will never be logical - or complex - enough to consider complete treatment of the tick-borne disease mix.
And, the REAL bottom line, in practical terms, is that this study will be used by less than educated doctors and insurance companies to deny treatment that, if combined, rotated, or used long enough for particular patients, could changes lives for the better.
Most regular doctors and the IDSA will not even consider anything about this beyond the headline. And that is very sad.
A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy B. A. Fallon MD*, J. G. Keilp PhD, K. M. Corbera MD, E. Petkova PhD, C. B. Britton MD, E. Dwyer MD, I. Slavov PhD, J. Cheng MD, PhD, J. Dobkin MD, D. R. Nelson PhD, and H. A Sackeim PhD
. . .
Excerpts:
Background: Optimal treatment remains uncertain for patients with cognitive impairment that persists or returns after standard IV antibiotic therapy for Lyme disease.
Methods: Patients had well-documented Lyme disease, with at least 3 weeks of prior IV antibiotics, current positive IgG Western blot, and objective memory impairment.
Healthy individuals served as controls for practice effects. Patients were randomly assigned to 10 weeks of double-masked treatment with IV ceftriaxone or IV placebo and then no antibiotic therapy.
The primary outcome was neurocognitive performance at week 12--specifically, memory. Durability of benefit was evaluated at week 24.
Group differences were estimated according to longitudinal mixed-effects models.
Results: After screening 3368 patients and 305 volunteers, 37 patients and 20 healthy individuals enrolled.
Enrolled patients had mild to moderate cognitive impairment and marked levels of fatigue, pain, and impaired physical functioning.
Across six cognitive domains, a significant treatment-by-time interaction favored the antibiotic-treated group at week 12.
The improvement was generalized (not specific to domain) and moderate in magnitude, but it was not sustained to week 24.
On secondary outcome, patients with more severe fatigue, pain, and impaired physical functioning who received antibiotics were improved at week 12, and this was sustained to week 24 for pain and physical functioning.
Adverse events from either the study medication or the PICC line were noted among 6 of 23 (26.1%) patients given IV ceftriaxone and among 1 of 14 (7.1%) patients given IV placebo; these resolved without permanent injury.
Conclusion: IV ceftriaxone therapy results in short-term cognitive improvement for patients with posttreatment Lyme encephalopathy, but relapse in cognition occurs after the antibiotic is discontinued.
Treatment strategies that result in sustained cognitive improvement are needed.
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Posted by TerryK (Member # 8552) on :
Good info Keebler.
I think Dr. F. is supposed to be impartial. Not on anyone's side. This would give him credibility with both sides.
Terry
Posted by Keebler (Member # 12673) on :
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Oh, yes. Dr. F is impartial. I did not mean to say he is not.
If that comes across that way, please let me know what and I will change my words. I am pretty foggy and not sure if my words come out right.
I did not mean to criticize the research team but express sadness that a more complex study was not able to be funded.
It's just that the way studies are designed have to be so simple. Had they been able to do a 6-month study, that might have really shown more.
What this study says is that better treatment methods are needed. True.
But, I sure wish the collected experiences of the LLMDs would count for something. Devising just the right research study may actually be impossible as combination and rotation is a vital key to success and lyme is never just lyme - it's many forms.
And I thank Dr. F and the entire team for their work on this. Mostly, I thank the patients who had to settle for treatment that most LLMDs already knew would not be enough.
But, now they have the research project that says so. Someone has to do the studies.
I only hope that those who FUND the studies will look at the big picture.
[edited to add: and that bigger picture would also include the importance of complementary support measures - and maybe even looking totally outside of the box to treatment such as with the Bionic 880 as its being used in Germany.]
`` . . . the immune system does not begin to repair itself until the beginning of the fourth month of antibiotic treatment. . . . ``
- Full 2-page article at link above
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[ 08. September 2008, 05:13 PM: Message edited by: Keebler ]
Posted by TerryK (Member # 8552) on :
I was responding to this:
"Apparently Dr. F (who's on our side, I thought)"
I think it is a common thought and I understand why but I've read things that indicate that he is supposed to be an impartial researcher and that is what we want so we can find out the truth.
Nothing wrong with what anyone said here in my view.
You made some very good points Keebler.
Terry
Posted by TerryK (Member # 8552) on :
Cathy wrote: Still working on insurance appeal and wondering if anyone has any information to combat this.
Someone posted this recently but unfortunately I can't find the thread. I re-posting the page in case you haven't seen it. Public Law 107-116
Look for the sample letter to the insurance company.
Terry
Posted by TerryK (Member # 8552) on :
I don't want to divert the post subject but quickly, I think the best way to find out if you might have lyme disease is for you to be evaluated by a top notch LLMD (Lyme Literate Medical Doctor).
I don't think Dr. F. is an LLMD but I could be wrong.
If you don't have one, go to the seeking doctors section of this site and put your location in the subject line. Hopefully someone can help you find someone who can meet your needs.
Terry
[ 12. September 2008, 05:35 PM: Message edited by: Jenifer ]
Posted by bettyg (Member # 6147) on :
cathy,
do you have a WRITTEN DENIAL LETTER? if yes, please email me at home; i have an idea for you. thanks! Posted by tdtid (Member # 10276) on :
Thanks for all the information here.
Betty their Denial was about 21 pages worth. That's a lot of pages to type into an email by hand.
AFter they denialed, my husband requested all grounds on what they denied my case on as well as the doctor who was overseeing this case. Obviously an IDSA that was hard core by their rules.
My husband has rebuttals for most of it, but got stuck on how to respond about this Dr. F situation since I guess we have to dispute each one of the reasons they are denying.
Just need solid facts on how to take their Dr. F study and put a positive spin on it in OUR favor.
Cathy
Posted by bettyg (Member # 6147) on :
cathy, be sure to read the pm i just sent you about the above ok! Posted by tdtid (Member # 10276) on :
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