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» LymeNet Flash » Questions and Discussion » Medical Questions » Drum roll please ^^^^^^ IT's ANNOUNCED!!! (Page 3)

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Author Topic: Drum roll please ^^^^^^ IT's ANNOUNCED!!!
Skyler
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Oh thank god! [woohoo]

Finally a win for the Lymies! Thank god.

Funny that this week the new england medical journal released something much different.

Thank god we got this though!!!

oh and canbrave, I am in the same situation. I have an apt with my LLMD at 9 am...hmm

--------------------
I'm probably sleeping...

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Tincup
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I see happy faces!! That's great!

[lol]

Good news, eh?

BUT..

someone asked..

"Does anyone know whether this mean that I shouldn't show this to my neurologist (1st appointment; non-LLMD) when I see him at 9AM tomorrow?"

Let me tell you something. Oops!

I got this info just as another bad storm was rolling through and was so anxious to get it to you... as you all have waited LONG enough.. and truth is I didn't have time to even READ it myself cause I had to post it quickly and shut down the computer to avoid the power surges and lightening... which DID occur so I am glad I posted and ran!

Sooooooooooooooooooooo...

Guess who just got fussed at for sending it out too soon?

Yeah.

Soooooooooooooooooooooo.. since I am already in the dog house... I'd say go ahead and give your good news to your LLMD tomorrow. I'll have to take the heat on it.. but the news is too fantastic NOT to share.

And you are right. Punishing me as a kid was tough. If I KNEW I was gonna be in trouble for something... I figured why not go ahead and be in more trouble and get it over with while I had a chance.

HA!

But I am glad you all like the news. More info about it later.

Sleep well.. the sweetness of this report should be enough to make us all have nice dreams.

[Big Grin]

--------------------
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Dawn in VA
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Tincup, you are friggin AWESOME!

May your cup always runneth over.

Dawn

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(The ole disclaimer: I'm not a doctor.)

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bettyg
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tincup posted in OFFICIAL GOOD NEWS that the are going to work on something for US LYMMIES TO PUBLICIZE this to the media, etc. since no onne is hired to do that sort of thing.


personally, i'd make a copy of his official statements and have there with me.


i'd give one to LLMD;
///////////////////

NOT to non-llmd


UNLESS TINCUP LETS YOU KNOW DIFFERENT OK!

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breathwork
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Tincup...

Asking for forgiveness is often easier than asking for permission...and in this case, I think you'll be forgiven...Your rep precedes you....

Thank you...

Carol Ann

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LocalMan
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Does anyone know if there is any comparable study in the works re: use of oral antibiotics?

And, I hate to ask this, but...did all the patients relapse once off the IV, or did any have lasting success?

I know this is VERY important from the medical case-building perspective, I just find it discouraging from the individual-with-lyme perspective.

LM

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Geneal
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Dear TinCup,

I'll gladly post your bond to get you out of the doghouse. [Big Grin]

You did much better at holding it in than I ever would.

If it is a good suprise I just can't hold it in.
[Smile]

So....what is bail?

I can get my hands on some chocolate from Germany (absolutely sinful [lick] ).

Hugs,

Geneal

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canbravelyme
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Thank you TC [bow]

It's actually a non-LLMD. I'll keep it to myself unless I actually think it will produce results with my treatment for seizures. IOW, most likely: kept to myself.

xoxoxox [kiss]

CBL.

--------------------
For medical advice related to Lyme disease, please see an ILADS physician.

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roro
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wow, this is great news!!! Didn't the columbia university research just start this year? how can this be "years in the making"

I was told many LLMD's didn't want to do studies because then they would have to have a placebo group, and they didn't feel comfortable giving someone a placebo if they were very sick and needed medicine.

localman - I think that if someone is kept on oral after they finish the IV they probably won't relapse. even if they just stay on low-dose of doxy. i know a guy been on 100mg doxy twice a day for three years now and he never relapsed. he said he will probably be on it the rest of his life. and he had such bad heart damage, he had to be on IV and has a pacemaker now.

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Truthfinder
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Wow, this is great news, and talk about perfect timing in view of the other junk being published....

I hope somebody makes sure AG Blumenthal has a copy of this sitting on his desk at the earliest possible moment.....? [Smile]

Tracy

--------------------
Tracy
.... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time � just take a few moments to say a prayer wherever you are�.

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tdtid
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Outstanding News!!!!! Finally clinical trials to support what we've always known, that abx really work for lyme.

One question: In the article is the following paragraph ``These findings replicate results from a prior placebo-controlled trial of post-Lyme fatigue, which found positive treatment results from repeated antibiotic therapy."

The question is, what is this other study? IDSA is constantly quoted as saying there is no clinical data to support long term abx use is effective for lyme disease, yet this quote suggests there has been data.

Certainly this NEW clinical study will get wide spread attention, particularly based on the increasing lyme awareness, but has there been evidence to support abx's effectiveness against lyme prior to this?

Thanks again, TC!!!!

Cathy

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"To Dream The Impossible Dream" Man of La Mancha

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CaliforniaLyme
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They need to have a Press Release about this sent to all the places that did articles re NEJM-

Good for Fallon-
hope it gets write-ups somewhere- !!!

--------------------
There is no wealth but life.
-John Ruskin

All truth goes through 3 stages: first it is ridiculed: then it is violently opposed: finally it is accepted as self evident. - Schopenhauer

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Aniek
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Tsk tsk TC! Breaking the rules like that!

I was very excited to receive the press releaes via email this morning. This is truly wonderful news.

I'm looking forward to reading the paper and being able to counter the evil study in my article that I promise to edit and try to publish before next summer.

--------------------
"When there is pain, there are no words." - Toni Morrison

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ldfighter
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quote:
Originally posted by tdtid:
One question: In the article is the following paragraph ``These findings replicate results from a prior placebo-controlled trial of post-Lyme fatigue, which found positive treatment results from repeated antibiotic therapy."

The question is, what is this other study? IDSA is constantly quoted as saying there is no clinical data to support long term abx use is effective for lyme disease, yet this quote suggests there has been data.

It's the Krupp study ("STOP-LD"), I think it was also published in Neurology. 4 weeks of repeat IV for patients who had severe fatigue after lyme. They found statistically significant improvement in fatigue (not cognitive symptoms, but the patients didn't have significant cognitive symptoms to begin with), then the authors said don't use IV because fatigue is a "nonspecific symptom" and it's too risky.

The IDSA distorted the actual findings by saying there's no evidence abx helped. ???? The kind of stuff we can't let them get away with.

So there are now 3 NIH-funded controlled clinical trials: Klempner, Krupp and Fallon. If you just look at whether or not abx helped people vs. placebo, 2/3 of the studies say YES!!

I'm glad Fallon has the guts to take them on. Can't imagine what he's been through to get this work published.

[bow] [bow] [bow]

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Ann-OH
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What happened?
It doesn't show up in the table of contents of the Oct. 9, 2007 issue.
http://www.neurology.org/current.shtml#ARTICLES

Do I have the right journal???

Ann - OH

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Michelle M
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Holy MOTHER!!!

GO, Dr. Fallon!!

And his study was so rigorous and so tightly controlled that even the freakin IDSA couldn't argue with it --- unlike THEIR slipshod studies and suspect conclusions. For which I grovel with gratitude!!!

Michelle

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lymednva
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Ann-OH, it's embargoed until this afternoon. That means it is released to the press, but is not to be published/announced until 4 PM. That's why you can't find it yet.

My ex was a journalist, so I'm privy to the lingo! [Big Grin]

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Lymednva

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5dana8
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Thanks Tincup for posting this great news [kiss]

[woohoo] [woohoo] [woohoo] [woohoo]

yeah!!!!!!!!!!! [Smile]

I always knew from personal experience that IV abx helped me alot.

Now I hope he does a study that shows orals will help KEEP a person in remmission that the IV's brought. Because in the study the gains where lost after stopping the IV treatment...Did I read that right?

Hope I am making any sense at all.

--------------------
5dana8

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Ann-OH
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Thanks, Lymednva. I know about embargoed press releases and understand that the press release is not allowed to be published until 4:00 today.

I was talking about the publication of the study in the journal, Neurology. This is what the press release says:

[quote]
The study, titled ``A Randomized, Placebo-Controlled Trial of Repeated IV Antibiotic Therapy for Lyme Encephalopathy,'' will be published on-line by the journal Neurology on Oct. 10, 2007. [end quote]

If you go to the website for Neurology, you will find that the current issue was published yesterday - October 9th, and there is no reference to the study.

That is what I found confusing.

Ann - OH

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Melanie Reber
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This has been a LONG time coming! Zippity-do-dah!

(BTW...what do I win?) [Smile]

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Mo
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aaaah, now we're cookin' with gas.

..at the very least, at this point, the guidelines seem medically biased and baseless at best.

(they do also by their small and skewed research pool)

this greatly reinforces your basic freedom to choose your medical care, and that there are clearly two standards of care.

i'm hoping the attorney general will uncover critical info in his investigation regarding IDSA guidelines for treatment, it's authors, and anti-trust issues.

mo [Cool]

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BorreliaBrain
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Yay! I guessed it, i guessed it... maybe I'll break down and have just a *little* ice cream...

But I am also confused by why it's not showing up in the table of contents for the Oct. 9th edition of "Neurology". It really should be there, press blackout or not.

Is it going to be published online first, and in print only in the next edition of "Neurology?" Anybody know?

A

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Tincup
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AH! More happy faces!!!

I LOVE IT!

[woohoo]

As for any more info on what is what.. or why it is so.. or not...

Ya don't think they are going to tell old blabber mouth anything else here, do ya?

HA!

And thanks for the offer for bail money to get me out of the dog house. And for the offer of chocolate.

But do note.. I had NOTHING to do with this study... I couldn't even be in it.

I'm just bringing the good news to folks who REALLY deserve to have some. And YES.. I almost BUSTED at the seams trying to keep my big mouth shut.

[Big Grin]

Oh.. and I DO believe Melanie wins the prize for guessing right first off the bat.

Yippee to Melanie!!! But I guess SHE gets the chocolate?

[Big Grin]

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Beverly
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WTG Tincup!!! yay!!!
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Tincup
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Well, looky here...

http://www.neurology.org/papbyrecent.shtml

[Big Grin]

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kelmo
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Dang, to see it, you gotta pay up.
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Melanie Reber
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It looks as though one must have a subscription to get the whole thing. Can anyone help us here?
..........................................


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

From the Department of Psychiatry (B.A.F., J.G.K., K.M.C., E.P., I.S., J.C., H.A.S.), Department of Biostatistics (E.P.), Department of Neurology (C.B.B.), Department of Medicine (E.D., J.D.), and New York State Psychiatric Institute (B.A.F., J.G.K., K.M.C., E.P., I.S., J.C., H.A.S.), Columbia University, New York; and Department of Cell and Molecular Biology, University of Rhode Island, Kingston (D.R.N.).

* To whom correspondence should be addressed. E-mail: [email protected].

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.

http://tinyurl.com/2ftf3h

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nan
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Wonder what the Halperin article says!?

http://www.neurology.org/papbyrecent.shtml

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nan

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Ann-OH
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Okay! This solves my questions. It is a weekly, which they publish on Tuesday and then publish
"E-publish" ahead of print on Thursday. When does this come out on paper???

Melanie, Thank you for the abstract!

Now for Halperin. How do we get that piece of inspiration?

Ann - OH

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Melanie Reber
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Hi Ann,

I thought that what was provided on page 3 was a press release ABOUT the study, and not necessarily THE study itself.

Am I mistaken? (It wouldn't be the first time) [Smile]

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Tincup
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"Now for Halperin. How do we get that piece of inspiration?"

I have a copy down at the outhouse... but it is being used right now for the only thing it was meant for.

[Big Grin]

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nan
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I think you are correct, Melanie. What we have seen is an Abstract.

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nan

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Melanie Reber
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Hahaha...OK, I was answering a comment on Ann's post above mine...but now it looks like her post was changed???

(either that or I am really loosing it!) [Smile]

No need to comment on that, TC!

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BorreliaBrain
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Uh oh uh oh, what is a Halperin article doing in the same edition????? What's going on?

Is the esteemed journal trying to hedge its bets by publishing a pro and con at the same time? What's going on here?

Can anyone get a copy of this latest piece of pure inspiration from the esteemed *Dr.* Halperin? I gotta see it...

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Ann-OH
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Yep, Melanie, I saw my error and repaired it. Don't know what I was thinking.

Ann - OH

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AliG
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[bow] [bow] ALL HAIL TINCUP!!!! [kiss]

You can't imagine how much I needed this news! (OK, maybe you can [Big Grin] )

It was even worth dragging my very, very sorry butt back and forth to my computer for a few days. [Roll Eyes] [Big Grin]

Also, my compliments on that magnificently worded press release. [Wink]

I must say, Tincup ******YOU ROCK!!!!!****** [Big Grin]

Thank you SO much!!!!!!

(great big(no)) H U G E hugs,
Ali

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Note: I'm NOT a medical professional. The information I share is from my own personal research and experience. Please do not construe anything I share as medical advice, which should only be obtained from a licensed medical practitioner.

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5dana8
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Kelmo [Smile]

I don't think you have to pay ~ First click on Tinne's link on page 4 "Well Looky here".

Then scroll down to where Dr. F's study is & click( check the left hand box next to it) or any other study you want to view

Then scroll back up & click on the box that says Get "All Checked Abstracts Box" Thats should get you in.

Unless you where referring to the Halperin Study...Seems to be the only study or article that can not be viewed. Hummm.....kinda strange

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5dana8

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5dana8
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sorry, double post [bonk]

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5dana8

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nan
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http://neurology.jwatch.org:80/cgi/content/full/2007/1002/1?q=etoc_jwid

http://tinyurl.com/2yrt5h

AAN Practice Parameter: Antimicrobial Therapy of Neuroborreliosis Experts provide evidence-based recommendations for the treatment of Lyme disease and discuss the evidence against persistent infection in "post-Lyme syndrome."

Ongoing controversy surrounds the choice of antibiotic for the treatment of neurologic Lyme disease, the appropriate duration of treatment, and whether or not chronic symptoms of "post-Lyme syndrome" are due to persistent or relapsing infection.

A panel of experts from the U.S. and Europe, who have published extensively about Lyme disease, developed this evidence-based review of the
treatment of neurologic Lyme disease for the American Academy of Neurology.

The panel performed a literature search of studies published from 1983 to 2003. From the resulting 353 citations, 122 potentially relevant articles were reviewed in detail, of which 37 ultimately were used for the analysis.

There were sufficient data to conclude that neurologic Lyme disease in adults and children age 8 years is effectively treated with a 2-
week course of parenteral penicillin,ceftriaxone, or cefotaxime.

There was no evidence of antibiotic resistance in Borrelia burgdorferi. European studies provided substantial evidence that oral
doxycycline is as efficacious as parenteral antibiotics in patients who have Lyme-associated meningitis, facial nerve palsy, or radiculitis.

Evidence from three trials suggested a lack of benefit from prolonged antibiotic treatment of "post-Lyme syndrome" (symptoms persisting or recurring after appropriate treatment in the absence of evidence of ongoing infection).

Comment: Misunderstanding of Lyme disease has created a demand by patients with pain, fatigue, and perceived cognitive trouble to seek
prolonged parenteral treatment for Lyme disease and "post-Lyme syndrome."

This study provides evidence-based recommendations for appropriate types and duration of antimicrobial therapy for
neurologic Lyme disease. It also provides reassurance that the disease can be treated and highlights the lack of evidence that post-
Lyme syndrome is due to active B. burgdorferi infection that would require prolonged antibiotic therapy.

-- Karen L. Roos, MD

Dr. Roos is John and Nancy Nelson Professor of Neurology, Indiana University School of Medicine, Indianapolis.

Published in Journal Watch Neurology October 2, 2007 [rant]

***Keep in mind that this Journal Watch is sponsored by NEJM, and the editors pick their favorites. Klempner is one of the Associate Editors.***

Anyone smell a rat?????????

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nan

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Boomerang
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Great news!! Thanks tincup!
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gwenb
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I was sorry to hear this . . .

"Fallon said he does not believe live bacteria persist in patients and cause their symptoms, but that certain antibiotics have properties beyond killing bacteria and act on neurotransmitters in the brain."

http://www.newsday.com/news/health/ny-hslyme115408570oct11,0,5381929.story

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5dana8
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Maybe he was mis-quoted? [Frown]

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5dana8

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bettyg
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gwen, for the link you posted, i read it.


we can rate article and 2 comments are below!

3 votes for 4. of FALLON'S STUDY
*******************************


COMMENTS
Showing posts 1 - 2 of 2


Eli
Palo Alto, CA Reply �
|Flag |#1 5 hrs ago

I have serious doubts about the appropriate context of opinions contributed to Brian Fallon about the persistence of Lyme infection.

The patients in his study were all documented to be INFECTED, all after having had at least three weeks of IV antibiotics prior to the study - that's what the whole business of meeting the CDC surveillance criteria is about, demonstrating in very strict terms that the patients are still infected. The CDC admits that their surveillance criteria catches only a small percentage of cases and that the true incidence is anywhere from 6 to 12 times higher.

So if that's not "chronic" infection, what is? All of the patients in this study had at least 3 weeks of IV antibiotics prior to the study, some had more, all were proven to be infected by CDC surveillance criteria. How exactly do you get that Fallon doesn't believe live bacteria persist when he narrowed his study only to people he could prove in strict terms had persistent infection?

Patients then improved with ten weeks of antibiotic treatment as compared to a placebo. They relapsed OVER TIME, not immediately, when the drugs were withdrawn.

Wormser, Dattwyler, Sigal, et al, are well known for their A PRIORI views about Lyme. How about looking at the evidence and writing something that doesn't hammer readers with their flat earth bias?

Can you imagine a ten week double blind study for any other infectious disease? In spite of more evidence that with just about any other disease that longer treatment helps patients with Lyme disease (mainly those who are infected for a long time before diagnosis), the media continue to let the usual suspects twist the facts to the detriment of patients.


allmine
Huntington Station, NY
Reply �
|Flag |#2 4 hrs ago


i have had lyme for 15 years. i hsd it for over 2 years before they figured out what was "wrong" with me. it is horrible what the disease can do to your body. i am in constant pain and have vision problems. i want to be in that study so maybe i can get some help and relief.

Showing posts 1 - 2 of 2

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dontlikeliver
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As I recall, it was said at the Columbia Research Center's opening that they weren't SURE that the bacteria persisted or if the antibiotics had some otehr quality that improved people's lives.


I am glad this study has come out, but not sure it will help a lot of us who are continually trying to convince our docs to prescribe abx for us after longer than 12 weeks for instance...............this study says nothing about abx after 3-4 years and more, etc...

So, on the one hand, I want to show my GP (who writes my rx's under LLMDs guidance) but on the other hand, I don't want to show him as he might just point out that the study does not say that abx are beneficial after 3+ years.

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Soleilpie
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quote:
Originally posted by gwenb:
I was sorry to hear this . . .

"Fallon said he does not believe live bacteria persist in patients and cause their symptoms, but that certain antibiotics have properties beyond killing bacteria and act on neurotransmitters in the brain."

http://www.newsday.com/news/health/ny-hslyme115408570oct11,0,5381929.story

Gwenb,

I don't know about that statement because in his study he states:

Ceftriaxone upregulates the expression of glutamate transporters on the astroglia of rat brains with neuroprotective effects30--presumably because of reduced extracellular glutamate, a potentially neurotoxic neurotransmitter. This could explain short-duration improvement in that continued exposure to ceftriaxone would be required for sustained upregulation of the glutamate transporter.

Another explanation for the observed relapse is that the course of ceftriaxone may have killed some borrelia, but it exerted little effect on other organisms in sequestered sites.31,32 There is one North American report of persistent B burgdorferi by culture after antibiotic therapy,33 and there are several such European cases.34-38


Dr. Fallon is just voicing a couple of theories. The article you quoted appears to have left out the second theory Dr. Fallon postulated. I did not find anywhere in the study where he said he didn't believe live bacteria persisted in patients. That statement is opposite what he put in his study. I'll have to reread the study to make sure I didn't miss it, but it's obvious from what I cut/pasted above that he believes it's possible that antibiotics may not have reached Bb's that were secluded elsewhere.

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The best index to a person's character is how he treats people who can't do him any good, and how he treats people who can't fight back.
-Abigail van Buren (Pauline Esther Friedman) (1918-2002)

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Soleilpie
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Bettyg,

That comment left by that reader was right on! I mean it states right in the study that the subjects had to be CDC positive for IgG and had to have been treated with at least 3 weeks of IV Ceftriaxone.

It would be a contradiction for Fallon to make such a statement when his research subjects were positive for Lyme after at least 3 weeks of treatment. I guess someone could say that being IgG positive doesn't necessarily mean current infection. But it also doesn't mean it's necessarily past infection either.

But you and I both know that if you're positive for Lyme AND have clinical signs of Lyme, then you probably have spirochetes swimming around. And since the research subjects had to exhibit subjective and objective memory impairment (though many exhibited other Lyme symptoms as well, but this study mainly concentrated its efforts on memory and cognitive domains), I'd have to say they clearly showed clinical symptoms as well as laboratory confirmation.

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The best index to a person's character is how he treats people who can't do him any good, and how he treats people who can't fight back.
-Abigail van Buren (Pauline Esther Friedman) (1918-2002)

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lorima
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Sorry to say this, but: the patients weren't proven to be "currently infected".

The only way to do that would be to culture out the bacteria, or maybe by PCR show that the Bb DNA is there (although some have said that the PCR remains positive for a while after live spirochetes have all been killed, presumably due to dead spirochetal DNA still being present).

Also sorry to say, the study is disappointing. Just rehashes that if 3 weeks of IV abx didn't "cure", neither will 1o weeks. And that the IVs themselves are risky, so not the first choice for treatment.

That's totally unsurprising, and it doesn't help us out. We all know it (often? usually?) takes longer than 10 weeks, and probably addition of cyst-busters, etc. And then, probably re-treatment anytime symptoms reappear.

For that reason I favor high-dose, long-term orals whenever possible. If IV was saved as a last resort, we wouldn't get so much resistance to long-term treatment (or at least not the reasonable resistance, just the political kind ;-)

I'm not saying people shouldn't be able to get IV! Just that it shouldn't be considered necessarily better than orals. For heart block or seizures, starting with IV makes sense to get it in there fast, but after a few days orals can get in there too.

Just my opinion, I'm a scientist but not an MD.

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nan
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This is EXACTLY why we need research and production of gold standard testing. Without that, neither side can conclusively say one way or the other.

Not sure whether a test can be developed that would actually show ongoing infection. Wonder if that would be possible.

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nan

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aklnwlf
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Yeah TC!! Thanks for getting us this great news!

[kiss]

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Do not take this as medical advice. This comment is based on opinion and personal experience only.

Alaska Lone Wolf

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Aniek
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The most important part of the study is he states the need for more research.

It's also important to note the study showed continued improvement in reduction of pain.

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"When there is pain, there are no words." - Toni Morrison

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