Re: Key Questions About Fluconazole for NeuroLyme

April 17, 2005

, you’ve asked some excellent

questions, none of which I know the answer to.

You’re correct that Fluconazole does

not kill the spirochete. If you put the spirochete and Lyme in a test

tube, squat happens. However, it’s my understanding that

Fluconazole MAY starve out the spirochetes nutrients, hence, succumbing the

spirochete to starve to death. Is there a die off then & consequently

a herx? I’m not sure.

I would not describe my reaction to the

Fluconazole at 200mg a day a “herx.” I would say the 1st

three weeks I was powerfully fatigued, but not unlike situations in my past

where I’ve had an increase in disease activity and was extra

fatigued. I did not experience an increase in pain.

There is certainly not enough data from

Schart’s study to draw a lot of definitive conclusions. It’s

one small study w/a lot of variables. My ID Dr. seems to think his theory,

however, makes sense & is worthy of consideration. One reason why he’s

so willing to try it is that he doesn’t feel he has a lot to offer

Chronic Lyme patients. This isn’t real risky therapy which one

should always consider risk vs. benefit when deciding to embark on an

experimental protocol. Taking 4X the maximum amount of a therapeutic dose

of Benicar IS risky therapy, IMO. It isn’t a drain on the

pocketbook and the side effects are pretty short term and negligible in the

long run. In other words, it’s a crap shoot, but one that may be

worthy of investigating.

The LLMD’s probably need to

seek some funding to do a larger sample study & obtain more objective

conclusive data. Meanwhile, I don’t have time to wait until all the

data & conclusions roll in & want to try this now, particularly since

it’s relative risk free. Get liver enzymes checked periodically

& that’s it.

Regards, patrice

From: infections [mailto:infections ] On Behalf Of Schaafsma

Sent: Sunday, April 17, 2005 12:50

PM

infections

Subject:

[infections] Key Questions About Fluconazole for NeuroLyme

Here are the questions I would like to see

answered about

Fluconazole for neuroLyme:

1) Questions About " Herxing " on

Fluconazole

a) If Schardt is correct about the mechanism,

Fluconazole would

weaken Borrelia burgdorferi, not kill it outright

like a

bacteriocidal drug. I would expect any 'herx' to

be quite a bit more

mild, and to occur only when the Fluconazole has

been given long

enough for Bb to succumb. Why are some patients

'herxing' on the

first dose?

As I recall, Schardt's orginal sample favored

those who had

already undergone the standard regimen for

neuroLyme, IV Rocephin.

They likely have lightened spirochete loads. Do

these

patients 'herx' early on, or is it mostly those

who have less prior

antibiotic treatment?

c) We saw with the Unnameable Protocol that any

adverse response was

often referred to as 'herx' - how do we know that

isn't true here,

as well?

d) Assuming " Herx " does come into play,

is it possible that this

Fluconazole treatment should be AVOIDED by those

who have not

undergone extensive antibiotic therapy in the

fairly recent past? Do

we really 'know' that this is a safe and

appropriate treatment for

those whose CNS spirochete loads may be

substantially higher than

Schardt's initial sample?

e) Assuming that some who embark on Fluconazole

for neuroLyme do

experience 'herx', how does that manifest, in what

types of

symptoms, and how is it distinguished from

yeast-die off. Which

leads to:

f) Most patients who have been on long antibiotic

regimens are more

at risk for yeast overgrowth than an average

person. Yeast die off

can be unpleasant. How do we know these 'herxes'

aren't really

triggered by that?

2) As I recall, Schardt's patients got feeling a

lot better very

quickly, by Lyme standards, within a few weeks of

commencing

treatment. Why exactly do we assume this is

because of action

against a slow-cycle spirochete like Lyme?

3) Is the logic of combining antibiotics that

Schardt's mechanism

may allow Fluconazole to weaken or soften up the

bugs rather than

kill them, so that a more overtly bacterocidal

drug is needed to

polish them off?

4) As I recall, the initial course of treatment

Schardt contemplated

was fairly brief, a month or two. Are we seeing

people now adopting

longer term (someone mentioned 9 months)

Fluconazole treatment for

the purpose of putting neuroLyme into remission?

5) Does Schart's mechanism really permit there to

be non-responders?

If Fluconazole impacts Bb as Schardt envisions,

shouldn't we see an

across the board response? If not, what are the

variables that might

conceivably distinguish responders from

non-responders over the same

course of treatment?

6) When will we see before-and-after neuropsych

assessments like

those used by Fallon, to show measurable gain in

function through

neuroLyme treatment?

7) Has Schardt produced such studies of his

original patients? Are

the doctors administering Fluconazole for

neuroLyme using measures

like these to guage the effectiveness of

treatment? Or is there a

general reliance on self-reported improvement?

April 17, 2005

Thanks, Patrice! I think I understand where you're coming from

pretty well, and it makes sense to me.

posts here in a different capacity, as an observer of trends,

who makes a point of staying in touch with physicians and patients

trying new things that make sense to him. I'm glad he does. I would

never discourage him.

In that capacity, not so very long ago was offering extremely

enthusiastic reports about the Unnameable Protocol [uP]. That's not

a put-down, coming from me, because I went so far as to join the

board staff on the UP before realizing how deeply flawed an effort

that was.

The fact is, bright people with relevant expertise can be fooled,

just like everyone else.

We've all learned something from that experience, I suspect. What

I've learned is that the right time to ask the hard questions is

always NOW.

I'm sure there are other questions that need to be asked about

Fluconazole for neuroLyme, as well. But I thought I'd put some out

there to get us going.

My ethos for this list is: apply the same rigorous questioning to

everything.

If we start acquiring, as a list, " pet protocols " that we reserve

gentle treatment for, I will have to leave. I'm not looking for

pets, I'm looking for workhorses, that earn their keep by making

people well in measurable, reproducible ways.

Fortunately, the will to question and think together in a

disciplined way about these things is very strong on I & I.

It was in that spirit that my questions were offered up, primarily

with in mind, because his enthusiasm for this protocol has

been expressed in the broadest, least equivocal terms.

> , you've asked some excellent questions, none of which I know

the answer

> to.

>

> You're correct that Fluconazole does not kill the spirochete. If

you put

> the spirochete and Lyme in a test tube, squat happens. However,

it's my

> understanding that Fluconazole MAY starve out the spirochetes

nutrients,

> hence, succumbing the spirochete to starve to death. Is there a

die off

> then & consequently a herx? I'm not sure.

>

> I would not describe my reaction to the Fluconazole at 200mg a day

a " herx. "

> I would say the 1st three weeks I was powerfully fatigued, but not

unlike

> situations in my past where I've had an increase in disease

activity and was

> extra fatigued. I did not experience an increase in pain.

>

> There is certainly not enough data from Schart's study to draw a

lot of

> definitive conclusions. It's one small study w/a lot of

variables. My ID

> Dr. seems to think his theory, however, makes sense & is worthy of

> consideration. One reason why he's so willing to try it is that

he doesn't

> feel he has a lot to offer Chronic Lyme patients. This isn't real

risky

> therapy which one should always consider risk vs. benefit when

deciding to

> embark on an experimental protocol. Taking 4X the maximum amount

of a

> therapeutic dose of Benicar IS risky therapy, IMO. It isn't a

drain on the

> pocketbook and the side effects are pretty short term and

negligible in the

> long run. In other words, it's a crap shoot, but one that may be

worthy of

> investigating.

>

> The LLMD's probably need to seek some funding to do a larger

sample study &

> obtain more objective conclusive data. Meanwhile, I don't have

time to wait

> until all the data & conclusions roll in & want to try this now,

> particularly since it's relative risk free. Get liver enzymes

checked

> periodically & that's it.

>

> Regards, patrice

>

> _____

>

> From: infections

> [mailto:infections ] On Behalf Of

> Schaafsma

> Sent: Sunday, April 17, 2005 12:50 PM

> infections

> Subject: [infections] Key Questions About

Fluconazole for

> NeuroLyme

>

> Here are the questions I would like to see answered about

> Fluconazole for neuroLyme:

>

> 1) Questions About " Herxing " on Fluconazole

>

> a) If Schardt is correct about the mechanism, Fluconazole would

> weaken Borrelia burgdorferi, not kill it outright like a

> bacteriocidal drug. I would expect any 'herx' to be quite a bit

more

> mild, and to occur only when the Fluconazole has been given long

> enough for Bb to succumb. Why are some patients 'herxing' on the

> first dose?

>

> As I recall, Schardt's orginal sample favored those who had

> already undergone the standard regimen for neuroLyme, IV Rocephin.

> They likely have lightened spirochete loads. Do these

> patients 'herx' early on, or is it mostly those who have less

prior

> antibiotic treatment?

>

> c) We saw with the Unnameable Protocol that any adverse response

was

> often referred to as 'herx' - how do we know that isn't true here,

> as well?

>

> d) Assuming " Herx " does come into play, is it possible that this

> Fluconazole treatment should be AVOIDED by those who have not

> undergone extensive antibiotic therapy in the fairly recent past?

Do

> we really 'know' that this is a safe and appropriate treatment for

> those whose CNS spirochete loads may be substantially higher than

> Schardt's initial sample?

>

> e) Assuming that some who embark on Fluconazole for neuroLyme do

> experience 'herx', how does that manifest, in what types of

> symptoms, and how is it distinguished from yeast-die off. Which

> leads to:

>

> f) Most patients who have been on long antibiotic regimens are

more

> at risk for yeast overgrowth than an average person. Yeast die off

> can be unpleasant. How do we know these 'herxes' aren't really

> triggered by that?

>

> 2) As I recall, Schardt's patients got feeling a lot better very

> quickly, by Lyme standards, within a few weeks of commencing

> treatment. Why exactly do we assume this is because of action

> against a slow-cycle spirochete like Lyme?

>

> 3) Is the logic of combining antibiotics that Schardt's mechanism

> may allow Fluconazole to weaken or soften up the bugs rather than

> kill them, so that a more overtly bacterocidal drug is needed to

> polish them off?

>

> 4) As I recall, the initial course of treatment Schardt

contemplated

> was fairly brief, a month or two. Are we seeing people now

adopting

> longer term (someone mentioned 9 months) Fluconazole treatment for

> the purpose of putting neuroLyme into remission?

>

> 5) Does Schart's mechanism really permit there to be non-

responders?

> If Fluconazole impacts Bb as Schardt envisions, shouldn't we see

an

> across the board response? If not, what are the variables that

might

> conceivably distinguish responders from non-responders over the

same

> course of treatment?

>

> 6) When will we see before-and-after neuropsych assessments like

> those used by Fallon, to show measurable gain in function through

> neuroLyme treatment?

>

> 7) Has Schardt produced such studies of his original patients? Are

> the doctors administering Fluconazole for neuroLyme using measures

> like these to guage the effectiveness of treatment? Or is there a

> general reliance on self-reported improvement?

>

> _____

>

April 17, 2005

Good questions , here's my comments:

Q: If Schardt is correct about the mechanism, Fluconazole would

weaken Borrelia burgdorferi, not kill it outright like a

bacteriocidal drug. I would expect any 'herx' to be quite a bit more

mild, and to occur only when the Fluconazole has been given long

enough for Bb to succumb. Why are some patients 'herxing' on the

first dose?

A: First of all I'm not going to say we know these are herxes for

sure…no one knows. However, in most cases, I suspect they are.

I'm not sure Schardt is correct that fluconazole is simply weakening

borrelia…it may be borreliocidal. Even if it's borreliostatic at

low doses, the higher dose may be cidal. Empirical/clinical

evidence suggests that the high dose does seem to be a key factor.

I think fluconazole can cause severe herx reactions. The best

evidence for the herxing theory seems to be the individuals that

gradually increase the dose and eventually tolerate the full dose

well. The longer we are on the high dose, the better we seem to

tolerate it…another hint it may be a herx initially.

Q: As I recall, Schardt's orginal sample favored those who had

already undergone the standard regimen for neuroLyme, IV Rocephin.

They likely have lightened spirochete loads. Do these

patients 'herx' early on, or is it mostly those who have less prior

antibiotic treatment?

A: I don't think it matters…we primarily see individuals that have

been on abx and are refractory to them. I do know of one individual

that hasn't been on abx for many months, she couldn't tolerate any.

She gradually began fluconazole and was on the full dose in 3 weeks

and is doing well. This is the first anti-microbial that has really

helped her and the first one she's been able to tolerate. I don't

think she would have been able to if she started at 200 mg/day.

Q: We saw with the Unnameable Protocol that any adverse response was

often referred to as 'herx' - how do we know that isn't true here,

as well?

A: We don't know! Time will tell. We do know that AIDS patients

tolerate these doses of fluconazole well. They use it to manage

their crypto infections. They are often on it permanently. It's

still prudent to have chem profiles monitored.

Q: Assuming " Herx " does come into play, is it possible that this

Fluconazole treatment should be AVOIDED by those who have not

undergone extensive antibiotic therapy in the fairly recent past? Do

we really 'know' that this is a safe and appropriate treatment for

those whose CNS spirochete loads may be substantially higher than

Schardt's initial sample?

A: That's why I'd recommend initiate therapy with low-dose and

gradually increasing it to full dose.

Q: Assuming that some who embark on Fluconazole for neuroLyme do

experience 'herx', how does that manifest, in what types of

symptoms, and how is it distinguished from yeast-die off. Which

leads to:

A: In herxes, we are seeing aggravation of symptoms followed by

improvement in those same symptoms. I personally noticed pressure

in my head when I take an effective abx, and fluconazole was the

most potent in doing this for me. I don't get this herx anymore. I

don't have headaches and my cognitive function has improved

significantly. Some physicians are reporting improvements in chem

profiles and inflammatory markers too.

Q: Most patients who have been on long antibiotic regimens are more

at risk for yeast overgrowth than an average person. Yeast die off

can be unpleasant. How do we know these 'herxes' aren't really

triggered by that?

A: We don't know for sure. It's my hunch it's borrelia, but I'm not

dogmatic about it. I really don't care what the pathogen is that is

triggering A-CIDs. I simply want the therapy to work.

Q: As I recall, Schardt's patients got feeling a lot better very

quickly, by Lyme standards, within a few weeks of commencing

treatment. Why exactly do we assume this is because of action

against a slow-cycle spirochete like Lyme?

A: I don't know, but this response seems variable. I personally

noticed significant improvement beginning 3-5 days after therapy and

throughout in the early weeks, while others don't notice improvement

until 30 days or more. These strong and early responses suggest

that borrelia is extremely susceptible to fluconazole. Why the

variability? I don't know.

3) Is the logic of combining antibiotics that Schardt's mechanism

may allow Fluconazole to weaken or soften up the bugs rather than

kill them, so that a more overtly bacterocidal drug is needed to

polish them off?

A: IMO, it's the fluconzole that is likely the drug to polish them

off. The use of abx in combo with fluconazole is to treat potential

coinfections such as mycoplasmosis and to inhibit protein synthesis

of any bacterial pathogen and reduce the production of BPLs that

trigger inflammation.

Q: As I recall, the initial course of treatment Schardt contemplated

was fairly brief, a month or two. Are we seeing people now adopting

longer term (someone mentioned 9 months) Fluconazole treatment for

the purpose of putting neuroLyme into remission?

A: We think Schardt's therapy may be too short for full remission

of refractory cases. I'm in I'm 4 months into my fluconazole

therapy and I've been discussing this with a couple of physicians

that I work with. I'm concerned that if I quit too early, the

remission won't hold long term. We believe Schardt's course of 3-4

months is likely too short to completely clear chronic borreliosis.

We look at TB and leprosy, which is treated for 9-12 months. Since

the therapy has been benign in me… i.e., my chem panels are normal

and I feel good, I am choosing to continue the therapy. I don't

know for how long…I see this as an opportunity and I don't want to

miss this chance of getting them all.

Q: Does Schart's mechanism really permit there to be non-responders?

If Fluconazole impacts Bb as Schardt envisions, shouldn't we see an

across the board response? If not, what are the variables that might

conceivably distinguish responders from non-responders over the same

course of treatment?

A: Response to therapy is probably the best way to test this.

However, the test should last several weeks at full dose, due to the

variability in response. Non-responders would be individuals that

have A-CIDs caused by pathogens not susceptible to fluconazole.

Q: When will we see before-and-after neuropsych assessments like

those used by Fallon, to show measurable gain in function through

neuroLyme treatment?

A: Unfortunately, this will likely be a long time coming. I can

say that my cognitive ability has significantly improved. I've seen

and heard this in several other cases as well. There is one case of

a young man (teenager) with severe psych problems that has responded

remarkably well. He hadn't responded well to other therapies.

Q: Has Schardt produced such studies of his original patients? Are

the doctors administering Fluconazole for neuroLyme using measures

like these to guage the effectiveness of treatment? Or is there a

general reliance on self-reported improvement?

A: The evidence is primarily clinical. No formal studies ongoing

that I know of. That's why I mentioned the desire to see a study

using the new PCR to monitor fluconazole therapy. That would be

extremely valuable information.

April 17, 2005

,

I appreciate this post and I couldn't agree more!

However, IMO the role of ATII in inflammation is a breakthrough. So,

in my defense, I believe I was correct regarding that. My mistake

was trusting that high dose ARB therapy was more promising than it

actually is.

We learn from our mistakes, but we keep probing for the truth.

I am impressed with what we've learned in the past year...it's been

awesome to say the least.

> > , you've asked some excellent questions, none of which I

know

> the answer

> > to.

> >

> > You're correct that Fluconazole does not kill the spirochete.

If

> you put

> > the spirochete and Lyme in a test tube, squat happens. However,

> it's my

> > understanding that Fluconazole MAY starve out the spirochetes

> nutrients,

> > hence, succumbing the spirochete to starve to death. Is there a

> die off

> > then & consequently a herx? I'm not sure.

> >

> > I would not describe my reaction to the Fluconazole at 200mg a

day

> a " herx. "

> > I would say the 1st three weeks I was powerfully fatigued, but

not

> unlike

> > situations in my past where I've had an increase in disease

> activity and was

> > extra fatigued. I did not experience an increase in pain.

> >

> > There is certainly not enough data from Schart's study to draw a

> lot of

> > definitive conclusions. It's one small study w/a lot of

> variables. My ID

> > Dr. seems to think his theory, however, makes sense & is worthy

of

> > consideration. One reason why he's so willing to try it is that

> he doesn't

> > feel he has a lot to offer Chronic Lyme patients. This isn't

real

> risky

> > therapy which one should always consider risk vs. benefit when

> deciding to

> > embark on an experimental protocol. Taking 4X the maximum

amount

> of a

> > therapeutic dose of Benicar IS risky therapy, IMO. It isn't a

> drain on the

> > pocketbook and the side effects are pretty short term and

> negligible in the

> > long run. In other words, it's a crap shoot, but one that may

be

> worthy of

> > investigating.

> >

> > The LLMD's probably need to seek some funding to do a larger

> sample study &

> > obtain more objective conclusive data. Meanwhile, I don't have

> time to wait

> > until all the data & conclusions roll in & want to try this now,

> > particularly since it's relative risk free. Get liver enzymes

> checked

> > periodically & that's it.

> >

> > Regards, patrice

> >

> > _____

> >

> > From: infections

> > [mailto:infections ] On Behalf Of

>

> > Schaafsma

> > Sent: Sunday, April 17, 2005 12:50 PM

> > infections

> > Subject: [infections] Key Questions About

> Fluconazole for

> > NeuroLyme

> >

> > Here are the questions I would like to see answered about

> > Fluconazole for neuroLyme:

> >

> > 1) Questions About " Herxing " on Fluconazole

> >

> > a) If Schardt is correct about the mechanism, Fluconazole would

> > weaken Borrelia burgdorferi, not kill it outright like a

> > bacteriocidal drug. I would expect any 'herx' to be quite a bit

> more

> > mild, and to occur only when the Fluconazole has been given long

> > enough for Bb to succumb. Why are some patients 'herxing' on the

> > first dose?

> >

> > As I recall, Schardt's orginal sample favored those who had

> > already undergone the standard regimen for neuroLyme, IV

Rocephin.

> > They likely have lightened spirochete loads. Do these

> > patients 'herx' early on, or is it mostly those who have less

> prior

> > antibiotic treatment?

> >

> > c) We saw with the Unnameable Protocol that any adverse response

> was

> > often referred to as 'herx' - how do we know that isn't true

here,

> > as well?

> >

> > d) Assuming " Herx " does come into play, is it possible that this

> > Fluconazole treatment should be AVOIDED by those who have not

> > undergone extensive antibiotic therapy in the fairly recent

past?

> Do

> > we really 'know' that this is a safe and appropriate treatment

for

> > those whose CNS spirochete loads may be substantially higher

than

> > Schardt's initial sample?

> >

> > e) Assuming that some who embark on Fluconazole for neuroLyme do

> > experience 'herx', how does that manifest, in what types of

> > symptoms, and how is it distinguished from yeast-die off. Which

> > leads to:

> >

> > f) Most patients who have been on long antibiotic regimens are

> more

> > at risk for yeast overgrowth than an average person. Yeast die

off

> > can be unpleasant. How do we know these 'herxes' aren't really

> > triggered by that?

> >

> > 2) As I recall, Schardt's patients got feeling a lot better very

> > quickly, by Lyme standards, within a few weeks of commencing

> > treatment. Why exactly do we assume this is because of action

> > against a slow-cycle spirochete like Lyme?

> >

> > 3) Is the logic of combining antibiotics that Schardt's

mechanism

> > may allow Fluconazole to weaken or soften up the bugs rather

than

> > kill them, so that a more overtly bacterocidal drug is needed to

> > polish them off?

> >

> > 4) As I recall, the initial course of treatment Schardt

> contemplated

> > was fairly brief, a month or two. Are we seeing people now

> adopting

> > longer term (someone mentioned 9 months) Fluconazole treatment

for

> > the purpose of putting neuroLyme into remission?

> >

> > 5) Does Schart's mechanism really permit there to be non-

> responders?

> > If Fluconazole impacts Bb as Schardt envisions, shouldn't we see

> an

> > across the board response? If not, what are the variables that

> might

> > conceivably distinguish responders from non-responders over the

> same

> > course of treatment?

> >

> > 6) When will we see before-and-after neuropsych assessments like

> > those used by Fallon, to show measurable gain in function

through

> > neuroLyme treatment?

> >

> > 7) Has Schardt produced such studies of his original patients?

Are

> > the doctors administering Fluconazole for neuroLyme using

measures

> > like these to guage the effectiveness of treatment? Or is there

a

> > general reliance on self-reported improvement?

> >

> > _____

> >

April 18, 2005

's Q: Does Schart's mechanism really permit there to be non-responders?If Fluconazole impacts Bb as Schardt envisions, shouldn't we see anacross the board response? If not, what are the variables that mightconceivably distinguish responders from non-responders over the samecourse of treatment?'s A: Response to therapy is probably the best way to test this. However, the test should last several weeks at full dose, due to the variability in response. Non-responders would be individuals that have A-CIDs caused by pathogens not susceptible to fluconazole.

Nelly's experience with fluconazole: 74 days at 200 mg/day, nothing good happened, I was PCR + for Bb around that time and was also treating for potential co-infections (macrolide alternating with doxy or mino and artemisinin ).

Sorry , I am raining on your party (again!) but that's my experience. Jacques also took it for similar length of time and didn't improve on it, liver enzymes suffered though.

, is your "confidence that this treatment will work" a cultural thing, shared by Americans only, something that makes you all feel warm and on the same level, whilst us "aliens" are kept at bay with our skeptical (negative?) attitudes? I must admit, I felt quite lonely when you "felt confident that the bla-bla protocol was the best thing since slice bread and I was negative and trying to get in the way of progress, etc" remember?

So what have we got now with fluconazole?

My take on it: it didn't work on us, and Jacques' liver enzymes became elevated as a result. I know several people in Europe who tried it and ...no go either, so nothing like what you are reporting.

In our cases, we had been on oral abx for a couple of years at the time AND we had always taken GI antifungal + probiotics, so chances are we didn't have a very high fungal count, so we might not have benefitted the way some people who have a secondary fungal infection (due to previous abx?) might have reacted. They might have experienced an improvement due to the fluconazole lowering their fungal infection.

Nelly

[infections] Re: Key Questions About Fluconazole for NeuroLyme

Good questions , here's my comments:Q: If Schardt is correct about the mechanism, Fluconazole wouldweaken Borrelia burgdorferi, not kill it outright like abacteriocidal drug. I would expect any 'herx' to be quite a bit moremild, and to occur only when the Fluconazole has been given longenough for Bb to succumb. Why are some patients 'herxing' on thefirst dose?A: First of all I'm not going to say we know these are herxes for sure.no one knows. However, in most cases, I suspect they are. I'm not sure Schardt is correct that fluconazole is simply weakening borrelia.it may be borreliocidal. Even if it's borreliostatic at low doses, the higher dose may be cidal. Empirical/clinical evidence suggests that the high dose does seem to be a key factor. I think fluconazole can cause severe herx reactions. The best evidence for the herxing theory seems to be the individuals that gradually increase the dose and eventually tolerate the full dose well. The longer we are on the high dose, the better we seem to tolerate it.another hint it may be a herx initially.Q: As I recall, Schardt's orginal sample favored those who hadalready undergone the standard regimen for neuroLyme, IV Rocephin.They likely have lightened spirochete loads. Do thesepatients 'herx' early on, or is it mostly those who have less priorantibiotic treatment?A: I don't think it matters.we primarily see individuals that have been on abx and are refractory to them. I do know of one individual that hasn't been on abx for many months, she couldn't tolerate any. She gradually began fluconazole and was on the full dose in 3 weeks and is doing well. This is the first anti-microbial that has really helped her and the first one she's been able to tolerate. I don't think she would have been able to if she started at 200 mg/day.Q: We saw with the Unnameable Protocol that any adverse response wasoften referred to as 'herx' - how do we know that isn't true here,as well?A: We don't know! Time will tell. We do know that AIDS patients tolerate these doses of fluconazole well. They use it to manage their crypto infections. They are often on it permanently. It's still prudent to have chem profiles monitored.Q: Assuming "Herx" does come into play, is it possible that thisFluconazole treatment should be AVOIDED by those who have notundergone extensive antibiotic therapy in the fairly recent past? Dowe really 'know' that this is a safe and appropriate treatment forthose whose CNS spirochete loads may be substantially higher thanSchardt's initial sample?A: That's why I'd recommend initiate therapy with low-dose and gradually increasing it to full dose. Q: Assuming that some who embark on Fluconazole for neuroLyme doexperience 'herx', how does that manifest, in what types ofsymptoms, and how is it distinguished from yeast-die off. Whichleads to:A: In herxes, we are seeing aggravation of symptoms followed by improvement in those same symptoms. I personally noticed pressure in my head when I take an effective abx, and fluconazole was the most potent in doing this for me. I don't get this herx anymore. I don't have headaches and my cognitive function has improved significantly. Some physicians are reporting improvements in chem profiles and inflammatory markers too.Q: Most patients who have been on long antibiotic regimens are moreat risk for yeast overgrowth than an average person. Yeast die offcan be unpleasant. How do we know these 'herxes' aren't reallytriggered by that?A: We don't know for sure. It's my hunch it's borrelia, but I'm not dogmatic about it. I really don't care what the pathogen is that is triggering A-CIDs. I simply want the therapy to work.Q: As I recall, Schardt's patients got feeling a lot better veryquickly, by Lyme standards, within a few weeks of commencingtreatment. Why exactly do we assume this is because of actionagainst a slow-cycle spirochete like Lyme?A: I don't know, but this response seems variable. I personally noticed significant improvement beginning 3-5 days after therapy and throughout in the early weeks, while others don't notice improvement until 30 days or more. These strong and early responses suggest that borrelia is extremely susceptible to fluconazole. Why the variability? I don't know. 3) Is the logic of combining antibiotics that Schardt's mechanismmay allow Fluconazole to weaken or soften up the bugs rather thankill them, so that a more overtly bacterocidal drug is needed topolish them off?A: IMO, it's the fluconzole that is likely the drug to polish them off. The use of abx in combo with fluconazole is to treat potential coinfections such as mycoplasmosis and to inhibit protein synthesis of any bacterial pathogen and reduce the production of BPLs that trigger inflammation.Q: As I recall, the initial course of treatment Schardt contemplatedwas fairly brief, a month or two. Are we seeing people now adoptinglonger term (someone mentioned 9 months) Fluconazole treatment forthe purpose of putting neuroLyme into remission?A: We think Schardt's therapy may be too short for full remission of refractory cases. I'm in I'm 4 months into my fluconazole therapy and I've been discussing this with a couple of physicians that I work with. I'm concerned that if I quit too early, the remission won't hold long term. We believe Schardt's course of 3-4 months is likely too short to completely clear chronic borreliosis. We look at TB and leprosy, which is treated for 9-12 months. Since the therapy has been benign in me. i.e., my chem panels are normal and I feel good, I am choosing to continue the therapy. I don't know for how long.I see this as an opportunity and I don't want to miss this chance of getting them all.Q: Does Schart's mechanism really permit there to be non-responders?If Fluconazole impacts Bb as Schardt envisions, shouldn't we see anacross the board response? If not, what are the variables that mightconceivably distinguish responders from non-responders over the samecourse of treatment?A: Response to therapy is probably the best way to test this. However, the test should last several weeks at full dose, due to the variability in response. Non-responders would be individuals that have A-CIDs caused by pathogens not susceptible to fluconazole.Q: When will we see before-and-after neuropsych assessments likethose used by Fallon, to show measurable gain in function throughneuroLyme treatment?A: Unfortunately, this will likely be a long time coming. I can say that my cognitive ability has significantly improved. I've seen and heard this in several other cases as well. There is one case of a young man (teenager) with severe psych problems that has responded remarkably well. He hadn't responded well to other therapies.Q: Has Schardt produced such studies of his original patients? Arethe doctors administering Fluconazole for neuroLyme using measureslike these to guage the effectiveness of treatment? Or is there ageneral reliance on self-reported improvement?A: The evidence is primarily clinical. No formal studies ongoing that I know of. That's why I mentioned the desire to see a study using the new PCR to monitor fluconazole therapy. That would be extremely valuable information.

April 18, 2005

I really have to respond to this. I

don’t even know (never met him), but I know he’s not

operating in a vacuum here. One of the persons that he corresponds

with daily about this Fluconazole tx. is my Infectious Dz. Dr. who is utilizing the

Fluconazole tx. for most of his Lyme patients now. It’s true, the

protocol is too new to extract 100% reliable data from & it may be months

before we know for sure whether this is the ticket or not. The ID Dr. he

corresponds with doesn’t operate his practice out of a strip mall

either. He has an academic position at a teaching hospital (a very

reputable one) and is Chair of the Infectious Dz. Dept. His practice is

essentially closed to new patients because he VERY busy. And he makes

essentially no profit from patients. He basically only charges what

insurance will pay & writes off the rest. My appointments generally

last 2-3 hours.

My point in saying all of this………for

those who haven’t tried this treatment, it is a pretty benign treatment (when

considering the risk vs. benefit ratio) that is so much less drastic than

getting a PICC line or central line & embarking on IV antibiotics for

prolonged periods of time, that also aren’t proven to work or else this

group wouldn’t exist. If the fluconazole didn’t work for you,

I can understand your skepticism of someone getting on this “bandwagon,”

and I would probably be reacting the same way. But IMO, this treatment

option is just that…….an OPTION that may have merit. Prior to

the MP craze, I was already on an ARB b/c I understood it’s anti-inflammatory

potential, but HUGE red flags were waving at me when I realized it was being

pushed at 4X the maximum therapeutic dose. There’s just no red

flags with Fluconazole. Yes, do monitor liver enzymes which if elevated,

can be reversed with suspension of the drug.

I’m certainly not convinced (yet)

that this is the prayer we’ve all been searching for, but I do hope

people will give it consideration. Patrice

From: infections [mailto:infections ] On Behalf Of Nelly Pointis

Sent: Sunday, April 17, 2005 6:30

PM

infections

Subject: Re:

[infections] Re: Key Questions About Fluconazole for NeuroLyme

's Q: Does Schart's mechanism really permit there to be

non-responders?

If Fluconazole impacts Bb as Schardt envisions, shouldn't we see an

across the board response? If not, what are the variables that might

conceivably distinguish responders from non-responders over the same

course of treatment?

's A: Response to therapy is probably the best way to test this.

However, the test should last several weeks at full dose, due to the

variability in response. Non-responders would be individuals that

have A-CIDs caused by pathogens not susceptible to fluconazole.

Nelly's experience with fluconazole: 74 days at 200 mg/day, nothing

good happened, I was PCR + for Bb around that time and was also treating for

potential co-infections (macrolide alternating with doxy or mino and

artemisinin ).

Sorry , I am raining on your party (again!) but that's my

experience. Jacques also took it for similar length of time and didn't improve

on it, liver enzymes suffered though.

, is your " confidence that this treatment will work " a

cultural thing, shared by Americans only, something that makes you all

feel warm and on the same level, whilst us " aliens " are kept at bay

with our skeptical (negative?) attitudes? I must admit, I felt quite lonely

when you " felt confident that the bla-bla protocol was the best thing

since slice bread and I was negative and trying to get in the way of progress,

etc " remember?

So what have we got now with fluconazole?

My take on it: it didn't work on us, and Jacques' liver enzymes became

elevated as a result. I know several people in Europe

who tried it and ...no go either, so nothing like what you are reporting.

In our cases, we had been on oral abx for a couple of years at the time

AND we had always taken GI antifungal + probiotics, so chances are we didn't

have a very high fungal count, so we might not have benefitted the way some

people who have a secondary fungal infection (due to previous abx?) might have

reacted. They might have experienced an improvement due to the fluconazole

lowering their fungal infection.

Nelly

[infections] Re: Key Questions About Fluconazole for NeuroLyme

Good questions , here's my comments:

Q: If Schardt is correct about the mechanism, Fluconazole would

weaken Borrelia burgdorferi, not kill it outright like a

bacteriocidal drug. I would expect any 'herx' to be quite a bit more

mild, and to occur only when the Fluconazole has been given long

enough for Bb to succumb. Why are some patients 'herxing' on the

first dose?

A: First of all I'm not going to say we know these are herxes for

sure.no one knows. However, in most cases, I suspect they are.

I'm not sure Schardt is correct that fluconazole is simply weakening

borrelia.it may be borreliocidal. Even if it's borreliostatic at

low doses, the higher dose may be cidal. Empirical/clinical

evidence suggests that the high dose does seem to be a key factor.

I think fluconazole can cause severe herx reactions. The best

evidence for the herxing theory seems to be the individuals that

gradually increase the dose and eventually tolerate the full dose

well. The longer we are on the high dose, the better we seem to

tolerate it.another hint it may be a herx initially.

Q: As I recall, Schardt's orginal sample favored those who had

already undergone the standard regimen for neuroLyme, IV Rocephin.

They likely have lightened spirochete loads. Do these

patients 'herx' early on, or is it mostly those who have less prior

antibiotic treatment?

A: I don't think it matters.we primarily see individuals that have