Safety of IV antibiotic therapy of neurologic Lyme disease

Topics with information and discussion about published studies related to Lyme disease and other tick-borne diseases.
Martian
Posts: 1944
Joined: Thu 26 Jul 2007 18:29
Location: Friesland, the Netherlands

Re: Safety of IV antibiotic therapy of neurologic Lyme disea

Post by Martian » Wed 24 Mar 2010 15:57

Apparently "RR" got his hands on the full-text of the publication about safety of intravenous antibiotic therapy by Stricker et al. What follows is his discussion based on the full text article:


Source: http://relative-risk.blogspot.com/2010/ ... y-who.html
23 March 2010

i.v. infusion: Safe? Maybe. Necessary? Who knows?

Well, Stricker’s paper on i.v. treatments for Lyme disease isn’t much more enlightening than the earlier abstract.

As a reminder, the authors of this trial are 1) people who believe in long-term antibiotic use for the persistent symptoms of presumptive Lyme disease, 2) people who are members of an organization (ILADS) dedicated to the use of long-term antibiotics for presumptive Lyme disease, 3) people from a home infusion company who market themselves as a “Lyme literate” pharmacy*, and 4) people who are members of a patient advocacy group dedicated to the belief in chronic antibiotic usage for chronic Lyme disease. Therefore, expect some serious bias.

So Stricker et al. gathered up some data on 200 patients (in 18 states) who had been diagnosed and treated for Lyme disease.

According to the authors, “all patients had significant neuropsychiatric symptoms,” which the authors and the treating physicians apparently attributed solely to Lyme disease. No inclusion criteria for patient selection are provided in the text. There’s no case definition for persistent neurologic Lyme disease. There is only a reference to Fallon’s 2008 clinical trial in which he famously had so much trouble finding well-defined chronic Lyme patients. (After screening 3,368 potential patients, he found 37 with some convincing evidence of Lyme disease. They got treated with 10 weeks of iv ceftriaxone after which Fallon concluded: “10 weeks of iv ceftriaxone…is not an effective strategy.” I wonder why he’s not on this particular study?)

All of the patients also tested positive for B. burgdorferi, but again, they don’t say how they were tested or where. (I’m guessing the various treating physicians in the unnamed 18 states had Igenex do some serology.)

The patients were largely middle-aged (mean 41 years) women (141 women vs. 59 men), plugged into some manner of i.v. device for an average of 118 days. (Interesting sex ratio. According to the CDC surveillance data, men and women contract Lyme in about equal numbers. Then why so many women with “significant neuropsychiatric symptoms”?)

The i.v. devices include PICC lines, peripheral catheters, s.c. ports, c.v. catheters, and midline catheters. The particular device was selected by the various treating physicians, along with the particular antibiotic and dosage. Table 1 in the paper lists 13 different antibiotics used among 200 patients.

So we have 200 people who may or may not have an active borreliosis, enrolled based on vague criteria from an unknown number of primary care physicians using five different i.v. devices and 13 different kinds of antibiotics over a period of time that ranged from 7 to 750 days.

What a mess of variables and unknowns. The stats software must have imploded trying to make sense of this trial. But then some of the virtues of InStat software are 1) that it “does not assume that you are a statistics whiz,” 2) “you don’t have to know the name of the test you need," and 3) “all prompts to the user are in plain English and simple to follow.” Stats for Dummies.

Conclusions?

Table 2 lists complications from the i.v. devices and the medication. There were 24 patients with complications. So that’s 12% of the study population who experienced an adverse event. Is that considered safe? Stricker says so.

Is it effective? Stricker writes, “It remains to be seen whether this length of treatment was able to reduce or eliminate an underlying infection.” (Assuming one ever existed.) Apparently we have to wait for the sequel in the form of another bad paper in an obscure foreign journal. He writes, “The present study…makes no comment about the efficacy of this treatment.”

Was this really ethical? Lining up a bunch of people (with significant neuropsychiatric symptoms) to see if procedure X is not therapeutic but merely safe? Sounds like something you’d do with guinea pigs.

*"The QMedRx Clinical Staff and Medical Advisory Committee have prepared a web based patient outcome questionnaire. Our goal is to help your physician maximize your response to treatment, make data easier for you to document and easier for your physician to retrieve. Some benefits may include the collection and publishing of data to document the positive outcome of IV antibiotic treatment."

LymeH
Posts: 290
Joined: Mon 1 Mar 2010 16:41

Re: Safety of IV antibiotic therapy of neurologic Lyme disea

Post by LymeH » Wed 24 Mar 2010 16:44

Does RR read this board?

Quote RR " The patients were largely middle-aged (mean 41 years) women (141 women vs. 59 men), plugged into some manner of i.v. device for an average of 118 days. (Interesting sex ratio. According to the CDC surveillance data, men and women contract Lyme in about equal numbers. Then why so many women with “significant neuropsychiatric symptoms”?)"

I think that women are more likely to seek help for symptoms.

Patients see that the doctor appears to be taking some sort of action towards trying to 'help' them, albeit reckless and damaging. Some people say if there is a problem or illness, then we must do something, anything, to treat it. They say if some people believe they have a chronic infection, then give them antibiotics. They don't want to just sit back and do nothing.

The problem is that sometimes it is the treatment and the medical 'care' that is the source of the perceived severe illness. Legislators and others that do not know all the details about every speakers (patients) history, can be too easily misled into wanting to help and end up throwing more 'gas on the fire', by passing these reform (get out of jail free) laws.
Last edited by LymeH on Tue 26 Jun 2012 17:41, edited 2 times in total.

Martian
Posts: 1944
Joined: Thu 26 Jul 2007 18:29
Location: Friesland, the Netherlands

Re: Safety of IV antibiotic therapy of neurologic Lyme disea

Post by Martian » Wed 24 Mar 2010 18:03

LymeHystorian wrote:Does RR read this board?!
It seems so, because RR sometimes links to this board.

Cobwebby
Posts: 1716
Joined: Mon 29 Oct 2007 0:55

Re: Safety of IV antibiotic therapy of neurologic Lyme disea

Post by Cobwebby » Mon 9 Aug 2010 0:35

Sorry Martian-didn't mean to ignore your question- guess I thought it was a rhetorical question-since there is no data discussing use of IV for more than a month, as far as I can find.

Martian wrote:
Cobwebby wrote:would oral antibiotics have crossed the brain barrier as efficiently?
That depends on the properties of the antibiotic, and it seems to me that the route (IV or oral) in principle doesn't make a difference to that. Of course some antibiotics are only suitable for oral or IV.

What does make a difference though is the dosage and timing. Since antibiotics can be time- or concentration-dependent, it could make a difference in some cases that higher peak levels can be reached with IV administration. That can be both positive and negative depending on the type of antibiotic.

But even if it would indeed be mandatory to use IV to cross the blood brain barrier efficiently, where is the evidence that this needs to be done over an extended period of time, let's say over 6 months?
The greater part of our happiness or misery
depends on our dispositions,
and not on our circumstances.
Martha Washington

User avatar
Spanky
Posts: 2762
Joined: Sun 20 Jul 2008 19:40

Re: Safety of IV antibiotic therapy of neurologic Lyme disea

Post by Spanky » Tue 10 Aug 2010 17:55

"Cobwebby":
Sorry Martian-didn't mean to ignore your question- guess I thought it was a rhetorical question-since there is no data discussing use of IV for more than a month, as far as I can find.

THIS is the part of Martian's comments that you have been ignoring:
Martian:

But even if it would indeed be mandatory to use IV to cross the blood brain barrier efficiently, where is the evidence that this needs to be done over an extended period of time, let's say over 6 months?

Cobwebby
Posts: 1716
Joined: Mon 29 Oct 2007 0:55

Re: Safety of IV antibiotic therapy of neurologic Lyme disea

Post by Cobwebby » Tue 10 Aug 2010 18:49

And this was part of my answer-since there is no data discussing use of IV for more than a month, as far as I can find. not good enough for you?
Spanky wrote:
"Cobwebby":
Sorry Martian-didn't mean to ignore your question- guess I thought it was a rhetorical question-since there is no data discussing use of IV for more than a month, as far as I can find.

THIS is the part of Martian's comments that you have been ignoring:
Martian:

But even if it would indeed be mandatory to use IV to cross the blood brain barrier efficiently, where is the evidence that this needs to be done over an extended period of time, let's say over 6 months?
The greater part of our happiness or misery
depends on our dispositions,
and not on our circumstances.
Martha Washington

User avatar
Spanky
Posts: 2762
Joined: Sun 20 Jul 2008 19:40

Re: Safety of IV antibiotic therapy of neurologic Lyme disea

Post by Spanky » Tue 10 Aug 2010 19:50

"Cobwebby":

And this was part of my answer-since there is no data discussing use of IV for more than a month, as far as I can find. not good enough for you?

Well, what that means, though, is that you can't find any evidence that supports the length of time that you were on iv.

You understand that, right?

And why do you think these studies only lasted a month?

X-member
Posts: 7682
Joined: Mon 30 Jul 2007 18:18

Re: Safety of IV antibiotic therapy of neurologic Lyme disea

Post by X-member » Thu 12 Aug 2010 14:17

Someone wrote earlier:
Quote RR " The patients were largely middle-aged (mean 41 years) women (141 women vs. 59 men), plugged into some manner of i.v. device for an average of 118 days. (Interesting sex ratio. According to the CDC surveillance data, men and women contract Lyme in about equal numbers.
I give you some Swedish info (I used Google translate with the translation):

http://www.medicallink.se/news/showNews.cfm?newsID=2425
Borrelia, women are hit harder
Press release from Linköping University

Tick season is upon us and this year, about 10 000 people in Sweden suffer from Lyme disease infection. Most people get mild symptoms and quickly becomes healthy, while others have a chronic illness. Part of the explanation lies in the immune system, shows the research at Linköping University.


The immune system appears to differ between those who recover quickly after infection and those who, despite antibiotic treatment may be further appealed. Exactly what causes this difference is not fully understood. But a new paper by Sara Jarefors of the Division of Clinical Immunology is now pointing out two specific factors that are important:

* Sex. Women undergoing menopause seem to have an immune system that are less able to kill Borrelia bacteria in comparison with men of similar age. This may be one explanation for why these women have a higher risk of developing the disease several times, although they are not tick-bitten more often than men.

* Past infection by tick fever. This is an infection caused by the bacterium Anaplasma, although the spread through tick bites. People who had such showed a weaker immune response to Borrelia.

The symptoms of Lyme disease are varied. The most common is a red, round rash. More difficult is facial paralysis, muscle pain and joint pain. Lyme disease is treated with antibiotics and the vast majority are healthy, but few patients receive any further complaints, so-called chronic Lyme disease. Why do some people get chronic Lyme disease, while others have no symptoms at all of infection is yet unknown.

The theory that the immune system is important for leaching and possibly even the cause of symptoms, is strengthened by the results of the thesis, which also increases our understanding of what lies behind chronic Lyme disease. In the future, these results lead to a possible treatment for the symptoms that arise.
Maybe an explanation why they find more women with lyme in the middle-age population?

Martian
Posts: 1944
Joined: Thu 26 Jul 2007 18:29
Location: Friesland, the Netherlands

Re: Safety of IV antibiotic therapy of neurologic Lyme disea

Post by Martian » Thu 12 Aug 2010 14:26

Carina wrote:Maybe an explanation why they find more women with lyme in the middle-age population?
I don't think this is relevant to the subject of this thread.

X-member
Posts: 7682
Joined: Mon 30 Jul 2007 18:18

Re: Safety of IV antibiotic therapy of neurologic Lyme disea

Post by X-member » Thu 12 Aug 2010 14:39

I am sorry, Martian, but i got "the feeling" that someone didn't know this, and used it to say "it can't be right" that more women in that specific age have those problems.

The subject is (of course), about the safety of IV therapy.

Post Reply