March 31st NEJM: Netherlands Group Publish Study -3 months of Antibiotics Fails in Chronic Lyme

[valentinelynx]

So I have a question. Why not take this study at face value? What if antibiotics really don't work, maybe because the participants really didn't have Lyme? It doesn't mean it's all in your heads, though I can see the worry that some people might jump to that conclusion.

But what if all the belief, attention, time, money being spent on chronic Lyme is actually contributing to the real cause and effective treatments continuing to be elusive?

The study in no way shows that "antibiotics don't work." They trailed two regimens that no one who actually treats Chronic Lyme disease would actually use: too short a treatment period, wrong doses and mono therapy rather than using multiple antibiotics at high doses.

If someone published a study that showed that 3 months of doxycycline did not cure "chronic tuberculosis" (there is no other kind...) no one would eagerly accept this as conclusive evidence that antibiotics don't work for TB! Likewise, a trial of AZT alone for HIV treatment would fail to suppress HIV sufficiently to save lives, but this does not mean that antivirals are useless in HIV! A certain amount of empiric therapy is needed to identify protocols that are likely to be effective and then these must be tested with controlled trials. There is a lot of experience in the "Lyme Literate" world on what treatments appear to work. If clinical researchers really want to contribute to the science of treatment, they would consult with the experts treating Lyme on the front lines and test the protocols that appear to be working.

For starters, they could try the ILADs Clinical Guidelines, which according to Lorraine Johnson of Lymedisease.org (who is also an author of the Guidelines) are "the first Lyme guidelines which comply with the Institute of Medicine’s new standards for rigorous evidence assessment and patient engagement in the development process." The ILADs Guidelines have been accepted by the the National Guideline Clearinghouse, which has removed the IDSA guidelines.

One of the recommendations of the ILADs Guidelines (recommended with "very low-quality evidence, meaning it is based on expert opinion, a common basis of recommendation in guidelines, and an indicator of the strong need for specific research on the recommended treatment) is as follows: "For patients with significant impairments and/or a minimal or absent therapeutic response, a combination of oral antibiotics, injectable penicillin G benzathine or iv. ceftriaxone (with the latter two used alone or in combination with other agents) is preferred. For patients who experienced disease progression despite earlier therapy, treatment with injectable penicillin G benzathine or iv. ceftriaxone, alone or in combination with other antibiotics, is advisable."

 

[alex3619]

First impression - the ceftriaxone wasn´t given for long enough, the doxy was at too low dose, and they effectively only used monotherapy.

I do not know enough about Lyme protocols to comment, but there is a long history in medicine of research using inappropriate therapies and making inappropriate conclusions.

Lots of this was with new drugs, they compared them to old drugs, but old drugs with an ineffective protocol. They could then go on to say that their drug was better than the other drug.

We also saw this in the PACE trial. A comparison arm with Adaptive Pacing was used, where Adaptive Pacing was a new therapy in conflict with the principles of pacing. However by making that comparison they then implied that CBT and GET were better than pacing.

To discuss the implications of this would require a deep understanding of Lyme protocols.

 

[msf]

The study in no way shows that "antibiotics don't work." They trailed two regimens that no one who actually treats Chronic Lyme disease would actually use: too short a treatment period, wrong doses and mono therapy rather than using multiple antibiotics at high doses.

If someone published a study that showed that 3 months of doxycycline did not cure "chronic tuberculosis" (there is no other kind...) no one would eagerly accept this as conclusive evidence that antibiotics don't work for TB! Likewise, a trial of AZT alone for HIV treatment would fail to suppress HIV sufficiently to save lives, but this does not mean that antivirals are useless in HIV! A certain amount of empiric therapy is needed to identify protocols that are likely to be effective and then these must be tested with controlled trials. There is a lot of experience in the "Lyme Literate" world on what treatments appear to work. If clinical researchers really want to contribute to the science of treatment, they would consult with the experts treating Lyme on the front lines and test the protocols that appear to be working.

For starters, they could try the ILADs Clinical Guidelines, which according to Lorraine Johnson of Lymedisease.org (who is also an author of the Guidelines) are "the first Lyme guidelines which comply with the Institute of Medicine’s new standards for rigorous evidence assessment and patient engagement in the development process." The ILADs Guidelines have been accepted by the the National Guideline Clearinghouse, which has removed the IDSA guidelines.

One of the recommendations of the ILADs Guidelines (recommended with "very low-quality evidence, meaning it is based on expert opinion, a common basis of recommendation in guidelines, and an indicator of the strong need for specific research on the recommended treatment) is as follows: "For patients with significant impairments and/or a minimal or absent therapeutic response, a combination of oral antibiotics, injectable penicillin G benzathine or iv. ceftriaxone (with the latter two used alone or in combination with other agents) is preferred. For patients who experienced disease progression despite earlier therapy, treatment with injectable penicillin G benzathine or iv. ceftriaxone, alone or in combination with other antibiotics, is advisable."

Yes, it goes on to say that the reason they accepted very-low quality evidence was because of the negligible risks of antibiotic therapy, which seems to be borne out by this study (which is one of the few conclusions that can be drawn from it).

 

[duncan]

@alex3619 , having a deep understanding of Lyme protocols is helpful, but not essential, to grasp the implications of studies like this.

What is essential is a deep understanding of Lyme politics. To get that, you need to immerse yourself in its history - and I'm sure you've better things to do than that.

As with ME/CFS, Science associated with Lyme and other TBD's in many ways has given way to scientists posturing. Many feel it has given way to manufactured-to-spec study results. It has with gusto replaced the voice of the patient as a valuable variable with derision and feigned suspicion. It is agenda-driven; hypothesis forming and proving somehow were lost along the way (back in the early 90's, if not even earlier).

ME/CFS concerns would do well to study how the CDC and NIH deal with Lyme. It's a case study in sleight-of-hand dismissing, despite known pathogens being in play, and often demonstrably so. If disappearing a disease like Lyme - with an established etiology - can be orchestrated in plain sight, under the scrutiny and guidance of world-class research institutions, what do you imagine can be done with ME/CFS?

 

[Antares in NYC]

I suggest you guys check the comments section for the replies to this study. Mostly come from doctors. They are nailing it:
http://www.nejm.org/doi/full/10.1056/NEJMoa1505425#t=comments

Most comments point one interesting thing about the study that seems to completely contradict its premise: the fact that the short dose of IV rocephin actually did help all subject groups. Also the fact that the extended 12 weeks of oral abx used drugs that are not usually recommended to treat Lyme.

 

[valentinelynx]

I suggest you guys check the comments section for the replies to this study. Mostly come from doctors. They are nailing it:
http://www.nejm.org/doi/full/10.1056/NEJMoa1505425#t=comments

Most comments point one interesting thing about the study that seems to completely contradict its premise: the fact that the short dose of IV rocephin actually did help all subject groups. Also the fact that the extended 12 weeks of oral abx used drugs that are not usually recommended to treat Lyme.

You're right, the comments are pretty awesome. Now if only the *&%$! media would read the comment before parroting the "talking point" that "longer term antibiotics don't work...".

Several of the comments call for access to the raw data, and one points out that the paper doesn't even describe the baseline characteristics of the subjects... a bizarre and egregious omission!

and the War continues... but maybe we're seeing some troops rallying to our cause?

 

[valentinelynx]

In a HuffPo blog, David Michael Connor has written a nice rebuttal of the NEJM article (and the Forbes article that promoted its findings as gospel:

New Lyme Disease Study Reveals Strong Reporting Bias