Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Medical topics with questions, information and discussion related to Lyme disease and other tick-borne diseases.
RitaA
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Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by RitaA » Mon 27 Apr 2015 22:56

Thanks for tweeting this link, Camp Other. I'm sure everyone here is interested in the preliminary results of the PLEASE study.

http://nos.nl/artikel/2032732-nijmeegse ... enten.html
Nijmeegse Lyme-studie teleurstellend voor patiënten

Vandaag, 15:30
Binnenland

Rinke van den Brink
Redacteur gezondheidszorg, deze week aanwezig op het Europese congres van microbiologen en infectiologen in Kopenhagen

Mensen die de ziekte van Lyme hebben of hebben gehad en last hebben van chronische klachten zoals pijn, vermoeidheid en aandoeningen van het zenuwstelsel, zijn niet gebaat bij een extra lange behandeling met antibiotica. Dat blijkt uit de eerste resultaten van de PLEASE-studie van het Radboudumc en de Maartenskliniek in Nijmegen.

Onderzoekster Anneleen Berende presenteerde die vandaag in Kopenhagen op de ESCMID, het Europese congres van microbiologen en infectiologen.

Uniek

De Nijmeegse studie is uniek. Niet eerder werd in een zo omvangrijke, goed opgezette studie gekeken naar het effect van een verschillende duur van de behandeling van de ziekte van Lyme met antibiotica. In totaal werden 280 volwassen patiënten verdeeld over drie groepen.

Alle groepen kregen de standaardbehandeling van twee weken antibiotica per infuus. In de volgende twaalf weken kreeg een groep een tweede antibioticum, een andere groep een combinatie van twee antibiotica en een controlegroep kreeg een placebo.

Geen verschil

De uitkomsten van het onderzoek lieten geen enkel verschil zien tussen de drie groepen. De deelnemende patiënten in alle drie de groepen gaven meteen na de behandeling een vergelijkbare, lichte verbetering aan in hun gezondheidstoestand. Drie, zes en negen maanden later zijn alle patiënten weer ondervraagd. Telkens was er geen verschil in de uitkomsten tussen de drie onderzoeksgroepen.

Voor onderzoekers van de ziekte van Lyme lijkt de uitkomst van de PLEASE-studie niet helemaal onverwacht te komen. Voor veel patiënten die met ernstige klachten kampen na het doormaken van de ziekte, zijn de resultaten een forse tegenvaller. Zij hadden op een tegengesteld resultaat gehoopt, want dat zou een mogelijke oplossing van hun klachten hebben betekend.

De ziekte van Lyme wordt veroorzaakt door de bacterie Borrelia. Teken pikken die op van dieren en kunnen mensen ermee besmetten.
Here's a rough translation from Google Translate
Nijmegen Lyme study disappointing for patients

Rinke van den Brink
Editor healthcare, this week attended the European Congress of microbiologists and infectious disease specialists in Copenhagen

People who have Lyme disease, or have had, and suffer from chronic symptoms such as pain, fatigue and diseases of the nervous system, do not benefit from an extra-long treatment with antibiotics. This is shown by the initial results of the study of the PLEASE Radboudumc and Maartenskliniek in Nijmegen.

Researcher Anneleen Berende which presented today in Copenhagen at the ESCMID, the European Congress of microbiologists and infectious disease specialists.

Unique

The Nijmegen study is unique. Never before was such a large, well-designed study looked at the effect of a different duration of treatment of Lyme disease with antibiotics. A total of 280 adult patients were divided into three groups.

All groups received the standard treatment of two weeks antibiotics intravenously. In the next twelve weeks, a group of a second antibiotic, a different group of a combination of two antibiotics and a control group was given a placebo.

No difference

The results of the study showed no difference between the three groups. Participating patients in all three groups gave immediately after treatment similar, slight improvement in their health condition. Three, six and nine months later, all patients have been questioned again. Every time there was no difference in results between the three groups.

For researchers of the Lyme disease seems to be the outcome of the PLEASE-study did not come completely unexpected. For many patients with severe symptoms after experiencing the disease, the results are a major setback. They had hoped for an opposite result because that would have meant a possible solution to their complaints.

Lyme disease is caused by the bacterium Borrelia.

Martian
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Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by Martian » Mon 27 Apr 2015 23:39

Of course one can criticize the study set-up, and this is what is going to happen in Lymeland, but if longer term treatment is the way to go with persistent symptoms after Lyme disease treatment ("chronic Lyme disease"), then wouldn't you expect at least a tiny bit of difference between the control group and the other two groups who received 12 weeks longer treatment than the 2 weeks all groups received? But it's no difference at all...

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ChronicLyme19
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Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by ChronicLyme19 » Tue 28 Apr 2015 0:27

Martian wrote:Of course one can criticize the study set-up, and this is what is going to happen in Lymeland, but if longer term treatment is the way to go with persistent symptoms after Lyme disease treatment ("chronic Lyme disease"), then wouldn't you expect at least a tiny bit of difference between the control group and the other two groups who received 12 weeks longer treatment than the 2 weeks all groups received? But it's no difference at all...
That's kinda like saying we pulled one nail out of ten in your foot, so now you can walk right? My guess is that these patients they choose to study have multiple issues and co-infections, not just Lyme. Addressing the Lyme alone isn't going to do much. You need to treat the person holistically.

This was my experience. I was placed on single therapy oral antibiotics, and while I did not get worse, it did not get me better. It was only when they addressed the babesia, MTHFR gene mutation, immune deficiency AND Lyme did I finally start getting better.
Half of what you are taught is incorrect, but which half? What if there's another half missing?

Martian
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Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by Martian » Tue 28 Apr 2015 13:30

ChronicLyme19 wrote:My guess is that these patients they choose to study have multiple issues and co-infections, not just Lyme. Addressing the Lyme alone isn't going to do much. You need to treat the person holistically.
Subjects with "multiple issues and co-infections, not just Lyme" were excluded from the study:

Some of the exclusion criteria are:
  • Subjects with a known diagnosis of HIV-seropositivity or other immune disorders. (No HIV serologic testing is required for the study).
  • Subjects with positive syphilis serology or signs of other spirochetal diseases.
  • Subjects with moderate or severe liver disease defined as alkaline phosphatase, ALAT, or ASAT greater than 3 times upper limit of normal.
  • Severe physical or psychiatric co-morbidity that interferes with participation in the study protocol, including previous medical diagnosis of rheumatic conditions, chronic fatigue syndrome or chronic pain conditions as well as insufficient command of the Dutch language.
  • Co-morbidity that could (partially) account for the symptoms of the subject (e.g. vitamin B12 deficiency, anemia, hypothyroidism).
However, I don't think they have (extensively) checked for possible tick bite co-infections, at least not all, let alone other diseases and issues. So, some subjects may have had an unknown comorbidity, but do you want to suggest all of them had? If so, why would you think so?

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Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by X-member » Tue 28 Apr 2015 14:46

Chronic Lyme disease/borreliosis stands for an active, late infection, no matter if an earlier (insufficient!) treatment has been given or not!

If they (in this study) didn't include people that (after treatment) still had signs of an active infection, then this study can only be used to say that more abx don't work on persistent symptoms efter treatment without any signs of a still active infection.

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Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by X-member » Tue 28 Apr 2015 15:25

Here is another study that only can be used* to say that more abx don't work on persistent symptoms without any signs of an active infection (after treatment):

Doxycycline-mediated effects on persistent symptoms and systemic cytokine responses post-neuroborreliosis: a randomized, prospective, cross-over study

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3507907/

* But in cases where more abx actually have effect, the study above can be used to say that it is not some kind of "anti inflammatory effect" or "placebo effect".

Martian
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Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by Martian » Tue 28 Apr 2015 15:28

X-member wrote:Chronic Lyme disease/borreliosis stands for an active, late infection, no matter if an earlier (insufficient!) treatment has been given or not!

If they (in this study) didn't include people that (after treatment) still had signs of an active infection, then this study can only be used to say that more abx don't work on persistent symptoms efter treatment without any signs of a still active infection.
You can check out the study set-up for yourself, for example see first posts and links.

I think that for the majority of Lyme patients with persistent symptoms after treatment it is hard to tell if the symptoms are caused by a persistent active infection. Mostly it is assumed, not established. If there is convincing evidence that it is the case in a patient, "even" the IDSA will recommend re-treatment with antibiotics.

So I think the study set-up resembles the common practice of ILADS-docs in terms of whom gets treated for persistent symptoms after treatment (which they call often call "chronic Lyme disease").

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Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by X-member » Tue 28 Apr 2015 15:41

Martian wrote:
So I think the study set-up resembles the common practice of ILADS-docs in terms of whom gets treated for persistent symptoms after treatment (which they call often call "chronic Lyme disease").
ILADS (Burrascano), chronic Lyme borreliosis:

http://www.borrelia-tbe.se/media/burrguide200810.pdf

Two quotes:
Illness present for at least one year....
Still have active infection ....

Martian
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Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by Martian » Tue 28 Apr 2015 16:18

This not a topic meant for a debate about the meaning of "chronic Lyme disease".

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Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by X-member » Tue 28 Apr 2015 16:27

Martian, is it possible for me to discuss an active, late infection after treatment, or shall we only talk about what is not an active infection after treatment in this thread?

My point is: We do not need any more studies on the wrong borreliosis cases!

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