Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Medical topics with questions, information and discussion related to Lyme disease and other tick-borne diseases.
X-member
Posts: 7670
Joined: Mon 30 Jul 2007 18:18

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by X-member » Sat 2 May 2015 14:45

Sweden:

Folkhälsomyndigheten/Public Health authority

A translated quote:
Long-term treatment may be considered in certain cases where the initial treatment has not yielded sufficient results.
http://www.anvisningar.se/PageFiles/233 ... _tryck.pdf

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

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by Martian » Sat 2 May 2015 16:10

X-member wrote:http://www.lymeneteurope.org/forum/view ... =50#p42049

ChronicLyme19 wrote:
Also, it definitely does look like the patients improved during the treatment period vs afterwards and that they are just saying that the improvement wasn't great enough.
I agree, but did the patients included in this study need more than 14 days of abx (IV in this study)?
Maybe not, but it seems that a.o. the ILADS recommends longer term treatments in all cases. For example see these quotes from the ILADS guidelines 2014 that deal with treatment duration. The usefulness of such recommendations is what the PLEASE study wants to investigate.

Unfortunately, in the PLEASE study there isn't a placebo control group to compare with that also received a placebo in the first 2 weeks. All the 3 groups knew that everyone was getting ABX in those first two weeks.

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

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by Martian » Sat 2 May 2015 17:59

See LNE topic Results PLEASE study on prolonged antibiotic treatment with an abstract of the results of the PLEASE study. This abstract is included with the presentation of the study results by author Anneleen Berende at the conference in Copenhagen last week.

X-member
Posts: 7670
Joined: Mon 30 Jul 2007 18:18

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by X-member » Sat 2 May 2015 21:39

From the study:

https://clinicaltrials.gov/ct2/show/NCT01207739
Patients with presumed or proven PLD. In this study, clinical suspicion of PLD is defined as complaints of musculoskeletal pain, arthritis or arthralgia, neuralgia or sensory disturbances (such as paresthesias or dysesthesias), neuropsychological or cognitive disorders, and persistent fatigue, that are:

temporally related to an episode of erythema migrans or otherwise proven symptomatic Lyme disease (defined as within 4 months after erythema migrans as assessed by a physician, or positive biopsy, PCR, culture, intrathecal B. burgdorferi antibodies), OR

accompanied by a positive B. burgdorferi IgG or IgM immunoblot (as defined by strict criteria in line with the European Union Concerted Action on Lyme Borreliosis (EUCALB)), regardless of prior ELISA IgG/IgM screening results.
But radicale wrote earlier:

http://www.lymeneteurope.org/forum/view ... =50#p42052

A quote:
A large portion of patients (from the study) had persisting symptoms after earlier treatment, presumed to be due to an active borrelia (or some other) infection.
I can not find any information that the patients included in this study have had any treatment at all before this study was done. But if they had, then this study must have proved that an active persistent borreliosis after an earlier treatment actually exist, don't you think?

http://www.lymeneteurope.org/forum/view ... f=5&t=5776

A quote (from the thread above):
The mean PCS was significantly improved at EOT compared to baseline (p<0.001, for all groups).
Last edited by X-member on Sat 2 May 2015 22:45, edited 1 time in total.

duncan
Posts: 1370
Joined: Wed 5 Sep 2012 18:48

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by duncan » Sat 2 May 2015 21:44

Within four months of an EM or clinical assessment? So, could have been four months? Or three? Or two? Hell, could have been two days?

I would qualify such peeps as "not very late stage Lyme disease." And that's being kind. This is not disseminated. Geez.

No wonder such aggressive treatment worked so well. Might as well just have called them acute.

Now, come back with a study of people infected four YEARS before, and with clinically confirmed EMs in their past, who remain symptomatic. Then let's see how the results play out.

X-member
Posts: 7670
Joined: Mon 30 Jul 2007 18:18

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by X-member » Sat 2 May 2015 21:49

The mean duration of the patients symptoms was more than 2 years*. So it was not only patients with early borreliosis.

* Source:

http://eccmidlive.org/resources/persist ... eliosis--2
Last edited by X-member on Sun 3 May 2015 0:52, edited 1 time in total.

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

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by Martian » Sat 2 May 2015 22:10

X-member wrote:I can not find any information that the patients included in this study have had any treatment at all before this study was done. But if they had, then this study must have proved that an active persistent borreliosis after an earlier treatment actually exist, don't you think?
It is mentioned in the presentation at 5m40s and shown with slide 19:

250 of 280 patients (89%) had received previous antibiotic treatment.

So the final study results should also differentiate between the patients who had received previous antibiotic treatment, and the patients who had not received previous antibiotic treatment.

It is very well possible that the patients who had not received previous antibiotic treatment, are largely responsible for the improvement seen in all 3 groups. Further, the placebo-effect needs to be taken into account.

X-member
Posts: 7670
Joined: Mon 30 Jul 2007 18:18

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by X-member » Sat 2 May 2015 22:13

Thank you Martian!

I must have missed it.

X-member
Posts: 7670
Joined: Mon 30 Jul 2007 18:18

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by X-member » Sat 2 May 2015 22:34

So this was not a study on patients with confirmed persistent Lyme disease after treatment. Only on patients that maybe had it.

X-member
Posts: 7670
Joined: Mon 30 Jul 2007 18:18

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by X-member » Sat 2 May 2015 23:03

http://www.lymeneteurope.org/forum/view ... f=5&t=5776
The mean PCS was significantly improved at EOT compared to baseline (p<0.001, for all groups).
The result above can also include patients that have had earlier treatment, and actually had (when they was included in this study) an active, persistent borreliosis. We don't know, do we?

Post Reply