Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

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

Post by duncan » Sun 3 May 2015 0:07

Exclusion criteria precluded anyone with Neuroborreliosis.

nnecker
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Joined: Wed 19 Dec 2012 22:57

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by nnecker » Sun 3 May 2015 0:27

Inclusion criteria:

neuropsychological/cognitive disorders

Patients had a mean duration of symptoms of 2.5 years.What do you call that?

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

Post by duncan » Sun 3 May 2015 0:34

Conflicted and ambivalent cohort criteria? :)

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

Post by nnecker » Sun 3 May 2015 0:45

86% of the patients had neurocognitive symptoms for a mean duration of 2.5 years.What's so conflicting about that?

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

Post by duncan » Sun 3 May 2015 1:11

So almost 9 out of 10 of these patients suffered with neurocognitive symptoms but NONE had NB. :?

And no one in this study reported any statistically significant improvement? Really?

I would think SOMEONE would improve just, well, because that's the way the world works, you see. It is possible outliers were buried in the group data, but I dunno.

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

Post by velvetmagnetta » Sun 3 May 2015 11:24

I have a question for Martian:

In reference to that graph that ChronicLyme19 posted on page 6 of this thread:

http://www.lymeneteurope.org/forum/view ... 0&start=50

Martian, you said:
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.
Looking at that graph, especially at the initial 14 weeks of treatment, and considering that many people from Lyme-Land (with no positive serology indicating that they ever really had Lyme disease) may have participated in this study, would you say that the placebo effect is really that strong?

And it is striking to me that if several test subjects never had any indication of ever having Lyme disease (rash, positive serology) but merely presented with subjective clinical symptoms of a non-acute infection, that there would be such a sharp increase in the Rand well-being score in those first 14 weeks.

Martian, are you saying that - just considering the first 14 weeks on the above graph - the placebo effect could indeed be that powerful?

Martian
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Location: Friesland, the Netherlands

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by Martian » Sun 3 May 2015 17:59

velvetmagnetta wrote:I have a question for Martian:

In reference to that graph that ChronicLyme19 posted on page 6 of this thread:

http://www.lymeneteurope.org/forum/view ... 0&start=50

Martian, you said:
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.
Looking at that graph, especially at the initial 14 weeks of treatment, and considering that many people from Lyme-Land (with no positive serology indicating that they ever really had Lyme disease) may have participated in this study, would you say that the placebo effect is really that strong?

And it is striking to me that if several test subjects never had any indication of ever having Lyme disease (rash, positive serology) but merely presented with subjective clinical symptoms of a non-acute infection, that there would be such a sharp increase in the Rand well-being score in those first 14 weeks.

Martian, are you saying that - just considering the first 14 weeks on the above graph - the placebo effect could indeed be that powerful?
If I look at the inclusion criteria, it seems to me that none of the study subjects were merely presenting with subjective clinical symptoms. The subjects needed to have had an erythema migrans or otherwise proven symptomatic Lyme disease and/or a positive B. burgdorferi IgG or IgM immunoblot.

Some of the inclusion criteria are:

Source: 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.
From the presentation, slide 19, it becomes clear that 78% of the subjects had a positive B. burgdorferi serology.

Further, 11% of the subjects did not have had previous antibiotic treatment, and from the subjects who have had previous antibiotic treatment, we don't know what percentage truly had an active persistent infection, but I assume at least some of them did.

So, I think it is not possible to say if there was a strong placebo effect, since probably a significant number of subjects had an active (persistent) infection and therefore were expected to benefit from the treatment.

Martian
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Location: Friesland, the Netherlands

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by Martian » Sun 3 May 2015 18:23

X-member wrote:So this was not a study on patients with confirmed persistent Lyme disease after treatment. Only on patients that maybe had it.
Not necessarily. It is possible that some subjects had a confirmed (persistent) Lyme disease by a positive biopsy, PCR, or culture when they joined the study. We don't know (yet).

X-member wrote: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?
Yes, it is possible, and maybe it was conformed in some cases. I hope the full-text of the study will answer these and other questions. The current data is not showing enough details, only summaries.

admin
Site Admin
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Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by admin » Thu 23 Jun 2016 14:01

The last 4 posts of this topic have been split to a new topic: Randomized Trial of Longer-Term Therapy for Symptoms Attributed to Lyme Disease. It discusses the published study.

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