PLEASE Studie Radboud

[eus]

Tegen een arts bij het tuchtcollege....
Kwaad, ach 80 % van de zaken wordt niet ontvankelijk verklaard. Gister de hele doos met spullen vernietigd, zo dat ruimt op!

[Lymefighter]

Tegen een arts bij het tuchtcollege....
Kwaad, ach 80 % van de zaken wordt niet ontvankelijk verklaard. Gister de hele doos met spullen vernietigd, zo dat ruimt op!

bizar eis. Hoop op wereldwijde verandering. Wat zou jij graag willen zien en had je liever gewenst mbt lyme verhaal?

[koster04]

Zijn er al mensen die de uitslag hebben van deze please studie?

[Martijn]

Is er nog nieuws over de PLEASE studie? Bijvoorbeeld van deelnemers aan de studie.

[eus]

Alles moet nog uitgewerkt gaan worden; daar is een vacature voor. Dus de eerste drie maanden zijn er waarschijnlijk geen resultaten bekend.

[abx]

Alles moet nog uitgewerkt gaan worden; daar is een vacature voor. Dus de eerste drie maanden zijn er waarschijnlijk geen resultaten bekend.

Ik ga direct solliciteren.

[Susann]

Weet iemand wat de " echte " reden is dat er nog steeds geen uitwerking is van dit PLEASE onderzoek wat destijds in 2011 (!!) gestart is ??

Ik zal eens informeren bij het Radboud..


Grt Susan

[Tulipano]

Eerste (?) voorlopig verslag van de PLEASE studie is te lezen op onderstaande site

http://www.biomedcentral.com/1471-2334/14/543

Persistent Lyme Empiric Antibiotic Study Europe (PLEASE) - design of a randomized controlled trial of prolonged antibiotic treatment in patients with persistent symptoms attributed to Lyme borreliosis

Met dank aan RitaA - Lymenet Europe

[eus]

Nog geen resultaten, uitsluitend de opzet van de studie.

[Tulipano]

Aangepast Eus

Discussion

The PLEASE study evaluates whether long-term antibiotic treatment of patients diagnosed with borreliosis-attributed persistent symptoms is efficient and leads to better patient outcome than short-term treatment. So far, there are few prospective, controlled data to support prolonged antibiotic treatment. Indeed, some studies have suggested positive outcomes on selected endpoints, such as persistent fatigue [17], cognitive functioning [29], quality of life [18], or clinical response rate [48], in specific groups of patients with putative persistent Lyme disease. However, these results were generally disappointing, and cannot be generalized. Other randomized clinical trials have not demonstrated beneficial effects of prolonged antibiotic treatment [10],[30]. Importantly, all of these studies were performed in North America. Borreliosis is caused by different Borrelia species in the US and Europe, with different clinical manifestations [49]. The present study will be the first randomized clinical trial to study long-term antibiotic treatment for borreliosis-attributed persistent symptoms in Europe.

The strategic choices leading to the design of a prospective, randomized, 3-arm study are complex. First, i.v. ceftriaxone followed by doxycycline is generally considered the gold standard therapy for complicated borreliosis [10]. Whereas administration of ceftriaxone for longer than 2 weeks has been advocated, a randomized, open-label study was unable to demonstrate that ceftriaxone treatment for 4 weeks would be significantly better [48].

Prolonged therapy with oral doxycycline has been associated with success in a large case series of patients with borreliosis-attributed persistent symptoms [50]. Data from another case series suggested that combined therapy with oral clarithromycin and hydroxychloroquine for at least 3 months may be at least as effective as prolonged doxycycline [51]. Hydroxychloroquine increases the lysosomal pH and is hypothesized to increase macrolide activity [52]. However, few conclusions can be drawn from those clinical studies, as they were retrospective, uncontrolled, observational studies. Based on these considerations, the present study was designed to compare a 12 weeks’ course of doxycycline to 12 weeks of clarithromycin and hydroxychloroquine versus placebo.

To provide a standard treatment for all patients, and to cover potentially undiagnosed neuroborreliosis, all randomized patients receive an open-label course of i.v. ceftriaxone for 2 weeks preceding randomized blinded study drugs. In this respect, the present study differs from previous trials comparing prolonged therapy to placebo [10],[17],[18],[29]. By applying a standardized open-label treatment to patients in all treatment arms, the study is designed to compare short-term standard treatment [15] to prolonged therapy as advocated by several position papers [16],[53]. In addition, this approach does not leave potentially active infection untreated in patients who are randomized to the control arm, and it also controls for the wide variation in prior antibiotic therapies (or lack thereof) that patients with borreliosis-attributed persistent symptoms may have received.

As the primary outcome measure, we have chosen the physical component summary score (PCS) of the RAND-36 Health Status Inventory (RAND SF-36) [22]. The RAND SF-36 is similar to the Medical Outcomes Study (MOS) 36-item Short-Form General Health Survey (SF-36) [54]. The PCS, also known as the physical health composite score (PHC) [22], is computed by a non-orthogonal scoring algorithm. Several previous studies have used the alternate (SF-36) version of the PCS, applying a principal components analysis with orthogonal factors, with mental health components contributing negatively to this PCS score [54]. This SF-36 PCS has proven difficult to interpret as the level of mental health influences the physical health score and is therefore not purely a reflection of physical health. Furthermore, the SF-36 PCS is less sensitive to change than the underlying scales, while the RAND SF-36 PCS has been shown to be sensitive to change [55]-[62]. Despite the differences in calculation of both composite scores, they do correlate highly, indicating that they do represent similar constructs [58],[59].

In conclusion, the PLEASE study is expected to provide evidence for prescribing or withholding prolonged antibiotic treatment as compared to standard short-term treatment in patients with borreliosis-attributed persistent symptoms. In addition, this study may help to define subgroups of patients who may or may not benefit from

Bron: http://www.biomedcentral.com/1471-2334/14/543