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Bee Venom for the Treatment of Parkinson Disease – A Randomized Controlled Clinical Trial

In the present study, we examined the potential symptomatic and/or disease-modifying effects of monthly bee venom injections compared to placebo in moderatly affected Parkinson disease patients. We conducted a prospective, randomized double-blind study in 40 Parkinson disease patients at Hoehn &...

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Autores principales: Hartmann, Andreas, Müllner, Julia, Meier, Niklaus, Hesekamp, Helke, van Meerbeeck, Priscilla, Habert, Marie-Odile, Kas, Aurélie, Tanguy, Marie-Laure, Mazmanian, Merry, Oya, Hervé, Abuaf, Nissen, Gaouar, Hafida, Salhi, Sabrina, Charbonnier-Beaupel, Fanny, Fievet, Marie-Hélène, Galanaud, Damien, Arguillere, Sophie, Roze, Emmanuel, Degos, Bertrand, Grabli, David, Lacomblez, Lucette, Hubsch, Cécile, Vidailhet, Marie, Bonnet, Anne-Marie, Corvol, Jean-Christophe, Schüpbach, Michael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4942057/
https://www.ncbi.nlm.nih.gov/pubmed/27403743
http://dx.doi.org/10.1371/journal.pone.0158235
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author Hartmann, Andreas
Müllner, Julia
Meier, Niklaus
Hesekamp, Helke
van Meerbeeck, Priscilla
Habert, Marie-Odile
Kas, Aurélie
Tanguy, Marie-Laure
Mazmanian, Merry
Oya, Hervé
Abuaf, Nissen
Gaouar, Hafida
Salhi, Sabrina
Charbonnier-Beaupel, Fanny
Fievet, Marie-Hélène
Galanaud, Damien
Arguillere, Sophie
Roze, Emmanuel
Degos, Bertrand
Grabli, David
Lacomblez, Lucette
Hubsch, Cécile
Vidailhet, Marie
Bonnet, Anne-Marie
Corvol, Jean-Christophe
Schüpbach, Michael
author_facet Hartmann, Andreas
Müllner, Julia
Meier, Niklaus
Hesekamp, Helke
van Meerbeeck, Priscilla
Habert, Marie-Odile
Kas, Aurélie
Tanguy, Marie-Laure
Mazmanian, Merry
Oya, Hervé
Abuaf, Nissen
Gaouar, Hafida
Salhi, Sabrina
Charbonnier-Beaupel, Fanny
Fievet, Marie-Hélène
Galanaud, Damien
Arguillere, Sophie
Roze, Emmanuel
Degos, Bertrand
Grabli, David
Lacomblez, Lucette
Hubsch, Cécile
Vidailhet, Marie
Bonnet, Anne-Marie
Corvol, Jean-Christophe
Schüpbach, Michael
author_sort Hartmann, Andreas
collection PubMed
description In the present study, we examined the potential symptomatic and/or disease-modifying effects of monthly bee venom injections compared to placebo in moderatly affected Parkinson disease patients. We conducted a prospective, randomized double-blind study in 40 Parkinson disease patients at Hoehn & Yahr stages 1.5 to 3 who were either assigned to monthly bee venom injections or equivalent volumes of saline (treatment/placebo group: n = 20/20). The primary objective of this study was to assess a potential symptomatic effect of s.c. bee venom injections (100 μg) compared to placebo 11 months after initiation of therapy on United Parkinson’s Disease Rating Scale (UPDRS) III scores in the « off » condition pre-and post-injection at a 60 minute interval. Secondary objectives included the evolution of UPDRS III scores over the study period and [123I]-FP-CIT scans to evaluate disease progression. Finally, safety was assessed by monitoring specific IgE against bee venom and skin tests when necessary. After an 11 month period of monthly administration, bee venom did not significantly decrease UPDRS III scores in the « off » condition. Also, UPDRS III scores over the study course, and nuclear imaging, did not differ significantly between treatment groups. Four patients were excluded during the trial due to positive skin tests but no systemic allergic reaction was recorded. After an initial increase, specific IgE against bee venom decreased in all patients completing the trial. This study did not evidence any clear symptomatic or disease-modifying effects of monthly bee venom injections over an 11 month period compared to placebo using a standard bee venom allergy desensitization protocol in Parkinson disease patients. However, bee venom administration appeared safe in non-allergic subjects. Thus, we suggest that higher administration frequency and possibly higher individual doses of bee venom may reveal its potency in treating Parkinson disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT01341431
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spelling pubmed-49420572016-08-01 Bee Venom for the Treatment of Parkinson Disease – A Randomized Controlled Clinical Trial Hartmann, Andreas Müllner, Julia Meier, Niklaus Hesekamp, Helke van Meerbeeck, Priscilla Habert, Marie-Odile Kas, Aurélie Tanguy, Marie-Laure Mazmanian, Merry Oya, Hervé Abuaf, Nissen Gaouar, Hafida Salhi, Sabrina Charbonnier-Beaupel, Fanny Fievet, Marie-Hélène Galanaud, Damien Arguillere, Sophie Roze, Emmanuel Degos, Bertrand Grabli, David Lacomblez, Lucette Hubsch, Cécile Vidailhet, Marie Bonnet, Anne-Marie Corvol, Jean-Christophe Schüpbach, Michael PLoS One Research Article In the present study, we examined the potential symptomatic and/or disease-modifying effects of monthly bee venom injections compared to placebo in moderatly affected Parkinson disease patients. We conducted a prospective, randomized double-blind study in 40 Parkinson disease patients at Hoehn & Yahr stages 1.5 to 3 who were either assigned to monthly bee venom injections or equivalent volumes of saline (treatment/placebo group: n = 20/20). The primary objective of this study was to assess a potential symptomatic effect of s.c. bee venom injections (100 μg) compared to placebo 11 months after initiation of therapy on United Parkinson’s Disease Rating Scale (UPDRS) III scores in the « off » condition pre-and post-injection at a 60 minute interval. Secondary objectives included the evolution of UPDRS III scores over the study period and [123I]-FP-CIT scans to evaluate disease progression. Finally, safety was assessed by monitoring specific IgE against bee venom and skin tests when necessary. After an 11 month period of monthly administration, bee venom did not significantly decrease UPDRS III scores in the « off » condition. Also, UPDRS III scores over the study course, and nuclear imaging, did not differ significantly between treatment groups. Four patients were excluded during the trial due to positive skin tests but no systemic allergic reaction was recorded. After an initial increase, specific IgE against bee venom decreased in all patients completing the trial. This study did not evidence any clear symptomatic or disease-modifying effects of monthly bee venom injections over an 11 month period compared to placebo using a standard bee venom allergy desensitization protocol in Parkinson disease patients. However, bee venom administration appeared safe in non-allergic subjects. Thus, we suggest that higher administration frequency and possibly higher individual doses of bee venom may reveal its potency in treating Parkinson disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT01341431 Public Library of Science 2016-07-12 /pmc/articles/PMC4942057/ /pubmed/27403743 http://dx.doi.org/10.1371/journal.pone.0158235 Text en © 2016 Hartmann et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Hartmann, Andreas
Müllner, Julia
Meier, Niklaus
Hesekamp, Helke
van Meerbeeck, Priscilla
Habert, Marie-Odile
Kas, Aurélie
Tanguy, Marie-Laure
Mazmanian, Merry
Oya, Hervé
Abuaf, Nissen
Gaouar, Hafida
Salhi, Sabrina
Charbonnier-Beaupel, Fanny
Fievet, Marie-Hélène
Galanaud, Damien
Arguillere, Sophie
Roze, Emmanuel
Degos, Bertrand
Grabli, David
Lacomblez, Lucette
Hubsch, Cécile
Vidailhet, Marie
Bonnet, Anne-Marie
Corvol, Jean-Christophe
Schüpbach, Michael
Bee Venom for the Treatment of Parkinson Disease – A Randomized Controlled Clinical Trial
title Bee Venom for the Treatment of Parkinson Disease – A Randomized Controlled Clinical Trial
title_full Bee Venom for the Treatment of Parkinson Disease – A Randomized Controlled Clinical Trial
title_fullStr Bee Venom for the Treatment of Parkinson Disease – A Randomized Controlled Clinical Trial
title_full_unstemmed Bee Venom for the Treatment of Parkinson Disease – A Randomized Controlled Clinical Trial
title_short Bee Venom for the Treatment of Parkinson Disease – A Randomized Controlled Clinical Trial
title_sort bee venom for the treatment of parkinson disease – a randomized controlled clinical trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4942057/
https://www.ncbi.nlm.nih.gov/pubmed/27403743
http://dx.doi.org/10.1371/journal.pone.0158235
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