title: Bee Venom for the Treatment of Parkinson Disease - A Randomized Controlled Clinical Trial.
abstract: 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.
  
  
  
  ClinicalTrials.gov NCT01341431.
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Andreas
authors.initials: A
authors.lastname: Hartmann
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Julia
authors.initials: J
authors.lastname: Müllner
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Niklaus
authors.initials: N
authors.lastname: Meier
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Helke
authors.initials: H
authors.lastname: Hesekamp
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Priscilla
authors.initials: P
authors.lastname: van Meerbeeck
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), Service de Médecine Nucléaire, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Marie-Odile
authors.initials: MO
authors.lastname: Habert
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), Service de Médecine Nucléaire, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Aurélie
authors.initials: A
authors.lastname: Kas
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), Unité de Recherche Clinique, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Marie-Laure
authors.initials: ML
authors.lastname: Tanguy
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), Unité de Recherche Clinique, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Merry
authors.initials: M
authors.lastname: Mazmanian
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), Unité de Recherche Clinique, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Oya
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), Service de Dermatologie et d'Allérgie, Hôpital Tenon, Paris, France.
authors.forename: Nissen
authors.initials: N
authors.lastname: Abuaf
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), Service de Dermatologie et d'Allérgie, Hôpital Tenon, Paris, France.
authors.forename: Hafida
authors.initials: H
authors.lastname: Gaouar
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), Agence Générale des Equipements et Produits de Santé, Paris, France.
authors.forename: Sabrina
authors.initials: S
authors.lastname: Salhi
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), Pharmacie, Secteur Essais Cliniques et Dispensation des Médicaments aux Patients Externes, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Fanny
authors.initials: F
authors.lastname: Charbonnier-Beaupel
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), Pharmacie, Secteur Essais Cliniques et Dispensation des Médicaments aux Patients Externes, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Marie-Hélène
authors.initials: MH
authors.lastname: Fievet
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), Service de Neuroradiologie, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Damien
authors.initials: D
authors.lastname: Galanaud
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Arguillere
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Roze
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Degos
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: David
authors.initials: D
authors.lastname: Grabli
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Lucette
authors.initials: L
authors.lastname: Lacomblez
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Hubsch
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Vidailhet
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Bonnet
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Corvol
authors.affiliation: Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Michael
authors.initials: M
authors.lastname: Schüpbach
mesh_terms: D001514:Bee Venoms / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use*; D050483:Dopamine Plasma Membrane Transport Proteins / Q000378:metabolism; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D007074:Immunoglobulin G / Q000276:immunology; D007267:Injections; D007700:Kinetics; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy* / Q000378:metabolism; D016896:Treatment Outcome
chemical_list: D001514:Bee Venoms; D050483:Dopamine Plasma Membrane Transport Proteins; D007074:Immunoglobulin G; D007073:Immunoglobulin E