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PLoS One. 2016 Jul 12;11(7):e0158235. doi: 10.1371/journal.pone.0158235. eCollection 2016.

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

Author information

1
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.
2
Assistance Publique Hôpitaux de Paris (APHP), Service de Médecine Nucléaire, Hôpital Pitié-Salpêtrière, Paris, France.
3
Assistance Publique Hôpitaux de Paris (APHP), Unité de Recherche Clinique, Hôpital Pitié-Salpêtrière, Paris, France.
4
Assistance Publique Hôpitaux de Paris (APHP), Service de Dermatologie et d'Allérgie, Hôpital Tenon, Paris, France.
5
Assistance Publique Hôpitaux de Paris (APHP), Agence Générale des Equipements et Produits de Santé, Paris, France.
6
Assistance Publique Hôpitaux de Paris (APHP), Pharmacie, Secteur Essais Cliniques et Dispensation des Médicaments aux Patients Externes, Hôpital Pitié-Salpêtrière, Paris, France.
7
Assistance Publique Hôpitaux de Paris (APHP), Service de Neuroradiologie, Hôpital Pitié-Salpêtrière, Paris, France.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01341431.

PMID:
27403743
PMCID:
PMC4942057
DOI:
10.1371/journal.pone.0158235
[Indexed for MEDLINE]
Free PMC Article

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