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

被引:38
|
作者
Hartmann, Andreas [1 ]
Mullner, Julia [1 ]
Meier, Niklaus [1 ]
Hesekamp, Helke [1 ]
van Meerbeeck, Priscilla [1 ]
Habert, Marie-Odile [2 ]
Kas, Aurelie [2 ]
Tanguy, Marie-Laure [3 ]
Mazmanian, Merry [3 ]
Oya, Herve [3 ]
Abuaf, Nissen [4 ]
Gaouar, Hafida [4 ]
Salhi, Sabrina [5 ]
Charbonnier-Beaupel, Fanny [6 ]
Fievet, Marie-Helene [6 ]
Galanaud, Damien [7 ]
Arguillere, Sophie [1 ]
Roze, Emmanuel [1 ]
Degos, Bertrand [1 ]
Grabli, David [1 ]
Lacomblez, Lucette [1 ]
Hubsch, Cecile [1 ]
Vidailhet, Marie [1 ]
Bonnet, Anne-Marie [1 ]
Corvol, Jean-Christophe [1 ]
Schupbach, Michael [1 ]
机构
[1] UPMC, Hop La Pitie Salpetriere, AP HP,Dept Malad Syst Nerveux, INSERM,ICM,Ctr Invest Clin Pitie Neurosci,CIC 142, Paris, France
[2] Hop La Pitie Salpetriere, AP HP, Nucl Med Serv, Paris, France
[3] Hop La Pitie Salpetriere, AP HP, Unite Rech Clin, Paris, France
[4] Hop Tenon, AP HP, Serv Dermatol & Allergie, Paris, France
[5] AP HP, Agence Gen Equipements & Prod Sante, Paris, France
[6] Hop La Pitie Salpetriere, AP HP, Pharm, Sect Essais Clin & Dispensat Medicaments Aux Pati, Paris, France
[7] Hop La Pitie Salpetriere, AP HP, Serv Neuroradiol, Paris, France
来源
PLOS ONE | 2016年 / 11卷 / 07期
基金
瑞士国家科学基金会;
关键词
CA2+-ACTIVATED K+ CHANNELS; SMALL-CONDUCTANCE; DOPAMINERGIC-NEURONS; MOUSE MODEL; ACUPUNCTURE; STIMULATION; THERAPY; PATTERN; MEMORY;
D O I
10.1371/journal.pone.0158235
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
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 mu g) 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 [1231]-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.
引用
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页数:15
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