Placebo effects in allergen immunotherapy-An EAACI Task Force Position Paper

被引:42
|
作者
Pfaar, Oliver [1 ]
Agache, Ioana [2 ]
Bergmann, Karl-Christian [3 ,4 ,5 ,6 ]
Bindslev-Jensen, Carsten [7 ,8 ]
Bousquet, Jean [9 ,10 ]
Creticos, Peter S. [11 ,12 ]
Devillier, Philippe [13 ]
Durham, Stephen R. [14 ]
Hellings, Peter [15 ,16 ,17 ]
Kaul, Susanne [18 ]
Kleine-Tebbe, Joerg [19 ,20 ]
Klimek, Ludger [21 ]
Jacobsen, Lars [22 ]
Jutel, Marek [23 ,24 ]
Muraro, Antonella [25 ]
Papadopoulos, Nikolaos G. [26 ,27 ]
Rief, Winfried [28 ]
Scadding, Glenis K. [29 ]
Schedlowski, Manfred [30 ]
Shamji, Mohamed H. [31 ,32 ]
Sturm, Gunter [33 ,34 ]
van Ree, Ronald [35 ,36 ]
Vidal, Carmen [37 ,38 ]
Vieths, Stefan [18 ]
Wedi, Bettina [39 ]
Gerth van Wijk, Roy [40 ]
Frew, Anthony J. [41 ,42 ]
机构
[1] Philipps Univ Marburg, Univ Hosp Marburg, Sect Rhinol & Allergy, Dept Otorhinolaryngol Head & Neck Surg, Baldingerstr, D-35043 Marburg, Germany
[2] Transylvania Univ, Brasov, Romania
[3] Charite Univ Med Berlin, Berlin, Germany
[4] Free Univ Berlin, Berlin, Germany
[5] Humboldt Univ, Berlin, Germany
[6] Berlin Inst Hlth, Allergy Ctr Charite, Berlin, Germany
[7] Odense Univ Hosp, Dept Dermatol, Odense Res Ctr Anaphylaxis ORCA, Odense, Denmark
[8] Odense Univ Hosp, Allergy Ctr, Odense Res Ctr Anaphylaxis ORCA, Odense, Denmark
[9] MACVIA France, Montpellier, France
[10] Univ Hosp Montpellier, Montpellier, France
[11] Johns Hopkins Univ, Sch Med, Div Allergy & Clin Immunol, Baltimore, MD USA
[12] Creticos Res Grp, Crownsville, MD USA
[13] Univ Paris Saclay, Hop Foch, Dept Airway Dis, Exhal, Suresnes, France
[14] Imperial Coll London, Natl Heart & Lung Inst, Allergy & Clin Immunol, London, England
[15] Univ Hosp Leuven, Dept Otorhinolaryngol, Leuven, Belgium
[16] Univ Amsterdam, Acad Med Ctr, Dept Otorhinolaryngol, Amsterdam, Netherlands
[17] Univ Ghent, Dept Neurosci, Ghent, Belgium
[18] Paul Ehrlich Inst, Fed Inst Vaccines & Biomed, Langen, Germany
[19] Outpatient Clin, Allergy & Asthma Ctr Westend, Berlin, Germany
[20] Clin Res Ctr, Berlin, Germany
[21] Ctr Rhinol & Allergol, Wiesbaden, Germany
[22] Allergy Learning & Consulting, ALC, Copenhagen, Denmark
[23] Wroclaw Med Univ, Dept Clin Immunol, Wroclaw, Poland
[24] All Med Med Res Inst, Wroclaw, Poland
[25] Univ Padua, Food Allergy Referral Ctr, Hosp Padua, Padua, Italy
[26] Univ Manchester, Div Infect Immun & Resp Med, Manchester, Lancs, England
[27] Univ Athens, Allergy Dept, Pediat Clin 2, Athens, Greece
[28] Philipps Univ Marburg, Dept Clin Psychol & Psychotherapy, Marburg, Germany
[29] Univ Coll London Hosp, RNTNE Hosp, London, England
[30] Univ Clin Essen, Inst Med Psychol & Behav Immunobiol, Essen, Germany
[31] Imperial Coll London, Natl Heart & Lung Inst, London, England
[32] Imperial Coll London, NIHR Biomed Res Ctr, London, England
[33] Med Univ Graz, Dept Dermatol & Venereol, Graz, Austria
[34] Allergy Outpatient Clin Reumannpl, Vienna, Austria
[35] Univ Amsterdam, Med Ctr, Dept Expt Immunol, Amsterdam, Netherlands
[36] Univ Amsterdam, Med Ctr, Dept Otorhinolaryngol, Amsterdam, Netherlands
[37] Univ Santiago Compostela, Dept Allergy, Santiago, Spain
[38] Univ Santiago Compostela, Fac Med, Santiago, Spain
[39] Hannover Med Sch, Comprehens Allergy Ctr, Dept Dermatol & Allergy, Hannover, Germany
[40] Erasmus MC, Dept Internal Med, Sect Allergol, Rotterdam, Netherlands
[41] Univ Sussex, Royal Sussex Cty Hosp, Dept Resp Med, Brighton, E Sussex, England
[42] Univ Brighton, Brighton, E Sussex, England
关键词
allergy; allergen immunotherapy; clinical trials; methods; placebo effects; Position Paper; GRASS-POLLEN IMMUNOTHERAPY; SKIN WHEAL RESPONSES; CLINICAL-TRIALS; DOUBLE-BLIND; MECHANISMS; ASTHMA; EFFICACY; RHINITIS; RHINOCONJUNCTIVITIS; NOCEBO;
D O I
10.1111/all.14331
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
The placebo (Latin "I will please") effect commonly occurs in clinical trials. The psychological and physiological factors associated with patients' expectations about a treatment's positive and negative effects have yet to be well characterized, although a functional prefrontal cortex and intense bidirectional communication between the central nervous system and the immune system appear to be prerequisites for a placebo effect. The use of placebo raises certain ethical issues, especially if patients in a placebo group are denied an effective treatment for a long period of time. The placebo effect appears to be relatively large (up to 77%, relative to pretreatment scores) in controlled clinical trials of allergen immunotherapy (AIT), such as the pivotal, double-blind, placebo-controlled (DBPC) randomized clinical trials currently required by regulatory authorities worldwide. The European Academy of Allergy and Clinical Immunology (EAACI) therefore initiated a Task Force, in order to better understand the placebo effect in AIT and its specific role in comorbidities, blinding issues, adherence, measurement time points, variability and the natural course of the disease. In this Position Paper, the EAACI Task Force highlights several important topics regarding the placebo effect in AIT such as a) regulatory aspects, b) neuroimmunological and psychological mechanisms, c) placebo effect sizes in AIT trials, d) methodological limitations in AIT trial design and e) potential solutions in future AIT trial design. In conclusion, this Position Paper aims to examine the methodological problem of placebo in AIT from different aspects and also to highlight unmet needs and possible solutions for future trials.
引用
收藏
页码:629 / 647
页数:19
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