Skip to main content

Tipp

Weitere Artikel dieser Ausgabe durch Wischen aufrufen

Erschienen in: rheuma plus 5/2020

07.08.2020 | Rheumatologie | Unerwünschte Wirkungen

Biosimilars und der Nocebo-Effekt

verfasst von: J. Braun, S. Tsiami, B. Buehring, D. Kiefer, I. Andreica, X. Baraliakos, PD Dr. med. U. Kiltz

Erschienen in: rheuma plus | Ausgabe 5/2020

Einloggen, um Zugang zu erhalten
share
TEILEN

Zusammenfassung

In Deutschland sind seit vielen Jahren Biosimilars zugelassen, seit wenigen Jahren auch in der Rheumatologie. Zwar haben die Biosimilars, die wie die Referenzbiologika biotechnologisch hergestellten Produkte sind, inzwischen in einigen Regionen schon erheblich Marktanteile erreicht, es gibt aber bei Patienten und Ärzten immer noch viele Zweifler, die einen Qualitätsverlust befürchten – auch, wenn es dafür keinen Anhalt gibt. Ein Teil dieses Problems ist durch den Nocebo-Effekt zu erklären, der aber auch darüber hinaus eine erhebliche medizinische Bedeutung hat. Dieser Effekt wird in diesem Artikel beschrieben und erläutert. Psychosoziale und kontextbezogene Faktoren wie die Beziehung zwischen Patient und Arzt, frühere Behandlungserfahrungen und Behandlungserwartungen können die Wirksamkeit einer therapeutischen Intervention entweder verbessern oder beeinträchtigen. Diese Phänomene werden üblicherweise als Placebo- und Nocebo-Effekte bezeichnet. Da Placebo- und Nocebo-Effekte die Symptomentwicklung, die Häufigkeit unerwünschter Ereignisse und die Wirksamkeit der Behandlung beeinflussen können, ist es entscheidend, diese Effekte zu kennen und Strategien zur Prävention zu entwickeln, um die Behandlungsergebnisse zu optimieren. Während experimentelle Studien in den letzten Jahren wesentliche Fortschritte bei der Aufklärung der psychosozialen und neurobiologischen Mechanismen von Placebo-Effekten erzielt haben, sind die detaillierten Mechanismen von Nocebo-Effekten noch weitgehend unerforscht. Ein besseres Verständnis dieser Mechanismen verspricht die Entwicklung benutzerfreundlicher Strategien für die klinische Versorgung zur Verbesserung der Behandlungsergebnisse und der Patientenzufriedenheit.
Literatur
2.
Zurück zum Zitat Krüger K (2018) Kompendium Biosimilars Bd. 3. Thieme, Stuttgart, S 20–24 Krüger K (2018) Kompendium Biosimilars Bd. 3. Thieme, Stuttgart, S 20–24
3.
Zurück zum Zitat Jørgensen KK, Olsen IC, Goll GL, NOR-SWITCH study group et al (2017) Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet 389(10086):2304–2316 PubMed Jørgensen KK, Olsen IC, Goll GL, NOR-SWITCH study group et al (2017) Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet 389(10086):2304–2316 PubMed
4.
Zurück zum Zitat Braun J, Lorenz HM, Müller-Ladner U et al (2018) Revised version of the statement by the DGRh on biosimilars-update 2017. Z Rheumatol 77(1):81–90 PubMed Braun J, Lorenz HM, Müller-Ladner U et al (2018) Revised version of the statement by the DGRh on biosimilars-update 2017. Z Rheumatol 77(1):81–90 PubMed
5.
Zurück zum Zitat Kay J, Schoels MM, Dörner T, Task Force on the Use of Biosimilars to Treat Rheumatological Diseases, Task Force on the Use of Biosimilars to Treat Rheumatological Diseases (2018) Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann Rheum Dis 77(2):165–174 (Epub 2017 Sep 2) PubMed Kay J, Schoels MM, Dörner T, Task Force on the Use of Biosimilars to Treat Rheumatological Diseases, Task Force on the Use of Biosimilars to Treat Rheumatological Diseases (2018) Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann Rheum Dis 77(2):165–174 (Epub 2017 Sep 2) PubMed
6.
Zurück zum Zitat Smolen JS, Landewé R, Bijlsma J et al (2017) EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis 76(6):960–977 (Epub 2017 Mar 6) PubMed Smolen JS, Landewé R, Bijlsma J et al (2017) EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis 76(6):960–977 (Epub 2017 Mar 6) PubMed
7.
Zurück zum Zitat Fiehn C, Holle J, Iking-Konert C et al (2018) S2e guideline: treatment of rheumatoid arthritis with disease-modifying drugs. Z Rheumatol 77(Suppl 2):35–53 PubMed Fiehn C, Holle J, Iking-Konert C et al (2018) S2e guideline: treatment of rheumatoid arthritis with disease-modifying drugs. Z Rheumatol 77(Suppl 2):35–53 PubMed
8.
Zurück zum Zitat Kardas P, Lewek P, Matyjaszczyk M (2013) Determinants of patient adherence: a review of systematic reviews. Front Pharmacol 4:91 PubMedPubMedCentral Kardas P, Lewek P, Matyjaszczyk M (2013) Determinants of patient adherence: a review of systematic reviews. Front Pharmacol 4:91 PubMedPubMedCentral
9.
Zurück zum Zitat Howick J, Hoffmann T (2018) How placebo characteristics can influence estimates of intervention effects in trials. Cmaj 190(30):E908–E911 PubMedPubMedCentral Howick J, Hoffmann T (2018) How placebo characteristics can influence estimates of intervention effects in trials. Cmaj 190(30):E908–E911 PubMedPubMedCentral
11.
Zurück zum Zitat Jütte R (2019) Placeboforschung: Selbst eingebildete Pillen können wirken. DÄB 116(31–32):1181–1182 Jütte R (2019) Placeboforschung: Selbst eingebildete Pillen können wirken. DÄB 116(31–32):1181–1182
12.
Zurück zum Zitat Pouillon L et al (2018) The nocebo effect: a clinical challenge in the era of biosimilars. Expert Rev Clin Immunol 14(9):739–749 (Epub 2018 Aug 30) PubMed Pouillon L et al (2018) The nocebo effect: a clinical challenge in the era of biosimilars. Expert Rev Clin Immunol 14(9):739–749 (Epub 2018 Aug 30) PubMed
13.
Zurück zum Zitat Kristensen LE, Alten R, Puig L et al (2018) Non-pharmacological effects in switching medication: the Nocebo effect in switching from originator to biosimilar agent. BioDrugs 32(5):397–404 PubMedPubMedCentral Kristensen LE, Alten R, Puig L et al (2018) Non-pharmacological effects in switching medication: the Nocebo effect in switching from originator to biosimilar agent. BioDrugs 32(5):397–404 PubMedPubMedCentral
14.
Zurück zum Zitat Odinet JS, Day CE, Cruz JL, Heindel GA (2018) The biosimilar Nocebo effect ? A systematic review of double-blinded versus open-label studies. J Manag Care Spec Pharm 24(10):952–959 PubMed Odinet JS, Day CE, Cruz JL, Heindel GA (2018) The biosimilar Nocebo effect ? A systematic review of double-blinded versus open-label studies. J Manag Care Spec Pharm 24(10):952–959 PubMed
15.
Zurück zum Zitat Petrie KJ, Rief W (2019) Psychobiological mechanisms of placebo and Nocebo effects: pathways to improve treatments and reduce side effects. Annu Rev Psychol 70:599–625 (Epub 2018 Aug 15) PubMed Petrie KJ, Rief W (2019) Psychobiological mechanisms of placebo and Nocebo effects: pathways to improve treatments and reduce side effects. Annu Rev Psychol 70:599–625 (Epub 2018 Aug 15) PubMed
16.
Zurück zum Zitat Evers AWM, Colloca L, Blease C et al (2018) Implications of placebo and Nocebo effects for clinical practice: expert consensus. Psychother Psychosom 87(4):204–210 (Epub 2018 Jun 12) PubMed Evers AWM, Colloca L, Blease C et al (2018) Implications of placebo and Nocebo effects for clinical practice: expert consensus. Psychother Psychosom 87(4):204–210 (Epub 2018 Jun 12) PubMed
17.
Zurück zum Zitat Kennedy WP (1961) The Nocebo reaction. Med World 95:203–205 PubMed Kennedy WP (1961) The Nocebo reaction. Med World 95:203–205 PubMed
18.
Zurück zum Zitat Kessner S, Wiech K, Forkmann K, Ploner M, Bingel U (2013) The effect of treatment history on therapeutic outcome: an experimental approach. JAMA Intern Med 173:1468–1469 PubMed Kessner S, Wiech K, Forkmann K, Ploner M, Bingel U (2013) The effect of treatment history on therapeutic outcome: an experimental approach. JAMA Intern Med 173:1468–1469 PubMed
19.
Zurück zum Zitat Gupta A, Thompson D, Whitehouse A, Collier T, Dahlof B et al (2017) Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its nonrandomized non-blind extension phase. Lancet 389(10088):2473–2481 PubMed Gupta A, Thompson D, Whitehouse A, Collier T, Dahlof B et al (2017) Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its nonrandomized non-blind extension phase. Lancet 389(10088):2473–2481 PubMed
20.
Zurück zum Zitat Mahr A, Golmard C, Pham E, Iordache L, Deville L, Faure P (2017) Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials. Pharmacoepidemiol Drug Saf 26:731–741 PubMed Mahr A, Golmard C, Pham E, Iordache L, Deville L, Faure P (2017) Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials. Pharmacoepidemiol Drug Saf 26:731–741 PubMed
21.
Zurück zum Zitat Clark PI, Leaverton PE (1994) Scientific and ethical issues in the use of the placebo control in clinical trials. Annu Rev Public Health 15:19–38 PubMed Clark PI, Leaverton PE (1994) Scientific and ethical issues in the use of the placebo control in clinical trials. Annu Rev Public Health 15:19–38 PubMed
22.
Zurück zum Zitat Barsky AJ, Saintfort R, Rogers MP, Borus FJ (2002) Nonspecific medication side effects and the nocebo phenomenon. Jama 287:622–627 PubMed Barsky AJ, Saintfort R, Rogers MP, Borus FJ (2002) Nonspecific medication side effects and the nocebo phenomenon. Jama 287:622–627 PubMed
23.
Zurück zum Zitat Petrie KJ, Sivertsen B, Hysing M, Broadbent E, Moss-Morris R et al (2001) Thoroughly modern worries: the relationship of worries about modernity to reported symptoms, health, and medical care utilization. J Psychosom Res 51:395–401 PubMed Petrie KJ, Sivertsen B, Hysing M, Broadbent E, Moss-Morris R et al (2001) Thoroughly modern worries: the relationship of worries about modernity to reported symptoms, health, and medical care utilization. J Psychosom Res 51:395–401 PubMed
24.
Zurück zum Zitat Rief W, Glaesmer H, Baehr V, Broadbent E et al (2012) The relationship of modern health worries to depression, symptom reporting and quality of life in a general population survey. J Psychosom Res 72:318–320 PubMed Rief W, Glaesmer H, Baehr V, Broadbent E et al (2012) The relationship of modern health worries to depression, symptom reporting and quality of life in a general population survey. J Psychosom Res 72:318–320 PubMed
25.
Zurück zum Zitat Rubin GJ, Hillert L, Nieto-Hernandez R et al (2011) Do people with idiopathic environmental intolerance attributed to electromagnetic fields display physiological effects when exposed to electromagnetic fields? A systematic review of provocation studies. Bioelectromagnetics 32:593–609 PubMed Rubin GJ, Hillert L, Nieto-Hernandez R et al (2011) Do people with idiopathic environmental intolerance attributed to electromagnetic fields display physiological effects when exposed to electromagnetic fields? A systematic review of provocation studies. Bioelectromagnetics 32:593–609 PubMed
26.
Zurück zum Zitat Chapman S, George SA, Waller K, Cakic V (2013) The pattern of complaints about Australian wind farms does not match the establishment and distribution of turbines: support for the psychogenic, “communicated disease” hypothesis. Plos One 8:e76584 PubMedPubMedCentral Chapman S, George SA, Waller K, Cakic V (2013) The pattern of complaints about Australian wind farms does not match the establishment and distribution of turbines: support for the psychogenic, “communicated disease” hypothesis. Plos One 8:e76584 PubMedPubMedCentral
27.
Zurück zum Zitat Crichton F, Chapman S, Cundy T, Petrie KJ (2014) The link between health complaints and wind turbines: support for the Nocebo expectations hypothesis. Front Public Health 2:220 PubMedPubMedCentral Crichton F, Chapman S, Cundy T, Petrie KJ (2014) The link between health complaints and wind turbines: support for the Nocebo expectations hypothesis. Front Public Health 2:220 PubMedPubMedCentral
28.
Zurück zum Zitat Lionetti E, Pulvirenti A, Vallorani M, Catassi G, Verma AK et al (2017) Re-challenge studies in non-celiac gluten sensitivity: a systematic review and meta-analysis. Front Physiol 8:621 PubMedPubMedCentral Lionetti E, Pulvirenti A, Vallorani M, Catassi G, Verma AK et al (2017) Re-challenge studies in non-celiac gluten sensitivity: a systematic review and meta-analysis. Front Physiol 8:621 PubMedPubMedCentral
29.
Zurück zum Zitat Freeman S, Yu R, Egorova N, Chen X, Kirsch I, Claggett B, Kaptchuk TJ, Gollub RL, Kong J (2015) Distinct neural representations of placebo and Nocebo effects. Neuroimage 112:197–207 (Epub 2015 Mar 14) PubMed Freeman S, Yu R, Egorova N, Chen X, Kirsch I, Claggett B, Kaptchuk TJ, Gollub RL, Kong J (2015) Distinct neural representations of placebo and Nocebo effects. Neuroimage 112:197–207 (Epub 2015 Mar 14) PubMed
30.
Zurück zum Zitat Kirsch I (1985) Response expectancy as a determinant of experience and behaviour. Am Psychol 40:1189–1202 Kirsch I (1985) Response expectancy as a determinant of experience and behaviour. Am Psychol 40:1189–1202
31.
Zurück zum Zitat Myers MG, Cairns JA, Singer J (1987) The consent form as a possible cause of side effects. Clin Pharmacol Ther 42:250–253 PubMed Myers MG, Cairns JA, Singer J (1987) The consent form as a possible cause of side effects. Clin Pharmacol Ther 42:250–253 PubMed
32.
Zurück zum Zitat Nestoriuc Y, Orav EJ, Liang M, Horne R, Barsky AJ (2010) Prediction of nonspecific side effects in rheumatoid arthritis patients by beliefs about medicines. Arthritis Care Res 62:791–799 Nestoriuc Y, Orav EJ, Liang M, Horne R, Barsky AJ (2010) Prediction of nonspecific side effects in rheumatoid arthritis patients by beliefs about medicines. Arthritis Care Res 62:791–799
33.
Zurück zum Zitat Nestoriuc Y, von Blanckenburg P, Schuricht F, Barsky AJ, Hadji P et al (2016) Is it best to expect the worst ? Influence of patients’ side-effect expectations on endocrine treatment outcome in a 2-year prospective clinical cohort study. Ann Oncol 27:1909–1915 PubMed Nestoriuc Y, von Blanckenburg P, Schuricht F, Barsky AJ, Hadji P et al (2016) Is it best to expect the worst ? Influence of patients’ side-effect expectations on endocrine treatment outcome in a 2-year prospective clinical cohort study. Ann Oncol 27:1909–1915 PubMed
34.
Zurück zum Zitat Webster RK, Weinman J, Rubin GJ (2018) Medicine related beliefs predict attribution of symptoms to a sham medicine: a prospective study. Br J Health Psychol 23:436–454 PubMedPubMedCentral Webster RK, Weinman J, Rubin GJ (2018) Medicine related beliefs predict attribution of symptoms to a sham medicine: a prospective study. Br J Health Psychol 23:436–454 PubMedPubMedCentral
35.
Zurück zum Zitat Petrie KJ, Moss-Morris R, Grey C, Shaw M (2004) The relationship of negative affect and perceived sensitivity to symptom reporting following vaccination. Br J Health Psychol 9:101–111 PubMed Petrie KJ, Moss-Morris R, Grey C, Shaw M (2004) The relationship of negative affect and perceived sensitivity to symptom reporting following vaccination. Br J Health Psychol 9:101–111 PubMed
36.
Zurück zum Zitat Faasse K, Grey A, Horne R, Petrie KJ (2015) High perceived sensitivity to medicines is associated with higher medical care utilisation, increased symptom reporting and greater information-seeking about medication. Pharmacoepidemiol Drug Saf 24:592–599 PubMed Faasse K, Grey A, Horne R, Petrie KJ (2015) High perceived sensitivity to medicines is associated with higher medical care utilisation, increased symptom reporting and greater information-seeking about medication. Pharmacoepidemiol Drug Saf 24:592–599 PubMed
37.
Zurück zum Zitat Horne R, Faasse K, Cooper V et al (2013) Personal sensitivity to medicines scale. Br J Health Psychol 18:18–30 PubMed Horne R, Faasse K, Cooper V et al (2013) Personal sensitivity to medicines scale. Br J Health Psychol 18:18–30 PubMed
38.
Zurück zum Zitat Rief W, Nestoriuc Y, Weiss S et al (2009) Meta-analysis of the placebo response in antidepressant trials. J Affect Disord 118:1–8 PubMed Rief W, Nestoriuc Y, Weiss S et al (2009) Meta-analysis of the placebo response in antidepressant trials. J Affect Disord 118:1–8 PubMed
39.
Zurück zum Zitat Amanzio M, Corazzini LL, Vase L, Benedetti F (2009) A systematic review of adverse events in placebo groups of anti-migraine clinical trials. Pain 146:261–269 PubMed Amanzio M, Corazzini LL, Vase L, Benedetti F (2009) A systematic review of adverse events in placebo groups of anti-migraine clinical trials. Pain 146:261–269 PubMed
40.
Zurück zum Zitat Colgan S, Faasse K, Martin LR, Stephens MH, Grey A et al (2015) Perceptions of generic medication in the general population, doctors and pharmacists: a systematic review. Bmj Open 5:e8915 PubMedPubMedCentral Colgan S, Faasse K, Martin LR, Stephens MH, Grey A et al (2015) Perceptions of generic medication in the general population, doctors and pharmacists: a systematic review. Bmj Open 5:e8915 PubMedPubMedCentral
41.
Zurück zum Zitat Faasse K, Cundy T, Gamble G, Petrie KJ (2013) The effect of an apparent change to a branded or generic medication on drug effectiveness and side effects. Psychosom Med 75:90–96 PubMed Faasse K, Cundy T, Gamble G, Petrie KJ (2013) The effect of an apparent change to a branded or generic medication on drug effectiveness and side effects. Psychosom Med 75:90–96 PubMed
42.
Zurück zum Zitat Boone NW, Liu L, Romberg-Camps MJ et al (2018) The Nocebo effect challenges the non-medical infliximab switch in practice. Eur J Clin Pharmacol 74:655–661 PubMedPubMedCentral Boone NW, Liu L, Romberg-Camps MJ et al (2018) The Nocebo effect challenges the non-medical infliximab switch in practice. Eur J Clin Pharmacol 74:655–661 PubMedPubMedCentral
43.
Zurück zum Zitat Weissenfeld J, Stock S, Lungen M, Gerber A (2010) The Nocebo effect: a reason for patients’ non-adherence to generic substitution? Pharmazie 65:451–456 PubMed Weissenfeld J, Stock S, Lungen M, Gerber A (2010) The Nocebo effect: a reason for patients’ non-adherence to generic substitution? Pharmazie 65:451–456 PubMed
44.
Zurück zum Zitat Bartley H, Faasse K, Horne R, Petrie KJ (2016) You can’t always get what you want: the influence of choice on Nocebo and placebo responding. Ann Behav Med 50:445–451 PubMed Bartley H, Faasse K, Horne R, Petrie KJ (2016) You can’t always get what you want: the influence of choice on Nocebo and placebo responding. Ann Behav Med 50:445–451 PubMed
45.
Zurück zum Zitat Vögtle E, Barke A, Kröner-Herwig B (2013) Nocebo hyperalgesia induced by social observational learning. Pain 154:1427–1433 PubMed Vögtle E, Barke A, Kröner-Herwig B (2013) Nocebo hyperalgesia induced by social observational learning. Pain 154:1427–1433 PubMed
46.
Zurück zum Zitat Faasse K, Petrie KJ (2016) From me to you: the effect of social modelling on treatment outcomes. Curr Dir Psychol Sci 25:438–443 Faasse K, Petrie KJ (2016) From me to you: the effect of social modelling on treatment outcomes. Curr Dir Psychol Sci 25:438–443
47.
Zurück zum Zitat Lorber W, Mazzoni G, Kirsch I (2007) Illness by suggestion: expectancy, modeling, and gender in the production of psychosomatic symptoms. Ann Behav Med 33:112–116 PubMed Lorber W, Mazzoni G, Kirsch I (2007) Illness by suggestion: expectancy, modeling, and gender in the production of psychosomatic symptoms. Ann Behav Med 33:112–116 PubMed
48.
Zurück zum Zitat Witthöft M, Rubin GJ (2013) Are media warnings about the adverse health effects of modern life self-fulfilling? An experimental study on idiopathic environmental intolerance attributed to electromagnetic fields (IEIEMF). J Psychosom Res 74:206–212 PubMed Witthöft M, Rubin GJ (2013) Are media warnings about the adverse health effects of modern life self-fulfilling? An experimental study on idiopathic environmental intolerance attributed to electromagnetic fields (IEIEMF). J Psychosom Res 74:206–212 PubMed
49.
Zurück zum Zitat Bräscher AK, Raymaekers K, Van den Bergh O, Witthöft M (2017) Are media reports able to cause somatic symptoms attributed to WiFi radiation? An experimental test of the negative expectation hypothesis. Environ Res 156:265–271 PubMed Bräscher AK, Raymaekers K, Van den Bergh O, Witthöft M (2017) Are media reports able to cause somatic symptoms attributed to WiFi radiation? An experimental test of the negative expectation hypothesis. Environ Res 156:265–271 PubMed
50.
Zurück zum Zitat Faasse K, Cundy T, Petrie KJ (2010) Thyroxine: anatomy of a health scare. BMJ 340:20–21 Faasse K, Cundy T, Petrie KJ (2010) Thyroxine: anatomy of a health scare. BMJ 340:20–21
51.
Zurück zum Zitat Faasse K, Gamble G, Cundy T, Petrie KJ (2012) Impact of television coverage on the number and type of symptoms reported during a health scare: a retrospective pre-post observational study. Bmj Open 2:e1607 PubMedPubMedCentral Faasse K, Gamble G, Cundy T, Petrie KJ (2012) Impact of television coverage on the number and type of symptoms reported during a health scare: a retrospective pre-post observational study. Bmj Open 2:e1607 PubMedPubMedCentral
52.
Zurück zum Zitat Roscoe JA, Morrow GR, Aapro MS, Molassiotis A, Olver I (2011) Anticipatory nausea and vomiting. Support Care Cancer 19:1533–1538 PubMed Roscoe JA, Morrow GR, Aapro MS, Molassiotis A, Olver I (2011) Anticipatory nausea and vomiting. Support Care Cancer 19:1533–1538 PubMed
53.
Zurück zum Zitat Liccardi G, Senna G, Russo M et al (2004) Evaluation of the nocebo effect during oral challenge in patients with adverse drug reactions. J Investig Allergol Clin Immunol 14:104–107 PubMed Liccardi G, Senna G, Russo M et al (2004) Evaluation of the nocebo effect during oral challenge in patients with adverse drug reactions. J Investig Allergol Clin Immunol 14:104–107 PubMed
54.
Zurück zum Zitat van den Bergh O, Stegen K, Van Diest I, Raes C, Stulens P et al (1999) Acquisition and extinction of somatic symptoms in response to odours: a Pavlovian paradigm relevant to multiple chemical sensitivity. Occup Environ Med 56:295–301 PubMedPubMedCentral van den Bergh O, Stegen K, Van Diest I, Raes C, Stulens P et al (1999) Acquisition and extinction of somatic symptoms in response to odours: a Pavlovian paradigm relevant to multiple chemical sensitivity. Occup Environ Med 56:295–301 PubMedPubMedCentral
55.
Zurück zum Zitat Stewart-Williams S, Podd J (2004) The placebo effect: dissolving the expectancy versus conditioning debate. Psychol Bull 130:324–340 PubMed Stewart-Williams S, Podd J (2004) The placebo effect: dissolving the expectancy versus conditioning debate. Psychol Bull 130:324–340 PubMed
56.
Zurück zum Zitat Petersen GL, Finnerup NB, Colloca L, Amanzio M, Price DD et al (2014) The magnitude of the Nocebo effects in pain: a meta-analysis. Pain 155:1426–1434 PubMedPubMedCentral Petersen GL, Finnerup NB, Colloca L, Amanzio M, Price DD et al (2014) The magnitude of the Nocebo effects in pain: a meta-analysis. Pain 155:1426–1434 PubMedPubMedCentral
57.
Zurück zum Zitat Petrie KJ, Faasse K, Crichton F, Grey A (2014) How common are symptoms? Evidence from a New Zealand national telephone survey. Bmj Open 4(6):e5374 PubMedPubMedCentral Petrie KJ, Faasse K, Crichton F, Grey A (2014) How common are symptoms? Evidence from a New Zealand national telephone survey. Bmj Open 4(6):e5374 PubMedPubMedCentral
58.
Zurück zum Zitat Tan K, Petrie KJ, Faasse K, Bolland MJ, Grey A (2014) Unhelpful information about adverse drug reactions. Bmj 349:g5019 PubMed Tan K, Petrie KJ, Faasse K, Bolland MJ, Grey A (2014) Unhelpful information about adverse drug reactions. Bmj 349:g5019 PubMed
59.
Zurück zum Zitat Rief W, Avorn J, Barsky AJ (2006) Medication-attributed adverse effects in placebo groups: implications for assessment of adverse effects. Arch Intern Med 166:155–160 PubMed Rief W, Avorn J, Barsky AJ (2006) Medication-attributed adverse effects in placebo groups: implications for assessment of adverse effects. Arch Intern Med 166:155–160 PubMed
60.
Zurück zum Zitat Faasse K, Petrie KJ (2013) The Nocebo effect: patient expectations and medication side effects. Postgrad Med J 89:540–546 PubMed Faasse K, Petrie KJ (2013) The Nocebo effect: patient expectations and medication side effects. Postgrad Med J 89:540–546 PubMed
61.
Zurück zum Zitat Feldman PJ, Cohen S, Doyle W, Skoner DP, Gwaltner JM (1999) The impact of personality on the reporting of unfounded symptoms and illness. Journal of Personality and Social Psychology 77:370–378 PubMed Feldman PJ, Cohen S, Doyle W, Skoner DP, Gwaltner JM (1999) The impact of personality on the reporting of unfounded symptoms and illness. Journal of Personality and Social Psychology 77:370–378 PubMed
62.
Zurück zum Zitat Watson D, Pennebaker JW (1989) Health complaints, stress, and distress: exploring the central role of negative affectivity. Psychol Rev 96:234–254 PubMed Watson D, Pennebaker JW (1989) Health complaints, stress, and distress: exploring the central role of negative affectivity. Psychol Rev 96:234–254 PubMed
63.
Zurück zum Zitat Wells RE, Kaptchuk TJ (2012) To tell the truth, the whole truth, may do patients harm: the problem of the nocebo effect for informed consent. Am J Bioeth 12:22–29 PubMedPubMedCentral Wells RE, Kaptchuk TJ (2012) To tell the truth, the whole truth, may do patients harm: the problem of the nocebo effect for informed consent. Am J Bioeth 12:22–29 PubMedPubMedCentral
64.
Zurück zum Zitat Miller FG (2012) Clarifying the Nocebo effect and its ethical implications. Am J Bioeth 12(3):30–39 PubMed Miller FG (2012) Clarifying the Nocebo effect and its ethical implications. Am J Bioeth 12(3):30–39 PubMed
65.
Zurück zum Zitat Bromwich D (2012) Plenty to worry about: consent, control and anxiety. Am J Bioeth 12(3):35–36 PubMed Bromwich D (2012) Plenty to worry about: consent, control and anxiety. Am J Bioeth 12(3):35–36 PubMed
66.
Zurück zum Zitat Bingel U (2014) Avoiding nocebo effects to optimize treatment outcome. Jama 312:693–694 PubMed Bingel U (2014) Avoiding nocebo effects to optimize treatment outcome. Jama 312:693–694 PubMed
67.
Zurück zum Zitat O’Connor AM, Pennie RA, Dales RE (1996) Framing effects on expectations, decisions and side effects experienced: the case of influenza immunization. J Clin Epidemiol 49:1271–1276 PubMed O’Connor AM, Pennie RA, Dales RE (1996) Framing effects on expectations, decisions and side effects experienced: the case of influenza immunization. J Clin Epidemiol 49:1271–1276 PubMed
68.
Zurück zum Zitat Crichton F, Petrie KJ (2015) Health complaints and wind turbines: the efficacy of explaining the Nocebo response to reduce symptom reporting. Environ Res 140:449–455 PubMed Crichton F, Petrie KJ (2015) Health complaints and wind turbines: the efficacy of explaining the Nocebo response to reduce symptom reporting. Environ Res 140:449–455 PubMed
71.
Zurück zum Zitat Rief W, Shedden-Mora MC, Laferton JA et al (2017) Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial. BMC Med 15(1):4 PubMedPubMedCentral Rief W, Shedden-Mora MC, Laferton JA et al (2017) Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial. BMC Med 15(1):4 PubMedPubMedCentral
72.
Zurück zum Zitat Carvalho C, Caetano JM, Cunha L et al (2016) Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain 157:2766–2772 PubMedPubMedCentral Carvalho C, Caetano JM, Cunha L et al (2016) Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain 157:2766–2772 PubMedPubMedCentral
73.
Zurück zum Zitat Kirchhof J, Petrakova L, Brinkhoff A et al (2018) Learned immunosuppressive placebo responses in renal transplant patients. PNAS 115(16):4223–4227 PubMedPubMedCentral Kirchhof J, Petrakova L, Brinkhoff A et al (2018) Learned immunosuppressive placebo responses in renal transplant patients. PNAS 115(16):4223–4227 PubMedPubMedCentral
74.
Zurück zum Zitat Irwin MR, Cole SW (2011) Reciprocal regulation of the neural and innate immune systems. Nat Rev Immunol 11:625–632 PubMedPubMedCentral Irwin MR, Cole SW (2011) Reciprocal regulation of the neural and innate immune systems. Nat Rev Immunol 11:625–632 PubMedPubMedCentral
75.
Zurück zum Zitat Pacheco-López G, Engler H, Niemi MB, Schedlowski M (2006) Expectations and associations that heal: Immunomodulatory placebo effects and its neurobiology. Brain Behav Immun 20:430–446 PubMed Pacheco-López G, Engler H, Niemi MB, Schedlowski M (2006) Expectations and associations that heal: Immunomodulatory placebo effects and its neurobiology. Brain Behav Immun 20:430–446 PubMed
Metadaten
Titel
Biosimilars und der Nocebo-Effekt
verfasst von
J. Braun
S. Tsiami
B. Buehring
D. Kiefer
I. Andreica
X. Baraliakos
PD Dr. med. U. Kiltz
Publikationsdatum
07.08.2020
Verlag
Springer Vienna
Schlagwort
Rheumatologie
Erschienen in
rheuma plus / Ausgabe 5/2020
Print ISSN: 1868-260X
Elektronische ISSN: 2191-2610
DOI
https://doi.org/10.1007/s12688-020-00366-y

Weitere Artikel der Ausgabe 5/2020

rheuma plus 5/2020 Zur Ausgabe