Tags

Type your tag names separated by a space and hit enter

Nocebo in headaches: implications for clinical practice and trial design.
Curr Neurol Neurosci Rep. 2012 Apr; 12(2):132-7.CN

Abstract

The term nocebo refers to a harmful, unpleasant or undesirable adverse event a subject manifests after receiving an inert dummy drug or placebo. This reaction is originating by the patients fear and negative expectation that medical treatment most likely will produce unfavorable consequences instead of healing. Like placebo, nocebo shares key functions in pain conditions. Two recent systemic meta-analyses searched for nocebo in trials for prevention of migraine and tension-type headache and revealed that 1 out of 20 patients treated with placebo withdraw treatment due to adverse effects. Additionally, adverse events in placebo groups mirrored the adverse events expected of the active medication studied, confirming that pretrial suggestions induce the adverse events in placebo-treated patients. Therefore, nocebo reduces the study population by 10% and limits the treatment outcomes in randomized controlled trials for primary headaches. The potential implications of this substantial nocebo effect for both trial designing and clinical practice are discussed in this article.

Authors+Show Affiliations

Neurology Department, Athens Naval Hospital, 77A Vas. Sofias Avenue, Athens 11529, Greece. dmitsikostas@ath.forthnet.gr

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

22193945

Citation

Mitsikostas, Dimos D.. "Nocebo in Headaches: Implications for Clinical Practice and Trial Design." Current Neurology and Neuroscience Reports, vol. 12, no. 2, 2012, pp. 132-7.
Mitsikostas DD. Nocebo in headaches: implications for clinical practice and trial design. Curr Neurol Neurosci Rep. 2012;12(2):132-7.
Mitsikostas, D. D. (2012). Nocebo in headaches: implications for clinical practice and trial design. Current Neurology and Neuroscience Reports, 12(2), 132-7. https://doi.org/10.1007/s11910-011-0245-4
Mitsikostas DD. Nocebo in Headaches: Implications for Clinical Practice and Trial Design. Curr Neurol Neurosci Rep. 2012;12(2):132-7. PubMed PMID: 22193945.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nocebo in headaches: implications for clinical practice and trial design. A1 - Mitsikostas,Dimos D, PY - 2011/12/24/entrez PY - 2011/12/24/pubmed PY - 2012/7/21/medline SP - 132 EP - 7 JF - Current neurology and neuroscience reports JO - Curr Neurol Neurosci Rep VL - 12 IS - 2 N2 - The term nocebo refers to a harmful, unpleasant or undesirable adverse event a subject manifests after receiving an inert dummy drug or placebo. This reaction is originating by the patients fear and negative expectation that medical treatment most likely will produce unfavorable consequences instead of healing. Like placebo, nocebo shares key functions in pain conditions. Two recent systemic meta-analyses searched for nocebo in trials for prevention of migraine and tension-type headache and revealed that 1 out of 20 patients treated with placebo withdraw treatment due to adverse effects. Additionally, adverse events in placebo groups mirrored the adverse events expected of the active medication studied, confirming that pretrial suggestions induce the adverse events in placebo-treated patients. Therefore, nocebo reduces the study population by 10% and limits the treatment outcomes in randomized controlled trials for primary headaches. The potential implications of this substantial nocebo effect for both trial designing and clinical practice are discussed in this article. SN - 1534-6293 UR - https://www.unboundmedicine.com/medline/citation/22193945/Nocebo_in_headaches:_implications_for_clinical_practice_and_trial_design_ L2 - https://dx.doi.org/10.1007/s11910-011-0245-4 DB - PRIME DP - Unbound Medicine ER -