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Nocebo is the enemy, not placebo. A meta-analysis of reported side effects after placebo treatment in headaches.
Cephalalgia. 2011 Apr; 31(5):550-61.C

Abstract

The aim was to determine the magnitude of the nocebo (adverse effects following placebo administration) in clinical trials for primary headache disorders. We reviewed randomized, placebo-controlled studies for migraine, tension-type headache (TTH), and cluster headache treatments published between 1998 and 2009. The frequency of nocebo was estimated by the percentage of placebo-treated patients reporting at least one adverse side effect. The dropout frequency was estimated by the percentage of placebo-treated patients who discontinued the treatment due to intolerance. In studies of symptomatic treatment for migraine, the nocebo and dropout frequencies were 18.45% and 0.33%, but rose to 42.78% and 4.75% in preventative treatment studies. In trials for prevention of TTH, nocebo and dropout frequencies were 23.99% and 5.44%. For symptomatic treatment of cluster headache, the nocebo frequency was 18.67%. Nocebo is prevalent in clinical trials for primary headaches, particularly in preventive treatment studies. Dropouts due to nocebo effect may confound the interpretation of many clinical trials.

Authors+Show Affiliations

Neurology Department, Athens Naval Hospital, 77A Vas. Sofias Avenue, Athens, Greece. dmitsikostas@ath.forthnet.grNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis

Language

eng

PubMed ID

21216874

Citation

Mitsikostas, Dimos D., et al. "Nocebo Is the Enemy, Not Placebo. a Meta-analysis of Reported Side Effects After Placebo Treatment in Headaches." Cephalalgia : an International Journal of Headache, vol. 31, no. 5, 2011, pp. 550-61.
Mitsikostas DD, Mantonakis LI, Chalarakis NG. Nocebo is the enemy, not placebo. A meta-analysis of reported side effects after placebo treatment in headaches. Cephalalgia. 2011;31(5):550-61.
Mitsikostas, D. D., Mantonakis, L. I., & Chalarakis, N. G. (2011). Nocebo is the enemy, not placebo. A meta-analysis of reported side effects after placebo treatment in headaches. Cephalalgia : an International Journal of Headache, 31(5), 550-61. https://doi.org/10.1177/0333102410391485
Mitsikostas DD, Mantonakis LI, Chalarakis NG. Nocebo Is the Enemy, Not Placebo. a Meta-analysis of Reported Side Effects After Placebo Treatment in Headaches. Cephalalgia. 2011;31(5):550-61. PubMed PMID: 21216874.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nocebo is the enemy, not placebo. A meta-analysis of reported side effects after placebo treatment in headaches. AU - Mitsikostas,Dimos D, AU - Mantonakis,Leonidas I, AU - Chalarakis,Nikolaos G, Y1 - 2011/01/07/ PY - 2011/1/11/entrez PY - 2011/1/11/pubmed PY - 2011/8/2/medline SP - 550 EP - 61 JF - Cephalalgia : an international journal of headache JO - Cephalalgia VL - 31 IS - 5 N2 - The aim was to determine the magnitude of the nocebo (adverse effects following placebo administration) in clinical trials for primary headache disorders. We reviewed randomized, placebo-controlled studies for migraine, tension-type headache (TTH), and cluster headache treatments published between 1998 and 2009. The frequency of nocebo was estimated by the percentage of placebo-treated patients reporting at least one adverse side effect. The dropout frequency was estimated by the percentage of placebo-treated patients who discontinued the treatment due to intolerance. In studies of symptomatic treatment for migraine, the nocebo and dropout frequencies were 18.45% and 0.33%, but rose to 42.78% and 4.75% in preventative treatment studies. In trials for prevention of TTH, nocebo and dropout frequencies were 23.99% and 5.44%. For symptomatic treatment of cluster headache, the nocebo frequency was 18.67%. Nocebo is prevalent in clinical trials for primary headaches, particularly in preventive treatment studies. Dropouts due to nocebo effect may confound the interpretation of many clinical trials. SN - 1468-2982 UR - https://www.unboundmedicine.com/medline/citation/21216874/Nocebo_is_the_enemy_not_placebo__A_meta_analysis_of_reported_side_effects_after_placebo_treatment_in_headaches_ L2 - http://journals.sagepub.com/doi/full/10.1177/0333102410391485?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -