TY - JOUR
TI - Placebo and nocebo phenomena in anti- CGRP monoclonal antibody trials for migraine prevention: a meta-analysis
AU - Kokoti, L.
AU - Drellia, K.
AU - Papadopoulos, D.
AU - Mitsikostas, D.D.
JO - Egyptian Journal of Neurology, Psychiatry and Neurosurgery
PY - 2020
VL - 267
TODO - 4
SP - 1158-1170
PB - Springer-Verlag
SN - null
TODO - 10.1007/s00415-019-09673-7
TODO - botulinum toxin A;  calcitonin gene related peptide;  eptinezumab;  erenumab;  fremanezumab;  galcanezumab;  monoclonal antibody;  topiramate;  analgesic agent;  anticonvulsive agent;  calcitonin gene related peptide;  monoclonal antibody;  muscle relaxant agent, arthralgia;  Article;  dizziness;  episodic migraine;  fatigue;  human;  influenza;  injection site erythema;  injection site induration;  injection site pain;  meta analysis;  nausea;  nocebo effect;  placebo effect;  priority journal;  prophylaxis;  randomized controlled trial (topic);  rhinopharyngitis;  sinusitis;  transformed migraine;  upper respiratory tract infection;  urinary tract infection;  immunology;  migraine;  nocebo effect;  randomized controlled trial (topic), Analgesics, Non-Narcotic;  Antibodies, Monoclonal;  Anticonvulsants;  Calcitonin Gene-Related Peptide;  Humans;  Migraine Disorders;  Neuromuscular Agents;  Nocebo Effect;  Outcome Assessment, Health Care;  Placebo Effect;  Randomized Controlled Trials as Topic
TODO - High placebo and low nocebo phenomena mirror high positive expectations for a novel treatment, among other reasons. In a meta-analysis aimed to identify placebo and nocebo phenomena in the placebo-controlled randomized trials (RCTs) with the monoclonal antibodies targeting the calcitonin gene-related peptide pathway (anti-CGRP mAbs) all the placebo-treated patients were pooled and compared with the placebo-treated patients in RCTs with topiramate and onabotulinum toxin A (OBTA). In episodic migraine (EM), the proportion of placebo-treated patients who achieved the 50% responder rate (placebo) was 32.7% (95% CI 28.6%–37.0%) in anti-CGRP mAbs vs. 24.4% (95% CI 20.5%–28.5%) in topiramate trials. The proportion of dropouts due to adverse events in placebo-treated patients (nocebo) was 1.9% (95% CI 1.4%–2.6%) in anti-CGRP mAbs vs. 9.9% (95% CI 7.7%–12.3%) in topiramate RCTs. In chronic migraine (CM), the placebo 50% responder rate was 23.6% (95% CI 11.2%–38.8%) in anti-CGRP mAbs RCTs vs. 36.4% (95% CI 32.6%–39.3%) in RCTs with OBTA. The nocebo dropout in anti-CGRP mAbs and OBTA RCTs was 1.4% (95% CI 0.8%–2.1%) and 0.9 (95% CI 0.3%–1.7%), respectively. The stronger placebo and weaker nocebo phenomena in RCTs with anti-CGRP mAbs vs. those with topiramate in the prophylaxis of EM, may decisively determine anti-CGRP mAbs treatment success. No differences were detected between the anti-CGRP mAbs and OBTA in the treatment of CM. © 2020, Springer-Verlag GmbH Germany, part of Springer Nature.
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