Original articleThe Placebo Response in Studies of Acute Migraine
Section snippets
Methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; Cochrane Library, Issue 4, 2006) using the terms “headache,” “migraine,” “cephalgia,” “cephalalgia,” “p(a)ediatric,” “infan,*” “child*,” “teenage,*” and “adolescent*.” We also searched MEDLINE from 1966 through November 2006 using these same terms, along with the search strategy for identifying randomized controlled trials (RCTs) described by Dickersin et al.19 Additional strategies for identifying trials included hand
Results
A total of 5416 potential relevant articles were identified after the first search, aimed at sensitivity. Most were discarded after title or abstract analysis because they were not acute migraine treatment RCTs or CCTs, they did not include children or adolescent groups, or they did not include a placebo comparator group. Only 16 trials remained, of which a further 3 trials were excluded, 2 because the abstracts did not report adequate placebo group data22, 23 and the third because it was an
Discussion
Our systematic review has demonstrated a high and variable placebo response rate in pediatric migraine trials. There are only a limited number of studies in this age group as opposed to adults, in whom more than 100 trials with available placebo data have been reported.16 Although there are few variations in design, quality scores, and migraine definition among these studies, some criteria used for inclusion and the reporting of participant characteristics and outcomes vary sufficiently to make
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Ropivacaine Intramuscular Paracervical Injections for Pediatric Headache: A Randomized Placebo-Controlled Trial
2017, Annals of Emergency MedicineCitation Excerpt :Sample size was calculated assuming 80% power to detect a 30% difference in the rate of headache resolution between ropivacaine and placebo, given a 2-sided type I error probability of .05. When a previously published headache resolution rate of 65% after ropivacaine injections in adults5 and a 35% placebo effect7 was used, 48 subjects were needed to detect a difference between ropivacaine and placebo in each of the 2 injection groups. A balanced group of 50 patients (natural history) was enrolled to control for the unlikely event that patients would spontaneously improve without therapy during the 30-minute duration of the study.
Survey on treatments for primary headaches in 13 specialized juvenile Headache Centers: The first multicenter Italian study
2017, European Journal of Paediatric NeurologyCitation Excerpt :Overall the perceived efficacy of melatonin (75%) and nutraceuticals (68%) was similar to the prophylactic drugs (75%). While it cannot be excluded that a placebo effect had an additive effect in the efficacy of these compounds, this response rate exceeded the rate of “placebo-responders” in children with primary headaches, which ranged between 20 and 60% in a meta-analysis published in 2009.40 Tolerability of melatonin and nutraceuticals was definitely higher than the majority of the preventive drugs used except for pizotifen.
Placebo and nocebo responses in drug trials of epilepsy
2015, Epilepsy and BehaviorPlacebo effect in child and adolescent psychiatric trials
2012, European NeuropsychopharmacologyCitation Excerpt :The use of a placebo in clinical situations is controversial. Inert pills are frequently used in clinical settings for the treatment of pain or anxiety/agitation, and there may be a basis for that (Vitiello et al., 1991; Fernandes et al., 2008; Hrobjartsson and Gotzsche, 2010), although there is little specific evidence of this in children. In fact, there is preliminary evidence suggesting that for some paediatric neuropsychiatric conditions deception might not be necessary for a placebo to work (Sandler et al., 2010), thus overcoming the ethical issues inherent in the use of this intervention in clinical settings (Miller and Colloca, 2009).
No reprints are available from the authors.