title: A prospective randomized double blind placebo controlled crossover study of fluoxetine efficacy in the prophylaxis of chronic daily headache in children and adolescents.
abstract: Thirty-two children (21 female and 11 male), between 7 and 14 years old, with chronic daily headache (CDH) were consecutively included in a prospective, randomized, double blind, placebo controlled crossover study. The patients were divided in group I (fluoxetine vs. placebo), with 17 patients and group II (placebo vs. fluoxetine), with 15 patients. After one month of baseline headache frequency recording, the patients received fluoxetine in dosages from 0.25 to 0.50 mg/kg for three months. A wash out period of one month was followed by another three months treatment period. Results showed a significant decrease in headache frequency in the study period [78% reduction in group I (p<0.025), and 45% reduction in group II (p=0.025)]. Gastrointestinal adverse effects were observed in nine patients (29%) that received fluoxetine, compared with 3 (10%), with placebo. We conclude that fluoxetine efficacy is not higher than placebo in the prophylaxis of CDH in children and adolescents.
authors.affiliation: Child and Adolescence Headache Clinic, Department of Neurology, University of São Paulo Medical School, São Paulo, SP, Brazil. jldg@osite.com.br
authors.forename: José Luiz Dias
authors.initials: JL
authors.lastname: Gherpelli
authors.forename: Sandro Blasi
authors.initials: SB
authors.lastname: Esposito
mesh_terms: D000293:Adolescent; D002648:Child; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D020773:Headache Disorders / Q000188:drug therapy*; D006801:Humans; D008297:Male; D010919:Placebos / Q000627:therapeutic use; D011446:Prospective Studies; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D005473:Fluoxetine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors