title: A randomized, one-year clinical trial comparing the efficacy of topiramate, flunarizine, and a combination of flunarizine and topiramate in migraine prophylaxis.
abstract: OBJECTIVE
  The objective of this study was to observe the efficacy, safety, and side effects of a combination of flunarizine plus topiramate compared with either flunarizine and or toparamate alone for migraine prophylaxis.
  
  
  METHODS
  Out of 150 patients with migraine recruited into the study and randomly assigned to one of three conditions, 126 completed the trial in their group: flunarizine (39), topiramate (44), and flunarizine plus topiramate (43). Patient information was assessed at enrollment and at follow-up visits at the end of months 1-3, 6, 9, and 12. The primary measure of efficacy reduction in mean monthly migraine frequency of at least 50% as compared with baseline. Secondary efficacy parameters included reduction in mean monthly migraine days and severity of headache. Side effects were compared in the three groups by recording adverse reactions and weight changes.
  
  
  RESULTS
  The proportion whose monthly headache frequency decreased more than 50% was 66.7% (26/39) in the flunarizine group, 72.7% (32/44) in the topiramate group and 76.7% (33/43) in the combination group, respectively (P=0.593). The mean monthly days and severity of headache in the three groups also declined and was more significant in the flunarizine plus topiramate group than in the flunarizine group and the topiramate group (P<0.05). In the flunarizine group, the average weight change was 0.6kg. Topiramate was associated with a mean weight loss was of -0.9kg in the topiramate group and -0.2kg in the flunarizine plus topiramate group.
  
  
  CONCLUSIONS
  Flunarizine, topiramate, and the combination of flunarizine with topiramate are all effective and have good tolerability in migraine prophylaxis. Adding topiramate to flunarizine may reduce the latter's impact on body weight.
authors.affiliation: Departments of Neurology Emergency Rehabilitation, the First Affiliated Hospital Zhongshan School of Medicine, Sun Yat-Sen University, Guangzhou, China The Carolinas Center for Medical Excellence, Cary, North Carolina, USA.
authors.forename: Ning
authors.initials: N
authors.lastname: Luo
authors.forename: Wei
authors.initials: W
authors.lastname: Di
authors.forename: Aiwu
authors.initials: A
authors.lastname: Zhang
authors.forename: Ying
authors.initials: Y
authors.lastname: Wang
authors.forename: Minghui
authors.initials: M
authors.lastname: Ding
authors.forename: Weiwei
authors.initials: W
authors.lastname: Qi
authors.forename: Yingting
authors.initials: Y
authors.lastname: Zhu
authors.forename: Mark W
authors.initials: MW
authors.lastname: Massing
authors.forename: Yannan
authors.initials: Y
authors.lastname: Fang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004359:Drug Therapy, Combination; D005260:Female; D005444:Flunarizine / Q000008:administration & dosage*; D005500:Follow-Up Studies; D005632:Fructose / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy* / Q000453:epidemiology / Q000517:prevention & control*; D011446:Prospective Studies; D000077236:Topiramate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000077236:Topiramate; D005632:Fructose; D005444:Flunarizine