Butterbur root extract and music therapy in the prevention of childhood migraine: an explorative study.
BACKGROUND
Migraine is very common in school-aged children, but despite a number of pharmacological and non-pharmacological options for prophylaxis, randomized controlled evidence in children is small. Evidence-based prophylactic drugs may have considerable side effects.


OBJECTIVE
This study was to assess efficacy of a butterbur root extract (Petadolex) and music therapy in primary school children with migraine.


METHODS
Prospective, randomized, partly double-blind, placebo-controlled, parallel-group trial.


METHODS
Following a 8-week baseline patients were randomized and received either butterbur root extract (n=19), music therapy (n=20) or placebo (n=19) over 12 weeks. All participants received additionally headache education ("treatment as usual") from the baseline onwards. Reduction of headache frequency after treatment (8-week post-treatment) as well as 6 months later (8-week follow-up) was the efficacy variable.


RESULTS
Data analysis of subjects completing the respective study phase showed that during post-treatment, only music therapy was superior to placebo (p=0.005), whereas in the follow-up period both music therapy and butterbur root extract were superior to placebo (p=0.018 and p=0.044, respectively). All groups showed a substantial reduction of attack frequency already during baseline.


CONCLUSIONS
Butterbur root extract and music therapy might be superior to placebo and may represent promising treatment approaches in the prophylaxis of paediatric migraine.
Oelkers-Ax
Rieke
R
Department of Child and Adolescent Psychiatry, University of Heidelberg, Blumenstrasse 8, D-69115 Heidelberg, Germany. rieke_oelkers@med.uni-heidelberg.de
Leins
Anne
A
Parzer
Peter
P
Hillecke
Thomas
T
Bolay
Hans V
HV
Fischer
Jochen
J
Bender
Stephan
S
Hermanns
Uta
U
Resch
Franz
F
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005190:Family; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019018:Imagery, Psychotherapy; D008297:Male; D001523:Mental Disorders / Q000453:epidemiology; D008881:Migraine Disorders / Q000517:prevention & control* / Q000523:psychology; D009147:Music Therapy; D010349:Patient Compliance; D010353:Patient Education as Topic; D036901:Petasites; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D018517:Plant Roots / Q000737:chemistry; D011446:Prospective Studies; D012064:Relaxation Therapy
D000894:Anti-Inflammatory Agents, Non-Steroidal; D010936:Plant Extracts