Reviewed by F. Perry Wilson, MD, MSCE; Instructor of
Medicine, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner
BOSTON -- Adding cognitive behavioral therapy (CBT) to amitriptyline improved migraine control in children with near-daily headaches, a researcher reported here.
In a randomized, controlled trial involving 135 children with chronic
migraine, the combination of CBT and amitriptyline reduced the number of monthly headache days by 11.6 after 20 weeks, compared with 6.7 (P<0.01) in children receiving the drug plus an educational and supportive program, according to Scott Powers, PhD, of Cincinnati Children's Hospital in Cincinnati.
About 66% of children in the cognitive therapy group had a reduction of at least 50% in the number of monthly headache days, versus 36% of the control group, Powers told attendees at the International Headache Congress.
The between-group differences persisted to the end of follow-up in the 1-year study, and remained statistically significant, he said.
Amitriptyline, the old-line antidepressant drug, is one of the standard treatments for childhood chronic migraine. In other chronic pain states in children, studies have shown that CBT is helpful in reducing severity, Powers explained, but it had not been rigorously tested in migraine.
In this trial, Powers and colleagues recruited children with confirmed chronic migraine (at least 15 moderate-severe headache days per month) according to standard criteria and supported by headache diaries.
CBT in the study was delivered in weekly sessions for 8 weeks, followed by monthly sessions for 3 months. Powers said it was a relatively standard type of program for children, with biofeedback and also parental involvement.
It was provided by the same therapists that administered the CBT and involved the same amount of time with study participants.
Amitriptyline was given to both groups, phased in and titrated over the first 8 weeks with a dosage goal of 1 mg/kg/day. The mean final dose actually given in the study was, in fact, 1 mg/kg/day, Powers reported.
Patients had a mean age of 14 and were primarily girls, reflective of the general pediatric migraine population. Their mean migraine frequency was 21 days per month and they had a mean score on the PedMIDAS index (the childhood version of the standard migraine disability scale) of 68, indicating severe disability.
Evaluations were conducted at 20 weeks after starting treatment and again at 1 year.
In addition to the reductions in headache frequency seen with the CBT, headache-related disability also improved, Powers said.
Reductions in PedMIDAS scores of 52.7 points were seen with CBT at the end of 20 weeks, compared with 38.6 points in the control group (P<0.05). Disability was rated as mild or moderate in 75% of the CBT group, versus 56% of controls.
Powers said the additive benefit of CBT was especially apparent because the improvements from baseline in the control group were similar to what has been documented in adults with approved medical therapies including botulinum toxin A
(Botox) and topiramate (Topamax).
He said his group had wanted to test CBT alone in a third study arm. However, grant reviewers for the NIH, which funded the trial, preferred the simpler two-arm design.
He also said it would be important to evaluate longer-term outcomes of CBT to see if it helps prevent severe childhood migraine from persisting into adulthood.
The study was funded by the National Institute of Neurological Disorders and Stroke.
Powers declared he had no relevant financial conflicts of interests.
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