The combination of preventive medication and behavioral changes offered significant relief for 77 percent of the individuals enrolled in a study aimed at combating frequent, disabling migraine headaches, according to new Ohio University research published this week in the British Medical Journal.
Though daily preventive medication and behavioral techniques individually have been shown to improve headache pain, the new research is the first controlled study to assess if the combination of the two types of interventions might bring more relief to people whose debilitating migraines can interfere with career, social and family life, said lead author Kenneth Holroyd, an Ohio University Distinguished Professor of psychology.
The new study, funded by the National Institutes of Health, collected data daily from 232 adult participants for 16 months -- a longer duration than usual for evaluations of new therapies.
"Migraines are a long-term disorder," Holroyd said, "and we wanted to closely monitor participants every day for at least 16 months to find out if these treatments keep working over time."
Participants needed to experience at least three debilitating migraines per 30 days, even when using the best acute migraine medication (which is taken when a migraine first occurs), to qualify for the project. On average, participants recorded 5.5 migraines and 8.5 days with migraine per 30 days, despite using the acute migraine therapy best suited to their needs.
Participants who continued to experience severe migraines were assigned randomly to have one of four treatments added to their existing therapy: One group received the combination of preventive medication (beta blockers) and behavioral migraine management, one received only the medication, one received only the behavioral therapy, and one served as a control group. Seventy-nine percent of the study participants were women, and subjects had a mean age of 38.
The combined therapy group showed the greatest improvement in the number of migraines, days with migraine and in quality of life, the researchers report. In comparison, the other three groups experienced modest improvements, a finding that's been reported previously by studies of those individual techniques.
Patients learned behavioral migraine management skills at the four monthly clinic visits used for medication dose adjustment, and then worked on their own between sessions with a workbook and 10 audio lessons. The researchers addressed problems with medication adherence or behavioral management assignments during phone calls between visits.
The first two sessions involved basic migraine management skills, including identification of migraine triggers and early signs of a pending migraine attack. Study participants also learned progressive relaxation skills and muscle stretching exercises to prevent or stop migraines.
The third session either continued focus on basic skills or introduced cognitive-behavioral stress management (if stress was a notable migraine trigger), or introduced thermal biofeedback training (if stress was not a significant trigger). Thermal biofeedback offers information about a patient's hand temperature or blood flow, which can help control or prevent migraines, Holroyd explained.
The final session offered trouble-shooting for the behavioral skills, preparation of a written migraine management plan, and advice on relapse prevention and coping with other problems that might arise.
A small percentage of participants reported fatigue as a side effect of the preventive medication, and some participants reported lack of time to learn or practice the behavioral techniques. But used consistently and together, the two approaches were effective for prevention and management of migraines, Holroyd said.
Gary Cordingley, an associate professor of neurology at the Ohio University College of Osteopathic Medicine involved with the new study, noted that the findings could be useful to clinicians seeking an edge in treating patients with frequent, hard-to-control migraines.
"Relentless, individualized fine-tuning of the acute therapy improves outcomes," Cordingley said. "Supplemental treatment combining preventive medication and behavioral management raises that improvement to a still-higher level."
Some people progress from frequent migraines to chronic migraines, a condition in which headaches occur daily or nearly every day. These chronic migraines can be very debilitating and even more difficult to treat, Holroyd said.
"Frequent disabling migraines may be bad for the brain," he said. "Effectively controlling this disorder may have long-term benefits in addition to the immediate benefits of reducing pain and improving quality of life."
In future studies, Holroyd would like researchers to test specifically whether the behavioral migraine management program reduces the number of people who progress to chronic migraines, as well as whether such a management program modified for chronic migraines can improve outcomes for individuals with the disabling disorder.
Other collaborators on the study were Constance Cottrell and Jana Drew of Ohio University and Headache Treatment and Research of Westerville, Ohio; Frank O'Donnell of the Ohio University College of Osteopathic Medicine, Headache Treatment and Research and OrthoNeuro Inc., of Westerville, Ohio; and Bruce Carlson and Lina Himawan of the Ohio University Department of Psychology.
- K. A. Holroyd, C. K. Cottrell, F. J. O'Donnell, G. E. Cordingley, J. B. Drew, B. W. Carlson, L. Himawan. Effect of preventive (β blocker) treatment, behavioural migraine management, or their combination on outcomes of optimised acute treatment in frequent migraine: randomised controlled trial. BMJ, 2010; 341 (sep29 2): c4871 DOI: 10.1136/bmj.c4871
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