SAN FRANCISCO – A brief course of mindfulness training for chronic migraine patients after their withdrawal from overuse of acute migraine medications proved as effective as prophylactic medication over the course of 12 months of follow-up, Frank Andrasik, PhD, reported at the annual meeting of the American Headache Society.
“The effects of mindfulness by and large rivaled those for medication alone. And although not specifically assessed, patients commented that mindfulness didn’t have side effects and promoted greater involvement and adherence,” said, professor and chair, department of psychology, and director of the Center for Behavioral Medicine at the University of Memphis.
He noted that his recently published study () is best considered exploratory because of its small size and nonrandomized design. Participants, after 5 days of structured acute medication withdrawal in a day hospital setting, got to choose whether to opt for pharmacologic prophylaxis for migraine – most often using botulinum toxin – or a brief course in mindfulness training entailing six once-weekly 45-minute sessions plus home practice for 7-10 minutes per day. And while this study design doesn’t rise to the status of level 1 randomized trial evidence, it does reflect real-world clinical practice, where patients often have a big say in choosing their treatment plan, the psychologist observed.
At baseline, all 44 patients met diagnostic criteria for chronic migraine with associated acute medication overuse. They averaged 20.5 headache days per month, with 18.4 days of acute migraine medication use.
At 3, 6, and 12 months of follow-up, the 22 patients in the mindfulness group averaged 8.3, 10.4, and 12.4 headache days per month, while the 22 on preventive migraine drugs averaged 8.8, 11, and 8.6 headache days per month. Both groups averaged similar 7- to 10-day reductions in days of acute migraine medication use per month.
Using the widely accepted endpoint of at least a 50% reduction in headache days per month, 50% of the mindfulness-only group and 52.6% of the prophylactic medication-only group met that standard at 12 months of follow-up. Moreover, at 12 months, 65% of the mindfulness therapy group and a similar 73.7% of the preventive medication group no longer met diagnostic criteria for chronic migraine.
The mindfulness protocol used in the study was based upon the popular mindfulness-based stress reduction program developed by Jon Kabat-Zinn, PhD.
Scores on the Migraine Disability Assessment (MIDAS) measure improved significantly and to a similar extent over baseline in both groups. So did scores on the Beck Depression Inventory. In contrast, scores on the State-Trait Anxiety Inventory didn’t change significantly in either study arm.
Both Dr. Andrasik and session chair mindfulness is still in its infancy for treatment of migraine. Large randomized, controlled clinical trials are ongoing or in the planning stages, with no results yet available., cautioned that despite solid evidence of efficacy for mindfulness training in the treatment of depression and a number of chronic pain disorders,
Dr. Seng, a clinical psychologist at Albert Einstein College of Medicine in New York, described mindfulness and acceptance as “third wave” behavioral treatments for migraine. The first wave therapies focused on fostering behavioral changes to reduce perceived stress in order to avoid triggering migraine attacks. The second wave involved therapeutic interactions aimed at helping patients reframe maladaptive automatic thoughts to reduce stress stemming from the daily hassles of life.
“The focus in the first- and second-wave therapies is, ‘Change something and your life will be better. Change your behaviors, clean up your act, change your thoughts because your thoughts are not helping you, and thereby reduce stress and reduce migraine.’ These mindfulness therapies are incredibly different from that,” she explained.
Indeed, the third-wave therapies aren’t trying to change daily hassles or automatic thoughts; instead, they seek to change the patient’s relationship to them such that they no longer create barriers to engaging in life activities that the patient finds nourishing and meaningful. It’s a matter of creating a willingness to experience pain in order to achieve worthwhile objectives, Dr. Seng continued.
It’s unclear that a reduction in migraine days – the traditional yardstick for therapeutic efficacy in migraine research – is the right primary outcome measure for third-wave therapies, according to the psychologist.
“So far, our evidence would suggest that mindfulness-based therapies do not reduce migraine days as much as other behavioral treatments, but what they’re doing is increasing migraine-related quality of life and reducing migraine-related disability to the same or possibly larger extent than our other behavioral treatments,“ she said. “Maybe what these third-wave therapies are actually doing is impacting our cognitive and emotional functioning, and that even if patients still experience similar levels of headache frequency, their reaction to those headache days no longer leads to a bunch of suffering. And that could be a clinically relevant outcome.”
Dr. Seng is particularly eager to formally study mindfulness therapies in a subgroup of migraine patients with high levels of depression. They might respond especially well, since mindfulness was originally developed as a treatment for severe depression. “Patients who are depressed have a hard time overcoming barriers to engaging in nourishing life activities, and when they have a headache day it’s even worse. That’s one of the things that’s leading them to have migraine-related disability,” she said.
Dr. Andrasik, whose study was supported by the European Commission and an Italian research foundation, reported having no financial conflicts of interest regarding his presentation. Dr. Seng reported serving as a consultant to GlaxoSmithKline.
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