BARCELONA — A mindfulness-based treatment has shown multiple benefits in patients with chronic migraine and medication-overuse headaches, results of a new randomized trial, show.
In the MIND-CM study, six weekly mindfulness sessions and short daily self-practice, added on to good medical care, showed superior improvement in headache frequency, quality of life and disability, headache impact, loss of productive time, medication intake, and in total, indirect and direct healthcare costs.
"We found real improvements in the group of patients practicing mindfulness which continued to be evident out to 12 months; our patients learned to use the practice to manage the pain," study investigator Licia Grazzi, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy, told Medscape Medical News.
"Mindfulness should therefore be considered as part of the regular treatment of patients with chronic migraine and medication overuse headache," she added.
The findings were presented at the 17th European Headache Congress (EHC). The MIND-CM study was published in the Journal of Headache and Pain. Further details of the mindfulness program used are available in the study's supplementary information.
A Complex Condition
Grazzi noted that several small studies have suggested a benefit of mindfulness on migraine, but there have not been many randomized trials, particularly with adequate sample size and well-defined outcomes. The MIND-CM study is, to date, one of the largest on behavioral treatments, and the largest on mindfulness in patients with migraine.
In the phase 3 study, 177 patients with chronic migraine and medication-overuse headache were randomly assigned to receive either usual treatment (which included withdrawal from overused drugs; education on proper medication use and lifestyle issues; and tailored prophylaxis) or mindfulness-based intervention added to usual treatment.
The mindfulness-based intervention consisted of six group sessions of mindfulness practice and 7-10 min daily self-practice.
The primary endpoint was the achievement of ≥ 50% headache frequency reduction at 12 months compared with baseline. This was achieved by 78.4% in the mindfulness group vs 48.3% in the usual care alone group (P < .0001).
The mindfulness group also showed significant reductions compared to the usual care alone group in total drug intake and NSAIDs intake, and more frequently achieved a meaningful reduction in headache impact, as defined by a reduction of 6 points or more in the Headache Impact Test (HIT-6) score.
In addition, the practice of mindfulness led to less loss of productive time (using a measure that accounts for both lost workdays and days worked with headache), and lower direct and indirect healthcare costs throughout the study. It was also associated with better quality of life and disability scores (as measured by the MIDAS score) at 12 months.
The mindfulness program used in the study consisted of six in-person 90-minute sessions held weekly in which patients were educated and trained to use the practice. The actual mindfulness meditation was increased from an initial 4 minutes to a length of 25 minutes by the end of the program. Patients were trained to focus on breathing and to reduce judgments by acknowledging arising thoughts, feelings, and emotions, without any emotional reaction.
Patients were encouraged to share information about their migraine and disease history and received ideas on how to be more accepting of their condition, and to recognize when they need headache medications and when they do not.
They were also invited to try practicing mindfulness at home and were provided with a 12-minute audio file to use at any time after the structured intervention concluded.
"Rather than trying to cancel the pain, we try to teach patients how to stay with it and how to manage it themselves to use their internal locus of control during the course of their life," said Grazzi.
Grazzi, who is a neurologist and headache specialist, has taken courses in mindfulness and teaches the program herself.
"We are working to expand our view that migraine is a very complex condition that has a social, emotional, and biological aspect that work together. It is important to try and understand all these aspects. I am hopeful that the field of migraine medicine starts to embrace this more," she said.
However, she added, if clinicians do not want to become educated in mindfulness themselves, they can just recommend patients find their own mindfulness courses.
Grazzi says mindfulness is a practice that should be integrated into everyday life, not just at migraine onset.
"Mindfulness practice should be part of your routine — you sit down with the specific purpose of practicing mindfulness, and by doing that you learn skills that gradually becomes incorporated into every part of your life."
Impressive Results
Commenting on the study for Medscape Medical News, Anne MacGregor, MBBS, MD, specialist in headache and women's health at St. Bartholomew's Hospital, London, UK, said the results were impressive as the patients included were particularly difficult to manage.
"The results were very clear in that the benefits were seen in a randomized trial on top of high-quality medical care with withdrawal of medication and lifestyle advice," MacGregor noted.
MacGregor said the results of the study were consistent with other cognitive behavioral-type treatments that have been shown to be effective for chronic pain conditions.
"There is such a strong link between the mind and symptom management in migraine, [that] it makes total sense that this would work. In this study, the improvements were still there at 12 months, so patients were clearly getting benefits of the self-strategies that they had been taught to use," she noted.
MacGregor suggested that the group meetings involved in the program in this study likely made a difference. "Talking to others and sharing experiences and understanding of a condition you all have in common can, in itself, bring real benefits."
However, she added that it would be interesting to see if these same strategies can be created by building on a web-based app.
"Mindfulness can give control back to patients by giving patients tools on how to live with migraine and removing the catastrophizing that can occur when an attack strikes," she said.
She explained that migraine occurs as a result of sensory overload, whether it's bright lights, stress, smells, or hormonal changes, to name a few.
"As these build, the brain reaches a point where it can't filter them out anymore, and that's when the migraine comes," she said. "Just taking time out can be very helpful. Removing yourself from the environmental stimuli around you calms the brain. This can take many forms. It could be doing a mindfulness program like this one, or it could be doing yoga, or just going for a walk in nature and taking your mind away from the things that are causing anxiety."
MacGregor noted that mindfulness has been shown to work in reducing hot flashes in menopause and even reducing severity of epilepsy.
"It may not work for everybody, but I think it's a useful adjunct to medication in migraine patients for those who are interested in pursuing that as a concept," she concluded.
The MIND-CM project received funding from the Italian Ministry of Health.
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