Monday September 15 2014
Migraines can cause a severe headache and nausea
“Daily meditation may be the most effective way of tackling migraine,” the Daily Express reports.
This headline is not justified, as it was based on a small pilot study involving just 19 people.
It showed that an eight week "mindfulness-based stress reduction course" (a combination of mediation and yoga-based practices) led to benefits in measures of headache duration and subsequent disability in 10 adult migraine sufferers, compared to nine in a control group who received usual care.
There were no statistically significant differences found for the arguably more important measures of migraine frequency (migraines per month) and severity. However, the study may have been too small to reliably detect any differences in these outcomes. Both groups continued to take any migraine medication (preventative or for treatment during a headache) they were already taking before the trial.
Overall, this trial showed weak and tentative signs that mindfulness-based stress reduction might be beneficial in a very small group of highly select adults with migraines. However, we will only be able to say it works with any confidence after much larger studies have been carried out.
Where did the story come from?
The study was carried out by researchers from Wake Forest School of Medicine, North Carolina (US) and Harvard Medical School, Boston. It was funded by the American Headache Society Fellowship and the Headache Research Fund of the John Graham Headache Center, Brigham and Women’s Faulkner Hospital.
The study was published in the peer-reviewed journal Headache.
One of the study authors reported receiving research support from GlaxoSmithKline, Merck and Depomed. All other authors report no conflicts of interest.
The Daily Express’ coverage of this small study arguably gave too much prominence and validity to the findings, indicating they were reliable: “The ancient yoga-style technique lowers the number of attacks and reduces the agonising symptoms without any nasty side effects”.
Many of the limitations associated with the study were not discussed, including the fact that some of the findings may have been chance, due to the small sample size.
To be fair, the researchers themselves were forthright in highlighting the limitations of their research.
What kind of research was this?
This was a small randomised controlled trial (RCT) investigating the effects of a standardised eight week mindfulness-based stress reduction course in adults with migraines.
Stress is known to be associated with headaches and migraines, but the research group said solid evidence on whether stress-reducing activities might reduce the occurrence or severity of migraines was lacking. Because of this, they designed a small RCT to test one such activity – an eight-week mindfulness-based stress reduction course.
This was a small pilot RCT. These are usually designed to provide proof of concept that something might work and is safe before moving on to larger trials involving more people. The larger trials are designed to reliably and robustly prove effectiveness and safety. Hence, on their own, pilot RCTs rarely provide reliable evidence of effectiveness.
What did the research involve?
Researchers took a group of 19 adults who had been diagnosed with migraines (with or without aura) and randomly divided then into two groups. One group (n=10) received an eight-week mindfulness-based stress reduction course, while the others (n=9) received “usual care” – they were asked to continue taking any migraine medication they had, and not to change the dose during the eight-week trial.
During the mindfulness trial, participants were also allowed to continue to take any medication they usually would. The main outcome of interest was change in migraine frequency from the start of the trial to eight weeks. Secondary measures included change in headache severity, duration, self-efficacy, perceived stress, migraine-related disability/impact, anxiety, depression, mindfulness and quality of life from the start to the end of the eight-week trial period.
The standardised mindfulness-based stress reduction course class met for eight weekly, two-hour sessions, plus one “mindfulness retreat day”, which comprised six hours led by a trained instructor and followed a method created by Dr Jon Kabat-Zinn. The intervention is based on systematic and intensive training in mindfulness meditation and mindful hatha yoga in the context of mind/body medicine. Participants were encouraged to practice at home to build their daily mindfulness practice for 45 minutes per day, on at least five additional days per week. Compliance was monitored through class attendance and by daily logs of home practice.
To be included in the trial, participants had to have reported between 4 and 14 migraine days per month, more than a year of migraine history, be over 18, in good general health and be able and willing to attend weekly sessions of mindfulness and to practice every day at home for up to 45 minutes. Excluding criteria included participating in yoga/meditation practice and having a major illness (physical or mental).
All participants in both groups were taking medications for their headaches.
At the end of the eight-week period, the control group were offered the mindfulness course as a courtesy for their participation in the trial. In an attempt to blind the control group to treatment allocation,they were told there were two start periods for the eight-week trial and they were merely on the second, continuing usual care in the interim.
For all final analyses, migraines were more precisely defined as those headaches that were more than 4 hours long with a severity of 6 to 10, based on patient diary information.
The study aimed to recruit 34 people, but only recruited 19, so was underpowered to detect statistically significant differences in the outcomes assessed.
All participants kept a daily headache diary for 28 days before the study began.
What were the basic results?
All nine people completed the eight-week stress reducing course, averaging 34 minutes of daily meditation. In both groups, more than 80% took daily prophylactic migraine medication, such as Propranolol and 100% used abortive medication, such as Triptans, when a migraine struck. There were no adverse events recorded, suggesting the intervention was safe, at least in the short term.
The main findings were:
Mindfulness participants had 1.4 fewer migraines per month compared to controls (intervention 3.5 migraines during 28-day run-in, reduced to 1.0 migraines per month during the eight-week study, vs. control: 1.2 to 0 migraines per month, 95% confidence interval (CI) [−4.6, 1.8], an effect that did not reach statistical significance in this pilot sample. The lack of statistical significance means the result could be due to chance alone.
Headaches were less severe (−1.3 points/headache on 0-10 scale, [−2.3, 0.09], on the borderline of statistical significance) and shorter (−2.9 hours/headache, [−4.6, −0.02], statistically significant) in the intervention group compared to the controls
Migraine Disability Assessment and Headache Impact Test-6 (a widely used test that assesses the impact of migraines on quality of life and day to day function) dropped in intervention group compared with the control group (−12.6, [−22.0, −1.0] and −4.8, [−11.0, −1.0], respectively), both of which were statistically significant. Self-efficacy and mindfulness improved in the intervention group compared with control (13.2 [1.0, 30.0] and 13.1 [3.0, 26.0]) and was also a statistically significant finding.
How did the researchers interpret the results?
The researchers indicated the mindfulness-based stress reduction course was “safe and feasible for adults with migraines. Although the small sample size of this pilot trial did not provide power to detect statistically significant changes in migraine frequency or severity, secondary outcomes demonstrated this intervention had a beneficial effect on headache duration, disability, self-efficacy and mindfulness. Future studies with larger sample sizes are warranted to further evaluate this intervention for adults with migraines”.
This pilot RCT, based on just 19 adult migraine sufferers, showed an eight-week mindfulness-based stress reduction course led to benefits for headache duration, disability, self-efficacy and mindfulness measures, compared to a control group who received usual care. There were non-significant benefits observed for measures of migraine frequency and severity. Both groups continued to take any migraine medication (prophylactic or for treatment during a headache) they were already taking before the trial.
The research group themselves were very reasonable in their conclusions and called for larger trials to be done to investigate this issue further. As they acknowledge, relatively little can be said with reliability based on this small pilot study alone. This is because small studies van often not be generalised to the wider population.
For example, what are the chances the experience of a group of nine people will represent the experiences of the UK population as a whole who could be different ages, have different attitudes and expectations of meditation and have different medical backgrounds?
Also, larger trials are able to more accurately estimate the magnitude of any effect, whereas small studies may be more volatile to change or extreme findings. Taken together, a pilot study of this size cannot and does not prove that "mindfulness-based stress reduction" is beneficial for migraine sufferers. This point may have been missed by those reading The Daily Express’ coverage, which appeared to accept some of the positive findings at face value and assume widespread effectiveness, without considering the limitations inherent in a pilot RCT of this size.
It is also worth noting that the participants were recruited if they suffered between 4 and 14 migraines per month, but the actual frequency of headache was much smaller for all participants during the run-in period and the eight-week study period. Indeed, some participants in each group had no headaches during each period. This further reduces the ability of this study to show any significant difference between the groups.
Overall, the eight-week mindfulness-based stress reduction course showed tentative signs that it might be beneficial in a very small group of highly select adults with migraines. However, we will only be able to say it is beneficial with any confidence after much larger studies have been carried out. Until then, we simply don’t know if this type of course will help migraine sufferers, hence the Daily Express’ headline is premature.
That said, adopting a psychological approach to chronic pain conditions, rather than relying on medication alone, can help improve symptoms in some people. Read more about coping with chronic pain.
Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on Twitter. Join the Healthy Evidence forum.