-48% decrease in headache frequency with intervention
by Zeena Nackerdien PhD, CME Writer, MedPage Today | May 21, 2020
Study Authors: Anand Kumar, Rohit Bhatia, et al.
Target Audience and Goal Statement: Neurologists, primary care physicians
The goal of this study was to evaluate the effectiveness of yoga as an adjuvant to conventional medical management on clinical outcomes in patients with migraine.
Question Addressed:
- Could yoga as an add-on therapy provide more episodic migraine relief than medical treatment alone?
Study Synopsis and Perspective:
Migraines affect one in every four U.S. households, with adult women experiencing attacks more than men by a ratio of 3:1. A hallmark of this common episodic disorder is a disabling headache generally associated with nausea and/or light and sound sensitivity.
Action Points
- The addition of yoga to conventional medical therapy for adults with episodic migraine resulted in a 48% decrease in headache frequency compared with a 12% decrease with medication alone, according to a single-center trial in India.
- Note that migraines affect one in every four U.S. households and impact activities of daily living, work-life, and financial status, especially in those with four or more monthly migraine days and prior treatment failures.
Migraines, which appear to be hereditary, cause disturbances in serotonin use and activity. Migraine attacks can reportedly be triggered by menstruation, foods containing vasoactive amines, strong odors, too much or too little sleep, sun glare, altitude, weather changes, exertion, and fasting.
They are also a risk factor for ischemic cerebrovascular disease and psychological impairment, including depression and increased suicidal tendency.
Needless to say, migraine impacts individuals’ activities of daily living, work-life, and financial status, especially those with four or more monthly migraine days and prior treatment failures.
Medications — typically the first-line treatment option — include beta-blockers, calcium channel blockers, antiepileptics, and antidepressants. However, only half of migraine sufferers are responsive to these types of treatment, and 10% may discontinue medications due to adverse events. Patient dissatisfaction with existing treatment strategies leaves room for exploring additional options.
Evidence from the literature has shown that yoga — an ancient Indian practice based on the principles of mind-body medicine — had beneficial effects on various migraine measures. In the CONTAIN trial, Rohit Bhatia, MD, DM, DNB, of the All India Institute of Medical Sciences in New Delhi, and colleagues randomized 160 eligible patients ages 18-50 with a diagnosis of episodic migraine 1:1 to yoga plus conventional medical therapy or medical therapy alone. Patients were treated at the tertiary care academic hospital in New Delhi from April 2017 to August 2019.
Add-on yoga was superior to medical therapy alone, they reported in Neurology. While patients with migraine improved in both groups, the benefit was significantly greater in the yoga group for all measures, including headache frequency and intensity, as well as scores on the Migraine Disability Assessment (MIDAS) questionnaire and the six-item Headache Impact Test (HIT-6) survey, which assess headache-specific disability.
Each yoga module was 1 hour and included meditation, breathing exercises, relaxation exercises, yogic postures, and pranayama (the formal practice of controlling the breath). The yoga module was supervised 3 days a week for 1 month at the institute, followed by 5 days a week for the next 2 months at home.
A total of 114 patients completed the trial, 57 in each group. All patients were advised on lifestyle modifications including adequate sleep, regular meals, mental relaxation, and an appropriate regular schedule of physical activity. Forty-six patients completed the expected 12 yoga sessions at the hospital and all patients completed the expected 40 sessions of yoga at home.
Baseline demographic and clinical characteristics were similar between groups, except for mean headache frequency, which was higher in the yoga group compared with the medical group (9.07 vs 7.7 headache days/month, P=0.012). Patients in both groups were about 31 years old, on average. Women comprised 66.25% of the medical group and 72.5% of the yoga group.
Headache severity was assessed using a Visual Analogue Scale, while the change in headache-specific disability was assessed using the MIDAS and the HIT-6 surveys. A decrease in headache frequency, headache intensity, and HIT-6 score served as the primary endpoint. Secondary endpoints included a change in the MIDAS score, rescue pill count, and proportion of headache-free patients.
Propranolol was the most commonly used prophylactic medication, followed by amitriptyline, in both the yoga and medical groups. Compliance with medical treatment was similar between both groups. The most commonly used rescue medications in both study arms were acetaminophen and a combination of naproxen-domperidone.
At baseline, the medication-only group reported an average of 7.7 headache days per month and this frequency dropped to 6.8 per month after 3 months — a 12% decrease. By comparison, the yoga group started with an average of 9.1 headache days per month and this dropped to 4.7 — a 48% decrease. Similarly, the average number of pills used as rescue medication decreased by 47% in the yoga group, compared with a 12% decline in the medication-only group.
High delta values and differences between delta values favored the yoga group in all measures. Delta differences were:
- Headache frequency 3.53, 95% CI 2.52-4.54, P<0.0001
- Headache intensity 1.31, 95% CI 0.60-2.01, P=0.0004
- HIT-6 score 8.0, 95% CI 4.78-11.22, P<0.0001
- MIDAS score 7.85, 95% CI 4.98-10.97, P<0.0001
- Rescue pill count 2.28, 95% CI 1.06-3.51, P<0.0003
Bhatia and team observed a gradual improvement in clinical outcome measures in both groups, but the trend towards improvement was faster and more consistent in the yoga group. More patients were headache free at the end of 3 months in the yoga group (12.28% vs 0% in the control arm, P=0.006; number needed to treat 8, 95% CI 5-27).
Three participants in the medication-only group experienced adverse effects (weight gain or dryness of mouth) compared with one participant in the yoga group (weight gain). No episodes of headache, nausea, or vomiting were experienced by participants during the yoga sessions, according to the researchers.
The study lasted only 3 months and more research is needed to determine whether the benefits of yoga would persist, Bhatia said. The study also had other limitations: it did not have a sham yoga group and outcome measures were subjective and questionnaire-based, and other factors may have influenced the results.
Source Reference: Neurology 2020; DOI: 10.1212/WNL.0000000000009473
Study Highlights and Explanation of Findings:
“Our results show that yoga can reduce not just the pain, but also the treatment cost of migraines,” Bhatia said in a statement. “That can be a real game changer, especially for people who struggle to afford their medication. Medications are usually prescribed first, and some can be expensive.”
While migraine is one of the most common headache disorders, “only about half the people taking medication for it get real relief,” he pointed out.
“The good news is that practicing something as simple and accessible as yoga may help much more than medications alone. And all you need is a mat,” he added.
The economic burden associated with the treatment of migraine is $3.2 billion in direct costs and $13 billion in indirect costs, including loss of productivity and reduced performance at work, in the U.S. alone. Based on results from this study, the researchers stated that a low-cost intervention in the form of yoga would reduce both direct and indirect costs significantly (reduction in mean pill count by 47.3% after 3 months, MIDAS reduced by 37.25% over 3 months).
The study was the largest randomized controlled trial of yoga and migraine to date, the researchers noted. “More nonpharmacologic trials are needed in the field of headache medicine,” commented Mia Minen, MD, MPH, of NYU Langone Health in New York City, who was not involved with the study. “Many of these treatments can be administered safely.”
It is not surprising that the program studied in the trial yielded beneficial results, Minen told MedPage Today.
“There were some aspects of migraine therapy known to help included in the protocol,” she said. “For example, we know that relaxation is a top evidence-based form of behavioral therapy for the prevention of migraine.” Other non-medication treatments, such as mindfulness-based cognitive therapy, have been associated with statistically significant reductions in perceived disability in recent migraine studies.
Bhatia’s group noted that it would be of scientific interest to compare yoga versus best medical management. Understanding the beneficial effects of yoga on migraine could be further enhanced with blood and imaging biomarkers.
Primary Source
Neurology
Source Reference: Kumar A, et al “Effect of yoga as add-on therapy in migraine (CONTAIN): a randomized clinical trial” Neurology 2020; DOI: 10.1212/WNL.0000000000009473.
Secondary Source
MedPage Today
Source Reference: George J “Does Yoga Have a Place in Migraine Treatment?” 2020.