Effect of yoga as add-on therapy in migraine (CONTAIN) A randomized clinical trial

Objective To evaluate the effectiveness of yoga as an adjuvant to conventional medical management on clinical outcomes in patients with migraine. Methods CONTAIN was a prospective, randomized, open-label superiority trial with blinded endpoint assessment carried out at a single tertiary care academic hospital in New Delhi, India. Patients enrolled were aged 18-50 years with a diagnosis of episodic migraine and were randomized into medical and yoga groups (1:1). Randomization was computer-generated with a variable block size and concealed. A predesigned yoga intervention was given for 3 months. Outcomes were recorded by a blinded assessor. The primary endpoint was a decrease in headache frequency, headache intensity, and Headache Impact Test (HIT)-6 score. Secondary outcomes included change in Migraine Disability Assessment (MIDAS) score, pill count, and proportion of headache free patients. Results Between April 2017 and August 2018, 160 patients with episodic migraine were randomly assigned to medical and yoga groups. A total of 114 patients completed the trial. Baseline measures were comparable except for a higher mean headache frequency in the yoga group. Compared to medical therapy, the yoga group showed a significant mean delta value reduction in headache frequency (delta difference 3.53 [95% confidence interval 2.52-4.54];p< 0.0001), headache intensity (1.31 [0.60-2.01];p= 0.0004), HIT score (8.0 [4.78-11.22];p< 0.0001), MIDAS score (7.85 [4.98-10.97];p< 0.0001), and pill count (2.28 [1.06-3.51];p< 0.0003). Conclusion Yoga as an add-on therapy in migraine is superior to medical therapy alone. It may be useful to integrate a cost-effective and safe intervention like yoga into the management of migraine. Clinicaltrials.gov identifier CTRI/2017/03/008041. Classification of evidence This study provides Class III evidence that for patients with episodic migraine, yoga as adjuvant to medical therapy improves headache frequency, intensity, impact, and disability.