RESUMO
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. CLINICALTRIALSGOV 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.
