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Neither preventive medication nor behavioral migraine management improve optimal acute therapy outcomes, but their combination does: The Treatment of Severe Migraine (TSM) trial
Kenneth A. Holroyd, PhD1, Constance Cottrell, PhD1, Francis O'Donnell, DO2, Gary E. Cordingley, MD, PhD3, Jana Drew, PhD1, Bruce Carlson, PhD1, Lina Himawan, MS1, and Victor Heh, MS1. (1) Department of Psychology, Ohio University, 200 Porter Hall, Athens, OH 45701-2979, (2) Headache Treatment & Research, OrthoNeuro, 70 North Cleveland Ave., Westerville, OH 43018, (3) Department of Specialty Medicine, Ohio University College of Osteopathic Medicine, 65 Hospital Drive, Athens, OH 45701
The TSM trial evaluated the ability of Preventive Drug Therapy (PDT) and Behavioral Migraine Management (BMM) separately and combined to improve outcomes with Optimal Acute Therapy (OAT) in frequent migraine. Potential trial participants with frequent migraine (IHS migraine, minimum of 3 migraines/mo., significant migraine-related disability) completed a 5-week acute therapy (Triptans, NSAID, anti-emetic and, as needed, rescue medication) run-in. Ss with diary confirmed migraine frequency/disability despite acute therapy were randomized (N=232; 79% female; means, age = 38 migraines/mo.= 6.3, migraine days/mo= 8.1.) to the 4 experimental treatments. The four experimental treatments were: 1) OAT (social learning based education to maximize effective use of acute therapies) + Preventive Placebo (PL), 2) OAT + PDT (Propranolol LA (PR) to 240 mg/d. or, if ineffective or not tolerated, Nadalol (NA) to 120 mg./d.), 3) OAT + BMM ( migraine education, relaxation, thermal biofeedback or stress-management, pain management) + PL, and 4) OAT + BMM + PDT. Migraine activity and medication use was monitored by hand-held computer diary throughout the 16 mo. trial. Quality-of-Life (Headache Disability Inventory; HDI & Migraine Specific Quality of Life; MSQL) measures were collected periodically (mo. 0,1, 3,5,7,10,13,16).. Mixed models analysis (N = 232) revealed all 4 treatments produced substantial improvements across all outcome measures (p < .001), but the 4 treatments also differed in effectiveness (p < .001). Only the addition of BMM + PDT significantly improved migraine activity (episodes/mo, migraine days/mo.) beyond OAT alone (p < .01). However, both BMM + PDT and BMM alone improved outcomes on Q-of-L (HDI, MSQL) beyond both OAT alone and OAT + PDT. BMM + PDT optimally improved all outcomes obtained with OAT. OAT alone may effectively control migraines in up to 50% of Ss, raising the possibility that effective early abortion of migraine reduces the probability of migraine on subsequent days.
