Saturday, October 9, 2010

New Study: What Works Best for Frequent Migraine?

HeadacheMigraine is relatively common, affecting about 14% of women and 6% of men worldwide, and a third of them experience 3 or more debilitating attacks per month. In a recent report, investigators suggest an approach for significantly bolstering the acute pharmacologic treatment of migraines; however, this may not be attainable in everyday clinical practice.

Researchers at the University of Ohio designed a randomized, placebo-controlled trial to determine if the addition of preventive drug treatment (a β blocker; eg, propranolol or nadolol), behavioral migraine management, or both would improve the outcome of acute pharmacological treatment for the management of frequent migraine [Holroyd et al. 2010]. Participants included 232 adults (mean age 38 years; 79% female) with a diagnosis of migraine with or without aura, who recorded at least 3 migraines with disability per month (mean 5.5 migraines/30 days), during an optimized run-in of acute treatment. The acute treatment included a triptan (5-HT agonist) with an NSAID (eg, ibuprofen), antiemetic (eg, metoclopramide), and/or rescue drug (eg, steroid) added as necessary.

To the optimized acute treatment, one of four preventive therapies were added: (A) β blocker (n=53), (B) matched placebo (n=55), (C) behavioral migraine management plus placebo (n=55), or (D) behavioral migraine management plus β blocker (n=69). The primary outcome measure was change in migraine-attack frequency during 30 days; secondary outcomes included change in migraine days/30 days and change in migraine-specific quality of life scores. Results demonstrated that the addition of combined β blocker plus behavioral migraine management — but not the addition of β blocker alone or behavioral migraine management alone —significantly improved outcomes compared with optimized acute treatment alone. Results were consistent for the two secondary outcomes, and at both month 10 (the primary endpoint) and month 16 followup. Overall, during the entire 16-month trial, differences in side effect incidence associated with pharmacologic therapies compared with placebo were not statistically significant, and attrition specifically due to β blocker side effects was 13% as compared with 8% assigned to placebo (p=0.25).

COMMENTARY: The authors found that, for a clinically significant (≥50% reduction) in migraines/30 days, the number needed to treat for combining a β blocker plus behavioral management with optimized acute care was roughly 3. In other words, 1 of every 3 patients treated with the new approach would benefit, above and beyond what could be achieved with optimized acute care alone. However, it might be questioned whether the group sizes (n=53 to 69) were sufficiently large to provide adequate statistical power for a valid assessment (recently discussed in our UPDATE [here]).

The behavioral migraine management program in this study was an extensive workbook-and-audiotape intervention teaching subjects about migraine and its causes, as well as skills such as relaxation techniques, stress management, how to identify and moderate triggers, and other strategies. The program was administered by trained health psychologists and lasted several months. While it was effective, when combined with β blocker therapy, such a behavioral program would seem to be the purview only of specialized clinical settings and would add significantly to the costs of medications alone. And, although this could be very worthwhile for the one-third of migraineurs who might benefit, further research might be appropriate to verify the outcomes of this study and justify costs.

REFERENCE: Holroyd KA, Cottrell CK, O’Donnell FJ, et al. Effect of preventive (β blocker) treatment, behavioral migraine management, or their combination on outcomes of optimized acute treatment in frequent migraine: randomized controlled trial. BMJ. 2010(Sep 29);341:c4871 [article available here].