Re: Question on Guidelines: Are There Additional Complementary Treatments for the Prevention of Episodic Migraine?
StarrHolland, Savannah GA;
S.D. Silberstein, MD, FACP, Philadelphia, PA; F. Freitag, DO, Dallas, TX; D.W. Dodick, MD, Scottsdale, AZ; C. Argoff, MD, Albany, NY
Published May 11, 2012
Dr. Charleston is correct that thioctic acid was not included in the Silberstein et al. guideline. Upon supplemental review of Magis and colleagues' article, [2] we agree that it is a double-blind, placebo-controlled, randomized trial of migraine prevention in patients with 2-6 attacks per month, up to 10 days of interval headaches, no medication overuse, and no use of other preventive therapies. This was a 3-month trial that was terminated early due to lack of recruitment, and consequently, the study was underpowered (n=54 recruited; n=44 completed; powered for intended n=80). Assessment of the 44 patients who completed the trial (target n=80) showed that significant differences between treatments were not achieved from placebo for monthly attack frequency (primary endpoint). Secondary endpoints suggest a possible treatment benefit, with decrease in attack frequency noted from baseline measures. However, on the basis of this article, further studies are warranted in a larger sample size to determine whether thioctic acid is effective for the preventive treatment of episodic migraine.
Regarding the article by Ziaei et al. [3], the efficacy of vitamin E for treatment of menstrual migraine was not identified for inclusion in this trial, as the outcomes assessment was limited to acute treatment parameters. Women aged 20-30 were selected to take 400 IU vitamin E starting 2 days before and through 3 days after menstrual flow began; however, assessment was limited to headache response, and reduction in non-pain-related migraine symptoms, including severity of photophobia, phonophobia, and nausea (reduction of moderate or severe to mild or none). No assessment of reduction in attack frequency, headache days, or other standard headache preventive outcomes was reported.
Finally, D'Andrea et al.’s study [4] was an open-label, uncontrolled trial that assessed the change in aura status following combination treatment of 60 mg ginkgo biloba terpenes phytosome, 11 mg coenzyme Q 10, and 8.7 mg vitamin B2. Standard outcomes used in migraine preventive trials, including frequency of attacks or number of headache days, were not assessed.
For disclosures, contact the editorial office at journal@neurology.org.
Dr. Charleston is correct that thioctic acid was not included in the Silberstein et al. guideline. Upon supplemental review of Magis and colleagues' article, [2] we agree that it is a double-blind, placebo-controlled, randomized trial of migraine prevention in patients with 2-6 attacks per month, up to 10 days of interval headaches, no medication overuse, and no use of other preventive therapies. This was a 3-month trial that was terminated early due to lack of recruitment, and consequently, the study was underpowered (n=54 recruited; n=44 completed; powered for intended n=80). Assessment of the 44 patients who completed the trial (target n=80) showed that significant differences between treatments were not achieved from placebo for monthly attack frequency (primary endpoint). Secondary endpoints suggest a possible treatment benefit, with decrease in attack frequency noted from baseline measures. However, on the basis of this article, further studies are warranted in a larger sample size to determine whether thioctic acid is effective for the preventive treatment of episodic migraine.
Regarding the article by Ziaei et al. [3], the efficacy of vitamin E for treatment of menstrual migraine was not identified for inclusion in this trial, as the outcomes assessment was limited to acute treatment parameters. Women aged 20-30 were selected to take 400 IU vitamin E starting 2 days before and through 3 days after menstrual flow began; however, assessment was limited to headache response, and reduction in non-pain-related migraine symptoms, including severity of photophobia, phonophobia, and nausea (reduction of moderate or severe to mild or none). No assessment of reduction in attack frequency, headache days, or other standard headache preventive outcomes was reported.
Finally, D'Andrea et al.’s study [4] was an open-label, uncontrolled trial that assessed the change in aura status following combination treatment of 60 mg ginkgo biloba terpenes phytosome, 11 mg coenzyme Q 10, and 8.7 mg vitamin B2. Standard outcomes used in migraine preventive trials, including frequency of attacks or number of headache days, were not assessed.
For disclosures, contact the editorial office at journal@neurology.org.