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CLINICAL TRIAL
JOURNAL ARTICLE
Use of a pine bark extract and antioxidant vitamin combination product as therapy for migraine in patients refractory to pharmacologic medication.
Headache 2006 May
OBJECTIVE: To evaluate the potential benefit of a pine bark extract and antioxidant vitamin combination product in the treatment of migraine headache.
BACKGROUND: This was an uncontrolled preliminary study to investigate the potential of an antioxidant formulation as therapy for migraine headache.
METHODS: Twelve patients with a long-term history of migraine with and without aura who had failed to respond to multiple treatments with beta-blockers, antidepressants, anticonvulsants, and 5-hydroxytryptamine receptor agonists were selected for the study. They were treated with 10 capsules of an antioxidant formulation of 120 mg pine bark extract, 60 mg vitamin C, and 30 IU vitamin E in each capsule daily for 3 months. Following enrollment patients completed a migraine disability assessment (MIDAS) questionnaire to give a baseline measure of migraine impact on work, school, domestic, and social activities over the previous 3 months. Patients were then treated for 3 months with the antioxidant formulation while continuing to receive existing pharmacologic medications. A second MIDAS was given at the conclusion of the treatment period.
RESULTS: There was a significant mean improvement in MIDAS score of 50.6% for the 3-month treatment period compared with the 3 months prior to baseline (P < .005). The treatment was also associated with significant reductions in number of headache days and headache severity score. Mean number of headache days was reduced from 44.4 days at baseline (95% CI 28.9 to 59.8) to 26.0 days (95% CI 5.3 to 46.7; P < .005) after 3 months' therapy and mean headache severity was reduced from 7.5 of 10 (95% CI 6.7 to 8.4) to 5.5 (95% CI 4.1 to 7.0; P < .005).
CONCLUSION: These data suggest that the antioxidant therapy used in this study may be beneficial in the treatment of migraine possibly reducing headache frequency and severity. Further clinical investigation into the efficacy of antioxidant as therapy for chronic migraine is warranted.
BACKGROUND: This was an uncontrolled preliminary study to investigate the potential of an antioxidant formulation as therapy for migraine headache.
METHODS: Twelve patients with a long-term history of migraine with and without aura who had failed to respond to multiple treatments with beta-blockers, antidepressants, anticonvulsants, and 5-hydroxytryptamine receptor agonists were selected for the study. They were treated with 10 capsules of an antioxidant formulation of 120 mg pine bark extract, 60 mg vitamin C, and 30 IU vitamin E in each capsule daily for 3 months. Following enrollment patients completed a migraine disability assessment (MIDAS) questionnaire to give a baseline measure of migraine impact on work, school, domestic, and social activities over the previous 3 months. Patients were then treated for 3 months with the antioxidant formulation while continuing to receive existing pharmacologic medications. A second MIDAS was given at the conclusion of the treatment period.
RESULTS: There was a significant mean improvement in MIDAS score of 50.6% for the 3-month treatment period compared with the 3 months prior to baseline (P < .005). The treatment was also associated with significant reductions in number of headache days and headache severity score. Mean number of headache days was reduced from 44.4 days at baseline (95% CI 28.9 to 59.8) to 26.0 days (95% CI 5.3 to 46.7; P < .005) after 3 months' therapy and mean headache severity was reduced from 7.5 of 10 (95% CI 6.7 to 8.4) to 5.5 (95% CI 4.1 to 7.0; P < .005).
CONCLUSION: These data suggest that the antioxidant therapy used in this study may be beneficial in the treatment of migraine possibly reducing headache frequency and severity. Further clinical investigation into the efficacy of antioxidant as therapy for chronic migraine is warranted.
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