D Melchart1, J Thormaehlen, S Hager, J Liao, K Linde, W Weidenhammer. 1. Department of Internal Medicine II, Center for Complementary Medicine Research, Technical University, Kaiserstrasse 9, 80801 Munich, Germany. dieter.melchart@lrz.tu-muenchen.de
Abstract
OBJECTIVES: To investigate whether acupuncture is superior to placebo and equivalent to sumatriptan for the early treatment of an acute migraine attack. DESIGN: Randomized, partly double-blind (sumatriptan versus placebo) trial. SETTING:Two hospitals in Germany (one specialized in traditional Chinese medicine and one in the treatment of headache). SUBJECTS: A total of 179 migraineurs experiencing the first symptoms of a developing migraine attack. INTERVENTIONS:Traditional Chinese acupuncture, sumatriptan (6 mg subcutaneously) or placebo injection. MAIN OUTCOME MEASURE: Number of patients in whom a full migraine attack (defined as severe migraine headache) within 48 h was prevented. In patients who developed a migraine attack in spite of early treatment, acupuncture and sumatriptan were applied a second time, whilst patients initially randomized to placebo received sumatriptan. RESULTS: A full migraine attack was prevented in 21 of 60 (35%) patients receiving acupuncture, 21 of 58 (36%) patients receiving sumatriptan and 11 of 61 (18%) patients receiving placebo (relative risk of having a full attack 0.79 (95% CI, 0.64-0.99) for acupuncture versus placebo, and 0.78 (95% CI, 0.62-0.98) for sumatriptan versus placebo). Response to the second intervention in patients who developed a full attack was better with sumatriptan (17/31 patients who received sumatriptan twice and 37/46 patients who had had placebo first) than with acupuncture (4/31). The number of patients reporting side-effects was 14 in the acupuncture group, 23 in the sumatriptan group and 10 in the placebo group. CONCLUSIONS: In this trial acupuncture and sumatriptan were more effective than a placebo injection in the early treatment of an acute migraine attack. When an attack could not be prevented, sumatriptan was more effective than acupuncture at relieving headache.
RCT Entities:
OBJECTIVES: To investigate whether acupuncture is superior to placebo and equivalent to sumatriptan for the early treatment of an acute migraine attack. DESIGN: Randomized, partly double-blind (sumatriptan versus placebo) trial. SETTING: Two hospitals in Germany (one specialized in traditional Chinese medicine and one in the treatment of headache). SUBJECTS: A total of 179 migraineurs experiencing the first symptoms of a developing migraine attack. INTERVENTIONS: Traditional Chinese acupuncture, sumatriptan (6 mg subcutaneously) or placebo injection. MAIN OUTCOME MEASURE: Number of patients in whom a full migraine attack (defined as severe migraineheadache) within 48 h was prevented. In patients who developed a migraine attack in spite of early treatment, acupuncture and sumatriptan were applied a second time, whilst patients initially randomized to placebo received sumatriptan. RESULTS: A full migraine attack was prevented in 21 of 60 (35%) patients receiving acupuncture, 21 of 58 (36%) patients receiving sumatriptan and 11 of 61 (18%) patients receiving placebo (relative risk of having a full attack 0.79 (95% CI, 0.64-0.99) for acupuncture versus placebo, and 0.78 (95% CI, 0.62-0.98) for sumatriptan versus placebo). Response to the second intervention in patients who developed a full attack was better with sumatriptan (17/31 patients who received sumatriptan twice and 37/46 patients who had had placebo first) than with acupuncture (4/31). The number of patients reporting side-effects was 14 in the acupuncture group, 23 in the sumatriptan group and 10 in the placebo group. CONCLUSIONS: In this trial acupuncture and sumatriptan were more effective than a placebo injection in the early treatment of an acute migraine attack. When an attack could not be prevented, sumatriptan was more effective than acupuncture at relieving headache.
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