Intranasal sumatriptan study with high placebo response in Taiwanese patients with migraine.

Author(s): Wang SJ, Fuh JL, Wu ZA

Affiliation(s): Neurological Institute, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei, Taiwan, ROC. sjwang@vghtpe.gov.tw

Publication date & source: 2007-02, J Chin Med Assoc., 70(2):39-46.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Triptan's efficacy in the treatment of migraine has never been reported in Taiwanese. A high placebo effect was reported in Japanese. The objective of this study was to evaluate the efficacy of intranasal sumatriptan in the acute treatment of migraine in Taiwanese patients. METHODS: Fifty-eight patients who had experienced migraine for at least 1 year were randomly assigned to 2 groups, self-administered intranasal sumatriptan 20 mg or placebo to treat a single migraine attack of moderate or severe intensity. RESULTS: A significant difference in headache relief rates between the 2 groups was observed at 30 minutes postdose (46% vs. 21%, p < 0.05). One hour postdose, 61% of sumatriptan recipients experienced headache relief compared with 43% of placebo recipients (p = 0.181). The difference in relief rates between groups diminished over time, mainly due to a high placebo response (54% at 2 hours postdose). CONCLUSION: Our study suggests that ethnicity might have a role in placebo response, and highlights the importance of a placebo group in acute migraine trials. However, the small sample size in this study should also be taken into consideration.