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

Abstract

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.