Efficacy and safety of Dingluo nasal drops for the acute treatment of migraine: a pilot randomized trial.

OBJECTIVE: To evaluate the efficacy and safety of two doses of Dingluo nasal drops compared to placebo in the acute treatment of migraine. METHODS: This randomized, parallel-treatment, placebo-controlled, double-blind trial was conducted at Dongzhimen hospital, Beijing University of Chinese Medicine. Eligible participants were randomly assigned (1∶1∶1) to receive either full-dose Dingluo nasal drops, half-dose Dingluo nasal drops, or a placebo for three migraine attacks. The primary endpoint was the proportion of participants achieving pain freedom at 2 h postdose, assessed in all randomly assigned participants who received study medication. RESULTS: A total of 91 participants with 257 attacks were included in the statistical analysis. At 2 h postdose, Dingluo nasal drops were superior to placebo for freedom from pain [high dose vsplacebo: 14.61% vs1.20%, P = 0.001, risk difference 13.40, 95% CI(5.70, 21.11); low dose vsplacebo: 17.65% vs1.20%, P <0.001, risk difference: 16.44, 95% CI (8.00, 24.88)]. The high dose and the low dose effected similarly for freedom from pain [14.61% vs17.65%, P = 0.585, risk difference: －3.04, 95% CI(－13.97, 7.89)]. It showed a good efficacy in pain relief. The most common adverse events were nasal burning and nasal itchiness. All adverse events are transient and dissipate within a relatively short time frame. CONCLUSIONS: Dingluo nasal drops demonstrated superior efficacy to placebo in achieving pain freedom for acute migraine treatment. Mild nasal reactions were observed, with a trend toward reduced discomfort at the half-dose concentration.