Dihydroergotamine Nasal Spray in the Treatment Of Attacks of Cluster Headache: A Double-Blind Trial Versus Placebo

Abstract

A double-blind trial of dihydroergotamine (DHE) nasal spray compared with placebo was carried out in patients with cluster headache. Twenty-five patients were included in the trial. In three patients, all receiving DHE, the pain attacks ceased after five attacks. In the other 22 patients, 133 attacks were treated with placebo and 137 attacks with DHE nasal spray (dosage, 1 mg of DHE). The trial showed that the treatment given has no effect on the attack frequency or the duration of the single attack. However, the treatment had a significant effect on the intensity of the single attacks. It can be concluded that the trial should be repeated, using a larger dosage of DHE. This should be ethically justifiable, since none of the patients had any adverse reactions locally in the mucous membrane of the nose or systemically.

Serotonergic Agents in the Management of Cluster Headache

“…DHE nasal spray, 1 mg, was studied in a double-blind, placebo-controlled, crossover trial in 25 patients [27]. There was no difference in headache frequency or duration, but pain intensity was significantly lower with DHE than with placebo.…”

Topical agents in the treatment of cluster headache

“…A double-blind, crossover trial comparing intranasal DHE (1 mg) with placebo in the treatment of cluster headache found no effect on headache frequency or duration, but pain intensity was reduced significantly [7]. The effect was not impressive, probably because the dosage used was lower than what is available in commercial preparations of DHE nasal spray (2 mg).…”

Management of Chronic Cluster Headache

“…Oral ergotamine has been used as a CH treatment for over 50 years [18, Class IV], but in a trial performed in the 1980s, intranasal dihydroergotamine as an acute treatment proved no better than placebo at reducing pain and stopping attacks [19,Class III]. Other controlled trials do not appear to have been performed.…”