Abstract | BACKGROUND: METHODS: We conducted a randomized, double-blind, placebo-controlled crossover study to assess the efficacy and tolerability of sumatriptan in 49 patients with cluster headache. The patients received, in random order, a subcutaneous injection of 6 mg of sumatriptan for one cluster-headache attack and placebo for another attack. The results for the two attacks could be fully evaluated for 39 patients. A response to treatment was defined as complete or almost complete relief of headache (no pain or mild pain) within 15 minutes after the injection. RESULTS: In the 39 patients, the severity of headache decreased in 74 percent of the attacks within 15 minutes of treatment with sumatriptan, as compared with 26 percent of the attacks for which placebo was given (P less than 0.001). Thirty-six percent of the patients were free of pain within 10 minutes after the administration of sumatriptan, as compared with 3 percent after placebo (P less than 0.001); by 15 minutes these numbers had increased to 46 percent and 10 percent, respectively (P less than 0.001). Thirteen percent of the patients required oxygen as an additional treatment 15 minutes after receiving sumatriptan, as compared with 49 percent of those who received placebo. The severity of functional disability and the incidence of ipsilateral conjunctival injection also decreased more in response to sumatriptan than placebo. Sumatriptan was well tolerated, and there were no serious adverse events. CONCLUSIONS:
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Authors | Sumatriptan Cluster Headache Study Group |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 325
Issue 5
Pg. 322-6
(08 01 1991)
ISSN: 0028-4793 [Print] United States |
PMID | 1647496
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Indoles
- Receptors, Serotonin
- Sulfonamides
- Vasoconstrictor Agents
- Sumatriptan
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Topics |
- Acute Disease
- Adult
- Cluster Headache
(drug therapy, physiopathology)
- Double-Blind Method
- Drug Tolerance
- Female
- Humans
- Indoles
(administration & dosage, adverse effects, therapeutic use)
- Injections, Subcutaneous
- Male
- Receptors, Serotonin
(drug effects)
- Sulfonamides
(administration & dosage, adverse effects, therapeutic use)
- Sumatriptan
- Vasoconstrictor Agents
(administration & dosage, adverse effects, therapeutic use)
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