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January 14, 2004
Customized Therapy for Acute Treatment of Multiple Migraine Attacks

In the U.S., one of the most commonly prescribed drugs for the treatment of migraine headaches is sumatriptan (Imitrex®). However, patients and
physicians in other countries have found other treatments to be more effective. For example, in Italy, a combination of indomethacin (a non-steroidal anti-inflammatory drug), prochlorperazine (commonly used in the U.S. to treat nausea), and caffeine is the most commonly used preparation for the acute treatment of migraine. To compare the efficacy of a fixed combination of indomethacin, prochlorperazine, and caffeine suppositories with sumatriptan suppositories in the treatment of 2 consecutive migraine attacks of moderate or severe intensity, researchers conducted a multicenter, randomized, crossover study. One hundred twelve patients with migraine with or without aura were randomized to treat 2 migraine attacks with the combination preparation (as a single dose) and to treat 2 migraine attacks with sumatriptan. Patients were asked to take each medication as close to the onset of headache as possible.

Of the 112 patients, 88 were compliant to the protocol. More patients with migraine attacks became pain-free at 2 hours postdose on the combination than on sumatriptan (49% versus 34%). The combination was statistically superior to sumatriptan in the time to a pain-free response (a higher percentage of attacks became pain-free from 0.5 hours postdose to 5 hours postdose), in alleviation of nausea, and in a sustained pain-free response (pain-free at 2 hours postdose with no use of rescue medication or relapses within 48 hours). A more significant consistent response was achieved for the combination compared with sumatriptan. Both drugs were well-tolerated.

This study, analyzed according to the more recent guidelines for controlled trials in migraine, showed that a fixed combination of indomethacin, prochlorperazine, and caffeine is significantly more effective than sumatriptan in the acute treatment of migraine attacks.

Headache 2003 Sep;43(8):835-44

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