Diclofenac epolamine is effective in the treatment of acute migraine attacks. A randomized, crossover, double blind, placebo-controlled, clinical study.

Author(s): Vecsei L, Gallacchi G, Sagi I, Semjen J, Tajti J, Szok D, Muller M, Vadass P, Kerekgyarto M

Affiliation(s): Department of Neurology, Albert Szent-Gyorgyi Medical and Pharmaceutical Centre, University of Szeged and Neurology Research Group of the Hungarian Academy of Sciences and University of Szeged, Szeged, Hungary.

Publication date & source: 2007-01, Cephalalgia., 27(1):29-34.

Publication type:

Hydrosoluble diclofenac epolamine (DHEP) represents an interesting approach to acute migraine attacks, where gastrointestinal motility and drug absorption are often reduced. Its efficacy was investigated in a randomized, crossover, double-blind trial on 155 patients who treated four consecutive mild-to-moderate migraine attacks, either with DHEP (65-mg sachet) or placebo. If pain was not relieved within 1 h, a second dose was given. The total number of treated attacks was 481. A pain-free condition was achieved within 2 h in 45.8% and 25.1% of attacks treated, respectively, with DHEP or placebo (P < 0.0001), with a therapeutic gain of 20.7%. Time to attack resolution, light and noise sensitivity and impact on working ability were significantly reduced by DHEP compared with placebo. Moreover, significantly fewer patients required a second drug dose or a rescue medication when treated with DHEP than with placebo. No adverse reaction was recorded. In conclusion, DHEP was effective and safe for pain relief in patients with an acute mild-to-moderate migraine attack.