The prophylactic effect in migraine of femoxetine, a 5-HT-uptake inhibitor, was compared to that of placebo in a double-blind group-comparative study. A total of 59 patients, referred to the department from general practitioners, was stratified according to age, sex, duration, and frequency of attacks and then allocated at random to treatment with either femoxetine or placebo. Each patient was treated for 12 weeks with 200 mg in the first week and 300 in the remaining weeks. Ten patients on femoxetine and four patients on placebo failed to complete the study.
Headache index as well as number and severity of attacks showed a significant reduction with time. The patients on femoxetine showed the greatest improvement over time. It was, however, not statistically significant. Direct comparison between femoxetine and placebo revealed no statistically significant difference.
Three patients in the femoxetine group withdrew due to side-effects combined with lack of therapeutic effect. Other side-effects were slight and infrequent. They did not interfere with the treatment.
These results indicate that femoxetine could be useful in migraine as a prophylactic drug.