Acupuncture is often recommended as an effective therapy to migraineurs without having an evidence-based rationale. The main objective of this pilot study was to evaluate the effect of standard acupuncture as add-on therapy to pharmacological attack-treatment in migraineurs. A secondary objective was to identify potential pitfalls that could be addressed when planning the protocol of a larger acupuncture study. Thirty-nine patients with a diagnosis of migraine without aura (32 women and 7 men, aged between 26 and 50 years, mean age 41 years) were recruited at a headache clinic. The patients were randomised to two treatment groups: a group (n = 20) where acupuncture was given as add-on therapy to pharmacological attack-treatment and a control group (n = 19), where no acupuncture was used. Acupuncture was given once or twice a week for 4 to 6 weeks, making a total of 7 to 10 sessions. The participants were instructed to keep headache diaries in which they registered days with migraine throughout the study. No significant outcome differences could be demonstrated between the two treatment groups. However, due to a high drop-out rate, nine patients (45%) in the acupuncture-group and seven patients (37%) in the control-group, no firm conclusions can be drawn from the results obtained. Cost and lack of time were the main explanations given for the high drop-out rate by the patients in the acupuncture group, whereas protocol violation was the main reason in the control group. Obviously, these factors have to be taken into account when planning a larger acupuncture study. Providing more convenient and flexible time schedules appears to be an absolute necessity in order to keep the compliance high in a future acupuncture study. In addition to that, free treatment and recurrent motivation of the participants may help them to complete such a study.

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