BACKGROUND: The aim of the study was to assess the efficacy and tolerability of a new electrophysiological intervention technique as an add on treatment in patients with migraine. METHODS: A randomized double-blind placebo-controlled study with a parallel group add on design and a 12-week treatment phase was conducted in a large outpatient headache clinic in a neurological center. Thirty-two patients (mean age 42.6 years, SD 11.8; range 23 to 79) with migraine without any pharmacological migraine prophylaxis in the past three months were studied. The electrophysiological stimulation with sound therapy applied via headphones three times a day for 10 minutes was compared against a placebo audiotape. The main outcome measure was a change in the headache subtest of a self-report test instrument, Giessener Beschwerdebogen (GBB), after 12 weeks of treatment. RESULTS: Significant decreases in the scores of the GBB were found in the treatment group after 12 weeks of treatment in the subtests 'headaches' (p < 0.05), 'stomach complaints' (p < 0.05), as well as 'general physical complaints' (p < 0.05). In the placebo group only, the decreases in 'fatigue proneness' and 'general physical complaints' reached statistical significance (p < 0.05) between the pre- and post-treatment scores. No adverse events occurred during the treatment period. CONCLUSIONS: In the small sample studied here a proprietary method, Psychofonie, is effective as an add on treatment in reducing subjective pain in migraine patients, although some of the effect could be attributed to placebo.

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