An Auditory Electrophysiological Intervention in Migraine: A Randomized Placebo Controlled Add On Trial
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.