Prophylaxis of Migraine and Mixed Headache. A Randomized Controlled Study




The three most commonly used modalities in the prophylactic treatment of headache, namely propranolol, amitriptyline and biofeedback training, were compared individually and in combination. Three hundred forty patients with migraine end 375 patients with mixed headache were randomly allotted to 8 therapeutic categories. The total duration of the study was 312 years and the therapeutic groups were evaluated for a period of 7 months including I month of pretreatment observation. Improvement was assessed by percentage of change in the average headache index during the last three months of evaluation from the pretreatment headache index. In the migraine group 273 patients completed the study. Improvement was significantly higher in patients receiving prophylactic treatment compared to control patients who were on abortive Ergotamine treatment. Propranolol plus biofeedback yielded the best results in the migraine group and addition of amitriptyline did not significantly change the percentage of improvement. Propranolol alone (62%) was significantly superior to amitriptyline (42%) (p < 0.01). The differences between propranolol alone and propranolol plus amitriptyline was not statistically significant.

In the mixed headache group 281 patients completed the study. The most effective treatment was combination of amitriptyline, propranolol and biofeedback training. Amitriptyline alone was superior to propranolol alone in the treatment of mixed headache (p<0.01). A combination of propranolol and amitriptyline was superior to either of those alone. Biofeedback, though by itself, did not appear to be the treatment of choice, significantly contributed to better results as an adjunct when it is combined with pharmacological agents. Concomitant use of propranolol and amitriptyline did not result in any adverse reactions or clinical incompatibility.