Efficacy of N-Alpha Methyl Histamine versus Propranolol in prevention of miigraine.

N alpha methyl histamine, possesses a greater affinity for H3 receptors, and could constitute a new therapeutic drug in migraine prophylaxis. OBJETIVE. To compare the superior efficacy of the subcutaneous administration of N alpha-methyl histamine versus oral propranolol in migraine prophylaxis, undertaking double-blind, placebo-controlled study. Hypothesis That subcutaneously injected N alpha methyl histamine (1-3ug) is more effective than propranolol (120mg/ day) in migraine prophylaxis. Null Hypothesis There is no difference between the subcutaneous administration of N- alpha methyl histamine in doses of 1-3 ng and oral propanolol as prophylactic agents against migraine METHODS. A randomized, double–blind study in 60 patients with migraine, male or female adults between the ages of 18 and 65 years. Selected patients will undergo a one-month period of prophylactic agent washout, they will then be divided into two groups for treatment in randomized blocks of three, double-blind fashion: N-alpha metyl histamine study group (n=30) and the propranolol control group (n=30). The treatment will consist of subcutaneous (back region of the upper arm) administration of N alpha methyl histamine twice a week, plus an oral placebo for a period of twelve weeks. Therapy with propranolol will begin at 40 mg/day for one week; until a total daily dose of 120 mg/day for a period of twelve weeks; plus a subcutaneous placebo. The variables we will study are: headache frequency; intensity of pain; duration of pain; intake of rescue analgesics and MIDAS. Statistical Analysis: The intent-to-treat (ITT) population will include all randomized patients. Two-tailed Student’s t test. Mann-Whitney U rank sum test. In order to analyze the temporal course of each treatment, a Friedman repeated measures ANOVA on ranks test will be used to evaluate the statistical significance of differences between basal values and values found for the 4th, 8th, and 12th weeks of treatment. This study has been approved by the Ethical and Scientific Committee of our hospital.