N alpha methyl histamine versus propranolol in migraine prophylaxis.

OBJECTIVES: To compare the efficacy and tolerability of the subcutaneous administration of N alpha methyl histamine versus oral propranolol in the treatment of migraine prophylaxis. BACKGROUND: N alpha methyl histamine has a selective affinity for H3 receptors and could constitute a new therapeutic drug in migraine prophylaxis. METHODS: Sixty patients with migraine were selected and enrolled in a 12-week double-blind controlled clinical trial to evaluate the efficacy of subcutaneous administration of N-alpha methyl histamine (1 to 3 ug twice a week ) n=30, compared to administration of 120 mg/day of oral propranolol n=30. the variables were: headache intensity, frequency of attacks, duration of migraine attacks and analgesic intake. RESULTS: fifty five patients completed the study. the data collected during the 4th week of treatment revealed that N alpha methyl histamine and propranolol caused a significantly (p<0.01) greater reduction between the basal values and final values of every variable studied. CONCLUSIONS: Both N alpha methyl histamine and propranolol are similarly effective in reducing or eliminating the headache in migraine prophylaxis. low doses of N-alpha methyl histamine injected subcutaneously may represent a novel and effective therapeutic alternative in migraine patients and may lay the clinical and pharmacological groundwork for the use of H3 receptor agonist in migraine prophylaxis.

Subcutaneous histamine versus topiramate in migraine prophylaxis: a double-blind study.

BACKGROUND: Histamine has a selective affinity for H3 receptors and it may specifically inhibit the neurogenic edema response involved in migraine pathophysiology. OBJECTIVE: To evaluate the therapeutic potential of subcutaneous administration of histamine in migraine prophylaxis, compared with oral administration of topiramate. METHODS: Ninety patients with migraine were selected in a 12-week double-blind controlled clinical trial to evaluate the efficacy of subcutaneous administration of histamine (1-10 ng twice a week) compared with oral administration of topiramate (100 mg daily dose). The variables studied were: headache intensity, frequency, duration, analgesic intake and Migraine Disability Assessment. RESULTS: The data collected during the 12 weeks of treatment revealed that headache symptoms improved in both the histamine and topiramate groups, which was evident within the first month after the initiation of treatment, with statistically significant (p < 0.001) reductions in headache frequency (50%), Migraine Disability Assessment score (75%), intensity of pain (51%), duration of migraine attacks (45%), as well as in the use of rescue medication (52%). CONCLUSION: The present study provides evidence of the efficacy of subcutaneously applied histamine and orally administered topiramate in migraine prophylaxis. Subcutaneously applied histamine may represent a novel and effective therapeutic alternative in resistant migraine patients.

Subcutaneous histamine versus sodium valproate in migraine prophylaxis: a randomized, controlled, double-blind study.

Histamine has a selective affinity for H3-receptors and it may specifically inhibit the neurogenic edema response involved in migraine pathophysiology. The objective of this study was to evaluate the therapeutic potential of subcutaneous administration of histamine in migraine prophylaxis, compared with oral administration of sodium valproate, in an open clinical trial. Ninety-two patients with migraine were selected under criteria established by the International Headache Society and enrolled in a 12-week double-blind controlled clinical trial to evaluate the efficacy of subcutaneous administration of histamine (1-10 ng twice a week; n = 46) compared with oral administration of sodium valproate (500 mg daily dose; n = 46). The variables studied were headache intensity, frequency, duration, analgesic intake and migraine disability assessment (MIDAS). Two-tailed Student's t- test was used to compare means and the Mann-Whitney U and anova tests were used. The data collected during the 4th, 8th and 12th weeks of treatment revealed that histamine caused a significantly greater reduction (P < 0.001) in intensity and duration of migraine attacks as well as in analgesic intake. No difference was detected in the frequency of attacks or in MIDAS. The present study provides evidence of the superior efficacy of histamine applied subcutaneously in migraine prophylaxis when compared with sodium valproate taken orally. Subcutaneously applied histamine may represent a novel and effective therapeutic alternative in resistant migraine patients.