Background: Subcutaneous histamine at low concentrations interacts with H3-receptors and may constitute a new therapeutic drug in migraine prophylaxis. It acts by limiting the excessive inflammatory response involved in migraine pathophysiology.
Objective: Describe the results of a 15-year trial administering histamine at low concentrations.
Methods: Different study designs were used with subcutaneous histamine (10 microg/ml in Evan's solution) twice weekly, with an initial administration of microg (0.1 ml) and gradually increasing the dose to 10 microg (1.0 ml) over a 12-week period together with placebo, sodium valproate and topiramate. A Friedman-type rank ANOVA test was used to assess the difference between basal values and different design outcomes.
Results: Data recorded during the 12-week period showed a significant reduction in variables from both treatment groups (histamine) compared with basaline stage results (p < 0.001). The histamine group reported a reduction of headache frequency (50%), decrease in pain intensity (51%), length of migraine attacks (45%) and painkiller use (52%).
Conclusions: The present study provides evidence on the safety and efficiency of subcutaneous histamine administered at a dose of 1-10 microg twice weekly. This treatment constitutes a new therapeutic alternative, and provides a clinical and pharmacological basis for the use of H3 histaminergic agonists in migraine prophylaxis.