Subcutaneous Histamine versus Topiramate in Migraine Prophylaxis: A Double-Blind Study

Abstract

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.

A systematic review of the psychosocial difficulties relevant to patients with migraine

“…With regard to treatments, limited evidence exists that symptomatic medication, such as Sumatriptan [42, 47], Naproxen Sodium [42] Zolmitriptan [54] and Eletriptan [48] have an impact on disability reduction. Strong evidence is instead reported by studies documenting improvements due to prophylactic medication such as Topiramate [32, 43, 49, 55, 56], Botulinum Toxin type A [33], subcutaneous histamine [56], beta-blockers such as Nebivolol and Metoprolol [50] and Amitriptyline [43]. Limited evidence is available for the effect of pain reduction, achieved through physical exercise, on disability reduction [57].…”

Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: [RETIRED]

“…Topiramate 100 mg/day was compared with histamine (1-10 ng 2 times/week SC), and both active treatments showed improvement over baseline measures for attack frequency, intensity, and use of rescue medication. 7 Eleven percent (5/45) of subjects treated with histamine withdrew from the histamine group because they were not satisfied with the speed of results, although no AEs were reported. Few subjects reported transitory burning and itching at the injection site.…”

Preventive treatment in migraine and the new US guidelines

“…There have been eleven studies since the 2000 guidelines reporting efficacy of topiramate in migraine prevention 32–34. One Class I placebo-controlled study showed a lower 28-day frequency of migraine headaches versus placebo (3.31 versus 3.81).…”