Fulvio Sorge

Flunarizine in Prophylaxis of Childhood Migraine: A Double-Blind, Placebo-Controlled, Crossover Study

An 8-month, double-blind, placebo-controlled, crossover trial of flunarizine in the prophylaxis of migraine has been performed in 70 children. After 4 weeks of medication-free base-line observation, 35 children (group A) received flunarizine (5 mg/day) and 35 (group B) received placebo over a 12-week period. After a 4-week washout they crossed treatments for another 12 weeks. Sixty-three patients completed the trial. In both groups flunarizine significantly reduced the frequency and average duration of headache attacks. In group A efficacy was maintained after placebo crossover for the last 4 months of the study. Five subjects in group B stopped placebo because of ineffectiveness; two children in group A discontinued flunarizine treatment, one because of excessive daytime sedation and the other because therapy was ineffective. The main side effects were daytime sedation and weight gain. It is concluded that flunarizine is an effective drug for the treatment of childhood migraine. In a study of this length no serious side effects were discovered.

Flunarizine v. Placebo in Childhood Migraine. A Double-Blind Study

Successful migraine prophylaxis with flunarizine has been reported in adults by several authors. We used flunarizine in a double-blind, placebo controlled, randomized trial in childhood migraine. Twenty-four children with classical or common migraine were followed by a 12-week flunarizine treatment period. Each patient took 5 mg/day of the drug before going to sleep. Twenty-four children with similar clinical characteristics were assigned to placebo treatment. Efficacy of flunarizine versus placebo was assessed on the basis of the reduction of headache frequency and duration. A statistical comparison was performed between values reported in the treatment period and those in the three months before. Children treated with flunarizine experienced a statistically significant reduction in headache (66%) and duration (51%). These results were statistically superior to those observed in the placebo group. Sixteen patients on flunarizine therapy experienced an improvement of more than 50% of both parameters. We found flunarizine is an effective agent in childrens migraine prophylaxis. Moreover it is suitable for the low incidence of mild side effects.

Source of pain and primitive dysfunction in migraine: an identical site?

Twenty common migraine patients received a one sided frontotemporal application of nitroglycerin (10 patients) or placebo ointment (10 patients) in a double blind study. Early onset migraine attacks were induced by nitroglycerin in seven out of 10 patients versus no patient in the placebo group. Subsequently 20 migraine patients, who developed an early onset attack with frontotemporal nitroglycerin, received the drug in a second induction test at other body areas. No early onset migraine was observed. Thus the migraine-inducing effect of nitroglycerin seems to depend on direct stimulation of the habitual site of pain, suggesting that the frontotemporal region is of crucial importance in the development of a migraine crisis. This is not consistent with a CNS origin of migraine attack.

The frontotemporal region plays a role in the genesis of migraine without aura.

We have compared the migraine‐inducing effect of nitroglycerin ointment applied to the frontotemporal region of the head, which is innervated by the ophthalmic and maxillary divisions of the trigeminal nerve, with that of nitroglycerin applied to the chin (innervated by the mandibular division), the posterolateral region of the neck (innervated by the second and third cervical roots), the lateral surface of the proximal third of the forearm (innervated by the sixth cervical root), and the medial surface of the upper‐arm region (second dorsal root). One hundred patients suffering from migraine without aura were randomly divided into five equal groups. Each group received an application of 5 mg nitroglycerin in 2% ointment on a preselected body area for 2 hours. Frontotemporal nitroglycerin induced a significantly greater number of early onset migraine attacks with respect to the arm and forearm regions. In all cases, nitroglycerin applied to the frontotemporal region resulted in subsequent migraine, whereas there was a significant number of negative trials with nitroglycerin applied to the neck, arm, and forearm vs the frontotemporal area. It, therefore, appears that the trigeminal nerve endings in the affected frontotemporal region are particularly sensitive to the migraine‐inducing effect of the nitrate. This suggests a peripheral neurogenic hypothesis of migraine genesis.

A double-blind placebo-controlled trial of indobufen in the prophylaxis of migraine.

ABSTRACT— In a double‐blind randomized trial of 42 patients with classic or common migraine, indobufen, an antiplatelet drug that inhibits platelet cyclo‐oxygenase, was compared with placebo in the prevention of migraine. The duration of treatment was 3 months, and the efficacy was assessed on the basis of the following variables: frequency and duration of attacks, headache index (intensity X frequency); 35 completed the investigation. Indobufen at an oral dose of 200 mg b.i.d. reduced all the variables considered, where placebo did not. The drug was generally well tolerated. The findings of the preliminary trial suggest that indobufen might be an useful alternative in the prophylaxis of migraine.

Platelet function in childhood migraine.

Platelet function in vitro and in vivo (ADP-induced platelet aggregation, circulating platelet aggregates, β-thromboglobulin plasma levels) has been studied in children with common migraine, in headache-free intervals. Migraine patients demonstrated increased circulating platelet aggregates when compared with controls. Moreover, two of ten patients had pathological β-thromboglobulin levels. These data indicate that in some children with migraine there is an abnormality of platelet function during headache-free periods.