Alternative therapy for paediatric migraine prophylaxis: An open study.

The aim of this study was to evaluate the efficacy and tolerability of a combination product with L-tryptophan, Griffonia simplicifolia, Vitamin PP and Vitamin B6 in prophylaxis therapy of pediatric migraine. Fifty outpatients (32 F, 18 M), between 4–18 years of age (mean age 10.7 years), (SD 5.8), suffering from ICHD-2 migraine without aura were enrolled for the study. The mean duration of disease was 2.9 (SD 1.6) years. At baseline the mean frequency of attacks was 7.6/month (SD 3.3), the mean number of drugs intake for acute attacks was 6.6 tablets/month (SD 2.2). During the six-month evaluation period the combination product with L-tryptophan, griffonia simplicifolia, vitamin PP and vitamin B6 was administered (at doses of 100 mg/day, 480 mg/day, 18 mg/day and 1 mg/day, respectively). All patients filled a headache-diary card during the evaluation. The basal frequency of attack was 7.6/month (SD 3.3) while it went down to 4.2/month (SD 2.6), 3.6/month (SD 2.8), and 2.2/month (SD2.6), after 1, 3 and 6 months of therapy respectively [P < 0.01; P < 0.01; P < 0.01]. The basal value of drug intake for acute attacks was 7.6 tablets/month (SD 3.3) which reduced to 2.1 tablets/month (SD 2.5), 1.9 tablets/month (SD 1.5) and 1.4tablets/month (SD 2.7) after 1, 3 and 6 months of therapy respectively [P < 0.01; P < 0.01; P < 0.1] (T-test analysis). The combination product with L-tryptophan, griffonia simplicifolia, vitamin PP and vitamin B6 was well tolerated (11 patients complained somnolence, diarrhea and gastralgia but none of the patients withdrew from the study). These data showed a good efficacy in reduction of frequency and intensity of headache attacks, a good tolerability and a very good reduction of drugs intake for acute attacks. Our study suggests that the combination Ltryptophan, griffonia simplicifolia, vitamin PP and vitamin B6 could be an alternative therapy for paediatric migraine prophylaxis.