ORIGINAL ARTICLE Nutraceuticals safety and efficacy in migraine without aura in a population of children affected by neurofibromatosis type I Marco Carotenuto • Maria Esposito Received: 31 January 2013 / Accepted: 13 March 2013 / Published online: 27 March 2013 Ó Springer-Verlag Italia 2013 Abstract Neurofibromatosis type 1 (NF1) is one of the most common autosomal dominant disorders with a prev- alence of one in 4,000 people worldwide, associated with many neurological comorbidities, such as headache. Despite the high prevalence of headache in this population, little data exist regarding the classification of headaches experienced by patients with NF1. Aim of this study is to verify the efficacy and safety of a nutraceutical complex containing Ginkgolide B/Coenzyme Q10/Riboflavin/Mag- nesium for prophylaxis in a sample of children affected by NF1 presenting migraine without aura. Ginkgolide B/Coenzyme Q10/Riboflavin/Magnesium complex was orally administered twice a day for 6 months, to 18 school- aged patients with NF1 and presenting symptoms of migraine without aura (10 M, mean age 8.4 ± 1.65). Each patient kept a journal to record: number, intensity (according VAS scale), duration of attacks and concomi- tant symptoms. In addition, the PedMIDAS scale was administered to assess migraine-related disability. To ver- ify the efficacy of the association, we tested the starting frequency (T 0 ) of headache after 6 months (T 1 ) and then we calculated the migraine frequency delta percentage to express the decrease in monthly frequency. After treat- ment, a reduction was reported (p \ 0.001) in all migraine outcomes (frequency, duration, intensity, and grade of disability). In conclusion, the present study should be considered as the first report on the efficacy and safety of nutraceutical complex containing Ginkgolide B/Coenzyme Q10/Riboflavin/Magnesium for the prophylaxis of migraine in children affected by NF1. Our findings suggest that headache symptoms should be considered a thera- peutic target independent of primary disorder. Keywords Neurofibromatosis type 1  Migraine without Aura  Children  Ginkolide B  Nutraceutical complex Introduction Neurofibromatosis type 1 (NF1, OMIM#162200) [1] is among the most common autosomal dominant disorders with a prevalence of one in 4,000 individuals worldwide [2, 3]. It is an extremely variable condition whose morbidity and mortality are largely dictated by complications, which are numerous and can involve any body system [2–5]. The last two decades have witnessed mapping and molecular cloning of the NF1 gene to chromosome 17q11.2 and identification of its protein product neurofibromin, a modulator of Ras- mediated cell proliferation [6, 7]. Attempts to establish genotype–phenotype correlations have so far identified two specific subgroups: (1) large NF1 gene deletions associated with more severe phenotypes including dysmorphic features, mental retardation and earlier occurrence of neurofibromas and (2) the so-called NF1 microdeletion syndrome accom- panied by increased occurrence of larger (plexiform) neu- rofibromas and malignant transformation of neurofibromas [6, 7]. Nervous system involvement in NF1 mainly consists of learning disabilities, plexiform neurofibromas, megalen- cephaly, cerebral tumors, headache, acqueductal stenosis, cerebrovascular disease, meningoceles, neurofibromatous neuropathy, and cerebral high-signal lesions on T 2 -weighted magnetic resonance images [2, 3, 5, 8, 9]. Regarding neu- rological comorbidities, reports of a relationship with M. Carotenuto (&)  M. Esposito Clinic of Child and Adolescent Neuropsychiatry, Department of Mental Health, Physical and Preventive Medicine, Center for Childhood Headache, Second University of Naples, Via Sergio Pansini 5 PAD XI, 80131 Naples, Italy e-mail: marco.carotenuto@unina2.it 123 Neurol Sci (2013) 34:1905–1909 DOI 10.1007/s10072-013-1403-z