Complementary and alternative medicine (CAM) in headache of children and adolescents: open-label Italian study

Objective: The aim of the present research is to evaluate and to compare various nutraceuticals and food supplements in the headaches prophylaxis.

Background: Recently the use of complementary and alternative medicine, nutraceuticals and food supplements, in prophylaxis and attack therapy of headaches is spreading both in adulthood and in childhood age.

Materials and methods: 99 children, 6-17 years, females 44 and males 55, suffering from primary headaches and admitted to Headache Center in the years 2016- 2017 are the sample. 7 patients were excluded because they did not adhere to the study due to lack of therapeutic compliance and because they did not return to clinical controls. The patients referred to the Headache Center are selected consecutively. The open-label study evaluating clinical trial concerns the evaluation of the following parameters: headache diagnosis according to International Headache Society criteria (ICHD-III, 2013 beta version), migraine index; the prophylaxis and attack therapies at time zero and after 12 months. The compounds used to prophylaxis therapy are: Mg citrate, Mg oxide and Mg aspartate (compound n°1), Bisglycinate Mg + L-Tryptophan + Niacin + B2 Vitamin + D Vitamin (compound n°2), Oxide Mg + Partenium + Andrographis paniculata + coenzyme Q10, B2 Vitamin (compound n°3). Each compound was compared with the other to evaluate clinical efficacy. Attack therapy: Paracetamol, Ibuprofen, ketoprofen, Indomethacin. Informed consent was obtained for participation in the study by the parents of the children. Statistical analysis is made by Kruskal -Wallis test and analysis post hoc Conover.

Result: 22 females and 24 males suffer from Migraine without aura, 9 females and 12 males from Migraine with Aura, 11 females and 14 males from Tension Type Frequent Headache. The therapy as with compounds n°1, 2 and 3 is effective in reducing migraine index and reduces the use of attack therapy in all the cases very significantly (p=0.000001). In MwoA the compound n° 1 is less effective than compounds n° 2 and 3(p=0.00089).In MA compound n° 3 is less effective than compounds n° 2 and 1 (p=0.0044). In FETTH, compound n° 3 is less effective compared to compound n° 2 (p=0.052).

Conclusion: The use of nutraceuticals and food supplements appears to be effective and also encouraging as it is well accepted by parents and children themselves.

Keywords: Children; Food supplements; Headache; Migraine disability; Nutraceuticals.