Onofri A, Necozione S, Tozzi E
Neuropsychiatric Clinic, Department of Life, Health and Environmental Sciences, University of L'Aquila.
Epidemiology Unit, Department of Life, Health and Environmental Sciences, University of L'Aquila, Italy.
Clin Ter. 2020 Sep-Oct;171(5):e393-e398. doi: 10.7417/CT.2020.2246.
The aim of the present research is to evaluate and to compare various nutraceuticals and food supplements in the headaches prophylaxis.
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.
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.
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).
The use of nutraceuticals and food supplements appears to be effective and also encouraging as it is well accepted by parents and children themselves.
本研究旨在评估和比较各种营养保健品和食品补充剂在预防头痛方面的效果。
近年来，补充和替代医学、营养保健品和食品补充剂在成人和儿童头痛的预防及发作治疗中的应用日益广泛。
选取2016年至2017年间99名6至17岁的儿童作为样本，其中女性44名，男性55名，均患有原发性头痛并入住头痛中心。7名患者因治疗依从性差未坚持研究且未返回进行临床复查而被排除。连续选取入住头痛中心的患者。这项评估临床试验的开放标签研究涉及以下参数的评估：根据国际头痛协会标准（ICHD-III，2013β版）进行头痛诊断、偏头痛指数；零时刻及12个月后的预防和发作治疗情况。用于预防治疗的化合物有：柠檬酸镁、氧化镁和天冬氨酸镁（化合物1号）、甘氨酸镁+L-色氨酸+烟酸+B2维生素+维生素D（化合物2号）、氧化镁+小白菊+穿心莲+辅酶Q10、B2维生素（化合物3号）。将每种化合物相互比较以评估临床疗效。发作治疗药物：对乙酰氨基酚、布洛芬、酮洛芬、吲哚美辛。已获得儿童家长关于参与本研究的知情同意书。采用Kruskal-Wallis检验和事后Conover分析进行统计分析。
22名女性和24名男性患有无先兆偏头痛，9名女性和12名男性患有有先兆偏头痛，11名女性和14名男性患有频发紧张型头痛。使用化合物1号、2号和3号进行治疗在降低偏头痛指数方面均有效，并且在所有病例中均显著减少了发作治疗药物的使用（p = 0.000001）。在无先兆偏头痛中，化合物1号的效果不如化合物2号和3号（p = 0.00089）。在有先兆偏头痛中，化合物3号的效果不如化合物2号和1号（p = 0.0044）。在频发紧张型头痛中，化合物3号的效果不如化合物2号（p = 0.052）。
营养保健品和食品补充剂的使用似乎是有效的，而且由于其被家长和儿童自身广泛接受，令人鼓舞。
