Haslam R H, Dalby J T, Rademaker A W
Pediatrics. 1984 Jul;74(1):103-11.
The effectiveness of a megavitamin regimen utilizing a two-stage trial in 41 subjects with attention deficit disorders was studied. Stage 1 was a 3-month clinical trial of vitamins (daily maximum: 3 g of niacinamide and ascorbic acid, 1.2 g of calcium pantothenate, and 0.6 g of pyridoxine). State 2 consisted of four, 6-week, double-blind repeated crossover periods. Twenty-nine per cent of the subjects showed significant behavior improvement during stage 1, and these subjects were used in the double-blind crossover phase of the study to evaluate megavitamin therapy. Using analysis of variance methods for crossover studies, there was no significant difference (P greater than .05) in most behavior scores between children receiving vitamin and those receiving placebo during stage 2. Children exhibited 25% more disruptive classroom behavior when treated with vitamins v placebo (P less than .01). There was no significant difference in serum pyridoxine and ascorbic acid levels between subjects and control subjects. Forty-two per cent of subjects exceeded the upper limits of serum transaminase levels while receiving vitamins. It is concluded that megavitamins are ineffective in the management of attention deficit disorders and should not be utilized because of their potential hepatotoxicity.
一项针对41名患有注意力缺陷障碍的受试者进行的两阶段试验,研究了大剂量维生素疗法的有效性。第一阶段是为期3个月的维生素临床试验(每日最大剂量:3克烟酰胺和抗坏血酸、1.2克泛酸钙和0.6克吡哆醇)。第二阶段包括四个为期6周的双盲重复交叉期。29%的受试者在第一阶段表现出显著的行为改善,这些受试者被用于研究的双盲交叉阶段,以评估大剂量维生素疗法。采用交叉研究的方差分析方法,在第二阶段,接受维生素治疗的儿童与接受安慰剂治疗的儿童在大多数行为评分上没有显著差异(P大于0.05)。与接受安慰剂治疗相比,接受维生素治疗的儿童在课堂上表现出的破坏性行为多25%(P小于0.01)。受试者与对照受试者的血清吡哆醇和抗坏血酸水平没有显著差异。42%的受试者在接受维生素治疗时血清转氨酶水平超过上限。结论是,大剂量维生素对注意力缺陷障碍的治疗无效,且因其潜在的肝毒性不应使用。