Department of Pediatrics, University of Calgary, and Behavioural Research Unit, Alberta Children's Hospital, Calgary, Alberta, Canada.
BMC Psychiatry. 2011 Apr 18;11:62. doi: 10.1186/1471-244X-11-62.
Theoretically, consumption of complex, multinutrient formulations of vitamins and minerals should be safe, as most preparations contain primarily the nutrients that have been in the human diet for millennia, and at safe levels as defined by the Dietary Reference Intakes. However, the safety profile of commercial formulae may differ from foods because of the amounts and combinations of nutrients they contain. As these complex formulae are being studied and used clinically with increasing frequency, there is a need for direct evaluation of safety and tolerability.
All known safety and tolerability data collected on one complex nutrient formula was compiled and evaluated.
Data were assembled from all the known published and unpublished studies for the complex formula with the largest amount of published research in mental health. Biological safety data from 144 children and adults were available from six sources: there were no occurrences of clinically meaningful negative outcomes/effects or abnormal blood tests that could be attributed to toxicity. Adverse event (AE) information from 157 children and adults was available from six studies employing the current version of this formula, and only minor, transitory reports of headache and nausea emerged. Only one of the studies permitted a direct comparison between micronutrient treatment and medication: none of the 88 pediatric and adult participants had any clinically meaningful abnormal laboratory values, but tolerability data in the group treated with micronutrients revealed significantly fewer AEs and less weight gain.
This compilation of safety and tolerability data is reassuring with respect to the broad spectrum approach that employs complex nutrient formulae as a primary treatment.
从理论上讲，食用多种维生素和矿物质的复杂配方应该是安全的，因为大多数制剂主要包含人类数千年来饮食中存在的营养素，并且其含量处于膳食参考摄入量定义的安全水平。然而，由于商业配方中所含营养素的数量和组合不同，其安全性特征可能与食物不同。随着这些复杂配方越来越频繁地在临床研究和应用，有必要对其安全性和耐受性进行直接评估。
编译并评估了一种复合营养素配方的所有已知安全性和耐受性数据。
从精神健康领域研究最多的复合配方的所有已知已发表和未发表的研究中收集了数据。从六个来源获得了 144 名儿童和成人的生物安全性数据：没有发生可归因于毒性的临床意义上的负面结果/影响或异常血液测试。从六项研究中获得了采用当前配方的 157 名儿童和成人的不良事件 (AE) 信息，仅出现轻微、短暂的头痛和恶心报告。只有一项研究允许对微量营养素治疗和药物治疗进行直接比较：没有一名 88 名儿科和成年参与者的实验室值出现任何临床意义上的异常，但接受微量营养素治疗的组的耐受性数据显示 AE 明显减少，体重增加减少。
就采用复合营养配方作为主要治疗方法的广谱方法而言，此次安全性和耐受性数据的汇编令人放心。
