Sadovsky Richard, Collins Nancy, Tighe Ann P, Brunton Stephen A, Safeer Richard
State University of New York Heath Science Center, Brooklyn College of Medicine, Brooklyn, NY 11203, USA.
Curr Med Res Opin. 2008 Apr;24(4):1209-16. doi: 10.1185/030079908x280743. Epub 2008 Mar 17.
The estimated prevalence of dietary-supplement use among US adults was 73% in 2002. Appropriate use of dietary supplements within the paradigm of evidence-based medicine may be a challenge for medical doctors and non-physician clinicians. Randomized, controlled, clinical trial data, which are considered the gold standard for evidence-based decision making, are lacking. Standardized guidelines for the use of dietary supplements are lacking, and dietary supplements can bear unsupported claims.
This article is intended to review clinically-relevant issues related to the widespread use of dietary supplements, with emphasis on regulatory oversight and safety.
Review articles and clinical trial articles published up until December 2007 were selected based on a search of the MEDLINE electronic database using PubMed. The Food and Drug Administration (FDA) Website was also used as a resource. We used the search terms dietary supplement(s), vitamin supplements, mineral supplements, and Dietary Supplement and Health Education Act. Articles discussing dietary supplements and their regulation, prevalence of use, prescription and nonprescription formulations, and/or adverse events were selected for review. Articles discussing one or more of these topics in adults were selected for inclusion.
New FDA regulations require dietary-supplement manufacturers to evaluate the identity, purity, strength, and composition of their products. However, these regulations are not designed to demonstrate product efficacy and safety, and dietary-supplement manufacturers are not required to submit efficacy and safety data to the FDA prior to marketing. Product contamination and/or mislabeling may undermine the integrity of dietary-supplement formulations.
The use of dietary supplements may be associated with adverse events. Although there are new regulatory requirements for dietary supplements, these products will not require FDA approval or submission of efficacy and safety data prior to marketing under the new regulation. A limitation to the literature used for this review is the lack of prospective, randomized clinical trials on the safety and efficacy of dietary supplements. Clinicians should be aware of all the dietary supplements that their patients consume, and help their patients make informed decisions appropriate to their medical care.
2002年美国成年人中膳食补充剂的估计使用率为73%。在循证医学范式内合理使用膳食补充剂对医生和非医生临床医生而言可能是一项挑战。缺乏被视为循证决策金标准的随机对照临床试验数据。缺乏膳食补充剂使用的标准化指南，而且膳食补充剂可能存在无依据的宣称。
本文旨在综述与膳食补充剂广泛使用相关的临床相关问题，重点关注监管监督和安全性。
通过使用PubMed搜索MEDLINE电子数据库，选取截至2007年12月发表的综述文章和临床试验文章。美国食品药品监督管理局（FDA）网站也用作资料来源。我们使用了膳食补充剂、维生素补充剂、矿物质补充剂以及《膳食补充剂健康教育法》等搜索词。选取讨论膳食补充剂及其监管、使用 prevalence、处方和非处方制剂以及/或不良事件的文章进行综述。选取讨论成年人中这些主题中一个或多个的文章纳入。
FDA的新规定要求膳食补充剂制造商评估其产品的身份、纯度、强度和成分。然而，这些规定并非旨在证明产品的有效性和安全性，并且膳食补充剂制造商在上市前无需向FDA提交有效性和安全性数据。产品污染和/或标签错误可能会破坏膳食补充剂制剂的完整性。
使用膳食补充剂可能与不良事件相关。尽管对膳食补充剂有新的监管要求，但根据新规定，这些产品在上市前无需FDA批准或提交有效性和安全性数据。本综述所使用文献的一个局限性是缺乏关于膳食补充剂安全性和有效性的前瞻性随机临床试验。临床医生应了解其患者服用的所有膳食补充剂，并帮助患者做出适合其医疗护理的明智决定。
