Schwingshackl Lukas, Hoffmann Georg, Buijsse Brian, Mittag Tamara, Stelmach-Mardas Marta, Boeing Heiner, Gottschald Marion, Dietrich Stefan, Arregui Maria, Dias Sofia
Department of Nutritional Sciences, Faculty of Life Sciences, University of Vienna, Althanstraße 14 (UZA II),, 1090, Vienna, Austria.
German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE), Arthur-Scheunert-Allee 114-116, 14558, Nuthetal, Germany.
Syst Rev. 2015 Mar 26;4:34. doi: 10.1186/s13643-015-0029-z.
In the Western world, dietary supplements are commonly used to prevent chronic diseases, mainly cardiovascular disease and cancer. However, there is inconsistent evidence on which dietary supplements actually lower risk of chronic disease, and some may even increase risk. We aim to evaluate the comparative safety and/or effectiveness of dietary supplements for the prevention of mortality (all-cause, cardiovascular, and cancer) and cardiovascular and cancer incidence in primary prevention trials.
METHODS/DESIGN: We will search PubMed, EMBASE, Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Cochrane Central Register of Controlled Trials, clinical trials.gov, and the World Health Organization International Trial Registry Platform. Randomized controlled trials will be included if they meet the following criteria: (1) minimum intervention period of 12 months; (2) primary prevention of chronic disease (is concerned with preventing the onset of diseases and conditions); (3) minimum mean age ≥18 years (maximum mean age 70 years); (4) intervention(s) include vitamins (beta-carotene, vitamin A, B vitamins, Vitamin C, Vitamin D, Vitamin E, and multivitamin supplements); fatty acids (omega-3 fatty acids, omega-6 fatty acids, monounsaturated fat); minerals (magnesium, calcium, selenium, potassium, iron, zinc, copper, iodine; multiminerals); supplements containing combinations of both vitamins and minerals; protein (amino acids); fiber; prebiotics; probiotics; synbiotics; (5) supplements are orally administered as liquids, pills, capsules, tablets, drops, ampoules, or powder; (6) report results on all-cause mortality (primary outcome) and/or mortality from cardiovascular disease or cancer, cardiovascular and/or cancer incidence (secondary outcomes). Pooled effects across studies will be calculated using Bayesian random effects network meta-analysis. Sensitivity analysis will be performed for trials lasting ≥5 years, trials with low risk of bias, trials in elderly people (≥65 years), ethnicity, geographical region, and trials in men and women. The results of the corresponding fixed effects models will also be compared in sensitivity analyses.
This is a presentation of the study protocol only. Results and conclusions are pending completion of this study. Our systematic review will be of great value to consumers of supplements, healthcare providers, and policy-makers, regarding the use of dietary supplements.
CRD42014014801 .
在西方世界，膳食补充剂常用于预防慢性病，主要是心血管疾病和癌症。然而，关于哪些膳食补充剂实际上能降低慢性病风险，证据并不一致，有些甚至可能增加风险。我们旨在评估在一级预防试验中，膳食补充剂预防死亡率（全因、心血管疾病和癌症）以及心血管疾病和癌症发病率方面的相对安全性和/或有效性。
方法/设计：我们将检索PubMed、EMBASE、Cochrane系统评价数据库、效果评价文摘数据库、Cochrane对照试验中心注册库、clinicaltrials.gov以及世界卫生组织国际临床试验注册平台。符合以下标准的随机对照试验将被纳入：（1）最短干预期为12个月；（2）慢性病的一级预防（关注预防疾病和病症的发生）；（3）最小平均年龄≥18岁（最大平均年龄70岁）；（4）干预措施包括维生素（β-胡萝卜素、维生素A、B族维生素、维生素C、维生素D、维生素E和多种维生素补充剂）；脂肪酸（ω-3脂肪酸、ω-6脂肪酸、单不饱和脂肪）；矿物质（镁、钙、硒、钾、铁、锌、铜、碘；多种矿物质）；含有维生素和矿物质组合的补充剂；蛋白质（氨基酸）；纤维；益生元；益生菌；合生元；（5）补充剂以液体、丸剂、胶囊、片剂、滴剂、安瓿或粉末的形式口服；（6）报告全因死亡率（主要结局）和/或心血管疾病或癌症死亡率、心血管疾病和/或癌症发病率（次要结局）的结果。将使用贝叶斯随机效应网络荟萃分析计算各研究的合并效应。将对持续时间≥5年的试验、偏倚风险低的试验、老年人（≥65岁）试验、种族、地理区域以及男性和女性试验进行敏感性分析。在敏感性分析中还将比较相应固定效应模型的结果。
这仅是研究方案的介绍。结果和结论有待本研究完成。我们的系统评价对于补充剂消费者、医疗保健提供者和政策制定者在膳食补充剂的使用方面将具有重要价值。
CRD42014014801 。
