Cardiology Unit, IRCCS INRCA, 60129 Ancona, Italy.
Scientific Direction, IRCCS INRCA, 60129 Ancona, Italy.
Nutrients. 2021 Sep 8;13(9):3128. doi: 10.3390/nu13093128.
There is an increasing number of nutraceutical combinations (NCs) on the market for hypercholesterolemia, although clinical trials to verify their safety and efficacy are scarce. We selected fourteen randomized, placebo-controlled clinical trials (RCTs) on different lipid-lowering NCs in hypercholesterolemic subjects. We described each compound's mechanism of action and efficacy in the mixtures and summarized the clinical trials settings and NCs safety and efficacy results. Almost all NCs resulted efficient against hypercholesterolemia; only one reported no changes. Interestingly, red yeast rice (RYR) was present in eleven mixtures. It is not clear whether the lipid-lowering efficacy of these combinations derives mainly from the RYR component monacolin K "natural statin" single effect. Up to now, few RCTs have verified the efficacy of every single compound vs. NCs to evaluate possible additive or synergistic effects, probably due to the complexity and the high resources request. In conclusion, to manage the arising nutraceutical tide against hypercholesterolemia, it could be helpful to increase the number and robustness of clinical studies to verify the efficacy and safety of the new NCs.
市场上有越来越多针对高胆固醇血症的营养保健品组合（NCs），尽管很少有临床试验来验证它们的安全性和有效性。我们选择了 14 项针对不同降脂 NCs 的高胆固醇血症患者的随机、安慰剂对照临床试验（RCTs）。我们描述了每种混合物中化合物的作用机制和功效，并总结了临床试验设置和 NCs 的安全性和功效结果。几乎所有的 NCs 对高胆固醇血症都有效；只有一项报告没有变化。有趣的是，红曲米（RYR）存在于 11 种混合物中。目前尚不清楚这些组合的降脂功效是否主要来自 RYR 成分洛伐他汀“天然他汀”的单一作用。到目前为止，很少有 RCT 验证了每种单一化合物与 NCs 的功效，以评估可能的附加或协同作用，这可能是由于其复杂性和高资源需求所致。总之，为了应对针对高胆固醇血症的营养保健品热潮，增加临床试验的数量和稳健性以验证新 NCs 的疗效和安全性可能会有所帮助。
