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A Critical Evaluation of the Clinical Evidence for Pomegranate Preparations in the Prevention and Treatment of Cardiovascular Diseases

机译:石榴制剂预防和治疗心血管疾病的临床证据的重要评价

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This study attempts a critical evaluation of the clinical evidence behind the use of dietary pomegranate preparations in the prevention and treatment of cardiovascular diseases. A search of PubMed on August 10, 2014 identified 228 references, which yielded extractable data from 24 clinical studies of pomegranate preparations. Hand searching identified two further studies. The quality of the studies and evidence of effectiveness of pomegranate were assessed by an established set of conventional criteria. Overall, the study quality was poor. Even in the best studies, indications of benefit did not reach the conventional levels of statistical significance. The only study with a definitive design had a biochemical rather than a clinical endpoint: it showed the expected difference in blood concentrations of myeloperoxidase after a single dose of either pomegranate or placebo. Only 10 of the 26 studies provided HPLC data on the amounts of co-active ingredients in the preparations that were consumed by the subjects. If pomegranate has a role in the prevention and treatment of cardiovascular diseases, there is a pressing need for dose-finding and long-term confirmatory studies. The ultimate endpoint for definitive studies would be mortality, but reductions in blood pressure or demonstrable decreases in atherosclerotic plaques would be useful surrogates. Sample sizes for various assumptions are provided. Future studies need to prove the clinical benefit. Copyright (c) 2015 John Wiley & Sons, Ltd.
机译:这项研究试图对饮食石榴制剂用于预防和治疗心血管疾病背后的临床证据进行重要评估。 2014年8月10日对PubMed进行的搜索确定了228个参考文献,这些参考文献来自24个石榴制品临床研究的可提取数据。手工搜索确定了两项进一步的研究。研究质量和石榴有效性的证据通过一套既定的常规标准进行评估。总体而言,研究质量较差。即使在最佳研究中,获益的指征也未达到统计意义上的常规水平。唯一具有确定性设计的研究具有生化指标,而不是临床指标:单剂量石榴或安慰剂治疗后,其血液中髓过氧化物酶浓度存在预期差异。 26项研究中只有10项提供了受试者消耗的制剂中活性成分含量的HPLC数据。如果石榴在预防和治疗心血管疾病中起作用,那么迫切需要进行剂量确定和长期的验证性研究。最终研究的最终终点将是死亡率,但降血压或明显减少动脉粥样硬化斑块将是有用的替代指标。提供了各种假设的样本量。未来的研究需要证明其临床益处。版权所有(c)2015 John Wiley&Sons,Ltd.

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