Safety and adherence of Umezu polyphenols in the Japanese plum (Prunus mume) in a 12-week double-blind randomized placebo-controlled pilot trial to evaluate antihypertensive effects.
Safety and adherence of Umezu polyphenols in the Japanese plum (Prunus mume) in a 12-week double-blind randomized placebo-controlled pilot trial to evaluate antihypertensive effects.
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在一项为期 12 周的双盲随机安慰剂对照试验中，研究了日本李子 (Prunus mume) 中梅多酚的安全性和依从性，以评估抗高血压效果。
DOI：
10.1007/s12199-014-0404-8
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发表时间：
2014
期刊：
影响因子：
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通讯作者：
Miyashita K.
中科院分区：
文献类型：
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作者：
Takemura S;Yoshimasu K;Fukumoto J;Mure K;Nishio N;Kishida K;Yano F;Mitani T;Takeshita T;Miyashita K.
目的轻度高血压患者往往需要通过药物或生活方式的改变来预防或改善高血压。胶囊包括乌梅多酚（UP），日本李子中的多酚，可以帮助他们控制血压（BP）。本研究的目的是评估UP对BP的有效性及其safety.MethodsA共有15名健康工人没有降压药谁有一些担心他们的BP，最好是正常高血压或高血压1级，随机双盲方式进入UP ingredient和安慰剂组。指导每名受试者每日服用4粒胶囊，持续12周（每日UP剂量，UP ingredient组为800 mg;安慰剂组为0 mg）。这些受试者被随访12周，在此期间监测他们在家中和检查现场的血压，以及自我感知的生活质量结果和可能的副作用。组×时间的相互作用对血压的变化进行了examined.ResultsAll的15名受试者完成了12周的干预试验。无论是在检查现场还是在家中，UP治疗组和安慰剂组的血压变化均无显著差异。结论UP对血压无明显影响。然而，在这项为期12周的随机对照试验中，更高剂量的UP被证实是安全的，并且依从性高。其对BP和其他结局的影响应在更大的样本中确认。
ObjectivesMedications or lifestyle changes to prevent or improve hypertension often press considerable efforts on patients suffering from mild hypertension. Capsules includingUmezupolyphenols (UP), polyphenols in Japanese plums, may help them to control their blood pressure (BP). The aim of this study is to evaluate the effectiveness of UP on BP and its safety.MethodsA total of 15 healthy workers without antihypertensive medication who had some concerns about their BP, preferably normal-high BP or hypertension level 1, were randomized in a double-blind manner into UP ingesting and placebo groups. Each subject was instructed to take four capsules daily for 12 weeks (daily UP dose, 800 mg for the UP ingesting group; and 0 mg for the placebo group). These subjects were followed for 12 weeks, and their BP both at home and at the examination site, as well as self-perceived quality-of-life outcomes and possible side effects, was monitored during that period. Group × time interactions on BP changes were examined.ResultsAll of the 15 subjects completed the 12-week intervention trial. The BP changes did not significantly differ between the UP ingesting and placebo groups, neither at the examination site nor at home. But during the study period, no adverse effects were observed.ConclusionsNo remarkable effect of UP on BP was observed. However, a higher dose of UP was confirmed safe and high in adherence in this 12-week randomized controlled trial. Its effect on BP and other outcomes shall be confirmed in a larger sample.