Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
JAMA Cardiol. 2017 Aug 1;2(8):902-907. doi: 10.1001/jamacardio.2017.0538.
Research shows that resveratrol, a sirtuin activator in red wine, improves exercise endurance and skeletal-muscle oxidative metabolism in animals and may enhance vascular function in humans. Resveratrol supplement sales exceed $30 million annually in the United States, but few data are available regarding its efficacy in humans.
To determine whether resveratrol, 125 mg/d or 500 mg/d, improves the 6-minute walk performance in patients with peripheral artery disease (PAD).
DESIGN, SETTING, AND PARTICIPANTS: This parallel-design, double-blind, randomized clinical trial, called Resveratrol to Improve Outcomes in Older People With PAD (RESTORE), was conducted at Northwestern University. Sixty-six participants 65 years or older with PAD were randomized to receive a daily capsule of resveratrol, 125 mg or 500 mg, or placebo for 6 months. Participants were randomized using a randomly permuted block method stratified by baseline 6-minute walk test performance. This trial was conducted between January 1, 2015, and August 5, 2016, and data analyses were performed according to the intention-to-treat concept.
Administration of resveratrol, 125 or 500 mg/d, or placebo once daily.
The primary outcome measure was the change in 6-minute walk distance at the 6-month follow-up. One of the secondary outcomes was change in maximal treadmill walking time. Because of the preliminary nature of the trial, the a priori power calculation used a 1-sided test with a significance level of P < .10.
The 66 participants were predominantly men (45 [68%]), had a mean (SD) age of 74.4 (6.6) years, and had a mean (SD) ankle brachial index of 0.67 (0.18). Sixty-four (97%) completed follow-up. Six-month mean (SE) changes in 6-minute walk distance were 4.6 (8.1) m for the 125-mg resveratrol group, -12.8 (7.5) m for the 500-mg resveratrol group, and -12.3 (7.9) m for the placebo group (P = .07 for the 125-mg resveratrol group vs placebo; P = .96 for the 500-mg resveratrol group vs placebo). Six-month mean (SE) changes in maximal treadmill walking time were 0.5 (2.3) minutes for the 125-mg resveratrol group, -0.6 (2.1) minutes for the 500-mg resveratrol group, and 0.4 (2.1) minutes for the placebo group (P = .18 for the 125-mg resveratrol group vs placebo; P = .12 for the 500-mg resveratrol group vs placebo).
The RESTORE trial found no consistent evidence that resveratrol improves walking performance in patients 65 years or older with PAD.
clinicaltrials.gov Identifier: NCT02246660.
目的：研究表明，红酒中的白藜芦醇作为一种组蛋白去乙酰化酶激活剂，可改善动物的运动耐力和骨骼肌氧化代谢，并且可能增强人类的血管功能。白藜芦醇补充剂在美国的年销售额超过 3000 万美元，但关于其在人体中的疗效的数据却很少。
方法和地点：这是一项在西北大学进行的平行设计、双盲、随机临床试验，称为白藜芦醇改善外周动脉疾病老年人的结局（RESTORE）。共纳入 66 名年龄在 65 岁及以上的外周动脉疾病患者，随机接受白藜芦醇 125mg/d 或 500mg/d 或安慰剂治疗 6 个月。使用随机区组方法按基线 6 分钟步行试验结果分层进行随机分组。该试验于 2015 年 1 月 1 日至 2016 年 8 月 5 日进行，根据意向治疗原则进行数据分析。
参与者：参与者 66 人，均为男性（45 人[68%]），平均（SD）年龄为 74.4（6.6）岁，平均（SD）踝肱指数为 0.67（0.18）。64 人（97%）完成了随访。6 个月时的主要结局是 6 分钟步行距离的变化。次要结局之一是最大跑步机步行时间的变化。由于试验的初步性质，事先的功效计算使用单侧检验，显著性水平为 P<0.10。
干预：每天服用白藜芦醇 125 或 500mg/d 或安慰剂一次。
结果：66 名参与者主要为男性（45[68%]），平均（SD）年龄为 74.4（6.6）岁，平均（SD）踝肱指数为 0.67（0.18）。64 名（97%）完成了随访。服用白藜芦醇 125mg/d 组 6 个月时 6 分钟步行距离的平均（SE）变化为 4.6（8.1）m，500mg/d 组为-12.8（7.5）m，安慰剂组为-12.3（7.9）m（白藜芦醇 125mg/d 组与安慰剂组相比，P=0.07；白藜芦醇 500mg/d 组与安慰剂组相比，P=0.96）。服用白藜芦醇 125mg/d 组 6 个月时最大跑步机步行时间的平均（SE）变化为 0.5（2.3）分钟，500mg/d 组为-0.6（2.1）分钟，安慰剂组为 0.4（2.1）分钟（白藜芦醇 125mg/d 组与安慰剂组相比，P=0.18；白藜芦醇 500mg/d 组与安慰剂组相比，P=0.12）。
结论：RESTORE 试验没有一致的证据表明白藜芦醇能改善 65 岁及以上外周动脉疾病患者的步行能力。
