摘要
导言：美国黑人罹患心血管疾病（CVD）的比例过高。社会心理压力是造成这种差异的原因之一。之前的研究报告称，超凡冥想（TM）技术可降低高危人群的心血管疾病风险因素、替代终点和临床事件。但是，还没有研究评估过冥想减压对颈动脉内膜中层厚度（cIMT）等代偿性心血管疾病标志物以及心血管疾病临床事件的影响。因此，这项随机临床试验评估了冥想和健康教育（HE）对高风险黑人成人颈动脉内膜中层厚度（cIMT）和心血管疾病事件的长期影响：参与者为患有心血管疾病或高风险的黑人女性和男性，他们被随机分配到冥想或健康教育中。主要结果是在基线和 12 个月时使用 B 型超声波测量的 cIMT 变化。主要次要结果是随访 5 年（最长）时的主要心血管不良事件 (MACE)。其他次要结果包括随访 1 年和 10 年的 MACE、血压和 1 年后的血清脂质。探索性变量包括 cIMT 变化与历史对照组的比较以及 14 年后的 MACE：共有 197 名随机参与者，其中 136 人完成了 cIMT 后测。1 年后，TM 组和 HE 组的 cIMT 平均变化分别为-0.0004 毫米和-0.0003 毫米，组间无显著差异。此外，血脂水平和血压在组间也无明显差异。不过，与历史对照组相比，TM 组和 HE 组在 12 个月时都能防止 cIMT 的进展。在 MACE 生存分析中，TM 组在随访 5 年（最长）后相对风险降低了 65%（HR = 0.346；95% CI = 0.134-0.893；P = 0.017）。在1年和10年的随访中，TM组与HE组相比风险显著降低，但在14年的随访中（所有年份的最大值）风险并不显著：讨论：与历史对照组相比，两个治疗组都能在 12 个月内防止 cIMT 的进展。但是，TM 组在 5 年后发生 MACE 的相对风险降低了 65%。因此，作为一种改变生活方式的方法，TM 可用于该高危人群以及其他可能的高危人群的心血管疾病二级预防：临床试验注册：ClinicalTrials.gov，NCT05642936。Introduction: Black Americans suffer from disproportionately high rates of cardiovascular disease (CVD). Psychosocial stress contributes to this disparity. Previous studies reported that the Transcendental Meditation (TM) technique reduced CVD risk factors, surrogate endpoints, and clinical events in high-risk populations. However, no study has evaluated the effects of stress reduction with meditation on surrogate CVD markers such as carotid intima-media thickness (cIMT) along with CVD clinical events. Therefore, this randomized clinical trial evaluated the long-term effects of meditation and health education (HE) on cIMT and CVD events in high-risk Black adults.
Materials and methods: Participants were Black women and men with CVD or at high risk who were randomized to either TM or HE. The primary outcome was a change in cIMT measured using B-mode ultrasound at baseline and 12 months. The main secondary outcome was major adverse cardiovascular events (MACE) at 5 years (maximum) of follow-up. Other secondary outcomes were MACE at 1 and 10 years of follow-up, blood pressure, and serum lipids after 1 year. Exploratory variables were a comparison of cIMT changes to historical controls and MACE after 14 years.
Results: There were 197 randomized participants, of whom 136 completed posttest for cIMT. After 1 year, the TM and HE groups showed average cIMT changes of -0.0004 and -0.0003 mm, respectively, with no significant difference between the groups. Additionally, there were no significant differences between the groups in lipid levels or BP. However, both TM and HE groups showed prevention of progression of cIMT compared to historical controls at 12 months. In the survival analysis of MACE, there was a 65% relative risk reduction in the TM group after 5 (maximum) years of follow-up (HR = 0.346; 95% CI = 0.134-0.893; p = 0.017). At 1 and 10 years of follow-up, there were significant risk reductions in the TM vs. HE group, which was not significant at 14 years (all yearly maximums).
Discussion: Both treatment groups demonstrated prevention of progression of cIMT over 12 months compared to historical controls. However, the TM group showed a relative risk reduction for MACE of 65% at 5 years. Therefore, as a lifestyle modification method, TM may be useful in the secondary prevention of CVD in this and possibly other high-risk groups.
Clinical trial registration: ClinicalTrials.gov, NCT05642936.
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