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Author Mehta, P. K.; Polk, D. M.; Zhang, X.; Li, N.; Painovich, J.; Kothawade, K.; Kirschner, J.; Qiao, Y.; Ma, X.; Chen, Y. D.; Brantman, A.; Shufelt, C.; Minissian, M.; Bairey Merz, C. N.
Title A randomized controlled trial of acupuncture in stable ischemic heart disease patients. Type of Study RCT
Year 2014 Publication International journal of cardiology Abbreviated Journal Int J Cardiol
Volume Issue Pages -
Keywords RCT; Cardiovascular Diseases; Myocardial Ischemia; Acu Versus > 1 Control; Acupuncture; TCM Acupuncture Style; Fixed Acupuncture Protocol; Restricted Modalities, Acupuncture Only; Sham Control; Non Penetrating Sham, Mechanical; Near Verum Acupoint Control; Wait List Control; Heart Rate Variability; Heart Disease; Ischemic Heart Disease
Abstract BACKGROUND: Heart rate variability (HRV) is reduced in stable ischemic heart disease (SIHD) patients and is associated with sudden cardiac death (SCD). We evaluated the impact of traditional acupuncture (TA) on cardiac autonomic function measured by HRV in SIHD patients. METHODS: We conducted a randomized controlled study of TA, sham acupuncture (SA), and waiting control (WC) in 151 SIHD subjects. The TA group received needle insertion at acupuncture sites, the SA group received a sham at non-acupuncture sites, while the WC group received nothing. The TA and SA groups received 3 treatments/week for 12weeks. 24-Hour, mental arithmetic stress, and cold pressor (COP) HRV was collected at entry and exit, along with BP, lipids, insulin resistance, hs-CRP, salivary cortisol, peripheral endothelial function by tonometry (PAT), and psychosocial variables. RESULTS: Mean age was 63+/-10; 50% had prior myocardial infarction. Comparison of WC and SA groups demonstrated differences consistent with the unblinded WC status; therefore by design, the control groups were not merged. Exit mental stress HRV was higher in TA vs. SA for markers of parasympathetic tone (p</=0.025), including a 17% higher vagal activity (p=0.008). There were no differences in exit 24-hour or COP HRV, BP, lipids, insulin resistance, hs-CRP, salivary cortisol, PAT, or psychosocial variables. CONCLUSIONS: TA results in intermediate effects on autonomic function in SIHD patients. TA effect on HRV may be clinically relevant and should be explored further. These data document feasibility and provide sample size estimation for a clinical trial of TA in SIHD patients for the prevention of SCD. CONDENSED ABSTRACT: We conducted a randomized, single-blind trial of traditional acupuncture (TA) vs. sham acupuncture (SA) vs waiting control (WC) in stable ischemic heart disease (SIHD) patients to evaluate cardiac autonomic function measured by heart rate variability (HRV). Exit mental stress HRV was higher in the TA compared to SA group for time and frequency domain markers of parasympathetic tone (all p</=0.025), including a 17% higher vagal activity (p=0.008). These data document feasibility and provide sample size estimation for an outcome-based clinical trial of TA in SIHD patients for the prevention of sudden cardiac death.
Address Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los Angeles, CA, United States.; Division of Cardiology, Brigham and Women's Hospital, Boston, MA, USA
Publisher
Language Number of Treatments 36
Treatment Follow-up N/A Frequency >1/WK Number of Participants 151
Time in Treatment 12 Weeks Condition Myocardial Ischemia
Disease Category Cardiovascular Diseases OCSI Score
Notes Approved no
Call Number Serial 847
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