title: A randomized controlled trial of acupuncture in stable ischemic heart disease patients.
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 12 weeks. 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los Angeles, CA, United States.
authors.forename: Puja K
authors.initials: PK
authors.lastname: Mehta
authors.affiliation: Division of Cardiology, Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: Donna M
authors.initials: DM
authors.lastname: Polk
authors.affiliation: Biostatistics and Bioinformatics, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, United States.
authors.forename: Xiao
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Biomathematics, University of California at Los Angeles, Los Angeles, CA, United States.
authors.forename: Ning
authors.initials: N
authors.lastname: Li
authors.affiliation: Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los Angeles, CA, United States.
authors.forename: Jeannette
authors.initials: J
authors.lastname: Painovich
authors.affiliation: Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los Angeles, CA, United States.
authors.forename: Kamlesh
authors.initials: K
authors.lastname: Kothawade
authors.affiliation: Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los Angeles, CA, United States.
authors.forename: Joan
authors.initials: J
authors.lastname: Kirschner
authors.affiliation: Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los Angeles, CA, United States.
authors.forename: Yi
authors.initials: Y
authors.lastname: Qiao
authors.affiliation: Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los Angeles, CA, United States.
authors.forename: Xiuling
authors.initials: X
authors.lastname: Ma
authors.affiliation: Molecular Biochemistry and Steroid Chemistry Laboratory, Cedars-Sinai Medical Center, Los Angeles, CA, United States.
authors.forename: Yii-Der Ida
authors.initials: YD
authors.lastname: Chen
authors.affiliation: Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los Angeles, CA, United States.
authors.forename: Anna
authors.initials: A
authors.lastname: Brantman
authors.affiliation: Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los Angeles, CA, United States.
authors.forename: Chrisandra
authors.initials: C
authors.lastname: Shufelt
authors.affiliation: Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los Angeles, CA, United States.
authors.forename: Margo
authors.initials: M
authors.lastname: Minissian
authors.affiliation: Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los Angeles, CA, United States. Electronic address: merz@cshs.org.
authors.forename: C Noel Bairey
authors.initials: CN
authors.lastname: Merz
mesh_terms: D015670:Acupuncture Therapy / Q000379:methods* / Q000592:standards; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000175:diagnosis* / Q000628:therapy*; D010919:Placebos / Q000592:standards; D016037:Single-Blind Method; D013997:Time Factors
chemical_list: D010919:Placebos
keywords: Acupuncture; Heart Disease; Heart rate variability
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