Research Article| Volume 176, ISSUE 2, P367-374, September 20, 2014

A randomized controlled trial of acupuncture in stable ischemic heart disease patients



      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.


      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.


      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.


      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.


      CES-D (Center for Epidemiologic Study Depression Scale), COP (cold pressor testing), DASI (Duke Activity Status Index), HOMA (homeostasis model assessment), HRV (heart rate variability), PAT (peripheral arterial tonometry), SA (sham acupuncture), SAQ (Seattle Angina Questionnaire), SIHD (stable ischemic heart disease), TA (traditional acupuncture), WC (waiting control)

      HRV abbreviations:

      TP (total power), HF (high frequency), LF (low frequency), SDNN (standard deviation of normal RR (NN) intervals), SDANN (standard deviation of 5-minute mean RR intervals), aSDNN (average of standard deviations of normal RR intervals in 24h), rMSSD (root-mean square of difference of successive RR intervals), pNN50 (proportion of adjacent RR intervals more than 50ms different)


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