A randomized controlled trial of acupuncture in stable ischemic heart disease patients
Puja K Mehta1, Donna M Polk2, Xiao Zhang3
1Barbra Streisand Women's Heart Center, Cedars-Sinai Heart Institute, Los Angeles, CA, United States.
Insights
Traditional acupuncture (TA) improved cardiac autonomic function in stable ischemic heart disease (SIHD) patients, specifically enhancing parasympathetic tone during mental stress tests. This suggests TA may be a relevant intervention for SIHD patients, warranting further investigation for sudden cardiac death prevention.
Area of Science:
- Cardiovascular Medicine
- Integrative and Complementary Medicine
- Autonomic Nervous System Research
Background:
- Reduced heart rate variability (HRV) in stable ischemic heart disease (SIHD) patients is linked to sudden cardiac death (SCD).
- Evaluating interventions to improve cardiac autonomic function in SIHD is crucial for risk reduction.
Purpose of the Study:
- To assess the impact of traditional acupuncture (TA) on cardiac autonomic function, measured by HRV, in patients with SIHD.
- To compare TA with sham acupuncture (SA) and a waiting control (WC) group.
Main Methods:
- A randomized controlled trial involving 151 SIHD subjects comparing TA, SA, and WC groups over 12 weeks.
- HRV was measured during 24-hour monitoring, mental arithmetic stress, and cold pressor tests.
- Additional assessments included blood pressure, lipids, insulin resistance, hs-CRP, salivary cortisol, endothelial function, and psychosocial variables.
Main Results:
- The TA group showed significantly higher HRV during mental stress tests, indicating improved parasympathetic tone compared to the SA group (p ≤ 0.025).
- Vagal activity was 17% higher in the TA group versus the SA group (p=0.008).
- No significant differences were observed in 24-hour HRV, cold pressor HRV, or other physiological and psychosocial markers between groups.
Conclusions:
- Traditional acupuncture demonstrates intermediate effects on autonomic function in SIHD patients, particularly enhancing parasympathetic activity under stress.
- The observed effects on HRV suggest TA may have clinical relevance for SIHD patients and warrants further study for SCD prevention.
- The study provides feasibility data and sample size estimations for future clinical trials investigating TA in SIHD.
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.
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.
