Acupuncture For Chronic Stable Angina Pectoris At Acupoints On Disease Affected Meridian: A Multi-center, Randomized, Controlled Trial And A Heart Rate Variability Study

Objective:To evaluate the clinical efficacy and explore the regulation function of the autonomic nervous related to Heart Rate Variability of puncturing at the acupoints on disease affected meridian for Chronic Stable Angina Pectoris patients.Methods:1. A multi-center randomized and controlled trial was designed.404 patients with CSAP were divided into four groups by the central randomization system: acupoints on disease affected meridian group (group A), acupoints on nonaffected meridian group (group B), non-acupoints group (group C) and waiting list group (group D). Neiguan (PC6) of the Pericardium Channel of Hand-Jueyin and Tongli (HT5) of the Heart Channel of Hand-Shaoyin were punctured in group A; Taiyuan (LU9) and Kongzui (LU6) of the Lung Meridian were punctured in group B; two non-acupoints were punctured in group C; no intervention was in group D. GroupA, groupB and groupC were punctured at acupoints or non-acupoints bilaterally. Treatment time and frequency is 30min and 3 times a week at intervals of one day respectively and the treatment lasts 4 weeks. The following outcome were assessed at the baseline,4th,8th,12th and 16th week after randomization:the primary outcome including frequency of angina attack and the secondary outcomes including visual analogue scale (VAS) score, seattle anginaquestionnaire (SAQ) score, the dosage of nitroglycerin, self-rating depression scale (SAS) score, self-rating anxiety scale (SDS) score, etc.2. Subjects and interventions were identical to the above mentioned trial. The following indicators of HRV were measured by power spectral analysis of 24-hour Holter monitoring before and after treatment:standard deviation of average normal to normal intervals index(SDANN Index), the square root of the mean of the sum of the squares of differences between adjacent NN intervals (rMSSD), standard deviation of all normal to normal intervals index, (SDNN Index), percentage of differences exceeding 50 ms between adjacent normal number of intervals (pNN50), standard deviation of all normal to normal intervals (SDNN), the frequency-domain power-24 hour, the minimum frequency-domain power-hour and the maximum frequency-domain power-hour.Results:1. The clinical efficacy of puncturing at the different acupoints, non-acupoints and waiting list(1) In evaluation of the primary outcome, group A (at 4th,8th,12th and 16th week), B (at 4th,8th,12th and 16th week) and C (at 4th week) reduced significantly comparing to group D in the frequency of angina attack (P<0.05). The frequency of angina attack of Group A (at 4th,8th,12th and 16th week) decreased statistically comparing to that in group D (P<0.05). For group B compared with group C, the frequency of angina attack was no statistical differences (P>0.05).(2) In evaluation of the secondary outcomes. Group A (at 4th,8th,12th and 16th week), B (at 4th,8th week) and C (a single assessment time) revealed significant improvements comparing to group D in the frequency of angina attack, anginal frequency (AF) and the treatment satisfaction (TS) in two dimension of SAQ (P<0.05). The following outcomes in group A (at 12th,16th week) revealed significant improvements comparing to those in group B and C:the frequency of angina attack and differences from baseline, VAS score, SAQ aggregate score and AF, anginal stability (AS) and TS in three dimension of SAQ (P<0.05); but For group B compared with group C, the above mentioned secondary outcomes were no statistical differences (P>0.05). For group A, B, C and D, SAS score, SDS score and the dosage of nitroglycerin were significant decrease but no statistical differences among the four groups(P>0.05).(3) At 16 weeks follow-up, there didn’t exist statistics difference in the incidence of cardiovascular events and vital signs among four groups. One patient died of acute myocardial infarct (AMI) during the study in group D and the dead case surely has nothing to do with acupuncture. But beyond that, the no serious adverse events occurred in the study.2. The influence of different acupoints, non-acupoints and waiting list on the ANF by power spectral analysis of HRV in CSAP patientsGroup A and B were respectively higher than group D in SDNN Index (P<0.05). There is no statistical differences in comparison of HRV among the rest groups (P>0.05).Conclusions:1. Acupuncture for CSAP at Acupoints on Disease Affected Meridian (group A), acupoints on nonaffected meridian (group B) and non-acupoints (group C) is more efficacious than waiting list (group D) in reducing the frequency of angina attack and improving the treatment satisfaction. Acupuncture in combination with the foundation treatment is safe and effective for CSAP patients.2. Acupoints on disease affected meridian (Group A) for CSAP can be more efficacious than acupoints on nonaffected meridian (Group B) and non-acupoints (Group C) in improving symptoms of angina and quality of life, may improve patients’ emotional status and reduce the dosage of nitroglycerin. The clinical efficacy of puncturing are better at the acupoints on disease affected meridian than at acupoints on nonaffected meridian and non-acupoints. The efficacy of acupoints on disease affected meridian has the characteristic of sustainability.3. Acupoints on disease affected meridian (Group A) and acupoints on nonaffected meridian (Group B) are higher than waiting list (group D) in HRV. Acupuncture at acupoits may be beneficial to the modulation of cardiovascular autonomic nervous function, which can improve the potential prognosis on patients with CSAP. Further researches are warranted.