The Superiority and Safety of Ershen Fumai Capsules (二参复脉胶囊) versus Xinbao Pills (心宝丸) for Senile Sinus Bradycardia: a Randomized Double-Blinded Clinical Trial
GUO Jianli, NIU Tianfu, YANG Xiaoyan, et al. The Superiority and Safety of Ershen Fumai Capsules (二参复脉胶囊) versus Xinbao Pills (心宝丸) for Senile Sinus Bradycardia: a Randomized Double-Blinded Clinical Trial[J]. Journal of Traditional Chinese Medicine2021, 62(3): 224-228.
GUO Jianli, NIU Tianfu, YANG Xiaoyan, et al. The Superiority and Safety of Ershen Fumai Capsules (二参复脉胶囊) versus Xinbao Pills (心宝丸) for Senile Sinus Bradycardia: a Randomized Double-Blinded Clinical Trial[J]. Journal of Traditional Chinese Medicine2021, 62(3): 224-228.DOI: 10.13288/j.11-2166/r.2021.03.009.
Objective To explore the superiority and safety of Ershen Fumai Capsules(二参复脉胶囊) versus Xinbao Pills(心宝丸) for the treatment of senile sinus bradycardia. Methods Totally 120 elderly patients with sinus bradycardia were randomly divided into a treatment group and a control group with 60 patients in each group. Besides the conventional treatment for the primary diseases
Ershen Fumai Capsules(0.5 g each capsule
4 capsules per time) plus Xinbao Pills placebo(5 pills per time) were given in the treatment group
while Ershen Fumai Capsules placebo(4 capsules per time) plus Xinbao Pills(60 mg each pill
5 pills per time) were given in the control group
all medication three times daily
for eight weeks. The 24-hour dynamic electrocardiogram
heart rate variability(HRV)
blood lipids
hemodynamic indicators
as well as safety indicators including blood routine
urine routine
stool routine
liver function
kidney function
and electrolytes were measured before and after treatment. The effects on traditional Chinese medicine(TCM) syndromes and dynamic electrocardiogram were evaluated. Results In the treatment group
the total effective rate by TCM syndromes was 85.0%
and the total effective rate by dynamic electrocardiogram was 88.3%
while those in the control group were 68.3% and 70.0%
respectively(P<0.05). The fastest heart rate
slowest heart rate
average heart rate
total heart rate
and HRV at different time-domain measurements were significantly improved in both groups after treatment(P<0.05)
with more improvements in treatment group than control group in all above indicators except for the root mean square of differences between adjacent or neighboring NN intervals(P<0.05). The blood lipid indicators including total cholesterol
triglycerides
high-density lipoprotein cholesterol
low-density lipoprotein cholesterol
as well as the hemodynamic indicators including left ventricular ejection fraction
stroke volume
cardiac output and cardiac index were all improved in both groups after treatment(P<0.05). There were no significant differences in safety indicators when compared after treatment with before treatment
and the incidence of adverse events was not significantly different between treatment and control group(P>0.05). Conclusion Ershen Fumai Capsules has better effects than Xinbao Pills in treatmenting senile sinus bradycardia