Published: Jun 7, 2013
By Chris Kaiser , Cardiology Editor, MedPage Today
Action Points
- Note that this randomized controlled trial performed in China demonstrated a beneficial effect of a Chinese herbal medicine, qiangxin, on NT-pro BNP levels in patients with heart failure.
- Be aware that the capsules are a mix of 11 herbs; the active ingredient remains unclear.
The traditional Chinese herbal medicine qili qiangxin proved better than placebo in reducing natriuretic peptide levels in heart failure patients, a randomized trial found.
Significantly more patients taking qili qiangxin capsules met the criterion of at least a 30% reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 12 weeks, compared with those on placebo (48% versus 32%, P<0.001), according to Xinli Li, MD, PhD, of the First Affiliated Hospital of Nanjing Medical University in Nanjing, China, and colleagues.
The traditional Chinese medicine group also had a lower rate of composite cardiac events compared with placebo (4.5% versus 11%, P=0.008), they reported in the study published online in theJournal of the American College of Cardiology.
In addition, the intervention group surpassed the placebo group in several metrics indicating improved heart failure over the 12 weeks:
- A gradual increase in the frequency of NYHA class I, while NYHA class III and IV gradually decreased, reaching significance at weeks 8 and 12
- Significantly greater mean change from baseline to 12 weeks in left ventricular ejection fraction and 6-minute walking distance
- Significantly greater mean change in quality of life score at 4, 8, and 12 weeks
Although not significant, the qili qiangxin group had fewer adverse events compared with placebo (66 versus 98), as well as fewer serious adverse events (12 versus 22).
Traditional Chinese medicine says the primary cause of heart failure is heart Yang deficiency that results from Qi inadequacy and blood stasis, the authors reported.
Western researchers, such as Nathan Bryan, PhD, an assistant professor of molecular medicine at the UT Health Science Center at Houston, suspect that Qi is nitric oxide.
“If you can restore nitric oxide production in the human body, you can restore this fundamental spirit of Qi, which they describe in the paper is what opens up the blood vessels, protects the heart, and is a positive inotrope for the heart,” Bryan told MedPage Today.
Qili qiangxin has been approved by the China Food and Drug Administration for use in chronic heart failure, but the evidence supporting its efficacy remains unclear, researchers said.
Li and colleagues therefore randomized 512 chronic heart failure patients on a 1:1 ratio to receive four capsules of qili qiangxin or placebo three times a day for 12 weeks, in addition to standard of care.
The mean age of patients was 57 and 75% were male. The mean duration of disease was about 6.5 years, and the mean blood pressure was 120/77 mmHg. A majority (56%) of patients had non-ischemic heart failure.
Another key finding was that both randomized groups exhibited significant reductions of NT-proBNP levels at 12 weeks, but the qili qiangxin capsule group demonstrated a significantly greater reduction than the placebo group (P=0.002).
“As few pharmacologic therapeutics have crossed the threshold in delivering much-needed breakthroughs in the field of heart failure over the past decades, the investigators should be congratulated in conducting a rigorous clinical trial that encompasses all the elements of an objective scientific evaluation of this traditional Chinese medicine patent drug,” wrote W. H. Wilson Tang, MD and Yanming Huang, MD PhD, from the Cleveland Clinic, in an accompanying editorial.
“Our data suggest that qili qiangxin capsules could be used in combination therapy for heart failure,” the investigators concluded.
They cautioned, however, that a “large, randomized, controlled study using all-cause mortality as the endpoint is needed to test the hypothesis” … that long-term treatment improves prognosis.
The study was supported by the 973 Program of China and the Priority Academic Program Development of Jiangsu Higher Education Institutions.
Li received research grants from Shijiazhuang Yiling Pharmaceutical. The other authors reported no conflicts of interest.
From the American Heart Association: