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HEART FAILURE Chinese herbal medicine shows promise in HF in early trial
Nanjing, China - In a randomized trial of more than 500 patients with chronic heart failure, capsules of the Chinese traditional medicine qili qiangxin, a mixture of 11 herbs, appeared to improve natriuretic-peptide levels compared with placebo when added to standard therapy [1]. The 12-week study is published June 4, 2013 in the Journal of the American College of Cardiology.
"The results of our study suggest that qili-qiangxin capsules can markedly reduce N-terminal pro-B-type natriuretic peptide [NT-proBNP] levels, which suggests that patients may receive an improved prognosis with long-term treatment," Dr Xinli Li (Nanjing Medical University, China) and colleagues write. "However, a large, randomized, controlled study using all-cause mortality as the end point is needed to test this hypothesis."
Does this mean that a supplement with qiangxin, which means "strong heart" and has been used for centuries in China, will soon be recommended as a complement to standard heart-failure therapy? This would require more and consistent clinical evidence, but the study does add to testimonial evidence of the efficacy of this herbal mixture, Dr WH Wilson Tang (Cleveland Clinic, OH), coauthor of an accompanying editorial, told heartwire [2].
The situation with Chinese patent medicine is "almost parallel to the turn of the [last] century when we had 'Doctor So and So's Elixir,' " he added. Some traditional Chinese herbal medicines may be beneficial, but there's always a "secret ingredient," which makes them difficult to study.
Li and colleagues made "a very noble attempt . . . to follow the most rigorous methodology to try to study a drug that has been used in traditional Chinese medicine," Tang continued. Despite the trial's definite limitationsâ€â€for example, a surrogate end point rather than hard outcomesâ€â€it's a "welcome first step" and he is "cautiously optimistic" about the findings, he said.
When East meets West
Although the China Food and Drug Administration approved the use of qili-qiangxin capsules for treatment of heart failure in 2004, evidence supporting its efficacy is unclear, the authors write.
To assess whether qili-qiangxin capsules were more effective than placebo, the researchers enrolled 512 patients with chronic HF seen at 23 clinical research centers in China from 2011 to 2012. The patients were aged 18 to 75 years (mean age 57) with NYHA class 2 to 4 heart failure; 75% were men. On average they had had chronic HF for 77.2 months.
The patients were randomized to standard heart-failure medications plus either four capsules of qili qiangxin or placebo three times daily for 12 weeks.
At the study end, patients in the qili-qiangxin group had greater reductions in NT-proBNP plasma levels; moreover, significantly more patients in the treatment group (48%) than in the placebo group (32%) had at least a 30% reduction in levels of this marker.
In addition, patients who received the herbal capsules had greater improvements in NYHA classification, six-minute-walk distance, LVEF, and quality of life compared with patients in the placebo group. There were fewer deaths (four vs seven) and readmissions for worsening HF (eight vs 16) in the patients who received the herbal capsules compared with those who received placebo.
The findings "may have broken the barrier in establishing clinical evidence [that] few traditional Chinese medicine drugs have been able to accomplish," Tang and coauthor Dr Yanming Huang (Cleveland Clinic) write. It is reassuring that no substantial harm was observed in this relatively large sample, although the trial duration was short, they add.
However, there is much that isn't known, Tang said. The active ingredients of qili-qiangxin capsules are unknown, and like other nutraceuticals, the capsules may contain different amounts of these ingredients. Other potential cardiotonic drugs with early promise did not turn out to be beneficial when studied in event-driven trials.
Nevertheless, with these promising results, the researchers have opened the door for further research to "explore how synergistic interactions among active traditional Chinese medicine ingredients can benefit the syndrome of heart failure, [which is] a challenge we should all warmly embrace," the editorialists conclude.
This study was supported by the 973 Program of China and the Priority Academic Program Development of Jiangsu Higher Education Institutions. Shijiazhuang Yiling Pharmaceutical provided research grants to Li and supplied the qili-qiangxin capsules for the study.
Sources
Li X, Zhang J, Huang J, et al. A multicenter randomized double-blind parallel-group placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure. J Am Coll Cardiol 2013; available at: http://content.onlinejacc.org.
Tang WHW, Huangi Y. Cardiotonic modulation in heart failure: Insights from traditional Chinese medicine. J Am Coll Cardiol 2013; available at: http://content.onlinejacc.org.
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