Is Qili Qiangxin capsule, a Chinese herbal medicine formula, effective in treating chronic heart failure?
Date of publication of the randomized controlled trial: September 2013
Design
Randomized controlled trial (RCT).
Participants
491 patients (mean age: 57.3 years, male %: 75.4%) with chronic heart failure (CHF) diagnosed according to the 2007 Chinese guideline.
Intervention
4 Qili Qiangxin capsules 3 times a day for 12 weeks. The formula is consist of 11 Chinese herbal medicines: astragali radix, ginseng radix et rhizoma, aconiti lateralis radix preparata, Salvia miltiorrhiza radix et rhizoma, semen descurainiae lepidii, alismatis rhizoma, polygonati odorati rhizoma, cinnamomi ramulus, carthami flos, periploca cortex, and citri reticulatae pericarpium.
Comparator
Comparison: Qili Qiangxin capsule versus placebo.
Major Outcomes
Outcome 1: Percentage reduction in plasma NT-proBNP level;
Outcome 2: Proportion of patients who had reduced NT-proBNP level of at least 30%.
Settings
This trial was performed in an outpatient setting.
Comparison    Qili Qiangxin capsule versus placebo
Main Results
Compared to placebo, CHF patients who were randomized to Qili Qiangxin capsule group had significantly greater reduction in plasma NT-proBNP level (p=0.002). And compared to placebo, significantly greater proportion of patients from Qili Qiangxin capsule group had at least 30% reduction on plasma NT-proBNP level (p<0.001).
Comparison: Qili Qiangxin capsule versus placebo among patients with chronic heart failure
Outcomes (units) No. of studies (Total number of participants) Difference in NT-proBNP (95% CI)/ No. of participants Heterogeneity test (I2) p value Overall quality of evidence*
Intervention Comparator
1 (pg/ml) 1 (491) 240.15 (-23.15 to 1113.85)/ 244 0.00 (-286.00 to 800.00)/ 247 Not applicable as there is only 1 study. 0.002 High
Outcomes No. of studies (Total number of participants) Proportion of patients with NT-proBNP reduction of ≥ 30%/ No. of participants Heterogeneity test (Isuperscript[2]) p value Overall quality of evidence*
2 1 (491) 47.95/ 244 31.98/ 247 Not applicable as there is only 1 study. <0.001 High
Keys: CI= confidence interval.
Comparison    Qili Qiangxin capsule versus placebo
Main Results
Compared to placebo, CHF patients who were randomized to Qili Qiangxin capsule group had significantly greater reduction in plasma NT-proBNP level (p=0.002). And compared to placebo, significantly greater proportion of patients from Qili Qiangxin capsule group had at least 30% reduction on plasma NT-proBNP level (p<0.001).
Comparison: Qili Qiangxin capsule versus placebo among patients with chronic heart failure
Outcomes (units) 1 (pg/ml) Outcomes 2
No. of studies (Total number of participants) 1 (491) No. of studies (Total number of participants) 1 (491)
Difference in NT-proBNP (95% CI)/ No. of participants Intervention 240.15 (-23.15 to 1113.85)/ 244 Proportion of patients with NT-proBNP reduction of ≥ 30%/ No. of participants Intervention 47.95/ 244
Comparator 0.00 (-286.00 to 800.00)/ 247 Comparator 31.98/ 247
p value 0.002 p value <0.001
Overall quality of evidence* High Overall quality of evidence* High
Keys: CI= confidence interval.
Conclusion
Benefits
Compared to placebo, Qili Qiangxin capsule is significantly more effective in reducing plasma NT-proBNP level among CHF patients. For Outcome 1-2, the overall quality of evidence is high. Further research is unlikely to have an important impact on our confidence in this estimate of effect.
Harms
66 cases of adverse event and 12 cases of serious adverse event occurred in the Qili Qiangxin capsule group. 98 cases of adverse event and 22 cases of serious adverse event occurred in placebo group. No serious adverse events reported were found to be related to Qili Qiangxin capsule.
Link to Original Article
https://www.ncbi.nlm.nih.gov/pubmed/23747768
The synopsis is based on the following article:
Li X, Zhang J, Huang J, Ma A, Yang J, Li W, 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. Journal of the American College of Cardiology. 2013 Sep 17;62(12):1065-72.


* Interpretation of quality assessment results:
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.

Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.