Aims To evaluate the efficacy of added treatment with Kanli granule in the patients with chronic heart failure (CHF).
Method 124 patients with CHF were involved in this study, and were divided into group TCM and the Control (both with 62 cases). All the patients received conventional therapy according to the guidelines of AHA/ACC for 24 weeks, and KanLi granule (containing 10 herbal medicines) 40 g day−1 for 24 weeks in addition only in group TCM. The syndrome integration (TCM), 6MWD, LHFQ score, curative efficacy, and withdrawal rates of diuretics and digoxin were observed at 0th, 4th, 8th, 12th and 24th week of treating period, LVEF assessed by echocardiography before and after treatment, the annual mortality and re-hospitalisation due to acute aggravation of heart failure (HF) were recorded as well.
Results The follow-up was accomplished in 109 patients (55 in group TCM, 54 in Control). 3.1. Syndrome integration significantly decreased both in 2 groups since 8th week of treatment (p<0.01), with the advantage in group TCM (p<0.05 or p<0.01). The curative efficacy of syndrome integration had been raised since 4th week in both two groups (p<0.01), and more excellent in group TCM (since 4th week, F=10.703, p<0.01). Therapeutic efficacy on NYHA grade increased since 8th week in group TCM (p<0.01), and the Control, since 12th week (p<0.05), with advantage in group TCM too (since 8th week, p<0.001). The LVEF increased in group TCM after treatment (p<0.05), but in the Control, no obvious change. 3.2. There had been significant increase of 6MWD and decrease of LHFQ score in both group since 4th week (p<0.01), with longer 6MWD (since 8th week, F=13.324, p<0.01) and the lower LHFQ scores (since 4th week, F=44.78, p<0.01) in group TCM. 3.3. The withdraw rate of diuretics (since 8th week, p<0.01) and of digoxin (since 12th week, p<0.01) in group TCM had increased more significantly than that in the group Control. 3.4. The annual re-hospitalisation rate due to acute aggravation of HF in group TCM was lower than that in the Control (p<0.05), so as the annual death (4.84% vs 11.29%), but without statistic difference because of the small case sample.
Conclusion 4.1. The patients with CHF received added treatment with KanLi granule may obtain more benefits as follows: increasing curative efficacy and LVEF, improving exercise tolerance and life quality, reducing use of diuretics and digoxin, reducing annual re-hospitalisation due to acute aggravation, and perhaps annual death as well. 4.2. The multiple advantages of the added therapy with TCM had presented earlier since 4th and lately since 12th week of treating period, so the treating period at least will be 12 weeks. 4.3. To evaluate the efficacy of combination therapy with TCM and conventional treatment on patients with CHF, the evaluating system should include short-term therapeutic efficacy (TCM syndrome integration and NYHA grade), laboratory indices (LVEF, BNP), quality of life (6MWD and LHFQ), the diuretics and digoxin withdrawal rate and long-term indices (annual re-hospitalisation and mortality), then the annual medical cost of CHF if possible.