SUMMARY: 92 elderly patients with acute heart failure (AHF) were randomly divided into control group and treatment group, with 46 subjects in each group. All subject met the diagnostic criteria of AHF according to the “Guidelines for Diagnosis and Treatment of Heart Failure in China (2014) (中國心力衰竭診斷和治療指南2014)”, as well as the diagnostic criteria for AHF due to blood stasis with water retention according to the “Guideline for Clinical Research of Traditional Chinese Medicine New Drugs (中藥新藥臨床研究指導原則)”. There was no significant difference in terms of gender, age, course of disease and underlying causes of AHF between treatment group and control group; therefore, the two groups were statistically comparable (P>0.05).
Subjects in control group and treatment group both received routine treatment for AHF, which included: routine monitor for blood pressure, respiration and pulse, oxygen intake, correct water/electrolyte balance, limit excessive sodium and salt intake, use diuretics, morphine, β blockers, ACEI/ARB and vasodilators accordingly, IV cedilan (0.4mg in 200ml 4% glucose solution), 0.125mg digoxin tablet, and IV levosimendan (12ug/kg of loading dose for 10 minutes, then switched to 0.1ug/(kg.min) for 1 hour and 0.2ug/(kg.min) for 23 hours). Subjects in treatment group also received 200ml of modified Linggui Zhugan Decoction (苓桂朮甘湯加味) twice a day (in the morning and evening); the decoction included the following ingredients: Bai Zhu 30 g (白朮 Rhizoma Atractylodis Macrocephalae), Fu Ling Pi 30g (茯苓皮 Poria), Fu Ling 30g (茯苓 Poria), Gui Zhi 25g (桂枝 Ramulus Cinnamomi), Yi Mu Cao 15g (益母草 Herba Leonuri), Zhu Ling 15g (猪苓 Polyporus Umbellatus), Ma Bian Cao 15mg (馬鞭草 Verbena officinalis), Ze Lan 15g (澤蘭 Herba Lycopi), Ze Xie 15g (澤瀉 Rhizoma Alismatis), and Zhi Gan Cao 6g (炙甘草 Radix Glycyrrhizae Preparata). Course of treatment was 7 days for both groups.
In order to evaluate the efficacy of treatment, the following parameters were monitored: 1) Traditional Chinese Medicine Syndrome Score Scale (TCMSSS), which assessed the severity of palpitations, shortness of breath, chest tightness, chest pain, facial and extremity edema, abdominal distension and oliguria; 2) 24-hour urine output; 3) cardiac function; 4) red blood cell distribution width (RDW) and brain natriuretic peptide (BNP). The result was considered as:
- Markedly Effective: clinical signs and symptoms basically resolved, cardiac function classification improved by > 2 levels, and TCMSSS reduced by > 70%.
- Effective: clinical signs and symptoms improved, cardiac function classification improved by 1 to 2 levels, and TCMSSS reduced by 30% to 69%.
- No Response: No improvement in clinical signs and symptoms, cardiac function classification improved by less than 1 grade, and TCMSSS reduced by < 30%.
Markedly Effective + Effective = Total Effective Rate
Table 1. Comparison of Clinical Efficacy between Treatment Group and Control Group
|Group||n||Markedly Effective||Effective||No Response||Total Effective Rate (%)|
|Treatment||46||27||15||4||42 (91.30) Δ|
After the treatment, TCMSSS, LVESV, LVEDV, BNP, and RDW levels significantly reduced (P<0.05), and 24h urine output and LVEF levels significantly increased in both groups (P< 0.05); the improvement was more significant in the treatment group comparing to the control group (P<0.05). The total effective rate of the treatment group was 91.30%, which was significantly higher than the control group (74.01%) (P<0.05). No serious adverse reaction occurred during the treatment in both treatment and control groups. The result of this study indicates that adding modified Linggui Zhugan Decoction to routine treatment for elderly patients with AHF may safely and effectively improve clinical signs and symptoms, cardiac function, and RDW and BNP levels.
Rong Fang, et al. JETCM. 2021. 30 (7): 1281-1285