Echocardiographic Evaluation of Qiangxin Decoction Combined with Cardiac Resynchronization Therapy for Patients with Chronic Heart Failure

Wei Yunfeng (卫云峰), Guo Daoning (郭道宁), Zou Xiaopan (邹晓攀), Ding Qian (丁倩)

Department of Ultrasound, Mianyang Central Hospital, Mianyang 621000, China

ABSTRACT OBJECTIVE: To explore the echocardiographic evaluation of patients with chronic heart failure (CHF) after Qiangxin Decoction combined with cardiac resynchronization therapy. METHODS: A total of 140 CHF patients admitted to our hospital were randomly divided into combined group (Qiangxin Decoction and cardiac resynchronization,n = 70) and routine group (cardiac resynchronization, n = 70), and they were treated for 2 courses (16 weeks), with 8 weeks as a course. The improvement of heart function classification (HYHA) was observed before and after treatment,and the therapeutic effects were evaluated according to the improvement of heart function classification (markedly effective, effective, invalid, and worsening). The traditional Chinese medicine (TCM) diagnostic criteria was the main symptoms (0 to 6 points), secondary symptoms (0 to 3 points), tongue picture (0 to 1 point) and pulse condition (0 to 1 point), and the higher the score was, the more obvious the symptoms were. The left ventricular end-diastolic diameter(LVEDD), left ventricular end-systolic diameter (LVESD), left ventricular ejection fraction (LVEF) and cardiac output(CO) were observed and recorded according to the heart color ultrasound before and after treatment. And the Minnesota Living with Heart Failure Questionnaire (MLHFQ) was used to evaluate the life quality before and after treatment, and the highest score of the scale was 105 points. The higher the score was, the obvious the symptoms were, and the worse the life quality was. And the adverse reactions were recorded in the 2 groups. RESULTS: After the treatment, the total effective rate in the routine group was significantly lower than that in the combined group (75.71% vs. 94.30%), and there was statistically significant difference (P ＜ 0.05). After the treatment, the TCM syndrome score in the routine group was higher than that in the combined group ((14.37±3.59) points vs. (10.53±3.11) points), and there was statistically significant difference (P ＜ 0.05). After the treatment, the levels of LVEDD and LVESD in the routine group were higher than those in the combined group, and there were statistically significant differences (P ＜ 0.05). The levels of LVEF and CO in the routine group were lower than those in the combined group, and there were statistically significant differences(P ＜ 0.05). After the treatment, the score of MLHFQ scale in the routine group was higher than that in the combined group ((57.38±8.53) points vs. (46.39±7.14) points), and there was statistically significant difference (P ＜ 0.05).CONCLUSION: Qiangxin Decoction combined with cardiac resynchronization therapy has good echocardiographic evaluation in patients with chronic heart failure.

KEYWORDS: Qiangxin Decoction; Cardiac resynchronization therapy; Chronic heart failure; Echocardiogram;TCM syndrome score

Chronic heart failure (CHF) refers to primary myocardiopathy and ventricular overload caused by prolonged excessive pressure or volume, which weaken the myocardial contractility, failing to continuously maintain cardiac output. CHF is a kind of clinical syndrome, whose main manifestations are dyspnea, fatigue, fluid retention and so on. It occurs in all comparatively serious stages of heart disease, with poor prognosis, high clinical incidence and high mortality, and is a key difficulty in medical clinical research[1]. According to research and investigation,the incidence of CHF is positively correlated with the age of patients, and the older the patient is, the higher the incidence will be. In the population over 50 years old, the incidence will be doubled for every 10 years of age. And the therapeutic effects are not obvious in the elderly and they are prone to repeated attacks due to the continuous decline of their various body metabolic levels[2]. Traditional Chinese medicine has its unique views on the study of chronic diseases. In this study, the self-designed Qiangxin Decoction combined with cardiac resynchronization therapy was used to treat patients with CHF in our hospital,which achieved good efficacy. The results are reported as follows.

MATERIALS AND METHODS

General materials

A total of 140 patients with CHF admitted to our hospital from August 2014 to February 2017 were selected and randomly divided into combined group (Qiangxin Decoction and cardiac resynchronization, n = 70) and routine group (cardiac resynchronization, n = 70). In the combined group, there were 37 males and 33 females aged from 65 to 80 years, with an average age of (71.23±5.67)years, and their course of disease was 4 to 10 years, with(6.3±3.1) years on average. Complications: 33 cases with coronary heart disease, 21 cases with diabetes, and 16 cases with hypertension. Heart function classification(HYHA): 46 cases of level Ⅱ, and 24 cases of level Ⅲ. In the routine group, there were 38 males and 32 females aged from 65 to 80 years, with an average age of (70.98±5.44)years, and their course of disease was 4 to 10 years, with(6.5±2.9) years on average. Complications: 31 cases with coronary heart disease, 25 cases with diabetes, and 14 cases with hypertension. Heart function classification(HYHA): 43 cases of level Ⅱ, and 27 cases of levelⅢ. There was no significant difference in general data between the 2 groups (P ＞ 0.05).

Diagnostic criteria Diagnostic criteria of western medicine

According to the 2014 guidelines for the diagnosis of CHF[3]: (1) shortness of breath, dyspnea, fatigue and fluid retention occur during rest or exercise; (2) left ventricular enlargement, increase in left ventricular endsystolic volume, and LVEF (40% and below) under heart color ultrasound; (3) in accordance with the American New York heart association (HYHA) heart function classification level Ⅱ-Ⅲ; (4) abnormal heart structure and function in imaging examination; (5) CNF manifestations in electrocardiogram.

Diagnostic criteria of TCM

According to the expert consensus of the integrated Chinese and Western medicine diagnosis and treatment on CHF[4], main symptoms: (1) chest pain, shortness of breath, palpitation; (2) lower limbs edema; (3) blued veins standing out in the neck or a lump under the ribside. Secondary symptoms: (1) poor spirit, fatigue, cough and panting; (2) symptoms aggravation after exercise; (3)dim complexion, purple lips, cyanosis of fingers (toes).Tongue picture: purple and dusky tongue, with stasis spots and stasis macules. Pulse condition: rough, knotted or intermittent pulse. Diagnostic criteria: 2 or more main symptoms; 1 main symptom with 2 or more secondary symptoms, taking tongue picture and pulse condition for diagnostic 参考文献.

Inclusion criteria and exclusion criteria

Inclusion criteria: (1) in line with the diagnostic criteria of Chinese and western medicine, and diagnosed as CHF patients; (2) patients aged between 60 and 80 years old; (3) before admission, the patients had taken conventional western medicine, and could not start the treatment until they were in stable physical condition for 2 weeks under drug quantification circumstances; (4) no TCM treatment before admission; otherwise, stop it for 1 week before treatment; (5) patients and their families all had informed consent and volunteered to participate in the study; (6) the study was approved by the medical ethics committee of our hospital, and relevant documents were signed. Exclusion criteria: (1) discordant with the diagnostic criteria of Chinese and western medicine in this study; (2) myocardial infarction occurred recently(within 8 weeks); (3) heart surgery was operated recently(within 12 weeks); (4) patients with serious liver, kidney and lung dysfunction, diseases of the blood system,malignant tumors and infections, etc; (5) patients with mental disorders who were not able to cooperate with the treatment; (6) allergic to medicines.

Therapeutic methods

The routine group was treated with cardiac resynchronization. The combined group was treated with Qiangxin Decoction on the basis of the treatment group.There were 8 weeks in 1 course, and both groups were treated for 2 courses, a total of 16 weeks.

Cardiac resynchronization therapy

A color ultrasound diagnostic apparatus (model:Philips EPIQ7C) was used, and the patient was in the left lateral position for surgery. A dual-chamber pacemaker was implanted into the patient's chest, and a cardiac defibrillator was implanted according to the patient's condition.

Qiangxin Decoction

Formula: Herba Leonuri 25 g, Poria, Radix et Rhizoma Salviae Miltiorrhizae, Rhizoma Chuanxiong,Radix Codonopsis, and Radix Astragali 15 g respectively,Radix Aconiti Lateralis Praeparata and Fructus Crataegi 12 g respectively, Ramulus Cinnamomi and Rhizoma Zingiberis 10 g respectively. Decoction method: the herbs were soaked for 15 minutes in cold water, boiled to boiling with high heat, then slowly simmered for 20 to 30 minutes with a small fire. The patient was given 1 dose per day, once in the morning and once in the evening, and 200 mL each time.

Observation index Efficacy evaluation criteria for heart function

The improvement of heart function classification(HYHA) in the 2 groups was observed before and after treatment. The therapeutic effects were evaluated according to the improvement of heart function classification. Among them, markedly effective: the heart function reached levelⅠ or increased more than 2 levels, and the symptoms of CHF were basically relieved; effective: the heart function increased 1 level, but less than 2 levels; invalid: no change in heart function classification; worsening: the heart function classification worsened 1 level or more. The total effective rate = (markedly effective + effective) / (invalid +worsening) × 100%.

TCM syndrome score

According to the s cores of main symptoms,secondary symptoms, tongue picture, and pulse condition in the diagnostic criteria of TCM, the main symptoms were classified by severity: 0 point for no symptoms,2 points for mild symptoms, 4 points for moderate symptoms, 6 points for severe symptoms; the secondary symptoms were classified by severity: 0 point for no symptoms, 1 point for mild symptoms, 2 points for moderate symptoms, 3 points for severe symptoms;tongue picture and pulse condition were scored: 1 point for abnormity, and 0 point for no abnormities.

Heart color ultrasound condition

Heart function was measured by color Doppler ultrasound diagnostic apparatus for heart color ultrasound before and after treatment. LVEDD, LVESD, LVEF and CO were measured and recorded. To reduce the measuring error,each measurement was operated by the same physician.

Life quality

The life quality was assessed by using the MLHFQ[5], which contained 21 items related to symptoms and signs of heart failure, grading from 0 to 5 points, with full score of 105. The higher the score was, the obvious the symptoms were, and the worse the life quality was.

Statistical methods

Statistical software SPSS 19.0 was used to process data, the measurement data were expressed by (x¯±s),the enumeration data was expressed by percentages,and analyzed by χ2test, and the t-test was used for comparison between groups. P ＜ 0.05 was considered as that there was statistically significant difference.

RESULTS

Efficacy evaluation for heart function

After the treatment, the total effective rate was 75.71% in the routine group, which was significantly lower than that of the combined group (94.30%). The difference was statistically significant (P ＜ 0.05). See Table 1.

TCM syndrome score

There was no significant difference in the TCM syndrome scores between the 2 groups before the treatment(P ＞ 0.05). After the treatment, the TCM syndrome scores of the 2 groups were significantly different (P ＜ 0.05). After the treatment, the TCM syndrome score of the routine group was (14.37±3.59), higher than that of the combined group (10.53±3.11), and the difference was statistically significant (P ＜ 0.05). See Table 2.

Heart color ultrasound condition

LVEDD, LVESD, LVEF and CO of the 2 groups before the treatment were compared, with no statistically significant difference (P ＞ 0.05). LVEDD, LVESD, LVEF and CO of the 2 groups after the treatment were compared,with statistically significant differences (P ＜ 0.05). After the treatment, LVEDD and LVESD in the routine group were higher than those in the combined group, with statistically significant differences (P ＜ 0.05); LVEF and CO in the routine group were lower than those in the combined group, with statistically significant differences (P ＜ 0.05).See Table 3.

Table 1. Comparison on evaluation of therapeutic effects of heart function in the 2 groups after the treatment (n (%))

Table 2. Comparison on TCM syndrome scores of the 2 groups before and after treatment (x-±S)

Life quality

There was no statistically significant difference in the MLHFQ scores between the 2 groups before the treatment(P ＞ 0.05). After the treatment, the MLHFQ scores were significantly different from those before the treatment (P ＜0.05). After the treatment, the MLHFQ score in the routine group was (57.38±8.53), higher than that in the combined group (46.39±7.14), and the difference was statistically significant (P ＜ 0.05). See Table 4.

Adverse reactions

Before, during and after the treatment, the blood,urine, stool routine, liver and kidney function and electrolytes were examined. The results showed no deterioration when compared with before treatment. The patients with Qiangxin Decoction were well tolerated. No serious adverse reactions occurred in the 2 groups.

DISCUSSION

TCM has a long history in the treatment of chronic diseases. According to the symptoms related to CHF, it is classified into the categories of palpitations, edema, heart impediment, panting syndrome, etc. The concept of heart failure was first proposed in the Important Formulas Worth a Thousand Gold Pieces for Emergency - the Heart Phylum,which was described as "heart failure leading to hidden pulse"[6]. In the Han Dynasty, Zhang Zhongjing's Essentials from the Golden Cabinet - Water Pathogen Diseases described in detail the edema and accompanying symptoms caused by heart water[7]. In the Qing Dynasty, Tang Zonghai's Treatise on Blood Syndromes also described accumulated blood causing blood stasis, blood stasis causing water metabolic disorders, and then leading to water retention in the epigastrium[8]. According to the relevant ancient Chinese classics, CHF is mainly caused by yang deficiency in the body, which is a syndrome of deficiency-excess complex.Heart yang is deficient, failing to nourish blood, and the blood accumulates in the vessels to form blood stasis,which leads to water retention. On the contrary, blood stasis and water retention can also lead to yang deficiency, and the recurring condition continues to worsen the disease[9].Treating CHF, TCM therapies of reinforcing healthy qi and dispelling pathogen, boosting qi and warming yang, as well as treating deficiency and excess simultaneously, assisting by draining water and dispersing edema, as well as dispelling stasis and invigoration blood should be used[10].

Table 4. Comparison on MLHFQ scores of the 2 groups before and after treatment (x-±S, score)

Table 3. Comparison on heart color ultrasound conditions of the 2 groups before and after treatment (x-±S)

In this paper, according to the traditional medical classics, the self-made Qiangxin Decoction is used to treat CHF. The formula is as follows: Radix Aconiti Lateralis Praeparata is characterized by mild flavor and exuberant qi, great heat and great acridity, entering heart, kidney and spleen channels, warming the kidney and supplementing yang, and pure yang medicine; Rhizoma Zingiberis is also characterized by acridity and heat, dispersing cold of channels, promoting the flow of heart yang, moving qi and blood, as well as dispelling cold and dispersing exterior pathogens; Herba Leonuri is characterized by acridity and bitterness, mild cold, acridity dispersing and bitterness discharging, invigorating blood without damage to new blood, nourishing blood without blood stasis, dissolving stasis to promote regeneration, and draining water to disperse edema; Radix et Rhizoma Salviae Miltiorrhizae is characterized by bitterness and cold, invigorating blood and dissolving stasis, as well as supplementing qi and boosting blood; Fructus Crataegi is characterized by sour and sweet, mild warm, moving qi and dissipating stasis, as well as removing turbidity and lowering lipid; Rhizoma Chuanxiong is characterized by acridity and warm, aromatic qi ascending and dispersing,invigorating blood and moving qi, as well as dispelling wind and relieving pain; the combination of Poria and Ramulus Cinnamomi can transform qi and promote the flow of yang, in order to discharge cold water from the bottom of the body; the combination of Radix Codonopsis and Radix Astragali can supplement the center and boost qi, as well as promote fluid production and nourish blood.The combination of all medicinals can warm yang and drain water, as well as rectify qi and invigorate blood.

In this study, patients with CHF were treated with Qiangxin Decoction combined with cardiac resynchronization therapy. Compared with the patients who were only given cardiac resynchronization therapy,the total effective rate in the combined group was 94.30%,which was significantly higher than that in the routine group 75.71%. After the treatment, the TCM syndrome score in the combined group was (10.53±3.11), which was lower than that in the routine group (14.37±3.59). In the heart color ultrasound, the LVEDD and LVESD in the combined group were lower than those in the routine group; the LVEF and CO were higher than those in the routine group; and the MLHFQ score in the combined group was (46.39±7.14),lower than that in the routine group (57.38±8.53). The differences were statistically significant (P ＜ 0.05). This is basically consistent with the research results of Gao Deju and others on CHF with Huoxue Qiangxin Decoction[11],and is basically consistent with the results of Yao Yuan and others on CHF with Buyi Qiangxin Pills[12].

In summary, the use of Qiangxin Decoction combined with cardiac resynchronization therapy in patients with CHF can improve the therapeutic effects, reduce the score of TCM syndrome, effectively control the aggravation of patient's condition and improve the life quality.