Research Article

Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome)

Table 1

Comparison of demographic and baseline clinical characteristics of participants between the SFI and placebo groups.

CharacteristicSFI PlaceboStatisticsP value

Basic information
Age (, yrs)68.58±8.4268.14±8.73-0.30420.7610
Gender
 Male n(%)42(56.76%)48(68.57%)2.14240.1433
 Female n(%)32(43.24%)22(31.43%)
Weight (, kg)65.43±13.1066.26±11.820.57440.5657
Height (, cm)164.10±7.30166.00±6.601.630.1052
SBP (, mmHg)132.55±21.89133.27±19.470.26480.7912
DBP (, mmHg)77.26±10.7777.64±11.040.31340.7540
Heart rate (, bpm)86.5±21.676.1±20.0-3.15260.0016
Medical history
Disease course of CHF (, yrs)4.62±6.073.76±3.69-0.42800.6687
Disease course of acute exacerbation (, days)6.08±5.076.94±8.270.18530.8530
History of myocardial infarction n(%)38(52.05%)43(61.43%)1.27850.2582
History of arrhythmia n(%)20(27.03%)19(27.14%)0.00020.9875
History of hypertension n(%)51(70.83%)44(62.86%)1.01970.3126
History of diabetes n(%)26(35.14%)16(22.86%)2.62480.1052
Medication use
Antiplatelet n(%)63 (85.14%)61 (87.14%)0.12120.7277
Beta-blockers n(%)36 (48.65%)44 (62.86%)2.94120.0863
ACE inhibitors n(%)32 (43.24%)35 (50.00%)0.66010.4165
ARB inhibitors n(%)23 (31.08%)19 (27.14%)0.27000.6033
Statins n(%)57 (77.03%)50 (71.43%)0.59050.4422
Nitric acid lipid n(%)44 (59.46%)44 (62.86%)0.17470.6759
Ca-antagonist n(%)18 (24.32%)17 (24.29%)0.00000.9957
Aldosterone receptor antagonist n(%)50 (67.57%)43 (61.43%)0.59270.4414
Diuretics n(%)45 (60.81%)35 (50.00%)1.70270.1919
Digoxin n(%)29 (39.19%)24 (34.29%)0.37190.5420
Clinical index
TCM syndrome score ()24.54±7.9023.37±7.13-1.19020.2340
Lee’s heart failure ()6.36±3.255.71±2.92-1.17870.2385
6MWD (, m)163.28±153.48185.70±143.301.05040.2935
LVEF (, %)38.69±8.5239.82±8.040.71830.4726
NYHA classification
 III n(%)46(62.16%)51(72.86%)1.87150.1713
 IV n(%)28(37.84%)19(27.14%)

P<0.01 compared to control group