Efficacy and Safety of Fuzi Formulae on the Treatment of Heart Failure as Complementary Therapy: A Systematic Review and Meta-Analysis of High-Quality Randomized Controlled Trials

Table 1

Basic characteristics of the included studies.

Included trial	Publication language	Study design and investigational sites	Type of HF	No. of participants (male/female; age years)		Intervention		Outcome index	Intergroup difference
				Experimental	Control	Experimental	Control
Huo et al. [19]	Chinese	RCT, multicenter, China	CHF	26/34; 18–75; 64.55 ± 7.33	31/28, 18–75; 61.95 ± 8.92	CHFST plus Huaxinsu granules (11 g, tid) plus placebo (0.125 mg qd) for 4 weeks	CHFST plus placebo (11 g, tid) plus DT (0.125 mg qd) for 4 weeks	(1) Efficacy on western medicinal symptoms; (2) Efficacy of TCM symptoms; (3) Adverse event	(1); (2); (3)
Zou [18]	Chinese	RCT, single-center, China	CHF	21/29; 63 ± 8.2	23/27; 64 ± 6.6	CHFST plus Nuanxin capsules (1.35 g tid); for 6 months	CHFST for 6 months	(1) NYHAfc; (2) Efficacy on TCM symptoms; (3) Readmission; (4) LVEF and LVED; (5) 6MWD; (6) NT-proBNP; (7) Adverse events	(1); (2); (3); (4); (5); (6); (7) —
Liu et al. [20]	Chinese	RCT, single-center, China	DHF	23/18; 67.7 ± 8.1	39/24; 66.1 ± 8.8	CHFST plus Nuanxin capsules (1.35 g tid) for 9 months	CHFST plus placebo (1.35 g tid) for 9 months	(1) Efficacy on NYHAfc; (2) TCM symptom scores; (3) Readmission and death; (4) 6MWD; (5) Adverse events	(1); (2); (3); (4); (5) —
Wang [21]	Chinese	RCT, single-center, China	CHF	14/16; 52–75; 72.33 ± 6.013	20/10; 40–75; 61.67 ± 10.949	CHFST plus Tongyang Huoxue decoction (9 g bid) for 3 weeks	CHFST for 3 weeks	(1) Efficacy on TCM symptoms; (2) TCM symptom scores; (3) Efficacy of NYHAfc; (4) Efficacy on LHFs; (5) TCM symptom scores; (6) Efficacy on 6MWT and 6MWD; (7) LVEF; (8) NT-proBNP; (9) MLHFQs; (10) MOS SF-36 scores; (11) BP and HR; (12) Safety and adverse events	(1); (2); (3); (4); (5); (6); (7); (8); (9); (10); (11); (12)
Cao et al. [22]	Chinese	RCT, single-center, China	CHF	Total: 39/61; 36–77/25–82; 66.04 ± 9.01/65.10 ± 8.74		CHFST plus Kangshuai decoction (10 ml tid) plus DT (0.125 mg qd) for 14 days	CHFST plus placebo (10 ml tid) plus DT (0.125 mg qd) for 14 days	(1) Efficacy on LHFs; (2) Efficacy on NYHAfc; (3) Efficacy on TCM symptoms; (4) LVED/LVEF/SV	(1); (2); (3); (4)
Zou et al. [23]	Chinese	RCT, single-center, China	CHF	32/39; 69.35 ± 1(2) 26	37/36; 70.06 ± 10.32	CHFST plus Nuanxin capsules (1.35 g tid) for 24 weeks	CHFST plus placebo capsule (1.35 g tid) for 24 weeks	(1) Efficacy on TCM symptoms; (2) Efficacy on NYHAfc; (3) MLHFQs; (4) LVEF; (5) Readmission; (6) Death; (7) Safety	(1); (2); (3); (4); (4); (6); (7) —
Li et al. [24]	English	RCT, multicenter, China	CHF	182/62; 56.98 ± 11.59	188/59; 57.53 ± 11.05	CHFST plus qili qiangxin capsule (4 granules tid) for 12 weeks	CHFST plus placebo capsules (4 granules tid) for 12 weeks	(1) NT-proBNP; (2) CCEs; (3) NYHAfc; (4) LVEF/LVED; (5) 6MWD; (6) MLHFQs; (7) Adverse event(s)	(1); (2); (3); (4); (5); (6); (7)
Dong [25]	Chinese	RCT, single-center, China	CHF	30/24; 45–74; 60.38 ± 5.41	29/24; 49–75; 59.92 ± 5.41	CHFST plus Shenfu cardiac pill (2 pills tid) for 3 months	CHFST for 3 months	(1) TCM symptom scores; (2) Efficacy on TCM symptoms; (3) Lee’s heart failure scores; (4) Efficacy on heart failure scores; (5) NYHAfc; (6) MLHFQs; (7) LVEF and LVED; (8) NT-proBNP; (9) 6MWD; (10) Safety	(1).; (2); (3); (4); (5); (6); (7); (8); (9); (10) —
Li et al. [26]	Chinese	RCT, single-center, China	CHF	13/17; 30–85; 61.45 ± 4.55	15/15; 32–83; 60.65 ± 4.35	CHFST plus Baoyuan Shipi decoction (one dose qd) for 1 weeks	CHFST for 1 weeks	(1) Efficacy on TCM symptoms; (2) Efficacy on NYHAfc; (3) NT-proBNP; (4) Safety	(1); (2); (3); (4) —
Wei [27]	Chinese	RCT, single-center, China	DHF/SHF	20/31; 74.33 ± 5.40	24/26; 75.84 ± 4.02	CHFST plus Shenfu Jiuxin decoction (130 ml tid) for 10 days	CHFST for 10 days	(1) TCM symptom scores; (2) Efficacy on TCM symptoms; (3) Efficacy on NYHAfc; (4) Lee’s heart failure scores; (5) Efficacy on LHFs; (6) NT-proBNP	(1); (2); (3); (4); (5); (6)
Zhu [28]	Chinese	RCT, single-center, China	SHF	14/16; 56.43 ± 9.85	13/17; 56.37 ± 10.01	CHFST plus Yiqi qiangxin decoction (150 ml bid) for 2 weeks	CHFST for 2 weeks	(1) Efficacy on NYHAfc; (2) TCM symptom scores; (3) Efficacy on TCM symptoms; (4) MLHFQs; (5) LVEF; (6) NT-proBNP; (7) 6MWT; (8) Safety	(1); (2); (3); (4); (5); (6); (7); (8) —
Wang et al. [29]	English	RCT, multicenter, China	CHF	42/32; 68.58 ± 8.42	48/22; 68.14 ± 8.73	CHFST plus SFJ for 7 ± 1 days	CHFST plus placebo for 7 ± 1 days	(1) Efficacy of NYHAfc; (2) Efficacy of TCM syndrome scores; (3) Efficiency of LHFs; (4) 6MED; (5) LVEF; (6) Death; (7) Safety; (8) Laboratory indexes	(1); (2); (3); (4); (5); (6); (7); (8)

RCT = randomized controlled trial; CHF = chronic heart failure; SHF = systolic heart failure; DSH = diastolic heart failure; CHFST = standard treatment of heart failure; DT = digoxin tablets; SFD = Shenfu decoction; SFJ = Shenfu injection; NYHAfc = NYHA functional classification; LHFs = Lee’s heart failure scores; MLHFQs = Minnesota Living with Heart Failure Questionnaire scores; CCEs = composite cardiac events.