Evidence-Based Complementary and Alternative Medicine

Review Article

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 6

Statement of facts (SoF) table for secondary outcomes.


Secondary outcomes of the treatment of heart failure as complementary therapy: a systematic review and meta-analysis of high-quality randomized controlled trials

Patient or population: patients with the treatment of heart failure as complementary therapy: a systematic review and meta-analysis of high-quality randomized controlled trials Settings: Intervention: secondary outcomes

Outcomes	Illustrative comparative risks (95% CI)		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Secondary outcomes

NYHA functional classification (NYHAfc) 1982 American New York Heart Association (NYHA) Follow-up: 6–252 days	Study population		RR 1.31 (1.21 to 1.41)	848 (9 studies)	⊕⊕⊕⊝ moderate
	653 per 1000	856 per 1000 (790 to 921)
	Moderate
	733 per 1000	960 per 1000 (887 to 1000)

NYHA functional classification (NYHAfc)-FZF plus CHFST vs CHFST 1982 American New York Heart Association (NYHA) Follow-up: 10–168 days	Study population		RR 1.37 (1.24 to 1.52)	483 (6 studies)	⊕⊕⊝⊝ low
	646 per 1000	885 per 1000 (801 to 982)
	Moderate
	733 per 1000	1000 per 1000 (909 to 1000)

NYHA functional classification (NYHAfc)-FZF plus CHFST vs placebo plus CHFST 1982 American New York Heart Association (NYHA) Follow-up: 6–252 days	Study population		RR 1.22 (1.08 to 1.38)	365 (3 studies)	⊕⊕⊕⊝ moderate
	663 per 1000	809 per 1000 (716 to 915)
	Moderate
	644 per 1000	786 per 1000 (696 to 889)

LVEF Simpson. Scale from 0 to 100 Follow-up: 6–168 days	The mean LVEF ranged across control groups from 28.25 to 46.17 percentage	The mean LVEF in the intervention groups was 0.48 standard deviations higher (0.03 to 0.94 higher)		1088 (7 studies)	⊕⊕⊝⊝ low	SMD 0.48 (0.03 to 0.94)

LVEF-FZF plus CHFST vs CHFST Simpson. Scale from 0 to 100. Follow-up: 14–168 days	The mean LVEF-FZF plus CHFST vs CHFST ranged across control groups from 41.7 to 46.17 percentage	The mean LVEF-FZF plus CHFST vs CHFST in the intervention groups was 0.98 standard deviations higher (0.42 to 1.54 higher)		322 (4 studies)	⊕⊝⊝⊝ very low	SMD 0.98 (0.42 to 1.54)

LVEF-FZF plus CHFST vs placebo plus CHFST Simpson. Scale from 0 to 100. Follow-up: 6–168 days	The mean LVEF-FZF plus CHFST vs placebo plus CHFST ranged across control groups from 28.25 to 39.82 percentage	The mean LVEF-FZF plus CHFST vs placebo plus CHFST in the intervention groups was 0.1 standard deviations lower (0.5 lower to 0.3 higher)		766 (3 studies)	⊕⊕⊕⊝ moderate	SMD −0.1 (−0.5 to 0.3)

6MWD 6MWT. Scale from 0 to 1000. Follow-up: 6–252 days	The mean 6MWD ranged across control groups from 82.99 to 405.97 meter	The mean 6MWD in the intervention groups was 0.55 standard deviations higher (0.39 to 0.72 higher)		1168 (7 studies)	⊕⊕⊕⊝ moderate	SMD 0.55 (0.39 to 0.72)

6MWD-FZF plus CHFST vs CHFST 6MWT. Scale from 0 to 1000 Follow-up: 6–168 days	The mean 6MWD-FZF plus CHFST vs CHFST ranged across control groups from 82.99 to 405.97 meter	The mean 6MWD-FZF plus CHFST vs CHFST in the intervention groups was 0.6 standard deviations higher (0.34 to 0.85 higher)		461 (5 studies)	⊕⊕⊕⊝ moderate	SMD 0.6 (0.34 to 0.85)

6MWD-FZF plus CHFST vs placebo plus CHFST 6MWT. Scale from 0 to 1000. Follow-up: 6–252 days	The mean 6MWD-FZF plus CHFST vs placebo plus CHFST ranged across control groups from 82.99 to 368.08 meter	The mean 6MWD-FZF plus CHFST vs placebo plus CHFST in the intervention groups was 0.52 standard deviations higher (0.25 to 0.78 higher)		707 (3 studies)	⊕⊕⊕⊝ moderate	SMD 0.52 (0.25 to 0.78)

MLHFQ scores and Lee’s heart failure scores Minnesota heart failure quality of life scale. Scale from 0 to 50. Follow-up: 10–84 days	The mean MLHFQ scores and Lee’s heart failure scores ranged across control groups from 1.33 to 43.13 points	The mean MLHFQ scores and Lee’s heart failure scores in the intervention groups was 0.57 standard deviations lower (0.75 to 0.39 lower)		495 (4 studies)	⊕⊕⊕⊝ moderate	SMD −0.57 (−0.75 to −0.39)

MLHFQ scores and Lee’s heart failure scores-MLHFQ scores Minnesota heart failure quality of life scale Follow-up: 14–84 days		The mean MLHFQ scores and Lee’s heart failure scores-MLHFQ scores in the intervention groups was 0.61 standard deviations lower (0.88 to 0.34 lower)		227 (3 studies)	⊕⊕⊝⊝ low¹	SMD −0.61 (−0.88 to −0.34)

MLHFQ scores and Lee’s heart failure scores-Lee's heart failure scores Minnesota heart failure quality of life scale. Scale from 0 to 50. Follow-up: 10–82 days	The mean MLHFQ scores and Lee’s heart failure scores-Lee's heart failure scores ranged across control groups from 1.33 to 6.58 points	The mean MLHFQ scores and Lee’s heart failure scores-Lee's heart failure scores in the intervention groups was 0.53 standard deviations lower (0.78 to 0.29 lower)		268 (3 studies)	⊕⊕⊝⊝ low	SMD −0.53 (−0.78 to −0.29)

CCEs Death and readmission Follow-up: 6–252 days	Study population		RR 0.45 (0.33 to 0.61)	1568 (4 studies)	⊕⊕⊕⊕ high
	130 per 1000	58 per 1000 (43 to 79)
	Moderate
	184 per 1000	83 per 1000 (61 to 112)

CCEs-deaths Death Follow-up: 6–252 days	Study population		RR 0.33 (0.17 to 0.64)	856 (4 studies)	⊕⊕⊕⊕ high
	75 per 1000	25 per 1000 (13 to 48)
	Moderate
	106 per 1000	35 per 1000 (18 to 68)

CCEs-readmission for heart failure Readmission for heart failure Follow-up: 84–252 days	Study population		RR 0.48 (0.34 to 0.67)	712 (3 studies)	⊕⊕⊕⊕ high
	201 per 1000	97 per 1000 (68 to 135)
	Moderate
	447 per 1000	215 per 1000 (152 to 299)

The basis for the assumed risk (e.g., the median control group risk across studies) is provided. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio. GRADE working group grades of evidence: high quality: further research is very unlikely to change our confidence in the estimate of effect; moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate; low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate; very low quality: we are very uncertain about the estimate.