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.