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 5

Statement of facts (SoF) table for first outcomes.

Primary 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 Intervention: primary outcomes

OutcomesIllustrative comparative risks (95% CI)Relative effect (95% CI)No. of participants (studies)Quality of the evidence (GRADE)Comments
Assumed riskCorresponding risk
ControlPrimary outcomes

Plasma NT-proBNP level
Enzyme-linked immunosorbent assay. Scale from 1 to 35000.
Follow-up: 10–168 days
The mean plasma NT-proBNP level ranged across control groups from 403.5 to 4455.8 pg/mlThe mean plasma NT-proBNP level in the intervention groups was 1.76 standard deviations lower (2.87 to 0.66 lower)483 (6 studies)⊕⊕⊝⊝ lowSMD −1.76 (−2.87 to −0.66)

Efficacy on TCM
Guiding Principles of clinical Research on new Chinese medicine for heart failure
Follow-up: 6–168 days
Study populationRR 1.37 (1.26 to 1.48)760 (7 studies)⊕⊕⊕⊝ moderate
638 per 1000874 per 1000 (804 to 945)
Moderate
620 per 1000849 per 1000 (781 to 918)

Efficacy on TCMS-FZF plus CHFST vs CHFST
Follow-up: 10–84 days
Study populationRR 1.35 (1.22 to 1.48)472 (5 studies)⊕⊕⊕⊝ moderate
652 per 1000881 per 1000 (796 to 965)
Moderate
620 per 1000837 per 1000 (756 to 918)

Efficacy of TCMS-FZF plus CHFST vs placebo plus CHFST
Follow-up: 6–168 days
Study populationRR 1.42 (1.23 to 1.64)288 (2 studies)⊕⊕⊕⊕ high
615 per 1000874 per 1000 (757 to 1000)
Moderate
615 per 1000873 per 1000 (756 to 1000)

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.