Systematic Review of Compound Danshen Dropping Pill: A Chinese Patent Medicine for Acute Myocardial Infarction

Table 4

GRADE analysis: summary of findings for the main comparison.

Compound Danshen dropping pill versus no intervention for acute myocardial infarction
Patient or population: patients with acute myocardial infarction
Settings: inpatients and outpatients
Intervention: compound Danshen dropping pill (CDDP)
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect; (95% CI)	None of Participants; (studies)	Quality of the evidence; (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	CDDP
All-cause mortality; Follow-up: 4 weeks–12 months	Study population		RR 0.65; (0.37–1.14)	945; (4 studies)	⊕ ⊕⊝ ⊝; low^1,2
	63 per 1000	41 per 1000; (23–72)
	Moderate
	104 per 1000	68 per 1000; (38–119)
Cardiac mortality; Follow-up: 3–12 months	Study population		RR 0.43; (0.2–0.95)	309; (2 studies)	⊕ ⊕⊕ ⊝; moderate^3,4
	127 per 1000	55 per 1000; (25–121)
	Moderate
	127 per 1000	55 per 1000; (25–121)
Recurrent myocardial infarction; Follow-up: mean 12 months	Study population		RR 0.30; (0.07–1.38)	146; (1 study)	⊕ ⊕⊝ ⊝; low^5
	100 per 1000	30 per 1000; (7–138)
	Moderate
	100 per 1000	30 per 1000; (7–138)
Heart failure; Follow-up: 4 weeks–12 months	Study population		RR 0.41; (0.22–0.75)	782; (3 studies)	⊕ ⊕⊕ ⊝; moderate^1
	85 per 1000	35 per 1000; (19–64)
	Moderate
	150 per 1000	62 per 1000; (33–112)
Recurrent angina; Clinical diagnosis based on patients complaint; Follow-up: 4 weeks–30 days	Study population		RR 0.33; (0.1–1.03)	636; (2 studies)	⊕ ⊕⊝ ⊝; low^1,6,7
	211 per 1000	70 per 1000; (21–217)
	Moderate
	201 per 1000	66 per 1000; (20–207)
Left ventricular ejection fraction; Measured with echocardiogram. Scale from 30% to 75%.; Duration of treatment: 4–6 weeks	The mean left ventricular ejection fraction in the control groups was 50.48%^9	The mean left ventricular ejection fraction in the intervention groups was 5.71% higher; (4.38%–7.04% higher)		590; (2 studies)	⊕ ⊕⊝ ⊝; low^1,8	Higher score indicates; improvement
Left ventricular ejection fraction; Measured with echocardiogram. Scale from: 30%–75%.; Duration of treatment: 6–12 months	The mean left ventricular ejection fraction in the control groups was 49.71%^9	The mean left ventricular ejection fraction in the intervention groups was 3.82% higher; (2.46%–5.19% higher)		191; (2 studies)	⊕ ⊕⊝ ⊝; low^3,8	Higher score indicates; improvement

∗The basis for the assumed risk (e.g., the median control group risk across studies) is provided in footnotes. 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.
¹One study had selective reporting. For the other studies, the overall risk of bias was felt to be unclear.
²95%CI includes possibility of both benefits and harms, and the sample size was not the optimal information size. After sensitive analysis excluding the lower quality study, the result suggested benefit, but the sample size was still small.
³The overall risk of bias of the studies was unclear. The sample size was not the optimal information size.
⁴95%CI included only benefit, so we were cautious about downgrading the imprecision although the sample size was less than the optimal information size.
⁵Unclear risk of bias and only 146 patients enrolled. 95%CI included possibility of both benefits and harms.
⁶The heterogeneity (𝐼² = 61%) can be explained by the major differences of conventional therapy and sample size between the two studies, and this outcome is not so important to affect the decision-making; therefore, we did not downgrade for this factor.
⁷95%CI suggested benefit as well as no benefit.
⁸This is an indirect outcome for AMI patients.
⁹Final measurements at the end of the study.