Abstract
Background: Shengmai San (SMS) is a traditional Chinese medicine formula used for supplementing Qi and Yin and can mitigate symptoms related to malignant arrhythmia and heart failure. This systematic review aimed at exploring the effectiveness and safety of SMS for viral myocarditis (VMC). Methods: Eight databases from their inception to June 2023 were searched to identified randomized controlled trials (RCTs) focusing on SMS for VMC. The Cochrane Risk of Bias Tool was used to assess methodological quality. Mean difference (MD), standardized mean difference (SMD), and risk ratio (RR) with 95% confidence interval (CI) were calculated and input into the meta-analysis using RevMan 5.4. Results: Forty-four RCTs were included involving 4298 participants. The interventions included 29 types of modified SMS decoctions and 15 patent medicines. Overall study quality was low. Compared with western medicine (WM), SMS was associated with higher recovery rate from palpitations (RR 2.3, 95% CI 1.59, 3.33, 2 RCTs, n = 89), chest pain (RR 1.57, 95% CI [1.17, 2.09], 2 RCTs, n = 89), and lower cTnI (MD -0.82 ng/ml, 95% CI -0.98, -0.66, 1 RCT, n = 60). SMS plus WM was more effective than WM in palpitation recovery rate (RR 1.52, 95% CI 1.21, 1.92, 3 RCTs, n = 136), dyspnea recovery rate (RR 1.47, 95% CI 1.12, 1.94, 3 RCT, n = 267), ECG (RR 1.43, 95% CI 1.32, 1.55, 20 RCT, n = 2035), CK-MB (MD -6.36, 95% CI -8.43, -4.28, 8 RCT, n = 946), and cTnI (MD -0.06, 95% CI -0.06, -0.05, 3 RCT, n = 307). No serious adverse events were reported using SMS alone or in combination with WM. Conclusion: SMS used alone or combined with WM may have potential effectiveness on symptom alleviation, ECG recovery rate, myocardial injury markers, and cardiac function, but the effectiveness is uncertain due to the low quality and absence of placebo-controlled trials. The exact efficacy of SMS for VMC needs to be confirmed by high-quality double-blind RCTs in the future.