Introduction

Shensong Yangxin Capsule (SSYX) is a famous traditional Chinese patent medicine produced in China for the treatment of arrhythmia. Recently, China released a series of randomized controlled trials (RCTs) using SSYX combined with antiarrhythmic drugs (ADs) for the treatment of paroxysmal atrial fibrillation (PAF). However, these RCTs have not been systematically evaluated. The purpose of this review was to assess the effectiveness and safety of SSYX combined with AD (SSYX-AD) in the treatment of PAF.

Methods

RCTs of SSYX-AD in the treatment of PAF were collected by searching the Chinese Knowledge Infrastructure Database (CNKI), PubMed, Chinese Scientific Journal Database (VIP), Wanfang Database, Cochrane Library, China Biomedical Database Network (CBM), Excerpt Medica Database (EMBASE), and clinical trial platforms such as the UK National Research Registry (NRR), the World Health Organization Clinical Trial Registry (ICTRP), and the Chinese Clinical Trial Registry (CCTR) from its creation until July 1, 2023. The primary outcome was the effective rate. The secondary outcomes were the frequency of atrial fibrillation (FAF), left atrial diameter (LAD), P wave dispersion (PWD), adverse reactions (ADRs), left ventricular ejection fraction (LVEF), and sinus rhythm maintenance rate (SRMR). The quality assessment of RCTs was completed using the Cochrane risk-of-bias tool, and the meta-analysis was completed using RevMan 5.3 software. This review was conducted in accordance with the PROSPERO-registered protocol (number: CRD42023413442).

Results

The review included a total of 29 RCTs including 2766 patients. The review showed that the SSYX-AD group had more advantages than AD group in improving the effective rate [RR=1.18; 95 % CI (1.12, 1.24); p < 0.01], LVEF [MD =3.40; 95 % CI (0.91, 5.88); p = 0.007], SRMA [RR=1.38; 95 % CI (1.22, 1.57); p < 0.01], and was superior to AD alone in reducing the FAF [MD=2.89; 95 % CI (1.57, 4.21); p < 0.01], LAD [MD=2.44; 95 % CI (0.85, 4.03); p < 0.01], PWD [MD = 4.90; 95 % CI (2.81, 6.99); p < 0.05], and ADRs [RR=0.41; 95 % CI (0.29, 0.58); p < 0.01].

Conclusions

Despite the apparently positive outcomes presented, due to the low methodological quality of the included RCTs there was insufficient evidence to recommend routine use of SSYX-AD for PAF. The aggregate effect must be validated by additional well-designed, adequately sampled, and methodologically sound clinical studies.