Adverse events associated with a patent Traditional Chinese Medicine (Shufeng Jiedu Capsule) in clinical practice: a systematic review and meta-analysis of randomized controlled trials
Shufeng Jiedu capsule (SFJD) is a traditional Chinese herbal medicine made from eight Chinese herbs which is widely used for upper respiratory tract infections, which has been on the market in China since 2009. Although there is some promising evidence on effectiveness of SFJD, there is lack of the evidence on its safety in clinical practice. This systematic review focuses on adverse events (AEs) caused by using SFJD to evaluate its safety.
Randomized controlled trials (RCTs) reporting AEs of SFJD were included in this study. PubMed, Science Direct, MEDLINE, EMBASE, Web of Science, EMBASE, China National Knowledge Infrastructure (CNKI), Wan Fang, Sino-Med Database, and Chinese Science and Technology Journal Database (VIP) were searched from inception to August 2019. Two reviewers selected and screened studies and extracted data independently. The outcome focused on adverse events of using SFJD. Effect size measures were mean differences (MD), standardized mean differences (SMD), or risk ratios with 95% credible intervals (CIs). This study protocol was registered under PROSPERO, number CRD42019149389.
No serious safety events were identified on the SFJD formula itself. Minor AEs included nausea, vomiting and diarrhea, as well as other unspecified gastrointestinal discomfort, dizziness and rash. However, there were no statistical differences in the AEs between SFJD and the control groups. There was no difference between SFJD + usual care and usual care as measured by the number of AEs in respiratory conditions (RR 0.85, 95% CI [0.51, 1.42]; P=0.45, I2=0%, studies=33, participants=5710) or in other conditions (RR 0.85, 95% CI [0.51, 1.42]; P=0.97, I2=0%, studies=14, participants=2360). Similarly, there was no difference between SFJD and usual care as measured by the number of AEs in either respiratory conditions (RR 0.66, 95% CI [0.27, 1.1]; P=0.98, I2=0%, studies=7, participants=1339) or in other conditions (RR 2.50, 95% CI [0.49, 12.65]; P=0.44, I2=0%, studies=2, participants=240). One trial which compared SFJD to placebo reported no adverse events in either group.
No serious safety event was identified. Minor AEs included nausea and vomiting as the most common AEs, however, there is limited evidence showing these AEs were directly related to the SFJD treatment. However, the findings in this study should be interpreted with caution due to limited methodological quality of the included trials. Furthermore, strict trials with precise methodological design and rigorous reporting on safety evaluation of SFJD should be promising.