Efficacy and safety of traditional Chinese medicine for acute ischemic stroke by resolving phlegm and unblocking fu-organs: A systematic review and meta-analysis

Many researchers have adopted resolving phlegm and unblocking fu-organs (RPUF) therapy for acute ischemic stroke (AIS) patients and yielded beneficial results in terms of clinical symptoms. However, there has been no systematically pooled analysis of RPUF therapy for AIS to date. Therefore, a well-designed systematic review and meta-analysis is necessary. This systematic review aims to determine the efficacy and safety of traditional Chinese medicine (TCM) therapy for resolving phlegm and unblocking fu-organs (RPUF) for the treatment of acute ischemic stroke (AIS). Eight databases were searched to identify eligible randomized controlled trials (RCTs) involving RPUF therapy for AIS. The primary outcome included the modified Rankin Scale (mRS), and the secondary outcomes were the National Institute of Health Stroke Scale (NIHSS), the Neurological Deficit Score (NDS), Barthel Index (BI), Fugel-Meyer assessment (FMA), and the Glasgow Coma Scale (GCS). The Cochrane Handbook for Systematic Reviews of Interventions was used to assess risk of bias. The quantitative synthesis was analyzed using RevMan 5.3 and Stata 14.0 software. The systematic review and meta-analysis comprised 61 RCTs with a total of 6056 participants. RPUF prescriptions combined with usual care were superior to usual care alone in individuals with AIS, as evidenced by decreased mRS (MD＝－0.34; 95%CI [－0.65, −0.03]; P＝0.03), NIHSS (MD＝－3.38; 95%CI [－4.07, −2.68]; P＜0.00001), and NDS (MD＝－3.65; 95%CI [－4.07, −3.24]; P＜0.00001), as well as improved BI (MD＝10.4; 95%CI [8.21, 12.59]; P＜0.00001), FMA (MD＝20.41; 95%CI [17.40, 23.41]; P＜0.00001), and GCS (MD＝3.08; 95%CI [1.95, 4.20]; P＜0.00001). No significant difference was observed in the incidence of adverse effects between the RPUF therapy group and the usual care group. RPUF therapy appears to be an effective and safe approach for treating AIS; it could decrease mRS, NIHSS, and NDS while improving BI, FMA, and GCS. However, the methodological quality of the included RCTs was far from sufficient, and further high-quality, well-designed RCTs with long-term follow-up are still required.