Abstract
BACKGROUND: The influence of butylphthalide on atherosclerotic plaque burden remains underexplored. This pooled analysis was aimed to evaluate its efficacy and safety in carotid atherosclerosis. METHODS: The literature were retrieved in online databases. Carotid intima-media thickness (IMT), plaque size, Crouse score, National Institute of Health Stroke Scale (NIHSS), circulating biomarkers, and drug-related adverse events were extracted and compared between the butylphthalide group and the control group without butylphthalide. RESULTS: Nine randomized controlled trials with 892 subjects were included. Compared with the control group, butylphthalide significantly reduced carotid IMT (MD -0.24 mm, 95% CI [-0.31, -0.16], P < 0.00001), plaque size (MD -3.83 mm(2), 95% CI [-5.64, -2.01], P < 0.0001), Crouse score (MD -0.48, 95% CI [-0.89, -0.08], P = 0.02), hs-CRP (MD -1.65 mg/L, 95% CI [-2.99, -0.30], P = 0.02) and MMP-9 (MD -12.29 μg/L, 95% CI [-16.24, -8.33], P < 0.00001). Neurological improvement (NIHSS reduction: MD -2.94, 95% CI [-4.15, -1.73], P < 0.00001) and comparable safety profiles (OR 0.93, 95% CI [0.37, 2.37], P = 0.89) were observed. CONCLUSION: Butylphthalide treatment reduces carotid plaque burden, improves neurological recovery and has a high safety profile, supporting its role in stroke prevention.