Ren · Zhonghua yi xue za zhi 2017 · randomized controlled trial · n=76

[A clinical study on the effect of nattokinase on carotid artery atherosclerosis and hyperlipidaemia].

Level 2 - randomized trial

Individual randomized controlled trial

PubMed 28763875 · doi:10.3760/cma.j.issn.0376-2491.2017.26.005 · record verified 2026-08-26

What was done

Eighty-two patients from an outpatient clinic in China with carotid atherosclerosis and hyperlipidemia were randomly assigned to receive either oral nattokinase (6,000 FU daily, n=41) or simvastatin (20 mg daily, n=41) for 26 weeks. Common carotid artery intimal medial thickness (CCA-IMT), carotid plaque size, and serum lipid profiles (TC, LDL-C, TG, HDL-C) were measured before and after the 26-week intervention.

What was found

Seventy-six patients completed the trial (39 in the nattokinase group, 37 in the statin group). Both treatments significantly reduced CCA-IMT and plaque size, but nattokinase produced a significantly larger plaque reduction (36.6% reduction, from 0.25 ± 0.12 cm² to 0.16 ± 0.10 cm²) than simvastatin (11.5% reduction, P < 0.01). CCA-IMT in the nattokinase group decreased from 1.13 ± 0.12 mm to 1.01 ± 0.11 mm. Simvastatin reduced TC, LDL-C, and TG to a significantly greater degree than nattokinase (P < 0.05). Nattokinase significantly increased HDL-C (P < 0.05), whereas simvastatin did not. Plaque reduction in the nattokinase group did not correlate with lipid-lowering magnitude (r = 0.35, P = 0.09).

Why it matters

This study provides initial clinical evidence that oral nattokinase may reduce carotid plaque burden more effectively than moderate-dose simvastatin, operating through mechanisms largely independent of blood lipid reduction.

Limits

The sample size was small (76 completers) and conducted at a single center. The abstract does not report blinding of participants or outcome assessors, nor does it report clinical cardiovascular events (such as stroke or myocardial infarction) or adverse event rates.

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