Abstract
Blackcurrant oil soft capsule (BOSC) is an effective and safe herbal medicine for the treatment of hyperlipidemia and has been approved for the market in China. No studies have been performed, however, to confirm whether BOSC is effective in reducing the serum lipid level in a large-scale ordinary or special patient population. In this study, we conducted an observational study at five investigative sites that was designed to further investigate the efficacy of BOSC on serum lipid level lowering in a large-scale target patient population and include a relative factors analysis for the serum lipid decrease. Serum total cholesterol (TC), triglycerides (TGs) and high density lipoprotein-cholesterol (HDL-C) were measured before and after drug administration. TC and TGs were detected by enzymatic analysis, while HDL-C was detected by PTA-Mg(2+) precipitation. A total of 2,154 dyslipidemic patients were recruited and took BOSC 1.8 g b.i.d. every day for 6 weeks. In terms of serum lipid lowering, the overall curative rate was 37.19%, the marked effective rate was 52.28% and the effective rate was 79.06%. The corresponding effective rate of TC, TGs and HDL-C was 80.98%, 78.28% and 67.07%, respectively. Multivariate analyses with adjustment for centers, gender and age indicated that BOSC was almost ineffective in patients with a disease course <36 months (OR: 0.467, 95% CI: 0.359-0.607) and was effective in mild hyperlipidemia (OR: 3.176, 2.535-3.978) and in subjects with lower BMIs (BMI <24: 3.472, 2.171-5.552; BMI between 24 and 28: 2.310, 1.832-2.911 compared with BMI >or= 28). No serious adverse events were reported during the study period. Therefore, we conclude that BOSC is effective in decreasing TC and TG levels and in increasing the serum HDL-C level, especially in mildly hyperlipidemic patients and those with a lower BMI. Moreover, because it is a natural raw material, BOSC may be safer and more effective in the treatment of hyperlipidemia.
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