만성 간질환에서 펜넬Ⓡ의 무작위, 이중맹검, 다기관 제4상임상시험

초록

Background/Aims: Biphenyl dimethyl dicarboxylate (DDB) combined with garlic oil (pennel) has been used to treat chronic liverdisease. A randomized, double-blind, active- and placebo-controlled clinical trial was conducted to investigate the efficacy, safetyand quality of life in chronic liver disease patients. Methods: A total of 237 patients with chronic liver disease were randomized into three groups; 100 patients were administeredpennel, 102 patients Legalon as an active-control and 35 patients placebo for 12 weeks. The primary endpoint was the rate ofalanine aminotransferase (ALT) normalization. We assessed differences in ALT levels and malondialdehyde (MDA) as anoxidative biomarker between 0 and 12 weeks, the improvement in quality of life using a chronic liver disease questionnaire (CLDQ)and the incidence of adverse events.Results: Among 237 patients, there were 157 patients with non-alcoholic fatty liver disease, 36 patients with alcoholic liverdisease, and 28 patients with chronic hepatitis B and C. The incidence of ALT normalization at 12 weeks was 89% for the pennelgroup, 18.6% for the active-control group, and 22.9% for the placebo-control group (p < 0.001). The difference in serum ALT levelbetween 0 and 12 weeks was significantly higher in the pennel group (p < 0.001) and the level of MDA was decreased in the pennelgroup, statistically (p < 0.001). There was no difference in incidence of adverse events among groups. The pennel group showedsignificant improvement based on the CLDQ (p < 0.001). Conclusions: Pennel can effectively improve the rate of ALT normalization and the quality of life with a safety profile in chronicliver disease.

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