The PERFECT Study (PEnnel Real liFe Efficacy Clinical Trial), a Double-Blind, Randomized, Multicenter Trial Examining the Efficacy of Biphenyl Dimethyl Dicarboxylate Combined with Garlic Oil in Patients with Transaminase Elevated Chronic Liver Disease.
- Author:
Hyung Joon KIM
1
;
June Sung LEE
;
Hyun Woong LEE
;
Mun Young KIM
;
Soon Woo NAM
;
Ju Hyun SOHN
;
Se Hyun CHO
;
Seung Gyu YOON
;
Jin Mo YANG
;
Chung Kee PARK
;
Gyu Sung RIM
;
Young Sok LEE
Author Information
1. Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
- Publication Type:Clinical Trial ; Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords:
Chronic liver disease;
Biphenyl dimethyl dicarboxylate;
Transaminase;
Clinical trial
- MeSH:
Alanine Transaminase;
Fatty Liver;
Garlic*;
Hepatitis B, Chronic;
Humans;
Incidence;
Liver Diseases*;
Liver Diseases, Alcoholic;
Liver*;
Malondialdehyde;
Quality of Life;
Surveys and Questionnaires;
Silymarin
- From:Korean Journal of Medicine
2014;86(2):179-189
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
BACKGROUND/AIMS: Biphenyl dimethyl dicarboxylate (DDB) combined with garlic oil (pennel) has been used to treat chronic liver disease. A randomized, double-blind, active- and placebo-controlled clinical trial was conducted to investigate the efficacy, safety and 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 administered pennel, 102 patients Legalon as an active-control and 35 patients placebo for 12 weeks. The primary endpoint was the rate of alanine aminotransferase (ALT) normalization. We assessed differences in ALT levels and malondialdehyde (MDA) as an oxidative 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 liver disease, and 28 patients with chronic hepatitis B and C. The incidence of ALT normalization at 12 weeks was 89% for the pennel group, 18.6% for the active-control group, and 22.9% for the placebo-control group (p < 0.001). The difference in serum ALT level between 0 and 12 weeks was significantly higher in the pennel group (p < 0.001) and the level of MDA was decreased in the pennel group, statistically (p < 0.001). There was no difference in incidence of adverse events among groups. The pennel group showed significant 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 chronic liver disease.
