| 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 |
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Hyung Joon Kim1, June Sung Lee2, Hyun Woong Lee1, Mun Young Kim3, Soon Woo Nam4, Ju Hyun Sohn5, Se Hyun Cho4, Seung Gyu Yoon4, Jin Mo Yang4, Chung Kee Park6, Gyu Sung Rim7, Young Sok Lee4 |
1Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea
2Department of Internal Medicine, Inje University College of Medicine, Busan, Korea
3Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea
4Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea
5Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea
6Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
7Department of Internal Medicine, CHA University, Seoul, Korea |
| 만성 간질환에서 펜넬Ⓡ의 무작위, 이중맹검, 다기관 제4상
임상시험 |
|
김형준1, 이준성2, 이현웅1, 김문영3, 남순우4, 손주현5, 조세현4, 윤승규4, 양진모4, 박충기6, 임규성7, 이영석4 |
1중앙대학교 의과대학 내과학교실
2인제대학교 의과대학 내과학교실
3연세대학교 원주의과대학 내과학교실
4가톨릭대학교 의과대학 내과학교실
5한양대학교 의과대학 내과학교실
6한림대학교 의과대학 내과학교실
7차의과대학교 내과학교실 |
Correspondence:
Young Sok Lee, Tel: +82-32-340-7005, Fax: +82-32-340-2255, Email: yslee525@gmail.com
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Received: 2 October 2013 • Revised: 21 October 2013 • Accepted: 18 November 2013 |
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| This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits
unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
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| 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. (Korean J Med 2014;86:179-189) |
| Key Words:
Chronic liver disease; Biphenyl dimethyl dicarboxylate; Transaminase; Clinical trial |
| 주제어:
만성 간질환; 펜넬; 트랜스아미나제; 임상 시험 |
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