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 / 대한내과학회지

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.

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 / 대한내과학회지

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.

A Case of Systemic Lupus Erythematosus Manifesting First as Mesenteric Vasculitis

Systemic lupus erythematosus (SLE) is a multisystem inflammatory disease that manifests various symptoms. Mesenteric vasculitis (MV) is one of the serious complications of SLE and carries a high mortality rate. Although MV is the main cause for acute abdominal pain in patients with SLE, it is very rare for the pain to be the first clinical manifestation of the disease. A 34-year old female presented with sudden onset abdominal pain accompanied by small intestinal bowel edema observed on abdominal computed tomography. We performed a diagnostic laparoscopy, as vital signs were becoming unstable and the diffuse abdominal tenderness was worsening rapidly. The examination showed a severe jejunal infarction; thus, the patient underwent a small bowel segmental resection. A histological examination revealed multiple, hemorrhagic, small-vessel vasculitis, and later serologic autoimmune markers were consistent with SLE. We suggest that SLE be considered in the differential diagnosis of young females presenting with an acute abdomen and unexplained enteropathy. A surgical approach such as exploratory laparoscopy could be an option in search for the cause.

Clinical Usefulness of Proton Pump Inhibitor Intravenous Treatment in Bleeding Peptic Ulcer / 대한소화기내시경학회지

BACKGROUND/AIMS: Recently, high dose PPI intravenous (IV) infusion after endoscopic hemostasis was found to decrease the recurrent bleeding rate. Therefore, we conducted this study to define the effect of endoscopic hemoclipping with PPI IV infusion on the recurrent bleeding rate. METHODS: We conducted a double-blinded prospective randomized control study. A total of 35 patients were endoscopically diagnosed with bleeding peptic ulcer of Forrest classification Ia, Ib, IIa between Jan. 2003 and Sep. 2003 in our hospital. We carried out epinephrine injection therapy around the ulcer, followed by hemoclipping at the exposed vessel. After controlling for endoscopic bleeding, we randomly divided the patients into two groups. One group received a PPI IV infusion (pantoprazole 80 mg/day) and the other group received a placebo for three days. RESULTS: Only one PPI IV-infused patient and one patient receiving placebo showed recurrent bleeding at two days after endoscopic therapy. The PPI IV infusion group showed 100% (17/17) initial hemostatic rate, 5.8% (1/17) recurrent bleeding rate within 3 days, 0% (0/17) recurrent bleeding rate after 3 days, and 0% (0/17) complication rate. For these same values, the placebo group showed 100% (18/18), 5.5% (1/18), 0% (0/18), and 0% (0/18), respectively. CONCLUSIONS: PPI IV infusion showed no addictive hemostatic effect. We think hemoclipping is a very effective hemostatic method, and PPI IV infusion may not be required after appropriate endoscopic management

Abdominal Obesity, Insulin Resistance, and the Risk of Colonic Adenoma / 대한소화기학회지

BACKGROUND/AIMS: Abdominal obesity and hyperinsulinemia or insulin resistance are of interest in connection with colon carcinogenesis. We conducted a prospective case controlled study for the evaluation of relationship between abdominal obesity, insulin resistance, and colorectal adenoma. METHODS: Fifty patients with colorectal adenoma and fifty healthy subjects were included in this study. Total colonoscopic examinations were performed in all the subjects. Fasting blood sugar (FBS), insulin, homeostasis model assessment (HOMA-IR), triglyceride (TG), cholesterol (CROL), BMI (body mass index), WHR (waist hip ratio), percent body fat (PBF) and obesity degree (OD) were measured. HOMA-IR was considered to represent insulin resistance. Diabetic patients were excluded from this study. RESULTS: There were no differences in sex, serum insulin, FBS, HOMA-IR, TG, CROL between adenoma and control group. Subjects with high BMI, WHR, percent body fat, and obesity were more likely to have colonic adenoma. Multiple logistic regression analysis after adjusting confounding factors, had revealed that WHR was the most important independent risk factor for colon adenoma. CONCLUSIONS: Abdominal obesity was most closely related to colonic adenoma. However, insulin resistance was not related to colonic adenoma. A larger case controlled study is needed.