In uncontrolled clinical studies, ursodeoxycholic acid (UDCA) had a beneficial effect on nonalcoholic steatohepatitis (NASH). However, a large controlled trial using UDCA (13-15 mg/ kg/day) was unable to confirm these results. Accordingly, a randomized, placebo-controlled study was initiated with a high dose of UDCA (23-28 mg/kg/day). The allocation of patients and the evaluation of liver histology were performed according to a modified Brunt score and the nonalcoholic fatty liver disease activity score (NAS). With the modified Brunt score, 185 patients with histologically proven NASH were randomized [intention to treat (ITT)], and 147 were treated per protocol (PP). With the NAS, 137 patients were confirmed to have NASH, 48 had borderline NASH, and 1 did not have NASH. The treatment time was 18 months. At entry, the treatment groups were comparable. A second biopsy sample was obtained from 139 of 185 patients (NAS: 107/137). The primary criterion for evaluation was a change in the liver histology; the secondary criteria were single histological variables and liver biochemistry. Significant differences in the overall histology could not be detected between the two treatment groups with the modified Brunt score (P 5 0.881) or NAS (P 5 0.355). Only lobular inflammation improved significantly (P for the modified Brunt score 5 0.011, P for NAS 5 0.005). In subgroup analyses, significant improvements in lobular inflammation were also observed in males, younger patients up to 50 years of age, slightly overweight patients, and patients with hypertension and an increased histology score. The fibrosis score did not change (P for ITT 5 0.133, P for PP 5 0.140). With the exception of cglutamyl transferase, UDCA did not improve laboratory data. Conclusion: High-dose UDCA failed to improve the overall histology in patients with NASH in comparison with placebo.

OBJECTIVE.The flow pattern in hepatic veins depends on cardiac physiology and liver histology. The aim of our study was to determine the dependence of the flow pattern of he patic and portal veins in relation to histologic features in patients with chronic hepatitis C. SUBJECTS AND METHODS.In 135 patients with chronic hepatitis C, the Doppler sonography spectrum of the right hepatic vein was classified as triphasic, biphasic, or monophasic. The flow of theportalvein wascharacterizedaccordingto theundulation(veloc itYm@min). A liver biopsy was performed during sonography, and biopsy specimens were semiquantitatively evaluatedon a histologicactivity index anda scoreof the hepaticfat con tent. Multiple logistic regression analysis was used to identify the histologic features that might contribute to the type of flow pattern. RESULTS.The hepatocyte fat content was the only variable associated with an indepen dent effect on the type of flow pattern (monophasic versus triphasic; odds ratio, 16.26; 95% confidence interval, 6.38â€"41.45; p < .0001). A pronounced undulation in the portal vein was associated with portal inflammation but not with other parameters of the histologic activity in dex or the intrahepatic fat deposition. The normal triphasic Doppler sonography waveformof hepaticveinsvanesaccordingto changes in the central venous pressure. During atrial and ventricular diastole, two portions of the signal (phase I and phase II) reflect the hepatofugalflow to the heart, while during atrial contraction a third portion (phase ifi) representsa short interval of reversedflow [1,10]. Conflicting data have been reported concerning changes of the flow pattern in rela tion to chronic liver disease. A few studiessug gested that liver fibrosis or cirrhosis and transplant rejection may reduce undulation of the hepatic flow pattern [2][3][4]7]. The possible contribution of inflammatory changes and mtra hepaticfat depositionhasneverbeensystemati cally investigated.To address thesequestions, chronichepatitis C is an attractiveclinical model [11â€"13] be causethe diseasecan causethe completehisto logic spectrum of inflammatory and fibrotic changes[14â€"17] andcan lead to variable intra hepaticfat deposition [3,18]. In the present study, we examined 135 patients with chronic hepatitis C and 75 age-and sex-matched healthy subjectsusing B-mode and duplex

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Hepatitis C virus (HCV) infection is one of the most comInflammatory processes in organs frequently lead to hypermon causes of chronic hepatitis and cirrhosis. 1,2 HCV is an plasia of regional lymph nodes. In the present study, we inves-RNA virus that preferentially replicates in hepatocytes; howtigated whether lymph node enlargement within the hepatoever, mononuclear lymphocytes may serve as a possible exduodenal ligament may reflect the inflammatory activity trahepatic site for HCV replication.3-5 Kinetic analysis of virus within the liver of patients chronically infected with the hepaturnover revealed that HCV replicates continuously and is titis C virus (HCV). In 114 patients with chronic hepatitis C highly productive in vivo. In chronically infected patients, and 49 healthy controls, the total lymph node volume within approximately 10 10 hepatitis C virions are produced and subthe hepatoduodenal ligament was prospectively investigated sequently degraded by antigen-specific and nonspecific proby ultrasound. In patients with chronic hepatitis C, a liver cesses every day. 6biopsy was taken at the same occasion, and specimens were Inflammatory processes in organs frequently lead to hypersemiquantitatively evaluated by the histological activity index plasia of regional lymph nodes. Lymph node enlargement (HAI). Hepatitis C viremia was assessed by quantitative rewithin the hepatoduodenal ligament may be present in paverse transcription-polymerase chain reaction (RT-PCR). Getients with acute or chronic liver disease, and could reflect notyping was performed by a reverse hybridization assay. In the inflammatory activity and/or the immunological response 104 of 114 patients (91.2%) and in 45 of 49 healthy controls of the host. Lymph nodes in the hepatoduodenal ligament (91.8%), adequate visualization of the region of the hepatoducan noninvasively be detected using modern imaging techodenal ligament was achieved by ultrasound. Lymph nodes niques such as ultrasound. 7-15were detected in all patients with chronic hepatitis C and in In the present study, we investigated the size of lymph 33 of 45 controls. The mean perihepatic lymph node volume nodes within the hepatoduodenal ligament in patients with in healthy controls (2.2 { 1.8 mL) was lower than in HCVchronic hepatitis C and healthy controls. The lymph node infected patients with mild to moderate inflammatory activity, status in the hepatoduodenal ligament was correlated with severe inflammatory activity, and patients with cirrhosis liver histology, HCV genotype, hepatitis C viremia, and liver (5.8 { 2.2 mL, 18.1 { 10.4 mL, and 22.8 { 18.8 mL, respecfunction tests. tively). In patients with HCV-RNA levels of less than 10 6 copies/mL, the total lymph node volume was 5.8 { 1.6 mL PATIENTS AND METHODS and was significantly increased in patients with higher viremia (20.3 { 13.8 mL; P õ 10 06 ). No correlation was found bePatients and Controls. Between February 1995 and May 1996, 114 tween the total lymph node volume within the hepatoduodeconsecutive patients with ch...