Effects of n-3 fish oil on metabolic and histological parameters in NASH: a double-blind, randomized, placebo-controlled trial.

BACKGROUND & AIMS: This study's aim was to assess the histological and metabolic effects of n-3 polyunsaturated fatty acids (PUFAs) vs. placebo while adjusting for the impact of age and weight change in NASH patients. (ClinicalTrials.gov: NCT00681408). METHODS: Forty-one subjects with non-cirrhotic NASH were enrolled, and 34 completed the study. 17 received n-3 fish oil 3000 mg/day and 17 received placebo daily for 1 year with typical counselling on caloric intake and physical activity for all subjects. RESULTS: N-3- and placebo-treated groups showed no significant difference for the primary end point of NASH activity score (NAS) reduction ⩾ 2 points without fibrosis progression after adjustment for known covariates (n-3, 4/17 (23.5%); placebo, 3/17, (17.6%), p = 0.99). Among subjects with increased or stable weight, n-3 subjects showed a larger decrease in liver fat content by MRI than placebo-treated subjects (p = 0.014 for 2nd quartile, p = 0.003 for 3rd quartile of weight change). N-3 treatment showed significant fat reduction on the paired analysis of image-assisted fat morphometry regardless of weight loss or gain. Exercise capacity remained markedly reduced in all subjects. No independent effects on markers of hepatocyte injury or insulin sensitivity indices were observed. CONCLUSION: N-3 PUFAs at 3000 mg/day for one year did not lead to an improvement in the primary outcome of histological activity in NASH patients (⩾ 2 point NAS reduction). N-3 led to reduced liver fat by multiple measures. Other metabolic effects were not seen, although no detrimental effects were apparent. Whether longer duration, higher dose, or different composition of n-3 therapy would lead to additional benefits is uncertain.

Sorafenib therapy for hepatocellular carcinoma prior to liver transplant is associated with increased complications after transplant.

This study compared post-transplant outcomes of patients with hepatocellular carcinoma (HCC) who took sorafenib prior to orthotopic liver transplantation (OLT) with those patients who were not treated with sorafenib. Thirty-three patients with HCC who were listed for liver transplantation were studied: 10 patients were treated with sorafenib prior to transplantation in an attempt to prevent progression of HCC while awaiting transplant. The remaining 23 patients were considered controls. The mean duration of sorafenib use was 19.2 (SD 25.2) weeks. Overall death rates were similar between the sorafenib group and control group (20% vs. 8.7%, respectively, P = 0.56). However, the patients in the sorafenib group had a higher incidence of acute cellular rejection following transplantation (67% vs. 22%, OR = 7.2, 95% CI 1.3-39.6, P = 0.04). The sorafenib group also had a higher rate of early biliary complications (67% vs. 17%, OR = 9.5, 1.6-55.0, P = 0.01). The use of sorafenib was found to be an independent predictor of post-transplant biliary complications (OR 12.6, 1.4-116.2, P = 0.03). Sorafenib administration prior to OLT appears to be associated with an increase in biliary complications and possibly in acute rejection following liver transplantation. Caution should be taken in this setting until larger studies are completed.

Bleeding gastric varices obliteration with balloon-occluded retrograde transvenous obliteration using sodium tetradecyl sulfate foam.

PURPOSE: Balloon-occluded retrograde transvenous obliteration (BRTO) of bleeding gastric varices (GV) is well described in the literature. Using ethanolamine oleate as the sclerosing agent in BRTO, but it is not readily available in the United States in the desired concentrations. The authors' aim is to describe their initial experience with BRTO using sodium tetradecyl sulfate (STS) foam as an alternative sclerosing agent. MATERIALS AND METHODS: The authors performed a retrospective review of their initial series in which STS foam was used to treat bleeding GV using BRTO. All study subjects had endoscopic evidence of gastric variceal bleeding. STS foam was made using a combination of agents with a 3:2:1 ratio of gas: 3% STS: Lipiodol (Ethiodol; Savage Laboratories, Melville, New York). Mean values and ranges were calculated for each variable, and clinical and imaging outcomes were assessed. RESULTS: The authors performed BRTO in 22 cirrhotic patients (11 men and 11 women) with a mean age of 52 years (range, 23-83 years). Technical success was achieved in 20 of 22 (91%) patients. Complications occurred in three of 22 (14%) patients. The overall mean dose of STS used was 300 mg (range, 30-600 mg) with mean total volume of sclerosant mixture of 34.1 mL (range, 10-65 mL). Follow-up imaging was available for 18 of 20 (90%) technically successful procedures with a mean period of 89 days (range, 1-359 days). Complete obliteration of GV was achieved in 16 of 18 (89%) patients. There were no cases of recurrent variceal bleeding with a mean clinical follow-up period of 130 days (range, 1-510). CONCLUSIONS: BRTO utilizing STS foam appears effective in obliterating bleeding GVs with good short-term outcomes.