Background The primary aim of this study was to compare the effects of pentoxifylline (PTX) versus placebo on the histological features of NASH. Methods 55 adults with biopsy-confirmed NASH were randomized to receive PTX at a dose of 400mg three times a day (n=26) or placebo (n=29) over 1 year. The primary efficacy endpoint was defined as improvement on histological features of NASH through reduction in steatosis, lobular inflammation, and/or hepatocellular ballooning as reflected by a decrease of ≥ 2 points in the NAFLD activity score (NAS). Results After 1 year, intention-to-treat analysis showed a decrease of >=2 points in the NAS in 38.5% of patients on PTX vs 13.8% of those on placebo (p=0.036). Per protocol analysis, a decrease of ≥ 2 points in the NAS from baseline was observed in 50% of the patients on PTX versus 15.4% of those on placebo (p=0.01). The mean change in NAS score from baseline was −1.6 in the PTX group, vs −0.1 in the placebo group (p<0.001). PTX significantly improved steatosis (mean change in score −0.9 vs −0.04 with placebo, p<0.001) and lobular inflammation (median change −1 vs 0 with placebo, p=0.02). No significant effects in hepatocellular ballooning were observed. PTX also improved liver fibrosis (mean change in fibrosis score was −0.2 among those on PTX versus +0.4 among those on placebo, p=0.038). Although not statistically significant (p=0.17), improvement in fibrosis was observed in a greater proportion (35%) of patients in the PTX group compared to placebo (15%). Adverse effects were similar in both groups. Conclusion PTX improved histological features of NASH compared to placebo. PTX was well tolerated in patients with NASH (ClinicalTrials.gov number NCT00590161).

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There is controversy regarding the presence of colonic mucosal abnormalities or mucosal invasion by Entamoeba histolytica in patients with "nondysenteric intestinal amebiasis." To determine the role of E. histolytica in causing symptoms and mucosal changes and to detect if mucosal invasion by E. histolytica is present in nondynsenteric intestinal amebiasis, we evaluated 24 E. histolytica-infected patients (stool microscopy positive for E. histolytica) and 12 noninfected controls who presented with chronic gastrointestinal symptoms, but without dysentery, to a clinic in Calcutta. The colonic mucosa was evaluated at colonoscopy, and mucosal biopsies obtained from the cecum, sigmoid colon, and rectum were evaluated by light microscopy, indirect immunofluorescence microscopy, and scanning electron microscopy. At colonoscopy mucosal ulcerations were absent in all the controls and all except one of the E. histolytica-infected patients. E. histolytica trophozoites or cysts were not seen in the lamina propria or on the luminal surface in any infected patient by light and immunofluorescence microscopy. On scanning electron microscopy, structures that resembled rounded E. histolytica trophozoites were seen on the luminal surface in two of 19 cecal specimens from the infected patients. Moderate or severe mucosal inflammation was frequent on light microscopy in both the E. histolytica-infected patients and the noninfected controls with the cecum involved in two thirds of both groups. Antibodies to E. histolytica were detected in serum of 25% of study patients and 58% of controls. Mucosal inflammation did not correlate with stool positivity for E. histolytica or seropositivity for ameba antibody.(ABSTRACT TRUNCATED AT 250 WORDS)