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• W2198536602 abstract "AimThe study was carried out to compare the efficacy of Vitamin E versus ursodeoxycholic acid (UDCA) in non-diabetic NAFLD patients.MethodsWe randomized 250 noncirrhotic and nondiabetic NAFLD patients diagnosed on ultrasound, with raised aminotransferase (ALT) (> 40 IU/L), to receive Vitamin E 400 mg twice a day (Group 1) or UDCA 300 mg twice a day (Group 2) for 52 weeks. Lifestyle modification to achieve at least 5% weight reduction and subsequent weight control and regular exercise was advised to both groups. The primary study endpoint was normalization in ALT levels from baseline. Secondary end points were the proportion of patients with reduction in ALT, relative reduction in the NAFLD fibrosis score (NFS), symptomatic improvement, and tolerability.Results150 patients received UDCA as compared to 100 patients receiving Vitamin E. The treatment groups were comparable at entry with regard to age (44.1 versus 42.4 years), gender (67% versus 63% female), risk factors for NASH, hypochondriac pain, serum liver biochemistries and NAFLD fibrosis score. The primary end point was achieved in 21 (14%) and 19 (19%) of patients in Group 1 and group 2 respectively (P = .2). The proportion of patients with reduction in ALT (56% versus 63%, P = .2), symptomatic improvement (78% versus 67%, P = .058), reduction in the NFS (44% versus 47%, P = .69) and tolerability (98% versus 95%, P = .2) were similar between Group 1 and Group 2 respectively.ConclusionUDCA is an effective and safe alternative to Vitamin E in non-diabetic, noncirrhotic Indian NAFLD patients. AimThe study was carried out to compare the efficacy of Vitamin E versus ursodeoxycholic acid (UDCA) in non-diabetic NAFLD patients. The study was carried out to compare the efficacy of Vitamin E versus ursodeoxycholic acid (UDCA) in non-diabetic NAFLD patients. MethodsWe randomized 250 noncirrhotic and nondiabetic NAFLD patients diagnosed on ultrasound, with raised aminotransferase (ALT) (> 40 IU/L), to receive Vitamin E 400 mg twice a day (Group 1) or UDCA 300 mg twice a day (Group 2) for 52 weeks. Lifestyle modification to achieve at least 5% weight reduction and subsequent weight control and regular exercise was advised to both groups. The primary study endpoint was normalization in ALT levels from baseline. Secondary end points were the proportion of patients with reduction in ALT, relative reduction in the NAFLD fibrosis score (NFS), symptomatic improvement, and tolerability. We randomized 250 noncirrhotic and nondiabetic NAFLD patients diagnosed on ultrasound, with raised aminotransferase (ALT) (> 40 IU/L), to receive Vitamin E 400 mg twice a day (Group 1) or UDCA 300 mg twice a day (Group 2) for 52 weeks. Lifestyle modification to achieve at least 5% weight reduction and subsequent weight control and regular exercise was advised to both groups. The primary study endpoint was normalization in ALT levels from baseline. Secondary end points were the proportion of patients with reduction in ALT, relative reduction in the NAFLD fibrosis score (NFS), symptomatic improvement, and tolerability. Results150 patients received UDCA as compared to 100 patients receiving Vitamin E. The treatment groups were comparable at entry with regard to age (44.1 versus 42.4 years), gender (67% versus 63% female), risk factors for NASH, hypochondriac pain, serum liver biochemistries and NAFLD fibrosis score. The primary end point was achieved in 21 (14%) and 19 (19%) of patients in Group 1 and group 2 respectively (P = .2). The proportion of patients with reduction in ALT (56% versus 63%, P = .2), symptomatic improvement (78% versus 67%, P = .058), reduction in the NFS (44% versus 47%, P = .69) and tolerability (98% versus 95%, P = .2) were similar between Group 1 and Group 2 respectively. 150 patients received UDCA as compared to 100 patients receiving Vitamin E. The treatment groups were comparable at entry with regard to age (44.1 versus 42.4 years), gender (67% versus 63% female), risk factors for NASH, hypochondriac pain, serum liver biochemistries and NAFLD fibrosis score. The primary end point was achieved in 21 (14%) and 19 (19%) of patients in Group 1 and group 2 respectively (P = .2). The proportion of patients with reduction in ALT (56% versus 63%, P = .2), symptomatic improvement (78% versus 67%, P = .058), reduction in the NFS (44% versus 47%, P = .69) and tolerability (98% versus 95%, P = .2) were similar between Group 1 and Group 2 respectively. ConclusionUDCA is an effective and safe alternative to Vitamin E in non-diabetic, noncirrhotic Indian NAFLD patients. UDCA is an effective and safe alternative to Vitamin E in non-diabetic, noncirrhotic Indian NAFLD patients." @default.
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• W2198536602 date "2015-07-01" @default.
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• W2198536602 title "An Open Label Randomized Control Study to Compare the Efficacy of Vitamin E Versus Ursodeoxycholic Acid in Non-diabetic Indian NAFLD Patients" @default.
• W2198536602 doi "https://doi.org/10.1016/j.cgh.2015.04.118" @default.
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