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Randomized Controlled Trial
. 2016 May-Jun;22(3):192-7.
doi: 10.4103/1319-3767.182451.

An open-label randomized control study to compare the efficacy of vitamin e versus ursodeoxycholic acid in nondiabetic and noncirrhotic Indian NAFLD patients

Pathik Parikh  1 , Meghraj Ingle  1 , Jatin Patel  1 , Prasad Bhate  1 , Vikas Pandey  1 , Prabha Sawant  1
Affiliations
Randomized Controlled Trial

An open-label randomized control study to compare the efficacy of vitamin e versus ursodeoxycholic acid in nondiabetic and noncirrhotic Indian NAFLD patients

Pathik Parikh et al. Saudi J Gastroenterol. 2016 May-Jun.

Abstract

Background/aim: The study was carried out to compare the efficacy of Vitamin E versus Ursodeoxycholic acid (UDCA) in nondiabetic nonalcoholic fatty liver disease (NAFLD) patients.

Patients and methods: We randomized 250 non cirrhotic and non diabetic NAFLD patients diagnosed on ultrasound, with raised alanine aminotransferase (ALT) level. (>40 IU/L), to receive Vitamin E 400 mg twice a day (Group A) or UDCA 300 mg twice a day (Group B) 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 of ALT. Secondary endpoints were the proportion of patients with reduction in ALT, relative reduction in the NAFLD Fibrosis score (NFS), symptomatic improvement and tolerability.

Results: One hundred and fifty patients received UDCA as compared to 100 patients receiving Vitamin E. The treatment groups were comparable at entry with regard to age (44.1 vs 42.4 years), gender (67% vs 63% female), risk factors for nonalcoholic steatohepatitis, hypochondriac pain, serum liver biochemistries, and NAFLD Fibrosis score. The primary endpoint was achieved in 21 (14%) and 19 (19%) of patients in Group A and Group B, respectively (P = 0.2). The proportion of patients with reduction in ALT (56% vs 63%, P = 0.2), symptomatic improvement (78% vs 67%, P= 0.058), reduction in the NFS (44% vs 47%, P= 0.69), and tolerability (98% vs 95%, P= 0.2) were similar between Group A and Group B, respectively.

Conclusion: UDCA is an effective and safe alternative to Vitamin E in nondiabetic-noncirrhotic Indian NAFLD patients.

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Figures

Figure 1
Figure 1
The randomization flow chart
Figure 2
Figure 2
The figure shows the weight of patients in Group A and Group B before and after treatment of 52 weeks. The difference between Group A and Group B is not statistically significant at baseline as well as after 24 and 52 weeks of therapy (t test). The weight (kg) loss achieved by either group is significant at the end of 52 weeks (Paired Student's t test). Group A - Vitamin E plus lifestyle modification. Group B – UDCA plus lifestyle modification
Figure 3a
Figure 3a
ALT values at baseline, 24 weeks, and at 52 weeks of treatment in both the groups. All values are in Mean. Student's t-test is utilized for analyses. P values correspond to univariate conditional logistic regression analyis to account for matching. The change in ALT levels from baseline at 24 weeks and 52 weeks is significant (P < 0.0001). However, the difference between ALT at 24 weeks and 52 weeks is not significant (P > 0.05). ALT, alanine aminotransferase
Figure 3b
Figure 3b
ALT values at baseline, 24 weeks, and at 52 weeks of treatment in both the groups. All values are in Mean. Student's t test is utilized for analyses. P values correspond to univariate conditional logistic regression analyis to account for matching. The change in ALT levels from baseline at 24 weeks and 52 weeks is significant (P < 0.0001). However, the difference between ALT at 24 weeks and 52 weeks is not significant (P > 0.05). AST, aspartate aspartate aminotransferase
Figure 4
Figure 4
The figure shows APRI, AAR, and NFS in patients of Group A and Group B at baseline and at 52 weeks. All values are in Median. The difference between Group A and Group B is not statistically significant before and after the treatment. The improvement in APRI, AAR, and NFS is significant before and after the 52 weeks of treatment for both the groups (P < 0.05). APRI, AST to platelet ratio; AAR, AST to ALT ratio; NFS, NAFLD Fibrosis Score. Group A - Vitamin E plus lifestyle modification. Group B - UDCA plus lifestyle modification
Figure 5
Figure 5
The figure shows Median FibroScan (in kPa) in patients of Group A and Group B at baseline and at 52 weeks. All values are in Median. The difference between Group A and Group B is not statistically significant before and after the treatment (P > 0.05). The improvement in Median FibroScan values is significant before and after the 52 weeks of treatment for both the groups (P < 0.05). Group A - Vitamin E plus lifestyle modification. Group B – UDCA plus lifestyle modification
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