Clinical trial: a nutritional supplement Viusid, in combination with diet and exercise, in patients with nonalcoholic fatty liver disease.
BACKGROUND
Nonalcoholic fatty liver disease (NAFLD) is a significant health problem for which there is no universally accepted pharmacological treatment. The combination of weight loss and antioxidant drugs to ameliorate insulin resistance and improve steatosis, inflammation and fibrosis provides the rational for therapeutic trials.


OBJECTIVE
To evaluate the efficacy and safety of a nutritional supplement Viusid in association with diet and exercise for NAFLD.


METHODS
A randomized, controlled and parallel-group trial was conducted at a tertiary care academic centre (National Institute of Gastroenterology, Havana, Cuba). We randomly assigned 60 patients with liver biopsy-proven NAFLD to 6 months of treatment with a hypocaloric diet plus aerobic exercise daily and three Viusid sachets daily or a hypocaloric diet and exercise. Endpoints were improvement in the NAFLD activity score (NAS), fibrosis and normalization of serum aminotransferase levels.


RESULTS
A significant improvement in steatosis, necroinflammation and fibrosis was seen in each group of treatment (P < 0.01 for each feature). The Viusid group, as compared with the control group, significantly reduced the mean of NAS [from 4.18 to 0.54 points in the Viusid group vs. 4.45 to 2.2 points in the control group (P < 0.001)]. On between-group comparison, Viusid was found to be associated with a significantly greater improvement in steatosis (P < 0.001), ballooning (P = 0.002) and lobular inflammation (P = 0.025), but not in fibrosis (P = 0.07). Viusid was well tolerated.


CONCLUSIONS
Our results indicate that treatment with diet and exercise leads to a notable improvement in the histological features of NAFLD; however, the administration of Viusid intensifies the improvements of histological findings, especially of steatosis and inflammation.
Vilar Gomez
E
E
Departments of Hepatology, National Institute of Gastroenterology, Havana, Cuba. vilar@infomed.sld.cu
Rodriguez De Miranda
A
A
Gra Oramas
B
B
Arus Soler
E
E
Llanio Navarro
R
R
Calzadilla Bertot
L
L
Yasells Garcia
A
A
Del Rosario Abreu Vazquez
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D003131:Combined Modality Therapy / Q000379:methods; D003462:Cuba; D019587:Dietary Supplements; D005081:Exercise Therapy; D005234:Fatty Liver / Q000097:blood / Q000178:diet therapy* / Q000473:pathology; D005260:Female; D005355:Fibrosis / Q000628:therapy; D006801:Humans; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D000637:Transaminases / Q000097:blood; D016896:Treatment Outcome; D055815:Young Adult
D001786:Blood Glucose; D000637:Transaminases