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. AIM: 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.

[Influence of hyponutrition on occurrence of complications and mortality among cirrhosis patients]. / Influencia de la desnutrición en la aparición de complicaciones y mortalidad en pacientes cirróticos.

Nutrient Energy Malnutrition (NEM) is a common feature among liver cirrhosis (LC) patients, and might constitute a negative predictor of patient's survival. A prospective descriptive study was carried out in order to assess the influence of LC patient's nutritional status on the occurrence of complications and mortality in a tertiary care health institution in Havana City (Cuba). One-hundred twenty-one patients were recruited for the study (Women: 52.9%; Younger than 60 years: 59.0%; Whites: 90.0%). C virus infection, alcoholism, and B virus infection accounted for 71.0% of LC cases. Ninety-two percents of the patients had less than 5 yearse of diagnosis. Subjective Global Assessment (SGA) of nutritional status returned a 45.0% of malnutrition. Malnutrition was associated with disease progression: twenty-one percent of A Child-Pugh Stage patients was malnourished, but this rate increased to become 90.0% among those in C stage. Fat and skeletal muscle compartments were reduced in 36.0 and 37.0% of the patients, respectively. Complications affected 44.6% of the patients. Sixty percent of them were malnourished (p <0.01). One-year mortality rate was 11.0%. Ninety-two percent of deceased patients were malnourished (p < 0.01). LC malnourished patients have greater risk of complications and death as compared to well-nourished ones.

Influencia de la desnutrición en la aparición de complicaciones y mortalidad en pacientes cirróticos / Influence of hyponutrition on occurrence of complications and mortality among cirrhosis patients

La Desnutrición Energética Nutrimental (DEN) es una manifestación muy frecuente entre los pacientes con Cirrosis Hepática (CH), y puede constituir un predictor negativo para la supervivencia de los mismos. Se realizó un estudio descriptivo prospectivo para identificar la influencia del estado nutricional de los pacientes con CH en la aparición de complicaciones y mortalidad en una institución terciaria de salud de La Habana (Cuba). Se reclutaron 121 pacientes cirróticos (mujeres: 52,9%; menor de 60 años: 59,0%; piel blanca: 90,0%). La infección por virus C, el alcoholismo, y la infección por virus B representaron el 71,0% de los casos de CH. El 92% de los enfermos tenían menos de 5 años de diagnosticados. La Evaluación Subjetiva Global (ESG) del estado nutricional arrojó un 45,o% de desnutrición. La desnutrición es proporcional al estadio de progresión de la enfermedad: el 21,0% de los cirróticos en estadio A (Child-Pugh) estaba desnutrido, pero esta frecuencia llegó a ser del 90,0% entre aquellos en el estadio C. Los compartimentos graso y muscular estaban disminuidos en el 36,0 y 37,0% de los pacientes, respectivamente. El 44,6% de los pacientes se complicaron durante el periodo de observación. El 60,0% de los enfermos que se complicaron estaba desnutrido (p < 0,01). La mortalidad-al-año fue del 11,0%. El 92,0% de los fallecidos estaba desnutrido (p < 0,01). Los pacientes con CH desnutridos tienen mayor riesgo de complicaciones y muerte que los no desnutridos (AU)

Nutrient Energy Malnutrition (NEM) is a common feature among liver cirrhosis (LC) patients, and might constitute a negative predictor of patient's survival. A prospective descriptive study was carried out in order to assess the influence of LC patient's nutritional status on the occurrence of complications and mortality in a tertiary care health institution in Havana City (Cuba). One-hundred twenty-one patients were recruited for the study (Women: 52,9%; Younger than 60 years: 59,0%; Whites: 90,0%). C virus infection, alcoholism, and B virus infection accounted for 71,0% of LC cases. Ninety-two percents of the patients had less than 5 years of diagnosis. Subjective Global Assessment (SGA) of nutritional status returned a 45,0% of malnutrition. Malnutrition was associated with disease progression: twenty-one percent of A Child-Pugh Stage patients was malnourished, but this rate increased to become 90,0% among those in C stage. Fat and skeletal muscle compartments were reduced in 36,0 and 37,0% of the patients, respectively. Complications affected 44,6% of the patients. Sixty percent of them were malnourished (p < 0,01). One-year mortality rate was 11,0%. Ninety-two percent of deceased patients were malnourished (p < 0,01). LC malnourished patients have greater risk of complications and death as compared to well-nourished ones (AU)

Influencia de la desnutrición en la aparición de complicaciones y mortalidad en pacientes cirróticos / Influence of hyponutrition on ocurrence of complications and mortality among cirrhosis patients

La Desnutrición Energética Nutrimental (DEN) es una manifestación muy frecuente entre los pacientes con Cirrosis Hepática (CH), y puede constituir un predictor negativo para la supervivencia de los mismos. Se realizó un estudio descriptivo prospectivo para identificar la influencia del estado nutricional de los pacientes con CH en la aparición de complicaciones y mortalidad en una institución terciaria de salud de La Habana (Cuba). Se reclutaron 121 pacientes cirróticos (mujeres: 52,9por ciento; menor de 60 años: 59,0 por ciento; piel blanca: 90,0 por ciento). La infección por virus C, el alcoholismo, y la infección por virus B representarion el 71,0 por ciento de los casos de CH. El 92 por ciento de los enfermos tenían menos de 5 años de diagnosticados. La Evaluación Subjetiva Global (ESG) del estado nutricional arrojó un 45,o por ciento de desnutrición. La desnutrición es proporcional al estadio de progresión de la enfermedad: el 21,0 por ciento de los cirróticos en estadio A (Child-Pugh) estaba desnutrido, pero esta frecuencia llegó a ser del 90,0% entre aquellos en el estadio C. Los compartimentos graso y muscular estaban disminuidos en el 36,0 y 37,0por ciento de los pacientes, respectivamente. El 44,6 por ciento de los pacientes se complicaron durante el periodo de observación. El 60,0por ciento de los enfermos que se complicaron estaba desnutrido (p < 0,01). La mortalidad-al-año fue del 11,0por ciento. El 92,0 por ciento de los fallecidos estaba desnutrido (p < 0,01). Los pacientes con CH desnutridos tienen mayor riesgo de complicaciones y muerte que los no desnutridos(AU)

Nutrient Energy Malnutrition (NEM) is a common feature among liver cirrhosis (LC) patients, and might constitute a negative predictor of patient's survival. A prospective descriptive study was carried out in order to assess the influence of LC patient's nutritional status on the occurrence of complications and mortality in a tertiary care health institution in Havana City (Cuba). One-hundred twenty-one patients were recruited for the study (Women: 52,9 percent; Younger than 60 years: 59,0percent; Whites: 90,0 percent). C virus infection, alcoholism, and B virus infection accounted for 71,0percent of LC cases. Ninety-two percents of the patients had less than 5 yearse of diagnosis. Subjective Global Assessment (SGA) of nutritional status returned a 45,0percent of malnutrition. Malnutrition was associated with disease progression: twenty-one percent of A Child-Pugh Stage patients was malnourished, but this rate increased to become 90,0 percent among those in C stage. Fat and skeletal muscle compartments were reduced in 36,0 and 37,0percent of the patients, respectively. Complications affected 44,6 percent of the patients. Sixty percent of them were malnourished (p < 0,01). One-year mortality rate was 11,0percent. Ninety-two percent of deceased patients were malnourished (p < 0,01). LC malnourished patients have greater risk of complications and death as compared to well-nourished ones(AU)