Long-term follow up of a randomized, controlled trial on prophylactic sclerotherapy of small oesophageal varices in liver cirrhosis.

BACKGROUND: In order to evaluate the prophylactic impact of sclerotherapy of small varices in patients with cirrhosis and no endoscopic signs suggesting risk of haemorrhage, a randomized clinical trial was performed. METHODS: Seventy-one hospitalized patients met the inclusion criteria of diagnosis of cirrhosis with no previous bleeding and small varices. Due to exclusion criteria of: gastroduodenal ulcers (n = 5), diverticulosis (n = 1), hepatic insufficiency (n = 10), hepatocellular carcinoma (n = 4), death before randomization (n = 6), age over 70 (n = 1) and denial of consent to participate in the study (n = 1), 43 patients could be randomized, 21 for sclerotherapy and 22 for the control group. Two patients (one in each group) were lost to follow up, and another patient, although not lost, refused sclerotherapy after randomization. Ethanolamine oleate was used as the sclerosing agent. All patients were followed up for a mean time of 60 months, initially every 2 months for the first 2 years and clinical and endoscopic controls were performed each 6-12 months thereafter. RESULTS AND CONCLUSIONS: During the first 2 years clinical assessment showed that there were five bleedings in the sclerotherapy group and none in the control group, but mortality was similar in both groups. Long-term follow up continued to show a higher prevalence of bleeding in the sclerotherapy group but that mortality was not different from the control group.

A prospective study of bacterial infections in patients with cirrhosis.

One hundred and seventy hospitalized patients with cirrhosis were included in a prospective and sequential study, to verify the prevalence and most frequent causes of bacterial infection. The differences in clinical and laboratory data between the two groups were analyzed: group I--80 patients who developed bacterial infection and group II--90 patients without bacterial infection. The prevalence or cumulative frequency of the development of bacterial infection during one hospitalization was 47.06%. Among these, the most frequent types of infection were: spontaneous bacterial peritonitis (SBP): 31.07%, urinary tract infection (UTI): 25.24% and pneumonia: 21.37%. Community infections were more frequent (56.25%) than nosocomial infections (32.50%) and they occurred sequentially in 11.25% of the cases. The agents responsible were gram negative bacteria in 72.34% of the cases. Clinical and biochemical parameters in bacterial infection were generally correlated with the severity of liver disease. Child-Pugh classification showed a predominance of class C in infected cirrhotic patients compared to non-infected ones. During hospitalization, the mortality rate of group I was 30% whereas in group II it was 5.55% (P = 0.0001). SBP and pneumonia were the most severe types of infection, with high mortality rates, 31.25% and 40.91%, respectively. These results indicate that bacterial infection is a severe complication in the course of cirrhosis.

Double-blind randomized clinical trial comparing neomycin and placebo in the treatment of exogenous hepatic encephalopathy.

Hepatic encephalopathy due to cirrhosis is frequently precipitated by exogenous factors, and the effectiveness of a specific treatment with neomycin sulfate has so far not been submitted to clinical trials. Over a period of five years, 102 cirrhotic patients developed hepatic encephalopathy at admission or during hospitalization, and 39 were randomized for treatment with either neomycin sulfate or placebo. Exclusion criteria were: 1. current usage of specific treatment for hepatic encephalopathy, 2. chronic hepatic encephalopathy and 3. multiple organ failure syndrome associated with hepatic encephalopathy. The group of excluded patients (n = 63) was compared with the randomized group (n = 39), and no statistical differences were found regarding sex and age distributions, Child-Pugh classification, etiology of cirrhosis, percipitating factors and grade of hepatic encephalopathy. These same parameters were also comparable among the 20 patients who received active neomycin and the 19 who were treated with placebo. The therapy for hepatic encephalopathy consisted in the control of precipitating factors associated with 6 g of neomycin sulfate "per os" or placebo. Therapeutic failure and death by the fifth day of treatment, occurred in four patients (10.2%), two in each of the randomized groups. The time elapsed between the initiation of the therapeutic procedure and regression to grade zero of hepatic encephalopathy was 39.11 +/- 23.04 hours for the group of active neomycin, and 49.47 +/- 21.92 hours for the placebo group, but this difference did not achieve statistical significance.

Cryptogenic cirrhosis: clinico-biochemical comparison with alcoholic and viral etiologies.

Cryptogenic cirrhosis defines a group of undetermined etiology that would either be caused by factors as alcohol, virus and others or be due to still unknown etiological factors. To test these hypotheses we have looked for similarities or differences in clinico-biochemical presentation of 196 cases of alcoholic, viral and cryptogenic cirrhosis. Age, jaundice, spiders, palmar erythema and factor V showed a statistically significant difference of the cryptogenic cirrhosis when compared with both alcoholic and viral etiologies. On clinico-biochemical grounds it could be suggested that cryptogenic cirrhosis would constitute a discrete group, based on the following parameters: predominance of females, a more advanced age, less marked peripheral signs of chronic hepatic failure (jaundice, spiders and palmar erythema) besides milder alterations of laboratory liver function tests.