Efficacy of the eradication of Helicobacter pylori infection in patients with chronic urticaria. A placebo-controlled double blind study.

Helicobacter pylori has been involved in the pathogenesis of chronic idiopathic urticaria (CIU) in patients suffering both CIU and H. pylori infection. We selected 49 patients with 13C urea breath test positive, long-lasting CIU and H. pylori infection; 20 remained symptomatic, had positive urease test or H. pylori histologic identification in gastric biopsy material and accepted to participate in a pacebo-controlled treatment trial. They were randomized for a 7-day, double-blind, placebo-controlled H. pylori eradication treatment with amoxicillin, clarithromycin and omeprazol or placebo. H. pylori eradication was assessed by a second 13C urea breath test six weeks after the end of treatment. We observed a significant improvement of more than 70 % of CIU; baseline clinical score was seen in 4 of the 9 (44 %) patients who eradicated H. pylori after active treatment and in 1 of the 7 (12,3 %) of those who did not (p = 0.19). No clinical differences in CIU characteristics were found between patients with and without improvement. No serious adverse effects were observed in either treatment group. We conclude that the eradication of H. pylori may be useful for patients suffering long-lasting CIU and H. pylori infection, although theses results did not reach statistical significance probably owing to the strict conditions of the recruitment.

Short- and long-term outcome of severe alcohol-induced hepatitis treated with steroids or enteral nutrition: a multicenter randomized trial.

Steroids are recommended in severe alcohol-induced hepatitis, but some data suggest that artificial nutrition could also be effective. We conducted a randomized trial comparing the short- and long-term effects of total enteral nutrition or steroids in these patients. A total of 71 patients (80% cirrhotic) were randomized to receive 40 mg/d prednisolone (n = 36) or enteral tube feeding (2,000 kcal/d) for 28 days (n = 35), and were followed for 1 year or until death. Side effects of treatment occurred in 5 patients on steroids and 10 on enteral nutrition (not significant). Eight enterally fed patients were prematurely withdrawn from the trial. Mortality during treatment was similar in both groups (9 of 36 vs. 11 of 35, intention-to-treat) but occurred earlier with enteral feeding (median 7 vs. 23 days; P =.025). Mortality during follow-up was higher with steroids (10 of 27 vs. 2 of 24 intention-to-treat; P =. 04). Seven steroid patients died within the first 1.5 months of follow-up. In contrast to total enteral nutrition (TEN), infections accounted for 9 of 10 follow-up deaths in the steroid group. In conclusion, enteral feeding does not seem to be worse than steroids in the short-term treatment of severe alcohol-induced hepatitis, although death occurs earlier with enteral nutrition. However, steroid therapy is associated with a higher mortality rate in the immediate weeks after treatment, mainly because of infections. A possible synergistic effect of both treatments should be investigated.

Genetic heterogeneity within ulcerative colitis determined by an interleukin-1 receptor antagonist gene polymorphism and antineutrophil cytoplasmic antibodies.

BACKGROUND: Although there is strong evidence implicating genetic predisposition in the pathogenesis of the chronic inflammatory bowel diseases, the number and identity of susceptibility genes remain uncertain. Cytokine genes are tentative candidate loci, but data regarding association studies in different populations are conflicting. AIMS: To determine potential associations of interleukin-1 receptor antagonist (IL-1ra), tumour necrosis factor alpha (TNF alpha), and tumour necrosis factor beta (TNF beta) gene polymorphisms with ulcerative colitis or subsets of ulcerative colitis in a Spanish population. METHODS: Genotyping for IL-1ra, TNF alpha and TNF beta gene polymorphisms was performed by the polymerase chain reaction in 95 patients with ulcerative colitis and 74 healthy controls. A variable number of tandem repeats (VNTR) in the IL-1ra gene, and a single base pair polymorphism in the TNF alpha gene promoter region (-308) and in the first intron of the TNF beta gene were analysed. Anti-neutrophil cytoplasmic antibodies (ANCA) were detected using an indirect immunofluorescence assay. RESULTS: There were no significant differences between ulcerative colitis patients and controls in either polymorphism analysed, nor between ulcerative colitis subgroups as a function of the clinical disease pattern. However, when stratified by their ANCA status, perinuclear ANCA (p-ANCA) ulcerative colitis showed an increased frequency of the genotype 1,2 of the IL-1ra gene compared with ANCA-negative ulcerative colitis (52% versus 28%; P = 0.02, Pcorr = 0.1). Furthermore, p-ANCA ulcerative colitis had a statistically significant increase of this genotype compared with cytoplasmic ANCA (c-ANCA)/ANCA-negative ulcerative colitis (52% versus 26.5%; P = 0.01, Pcorr = 0.05). CONCLUSIONS: In the Spanish population studied, the polymorphisms analysed in the IL-1ra, TNF alpha and TNF beta genes are unlikely to be important in the overall susceptibility to ulcerative colitis. However, the combination of a subclinical (p-ANCA) and a genetic (IL-1ra gene) marker identified a distinct ulcerative colitis subgroup (p-ANCA; IL-1ra genotype 1,2). These findings provide further evidence of genetic heterogeneity within ulcerative colitis, and support the concept that ANCA may represent a subclinical marker of genetic heterogeneity.

[antineutrophil cytoplasmic autoantibodies in inflammatory bowel disease]. / Anticuerpos anticitoplasma de neutrófilo en la enfermedad inflamatoria del intestino.

BACKGROUND: The aim of the present study was to determine the prevalence and diagnostic usefulness of antineutrophil cytoplasmic antibodies (ANCA) in a Spanish population of patients with inflammatory bowel disease from the province of Tarragona. PATIENTS AND METHODS: One hundred and fifty-six sera obtained from 116 patients with inflammatory bowel disease (75 ulcerative colitis and 41 Crohn's disease) and 40 healthy controls were tested using an indirect immunofluorescence assay. RESULTS: ANCA were detected in 65% of patients with ulcerative colitis but in only 12% of patients with Crohn's disease (p < 0.01), and 2.5% of control subjects (p < 0.01). The overall sensitivity of the test for the diagnosis of ulcerative colitis was 65% with a specificity of 88% and a positive predictive value of 91%. Among patients with ulcerative colitis there was no relationship between the presence or titre of ANCA and the duration, the clinical course, the extent, the disease activity or the need for medical treatment. CONCLUSIONS: In the population studied, ANCA occur more commonly in ulcerative colitis than in Crohn's disease, as reported in other populations. Their determination in patients with inflammatory bowel disease may be useful to differentiate ulcerative colitis from Crohn's disease.

Renal and neurohormonal changes following simultaneous administration of systemic vasoconstrictors and dopamine or prostacyclin in cirrhotic patients with hepatorenal syndrome.

BACKGROUND/AIMS: Intravenous ornipressin in cirrhotic patients with hepatorenal syndrome causes marked improvement of systemic hemodynamics and suppression of plasma renin and norepinephrine but only moderate improvement of renal function. This study was designed to investigate whether these beneficial effects could be enhanced by the simultaneous administration of dopamine. The renal effects of the i.v. infusion of norepinephrine plus prostacyclin in patients with hepatorenal syndrome were also assessed. METHODS: Renal plasma flow, glomerular filtration rate, free water clearance, sodium excretion and the plasma levels of renin and norepinephrine were measured in baseline conditions and during the administration of ornipressin (6 i.u./h) and ornipressin (6 i.u./h) plus dopamine (2 micrograms/kg.min) in nine patients with hepatorenal syndrome. Five additional patients with hepatorenal syndrome were studied prior to and following the administration of norepinephrine (0.45 +/- 0.1 microgram/kg.min) and norepinephrine (0.85 +/- 0.2 microgram/kg.min) plus prostacyclin (5 ng/kg.min). RESULTS: Despite a significant increase in arterial pressure and marked suppression of plasma renin activity during ornipressin and ornipressin plus dopamine administration, no significant improvement in renal function was observed. Norepinephrine and norepinephrine plus prostacyclin also failed to increase renal perfusion and glomerular filtration rate. CONCLUSIONS: The combined administration of systemic vasoconstrictors (ornipressin or norepinephrine) and vasodilators (dopamine or prostacyclin), at the doses used in the current study and for a short period of time, does not improve renal function in cirrhotic patients with hepatorenal syndrome. The current study does not confirm a potential role for ornipressin in the treatment of hepatorenal syndrome.

Randomized trial comparing albumin, dextran 70, and polygeline in cirrhotic patients with ascites treated by paracentesis.

BACKGROUND & AIMS: Paracentesis associated with plasma expanders is widely used for the treatment of ascites in cirrhosis. This study investigated the clinical importance of paracentesis-induced-circulatory dysfunction and compared the efficacy of albumin, dextran 70, and polygeline in preventing this complication. METHODS: A total of 289 cirrhotic patients with ascites were randomized to treatment by total paracentesis plus intravenous albumin (97 patients), dextran 70 (93 patients), or polygeline (99 patients). Postparacentesis circulatory dysfunction was defined as an increase in plasma renin activity on the sixth day after paracentesis of more than 50% of the pretreatment value to a level > 4 ng.mL-1.h-1. RESULTS: Postparacentesis circulatory dysfunction occurred more frequently in patients treated with dextran 70 (34.4%; P = 0.018) or polygeline (37.8%; P = 0.004) than in those receiving albumin (18.5%). The plasma expander used and the volume of ascites removed were independent predictors of this complication. Postparacentesis circulatory dysfunction persisted during follow-up and was associated with a shorter time to first readmission (1.3 +/- 0.5 vs. 3.5 +/- 0.8 months, median +/- SEM; P = 0.03) and shorter survival (9.3 +/- 4.2 vs. 16.9 +/- 4.3 months; P = 0.01). Creatinine and sodium levels in serum, and Child-Pugh score at inclusion, and postparacentesis circulatory dysfunction were independent predictors of survival. CONCLUSIONS: Postparacentesis circulatory dysfunction is not spontaneously reversible and is associated with a shorter time to first readmission and shorter survival. Albumin is the best plasma expander to prevent this complication.

Metastatic breast carcinoma presenting as obstructive jaundice.

A case of obstructive jaundice due to extrahepatic intraductal biliary metastasis from a breast carcinoma is reported. This clinical picture was a late manifestation and the first evidence of spread of the disease. The patient was treated by surgical decompression with relief of jaundice but died 5 months later. In patients with a history of carcinoma of the breast, the possibility of extrahepatic biliary metastasis should always be considered in the differential diagnosis of jaundice. Because this condition is amenable to palliation, it is important to differentiate it from jaundice due to hepatic involvement by this tumor.

Antineutrophil cytoplasmic antibodies in relatives of patients with inflammatory bowel disease.

BACKGROUND: The occurrence of antineutrophil cytoplasmic antibodies (ANCA) has been reported more frequently than expected in healthy first-degree relatives of patients with ulcerative colitis, suggesting that these antibodies may represent a subclinical marker of genetic disease susceptibility. AIM: To determine the prevalence of ANCA in unaffected first-degree relatives of inflammatory bowel disease patients in a Spanish population. METHODS: Three hundred and seventy sera obtained from 80 patients with inflammatory bowel disease (55 ulcerative colitis, 25 Crohn's disease), 217 unaffected first-degree relatives (157 from ulcerative colitis and 60 from Crohn's disease patients), 62 healthy controls, and 11 celiac disease patients were tested using an indirect immunofluorescence assay. RESULTS: Antibodies were detected in 64% of patients with ulcerative colitis but in only 12.5% of patients with Crohn's disease. ANCA were seldom present in their unaffected first-degree relatives (4.6%), control subjects (1.6%), and celiac disease patients (0%). CONCLUSIONS: In the Spanish population studied, antineutrophil cytoplasmic antibodies occur more commonly in ulcerative colitis than in Crohn's disease, as reported in other Caucasian populations. Moreover, their presence is not increased in their first-degree relatives. These findings indicate that ANCA are not a subclinical marker of genetic susceptibility to inflammatory bowel disease in this population.

[Esophageal intramural pseudodiverticulosis]. / Pseudodiverticulosis intramural esofágica.

Esophageal intramural pseudodiverticulosis is an uncommon and benign primary disease of the esophagus. Less than 150 cases have been reported. We report a new case diagnosed by endoscopy during the investigation of an upper gastrointestinal bleeding, in a 48-year-old man who was assymptomatic from the esophageal point of view. We discuss the clinical, pathogenic, diagnostic and therapeutic aspects of this disease.

Propranolol plus isosorbide-5-mononitrate for portal hypertension in cirrhosis: long-term hemodynamic and renal effects.

The effect on kidney function, vasoactive systems and ascites outcome of long-term treatment with propranolol plus isosorbide-5-mononitrate, a combined therapy proven more effective than propranolol alone in decreasing portal pressure in the cirrhotic patient, is unknown. Thirty cirrhotic patients who survived acute variceal bleeding and were treated with propranolol plus isosorbide-5-mononitrate were studied. Portal and systemic hemodynamics (n = 15), inulin clearance, free water clearance, plasma renin activity, aldosterone concentration and prostaglandin E2 excretion (n = 20) were measured before and after 3 mo of treatment. In addition, data on ascites outcome in the entire series after a mean follow-up of 9.6 mo were compared with those of 30 patients undergoing elective sclerotherapy and with those of 30 patients treated with propranolol alone matched for age, sex, presence of ascites, Child-Pugh class and mean follow-up length included in other randomized controlled trials. Combined therapy significantly decreased the hepatic venous pressure gradient and azygos blood flow. In addition, no changes in inulin clearance, free water clearance, plasma renin activity, aldosterone concentration and prostaglandin E2 excretion occurred, despite a mild decrease in mean arterial pressure. Moreover, no differences among the three groups of patients studied in ascites outcome were found. These results suggest that long-term treatment with propranolol plus isosorbide-5-mononitrate does not impair kidney function, vasoactive systems or ascites outcome in cirrhotic patients.

Magnesium hydrogen breath test using end expiratory sampling to assess achlorhydria in pernicious anaemia patients.

A modified magnesium hydrogen breath test, using end expiratory breath sampling, is described to investigate achlorhydria. The efficacy of this test in the diagnostic investigation of pernicious anaemia was compared with that of serum pepsinogen I. Twenty one patients with pernicious anaemia--that is, patients with achlorhydria--and 22 with healed duodenal ulcer and normal chlorhydria were studied. Magnesium hydrogen breath test, serum pepsinogen I, serum gastrin, and standard gastric acid secretory tests were performed in all subjects. The mean (SEM) hydrogen peak value was lower in patients with pernicious anaemia than in the duodenal ulcer group (21.7 (1.9) v 71.3 (5.2) ppm; p = 0.00005). The hydrogen peak value had a 95.2% sensitivity and a 100% specificity to detect pentagastrin resistant achlorhydria. Mean serum pepsinogen I concentrations were also significantly lower in patients with pernicious anaemia than in the duodenal ulcer group (10.7 (2.7) v 123.6 (11.8) micrograms/l p = 0.00005). Sensitivity and specificity to detect pernicious anaemia were both 100% for pepsinogen I. It is concluded that this modified magnesium hydrogen breath test is a simple, noninvasive, cost effective, and accurate method to assess achlorhydria and may be useful in the diagnostic investigation of patients with suspected pernicious anaemia.

Impact of shunt surgery for variceal bleeding in the natural history of ascites in cirrhosis: a retrospective study.

Despite the efficacy of shunt surgery in the treatment of variceal bleeding, less effective nonoperative therapies are being substituted because surgical shunt does not modify survival and increases hepatic encephalopathy. However, the real impact of shunt surgery on the natural history of ascites and its complications has not been established. The course of 204 Child-Pugh A and B cirrhotic patients with variceal bleeding included in three controlled trials of our units who survived first hospitalization was updated. Ninety-eight patients (group I) were treated by portacaval (56 patients) or distal splenorenal (42 patients) shunt, whereas 106 (group II) were treated by nonshunt procedures (sclerotherapy in 89 patients and staple transection in 17 patients). As expected, the 5-yr probability of variceal rebleeding was lower (13% vs. 44%) and hepatic encephalopathy higher (50% vs. 28%) in group I than in group II, and survival was similar (67% vs. 60%). Shunt surgery had a great impact on the natural history of ascites and its complications. The probability of occurrence of ascites (15% vs. 73%; p < 0.0001), spontaneous bacterial peritonitis (2% vs. 21%; p < 0.0001) and hepatorenal syndrome (4% vs. 21%; p < 0.01) was greatly reduced. These beneficial effects accounted for the lower percentage patients requiring readmissions (51% vs. 70%; p = 0.02) and shorter total time spent in hospital (14 +/- 22 vs. 26 +/- 39 days/patient; p = 0.01) in group I. These data indicate that shunt surgery, in addition to reducing the probability of rebleeding, markedly decreases the probability of ascites, spontaneous bacterial peritonitis and hepatorenal syndrome development.(ABSTRACT TRUNCATED AT 250 WORDS)

A prospective randomized trial comparing somatostatin and sclerotherapy in the treatment of acute variceal bleeding.

Somatostatin and endoscopic sclerotherapy are widely used in the treatment of acute variceal bleeding. Although objective evidence does exist about the advantages of either treatment, data comparing both procedures are scarce. In order to compare the effectiveness and safety of somatostatin and sclerotherapy in the treatment of acute variceal bleeding, 70 consecutive cirrhotic patients suffering from esophageal variceal hemorrhage and meeting the inclusion criteria were randomly assigned to treatment with somatostatin (35 patients) or sclerotherapy (35 patients). No differences in age, sex, alcohol intake, etiology of cirrhosis and severity of liver failure were found between groups. Failure of treatment (defined as persistence of bleeding despite therapy or subsequent rebleeding within the 48-hr trial period) occurred in seven patients (20%) in the somatostatin group and in six (17.1%) in the sclerotherapy group (NS). Early rebleeding occurred in seven of 28 patients (25%) in the somatostatin group and in five of 29 (17.2%) in the sclerotherapy group (NS). Mortality within the first 6 wk was no different between both groups: 10 (28.5%) and eight (22.8%) in the somatostatin and sclerotherapy groups, respectively. Sclerotherapy, but not somatostatin, was associated with major complications in five cases (14.2%) (p = 0.026), two of which resulted in patient's death. These results suggest that somatostatin is safer, and as effective as sclerotherapy, in controlling acute variceal bleeding until an elective treatment can be established.

Routine tests of renal function, alcoholism, and nutrition improve the prognostic accuracy of Child-Pugh score in nonbleeding advanced cirrhotics.

In an attempt to improve the prognostic capacity of Child-Pugh score in nonbleeding cirrhotics, 110 consecutive in-patients without gastrointestinal hemorrhage at admission were studied and followed up for 24 months or until death. Fifty-five of the 110 patients (50%) died during this period. Mean survival time was 18.8 +/- 1.4 months (mean +/- SEM). In addition to Child-Pugh score, eight variables, including anthropometric nutritional parameters, routine renal function tests, and alcoholism markers, were recorded at admission. The ability of these variables to improve the prognostic capacity of the Child-Pugh score was assessed with the proportional hazard Cox's regression procedure, using a stepwise method for covariate selection, after including the Child-Pugh score at the first step. Thus, in addition to Child-Pugh score (beta = 0.302), three variables were included in the final model: serum urea (beta = 0.113), MCV (beta = 0.027), and mid-arm muscle circumference (beta = -0.025). According to the contribution of each of these factors to the model, a prognostic index was obtained to estimate survival in the individual patient. An assessment of the predictive power of the model was made by means of a split-sample technique. The prognostic index described in this study may contribute to improve the selection of nonbleeding patients with advanced cirrhosis to receive specific therapies such as transplantation. However, its true clinical relevance will be established only by prospectively comparing its prognostic value with that of the Child-Pugh score in a new sample of patients.

Short-term prognosis of cirrhotics with spontaneous bacterial peritonitis: multivariate study.

In order to identify the predictive factors of hospital mortality in cirrhotics with spontaneous bacterial peritonitis (SBP), we studied 64 patients who fulfilled the accepted diagnostic criteria. All cases were treated with cefotaxime up to 2 days after the infection was considered cured (7.7 +/- 2.9 days). Eleven patients (17%) died while in hospital, six of them before SBP was cured. After uni- and multivariate analyses, only seven routine clinical, biological, and bacteriological variables studied were independently associated with hospital mortality. These were: the presence of upper gastrointestinal bleeding at admission (beta = 2.01), the absence of abdominal pain as presenting symptom (beta = -1.29), the polymorphonuclear count (%) in the ascites (beta = 0.48), prothrombin rate (beta = -0.22), and serum Na (beta = -0.64), creatinine (beta = 0.50), and cholesterol (beta = -0.68). When the equation obtained was computed in a randomly selected sample of the patients studied, it correctly predicted the outcome in 92.3% of the cases. We conclude that short-term outcome of SBP patients depends on the existence of recent gastrointestinal bleeding, the severity of SBP, and the degree of liver and renal failure. The prognostic value of this model needs prospective validation in a new series of patients.

Prognostic factors of hepatic encephalopathy after portacaval anastomosis: a multivariate analysis in 50 patients.

Portacaval anastomosis has proved to be effective in avoiding active and recurrent hemorrhage from gastroesophageal varices in liver cirrhosis. However, hepatic encephalopathy is the most common and serious complication of this procedure. The aim of this study was to investigate by multivariate analysis the predictive factors of development of hepatic encephalopathy in 50 Child's A and B cirrhotic patients whose variceal bleeding was treated with emergency (n = 17) or elective (n = 33) portacaval anastomosis. The etiology of the cirrhosis was alcoholic in 74% of cases. The mean follow-up was 22.7 +/- 16.6 months (range 1-60 months). The 2-yr probability of suffering from at least one episode of hepatic encephalopathy in the overall group was 43%. The multivariate analyses (Cox's regression method) of 37 variables based upon clinical history, physical examination, and laboratory data disclosed that only five of these variables had independent predictive value: need for diuretic treatment in the days prior to surgery, absence of hepatomegaly, and serum levels of total bilirubin, gamma-globulin, and hemoglobin. According to the contribution of each one of these factors to the final model, a prognostic index was obtained which allowed the division of patients in two different groups of risk for developing hepatic encephalopathy (20% and 74%, respectively, after 2 yr of surgery; p = 0.0002). This index may help to better choose those candidates for portacaval anastomosis.

CT demonstration of pelvic wall spread in primary colonic linitis plastica.

Primary linitis plastica of the colon is a rare entity, and its radiographic and CT findings have been described in previously published literature. We present the CT demonstration of the pelvic wall spread in this unusual disease, and briefly review its radiologic and pathologic features.

Aleatory clinical study comparing otilonium bromide with a fiber-rich diet in the treatment of irritable bowel syndrome.

We studied 114 patients affected by irritable bowel syndrome (IBS) (group A = 53 patients, group B = 61). Group A received diet with high content of roughage (20 g of fibers) and 10 g of bran, group B received otilonium bromide (OB) 40mg tid and normal diet (10-15 g of fibers). Abdominal pain, abdominal distension, bowel movements were evaluated before treatment (T0) at the end (T24) and after 12 months (T12). In group B otilonium bromide induced a significant improvement (p less than 0.01) of abdominal pain and distension when comparing T0 with T24. In group A diet produced an improvement, albeit not significant, of the aforementioned parameters at T24. On the basis of our data OB seems to be more effective than a high-fiber diet in the treatment of IBS.

[Impact on the energetic-proteic nutritional status of total paracentesis combined with infusion of albumin or dextran-70 in the therapy of tension ascites in liver cirrhosis]. / Repercusión sobre el estado nutricional energético-proteico de la paracentesis total asociada a la infusión de albúmina o dextrano-70 en el tratamiento de la ascitis a tensión en la cirrosis hepática.

The aim of this study was to investigate the effect of total paracentesis plus albumin or dextran-70 infusion on the nutritional status in cirrhotics with tense ascites. Seventeen patients were studied. Eight patients (group I) were treated with total paracentesis and albumin infusion, and in 9 cases (group II) dextran-70 infusion was associated to total paracentesis. The nutritional status was assessed before and two days after the procedure by measuring triceps skinfold thickness, mid-arm muscle circumference and serum albumin. No changes in anthropometric parameters were observed in either group. Patients in group I showed a significant increase in serum albumin levels (from 26.6 +/- 1.4 to 28.9 +/- 1.3 g/l; p = 0.007), whereas this parameter decreased in group II (from 25.5 +/- 1.3 to 23.1 +/- 1.4 g/l; p = 0.005). However, serum albumin levels returned to initial values in both groups one month after total paracentesis. There were no differences between both groups regarding the appearance of complications and mortality rate during admission. These results suggest that total paracentesis plus either i.v. albumin or dextran-70 has no long-term effect on the protein-energy nutritional status.

[Prophylactic sclerosis of esophageal varices. Results of a controlled prospective study]. / Esclerosis profiláctica de varices esofágicas. Resultados de un estudio prospectivo controlado.

BACKGROUND: Endoscopic sclerosis of esophageal varices is effective both to treat active hemorrhage and to prevent recurrences. By contrast, its usefulness for the prophylaxis of the first episode of hemorrhage is not well established, the available data being contradictory. METHODS: Overall 46 patients with cirrhosis and esophageal varices of type B or higher, without previous upper gastrointestinal hemorrhage, were randomized to be treated with prophylactic sclerosis or not (n = 22 and 24, respectively). Both groups were comparable in age, sex, etiology of cirrhosis (mainly alcoholic), Child's degree of hepatic failure, coagulation studies, laboratory data and endoscopic findings. RESULTS: In a mean follow up of 16 months, the patients treated with sclerosis had a higher frequency of hemorrhage from gastroesophageal varices (27%) than those in the control group (8%) (n.s.). However, this difference reached significance (p = 0.02) when only patients from Child's classes A and B were considered (31% in the sclerosis group vs 5% in the control group). The mortality rate was similar in both groups, with a probability of one year survival of 80 and 76% in the sclerosis and control groups, respectively. CONCLUSIONS: The results indicate that prophylactic sclerotherapy does not improve short-term survival or reduce the risk of a first hemorrhage due to gastroesophageal varices of type B or higher in hepatic cirrhosis. It may even facilitate the development of this severe complication in Child's A and B class patients.