Articular manifestations in inflammatory bowel disease patients: a prospective study.

BACKGROUND AND AIMS: Rheumatic manifestations are frequent in inflammatory bowel disease (IBD) and are associated with a wide range of clinical patterns. METHODS: Articular symptoms and signs were investigated by questionnaire in a cohort of 651 pts, mean age 42+/-14 years, followed at two referral hospitals over a 12-month period. RESULTS: 142 ulcerative colitis (UC) and 120 Crohn's disease (CD) patients referred articular pain during their IBD history: in 46% this was associated with active IBD, in 56% symptoms were intermittent and in 19% symptoms preceded IBD diagnosis. 62 pts (28 UC, 34 CD) complaining of articular symptoms at the time of the interview, were investigated by the rheumatologist: arthropathy was axial in 52%, oligoarticular in 16% and polyarticular in 23%. Oligoarthritis commonly involved the lower limbs and was more commonly associated with UC. The mean number of small joints involved was significantly higher in CD than in UC pts (9.9+/-8.2 vs. 5.6+/-4.3; p<0.01). Bone scintigraphy was abnormal in 70% of pts. CONCLUSIONS: Prevalence of self-reported articular symptoms in IBD patients exceeds 40% with 9.5% incidence during 1-year follow up. Symptoms predict entheropatic involvement of the locomotor system.

Consensus recommendations for managing asymptomatic persistent non-virus non-alcohol related elevation of aminotransferase levels: suggestions for diagnostic procedures and monitoring.

A persistent increase in non-virus non-alcohol related aminotransferase levels can have multiple causes, which differ in terms of prevalence and clinical importance. In the general population, the most frequent cause is non-alcoholic hepatic steatosis, which can evolve into steato-hepatitis and cirrhosis. The treatment for steatosis and non-alcoholic steato-hepatitis consists of modifying lifestyles, whereas the effectiveness of drug treatment remains to be determined. Other much less frequent (yet not rare) causes of persistent non-virus non-alcohol related elevations in aminotransferase levels are celiac disease and hemochromatosis, whereas autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, and alpha-1-anti-trypsin deficit are rare. Given that some of these conditions are susceptible to treatment, early diagnosis is important. No epidemiological data are available for evaluating the prevalence of elevated aminotransferase levels correlated with the toxicity of drugs or other xenobiotics, including herbal products. The present document, created by a panel of experts based on a systematic review of scientific evidence, is mainly geared towards physicians working in General Medicine and Transfusion Centres, who generally represent the first contact of persons with elevated aminotransferase levels. The document includes suggestions for diagnosing causes of persistent non-virus non-alcohol related increases in aminotransferase levels, considering the frequency and response to treatment. The conditions requiring specialized visits are also indicated.

A highly accurate method for monitoring histological recovery in patients with celiac disease on a gluten-free diet using an endoscopic approach that avoids the need for biopsy: a double-center study.

BACKGROUND AND STUDY AIM: Endoscopy with duodenal biopsy is often performed in order to assess histological recovery in patients with celiac disease who are on a gluten-free diet. Use of the "immersion" technique during upper endoscopy allows visualization of duodenal villi or detection of total villous atrophy. In this two-center study, we investigated the accuracy of the immersion technique in predicting histological recovery in patients on a gluten-free diet whose initial diagnosis of celiac disease had been made on the basis of total villous atrophy. PATIENTS AND METHODS: The immersion technique was performed in 62 patients with celiac disease who were being treated and who had been referred for follow-up (26 patients at the Rome center and 36 patients at the Vicenza center). All these patients had an initial diagnosis based on positive antibodies and biopsy-proved duodenal total villous atrophy. At the follow-up examination, the duodenal villi were re-evaluated as present or absent by one endoscopist at each center, and the results were compared with the histology. RESULTS: At the follow-up endoscopy, the duodenal villi were found to be present in 51 patients and absent in 11. The sensitivity, specificity, positive predictive value, and negative predictive value of the immersion technique for detecting the presence or absence of villi were all 100 %. CONCLUSIONS: This study demonstrated the feasibility and the high level of accuracy of the immersion technique in predicting the histological recovery of duodenal villi in patients with celiac disease who are following a gluten-free diet. An endoscopy-based approach that avoids the need for biopsy could be useful for monitoring the dietary adherence and/or response of patients with an initial diagnosis of celiac disease based on total villous atrophy.

Small intestine bacterial overgrowth in irritable bowel syndrome: a retrospective study with rifaximin.

AIM: Irritable bowel syndrome (IBS) is a frequent diagnosis in gastroenterology, but it is now clear that an altered dynamic equilibrium and bacterial overgrowth in the small intestine may mimic an IBS-like syndrome. METHODS: We have, therefore, evaluated the real prevalence of small intestinal bacterial overgrowth (SIBO) by retrospectively examining the glucose hydrogen (H(2)) breath test in 96 patients with a previous symptoms-based IBS diagnosis. Moreover, we wished to evaluate the efficacy of the locally acting antibiotic rifaximin in eradicating a SIBO syndrome. RESULTS: The breath test showed a SIBO syndrome in 44 out 96 IBS patients (45.8%), who had H(2) peaks in the expired air higher than 10 ppm over the baseline value (mean: 36.2+/-18.7 ppm). All these patients were treated with rifaximin (1 200 mg/day for 14 days) followed by a twenty-day cycle of probiotics. Twenty-three of them returned to a control visit within 4-5 months: the glucose breath test became negative in 19 cases (82.6%; P<0.01) and mean peak value of H(2) significantly decreased from 40.9+/-20.4 to 4.78+/-8.42 ppm (P<0.001). Patients reported also a substantial improvement of the IBS symptoms. No adverse effect was observed. CONCLUSIONS: These data indicate a SIBO syndrome is present in about half of patients with an IBS diagnosis and, therefore, it should always be suspected in these patients. Moreover, the use of broad-spectrum non absorbable antibiotics, such as rifaximin, represents a safe and effective approach to SIBO with a low risk of causing microbial resistance.

Bacterial infection in patients with advanced cirrhosis: a multicentre prospective study.

AIMS: To evaluate the prevalence, incidence and clinical relevance of bacterial infection in predominantly non-alcoholic cirrhotic patients hospitalised for decompensation. PATIENTS/METHODS: A total of 405 consecutive admissions in 361 patients (249 males and 112 females; 66 Child-Pugh class B and 295 class C) were analysed. Blood, urine, ascitic and pleural fluid cultures were performed within the first 24 hours, during hospitalisation whenever infection was suspected, and again before discharge. RESULTS: Over a one year period, 150 (34%) bacterial infections (89 community- and 61 hospital-acquired) involving urinary tract (41%), ascites (23%), blood (21%) and respiratory tract (17%) were diagnosed. The prevalence of bacterial peritonitis was 12%. Infections were asymptomatic in 69 cases (46%) and 130 (87%) involved a single site. Enteric flora accounted for 62% of infections, Escherichia Coli being the most frequent pathogen (25%). Community-acquired infections were associated with more advanced liver disease (Child-Pugh mean score 10.2+/-2.1 versus 9.5+/-1.9, p<0.05), renal failure (p<0.05), and high white blood cell count (p<0.01). Hospital-acquired infections occurred more frequently in patients admitted for gastrointestinal bleeding (p<0.05). The in-hospital mortality was significantly higher in infected than in non-infected patients (15% versus 7%, p<0.05), and infection emerged as an independent variable affecting survival. Moreover bacterial infection accounted for a significantly prolonged hospital stay. CONCLUSIONS: Bacterial infection, regardless of the aetiology, is a severe complication of decompensated cirrhosis, and, although frequently asymptomatic, accounts for both longer hospital stay and increased mortality.

Clinical practice guidelines for the management of cirrhotic patients with ascites. Committee on Ascites of the Italian Association for the Study of the Liver.

An ad hoc Committee appointed by the Italian Association for the Study of the Liver prepared these Clinical Practice Guidelines for the Management of Cirrhotic Patients with Ascites. The initial evaluation of a patient with ascites should include a history, physical evaluation, paracentesis with ascitic fluid analysis, abdominal ultrasonography and biochemistry to assess the severity of liver disease and renal functionality. To improve the efficiency of the choice between the different opportunities available in the treatment of ascites, patients can be classified into two subgroups: patients with uncomplicated ascites and patients with complicated ascites, including refractory ascites, bacterial peritonitis, hyponatraemia and renal failure. Based upon evidence emerging from controlled clinical trials or case-control studies, satisfactory treatment for uncomplicated ascites is represented by paracentesis, sodium-restricted diet and diuretics, whereas the treatment of patients with complicated ascites requires other specific approaches. As the prognosis for most patients with ascites is poor, the last part of the paper offers simple criteria in the selection of patients candidates for liver transplantation. The aim of these guidelines is to reduce inappropriate practice and to improve efficiency in the management of patients with ascites. The Committee holds that a periodic update will be necessary to conform to future scientific developments.

Reinfusion of concentrated ascitic fluid versus total paracentesis. A randomized prospective trial.

We compared the efficacy and safety of apheresis and reinfusion of concentrated ascites (ARCA) versus total paracentesis plus intravenous albumin (PARA) in a prospective trial on cirrhotic patients with tense ascites. Twenty-four patients were randomized to either ARCA (N = 12) or PARA (N = 12), and followed for two years. Sex, age, Child's class, and renal and liver function were similar in the two groups. The times the procedures were 2.7 +/- 1.0 (ARCA) vs 2.2 +/- 1.1 (PARA) hr, with removal of 8.8 +/- 3.5 (ARCA) and 6.9 +/- 3.4 (PARA) liters of ascites and intravenous infusion of 59.8 +/- 35.2 (ARCA) and 42.5 +/- 20.5 (PARA) g of albumin. Both procedures were safe. Biochemical signs of coagulative disturbances having no clinical relevance were observed after ARCA, with an increase in prothrombin time (P = 0.005) and serum FSP (P = 0.02). No significant changes in renal function, serum albumin, or plasma and urinary electrocytes were shown. Plasma renin activity increased after PARA (P = 0.02) and plasma atrial natriuretic factor increased after ARCA (P = 0.008), although no differences were observed in diuresis in the immediate follow-up. During the long-term follow-up, patient survival and recurrence of tense ascites were the same in both groups. We conclude that apheresis and reinfusion of concentrated ascites are as safe and effective as total paracentesis with albumin infusion for the treatment of tense ascites in cirrhotic patients.

Gastrectomy, lack of gastric first pass metabolism of ethanol and alcoholic liver disease. Results of a multicentre study.

BACKGROUND: Some conditions characterized by a loss (anatomical or functional) of parietal cells of the gastric antrum, containing an alcohol-dehydrogenase, may reduce the first pass metabolism of ethanol at that level and, simultaneously, raise its bioavailability. The observation that the first pass metabolism was drastically suppressed after gastrectomy would appear to suggest that the latter condition represents a risk for the development of liver damage in patients who continue to consume alcohol even in a non relevant amount. METHODS: Consecutively enrolled in the study were 304 individuals of both sexes aged between 45 and 70 years of whom 114 gastrectomized and 190 pair-matched control subjects all submitted to an Upper Gastrointestinal Endoscopy for whatever disturbance. All the patients were diagnosed as having liver disease with routine clinical and instrumental means. Information was collected concerning the mean daily alcohol intake, both before and after the operation. RESULTS: The overall prevalence of hepatic lesions was shown to be higher in the gastrectomized than in the control group (42.1% vs 25.8%, p = 0.005). Moreover, referring only to alcohol-related hepatic lesions (steatosis, steato-fibrosis and cirrhosis), the prevalence was higher in the gastrectomized patients than in the controls (29.8% vs 17.9%, p = 0.02). As far as concerns alcohol consumption, the gastrectomized group had consumed 71 g/day and the control group 39 g/day alcohol per person (p < 0.05) in a similar period of time (35 and 33 years, respectively). Also the non alcohol-related liver damage (especially the viral type) was slightly higher in the gastrectomized patients (gastrectomized 12.3% vs control 7.9%, p = ns). Accordingly, the percentage of serum markers of viral infection was higher in this group (HBs Ag: gastrectomized 3.9% vs control 2.2%, p = ns; anti-HCV: gastrectomized 13.5% vs control 5.0%, p = 0.03). Finally, to test the eventual damaging effects of gastrectomy alone (excluding ethanol and/or viral infection), two groups of patients with a medium to low alcoholic negative assumption (30-60 g ethanol/day) and no signs of viral infection (HBsAg and anti-HCV negative) were extrapolated. In these two selected groups, the prevalence of alcoholic-related hepatic lesions were not statistically different (28 gastrectomized 20.3% vs 44 control 18.4%). CONCLUSIONS: In conclusion, data emerging from investigations on the population under study indicate that the alcohol and viral infection appear to play a more important role in determining hepatic lesions than gastroresection.

Serum malondialdehyde and mitochondrial aspartate aminotransferase activity as markers of chronic alcohol intake and alcoholic liver disease.

Since lipid peroxidation is a well-know mechanism of alcohol-related liver damage, the aim of the present study was to assess the role of serum malondialdehyde (MDA), a secondary product of lipoperoxidation, in the detection of alcoholism and different stages of alcoholic liver disease and to correlate serum levels of malondialdehyde with other markers. Sixty-five patients with a mean alcohol intake of 151 gr/day, were divided into three groups: alcoholics with normal liver function (ANLF, 7 pts), non-cirrhotic alcoholic liver disease (NCALD, 26 pts) and alcoholic cirrhosis (ALC, 32 pts). The control group consisted of 15 healthy subjects. Serum MDA was measured by the thiobarbituric acid reaction test, and mitochondrial aspartate aminotransferase (mAST) with immunochemical assay. MDA had a higher sensitivity (70% vs 37.5%) and specificity (100% vs 93%) than mAST in detecting alcohol abuse, irrespective of the presence of liver disease. Serum MDA levels were significantly higher in all three groups than in controls (2.3 +/- 0.1 nmol/ml), the highest value being found in NCALD (4.6 +/- 0.4). Serum MDA levels were correlated with prothrombin time (p < 0.005) and blood alcohol levels (p < 0.05). mAST serum activity was also significantly higher in all three groups than in controls. A significant correlation was found between serum MDA and mAST only when the whole group was considered.(ABSTRACT TRUNCATED AT 250 WORDS)

Efficacy and safety of the stepped care medical treatment of ascites in liver cirrhosis: a randomized controlled clinical trial comparing two diets with different sodium content.

In order to clarify debated issues of the medical treatment of ascites in cirrhosis--the usefulness of a low sodium diet and washout period preceding diuretic administration, maximal dosage of antimineralocorticoid to be reached before the addition of a loop diuretic, identifications of factors influencing treatment efficacy--115 hospitalized patients with non-azotemic cirrhosis and ascites were recruited and randomized to receive a diet providing either 40 or 120 mmol of sodium daily. After a washout period from the outpatient diuretic regimen for 7 days (Step 1), increasing dosages of K-canrenoate (200 mg/day every 4th day up to 600 mg) were administered to patients not undergoing spontaneous diuresis (Step 2). Upon the failure of Step 2, K-canrenoate (400 mg/day) and furosemide at increasing dosage (25-50-100 mg every other day) were given (Step 3). Nine percent of patients underwent spontaneous diuresis, and 77% developed a negative sodium balance by the end of Step 2 (69% with a dosage of K-canrenoate < or = 400 mg/day) and 93% by the end of Step 3. Two patients were withdrawn from the protocol due to diuretic side-effects. Univariate analysis showed that the type of diet did not influence the response to treatment. The washout period led to a significant increase in endogenous creatinine clearance; natremia significantly rose in hyponatremic patients. Multivariate analysis showed that creatinine clearance and plasma aldosterone were independent predictive factors of the response to treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Concentrated ascitic fluid reinfusion after cascade filtration in tense ascites.

A new method for concentrated ascitic fluid reinfusion using a double ultrafiltration device is reported as 22 procedures in 20 cirrhotic patients (6 females, 14 males; median age 55 years, range 33-69) with tense, refractory ascites. Eight of the 20 patients had elevated creatinine levels. The mean time for each procedure was 189 +/- 82 min, during which a mean of 7.7 liters (1.3-13.3) of ultrafiltered ascitic fluid was removed and 613 ml (140-1700) of concentrated ascitic fluid rich in albumin (mean: 60 g, range 14-175) was reinfused. The procedure resulted in a mean weight loss of 8.1 kg (2.2-14.0) and a mean increase of 163 ml in urine output (24 hr). A reduction in the serum creatinine level (P < 0.05) and an increase in the plasma atrial natriuretic factor level (P < 0.02) 24 hr after reinfusion, while no changes in serum albumin, plasma and urinary electrolytes, plasma renin activity, aldosterone, and antidiuretic hormone levels were noted. Although minor evidence for a disturbance in coagulation was observed, there were no episodes of clinical bleeding. Four patients (20%) had transient chills or fever. Based upon this experience, it can be concluded that reinfusion of cascade filtered and concentrated ascitic fluid is a rapid, safe, and effective treatment for patients with tense ascites; it appears to have less side effects than more traditional methods and importantly does not require administration of heterologous plasma derivatives.

Prospective controlled trial with antiestrogen drug tamoxifen in patients with unresectable hepatocellular carcinoma.

Clinical and experimental evidence indicates that estrogens are involved in the control of hepatocyte proliferation both in normal and in neoplastic conditions. Thirty-two cirrhotic patients with unresectable or otherwise untreatable hepatocellular carcinoma were allocated to receive either tamoxifen (30 mg/day) or no treatment. The patients in the two groups were matched for age, male/female ratio, Child-Pugh class, approximate tumor volume (US and CT scan), and etiology of the underlying cirrhosis. Survival of the tamoxifen-treated patients (life-table, Wilcoxon-Breslow) was significantly prolonged (P = 0.0038), with 35% (vs 0%) survival at 12 months. No difference was observed between males and females or between alcoholic and nonalcoholic cirrhosis. In 40% of tamoxifen-treated patients, the levels of alpha-fetoprotein declined. In conclusion, the antiestrogen tamoxifen appears to be effective in the palliative treatment of hepatocellular carcinoma. An initial decline in alpha-fetoprotein levels may represent an early favorable prognostic sign.

Peptic ulcer in cirrhotic patients: a short- and long-term study with antisecretory drugs.

The clinical course of gastric and duodenal ulcer and the efficacy of H2 blockers in ulcer healing and the prevention of relapse in cirrhotic liver patients were studied. Seventy-four cirrhotic patients with endoscopically proven acute gastric ulcer (30), duodenal ulcer (34) or a combination of both gastric and duodenal ulcers (10) were treated for six weeks with either Cimetidine 800 mg/daily (27) or Ranitidine 300 mg/daily (47). Of the 77 patients 49 (66.2%) were healed after therapy, 11 cases (14.8%) remained unhealed even after two additional cycles of the same treatment and four were lost to follow-up. After an endoscopically proven healing of the active ulcer, 51 patients took part in the long-term study over a mean period of 24 months: 21.5% of the 27 patients were treated with a maintenance dosage of H2 blockers and 29.1% of the 24 patients left without therapy relapsed during the first year. We conclude that the ulcer healing rate with H2 blockers is lower and the relapse rate higher in cirrhotic patients than in the general ulcer population.

Anti-HCV positive hepatocellular carcinoma in cirrhosis. Prevalence, risk factors and clinical features.

Recent reports indicate that hepatitis C virus (HCV) may play a role in the pathogenesis of hepatocellular carcinoma in cirrhotics. Using an ELISA test, we evaluated the prevalence of anti-HCV antibodies in 97 patients with hepatocellular carcinoma (HCC) in cirrhosis and in a group of 223 patients, including: 49 patients with HBsAg-positive chronic liver disease (CLD), 42 with alcoholic CLD, 110 with cryptogenic CLD and 22 with post-transfusional HBsAg-negative CLD. All diagnoses were histologically confirmed. Overall, anti-HCV-positive HCC were 64% of the total, with no statistically significant difference with respect to CLD (60.9%). The prevalence of anti-HCV was higher in cryptogenic HCC (80%) than in HBsAg-positive (60%) or alcoholic HCC (42.8%) (p less than 0.005). When HCC and cirrhosis of similar putative etiology were considered, anti-HCV prevalence was significantly higher in HCC than in cirrhosis only in the groups of patients with alcoholic liver damage (60% in HCC vs. 38% in cirrhosis, p less than 0.005). In HBsAg-positive patients, anti-HCV prevalence was twice as high in HCC than in CLD, but the difference was not statistically significant. Overall, anti-HCV prevalence in HCC was significantly higher than in alcoholic or HBsAg-positive CLD (p less than 0.001 and p less than 0.01, respectively) but lower than in cryptogenic CLD (p less than 0.001). Association between anti-HCV and anti-HBc was significantly more prevalent in patients with CLD than in those with HCC.(ABSTRACT TRUNCATED AT 250 WORDS)

[Preservation of the liver with the University of Wisconsin solution. Clinical and experimental aspects]. / La conservazione del fegato con la soluzione dell'Università di Wisconsin. Alcuni aspetti clinici e sperimentali.

The University of Wisconsin solution discovered in 1987 by Belzer and associates, has dramatically changed the logistics associated with liver transplantation. The extension of hypothermic preservation time has mode at possible: a) to operate in a semi-elective situation, rather than urgent; b) to improve patient selection and to be able to admit them from distant locations, and c) to reduce postoperative complications with a better quality of organ preservation. In the present work we illustrate the pathophysiological background and the rationale behind the various chemical constituents included in the new solution, emphasizing the antiedemogenic effect. Furthermore we report some experimental data on the role of energy level (ATP) and intracellular pH in the monitoring of liver preservation. Together with the improvements of surgical technique and immunosuppression, the new solution of the University of Wisconsin represents a fundamental step in the development of organ transplantation.

[Ulcer and hepatic cirrhosis. Epidemiologic and clinical correlations]. / Malattia ulcerosa e cirrosi epatica. Correlazioni epidemiologiche e cliniche.

Peptic ulcer has been reported with increased frequency in patients with liver cirrhosis, its prevalence ranging form 5% to 20%. The aim of the present study is twofold: 1) to define the frequency of peptic ulcer in chronic liver disease in a large sample of cirrhotic patients, 2) to investigate the epidemiological and clinical features of a group of subjects affected by both peptic ulcer and liver cirrhosis. Two years of admission have been retrospectively investigated to define the frequency of peptic ulcer in chronic liver disease. In 237 subjects affected by both cirrhosis and peptic ulcer, epidemiological and clinical data were collected. Peptic ulcer was present in 16% of cirrhotic patients. There were no differences between ulcer subjects who drank and those did not. A linear positive correlation between smoking habit and frequency of ulcer disease has been found in the words. A positive history for peptic ulcer was described in a little subgroup of the studied sample, suggesting a low importance of the genetic factor in the pathophysiological pattern of ulcer disease in chronic hepatitis.

Diagnostic and prognostic value of the determination of the aminopropeptide of type III procollagen in patients with primary liver cancer.

Hepatic fibroplasia seems to play an important role in the course of primary liver cancer (PLC) since, for instance, encapsulated and fibrolamellar hepatocellular carcinomas show a definitely better prognosis. In this study, serum procollagen III amino-terminal peptide (PIIIP) levels, which reflect synthesis and release of procollagen type III, were measured with the aim of assessing hepatic fibrogenesis in PLC patients and determining whether serum PIIIP levels play a diagnostic or prognostic role in PLC. Twenty-five patients with PLC, 74 patients with cirrhosis and 38 healthy volunteers were studied. Serum PIIIP levels were determined by a radioimmunoassay (RIA) method. In PLC patients PIIIP serum levels were significantly higher than those of controls and cirrhotic patients (P less than 0.001 and P less than 0.01 respectively) but an analysis of individual values showed an important overlap between PLC and cirrhosis. No correlation was found between serum PIIIP levels and tumour histology, presence or absence of cirrhosis, Child status, possible aetiology of the disease, indices of hepatocellular inflammation, cholestasis and synthesis, or tumour markers. On the contrary, serum PIIIP levels correlated with tumour gross pattern (z = 3, P less than 0.001) and, inversely, with survival (r = 0.659, P less than 0.01), patients with serum PIIIP over 25 ng/mL showing a significantly worse prognosis. These data confirm that hepatic fibroplasia plays an important, but not yet fully understood, role in the course of PLC. From the clinical point of view, PIIIP determination does not add to the differential diagnosis between PLC and cirrhosis but helps to identify patients with larger liver replacements and worse prognoses.

Unresectable hepatocellular carcinoma: a prospective controlled trial with tamoxifen.

The liver is an estrogen responsive organ. Clinically, estrogens may play a role in the induction of liver tumors and, experimentally, estrogens are involved in the control of hepatocyte proliferation. The results of a prospective controlled clinical trial using an anti-estrogen, tamoxifen, in patients with unresectable hepatocellular carcinoma (HCC) are presented below. Thirty-eight consecutive cirrhotics with HCC were allocated to either 30 mg/day tamoxifen or no treatment. The two groups of patients were matched for mean age, male/female ratio, Child-Pugh risk group, approximate tumor volume (US and/or CT scan) and etiology of the underlying cirrhosis. The drug appeared to have no side effects. Survival was significantly prolonged in tamoxifen-treated patients with 22% (vs. 5%) survival at 12 months. No differences were observed between males and females or alcoholic and non-alcoholic cirrhosis. In 53% of tamoxifen-treated patients the levels of alpha-fetoprotein dropped and, in this subgroup, survival was further prolonged. Tumor volume, lactate dehydrogenase (LDH) and alkaline phosphatase slowly increased, suggesting a slower, but continuous, progression of the disease. In conclusion, anti-estrogen treatment appears effective in the palliation of unresectable or otherwise untreatable HCC. A reduction in alpha-fetoprotein levels appears to be a favorable prognostic index.