A new highly effective short-term therapy schedule for Helicobacter pylori eradication.

BACKGROUND: Although triple therapy regimens suggested in the Current European guidelines give fairly good results, several studies have reported an unsatisfactory Helicobacter pylori eradication rate (< 80%). AIM: To evaluate the efficacy of a new short-term treatment sequence on H. pylori eradication. METHODS: A total of 52 patients with H. pylori infection and either non-ulcer dyspepsia (34 patients) or peptic ulcer (18 patients) were enrolled to receive a 10-day therapy: omeprazole 20 mg b.d. plus amoxycillin 1 g b.d. for the first 5 days, followed by omeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days. H. pylori infection at entry was assessed by rapid urease test and histology on biopsies from the antrum and the corpus. Bacterial eradication was assessed by endoscopy (peptic ulcer patients) or 13C urea breath test (non-ulcer dyspepsia patients) 4-6 weeks after therapy had ended. RESULTS: All patients completed the study. H. pylori eradication was achieved in all but one patient, with an eradication rate of 98% (95% CI: 94.3-100) with intention-to-treat analysis. Patient compliance was good (consumption of prescribed drugs > 95%) for all but one patient, who took the triple therapy regimen for 4 days instead of 5 days. No major side-effects were reported but three (6%) patients complained of mild side-effects. CONCLUSIONS: The use of this 'five plus five' therapy schedule as an initial treatment for H. pylori deserves further investigation.

Whole body and regional body composition analysis by dual-energy X-ray absorptiometry in cirrhotic patients.

OBJECTIVES: To compare whole body and regional (arms, legs and trunk) fat mass, fat-free mineral-free mass bone mineral content and bone mineral density, measured by DXA, in cirrhotic patients and age, sex and BMI matched healthy volunteers. DESIGN: Cross-sectional study. SETTING: Two medical research institutions. SUBJECTS: Twenty-two non ascitic cirrhotic patients and 16 age, sex and BMI matched healthy volunteers. INTERVENTIONS: The Lunar DPX whole-body X-ray densitometer with Lunar software version 3.6z (Lunar Radiation Corp., Madison WI, USA) was used. Regional analysis was performed on the arms, legs, trunk and head. RESULTS: Compared to controls, cirrhotic patients showed a significant reduction in percentage body fat. When differentiated by gender, however, the reduction in percentage body fat was evident in female cirrhotics only, particularly in the trunk. In male cirrhotic patients fat-free mineral-free mass was reduced in absolute terms in the whole body and the limbs. For both genders and in each body segment bone mineral content and density were reduced in cirrhotics compared to controls. In cirrhotic patients bone mineral density was significantly correlated to both fat-free, mineral-free mass (r = 0.85; P < 0.001) and to the Physical Activity Index (r = 0.52; P < 0.01). CONCLUSIONS: Two different patterns of soft tissue loss may be found in cirrhotic patients: in women lean tissue is maintained while fat stores are reduced, as in early starvation; in men lean tissue is reduced, as seen under conditions of stress. Moreover, factors influencing lean body mass, such as nutritional depletion and physical inactivity, may contribute to the reduction of bone density frequently observed in cirrhotic patients.

Helicobacter pylori infection in dyspeptic cirrhotic patients.

BACKGROUND/AIMS: To date, few studies have focused on the role of Helicobacter pylori (H. pylori) in cirrhotic patients with gastroduodenal disease and reported results are conflicting. The aim of this study was to assess the H. pylori infection rate in dyspeptic cirrhotic patients with or without gastroduodenal lesions at endoscopy. METHODOLOGY: In a prospective study, 226 consecutive dyspeptic cirrhotic patients were enrolled in the study upon assessment of H. pylori infection. Two-hundred dyspeptic non-cirrhotic patients were also included as controls. The presence of H. pylori was detected by rapid urease test and histology (Giemsa staining) in 3 biopsy specimens from the antrum and 3 from the gastric body. RESULTS: H. pylori infection was found in 135 (59.7%) cirrhotics and in 121 (60.5%) controls (p = NS). The prevalence of gastric ulcer was higher in cirrhotics than in controls (16% vs. 2.5%, p = 0.0001), while the prevalence of duodenal ulcer was similar (11% vs. 12%, respectively). The H. pylori infection rate was similar between cirrhotics and controls, both with gastric (83% vs. 80%) and with duodenal (88% vs. 96%) ulcers. Moreover, in our study, a H. pylori-related peptic lesion was the cause of previous gastroduodenal bleeding in 6 of 50 (12%) cirrhotic patients. CONCLUSIONS: Our results indicated that H. pylori infection is implicated in the pathogenesis of peptic ulcer in cirrhotic patients, similar to findings in non-cirrhotic patients.

Helicobacter pylori infection, plasma ammonia levels, and psychometric testing in cirrhotic patients.

OBJECTIVE: The role of Helicobacter pylori (H. pylori) infection as a cause of hepatic encephalopathy is still debated. This study focused on the relationship between H. pylori, plasma ammonia levels, and intellectual function in cirrhotic patients. METHODS: Forty-seven cirrhotics with latent or mild hepatic encephalopathy were enrolled in the study, upon H. pylori assessment at endoscopy. Plasma ammonia level determinations and psychometric testing were performed at entry in all patients. Patients with H. pylori infection received a 2-wk standard dual therapy and bacterial eradication was assessed at endoscopy 6-8 wk later. On this occasion, plasma ammonia levels and psychometric assessments were repeated. Patients without H. pylori infection at entry were also studied after 6-8 wk for ammonia level assessment and psychometric testing, as a control group. Patients receiving lactulose therapy and those without therapy were grouped separately for statistical analysis. RESULTS: Among 21 patients without lactulose therapy (group A), basal plasma ammonia levels and psychometric testing scores did not significantly differ between 13 infected and eight uninfected patients. Similarly, among 26 patients undergoing lactulose therapy (group B), basal plasma ammonia concentration and psychometric testing scores did not significantly differ between 13 infected and 13 uninfected patients. Moreover, in group B, both the prevalence of previous overt hepatic encephalopathy episodes and the mean daily dose of lactulose therapy were similar between infected and uninfected patients. In addition, no significant reduction in the plasma ammonia concentrations and in psychometric testing scores emerged in both groups A and B after bacterial eradication. CONCLUSIONS: This study failed to find a relationship between H. pylori, plasma ammonia levels, and psychometric testing scores in cirrhotic patients with latent or mild hepatic encephalopathy.

Helicobacter pylori eradication with dual and low-dose triple therapy in patients with liver cirrhosis.

BACKGROUND AND AIMS: Few data exist on the treatment of Helicobacter pylori infection in cirrhotic patients. In this study we assessed the efficacy of standard dual and one-week low-dose triple therapy on Helicobacter pylori eradication in cirrhotics. PATIENTS AND METHODS: In a prospective study, 83 cirrhotic patients with epigastric pain were randomised to receive either a two-week course of dual therapy, composed of omeprazole 20 mg b.d. plus amoxycillin 1 g b.d. (n = 41) or a one-week course of triple therapy, composed of omeprazole 20 mg b.d., clarithromycin 250 mg b.d., and tetracycline 500 mg b.d (n = 42). Helicobacter pylori infection at entry and eradication 6-8 weeks after the end of therapy were assessed by rapid urease test and histology on biopsies from the antrum and corpus. When eradication did not occur with either dual or triple therapy, patients were given the alternative regimen. Helicobacter pylori eradication in these patients was assessed 6-8 weeks after the end of treatment by a further endoscopy. RESULTS: Helicobacter pylori eradication was achieved in 87.8% (36 out of 41; 95% confidence interval 77.8-97.8%) of patients after dual therapy and in 85.7% (36 out of 42; 95% confidence interval 75.1-96.3%) of patients treated with triple therapy (p = NS). In patients in whom initial eradication was unsuccessful, re-treatment eradicated Helicobacter pylori in 4 out of 5 patients given the triple regimen and in all 5 patients who received the dual therapy. One patient was lost to follow-up. No major side-effects were reported for either treatment regimen. CONCLUSIONS: Our data show that both dual and triple therapies are effective in Helicobacter pylori eradication in cirrhotics as well as in eradication failure patients. Therefore, the use of the dual therapy regimen is strongly suggested as an initial treatment for Helicobacter pylori eradication in cirrhotic patients.

Hepatic encephalopathy after transjugular intrahepatic portosystemic shunt. Incidence and risk factors.

Forty-seven consecutive patients were prospectively evaluated to study the incidence of hepatic encephalopathy as well as modifications in the PSE index after TIPS. Various clinical, laboratory, and angiographic parameters were also recorded to identify risk factors for the development of post-TIPS hepatic encephalopathy (HE). Mean follow-up was 17 +/- 7 months. During follow-up, six patients died and one underwent transplantation. All other patients were followed for at least a year. Fifteen patients (32%) experienced 20 acute episodes of precipitated HE (hospitalization was necessary in 10 instances), and five patients (11%) presented a continuous alteration in mental status with frequent spontaneous exacerbation during follow-up. Both precipitated and spontaneous HE occurred more frequently during the first three months of follow-up. Moreover the PSE index was significantly worse than basal values one month after TIPS, thereafter returning to near basal values. HE was successfully treated in all patients but one who required a reduction in the stent/shunt diameter. Increasing age (>65 years) and low portacaval gradient (<10 mm Hg) were predictors of HE after TIPS. A gradual dilation of the stent/shunt should be performed to obtain a portacaval gradient >10 mm Hg to avoid an unacceptable rate of HE after TIPS.

Cost analysis for the prevention of variceal rebleeding: a comparison between transjugular intrahepatic portosystemic shunt and endoscopic sclerotherapy in a selected group of Italian cirrhotic patients.

The aim of the present study was to compare the cumulative cost of the first 18-month period in a selected group of Italian cirrhotic patients treated with transjugular intrahepatic portosystemic shunt (TIPS) versus endoscopic sclerotherapy (ES) to prevent variceal rebleeding. Thirty-eight patients enrolled in a controlled trial were considered (18 TIPS and 20 sclerotherapy). The number of days spent in the hospital for the initial treatment and during the follow-up period were defined as the costs of hospitalization. ES sessions, TIPS procedures, angioplasty or addition of a second stent to maintain the shunt patency, were defined as the costs of therapeutic procedures. The two groups were comparable for age, sex, and Child-Pugh score. During the observation period 4 patients died in the TIPS group, and 2 died and 1 was transplanted in the sclerotherapy group. The rebleeding rate was significantly higher in the sclerotherapy group. Despite this, the number of days spent in the hospital was similar in the two groups. This was because of a higher number of hospital admissions for the treatment of hepatic encephalopathy and shunt insufficiency in the TIPS group. The therapeutic procedures were more expensive for TIPS. Consequently, the cumulative cost was higher for patients treated with TIPS than for those treated with sclerotherapy. The extra cost was because of the initial higher cost of the procedure and the difference was still maintained at the end of the 18-month follow-up. When the cumulative costs were expressed per month free of rebleeding, the disadvantage of TIPS disappeared. In conclusion, a program of prevention of variceal rebleeding with TIPS, despite the longer interval free of rebleeding, is not a cost-saving strategy in comparison with sclerotherapy.

Transjugular intrahepatic portosystemic shunt versus endoscopic sclerotherapy for the prevention of variceal bleeding in cirrhosis: a randomized multicenter trial. Gruppo Italiano Studio TIPS (G.I.S.T.).

Transjugular intrahepatic portosystemic shunt (TIPS), a new technique for the treatment of portal hypertension, has been successful in preliminary studies to treat acute variceal hemorrhage and to prevent variceal rebleeding. The purpose of this multicenter, randomized controlled trial is to compare the efficacy of TIPS with that of endoscopic sclerotherapy in the prevention of variceal rebleeding in cirrhosis. Eighty-one cirrhotic patients, with endoscopically proven variceal bleeding, were randomized to either TIPS (38 patients) or endoscopic sclerotherapy (43 patients). Randomization was stratified according to the following: if bleeding occurred < 1 week (stratum I); if bleeding occurred 1 to 6 weeks (stratum II); and if bleeding occurred 6 weeks to 6 months (stratum III) before enrollment. Follow-up included clinical, biochemical, Doppler Ultrasound, and endoscopic examinations every 6 months. During a mean follow-up of 17.7 months, 51% of the patients treated with sclerotherapy and 24% of those treated with TIPS rebled (P = .011). Mortality was 19% in sclerotherapy patients and 24% in TIPS patients (P = .50). Hepatic encephalopathy (HE) developed in 26% and 55%, respectively (P = .006). A separate analysis of the three strata showed that TIPS was significantly more effective than sclerotherapy (P = .026) in preventing rebleeding only in stratum I patients. TIPS is significantly better than sclerotherapy in preventing rebleeding only when it is performed shortly after a variceal bleed; however, TIPS does not improve survival and is associated with a significantly higher incidence of HE. The overall performance of TIPS does not seem to justify the adoption of this technique as a first-choice treatment to prevent rebleeding from esophageal varices in cirrhotic patients.