Reasons for nonuse of antiviral treatment in patients with chronic hepatitis C infection and thrombocytopaenia: a retrospective chart review from five European countries.

Antiviral therapy has been shown to reduce the risk of disease progression, liver damage and death in patients with chronic hepatitis C virus (HCV) infection. While interferon labels recommend that patients with platelet counts below 50 × 10(3) /µL not receive interferon-based therapy, it is unknown to what extent thrombocytopaenia influences treatment decisions in practice. This study profiles the reasons for withholding antiviral treatment in HCV patients with thrombocytopaenia in five European countries. Medical records of 466 patients who had HCV infection and thrombocytopaenia (platelet count <100 × 10(3) /µL) in 2006 were retrospectively reviewed for clinical characteristics. Collected data included use of antiviral therapy and reasons for withholding therapy. In total 184 of 466 patients (39.5%) did not receive interferon-based therapy during the study period, with treatment withheld most frequently due to multiple clinical characteristics including hepatic cirrhosis (16.3%), thrombocytopaenia (16.3%) and age >60 years (10.9%). The reasons for lack of treatment varied among countries, with thrombocytopaenia as a reason being more common in Italy (10.9%) and Spain (20.0%), and less common in France, Germany and the UK (3.2-7.1%). Overall, thrombocytopaenia was reported as the only reason for withholding treatment in 4.9% of untreated patients. This study demonstrates that thrombocytopaenia is one of many factors, indicative of the poor clinical state of the patient, that contributes to withholding antiviral treatment. In 4.9% of untreated patients, thrombocytopaenia can be considered as a modifiable factor to enable more HCV patients to receive guideline-recommended therapy and thus improved clinical outcomes.

Inflammatory bowel diseases and primary sclerosing cholangitis: hepatic and pancreatic side effects due to azathioprine.

BACKGROUND AND OBJECTIVES: In up to 80% of cases primary sclerosing cholangitis (PSC) is associated with inflammatory bowel diseases (IBD). The efficacy of azathioprine (AZA), in the maintenance of remission of IBD has been suggested by several studies. However, AZA tends to exter varied well-known toxicity. Since the rate of hepato-pancreatic side-effects in patients with IBD and PSC is still unclear, we investigated this issue. MATERIALS AND METHODS: Consecutive subjects who underwent Outpatient Clinic admission for both IBD and PSC were included. Both conditions were diagnosed according to International Guidelines. RESULTS: Data of 43 patients were elaborated. Twelve of them underwent therapy with AZA. Five (41.7%) presented hepatic (n=4) or pancreatic toxicity. Eighty percent of the patients with hepato-pancreatic reactions versus 28.6% of those without (p < 0.001) were males, with 60% affected by ulcerative colitis and 40% by Crohn's disease versus 57% and 43%, respectively. Forty percent of patients with reactions versus 43% of those without needed an operation for IBD, and the same percentage underwent orthotopic liver transplantation, with a 100% versus 66.7% (p < 0.001) need of second transplantation. Colonic neoplasia (20%) was detected only in the former group while cholangiocarcinoma (28.6%) only in the latter. CONCLUSIONS: The occurrence of hepato-pancreatic reactions from AZA in our caseload is higher (41.7%) compared to that reported in literature (4%). Therefore, the presence of PSC, in association to IBD, may strongly affect AZA tolerability compared to presence of IBD only.  

Endoscopic ultrasound in the 2013 preoperative evaluation of gastric cancer.

The capacity of endoscopic ultrasound (EUS) to distinguish the different wall layers of the gastrointestinal (GI) tract and the possibility to obtain samples of suspicious lesions or lymph nodes by means of EUS-guided fine-needle aspiration (EUS-FNA), make EUS an ideal staging modality for GI cancers. After an endoscopic and histological diagnosis of gastric cancer (GC), an accurate preoperative evaluation is essential to choose the correct management decision, because for this malignancy various and radically different stage-oriented therapies can be performed. Even if EUS is inserted in the last guidelines for the management of GC as an essential pretherapeutic staging modality, in the literature the reported accuracy, the imaging features and the performances of the technique are variable. In this review, we synthesize the current status and the imaging findings of EUS when describing and staging GC, with a particular attention to the early GC that represents till today a diagnostic and therapeutic challenge. Currently, the EUS study is mandatory for the preoperative staging, to assess with a good accuracy the tumor depth of wall invasion, the presence of suspicious lymph-nodes and of ascites (predictive of peritoneal involvement). The main limitations for a correct EUS staging remain some features of the lesion or its localization, so more attention should be paid when these characteristics are present.

Thymosin alpha-1 with peginterferon alfa-2a/ribavirin for chronic hepatitis C not responsive to IFN/ribavirin: an adjuvant role?

This study was conducted to determine whether the adding thymosin alpha-1 to standard of care for re-treatment of nonresponding hepatitis C infections can improve sustained viral response (SVR) rates. Patients (n = 552) with hepatitis C infections not responding to the combination of Peginterferon alfa-2a or 2b with ribavirin (RBV)were randomized to receive peginterferon alfa-2a 180 mg/week with RBV 800-1200 mg/daily plus either thymosin alpha-1 1.6 mg SC twice weekly (n = 275) or placebo (n = 277) for 48 weeks. Eighty-eight per cent of patients had HCV genotype 1, 6.6% type 4, 2.2% type 2 and 3.6% type 3. SVR rates in the intention to treat population were similar between thymosin alpha-1 and placebo (12.7%vs 10.5%; P = 0.407). Among patients who completed all 48 weeks of therapy, the SVR rate was significantly higher in the thymosin alpha-1 group at 41.0% (34/83) compared with 26.3% (26/99) in the placebo group (P = 0.048). No significant difference was observed between treatment groups in the incidence of adverse events. The addition of thymosin alpha-1 to the standard of care did not increase the on-treatment HCV viral response. Thymosin alpha-1 seems to play no role in the primary therapy of the disease. This study raises the hypothesis that thymosin alpha-1 may have a secondary therapeutic role as an adjuvant in the prevention of relapses in patients achieving a virologic response during therapy.

Optimized threshold for serum HCV RNA to predict treatment outcomes in hepatitis C patients receiving peginterferon alfa-2a/ribavirin.

It is unclear whether the current threshold for 'high' hepatitis C virus (HCV) RNA level (800,000 IU/mL) is optimal for predicting sustained virological response (SVR). We retrospectively analysed pretreatment HCV RNA levels and SVR rates in 1529 mono-infected and 176 HIV-HCV co-infected patients treated with peginterferon alfa-2a (40 kD) plus ribavirin. We improved the threshold for differentiating low and high viral load by fitting semiparametric generalized additive logistic regression models to the data and constructing receiver operating characteristics curves. Among HCV genotype 1 mono-infected patients, the difference in SVR rates between those with low and high baseline HCV RNA levels was 27% (70%vs 43%) when 400,000 IU/mL was used and 16% (59%vs 43%) when 800,000 IU/mL was used. In HIV-HCV genotype 1 co-infected patients, the difference was 51% (71%vs 20%) when 400,000 IU/mL was used and 43% (61%vs 18%) when 800,000 IU/mL was used. A lower threshold (200,000 IU/mL) was identified for genotype 1 mono-infected patients with 'normal' alanine aminotransferase (ALT) levels. No threshold could be identified in HCV genotype 2 or 3 patients. A threshold HCV RNA level of 400,000 IU/mL is optimal for differentiating high and low probability of SVR in genotype 1-infected individuals with elevated ALT.

Diagnosis of deep-seated lymphomas by endoscopic ultrasound-guided fine needle aspiration combined with flow cytometry.

OBJECTIVE: Although endoscopic ultrasound combined with fine needle aspiration (EUS-FNA) is rapidly becoming the preferred diagnostic approach for the sampling and diagnosis of gastrointestinal and mediastinal malignancies, there are limited data as to its use in the diagnosis of lymphoproliferative disorders. Therefore, we carried out a retrospective evaluation of the performance of EUS-guided FNA combined with flow cytometry (FC) as a tool to improve overall sensitivity and specificity in the diagnosis of lymphoma. METHODS: Of 1560 patients having EUS-guided FNA during the period of the study, a total of 56 patients were evaluated by cytology with FC after EUS-FNA. There was adequate material to perform FC analysis for all but one case. RESULTS: EUS-FNA-FC gave a diagnosis of lymphoma in 11 cases and of reactive lymphadenopathy in 20. A specific histological type was defined by FC alone in eight cases. The remaining cases were diagnosed later by cytology and cell block sections: 13 carcinomas, nine granulomatous lymphadenopathies and one mediastinal extramedullary haematopoiesis. One case was considered only suspicious for lymphoma on cytology and FC but was not confirmed on molecular analysis and one had insufficient material for FC. CONCLUSIONS: Our results show that a combination of EUS-FNA-FC is a feasible and highly accurate method, which may be used for the diagnosis and subtyping of deep-seated lymphoma, providing a significant improvement to cytomorphology alone both for diagnosis and treatment planning, as long as immunocytochemistry is available for non-lymphoma cases.

The state of hepatitis B and C in Europe: report from the hepatitis B and C summit conference*.

Worldwide, the hepatitis B virus (HBV) and the hepatitis C virus (HCV) cause, respectively, 600,000 and 350,000 deaths each year. Viral hepatitis is the leading cause of cirrhosis and liver cancer, which in turn ranks as the third cause of cancer death worldwide. Within the WHO European region, approximately 14 million people are chronically infected with HBV, and nine million people are chronically infected with HCV. Lack of reliable epidemiological data on HBV and HCV is one of the biggest hurdles to advancing policy. Risk groups such as migrants and injecting drug users (IDU) tend to be under-represented in existing prevalence studies; thus, targeted surveillance is urgently needed to correctly estimate the burden of HBV and HCV. The most effective means of prevention against HBV is vaccination, and most European Union (EU) countries have universal vaccination programmes. For both HBV and HCV, screening of individuals who present a high risk of contracting the virus is critical given the asymptomatic, and thereby silent, nature of disease. Screening of migrants and IDUs has been shown to be effective and potentially cost-effective. There have been significant advances in the treatment of HCV and HBV in recent years, but health care professionals remain poorly aware of treatment options. Greater professional training is needed on the management of hepatitis including the treatment of liver cancer to encourage adherence to guidelines and offer patients the best possible outcomes. Viral hepatitis knows no borders. EU Member States, guided by the EU, need to work in a concerted manner to implement lasting, effective policies and programmes and make tackling viral hepatitis a public health priority.

Role of endoscopy in the management of gastroenteropancreatic neuroendocrine tumours.

Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) represent in clinical practice a diagnostic dilemma because they are often very small, located deeply within the retroperitoneum or in an extramucosal site in the gastrointestinal (GI) tract and, lastly, because they may be multi-sited. Modern digestive endoscopy offers a myriad of techniques, useful for localization, diagnosis and treatment (therapeutic endoscopy). The available tools include upper digestive endoscopy (esophagogastroduodenoscopy, endoscopic retrograde cholangiopancreatography), lower digestive endoscopy (ileo-colonoscopy), enteroscopy (push-type, intra-operative, capsule, double or single balloon), for examining the small intestine, diagnostic and interventional echo-endoscopy (EUS), with radial, linear and miniprobe equipment. This narrative review offers scientific support to affirm that endoscopy and EUS give imaging and diagnostic possibilities that are unbeatable in the localization of GEP-NETs both of the GI tract and the pancreas. Endoscopy is useful for localization, bioptic diagnosis and curative resection of small neuroendocrine lesions of the stomach, duodenum, colon-rectum and more recently of the jejuno-ileum. EUS associated with dedicated instruments, particularly high frequency miniprobes, is a valuable procedure in locoregional staging of lesions of the GI wall and can supply information which has a clinical impact on therapeutic options and prognostic value. EUS is still today the sole technique in a certain number of cases which provides a definitive diagnosis of pancreatic insulinoma and to detect and follow subcentimetric lesions of the pancreas in patients with MEN-1 syndrome. It should be used in all those cases where results from radiographic imaging or nuclear medicine techniques show negative or dubious.

Endoscopic banding for esophageal variceal bleeding: technique and patient outcome.

AIM: Endoscopic variceal ligation (EVL) is recommended for the treatment of esophageal variceal bleeding. The aim of this study was to assess the most cost-effective timing of endoscopic follow-up after variceal eradication. METHODS: Cirrhotics with esophageal varices treated between January 2008 and January 2009 until reached variceal obliteration were retrospectively analyzed for technical aspects and for outcomes. RESULTS: Out of 127 patients treated with EVL, 103 were included. Number of sessions to achieve variceal obliteration and number of bands for each session were 2.8±1.3 (range 1-7) and 4.6±1 (range 2-7), respectively. The placement of >5 bands per session was not associated with higher incidence of complications (19.6% vs. 17.8%, P=ns). Esophageal ulcers were observed in 42% of patients when the interbanding interval was <20 days (versus 15% for interval >20 days, P<0.05). Once obliteration was achieved, varices reappeared in 28% of patients; the early appearance of small varices was not associated with bleeding. CONCLUSION: A longer interbanding interval reduces the incidence of procedural-related complications. After variceal obliteration an early endoscopic control is not useful because it does not influence the approach and does not change the patient outcome.

Potential link between Helicobacter pylori and ischemic heart disease: does the bacterium elicit thrombosis?

Over the past fifteen years, numerous observations have linked Helicobacter pylori (H. pylori) infection to ischemic heart disease (IHD). Despite the controversial literature data, it has been postulated that if a role is plausible, it will be in the early events of the acute coronary syndrome. According to this model, we focused on the potential pathogenic mechanisms relating H. pylori to IHD like platelet aggregation and thrombosis. To identify all publications in this field, a MEDLINE search of studies published in English from 1965 to 2009 was conducted. Although very few investigations were found, these showed data of paramount importance. In particular, it has been demonstrated that some strains of H. pylori bind von Willebrand factor and interact with glycoprotein Ib to induce platelet aggregation in humans. In experiments from animal models, such infection promoted the formation of platelet aggregates by both a marked increase in the flux of rolling leukocytes and the appearance of platelet and leukocyte-platelet aggregates in gastric venules. This aggregate formation was abrogated by antibodies against specific adhesion molecules (L- and P-selectin). The future challenge is to gain more knowledge in this field and to translate these information into clinical practice.

A retrospective study on a cohort of patients with lymphocytic colitis.

OBJECTIVE: The term "microscopic colitis" includes lymphocytic colitis (LC) and collagenous colitis, bearing common clinical presentation distinguishable only by histopathological examination of colonic biopsies. This study reports on demographic and clinical characteristics, and outcome of a cohort of patients with LC. METHODS: Demographic, clinical and histopathological data were reviewed. Every patient underwent total colonoscopy with multiple biopsies examined by an expert pathologist. Diagnosis of LC was confirmed if histopathological criteria were present. Routine laboratory tests were collected to rule out other diagnosis. RESULTS: We included 80 patients (28 males; mean age: 46.4 years). At diagnosis, 71 patients (88%) reported diarrhea, 46 (58%) abdominal pain, 21 (36%) weight loss, 10 (13%) nausea. Regarding autoimmune or inflammatory diseases accompanying LC, thyroid disorders and celiac disease (CD) ranked first. Moreover, in over 10% of patients who underwent esophagogastroduodenoscopy, duodenal biopsies showed villi alterations classified as Marsh I damage, without clinical and serological data for diagnosis of CD. Mesalazine and oral topical steroids (budesonide or beclomethasone) were used to treat LC in 34 (43%) and 32 (39%) of patients, respectively, with similar percentages of clinical response (approximately 80%). CONCLUSIONS: The need for total colonoscopy with multiple biopsies in all patients with chronic watery diarrhea was confirmed. Since the association between CD and LC exists, additional tests should be performed in patients not responding to gluten-free diet or to LC specific therapy to exclude the other condition. Mesalazine obtained a similar outcome than oral steroids in this cohort.

Treatment of hepatitis D: an unmet medical need.

BACKGROUND: Therapy of chronic hepatitis D (CHD) is still based on interferon alpha (IFNα), introduced in clinical practice 30 years ago: results are modest and better therapies are an urgent medical need. AIMS: This article provides a critical overview of the new therapies under investigation for CHD. SOURCES: Review of the recently published medical literature. CONTENT: New therapeutic efforts aim to deprive the hepatitis D virus (HDV) of functions provided to its life cycle by the hepatitis B Virus (HBV) or by the host. Three therapeutic strategies are in evaluation: a) Myrcludex B, a myristolated lipopeptide of the pre-S1 domain of the HBsAg that blocks the entry of the HDV into hepatocyes and controls infection by preventing the spreading of the virus to liver cells not infected by the HBV; b) Lonafarnib, an inhibitor of a host farnesyl-transferase that hinders morphogenesis of the HDV by preventing the farnesylation of the large HD-antigen, necessary for virion assembly; c) REP 2139, a nucleic acid polymer that prevents export of the mature HDV by the presumed inhibition of the synthesis of subviral HBsAg particles with which the virion is coated. Myrcludex B and Lonafarnib increase therapeutic efficacy in combination with Peg-IFNα. In a pilot study, REP 2139 in combination with Peg-IFNα induced the clearance of serum HDV RNA and of the HBsAg in about half of 12 treated patients. IMPLICATIONS: Long-term therapies with either Myrcludex B or Lonafarnib in combination with Peg-IFNα are required to achieve clinical control of CHD. However, with prolonged therapies tolerance becomes a problem; studies are on the way to determine whether Peg-IFN lambda may be better tolerated that Peg-IFNα. The promising preliminary data of REP 2139 in combination with Peg-IFNα await confirmation of the original pilot study.

Management of chronic hepatitis C patients who have relapsed or not responded to pegylated interferon alfa plus ribavirin.

Development of therapeutic strategies for patients with chronic hepatitis C who experience virological breakthrough, relapse or nonresponse lag behind those for treatment-naïve patients. The probability of a previously treated patient responding to re-treatment depends on the nature of the previous regimen, the magnitude of the response to previous treatment and the patient's characteristics. Relapsers have higher sustained virological response rates than nonresponders when re-treated with pegylated interferon plus ribavirin. Re-treatment of nonresponders to pegylated interferon plus ribavirin with the standard 48-week regimen resulted in an approximate 6% sustained response rate in the EPIC-3 program. In the REPEAT trial, the sustained response rate was significantly higher in nonresponders to pegylated interferon alfa-2b (12 kD) plus ribavirin randomized to 72 weeks of peginterferon alfa-2a (40 kD) plus ribavirin, compared with a 48-week regimen (16%vs 8%, P = 0.0006). Based on available data, extended treatment is the best option for these individuals. Undetectable viral RNA at week 12 is an important criterion for re-treatment in the REPEAT and EPIC studies. Maintenance therapy with pegylated interferon is generally ineffective in nonresponders and cannot be recommended. Directly acting antivirals may increase response rates and the burden of adverse events when combined with the standard of care, but will not be available for some years. In conclusion, after careful evaluation of an individual's benefit-risk ratio, a 72-week regimen is the preferred strategy for optimizing sustained response rates in patients who have not responded to the standard of care, provided that viral RNA is undetectable at week 12 of re-treatment.

Clinical and biochemical parameters related to cardiovascular disease after Helicobacter pylori eradication.

AIM: Since the major established risk factors explain the pathogenesis of ischemic heart disease (IHD) in a proportion of cases, it is crucial to search for other causal mechanisms. The possible link between IHD and Helicobacter pylori (H.pylori) infection has been reported. However, the precise mechanism of this potential relationship, by a proinflammatory activity or metabolic disorder, is unclear. In order to investigate this issue, the authors assessed changes in clinical and biochemical parameters related to IHD after bacterial eradication. METHODS: A total of 496 patients (281 males; mean age 59.7+/-2.3) with H.pylori-positive dyspepsia and/or peptic ulcer were studied after cure of the bacterium. H.pylori status was determined by histology or 13C-urea breath testing. Examinations for body mass index, diastolic blood pressure and blood testing (C-reactive protein, fibrinogen, triglycerides, total cholesterol, high-density and low-density lipoprotein cholesterol, fasting glucose) were performed before eradication and annually for up to five years thereafter. For statistical analyses, the Student's t test was performed. RESULTS: HDL-C increased (P=0.02) while C-reactive protein and fibrinogen levels diminished (P<0.0001) significantly. BMI and diastolic blood pressure increased in a significant (P=0.032 and P=0.039 respectively) manner compared to baseline. CONCLUSIONS: H.pylori eradication is associated with modification of some clinical and biochemical parameters related to IHD during a follow-up of five years. There is a need for large interventional randomized studies in order to prove a causal association.

Anti-Saccharomyces cerevisiae as unusual antibodies in autoimmune hepatitis.

Autoantibodies are disease markers of autoimmune hepatitis (AIH). Antinuclear antibodies, smooth muscle antibodies, antibodies to liver/kidney microsome type 1, and perinuclear antibodies to neutrophil cytoplasm constitute the ''conventional'' battery of autoantibodies, while an emerging interest to evaluate new autoantibodies as diagnostic or prognostic markers, such as the anti-Saccharomyces cerevisiae antibodies, is detectable (ASCA). This paper focuses mainly on the findings and the potential role of ASCA in AIH. These antibodies are present in 5-6.3% of blood donors and in the gastrointestinal setting, ASCA have been found most often in Crohn's disease and with lower frequency in the course of ulcerative colitis and celiac disease. Furthermore, they have been described, to a lesser extent, in patients with primary sclerosing cholangitis and primary biliary cirrhosis and in AIH. ASCA occur in 20-30% of patients suffering from AIH with a statistically significant increase observed only for IgG ASCA in type 1 AIH. This probably indicates collateral immune reactivities to the primary pathogenic process. The outcome of hepatitis is not influenced by the presence of ASCA. In conclusion, ASCA positivity does not imply that there exists a distinct subgroup of patients with AIH and these autoantibodies are not involved in the pathogenetic mechanism of AIH.

An update on AIDS-related cholangiopathy.

Both hepatic parenchymal and biliary tract diseases are common in patients with human immunodeficiency virus (HIV). In this paper, the authors focus mainly on clinical aspects of acquired immunodeficiency syndrome (AIDS)-related cholangiopathy. Although the etiology is unclear, several opportunistic infections (cytomegalovirus, Cryptosporidium and others) are suspected to cause it. Endoscopic retrograde cholangiopancreatography (ERCP) is the diagnostic gold standard and it offers a therapeutic means to provide symptomatic relief in case of papillary stenosis. The most common ERCP pattern is diffuse sclerosing cholangitis in combination with papillary stenosis. Clinically, the presentation may be variable, although right upper quadrant pain and fever accompanied by an elevated serum alkaline phosphatase (ALP) level are the most common manifestations. Jaundice is unusual suggesting that complete ductal obstruction is rare. While ERCP results and the need of sphincterotomy do not influence the prognosis, antiretroviral therapy is a protective factor and, on the contrary, high ALP level is related to a less favorable outcome. Regarding the possible pathogenic mechanisms through which HIV infection could be involved in AIDS-related cholangiopathy, in vitro experiments have shown that concurrent active HIV replication and Cryptosporidium parvum infection synergistically increase cholangiocyte apoptosis and thus jointly contribute to AIDS-related cholangiopathies.

Is smoking a prognostic factor in patients with chronic hepatitis C?

The progression of chronic liver diseases is characterized by a common histopathological pathway comprising fibrosis formation and distortion of hepatic architecture which are the hallmark of evolution to cirrhosis. Several factors are responsible for the severity and progression of chronic hepatitis C. Here, we describe the most important data regarding the association between regular smoking and histological hepatic lesions. Some reports have shown that the proportion of patients with moderate or significant histological activity gradually increases with the daily consumption of tobacco. Moreover, fibrosis is associated with regular smoking in some studies. However, controversies result from other studies. Nicotine is mainly metabolised by the liver, and its administration in experimental animals showed development of steatosis and focal or confluent hepatic necrosis, probably linked to the oxidative stress associated with lipid peroxidation. In chronic hepatitis C patients, preliminary studies have suggested that hypoxia caused by smoking may induce expression of the cytokines vascular endothelial growth factor (VEGF) and VEGF-D and their corresponding soluble tyrosine kinase receptors fms-like tyrosine kinase receptor and kinase insert domain receptor. Since this issue is controversial and smoking is in any case unsafe, stopping is recommended for patients with liver diseases.

Risk factors for HCV infection. Focus on ethnic and cultural characteristics.

A precise understanding of the source of infection and modes of transmission of hepatitis C virus (HCV) is a worldwide priority in terms of public health. This is more evident where multi-ethnic customs cohabit. Despite the knowledge on risk factors for HCV transmission, nearly 50% of infected patients do not have a history suggesting a parenteral route of acquisition. In the present paper, the authors, focusing on ethnic and cultural aspects of HCV transmission, emphasize the need for health education in order to avoid the acquisition and the diffusion of the infection. With the current globalization and large-scale migrations, only by following a preventive strategy based on disseminate information risk behaviours may be modified.

Benefit of dietary integrators for treating functional dyspepsia: a prospective pilot study.

AIM: Because of the multifactorial pathogenesis of functional dyspepsia, strategies alternative to antacid therapy are being sought for treating the disorder. This prospective study evaluated the benefit of treatment with a dietary integrator composed of sodium alginate, sodium bicarbonate, bromelin and essential oils. METHODS: The study population included 53 consecutive patients (22 males, 31 females; mean age, 54+/-2.5 years) with functional dyspepsia and negative for Helicobacter pylori infection. The patients were categorized into four subgroups according to predominant symptom: ulcer-like dyspepsia, motility-like dyspepsia, reflux-like dyspepsia, and nonspecific dyspepsia. All received TUBES gastro (0.80 g oral tablets bid) for a minimum of 3 months (range, 3-11). Treatment efficacy was measured by means of a Visual Analogue Scale (VAS). RESULTS: Two patients were lost to follow-up; of the remaining 51 patients who completed the study, 35 (68%) showed an improvement in VAS score. The difference in scores between the initial and the final visit was -1.9+/-2.1 cm (range, -6 to +3), or 23.8+/-40.8% (range, -150% to 100%) compared to the scores at the baseline visit (P=0.0001). CONCLUSIONS: The study results indicate that in the short term TUBES gastro can significantly improve dyspeptic symptoms in dyspeptic patients negative for H. pylori infection through the synergistic action of its components: alginate buffers gastric acid; bicarbonate helps to eliminate gas and rebalance pH; essential oils regulate motility; and bromelin stimulates enzymatic activity.