Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg).

BACKGROUND & AIMS: After a first Helicobacter pylori eradication attempt, approximately 20% of patients will remain infected. The aim of the current study was to assess the effectiveness and safety of second-line empiric treatment in Europe. METHODS: This international, multicenter, prospective, non-interventional registry aimed to evaluate the decisions and outcomes of H pylori management by European gastroenterologists. All infected adult cases with a previous eradication treatment attempt were registered with the Spanish Association of Gastroenterology-Research Electronic Data Capture until February 2021. Patients allergic to penicillin and those who received susceptibility-guided therapy were excluded. Data monitoring was performed to ensure data quality. RESULTS: Overall, 5055 patients received empiric second-line treatment. Triple therapy with amoxicillin and levofloxacin was prescribed most commonly (33%). The overall effectiveness was 82% by modified intention-to-treat analysis and 83% in the per-protocol population. After failure of first-line clarithromycin-containing treatment, optimal eradication (>90%) was obtained with moxifloxacin-containing triple therapy or levofloxacin-containing quadruple therapy (with bismuth). In patients receiving triple therapy containing levofloxacin or moxifloxacin, and levofloxacin-bismuth quadruple treatment, cure rates were optimized with 14-day regimens using high doses of proton pump inhibitors. However, 3-in-1 single capsule or levofloxacin-bismuth quadruple therapy produced reliable eradication rates regardless of proton pump inhibitor dose, duration of therapy, or previous first-line treatment. The overall incidence of adverse events was 28%, and most (85%) were mild. Three patients developed serious adverse events (0.3%) requiring hospitalization. CONCLUSIONS: Empiric second-line regimens including 14-day quinolone triple therapies, 14-day levofloxacin-bismuth quadruple therapy, 14-day tetracycline-bismuth classic quadruple therapy, and 10-day bismuth quadruple therapy (as a single capsule) provided optimal effectiveness. However, many other second-line treatments evaluated reported low eradication rates. ClincialTrials.gov number: NCT02328131.

Unacceptable Antibiotic Resistance Rates for Helicobacter pylori in Turkey: Something Must Change.

BACKGROUND: It is known that clarithromycin resistance has increased over the years (success rate 60%). The aim of the study was to investigate the importance of regional antimicrobial resistance rates for full accuracy of both diagnosis and treatment of Helicobacter pylori infection. METHODS: This study was carried out in the University Hospital Department of Gastroenterology. A total of 116 patients were evaluated with upper gastrointestinal endoscopy. Gastric antrum and corpus biopsy samples were taken for the rapid urease test (RUT), culture, and antimicrobial susceptibility testing for the presence of H. pylori. Antimicrobial susceptibilities of isolated H. pylori strains for clarithromycin and levofloxacin were determined by the epsilometer test (E-test). Minimal inhibitory concentration values for clarithromycin and levofloxacin were ≥1 and >1 µg/mL, respectively. RESULTS: H. pylori infection was considered clinically positive in 93 (80.2%) patients with either the RUT, culture, or histopathological examination. Seventy (60.3%) of the patients had RUT positivity. Sixty (85.7%) of these 70 patients had RUT positivity within the first 20 min. Among the 90 patients, who had a histopathological examination, HLO was positive in 76 (84.4%) patients. Fifty-two (44.8%) out of 116 patients were culture positive. Resistance rates for both clarithromycin and levofloxacin were high. In these 52 culture-positive patients, resistance rates determined for clarithromycin and levofloxacin were 26.9% and 25.5%, respectively. CONCLUSION: Clarithromycin or levofloxacin-based treatment regimen may not be an ideal alternative therapy for Turkish patients regardless of culture.

Adverse Event Profile During the Treatment of Helicobacter pylori: A Real-World Experience of 22,000 Patients From the European Registry on H. pylori Management (Hp-EuReg).

INTRODUCTION: The safety of Helicobacter pylori eradication treatments and to what extent adverse events (AEs) influence therapeutic compliance in clinical practice are hardly known. Our aim was to assess the frequency, type, intensity, and duration of AEs, and their impact on compliance, for the most frequently used treatments in the "European Registry on Helicobacter pylori management." METHODS: Systematic prospective noninterventional registry of the clinical practice of European gastroenterologists (27 countries, 300 investigators) on the management of H. pylori infection in routine clinical practice. All prescribed eradication treatments and their corresponding safety profile were recorded. AEs were classified depending on the intensity of symptoms as mild/moderate/severe and as serious AEs. All data were subject to quality control. RESULTS: The different treatments prescribed to 22,492 patients caused at least 1 AE in 23% of the cases; the classic bismuth-based quadruple therapy was the worst tolerated (37% of AEs). Taste disturbance (7%), diarrhea (7%), nausea (6%), and abdominal pain (3%) were the most frequent AEs. The majority of AEs were mild (57%), 6% were severe, and only 0.08% were serious, with an average duration of 7 days. The treatment compliance rate was 97%. Only 1.3% of the patients discontinued treatment due to AEs. Longer treatment durations were significantly associated with a higher incidence of AEs in standard triple, concomitant, bismuth quadruple, and levofloxacin triple or quadruple therapies. DISCUSSION: Helicobacter pylori eradication treatment frequently induces AEs, although they are usually mild and of limited duration. Their appearance does not interfere significantly with treatment compliance.

Helicobacter pylori first-line and rescue treatments in patients allergic to penicillin: Experience from the European Registry on H pylori management (Hp-EuReg).

BACKGROUND: Experience in Helicobacter pylori eradication treatment of patients allergic to penicillin is very scarce. A triple combination with a PPI, clarithromycin (C), and metronidazole (M) is often prescribed as the first option, although more recently the use of a quadruple therapy with PPI, bismuth (B), tetracycline (T), and M has been recommended. AIM: To evaluate the efficacy and safety of first-line and rescue treatments in patients allergic to penicillin in the "European Registry of H pylori management" (Hp-EuReg). METHODS: A systematic prospective registry of the clinical practice of European gastroenterologists (27 countries, 300 investigators) on the management of H pylori infection. An e-CRF was created on AEG-REDCap. Patients with penicillin allergy were analyzed until June 2019. RESULTS: One-thousand eighty-four patients allergic to penicillin were analyzed. The most frequently prescribed first-line treatments were as follows: PPI + C + M (n = 285) and PPI + B + T + M (classic or Pylera® ; n = 250). In first line, the efficacy of PPI + C + M was 69%, while PPI + B + T + M reached 91% (P < .001). In second line, after the failure of PPI + C + M, two rescue options showed similar efficacy: PPI + B + T + M (78%) and PPI + C + levofloxacin (L) (71%) (P > .05). In third line, after the failure of PPI + C + M and PPI + C + L, PPI + B + T + M was successful in 75% of cases. CONCLUSION: In patients allergic to penicillin, a triple combination with PPI + C + M should not be generally recommended as a first-line treatment, while a quadruple regimen with PPI + B + T + M seems to be a better option. As a rescue treatment, this quadruple regimen (if not previously prescribed) or a triple regimen with PPI + C + L could be used but achieved suboptimal (<80%) results.

Rapid identification of Helicobacter pylori and assessment of clarithromycin susceptibility from clinical specimens using FISH.

Helicobacter pylori remains one of the most common bacterial infections worldwide. Clarithromycin resistance is the most important cause of H. pylori eradication failures. Effective antibiotic therapies in H. pylori infection must be rapidly adapted to local resistance patterns. We investigated the prevalence of clarithromycin resistance due to mutations in positions 2142 and 2143 of 23SrRNA gene of H. pylori by fluorescence in situ hybridisation (FISH), and compared with culture and antimicrobial susceptibility testing in 234 adult patients with dyspepsia who were enrolled. Antrum and corpus biopsy specimens were obtained for rapid urease test, histopathology and culture. Epsilometer test was used to assess clarithromycin susceptibility. H. pylori presence and clarithromycin susceptibility were determined by FISH in paraffin-embedded biopsy specimens. We found that 164 (70.1%) patients were positive for H. pylori based on clinical criteria, 114 (69.5% CI 62.5-76.6%) were culture positive, and 137 (83.5% CI 77.8-89.2%) were FISH positive. Thus the sensitivity of FISH was significantly superior to that of culture. However specificity was not significantly different (91.4 versus 100.0%, respectively). The resistance rate to clarithromycin for both antrum and corpus was detected in H. pylori-positive patients; 20.2% by FISH and 28.0% by E-test.The concordance between E-test and FISH was only 89.5% due to the presence of point mutations different from A2143G, A2142G or A2142C. We conclude that FISH is significantly more sensitive than culture and the E-test for the detection of H. pylori and for rapid determinination of claritromycin susceptibility. The superior hybridisation efficiency of FISH is becoming an emerging molecular tool as a reliable, rapid and sensitive method for the detection and visualisation of H. pylori, especially when the management of H. pylori eradication therapy is necessary. This is particularly important for the treatment of patients with H. pylori eradication failure.

The prevalence of Helicobacter pylori infection in patients with gastric and duodenal ulcers - a 10-year, single-centre experience.

INTRODUCTION: Helicobacter pylori (H. pylori) occurs throughout the world and causes gastroduodenal diseases. There is data indicating a change in the prevalence of H. pylori infection worldwide. The prevalence of H. pylori is 80% in Turkey, while it is higher in many developing countries, and the rate of infection varies throughout the world. In many developing countries, the prevalence of infection exceeds 90% by adulthood. AIM: To determine the change in the rate of H. pylori infection in gastric ulcers and duodenal ulcers for a 10-year period in a single centre. MATERIAL AND METHODS: The study population included 550 patients (342 in 2004, 208 in 1994) with gastric and duodenal ulcers. RESULTS: In 2004 there were 125 (36.5%) patients with gastric ulcer and 217 patients with duodenal ulcer (64.5%). CLO test positivity was 39.2% in patients with gastric ulcers and 60% in patients with duodenal ulcers. In 1994 there were 208 patients (159 duodenal ulcers, 49 gastric ulcers). Urease test was positive in 74.2% of patients with duodenal ulcer and in 65.2% of patients with gastric ulcer. The decrease in the rate of urease positivity in patients with gastric ulcer was statistically significant (p = 0.01) during this 10-year period. CONCLUSIONS: In the present study we found that the urease positivity decreased significantly in patients with gastric ulcer between 1994 and 2004.

Changes of Some Hormones Levels in Patients With Hepatitis B Virus-Related Chronic Liver Disease.

BACKGROUND: The purpose of the study was to evaluate some of the hormones in patients with chronic liver disease and cirrhosis. METHODS: The men patients with chronic hepatitis B (Group 1), liver cirrhosis secondary to hepatitis B (Group 2), were included in this study. Additionally, a control group of healthy volunteers (Group 3) was formed. We investigated serum levels of Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), Total testosterone (T. TES), Free-testosterone (F. TES), Estradiol (E2), Androstenedione (ANDR), Dihydroepiandrosterone (DHEA), Progesterone (PPOGES), Prolactin (PRL), Sex hormone binding protein (SHGB) were measured by radioimmunoassay and chemiluminescent immunoassay methods. RESULT: A total of 73 patients with chronic liver disease and cirrhosis were included in the study. Patients were grouped as cirrhosis (n = 28), chronic hepatitis B (n = 41) according to the type of their chronic liver disease. Serum F.TEST level in patient groups (group 1, group 2) was found to be lower than control group (P = 0.045, P = 0.047). Serum LH value was found to be higher in patient group (group 2) than control group (P = 0.048). Serum estradiol was higher in the group 2 compared to the control group (P = 0.046). CONCLUSIONS: The described disturbances of some of the observed hormones (LH, E2, F. TES) are complex, particularly in their relationship by which the clinical picture of the hepatitis B related cirrhotic patients and chronic liver disease can be explained.

Alpha-2-adrenergic receptor gene polymorphism in Turkish population with irritable bowel syndrome.

BACKGROUND/AIMS: Irritable bowel syndrome is a multifactorial functional gastrointestinal disorder affecting more than 10% of world population. Genetic component in pathophysiology of irritable bowel syndrome is still unknown. The aim of this study was to examine the potential impact of C-1291G polymorphism in α2-adrenergic receptor gene promoter region in the etiology of the disease. MATERIALS AND METHOD: This prospective case-control study included 100 irritable bowel syndrome patients and 100 healthy controls adjusted for sex and age. The subjects were genotyped by using polymerase chain reaction amplification of the promoterregion of α2-adrenergic receptor gene. Allele and genotype frequencies were compared in patient and control groups. The study was approved by the University ethics committee. RESULTS: The frequency of C allele was 72% and 75%, G allele was 28% and 25% in patient and control groups, respectively (p>0.05). We found that the frequencies of C1291C, C1291G, and G1291G genotypes were 50, 44, and 6%, respectively, in the patient group and 51, 48, and 1%, respectively, in the control group (p>0.05). The subgroup analysis of patients revealed that 70 patients were constipation-predominant, 27 patients were alternating diarrhea and constipation, and 3 patients were diarrhea-predominant irritable bowel syndrome. CONCLUSION: No significant association was observed between α2-adrenergic receptor gene C-1291G polymorphism and irritable bowel syndrome in Turkish population. The high number of constipation predominant irritable bowel syndrome and very low number of diarrhea predominant irritable bowel syndrome patients might be the reason for statistical non-significance since α2-adrenergic receptor gene is found to be responsible for mediating intestinal antisecretory action and probably is involved in the pathogenesis of diarrhea predominant irritable bowel syndrome. Further investigations are needed.

The diagnostic accuracy of urine IgG antibody tests for the detection of Helicobacter pylori infection in Turkish dyspeptic patients.

BACKGROUND/AIMS: There is increasing interest in noninvasive tests for the assessment of Helicobacter pylori infection, and urine-based tests have been widely used as noninvasive tests to detect Helicobacter pylori infection. The aim of this study was to evaluate the adaptation and usefulness of urine antibody enzyme-linked immunosorbent assay and urine card tests in the clinical setting to detect anti-Helicobacter pylori IgG antibody excreted into urine in Turkish adult patients with dyspepsia. MATERIALS AND METHODS: One-hundred twenty-four patients who were admitted and referred for upper endoscopy to Dokuz Eylül University Hospital, Gastroenterology Clinic were studied. Antrum and corpus biopsies were taken, and Helicobacter pylori status was defined in the presence of at least two positive results of rapid urease test, histopathology and culture. Urine and serum specimens of 124 patients were collected and examined for anti-Helicobacter pylori IgG antibody by URINELISA, RAPIRUN (Otsuka Pharmaceutical, Tokyo, Japan) and anti-Helicobacter pylori enzyme-linked immunosorbent assay (Euroimmun, Lübeck, Germany) tests, respectively. RESULTS: Helicobacter pylori infection was positive in 82 (66.1%) patients according to the gold standard methods. Among 82 Helicobacter pylori infection-positive patients, 69 patients were positive by both URINELISA and RAPIRUN; 109 of 124 patients were positive by anti-Helicobacter pylori IgG enzyme-linked immunosorbent assay. The sensitivity and specificity of URINELISA, RAPIRUN and anti-Helicobacter pylori IgG enzyme-linked immunosorbent assay were 74.4%, 73.2%, 100% and 81.0%, 78.6%, 35.7%, respectively. However, the urine antibody test cut-off values were searched for the best concordance with the results of gold standard methods. This yielded that the sensitivity and specificity of URINELISA with our new cut-off value (0.530) were 90.2% and 71.4%, respectively. CONCLUSIONS: As a first study among Turkish adult patients with dyspepsia, the efficacy of URINELISA was related with the determination of a new cut-off value for pretreatment as a screening test value. We suggest that the cut-off value of the URINELISA test should be evaluated and considered for each patient group and each country. The URINELISA (OD 0.530) and RAPIRUN tests were found useful for the diagnosis of Helicobacter pylori infection in our patients with dyspepsia.

[A real-time PCR assay for the quantification of hepatitis B virus DNA and concurrent detection of YMDD motif mutations]. / Hepatit B Virus DNA Düzeyi Tayini ve Es Zamanli Olarak YMDD Motif Mutasyonu Analizi Yapan Gerçek Zamanli PCR Testi.

Monitoring therapy in chronic hepatitis B patients receiving lamivudine therapy, is done by two different assays; determination of viral load and genotypic resistance. These methods are labor intensive and time consuming. It was aimed to develop an assay to quantitate hepatitis B virus (HBV) DNA in serum and detect YMDD (thyrosine, methionine, aspartate, aspartate) motif mutations in the same run. The assay was based on real-time polymerase chain reaction (Rt-PCR) with YMDD-specific hybridization probes. Determination of YMDD motif was done by melting temperature analysis. External standard curve was used for quantifying viral DNA, which was generated by standard sera (VQC S2220) including HBV-DNA between concentrations of 1000 to 3 million copies/ml. The assay was compared with commercial quantitative kit (Artus HBV RG PCR; Qiagen, Germany), commercial line prob assay (INNO-LiPA HBV DR v1.0; Innogenetics, Belgium) and direct DNA sequencing method. Thirty-eight serum samples obtained from 20 chronic hepatitis B patients (7 female, 13 male; age range: 27-70 years) treated with only lamivudine and were negative for HIV and HCV antigen and antibodies were tested in the study. The analytical sensitivity of the assay was found as 200 copies/ml, with a dynamic range of 1 x 103 to 3 x 107 copies/ml. PCR efficiency of the in-house assay was found to be 1.98. Comparison of log10 HBV-DNA concentrations determined by the in-house and commercial quantitative kits showed a significant correlation (r= 0.681). Melting temperature (Tm) analysis was used for the YMDD motif determination and found to be 59.86°C for YMDD, 56.34°C for YVDD and 55.10°C for YIDD. The results of the in-house assay, DNA sequencing and LiPA were concordant in samples with homogeneous virus population, and in-house assay could also detect the major type of YMDD motif in mixed viral populations The Rt-PCR method which was developed in this study is a rapid, accurate and reproducible method for quantifying HBV-DNA and detecting the predominant YMDD motif in the same run in two hours duration. It was concluded that this method may be a convenient tool for monitoring HBV-infected patients receiving lamivudine treatment.

Irritable bowel syndrome and other functional gastrointestinal disorders.

Irritable bowel syndrome is one of several highly prevalent functional gastrointestinal disorders (FGID) displaying symptoms of gastrointestinal dysmotility and visceral hypersensitivity. Substantial overlap of symptoms and comorbidities occur not only between irritable bowel syndrome and other FGID but also with gastrointestinal disorders that are not related to motility (eg, celiac disease and lactose intolerance) and to somatic conditions (eg, fibromyalgia and chronic fatigue syndrome). Pathogenic mechanisms common among FGIDs may include alternations in intestinal and colonic microflora. Evidence is also emerging of an interplay between gut immune cells/activity and alternations in motility, secretion, and sensation. The role of cytokine activity and inflammation is important in this regard. As recommended by Rome III, diagnostic testing should be guided by the patient's age, primary symptom characteristics, and other clinical and laboratory features. The high prevalence of coexisting conditions suggests the need to routinely assess patients for related disorders. Treatment should be based on an individualized evaluation, explanation, and reassurance.

[Molecular detection of Helicobacter pylori vacA and cagA genes in gastric tissue specimens of patients with peptic ulcer disease and non-ulcer dyspepsia]. / Peptik Ülserli ve Ülser Olmayan Dispepsili Hastalarin Mide Doku Örneklerinde Helicobacter pylori vacA ve cagA Genlerinin Moleküler Yöntemlerle Belirlenmesi.

Helicobacter pylori can colonize the gastric mucosa and is considered as a risk factor for chronic active gastritis, peptic ulcer, gastric adenocarcinoma and primary gastric lymphoma. Among its various virulence factors, vacuolating cytotoxin encoded by vacA and cytotoxin-associated toxin encoded by cagA gene play an important role. The aims of this study were the detection of H.pylori vacA s and m genotypes, investigation of the association between vacA genotypes and cagA gene presence, and evaluation of the correlation between those factors and the clinical diagnosis. Gastric tissue specimens of patients who were clinically diagnosed as peptic ulcer disease (PUD) and non-ulcer dyspepsia (NUD) were included in the study. A total of 29 patients (age range: 18-74 years, mean age: 47.8 ± 13.6 years; 19 were female) without any familial relationship were evaluated. Thirteen (44.8%) of the patients were diagnosed clinically as PUD, while 16 (55.2%) as NUD. All of the patients' gastric tissue samples obtained by endoscopy were urease positive. H.pylori DNA was extracted from the tissue specimens by proteinase-K, phenol-chloroform-isoamyl alcohol method and vacA s, m1, m2 and cagA regions were identified by polymerase chain reaction (PCR) using four different primer sets. In addition, DNA sequencing was performed for the protected 785 base-pairs region of vacA m gene in all of the samples, and the sequences were aligned with Gene-Bank sequences, creating a phylogenetic tree. The distribution of vacA genotypes between 29 H.pylori positive patients were found as; s1m1 (n= 16), s1m2 (n= 6) and s2m2 (n= 7), while 19 patients yielded positive results for cagA gene. CagA positivity was detected in all of the 16 patients harboring s1m1 genotype, and 13 of those were the patients diagnosed as PUD (p= 0.008). Genotyping data achieved by phylogenetic analysis of the vacA m region were compatible with m genotypes identified by PCR. In conclusion, we detected a significant relationship between PUD and vacA s1m1 and cagA positivity. It was also determined that PCR would be a reliable, simpler and cheaper alternative to nucleotide sequencing for the identification of H.pylori vacA m genotypes.

Comparison of high resolution magnifying endoscopy and standard videoendoscopy for the diagnosis of Helicobacter pylori gastritis in routine clinical practice: a prospective study.

BACKGROUND: It has been shown that standard endoscopic features often labeled as gastritis has a poor correlation with histopathology. Recently, high resolution magnifying endoscopy has been reported to be an effective method to diagnose gastritis. The aim of the present study was to compare standard endoscopy with magnifying endoscopy for the diagnosis of Helicobacter pylori gastritis, and to determine whether gastritis can be diagnosed based on findings at magnification endoscopy. MATERIALS AND METHODS: A total of 129 patients were enrolled into the study. Erythema, erosions, prominent area gastrica, nodularity, and regular arrangement of collecting venules (RAC) were investigated by standard endoscopy. Standard endoscopy was followed by magnifying endoscopy in all patients, and repeated in 55 patients after indigo carmine spraying. RESULTS: None of the standard endoscopic features showed a sensitivity of more than 70% for H. pylori gastritis, except RAC pattern analysis. Absence of a corporal RAC pattern had 85.7% sensitivity and 82.8% specificity for predicting H. pylori infection. Under magnification, the sensitivity and specificity of regular corporal pattern (regular collecting and capillary vascular structures with gastric pits resembling pinholes) for predicting normal histology were 90.3% and 93.9%, respectively. Loss of collecting venules, or both collecting and capillary structures was correlated with chronic inflammation and activity. With the progression of mucosal atrophy, irregular collecting venules became visible. The values for irregularly arranged antral ridge pattern for the prediction of antral gastritis were 89.3% and 65.2%, respectively. Indigo carmine staining increased sensitivity and specificity up to 97.6% and 100% for corporal gastritis, and up to 88.4% and 75.0% for antral gastritis, respectively. Indigo carmine staining significantly increases the detection of intestinal metaplasia. CONCLUSIONS: High resolution magnifying is superior to standard endoscopy for the diagnosis of H. pylori gastritis, and identification of specific histopathologic features such as atrophy and intestinal metaplasia seems possible.

Epidemiology and survival of hepatocellular carcinoma in Turkey: outcome of multicenter study.

OBJECTIVE: Hepatocellular cancer (HCC) is one of the important health problems in Turkey. We aimed to determine the clinical and demographic features of HCC in the Turkish population and to evaluate the prognostic and survival features. METHOD: Two hundred and twenty-one patients with HCC from five hospitals in Turkey are included in this study. RESULTS: In 44.4% of the 221 patients with hepatitis B virus and in 21.3% of the 221 patients with hepatitis C virus were found to be responsible for HCC etiology. It has been shown that HCC developed on cirrhosis basis in 74.2% of the patients. HCC was presented with single solitary nodule in 69.2% of the patients. Non-liver metastasis was present in 12.5% of the patients. In 21.7% of the patients, alpha-fetoprotein (AFP) levels were above the diagnostics level of 400 ng/ml. The median overall survival (OS) of 221 patients was 14 months. The median OS of the patients with Child-Pugh A class was significantly longer than that with Child-Pugh B and C classes. The OS of the individuals with normal AFP levels was also longer than that with high AFP levels. The OS of the patients with Stage I HCC according to tumor node metastasis (TNM) classification, the female patients and the treated patients group was found to be significantly good. CONCLUSIONS: In conclusion, the viral etiology (hepatitis B and C infections) in Turkish population is found to be an important factor in HCC development. The Child-Pugh classification, AFP levels, TNM classification, being female and treatment were determined to be important prognostic factors in HCC patients.

Esomeprazole in acute and maintenance treatment of reflux oesophagitis: a multicentre prospective study.

INTRODUCTION: The aim of this study was to assess the efficacy and safety of esomeprazole 40 mg once daily (q.d.) in healing reflux oesophagitis at 4 and 8 weeks, and the efficacy of esomeprazole 20 mg q.d. for 12 weeks in the maintenance of remission. METHODS: A total of 235 patients with endoscopically proven reflux oesophagitis were enrolled in this study, which consisted of two phases (healing and maintenance therapy). Patients who showed complete endoscopic and symptomatic healing at the end of 4 or 8 weeks were switched to maintenance treatment with esomeprazole 20 mg q.d. for 12 weeks. The primary efficacy endpoint was healing of reflux oesophagitis at week 8. Secondary assessments included the proportion of patients with symptomatic relapse in the maintenance phase. RESULTS: At the end of week 8, 88% (95% life-table confidence intervals [CI]: 84%, 92%) of patients were healed endoscopically and 90.6% of the patients were asymptomatic. Patient age, gender and Helicobacter pylori status had no effect on the efficacy of treatment. During the 12-week maintenance treatment phase, symptomatic relapse ratios were 0.5%, 2.2%, and 0%, for the first, second, and third 4-week periods, respectively. The proportions of patients satisfied with treatment were 95% and 99.4% at the end of acute and maintenance treatment, respectively. The most common adverse effects were headache, upper respiratory tract infection and abdominal pain. CONCLUSIONS: Esomeprazole is effective in the healing of reflux oesophagitis, the resolution of heartburn, and in maintaining symptomatic remission. The effectiveness of esomeprazole in patients with gastroesophageal reflux disease is not affected by the presence of H. pylori.

Prevalence patterns of gastric cancers in Turkey: model of a developing country with high occurrence of Helicobacter pylori.

AIM: In developed countries, there has been a recent increase in the prevalence of adenocarcinoma of the esophagus and cardia, along with a decrease in distal gastric cancers. Little is known regarding the prevalence of these diseases in developing countries. The aim of the present study was to evaluate changes in the prevalence of gastric adenocarcinomas in Turkey as a function of anatomic location. METHODS: Data were retrospectively collected from 16 centers from January 1990 to December 2000. Owing to the exclusion criteria, a total of 4065 cases of tumors of the stomach and distal esophagus were included. Tumors localized to the body, the antrum and pyloric channel were considered distal cancers. Helicobacter pylori (H. pylori) was also detected. RESULTS: Patients' mean age was 60.7 +/- 9 years, with a male : female ratio of 68:32. The ratio of distal/proximal adenocarcinoma was 2,1 [corrected] for the western part of Turkey and 3,8 [corrected] for the eastern part of the country (P < 0.0001), and this did not change during the 11 years. H. pylori was detected significantly less in the west compared to the east for distal tumors (65.7 vs 38.7%, respectively, P = 0.02). CONCLUSION: In Turkey, a developing country with a high H. pylori prevalence, contrary to the state of developed countries, the ratio of distal versus proximal gastric adenocarcinomas has not changed. Geographical distribution should be taken into the account in projecting the changing patterns of gastric cancers.

Helicobacter pylori and non-malignant diseases.

In recent years, the focus of Helicobacter pylori clinical research has been mainly on gastric malignancy. However, the role of H. pylori in non-malignant diseases, such as peptic ulcer, gastroesophageal reflux disease (GERD) and non-ulcer dyspepsia, as well as non-steroidal anti-inflammatory drug consumption, is still of great interest. A 1- to 2-week course of H. pylori eradication therapy is an effective treatment for H. pylori-positive peptic ulcer disease and a positive CagA status is a predictor for successful eradication of H. pylori. Antral prostaglandin-E2-basal levels appear to be critical for the development of aspirin-induced gastric damage in subjects without H. pylori infection. In clinical practice, among patients treated with proton-pump inhibitors, H. pylori status has no effect on the speed or degree of GERD symptom relief. For the management of dyspepsia in primary care, antisecretory therapy confers a small insignificant benefit compared to strategies based on H. pylori testing while these latter strategies may be cost-effective. H. pylori eradication therapy has a small but statistically significant effect on H. pylori-positive non-ulcer dyspepsia. An economic model suggests that this modest benefit may still be cost-effective but more research is needed.

Detection of Helicobacter pylori and determination of clarithromycin susceptibility using formalin-fixed, paraffin-embedded gastric biopsy specimens by fluorescence in situ hybridization.

BACKGROUND: Clarithromycin resistance and poor compliance to therapy are often responsible for Helicobacter pylori eradication therapy failure. AIM: To evaluate fluorescence in situ hybridization (FISH) as a nonculture method to simultaneously detect H. pylori and to identify clarithromycin resistance. METHODS: Fifty-four patients with dyspepsia (17 male, 37 female subjects; mean age, 46.5; range, 21-78 years) were studied. Two antrum and corpus biopsies were taken from each patient. Positive rapid urease test (RUT) and histopathologic examinations defined H. pylori positivity. A total of 108 formalin-fixed paraffin-embedded gastric mucosal biopsies were examined retrospectively by the FISH (seaFAST H. pylori Combi-Kit) method. RESULTS: Forty-five patients (83.3%) were H. pylori positive and 43 (95.5%) were also positive by FISH. There were two false-positive FISH results. Fourteen patients (31.1%) had clarithromycin-susceptible strains, 4 (8.9%) resistant strains, and 27 (60%) both susceptible and resistant strains. CONCLUSION: FISH results correlated well with H. pylori infection and were able to identify clarithromycin-susceptible and -resistant strains. This technique will be helpful in determining the bacterial density and the success of treatment where clarithromycin has been widely used in populations to increase the efficacy of the treatment and to clarify the treatment failure in vitro.

Diagnostic yield of routine duodenal biopsies in iron deficiency anaemia: a study from Western Anatolia.

OBJECTIVE: The role of routine endoscopic duodenal biopsies obtained during the evaluation of iron deficiency anaemia is being increasingly emphasized, but insufficiently applied. Diagnostic yield of this practice, mainly identification of coeliac disease, differs in different populations and geographic regions. The aim of this study is to assess the usefulness of routine duodenal biopsies during upper endoscopy in patients presenting with iron deficiency anaemia in Western Anatolia. METHODS: Routine duodenal biopsies were evaluated over a 12-month period in 100 consecutive adult patients with iron deficiency anaemia undergoing upper endoscopy. All potential bleeding lesions were identified and gastric as well as duodenal biopsies were taken for histopathologic investigation. RESULTS: A bleeding lesion is identified in 44% of cases. Duodenal biopsy gives an additional 5% diagnostic yield and revealed three patients with coeliac disease and two patients with giardiasis. One of the patients diagnosed with coeliac disease had a second bleeding lesion at the upper endoscopic examination. Appearance of the duodenal mucosa was normal in all patients including those with diagnostic duodenal biopsy. CONCLUSIONS: Routine duodenal sampling during the upper endoscopic examination gives an additional 5% diagnostic benefit and this practice should be included in the diagnostic work-up of patients with iron deficiency anaemia. As one of the patients who was found to have coeliac disease had a second bleeding lesion that may otherwise explain iron deficiency anaemia, finding a source for bleeding at the upper endoscopy should not preclude duodenal biopsy. Moreover, performing duodenal biopsy is still necessary even though the endoscopic appearance of the mucosa is normal. Aside from coeliac disease, Giardia infestation could be identified as a contributory factor for iron deficiency anaemia, in endemic regions.

Detection of H. pylori infection by ELISA and Western blot techniques and evaluation of anti CagA seropositivity in adult Turkish dyspeptic patients.

AIM: To detect H pylori infection and to evaluate the anti CagA seropositivity in adult Turkish dyspeptic patients. METHODS: We evaluated anti-H pylori IgA, IgG and anti-CagA antibodies using commercial enzyme-linked immunoassay (ELISA) and Western blot in dyspeptic Turkish patients. H pylori status was determined by histology and rapid urease testing. RESULTS: Fifty-six patients were entered. Forty-eight (85.7%) out of the 56 patients were positive for H pylori. H pylori IgG seropositivity was 82.1%, IgA seropositivity 48.2%. CagA ELISA showed that IgG was positive in 50% and IgA in 30.4% of those with H pylori infections. Western blot showed that IgG seropositivity was 80.4% and IgA seropositivity 33.9%. Western blot detected IgG antibodies with reactivity to CagA in 50%, VacA in 62.5%, UreB in 87.5%, UreA in 80.4%, and OMP in 57.1%. None of the tests had a sensitivity and specificity above 80%. CONCLUSION: None of these commercial tests seems clinically useful for H pylori detection in adult dyspeptic patients, while Western blot can give seropositivity and determine anti-CagA, VacA virulence factor status of Turkish dyspeptic patients in the Izmir region.