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Notes: Aim : To compare the efficacy of different regimens in patients in whom previous Helicobacter pylori eradication therapy has failed.Methods : In this study named StratHegy patients (n = 287) were randomized to receive one of three empirical triple therapy regimens or a strategy based on antibiotic susceptibility. The empirical regimens were omeprazole, 20 mg b.d., plus amoxicillin, 1000 mg b.d., and clarithromycin, 500 mg b.d., for 7 days (OAC7), clarithromycin, 500 mg b.d., for 14 days (OAC14) or metronidazole, 500 mg b.d., for 14 days (OAM14). In the susceptibility-based strategy, patients with clarithromycin-susceptible strains received OAC14, whilst the others received OAM14. The 13C-urea breath test was performed before randomization and 4–5 weeks after eradication therapy.Results : In the intention-to-treat analysis, the eradication rates for empirical therapies were as follows: OAC7, 47.4% (27/57); OAC14, 34.5% (20/58); OAM14, 63.2% (36/57); it was 74.3% (84/113) for the susceptibility-based treatment (P 〈 0.01 when compared with OAC7 and OAC14). In patients receiving clarithromycin, the eradication rates were 80% for clarithromycin-susceptible strains and 16% for clarithromycin-resistant strains; in patients receiving OAM14, the eradication rates were 81% for metronidazole-susceptible strains and 59% for metronidazole-resistant strains.Conclusions : Eradication rates of approximately 75% can be achieved with second-line triple therapy based on antibiotic susceptibility testing. If susceptibility testing is not available, OAM14 is an appropriate alternative.

Notes: Besides the well established Helicobacter pylori reservoir, i.e. the human stomach, numerous other sources have been hypothesized. However, none has been definitely proven. In some instances (pig, sheep), Helicobacter species closely related but different from H. pylori were detected but the results were misleading because culture of sufficiently discriminating molecular techniques were not used. In other cases, the strain was really H. pylori (cat) but the case was anecdotal or the animal species (monkey) has so little contact with humans that the possible source has no epidemiological consequence. This is also the case for houseflies which theoretically can be a vehicle, but practically speaking are not because of too few viable bacteria present in faeces. Molecular epidemiology studies demonstrating the route of transmission (faecal–oral, oral–oral or gastro–oral) are still lacking but recent studies have confirmed the presence of viable H. pylori in vomitus and in faeces in the event of diarrhoea.

Notes: Aim : Non-invasive tests for the assessment of Helicobacter pylori status are now an integral part of the management strategies for patients with dyspepsia. The aim of this study was to evaluate a urine based antibody ELISA and a near patient urine test for the diagnosis of H. pylori infection in a European population.Methods : Urine samples were collected from 449 patients (240 females, 209 males, mean age 54 years), with dyspeptic symptoms but no previous H. pylori eradication therapy, at five centres in four European countries. All patients underwent GI endoscopy and biopsies were taken for H. pylori diagnosis. Urine samples were analysed using an IgG ELISA (URINELISA) and a near patient urine test (RAPIRUN). In addition, a serum IgG ELISA (Pyloriset-EIA-GIII), a whole blood test (Pyloriset-Screen) and a 13C-urea breath test were performed.Results : The sensitivity of the urine based ELISA and the near patient urine test was 90% and 82%, and the specificity 68% and 83%, respectively. The accuracy of the serum ELISA and the whole blood test was comparable with the urine based test.Conclusion : The urine based ELISA and the near patient urine test are just as accurate as the serological tests. This comparable accuracy and complete non-invasiveness of the former gives it an advantage over blood based tests. This limits the application of these tests in general practice.

Notes: Aim : To study risk factors for failure of Helicobacter pylori eradication treatment.Methods : Individual data from 2751 patients included in 11 multicentre clinical trials carried out in France and using a triple therapy, were gathered in a unique database. The 27 treatment regimens were regrouped into four categories.Results : The global failure rate was 25.8%[95% CI: 24–27]. There was a difference in failure rate between duodenal ulcer patients and non-ulcer dyspeptic patients, 21.9% and 33.7%, respectively (P 〈 10−6). In a random-effect model, the risk factors identified for eradication failure in duodenal ulcer patients (n = 1400) were: to be a smoker, and to have received the group 4 treatment, while to receive a 10 day treatment vs. 7 days protected from failure. In non-ulcer dyspeptic patients (n = 913), the group 2 treatment was associated with failure. In both groups, age over 60 was associated with successful H. pylori eradication. There were less strains resistant to clarithromycin in duodenal ulcer patients than in non-ulcer dyspeptic patients. Clarithromycin resistance predicted failure almost perfectly.Conclusion : Duodenal ulcer and non-ulcer dyspeptic patients should be managed differently in medical practice and considered independently in eradication trials.

Notes: Significant progress and new insights have been gained in the 4 years since the first Maastricht Consensus Report, necessitating an update of the original guidelines. To achieve this, the European Helicobacter Pylori Study Group organized a meeting of specialists and experts from around the world, representatives from National Gastroenterology Societies and general practitioners from Europe to establish updated guidelines on the current management of Helicobacter pylori infection. The meeting took place on 21–22 September 2000.A ‘test and treat’ approach is recommended in adult patients under the age of 45 years (the age cut-off may vary locally) presenting in primary care with persistent dyspepsia, having excluded those with predominantly gastro-oesophageal reflux disease symptoms, non-steroidal anti-inflammatory drug users and those with alarm symptoms. Diagnosis of infection should be by urea breath test or stool antigen test.As in the previous guidelines, the eradication of H. pylori is strongly recommended in all patients with peptic ulcer, including those with complications, in those with low-grade gastric mucosa-associated lymphoid tissue lymphoma, in those with atrophic gastritis and following gastric cancer resection. It is also strongly recommended in patients who are first-degree relatives of gastric cancer patients and according to patients’ wishes after full consultation.It is advised that H. pylori eradication is considered to be an appropriate option in infected patients with functional dyspepsia, as it leads to long-term symptom improvement in a subset of patients. There was consensus that the eradication of H. pylori is not associated with the development of gastro-oesophageal reflux disease in most cases, and does not exacerbate existing gastro-oesophageal reflux disease. It was agreed that the eradication of H. pylori prior to the use of non-steroidal anti-inflammatory drugs reduces the incidence of peptic ulcer, but does not enhance the healing of gastric or duodenal ulcer in patients receiving antisecretory therapy who continue to take non-steroidal anti-inflammatory drugs.Treatment should be thought of as a package which considers first- and second-line eradication therapies together. First-line therapy should be with triple therapy using a proton pump inhibitor or ranitidine bismuth citrate, combined with clarithromycin and amoxicillin or metronidazole. Second-line therapy should use quadruple therapy with a proton pump inhibitor, bismuth, metronidazole and tetracycline. Where bismuth is not available, second-line therapy should be with proton pump inhibitor-based triple therapy. If second-line quadruple therapy fails in primary care, patients should be referred to a specialist. Subsequent failures should be handled on a case-by-case basis by the specialist. In patients with uncomplicated duodenal ulcer, eradication therapy does not need to be followed by further antisecretory treatment. Successful eradica- tion should always be confirmed by urea breath test or an endoscopy-based test if endoscopy is clinically indicated. Stool antigen test is the alternative if urea breath test is not available.

Notes: Helicobacter pylori eradication rates in France after therapy with omeprazole, amoxicillin and clarithromycin are among the lowest in Europe. This study evaluated alternative eradication regimens.〈section xml:id="abs1-2"〉〈title type="main"〉Methods: Helicobacter pylori-positive patients (n=323) with non-ulcer dyspepsia were randomized to receive one of four 1-week regimens consisting of omeprazole, 20 mg b.d., plus either: amoxicillin, 1000 mg b.d., and clarithromycin, 500 mg b.d. (OAC); bacampicillin, 1200 mg b.d., and clarithromycin, 500 mg b.d. (OBC); clarithromycin, 250 mg b.d., and metronidazole, 500 mg b.d. (OCM); or amoxicillin, 1000 mg b.d, and azithromycin, 500 mg on day 1 and 250 mg on days 2–5 (OAAz). Eradication was confirmed by urea breath test 4–6 weeks after treatment. Susceptibility testing was performed in the case of eradication failure.〈section xml:id="abs1-3"〉〈title type="main"〉Results:The eradication rate with OAAz was 38% (95% CI, 25.6–49.4) on intention-to-treat analysis, which was lower (P 〈 0.05) than with the other regimens [OCM, 61% (50.0–72.8); OBC, 65% (54.0–76.5); OAC, 72% (61.8–81.8)]. Of the strains isolated following treatment failure with OAC, OBC or OCM, 84% were clarithromycin resistant.〈section xml:id="abs1-4"〉〈title type="main"〉Conclusions:OAC remains the reference treatment for H. pylori eradication in France, although bacampicillin offers a useful alternative to amoxicillin. Susceptibility testing should be considered after unsuccessful eradication therapy.

Notes: Aim : To assess the decline in Helicobacter pylori antibodies after eradication of infection.Methods : The H. pylori status was determined at entry (D0) by culture and histology performed on antral biopsies and after eradication treatment at day 42 (day 42) and after 6 months (M6) by the 13C-urea breath test. The EIA kits used to determine the anti-H. pylori antibody titre were HM-CAP (immunoglobulin-G) and PP-CAP (immunoglobulin-A) kits (Enteric Products, Inc.) and Pyloriset EIA-G (Orion Diagnostica).Results : Ninety-three patients were included. For 82 patients who were successfully treated, no kit was sufficiently accurate at D42 to show eradication. The antibody titre decreased for HM-CAP, PP-CAP and Pyloriset EIA-G by a mean of 35.6%, 41.2% and 64.7% between D0 and M6, respectively. According to the cut-off values defined by the manufacturers, 8.5% (PP-CAP, Pyloriset EIA-G) and 9.7% (HM-CAP) of the patients became H. pylori negative at M6. Using a 25% decrease in antibody titre between D0 and M6 as a threshold for H. pylori eradication, specificity was 100% for HM-CAP, 89.9% for Pyloriset EIA-G and 100% for PP-CAP, whereas the sensitivity was 76.8%, 98.8% and 72%, respectively.Conclusion : An antibody titre decrease of 25% at M6 was found to be accurate in confirming H. pylori eradication.

Notes: Rebamipide exerts a positive effect on the digestive epithelial barrier by reinforcing its integrity in normal and in inflammatory conditions, and by normalizing the macromolecular transport across this barrier, increased by Helicobacter infection. Moreover, in mice, rebamipide is capable of diminishing allergic sensitization and of counteracting the inhibitory effect of Helicobacter pylori on oral tolerance to dietary antigens. These properties of rebamipide could explain its anti-inflammatory activity with respect to the digestive mucosa and could provide protection against allergic sensitization to foreign antigens in susceptible individuals.

Notes: Background : The high prevalence of Helicobacter pylori resistance to metronidazole demands treatments more effective than standard bismuth-based triple therapy against these strains.Aim : To evaluate the H. pylori eradication rate in both metronidazole-sensitive and -resistant strains following quadruple therapy using single-triple capsules of bismuth biskalcitrate, metronidazole and tetracycline, given with omeprazole.Methods : One hundred and seventy valid patients with duodenal ulcer, gastric ulcer or non-ulcer dyspepsia were treated in eight centres located in five countries. H. pylori was confirmed at baseline using 13C-urea breath test, histology and/or culture. Patients received three single-triple capsules q.i.d. and omeprazole, 20 mg b.d., for 10 days. Each capsule contained bismuth biskalcitrate, 140 mg (as 40 mg Bi2O3 equivalent), metronidazole, 125 mg, and tetracycline, 125 mg. 13C-Urea breath test was repeated at least 4 and 8 weeks post-treatment.Results : Overall eradication rates were 93% (158/170) by modified intention-to-treat analysis and 97% (142/146) by per protocol analysis. Eradication rates were 93% (40/43) and 95% (38/40) for strains resistant to metronidazole and 95% (82/86) and 99% (75/76) for strains sensitive to metronidazole by modified intention-to-treat and per protocol analysis, respectively.Conclusion : This omeprazole–bismuth biskalcitrate–metronidazole–tetracycline 10-day regimen is a very effective and well-tolerated treatment, which overcomes metronidazole resistance.

Notes: The occurrence of refractory Helicobacter pylori infection is increasing. When the bacteria are not eradicated it means that the antibiotics have not reached the gastric mucosa at a sufficient concentration and over a sufficient time lapse to kill them. The main reasons for this are poor patient compliance, resistant bacteria, low gastric pH and a high bacterial load. Therefore, when administering a new treatment, it is important to choose antibiotics which do not face resistance problems and which increase the dosage of antisecretory drugs and the duration of treatment and, if possible, to add a topical agent such as bismuth salt.The recommended empirical strategy is to prescribe quadruple therapy or, alternatively, 2-week triple therapy including amoxicillin–metronidazole, tetracycline–metronidazole or amoxicillin–rifabutin. However, when H. pylori is susceptible, clarithromycin can still be used. In the case of a high level of metronidazole resistance, furazolidone can be employed. In each case, it is important to ensure good patient compliance, and counselling is helpful in this regard. However, the best approach remains the prevention of refractory H. pylori infection and, for this purpose, antimicrobial susceptibility testing before first-line therapy is important and should be encouraged.