European helicobacter Pylori Study Group Guidelines

Patient Management

Current European concepts in the management of Helicobacter pylori infection - the Maastricht Consensus Report

P. Malfertheiner, F. Mégraud, C. O'Morain , D. Bell, G. Blanchi Porro, M. Deltenre, D. Forman, G. Gasbarrini, B. Jaup, J.J. Misiewicz, J. Pajares, M. Quina and E. Rauws
for the European Helicobacter pylori Study Group (EHPSG)

Gjengitt med tillatelse.

Helicobacter pylori has already made a major impact on clinical practice and our knowledge of the bacterium continues to evolve rapidly. Considerable confusion remains particularly in primary care over management of the infection.

Guidelines for the management of H. pylori infection have been developed independently in eight European countries, but they differ in their recommendations and many countries are without national guidelines. A European Helicobacter pylori Study Group meeting was therefore held in Maastricht in September 1996 to develop European consensus guidelines on how advances in our understanding of H. pylori should be applied to clinical practice.

Primary care physicians (PCPs), representative specialists from national gastroenterological societies and experts in the field from 19 European countries participated, together with observers from Canada, Japan and the USA. They focused on the role of the PCP, patient management at the specialist level and public health care issues. Recommendations were agreed at one of three levels (strongly recommended, advisable or uncertain), based mainly on the strength of published evidence. These guidelines may require local adaptation to conform with current national regulatory approvals.

As in previous guidelines, eradication of H. pylori was strongly recommended in all infected peptic ulcer patients, including those in remission or receiving long-term anti-secretory therapy. Further, treatment was strongly recommended in unequivocally diagnosed H. pylori-positive patients with bleeding peptic ulcer, low grade MALT lymphoma (management in specialized centres advised), gastritis with severe macro- or microscopic abnormalities and following resection of early gastric cancer.

Eradication therapy was classed as advisable in H. pylori-positive patients with functional dyspepsia, after full investigation in those with a family history of gastric cancer, when long-term proton pump inhibitor (PPI) therapy is necessary for gastro-oesophageal reflux disease (GORD), when NSAID therapy is planned or ongoing, following gastric surgery for peptic ulcer disease or cancer, and in response to the patients wishes. The strength of evidence for these recommendations ranged from equivocal to supportive.

Recommendations for treatment of H. pylori were not made uncertain for large-scale gastric cancer prevention in people with no known risk factors, in extra-alimentary tract disease, asymptomatic individuals, or relatives of infected patients. The meeting felt that H. pylori infection should be considered as a health care issue and that controled studies are needed to assess the value of screening programmes.

Given close collaboration between PCPs and specialist gastroenterologists and microbiologists, the facility for testing for H. pylori should be accessible by PCPS. 13C-urea breath test and locally validated laboratory serology are acceptable tests and should be widely available. Rapid ('office') serological test kits at present need further validation.

It was considered acceptable that dyspeptic patients, aged 45 years or younger and without alarm symptoms, who test H. pylori-positive for the first time, can be treated by PCPs without further investigation. This indication was classed as advisable by the majority of the participants, but opinion was not unanimous. Patients over 45 years with significant symptoms, those with gastric ulcer and patients with alarm symptoms (irrespective of age) should be referred for endoscopy.

There was consensus that treatment regimens should be simple, well-tolerated and achieve an eradication rate of over 80% on an ITT basis. It was strongly recommended, therefore, that 'eradication treatment should be with PPI-based triple therapy for 7 days, using a PPI and t-o of clarithromycin, a nitroimidazole (metronidazole or tinidazole) and amoxycillin. More data are needed to define the role of ranitidine bismuth citrate. A re-treatment regimen should be selected after consideration of previous therapy and/or microbial sensitivities. It was thought advisable that quadruple therapy (PPI plus classical triple) should be used for triple therapy failures.

European Journal of Gastroenterology & Hepatology 1997, Vol 9 No 1