Select Committee on Science and Technology Written Evidence


Memorandum by the Helicobacter Working Group

INTRODUCTION

  The bacterium Helicobacter pylori causes chronic gastritis, predisposes to gastric and duodenal ulcers, and has been recognized as a class I gastric carcinogen.[79] Infection with Helicobacter pylori is very common throughout the world, occurring in 40-50 per cent of the population in developed countries and 80-90 per cent of the population in developing regions.[80]

  An estimated total of 7.5 million people living in England and Wales have an active infection, Helicobacter pylori being acquired at an early age and unlikely to be resolved unless suitable antibiotic treatment is sought.[81]

  The discovery that Helicobacter pylori is a gastroduodenal pathogen has affected the management of many gastroenterological diseases. The management of dyspepsia which is the single largest area of cost for primary care in the UK,[82] now includes the diagnosis and treatment of Helicobacter pylori. The eradication of Helicobacter pylori in patients with peptic ulcers offers the prospect of reducing the enormous costs of these drugs.[83], [84]and is of cost effective benefit to both patients and society. The Maastricht 2-2000 Consensus Report published in 2002 gives useful guidelines for current concepts in the management of Helicobacter pylori infection.[85]

  A recent MDA bulletin describes the transmission of Helicobacter pylori via endoscopes.[86]

1.   What are the main problems facing the surveillance, treatment and prevention? [87]

  Currently the UK has no system for identifying this problem. We would recommend a system such as that in Germany, known as ResiNet, where a small number of strategically placed units (gastroenterology and microbiology), undertake a programme of surveillance and feedback.

  Surveillance should:

    —  Monitor national and regional trends in incidence of infection and antibiotic resistance.

    —  Assess rates and determinants of treatment failure.

    —  Assess determinants and risks of re-infection after successful eradication.

    —  Determine significance of strain resistance type on clinical outcome.

2.   Will these problems be adequately addressed by the Government's recent infectious disease strategy, Getting Ahead of the Curve?

  There is no specific mention of Helicobacter pylori disease in this document; the section on management of chronic diseases should include HELICOBACTER PYLORI. We are concerned that this important, common and costly issue of public health could get overlooked.

  There is no comprehensive nationally coordinated surveillance of Helicobacter pylori infection in the UK and it is recommended that a Helicobacter pylori surveillance network of sentinel centres should be established in the United Kingdom.

  It should be noted:

    —  A US Helicobacter pylori antimicrobial resistance monitoring project (HARP) based at CDC Atlanta was initiated in 2001. A multi-site network of academic medical centres was formed to submit isolates to CDC for antimicrobial susceptibility testing.

    —  A German National Reference Centre for Helicobacter pylori (located in Freiburg) was established by the German Ministry of Health in April 2000. A network (ResiNet) was initiated, now comprising 14 local gastroenterological sentinel centres in different parts of Germany. Gastric biopsies and patient data will be collected systematically for continuous nationwide surveillance of Helicobacter pylori and prevalence of antimicrobial resistance.

    —  In Canada, a nationwide study was initiated in 1999 with microbiologists working with gastroenterologists at eight sites to monitor resistance rates.

    —  In France, cross-sectional studies were initiated in 1997 to understand the epidemiology of Helicobacter pylori infections based on prevalence, risk factors, and antibiotic susceptibility.

    —  Other multicentred European studies, coordinated by the European Helicobacter pylori Study Group, were performed in the mid 1990s to standardise methods and to compare resistance rates in different countries.

3.   Is the United Kingdom benefiting from advances in surveillance and diagnostic technologies; if not, what are the obstacles to its doing so?

  As the consequences of infection with Helicobacter pylori are chronic and do not show a marked temporal variation in incidence from year to year, surveillance of this infection cannot be based upon systems used for the surveillance of acute infections. Detection of infection is also complex, as non-invasive diagnosis is expensive and detection of antibiotic resistance is dependent on specimens taken at endoscopy for histology and culture. A focused and carefully tailored programme across the UK is required.

4.   Should the United Kingdom make greater use of vaccines to combat infection and what problems exist for developing new, more effective or safer vaccines?

  There is no vaccine work in the UK. In general vaccine development for Helicobacter pylori is progressing slowly and is not an area in which we would recommend involvement at present.

5.   Which infectious diseases pose the biggest threats in the foreseeable future?

  Infections such as Helicobacter pylori may result in chronic ill health of the population over time. The very real risk of an increased incidence of stomach cancer, resulting from exposure to Helicobacter pylori, remains a possibility. Without effective surveillance and feedback regarding information about this organism, we could be in danger of delaying diagnosis and effective treatment, resulting in chronic disease of the population of immense proportions.

6.   What policy interventions would have the greatest impact on preventing outbreaks of and damage caused by infectious disease in the United Kingdom?

  Appropriate treatment of Helicobacter pylori related peptic ulceration. Prevention of development of antibiotic resistance by reducing indiscriminate use of antimicrobials.

  The Helicobacter Working Group recognises the need for continued surveillance of Helicobacter pylori prevalence rates over time in the general population, and associations with trends in non-ulcer dyspepsia and with other selected diseases—notably general practice diagnosis of duodenal ulcer and gastric ulcer; hospital admissions for perforated ulcer, and longer term trends in gastric cancer. The Maastricht 2-200 Consensus Report commented that surveillance of antibiotic susceptibility of Helicobacter pylori in the paediatric population is urgently required, especially in areas or populations with a high resistance rate against macrolides (clarithromycin). 84

Priorities are:

  1.  The identification of strategically placed laboratories and their associated gastroenterological units across the UK, including several with strong paediatric endoscopy units, with the objective that they should be involved in a comprehensive programme of collecting endoscopy samples, histology, culture and other tests as agreed. The results of the Helicobacter Working Group survey within the PHLS carried out in 2001 showed that while most laboratories accepted samples for serology, just 10 laboratories routinely performed microbiology (isolation) with nine of those laboratories performing susceptibility testing. The appropriate laboratories, which should include laboratories with expertise in the field, should be selected to form a strategically located network that is representative of the population.

  2.  The development of schemes to monitor emergence of changes in antibiotic susceptibility to selected antibiotics by age of patient, diagnosis and previous treatment, and to establish trends with time.

  3.  The collation of available microbiological laboratory data from laboratories performing testing to produce a minimum data set for monitoring Helicobacter pylori susceptibility. The data set should be completed and collated, and information presented annually.

  4.  Schemes should be developed to monitor rates and determinants of treatment failure and risks of re-infection after successful eradication. Resulting information should be evaluated to determine if it is of practical value in guiding decisions regarding the most effective antimicrobial prescribing.

To develop laboratory methods to assist surveillance

Priorities are:

  1.  Harmonisation and standardisation of methods to facilitate meaningful inter-laboratory comparisons of antimicrobial susceptibility test data. Establish Standard Operating Procedures (SOPs) to provide a benchmark for evaluation and validation of techniques and ensure that the Helicobacter pylori has a key role in advising on development and validation of new diagnostic methods and their performance. As there are no published nationally agreed standards for disc diffusion testing of Helicobacter pylori, The Helicobacter Working Group has recently published a recommended method for disc diffusion tests. 84 A recommended method should be developed for the Etest which provides information on the level of individual strain resistance. These methods need to be evaluated in relation to methods recommended by other bodies (BSAC, and NCCLS Performance Standards).

  2.  Design of minimum data set (mds) (demographic, clinical and microbiological details) for each isolate.

  3.  Promote initiatives to extend this surveillance activity by contributing to international collaborations particularly with other European countries such as Germany where a surveillance scheme has been put in place (ResiNet), and the US. The projected outcome will be to establish international networks to develop harmonised approaches for testing, data collation and dissemination.








Members of the Working Group

  Dr Jeffrey Graham, Dr Peter Hawtin, Prof Kenneth McColl, Dr Cliodna McNulty, Dr Robert Owen, Dr Gillian Smith and Dr Louise Teare

October 2002


79   International Agency for Research on Cancer, WHO. Infection with Helicobacter pylori. In: Schistosomes, liver flukes and Helicobacter pylori. Lyon: LARC, 1994: 177-202. Back

80   Vaira D, Miglioli M, Mule P, et al. Prevalence of peptic ulcer in Helicobacter pylori positive blood donors. Gut 1994; 35: 309-12. Back

81   Vyse AJ, Gay NJ, Hesketh LM, et al The burden of Helicobacter pylori infection in England and Wales. Epidemiol Infect 2002 128, 411-417. Back

82   Helicobacter pylori eradication in primary care. RC Delaney, FDR Hobbs. BMJ 1998; 316: 1634 Back

83   Treatment of Helicobacter pylori infection. Wink A de Boer, Guido NJ Tytgat. BMJ 2000; 320: 31-34. Back

84   How to treat Helicobacter pylori infection. Should treatment strategies be based on testing bacterial susceptibility? A personal viewpoint. Wink A de Boer, GN Tytgat. Bur J Gastroenterol Hepatol 1996; 8: 709-16. Back

85   Malfertheiner P, Megraud F, O'Morain C et al. Current concepts in the management of Helicobacter pylori infection-the Maastricht 2-2000 consensus report. Aliment Pharmocol Ther 2002; 19, 167-180. Back

86   MDA DB 2002 (05) July 2002. Back

87   McNulty C et al. 2002 J Antimicrob Chemother 49, 601-60. Back


 
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