Helicobacter pylori eradication in adults Full Title of Guideline: Guidelines on the Eradication of Helicobacter pylori in Adult Patients Author (include email and role): Professor Atherton - Consultant Gastroenterologist Nicola Fawcett – Specialist Clinical Pharmacist: Antimicrobials and Infection Control Dr Vivienne Weston – Consultant Microbiologist Division & Speciality: Gastroenterology Scope (Target audience, state if Trust Doctors, pharmacists, microbiology wide): Review date (when this version goes out April 2021 of date): Explicit definition of patient group to which it applies (e.g. inclusion and Diagnosis and treatment of Helicobacter pylori in adult patients exclusion criteria, diagnosis): Changes from previous version (not applicable if this is a new guideline, enter below if extensive): Summary of evidence base this guideline has been created from: Diagnostic guidance added Treatment duration amended nd New alternative 2 line regimen added 1. Recommended best practice based on clinical experience of guideline developers 2. NICE Clinical Guidance No 184 (2014) Dyspepsia and Gastro-oesophageal Reflux Disease. Available from: http://www.nice.org.uk/guidance/cg184/ (accessed 01-1214) 3. Public Health England (2012) Test and Treat Helicobacter pylori (HP) in Dyspepsia – Quick Reference Guide for Primary care. Available from: https://www.gov.uk/government/publications/helicobacterpylori-diagnosis-and-treatment (accessed: 01-12-14) 4. Malfertheiner P et al. (2017) Management of Helicobacter pylori infection – The Maastrict V / Florence Consensus Report. Gut; 66: 6-30 5. NICE Guidance NG12 (June 2015). Suspected Cancer: recognition and referral. Available from: https://www.nice.org.uk/guidance/ng12 Please note this guidance differs slightly from that published by PHE due to expert opinion and experience of the guideline developer. This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date or outside of the Trust. Page 1 of 5 Guidelines on the Eradication of Helicobacter pylori in Adult Patients Background This guideline is about the eradication of Helicobacter pylori. The gastric bacterium H. pylori is widely present in the population but causes no harm in the majority of patients. H. pylori prevalence is approximately 40% in the UK, though the prevalence increases with age. There is now clear cut evidence that peptic ulcer disease (PUD) may be cured by eradicating H. pylori. H. pylori eradication also resolves dyspeptic symptoms in 10% of H. pylori-colonised dyspeptic patients without ulcers. It has no role in treatment of gastric adenocarcinoma and whether it may slightly reduce the risk of future cancer remains unclear. In the community, dyspeptic patients below the age of 55 and with no alarm symptoms (see below) are often tested for H. pylori and treated if positive, particularly if symptoms have not resolved or recurred after a course of proton pump inhibitor therapy. Diagnosis Choice of investigation in a patient with suspected H. pylori should be determined depending on patient specific factors and whether or not there are any alarm symptoms present (see below). In patients with simple dyspepsia aged <55 without alarm symptoms, endoscopy is not usually indicated and a non-invasive test is appropriate, preferably a urea breath test. Some groups of dyspeptic patientswith alarm symptoms should be referred for endoscopy on the two week wait system for suspected cancer (see below). H. pylori can then be tested for by an endoscopic biopsy-based test, usually a biopsy urease test. Most tests for H. pylori are only reliable if the patient has had no antibiotics or bismuth compounds within 4 weeks and proton pump inhibitors have been stopped for at least two weeks. The exception is serology, but this is less accurate than other tests and often remains positive even after successful treatment; thus it cannot be used to assess treatment success, even in the distant past. The table 1 summarises the different diagnostic tests commonly used, along with their advantages and disadvantages. TABLE 1: TESTS COMMONLY USED TO DETECT HELICOBACTER PYLORI Test Advantages Disadvantages Tests Based on Endoscopic Biopsy Biopsy urease test Quick, simple Some commercial tests not fully sensitive before 24 h Histology May give additional histologic information Sensitivity dependent on experience and use of special stains Culture Permits determination of antibiotic susceptibility Sensitivity dependent on experience Serology Inexpensive and convenient; not affected by recent antibiotics or proton pump inhibitors to the same extent as breath and stool tests Cannot be used for follow-up after treatment; some commercial kits inaccurate, and most less accurate than urea breath test 13 Inexpensive and simpler than endoscopy; useful for follow-up after treatment Requires fasting; not as convenient as blood or stool tests Stool antigen test Note: not currently available at NUH Inexpensive and convenient; useful for follow-up after treatment; may be particularly useful in children Note: not currently available at NUH Stool-based tests are disliked by people from some cultures Noninvasive Tests C urea breath test Page 2 of 5 Current NICE guidelines for referral for upper GI endoscopy for suspected upper gastrointestinal cancer Urgent (within 2 weeks) referral for upper gastrointestinal endoscopy in patients with : Dysphagia >55 years, with unexplained weight loss and: o Upper abdominal pain o Reflux o Dyspepsia Non-urgent referral for endoscopy in patients with Haematemesis (if not referred acutely for same day endoscopy, which would be the normal recommended action) >55 years with: o Treatment resistant dyspepsia o Upper abdominal pain plus low haemoglobin o Raised platelet count plus nausea or vomiting or weight loss or reflux or dyspepsia or upper abdominal pain o Nausea or vomiting plus weight loss or reflux or dyspepsia or upper abdominal pain Who requires treatment for the eradication of Helicobacter pylori? Offer treatment to all patients newly diagnosed with H. pylori according to Table 2. # Do not use clarithromycin if the patient has history of use for any infection – go to Table 3. Helicobacter pylori Treatment Regimens Table 2: First Line Treatment 1st Line: If Penicillin allergic Lansoprazole PO 30mg BD* Lansoprazole PO 30mg BD* Amoxicillin PO 1g BD Metronidazole PO 400mg BD Clarithromycin PO 500mg BD# Clarithromycin PO 500mg BD# For total duration of 14 days Table 3: Second Line Treatment – QUAD therapy To be used after 1st line treatment failure or if patient has previously had clarithromycin ~. For total Lansoprazole PO 30mg BD* duration of 14 Bismuth salicylate (Pepto Bismol®) PO 262.5mg (2 chewable days tablets) QDS (see notes below) Tetracycline HCl PO 500mg QDS Metronidazole PO 400mg TDS Page 3 of 5 Helicobacter pylori Treatment Regimens Table 4: Alternative Second Line Treatment To be used after 1st line treatment failure or if patient has had clarithromycin prescribed in the last year ~. If Penicillin allergic Lansoprazole PO 30mg BD* Lansoprazole PO 30mg BD* Amoxicillin PO 1g BD Metronidazole PO 400mg TDS Levofloxacin PO 250mg BD Levofloxacin PO 500mg BD For total duration of 10 days Notes: * The proton pump inhibitor (PPI) may need to be continued at a ONCE daily dose for 4 weeks, or until healing is complete for large or complicated duodenal ulcers (DU) and all gastric ulcers (GU). # Do not use Clarithromycin if patient has history of use for any infection – go to Table 2 or 3, and then in the case of treatment failure to the other of Table 2 or 3. ~ Whether to use the regimen 2 or 3 is personal choice. Regimen 3 is simpler to take, but there is a theoretically higher risk of Clostridium difficile infection which, while very low for any individual patient, may be important at a community level. Thus the authors prefer regimen 2 Pepto Bismol® The use of Pepto Bismol® in the eradication of H. pylori is off-label and the Trust policy on medicines used outside of their marketing authorisation should be followed. It contains salicylates and therefore: o do not use if patient has an allergy to aspirin / salicylates, o the manufacturer recommends that it should not be given concomitantly with aspirin or other salicylates. Common side effects include black stools and tongue. Re-testing patients All GU or DU patients should be retested for H. pylori at least 4 weeks after the end of antibiotic treatment. Treated patients who did not have an ulcer should be retested if symptoms recur. A carbon-13 urea breath test (UBT) or a stool antigen test should normally be used to retest patients. However, if they are having a further endoscopy for any indication (for example all GU patients have repeat endoscopy to ensure healing and exclude gastric adenocarcinoma) biopsy-based tests can also be used. Note the PPI will need to be stopped at least 2 weeks, and any antibiotics or bismuth compounds at least 4 weeks before H. pylori testing is carried out. Page 4 of 5 What to do in eradication failure? Reassess need for eradication. In Gastro-Oesophageal Reflux Disease (GORD), or non-ulcer dyspepsia patients with no family history of cancer or PUD, maintenance PPI may be appropriate, after discussion with the patient. Which patients should be referred for specialist Gastroenterologist advice? Patients in whom the above drug regimens cannot be used due to antibiotic hypersensitivity or contra-indications. Patients who have received two courses of different antibiotic treatment, remain H. pylori positive by stool antigen or urea breath test, and in whom there is a clear indication for treatment. How to refer patients? Patients should be referred to Professor John Atherton, Consultant Gastroenterologist for outpatient review and consideration of third line treatments or H. pylori culture and susceptibility testing on his specialised endoscopy list. Page 5 of 5
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