• Summary
  Click here to print a Quick Reference Guide
• Background
• Clinical Diagnosis
• Investigation
• Treatment
• Duration of Treatment
• Treatment Failure
• Referral Criteria

• Guideline for Treatment of Helicobacter pylori Infection in Adults in Primary Care

1. Who should be tested for H. pylori?
• Patients with uncomplicated dyspepsia that is unresponsive to lifestyle change and antacids, following a single one month course of proton pump inhibitor (PPI), without alarm symptoms (see below). In patients aged 55 years and older with unexplained and persistent recent-onset dyspepsia alone, an urgent referral for endoscopy should be made
• Patients with peptic ulcer disease
• Patients with gastric cancer (particularly if undergoing curative endoscopic therapy or partial gastrectomy)
• Patients with functional dyspepsia (dyspepsia in the presence of a structurally normal upper endoscopy)
• Patients with a first degree relative with gastric cancer
• Patients with MALToma
  
  
2. Investigations required- one of the following:
• Stool sample (faecal antigen test)
• CLO test (Campylobacter-like organism or rapid urease test - requires biopsy during endoscopy)
  
  
3. Non-Antimicrobial Management
• The following washout periods are recommended before testing for H. pylori
• PPIs – 2 weeks
• Bismuth and antibiotics - 4 weeks
• H2-receptor Antagonists – 48 hours
• Follow NICE guidance for other non-antimicrobial treatment of uninvestigated dyspepsia, peptic ulcer disease, and functional dyspepsia.
   https://www.nice.org.uk/guidance/cg184
  
  
4. Antimicrobial treatment - Who should be treated for H. pylori?
   
   Offer treatment to all patients newly diagnosed with H. pylori according to Table 1.
   Do not use clarithromycin or metronidazole if patient has a history of use in the past year for any infection.
   Do not retest or retreat for uninvestigated dyspepsia or functional dyspepsia

*Previous second line therapy for LTH guidelines is a quadruple therapy including tripotassium dicitratobismuthate 240mg 6-hourly (Denol). Denol manufacture was discontinued early 2016. Bismuth Subsalicylate (Peptobismol) 525mg 6-hourly will be substituted for Denol. This alternative is supported by PHE guidelines and American guidelines.

Leave at least 4 weeks before retesting after eradication for PUD, gastric cancer or MALToma

Duration of treatment
First line and second line therapy: 7 days
MALToma: 14 days

Referral criteria

• Failure of eradication with second line regimens (peptic ulcer disease or MALToma only) contact Gastroenterology for advice

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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. This may be largely a cohort effect - most individuals acquire the infection in childhood, and poorer socioeconomic conditions 70 years ago meant most children were infected. There is now substantial evidence that peptic ulcer disease may be cured by eradicating H. pylori. The potential to reduce gastric cancer and ameliorate functional dyspepsia is less clear.¹

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Criteria for use of guidelines (Evidence level A)
Patients with one of the following should be tested

• Uninvestigated dyspepsia - At 12 months, there were no significant differences in QALYs, costs, or dyspeptic symptoms between the group assigned to initial H. pylori test and treat and the group assigned to initial acid suppression² In patients with alarm features (dysphagia, odyophagia, haematemesis or melaena, persistent vomiting, unintentional weight loss, iron deficiency anaemia, family history of gastric cancer, palpable epigastric mass), and those aged 55 years and older with unexplained and persistent recent-onset dyspepsia alone, an urgent referral for endoscopy should be made
• Peptic ulcer disease - Eradication of H. pylori has been shown to speed up healing of duodenal ulcers as compared to acid suppression alone. After 4 to 8 weeks, patients receiving acid suppression average 69% healing, eradication increases this by a further 5.4%, a NNT of 18. Healing of gastric ulcers is not increased by H. pylori eradication. The principal benefit in eradication is the reduction in recurrence rates, thereby removing the need for long term acid suppression therapy. For duodenal ulcers 39% of patients receiving short term acid suppression are without ulcer after 3-12 months, eradication increases this by 52% (NNT 2). For gastric ulcers the equivalent figures are 45% increased by a further 32% by eradication (NNT 3)¹
• Functional dyspepsia (dyspepsia in the presence of a structurally normal upper endoscopy) - Symptoms will naturally improve in 36% of patients; 7% will improve due to eradication therapy but 57% of substantial symptoms will remain over a 3–12 month period.¹
• Gastric cancer (particularly if undergoing curative endoscopic therapy or partial gastrectomy). There is evidence that the incidence of metachronous gastric cancer is reduced with eradication therapy compared to no treatment.
• A first degree relative with gastric cancer
• MALToma

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Recommendation: either of the following tests can be used to diagnose H. pylori infection:

1. Stool sample (faecal antigen test)
2. CLO test (Campylobacter-like organism or rapid urease test) - requires biopsy during endoscopy
   [Evidence level C]

• Evidence from evaluations of diagnostic test accuracy show that serological testing (sensitivity 92%, specificity 83%) performs less well than breath testing (sensitivity 95%, specificity 96%) and stool antigen testing (sensitivity 95%, specificity 94%). The resultant lower positive predictive value* (64% vs. 88% or 84%, respectively) leads to concerns about the unnecessary use of antibiotics when serology testing is used. CLO testing also provides high sensitivity and specificity¹.
• Recent use of PPIs, antibiotics, bismuth and possibly H2-receptor antagonists can increase the possibility of a false negative test^1,6.

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Antimicrobial treatment (Evidence level A)

• Eradication is effective in 80–85% of patients.
• Clarithromycin  250 mg twice-daily is as effective as 500 mg twice-daily when combined with Metronidazole ¹.
• PPI, Amoxicillin , Clarithromycin 500 mg (PAC500) regimens and PPI, Metronidazole , Clarithromycin 250 mg (PMC250) regimens achieve the same eradication rate¹.
• Clarithromycin  resistance is an important risk factor for treatment failure. In a meta-analysis, Clarithromycin resistance reduced efficacy by 66% for PAC regimens, and 35% in PMC regimens³.
• Metronidazole  resistance seems to be less important. Resistance decreased efficacy by 18% for PMC regimens and by 14% in bismuth based quadruple therapy regimens.³
• European guidelines support bismuth based quadruple therapy as a second line therapy or an alternative first line therapy.⁴
• Individuals prescribed an antibiotic in primary care for a respiratory or urinary infection develop bacterial resistance to that antibiotic. The effect is greatest in the month immediately after treatment but may persist for up to 12 months⁵. As resistance to Clarithromycin in H. pylori is the principal concern, the group felt it was reasonable to apply this to the use of Clarithromycin in H. pylori eradication

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Duration of treatment (Evidence level A)

• Although 14-day therapy gives an almost 10% higher eradication rate, the absolute benefit of H. pylori therapy is relatively modest in functional dyspepsia and uninvestigated dyspepsia and the longer duration of therapy does not appear cost-effective. In patients with peptic ulcer, increasing the course to 14 days duration improves the effectiveness of eradication by nearly 10% but does not appear cost-effective¹

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