Dr Mary Denholm and Professor Janusz Jankowski review the NICE quality standard for dyspepsia and GORD, outlining a strategy for primary care management
Read this article to learn more about:
- the specific aims of NICE Quality Standard 96 on dyspepsia and GORD
- the factors that complicate H. pylori testing and treatment
- when urgent endoscopy is required.
The management of gastro-oesophageal reflux disease (GORD) should be very simple but is complicated for various reasons, including unusual presentations, complex interplay of aetiological factors, compounding medications, competing clinical imperatives, and underdeveloped clinical pathways. Consequently, diagnosis, management, and patterns of referral to secondary care are hugely heterogeneous, with arbitrary thresholds for investigation and treatment varying considerably across the UK. Furthermore, advice provided on the websites of the various patient support groups is conflicting, which results in inappropriate complacency or anxiety in patients and their carers.
The need for a quality standard
Current estimates suggest that between 1.2 and 4% of primary care consultations in the UK are due to dyspepsia.1 Over recent years there has been a continuing increase in prescriptions for both dyspepsia and GORD.1 The natural course of both dyspepsia and GORD is most often an intermittent and recurring symptom pattern leading to significant prescribing and investigation costs to the NHS, and significant impacts on patients' general wellbeing and productivity. A NICE quality standard was needed to clarify and improve the overall care and support of patients with dyspepsia and GORD, with specific aims including promotion of self management, improvements in consistency of investigation use including Helicobacter pylori testing, and endoscopy referral.1
NICE Quality Standard 96
NICE Quality Standard 96 (QS96) for investigation and management of dyspepsia and GORD in adults was published in July 2015.1 It contains five statements (see Table 1, below). Definitions for terms used throughout this article are listed in Box 1 (see below).
|1||Adults with dyspepsia or reflux symptoms who present to community pharmacists are given advice about making lifestyle changes, using over-the-counter medicines, and when to consult their GP.|
|2||Adults presenting with dyspepsia or reflux symptoms are referred for urgent direct access endoscopy to take place within 2 weeks if they have dysphagia, or are aged 55 and over with weight loss.|
|3||Adults with dyspepsia or reflux symptoms have a 2-week washout period before a test for Helicobacter pylori if they are receiving proton pump inhibitor therapy.|
|4||Adults aged 55 and over with dyspepsia or reflux symptoms that have not responded to treatment have a discussion with their GP about referral for non-urgent direct access endoscopy.|
|5||Adults with persistent, unexplained dyspepsia or reflux symptoms have a discussion with their GP about referral to a specialist service.|
Box 1: Definitions27
- Dyspepsia refers to pain or discomfort in the upper abdomen, the latter including upper abdominal fullness, early satiety, belching, bloating, and nausea and/or vomiting
- Functional dyspepsia is the presence of gastroduodenal symptoms in the absence of any organic, metabolic, or systemic disease to explain them. It can be further divided according to the Rome III criteria into postprandial distress syndrome and epigastric pain syndrome
- Gastro-oesophageal reflux disease is defined as symptoms or mucosal damage produced by the abnormal reflux of gastric contents into the oesophagus. The key symptoms that distinguish it from dyspepsia are retrosternal pain and acid regurgitation
- Barrett's oesophagus is a premalignant lesion defined by the presence of columnar mucosa in the oesophagus, replacing the normal squamous mucosa. Its significance relates to its role as a precursor lesion for oesophageal adenocarcinoma.
NICE QS96 contains guidance on the investigation and management of dyspepsia and GORD, including in the context of their role as a risk factor for oesophagogastric cancer. Additionally, it contains advice on first-line community management of these symptoms by pharmacists, and clarifies procedures for ensuring best practice with respect to investigations for H. pylori status. This quality standard intends to provide advice for primary care teams while also providing guidance for the standards expected in secondary care. It aims to provide clear and accessible advice and to have an anticipated co-existing positive impact on cancer-related outcomes (incidence, mortality, and survival), patient experience and quality of life, self-management of dyspeptic symptoms, and H. pylori antimicrobial resistance rates.1
Advice to support self-management—statement 1
NICE QS961 emphasises the role of community pharmacists in providing first-line advice to adults presenting with dyspepsia, in accordance with source guidance (NICE Clinical Guideline 184 [CG18 4]).8 This is via a dual mechanism of not only advising about over-the-counter medications and dosing strategies for these but also providing advice on modifiable factors, including a healthy diet (e.g. increasing fibre intake and reducing dietary fat intake), weight loss, and smoking cessation.
Weight loss in particular is the lifestyle intervention with the most consistent supporting evidence to date, the literature on other measures being more variable in its recommendations.91011 Evidence from the pharmacy community frontline is hard to gather and has not been a focus of research in this field, but a national study in Australia showed that pharmacists and non-pharmacist support staff consistently took a detailed history and offered comprehensive counselling.12 Using a simulated scenario, the authors found that a consultation was undertaken in 77% of cases and referral to a doctor was made in 63%. One key issue highlighted by the study was the need for pharmacy staff to be aware of national guidelines and for these to be readily available to them, as a consistent approach is essential.
Urgent endoscopy—statement 2
Dyspepsia and reflux symptoms have a high prevalence, particularly in Western populations. The vast majority of patients will not have a malignant cause for their symptoms, but the prognosis for oesophageal cancer remains poor and early detection is the most favourable prognostic factor, so selection of high-risk patients for early endoscopy is key. Table 2 (see below) summarises the current NICE recommendations for referral for endoscopy.813
|Urgent direct access|
|Non-urgent direct access|
Rates of oesophageal cancer continue to increase in the Western world, with a disproportionate increase in the adenocarcinoma subtype.14 Identification of its premalignant lesion—Barrett's oesophagus—is therefore crucially important. NICE QS96 makes reference to the fact that there is a large geographical variation in current endoscopic referral rates,1 and the same has so far been true for management and surveillance of Barrett's oesophagus.
The Benign Barrett's and Cancer Taskforce (BOB CAT) has recently published a multinational consensus guideline for management of Barrett's oesophagus with no dysplasia, an indefinite result, or low-grade dysplasia.2 Although this review is a useful reference for clinicians in primary and secondary care, it also consolidates evidence on those patients most at risk—namely men older than 60 years with a history of reflux symptoms exceeding 10 years and, within this group, Caucasians with persisting symptoms or central adiposity (see Figure 1, below).
The Barrett's Dysplasia and Cancer Taskforce (BAD CAT) used a similar consensus approach to refine guidelines for management of dysplasia and early oesophageal adenocarcinoma; while aimed primarily at secondary care, it is still useful guidance on managing expectations for patients diagnosed with Barrett's oesophagus.15
Testing conditions for Helicobacter pylori—statement 3
Testing for H. pylori is helpful if completed correctly, but a number of factors complicate both the testing process and treatment. The new NICE guideline advocates a 2-week washout period prior to H. pylori testing in people receiving proton pump inhibitor therapy, in order to improve test accuracy and cost-effectiveness.1 NICE recommends stool antigen testing or carbon-13 urea breath test (13C-UBT) for diagnosis. Serological testing should be used only when it has been validated locally. Additional issues to consider include interpretation of positive results, as previous exposure can result in a low positive titre and serological testing is less reliable in those older than 65 years.
Literature is clear that the sensitivity and specificity of any test for H. pylori should ideally be >90%,16 and while more invasive tests allow for culture and, in some cases, determination of antibiotic resistance, the high sensitivity and specificity of the 13C-UBT (88–95% sensitivity; 95–100% specificity)17 and stool antigen testing (94% sensitivity; 97% specificity18) make them good initial tests. The 13C-UBT is regarded as the non-invasive test of choice for confirming eradication after treatment.19
Current NICE guidance from 2014 (NICE CG184) continues to advocate triple therapy with proton pump inhibitor (PPI), clarithromycin/metronidazole, and amoxicillin first line for eradication or bismuth-based quadruple therapy in those with previous exposure to clarithromycin.8 A course of treatment to eradicate H. pylori is not an insignificant undertaking for patients, as up to 5–20% of patients experience significant side-effects,20 which explains why poor compliance was the leading reason for treatment failure in several studies. This in turn fosters an environment predisposing to increased antimicrobial resistance. Concerns over antimicrobial resistance—particularly relating to clarithromycin20 and the increased risk of antibiotic-associated diarrhoea and Clostridium difficile—have also strengthened the case for further rationalisation of eradication therapy.
Discussion about referral for non-urgent endoscopy—statement 4
For patients without alarm symptoms, an empirical trial of therapy, usually a PPI, is regarded as an appropriate first step.21 NICE QS96 defines non-response to treatment as persistence of symptoms with no significant improvement after a month of full-dose PPI, a subsequent full month of H2 receptor antagonist, and a negative H. pylori test.1 In accordance with the recommendations of the BAD CAT consensus group, endoscopy for diagnosis of Barrett's oesophagus should not be offered routinely.15
Individual preferences should be taken into account, as well as specific risk factors for the development of Barrett's oesophagus—namely male sex, a long duration of symptoms (>5 years being of particular significance), increasing frequency of symptoms, history of previous oesophagitis or hiatus hernia, oesophageal stricture, or ulcers.15 Any previous endoscopy results should be taken into account.
Referral to a specialist service—statement 5
The literature supports the statement that persistent symptoms of reflux or dyspepsia negatively impact on quality of life in all areas,22 and include psychological effects for patients and impairment of productivity.23 At this stage, the goals of referral to a specialist service (defined as a consultant-led medical or surgical service) include reducing the burden of symptoms and avoiding potential complications, including oesphageal scarring, strictures, Barrett's oesophagus (and possible oesophageal cancer), and pyloric cancer.1 Assessments already carried out in primary care in this context potentially include empirical trials of therapy, H. pylori testing, and endoscopy.
For patients with functional dyspepsia (ongoing symptoms in the presence of a normal upper gastrointestinal endoscopy), further treatment options could include alternative pharmacological options such as tricyclic antidepressants or prokinetic agents.3
The information contained in NICE QS961 for dyspepsia outlines a strategy for primary care management and for primary care teams to offer patients support through links with pharmacy colleagues, as well as consolidating advice on referral for endoscopy and assessment by specialist services. Taken in conjunction with other recent NICE guidance and consensus statements,131415
NICE QS96 can be used to inform primary care management of dyspepsia and gastro-oesophageal reflux disease while assisting with risk stratification for urgent referral and surveillance.
Sources of further information
- NICE. Suspected cancer: recognition and referral. NICE Guideline 12. NICE, 2015. www.nice.org.uk/guidance/ng1213
- NICE. Gastro-oesophageal reflux disease and dyspepsia in adults: investigation and management. Clinical Guideline 184. NICE, 2014. www.nice.org.uk/guidance/cg1848
- BOB CAT consensus guideline/review:
- Bennett C, Moayyedi P, Corley D et al. BOB CAT: a large-scale review and Delphi consensus for management of Barrett's esophagus with no dysplasia, indefinite for, or low-grade dysplasia. Am J Gastroenterol 2015; 110 (5): 662–682.2
- BAD CAT consensus statements/review:
- Bennett C, Vakil N, Bergman J et al. Consensus statements for management of Barrett's dysplasia and early-stage esophageal adenocarcinoma, based on a Delphi process. Gastroenterology 2012; 143 (2): 336–346.15
- There is inconsistency in the management, treatment, and referral of people with dyspepsia and GORD in the UK
- Prescriptions for dyspepsia and GORD are increasing and management of these conditions brings significant costs to the NHS
- NICE QS96 provides standards for both primary and secondary care and is expected to improve outcomes in:
- incidence of oesophageal cancer, mortality, and survival
- self-management of dyspepsia
- patient experience and quality of life
- H. pylori antimicrobial resistance rates
- NICE QS96 can assist with risk stratification for urgent referral and surveillance.
GORD=gastro-oesophageal reflux disease; QS=quality standard
- Proportion of:
- presentations of adults with dyspepsia or reflux symptoms to community pharmacists in which advice is received about making lifestyle changes, using over-the-counter medicines and when to consult a GP
- adults presenting with dyspepsia or reflux symptoms and dysphagia who are referred for urgent direct access endoscopy
- referrals for adults presenting with dyspepsia or reflux symptoms and dysphagia who receive urgent direct access endoscopy within 2 weeks
- adults aged 55 and over presenting with dyspepsia or reflux symptoms and weight loss who are referred for urgent direct access endoscopy
- referrals for adults aged 55 and over presenting with dyspepsia or reflux symptoms and weight loss who receive urgent direct access endoscopy within 2 weeks
- adults with dyspepsia or reflux symptoms receiving PPI therapy who are tested for H. pylori who had a 2-week washout period before the test
- adults aged 55 and over with dyspepsia or reflux symptoms that have not responded to treatment who have a recorded discussion with their GP about referral for non-urgent direct access endoscopy
- adults presenting with persistent, unexplained dyspepsia or reflux symptoms with a recorded discussion with their GP about referral to a specialist service.
PPI=proton pump inhibitor
NICE (2015) QS96.Dyspepsia and gastro-oesophageal reflux disease in adults: investigation and management. Available at: www.nice.org.uk/guidance/qs96
Reproduced with permission.
GP commissioning messages
written by Dr David Jenner, NHS Alliance GMS contract/PBC Lead
- NICE QS96, along with NICE Guideline 12 on suspected cancer, will have implications for CCGs as it is likely to impact on referrals for upper GI endoscopy
- CCGs with local specialists should consider consolidating the various NICE guidelines on dyspepsia and suspected cancer, together with QS96, into a local area pathway to cover the investigation and management of dyspepsia
- this pathway should clearly identify which patients should be referred urgently and which routinely for investigation with endoscopy
- CCGs, with NHS England, should consider targeted interventions with pharmacies, which are often the first point of contact for patients seeking over-the-counter remedies for dyspepsia, to identify patients who may need further investigation.
QS=quality standard; GI=gastrointestinal
- NICE. Dyspepsia and gastro-oesophageal reflux disease in adults: investigation and management. Quality Standard 96. NICE, 2015. Available at: www.nice.org.uk/guidance/qs96↩
- Bennett C, Moayyedi P, Corley D et al. BOB CAT: a large-scale review and Delphi consensus for management of Barrett’s esophagus with no dysplasia, indefinite for, or low-grade dysplasia. Am J Gastroenterol 2015; 110 (5): 662–682. ↩
- Lacy B, Talley N, Locke G et al. Review article: current treatment options and management of functional dyspepsia. Aliment Pharmacol Ther 2012; 36 (1): 3–15. ↩
- Talley N, Stanghellini V, Heading R et al. Functional gastroduodenal disorders. Gut 1999; 45 (Suppl 2): II37–II42. ↩
- Bredenoord A, Pandolfino J, Smout A. Gastro-oesophageal reflux disease. Lancet 2013; 381 (9881): 1933–1942. ↩
- Jankowski J, Bennett C, Jankowski J. Management of Barrett’s esophagus—a practical guide for clinicians based on the BAD CAT and BOB CAT recommendations. Pol Arch Med Wewn 2015; 125 (10): 765–770. ↩
- Domper Arnal M, Ferrández Arenas Á, Lanas Arbeloa Á. Esophageal cancer: risk factors, screening and endoscopic treatment in Western and Eastern countries. World J Gastroenterol 2015; 21 (26): 7933–7943. ↩
- NICE. Gastro-oesophageal reflux disease and dyspepsia in adults: investigation and management. Clinical Guideline 184. NICE, 2014. Available at: www.nice.org.uk/guidance/cg184↩
- Eherer A. Management of gastroesophageal reflux disease: lifestyle modification and alternative approaches. Dig Dis 2014; 32 (1–2):149–151. ↩
- Kaltenbach T, Crockett S, Gerson L. Are lifestyle measures effective in patients with gastroesophageal reflux disease? An evidence-based approach. Arch Intern Med 2006; 166 (9): 965–971. ↩
- Kang J, Kang J. Lifestyle measures in the management of gastro-oesophageal reflux disease: clinical and pathophysiological considerations. Ther Adv Chronic Dis 2015; 6 (2): 51–64. ↩
- MacFarlane B, Matthews A, Bergin J. Non-prescription treatment of NSAID induced GOR D by Australian pharmacies: a national simulated patient study. Int J Clin Pharm 2015; 37 (5): 851–856. ↩
- NICE. Suspected cancer: recognition and referral. NICE Guideline 12. NICE, 2015. Available at: www.nice.org.uk/guidance/ng12↩
- Lepage C, Rachet B, Jooste V et al. Continuing rapid increase in esophageal adenocarcinoma in England and Wales. Am J Gastroenterol 2008; 103 (11): 2694 –2699. ↩
- Bennett C, Vakil N, Bergman J et al. Consensus statements for management of Barrett’s dysplasia and early-stage esophageal adenocarcinoma, based on a Delphi process. Gastroenterology 2012; 143 (2): 336–346. ↩
- Lopes A, Vale F, Oleastro M. Helicobacter pylori infection—recent developments in diagnosis. World J Gastroenterol 2014; 20 (28): 9299–9313 ↩
- Malfertheiner P, Megraud F, O’Morain C et al. Current concepts in the management of Helicobacter pylori infection: the Maastricht III consensus report. Gut 2007; 56 (6): 772–781. ↩
- Gisbert J, de la Morena F, Abraira V. Accuracy of monoclonal stool antigen test for the diagnosis of H. pylori infection: a systematic review and meta-analysis. Am J Gastroenterol 2006; 101 (8): 1921–1930. ↩
- Howden C, Chey W, Vakil N. Clinical rationale for confirmation testing after treatment of Helicobacter pylori infection: implications of rising antibiotic resistance. Gastroenterol Hepatol 2014; 10 (7 Suppl 3): 1–19. ↩
- Chey W, Wong B, Gastroenterology PACotACo. American College of Gastroenterology guideline on the management of Helicobacter pylori infection.Am J Gastroenterol 2007; 102 (8): 1808–1825. ↩
- DeVault K. Catheter-based pH monitoring: use in evaluation of gastroesophageal reflux disease symptoms (on and off therapy). Gastrointest Endosc Clin N Am 2005; 15 (2): 289–306. ↩
- Camilleri M, Dubois D, Coulie B et al. Prevalence and socioeconomic impact of upper gastrointestinal disorders in the United States: results of the US Upper Gastrointestinal Study. Clin Gastroenterol Hepatol 2005; 3 (6): 543–552. ↩
- Piessevaux H, De Winter B, Louis E et al. Dyspeptic symptoms in the general population: a factor and cluster analysis of symptom groupings. Neurogastroenterol Motil 2009; 21 (4): 378–388. ↩