Dr James Dalrymple revisits the guideline from NICE on the management of dyspepsia in primary care, and assesses its impact on initial diagnosis, treatment, and prescribing costs

IIn 2002, the Centre for Health Services Research was commissioned by NICE to produce a guideline on the management of dyspepsia in adults in primary care.1,2

The need for a guideline

Although there were already a number of dyspepsia guidelines in existence, for example, those from the American Gastroenterological Association,3 British Society of Gastroenterology,4 and the Scottish Intercollegiate Guidelines Network,5 these existing guidelines gave similar advice on only some aspects of dyspepsia management, such as ‘test and treat’ for Helicobacter pylori infection. Differences existed, notably, in the advice on the use of endoscopy, particularly with regard to the suitable age of patients for the routine use of the procedure, as well as its actual role in dyspepsia management.2

The cost to the NHS of prescribing and investigating this condition was £600 million in 2004 and had increased year-on-year for the preceding 5 years.6 Over-the-counter medications cost patients £100 million in 2004.2 In secondary care, dyspepsia was estimated to account for 50% of a gastroenterologist’s workload.7 Endoscopy is the ‘gold standard’ for detecting oesophageal, gastric, and duodenal lesions, but, in practice, endoscopy is used extensively for the investigation of dyspepsia even though its use has never been formally scrutinised.2

Prevalence of dyspepsia

From a primary care perspective, dyspepsia is a common reason for patients to consult their GP. Population surveys have shown that 40% of the population have suffered from dyspepsia, and of them only about 25% consulted their GP.8 National data have shown a steady rise in consultation rates for dyspepsia according to age, from 361 per 10,000 patient years at age 25–44 to 774 per 10,000 patient years at age 75–84.9Therefore a GP with a list of 2000 patients can expect to see almost 70 patients with new onset dyspepsia each year.

What is dyspepsia?

Dyspepsia literally means ‘bad digestion’ and, popularly, it is used to describe a range of symptoms arising from the upper gastrointestinal tract, but which for many years had no universally accepted definition.2

The 1996 British Society of Gastroenterology classification defined dyspepsia as ‘any symptom of the upper gastrointestinal tract, present for 4 weeks or more, including upper abdominal pain or discomfort, heartburn, acid reflux, nausea, or vomiting’.2 Subsequent redefinitions of dyspepsia did not refine the meaning and the NICE guideline development group adopted the BSG definition.

NICE dyspepsia guideline

In 2004, NICE produced its dyspepsia guideline with recommendations and supporting evidence on caring for patients with the condition. The guideline sought to identify appropriate investigations and management for dyspepsia in primary care.1

For the purposes of this article, only the guideline referring to uninvestigated dyspepsia will be considered. This is how the condition is most commonly encountered in primary care and this guideline will usually be that referred to most by GPs and other primary care health professionals. Other aspects of dyspepsia management in the guideline refer to conditions such as gastro-oesophageal reflux disease, non-ulcer dyspepsia, and peptic ulcer disease, which are diagnosed after endoscopy.

Management of dyspepsia

A diagram for the management of uninvestigated dyspepsia is shown in Figure 1. If dyspepsia is suspected, the GP should first decide on the need for referral by excluding the presence of alarm signs. These include:1

  • gastrointestinal bleeding
  • progressive difficulty swallowing
  • progressive unintentional weight loss
  • epigastric mass
  • iron-deficiency anaemia
  • persistent vomiting
  • suspicious barium meal.

It should be emphasised that alarm symptoms do not form any part of the symptom complex of dyspepsia as defined by the BGS.

If referral is not required, the further recommendations for the management of uninvestigated dyspepsia involve a number of stages dependent on whether there are modifiable factors (such as those identified through a medication or lifestyle review) that might be adjusted to result in an improvement in the dyspepsia. A lack of response to these interventions would direct the GP either to test for and treat H. pylori infection, or to treat the patient using a proton pump inhibitor (PPI) for 1 month. Currently there is insufficient evidence to determine which step should be performed first.1

Further intervention would include treatment with an H2-receptor antagonist (H2RA) or prokinetic, either as an addition to treatment or as monotherapy. Long-term treatment for relapsing symptoms includes a step-down approach to the lowest effective dose, or discussing with patients the possibility of them managing their own symptoms on an ‘as required’ basis.1

At no stage in the management flowchart (Figure 1) does endoscopy feature as a decision point in the management of dyspepsia. This proved a controversial recommendation of the guideline development group, but it was supported by the research findings. For example, research has shown that the rate of malignancy in individuals less than 55 years of age who did not have alarm symptoms was 1 per million population per year.10

Figure 1: Management flowchart for patients with uninvestigated dyspepsia

Management flowchart for patients with uninvestigated dyspepsia
* Review medications for possible causes of dyspepsia, for example, calcium antagonists, nitrates, theophyllines, bisphosphonates, steroids and NSAIDs.
† Offer lifestyle advice, including advice on healthy eating, weight reduction and smoking cessation, promoting continued use of antacid/alginates.
‡ There is currently inadequate evidence to guide whether full-dose PPI for 1 month or H. pylori ‘test and treat’ should be offered first. Either treatment may be tried first with the other being offered if symptoms persist or return.
§ Detection: use carbon-13 urea breath test, stool antigen test or, when performance has been validated, laboratory-based serology.
Eradication: use a PPI, amoxicillin, clarithromycin 500 mg (PAC500) regimen or a PPI, metronidazole, clarithromycin 250 mg (PMC250) regimen.
Do not re-test even if dyspepsia remains unless there is a strong clinical need.
| Offer low-dose treatment with a limited number of repeat prescriptions. Discuss the use of treatment on an as-required basis to help patients manage their own symptoms.
¶ In some patients with an inadequate response to therapy it may become appropriate to refer to a specialist for a second opinion.
Emphasise the benign nature of dyspepsia. Review long-term patient care at least annually to discuss medication and symptoms.PPI=proton pump inhibitor; H2RA=H2-receptor antagonist; NSAID=non-steroidal anti-inflammatory drugNational Institute for Health and Care Excellence (NICE) (2004) CG17 Dyspepsia: management of dyspepsia in adults in primary care. London: NICE. Available from www.nice.org.uk.
Reproduced with permission.

What was different in the NICE guideline?

When the NICE guideline was published in 2004 there were four main differences from previous recommendations. These were:

  • the guideline suggested that the management of symptoms in primary care is more important than striving for a pathological diagnosis
  • it recommended urgent specialist referral for endoscopic investigation for patients of any age with dyspepsia who presented with alarm signs
  • routine endoscopy for patients of any age presenting without alarm signs was not deemed necessary
  • a step-down strategy and the possibility of ‘as required’ treatment was recommended for the pharmacological treatment of uninvestigated dyspepsia.

Amendments to the guideline

Initially, the 2004 NICE guideline recommended that endoscopy should be reserved for certain groups of patients. These were:1

  • people with alarm signs—chronic gastrointestinal bleeding; progressive unintentional weight loss; progressive difficulty swallowing; persistent vomiting; iron-deficiency anaemia; epigastric mass; or suspicious barium meal
  • those aged over 55 years, if symptoms persisted despite H. pylori testing and acid suppression therapy, and if patients had one or more of: previous gastric ulcer or surgery; continuing need for treatment with non-steroidal anti-inflammatory drugs; or raised risk of gastric cancer or anxiety about cancer.

In June 2005, NICE amended the guideline to reflect the recommendations of the NICE clinical guideline on referral for suspected cancer.11 The revised guideline advised that the role of endoscopy should be reserved for those patients over the age of 55 years who suffer persistent and unexplained recent onset dyspepsia. The recommendations referring to persisting symptoms, existing conditions or treatment, and anxiety were removed. ‘Persistent’ was defined as ‘the continuation of specified symptoms and/or signs’, and ‘unexplained’ as ‘a symptom(s) and/or sign(s) that has not led to a diagnosis being made by the primary care professional after initial assessment of the history, examination and primary care investigations (if any)’.1

Implementation of the guideline in primary care

The recommendations were written in a way that made them suitable for implementation in clinical practice, and many endoscopy units have adopted them as criteria for endoscopy referral. Consequently, the algorithm for the management of uninvestigated dyspepsia (see Figure 1) was used in the design of referral forms for endoscopy in those units. This reduces the number of inappropriate referrals and ensures that the initial steps for the treatment of dyspepsia have been fully implemented before referral is considered.

In addition, primary care trust prescribing advisers have adopted the principles of step-down, and ‘as required’ treatment regimens. However, there is no current research to demonstrate the effect of this change. Costs of prescribing have reduced since the NICE guideline was implemented, but this probably reflects the fact that some PPIs are now off patent. However, it should be stated that over the 5-year period from 2001 the number of PPIs prescribed almost doubled, and prescription of H2RA has fallen by 33% over the same period.6

There is some evidence to support the assertion that introduction of the guideline has reduced the number of upper gastrointestinal tract endoscopies. A survey undertaken in Wales in 2006 demonstrated a 17% reduction in the number of gastroscopies performed in the principality in that year compared with 2004.12

Research recommendations

In considering the large body of evidence that was analysed in order to produce the dyspepsia guideline, numerous gaps in the knowledge were identified. These deficiencies were highlighted in the research recommendations. They include longitudinal studies of the natural history of dyspepsia as very little is known about the prognosis of dyspepsia in the community setting. This will allow production of a model of care for the person presenting with dyspepsia, including treatment, investigation, and, importantly, prognosis. Another unanswered question looks at the role of H. pylori eradication in initial management of dyspepsia. In the algorithm for the management of uninvestigated dyspepsia (see Figure 1), no distinction is made between the strategy of ‘test and treat’ for H. pylori or 1-month treatment with a PPI.

Research is needed into appropriate long-term care and management of chronic dyspepsia sufferers to determine those patients who can be managed on low-dose treatments, as required, and cease treatment at periodic reviews.

Summary

Dyspepsia is a common condition in primary care. It is, in many ways, poorly understood but its management involves a number of interlocking issues. The NICE guideline on the management of dyspepsia in adults in primary care endeavours to provide a simple, evidence-based framework that addresses the issues of definition and diagnosis of dyspepsia, the potential benefits and harms of lifestyle and pharmacological interventions, and the targeting of limited healthcare resources at the most appropriate patients.

  • Patients with dyspepsia can usually be managed entirely in primary care using the NICE algorithm
  • Drug costs are now inexpensive—generic omeprazole for 28 days = £2.03*
  • Endoscopy should be reserved for those patients over the age of 55 years who suffer persistent and unexplained recent onset dyspepsia
  • NICE has developed a commissioning guide for endoscopy services1
  • Endoscopy can easily be provided in primary care by GPwSIs, thus avoiding full tariff costs
  • Tariff costs:2
      • gastroenterology outpatient = £193 (new) £95 (follow-up)
      • upper gastrointestinal endoscopy (FO6) = £407
  1. National Institute for Clinical Excellence. Dyspepsia: management of dyspepsia in adults in primary care. Clinical guideline 17. London: NICE, 2004 (revised 2005).
  2. North of England Dyspepsia Guideline Development Group. Dyspepsia: managing dyspepsia in adults in primary care. Newcastle upon Tyne: Centre for Health Services Research, 2004.
  3. American Gastroenterological Association. Medical position statement: evaluation of dyspepsia. Gastroenterology 1998; 114 (3): 579–581.
  4. British Society of Gastroenterology. Dyspepsia management guidelines. London: BSG, 2002.
  5. Scottish Intercollegiate Guidelines Network. Dyspepsia. A national clinical guideline. SIGN 68. Edinburgh: SIGN, 2003.
  6. PACT Prescribing Review — Drugs for Dyspepsia, at: www.ppa.org.uk//news/pact-082006.htm
  7. Smith P, Williams R. A comparison of workloads of physician-gastroenterologists and other consultant physicians. Prepared on behalf of the Clinical Services Committee, British Society of Gastroenterology. J R Coll Physicians Lond 1992; 26 (2): 167–168.
  8. Jones R, Lydeard S. Prevalence of symptoms of dyspepsia in the community. Br Med J 1989; 298 (6665): 30–32.
  9. McCormick A, Fleming D, Charlton J. Morbidity statistics from general practice: Fourth National Study 1991–1992. Series MB5 No3. London: Her Majesty’s Stationery Office 1995: pp.182–183.
  10. Cagna C, Vakil N. Upper GI malignancy, uncomplicated dyspepsia, and the age threshold for endoscopy. Am J Gastroenterology 2002; 97 (3): 600–603.
  11. National Insitute for Health and Clinical Excellence. Referral guidelines for suspected cancer. Clinical guideline 27. London: NICE, 2005.
  12. Second survey of endoscopy facilities and waits in Wales. www.grs.wales.nhs.ukG