The new SIGN guideline sets out a clear evidence based approach to the management of dyspepsia, says Dr Jack Taylor

Dyspepsia is common. Up to 40% of adults experience upper gastrointestinal symptoms in any one year. The management of dyspepsia has changed frequently since the time when diets, antacids, bed rest and ulcer surgery were the mainstay.

Management has changed mainly as a result of the advent of endoscopy, acid suppressing drugs and the discovery of the significance of Helicobacter pylori and its eradication. One consequence has been heavy use of endoscopy services, often for patients without serious disease.

The management options for dyspepsia are often applied inconsistently. Clear evidence is therefore needed about their safety and effectiveness.

Developing the guideline

SIGN has previously produced guidelines on H. pylori eradication,1, 2 but has not until now considered the management of dyspepsia in the wider sense. The recently published SIGN guideline on dyspepsia now proposes a clear evidence-based strategy for its management.

The guideline gives a clear definition of dyspepsia. It suggests that terms such as ulcer-like, non-ulcer and dysmotility-like dyspepsia are not useful clinically, and that the Rome II definition is used, i.e.

dyspepsia refers to pain or discomfort centred in the upper abdomen.3

The SIGN dyspepsia guideline addresses the following questions:

  • When should H. pylori be eradicated?
  • Who should be referred for a specialist opinion?
  • How important is the age of onset of dyspepsia?
  • What is the role of the barium meal?
  • What is the best H. pylori test?
  • When can functional dyspepsia be diagnosed?
  • What treatments of functional dyspepsia are effective?

The guideline does not specifically address the management of:

  • diagnosed GORD
  • diagnosed gastric or duodenal ulcers
  • dyspepsia associated with NSAIDs.

SIGN guidelines are internationally recognised for their rigorous, evidence-based and consistent methodology. The dyspepsia guideline development group consisted of representatives from the areas of gastro-enterology, general practice, gastrointestinal surgery, pharmacy, bacteriology, radiology, specialist nurse endoscopy and dietetics.

How good is the evidence?

SIGN grades evidence from 1++ for high quality meta-analyses, systematic reviews of RCTs or RCTs with a low risk of bias, to 4 for expert opinion, and recommendations are graded A to D accordingly (Figure 1, below).

Figure 1: Key to evidence statements and grades of recommendations

As dyspepsia is not a major health priority, there is a lack of large multi-centre trial evidence. Also, as the ROME II definition has not been widely used in research, much of the evidence considered did not deal directly with dyspepsia as defined in the guideline. Nonetheless, robust evidence was found in the following important areas:

1++, grade A recommendation

  • A non-invasive H. pylori test and treat strategy is as effective as endoscopy in the initial management of patients with uncomplicated dyspepsia who are less than 55 years old.
  • H. pylori eradication therapy should be considered in the management of functional dyspepsia

1+, 2++, grade C recommendation

  • A non-invasive test and treat policy may be as appropriate as early endoscopy for the initial investigation and management of patients over the age of 55 years presenting with uncomplicated dyspepsia.

2++, 4, grade B recommendation

  • Patients with dyspepsia and alarm features should be referred to a hospital specialist for assessment.

1+, 4, no adequate evidence for recommendation

  • There is no evidence to support the mandatory use of early upper GI endoscopy to investigate patients over 55 years old who present with new onset uncomplicated dyspepsia

Grade 2+ to 4 evidence is presented in relation to the role of the community pharmacist, endoscopy versus barium meal, H. pylori testing, the place of diet and lifestyle, and the management of functional dyspepsia.

Implications of the guideline

The main implication of the guideline will be that GPs and hospital specialists can now confidently treat all patients with uncomplicated dyspepsia, at least initially, with an H. pylori ‘test and treat’ strategy, without adversely affecting the outcome of the very small number who have an upper GI cancer; endoscopy is not necessary.

They will cure a significant proportion of those with peptic ulcer and help some who have functional dyspepsia.

Patients under 55 years without alarm features who remain symptomatic in spite of being, or becoming, H. pylori negative can now be managed as though they had functional dyspepsia without further investigation.

Patients over 55 years who remain symptomatic should be referred for specialist advice.

Consequently, there should be a reduction in the number of endoscopies requested, leading to more rapid diagnosis for those with significant pathology.

The information in the guideline will enable health authorities, local health boards and trusts to target resources, for example towards H. pylori testing, treatment and confirmation of eradication in primary care.

What else does the guideline cover?

Patients do not use the word dyspepsia to describe their symptoms. The guideline recognises this by including a very clear algorithm starting with "indigestion” (see quick reference guide, Figures 2 and 3, below). It informs doctors how to establish whether their patient has dyspepsia as defined by the guideline. They are reminded to think of the heart, the gall bladder, the pancreas, the oesophagus, the colon and of drugs such as NSAIDs. They should enquire about the predominant symptom, and if this is "heartburn”, they should treat as GORD.

If the patient has alarm features, he or she should be referred immediately to a specialist. Only then should the management pathway for dyspepsia be entered.

Figure 2: Front of the quick reference guide
Figure 3: Reverse of the quick reference guide showing the management algorithm
© Scottish Intercollegiate Guidelines Network

Dyspepsia and GORD

The guideline explains why the guideline group chose to separate dyspepsia from GORD. It says that the two are essentially different entities and that, while the symptoms may overlap, the evidence base for each is separate.

This may cause difficulty for doctors looking for a guideline for the management of patients with all upper GI symptoms. The entry algorithm is very helpful in this respect.

An update on H. pylori

Users of this guideline will wish to know the latest evidence about which patients should receive H. pylori eradication therapy (Figure 4, below), and which treatment options are most effective. This is reproduced in an annex.

Figure 4: Patients who should receive H. pylori eradication therapy

Patient information

One of SIGN’s strengths is that it includes patient representatives in its guideline groups. This means that experts can be called to task and that good patient information can be included in the guidelines.

The dyspepsia patient information section is clear and easy to understand and answers the questions:

  • What is dyspepsia?
  • What can you do about it?
  • What can the doctor do?

There is also a section for health professionals containing helpful points they can use to explain functional dyspepsia.

These state that it is common, it is not caused by any pathology, that its cause is not known, that it is not caused by acid, stress or food allergy, and that drug treatment is not always effective.

Future research

SIGN is conscious that its recommendation that early endoscopy is not mandatory for the initial management of uncomplicated dyspepsia in patients older than 55 years is not based on grade 1++ evidence.

Therefore, the first two priorities it suggests for further research are:

  • A comparative study of the pathological stage and presenting symptoms of upper GI cancer before and after implementation of the guideline.
  • The efficacy and safety of the ‘test and treat’ policy versus upper GI endoscopy in the management of patients over 55 years of age presenting with recent onset uncomplicated dyspepsia.

Other potential research topics are:

  • The effect of lifestyle, patient education, psychosocial interventions and drugs on functional dyspepsia.
  • Definition of the age risk of having upper GI cancer associated with a presentation of dyspepsia along with one of the commonly quoted alarm features.
  • A health economic study into whether short term increases in the resources required and workload involved in H. pylori ‘test and treat’ leads to longer term savings in costs of endoscopies and drugs to manage the symptoms of dyspepsia.
  • Adverse effects of wider use of antibacterial therapy and of H. pylori eradication.

SIGN 68: Dyspepsia. A national clinical guideline, can be downloaded free of charge from the SIGN website: www.sign.ac.uk

Reference

  1. Scottish Intercollegiate Guidelines Network. SIGN 7: Helicobacter pylori: eradication therapy in dyspeptic disease. Edinburgh: SIGN, 1997.
  2. Scottish Intercollegiate Guidelines Network. SIGN 19: Helicobacter pylori: eradication therapy in dyspeptic disease. Edinburgh: SIGN, 1999.
  3. Talley NJ, Stanghellini V, Heading RC et al. Functional gastroduodenal disorders. Gut 1999; 45: 1137-42.

 

Guidelines in Practice, April 2003, Volume 6(4)
© 2003 MGP Ltd
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