1.1 Background

This guideline builds on the work already undertaken by SIGN on dyspepsia and incorporates new evidence in controversial areas. In August 1996, SIGN published a national clinical guideline on Helicobacter pylori (H. pylori) eradication therapy in dyspeptic disease.¹ A single sheet update of this guideline was issued in October 1999.² Both publications provided evidence-based recommendations on which patients with H. pylori should receive eradication therapy and which eradication regimens to use. These SIGN Guidelines on H. pylori eradication therapy raised the issue of how H. pylori infection may alter the way in which we investigate patients presenting with dyspepsia.

This guideline specifically addresses the investigation and management of dyspepsia and updates the evidence base for the key indications for H. pylori eradication in duodenal ulcer, gastric ulcer and low grade gastric MALT lymphoma (see Annex 1).

1.2 The need for a guideline

Upper gastrointestinal symptoms affect up to 40% of adults in any one year.^{3, 4, 5} Some 50% of sufferers self-medicate, perhaps with advice from community pharmacists, with only about one in four sufferers consulting their general practitioner.^{3, 4, 5}

Scottish prescribing data revealed a 27% increase in the number of prescriptions for ulcer healing drugs between 1996 and 2001.⁶ Despite the significant increase in the volume of prescribing, the cost in absolute terms has reduced, from £72.5 m per annum to £71 m over the same period. This is partly due to price reductions of Proton Pump Inhibitors (PPIs) and the generic tariff prices for those H2 receptor antagonists (H2RA) available on the Scottish Drug Tariff, and partly due to increasing use of maintenance doses of PPIs. Upper gastrointestinal symptoms nonetheless impose a substantial burden on the Scottish healthcare system^{3, 7} as well as causing significant quality of life impairment for the individuals who suffer them.^{8, 9}

1.3 Terminology

1.3.1 DYSPEPSIA

The term dyspepsia has been used inconsistently by healthcare professionals to describe differing patterns of upper gastrointestinal (GI) symptoms. The consequent lack of comparability between published studies of dyspepsia has been a major barrier to resolving clinical uncertainty about best practice for investigation and treatment of patients. Clarity about the terminology is thus an essential preliminary to formulating an up to date guideline on clinical practice. Dyspepsia denotes symptoms and is not itself a disease. The guideline development group accepted the Rome II definition:¹⁰ Dyspepsia refers to pain or discomfort centred in the upper abdomen.

“Centred” refers to pain or discomfort in or around the midline. Pain in the right or left hypochondrium is not considered to constitute dyspepsia. “Discomfort” refers to a subjective negative sensation that the patient does not interpret as pain, which may be characterised by or associated with upper abdominal fullness, early satiety, bloating, belching, nausea, retching and/or vomiting.

On investigation, organic disease (eg duodenal or gastric ulcers) thought likely to explain the dyspepsia will be found in some patients. In others, no such causal pathology or disease is identified: these patients are said to have functional dyspepsia. The older synonym “non-ulcer dyspepsia”, though still widely used, is not recommended because some of the patients have symptoms typical of ulcer disease while others have symptoms not at all like an ulcer. Furthermore, peptic ulcer is not the only organic disease to be excluded before the diagnosis of functional dyspepsia is appropriate.

Patients with functional dyspepsia who identify pain as their predominant symptom may be said to have ulcer-like dyspepsia whereas patients with discomfort as their predominant symptom may be said to have dysmotility-like dyspepsia.¹⁰

1.3.2 HEARTBURN, DYSPEPSIA AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)

Confusion often accompanies consideration of the relationship between heartburn, dyspepsia and GORD. A first step towards minimising this confusion is to recognise that heartburn and dyspepsia describe symptoms, whereas GORD is a collective term embracing all diseases caused by gastro-oesophageal reflux.

Retrosternal heartburn, the classical symptom of GORD, is not included within the Rome II definition of dyspepsia because it is not an upper abdominal symptom. A diagnosis of GORD may be made with high confidence for patients who describe retrosternal heartburn and/or acid regurgitation as their principal complaints. This diagnosis is less certain when pain or discomfort centred in the upper abdomen (Rome II dyspepsia) is accompanied by heartburn as a secondary, subordinate symptom, hence the emphasis given to the predominant symptom as the basis for diagnosis.

Not all patients with GORD present with classical heartburn. A minority of patients describe upper abdominal pain or discomfort (Rome II dyspepsia) as their principal symptom: other recognised “atypical” presentations of GORD include asthma and non-cardiac chest pain.

Distinguishing dyspepsia from heartburn potentially allows appropriate diagnostic significance to be attached to each of these symptoms. Recognition that heartburn is the classical, but not the only, clinical presentation of GORD serves as a reminder that heartburn and GORD should not be equated.

A diagnosis of gastro-oesophageal reflux disease (GORD) is likely if retrosternal heartburn and acid regurgitation are a patient’s principal complaints. The term “reflux-like dyspepsia” is no longer recommended to describe these symptoms.

1.3.3 OESOPHAGEAL AND GASTRIC CANCER

A minority of patients with dyspepsia will have major organic pathology, e.g oesophageal or gastric cancer. This guideline highlights the alarm features (see sections 2.2 and 2.4) that would identify patients who require early referral to a hospital specialist.

1.4 Remit of the guideline

This guideline provides recommendations based on current evidence for best practice in the management of dyspepsia in adults. It includes guidance on investigation and treatment of dyspepsia, but does not specifically address the clinical management of:

• Diagnosed gastro-oesophageal reflux disease (GORD) (this may be addressed by a future SIGN guideline)
• diagnosed gastric or duodenal ulcers (but see Annex 1 for an update on H. pylori eradication)
• dyspepsia associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs).

This guideline is likely to be of particular interest to general practitioners, community pharmacists, gastroenterologists, upper GI surgeons, general surgeons, nurse endoscopists, public health physicians, radiologists and clinicians who specialise in the care of the elderly.

1.5 Statement of intent

This guideline is not intended to be construed or to serve as a standard of medical care. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. These parameters of practice should be considered guidelines only. Adherence to them will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate judgement regarding a particular clinical procedure or treatment plan must be made by the doctor, following discussion of the options with the patient, in light of the diagnostic and treatment choices available. However, it is advised that significant departures from the national guideline or any local guidelines derived from it should be fully documented in the patient’s case notes at the time the relevant decision is taken.

1.6 Review and updating

This guideline will be issued in 2003 and will be considered for review as new evidence becomes available. Any updates to the guideline will be noted on the SIGN website: www.sign.ac.uk