Primary Care Pharmacy September 2000 Vol 1 No 4 p96-98

Medicines Resource Management

Dyspepsia and its management

By Lee Furniss MSc, MRPharmS

This article aims to provide concise information for prescribing advisers on the management of patients with dyspepsia

The management of dyspepsia is an important area for all primary care groups (PCGs) and their equivalents in Scotland and Wales. The profile of this disorder has been raised recently by the publication of guidance in England and Wales by the National Institute for Clinical Excellence (NICE) on the use of proton pump inhibitors (PPIs).1 The use of ulcer-healing drugs accounts for a large proportion of general practitioner (GP) prescribing. It is important that these drugs are prescribed safely and cost-effectively because their judicious use can have a large impact on the morbidity and mortality of patients and on the cash-limited prescribing budget of a PCG.

The aim of this article is to provide concise information for prescribing advisers on the management of patients with this common condition and to incorporate parts of the recent NICE guidance. Specific reference will be made to gastro-oesophageal reflux disease (GORD). The treatment and prevention of non-steroidal anti-inflammatory drug-induced ulcers will not be covered.

Facts and figures

Dyspepsia is a common complaint. Surveys in general practice have suggested a prevalence for the disease of 40 per cent, with up to a quarter of sufferers consulting their GP. It is estimated that about 4 per cent of general practice consultations are for dyspepsia, with 10 per cent of patients who attend their GP with dyspepsia being referred to secondary care for further consultation or investigation.2
Terminology

Dyspepsia is the term given to a group of symptoms that alert doctors to consider disease of the upper gastrointestinal (GI) tract. It is not a diagnosis and includes symptoms such as heartburn, upper abdominal (often food-related) discomfort (indigestion), bloating, fullness, nausea and anorexia.2,3 Many diseases cause dyspepsia and these include GORD, peptic ulcer disease (PUD), cancer of the stomach or pancreas, and gallstones. Some of the symptoms described could also indicate lower GI disease, eg, irritable bowel syndrome. Non-ulcer dyspepsia is also known as functional dyspepsia and is effectively a diagnosis made by exclusion of other disease. There is no macroscopic mucosal abnormality and functional dyspepsia should not be routinely treated with PPIs.1,2
Immediate referral

Patients of any age with dyspepsia and so-called “alarm” symptoms and signs (see Table 1) should be referred urgently for investigation. Recent guidance has raised the age threshold above which patients should be referred, regardless of presence of alarm signs and symptoms, to 55 years.1 The previous cut-off was 45 years2 but it is still a matter of debate whether patients in the 45-55 age group without alarm symptoms or signs should be referred for endoscopy. Presumably, local availability of prompt endoscopy will need to be factored into this debate. Universal investigation for dyspepsia is neither desirable nor affordable but there is evidence that subsequent therapeutic decisions and consulting behaviour change in those investigated, even when major diagnoses are absent.2 Consequently, savings made by preventing long-term prescribing of potent acid-suppressant drugs may offset costs of early endoscopy. Use of PPIs before endoscopy may mask endoscopic signs and should be discouraged.

Helicobacter pylori

The role of this microbe in the pathogenesis of PUD is now well established. It is strongly associated with the relapse of duodenal ulcers (implicated in 95 per cent of cases) but less so in gastric ulcers (implicated in about 70 per cent of cases). In these conditions, testing for the organism and eradicating it, if the test is positive, is recommended.1 H pylori infection is also associated with gastric cancer. In oesophagitis, eradication often makes symptoms worse.
Eradication

Eradication of the organism with triple therapy for one week is now acceptable and the regimes shown in Table 2 give eradication rates greater than 90 per cent, with good compliance. Resistance to metronidazole is an emerging problem, especially in inner city areas, and regimes that exclude this drug may be preferred in such areas. If clarithromycin cannot be used, then both amoxicillin and metronidazole should be used together.3 The eradication rate for such a regime is just under 90 per cent.2

Tests

There are a number of tests for H pylori. Serum tests show up antibodies to the organism, so are not useful for demonstrating eradication, since antibodies will still be present even if eradication is successful (false positive result). In addition, near-patient blood tests are less effective than breath tests. Breath tests are useful for demonstrating eradication but must not be performed within four weeks of the patient taking an antisecretory drug or antibiotic.3 Breath tests need to be validated for the population in which they are performed; centralisation of the process would help to facilitate this and allow co-ordination of testing. Biopsy at endoscopy shows histology and culture/sensitivity of the organism but is expensive.

Gastro-oesophageal reflux

Gastro-oesophageal reflux occurs when the gastric contents enter the oesophagus through an incompetent gastro-oesophageal junction.4,5 Oesophagitis (defined by mucosal breaks) is found in fewer than half of patients undergoing endoscopy for reflux4 and symptoms of the disease do not correlate well with severity of oesophagitis. Symptoms of GORD are predominantly heartburn and regurgitation.
Lifestyle interventions

Many lifestyle interventions are based on physiological studies and their effectiveness has not been assessed in well-controlled trials. Raising the head of the bed while sleeping has proven beneficial.6 It would appear that appropriate advice would be to moderate consumption of any food or drink that causes or worsens symptoms (eg, fatty foods or alcohol) and to consider stopping smoking as a good general health measure.

Drug therapy

There is a scant evidence-base for the use of antacids and alginates in GORD but patients often report them to be effective. Alginates have been shown to be effective at maintaining remission for up to six months in patients whose mild oesophagitis has been healed7 but the evidence for this comes from a single open trial. Systematic review has demonstrated that PPIs are more effective than H2-receptor antagonists (H2RAs) for symptom relief, healing oesophagitis and achieving remission and motility stimulants appear to have similar efficacy to H2RAs.4,5

Surgery

There are no published data on the comparative efficacy of surgical interventions and PPIs but trials are in progress.4,5 Long-term follow-up of laparoscopic surgical methods is lacking but deterioration has occurred 10 to 20 years after open surgery.4

Management strategies

There is no evidence to determine whether a “step-up” (typically starting with an antacid or alginate and working up to a PPI) or “step-down” (starting with a PPI) approach to treatment is best.4 However, patients presenting with mild symptoms of GORD, who are not appropriate for immediate referral (see above) can frequently be managed, in the first instance, with antacids, alginates or H2RAs.1 There is now good consensus on the use of acid suppressants without endoscopic assessment in these patients.4 However, recent advice is that treatment with a PPI on a long-term basis is not recommended without a confirmed clinical diagnosis.1 A large, case-control study has shown that patients who report reflux symptoms once or more each week are more likely to develop oesophageal adenocarcinoma than controls.8

Patients with more severe symptoms (but with no need for immediate referral) or who have a proven pathology (eg, stricture or Barrett’s oesophagus) should be treated with a healing dose of PPI until symptoms have been controlled. Treatment should then be “stepped-down” to the lowest dose that controls symptoms.1 This will prevent recurrence of GORD in 70 to 80 per cent of patients.

In complicated oesophagitis (eg, stricture, ulcer or haemorrhage), the full dose of PPI should be maintained.1 PPIs are often prescribed in high-doses in Barrett’s oesophagus. Omeprazole, at a dose of 40mg twice daily, caused the metaplasia associated with this condition to regress by only 8 per cent with two years of treatment. Ranitidine produced no detectable improvement.9

Choice of PPI and audit

There is a constant state of flux in the prices of PPIs. Proposals have been made to “switch” to the cheapest one but, given that prices are constantly changing, this may serve only to confuse patients and may undermine their confidence in the prescriber and pharmacist. It is more important to use PPIs appropriately than to spend time deciding on which one to use.10

If the principles of quality prescribing are followed, the overall cost should fall simultaneously. When deciding on which PPI to use initially, the least expensive with a licensed indication is a good start.1 Some GPs express concern at the reasons why PPIs are commenced in secondary care and this may be a good area for a joint audit, if it is considered significant locally.

The inclusion of information on discharge letters regarding duration of PPI treatment and other long-term management details are also areas that could be included in an audit.

Conclusions

Dyspepsia management will have significant quality and cost implications. Many management choices (for example, endoscopy use) are linked with local availability of secondary care services. Consequently, the primary care pharmacist must become involved in discussions around the provision of related services; the implications of having a unified budget are starting to become real.

If this area of prescribing is managed adequately, primary care pharmacists can have a beneficial impact on the quality of life of patients and, potentially, the mortality of some of them. Primary care pharmacists should seize upon these opportunities and take them forward with local players (eg, gastroenterologists). If they do not then the results may be difficult to swallow.

Mr Furniss is the prescribing adviser at North Islington primary care group, London

References