2000/022 NICE Issues Guidance on Proton Pump Inhibitors (PPI) for Dyspepsia

Ref: NICE 2000/022 Issued 12 July 2000

The National Institute for Clinical Excellence has today issued its guidance on the use of Proton Pump Inhibitors (PPIs) in the treatment of dyspepsia to the NHS. Dyspepsia affects up to 40% of the adult population every year, and 1 in 10 will visit their GP. For most people dyspepsia is not serious, however, for some patients dyspepsia may be caused by a more serious underlying condition (e.g. a peptic ulcer). At present the NHS spends over £300 million every year on PPIs in England and Wales.

The Institute's guidance has been circulated to all GPs and Consultant gastroenterologists in England and Wales. The guidance describes some of the causes of dyspepsia and provides advice as to where a PPI should be used in each case. All doctors prescribing PPIs have been asked to review their use of PPIs against the guidance with the aim of reducing the dose or even stopping the medicine where appropriate.

The Institutes Chief Executive, Andrew Dillon said, 'This advice, if implemented fully, will have real benefits to patients because there is no advantage in having more of a drug than is needed. It could also save the NHS up to £50 million a year, money may be used to fund increases in testing and the monitoring of those patients who have to take PPIs over a long period of time'. Ends

Notes for Editors

• Dyspepsia is a general term used to describe discomfort or pain in the upper abdomen or chest, often after meals. Other symptoms include burning, fullness, bloating, wind, nausea and vomiting. Pain may be mild or severe, it may come and go and it often resolves itself without medication.
• At any one time it is estimated that 4 out of 10 adults each year may suffer from dyspepsia. Each year about 1 in 10 people will need to seek their GP's advice for dyspepsia symptoms, and about 1 in 10 of those who visit their GP need to be referred for a specialist opinion, or tests, because of continuing or more severe symptoms.
• Some causes of this more severe dyspepsia are:
  • Gastro-oesophageal reflux disease (GORD): this is an irritation and sometimes inflammation (sometimes described as a burning) of the lower end of the oesophagus (gullet) This is usually caused by digestive juices (especially acid) repeatedly moving upward from the stomach into the gullet.
  • An ulcer is a break in the lining of the stomach or the duodenum (the first part of the small intestine) resembling ulcers that some people get from time to time in their mouth. Because of a component of digestive juice, called pepsin, they are often described as a 'peptic ulcer'. Infection of the stomach lining by the bacterium Helicobacter pylori (H pylori) is the major cause of ulcers in the UK, and eradication of this infection leads to healing of the ulcers in the majority of cases.
  • Sometimes dyspepsia may be caused by the medicines commonly taken for arthritis (Non-steroidal anti-inflammatory drugs - NSAIDs). It is known that these medicines can cause irritation of the stomach lining, possibly leading to ulcers. Therefore patients will often be prescribed another medicine to relieve the dyspepsia symptoms.
  • Non-ulcer dyspepsia (NUD): if tests are performed and no medical cause for the dyspepsia is found, the term 'non-ulcer dyspepsia'is used. This means that no ulcer has been found to account for the symptoms
• A number of medicines are available for the treatment of dyspepsia:
  • antacids - reduce the effect of acids in the stomach;
  • alginates - form a protective layer on the contents of the stomach and therefore reduce acid contact within the oesophagus (gut)
  • prokinetics - speed up the movement of the gut
  • histamine antagonists (sometimes called H2 Antagonists) and PPIs keep in check (suppress) acid production. They are also known as acid-suppressors.
• In 1998, the NHS in England spent £291 million on PPIs, £139 million on histamine antagonists and £52 million on other dyspepsia drugs. In Wales, £23 million were spent on PPIs, £11 million on H2RAs and £5 million on other dyspepsia drugs.
• NICE has issued the following guidance on the use of PPIs in the treatment of dyspepsia: (Please note this should be reading conjunction with the full guidance and or patient notes
  • In patients with documented duodenal or gastric ulcers, a treatment strategy of testing for Helicobacter pylori and, where positive, eradicating the infection is recommended. Long-term acid-suppressing therapy should not be used. Those patients who are H.pylori negative or remain symptomatic after eradication therapy should be treated as described below.
  • For patients with a documented non-steroidal anti-inflammatory drug (NSAID)-induced ulcer, who must unavoidably continue with NSAID therapy (e.g. those with severe rheumatoid arthritis), an acid suppressor, usually a proton pump inhibitor (PPI), should be prescribed. After the ulcer has healed, the patient, where possible, should be stepped down to a maintenance dose of the acid suppressor.
  • Patients who have severe gastro-oesophageal reflux disorder (GORD) symptoms or who have a proven pathology (e.g. oesophageal ulceration, Barrett's oesophagus) should be treated with a healing dose of a PPI until symptoms have been controlled. After that has been achieved, the dose should be stepped down to the lowest dose that maintains control of symptoms. A regular maintenance low dose of most PPIs will prevent recurrent GORD symptoms in 70-80% of patients and should be used in preference to the higher healing dose. Where necessary, should symptoms re-appear, the higher dose should be recommenced. In complicated oesophagitis (stricture, ulcer, haemorrhage), the full dose should be maintained. Patients with mild GORD symptoms and/or those who do not have a proven pathology can frequently be managed by alternative therapies (at least in the first instance) including antacids, alginates, or H2RAs (H2 receptor antagonists).
  • Patients diagnosed with non-ulcer dyspepsia (NUD) may have symptoms caused by different aetiologies and should not be routinely treated with PPIs. Should the symptoms appear to be acid-related, an antacid or the lowest dose of an acid suppressor to control symptoms should be prescribed. If they do not appear to be acid-related, an alternative therapeutic strategy should be employed.
  • Patients presenting in general practice with mild symptoms of dyspepsia may be treated on either a 'step-up' or a 'step-down' basis. Neither group should normally be treated with PPIs on a long-term basis without a confirmed clinical diagnosis being made.
  • In circumstances where it is appropriate to use a PPI and where healing is required, the optimal dose to achieve this should be prescribed initially. Once healing has been achieved, or for conditions where it is not required, the lowest dose of the PPI that provides effective symptom relief should be used.
  • The least expensive appropriate PPI should be used.
  • The use of PPIs in paragraphs above refers for each indication only to those PPIs that have been licensed for that use.
  • On present evidence, PPIs do not have any serious contraindications for the vast majority of users, and have been in common use for some eight or nine years. While their use in sufficient dosage to cure, or to control symptoms, is well warranted in terms of their clear benefits, any additional use cannot be recommended.
• This advice, if implemented fully, will have real benefits to patients because there is no advantage in having more of a drug than is needed. It could also lead to a reduction in the usage of PPIs of at least 15%, and therefore save the NHS in England and Wales £40 to £50 million per year in drug costs. Some of these savings may be used to fund increases in diagnostic testing and the monitoring of long-term PPI use.
• This guidance means that no matter where they live in England or Wales, both patients and health professionals, have access to information on what the NHS considers to be best practice in the use of PPIs in the treatment of dyspepsia.
• Health professionals are expected to take the guidance fully into account when exercising their clinical judgement about the circumstances in which it is appropriate to use PPIs to treat dyspepsia. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
• The National Institute for Clinical Excellence (NICE) is a part of the NHS. Part of its work is technology appraisals. That is we use a team of experts to produce guidance for both the NHS and patients on medicines, medical equipment and clinical procedures based on evidence of clinical and cost effectiveness. Each appraisal takes around 12 months to complete and involves the manufacturers of the technology, patient groups and professional organisations.
• An appeal was made against the guidance on PPIs. An appeal panel heard the appeal, which was not upheld. Full details of the appeal are available on the Institute' website, at www.nice.org.uk.
• NICE follows an transparent and well structured process for its technology appraisals, which gives appropriate groups (patients professionals and manufacturers) with the opportunity to submit evidence, to comment on draft conclusions and to appeal, if required, to a panel of those independent of the original judgement. Its task is to assess the evidence of all the clinical and other health related benefits of an intervention. This will include impact on quality of life, relief of pain or disability as well as any impact on likely length of life; to estimate the associated costs and to reach a judgement as to whether, on balance, the intervention can be recommended.
• At the end of the appraisal process the Appraisal Committee produces a Final Appraisal Determination (FAD). The FAD is then considered by the Institute's Guidance Executive who use it as the basis for producing the Guidance to the NHS. The Institute then makes the Guidance to the NHS available to all interested parties, initially on a confidential basis, who, should they wish to, have 10 working days to lodge an appeal against the guidance. The document Appeal Against Guidance to the NHS on a New or Existing Technology - Guidance for Appellants provides guidance appellants.
• NICE promotes clinical and cost effectiveness through its technology appraisals, clinical guidelines and audit tools. NICE supports the work of those who make the complex treatment decisions - doctors, nurses, and other health professionals. The needs of the patient are central to NICE's work, and the Institute has forged strong links with patient groups and representatives.
• NICE appraises new and existing health technologies, as selected by the Department of Health and the National Assembly for Wales and advises the NHS on how these technologies can best be used. It is also responsible for the production of national clinical guidelines, promoting best practice throughout the NHS. To support and assess the implementation of such guidelines, NICE will produce audit tools for use in the clinical setting.
• Copies of the full guidance and information for patients are available on the NICE web site (www.nice.org.uk).
• The full Guidance and patient notes are also available from:

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