November 26, 2004
Test and Treat Helicobacter Pylori Before Endoscopy
Background Helicobacter pylori may have major implications for patients' wellbeing and future health. If a patient is found to be H. pylori positive it is important that the infection is eradicated because of the risk of associated peptic ulcers and gastric cancers. There are, however, great demands on NHS gastroenterology and endoscopy services and following the introduction of recent guidelines for dyspepsia some of these issues may be addressed. The literature suggests that a strategy of test and treat before endoscopy referral will benefit patients and be cost-effective.
* Gastrointestinal system and disorders
* Peptic ulcers
These key words are based on the subject headings from the British Nursing Index. This article has been subject to double- blind review.
EVIDENCE suggests that Helicobacter pylori, a species of Gram- negative bacteria, has major implications not only for patients' wellbeing and future health but also for gastroenterology and endoscopy services. If a patient is H. pylori positive then it is necessary to eradicate the infection because of the risk of associated peptic ulcers and gastric cancer. The 'test and treat' strategy involves testing patients for H. pylori using a breath test or serology followed by H. pylori eradication in those with H. pylori (Box 1) and symptomatic therapy for the remainder. A number of management trials have demonstrated that the test and treat strategy is as effective as endoscopy in determining therapy for dyspepsia (British Society of Gastroenterology (BSG) 2002).
H. pylori is associated with symptoms that come under the general heading of dyspepsia. Koch and Lancaster Smith (2003) describe two types of dyspepsia: 'ulcer-like' and 'dysmotility-like' dyspepsia. Ulcer-like symptoms include a burning epigastric pain or discomfort that often occurs at night and improves after eating, while dysmotility-like dyspepsia relates to a sensation of fullness, nausea, bloating and vomiting. Dyspepsia is extremely common in western society with a prevalence of 25-40 per cent over a six to 12 month period - 25 per cent of patients consult a doctor and 2 per cent of the UK population undergo upper gastrointestinal endoscopy (Koch and Lancaster Smith 2003).
H. pylori is a Gram-negative micro-aerophillic rodshaped bacterium (Roderick et al 2003). Evidence shows that it resides in the gastric mucosa and causes chronic active inflammation (Asaka et al 1995). Once acquired in childhood, it has been shown to be prevalent for several years (Blaser 1998, Danesh et al 2000, Figura et al 1998). H. pylori was discovered as early as 1906 (Caiman 1996). Originally called Campylobacter pylori its name was changed when it was realised that the bacteria's ribonucleic acid (RNA) structure did not contain any of the characteristics of Campylobacter RNA. One of the most recent events in the field of gastroenterology was the cultivation of H. pylori in 1981.
The main causes of dyspepsia are functional and non-functional dyspepsia (greater than 50 per cent), peptic ulcer disease (20 per cent), gastrooesophageal reflux (20 per cent), and gastric carcinoma (less than 2 per cent) (Lassen et al 2000). H. pylori contributes to several of these conditions, for example, 90 per cent of duodenal ulcers and 70 per cent of gastric ulcers are thought to be associated with H. pylori infection (Axon et al 1997). The other cases of ulcer disease are associated with polypharmacology and related side effects, in particular aspirin and non-steroidal antiinflammatory drugs (NSAIDs) (Roderick et al 2003).
Box 1. Suggested Helicobacter pylori eradication regimens
Helicobacter pylori and cancer
H. pylori infection has been linked to gastric cancer due to changes in the mucosal lining in the stomach, which promotes an anti- inflammatory response and alters the stomach's ability to protect itself against hydrochloric acid (Figura et al 1998). Research into the relationship between the two is ongoing, however, Forman et al (1991) suggested that between 35 and 55 per cent of all gastric cancers may be related to H. pylori infection.
The risk of gastric cancer in patients under the age of 45 is rare (Christie et al 1997). A total of 319 cases of gastric cancer were examined. Of these patients, only 25 were less than 55 years and of these, 24 presented with alarm symptoms. Christie et al (1997) concluded that the prevalence of gastric cancer in patients presenting with uncomplicated dyspepsia in the under 55 age group is very low. In a similar study, Williams et al (1988) researched patients who had already been diagnosed with gastric cancer and found that all patients under 45 years had presented to the GP with alarm symptoms.
The aim of this literature review was to establish when H. pylon should be treated. Sreedharan et al (2004) showed that a test and treat strategy is effective in reducing the number of referrals to endoscopy in patients under the age of 40 from 33.4-34.6 per cent to 23.2-26.2 per cent during a five-year period.
Data for this article were gathered from textbooks, journals and the internet. Athens programmes including Ovid, ScienceDirect and British Medical Journal sties have been used in research collection. The keywords used included dyspepsia, Helicobacter pylori, and test and treat. Documents were also obtained from organisations such as the National Institute for Clinical Excellence (NICE), the British Society of Gastroenterology (BSG) and Scottish Intercollegiate Guidelines Network (SIGN).
The endoscopy unit at the University Hospitals of Coventry and Warwickshire NHS Trust is modernising its services: this involves the redesign of endoscopy services, increasing the number of endoscopists and tackling variation in existing approaches to care. For the open access service provided - it is a GP-led service - referral of patients with dyspepsia is high. Currently, all patients referred for upper gastrointestinal endoscopy under this system are referred before treatment of symptoms, regardless of age, gender or social background. This has put staff at the endoscopy unit under pressure to achieve the number of endoscopies required to meet the demand and has created long waiting lists. A new strategy was therefore needed to accommodate these patients.
In accordance with the Dyspepsia Management Guidelines (BSG 2002) and NICE (2004) guidelines, a protocol was developed, in conjunction with the primary care trust (PCT), to recommend medical management of all patients under the age of 55 with new onset dyspepsia who do not have alarm symptoms. Under this regimen all patients would be automatically tested for H. pylori and treated accordingly. They would only be referred for endoscopy and further investigation if symptoms persisted or if consultant referral was required, for example, in cases of unexplained anaemia associated with dyspepsia or anxiety in relation to fears about cancer. If a patient, regardless of age, presents with alarm symptoms related to a suspicion of gastric cancer, he or she should be automatically referred to endoscopy via the two-week referral system for patients with suspected cancers, ensuring prompt investigation. The alarm symptoms identified by the BSG (2002) are listed in Box 2.
NICE produced guidelines for the treatment of dyspepsia in August 2004. These guidelines state that: 'any patient of any age presenting without alarm symptoms does not need routine endoscopie investigation'. Consideration is, however, given to patients over the age of 55 whose symptoms persist despite H. pylori testing and acid suppression therapy. In this category of patient a history of previous gastric ulcer or surgery should be considered. Consideration should also be given to the long-term need for NSAIDs or increased risk of gastric cancer or anxiety about cancer (NICE 2004).
For practice in relation to H. pylori to change throughout the NHS, the strategy adopted must satisfy patients, provide effective testing and be cost-effective. Dyspepsia is a frequent and costly problem. In 1998, 1.1 billion was spent by the NHS on managing dyspepsia and 450,000 patients had an endoscopy (Delaney et al 2001).
At present, primary care pays the cost of patients' treatment for dyspepsia and endoscopic procedures. Therefore, the impact of the test and treat strategy for H. pylori on consultation time and budgets would be considerable. There is evidence, however, that it is more prudent to test and treat H. pylori first, then review the patient's condition post-eradication or if symptoms persist.
Jones et al (1999) performed a trial of a test and treat strategy for H. pylori-positive dyspeptic patients in the primary care setting. For the trial, patient referrals were restricted to those under 45 years of age with no alarm symptoms. A total of 165 patients entered the study. Eradication therapy was administered if the patients were positive for H. pylori. Patients were followed up after one year and information was gathered in audit format. The results were that the test and treat strategy is clinically appropriate and cost-effective during the fir\st year of follow-up. The cost saving of avoiding endoscopy offsets the initial cost of eradication therapy over the one-year period.
Box 2. Patients in whom diagnostic endoscopy is appropriate
Another outcome was that there was no evidence that serious lesions were missed using this approach. Manes et al (2003) identifies that test and treat is as safe and efficient as endoscopy when dealing with dyspepsia. They also found no evidence that gastric cancer was either missed or diagnosed in the 219 patients studied. After a one-year period, symptoms of dyspepsia had been eradicated in 60 per cent of patients.
In contrast to the findings of Manes et al's (2003) study, Axon et al (1997), on studying the incidence of recurring ulcers post- eradication of H. pylori, found that patients already had ulcers of at least 5mm in diameter, but did not have other active upper gastrointestinal disease, cardiovascular, renal or liver disease. Of the 172 patients with benign ulcers, 19 were found to have cancer when the ulcer was biopsied at follow-up endoscopy. Axon et al (1997) advocate repeat endoscopy of patients found to have gastric ulcers, even post-eradication of H. pylori.
Delaney et al (2001) examined the comparison of endoscopy and H. pylori testing for dyspepsia in the primary care setting. Patients were chosen who were under the age of 50 and had presented to the GP complaining of dyspepsia for a period of more than four weeks. Exclusion criteria included patients who had undergone endoscopy or a barium meal in the past three years, or patients who were unable to give consent or were unfit for endoscopy. One of the areas for examination was the cost-effectiveness of managing dyspepsia, the other was the effectiveness of the regimen.
A total of 478 patients entered the trial of which 285 were randomised to test and endoscopy, and 193 to empirical management (eradication therapy). Forty per cent of the patients tested were found to be H. pylori-positive. Total mean costs for test and endoscopy were 367.85 compared with 253.16 for the usual management. The study showed that the test and endoscopy method was less cost- effective but there were no significant differences found in the effectiveness of the routes of treatment.
Delaney et al (2001) also focused on the effectiveness of treatments. This was assessed by patients' interpretation of symptoms using the Birmingham Dyspepsia Symptom Score. This enabled the researchers to measure patient satisfaction in terms of quality of life, pain, emotion and social function. Delaney et al (2001) concluded that test and endoscopy does not improve dyspeptic symptoms or quality of life compared with empirical management.
Heaney et al (1999) performed a study comparing test and treat for H. pylori with endoscopybased management in a hospital setting. Patients included in the research were 45 years of age or under and presented with symptoms of dyspepsia. Exclusion criteria for patients included alarm symptoms, symptoms of gastro-oesophageal reflux disease, regular use of NSAIDs, pregnancy or patients who had been treated for H. pylori in the past two weeks. The Glasgow Dyspepsia Severity Score (Medical Algorithms Project (MAP) 2004a) was used to assess dyspeptic symptoms. This is considered to be a valid and reproducible means of evaluating the severity of dyspepsia in patients. The SF36 health survey questionnaire (MAP 2004b) was used to assess quality of life and the Crown Crisp experimental index - another questionnaire -was used to measure the individual's response or likelihood of attributing his or her somatic symptoms and distress to physical illness. Symptoms were reviewed frequently and quality of life was reviewed at five months. A total of 104 patients were enlisted, 52 were randomised to test and treat, the other 52 received endoscopy. Over a period of 12 months, 73 per cent of endoscopy referrals were avoided, however, dyspeptic symptoms were not eradicated in all patients in either group. Forty three per cent of the test and treat group and 30 per cent of the endoscopy group were, however, asymptomatic at 12 months. More recent research suggests that, although superficial epithelial damage recovers within weeks, it may take several years for chronic inflammatory cells to disappear (Koelz et al 2003).
The Glasgow Dyspepsia Severity Score was also used by McColl et al (2002) as an indicator for H. pylori status following eradication. A total of 114 patients were referred to the trial who, on endoscopy, were found to have active duodenal and/or gastric ulcers. H. pylori status was checked using the C-urea breath test, endoscopy and biopsy. If these tests were positive, then the patient was given eradication therapy. The dyspepsia score was completed before and after eradication. When reassessed, 47 per cent of patients experience complete, or almost complete, resolution of symptoms. According to McColl et al (2002) this was directly related to the successful eradication of H. pylori. In 43 out of 44 patients whose dyspeptic symptoms had resolved H. pylori was found to have been eradicated.
However, Talley et al (1999) found there was little difference in the symptom scores of 370 patients post-eradication of H. pylori. Patients who had had dyspepsia for more than three months and were found to be H. pylori positive after an endoscopy were enrolled in the study. An extensive list of exclusion criteria is provided, for example, patients with duodenal ulcers or Barrett's oesophagus. Patients were then randomised; one group (n=182) received H. pylori eradication therapy, the other group (n=188) received a placebo. Following treatment, or not, patients were followed up in regular clinics for up to 12 months. Diary cards used a Likert scale with seven markers. These ranged from none to very severe to establish and determine the severity of symptoms. A quality of life form was completed at the six and 12 months visits. A repeat endoscopy at three and 12 months was performed and biopsies were taken.
On evaluating the results, Talley et al (1999) found 'no convincing evidence that successful eradication of Helicobacter pylori relieves or reduces symptoms in patients with functional dyspepsia over 12 months'. However, they advocate using the test and treat strategy in patients under 45 years and point out that only a small number of patients are likely to have long-term symptomatic relief from H. pylori eradication therapy.
Patient satisfaction is another important factor when implementing strategies that change their care pathway; however, literature on this aspect of care is poor and evidence is limited. Lassen et al (2000) found that 12 per cent of their study group - identified as patients over 18 years who had a clinical history of dyspeptic symptoms for less than two weeks but which were severe enough to require investigation or treatment - were not satisfied when assigned to the test and treat strategy, and concluded that this strategy makes the process less efficient.
They enrolled 500 patients presenting to the GP with a two-week history of dyspepsia without alarm symptoms. A total of 250 patients were randomised to the test and treat strategy and the remainder were referred for endoscopy. H. pylori status was obtained using the C-urea breath test. Diary cards were used as a data collection tool, with a four-stage Likert scale, and a questionnaire was completed after one month and at the annual follow-up. In view of the findings, Lassen et al (2000) advocate test and treat for H. pylori as a safe and efficient alternative to endoscopy, but they point out that patients may still request invasive procedures.
On examining the effectiveness of endoscopy in the management of dyspepsia (Figure 1), McColl et al (2002) studied 208 patients referred directly from the GP to endoscopy. They looked specifically at the comparison of test and treat for H. pylori with endoscopy management. Patients were excluded for various reasons, for example, patients over the age of 55, those on certain medications such as NSAIDs, and patients with alarm symptoms.
Figure 1. Management of dyspepsia
The severity of dyspeptic symptoms was assessed using the Glasgow Dyspepsia Severity Score (MAP 2004a) six months before the trial, and quality of life was evaluated using the SF36 health survey questionnaire (MAP 2004b). Sinister perceptions of what the patient believed to be wrong (for example, cancer) were recorded on a Likert scale of 0-10. The study showed that the most anxious patients received equivalent reassurance from endoscopy management and the test and treat strategy. In contrast to Lassen et al (2000), McColl et al (2002) conclude that test and treat is as effective and safe as prompt endoscopy, with patients being satisfied on both counts.
If the test and treat strategy is to take place then reassurance is necessary for the patient to be satisfied that the outcomes of the test are safe and reliable, and that no serious underlying cancer will be missed. Patients who remain anxious about their health may experience distress and could, potentially, become a further strain on NHS resources. Some patients may require further consultations to reassure them of test results.
Lucock et al (1997) state that anxious patients can misinterpret patient-doctor communication. They performed a quantitative study observing 50 patients, aged between 18 and 74, referred for gastroscopy. The results demonstrated the importance of patients receiving reassurance, and emphasised the need for patients to receive a positive explanation of the symptoms and test results in acceptable, understandable language. Thus giving the patient confirmation of diagnosis and followup implications will help to reduce the number of consultation appointments with medical staff.
The current demands on endoscopy services are high and are likely to \increase. This is partly due to new national screening programmes such as colorectal screening (Cairns and Scholefield 2002), and the throughput of patients requiring endoscopy. The NICE (2004) guidelines on dyspepsia will help to address some of the problems of capacity and demand in endoscopy services.
At the University Hospital of Coventry and Warwickshire NHS Trust the PCT has a key role in changing the care pathway for patients experiencing dyspepsia. Without the trust's involvement change will not occur. Members of the PCT will need to allow for extra consultation time and a possible initial increase in the budget. This would eliminate the need for endoscopy in patients under the age of 45 unless the patient is concerned or anxious about their symptoms.
Under the trust's protocol, patients presenting with alarm symptoms would automatically be referred under the two-week urgent referral system for suspected cancer. However, in a study of 25 patients who had no alarm symptoms Christie et al (1997) found one patient with gastric cancer. Two reports on patient satisfaction highlight the fact that this is an area that requires further examination (Lassen et al 2000, McColl et al 2002). The common theme throughout these two studies was the need for patients to be fully informed, reassured and to participate in their health care, otherwise the implementation of the test and treat strategy may not be as effective as previously thought.
It is well known that increasing age is associated with an increased risk of cancer (National Institute of Aging 2004). Age and H pylori are major factors associated with gastric cancer. The safest way to identify cancer early may be to perform endoscopies on those patients at greater risk rather than waiting for acid suppressant medication to take effect or referring for endoscopy at later stages of the disease.
From the evidence provided in this article, H. pylori has a major impact on co-morbidity and pathophysiology. Research suggests that the strategy of test and treat before endoscopy referral is costeffective, although it will take time before the benefits become evident. The effectiveness of a test and treat strategy appears to be the same as endoscopy management
Livett H (2004) Test and treat Helicobacter pylori before endoscopy. Nursing Standard. 19, 8, 33-38. Date of acceptance: June 22 2004.
For related articles and author guidelines visit our online archive at: www.nursing-standard.co.uk and search using the key words above.
Implications for practice
* Test and treat for Helicobacter pylori before endoscopy can be a cost-effective alternative
* More research needs to be conducted into how satisfied patients are with this strategy
* Primary care needs to allow for extra consultation time and possible budget increases to adopt a test and treat strategy
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Helen Livett RGN, BSc, is nurse endoscopist, University Hospitals Coventry and Warwickshire NHS Trust, Coventry.
Email: [email protected]
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