Introduction

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The NHS spent £1.1bn on managing dyspepsia in 1998,¹ and 450 000 patients had endoscopy. If endoscopy is reserved for patients who test positive for Helicobacter pylori, it should maximise the yield of peptic ulceration (for which eradication therapy is effective ^{2 3} ) and reduce overall endoscopy workload. Patients negative for H pylori can be given empirical acid suppression treatment.

Two non-randomised studies in secondary care have examined this "test and endoscopy" strategy. A retrospective cohort study found that positive H pylori test results were highly predictive of peptic ulcer and suggested that screening out negative patients could have reduced endoscopy workload by 23%.⁴ A controlled before and after study found that test and endoscopy was as effective in reducing dyspeptic symptoms as the previous practice of endoscopy in all patients referred.⁵ The test and endoscopy strategy has not been investigated in a randomised controlled trial, and there are no studies based in primary care.

Near patient testing allows general practitioners to base their initial management on the results of tests.⁶ However, there are few outcome studies of near patient tests in clinical decision making.⁷ We used the Helisal rapid blood test to determine the cost effectiveness of the test and endoscopy strategy in primary care.

	Participants and methods

Top Abstract Introduction Participants and methods Results Discussion References

Participants
All patients aged 18-49 years who consulted their general practitioner with dyspepsia of more than four weeks duration were eligible for the trial. We excluded patients who had had endoscopy or a positive barium meal examination in the past three years, who were unable to give informed consent, or who were unfit for endoscopy. Dyspepsia was defined as epigastric pain or heartburn with or without nausea and bloating.⁸

Interventions
Patients were randomised on a 60:40 basis (study:control) to test and endoscopy or to usual management. The Helisal test (Cortecs Diagnostics, Deeside) was done by the general practitioner or practice nurse. Endoscopies on patients with positive results were carried out according to usual practice at open access services at six local hospitals. Patients with negative results were not referred for endoscopy but received empirical acid suppressing drugs chosen by their general practitioner.

Outcomes
The main outcomes were effectiveness (assessed by symptoms) and costs of managing dyspepsia. We measured symptoms at recruitment and 15-18 months using the Birmingham dyspepsia symptom score, a postal measure previously validated in the local population.⁹ We calculated the costs of dyspepsia from a health service perspective. We assessed use of resources in primary and secondary care for 12 months after randomisation by abstracting data from primary care case records.

View larger version (38K): [in this window] [in a new window]   Fig 1.   Trial profile

View larger version (32K): [in this window] [in a new window]   Fig 2.   Numbers of participants having open and direct access endoscopy in study and control groups

	Results

Top Abstract Introduction Participants and methods Results Discussion References

Figure 1 shows the trial profile. Four hundred and seventy eight patients entered the trial; 285 were randomised to test and endoscopy and 193 to usual management.

Full data on use of resources were collected for 475 patients (99%). Records for three patients could not be traced. We obtained evaluable symptom scores and quality of life scores from 290 (61%) patients. Two hundred and seventy three (57%) patients returned satisfaction questionnaires.

Interventions and diagnostic findings
The Helisal test gave positive results in 40% (112/278) of patients (fig 2 ).

Outcomes and costs
Symptoms and quality of life scores in the test and control groups significantly improved by 18 months. There was no evidence of a difference in the size of improvement between the groups (table 2). Non-respondents were more likely to smoke and were younger than respondents (smoking odds ratio=1.63, 95% confidence interval 1 to 2.65; age 0.96, 0.93 to 0.99), but no difference in sex or baseline symptoms was observed. Analysis of covariance found that age and smoking had no significant effect on symptoms or quality of life. No significant differences were observed in the satisfaction questionnaire.

	Discussion

Top Abstract Introduction Participants and methods Results Discussion References

In contrast to non-randomised studies in secondary care, ^{4 5} our study shows that the test and endoscopy strategy increased endoscopy referral rates by almost twofold over usual practice. Some of the increase in referral was due to the choice of non-invasive test. However, even if a carbon-13 urea breath test had been used, at least 92 patients would have been referred (33% of the total would test H pylori positive) compared with the 69 (25%) expected from the rate in the control group.

We found that test and endoscopy did not improve dyspeptic symptoms or quality of life compared with usual management. The number of questionnaires returned was lower than expected, but the numbers returned were still large enough to detect the predefined differences with adequate power (80%). As the trial was subject to 39% attrition on the symptom and quality of life scores, the possibility of bias needs to be considered. Investigation of dyspeptic patients by test and endoscopy increased the use of resources without producing benefit. Contrary to expectation, there was no fall in primary care consultations for dyspepsia or outpatient attendance in the test and endoscopy group. Most patients investigated had non-ulcer dyspepsia, and the number of peptic ulcers was too small to detect an effect of H pylori eradication. The low prevalence of treatable disease in patients under 50 means that relatively expensive methods of case finding such as endoscopy are not cost effective. Empirical prescribing is therefore the best treatment. In older patients, however, who have a greater frequency of treatable disease, a primary care based randomised controlled trial has shown that initial endoscopy may be cost effective compared with empirical management.¹²

Although acid suppression is effective for undiagnosed dyspepsia, especially reflux symptoms,¹³ treatment with these drugs misses the opportunity to cure an important minority of patients with recurrent peptic ulcer disease due to H pylori. Eradication of H pylori may also have a small but important effect in non-ulcer dyspepsia, possibly by preventing the development of ulcers in susceptible patients.¹⁴ It is unclear whether a strategy to test for H pylori and then eradicate is cost effective as an initial management strategy in primary care. Future trials should evaluate the cost effectiveness of this strategy compared with empirical prescribing. Until then, near patient testing for H pylori is probably unwarranted in patients under 50.

	Acknowledgments

We thank Dr A Briggs, Health Economics Research Centre, Oxford University, for advice on the economic analysis and Dr R P Walt, Heartlands Hospital, Birmingham, Dr B Cooper, City Hospital Birmingham, and Mr M Hallissey, Queen Elizabeth Hospital, Birmingham, for providing open access endoscopy for study patients. We thank the following practices for enrolling patients: Bellevue Medical Centre, Riverbrook Medical Centre, Laurie Pike Health Centre, Frankley Health Centre, Dr M Fernell and partners, Cofton Medical Centre, Hill Top Surgery, Dr J Crosland and partners, Northfield Health Centre, Swanswell Medical Centre, Dr D Taylor and partners, Ley Hill Surgery, The Reabrook Surgery, University Medical Centre, Ash Tree Medical Centre, Dr J Parle and partners, Dr B Dicker and partner, Green Ridge Surgery, Harborne Medical Practice, Dr Hayes, Dr P Machin and partners, Fernley Medical Centre, Dr E Pennington and partners, Severn House Surgery, Dr N Gaballa, Moor Green Medical Centre, Dr P Beyer, Northgate Medical Centre, Yardley Wood Health Centre, Grange Hill Surgery, West Heath Surgery, Stockland Green Health Centre, Kendrick Surgery, James Preston Health Centre, Ashfurlong Health Centre, Medical Centre, Selly Oak Health Centre, Dr B Pattni, Kingsmount Surgery, Church Lane Medical Centre, Hollyoaks Medical Centre, Mirfield Surgery, Castle Practice.

Contributors: BCD, SW, and FDRH designed and managed the study. BCD, AW, and VR recruited the practices. Data were collected and entered by VR and LR. BCD, AW, and LR coded the data, and AR analysed the data. BCD did the economic analysis. All authors contributed to writing the paper. BCD is the guarantor.

	Footnotes

Funding: The study was funded by the NHS research and development primary secondary care interface programme, grant no PSI 37-01 and the NHS Executive, West Midlands. The Astra Foundation supplied the Helisal tests. BCD holds a NHS research and development national primary care career scientist award. LR holds a NHS Executive, West Midlands new blood fellowship.

Competing interests: None declared.

The full version of this paper is available on the BMJ's website

	References

Top Abstract Introduction Participants and methods Results Discussion References

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(Accepted 23 January 2001)