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. 2001 Aug 11;323(7308):342.

H pylori testing and endoscopy for dyspepsia in primary care

Improved diagnostic accuracy is important in dyspepsia

Val Heatley 1
PMCID: PMC1120944  PMID: 11556284

Editor—Delaney et al's trial of Helicobacter pylori testing and endoscopy for dyspepsia in primary care surely misses the point of medical consultations for dyspepsia.1 Most doctors would view the purpose of a consultation as primarily to make a diagnosis before starting treatment. If the purpose is to initiate empirical prescribing—these authors seem to advocate this as they conclude that this “is . . . the best treatment”— the patients might as well go to a pharmacist and treat themselves.

This study is flawed. It uses a screening test for H pylori (Helisal) that has been reported to have sensitivities of only 67-88%, with a specificity of 78-91%.2,3 The test is therefore not an accurate means of detecting H pylori, which presumably explains why so many ulcers were found in the control patients who were H pylori negative (four out of 48 endoscopies carried out).

Conclusions have been drawn on symptomatic follow up and quality of life data that were recorded for only just over half the patients studied. Costs were greater in patients in the study group, who all had endoscopy. We are not told whether these costs were significantly higher, but certainly some of this was due to the cost of H pylori testing, which, for some reason, was significantly higher (P<0.0001) in the study group.

As the authors acknowledge, endoscopic investigation showed significantly more peptic ulcers than did standard management. Presumably the patients themselves would be interested in knowing this, since subsequent successful H pylori eradication treatment should produce cure of their ulcers rather than them having to continue with empirical acid suppressant treatment long term. The National Institute for Clinical Excellence has produced guidance on the use of proton pump inhibitors in the treatment of dyspepsia. It concluded that patients with non-ulcer dyspepsia—whom Delaney et al accept make up most of their patients—"may have symptoms caused by different aetiologies and should not be routinely treated with [proton pump inhibitors].”4

Time has left these authors behind. Colleagues and I have shown that adding serum recognition of the CagA protein and serum pepsinogen I levels to simple but reliable H pylori serology further refines diagnostic accuracy and could reduce the endoscopy workload for patients with dyspepsia by about half.5 What patients with dyspepsia need is improved diagnostic accuracy and specifically tailored treatment, not further encouragement to take empirical treatment for life without any clear idea of why, apart from amelioration of symptoms.

References

  • 1.Delaney BC, Wilson S, Roalfe A, Roberts L, Redman V, Wearn A, et al. Randomised controlled trial of Helicobacter pylori testing and endoscopy for dyspepsia in primary care. BMJ. 2001;322:898–901. doi: 10.1136/bmj.322.7291.898. . (14 April.) [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 2.Duggan A, Logan R, Knifton A, Logan R. Accuracy of near-patient blood tests for Helicobacter pylori. Lancet. 1996;348:617. doi: 10.1016/S0140-6736(05)64835-0. [DOI] [PubMed] [Google Scholar]
  • 3.Moayyedi P, Carter AM, Catto A, Heppell RM, Grant PF, Axon ATR. Validation of a rapid whole blood test for diagnosing Helicobacter pylori infection. BMJ. 1997;314:119. doi: 10.1136/bmj.314.7074.119. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 4.National Institute for Clinical Excellence. guidance on the use of proton pump inhibitors in the treatment of dyspepsia. London: NICE; 2000. [Google Scholar]
  • 5.Bodger K, Wyatt JI, Heatley RV. Serologic screening before endosocpy: the value of Helicobacter pylori serology, serum recognition of the CagA and VacA proteins, and serum pepsinogen I. Scand J Gastroenterol. 1999;34:856–863. doi: 10.1080/003655299750025309. [DOI] [PubMed] [Google Scholar]
BMJ. 2001 Aug 11;323(7308):342.

Authors' reply

Brendan C Delaney 1,2, Sue Wilson 1,2, Andrea Roalfe 1,2, Lesley Roberts 1,2, Andrew Wearn 1,2, F D Richard Hobbs 1,2

Editor—Initial empirical treatment for symptomatic presentations when the risk of serious disease is low remains an essential component of gatekeeping in primary care. Without such pragmatic problem solving, the proportion of the NHS expenditure that is consumed by primary care would rise considerably above the current 6.5%.

Time has indeed moved on, and randomised controlled trials take longer to perform than it takes to write guidelines without appropriate evidence. Reliable data fortunately support common sense in suggesting that we do not yet need to explore the consequences of such diagnostic reductionism.

The comparator in this study was not empirical prescribing forever, as Heatley suggests, but general practitioners' usual care, consisting of empirical prescribing, referral, and follow up as judged appropriate. In fact, 25% of the control group had an endoscopy during the year of follow up. Given that symptom patterns and tests for Helicobacter pylori do not predict diagnosis,1-1 initial empirical prescribing is appropriate for many patients.1-2

The Helisal test was locally validated, with a sensitivity of 89% and a specificity of 84%. More accurate tests would reduce the false positive rate, but even if the H pylori status was known with 100% accuracy more than half of the additional referrals for endoscopy would still have been made.

Although only 61% of patients returned symptom and quality of life questionnaires, we had resource use data on 99%, and the result was stable to adjustment for differences in baseline characteristics of non-responders. Costs were significantly higher in the study group (P=0.0044), due mainly to the cost of the additional 20% of patients who had endoscopy, as the cost of endoscopy is £246 compared with £12 for an H pylori test.

Healthcare expenditure is to a large extent determined by the decisions made by individual clinicians. Some treatments produce more health gain than others, and some entail more parsimonious use of resources. Although we did detect more peptic ulcers, it is symptom resolution that matters. As non-ulcer dyspepsia responds to H pylori eradication with symptom resolution in 1 in 15 patients treated,1-3 “test and eradicate” has been proposed as a cost effective management strategy. We have recently received funding to conduct the CUBE trial, a randomised controlled trial of test and eradicate using a breath test versus four weeks' treatment with a proton pump inhibitor for the initial management of dyspepsia.

References

  • 1-1.Hansen JM, Bytzer P, deMuckadell OBS. Management of dyspeptic patients in primary care: value of the unaided clinical diagnosis and of dyspepsia subgrouping. Scand J Gastroenterol. 1998;33:799–805. doi: 10.1080/00365529850171431. [DOI] [PubMed] [Google Scholar]
  • 1-2.National Institute for Clinical Excellence. Guidance on the use of proton pump inhibitors in the treatment of dyspepsia. London: NICE; 2000. www.nice.org.uk/nice-web/pdf/proton.pdf . ( www.nice.org.uk/nice-web/pdf/proton.pdf; accessed 19 March 2001.) ; accessed 19 March 2001.) [Google Scholar]
  • 1-3.Moayyedi P, Soo S, Deeks J, Innes MA, Forman D, Delaney BC. A systematic review and economic analysis of the cost-effectiveness of H pylori eradication therapy in non-ulcer dyspepsia (NUD) BMJ. 2000;321:659–664. doi: 10.1136/bmj.321.7262.659. [DOI] [PMC free article] [PubMed] [Google Scholar]
BMJ. 2001 Aug 11;323(7308):342.

Test and treat seems best

M J Lancaster Smith 1

Editor—Delaney at al have shown that near patient testing for Helicobacter pylori, followed by open access endoscopy for patients in whom results are positive, increases demand for endoscopy and is not cost effective.2-1 By contrast, trials of test and treat strategies without endoscopy in young patients indicate that this policy may be cost effective in the clinical setting.2-2–2-4 A recent survey of practice in my own department tends to support this proposition.

In 1997, as part of locally based dyspepsia management guidelines, a test and treat policy for patients under 45 with dyspepsia and without alarm symptoms was introduced in the community referring patients to the open access endoscopy service at Queen Mary's Hospital, Sidcup. Only those young patients who continued to have dyspepsia after treatment appropriate to their H pylori status and predominant symptoms were accepted for endoscopy.

Open access referrals from the community before and after the guidelines were introduced were compared. In the three years after the test and treat policy was introduced there was a 4.3% decrease (from a mean of 163 to 156 per year) in the referral of young patients but a 21% increase (from a mean of 466 to 564 per year) in the referral of those aged over 45. Had the referral rate in young patients kept pace with that in older patients it would have increased the open access waiting list by a further nine weeks over this three years.

The policy seems not to have devalued the procedure in this group of patients. Altogether 54% of young patients with dyspepsia (88/163) had a normal endoscopy before the test and treat policy was introduced, compared with 42% (65/156) after the policy was introduced; the reduction was almost entirely due to an increase in the diagnosis of oesophagitis.

This survey therefore suggests that, in contrast to “test and endoscope,” test and treat when applied in routine primary care can reduce demand for endoscopy and may be more cost effective than early endoscopy based strategies.

Footnotes

Kerry.sharpe@qms-tr.sthames.nhs.uk

References

  • 2-1.Delaney BC, Wilson S, Roalfe A, Roberts L, Redman V, Wearn A, et al. Randomised controlled trial of Helicobacter pylori testing and endoscopy for dyspepsia in primary care. BMJ. 2001;322:898–901. doi: 10.1136/bmj.322.7291.898. . (14 April.) [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 2-2.Heaney A, Collins JSA, Watson PRG, McFarland JR, Bamford KB, Tham TCK. A prospective randomised trial of a “test and treat” policy versus endoscopy based management in young Helicobacter pylori positive patients with ulcer-like dyspepsia referred to a hospital clinic. Gut. 1999;45:186–190. doi: 10.1136/gut.45.2.186. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 2-3.Jones R, Tait C, Sladen G, Weston-Baker J. A trial of a test and treat clarity strategy for Helicobacter pylori positive dyspeptic patients in general practice. Int J Clin Pract. 1999;53:413–416. [PubMed] [Google Scholar]
  • 2-4.Lassen AT, Pedersen FM, Bytzer P, Schaffalitzky de Muckadell OB. Helicobacter pylori test-and-eradicate versus prompt endoscopy for management of dyspeptic patients: a randomised trial. Lancet. 2000;356:455–460. doi: 10.1016/s0140-6736(00)02553-8. [DOI] [PubMed] [Google Scholar]

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