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Comparing H pylori eradication and simple anti-ulcer treatment lacks equipoise.
- Christopher J Martin (27 May 2003)
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Study of H.pylori test and treat v. PPI cannot be applied to the Primary Care setting.
- Brendan C Delaney, Paul Moayyedi, Richard FA Logan, Sue Wilson, Cliodna McNulty, Michelle Qume, John Duffy, Alex Ford, Adam Fraser, Cathy Elliott, Val Redman, F D Richard Hobbs. (30 May 2003)
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The efficacy of the Test and treat treatment for dyspepsia is improved by super-selection of patient
- Cesare Tosetti (6 June 2003)
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Christopher J Martin, GP principal Laindon Health Centre, High Road, Laindon, Essex, SS15 5TR
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EDITOR, I read with interest the article by Manes et al(1), but would argue that the study lacked equipoise. It has been known for over a decade that eradication of H pylori in infected individuals with a history of peptic ulceration leads better healing rates, and lower relapse rates than anti-ulcer treatment alone.(2) There is evidence that the same is true whether the anti-ulcer treatment used is H2 blockers or proton pump inhibitors.(2;3) For more than half a decade, this evidence has been reflected in several national or supra- national guidance on the management of H. pylori infected individuals with peptic ulceration.(4) We know that about 28% of people with dyspepsia on an empty stomach have active peptic ulceration and the positive predictive value of a history suggesting peptic ulcer is between 23% and 40%. (5)We also know that endoscopy to confirm peptic ulceration adds little to the outcome of treatment. The implication is that all H pylori positive people under 45 years of age with persistent or recurrent dyspepsia on an empty stomach should receive eradication therapy rather than anti-ulcer treatment alone. A far more important question is how do we ensure that all patients with peptic ulceration and H pylori infection receive eradication therapy. We need to decide whether the sensitivity of existing non-invasive tests are sufficient to justify testing as a means to identify those who might benefit from eradication therapy. No test is 100% sensitive. Some people will have false negative results and would not be treated using a test and treat policy. In the case of ELISA testing, the sensitivity is probably around 90%(5), though estimates vary from 57% to 96%. Therefore using ELISA testing to decide whom to give eradication therapy would result in 10% of patients who would benefit being left untreated. If C-urea breath testing were used with an estimated 95% sensitivity (5) then 5% of those who would benefit would be left untreated. Given the long term benefits of eradication compared to repeated courses of H2 blockers or proton pump inhibitors, is this justified? Reference List (1) Manes G, Menchise A, De Nucci C, Balzano A. Empirical prescribing for dyspepsia: randomised controlled trial of test and treat versus omeprazole treatment. BMJ 2003; 326(7399):1118. (2) Marshall BJ, Goodwin CS, Warren JR, Murray R, Blincow ED, Blackbourn SJ et al. Prospective double-blind trial of duodenal ulcer relapse after eradication of Campylobacter pylori. Lancet 1988; 2(8626-8627):1437-1442. (3) Logan RP, Bardhan KD, Celestin LR, Theodossi A, Palmer KR, Reed PI et al. Eradication of Helicobacter pylori and prevention of recurrence of duodenal ulcer: a randomized, double-blind, multi-centre trial of omeprazole with or without clarithromycin. Aliment Pharmacol Ther 1995; 9(4):417-423. (4) National Institute of Health. NIH Consensus Statement: Helicobacter pylori in Peptic Ulcer Disease. NIH Consensus Statement 12[1]. 9-2-1994. U.S. Department of Health and Human Services. (5) Delaney B, Moayyedi P, Deeks J, Innes M, Soo S, Barton P et al. The management of dyspepsia: a systematic review. Health Technology Assessment 2000. 4 (39). 2000. Competing interests: None declared |
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Brendan C Delaney, Reader in Primary Care The University of Birmingham, UK, B15 2TT, Paul Moayyedi, Richard FA Logan, Sue Wilson, Cliodna McNulty, Michelle Qume, John Duffy, Alex Ford, Adam Fraser, Cathy Elliott, Val Redman, F D Richard Hobbs.
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Dear Editor, We were interested to read the report by Manes et al of their trial of Helicobacter pylori ‘test and treat’ v. initial PPI. [1] Their results in a secondary care setting are encouraging in that H.pylori eradication therapy reduced symptom relapse by 33% compared to a short course of acid suppression therapy. It is thus in line with the results of the CADET-HP study, published in the BMJ last year. This study showed a 14% absolute reduction in dyspeptic symptoms in H.pylori positive patients with dyspepsia given eradication therapy compared to PPI and placebo. [2] However we doubt whether their findings have any relevance to the use of test and treat in the primary care setting in the UK or in most other European countries. Manes et al is a study of an aggressively investigative strategy of ‘test, treat and endoscope’ v. ‘PPI and endoscope’ in a modest number of patients with dyspepsia attending a single hospital clinic. All the patients in the trial had intensive monthly then two monthly follow up, being endoscoped if symptoms recurred after their initial treatment. This would not be usual practice in Primary Care, where trials have shown that only 25% of young dyspeptic patients undergo endoscopy within a year of consultation, [3] and some degree of empirical management is likely to continue. The study findings indicate that endoscopy is a waste of resources in these patients, since none of the 61 patients who had endoscopy after ‘test and treat’ had any findings that would require anything other than continued empirical acid suppression. In addition the prevalence of H.pylori was extremely high (61%), whereas the prevalence in most Northern European countries and North America may only be 20-30% in similar young patients, reducing the effectiveness of the intervention. Further, the true ‘effectiveness’ of the strategy is hard to ascertain, as we do not know the effect of the strategy on symptoms over time. It appears that patients relapsing and being endoscoped were not subsequently included in symptom assessment. We therefore do not share the authors’ statement that: ‘in a public health perspective, good clinical judgment, the patient’s wishes and the availability of resources’ may influence strategy choice. Such a limited perspective could lead to harm as resources are consumed that might yield greater benefits elsewhere. Whether an initial strategy of ‘H.pylori test and treat’ or acid suppression should be employed is really an issue of cost-effectiveness.[4] We agree with Manes et al this can only be determined by much larger, primary care based trials, designed with cost- effectiveness as the primary outcome. We are currently recruiting patients to an MRC funded trial of test and treat v. PPI from 55 practices in the UK. 1. Gianpiero Manes, Antonella Menchise, Claudio de Nucci, and Antonio Balzano Empirical prescribing for dyspepsia: randomised controlled trial of test and treat versus omeprazole treatment. BMJ 2003; 326: 1118-0. 2. Naoki Chiba, Sander J O Veldhuyzen van Zanten, Paul Sinclair, Ralph A Ferguson, Sergio Escobedo, and Eileen Grace Treating Helicobacter pylori infection in primary care patients with uninvestigated dyspepsia: the Canadian adult dyspepsia empiric treatment Helicobacter pylori positive (CADET-Hp) randomised controlled trial. BMJ 2002; 324: 1012. 3. Delaney B C, Wilson S, Roalfe A, Roberts L, Wearn A, Redman V, Briggs A, Hobbs FDR. A randomised controlled trial of Helicobacter pylori test and endoscopy for dyspepsia in primary care. BMJ 2001; 322: 898-901. 4. Delaney BC, Deeks J, Wilson S, Moayyedi P, Forman D. Initial management strategies for dyspepsia (Full Cochrane Review: version 3 ). In: The Cochrane Library, Oxford: Update Software. 2003, Issue 2. Brendan C Delaney, Sue Wilson, Michelle Qume, John Duffy, Adam Fraser, Val Redman, FD Richard Hobbs. Department of Primary Care and General Practice, The University of Birmingham, UK Paul Moayyedi. Gastroenterology Unit, City Hospital NHS Trust, Birmingham, UK Richard F A Logan, Cathy Elliott. Department of Public Health and Epidemiology, University of Nottingham, UK Cliodna McNulty. Health Protection Agency, Gloucester UK. Alex Ford, Centre for Digestive Diseases, Leeds General Infirmary, UK Competing interests: None declared |
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Cesare Tosetti, General Practitioner and Gastroenterologist I-40046 Porretta Terme (BO) Italy
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Sir, Manes et coll. presented an interesting study about empirical treatment for young patients with uninvestigated dyspepsia (1). The main result after a 12 month follow up is the reduction of endoscopic workload in H.pylori infected patients after eradication (40% had endoscopy), compared to H.pylori negative patients (79% - not 55% as reported - had endoscopy) and to the control group (88% had endoscopy). Indeed the generability of findings should be limited to study the population that is super-selected from general practice. The study was carried out in young adults (18-45 years of age) referred from general practitioners to an hospital clinic. The causes of referral are not reported, but the study design does not provide any form of structured methodology of inclusion directly from primary care, so we should consider that these patients have been substantially referred for endoscopy. In Italy H.pylori non-invasive tests and PII treatment are directly available in primary care and we should believe that these patients, although of young age, have been individually considered for appropriate referral to instrumental investigation (2). A large amount of these subjects (522 out of 765 patients) were consequently excluded from the study because of alarm symptoms, symptoms of gastro-oesophageal reflux disease, regular use of non-steroidal anti-inflammatory drags and other. So the 210 remaining patients represent those young patients suspected for uncomplicated (not haemorrhagic) gastro-duodenal peptic disease, as confirmed by the high number of endoscopies performed in the control group. In these super- selected patients (50% H.pylori positive) Test and treat treatment resulted clearly effective, but these results are not directly generalizable in the whole group of dyspeptic patients seen in general practice. The debate about optimal selection of young patients for test and treat strategy remains open (3-4). Economic evaluations demonstrate that a symptom guided selection may be cost-effective (5), but ad-hoc studies, with great attention to symptom assessment, should be carried out in primary care. Cesare Tosetti
1. Manes G, Menchise A, de Nucci C, Balzano A. Empirical prescribing for dispepsia: randomized controlled trial of test and treat versus omeprazole treatment.. BMJ 2003;326:1118-23. 2. Cardin F, Zorzi M, Furlanetto A, Guerra C, Bandini F,Polito D, et al. Are dispepsia management guidelines coherent with primary care practice. Scand JU Gastroenterol 2002;37:1269-75. 3. Andriulli A, Grossi E, Buscema M, Festa V, Intraligi NM, Dominici P, et al. Contribution of artificial neural networks to the classification and treatment of patients with uninvestigated dyspepsia. Dig Liv Dis 2003;35:222-31. 4. Regula J, Henning E, Burzykowski T, Orlowska J, Przytulski K, Polkowski M, et al. Multivariate analysis of risk factors for development of duodenal ulcer in Helicobacter pylori-infected patients. Digestion 2003;67:25-31. 5. Bozzani A, Sturkenboom MCJM, Ravasio R, Nicolosi A. Diagnostic work-up and management of young patients with ulcer-like dispepsia. Eur J Gen Pract 2001;7:148-53. Competing interests: None declared |
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