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PRIMARY CARE:
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 [Abstract] [Full text]
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[Read Rapid Response] Dyspeptic patients must be precisely evaluated even at the bed-side
Sergio Stagnaro   (26 April 2002)
[Read Rapid Response] Test and treat strategy for H Pylori in primary care – should patients with reflux be included?
Martin Ashton-Key   (29 April 2002)
[Read Rapid Response] Managment of dyspepsia should be individualised
Maskrey Neal, Ruth Micklewright   (4 May 2002)

Dyspeptic patients must be precisely evaluated even at the bed-side 26 April 2002
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Sergio Stagnaro,
Specialist in Blood, Gastrointestinal and Metabolic Diseases. Researcher in Biophysical Semeiotics.
Via Erasmo Piaggio 23/8 16037 Riva Trigoso (Genoa) Italy

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Re: Dyspeptic patients must be precisely evaluated even at the bed-side

Sir,

Chiba N. et al. conclude their article (1) stating that a "test for H pylori with 13C-urea breath test and eradicate" strategy shows significant symptomatic benefit at 12 months in the management of primary care patients with "uninvestigated" dyspepsia.

I can’t agree with both such a "non-investigation" and result, based on my 45 year-long clinical experience with the aid of a new physical semeiotics, illustrated in a large bibliography (See Bibliography in the site HONCode ID. N.233736: http://digilander.iol.it/semeioticabiofisica). Nowadays, fortunately, doctor can assess at the bed-side in a precise manner dyspeptic patients, including those involved by H.pylori, recognizing it as the “real” cause of the disorder. In my opinion, it is not justified treating patients with “only” positive breath test and/or with a positive endoscopic examination, with daily treatment for 7 days with omeprazole 20 mg, metronidazole 500 mg, and clarithromycin 250 mg.

Analogously, non-vascular leg pain in the leg or foot suggests arterial occlusive disease, but in a large variety of cases specialist assessement shows that, altough it is “present” a vascular disorder, this is not the cause of intermittent claudication.

As a matter of fact, H pylori is notoriously a Gram-neg. bacterium, which – as I demonstrated clinically, for the first time (See Bibliography in my site) – can induce antritis, for instance, without stimulating antibody synthesis in the spleen, but activating exclusively the Reticulo- Endothelial System of bone marrows as well as MALT and BALT function elsewhere. Biophysical Semeiotics allows doctor to recognize promptly and easily this particular immunological defence activation, against Gram negative bacteria, I named Reticulo Endothelial System Hyperfunction Syndrome, "intermediate" type (2).

In conclusion, a long well established "clinical" experience allows me to state that H pylori is more often - I say usually - an "innocent bystander", which certainly can sometimes become dangerous, bringing about the above-mentioned biophysical semeiotic syndrome. I hope that the current "fashion" about the role played by this "almighty" Gram-neg. agent in the aetiopathogenesis of human disorders(gastritis B, tumour, arteriosclerosis a.s.o.) will be at its end as soon as possible, in the interest of the NHS and human reason.

Yours.

Stagnaro Sergio MD. Riva Trigoso (Genoa) Italy.
Member NYAS and AAAS

1) Chiba N et al. 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, 27 April ).

2) Stagnaro S., Sindrome percusso-ascoltatoria di Iperfunzione del Sistema Reticolo-Istiocitario. Min. Med. 74, 479, 1983 (Pub-Med indexed for Medline)

Test and treat strategy for H Pylori in primary care – should patients with reflux be included? 29 April 2002
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Martin Ashton-Key,
Specialist Registrar in Public Health
Brighton and Hove City Primary Care Trust, Vantage Point, New England Road, Brighton BN1 4GW.

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Re: Test and treat strategy for H Pylori in primary care – should patients with reflux be included?

Editor - I should like to commend Chiba et al's paper advocating a test and treat strategy for H pylori in primary care patients (1). However, I should like to raise a caution regarding including any patients with symptoms of reflux.

I undertook a pragmatic study to identify all patients receiving anti-ulcer treatments in a general practice with 8,000 patients in Oxfordshire, and invited them to attend for H Pylori testing using the Helisal kit and a clinical assessment using a detailed symptom questionnaire. The Helisal kits were supplied by Astra at no cost. A total of 85 patients were identified and invited to participate.

Fifty-seven patients replied (67%). Forty-three were tested (age range 33-84 years), the remainder either declined to take part or were not tested because they were taking anti-ulcer treatments to cover concomitant NSAID use. Of the 43 tested, 18 (43%) were found to be positive and treated with a one-week course of omeprazole, clarithromycin and tinidazole. Follow-up revealed that 6 of the 18 treated patients had a return of symptoms within one month, with a further patient having symptoms return at 3 months. Of these 7 patients 6 (86%) had symptoms of reflux. Their age range was 53-81 years. The other 11 patients (61%) remained symptom free one year after completing the treatment. Their age range was 33-79 years, and only 1 (9%) had symptoms of reflux before treatment.

An analysis of costs taking into account the cost of the eradication therapy used, and the savings accrued through reduced prescribing following symptom resolution, demonstrated that real savings to the prescribing budget occurred after 7 months. If the Helisal kits had been purchased by the practice savings would not have occurred until 14 months after treatment. Thus a test and treat strategy can prove cost effective. Although this was only a small pragmatic study it does demonstrate what a practice might hope to achieve with a test and treat strategy in patients already receiving anti-ulcer treatments.

However, these results demonstrate that successful relief of symptoms was unlikely in patients who had symptoms of reflux, and I would recommend caution in including any patients with symptoms of reflux in a test and treat strategy based in primary care.

1. Chiba N, Veldhuyzen van Zanten SJO, Sinclair P, Ferguson RA, Escobedo S, Grace E. 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;324:1012-6.

Martin Ashton-Key
Specialist Registrar in Public Health
Brighton and Hove City Primary Care Trust, 6th Floor, Vantage Point, New England Road, Brighton BN1 4GW
e-mail: martin.ashton-key@bhcpct.nhs.uk

Managment of dyspepsia should be individualised 4 May 2002
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Maskrey Neal,
Medical Director
National Prescribing Centre, The Infirmary, 70 Pembroke Place, Liverpool. L69 3GF,
Ruth Micklewright

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Re: Managment of dyspepsia should be individualised

The papers by Chiba et al [1] and McColl et al [2] demonstrate that, in the medium term, a ‘test and treat’ approach for people with dyspepsia can be as effective or better than endoscopically-led management. However, we would like to draw attention to two points that indicate that an individualised approach to the management of dyspepsia remains prudent, particularly in primary care.

First, in the eBMJ version of Chiba’s paper, 33% of people with a positive initial near-patient test were negative on breath testing. Such results are important in populations where the prevalence of H Pylori is relatively low. For example, young adults with dyspepsia have a low pre- test probability of being H Pylori positive in most developed countries and this, as McColl states, alters the investigation strategies used. In such patients, there is a significant possibility that a positive test for H Pylori is a false positive. We agree with Chiba that breath testing is the diagnostic method of choice, but even when the prevalence of H Pylori is 25%, we estimate that 11-12% of positive breath tests will be false positives . In the same population, the false positive rate is 25% when serological tests are used, and with near-patient tests the false positive rate approaches 50%. [3] Eradicating non-existent H Pylori is unlikely to improve dyspepsia.

Secondly, the 15% of people with undifferentiated dyspepsia whose symptoms are caused by peptic ulcers will benefit most from a test and treat policy. The 25% whose symptoms are related to gastro-oesophageal reflux disease are unlikely to benefit. This leaves about 60% of people who have non-ulcer dyspepsia (NUD). If we accept the results of a Cochrane review, around fifteen people with NUD have to receive H Pylori eradication for one to benefit [4] . However, patients and their clinicians should take into account concerns that: the number needed to harm can be close to the number needed to treat; different scales for measuring dyspepsia were used in the studies included in the systematic review; the studies included were mainly from secondary care and might not apply to primary care; and eradication of H pylori does not substantially decrease long-term use of acid suppressants. In addition, observational data links H Pylori with gastric cancer but also indicates that a lack of H Pylori is associated with gastro-oesophageal reflux disease, Barrett’s oesophagus, and the risk of adenocarcinoma of the oesophagus and gastric cardia. [5] A potential protective effect of H Pylori against oesophageal cancer should be considered when making test and treat decisions when only one person out of fifteen benefits symptomatically from eradication of H Pylori in NUD. H Pylori will be successfully eradicated in most of the other fourteen, but with unknown long-term consequences.

A test and treat approach can therefore be useful in the medium term for the management of dyspepsia for some people, but alternative strategies should be discussed with patients and an informed decision made on an individual basis.

Neal Maskrey Medical Director

Ruth Micklewright Associate Editor, MeReC Publications

National Prescribing Centre The Infirmary 70 Pembroke Place Liverpool L69 3GF

e-mail: neal.maskrey@talk21.com

488 words

1. Chiba N et al. 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: 1012–6.

2. McColl KEL et al. Randomised trial of endoscopy with testing for Helicobacter pylori compared with non-invasive H pylori testing alone in the management of dyspepsia. BMJ 2002; 324: 999–1002.

3. National Prescribing Centre. Managing dyspepsia: the role of Helicobacter pylori. MeReC Bulletin 2001; 12: 1–4.

4. Moayyedi P et al. Systematic review and economic evaluation of Helicobacter pylori eradication treatment for non-ulcer dyspepsia. BMJ 2000; 321: 659–64.

5. Blaser MJ. Helicobacter pylori and gastric diseases. BMJ 1998; 316: 1507-10.