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The Stool Antigen Test for Detection of Helicobacter pylori after Eradication Therapy

Dino Vaira, MD; Nimish Vakil, MD; Marcello Menegatti, MD; Ben van't Hoff, MD; Chiara Ricci, MD; Luigi Gatta, MD; Giovanni Gasbarrini, MD; Mario Quina, MD; Jose M. Pajares Garcia; Arie van der Ende, MD; Rene van der Hulst, MD; Marcello Anti, MD; Cristina Duarte, MD; Javier P. Gisbert, MD; Mario Miglioli, MD; and Guido Tytgat, MD
[+] Article and Author Information

From University of Bologna, Bologna, and Policlinico Gemelli, Rome, Italy; University of Wisconsin Medical School, Milwaukee, Wisconsin; University of Amsterdam, Amsterdam, the Netherlands; Hospital de Pulido Valente, Lisbon, Portugal; and Hospital de la Princesa, Madrid, Spain.


Grant Support: Stool testing kits were provided by Meridian Diagnostics, Inc.

Requests for Single Reprints: Dino Vaira, MD, Department of Internal Medicine and Gastroenterology, S. Orsola Hospital, via Massarenti 9, 40138 Bologna, Italy; e-mail, vairadin@med.unibo.it.

Current Author Addresses: Drs. Vaira, Menegatti, Ricci, Gatta, and Miglioli: Department of Internal Medicine and Gastroenterology, S. Orsola Hospital, via Massarenti 9, 40138 Bologna, Italy.

Dr. Vakil: University of Wisconsin Medical School, Sinai Samaritan Medical School, 945 North 12th Street, Room 4040, Milwaukee, WI 53233.

Drs. van't Hoff, van der Ende, van der Hulst, and Tytgat: Academisch Ziekenhuis bij de Universiteit van Amsterdam, Academisch Medisch Centrum, Amsterdam, the Netherlands 1100DE.

Drs. Gasbarrini and Anti: Policlinico Gemelli, via Pineta Sacchetti, 00168 Rome, Italy.

Drs. Quina and Duarte: Servico Universitario de Medicina Interna e Gastroenterologia, Hospital de Pulido Valente, Alameda das Linhas de Torres 117, P-1750 Lisboa, Portugal.

Dr. Pajares Garcia and Gisbert: Hospitales Universitarios, La Princesa-Niño Jesus-Santa Cristina, Diego de Leon, 62, 28006 Madrid, Spain.

Author Contributions: Conception and design: D. Vaira, N. Vakil, M. Menegatti, B. van't Hoff, C. Ricci, L. Gatta, G. Gasbarrini, M. Quina, J. Pajares Garcia, A. van der Ende, R. van der Hulst, M. Anti, C. Duarte, J.P. Gisbert, M. Miglioli, G. Tytgat.

Analysis and interpretation of the data: D. Vaira, N. Vakil, M. Menegatti, B. van't Hoff, C. Ricci, L. Gatta, A. van der Ende, R. van der Hulst, C. Duarte, J.P. Gisbert, G. Tytgat.

Drafting of the article: D. Vaira, N. Vakil, M. Menegatti, B. van't Hoff, C. Ricci, L. Gatta, A. van der Ende, R. van der Hulst, C. Duarte, J.P. Gisbert, G. Tytgat.

Critical revision of the article for important intellectual content: D. Vaira, N. Vakil, M. Menegatti, C. Ricci, L. Gatta, G. Gasbarrini, M. Quina, J. Pajares Garcia, R. van der Hulst, M. Anti, C. Duarte, M. Miglioli, G. Tytgat.

Final approval of the article: D. Vaira, N. Vakil, M. Menegatti, B. van't Hoff, C. Ricci, L. Gatta, G. Gasbarrini, J. Pajares Garcia, A. van der Ende, R. van der Hulst, M. Anti, C. Duarte, J.P. Gisbert, G. Tytgat.

Provision of study materials or patients: D. Vaira, B. van't Hoff, M. Miglioli.

Statistical expertise: N. Vakil.

Collection and assembly of data: D. Vaira, N. Vakil, B. van't Hoff, C. Ricci, L. Gatta, C. Duarte, J.P. Gisbert.


Ann Intern Med. 2002;136(4):280-287. doi:10.7326/0003-4819-136-4-200202190-00007
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We prospectively studied 84 patients infected with H. pylori at six clinical centers (31 in Bologna, Italy; 29 in Amsterdam, the Netherlands; 9 in Rome, Italy; 8 in Lisbon, Portugal; 4 in Madrid, Spain; and 3 in Milwaukee, Wisconsin). The sample consisted of consecutive patients with dyspepsia (defined as pain or discomfort centered in the upper abdomen) who were referred by primary care physicians for upper endoscopy (11). Consenting patients were enrolled if they tested positive for H. pylori on endoscopic tests. Patients enrolled in this study have not been enrolled in other studies. Patients were excluded if they had taken proton-pump inhibitors, H2-receptor antagonists, nonsteroidal anti-inflammatory agents, or antibiotics in the 4 weeks before the study. Failure to return for follow-up endoscopy was an a priori exclusion criterion. All patients gave written informed consent, and the study was approved by the human subjects review committee or equivalent at each participating institution.

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Figures

Grahic Jump Location
Figure.
Mean stool antigen values over time in patients with (gray bars) and without (white bars) eradication of Helicobacter pylori. PH. pylori

Extensions of the bars represent the SD. The stool antigen value was determined spectrophotometrically. The time point of 0 represents baseline (before eradication therapy). Subsequent time points are measured from completion of eradication therapy. * < 0.05 compared with patients in whom was eradicated.

Grahic Jump Location

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Sequential therapy: Minimizing risk and maximizing outcome
Posted on May 4, 2007
Dino Vaira
Department of Internal Medicine & Gastroenterology
Conflict of Interest: None Declared

There are several misstatements in the letter which we will address first: (a) there was no sponsor for our study; (b) triple therapy is a ¡§legacy¡¨ therapy solely in a fantasy world. Triple therapy was recently reaffirmed by an International Consensus Group as the principal therapy to be used worldwide and by US and Japanese guidelines. (1-3) It is therefore an appropriate control group for any new therapy. Our study began in 2003 when it was uncertain whether sequential therapy was truly effective in large cohorts. A fundamental question remained unanswered until now- Was sequential therapy the answer to Clarithromycin resistance? An expert International Consensus group reviewed the data on sequential therapy in 2005 and concluded that it was promising but more data were needed, particularly with regard to clarithromycin resistance. (1) As there were no safety issues with either treatments in our study and as the international community of experts felt that more data were needed, it was imperative that we continue the trial. We have already demonstrated that a triple therapy with levofloxacin is an effective salvage therapy for patients who fail sequential therapy. (4) Therefore, a perfectly satisfactory alternative therapy of proven efficacy was available for failures. Data on failures will be reported elsewhere.

Ethical trial designs minimize risk to patients and maximize the likelihood of a meaningful outcome for patients and society. Early termination of a trial requires the demonstration of a serious unanticipated side-effect or an unanticipated difference between treatments that is much larger than expected. (5) Individuals taking a decision to terminate a trial early have a heavy responsibility to both those who have taken part in the trial already and to society. (5) The results of our study were within the anticipated treatment estimates and there were no safety issues, therefore our responsibility to the patients who volunteered, to society, and to the scientific community was to continue. The suggestion that we not have a control group is inappropriate. The limitations of uncontrolled studies are well known to all serious researchers. Underpowered, uncontrolled trials continue to be published, sometimes with unsafe agents, These studies yield biased results with wide confidence intervals that mislead rather than illuminate, and place patients at risk of drug toxicity and resistant organisms. These should be deplored rather than encouraged. The benefits of our study to individual patients and to society in general should be obvious to impartial observers.

Dino Vaira MD Dept of Internal Medicine and Gastroenterology, University of Bologna, Bologna, Italy;

Angelo Zullo MD Gastroenterology Unit, ¡§Nuovo Regina Margherita Hospital¡¨, Rome, Italy;

Nimish Vakil MD University of Wisconsin School of Medicine and Public Health, Madison WI, USA and Marquette University College of Health Sciences, Milwaukee WI, USA

References: 1. Malfertheiner P, Megraud F, O'Morain C, Bazzoli F, El Omar E, Graham DY, et al. Current concepts in the management of Helicobacter pylori infection Æ’{ The Maastricht III Consensus Report. Gut 2006 Dec 14; [Epub ahead of print]. 2. Fujioka T, Yoshiiwa A, Okimoto T, Kodama M, Murakami K. Related Articles, Guidelines for the management of Helicobacter pylori infection in Japan: current status and future prospects. J Gastroenterol. 2007;42 Suppl 17:3-6. 3. Chey WD, Wong BCY. American College of Gastroenterology guideline for H pylori infection. Am J Gastroenterol 2007, in press. 4. Gatta L, Zullo A, Perna F, Ricci C, De Francesco V, Tampieri A, Bernabucci V, Cavina, M, Hassan C, Ierardi E, Morini S, Vaira D. A 10 days levofloxacin base triple therapy in patients who failed two eradication courses. Alimentary Pharmacology Therapeutics 2005; 22: 45-49. 5. Grant A. Stopping clinical trials early. BMJ 2004;329:525-6.

Conflict of Interest:

They have been decalred in the paper and have not been changed since

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Summary for Patients

Detection of Persistent Helicobacter pylori Infection

The summary below is from the full report titled “The Stool Antigen Test for Detection of Helicobacter pylori after Eradication Therapy.” It is in the 19 February 2002 issue of Annals of Internal Medicine (volume 136, pages 280-287). The authors are D Vaira, N Vakil, M Menegatti, B van't Hoff, C Ricci, L Gatta, G Gasbarrini, M Quina, JM Pajares Garcia, A van der Ende, R van der Hulst, M Anti, C Duarte, JP Gisbert, M Miglioli, and G Tytgat.

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