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• W2123403496 abstract "We read with great interest the comprehensive commentary by de Boer et al. regarding the use of sequential therapy for Helicobacter pylori eradication [ [1] de Boer W.A. Kuipers E.J. Kusters J.G. Sequential therapy: a new treatment for Helicobacter pylori infection. But it is ready for general use?. Dig Liver Dis. 2004; 36: 311-314 Abstract Full Text Full Text PDF PubMed Scopus (17) Google Scholar ]. However, we do not understand why the authors should ‘scientifically be warred’ regarding the possibility to find out a better eradication regimen, whichever it is and wherever does it came. We do think the following comments could be useful to the authors as well as to the readers of the Journal. It has been stated that ‘presently, only quadruple therapy qualifies to replace PPI-triple regimen as first-line therapy’. Unfortunately, this opinion does not seem to be supported by available data. On the contrary, a meta-analysis including five well-designed, ‘head-to-head’ comparison studies failed to find a significant difference in the success rate between 7-day quadruple and triple therapies, bacterial infection being cured in 449 of 559 (80%; 95% CI: 77–84), and in 451 of 569 (79%; 95% CI: 74–81) patients, respectively [ [2] Genè E. Calvet X. Azagra R. Gisbert J.P. Triple vs. quadruple therapy for treating Helicobacter pylori infection: an updated meta-analysis. Aliment Pharmacol Ther. 2003; 18: 543-544 Crossref PubMed Scopus (38) Google Scholar ]. It has been stated that ‘most cures with quadruple therapy occur in the first few days of therapy (even after 2 days)’. However, recent data suggest that quadruple therapy may achieve >90% eradication rate only following a 14-day regimen [ [3] Graham D.Y. Belson G. Abudayyedi S. Osato M.S. Dore M.P. El Zimaity H.M.T. Twice daily (mid day and evening) quadruple therapy for H. pylori infection in the United States. Dig Liver Dis. 2004; 36: 384-387 Abstract Full Text Full Text PDF PubMed Scopus (26) Google Scholar ]. Therefore, quadruple therapy needs to be administered for at least 2 weeks in order to achieve an acceptable cure rate, and shorter regimens have not to be proposed [ [4] Zullo A. Hassan C. Morini S. Quadruple therapy as a first-line Helicobacter pylori treatment: past or future?. Dig Liver Dis. 2004; 36: 377-379 Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar ]. It has also been stated that ‘the main disadvantage of quadruple therapy is that it is the most complex therapy with the greatest number of tablets per day’ and that such problem may be overcome by a novel single capsule containing bismuth, metronidazole and tetracycline, which will soon be available. Unfortunately, even using such new three-drug tablets, a 10-day quadruple therapy still failed to eradicate the infection in more than 20% of duodenal ulcer patients [ [5] Laine L. Hunt R. El-Zimaity H. Nguyen B. Osato M. Spenard J. Bismuth-based quadruple therapy using a single capsule of bismuth biskalcitrate, metronidazole, and tetracycline given with omeprazole versus omeprazole, amoxicillin, and clarithromycin for eradication of Helicobacter pylori in duodenal ulcer patients: a prospective, randomized, multicenter, North American trial. Am J Gastroenterol. 2003; 98: 562-567 Crossref PubMed Scopus (220) Google Scholar ], suggesting that eradication failure following quadruple therapy cannot be solely related to a low compliance. Moreover, surprisingly, bismuth toxicity has never been mentioned. A recent study found that 9% of patients receiving the quadruple regimen had very high blood bismuth concentrations within the Hillemand alarm level, suggesting more caution in prescribing bismuth salt with proton pump inhibitors [ [6] Phillips R.H. Whitehead M.W. Doig L.A. Sieniawska C.E. Delves H.T. Thompson R.P. et al. Is eradication of Helicobacter pylori with colloidal bismuth subcitrate quadruple therapy safe?. Helicobacter. 2001; 6: 151-156 Crossref PubMed Scopus (33) Google Scholar ]. Finally, the allergic penicillin-related reactions in adult patients are very rare and usually mild after oral administration. Regarding the potential benefit of avoiding penicillin with the quadruple regimen can be marginalised, and the risk of its use in the sequential therapy appears to be not higher than that of the amoxicillin/clarithromycin-based triple regimen advised as best first-line therapy by current European guidelines. As far as the sequential therapy is concerned, we think that the attempt to improve eradication rate with conventional drugs must be considered as a ‘legitimate’ rather than an ‘aberrant’ approach, new specific antibiotics for H. pylori being lacking. The sequential regimen has been extensively validated in Italy, and its efficacy has been consistently proved in several separate studies coming from nine different centres covering the entire country. It should be noted that, to date, 1.208 patients have been treated with sequential regimen in these studies, with an overall 93.5% (95% CI: 92–95) eradication rate at intention-to-treat analysis. Such a large experience has not been actually described for quadruple therapy as a first-line approach. The high efficacy of the sequential schedule in our country is particularly meaningful due to the high primary bacterial resistance (12–44% for metronidazole; 9–23% for clarithromycin) pointed out in Italy [ 7 Pilotto A. Rassu M. Leandro G. Franceschi M. Di Mario F. Prevalence of Helicobacter pylori resistance to antibiotics in Northeast Italy: a multicentre study. Dig Liver Dis. 2000; 32: 763-768 Abstract Full Text PDF PubMed Scopus (84) Google Scholar , 8 Toracchio S. Cellini L. Di Campli E. Cappello G. Malatesta M.G. Ferri A. et al. Role of antimicrobial susceptibility testing on efficacy of triple therapy in Helicobacter pylori eradication. Aliment Pharmacol Ther. 2000; 14: 1639-1643 Crossref PubMed Scopus (99) Google Scholar ], which is, presumably, the cause of the very low efficacy of standard triple therapy in our and several other European countries. Indeed, our preliminary data showed that the efficacy of sequential therapy in patients harbouring H. pylori-resistant strains is higher when compared to the standard triple therapy [ [9] Zullo A. Vaira D. Vakil N. Hassan C. Gatta L. Ricci C. et al. High eradication rates of Helicobacter pylori with a new sequential treatment. Aliment Pharmacol Ther. 2003; 17: 719-726 Crossref PubMed Scopus (215) Google Scholar ]. Sequential therapy appears fairly to perform, all drugs being simply administered twice daily. We usually give a simple preprinted sheet reporting the therapeutic schedule in a short 5-min visit, generally sandwiched between two endoscopic examinations, and patient's compliance was excellent. This effortless procedure does not seem to be applicable for the quadruple therapy, as it has authoritatively been point out [ [10] de Boer W.A. How to achieve a near 100% cure rate for H. pylori infection in peptic ulcer patients. J Clin Gastroenterol. 1996; 22: 313-316 Crossref PubMed Scopus (58) Google Scholar ]. Moreover, effective rescue therapies are currently available in the event of sequential therapy failure. For instance, we did report during the last Digestive Diseases Week in New Orleans the success of a simple 10-day levofloxacin–amoxicillin-based triple therapy [ [11] Gatta L, Ricci C, Zullo A, De Francesco V, Perna F, Tampieri A, et al. High eradication rate with a rescue levofloxacin-based treatment for Helicobacter pylori. DDW New Orleans, in press. Google Scholar ], which was found to be highly effective also in those patients who failed two or more therapeutic attempts [ [12] Zullo A. Hassan C. Lorenzetti R. Marignani M. Angeletti S. Porto D. et al. A third-line levofloxacin-based rescue therapy for Helicobacter pylori eradication. Dig Liver Dis. 2003; 35: 232-236 Abstract Full Text Full Text PDF PubMed Scopus (91) Google Scholar ]. Finally, there is something we do agree with the authors: we too strongly encourage gastroenterologists to validate the sequential therapy in other geographical areas where data are lacking. In conclusion, available data show how 7-day quadruple therapy is not more effective than standard triple regimen as first-line therapy for H. pylori eradication, whilst sufficient data support the use of a sequential therapy in clinical practice. We hope that the real meaning of the term ‘aberrant’ may be ‘out of current scheme’. Indeed, this concept is known to qualify every ‘new idea’. These are the facts." @default.
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