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Article: A prospective randomized trial comparing the use of omeprazole-based dual and triple therapy for eradication of Helicobacter pylori

TitleA prospective randomized trial comparing the use of omeprazole-based dual and triple therapy for eradication of Helicobacter pylori
Authors
Issue Date1998
PublisherNature Publishing Group. The Journal's web site is located at http://www.nature.com/ajg/index.html
Citation
American Journal Of Gastroenterology, 1998, v. 93 n. 9, p. 1436-1442 How to Cite?
AbstractBackground: Controversy surrounds the optimal composition, dosage, and duration of therapies for eradication of Helicobacter pylori. We prospectively compared omeprazole-based dual and triple therapies in the eradication of H. pylori in a randomized manner. Methods: Between June 1995 and March 1997, 1000 consecutive patients with acid-peptic disease associated with H. pylori infection (duodenal ulcer, 388 patients, gastric ulcer, 179 patients; duodenitis, 173 patients; gastritis, 260 patients) were prospectively recruited. They were randomized to either a 2-wk (OA) course of omeprazole 20 mg and amoxicillin 1 g, both given twice daily, or treatment for 1 wk (OCM) with omeprazole 20 mg once daily, clarithromycin 500 mg twice daily, and metronidazole 400 mg twice daily. Results: The age of these 1000 patients ranged from 16 to 90 yr, with a mean of 54.9 yr. Side effects occurred in 29.6% (95% confidence interval [CI] 25.6-33.8%) and 10.6% (95% CI 8.0-13.6%) of patients taking OCM and OA, respectively (p < 0.0001). Apart from taste disturbance, however, there were no significant differences in the incidences of side effects between the two groups. One patient in the OA group and four patients of the OCM group could not tolerate the medications, and therefore did not complete treatment (p = 0.37). Seven and 13 patients in the OA and OCM groups, respectively, refused a second endoscopy (p = 0.25). The remaining 975 patients underwent a second endoscopy. Positive endoscopic findings were significantly more common in the OA group (51/492; 10.4%; 95% CI 7.8-13.4%) than in the OCM group (25/483; 5.2%; 95% CI 3.4-7.5%) in the per-protocol (PP) analysis (p = 0.004). On intent-to-treat (ITT) analysis, the overall eradication rates in the OA and OCM groups were 73.6% (95% CI 69.5-77.4%) and 92% (95% CI 89.3-94.2%), respectively (p < 0.0001). On PP analysis, the corresponding rates were 74.8% (95% CI 70.7-78.6%) and 95.2% (95% CI 92.9-97.0%), respectively (p < 0.0001). Conclusions: A course of omeprazole, clarithromycin, and metronidazole for 1 wk is a safe, well- tolerated, efficacious, and cost-effective treatment for H. pylori infection.
Persistent Identifierhttp://hdl.handle.net/10722/172750
ISSN
2015 Impact Factor: 10.383
2015 SCImago Journal Rankings: 3.946
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorChu, KMen_HK
dc.contributor.authorChoi, HKen_HK
dc.contributor.authorTuen, HHen_HK
dc.contributor.authorLaw, SYKen_HK
dc.contributor.authorBranicki, FJen_HK
dc.contributor.authorWong, Jen_HK
dc.date.accessioned2012-10-30T06:24:41Z-
dc.date.available2012-10-30T06:24:41Z-
dc.date.issued1998en_HK
dc.identifier.citationAmerican Journal Of Gastroenterology, 1998, v. 93 n. 9, p. 1436-1442en_HK
dc.identifier.issn0002-9270en_HK
dc.identifier.urihttp://hdl.handle.net/10722/172750-
dc.description.abstractBackground: Controversy surrounds the optimal composition, dosage, and duration of therapies for eradication of Helicobacter pylori. We prospectively compared omeprazole-based dual and triple therapies in the eradication of H. pylori in a randomized manner. Methods: Between June 1995 and March 1997, 1000 consecutive patients with acid-peptic disease associated with H. pylori infection (duodenal ulcer, 388 patients, gastric ulcer, 179 patients; duodenitis, 173 patients; gastritis, 260 patients) were prospectively recruited. They were randomized to either a 2-wk (OA) course of omeprazole 20 mg and amoxicillin 1 g, both given twice daily, or treatment for 1 wk (OCM) with omeprazole 20 mg once daily, clarithromycin 500 mg twice daily, and metronidazole 400 mg twice daily. Results: The age of these 1000 patients ranged from 16 to 90 yr, with a mean of 54.9 yr. Side effects occurred in 29.6% (95% confidence interval [CI] 25.6-33.8%) and 10.6% (95% CI 8.0-13.6%) of patients taking OCM and OA, respectively (p < 0.0001). Apart from taste disturbance, however, there were no significant differences in the incidences of side effects between the two groups. One patient in the OA group and four patients of the OCM group could not tolerate the medications, and therefore did not complete treatment (p = 0.37). Seven and 13 patients in the OA and OCM groups, respectively, refused a second endoscopy (p = 0.25). The remaining 975 patients underwent a second endoscopy. Positive endoscopic findings were significantly more common in the OA group (51/492; 10.4%; 95% CI 7.8-13.4%) than in the OCM group (25/483; 5.2%; 95% CI 3.4-7.5%) in the per-protocol (PP) analysis (p = 0.004). On intent-to-treat (ITT) analysis, the overall eradication rates in the OA and OCM groups were 73.6% (95% CI 69.5-77.4%) and 92% (95% CI 89.3-94.2%), respectively (p < 0.0001). On PP analysis, the corresponding rates were 74.8% (95% CI 70.7-78.6%) and 95.2% (95% CI 92.9-97.0%), respectively (p < 0.0001). Conclusions: A course of omeprazole, clarithromycin, and metronidazole for 1 wk is a safe, well- tolerated, efficacious, and cost-effective treatment for H. pylori infection.en_HK
dc.languageengen_US
dc.publisherNature Publishing Group. The Journal's web site is located at http://www.nature.com/ajg/index.htmlen_HK
dc.relation.ispartofAmerican Journal of Gastroenterologyen_HK
dc.subject.meshAdolescenten_US
dc.subject.meshAdulten_US
dc.subject.meshAgeden_US
dc.subject.meshAged, 80 And Overen_US
dc.subject.meshAnti-Bacterial Agents - Therapeutic Useen_US
dc.subject.meshAnti-Ulcer Agents - Therapeutic Useen_US
dc.subject.meshClarithromycin - Therapeutic Useen_US
dc.subject.meshDrug Administration Scheduleen_US
dc.subject.meshDrug Therapy, Combinationen_US
dc.subject.meshFemaleen_US
dc.subject.meshHelicobacter Infections - Drug Therapyen_US
dc.subject.meshHelicobacter Pylorien_US
dc.subject.meshHumansen_US
dc.subject.meshMaleen_US
dc.subject.meshMetronidazole - Therapeutic Useen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshOmeprazole - Therapeutic Useen_US
dc.subject.meshProspective Studiesen_US
dc.titleA prospective randomized trial comparing the use of omeprazole-based dual and triple therapy for eradication of Helicobacter pylorien_HK
dc.typeArticleen_HK
dc.identifier.emailChu, KM: chukm@hkucc.hku.hken_HK
dc.identifier.emailLaw, SYK: slaw@hku.hken_HK
dc.identifier.emailWong, J: jwong@hkucc.hku.hken_HK
dc.identifier.authorityChu, KM=rp00435en_HK
dc.identifier.authorityLaw, SYK=rp00437en_HK
dc.identifier.authorityWong, J=rp00322en_HK
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1111/j.1572-0241.1998.00458.xen_HK
dc.identifier.pmid9732921-
dc.identifier.scopuseid_2-s2.0-0032173214en_HK
dc.identifier.hkuros39178-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-0032173214&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume93en_HK
dc.identifier.issue9en_HK
dc.identifier.spage1436en_HK
dc.identifier.epage1442en_HK
dc.identifier.isiWOS:000075746400012-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridChu, KM=7402453538en_HK
dc.identifier.scopusauthoridChoi, HK=7404339913en_HK
dc.identifier.scopusauthoridTuen, HH=6602991320en_HK
dc.identifier.scopusauthoridLaw, SYK=7202241293en_HK
dc.identifier.scopusauthoridBranicki, FJ=7003617514en_HK
dc.identifier.scopusauthoridWong, J=8049324500en_HK

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