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Dual vs. triple therapy for childhood Helicobacter pylori gastritis: a double-blind randomized multicentre trial.
Helicobacter 2004; 9(4):293-301H

Abstract

BACKGROUND

Data on the efficacy of eradication treatment for Helicobacter pylori gastritis in children are scarce.

AIM

To evaluate the efficacy of triple therapy with lansoprazole plus amoxicillin and tinidazole vs. dual therapy with amoxicillin and tinidazole in a double-blind randomized multicentre trial, and the usefulness of eradication in terms of long-term symptom resolution.

SUBJECTS

We enrolled 43 consecutive children undergoing endoscopy for upper gastrointestinal dyspepsia with H. pylori gastritis. They underwent a 13C-urea breath test, completed a 2-week symptom diary card, and were randomized. Treatment was given in a Redidose box (Redidose Company Ltd., Brighton, UK) containing either lansoprazole-amoxicillin-tinidazole (triple therapy) or placebo plus amoxicillin-tinidazole (dual therapy) for 1 week. The completion of a 2-week symptom diary card and the performance of a breath test were repeated 6 weeks and 6 months after the end of therapy. One to two years later, a structured telephone interview was conducted with 36 of the children.

RESULTS

According to the breath test, 6 weeks after the end of therapy H. pylori was eradicated in 15 of 22 children on triple therapy [68.2%; 95% confidence interval (CI) = 45-88] and in 15 of 21 children on dual therapy (71%; 95% CI = 48-89; not significant), and 6 months after the end of therapy it was eradicated in 16 of 22 children on triple therapy (72.7%) and in 15 of 21 children on dual therapy. Six months after therapy, symptoms were analysed in 11 H. pylori-positive and 31 H. pylori-negative children, and it was found that dyspeptic symptoms had disappeared or improved in both groups, with no difference between them. One to two years later, 36 children were interviewed. Epigastric pain had recurred in three of 26 H. pylori-negative and in seven of 10 H. pylori-positive children (p = .001); in three of the latter, pain was severe and required additional treatment.

CONCLUSION

One-week triple or dual therapy with two antibiotics achieved similar eradication rates. Soon after treatment, symptoms disappeared or improved in most children irrespective of eradication, but epigastric pain recurred in the majority of the still-infected children within 2 years.

Authors+Show Affiliations

Pediatric Department of the University of Novara, Italy. oderda@med.unipmn.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15270743

Citation

Oderda, Giuseppina, et al. "Dual Vs. Triple Therapy for Childhood Helicobacter Pylori Gastritis: a Double-blind Randomized Multicentre Trial." Helicobacter, vol. 9, no. 4, 2004, pp. 293-301.
Oderda G, Marinello D, Lerro P, et al. Dual vs. triple therapy for childhood Helicobacter pylori gastritis: a double-blind randomized multicentre trial. Helicobacter. 2004;9(4):293-301.
Oderda, G., Marinello, D., Lerro, P., Kuvidi, M., de'Angelis, G. L., Ferzetti, A., ... Pensabene, L. (2004). Dual vs. triple therapy for childhood Helicobacter pylori gastritis: a double-blind randomized multicentre trial. Helicobacter, 9(4), pp. 293-301.
Oderda G, et al. Dual Vs. Triple Therapy for Childhood Helicobacter Pylori Gastritis: a Double-blind Randomized Multicentre Trial. Helicobacter. 2004;9(4):293-301. PubMed PMID: 15270743.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dual vs. triple therapy for childhood Helicobacter pylori gastritis: a double-blind randomized multicentre trial. AU - Oderda,Giuseppina, AU - Marinello,Daniela, AU - Lerro,Pietro, AU - Kuvidi,Maria, AU - de'Angelis,Gian Luigi, AU - Ferzetti,Anna, AU - Cucchiara,Salvatore, AU - Franco,Maria Teresa, AU - Romano,Claudio, AU - Strisciuglio,Pietro, AU - Pensabene,Lucia, PY - 2004/7/24/pubmed PY - 2004/10/20/medline PY - 2004/7/24/entrez SP - 293 EP - 301 JF - Helicobacter JO - Helicobacter VL - 9 IS - 4 N2 - BACKGROUND: Data on the efficacy of eradication treatment for Helicobacter pylori gastritis in children are scarce. AIM: To evaluate the efficacy of triple therapy with lansoprazole plus amoxicillin and tinidazole vs. dual therapy with amoxicillin and tinidazole in a double-blind randomized multicentre trial, and the usefulness of eradication in terms of long-term symptom resolution. SUBJECTS: We enrolled 43 consecutive children undergoing endoscopy for upper gastrointestinal dyspepsia with H. pylori gastritis. They underwent a 13C-urea breath test, completed a 2-week symptom diary card, and were randomized. Treatment was given in a Redidose box (Redidose Company Ltd., Brighton, UK) containing either lansoprazole-amoxicillin-tinidazole (triple therapy) or placebo plus amoxicillin-tinidazole (dual therapy) for 1 week. The completion of a 2-week symptom diary card and the performance of a breath test were repeated 6 weeks and 6 months after the end of therapy. One to two years later, a structured telephone interview was conducted with 36 of the children. RESULTS: According to the breath test, 6 weeks after the end of therapy H. pylori was eradicated in 15 of 22 children on triple therapy [68.2%; 95% confidence interval (CI) = 45-88] and in 15 of 21 children on dual therapy (71%; 95% CI = 48-89; not significant), and 6 months after the end of therapy it was eradicated in 16 of 22 children on triple therapy (72.7%) and in 15 of 21 children on dual therapy. Six months after therapy, symptoms were analysed in 11 H. pylori-positive and 31 H. pylori-negative children, and it was found that dyspeptic symptoms had disappeared or improved in both groups, with no difference between them. One to two years later, 36 children were interviewed. Epigastric pain had recurred in three of 26 H. pylori-negative and in seven of 10 H. pylori-positive children (p = .001); in three of the latter, pain was severe and required additional treatment. CONCLUSION: One-week triple or dual therapy with two antibiotics achieved similar eradication rates. Soon after treatment, symptoms disappeared or improved in most children irrespective of eradication, but epigastric pain recurred in the majority of the still-infected children within 2 years. SN - 1083-4389 UR - https://www.unboundmedicine.com/medline/citation/15270743/Dual_vs__triple_therapy_for_childhood_Helicobacter_pylori_gastritis:_a_double_blind_randomized_multicentre_trial_ L2 - https://doi.org/10.1111/j.1083-4389.2004.00242.x DB - PRIME DP - Unbound Medicine ER -