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Quadruple therapy with lactoferrin for Helicobacter pylori eradication: a randomised, multicentre study.
Dig Liver Dis 2005; 37(7):496-500DL

Abstract

BACKGROUND

Helicobacter pylori eradication rate with standard triple therapies is decreasing. Recently, lactoferrin administration has been shown to significantly increase the cure rate of 7-day rabeprazole, clarithromycin and tinidazole triple therapy. We assessed whether lactoferrin also increases the eradication rate of 7-day esomeprazole, clarithromycin and amoxycillin triple therapy as first-line treatment.

METHODS

Overall, 133 consecutive patients with non-ulcer dyspepsia and H. pylori infection were randomised to receive either a standard 7-day triple therapy with esomeprazole 20mg b.i.d., clarithromycin 500 mg b.i.d. and amoxycillin 1g b.i.d. (68 patients) or a quadruple therapy comprising of the same regimen plus lactoferrin 200mg b.i.d. (65 patients). H. pylori at entry was assessed by endoscopy, while bacterial eradication was checked by (13)C urea breath test 4-6 weeks after treatment.

RESULTS

H. pylori eradication following standard triple therapy was achieved in 53/68 (77.9%; 95% CI = 68-88) and in 53/66 (80.3%; 95% CI = 71-89) patients at ITT and PP analyses, respectively. Following the quadruple regimen, the infection was cured in 50/65 (76.9%; 95% CI = 67-87) and 50/64 (78.1%; 95% CI = 68-88) patients at ITT and PP analyses, respectively. No statistically significant difference emerged between the two therapeutic regimens, both at ITT (p = 0.9) and PP analyses (p = 0.9). Side effects were complained by seven (10.3%) patients and six (9.2%) patients following the triple and quadruple regimens, respectively (p = 0.9), with only one patient in the quadruple group interrupting the treatment due to side effects.

CONCLUSIONS

Quadruple therapy with lactoferrin did not significantly increase the H. pylori cure rate of standard 7-day clarithromycin-amoxycillin based triple therapy in non-ulcer dyspepsia patients.

Authors+Show Affiliations

Gastroenterology and Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy. zullo66@yahoo.itNo 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
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

15975536

Citation

Zullo, A, et al. "Quadruple Therapy With Lactoferrin for Helicobacter Pylori Eradication: a Randomised, Multicentre Study." Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, vol. 37, no. 7, 2005, pp. 496-500.
Zullo A, De Francesco V, Scaccianoce G, et al. Quadruple therapy with lactoferrin for Helicobacter pylori eradication: a randomised, multicentre study. Dig Liver Dis. 2005;37(7):496-500.
Zullo, A., De Francesco, V., Scaccianoce, G., Hassan, C., Panarese, A., Piglionica, D., ... Ierardi, E. (2005). Quadruple therapy with lactoferrin for Helicobacter pylori eradication: a randomised, multicentre study. Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 37(7), pp. 496-500.
Zullo A, et al. Quadruple Therapy With Lactoferrin for Helicobacter Pylori Eradication: a Randomised, Multicentre Study. Dig Liver Dis. 2005;37(7):496-500. PubMed PMID: 15975536.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Quadruple therapy with lactoferrin for Helicobacter pylori eradication: a randomised, multicentre study. AU - Zullo,A, AU - De Francesco,V, AU - Scaccianoce,G, AU - Hassan,C, AU - Panarese,A, AU - Piglionica,D, AU - Panella,C, AU - Morini,S, AU - Ierardi,E, Y1 - 2005/04/01/ PY - 2004/12/23/received PY - 2005/01/31/accepted PY - 2005/6/25/pubmed PY - 2005/10/21/medline PY - 2005/6/25/entrez SP - 496 EP - 500 JF - Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver JO - Dig Liver Dis VL - 37 IS - 7 N2 - BACKGROUND: Helicobacter pylori eradication rate with standard triple therapies is decreasing. Recently, lactoferrin administration has been shown to significantly increase the cure rate of 7-day rabeprazole, clarithromycin and tinidazole triple therapy. We assessed whether lactoferrin also increases the eradication rate of 7-day esomeprazole, clarithromycin and amoxycillin triple therapy as first-line treatment. METHODS: Overall, 133 consecutive patients with non-ulcer dyspepsia and H. pylori infection were randomised to receive either a standard 7-day triple therapy with esomeprazole 20mg b.i.d., clarithromycin 500 mg b.i.d. and amoxycillin 1g b.i.d. (68 patients) or a quadruple therapy comprising of the same regimen plus lactoferrin 200mg b.i.d. (65 patients). H. pylori at entry was assessed by endoscopy, while bacterial eradication was checked by (13)C urea breath test 4-6 weeks after treatment. RESULTS: H. pylori eradication following standard triple therapy was achieved in 53/68 (77.9%; 95% CI = 68-88) and in 53/66 (80.3%; 95% CI = 71-89) patients at ITT and PP analyses, respectively. Following the quadruple regimen, the infection was cured in 50/65 (76.9%; 95% CI = 67-87) and 50/64 (78.1%; 95% CI = 68-88) patients at ITT and PP analyses, respectively. No statistically significant difference emerged between the two therapeutic regimens, both at ITT (p = 0.9) and PP analyses (p = 0.9). Side effects were complained by seven (10.3%) patients and six (9.2%) patients following the triple and quadruple regimens, respectively (p = 0.9), with only one patient in the quadruple group interrupting the treatment due to side effects. CONCLUSIONS: Quadruple therapy with lactoferrin did not significantly increase the H. pylori cure rate of standard 7-day clarithromycin-amoxycillin based triple therapy in non-ulcer dyspepsia patients. SN - 1590-8658 UR - https://www.unboundmedicine.com/medline/citation/15975536/Quadruple_therapy_with_lactoferrin_for_Helicobacter_pylori_eradication:_a_randomised_multicentre_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1590-8658(05)00094-0 DB - PRIME DP - Unbound Medicine ER -