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1.
Eur Rev Med Pharmacol Sci ; 12(4): 251-6, 2008.
Article in English | MEDLINE | ID: mdl-18727457

ABSTRACT

The Helicobacter pylori (H. pylori) cure rate following standard triple therapies is decreasing worldwide. Therefore, further approaches aimed to improve standard triple therapy efficacy should be attempted. This prospective, pilot study aimed to evaluate the therapeutic role of either Lactobacillus reuteri (L. reuteri) or a high concentration of probiotics in addition to standard triple therapies for H. pylori eradication. The study enrolled 65 consecutive dyspeptic patients with H. pylori infection. All patients underwent upper endoscopy with gastric biopsies. Patients were assigned to receive one of the following therapies: (a) standard 7-day triple; (b) the same 7-day triple therapy plus L. reuteri supplementation; (c) the same 7-day triple therapy plus a probiotic mixture; and d) a 14-day standard triple therapy plus a probiotic mixture. H. pylori eradication was checked by using a 13C-urea breath test performed 4-6 weeks after treatment. No therapy regimen achieved > 80% eradication rate at both intention-to-treat (ITT) and per protocol (PP) analyses. Although the 14-day therapy plus a probiotic mixture tended to achieve higher eradication rate (71%), no statistically significant difference emerged among the different therapy regimens tested (range: 53-71%). The lowest incidence of side-effects was observed following the 7-day therapy plus L. reuteri (6%) and highest with the 14-day triple therapy plus probiotic mixture (33%), although the difference failed to reach the statistically significance. In conclusion, our data found that 7-14 days triple therapy with or without probiotic supplementation failed to achieved acceptable H. pylori eradication rates.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Anti-Ulcer Agents/therapeutic use , Helicobacter Infections/drug therapy , Probiotics/therapeutic use , 2-Pyridinylmethylsulfinylbenzimidazoles/adverse effects , 2-Pyridinylmethylsulfinylbenzimidazoles/therapeutic use , Adult , Aged , Amoxicillin/adverse effects , Amoxicillin/therapeutic use , Anti-Bacterial Agents/adverse effects , Anti-Ulcer Agents/adverse effects , Clarithromycin/adverse effects , Clarithromycin/therapeutic use , Drug Therapy, Combination , Female , Follow-Up Studies , Helicobacter pylori/drug effects , Humans , Limosilactobacillus reuteri/chemistry , Lansoprazole , Male , Middle Aged , Pilot Projects , Probiotics/adverse effects , Prospective Studies
2.
Dig Liver Dis ; 39(9): 806-10, 2007 Sep.
Article in English | MEDLINE | ID: mdl-17644057

ABSTRACT

BACKGROUND: Helicobacter pylori eradication rate following standard triple therapy is decreasing worldwide. A quadruple therapy with lactoferrin and a levofloxacin-based triple therapy has been found to achieve a very high (>90%) cure rate. This study aimed to confirm these encouraging results. METHODS: This was a prospective, open-label, randomised, multicentre, Italian study enrolling consecutive H. pylori infected patients. The infection at entry was assessed by endoscopy and biopsies (histology plus rapid urease test) in all patients, whilst bacterial eradication was assessed by 13C-urea breath test 4-6 weeks after therapy ended. Patients were randomised to receive either a 7-day, triple therapy with rabeprazole 20mg o.d., levofloxacin 500 mg o.d., and amoxycillin 1g b.i.d. (4 tablets/day) or a 7-day quadruple therapy comprising of rabeprazole 20mg, clarithromycin 500 mg, tinidazole 500 mg plus bovine lactoferrin 200mg, all given twice daily (10 tablets/day). RESULTS: Overall, 144 consecutive patients were enrolled in the study. Following the triple therapy, H. pylori infection was cured in 49 out of 72 (68.1%; 95% CI=57-79) patients and in 49 out of 71 (69.1%; 95% CI=58-80) at intention-to-treat and per protocol analyses, respectively. Following the quadruple regimen, the infection was cured in 52 out of 72 (72.2%; 95% CI=62-83) and in 52 out of 68 (76.5; 95% CI=66-87) patients at intention-to-treat and per protocol analyses, respectively. No statistically significant difference emerged between the two therapy regimens. CONCLUSIONS: H. pylori eradication rate following both quadruple therapy with lactoferrin and a low-dose PPI, triple therapy with levofloxacin is disappointingly low.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Helicobacter Infections/drug therapy , Helicobacter pylori/drug effects , Levofloxacin , Ofloxacin/therapeutic use , 2-Pyridinylmethylsulfinylbenzimidazoles/therapeutic use , Adult , Amoxicillin/therapeutic use , Clarithromycin/therapeutic use , Drug Therapy, Combination , Female , Humans , Lactoferrin/therapeutic use , Male , Middle Aged , Rabeprazole , Tinidazole/therapeutic use , Treatment Outcome
3.
Dig Liver Dis ; 38(1): 45-50, 2006 Jan.
Article in English | MEDLINE | ID: mdl-16216566

ABSTRACT

BACKGROUND: Endoscopic follow-up is advised in patients operated for colorectal cancer due to a high risk for both metachronous colorectal cancer and adenomas. Such issue has been scarcely addressed in Italy. This study aimed to evaluate the incidence of neoplastic lesions at a scheduled endoscopic follow-up and to identify the patients at higher risk of recurrence. METHODS: Colorectal cancer patients diagnosed in the three participating hospitals (one North, one Centre and one South Italy) were scheduled for colonoscopies at 1, 3 and 5 years after surgery. Incidence of adenomas, advanced adenomas and colorectal cancer was assessed in all patients. Neoplastic incidence in patients with and without synchronous lesions at entry was also compared. RESULTS: Overall, 318 consecutive patients were prospectively enrolled including 108 (34%, group A) with a synchronous lesion and 210 (group B) without it. A cumulative neoplastic incidence of 20.1, 32.4 and 44% was observed at 1, 3 and 5 years of follow-up, respectively. The cumulative incidence of all the lesions was 70% in group A and 30.2% in group B at 5-year follow-up, being 39.5 and 15.5% after excluding the lesions detected at 1-year examination. A neoplastic lesion was detected more frequently in group A at 1year (30.5% versus 14.7%; p = 0.0013), 3 years (21.4% versus 7.6%; p = 0.0008) and at 5years (18.1% versus 7.8%; p = 0.02). CONCLUSIONS: Our data showed that the incidence of adenomas in patients operated for colorectal cancer is fairly high. Colorectal cancer patients with synchronous lesions are at higher risk of neoplastic recurrence at follow-up as compared to those without them.


Subject(s)
Colorectal Neoplasms/surgery , Adenoma/diagnosis , Aged , Aged, 80 and over , Colonoscopy , Colorectal Neoplasms/diagnosis , Female , Follow-Up Studies , Humans , Male , Middle Aged , Neoplasm Recurrence, Local/diagnosis , Neoplasms, Second Primary/diagnosis , Prospective Studies
4.
Dig Liver Dis ; 37(7): 496-500, 2005 Jul.
Article in English | MEDLINE | ID: mdl-15975536

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.


Subject(s)
Amoxicillin/therapeutic use , Anti-Bacterial Agents/therapeutic use , Clarithromycin/therapeutic use , Helicobacter Infections/drug therapy , Helicobacter pylori , Lactoferrin/therapeutic use , Drug Therapy, Combination , Dyspepsia/drug therapy , Dyspepsia/microbiology , Humans , Prospective Studies
5.
Aliment Pharmacol Ther ; 18(6): 641-6, 2003 Sep 15.
Article in English | MEDLINE | ID: mdl-12969091

ABSTRACT

BACKGROUND: Several studies have shown that Helicobacter pylori eradication rates with standard 7-day triple therapy are unsatisfactory. A novel 10-day sequential treatment regimen recently achieved a significantly higher eradication rate. To improve the pharmacotherapeutic cost, we evaluated whether an acceptable eradication rate could be achieved in peptic ulcer patients by halving the dose of clarithromycin. METHODS: In a prospective, open-label study, 152 duodenal ulcer patients with H. pylori infection, assessed by rapid urease test and histology, were enrolled. Patients were randomized to receive either a 10-day sequential treatment comprising rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days (high-dose therapy), or a similar schedule with the clarithromycin doses halved to 250 mg b.d. (low-dose therapy). No further antisecretory drugs were offered. Four to six weeks after therapy, H. pylori eradication and ulcer healing rates were assessed by endoscopy. RESULTS: Similar H. pylori eradication rates were observed following high- and low-dose regimens for both per protocol (97.3% vs. 95.9%; P = N.S.) and intention-to-treat (94.7% vs. 92.2%; P = N.S.) analyses. No major side-effects were reported. At repeat endoscopy, peptic ulcer healing was observed in 93% and 93% of patients following high- and low-dose therapy, respectively. CONCLUSION: The cheaper low-dose sequential regimen may be suggested for H. pylori eradication in duodenal ulcer patients, even without continued proton pump inhibitor therapy after eradication treatment.


Subject(s)
Anti-Ulcer Agents/administration & dosage , Drug Therapy, Combination/administration & dosage , Duodenal Ulcer/microbiology , Helicobacter Infections/drug therapy , Helicobacter pylori , 2-Pyridinylmethylsulfinylbenzimidazoles , Adult , Aged , Amoxicillin/administration & dosage , Amoxicillin/economics , Antacids/administration & dosage , Antacids/economics , Anti-Ulcer Agents/economics , Benzimidazoles/administration & dosage , Benzimidazoles/economics , Clarithromycin/administration & dosage , Clarithromycin/economics , Cost-Benefit Analysis , Drug Costs , Drug Therapy, Combination/economics , Duodenal Ulcer/drug therapy , Duodenal Ulcer/economics , Female , Helicobacter Infections/economics , Humans , Male , Middle Aged , Omeprazole/analogs & derivatives , Prospective Studies , Rabeprazole , Tinidazole/administration & dosage , Tinidazole/economics , Treatment Outcome
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