Bovine lactoferrin for Helicobacter pylori eradication: an open, randomized, multicentre study.

BACKGROUND: Cure rates for eradication of Helicobacter pylori appear to be decreasing, thus more effective therapies must be identified. AIM: To evaluate the efficacy of bovine lactoferrin in the treatment of H. pylori infection. METHODS: In a multicentered prospective study, 402 (mean age 52.4, range 19-84 years) H. pylori-positive patients were assigned to one of three regimens: group A - esomeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for 7 days; group B - lactoferrin 200 mg b.d. for 7 days followed by the same schedule of group A; group C - esomeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. plus lactoferrin 200 mg b.d. for 7 days. RESULTS: Of the 402 patients, 389 completed the study. Six patients were discontinued due to side effects, one patient in group B died and six patients were lost to follow up. The eradication rate (intention-to-treat analysis) was 77% in group A (105/136), 73% in group B (97/132) and 90% in group C (120/134) (chi(2)-test P < 0.01). The incidence of side effects was 9.5% in group A, 9% in group B and 8.2% in group C (chi(2)-test P = 0.1). CONCLUSION: This study demonstrates that bovine lactoferrin is an effective adjuvant to 7-day triple therapy for eradication of H. pylori infection.

Cure of Helicobacter pylori-positive active duodenal ulcer patients: a double-blind, multicentre, 12-month study comparing a two-week dual vs a one-week triple therapy. GISU (Interdisciplinary Group for Ulcer Study).

AIMS: To compare a two-week dual therapy to a one-week triple therapy for the healing of duodenal ulcer and the eradication of the Helicobacter pylori infection. PATIENTS AND METHODS: A total of 165 patients with active duodenal ulcer were enrolled in the study. At entry, endoscopy, clinical examination and laboratory tests were performed. Histology and the rapid urease test were used to diagnose Helicobacter pylori infection. Patients received either lansoprazole 30 mg plus amoxycillin 1 g bid for two weeks (two-week, dual therapy) or lansoprazole 30 mg plus amoxycillin 1 g plus tinidazole 500 mg bid for one week plus lansoprazole qd for an additional week (one-week, triple therapy). Two and twelve months after cessation of therapy, endoscopy and clinical assessments were repeated. RESULTS: Duodenal ulcer healing and Helicobacter pylori eradication were both significantly greater (p<0.0001) in the triple therapy group (healing: 98.6%; Helicobacter pylori cure rate: 72.6%) than in the dual therapy group (healing: 77.3%; Helicobacter pylori cure rate: 33.3%). Ulcers healed more frequently in Helicobacter pyloricured than in Helicobacter pylori-not cured patients (94.9% vs. 77.2%; p<0.0022). After one year, Helicobacter pylori eradication was re-confirmed in 46/58 patients previously treated with the triple therapy and in 10/40 patients treated with the dual therapy [p<0.0001]. Only three duodenal ulcer relapses were observed throughout follow-up: all were in Helicobacter pylori-not cured patients. CONCLUSIONS: Triple therapy was more effective than dual both in curing Helicobacter pylori infection and healing active duodenal ulcers. The speed of ulcer healing obtained after only 7 days of antibiotics and 14 days of proton pump inhibitors confirmed that longer periods of anti ulcer therapy were not necessary. Helicobacter pylori -not cured patients had more slowly healing ulcers which were more apt to relapse when left untreated.

Rapid improvement of symptomatology with pantoprazole, amoxycillin and metronidazole in Helicobacter pylori-positive duodenal ulcer patients.

BACKGROUND/AIMS: To evaluate the efficacy and tolerability of a new 1-week triple therapy regimen consisting of pantoprazole, amoxycillin and metronidazole. METHODOLOGY: The study involved 51 Helicobacter pylori (H. pylori) positive patients (M:30, F:21, mean age: 52.5 years, range: 24-75) affected with duodenal ulcer in active phase. At baseline and 6 weeks after the completion of treatment, clinical assessment, endoscopy with gastric biopsies, rapid urease test, 13C urea breath test, and serum laboratory analyses were performed. All patients were treated with pantoprazole 40 mg once daily, plus amoxycillin 1 gram tid and metronidazole 250 mg tid for 1 week, and pantoprazole 40 mg once daily for a second week. A clinical diary for daily assessment of symptoms and side effects was completed by patients during the treatment period. RESULTS: Three patients were discontinued from the study. Six weeks after therapy, the ulcer was healed in 47 of 48 patients (97.9%, 95% CI = 93.9-100). The cure rates of H. pylori infection, expressed using both the intention-to-treat and per protocol analyses, were 80.4% (95% CI = 69.5-91.3) and 85.4% (95% CI = 75.4-95.4), respectively. The therapy led to a significant, rapid disappearance or reduction in daytime epigastric pain, from 68.8% on day 1 to 82.2% on day 3 (p < 0.001) and in nocturnal epigastric pain, from 80.6% on day 1 to 93.3% on day 3 (p < 0.001). After 2 weeks of treatment, the percentage of patients completely free of pain was 82.2% for daytime pain and 90.3% for nocturnal pain. A rapid improvement in acid regurgitation, heartburn, nausea and vomiting was also observed with a median value of symptom disappearance of 2 days. The percentages of patients completely symptom-free were 37.5% after 1 day, 54.1% after 3 days, 75% after 2 weeks, and 83.3% after 2 months. H. pylori-cured patients showed a significant decrease in the histological activity of both antral (p = 0.0001) and body (p < 0.008) gastritis. Mild to moderate adverse events were reported by 15 patients. CONCLUSIONS: One week triple therapy with pantoprazole in combination with amoxycillin and metronidazole, followed by a second week of pantoprazole, was well tolerated and highly effective for the 1) rapid improvement or resolution of symptoms; 2) healing of the DU; 3) eradication of H. pylori infection; and, 4) reduction of histological signs of chronic gastritis activity.

Gastric ulcer as a pre-cancerous condition.

There are two schools of thought: one believes that the benign gastric ulcer cannot convert into cancer, and the other affirms that it represents a precancerous condition. Gastric ulcer is probably just a symptom of a multifactorial disease or other alteration (like dysplasia, metaplasia) associated with a precancerous condition. Up to now the only possibility of following up precancerous lesions and diagnosing early gastric cancer has been to perform multiple biopsies during endoscopy since the search of specific markers has not shown any practical utility.

Treatment of erosive reflux oesophagitis: a double-blind multicentre trial with nizatidine 300 mg b.i.d. versus placebo.

Histamine H2-receptor antagonists at conventional doses have proved only partly efficacious in the treatment of reflux oesophagitis. The aim of this study, therefore, was to compare the efficacy of high doses of nizatidine (300 mg b.i.d.) versus placebo in 117 patients with grade I and II oesophagitis. After 6 weeks' treatment, 70.6% of nizatidine-treated patients showed complete endoscopic healing against 25.4% of placebo-treated subjects (p less than 0.001). After 12 weeks, the respective healing rates were 77.5% and 47.4% (p less than 0.01). Nizatidine also proved significantly more effective than placebo in improving overall symptoms (p less than 0.05). Antacid intake was significantly greater in the placebo group (p less than 0.001). Both treatments were well tolerated. In conclusion, this study demonstrates that nizatidine at the dose of 300 mg b.i.d. for 6-12 weeks constitutes an effective treatment for patients with reflux oesophagitis.

Cimetidine, 800 mg at night versus 400 mg twice daily, in the treatment of duodenal ulcer.

A multicentre double-blind study was carried out on a total of 197 patients, to evaluate the safety and efficacy of an 800 mg nighttime dose of cimetidine in comparison with 400 mg twice daily in the treatment of duodenal ulcer. At 4 weeks 84% of the 187 patients eligible for analysis had healed ulcers with the once daily regimen and 68% with the twice daily regimen (p less than 0.05). An early decrease in both day and nighttime pain and in antacid consumption was observed during the first 2 weeks. Adverse effects were few and mild, confirming the safety profile of cimetidine.

Comparison of cimetidine 800 mg once daily and 400 mg twice daily in acute duodenal ulceration.

A double blind trial was conducted in seven centres to evaluate the safety and efficacy of cimetidine 800 mg given at night compared with 400 mg given at breakfast and at bedtime. Altogether 197 patients with active duodenal ulcer confirmed by endoscopy entered the study, of whom 187 were eligible for analysis. After four weeks' treatment the ulcer was healed in 76 of 91 patients (84%) receiving the once daily regimen and in 65 of the 96 patients (68%) receiving the twice daily regimen (p less than 0.05). Both dosage regimens were equally effective in reducing ulcer pain and consumption of antacids. Pain relief was considerable within the first two weeks, and most of the patients were free of symptoms by the end of treatment. No patients were withdrawn because of adverse events as these were few and mild, consistent with the proved safety profile of cimetidine. Cimetidine 800 mg given at night is as effective as 400 mg twice daily; the single dose regimen may improve patient compliance, thus facilitating treatment.

[Acute herpes simplex hepatitis with favorable outcome in an otherwise healthy adult]. / Epatite acuta da Virus Herpes Simplex a decorso favorevole in un adulto normale.

A non fatal case of Human Herpes Simplex hepatitis is presented, and the features of 15 previously reported cases are briefly reviewed. The patient, an otherwise normal middle-aged woman, presented as acutely ill, with typical mucocutaneous lesions, but recovered in a few days. Liver biopsy showed multiple focal areas of cellular necrosis with marked inflammatory infiltration, but without evidence of intranuclear eosinophilic inclusions. The possible underestimation of cases of Herpes Simplex hepatitis is proposed.

[Controlled clinical trial of parsalmide, a drug with analgesic and anti-inflammatory activity]. / Sperimentazione clinica controllata di parsalmide, farmaco ad attività analgesica ed antiinfiammatoria

A controlled clinical trial of the anti-inflammatory, analgesic, muscle-relaxing and anxiolytic activity of a new compound (parsalmide) was compared with that of phenybutazone in 40 patients with acute or exacerbated inflammatory or degenerative processes randomly distributed into two treatment groups. Parsalmide was more effective in the relief of joint swelling and anxiety and gave better motility. On an overall evaluation, however, it was on a par with phenylbutazone. Treatment had to be suspended in two cases treated with phenylbutasone, whereas tolerance was good with parsalmide and no suspensions were required.