Cure of Helicobacter pylori-positive active duodenal ulcer patients: double-blind, multicentre, 12-month study comparing a two-week dual vs a one-week triple therapy

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 pylori-cured 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.     

Cure of Helicobacter pylori infection and healing of duodenal ulcer: comparison of pantoprazole-based one-week modified triple therapy versus two-week dual therapy

Objective: Eradication of Helicobacter pylori ( H. pylori ) is recommended as the first-line therapeutic concept for reliable long-term prevention of duodenal ulcer (DU) relapse. Current treatment regimens vary in efficacy, complexity, and compliance. To assess the efficacy of pantoprazole in H. pylori eradication in parallel groups of patients using two eradication regimens.
Methods: Patients, (18–85 yr old; intention-to-treat,  n = 286  ) with proven DU, positive rapid urease test (biopsy), and ¹³C-urea breath test (UBT) were included in a prospective, randomized, multicenter study. Modified triple therapy consisted of 40 mg pantoprazole b.i.d ., 500 mg clarithromycin t.i.d ., and 500 mg metronidazole t.i.d . for 7 days (PCM therapy); dual therapy consisted of 40 mg pantoprazole b.i.d . and 500 mg clarithromycin t.i.d . for 14 days (PC therapy). In both groups 40 mg pantoprazole o.d . was given until day 28 when healing of DU was evaluated endoscopically; H. pylori status was assessed by UBT on day 56.
Results: H. pylori eradication rate was 95% in PCM versus 60% in PC therapy groups (per-protocol population,   p < 0.001  ), and 82% in PCM versus 50% in PC therapy in the intention-to-treat patient population (   p < 0.001  ). The DU healing rate was 98% in the PCM and 95% in the PC therapy groups (per-protocol population). Both regimens were similarly well tolerated. Adverse events in both regimens included taste disturbance, diarrhea, and increased serum concentration of liver enzymes, at an incidence of < 10%.
Conclusions: Compared to 2-wk PC therapy (pantoprazole and clarithromycin), the 1-wk PCM therapy (pantoprazole, clarithromycin, and metronidazole) is a significantly superior and highly promising strategy for eradication of H. pylori .     

Prevalence of Helicobacter pylori resistance to antibiotics in Northeast Italy: a multicentre study. GISU. Interdisciplinary Group for the Study of Ulcer.

Aims. To evaluate prevalence of primary Helicobacter pylori antibiotic resistances in Northeast Italy and to identify risk factors associated with this resistance.

Materials and methods. A total of 248 patients undergoing upper gastrointestinal endoscopy were enrolled from 19 Endoscopy Units over a 6-month period. From each patient, 4 gastric biopsies were taken for histology and 2 were sent to the Central Referral Microbiological Laboratory for culture and determination of antibiotic activity against Helicobacter pylori by means of E-test. Strains were considered resistant when minimum inhibitory concentration was >8 μg/ml for metronidazole and > 1 μg/ml for clarithromycin. No cut-off value was predefined for amoxycillin.

Results. Culture of Helicobacter pylori was successfully performed in 167 patients. Primary resistance to metronidazole, clarithromycin or amoxycillin was 14.9%, 1.8% and 0.%, respectively. Patients infected with Helicobacter pylori strains resistant to antibiotics were more frequently females than males (70.3% vs 41.4%), had a significantly lower coffee intake (66.6% vs 86.6%) and lower body mass index (23.7±2.6 vs 25.3±3.6) than patients with susceptible Helicobacter pylori strains. Age, smoking, alcohol use, family history of Helicobacter pylori infection, concomitant diseases and treatments, endoscopic diagnoses, Helicobacter pylori density and histological activity of chronic gastritis were not associated with antibiotic resistance. Multivariate analysis confirmed that female gender (odds RATIO = 2.74, 95% confidence INTERVAL = 1.03–7.27) was the only significant risk factor associated with antibiotic resistance.

Conclusions. In this population, primary Helicobacter pylori resistance to metronidazole was higher than resistance to clarithromycin, and female gender was significantly associated with this resistance. The low prevalence of resistance to metronidazole, clarithromycin and amoxycillin identified in this geographical area suggests that proton pump inhibitor-based triple regimens including these antibiotics may still be used as first line therapies against Helicobacter pylori infection.     

Omeprazole triple therapy versus omeprazole quadruple therapy for healing duodenal ulcer and eradication of Helicobacter pylori infection: a 24-month follow-up study

OBJECTIVE: To evaluate the efficacy of omeprazole triple therapy versus omeprazole quadruple therapy for Helicobacter pylori infection. DESIGN: Prospective, randomized, single-centre, investigator-blind study. SETTINGS: Departments of Gastroenterology and Histopathology, Evangelismos Hospital, Athens, Greece. METHODS: One hundred and forty-nine consecutive patients with active duodenal ulcer were randomized to receive omeprazole (20 mg b.d.), amoxicillin (1 g b.d.) and clarithromycin (0.5 g b.d.) (OAC, n = 78), or omeprazole (20 mg b.d.), colloidal bismuth subcitrate (120 mg q.i.d.), metronidazole (0.5 g t.i.d.) and tetracycline hydrochloride (0.5 g q.i.d.) (OBMT, n = 71) for 10 days. Patients' symptoms were scored, and compliance and treatment-related side effects were assessed. Endoscopy was performed before treatment and at 10-12 weeks and 12 months after treatment. H. pylori infection and its successful eradication were sought by histology, immunohistochemistry and campylobacter-like organisms (CLO) tests on multiple biopsies taken from the gastric antrum, corpus and fundus. Patients were re-evaluated clinically and underwent a C-urea breath test (UBT) at 21-24 months. Those with dyspepsia and/or recrudescence of H. pylori were re-endoscoped. RESULTS: Patient groups were comparable for age, sex, smoking, occasional use of nonsteroidal anti-inflammatory drugs (NSAIDs), and current or past bleeding episodes. Six and seven patients in the OAC and OBMT treatment groups, respectively, were lost to follow-up. Eight patients were non-compliant. Two ulcers in the OAC group and one in the OBMT group did not heal. By intention-to-treat (ITT) and per-protocol (PP) analyses, ulcer healing rates were 86% (67/78) and 97% (67/69), respectively, for the OAC group, and 82% (58/71) and 98% (58/59), respectively, for the OBMT group. H. pylori eradication at 10-12 weeks after treatment was 78% (61/78) and 88% (61/69) for OAC, and 65% (46/71) and 78% (46/59) for OBMT, by ITT and PP analyses, respectively (P > 0.1). Side effects were more common with OBMT. Relapse rates of H. pylori were 3% and 2% for the first and second years, respectively. Four H. pylori-negative patients developed reflux symptoms, but only two developed erosive oesophagitis between 12 and 24 months. CONCLUSIONS: OAC and OBMT were equally effective in healing active duodenal ulcers and eradicating H. pylori, but OAC should be used as a first-line treatment because of its better tolerance.     

A multicenter, randomized, double-blind study comparing famotidine with cimetidine in the treatment of active duodenal ulcer disease

The efficacy and safety of famotidine (40 mg at night), a new potent H2-receptor antagonist, has been studied in 119 patients by four investigators in four Spanish hospitals in a randomized double-blind comparative study with cimetidine (800 mg at night). Antacid tablets were allowed as additional treatment, if needed for pain relief. There were no significant differences between the groups in baseline characteristics, including duodenal ulcer size. Efficacy parameters included daytime and nocturnal symptom relief and duodenal ulcer healing, documented by endoscopy, and defined as complete reepithelization of the ulcer crater. Endoscopy was performed at baseline and after 4 and 6 weeks of treatment. One hundred and five patients fulfilled the evaluation criteria (51 patients in the famotidine group and 54 in the cimetidine group). After 4 weeks, in 91.6% of the patients receiving famotidine and 82.3% of the patients receiving cimetidine ulcers were healed. After 6 weeks, healing rates were 96% (famotidine) and 85.1% (cimetidine) (p = 0.056). Pain relief was rapid in both treatment groups, with a tendency to better response during the day in the famotidine group. The intake of antacids, as well as the clinical and laboratory safety profile were similar for both groups.     

Comparison of esomeprazole enteric-coated capsules vs esomeprazole magnesium in the treatment of active duodenal ulcer： A randomized, double-blind, controlled study

AIM： To evaluate the efficacy and tolerability of two different preparations of esomeprazole in healing duodenal ulcers. METHODS： A total of 60 patients with active duodenal ulcers were enrolled and randomized to receive esomeprazole enteric-coated capsules （40 mg） or esomeprazole magnesium （40 mg）, once daily, for 4 consecutive wk, with ulcer healing being monitored by endoscopy. Safety and tolerability were also assessed. RESULTS： Fifty seven patients completed the whole trial. The ulcer healing rates at the end of wk 2 were 86.7% and 85.2% in the esomeprazole enteric-coated capsules and esomeprazole magnesium groups, respectively （P = 0.8410）, and reached 100% at the end of wk 4 in beth groups. Symptom relief at the end of wk 2 was 90.8% in the esomeprazole enteric-coated capsules group and 86.7% in the esomeprazole magnesium group （P = 0.5406）; at the end of wk 4 symptom relief was 95.2% and 93.2%, respectively （P = 0.5786）. Adverse events occurred in 16.7% of the esomeprazole entericcoated capsules group and 14.8% of the esomeprazole magnesium group （P = 1.0000）. CONCLUSION： The efficacies of esomeprazole entericcoated capsules and esomeprazole magnesium in healing duodenal ulcer lesions and relieving gastrointestinal symptoms are equivalent. The tolerability and safety of beth drugs were comparable.     

A multicenter, randomized, double-blind study comparing once-daily bedtime administration of famotidine and ranitidine in the short-term treatment of active duodenal ulcer

The efficacy and safety of famotidine and ranitidine in the treatment of active duodenal ulcer were compared in a multicenter, randomized double-blind study. The study was carried out at 5 centers and involved a total of 143 patients with endoscopically documented active duodenal ulcer. The patients received either famotidine (1 40 mg tablet at night) or ranitidine 2 150 mg tablets at night). Endoscopic examinations were performed at 4 and 6 weeks of active treatment. Day and nocturnal pain were also monitored, and the laboratory and clinical profiles evaluated. One hundred and thirty-three patients fulfilled the evaluation criteria (66 patients in the famotidine group and 67 in the ranitidine group). Healing rates at weeks 4 or 6 of treatment showed no significant differences between the famotidine group and the ranitidine group. The healing rates were 78% at week 4 and 96% at week 6 in the famotidine group, and 76% at week 4 and 95% at week 6 in the ranitidine group. Similar results were observed in both treatment groups with regard to pain resolution, decrease in antacid intake and safety profile.     

Follow-up survey of a large-scale multicenter,double-blind study of triple therapy with lansoprazole,amoxicillin, and clarithromycin for eradication of Helicobacter pylori in Japanese peptic ulcer patients

Background: To evaluate histopathological changes and effects on inhibition of ulcer recurrence, a follow-up survey was performed in Japanese patients with Helicobacter pylori-positive active peptic ulcers. These patients had previously participated in a large-scale multicenter trial of triple therapy with lansoprazole (LPZ)/amoxicillin (AMPC)/clarithromycin (CAM) for eradication of H. pylori. Methods: Patients who had been treated with LPZ only or a combination of LPZ, AMPC, and CAM for a period of 7 days and in whom ulcer healing had been confirmed after treatment were grouped according to successful or failed eradication of H. pylori. They were examined endoscopically to determine whether ulcers had recurred. The updated Sydney system was applied to study histological changes after H. pylori eradication therapy, compared with baseline. Results: Twelve months after treatment for H. pylori eradication, gastric ulcers had recurred in 11.4% of those with successful H. pylori eradication and in 64.5% of those with unsuccessful H. pylori eradication. Duodenal ulcers had recurred in 6.8% of patients for whom H. pylori eradication was successful and in 85.3% of patients in whom eradication failed. These findings proved that H. pylori eradication significantly reduced ulcer recurrence (P < 0.0001 for both types of ulcers). Histopathological findings of inflammation and activity grade in both gastric and duodenal ulcers were more favorable in patients with successful eradication than in those with unsuccessful eradication. Conclusions: H. pylori eradication significantly inhibited ulcer recurrence in Japanese peptic ulcer patients. Histopathological findings were also improved with regard to inflammation and activity (neutrophils) in patients in whom H. pylori eradication was successful. Received: May 13, 2002 / Accepted: September 6, 2002 Reprint requests to: M. Asaka Editorial on page 410     

Amoxicillin plus omeprazole versus triple therapy for eradication of Helicobacter pylori in duodenal ulcer disease: a prospective, randomized, and controlled study.

Treatment with amoxicillin and omeprazole resulted in encouraging Helicobacter pylori eradication rates in pilot studies that included medium term follow up. These results were evaluated in a prospective, randomised and controlled study. Forty patients with active duodenal ulcer disease and H pylori colonisation of the gastric mucosa were randomly assigned to receive either omeprazole (20 mg twice daily) and amoxicillin suspension (500 mg four times daily) for two weeks (group I) or bismuth subsalicylate (600 mg three times daily), metronidazole (400 mg three times daily), tetracycline (500 mg three times daily), and ranitidine (300 mg in the evening) for two weeks (group II). Study medication was followed in both groups by a four week treatment course with 300 mg ranitidine up to the final examination. One patient from each group was lost to follow up. H pylori was eradicated in 78.9% of group I and 84.2% of group II (p = 1.00). All ulcers in patients on omeprazole plus amoxicillin healed but in the triple treatment group four patients had residual peptic lesions after six weeks (ulcer healing rate: 78.9%, p = 0.11). Complete pain relief occurred after a median duration of 1 day in group I and of 6 days in group II (p = 0.03). There were no major complications in either group but minor side effects were more frequently recorded in patients on triple therapy (63.2% v 15.8%, p < 0.01). In conclusion, two weeks of treatment with omeprazole plus amoxicillin is as good as triple therapy plus ranitidine in eradicating H pylori but seems better with regard to safety, pain relief, and ulcer healing. Thus, amoxicillin plus omeprazole should be recommended as the treatment of choice in eradicating H pylori in patients with duodenal ulcer disease.     

Double-blind study comparing cimetidine and two doses of a slow release formulation of trimoprostil in duodenal ulcer patients with a 6-month follow-up

120 adult outpatients with endoscopically proven duodenal ulcer were randomly allocated to three groups of 40, treated in a double-blind manner with cimetidine 400 mg twice daily, trimoprostil 3 mg twice daily and trimoprostil 3 mg at bedtime. Trimoprostil was administered as a slow release formulation. Healing rates after 4 weeks were 78, 74 and 58%, respectively, the difference being not significant (p = 0.12). Similarly there was no significant difference regarding subjective symptoms, side effects and biochemical analysis. Healed patients were followed at bimonthly intervals for 6 months. The relapse rates were 71, 59 and 61% for patients initially treated with cimetidine, trimoprostil 6 or 3 mg, respectively, a difference not statistically significant.     

雷贝拉唑与兰索拉唑对幽门螺杆菌阳性的消化性溃疡患者安全性与有效性的Meta分析

目的 比较雷贝拉唑与兰索拉唑对根除幽门螺杆菌阳性消化性溃疡患者的安全性与有效性.方法 计算机检索PubMed、EMbase、CNKI、万方数据库和维普数据库查找所有比较雷贝拉唑和兰索拉唑根除幽门螺杆菌阳性消化性溃疡的随机对照试验,检索时间为建库到2014年1月24日.按照纳入及排除标准由两名系统性评价员独立进行随机对照试验的筛选,资料提取和质量评价后采用RevMan 5.2软件进行Meta分析.结果 纳入9个研究,共1 421例患者.安全性方面,雷贝拉唑与兰索拉唑不良反应发生率比较,差异无统计学意义[OR=1.10,95％ CI（0.71～1.71）,P＞0.05];药物依从性方面,雷贝拉唑与兰索拉唑比较,差异无统计学意义[R=0.51,95％CI（0.13 ～1.92）,P＞0.05];有效性方面,雷贝拉唑对幽门螺杆菌根除率优于兰索拉唑,差异有统计学意义[OR=0.65,95％ CI（0.47 ～0.88）P ＜0.01],.雷贝拉唑对溃疡愈合率亦优于兰索拉唑,差异有统计学意义[OR =0.36,95％ CI（0.20～0.65）,P＜0.01].结论 雷贝拉唑有效性优于兰索拉唑,且安全性上无差异.因原始研究的质量高低不一,建议临床上谨慎选择使用,需要更多的大样本多中心的随机对照试验进一步论证.     

Ranitidine bismuth citrate-based triple therapy for seven days, with or without further anti-secretory therapy, is highly effective in patients with duodenal ulcer and Helicobacter pylori infection

OBJECTIVE: To compare the efficacy of two protocols for the eradication of Helicobacter pylori infection and the healing of active duodenal ulcer: (i) ranitidine bismuth citrate (RBC) plus two antibiotics for 7 days, and (ii) the same triple therapy followed by 3 weeks of anti-secretory drug treatment. METHODS: The study comprised 102 patients with active duodenal ulcer and H. pylori infection; the patients were randomized to open treatment with either RBC 400 mg b.d. plus amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. for 7 days, or the same treatment followed by 3 weeks of RBC 400 mg b.d. alone. Ulcer healing was confirmed by endoscopy. H. pylori eradication was assessed by endoscopy, rapid urease test and histology. RESULTS: The ulcer healed in 48/50 patients on RBC-based triple therapy alone (96.0%) and in 51/52 patients on triple therapy plus further anti-secretory treatment (98.1%). On an intention-to-treat basis, H. pylori had been successfully eradicated in 42/50 patients on triple therapy (84.0%) and in 44/52 patients on triple therapy plus anti-secretory treatment (84.6%), while by per protocol analysis the H. pylori eradication rates were 91.3% (42/46) and 89.8% (44/49), respectively. CONCLUSIONS: One-week triple therapy with RBC, amoxycillin and clarithromycin is highly effective in eradicating H. pylori and healing duodenal ulcers, even if not followed by anti-secretory drug treatment.     

治疗的依从性、年龄、性别对胃溃疡患者使用三联7天疗法根除幽门螺杆菌治疗的影响

目的研究胃溃疡患者使用三联7天疗法治疗幽门螺杆菌（Helicobacter pylori,H.pylori）感染的根除率,评估患者依从性、年龄、性别对于此类人群根除H.pylori治疗的影响。方法将经胃镜检查确诊为新发胃溃疡,并经活组织病理学检查明确有H.py-lori感染的1 075例患者纳入研究范围,所有入选患者均接受三联（洛赛克或耐信20 mg/次、2次/天,联合克拉霉素500 mg/次、2次/天,与阿莫西林1 000 mg/次、2次/天）7天疗法行根除H.pylori治疗,之后予以耐信或洛赛克20 mg/次、1次/天、治疗49天。所有入选患者系统治疗完成后6-8周复查胃镜。结果40-59岁与60岁以上人群的胃溃疡患者对治疗的依从性差异无显著性,而40岁以下人群对治疗的依从性较差（P〈0.05）。〈40岁、40-59岁和≥60岁胃溃疡患者的H.pylori根除率分别为61.0%、72.7%和81.9%。〈40岁与40-59岁和≥60岁患者的H.pylori根除率差异有统计学意义（P〈0.05）。不同性别胃溃疡患者的H.pylori根除率差异无显著性（P〉0.05）。结论使用三联7天疗法治疗胃溃疡患者的H.pylori感染,H.pylori的根除率较低,患者对治疗的依从性、年龄是影响胃溃疡患者H.pylori根除率的重要因素,而性别对此无影响。     

Twice-daily, 10-day triple therapy with omeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in duodenal ulcer disease: results of three multicenter, double-blind, United States trials

Objective: We assessed the safety and efficacy of 10-day twice-daily triple therapy for Helicobacter pylori ( H. pylori ) in three double-blind, controlled trials in patients with duodenal ulcer disease.
Methods: H. pylori -infected patients with one or more duodenal ulcer(s) at endoscopy (studies 1, 2) or with a documented duodenal ulcer history and no duodenal ulcer or erosions at endoscopy (study 3) were randomly assigned to 10-day courses of omeprazole 20 mg b.i.d . plus amoxicillin 1 g b.i.d . plus clarithromycin 500 mg b.i.d . (OAC) or placebo plus amoxicillin 1 g b.i.d . plus clarithromycin 500 mg b.i.d . (AC). In studies 1 and 2, patients received an additional 18 days of omeprazole 20 mg q.d . (OAC group) or placebo (AC group). Endoscopy was repeated 4 wk after therapy in studies 1 and 2 and 4–6 wk after therapy in study 3. At baseline, H. pylori was diagnosed by CLOtest plus histology, or by culture. Eradication was defined as no positive biopsy test and two or more negative tests. Patients were defined as compliant if they took 75% or more of each study drug and missed ≤ 3 consecutive days of the 10-day therapy.
Results: Intent-to-treat populations of the three studies combined were 241 patients for OAC and 266 for AC. Of all OAC patients combined, 2% stopped study medications due to adverse events, and 93% were compliant. Per-protocol cure rates were 78% to 90% (all studies combined, 84%) for OAC vs 33% to 45% (combined, 39%) for AC (   p < 0.001  , OAC vs AC); intent-to-treat eradication rates were 69% to 83% (combined, 75%) for OAC vs 32% to 37% (combined, 35%) for AC; (   p < 0.001  , OAC vs AC).
Conclusion: Rigorously designed studies indicate that 10 days of twice-daily triple therapy with omeprazole, amoxicillin, and clarithromycin achieves per-protocol eradication rates of approximately 80% to 90% in the U.S.     

4-day triple therapy with rabeprazole, amoxicillin and clarithromycin in the eradication of Helicobacter pylori in patients with peptic ulcer disease--A pilot study

BACKGROUND: It is well established that a 7-day triple therapy achieves eradication rates of Helicobacter pylori between 90% and 95%. Due to a lack of highly effective short-term eradication studies the aim of the present pilot study was to investigate the effect of a 4-day triple therapy with the new proton pump inhibitor rabeprazole (20 mg b. i. d.) in combination with clarithromycin (500 mg b. i. d.) and amoxicillin (1 g b. i. d.) without acid-suppressive pre-treatment in patients with H. pylori-related peptic ulcer disease. METHODS: 20 patients (11 men, 9 women) with endoscopically diagnosed peptic ulcers (gastric ulcer: n = 5; duodenal ulcer: n = 9; combined gastric and duodenal ulcer: n = 2, gastric or duodenal ulcer scars: n = 4) and H. pylori infection were consecutively recruited. The Helicobacter pylori status was assessed by means of histology, CLO (urea-) test and C13-urea breath test (C13-UBT) at entry. Treatment success was determined by C13-UBT 35-42 days after end of treatment. RESULTS: In 18 out of the 20 patients (90%) [77-100%, 95%-CI] a negative test result was found in C13-UBT 35-42 days after treatment. The 2 patients who remained H. pylori-positive had a duodenal ulcer. CONCLUSION: A 4-day triple therapy of rabeprazole in combination with clarithromycin and amoxicillin seems to be highly effective in eradicating H. pylori and well tolerated in patients with gastric and duodenal ulcer disease. The achieved eradication rate of 90% is comparable with the established 7-day triple therapy regimens. On the basis of these results and considering costs, side effects and compliance a large number of patients should be enrolled in a confirmatory 4-day eradication trial.     

Bismuth-based triple therapy with bismuth subcitrate, metronidazole and tetracycline in the eradication of Helicobacter pylori: a randomized, placebo controlled, double-blind study.

OBJECTIVE: To determine the rate of Helicobacter pylori eradication following bismuth-based triple therapy with colloidal bismuth subcitrate, tetracycline hydrochloride and metronidazole. PATIENTS AND METHODS: One hundred and eleven patients were randomly assigned, in a two to one ratio, to colloidal bismuth subcitrate 120 mg qid plus metronidazole 250 mg qid plus tetracycline 500 mg qid (Gastrostat), or matching placebo tablets and capsules for 14 days. Presence or absence of H pylori was documented by histology at entry and at least 28 days after treatment. Patients had dyspeptic symptoms with or without a history of peptic ulcer. Patients with any previous attempt(s) at eradication of H pylori, who used bismuth, antibiotics, H2 receptor antagonists or proton pump inhibitors in the previous four weeks were excluded. RESULTS: Fifty-three of 59 (90%) patients on bismuth-based treatment and only one of 35 (3%) on placebo achieved eradication by per protocol analysis. Fifty-three of 65 (82%) patients on bismuth-based treatment achieved eradication, while only two of 34 (5%) achieved eradication on placebo by intention to treat analysis. Eradication rates for bismuth-based treatment across sites ranged from 83% to 100%. Only two patients in the bismuth-based treatment group (4%) and one in the placebo group (3%) discontinued treatment because of adverse events. CONCLUSIONS: Colloidal bismuth subcitrate plus metronidazole plus tetracycline, given in the doses studied for 14 days, is safe and highly effective against H pylori infection and would be appropriate as a first-line therapy for eradication.     

Effect of the mucolytic erdosteine on the success rate of PPI-based first-line triple therapy for Helicobacter pylori eradication: a prospective,double-blind,randomized, placebo-controlled study

Abstract

Objective. Because Helicobacter pylori creates a well-sheltered microenvironment within the gastric mucus layer, it has been speculated that the disruption of this space by a mucolytic agent may enhance the eradication rate. The aim of the present study was to investigate the effect of erdosteine, a strong mucolytic agent, on the effectiveness of PPI-based, first-line triple therapy in the eradication of H. pylori. Material and methods. Initially, 196 patients were enrolled to the study. Of these, 79 H. pylori-positive patients were randomized to the erdosteine group (triple therapy consisting of pantoprazole, amoxicillin and clarithromycin plus erdosteine; n = 40) or the placebo group (triple therapy plus placebo; n = 39) for 14 days. Endoscopic biopsies and ¹³C-urea breath tests were performed at entry and at 4–6 weeks after the completion of the treatment. Additionally, rapid urease tests were performed at entry. Results. The eradication of H. pylori was achieved in 30 (75%) of the 40 patients in the erdosteine group and in 20 (51.3%) of the 39 patients in the placebo group, according to the ITT analysis (p = 0.028). When the PP analysis was performed as well, H. pylori eradication was achieved in 30 (78.9%) of the 38 patients in the erdosteine group and in 20 (52.6%) of the 38 patients in the placebo group (p = 0.016). Conclusions. Erdosteine is an efficient adjuvant therapy that could be used in conjunction with first-line triple therapy in the treatment of H. pylori.