Helicobacter pylori eradication with either quadruple regimen with lactoferrin or levofloxacin-based triple therapy: A multicentre study

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.     

含铋剂和克拉霉素的四联根除方案在幽门螺杆菌一线治疗中的作用

背景：近年经典三联方案对幽门螺杆菌（H.pylori）感染的根除疗效明显下降,建立新型、安全和高效的一线标准治疗方案是临床工作的当务之急。目的：评估含铋剂和克拉霉素的四联方案作为H.pylori一线治疗方案的疗效和安全性。方法：120例胃镜诊断为非溃疡性消化不良的H.pylori感染患者随机分为3组：7 d三联组（奥美拉唑20 mgbid＋阿莫西林1000 mg bid＋克拉霉素500 mg bid,疗程7 d）、7 d四联组（7 d三联方案＋枸橼酸铋钾220 mg bid,疗程7 d）和2周四联组（方案同7 d四联组,疗程2周）。治疗结束后至少4周行13C-尿素呼气试验以评估根除疗效。H.pylori分离菌株行克拉霉素、甲硝唑和阿莫西林药敏试验。结果：115例患者按方案完成治疗。7 d三联组、7 d四联组和2周四联组按意向治疗（ITT）分析H.pylori根除率分别为70.0%、75.0%和90.0%,按方案（PP）分析分别为73.7%、76.9%和94.7%。2周四联组ITT和PP根除率均显著高于7 d三联组（P〈0.05）,PP根除率显著高于7 d四联组（P=0.026）,而7 d三联组ITT和PP根除率与7 d四联组相比均无明显差异。H.pylori对克拉霉素、甲硝唑和阿莫西林的耐药率分别为24.2%、48.3%和0%,7 d三联组、7 d四联组和2周四联组对克拉霉素耐药菌株的根除率逐渐升高（37.5%、55.6%、80.0%）,但差异无统计学意义。除2周四联组中1例患者因皮肤过敏而未完成治疗外,其余患者的不良反应相似且轻微,耐受性良好。结论：含铋剂和克拉霉素的2周四联方案可明显提高H.pylori根除疗效,且安全性较高,可作为H.pylori一线治疗的标准方案。     

评估以泮托拉唑为基础的三联和四联疗法根除幽门螺杆菌的疗效

目的 比较以泮托拉唑为基础的7d标准三联疗法与泮托拉唑+铋剂+甲硝唑+四环素的10 d四联疗法根除Hp的疗效和安全性.方法 170例非溃疡性消化不良的Hp感染者随机入选三联、四联治疗组.三联治疗组实行PAC方案:泮托拉唑40 mg(2次/d)+阿莫西林1.0 g(2次/d)+克拉霉素500 mg(2次/d),口服7 d.四联治疗组实行PBMT方案:泮托拉唑40 mg(2次/d)+胶体次枸橼酸铋220 mg(2次/d)+四环素750 mg(2次/d)+甲硝唑400 mg(2次/d),口服10 d.治疗结束后至少停药4周后复查13C-尿素呼气试验,结果≤4%.为Hp阴性,表示根除成功.同时评估疗效及安全性.结果 166例患者按方案完成治疗.三联治疗组按意图治疗分析(ITT)根除率为63.53%(54/85),较四联治疗组低[89.41%(76/85),x2=17.168,P=0.000].三联治疗组按实验方案分析(PP)根除率为65.06%(54/83),亦较四联治疗组低[91.57%(76/83),x2=13.588,P=0.000].从年龄段分析,年龄＞30岁者三联治疗组根除失败率为22.22%(4/18),较四联治疗组高[3.84%(1/26),x2=19.884,P=0.000].三联和四联治疗组不良反应发生率分别为60.00%(51/85)和42.35%(36/85).结论 在7 d标准三联疗法Hp根除疗效降低的情况下,含泮托拉唑、铋剂、四环素和甲硝唑的10 d四联方案可考虑为首选方案.

Abstract：

Objective Compare the efficacy and safety of pantoprazole-based 7-day standard triple therapy with 10-day quadruple therapy including pantoprazole, bismuth, metronidazole and tetracycline in Helicobacter pylori (H.pylori) eradication.Methods A total of 170 H.pylori positive patients with non-ulcer dyspepsia were recruited and randomly assigned into triple and quadruple therapy groups.The triple therapy group was implemented with PAC program which included orally taking pantoprazole 40 mg twice per day, amoxicillin 1.0 g twice per day and clarithromycin 500 mg twice per day for seven days.The quadruple therapy group was implemented with PBMT program which consisted of orally taking pantoprazole 40 mg twice per day, colloidal bismuth subcitrate 220 mg twice per day, metronidazole 400 mg three times per day and tetracycline 750 mg twice per day for ten days.The 13C -urea breathe test was re-examined at least 4 weeks after the completion of treatment, the result lower than 4%.was H.pylori negative which indicated the success of H.pylori eradication.The efficacy and safety were also evaluated.Results A total of 166 patients completed the treatment.With intention-to-treat (ITT) analysis, the H.pylori eradication rate in the triple therapy group was 63.5% (54/85), lower than that of the quadruple therapy group (89.41%(76/85) ,x2= 17.168,P=0.000).With per protocol (PP) analysis, the eradication rate in the triple therapy group was 65.06% (54/83), also lower than that of the quadruple therapy group (91.57 % (76/83) ,x2 = 13.588 ,P=0.000).Through the age analysis, in patients over 30 years old,the eradication failed rate in the triple therapy group was 22.22% (4/18), higher than that of the quadruple therapy group (3.84% (1 / 26), x2 = 19.884, P=0.000).The incidence of adverse reaction rates of the triple and quadruple therapy group were 60.00% (51/85) and 42.35 % (36/85) respectively.Conclusion Since the reduction of eradication rate with seven day standard triple therapy,the 10-day pantoprazole, bismuth, metronidazole and tetracycline quadruple therapy may be considered as the first choice.     

以泮托拉唑为基础的三联和四联疗法根除幽门螺杆菌疗效比较——一项单中心、随机、开放、平行对照研究

背景：近年质子泵抑制剂（PPI）＋阿莫西林＋克拉霉素标准三联疗法对幽门螺杆菌（H.pylori）的根除率有所降低,PPI＋铋剂＋甲硝唑＋四环素的四联疗法能否成为一线治疗的首选以及适当延长疗程能否提高根除率尚有待明确。目的：比较以泮托拉唑为基础的7d标准三联疗法与7d、10d四联疗法根除H.pylori的疗效。方法：133例非溃疡性消化不良的H.pylori感染患者随机分配至7d三联组（45例,泮托拉唑40mgbid＋阿莫西林1.0gbid＋克拉霉素500mgbid,PAC方案）以及7d、10d四联组（43例和45例,泮托拉唑40mgbid＋枸橼酸铋钾220mgbid＋甲硝唑400mgtid＋四环素750mgbid,PBMT方案）。治疗结束后至少间隔4周行13C-尿素呼气试验复查H.pylori,评估治疗结果。结果：共129例患者按方案完成治疗。三组H.pylori根除率按意图治疗（ITT）分析分别为73.3%、79.1%和88.9%,按方案（PP）分析分别为75.0%、82.9%和90.9%。7dPAC方案的PP根除率显著低于10dPBMT方案（P〈0.05）。除四联组中有2例患者分别因头晕和腹泻而未完成治疗外,其余患者的不良反应相似且均能耐受。结论：在7d标准三联疗法H.pylori根除疗效降低的情况下,含泮托拉唑、铋剂、甲硝唑和四环素的10d四联疗法可考虑作为根除治疗的首选方案。     

Helicobacter pylori eradication therapy is more effective in peptic ulcer than in non-ulcer dyspepsia.

AIM: To evaluate whether eradication therapy is more effective in peptic ulcer disease (PUD) than in non-ulcer dyspepsia (NUD). METHODS: We retrospectively studied 481 patients with NUD (183 patients) or PUD (298 patients) infected with Helicobacter pylori included in several prospective clinical trials. Three eradication regimens were given: (1) proton pump inhibitor (PPI) plus clarithromycin, plus either amoxycillin or metronidazole for 7 days (297 patients); (2) ranitidine bismuth citrate (RBC) plus clarithromycin plus amoxycillin for 7 days (79 patients); and (3) RBC plus clarithromycin plus amoxycillin plus metronidazole for 5 days (105 patients). H. pylori eradication was defined as a negative 13C-urea breath test 4 weeks after completing treatment. RESULTS: H. pylori eradication rates were 82% (95% CI 78-87%) with PPI plus two antibiotics for 7 days, 85% (95% CI 75-91%) with RBC plus two antibiotics for 7 days, and 91% (95% CI 86-97%) with RBC plus three antibiotics for 5 days (P < 0.05 compared with the first regimen). Overall, the H. pylori eradication rate in patients with NUD was 78% (95% CI 71-84%), while in patients with PUD it was 89% (95% CI 86-93%) (P < 0.001). Both the combination of PPI plus two antibiotics for 7 days and the combination of RBC plus three antibiotics for 5 days were more effective in PUD than in NUD patients. However, RBC plus clarithromycin plus amoxycillin for 7 days was equally effective in both diseases. RBC plus two antibiotics for 7 days achieved better results than the same therapy with PPI only in NUD patients (84% v. 59%, P < 0.01), but both regimens were similar when prescribed in PUD patients (86% v. 88%). In the multivariate analysis, the type of therapy, the diagnosis (NUD v. PUD), and the product variable of therapy (with RBC plus 2 antibiotics for 7 days) and diagnosis (interaction variable) were the only variables that influenced H. pylori eradication. The odds ratio (OR) for the effect of RBC versus PPI plus two antibiotics for 7 days in patients with NUD was 4 (95% CI 1.7-9.7; P < 0.01), whereas in patients with PUD no statistical significance was achieved (OR 0.79; 95% CI 0.2-3.9). CONCLUSION: Overall, H. pylori eradication therapy is more effective in PUD than in NUD patients. This advantage of eradication therapies in PUD patients seems to be observed with 7-day PPI-based triple regimens, and with 5-day RBC-based quadruple therapy, while the 7-day RBC-based triple regimen seems to be equally effective in both diseases.     

四联疗法根治幽门螺旋杆菌感染疗效分析

目的探讨四联疗法治疗幽门螺杆菌(Hp)所致消化性溃疡和胃炎的疗效。方法将317例消化性溃疡和慢性萎缩性胃炎患者随机分为标准三联疗法组、四联7d组和四联10d组。四联疗法组采用左氧氟沙星+阿莫西林+奥美拉唑+枸橼酸铋钾胶囊,治疗周期分别为7d和10d。三联疗法采用奥美拉唑+克拉霉素+阿莫西林,治疗周期14d。结果采用PP分析法计算Hp根除率三联疗法组为78.43%,四联7d组为85.71%,四联10d组为91.00%,差异有统计学意义(P<0.05);采用ITT分析法计算3组的Hp根除率分别为76.19%、83.33%和87.50%,差异无统计学意义(P>0.05);总有效率分别为81.37%、85.71%和89.00%,差异无统计学意义(P>0.05)。三联疗法、四联7d组和四联10d组的成本-效果比分别为4.12、2.58、3.47,四联7d组与四联10d组相对于标准三联组的增量成本-效果比值分别为-14.11和-0.64。结论四联7d及10d方案均具有较高的Hp根除率,两种方案均为安全、有效、经济的一线治疗方案,符合我国国情,值得临床推广。     

Comparison of short- and long-term treatment protocols and the results of second-line quadruple therapy in children with <Emphasis Type="Italic">Helicobacter pylori</Emphasis> infection

BACKGROUND: Research regarding the optimal therapeutic approach to Helicobacter pylori infection in children is ongoing. There is no consensus as to duration of treatment or second-line therapy. The purpose of this study was compare the efficacy of 7-day and 14-day triple therapies and report the results of second-line quadruple therapy in children. METHODS: A total of 275 consecutive H. pylori-infected patients were enrolled into two groups. Group 1 (n = 180) received triple therapy with 14 days of amoxicillin and clarithromycin and 21 days of proton pump inhibitor. Group 2 (n = 95) received triple therapy including 7 days of amoxicillin and clarithromycin with 21 days of proton pump inhibitor. Subsequently, 89 patients not responding to the triple therapies received quadruple therapy comprising omeprazole (14 days), bismuth subcitrate (7 days), doxycycline (7 days), and metronidazole (7 days). Eradication was evaluated by 13C-urea breath test. RESULTS: The per-protocol eradication rates in groups 1 and 2 were 60.5% and 55.8%, respectively (P = 0.44). In the second interview with 227 patients, severe symptoms were reported to have disappeared in 59% and decreased notably in 34.8%. Helicobacter pylori was eradicated in 66.7% of patients at the end of the quadruple therapy. In the third interview with 75 patients, severe symptoms had decreased in 38.6% and disappeared in 56%. CONCLUSIONS: The different duration of the two treatment regimens had no impact on eradication rates. Furthermore, quadruple therapy was necessary to achieve H. pylori eradication after triple therapy. However, the eradication rate with quadruple therapy was still insufficient. Consequently, a new therapeutic approach to H. pylori infection in children is needed.     

序贯疗法与标准四联疗法对幽门螺杆菌根除失败后补救治疗的疗效分析

近年经典三联疗法的幽门螺杆菌（11．pylori）根除疗效明显降低,选择有效补救疗法对Hpylori根除失败者有重要意义。目的：比较序贯疗法与标准四联疗法对且pylori根除失败者的疗效。方法：将98例Hpylori根除失败者随机分为序贯疗法组（前5d予奥美拉唑20mg＋阿莫西林1000mgbid,后5d予奥美拉唑20mg＋左氧氟沙星200mg＋克拉霉素500mgbid）和标准四联疗法组（予奥美拉唑20mg＋胶体次枸橼酸铋钾220mg＋阿莫西林1000mg＋克拉霉素500mgbid,疗程7d）。停药4周后复查”C一尿素呼气试验,评估Hpylori根除疗效。结果：共95例患者完成方案,序贯疗法组11Tr和PP分析的Hpylori根除率均显著高于标准四联疗法组（ITF：89．8％对71,4％,PP：91．7％对74。5％,P〈0．05）,序贯疗法组临床症状改善的总有效率亦显著高于标准四联疗法组（95．8％对80．9％,P〈0．05）,两组不良反应发生率无明显差异（P〉0．05）。结论：对Hpylori根除治疗失败的患者,序贯疗法和标准四联疗法均可作为有效的补救治疗方案,但10d序贯疗法的疗效优于7d标准四联疗法。     

Preoperative versus postoperative Helicobacter pylori eradication therapy in gastric cancer patients: a randomized trial

OBJECTIVES: Helicobacter pylori (H. pylori) eradication is strongly recommended for gastric cancer patients who undergo subtotal gastrectomy. The efficacy of proton pump inhibitor-based triple therapy for H. pylori eradication has not been adequately assessed in the gastric remnant. The aim of this study was to compare the efficacy of postoperative versus preoperative H. pylori eradication therapy. METHODS: A total of 138 distal gastric cancer patients with H. pylori infection were randomized to receive either preoperative (preop, N = 68) or postoperative (postop, N = 70) proton pump inhibitor-based triple therapy for H. pylori eradication. The regimen consisted of rabeprazole 10 mg, clarithromycin 500 mg, and amoxicillin 1,000 mg, all twice daily for 7 days. Eradication was assessed by rapid urease test and histology 12 wk after surgery. RESULTS: By intention-to-treat (ITT) analysis, H. pylori eradication rates were 84.6% (95% CI 73.5-92.4) in the preop group and 83.1% (95% CI 71.7-91.2) in the postop group (P= 0.99). By per protocol (PP) analysis, the rates were 87.3% (95% CI 76.5-94.4) in the preop group and 86.9% (95% CI 75.8-94.2) in the postop group (P= 0.99). In the postop group, eradication rates did not differ with reconstruction method (Billroth I vs II, 80.4%[95% CI 66.1-90.6]vs 89.5%[95% CI 66.9-98.7] by ITT analysis (P= 0.49), and 85.7%[95% CI 71.5-94.6]vs 89.5% (95% CI 66.9-98.7) by PP analysis, P= 0.99). CONCLUSIONS: In distal gastric cancer patients, the effect of proton pump inhibitor-based triple therapy for H. pylori eradication was not different whether given postoperatively or preoperatively.     

Is a 7-day Helicobater pylori treatment enough for eradication and inactivation of gastric inflammatory activity？

AIM： To compare the efficacy of a 7-d vs 10-d triple therapy regarding H pylori eradication, endoscopic findings and histological gastric inflammatory inactivation in the Ecuadorian population.
METHODS： 136 patients with dyspepsia and H pylori infection were randomized in 2 groups （68 per group）： group 1, 7-d therapy; group 2, 10-d therapy. Both groups received the same medication and daily dosage： omeprazole 20 mg bid, clarithromycin 500 mg bid and amoxicillin 1 g bid. Endoscopy was performed for histological assessment and H pylori infection status before and 8 wk after treatment.
RESULTS： H pylori was eradicated in 68% of group 1 vs 83.8% of group 2 for the intention-to-treat analysis （ITT） （P = 0.03; OR = 2.48; 95% CI, 1.1-5.8）, and 68% in group 1 vs 88% in group 2 for the per-protocol analysis （PP） （P = 0.008; OR = 3.66; 95% CI, 1.4-10）. Endoscopic gastric mucosa normalization was observed in 56.9% in group 1 vs 61.2% in group 2 for ITT, with similar results for the PP, the difference being statistically not significant. The rate of inflammatory inactivation was 69% in group 1 vs 88.7% in group 2 for ITT （P = 0.007; OR = 3.00; 95% CI, 1.2-7.5）, and 69% in group 1 vs96% in group 2 for PP （P = 0.0002; OR = 7.25; 95% CI, 2-26）.
CONCLUSION： In this Ecuadorian population, the 10-d therapy was more effective than the 7-d therapy for H pylori eradication as well as for gastric mucosa inflammatory inactivation.     

The efficacy of bismuth containing quadruple therapy as a first-line treatment option for Helicobacter pylori

BACKGROUND: Helicobacter pylori eradication rates have tended to decrease recently, mostly due to increasing antibiotic-resistance. The present study aimed to compare the efficacy of bismuth-based quadruple regimen with proton pump inhibitor-based triple regimen for eradication of H. pylori. METHODS: Consecutive H. pylori-positive patients with non-ulcer dyspepsia were randomized into one of two regimens: (i) bismuth subsalicylate 300 mg q.i.d., lansoprazole 30 mg b.i.d., tetracycline 500 mg q.i.d. and metronidazole 500 mg t.i.d. (BLTM group) for 14 days; (ii) lansoprazole 30 mg b.i.d., amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d. (LAC) for 14 days. Gastroscopy and (14)C-Urea breath test (UBT) were performed before enrollment, and UBT only was repeated for 6 weeks after treatment. RESULTS: A total of 240 patients were randomized into groups and 212 of them completed the protocols. The 'intention-to-treat' (ITT) and 'per protocol' (PP) H. pylori eradication rates were 70% (95%CI 61-78) and 82.3% (95%CI 74-89) in the BLTM group, and 57.5% (95%CI 48-66) and 62.7% (95%CI 53-71) in the LAC group. The BLTM treatment achieved a significantly better eradication rate compared with LAC treatment in PP analysis (82.3% vs. 62.7%, P = 0.002). Mild to severe side-effects, which were more frequent in the BLTM group, were reported in 18.2% of the patients. CONCLUSION: The bismuth-based quadruple regimen achieved a better eradication rate compared with proton pump inhibitor-based triple regimens as a first-line eradication option for H. pylori in our population.     

Levofloxacin-based triple therapy versus bismuth-based quadruple therapy for persistent Helicobacter pylori infection: a meta-analysis

BACKGROUND: Levofloxacin-based triple therapy has been suggested as an alternative salvage therapy to bismuth-based quadruple therapy for persistent Helicobacter pylori (H. pylori) infection.METHODS: A search of PUBMED, EMBASE, EBM Review databases and abstracts from recent Digestive Disease Week, United European Gastroenterology Week, and European Helicobacter Study Group conferences was performed. Randomized controlled trials (RCTs) comparing levofloxacin-based triple salvage therapy (levofloxacin + amoxicillin + PPI) to bismuth-based quadruple salvage therapy (bismuth + tetracycline + metronidazole + PPI) were selected for meta-analysis. Additionally, all prospective trials evaluating this levofloxacin-based triple therapy as salvage therapy were pooled to analyze optimal levofloxacin treatment duration and dosing. All selected trials confirmed prior treatment failure and post-salvage treatment eradication.RESULTS: Four RCTs compared a 10-day regimen of levofloxacin-based triple therapy to 7-day bismuth-based quadruple therapy (n = 391 patients). Levofloxacin-based triple therapy was superior to quadruple therapy (RR = 1.41 [95% CI: 1.25-1.59]). Levofloxacin-based triple therapy was better tolerated than quadruple therapy with a lower incidence of side effects (RR = 0.51 [95% CI: 0.34-0.75]) and side effects prompting discontinuation of therapy (RR = 0.30 [95% CI: 0.10-0.89]). Eleven trials (n = 547 patients) evaluating levofloxacin-based triple therapy demonstrated higher eradication rates with 10-day versus 7-day regimen (87%[95% CI: 82%-92%]vs 68%[95% CI: 62%-74%]) yet eight trials (n = 477 patients) demonstrated no difference with 500 mg daily versus 250 mg b.i.d. dosing of levofloxacin (81%[95% CI: 78%-89%]vs 84%[95% CI: 66%-97%]).CONCLUSIONS: A 10-day course levofloxacin triple therapy is more effective and better tolerated than 7-day bismuth-based quadruple therapy in the treatment of persistent H. pylori infection.     

十二指肠溃疡患者根除幽门螺杆菌后抑酸维持治疗的疗效研究

背景：对感染幽门螺杆菌（H.pylori）的消化性溃疡患者成功根除且H.ylori后,是否应继续行抑酸治疗,目前尚存在争议。目的：探讨合并H.pylori感染的十二指肠溃疡（DU）患者根除H.pylori后抑酸维持治疗的疗效。方法：112例合并H.pylori感染的DU患者随机分为A组和B组,A组给予10d四联疗法：兰索拉唑30mg＋阿莫西林1g＋克拉霉素0．5gbid＋枸橼酸铋钾110mg qid,疗程10d。B组：在A组方案的基础上,疗程结束后再予兰索拉唑30mg,1次／d,维持4周。治疗结束4周后复查胃镜,评估H.pylori根除疗效、溃疡愈合率和腹痛缓解率。结果：109例患者完成方案。A、B两组按意向治疗（ITT）和按方案（PP）分析的H.pylori根除率（ITT：85．7％对87．5％;PP：88．9％对89．1％）和溃疡愈合率（ITT：87．5％对94．6％;PP：90．7％对96．4％）以及腹痛缓解率（95．6％对95．7％）相比差异均无统计学意义（P〉0．05）。结论：以10d四联疗法根除H.pylori后,可使多数DU患者的溃疡愈合,无需进一步行维持抑酸治疗。     

Effects of a specially designed fermented milk product containing probiotic Lactobacillus casei DN-114 001 and the eradication of H. pylori in children: a prospective randomized double-blind study

GOALS: To determine the efficacy of triple therapy supplemented with a specially designed fermented milk product containing specific probiotic Lactobacillus casei (L. casei) DN-114 001 strain on Helicobacter pylori eradication in children. BACKGROUND: Lactobacillus species possess in vitro activity against H. pylori. There are no consistent data on the impact of eradication therapy supplemented with probiotics on H. pylori cure rates in childhood in vivo. STUDY: Multicenter, prospective, randomized, double-blind controlled study. Eighty-six symptomatic H. pylori-positive children were randomized either to receive the control treatment of omeprazole, amoxicillin, and clarithromycin (OAC) for 7 days or the test treatment of omeprazole, amoxicillin, and clarithromycin for 7 days supplemented with fermented milk (Actimel) containing L. casei DN-114 001 (OAC-LC), for 14 days. H. pylori status was assessed at 4 weeks following therapy using two noninvasive tests. RESULTS: Intention-to-treat (ITT) based eradication rates for the OAC-LC group were 84.6% (95% CI, 71.2%-95.5%), and 91.6% (95% CI, 76.9%-98.2%) by per-protocol (PP) analysis. Eradication in the OAC group was 57.5% (95% CI, 42.2%-72.3%) in the ITT set and 61.3% (95% CI, 44.4%-75.0%) in the PP group. Eradication success was higher in the OAC-LC group compared with the OAC group in both ITT (P=0.0045) and PP analysis (P=0.0019). Primary resistance for clarithromycin could be determined in 21.2%. Side effects were infrequent. Drug compliance was good throughout the study. CONCLUSION: Supplementation with fermented milk, containing live special probiotic L. casei DN-114 001, confers an enhanced therapeutic benefit on H. pylori eradication in children with gastritis on triple therapy.     

Use of lactoferrin for Helicobacter pylori eradication. Preliminary results

BACKGROUND: One-week triple therapy is the most frequently recommended treatment of Helicobacter pylori infection. The associated eradication rate is satisfactory; nevertheless, it is advisable to look for more effective therapies. Our aim was to test the efficacy of a standard triple therapy plus bovine lactoferrin for the eradication of H. pylori infection. STUDY: This open, randomized, single-center study was designed to include 150 consecutive H. pylori-positive patients with dyspeptic symptoms and gastritis who received triple therapy with rabeprazole, clarithromycin, and tinidazole plus lactoferrin for 7 days (group A), rabeprazole, clarithromycin, and tinidazole for 7 days (group B), or rabeprazole, clarithromycin, and tinidazole for 10 days (group C). H. pylori status was assessed 8 weeks after the end of treatment by means of the 13C-urea breath test or H. pylori stool antigen test. RESULTS: The 7-day treatment including lactoferrin (group A) was successful in 100% (24/24) of the patients. The eradication rates in groups B and C were 76.9% (20/26 patients; 95% CI, 61%-93%) and 70.8% (17/24 patients; 95% CI, 53%-89%), respectively. A significant difference was found between group A and group B (P = 0.023) and group A and group C (P = 0.022). No differences were found between group B and group C (P = 1.00). CONCLUSION: These results suggest that lactoferrin could be a new, effective agent when added to antimicrobial therapy for the eradication of H. pylori. This treatment schedule could be proposed for larger trials of H. pylori eradication therapy, focusing on the excellent preliminary cure rate, good compliance to the treatment schedule, and relatively low price of lactoferrin for full treatment.     

A randomized trial comparing seven-day ranitidine bismuth citrate and clarithromycin dual therapy to seven-day omeprazole, clarithromycin and amoxicillin triple therapy for the eradication of Helicobacter pylori.

OBJECTIVE: To assess Helicobacter pylori eradication after one week dual ranitidine bismuth citrate-clarithromycin (RBC-C) or triple omeprazole, clarithromycin and amoxicillin (OCA) therapy. METHODS: In this multicentre Canadian trial, H pylori-positive patients with functional dyspepsia or inactive peptic ulcer disease were randomized to open-label treatment with RBC-C (ranitidine bismuth citrate 400 mg plus clarithromycin 500 mg) or OCA (omezaprole 20 mg, clarithromycin 500 mg and amoxicillin 1000 mg), given twice a day for seven days. Treatment allocation was randomly assigned. H pylori infection was confirmed by positive 13C-urea breath test (13C-UBT). H pylori status was reassessed by UBT at least four and 12 weeks after treatment (negative: d13CO2 below 3.5 per mil). Intention-to-treat (ITT) eradication rates were determined for all patients with confirmed H pylori infection. Per protocol (PP) rate was determined for all patients treated with at least two evaluable follow-up visits. RESULTS: Three hundred five patients were included in the ITT and 222 in the PP analysis. The ITT eradication rates were 66% for RBC-C and 78% for OCA. The PP success rates were 84% for RBC-C and 96% for OCA. The difference for both ITT 12% (95% CI 2 to 22) and PP 12% (95% CI 4 to 19) were statistically significant, P=0.030 and P=0.007, respectively. Treatment was generally well tolerated. CONCLUSION: The eradication rate for the seven-day dual RBC-C regimen was lower than that for OCA.     

Esomeprazole versus omeprazole for the eradication of Helicobacter pylori infection: results of a randomized controlled study

BACKGROUND: Esomeprazole has higher oral bioavailability and increased antimicrobial activity against Helicobacter pylori than omeprazole. GOALS: To compare 7 days esomeprazole with 7 days of omeprazole based triple therapies for the eradication of H. pylori, and to assess whether the administration of higher dose of esomeprazole leads to improved eradication rates. STUDY: One hundred and fifty-six dyspeptic patients with H. pylori received either: (1) 1-week treatment including esomeprazole 40 mg once daily, amoxicillin 1 g, and clarithromycin 500 mg, both twice daily (EAC1 group, n = 52); (2) 1-week treatment of omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, all administered twice daily (OAC group, n = 52); or (3) 1-week treatment with esomeprazole 40 mg, amoxicillin 1 g, and clarithromycin 500 mg, all given twice daily (EAC2 group, n = 52). RESULTS: H. pylori was eradicated in 37 of 52 patients in the OAC group (Intension to treat [ITT] 71%), and in 42 patients in the EAC1 group (ITT 81%). High eradication rate was achieved by the EAC2 regimen (ITT; 96%), but more patients reported unwanted effects. CONCLUSION: Seven days of esomeprazole based triple therapy is a satisfactory eradication regimen for H. pylori infection. Higher doses of esomeprazole have excellent eradication rates, but they may lead to increased side effects.     

Non-bismuth quadruple therapy for first-line Helicobacter pylori eradication: A randomized study in Japan

AIM:To find the way to improve the eradication rate of first-line therapy in Japanese patients.METHODS:We prospectively compared the effectiveness of 7-d quadruple therapy to standard 7 d triple therapy in Japanese patients infected with Helicobacter pylori(H.pylori).One hundred and nineteen patients were randomly assigned to receive 7-d non-bismuth quadruple therapy with lansoprazole,amoxicillin,clarithromycin and metronidazole(LACM7) or 7-d triple therapy with lansoprazole,amoxicillin and clarithromycin(LAC7).After three months,H.pylori status was analyzed by 13C-urea breath test.Incidence rates of adverse events were evaluated by use of questionnaires.RESULTS:By intention-to-treat(ITT) analysis,the eradication rate in the LACM7 group was 94.9%,which was significantly higher than the LAC7 group(68.3%,P < 0.001).Per protocol analysis also showed a significantly higher eradication rate in the LACM7 group(98.3%) than the LAC7 group(73.2%,P < 0.001).Nevertheless,the incidence of serious adverse events did not differ between the two groups(RR:1.10,95% CI:0.70-1.73,P = 0.67).CONCLUSION:Seven day non-bismuth quadruple therapy(LACM7) was superior to standard 7-d triple therapy(LAC7) for first-line eradication.     

Use of bovine lactoferrin for Helicobacter pylori eradication

BACKGROUND: One-week triple therapy is the most frequently recommended treatment for Helicobacter pylori infection. Eradication rate is satisfactory, nevertheless is advisable to look for more effective therapies. AIM: To test the efficacy of a standard triple therapy plus bovine lactoferrin in the eradication of H. pylori infection. PATIENTS AND METHODS: One hundred and fifty consecutive H. pylori positive patients, suffering from dyspeptic symptoms were recruited in a 7-day triple therapy open randomised single centre study with rabeprazole, clarithromycin, tinidazole, bovine lactoferrin (group A) or rabeprazole, clarithromycin, tinidazole (group B), or a 10-day therapy with rabeprazole, clarithromycin, tinidazole (group C). H. pylori status was assessed 8 weeks after the end of the treatment by means of a 13C-urea breath test or a H. pylori stool antigen-test. RESULTS: Eradication rates (intention to treat/per protocol) were: group A (92.2/95.9%), group B (71.2/72.5%) and group C (70.2/75%). The efficacy of triple therapy added with lactoferrin was significantly higher than other two regimens (p=0.01, intention to treat analysis; p=0.005, per protocol analysis). CONCLUSION: These results suggest that lactoferrin tested in the present study was effective in curing H. pylori and could be a new agent to assist the antimicrobials in the eradication of the bacterium.     

The prolongation of triple therapy for Helicobacter pylori does not allow reaching therapeutic outcome of sequential scheme: a prospective, randomised study

BACKGROUND AND AIM: One-week triple therapy for Helicobacter pylori revealed, during these last few years, a decrease in the eradication rate, so that the prolongation of its duration has been proposed. A sequential scheme recently showed very satisfactory results. We performed a prospective randomised study with the aim of either evaluating whether the triple therapy prolongation may improve its effectiveness and comparing its outcome with that of sequential regimen. PATIENTS AND METHODS: Three hundred and forty-two H. pylori positive patients completed the study. They were randomised to receive one of the following treatments: (i) a 7-day triple therapy comprising of rabeprazole (20 mg, b.i.d.) plus clarithromycin (500 mg, b.i.d.) and amoxycillin (1 g, b.i.d.); (ii) a 10-day triple therapy comprising the same scheme; (iii) a 10-day sequential regimen comprising of rabeprazole (20 mg, b.i.d.) plus amoxycillin (1 g, b.i.d.) for 5 days followed by rabeprazole (20 mg, b.i.d.) plus clarithromycin (500 mg, b.i.d.) and tinidazole (500 mg, b.i.d.) for the next 5 days. Therapeutic results were expressed using both intention-to-treat and per protocol analyses with 95% confidence intervals. A model of multivariate logistic regression analysis was performed using therapeutic outcome as a dependent variable and including endoscopic finding, smoking habit, age and sex as candidates for the model. RESULTS: Sequential regimen showed a significant gain in the eradication rate as compared to the 7-day (P < 0.0001) and the 10-day (P < 0.01) triple therapies, respectively. Overall eradication was lower in smokers than in non-smokers, but the difference remained significant only in the 7-day triple therapy (P < 0.01). Additionally, the overall eradication was higher in peptic ulcer than dyspepsia (P < 0.01), even if this difference was significant only for both triple therapies. CONCLUSIONS: Seven-day triple therapy achieves disappointing eradication rates in dyspeptics and smokers. Prolonging triple therapy to 10 days does not significantly improve the eradication rate. The novel 10-day sequential regimen is more effective and equally tolerated than the 10-day triple therapy.