Meta-analysis:Is combination of tetracycline and amoxicillin suitable for Helicobacter pylori infection?

AIM:To access the efficacy of combination with amoxicillin and tetracycline for eradication of Helicobacter pylori(H.pylori),thus providing clinical practice guidelines.METHODS:Pub Med,EMBASE,Cochrane Central Register of Controlled Trials,Science Citation Index,China National Knowledge Infrastructure,Wanfang,and Chinese Biomedical Literature databases and abstract books of major European,American,and Asian gastroenterological meetings were searched.All clinical trials that examined the efficacy of H.pylori eradication therapies and included both tetracycline and amoxicillin in one study arm were selected for this systematic review and meta-analysis.Statistical analysis was performed with Comprehensive Meta-Analysis Software(Version 2).Subgroup,meta-regression,and sensitivity analyses were also carried out.RESULTS:Thirty-three studies met the inclusion criteria.The pooled odds ratio(OR)was 0.90(95%CI:0.42-1.78)for quadruple therapy with amoxicillin and tetracycline vs other quadruple regimens,and total eradication rates were 78.1%by intention-to-treat(ITT)and 84.5%by per-protocol(PP)analyses in the experimental groups.The pooled eradication rates of 14-d quadruple regimens with a combination of amoxicillin and tetracycline were 82.3%by ITT and89.0%by PP,and those of 10-d regimens were 84.6%by ITT and 93.7%by PP.The OR by ITT were 1.21(95%CI:0.64-2.28)for triple regimens with amoxicillin and tetracycline vs other regimens and 1.81(95%CI:1.37-2.41)for sequential treatment with amoxicillin and tetracycline vs other regimens,respectively.CONCLUSION:The effectiveness of regimens employing amoxicillin and tetracycline for H.pylori eradication may be not inferior to other regimens,but further study should be necessary.     

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.     

Pooled analysis of Helicobacter pylori eradication regimes in Asia

BACKGROUND AND AIMS: Differences in Helicobacter pylori strains and their resistance to antimicrobials between Asian and Western countries may affect the success in eradicating this bacterium. Our objective was to systematically review the regimens that have been tested in Asia. METHODS: Data on anti-H. pylori therapies reported from Asia in a large number of publications identified up to December 1998 were pooled into a few groups based on the combination of drugs used. A comparison of different groups was made by calculating the pooled eradication rates. RESULTS: Seventy-three studies with 134 treatment arms were reviewed. Pooled eradication rates of dual, triple and quadruple therapies were 61.0, 86.5 and 93.4%, respectively. Proton pump inhibitor (PPI)-based combinations were more widely used and effective, with overall eradication rates of 90.7% in triple therapy and 93.4% in quadruple therapy. Bismuth combined with tetracycline and metronidazole also showed a high eradication rate of 92.0%. CONCLUSIONS: Proton pump inhibitor-based triple therapy with either clarithromycin, amoxycillin or metronidazole was one of the most commonly used and effective anti-H. pylori triple therapy regimens in Asia. The classical triple therapy with a bismuth, tetracycline and metronidazole combination has a similar efficacy. The results of anti-H. pylori treatment in Asia are not different from those in Western countries.     

Meta-Analysis of the Efficacy of Antibiotic Therapy in Eradicating Helicobacter pylori

Despite numerous Helicobacter pylori treatment studies, the optimum regimen(s) for its eradication remain unclear. Our objective was to determine systematically which regimen(s) gave the best pooled eradication rates, by using meta-analysis methodology. A total of 27 studies were identified. Pooled eradication rates for single (18.6%), double (48.2%), and triple therapy (82.3%) were statistically highly different (p < 0.0005). Eradication rates with amoxicillin (23.0%) and bismuth compounds (19.6%) were equivalent. Combined treatment with bismuth+metronidazole was better than bismuth+amoxicillin (55.1% vs. 43.7%, p = 0.049). Triple therapy with bismuth+metronidazole+tetracycline gave a statistically higher eradication rate (94.1%) than bismuth+metronidazole+amoxicillin (73.1%, p < 0.0005). Despite increased side effects with multiple antibiotic regimens, patients tolerated these well, without significant drop-out. The combination of bismuth, metronidazole, and tetracycline gives the best eradication rate, but the optimal doses and duration of treatment have yet to be determined. Further studies are necessary to explore factors such as antibiotic resistance and drug compliance as important factors affecting antibiotic efficacy.     

First-line eradication of H pylori infection in Europe： A metaanalysis based on congress abstracts, 1997-2004

INTRODUCTIONNumerous treatment regimens have been tested for their efficacy in curing H pylori infection worldwide[1-3]. Meta-analysis has become a frequently used method for re-solving such uncertainties and obtaining sound data in evidence-based medicin…     

Moxifloxacin-containing triple therapy after non-bismuth quadruple therapy failure for Helicobacter pylori infection

AIM: To assess the efficacy of moxifloxacin-containing triple therapy after non-bismuth quadruple therapy failure for Helicobacter pylori(H. pylori) eradication.METHODS: Between January 2010 and December 2012,we screened individuals who were prescribed non-bismuth quadruple therapy for H. pylori eradication. Among them,a total of 98 patients who failed non-bismuth quadruple therapy received 1-wk or 2-wk moxifloxacin-containing triple therapy(400 mg moxifloxacin once daily,and 20 mg of rabeprazole and 1 g of amoxicillin twice daily). H. pylori status was evaluated using the 13C-urea breath test 4 wk later,after treatment completion. The eradication rates were determined by intention-to-treat and per-protocol analyses.RESULTS: In total,60 and 38 patients received 1-wk and 2-wk moxifloxacin-containing triple therapy,respectively. The intention-to-treat and per-protocol eradication rates were 56.7%(95%CI: 45.0-70.0) and 59.6%(95%CI: 46.6-71.7) in the 1-wk group and 76.3%(95%CI: 63.2-89.5) and 80.6%(95%CI: 66.7-91.9) in the 2-wk group(P = 0.048 and 0.036,respectively). All groups had good compliance(95% vs 94.9%). Neither group showed serious adverse events,and the proportions of patients experiencing mild side effects were not significantly different(21.1% vs 13.9%). Clinical factors such as age,sex,alcohol and smoking habits,comorbidities,and presence of gastric or duodenal ulcer did not influence the eradication therapy efficacy. The efficacy of second-line eradication therapy did not differ significantly according to the firstline regimen.CONCLUSION: Two-week moxifloxacin-containing triple therapy showed better efficacy than a 1-wk regimen after non-bismuth quadruple therapy failure.Key words: Helicobacter pylori; Moxifloxacin-based triple; Non-bismuth quadruple; Second-line; Eradication     

Does delayed gastric emptying shorten the H pylori eradication period？ A double blind clinical trial

INTRODUCTION H pylori has been implicated as a predisposing factor in gastric cancer, chronic active gastritis, duodenal ulcer, gastric ulcer and gastric lymphoma[1]. The incidence rate of stomach cancer in Iran is high, well above the world average; it i…     

Various durations of a standard regimen (amoxycillin, metronidazole, colloidal bismuth sub-citrate for 2 weeks or with additional ranitidine for 1 or 2 weeks) on eradication of Helicobacter pylori in Iranian peptic ulcer patients. A randomized controlled trial

INTRODUCTION: One of the most economical and effective therapeutic regimens for eradication of Helicobacter pylori is the classic triple therapy with amoxycillin or tetracycline, metronidazole and a bismuth derivative. Addition of H2-receptor antagonists to these drugs may heighten the rate of eradication and shorten the duration. We therefore performed a randomized controlled trial comparing twice daily metronidazole, bismuth derivative and amoxycillin for 2 weeks with additional ranitidine for 1 or 2 weeks. PATIENTS AND METHODS: In total, 240 adult patients with duodenal ulcer and H. pylori infection were randomly assigned to one of the following regimens: (1) amoxycillin 1 g bid, metronidazole 500 mg bid, bismuth sub-citrate 240 mg bid and ranitidine 300 mg bid for 1 week; (2) triple therapy without ranitidine for 2 weeks; or (3) triple therapy plus ranitidine 300 mg bid for 2 weeks. Side-effects of the drugs were evaluated two weeks after starting the treatment. The rapid urease test and histology from antrum and corpus, and/or 14C- urea breath test were used to determine H. pylori eradication six weeks after starting the treatment. RESULTS: In total, 195 patients were followed up for 6 weeks. The most frequent drug side-effects were unpleasant taste (46%), dry mouth (41%) and fatigue (26%), which had an equal distribution in all treatment groups. Endoscopy and 14C- urea breath test were performed for 178 and 123 patients, respectively. Eradication of H. pylori was documented in 19/64 (29.7%), 29/63 (46%) and 50/68 (73.5%) of patients in groups 1, 2 and 3, respectively (P < 0.000001 for group 1 versus group 3; P < 0.0014 for group 2 versus group 3; difference not significant for group 1 versus group 2). An intention-to-treat analysis showed eradication rates of 19/80 (23.75%), 29/80 (36.25%) and 50/80 (62.5%) for groups 1, 2 and 3, respectively. At four weeks post-treatment, the most sensitive test for evaluation of eradication of H. pylori was histology. CONCLUSION: Although combined use of an H2-receptor antagonist and twice daily triple therapy in a two-week regimen is more effective than two-week triple or one-week quadruple therapy in Iranian patients, none of these regimens is ideal in countries with a probable high rate of resistant and strongly toxic strains of H. pylori.     

3种幽门螺杆菌根除方案和抗生素耐药对其根除率的影响

背景:目前推荐的根除幽门螺杆菌(H.pylori)的治疗方案因H.pylori对大环内酯类和硝基咪唑类抗生素的耐药性快速增加而不能令人满意。目的:评估以质子泵抑制剂(PPI)为基础或以H2受体拮抗剂(H2RA)加铋剂为基础的三联或四联疗法根除H.pylori的疗效和安全性,评估H.pylori的耐药性及其对根除率的影响。方法:120例H.pylori感染的愈合期十二指肠球部溃疡或非溃疡性消化不良患者随机分入3个治疗组,疗程7天。A组:奥美拉唑、克拉霉素和替硝唑;B组:法莫替丁、枸橼酸铋钾、克拉霉素和替硝唑;C组:法莫替丁、枸橼酸铋钾、呋喃唑酮和四环素。根除治疗前取胃窦黏膜活检组织行快速尿素酶试验、H.pylori培养和组织学检查评估H.pylori感染状态。治疗结束后4～6周,采用13C-尿素呼气试验评估H.pylori根除情况。琼脂扩散法药物敏感试验测定抗生素的最小抑菌浓度(MIC)。结果:所有患者均完成治疗和随访。A组、B组和C组的H.pylori根除率分别为80%(32/40)、85％(34/40)和90％(36/40),3组间无显著差异(P>0.05)。耐药菌株与敏感菌株的H.pylori根除率有显著差异。结论:以PPI为基础或以H2RA加铋剂为基础的三联或四联疗法对H.pylori具有较高的根除率。H.py-lori的耐药性是影响根除率的主要因素。     

One-week dual therapy with ranitidine bismuth citrate and clarithromycin for the treatment of Helicobacter pylori infection in Brazilian patients with peptic ulcer

AIM: To assess the efficacy and safety of ranitidine bismuth citrate plus clarithromycin given for 1 wk in Brazilian patients with peptic ulcer. METHODS: One hundred and twenty patients with peptic ulcer were randomized in two treatment groups: (1)1-wk regimen consisting of ranitidine bismuth citrate 400 mg b.i.d. with clarithromycin 500 mg b.i.d. or (2) 2-wk regimen of the same treatment. Eradication of the infection was considered when both the histologic examination and the urease test were negative for the infection 3 mo after treatment. RESULTS: By intention to treat analysis, Helicobacter pylori (H pylori) was eradicated in 73% and 76% of patients, respectively treated for 1 or 2 wk (P>0.05). By per protocol analysis, the eradication rates were 80% and 83%, respectively, in patients treated for 1 or 2 wk (P>0.05). Nine patients (8.2%) reported minor side effects. CONCLUSION: One-week therapy with ranitidine bismuth citrate and clarithromycin is safe, well tolerated and effective for treatment of H pylori infection, and appears to be comparable to the 2-wk regimen in terms of efficacy.x     

Comparison of four-day and seven-day pantoprazole-based quadruple therapy as a routine treatment for Helicobacter pylori infection

BACKGROUND: H. pylori eradication is usually performed with three or four drugs for at least seven days. Recently four reports have shown a cure rate of approximately 90% using a four-day quadruple therapy. The objectives of this prospective study were: 1) to evaluate the efficacy of pantoprazole-based quadruple therapy, and 2) to compare the efficacy and tolerability of four-day with seven-day quadruple therapy. METHODS: The study was performed in a single centre. The first 56 consecutive patients with nonulcer dyspepsia or peptic ulcer disease and proven H. pylori infection received seven days of quadruple therapy (pantoprazole, bismuth, tetracycline and metronidazole). At least six weeks after treatment, endoscopy was repeated with six biopsies of the antrum and corpus for histology, urease test and culture. The next 59 consecutive patients followed the same protocol but received four-day quadruple therapy. RESULTS: Using an intention-to-treat analysis, the cure rate in the seven-day treatment group was 54/56 (96.4%, 95% confidence interval (CI) 87.7-99.6%). In the per protocol analysis the cure rate was 53/55 (96.3%, 95% CI 87.5-99.6%). Primary metronidazole resistance was observed in seven patients. All were cured. Using an intention-to-treat analysis, the cure rate in the four-day treatment group was 51/59 (86.4%, 95% CI 75.0-94.0%). In the per protocol analysis the cure rate was 50/58 (86.2%, 95% CI 74.6-93.8%). Primary metronidazole resistance was observed in seven patients, four of whom were cured. In three out of eight patients in whom four-day treatment failed, secondary metronidazole resistance was induced. Both treatment regimens were well tolerated. The difference between cure rates of both regimens did not reach statistical significance (p=0.0585). CONCLUSION: Routine use of both four-day and seven-day pantoprazole-based quadruple anti-H. pylori treatment is effective and well tolerated. The results of both regimens reach the required eradication standard, but results with the seven-day regimen were slightly but not significantly better. Seven-day treatment may be superior, especially in case of metronidazole resistance, and should be preferred.     

幽门螺杆菌根除治疗失败后的补救治疗

幽门螺杆菌（H.pylori)对抗生素的耐药率上升是导致根除治疗失败率上升的主要原因，对经标准方案根除H.pylori失败的患者有必要进行补救治疗。目的：评估铋剂、质子泵抑制剂（PPI）联用呋喃唑酮和四环素组成的7天四联方案用于根除H.pylori治疗失败后补救治疗的疗效，以及H.pylori耐药对疗效的影响。方法：予35例经含克拉霉素根除H.pylori方案治疗、H.pylori仍为阳性的患者以为期7天的四联治疗：枸橼酸铋钾220mg bid 奥美拉唑20mg bid 呋喃唑酮100mg bid 四环素750mg bid。治疗前取胃窦黏膜活检标本进行快速尿素酶试验、组织学检查和培养检测H.pylori。用琼脂扩散法测定克拉霉素、呋喃唑酮和四环素的最低抑菌浓度（MIC）。治疗结束后至少4周，采用^13C-尿素呼气试验进行H.pylori感染状态评估。结果：33例患者完成治疗和随访，2例失访。根据意图治疗（ITT）和试验方案（PP）分析，该补救方案的H.pylori根除率分别为68．6％（24／35）和72．7％（24／33）。10例（28．6％）患者发生轻度副反应（9例发生恶心、中上腹不适，1例发生皮疹）。35例中有27例H.pylori培养成功，克拉霉素的耐药率为51．8％（14／27），呋喃唑酮为3．7％（1／27），四环素为7．4％（2／27）。各药物耐药菌株和敏感菌株的H.pylori根除率无显著差异。结论：铋剂、PPI联用呋喃唑酮和四环素组成的7天联方案作为根除H.pylori治疗失败后的补救治疗可获得较高的H.pylori根除率。     

Pooled analysis on the efficacy of the second-line treatment regimens for Helicobacter pylori infection.

BACKGROUND: Although many of the currently available Helicobacter pylori eradication regimens fail to cure 5%-12% of patients, an optimal re-treatment therapy for eradication-failure patients has still not been established. The aim of this study was to examine all reports concerning the efficacy of re-eradication regimens for H. pylori infection, and to establish optimal re-eradication regimens. METHODS: Studies concerning re-eradication regimens were retrieved from the MEDLINE database, reference lists and major congress abstract lists up through December 1999. Data from all selected reports were pooled into several groups depending on second-line or initial therapies. Pooled eradication rates of re-treatment regimens were compared using Fisher's exact test (P < 0.05). RESULTS: Sixteen articles and 24 abstracts with 75 total treatment arms were included in this study. Pooled re-eradication rates by proton-pump inhibitor (PPI)-based dual therapy, PPI-based triple therapy, ranitidine bismuth-based triple therapy and quadruple therapy were 45.8%, 69.8%, 80.2% and 75.8%, respectively. Eradication rates from studies with two new antimicobials added were higher than rates from studies with only one new antimicrobial added (P = 0.0064). CONCLUSION: Ranitidine bismuth-based triple therapies, as well as quadruple therapies, seem to be the most effective re-treatment therapies in all currently undertaken therapies. The strategy of adding two new antimicrobials to previous regimens was also effective in re-eradication therapy.     

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。     

Eradication of Helicobacter pylori improves the healing rate and reduces the relapse rate of nonbleeding ulcers in patients with bleeding peptic ulcer

OBJECTIVE: A causal relationship between Helicobacter pylori (H. pylori) and peptic ulcer complications remains obscure. The aim of this study was to determine the importance of H. pylori and other risk factors for healing rate, ulcer recurrence, and rebleeding in patients with bleeding peptic ulcer. METHOD: A total of 223 patients with H. pylori positive bleeding peptic ulcer were randomly allocated to three treatment groups: 1) quadruple therapy (QT) (88 patients); 2) dual therapy (DT) (88 patients); and 3) omeprazole and placebo therapy (OPl) (47 patients). Endoscopic assessment was performed initially and at 8 and 52 wk. Ulcer healing and eradication rates were assessed; endpoints were ulcer relapse and ulcer rebleeding during 52 wk. RESULTS: Results after 8 and 52 wk were available for 211 and 179 patients, respectively. Eradication rate was 100% (95% CI = 96-100%) in the QT, 84% (95% CI = 74-91%) in the DT, and 4% (95% CI = 1-15%) in the OPl group. Ulcer healing rate was 95% (95% CI = 91-98%) in H. pylori negative and 8% (95% CI = 70-91%) in H. pylori positive patients. Ulcer relapses occurred in 2% (95% CI = 0.5-6%) of H. pylori negative and in 38% (95% CI = 24-54%) of H. pylori positive patients, and rebleeding occurred in five patients (three H. pylori positive and two negative). CONCLUSIONS: Eradication of H. pylori infection enhances healing of bleeding peptic ulcers after endoscopic therapy. H. pylori infection is an important independent risk factor for relapsing of nonbleeding ulcers in patients with bleeding peptic ulcer.     

1999年幽门螺杆菌若干问题的共识意见发表3年后的调查报告

背景：我国为幽门螺杆菌(H．pylori)感染高发地区。1999年制定的H.pylori若干问题的共识意见有助于临床医师正确诊治H.pylori感染患者。目的：了解共识意见发表3年后我国临床医师如何处理H.pylori感染。方法：设计由16个问题组成的问卷调查表，在中华医学会消化病学分会网站和医学空间网站上公布。结果：共收到合格答卷511份，57．1％的医师经常检查H.pylori感染。常用的检测方法是：快速尿素酶试验(RUT)60％，尿素呼气试验(UBT)40％，组织病理学检查36％。治疗H.pylori感染时，74．5％的医师选择三联疗法，19．0％选择四联疗法，5．7％选择二联疗法。50％的医师选用质子泵抑制剂(PPI) 两种抗生素，41％选用铋剂 两种抗生素，34％选用H2受体阻滞剂(H2RA)／PPI 铋剂 两种抗生素，14％选用雷尼替丁构橡酸铋(RBC) 两种抗生素；45％的医师选用呋喃唑酮。93％的医师认为H．pylori耐药是一严重问题。95％的医师选用四联疗法作为补救治疗，或更换更敏感的药物，或增加抗生素的剂量和疗程。83％的医师根除治疗后复查H.pylori感染情况。52％的医师获取诊治H.pylori感染相关信息的来源为1999年H.pylori处理共识意见。结论：共识意见对临床医师正确处理H.pylori感染起重要作用。     

One-Week Triple Therapy With Ranitidine Bismuth Citrate, Clarithromycin and Metronidazole Versus Two-Week Dual Therapy With Ranitidine Bismuth Citrate and Clarithromycin for Helicobacter pylori Infection: A Randomized, Clinical Trial

Objective: The aim of this study was to compare the efficacy and side effects of 1-wk triple therapy with ranitidine bismuth citrate (RBC) 400 mg b.i.d. , clarithromycin 500 mg b.i.d. , and metronidazole 500 mg b.i.d. , to 2-wk dual therapy with RBC 400 mg b.i.d. and clarithromycin 500 mg b.i.d. for H. pylori infection in a randomized, clinical trial.
Methods: Patients (18–80 yr) with a culture proven H. pylori infection were randomized to one of these regimens. Side effects were scored on a semiquantitative scale. Endoscopy was performed ≥4 wk after treatment. Antral biopsy samples were taken for hematoxylin-eosin stain (HE), rapid urease test, and culture and corpus samples for culture and HE. Two weeks after the endoscopy, a ¹³C-urea breath test was performed. Eradication failure was defined as detection of H. pylori by culture or by at least two other tests.
Results: A total of 104 patients, 54 men, age 54 ± 14 yr, (36 duodenal ulcer, 16 gastric ulcer, and 52 functional dyspepsia) were included. Gender, age, and diagnosis were comparable in both groups. Fourteen of 52 patients in both triple and dual therapy, respectively, had significant side effects, but all patients completed the course. Eradication results were 49 of 52 (94%; 95% CI: 84–99%) and 50 of 52 (96%; 95% CI: 87–100%) on intention to treat analysis and 44 of 46 (96%; 95% CI: 85–99%) and 48 of 49 (98%; 95% CI: 89–100%) on per protocol analysis for triple and dual therapy respectively.
Conclusion: Both regimens are very effective and well tolerated in the treatment of H. pylori infection. The triple regimen has the advantage of being shorter.     

Adverse events with bismuth salts for Helicobacter pylori eradication： Systematic review and meta-analysis

AIM： To assess the safety of bismuth used in Helicobacter pylori （H pylorl） eradication therapy regimens. METHODS： We conducted a systematic review and meta-analysis. MEDLINE and EMBASE were searched （up to October 2007） to identify randomised controlled tri- als comparing bismuth with placebo or no treatment, or bismuth salts in combination with antibiotics as part of eradication therapy with the same dose and duration of antibiotics alone or, in combination, with acid suppresion. Total numbers of adverse events were recorded. Data were pooled and expressed as relative risks with 95% confidence intervals （CI）.RESULTS： We identified 35 randomised controlled trials containing 4763 patients. There were no serious adverse events occurring with bismuth therapy. There was no statistically significant difference detected in total adverse events with bismuth rrelative risk （RR） = 1.01; 95% CI： 0.87-1.16], specific individual adverse events, with the exception of dark stools （RR = 5.06; 95% CI： 1.59-16.12）, or adverse events leading to withdrawal of therapy （RR = 0.86; 95% CI： 0.54-1.37）. CONCLUSION： Bismuth for the treatment of H py/ori is safe and well-tolerated. The only adverse event occurring significantly more commonly was dark stools.     

One-week ranitidine bismuth citrate versus colloidal bismuth subcitrate-based anti-Helicobacter triple therapy: a prospective randomized controlled trial

OBJECTIVE: The efficacy of 1 wk bismuth triple therapy is adversely influenced by the presence of metronidazole resistance. In vitro studies suggest that ranitidine bismuth citrate (RBC) plus metronidazole exhibit synergistic activity against metronidazole resistant strains of Helicobacter pylori (H. pylori). Whether this confers a superior clinical efficacy remains unproven. This study compared the efficacy of RBC-based triple therapy with bismuth triple therapy in eradication of H. pylori. METHODS: Patients with H. pylori-related ulcer disease or gastritis were randomized to receive either 400/mg of RBC twice daily plus 400/mg of metronidazole and 500/mg of tetracycline four times daily for 1 wk (RMT) or 120/mg of colloidal bismuth subcitrate, 400/mg of metronidazole, and 500/mg of tetracycline, all given four times daily for 1 wk (BMT). Metronidazole susceptibility was determined by the E-test and pretreatment resistance was defined as minimum inhibitory concentration > or = 32/mg/L. RESULTS: Of 100 consecutive patients randomized, two patients were lost to follow-up in each group. Forty-three of 85 (51%) H. pylori isolates were metronidazole resistant. Per-protocol cure rate for RMT and BMT was 40 of 41 (98%) and 37 of 44 (84%), respectively (p = 0.058). Intent-to-treat cure rate for RMT and BMT was 46 of 50 and 41 of 50, respectively (92% vs 82%, p = 0.23). A significantly higher eradication of metronidazole resistant H. pylori was observed in the RMT group (25 of 25, 100%) than in the BMT group (12 of 16, 75%), (p = 0.018). Side effects observed in the two treatment groups were comparable. CONCLUSIONS: One week of RBC triple therapy with metronidazole and tetracycline is an effective anti-Helicobacter therapy. This regimen is more appropriate in areas of high prevalence of metronidazole resistance.     

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.