Ranitidine bismuth citrate in the treatment of Helicobacter pylori infection.

OBJECTIVE: Examine the effectiveness of treatments that include ranitidine bismuth citrate (RBC) for Helicobacter pylori infection. DESIGN: Prospective and randomised study. PATIENTS AND METHOD: 137 patients were included (62 women, 75 males, average age 46.9 +/- 13) diagnosed with peptic ulcer and infection by Helicobacter pylori. None had received treatment previously. 67 patients were treated with RBC 400 mg bd and clarithromycin 500 mg bd for 14 days, and 70 patients with RBC 400 mg bd, clarithromycin 500 mg bd and amoxycillin 1 g bd for 7 days. The infection eradication was proven eight weeks after treatment end. The efficacy of treatment was evaluated using the intention-to-treat method. The Chisquare test (chi 2) was used for the statistical analysis of data. RESULTS: Infection in 48 out of 67 patients (71.64%) treated with RBC-clarithromycin for 14 days was eradicated, versus 88.57% (62 out of 70) among those treated with RBC-clarithromycin-amoxycillin for 7 days, with a significant difference between both regimens (p < 0.05). CONCLUSIONS: 7-day treatment with RBC-clarithromycin-amoxycillin has a good eradication rate (88.57%) and represents a valid alternative to regimens including a PPI and two antibiotics, as both regimens have a similar efficacy. Results obtained with the double therapy of RBC-clarithromycin for 14 days were not satisfactory, the rate of eradication being 71.64%. The use of an RBC treatment for Helicobacter pylori infection should always be accompanied by two antibiotics in a triple therapy.     

Ranitidine bismuth citrate or omeprazole-based triple therapy for Helicobacter pylori eradication in Helicobacter pylori- infected non-ulcer dyspepsia

AIM: To test the eradication rate of Helicobacter pylori by ranitidine bismuth citrate-based triple therapy, and evaluate the symptomatic response of Helicobacter pylori eradication therapy for non-ulcer dyspepsia. METHODS: A total of 59 consecutive Helicobacter pylori infected non-ulcer dyspepsia patients were randomly selected to receive either one of two triple therapy regimens, including metronidazole, amoxycillin plus ranitidine bismuth citrate (RAM group) or omeprazole (OAM group). To determine the success of eradication, patients underwent the 13C-urea breath test, 6 weeks and one year after treatment. The dyspeptic symptom scores were also assessed at the time of enrolment, 6 weeks and one year after treatment. RESULTS: Per-protocol and intention-to-treat eradication rates were 77.7% and 70% in RAM group and 83.8% and 68.9% in OAM group (p = non significant). At both the 6th week and at the first year after treatment, the mean symptom scores were lower than pre-treatment scores in the study population, regardless of whether treatment was successful or not. However, patients, whether eradicated successfully or not-eradicated, presented similar 6-week and 1-year scores. CONCLUSIONS: One-week RAM triple therapy, which is cheaper than the OAM regimen, is a relatively effective alternative regimen for Helicobacter pylori eradication in Taiwanese. Triple therapy for Helicobacter pylori eradication was not the whole management for the relief of dyspeptic symptoms of non-ulcer dyspepsia patients.     

Gastroprotective effect of ranitidine bismuth citrate is associated with increased mucus bismuth concentration in rats.

BACKGROUND: Antisecretory and bismuth compounds protect the gastric mucosa from injury resulting from non-steroidal anti-inflammatory drugs. AIM: To study the mechanism underlying the gastroprotective effects of ranitidine bismuth citrate (GG311) in rats. METHODS: Indomethacin rat injury model and in vivo microscopy in which acid output, surface cell intracellular pH (pHi), gastric mucus gel thickness, and mucosal blood flow were measured simultaneously. RESULTS: In injury studies, GG311 dose dependently protected against severe injury induced by indomethacin (60 mg/kg subcutaneously). In in vivo microscopic studies, indomethacin significantly decreased mucus gel thickness and increased the initial rate of acidification of gastric surface cells when the superfusate pH was lowered from 7.4 to 1.0, and impaired pHi during acid exposure. Indomethacin had no effect on mucosal blood flow or acid output. GG311 alone had no effect on gel thickness, blood flow, or pHi homeostasis during acid exposure, but improved the initial acidification rate and pHi during superfusion with pH 1.0 solutions in the presence of indomethacin. In separate experiments, indomethacin pretreatment considerably increased gastric mucus bismuth concentrations in rats given GG311. CONCLUSIONS: The gastroprotective effect of GG311 against indomethacin induced gastric injury is associated with high and prolonged gastric mucus bismuth concentrations, which may impair proton permeation across the mucus gel.     

Effect of ranitidine bismuth citrate on postprandial plasma gastrin and pepsinogens.

Ranitidine bismuth citrate was compared with an equipotent dose of ranitidine, to determine whether the former, by an anti-Helicobacter pylori activity, would counteract the rise of gastrin resulting from ranitidine's gastric acid antisecretory activity. Twenty four men with duodenal ulcers were studied before and on the 8th day of dosing with either ranitidine bismuth citrate 800 mg twice daily or ranitidine 300 mg twice daily (double blind, randomised, parallel groups). Fasting and postprandial plasma gastrin and plasma pepsinogen I and II concentrations were measured, and a 13C-urea breath test was performed before and on the 8th day of dosing. The 13C-urea breath tests were positive in 21 patients before dosing and remained positive in nine of nine of the ranitidine dosed patients, whereas only two of 12 patients treated with ranitidine bismuth citrate remained positive. The expected rise in meal stimulated plasma gastrin with ranitidine was seen in the 12 patients who received ranitidine but, despite suppression of H pylori urease activity in 10 of 12 patients taking ranitidine bismuth citrate, there was no attenuation of the meal stimulated gastrin rise. There was no significant difference in the mean derived (4 hour) plasma pepsinogen I and II concentrations after dosing with ranitidine or ranitidine bismuth citrate.     

Histochemical tracing of bismuth in Helicobacter pylori after in vitro exposure to bismuth citrate

BACKGROUND: Bismuth-containing drugs are widely used in the treatment of Helicobacter pylori associated peptic ulcer. The mechanism of action of bismuth salts is, however, not fully understood, and at present no histochemical techniques for the demonstration of bismuth in H. pylori are available. The aims were to present a histochemical method for the detection of bismuth in H. pylori and to demonstrate bismuth uptake in H. pylori after in vitro exposure to bismuth citrate. METHODS: H. pylori cultures (the strain used in this study was CCUG 17874), were exposed to bismuth citrate at different concentrations (0, 4.6, 80, 200 microM) and for different lengths of time (0 min, 15 min, 1 h, 24 h, 48 h). The samples were fixed in glutaraldehyde, centrifuged, and exposed to autometallographic (AMG) development in order to detect bismuth histochemically. RESULTS: A detailed protocol on the AMG bismuth technique on H. pylori exposed to bismuth in vitro is given. This method results in easily detectable AMG grains of silver enhanced bismuth particles at the electron microscopical level, and shows that bismuth accumulates in H. pylori, predominantly near the wall of the bacteria. Bismuth uptake is followed by bacterial degeneration. CONCLUSION: The present technique with its ability to trace bismuth constitutes a valuable tool in the efforts of clarifying the mechanism of action of bismuth on H. pylori, and supports the notion that bismuth has an antimicrobial activity in itself.     

Comparison of ranitidine bismuth citrate, tetracycline and metronidazole with ranitidine bismuth citrate and azithromycin for the eradication of Helicobacter pylori in patients resistant to PPI based triple therapy.

BACKGROUND/AIMS: Helicobacter pylori is the most common infectious disease all over the world. Ten to twenty percent of the patients remain infected despite treatment with proton pump inhibitors (PPIs), amoxicillin and clarithromycin. We compared PPI, bismuth, tetracycline and metronidazole with ranitidine bismuth citrate, tetracycline and metronidazole in cases resistant to PPIs-based triple therapies. METHODS: The study included 52 patients who underwent a triple therapy with PPI, clarithromycin and amoxicillin for 14 days between September 2001 and December 2002, and were found to be resistant to the therapy. They were randomized to take ranitidine bismuth citrate (Rb) 400 mg twice a day, tetracycline (T) 1 g twice a day and metronidazole (M) 500 mg three times a day for 14 days (RbTM), or ranitidine bismuth citrate (Rb) 400 mg twice a day for 14 days and azithromycin (A) 500 mg once a day for 7 days (RbA). Four weeks after the treatment, endoscopies were repeated, and patients were assessed with respect to changes in symptoms. When H. pylori was negative on histological analysis and urease test, eradication was achieved. RESULTS: A total of 52 patients, 32 females and 20 males with a mean age of 49+/-12 years, were included in the study. Eradication was achieved in 15 (28%) out of 52 patients in total. There was a significant difference between RbA and RbTM groups (p=0.01). In fact, H. pylori was eradicated in 3 (12%) out of 25 patients in the RbA group, whereas it was eradicated in 12 (44.4%) out of 27 patients in the RbTM group. Symptom scores significantly improved in both groups after the treatment, though there was not a significant difference between the groups (p=0.705). CONCLUSIONS: Triple therapy including azithromycin does not seem to be a good choice in cases resistant to the first line therapies; however, a similarly lower rate of eradication was achieved with the quadruple therapy proposed. Therefore, different treatment schemes should be applied in resistant patients, and further studies are needed as well.     

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.     

Ranitidine bismuth citrate-based triple therapies as a second-line therapy for Helicobacter pylori in Turkish patients

BACKGROUND: Quadruple therapy with a proton pump inhibitor, bismuth, metronidazole and tetracycline is recommended as the optimal second-line therapy of Helicobacter pylori infection in the Maastricht Consensus Report. The aim of the present paper was to evaluate the efficacy of ranitidine bismuth citrate (RBC)-based regimens as second-line therapies after failure of the standard Maastricht triple therapy. MATERIALS AND METHODS: One hundred and sixteen H. pylori-positive patients were given omeprazole 20 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d for 10 days. Patients remaining H. pylori-positive (n = 29) were combined with 27 patients enrolled after an initial eradication failure from proton-pump inhibitor (PPI), amoxicillin and clarithromycin therapy for at least 7 days and were randomly given one of the following second-line 10-day treatments: RBC 400 mg b.d., amoxicillin 1 g b.d and clarithromycin 500 mg b.d. (RAC group, n = 28) and RBC 400 mg b.d., metronidazole 500 mg b.d and tetracycline 500 mg b.d. (RMT group, n = 28). Eradication was assessed by either histology and rapid urease test or (13)C urea breath test 8 weeks after therapy. RESULTS: The eradication rate of first-line Maastricht therapy was 67% for intention-to-treat analysis (95% confidence interval [CI]: 58-75). Per-protocol and intention-to-treat eradication was achieved in 60.7% of patients (95%CI: 42-79) in the RAC group and in 85.7% of patients (95%CI: 73-98) in the RMT group (P = 0.03). Fifty-three percent of patients in the RAC and 50% of patients in the RMT group experienced at least one slight side-effect (P = 0.6). CONCLUSIONS: RMT is an effective and well-tolerated second-line therapy after H. pylori eradication failure from PPI, amoxicillin, and clarithromycin.     

以枸橼酸铋雷尼替丁为基础的三联疗法根除幽门螺杆菌的系统评价

目的 评价国产枸橼酸铋雷尼替丁(瑞倍)根除幽门螺杆菌(H.pylori)的疗效.方法 检索1995年1月至2008年10月中国生物医学文献数据库(CBM)、手工检索发表与未发表的中文文献,应用国际Cochrane协作网系统评价方法 收集比较瑞倍为主的三联方案与质子泵抑制剂(PPI)治疗根除H.pylori的随机对照试验(RCT).数据采用RevMan 4.2进行统计分析.结果 12篇文献共1254例患者满足纳入标准.经meta分析显示,瑞倍根除H.pylori疗效和对照组比较差异无统计学意义(OR 1.30,95%CI:0.94～1.81,P=0.12).试验未发现严重副反应.结论 瑞倍为主的三联方案根除H.pylori是一个值得选用的治疗方法 .     

枸橼酸铋钾对幽门螺杆菌耐药菌株体外抗菌活性研究

目的铋制剂被广泛应用于幽门螺杆菌（H．pylori）感染的根除治疗，目的在于了解枸橼酸铋钾在体外对H．pylori耐药菌株是否存在抗菌活性及枸橼酸铋钾在体外对甲硝唑和克拉霉素抗H．pylori耐药菌株活性的影响。方法选取H．pylori标准菌株NCTC11637（对照）和8株l临床分离H．pylori耐药菌株作为实验菌株：抑菌研究采用琼脂稀释法测定枸橼酸铋钾对H．pylori菌株的最小抑菌浓度（MIC），通过E试验法在含枸橼酸铋钾培养基和普通培养基上分别测定甲硝唑或克托霉素对H．pylori菌株的MIC值。杀菌研究采用时间一杀菌曲线法，分别在含有枸橼酸铋钾、甲硝唑、克拉霉素及枸橼酸铋钾与甲硝唑或克拉霉素混合物的液体培养基中对H．pylori标准菌株NCTC11637及l临床分离的H．pylori耐药菌株进行培养，分别计算空白对照组和各实验组0、4、8、24h的细菌数量，采用半对数法绘制时间-杀菌曲线：结果枸橼酸铋钾对H．pylori标准菌株及临床分离的H．pylori耐药菌株平均MIC值为2．6mg／L（铋）：枸橼酸铋钾降低甲硝哗和克拉霉素对H．pylori耐药菌株的MIC值。枸橼酸铋钾1mg／L（铋）对标准菌株H．pylori11637具有明显的体外杀菌作用，4mg／L（铋）对临床分离耐药菌株也具有明显的体外杀菌作用，其杀菌效果随剂量增加而增强：、枸橼酸铋钾与抗生素混合物对H．pylori标准菌株及临床耐药菌株的体外杀菌作用增强。结论枸橼酸铋钾对H．pylori标准菌株及临床分离的H．pylori耐药菌株均有体外抑菌和杀菌作用，并且与甲硝唑或克拉霉素联用对标准菌株及临床分离的H．pylori耐药菌株具有体外协同抑菌或杀菌作用。     

Comparison of bismuth citrate and 5-aminosalicylic acid enemas in distal ulcerative colitis: a controlled trial.

An enema that contained a complex of bismuth citrate and polyacrylate was compared with 5-aminosalicylic acid (5-ASA) enemas for treatment of distal ulcerative colitis. The multicentre trial involving 63 patients was randomised and double blind with enemas given over four weeks; clinical, sigmoidoscopic, and histological assessments were made. Improvements were seen in both treatment groups. Clinical remission was seen in 18 of 32 patients treated with 5-ASA and 12 of 31 patients treated with bismuth citrate-carbomer (chi 2 1.94; p = 0.16). Sigmoidoscopic remission occurred in 20 of 32 patients in the 5-ASA group and 15 of 31 patients given bismuth (chi 2 1.27; p = 0.26). Improvement of rectal biopsy histology by at least one grade was seen in 16 of 32 patients in the 5-ASA group and 14 of 31 patients with bismuth (chi 2 0.15; p = 0.70). Analysis of covariance gave no significant difference between groups, although there was a trend favouring 5-ASA. There was no evidence of bismuth accumulation during the trial. Bismuth enemas may offer a new therapeutic option in distal ulcerative colitis.     

Clinical observation of rabeprazole combined with bismuth potassium citrate in treatment of peptic ulcer

目的 评价雷贝拉唑联合枸橼酸铋钾治疗幽门螺杆菌(Hp)感染活动性消化性溃疡(PU)的临床疗效、安全性及复发率.方法 将160例消化性溃疡患者分为治疗组和对照组(各80例).治疗组予以雷贝拉唑+枸橼酸铋钾+阿莫西林克拉维酸钾+呋喃唑酮四联方案,共7天,继予雷贝拉唑+硫糖铝抗溃疡治疗,十二指肠溃疡患者疗程4周,胃溃疡患者疗程8周.对照组予奥美拉唑+阿莫西林克拉维酸钾+呋喃唑酮三联方案,共7天,继予奥美拉唑+硫糖铝抗溃疡治疗,十二指肠溃疡患者疗程4周,胃溃疡患者疗程8 周.完成全疗程4周后复查14C-尿素呼气试验及胃镜检查.结果 两组患者治疗1周后,症状改善显效率均达到95.00％以上;治疗组Hp根治率为95.00％,对照组为81.25％,两组比较差异有统计学意义(P＜0.01);治疗组溃疡总愈合率为93.75％,对照组为78.75％,两组比较差异有统计学意义(P＜0.(01);两组不良反应发生率均较低,两组比较差异无统计学意义(P＞0.05);治疗组1年随访消化性溃疡复发率和Hp复阳率分别为8.86％和12.66％,对照组分别为27.40％和35.62％,两组比较差异均有统计学意义(P＜0.01).结论 雷贝拉唑联合枸橼酸铋钾方案治疗活动性消化性溃疡能迅速控制临床症状,促进溃疡早期愈合,具有Hp根治率高,小良反应少,疗效可靠的特点.     

Effectiveness of ranitidine bismuth citrate, clarithromycin, and metronidazole therapy for treating Helicobacter pylori

OBJECTIVE: There are limited data available from the United States on the effectiveness of ranitidine bismuth citrate (RBC) plus two antibiotics to treat Helicobacter pylori. Therefore, the following study was undertaken to evaluate RBC with two antibiotics, which have been used successfully in combination, to treat H. pylori. METHODS: Adults with and without abdominal symptoms, who had never received H. pylori eradication therapy, were tested for the presence of H. pylori infection either by in-office rapid serology assays or histology. Positive subjects were administered the 13C-urea breath test. Subjects who had a positive urea breath test were then treated with RBC 400 mg b.i.d., clarithromycin 500 mg b.i.d., and metronidazole 500 mg b.i.d. for 10 days. Four to 6 wk after completing antibiotics all subjects were asked to return for a second urea breath test to assess treatment success. RESULTS: Forty-seven of the 50 subjects enrolled into this study completed the antibiotic regimen and returned for a repeat urea breath test. Thirty-seven subjects were negative for H. pylori by urea breath test and 10 were positive, resulting in a 79% eradication rate. Seven subjects (14%) stopped their medication because of side effects. When analysis was performed on the 40 subjects who took > or = 80% of their medication (per-protocol), the eradication rate was 90%. CONCLUSIONS: The combination of RBC with clarithromycin and metronidazole successfully treated H. pylori infection after only 10 days of therapy. The per-protocol eradication rate from this study was similar to that seen with Food and Drug Administration (FDA)-approved regimens. In conclusion, RBC plus clarithromycin and metronidazole should be considered as a first-line treatment regimen for H. pylori infection, and may only need to be taken for a period of 10 days, as opposed to 14 days for FDA-approved regimens.     

Duodenal ulcer healing rates in a one-year follow-up study with ranitidine bismuth citrate and antibiotics

BACKGROUND/AIMS: The aim of this study was to determine the one-year outcome of an eradication therapy with ranitidine bismuth citrate and antibiotics in Helicobacter pylori-positive duodenal ulcer patients in respect to ulcer and Helicobacter pylori relapse rates. METHODOLOGY: This multicenter, randomized, double-blind study involved 648 duodenal ulcer patients and had been carried out to compare the following regimens: ranitidine bismuth citrate b.i.d. co-prescribed with either clarithromycin 250 mg q.i.d. or clarithromycin 500 mg b.i.d. or clarithromycin 500 mg b.i.d. plus metronidazole 400 mg b.i.d. for 2 weeks, followed by a further 14 days of treatment with ranitidine bismuth citrate 400 mg b.i.d. to facilitate ulcer healing. H. pylori eradication was assessed by 13C-urea breath test and histology at least 4 weeks, 26 weeks and 52 weeks after the end of treatment. Ulcer relapse and H. pylori status were assessed 4 weeks, 26 weeks and 52 weeks post-treatment or if ulcer symptoms recurred. For the remainder of the follow-up period only serious adverse events were collected. RESULTS: At 12 months data of 438 (69%) patients were evaluable. The observed H. pylori eradication rates were 88-91%. H. pylori relapse rates were 2.1% after 26 weeks and 3.9% after 52 weeks. At the week 26 visit 26 patients (5.6%) and at the week 52 visit 25 patients (5.7%) had documented gastroesophageal reflux disease. CONCLUSIONS: Our data confirm the reduction of duodenal ulcer relapses after the cure of Helicobacter pylori infection.     

Comparison of three triple regimens with omeprazole or ranitidine bismuth citrate for Helicobacter pylori eradication

BACKGROUND: Regimens with ranitidine bismuth citrate (RBC) or omeprazole (O) are effective in eradicating Helicobacter pylori. This randomized, open, multicentre trial compares three different regimens with these drugs. METHODS: Consecutive H. pylori +ve outpatients were included. The alternative regimens were: 1) O 20 mg, clarithromycin (C) 250 mg and metronidazole (M) 500 mg (O.C.M), 2) RBC 400 mg, C 250 mg and M 500 mg (RBC.C.M), 3) RBC 400 mg, tetracycline (T) 1000 mg and M 500 mg [RBC.T.M]. All drugs were given twice daily for 7 days. H. pylori infection was assessed with H. pylori urea breath tests. RESULTS: 426 H. pylori +ve patients were included (mean age 58 years [range 18-88], male/female: 244/182). The eradication rates (intention to treat) in the O.C.M, RBC.C.M and RBC.T.M groups were 117/137 (85%), 141/146 (97%) and 117/143 (82%), respectively (P < 0.001, overall assessment). There were no significant differences in side effects between the alternatives. CONCLUSION: In this trial, RBC.C.M was the most effective one, it was well tolerated and compliance was satisfactory. RBC.T.M is an alternative to regimens with clarithromycin.     

One-week therapy with pantoprazole versus ranitidine bismuth citrate plus two antibiotics for Helicobacter pylori eradication

AIM: A combination of omeprazole plus amoxycillin (Amo) and clarithromycin (CIa) for 7 days has been studied extensively. However, the role of other proton pump inhibitors, such as pantoprazole (Pan), in this therapy is not well known. On the other hand, ranitidine bismuth citrate (RBC) also seems to be effective when combined with Amo and CIa. Our aim was to evaluate and to compare these two novel short-term triple therapies (Pan+Amo+Cla and RBC+Amo+Cla) for treatment of Helicobacter pylori. METHODS: In a randomized clinical trial 150 consecutive patients (38 with duodenal ulcer, 112 with non-ulcer dyspepsia) infected by H. pylori were studied prospectively. Exclusion criteria were: previous H. pylori eradication therapy, gastroerosive drug use, gastric surgery, and associated diseases. One of two regimens was given for 7 days: Pan (40 mg b.i.d.), Amo (1 g b.i.d.), Cla (500 mg b.i.d.) (group Pan+Amo+Cla, n = 75); or RBC (400 mg b.i.d.), Amo (1 g b.i.d.), Cla (500 mg b.i.d.) (group RBC+Amo+Cla, n = 75). All drugs were administered together after meals. Compliance was evaluated by return tablet count. Data were analysed by univariate (chi2) and multivariate (multiple logistic regression) analysis. Eradication was defined as a negative 13C-urea breath test 1 month after completing therapy. RESULTS: The distribution of studied variables (age, gender, smoking, duodenal ulcer/non-ulcer dyspepsia) was similar in both therapy groups. Per-protocol eradication was achieved in 48/71 (68%) in group Pan+Amo+Cla, and in 61/70 (87%) in group RBC+Amo+Cla (P= 0.01). Intention-to-treat (ITT) eradication was achieved in, respectively, 48/ 75 (64%) and in 61/75 (81%) (P= 0.03). The RBC+ Amo+Cla regimen was more effective than Pan+Amo+Cla in non-ulcer dyspepsia patients (ITT, 84% vs 58%; P = 0.005), but statistically significant differences were not demonstrated in duodenal ulcer patients (72% vs 80%). In the multivariate analysis the odds ratio for the effect of the type of therapy on H. pylori eradication in patients with non-ulcer dyspepsia was 3.8 (95% Cl, 1.6-9.3; P = 0.003). No relevant adverse effects were reported with any regimen. CONCLUSION: A RBC+Amo+Cla regimen for only 1 week is a promising therapy for H. pylori infection, due to its high efficacy, simple posology, and excellent tolerability. Combination of Pan with Amo and Cla, although effective in duodenal ulcer patients, but in non-ulcer dyspepsia has not achieved the favourable results previously reported with other proton pump inhibitors.