Three-day lansoprazole quadruple therapy for Helicobacter pylori-positive duodenal ulcers: a randomized controlled study

AIM: To compare the efficacy and tolerability of a 3-day quadruple therapy with a standard 7-day triple therapy in eradicating Helicobacter pylori infection and healing duodenal ulcers. METHODS: Patients with H. pylori-positive duodenal ulcers were randomized to receive either lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 400 mg twice daily for 7 days (LCM-7) or lansoprazole 30 mg, clarithromycin 500 mg, metronidazole 400 mg, and bismuth subcitrate 240 mg twice daily for 3 days (LCMB-3). No pre- or post-treatment acid suppression was used. Follow-up endoscopy was performed at week 6. RESULTS: A total of 118 patients were recruited. Sixty patients in the LCM-7 group and 53 patients in the LCMB-3 group returned for endoscopy. Intention-to-treat eradication rates were 87% and 86% (P=0.94) and per protocol eradication rates were 87% and 94% (P=0.29) in the LCM-7 and LCMB-3 groups, respectively. Per protocol and intention-to-treat ulcer healing rates were 98% and 98% in LCM-7 and 100% and 91% in LCMB-3, respectively. There were no significant differences in efficacy in relation to the initial metronidazole and clarithromycin susceptibility. Significant reduction in the duration of side-effects was found in the LCMB-3 group. CONCLUSION: The 3-day quadruple therapy is highly effective, better tolerated and can be considered as a first-line therapy in duodenal ulcer management.     

Omeprazole versus famotidine in the short-term treatment of duodenal ulcer disease

The efficacy and safety of omeprazole, in 241 patients with active recurrent duodenal ulcer from 21 Italian centres, was studied in a multicentre double-blind randomized trial comparing 20 mg omeprazole o.m. or 40 mg famotidine nocte with endoscopic examination, symptom recording, laboratory screening and gastrin assay. In a per protocol analysis, the duodenal ulcer healing rates for omeprazole and famotidine, documented by endoscopy, were 62% (68/109) and 33% (39/117) after 2 weeks of treatment (P less than 0.001), 92% (96/104) and 80% (86/108) cumulative after 4 weeks (P less than 0.05), and 99% (102/103) and 92% (96/104) after 6 weeks (P less than 0.05), respectively. The results of this trial demonstrate that 20 mg omeprazole o.m. is superior to 40 mg famotidine nocte in duodenal ulcer healing.     

Helicobacter pylori-positive duodenal ulcer: three-day antibiotic eradication regimen

BACKGROUND: The most widely used treatments for ulcer healing and Helicobacter pylori eradication consist of a 1-2 week regimen of a proton pump inhibitor plus two or three antimicrobials. AIMS: To evaluate the efficacy, safety, cost, and tolerance of a three-day regimen with three antibiotics vs. a 10-day treatment with a proton pump inhibitor or vs. a ranitidine bismuth citrate triple therapy. METHODS: Two hundred and twenty-one patients with endoscopically-proven H. pylori-positive duodenal ulcers were recruited to the study. Recruited patients were assigned to one of the following four regimens: (I) omeprazole 40 mg o.m. plus amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. for 10 days (OAC: 55 patients); (ii) omeprazole 40 mg o.m. on days 1-5, plus amoxycillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. on days 3-5 (OACM: 56 patients); (iii) ranitidine bismuth citrate 400 mg b.d. plus amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. for 10 days (RAC: 54 patients); (iv) ranitidine bismuth citrate 400 mg b.d. on days 1-5, plus amoxycillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. on days 3-5 (RACM: 56 patients). Fisher's exact test was used to compare data regarding healing and eradication in the four groups. RESULTS: The intention-to-treat eradication and ulcer healing rates for the RACM regimen were 95% and 98%, respectively. Statistically significant differences were observed, relating to the eradication and healing of ulcers, between RACM and either the RAC or OAC regimens. CONCLUSION: The three-day antibiotic therapy with amoxycillin, clarithromycin and metronidazole in addition to ranitidine bismuth citrate is a very effective anti-H. pylori regimen.     

Omeprazole or ranitidine bismuth citrate triple therapy to treat Helicobacter pylori infection: a randomized, controlled trial in Vietnamese patients with duodenal ulcer

Aim:

To evaluate the effectiveness of triple therapy containing either omeprazole or ranitidine bismuth citrate (RBC) to treat H. pylori infection in Vietnamese duodenal ulcer patients.

Methods:

Patients infected with H. pylori were randomized to receive either omeprazole (20 mg b.d.), clarithromycin (500 mg b.d.) and amoxycillin (1 g b.d.) for 10 days (OAC), or RBC (400 mg b.d.), clarithromycin (500 mg b.d.) and amoxycillin (1 g b.d.) for 10 days (RAC). H. pylori eradication and ulcer healing was established by a follow‐up oesophagogastroduodenoscopy (EGD) at least 4 weeks after therapy. Side‐effects and compliance were assessed.

Results:

One hundred and four out of 108 (96%) patients with a duodenal ulcer were infected with H. pylori. Eighty per cent of infected patients had detectable CagA IgG antibodies. Fifty‐seven patients received OAC and 47 received RAC. OAC eradicated H. pylori in 91 and 86% of patients by per protocol (PP) and intention‐to‐treat (ITT) analysis, respectively. PP and ITT eradication rates for RAC were 96 and 91%. Ulcer healing at the follow‐up EGD was 89% with OAC and 100% with RAC. Side‐effects were minor. No patient failed to complete the protocol due to side‐effects.

Conclusion:

Triple therapy with either omeprazole or RBC is highly effective in eradicating H. pylori and healing duodenal ulcer in Vietnamese patients.

     

Asymptomatic duodenal ulcers occurring during maintenance treatment with ranitidine

Fifty-seven patients who developed asymptomatic recurrence of duodenal ulceration during maintenance treatment with ranitidine were followed up to assess the risk of developing symptoms or complications of ulcer disease. The risk of development of symptomatic ulcer recurrence was 4% in the first year of follow-up during continuous maintenance treatment, irrespective of whether or not the asymptomatic ulcer had been actively treated (by doubling the dose of ranitidine used for maintenance therapy). The asymptomatic duodenal ulceration during maintenance treatment did not predispose to complications such as haemorrhage or perforation. It seems, therefore, that patients receiving maintenance treatment for duodenal ulceration do not require endoscopic re-examination unless symptoms have recurred, because the asymptomatic recurrences of duodenal ulceration occurring during maintenance treatment are clinically benign, usually heal spontaneously if maintenance treatment is continued, and do not require active medical intervention.     

Low-dose antacids versus ranitidine in the short-term treatment of patients with duodenal ulcer. Endoscopic and histologic placebo-controlled study.

In this double-blind randomized placebo-controlled trial we compared the efficiency of two Polish antacids (Alugastrin, dihydroxyaluminium sodium carbonate and Alumag, aluminium hydroxide with magnesium hydroxide; buffering capacity 189 and 224 mmol) with ranitidine in the healing of duodenal ulcer. We also examined the effect of drugs on the frequency and severity of gastritis and selected morphometric parameters of the fundic mucosa. The study showed that low-dose antacids effectively promote the healing of duodenal ulcer during four week therapy, similarly to ranitidine (72%, 76% and 80%, respectively) and significantly better than placebo (46%). Both antacids and ranitidine were without effects on the chronic gastritis and did not cause any trophic changes of the gastric mucosa.     

奥美拉唑或（和）庆大霉素治疗幽门螺旋杆菌十二指肠溃疡84例

经内窥镜诊断幽门螺旋杆菌（ＨＰ）十二指肠溃疡，用奥美拉唑（Ｏｍｅ）２０ｍｇ，ｑｄ或（和）庆大霉素（Ｇｅｎ）４万Ｕ，ｔｉｄ，ｐｏ，治疗２ｗｋ。２５例用Ｏｍｅ，２３例用Ｇｅｎ，３６例用Ｏｍｅ＋Ｇｅｎ。在疗程末（３ｄ内）和１４ｄ复查愈会率：Ｏｍｅ组７２％和８８％，Ｇｅｎ组６１％和７８％，Ｏｍｅ＋Ｇｅｎ组９２％和１００％。４ｗｋＨＰ清除率则分别为５２％，６５％及８３％。未见不良反应，可首选联合用药。     

Omeprazole, clarithromycin and furazolidone for the eradication of Helicobacter pylori in patients with duodenal ulcer

AIM: To evaluate the efficacy of omeprazole plus clarithromycin and furazolidone in Helicobacter pylori eradication and duodenal ulcer healing in Brazilian patients. METHODS: Forty H. pylori-positive patients with duodenal ulcer were randomized to receive 20 mg omeprazole o.m. or b.d. for 1 month plus 500 mg clarithromycin (b.d. ) and 200 mg furazolidone (b.d.) for 1 week. RESULTS: Three months after the end of the treatment the eradication rates were 90% by intention-to-treat analysis, and 97% by per protocol analysis. Mild side-effects were observed in 25 patients, none of whom abandoned the protocol. No difference was observed between the 20 mg and 40 mg omeprazole daily doses. Cure or significant improvement of the symptoms and of the histological alterations were observed after H. pylori eradication. CONCLUSION: Our results demonstrate that clarithromycin and furazolidone in combination with omeprazole are a good alternative for H. pylori eradication in Brazilian patients with duodenal ulcer.     

The effects of fasting on 24-h gastric secretion of patients with duodenal ulcers resistant to ranitidine

We compared the effects of fasting and feeding on the antisecretory actions of ranitidine in 19 patients whose duodenal ulcers remained unhealed or relapsed despite treatment with the drug. Nine of the patients received, and continued with, 150 mg ranitidine b.d. and 10 took 300 mg ranitidine b.d. In all patients, gastric secretion was inhibited during the night, with near-neutral pH and acid output less than an average of 2 mmol in 8 h. Gastric secretion was not inhibited during the day by either of the therapeutic regimens. However, on the day when the patients fasted, gastric acidity was, on average, 20-50 mmol/L less than on the day when food was consumed. Food-induced interference with the therapeutic inhibition of gastric secretion produced by H2-receptor antagonists may be responsible for the unsatisfactory clinical response of some patients with duodenal ulcers. Prolonged fasting can improve the control of gastric secretion and may allow resistant ulcers to heal.     

Omeprazole is superior to ranitidine plus metoclopramide in the short-term treatment of erosive oesophagitis

Histamine H₂-receptor antagonists are moderately effective in symptomatic treatment and healing of erosive oesophagitis, but they are not as effective as the proton pump inhibitor omeprazole. In some studies prokinetic agents seem to increase the effectiveness of H₂-antagonists, but no study comparing the efficacy of omeprazole to H₂-antagonists plus prokinetic agents has been performed. The purpose of this study was to compare the efficacy and tolerability of 20 mg omeprazole daily with 150 mg ranitidine b.d.s. plus the prokinetic agent 10 mg metoclopramide q.d.s. in patients with erosive oesophagitis. After both 4 and 8 weeks of treatment, omeprazole healed the mucosa in significantly more patients than did ranitidine plus metoclopramide. Omeprazole also provided significantly greater relief from daytime heartburn, nighttime heartburn, and acid regurgitation, and was associated with decreased concomitant antacid use. Although the overall incidence of adverse events was similar in the two treatment groups, a significantly higher number of treatment-related adverse events and more treatment-related withdrawals from the study occurred in the ranitidine plus metoclopramide treatment group. Omeprazole is more effective and better tolerated than the combination of standard dose ranitidine plus metoclopramide for patients with erosive oesophagitis.     

The therapeutic effect of proton pump inhibitors on Helicobacter pylori-positive gastric ulcers.

The aim of the present study was to elucidate the risk factors that could delay gastric ulcer healing when either a proton pump inhibitor or an H2-receptor antagonist is used for gastric ulcer treatment. Endoscopically-diagnosed gastric ulcer patients (216 men and 96 women, mean age: 57+/-13 years) were investigated. All patients were consecutively recruited and randomly assigned to receive H2-receptor antagonist (n = 196) or proton pump inhibitor (n = 116) treatment for eight weeks. Chi-squared tests and multivariate analysis to determine factors influencing ulcer healing were used to analyse the patients profiles, endoscopic findings, and Helicobacter pylori-infection status. In the H2-receptor antagonist group, the most important risk factor was a large ulcer size (> 2 cm diam.), followed by a linear shape of the ulcer, undermining tendency of ulcer, previous history of gastric ulcer, and H. pylori infection. In the proton pump inhibitor group, linear shape of the ulcer was the only significant risk factor for slow ulcer healing; other factors, including H. pylori infection, were insignificant. These results indicate that ulcer morphology may be the most important information for predicting ulcer healing, and that H. pylori infection does not delay gastric ulcer healing when proton pump inhibitor treatment is used.     

Comparison between ranitidine and cimetidine in the short-term treatment of duodenal ulcer

Two groups of 46 and 49 patients each with endoscopically proved duodenal ulcer and not previously treated, received ranitidine (150 mg X 2 daily) and cimetidine (1 g/day) respectively for eight weeks. The disappearance of the ulcer was observed endoscopically in 78% of both the first and second groups of patients. Of the ten patients non-responders to ranitidine, six were treated again for eight weeks with ranitidine and four with cimetidine for eight weeks; all of them recovered completely apart from one of the cimetidine treated patients. Of the 11 patients non-responders to cimetidine, seven were retreated with cimetidine and 4 with ranitidine for a further eight weeks and all of them obtained a complete recovery except for one of the cimetidine treated patients. No relevant side-effects were observed with either drug. In conclusion cimetidine and ranitidine showed a comparable therapeutic value.     

Omeprazole, azithromycin and either amoxycillin or metronidazole in eradication of Helicobacter pylori in duodenal ulcer patients

Background

Azithromycin is a new generation, acid stable, macrolide antibiotic that achieves remarkably high concentrations in gastric tissue (above the minimal inhibitory concentration for Helicobacter pylori) after oral administration.

Aim

To establish whether azithromycin plus omeprazole in association with either amoxycillin or metronidazole are useful in curing H. pylori infection in patients with a duodenal ulcer.

Methods

One hundred patients with active duodenal ulcers and H. pylori infection were treated with omeprazole (days 1–10, 40 mg b.d.; days 11–24, 40 mg o.m.; days 25–42, 20 mg o.m.) plus azithromycin 500 mg o.m. for the first 6 days. Patients were randomly assigned to receive either amoxycillin 1 g b.d. (OAzA group; n = 50) or metronidazole 400 mg t.d.s. (OAzM group; n = 50) during the first 10 days of treatment. H. pylori status was determined by urease test and histology before the treatment and 6 weeks after completion of therapy.

Results

Ninety-seven patients completed the study. H. pylori infection was eradicated in 85% (41/48) of patients in the OAzA group (intention-to-treat analysis 82%) vs. 74% (36/49) of patients in the OAzM group (intention-to-treat analysis: 72%) (N.S.). All ulcers had healed after 6 weeks of omeprazole treatment. Side-effects, usually minor, were recorded in 13% (OAzA group) and 47% (OAzM group) of patients (P < 0.001), but therapy was discontinued for only one patient in the OAzA group (N.S.).

Conclusion

Ten days of treatment with omeprazole plus (for the first 6 days) azithromycin and either amoxycillin or metronidazole provides effective regimens to cure H. pylori infection in patients with duodenal ulcer disease.

     

Omeprazole inhibition of nocturnal gastric secretion in patients with duodenal ulcer

We studied the effect of single 08.00 h doses of omeprazole or placebo on gastric acid secretion during the following night, 14 to 23 h after administration, in seven male subjects with duodenal ulcer. The drug was given orally, double-blind, in randomized order. Omeprazole 20 mg, 40 mg and 80 mg reduced mean total overnight acid output by 43%, 73% and 91% respectively and median pH increased from 1.4 with placebo to 1.6, 3.1 and 7.0 respectively. The inhibitory effect was maintained throughout the study period. No clinical side effects or abnormalities of laboratory screening tests were seen. Omeprazole is well tolerated and administration at 08.00 h produces prolonged dose related inhibition of acid output during the following night.     

Omeprazole versus famotidine in the healing and relapse of duodenal ulcer

Sixty patients with symptomatic duodenal ulcer were randomized to receive either omeprazole (20 mg each morning) or famotidine (40 mg at night time) for 2–4 weeks in a double-blind parallel group clinical trial. Healing rates were higher with omeprazole in comparison with famotidine after 2 weeks (77%vs. 40%, P < 0.001) and 4 weeks (93%vs. 80%, P= 0.2) of treatment. Assessment of daily diary cards completed by all patients revealed that omeprazole rapidly relieved ulcer-related day pain and nocturnal pain in comparison to famotidine. Treatment with omeprazole for 2 weeks was also associated with lower cumulative antacid intake (P < 0.05) and reduced absenteeism from work. Helicobacter pylori infection was present in all patients and remained unaffected by treatment with either of the drugs. None of the drugs produced any significant adverse effects. During 6 months follow-up of all the patients after ulcer healing (without maintenance therapy), ulcer relapse was seen in 40% of omeprazole- and 37% of famotidine-treated patients (P > 0.1). The duration of ulcer-free period following initial healing of ulcer was also similar in both the groups (median time: 22 weeks for omeprazole, 21 weeks for famotidine). We conclude that omeprazole is superior to famotidine in rapidly healing duodenal ulcers and achieving more rapid pain relief, but does not influence subsequent ulcer relapse.     

埃索美拉唑三联疗法不同疗程治疗幽门螺杆菌阳性活动期十二指肠溃疡的疗效观察

目的观察埃索美拉唑三联疗法不同疗程治疗幽门螺杆菌（Hp）阳性的活动期十二指肠溃疡的疗效及安全性。方法 80例经胃镜证实Hp阳性的活动期十二指肠球部溃疡患者,随机分成1周疗法组（A组）和2周疗法组（B组）。A、B2组用药均为埃索美拉唑20mg、阿莫西林1.0g、克拉霉素缓释片0.5g,均每天2次。A组疗程1周,B组疗程2周。治疗过程中观察不良反应发生情况,停药4周后复查胃镜,观察溃疡愈合率,并作14C尿素呼气试验（14C-UBT）了解Hp根除率。结果 A组溃疡愈合率、Hp根除率、不良反应发生率分别为91.9%、77.5%、5.0%;B组分别为92.1%、90.0%、5.0%。A、B2组之间比较Hp根除率差异有统计学意义（P〈0.05）;溃疡愈合率、不良反应发生率差异无统计学意义（P〉0.05）。结论埃索美拉唑＋阿莫西林＋克拉霉素三联2周疗法治疗Hp阳性的活动期十二指肠溃疡,可达到满意的Hp根除率和溃疡愈合率,且不良反应小。     

Different dosage regimens of ranitidine in the short-term therapy of duodenal ulcer: a multicentre trial

A multicentre clinical trial was conducted in 114 Italian endoscopy centres in order to evaluate the comparative efficacy of four different ranitidine dosage regimens in the short-term treatment of active duodenal ulcer. Results were analysed in a total of 1745 patients randomly allocated to treatment with ranitidine 150 mg twice daily - morning and 19h30 (440 patients), ranitidine 150 mg twice daily - morning and 22h30 (438 patients), ranitidine 300 mg once daily at 19h30 (434 patients) or ranitidine 300 mg once daily at 22h30 (433 patients). The four groups were well matched for patient characteristics at entry. Initial treatment was for three weeks, with continuation to six weeks in cases with endoscopically unhealed ulcers at three weeks. Efficacy was evaluated in terms of endoscopic ulcer healing and control of pain symptoms in 24 h (daytime, nocturnal, daytime plus nocturnal). No statistically significant differences were found between any of the groups either as regards control of pain symptoms or ulcer healing rates (mean healing rates at three and six weeks were 77% and 98%, respectively). The results in this very large patient sample confirm equivalent efficacy of twice daily and single bedtime dose regimens and provide no evidence for superior efficacy of early evening compared with bedtime administration. In the population as a whole, concomitance of the three main risk factors (more than 20 cigarettes/day, ulcer size greater than 1 cm, deformation of the duodenal cap) was associated with a distinctly lower three-week healing rate (40.9% versus 87.4% in patients presenting none of these factors), though this difference tended to disappear at six weeks.(ABSTRACT TRUNCATED AT 250 WORDS)     

3种疗程三联疗法根除十二指肠溃疡病人幽门螺杆菌感染的比较(英文)

目的 :通过与 7d三联疗法比较 ,观察 3d和 5d三联疗法根除幽门螺杆菌 (Hp)和治疗十二指肠溃疡的疗效。方法 :116例经胃镜检查确诊为十二指肠溃疡活动期并经快速尿素酶试验和血清抗Hp抗体 (ELASE)或病理学检查确定为Hp阳性的病人分为 3组 :3d(3d组 ,39例 )和 5d试验组 (5d组 ,37例 )和 7d对照组 (7d组 ,4 0例 )。 3组均给予三联治疗 :雷贝拉唑 10mg +呋喃唑酮 10 0mg +克拉霉素 2 5 0mg ,每日 2次 ,疗程分别为 3,5和 7d ,后再给予雷贝拉唑 10mg ,每日 1次 ,3d组为 2 5d ,5d组为 2 3d ,7d组为 2 1d。并于抗Hp方案结束后d 2 8～ 5 6内作13C 尿素呼气试验判断Hp根除率的效果。同时在用药后d 1,3,5 ,7,2 1和 35对病人的上腹痛、反酸以及上腹烧灼感等症状进行评估。结果 :10 7例病人完成全部治疗方案 ,9例失访 ,3,5 ,7d组人数分别为 37,35 ,35例。Hp根除率 3d组为 76 % (2 8/ 37) ,5d组为 89% (31/ 35 ) ,7d组为91% (32 / 35 ) ,5d组和 7d组之间差异无显著意义(P >0 .0 5 ) ,且均高于 3d组 (P <0 .0 5 )。3组从用药d 1起均能有效改善病人的上腹痛、反酸、上腹烧灼感等症状 ,各组症状缓解率无显著差异 (P >0 .0 5 )。结论 :3组治疗方案均能有效缓解十二指肠溃疡病人的症状 ,而根除Hp ,5d和 7d疗程较 3d疗程为优