[Treatment for the eradication of Helicobacter pylori. Recommendations of the Spanish Consensus Conference].
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Biomedical subjects
Publications and source records attributed to F Gomollón.
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AIM: To evaluate the predictive value of Helicobacter pylori eradication in the healing of duodenal ulcer. METHODS: A prospective study of 92 duodenal ulcer patients (diagnosed by endoscopy) with H. pylori infection demonstrated by rapid urease test, positive histology and culture. They were treated with a 7-day regimen of lansoprazole, clarithromycin and amoxicillin. Healing was evaluated in a follow-up gastroscopy performed one month after treatment had finished. Eradication was defined as negative urease test, histology and culture at 30 days and negative urea breath test at 60 days. RESULTS: Duodenal ulcer healing was observed in 85 patients (92.4%, CI 85-96.9). Eradication of H. pylori infection was the only variable independently associated with ulcer healing. Healing was observed in 97.2% of patients with H. pylori eradication versus 75% of those with persistent infection (p < 0.01; OR = 11.6; CI 95% = 2.06-65.9). CONCLUSION: Eliminating H. pylori infection favors duodenal ulcer healing and, from a clinical point of view, confirmation of H. pylori eradication almost always means healing of duodenal ulcer.
OBJECTIVE: To confirm whether 1-week anti-Helicobacter therapy to achieve ulcer healing is sufficient and safe. METHODS: We retrospectively analyzed patients with peptic ulcer who were infected with Helicobacter pylori and treated with 3 different 7-day regimens, according to predefined protocols in 3 different centers in the same geographical area (Aragón, Spain). Three combinations commonly described in the literature were used: a) omeprazole (40 mg/24 h), tetracycline hydrochloride (2 g/24 h), colloidal bismuth subcitrate (480 mg/24 h) and metronidazole (750 mg/24 h) (OBTM, n = 105); b) omeprazole (40 mg/24 h), clarithromycin (1.5 g/24 h) and amoxicillin (3 g/24 h) (O40C1.5A3, n = 13); and c) omeprazole (40 mg/24 h), clarithromycin (1 g/24 h) and amoxicillin (2 g/24 h) (O40C1A2, n = 4). In all patients the diagnosis of peptic ulcer disease was confirmed endoscopically, and H. pylori infection was verified with urease testing and histological analysis. After treatment ended, no other antacids were allowed until after endoscopic examination to check eradication and ulcer healing. RESULTS: 122 patients were included (107 with duodenal ulcer, 12 with gastric ulcer and 3 with both). Compliance was good and side effects infrequent and mild. Eradication rates were 88.5% (93/105) in the OBTM group, 100% (13/13) with O40C1.5A3, and 75% (3/4) with O40C1A2. Healing was achieved in 98.16% (107/109) of the patients in whom the bacterial infection was eradicated, and in 23.07% (3/13) of those in whom it was not (p < 0.0001). No patient had any complications during the period without treatment. CONCLUSIONS: 1-week eradication therapy with previously described combinations commonly used in clinical practice achieves high ulcer healing rates with no complications in the period without antacid treatment. We consider that it is not necessary, at least in most patients, to prolong antacid therapy.
BACKGROUND: Clarithromycin is a key antimicrobial in the combinations used to cure Helicobacter pylori infections, so there is a need to define the impact of in vitro resistance on in vivo results. METHODS: A prospective trial was designed to study the effectiveness of the 1-week combination of lansoprazole, clarithromycin and amoxycillin in 102 consecutive patients with active peptic ulcer. The pre-treatment and post-treatment sensitivity to amoxycillin, metronidazole and clarithromycin were studied by E-test, and H. pylori status was defined by histology, culture and urease test at diagnosis and one month after treatment, and by urea-breath test 2 months after treatment. RESULTS: The eradication rate (intention-to-treat analysis) was 77% (95% CI: 69-86). No clinical factor was found to be different between eradicated and non-eradicated patients. Clarithromycin-resistant strains were found in 10 (10%; CI: 5-17) patients. The eradication rate was 20% (CI: 3-56) in these patients vs. 83% (CI: 75-91) in patients harbouring clarithromycin-sensitive strains (P < 0.001). A logistic-regression analysis confirmed clarithromycin resistance as the only factor associated with treatment failure. CONCLUSIONS: Clarithromycin resistance significatively impairs the effectiveness of the combination of lansoprazole, amoxycillin, and clarithromycin. The 80% efficacy goal will be difficult to reach in areas with high (>10%) primary clarithromyicin resistance, if currently recommended proton pump inhibitor-triple therapies are used.
BACKGROUND: Data regarding the effectiveness of second-line treatment of Helicobacter pylori infection are limited, especially if microbiological studies are considered. METHODS AND PATIENTS: We conducted a prospective, uncontrolled study of a consecutive series of 21 peptic ulcer patients with failure of 1-week lansoprazole, amoxicillin, and clarithromycin. H. pylori status was evaluated by urease test, histology, culture, and urea breath test. Susceptibility to amoxicillin, clarithromycin, and metronidazole was studied by E-test. Cure of infection was defined as negative results from endoscopy-based tests 1 month after treatment and negative results from a urea breath test at 2 months. Treatment consisted of a 1-week combination of lansoprazole (30 mg bid), tetracycline (500 mg qid), metronidazole (500 mg tid), and bismuth subcitrate (120 mg qid). RESULTS: H. pylori was resistant to metronidazole in three cases, to clarithromycin in three cases, and to both clarithromycin and metroinidazole in an additional three patients. No resistance to amoxicillin was found. Eradication was obtained in 20 cases (95.2% confidence interval [CI], 76.2-99.9). The only patient in whom infection was not eradicated harbored a metronidazole-resistant (minimum inhibitory concentration > 32 micrograms/ml) strain. No significant side effects were reported. CONCLUSION: Quadruple therapy obtains a high eradication rate even in patients with clarithromycin- and metronidazole-resistant strains. Further randomized and controlled studies are warranted and are urgently needed.
OBJECTIVE: Butyrate enemas may be effective in the treatment of active distal ulcerative colitis. Because colonic fermentation of Plantago ovata seeds (dietary fiber) yields butyrate, the aim of this study was to assess the efficacy and safety of Plantago ovata seeds as compared with mesalamine in maintaining remission in ulcerative colitis. METHODS: An open label, parallel-group, multicenter, randomized clinical trial was conducted. A total of 105 patients with ulcerative colitis who were in remission were randomized into groups to receive oral treatment with Plantago ovata seeds (10 g b.i.d.), mesalamine (500 mg t.i.d.), and Plantago ovata seeds plus mesalamine at the same doses. The primary efficacy outcome was maintenance of remission for 12 months. RESULTS: Of the 105 patients, 102 were included in the final analysis. After 12 months, treatment failure rate was 40% (14 of 35 patients) in the Plantago ovata seed group, 35% (13 of 37) in the mesalamine group, and 30% (nine of 30) in the Plantago ovata plus mesalamine group. Probability of continued remission was similar (Mantel-Cox test, p = 0.67; intent-to-treat analysis). Therapy effects remained unchanged after adjusting for potential confounding variables with a Cox's proportional hazards survival analysis. Three patients were withdrawn because of the development of adverse events consisting of constipation and/or flatulence (Plantago ovata seed group = 1 and Plantago ovata seed plus mesalamine group = 2). A significant increase in fecal butyrate levels (p = 0.018) was observed after Plantago ovata seed administration. CONCLUSIONS: Plantago ovata seeds (dietary fiber) might be as effective as mesalamine to maintain remission in ulcerative colitis.
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BACKGROUND: Multiple therapeutic combinations have been tested to determine the optimal regimen(s) for Helicobacter pylori eradication, leading to very different results depending on the geographical area. Our goal was to evaluate the efficacy of a "quadruple" therapy with omeprazole, tetracycline, bismuth and metronidazole in our area. MATERIALS AND METHODS: We investigate 106 consecutive patients with active peptic ulcer disease (duodenal, gastric or both) and Helicobacter pylori infection. One-week therapy with omeprazole 20 mg b.i.d., tetracycline hydrochloride 500 mg q.i.d., colloidal bismuth subcitrate 120 mg q.i.d., and metronidazole 250 mg t.i.d was prescribed. Between the days 30 and 40 after treatment ended follow-up endoscopy was performed. Eradication was defined as both negative urease test and histology. Between days 90 and 360 a 13C urea breath test was performed in 100 patients. RESULTS: Of the 106 patients in the study, 91 had duodenal ulcer, 12 had gastric ulcer, and 3 had both. Side effects were observed in 25% of the cases. Eradication was achieved in 87.7% (93/106; CI 79.9-93.3). Healing was obtained in 95.2% (100/105; CI 89.2-98.4); 97.8% (CI 92.4-99.7) in those eradicated and 75% (CI 42.8-94.5) in non-eradicated (p < .01). CONCLUSIONS: Quadruple therapy with omeprazole, tetracycline, bismuth subcitrate and metronidazole achieves healing rates up to 95-100%. The 87.7% eradication rate obtained suggests that the regimen we used is a reasonable therapeutic alternative in our area.
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BACKGROUND: There are many reports that evaluate the efficacy of the combination of omeprazole, amoxicillin and clarithromycin in the eradication of Helicobacter pylori, but data about effectivity in clinical practice are sparse. The goal of our study is to evaluate the effectivity in the clinical setting of this combination with diverse durations and doses. METHODS: This is a retrospective analysis of 187 patients (128 male and 59 female), with an endoscopic diagnosis of duodenal ulcer (156), gastric ulcer (25) and both (6) with Helicobacter pylori infection as defined by both: a positive ureasa test and histology. After diagnosis the patient were treated with one of three combinations: a) omeprazole: 20 mg/12 h + amoxicillin: 1 g/12 h + clarithromycin: 500 mg/12 h, during 6 days (n = 60); b) omeprazole: 20 mg/12 h + amoxicillin: 1 g/12 h + clarithromycin: 500 mg/12 h, during 7 days (n = 74), and c) omeprazole: 20 mg/12 h + amoxicillin: 1 g/8 h + clarithromycin: 500 mg/8 h, during 7 days (n = 53). After the 6 or 7 day treatment period the patients did not receive any further treatment until a follow-up control unit. Eradication was evaluated with one of two tests: endoscopy (with ureasa test and at least 4 histologic samples) (n = 90) or urea breath test according to european protocol (n = 97). RESULTS: No patient dropped out because of side effects and compliance was above 80% in all cases. The global eradication rate was 87.2% (CI 95%: 82.4-92%). According to treatment the rate were respectively 80% (CI 95%: 67.7-89.2%) with scheme A; 89.2% (CI 95%: 79.8-95.2%) with scheme B, and 92.5% (CI 95%: 81.8-97.9%) with scheme C, with no statistically significant differences among groups. Difference between schemes and C, however, was almost reached (p = 0.053). CONCLUSIONS: The combination of omeprazole, amoxicillin and clarithromycin at standard doses (scheme B) is effective in clinical practice. Higher dose of amoxicillin and clarithromycin does not improve the results, and shorter duration of therapy associated with lower, although not significant rate of eradication.
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BACKGROUND: The eradication of Helicobacter pylori is becoming the therapy of choice for peptic ulcers, if the infection is present. Published data from primary care settings are, however, limited. METHODS: An open-ended, prospective study was undertaken that included 31 patients with active peptic ulcer demonstrated by endoscopy and H pylori infection confirmed by urease and histologic tests. After a 14-day period of treatment with omeprazole, bismuth, tetracycline, and metronidazole, healing and H pylori status were evaluated by repeat endoscopy done at least 28 days after the last treatment dose. Eradication is defined as absence of H pylori in at least four (two from the fundus and two from the antrum) samples taken from the gastric mucosa and a negative urease test. Drug side effects and patient compliance were monitored in all cases. RESULTS: Twenty-eight patients completed the protocol. Healing was obtained in all cases, and eradication was accomplished in 25 (89%). Side effects were common (69%) but mild. Compliance was good. After a mean follow-up of 300 days (range, 180 to 400), one ulcer recurrence was observed in an H pylori-positive patient and none in H pylori-negative patients. CONCLUSIONS: The treatment of H pylori infection is an effective way of healing peptic ulcers, and can be applied in primary care settings. Further studies with more patients and with shorter and easier therapies should be undertaken to confirm our findings.
GOAL: To evaluate which clinical data are useful to select those patients with peptic ulcers in primary care most likely to benefit from complementary studies. METHODS: This is a prospective study done on 101 patients evaluated in a period of a year in a Primary Care Center. In all patients an endoscopy was done when a peptic ulcer was considered a possibility. In all cases a standardized questionnaire was completed before endoscopy and the patient evaluated by his primary care physician. The final diagnosis was defined according to endoscopy, done by expert endoscopists within seven days of the clinical evaluation. Statistical analysis was undertaken with SPSS software. RESULTS: An active peptic ulcer was found in 45 (44.5%) cases. A high-grade MALT lymphoma was diagnosed in one case. Male sex, smoking status, number of cigarettes, smoking-index, and a previous history of ulcer complications were significantly associated with the diagnosis, as well as severe diurnal or nocturnal pain. Mean age was lower in ulcer patients. However no clinical data in individual or combined form did show any predictive value. CONCLUSIONS: Clinical data do not permit to obviate endoscopy as the key initial procedure to diagnosis, even in primary care.
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AIM: To compare the efficacy of omeprazole (40 mgs/12 h i.v.) and cimetidine (1,200 mgs/i.v./day) in the management of upper gastrointestinal bleeding. EXPERIMENTAL DESIGN: Randomized, prospective open clinical trial. The end points are: mortality, surgical requirements, transfusion requirements, and length of hospitalization in Bleeding Unit and Hospital. PATIENTS: We study patients with upper gastrointestinal bleeding from peptic sources (duodenal ulcer, gastriculcer, acute gastric erosions and peptic esophagitis). 462 patients are evaluated and 282 finally included. RESULTS: 151 patients were given cimetidine and 131 omeprazole. No significant differences in any of the end points were found. CONCLUSIONS: The use of omeprazole does not improve cimetidine efficacy in the entire group of patients with upper gastrointestinal bleeding.
We report a series of 15 patients with a postoperative biliary fistula treated by endoscopic sphincterotomy. The exact location of the bile leak was revealed by ERCP in 13 cases (87%): cystic duct remnant in 6 (39%), intrahepatic biliary tree in 4 (26%), and main bile duct in 3 (20%). In all cases a distal obstacle (ie: retained stones, hydatid material) to bile flow was also found in ERCP. Treatment consisted of endoscopic sphincterotomy and subsequent removal of the distal obstacle, and could be completed in 13 (87%) cases. In our experience the treatment of postoperative biliary fistula with a distal obstruction bile flow by endoscopic sphincterotomy is a safe and effective procedure, and should be recommended as the first option in those patients.
We study in a group of patients with endoscopically diagnosed duodenal ulcer (19; 17 males) and controls (11; 7 males) the gastric emptying of solids through scintigraphy and gastric acid secretion by standard tests. In the same way we investigated prospectively some clinical data, specially smoking habits. As a whole, patients with duodenal ulcer showed an emptying of solids slightly faster than controls (T 1/2-minutes-: 85.4 +/- 28.6 in patients with duodenal ulcer versus 116.9 +/- 46.5 in controls, p less than 0.03). However, most of our patients (15 of 19 or 79%) were found to have a normal emptying rate. No correlation was found between secretory outputs and gastric emptying. Smokers with duodenal ulcer had a faster emptying that non-smokers with duodenal ulcer (T 1/2 74.8 +/- 30.05 vs. 99.91 +/- 19.86; p = 0.05).