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L Laine

Publications and source records attributed to L Laine.

At least 37 records · Page 2Linked to original sources
PubMed2000

Endoscopic biopsy requirements for post-treatment diagnosis of Helicobacter pylori.

BACKGROUND: Data on sensitivities of biopsy tests for Helicobacter pylori diagnosis after modern eradication therapy are limited. We assessed diagnostic yield of endoscopic biopsy tests before and after therapy in 2 U.S. multicenter double-blind trials of 10-day proton pump inhibitor-based triple therapy versus dual antibiotic therapy. METHODS: Three hundred one patients with duodenal ulcer and H pylori infection had endoscopy at baseline and at 8 weeks. Four antral and 3 body biopsies were taken at both endoscopies: 1 antral biopsy for a rapid urease test (CLOtest), 2 antral and 2 body biopsies for histologic examination (Genta stain), and 1 antral and 1 body biopsy for culture. RESULTS: The 2 same-site biopsies (antral or body) for histologic examination were in agreement in 97% of cases before treatment and 100% after triple therapy. Histologic examination of antral biopsies without body biopsies missed H pylori infection in 2% of patients before treatment and 5% after triple therapy. Posttreatment sensitivities for triple therapy were significantly lower than pretreatment sensitivities for all tests (e. g., 18% decrease in sensitivity in antral histology, 22% decrease in antral culture); decreases in sensitivity were greater after triple therapy than after the less effective dual therapy. CLOtest plus histology had a post-treatment sensitivity of 96% in the triple therapy group. CONCLUSIONS: A single antral biopsy for histology provides excellent sensitivity for H pylori in untreated patients, but, after effective therapy, sensitivities of biopsy tests decrease. Use of more than one method of testing may increase diagnostic yield when assessing post-treatment H pylori status with endoscopy, whereas the addition of multiple biopsies for each type of test is of more limited value.

Amoxicillin↗
PubMed2000

Esomeprazole-based Helicobacter pylori eradication therapy and the effect of antibiotic resistance: results of three US multicenter, double-blind trials.

OBJECTIVES: To determine the efficacy of once-daily esomeprazole plus antibiotics for eradication of Helicobacter pylori, to assess the effect of antibiotic resistance on eradication rate, and to define the rate of emergent resistance. METHODS: Three separate randomized trials were performed in H. pylori-positive patients with a duodenal ulcer or history of documented duodenal ulcer within 5 yrs: 1) esomeprazole (40 mg once daily), amoxicillin (1 g b.i.d.), and clarithromycin (500 mg b.i.d.; this combination will be referred to as EAC) versus esomeprazole (40 mg once daily) plus clarithromycin (500 mg twice daily; this combination will be referred to as EC); 2) EAC versus esomeprazole (40 mg once daily; E); and 3) EC versus E. Therapy was given for 10 days. Endoscopy and biopsies for CLOtest, histology, and culture with susceptibility testing were done at baseline and 4 wk after completion of therapy. RESULTS: Per-protocol and intent-to-treat eradication rates, respectively, were as follows. For EAC versus EC in study 1 (N = 448), 84 versus 55% and 77 versus 52% (p < 0.001); for EAC versus E in study 2 (N = 98), 85 versus 5% and 78 versus 4% (p < 0.001); for EC versus E in study 3 (N = 66), 50% versus 0 and 46% versus 0 (p < 0.05). The 15% of patients in the combined studies with baseline clarithromycin resistance had significantly lower rates of eradication than those with susceptible strains (EAC: 45 vs. 89%; EC: 13 vs. 61%). Emergent resistance was less common after treatment with EAC [2/6 (33%)] than with EC (23/27 [85%]). CONCLUSIONS: Ten-day triple therapy with once-daily esomeprazole plus twice-daily amoxicillin and clarithromycin achieves an eradication rate virtually identical to that of the twice-daily proton pump inhibitor-based triple therapies. Baseline clarithromycin resistance, present in 15% of patients, predicts a markedly decreased rate. Use of an amoxicillin-containing regimen may decrease emergence of clarithromycin resistance.

Adult↗
PubMed1999

A randomized trial comparing the effect of rofecoxib, a cyclooxygenase 2-specific inhibitor, with that of ibuprofen on the gastroduodenal mucosa of patients with osteoarthritis. Rofecoxib Osteoarthritis Endoscopy Study Group.

BACKGROUND & AIMS: Prostaglandin production in the normal gastrointestinal tract, believed to be critical for mucosal integrity, is mediated by cyclooxygenase (COX)-1, whereas prostaglandin production at inflammatory sites seems to occur via induction of COX-2. We hypothesized that COX-2-specific inhibition with rofecoxib (25 mg once daily) in the treatment of patients with osteoarthritis would cause fewer gastroduodenal ulcers than an equally effective dose of ibuprofen (800 mg 3 times a day), a nonspecific COX inhibitor. METHODS: A total of 742 osteoarthritis patients without ulcers on baseline endoscopy were randomly assigned to receive rofecoxib (25 or 50 mg once daily), ibuprofen (800 mg 3 times daily), or placebo. Endoscopy was repeated at 6, 12, and 24 weeks. At 16 weeks, by study design, 95% of the placebo group and 5% of the other groups were discontinued. RESULTS: The cumulative incidence of gastroduodenal ulcers >/=3 mm with rofecoxib (25 or 50 mg once daily) was significantly (P < 0.001) lower than with ibuprofen and was statistically equivalent to placebo at week 12 (placebo, 9.9%; 25 mg rofecoxib, 4.1%; 50 mg rofecoxib, 7.3%; and ibuprofen, 27.7%). At 24 weeks, ulcer rates were 25 mg rofecoxib, 9. 6%; 50 mg rofecoxib, 14.7%; and ibuprofen, 45.8% (P < 0.001, ibuprofen vs. 25 and 50 mg rofecoxib). CONCLUSIONS: Rofecoxib, at doses 2-4 times the dose demonstrated to relieve symptoms of osteoarthritis, caused significantly less gastroduodenal ulceration than ibuprofen, with ulcer rates comparable to placebo.

Aged↗
PubMed1999

A multicentre evaluation of the laser assisted ratio analyser (LARA): a novel device for measurement of 13CO2 in the 13C-urea breath test for the detection of Helicobacter pylori infection.

BACKGROUND: The laser assisted ratio analyser (LARA) was developed as a novel device to measure 13CO2 in the urea breath test for the detection of H. pylori infection. The analyser was tested in a prospective multicentre study in 444 patients in North America (Phase 1) followed by second study involving 160 patients (Phase 2). METHODS: Patients undergoing endoscopy for clinical indications had antral and gastric biopsies taken for histological examination, culture and CLO test. One hour after endoscopy, a baseline breath sample was obtained, 100 mg of 13C-urea were ingested and breath samples were obtained at 30 and 60 min post ingestion. Data obtained with the LARA were compared with the results of culture, rapid urease testing and central pathology in two different combinations {reference standards}. The study was conducted in two phases: in Phase 2, a modification was made to the LARA that improved the removal of water vapour from the breath sample. RESULTS: In Phase I, data from 331 patients were analysed using a cut off of (delta) 7.8 +/- 0.8, the sensitivity of the method was 91.7% and the specificity was 86.5%, using the reference standard of 2 of 3 tests (CLO, culture or histology) being positive. Positive and negative predictive values were, respectively, 85.2% and 92.5%. In Phase 2 of the study, 160 patients were enrolled and 141 patients were analysed using the same standards. We used the same reference standards but with a cut off of (delta) 6.1 +/- 0.6. The sensitivity and specificity increased to 96.8% and 98.6%, respectively. Positive and negative predictive values were, respectively, 98.4% and 97.3%. The detection rates for H. pylori were similar in patients with peptic ulcer or H. pylori associated gastritis. CONCLUSIONS: The LARA provides an accurate non-invasive means of detecting 13CO2 in the 13C-urea breath test for H. pylori in a multicentre clinical environment that compares well with invasive 'gold standard' methods.

Adolescent↗
PubMed1999

Review article: nonsteroidal anti-inflammatory drug-associated gastrointestinal complications--guidelines for prevention and treatment.

Chronic ingestion of NSAIDs increases the risk for gastrointestinal complications, which range from dyspepsia to gastrointestinal bleeding, obstruction, and perforation. Among patients using NSAIDs, 0.1 to 2.0% per year suffer serious gastrointestinal complications. Patients who require analgesic therapy should be carefully assessed for the lowest possible dosage and shortest duration of NSAID use and for the potential of treatment with a non-NSAID pain reliever. These patients should also be assessed for factors that increase their risk of gastrointestinal complications, including increased age, concomitant anticoagulant or corticosteroid use, and past history of NSAID-associated gastrointestinal complications. The exact association between Helicobacter pylori infection and NSAID-related ulcer disease is unclear, and the routine testing and treatment of all NSAID using patients for H. pylori infection is not recommended at this time. NSAID-using patients who suffer from dyspepsia should have NSAIDs discontinued, the dosage changed, or be changed to a different class of NSAID. If NSAIDs cannot be discontinued, then an antisecretory agent should be initiated. Misoprostol prevents NSAID-associated gastrointestinal complications. Proton pump inhibitors are the most effective at healing NSAID-associated ulcers among patients who cannot discontinue NSAID therapy.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1999

Fingerstick Helicobacter pylori antibody test: better than laboratory serological testing?

OBJECTIVE: Antibody testing is the recommended method to screen for Helicobacter pylori (H. pylori) infection. Whole-blood fingerstick antibody tests are simple, in-office tests providing rapid results, but the accuracy of first-generation tests was lower than other diagnostic tests. We assessed a new whole-blood antibody test, using endoscopic biopsy tests as a "gold standard," and compared it with a laboratory quantitative serological test. METHODS: Two hundred-one patients not previously treated for H. pylori who were undergoing endoscopy had gastric biopsies for rapid urease test and histological examination; whole-blood antibody tests and quantitative serological tests were also performed. Two separate gold standards for H. pylori infection were employed: either rapid urease test or histological exam positive; and both rapid urease test and histological exam positive. RESULTS: Sensitivities for whole-blood test versus quantitative serology with gold standard 1 (either biopsy test positive) were 86% versus 92% (95% confidence interval [CI] of difference, -2-14%; p = 0.19) and specificities were 88% versus 77% (95% CI of difference, 0.4-22%; p = 0.052). Sensitivities with gold standard 2 (both biopsy tests positive) were 90% versus 94% (95% CI of difference, -4-12%; p = 0.41) and specificities were 79% versus 67% (95% CI of difference, 1-24%; p = 0.048). CONCLUSIONS: New generation in-office, whole-blood antibody tests that can achieve a sensitivity and specificity similar to or better than those of widely used quantitative laboratory serological tests may be used as the initial screening tests of choice for H. pylori.

Adult↗
PubMed1999

A comparison of three fingerstick, whole blood antibody tests for Helicobacter pylori infection: a United States, multicenter trial.

OBJECTIVE: We compared three whole blood antibody tests for Helicobacter pylori (H. pylori) in a United States, multicenter trial. METHODS: Patients referred for EGD at three medical centers were recruited. During EGD, biopsies were taken for histology and rapid urease testing (RUT). Immediately after endoscopy, patients underwent the antibody tests (FlexPack HP, Abbott Diagnostics; QuikVue, Quidel Corporation; AccuMeter, ChemTrak) using whole blood obtained by two to three fingersticks. Performance characteristics were calculated for each antibody test using the biopsy-based methods as a gold standard. RESULTS: A total of 131 patients participated; 50 (38%) patients had histological evidence of H. pylori infection. Using histology as a gold standard, the sensitivities of FlexPack HP, QuikVue, and Accumeter were 76%, 78%, and 84%, respectively. Specificity was 79% with FlexPack HP and 90% with QuikVue and Accumeter. There were no significant differences in the performance of the three antibody tests though there was a trend toward superior performance for AccuMeter compared to FlexPack HP (p = 0.019). However, RUT proved superior to FlexPack HP using histology as a gold standard (p = 0.008). Using either concordant histology and RUT results or a positive histology or RUT to define active H. pylori infection, there was no statistically significant difference between the antibody tests. CONCLUSIONS: There were no statistically significant differences in the performance of the three antibody tests. These tests proved only marginally sensitive in detecting patients infected with H. pylori. Clinicians should be aware of the limitations of these tests, particularly when using them as a sole means of testing for H. pylori.

Adult↗
PubMed1999

The 13C-urea blood test accurately detects active Helicobacter pylori infection: a United States, multicenter trial.

OBJECTIVES: Current nonendoscopic tests for Helicobacter pylori include antibody tests and the urea breath test. After the administration of 13C-urea, serum bicarbonate measurement can identify those infected with H. pylori. In this study, our aims were to determine the accuracy of the urea blood test, and to compare the accuracy of the urea blood test with that of rapid urease testing of gastric biopsies. METHODS: This was a multicenter trial conducted at five sites within the U.S. Patients scheduled for endoscopy were recruited. During endoscopy, biopsies were obtained from the gastric body and antrum for histology and rapid urease testing. Patients underwent the urea blood test, which required the ingestion of 125 mg of 13C-urea after endoscopy. Thirty minutes later, a 3-ml blood sample was obtained and later analyzed by mass spectrometry for 13C-bicarbonate. Performance characteristics for the urea blood test were calculated using the endoscopic biopsy tests as a gold standard. RESULTS: One hundred and twenty-one patients (54 infected) were enrolled. The urea blood test yielded sensitivity of 89%, specificity of 96%, positive predictive value of 94%, negative predictive value of 91%, and accuracy of 93% using histology as a gold standard. There was no difference between results obtained with the urea blood test and rapid urease testing of gastric biopsies. CONCLUSIONS: The urea blood test accurately identified active H. pylori infection. The performance characteristics of this nonendoscopic test were similar to those of endoscopic rapid urease testing.

Adult↗
PubMed1999

Once-daily therapy for H. pylori infection: a randomized comparison of four regimens.

OBJECTIVE: We sought to determine the efficacy and tolerability of novel, once-daily therapies in the treatment of Helicobacter pylori infection. METHODS: One hundred sixty subjects with H. pylori infection documented by endoscopic biopsy or serology plus 13C-urea breath test were randomly assigned to omeprazole 80 mg q.d. and metronidazole extended-release formulation 750 mg q.d. for 10 days (OM); OM plus amoxicillin 1.5 g q.d. for 10 days (OMAm); OM plus azithromycin 500 mg q.d. for 7 days (OMAz); or OM plus clarithromycin 1 g q.d. for 10 days (OMCI). A repeat breath test was done 6 wk after the completion of therapy. Subjects were considered compliant if they took > or = 80% of each study medication as prescribed. RESULTS: Intent-to-treat eradication rates were OM = 8% (95% confidence interval [CI], 2-20%), OMAm = 35% (95% CI, 21-52%), OMAz = 65% (95% CI, 48-79%), and OMCI = 78% (95% CI, 62-89%). Lack of compliance was seen in 5% of subjects given OM, 8% given OMAm, 3% given OMAz, and 15% given OMCI. CONCLUSIONS: This pilot study demonstrated that once-daily triple therapy with high-dose omeprazole, metronidazole extended-release formulation, and clarithromycin achieved an eradication rate approaching 80%. Further study may permit development of optimal once-daily dosing and enhance eradication rates.

Adult↗
PubMed1998

Effect of proton-pump inhibitor therapy on diagnostic testing for Helicobacter pylori.

BACKGROUND: Proton-pump inhibitor therapy may cause false-negative results on Helicobacter pylori diagnostic testing. OBJECTIVE: To determine the frequency and duration of conversion of urea breath test results from positive to negative in patients given a proton-pump inhibitor. SETTING: Two urban university gastroenterology clinics. PATIENTS: Patients infected with H. pylori who had positive results on urea breath tests. INTERVENTION: Lansoprazole, 30 mg/d for 28 days. MEASUREMENTS: The urea breath test was repeated at 28 days. If the results were negative, testing was repeated 3, 7, 14, and 28 days after completion of therapy until the results reverted to positive. RESULTS: 31 (33%) of 93 patients in whom H. pylori was not eradicated had a negative breath test result while receiving lansoprazole. The proportions of patients whose breath test results were positive after completion of lansoprazole therapy were 91% (95% CI, 83% to 96%) at 3 days, 97% (CI, 90% to 99%) at 7 days, and 100% (CI, 96% to 100%) at 14 days. CONCLUSION: Patients should not receive proton-pump inhibitors for 2 weeks before receiving the urea breath test for H. pylori infection.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1998

Accuracy of CLOtest after Helicobacter pylori therapy.

BACKGROUND: The accuracy of rapid urease testing after Helicobacter pylori therapy has not been widely studied and might be diminished because of decreased numbers of organisms. We assessed CLOtest results after therapy in two randomized, double-blind trials. METHODS: A total of 233 patients (in two separate studies) with true-positive baseline CLOtests (by histology or culture) received 2 weeks of omeprazole/amoxicillin, omeprazole, or amoxicillin. In study 1, patients received an additional 2 weeks of omeprazole therapy (20 mg/day) or placebo; no additional therapy was given in study 2. Endoscopy was repeated 4 weeks after completion of therapy in both studies. A diagnosis of cure required at least two negative endoscopic biopsy tests (histology, culture, CLOtest) and no positive tests. RESULTS: After therapy, 178 patients (76%) remained positive for H. pylori by histology and/or culture for both studies combined. Post-therapy CLOtest sensitivity was 86% and specificity was 95%. Sensitivity was poorer in patients after dual therapy than after monotherapy in both study 1 (68% vs. 89%; p = 0.03) and study 2 (75% vs. 94%; p = 0.03). CONCLUSIONS: CLOtest sensitivity after therapy was lower than expected in our large group of patients with baseline true-positive CLOtests. In addition, sensitivity was lower after the use of more effective therapy (i.e., dual therapy as compared with monotherapy). Although most patients with unsuccessful treatment will be identified with the CLOtest alone, a negative result should not be taken as diagnostic of eradication.

Amoxicillin↗
PubMed1998

Effect of blood on rapid urease testing of gastric mucosal biopsy specimens.

BACKGROUND: The effect of blood on rapid urease tests is uncertain. We assessed the effect of soaking gastric biopsy specimens in blood on the results of both agar gel (CLOtest) and strip (Pyloritek) rapid urease tests. METHODS: One hundred patients undergoing endoscopy had four adjacent biopsy specimens taken from normal appearing mucosa in the antrum. Two biopsies were soaked in blood for 1 minute; one specimen was placed on a CLOtest and one on a Pyloritek. The other two biopsy specimens were placed on CLOtest and Pyloritek without soaking in blood. The same process was performed with four adjacent biopsy specimens from the gastric body. CLOtests were read at 1, 4, and 24 hours; Pyloritek results were read at 1 hour. RESULTS: The number of positive tests for the blood-soaked and standard biopsy specimens were comparable at all times for both rapid urease tests. Discordant results between the blood-soaked and standard specimens were seen in 17 of 400 test comparisons (4%): in 8 of these only the blood-soaked specimen was positive, and in 9 only the standard specimen was positive. CONCLUSIONS: "Contamination" of biopsy specimens with blood does not alter rapid urease test results.

Biopsy↗
PubMed1998

US double-blind, controlled trials of omeprazole and amoxycillin for treatment of Helicobacter pylori.

BACKGROUND: Widely variable Helicobacter pylori eradication rates have been reported with omeprazole/amoxycillin dual therapy. We present the first US double-blind, controlled trials of this dual therapy. METHODS: Three separate studies were performed: Studies 1 and 2 included patients with an active duodenal ulcer and Study 3 included patients with a documented history of duodenal ulcer. H. pylori eradication regimens in all studies were omeprazole plus amoxycillin vs. omeprazole vs. amoxycillin for 2 weeks. Doses in Study 1 were omeprazole 40 mg b.d. and amoxycillin 500 mg t.d.s., and in Studies 2 and 3 they were omeprazole 20 mg b.d. and amoxycillin 1 g t.d.s. Endoscopic biopsy tests were used for H. pylori diagnosis, and testing for H. pylori eradication was done at least 4 weeks after the completion of therapy. Amoxycillin sensitivities were performed in Study 2. RESULTS: Intention-to-treat (ITT) and per protocol (PP) analyses showed that eradication rates with omeprazole/amoxycillin [ITT: 39%, 40%, 46% (n = 72, 62, 48); PP: 50%, 46%, 54% (n = 54, 52, 37)] were significantly greater than monotherapy with either omeprazole (ITT: 0-4%); PP: 0-5%) or amoxycillin (ITT: 2-5%; PP: 0-11%). No patients taking the dual therapy discontinued therapy due to adverse events. Amoxycillin resistance was not seen at baseline (n = 76) or after amoxycillin therapy (n = 56). CONCLUSIONS: Omeprazole/amoxycillin dual therapy is well tolerated but the eradication rate which can be expected in the USA is at best about 50%.

Administration, Oral↗
PubMed1998

Low rate of emergence of clarithromycin-resistant Helicobacter pylori with amoxycillin co-therapy.

BACKGROUND: Patients with persistent Helicobacter pylori infection following treatment with clarithromycin or omeprazole plus clarithromycin often develop clarithromycin resistance. AIM: To assess pre- and post-treatment antibiotic resistance in three double-blind trials of triple therapy with omeprazole, amoxycillin and clarithromycin. METHODS: Patients with H. pylori and duodenal ulcer (studies 1 and 2) or history of duodenal ulcer (study 3) were randomly assigned to 10 day courses of omeprazole 20 mg b.d., amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. (OAC) or placebo, amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. (AC). Endoscopy was performed at baseline and 4 weeks after completion of therapy in studies 1 and 2, and at 4-6 weeks after therapy in study 3. At baseline, H. pylori was diagnosed by CLO test with confirmation by histology, or by culture. Eradication was defined as no positive biopsy test and > or = 2 negative tests. Susceptibility testing was performed using the Etest. RESULTS: In the 91 patients with pre-treatment susceptible isolates who had persistent infection after AC, 10 developed resistance, eight had intermediate susceptibility and 73 continued to have clarithromycin-susceptible H. pylori isolates. In the 10 patients with pre-treatment susceptible isolates who had persistent infection after OAC, three developed clarithromycin resistance and seven still had susceptible isolates. CONCLUSIONS: Use of amoxycillin co-therapy results in a low rate of clarithromycin resistance developing in patients with persistent H. pylori infection following therapy with a clarithromycin-containing regimen.

Amoxicillin↗