Evaluation of a new rapid immunoassay for the detection of Helicobacter pylori in faeces: a prospective pilot study.

BACKGROUND: Detection of Helicobacter pylori antigen in faeces is a valid method to diagnose H. pylori infection. Presently available stool tests are performed in the laboratory, and diagnostic report is delayed. AIM: To evaluate a new rapid stool test in a pre-treatment setting and to compare it with a validated laboratory stool test. METHODS: A total of 105 patients underwent gastroscopy with brush cytology, and biopsies for histology and rapid urease test, to assess H. pylori presence. Helicobacter pylori-status was considered positive if at least two tests were positive; negative if all tests were negative; indeterminate if one test was positive and two negative. Stool specimens were tested using either a rapid immunoassay kit (ImmunoCard STAT) or a laboratory enzyme immunoassay kit (Hp StAR). RESULTS: Sixty patients were infected with H. pylori, 44 non-infected, one indeterminate. The sensitivity and specificity of ImmunoCard STAT were 85 and 93%; those of Hp StAR were 88 and 100% (not significant). CONCLUSIONS: ImmunoCard STAT seems a reliable method for detecting H. pylori in untreated patients. It could replace laboratory stool tests, as it is easy and can be performed quickly. These characteristics might be a breakthrough for diagnosing H. pylori in the doctor's office.

Helicobacter pylori stool antigen test: clinical evaluation and cost analysis of a new enzyme immunoassay.

Noninvasive tests for Helicobacter pylori are increasingly used. Recently, an enzyme immunoassay for H. pylori detection in feces has been put on the market. Aim of this multicenter study was to evaluate the usefulness of this novel test as a predictor of H. pylori status in the pretreatment setting. Three hundred consecutive patients were enrolled. None of the patients had received any eradicating treatment in the last 12 months, and all underwent gastroscopy with biopsies of the antrum and body for histology (H) and rapid urease test (RUT). H. pylori status was defined positive (or negative) if both H and RUT were positive (or negative). When H and RUT gave conflicting results, the patients were classified as H. pylori-indeterminate. A stool specimen was collected for each patient and tested by using a novel enzyme immunoassay for H. pylori detection (HpSAT). Sensitivity, specificity, and diagnostic accuracy of the test were calculated, as was the cost of each assay. H. pylori status was positive in 159 patients, negative in 131, and indeterminate in 10. HpSAT gave evaluable results (positive or negative) in 293 patients, and doubtful results in 7 (2.3%). Sensitivity, specificity, and diagnostic accuracy of HpSAT were 96.8%, 89.7%, and 93.6% respectively. Considering the H. pylori-indeterminate patients as positive, the percentages were 95.8%, 98.7%, and 93.2% respectively. The cost for each assay was about US $27. These results suggest that HpSAT is a noninvasive, simple, reliable, fast, and cheap method for evaluating H. pylori status in the pretreatment setting.

Helicobacter pylori and chronic bronchitis.

BACKGROUND: Chronic infections such as those caused by Helicobacter pylori, Chlamydia pneumoniae, and cytomegalovirus have been epidemiologically related to coronary heart disease (CHD). Other studies place H. pylori in relation to other extradigestive diseases. We carried out an epidemiologic pilot study to evaluate the prevalence of H. pylori in patients with chronic bronchitis, a respiratory disease characterized by persistent chronic inflammation, in comparison with a matched control group. METHODS: An enzyme-linked immunosorbent assay IgG test for H. pylori diagnosis was performed in 60 consecutive patients with chronic bronchitis (15 women and 45 men; age range, 50-89 years; mean age, 70.38 years) and in 69 control subjects, well matched for age and social status (19 women and 50 men: age range, 52-90 years; mean age, 71.3 years). RESULTS: Foty-nine of 60 patients with chronic bronchitis (81.6%) and 40 of 69 subjects in the control group (57.9%) were H. pylori-positive (P = 0.0079). The odds ratio, calculated by simple analysis (3.2) and confirmed by logistic regression analysis (3.399), indicated that H. pylori infection greatly increases the risk of chronic bronchitis. CONCLUSIONS: To date, CHD is the only convincing association between H. pylori infection and an extradigestive disease. The main conclusion of this pilot study is that H. pylori infection seems to increase the risk of developing of chronic bronchitis. An important step in this field will be to evaluate the possible change in the clinical conditions after successful eradication therapy in H. pylori-positive patients with chronic bronchitis.

Evaluation of a new enzyme immunoassay for detecting Helicobacter pylori in feces: a prospective pilot study.

OBJECTIVE: There is an increasing interest in noninvasive tests for detecting Helicobacter pylori (H. pylori) infection. Unlike serological and urea breath tests, the possibility of searching for H. pylori in feces has been scarcely investigated. The aim of this prospective pilot study was to evaluate the usefulness of a new enzyme immunoassay for detecting H. pylori antigens in feces, as a predictor of H. pylori status in the pre- and posttreatment settings. METHODS: One hundred and fifty-four symptomatic, anti-H. pylori untreated patients (Group A) and 116 anti-H. pylori treated patients (Group B) underwent gastroscopy with biopsies of the antrum and corpus for histology (H) and rapid urease test (RUT). In the anti-H. pylori treated group, a 13C-urea breath test (UBT) was also performed. In Group A, H. pylori status was defined as positive or negative when both H and RUT gave concordant positive or negative results. In Group B, the patients were considered eradicated if all three tests were negative. A stool specimen was collected from all patients the day after gastroscopy, and tested by using an enzyme immunoassay commercial kit for detecting H. pylori antigens in feces (HpSAT). RESULTS: Eighty-five patients in Group A (55%) and 44 in Group B (38%) were H. pylori infected. On the whole, HpSAT showed a sensitivity of 94% and specificity of 86%. In Group A and Group B, sensitivity and specificity were 94% versus 93%, and 90% versus 82%, respectively (p < 0.05). CONCLUSIONS: HpSAT seems to be a reliable method for predicting H. pylori status in anti-H. pylori untreated patients. Conversely, the test appears less suitable to evaluate the outcome of the eradicating treatment. Consequently, it is likely to be accepted for the primary diagnosis of H. pylori status, particularly in dyspeptic young patients.

Histologic findings and Helicobacter pylori in duodenal biopsies.

We have studied the morphologic aspects of the duodenal bulb in relation to Helicobacter pylori infection in a large group of patients with endoscopically assessed duodenitis to learn more about the pathogenesis of nonspecific duodenitis (bulbitis) and to clarify the specific role of H. pylori. Eight duodenal biopsy specimens in the four quadrants of the first part of the bulb and four gastric antral biopsy specimens were taken in 208 patients. Specimens were fixed in formalin, or in glutaraldehyde, then slides were stained with hematoxylin and eosin, periodic acid-Schiff, and Alcian-Giemsa, and with toluidine blue for semithin sections. Duodenal histology revealed inflammation in 155 (74.5%) and H. pylori-like bacterial bodies in 153 (73.5%) of the patients; H. pylori infection in the gastric antrum was diagnosed in 173 (83.1%) of the patients. Distinguishing histologic aspects appeared to be related to the presence of H. pylori infection. We believe that the present histologic grading of duodenitis correlates better with the natural history of H. pylori infection in the duodenal bulb, and better fits the requirements of a modern classification than the classification commonly used in duodenitis. We conclude that the term H. pylori-linked bulbitis should be adopted as the proper term to identify the particular kind of duodenitis predisposing to peptic ulcer.

A four-day low dose triple therapy regimen for the treatment of Helicobacter pylori infection.

OBJECTIVE: The current guidelines recommend 1-wk triple therapy regimens for eradicating H. pylori infection. Until now, shorter regimens have scarcely been investigated. Azithromycin is a new generation macrolide antibiotic with unusual and favorable pharmacokinetics, and seems to be a very promising agent for innovative anti-H. pylori regimens. We assessed the efficacy and tolerability of a new 4-day low dose triple therapy in comparison with a well established 1-wk triple therapy in the treatment of Helicobacter pylori infection. METHODS: One hundred-sixty consecutive patients with biopsy-proven H. pylori infection were randomized to receive lansoprazole 30 mg b.i.d. on days 1-4, azithromycin 500 mg u.i.d. on days 2-4, and tinidazole 2000 mg u.i.d. on day 3 (LAT group), or 7 days of triple therapy of omeprazole 20 mg u.i.d., clarithromycin 250 mg b.i.d., and tinidazole 500 mg b.i.d. (OCT group). Patients with gastric or duodenal active ulcer received proton pump inhibitors for an additional 4 wk. H. pylori eradication was defined as negative of both rapid urease test and histology on biopsies taken from the gastric body and antrum at least 1 month after the end of treatment. RESULTS: Seven patients in the LAT group and four in the OCT group were lost to follow-up. No significant difference in either efficacy or tolerability was observed between the two regimens. Active ulcers healed in 97.8% of cases with LAT and in 100% of cases with OCT. The eradication rate was 80.8% in the LAT group and 85.5% in the OCT group, considering the per-protocol results, and 73.3% and 81.2%, respectively, considering the intention-to-treat results. Side effects occurred in one LAzT patient and in two OCT patients; they were mild and did not interfere with compliance. CONCLUSION: The new proposed ultrashort triple therapy, including lansoprazole, low dose azithromycin for 3 days, and a single dose of tinidazole, appears to be a very effective anti-H. pylori regimen, a simpler, cheaper, well-tolerated, and equally effective alternative to 1-wk triple therapy.

Usefulness of brushing urease test for diagnosis of Helicobacter pylori infection.

BACKGROUND AND AIMS: Gastric brushing cytology is an accurate technique for rapidly detecting Helicobacter pylori infection, but it is not routinely employed since the presence of personnel experienced in this field, is necessary in the endoscopy suite. To evaluate the diagnostic usefulness of rapid urease test carried out on cytological brushing. PATIENTS: A total of 143 consecutive patients with suspected Helicobacter pylori infection, referred for elective gastroscopy. METHODS: For each patient, 2 brushings were carried out and 4 biopsies were taken from antral mucosa during gastroscopy. The former brushing was smeared on a slide, and stained by a rapid staining set for blood smears. The latter was used for rapid urease test, by shaking the brush into the urea broth. Two biopsies were used for rapid urease test and two for histologic examination. Histology was considered as the gold standard. RESULTS: Of 143 patients, 73 were diagnosed as Helicobacter pylori infected using histology. Six brushing slides were inadequate due to insufficient cytology material. Biopsy-rapid urease test and brushing-rapid urease test had similar sensitivity (87.3% vs 83.5%), specificity (98.4% vs 96.8%) and overall accuracy (92.3% vs 89.5%). In 62 Helicobacter pylori infected patients, both rapid urease test techniques were positive. Brushing-rapid urease test became positive in a significantly shorter time than biopsy-rapid urease test (22 +/- 54 minutes vs 39 +/- 63 minutes; p < 0.01). CONCLUSIONS: Brushing-rapid urease test is as accurate as biopsy-rapid urease test in detecting Helicobacter pylori infection, but it is significantly faster. Special care should be taken to carry out brushing adequately, to minimize the occurrence of false negatives.

Evaluation of a new ultrashort triple therapy for Helicobacter pylori disease.

BACKGROUND: 1-week proton pump inhibitor-based triple therapies are considered the most effective and convenient drug combinations for curing Helicobacter pylori infection. Short therapies, lasting less than 1 week have been investigated rarely. AIM: To assess the efficacy and tolerability of a 3-day lansoprazole triple therapy after 1 day of lansoprazole pre-treatment. METHODS: Seventy H. pylori-positive (rapid urease test and histology) patients received LAzT3 regimen (lanzoprazole 30 mg b.d. and azithromycin 500 mg o.m. for 3 days; tinidazole 2000 mg o.m. on day 1 and 1000 mg o.m. on days 2-3) after 1 day of lansoprazole pretreatment. Patients with active ulcer received lansoprazole 30 mg o.m. for an additional 4 weeks. Follow-up gastroscopy was carried out 4-6 weeks after completion of therapy. Eradication was defined as negative histology and rapid urease test. RESULTS: Four patients failed to attend the follow-up endoscopy. One patient complained of minor side-effects. H. pylori was eradicated in 57 of 66 patients suitable for evaluation, with a per-protocol cure rate of 86.3% (95%CI: 76-94%), and an intention-to-treat cure rate of 81.4% (95%CI: 70-90%). CONCLUSIONS: This new ultrashort triple therapy including lansoprazole, azithromycin and tinidazole seems to be effective in eradicating H. pylori. It is safe and well-tolerated, and may be taken into consideration as a valid alternative to the better known and widely used 1-week proton pump inhibitor-based triple therapies.

Touch cytology. A reliable and cost-effective method for diagnosis of Helicobacter pylori infection.

A variety of reliable methods are available for detecting Helicobacter pylori (Hp) during upper gastrointestinal endoscopy. We evaluated the clinical utility and cost-effectiveness of rapid urease test (RUT), touch cytology (TC), and histology (H). Two hundred thirty-eight consecutive patients (178 without previous medical treatment and 60 formerly treated with anti-Hp therapy) were tested for Hp infection by RUT, TC, and H (H&E stain). The infection status for each patient was established by a concordance of two test results. The time to carry out the three tests and their cost were also calculated. Sensitivity of TC (100%) was significantly higher than that of RUT (86.8%; P < 0.001), but not than that of H (94.9%). RUT was significantly more specific than H (100% vs 95.6%; P < 0.05), but not than TC (96.4%). Hp infection was more frequent in the patients with chronic active gastritis than in those with chronic nonactive gastritis (P < 0.001). No Hp infection was detected in absence of chronic antral inflammation. RUT resulted the cheapest method and H the most expensive; TC is faster and cheaper than H. When additional information about the severity of mucosal damage or the presence of cell atypias is not necessary, histologic examination can be omitted, and a cost-effective strategy for assessing Hp status might consist in taking two antral biopsies, the former for performing RUT and the latter for preparing a slide by TC, which should be stained and examined only when the RUT result is negative.

Comparison of efficacy of spirapril and enalapril in control of mild-to-moderate hypertension.

The efficacy of spirapril, 6 mg once daily, was compared with enalapril, 5-20 mg once daily, in the control of mild-to-moderate hypertension in a placebo-controlled, parallel-group study. A total of 251 patients participated in the study, all of whom underwent a 4-week washout period on placebo. Thereafter, 100 patients were randomized to spirapril, 6 mg once daily, 101 patients to enalapril, 5-20 mg once daily, and 50 patients remained on placebo. Sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) were measured at 2-weekly clinic visits. Blood pressure profiles during peak and trough plasma drug concentrations (2-4 hours and 24-26 hours postdose, respectively) were determined at baseline and 4 and 8 weeks after starting the double-blind phase. Compared with placebo, treatment with both spirapril and enalapril resulted in significant reductions (p < 0.001) in DBP and SBP. DBP was reduced to a greater extent with spirapril than with enalapril both at peak (-17.4 mmHg vs. -14.8 mmHg) and trough (-14.7 mmHg vs. -12.4 mmHg). Thus, although the trough/peak DBP ratios for spirapril and enalapril were very similar (84% vs. 82%), actual reductions in DBP were different. Spirapril and enalapril treatment resulted in similar reductions in SBP at both peak and trough levels. Both drugs were well tolerated, and there were very few adverse events or changes in hematological or biochemical parameters during the study. In conclusion, spirapril, 6 mg once daily, as the initial and maintenance dose, is at least as effective and well tolerated as enalapril individually titrated.

Short-term low-dose triple therapy with azithromycin, metronidazole and lansoprazole appears highly effective for the eradication of Helicobacter pylori.

BACKGROUND: Although the OCN (omeprazole, clarithromycin and nitroimidazoles) short-term low-dose regimens are regarded as 'the standard' in the treatment of Helicobacter pylori infection, azithromycin is a new-generation, acid-stable macrolide which may prove particularly useful for a new short-term low-dose triple therapy regimen. OBJECTIVE: To further improve OCN eradication treatments by reducing both the number of pills and the total cost. METHODS: A new short-term low-dose triple therapy (LAM) using lansoprazole 30 mg once a day for 1 week, azithromycin 500 mg once a day for 3 days, and metronidazole 250 mg twice a day for the same 3 days, was administrated to 60 patients presenting with H. pylori-positive gastritis with or without peptic ulcer, and compared with the classic 'Bazzoli regimen' (OCT: omeprazole, clarithromycin, tinidazole) in 60 matched patients. H. pylori infection before and after therapy was evaluated by a rapid urease test, conventional histology and toluidine-stained semi-thin sections. Three biopsies from the corpus and three from the antrum were taken during endoscopical examination before and 7-8 weeks after discontinuation of the treatment. Patient compliance, drug tolerance and drug costs were also taken into consideration. RESULTS: H. pylori infection was eradicated 7-8 weeks after treatment in 56 of the 60 patients in the LAM group (93.3%), and in 52 of the 57 patients in the OCT group who completed the treatment (91.2%), with no statistical difference. When gastric or duodenal ulceration was present, ulcer healing was observed in all cases. CONCLUSION: The new proposed short-term low-dose triple therapy (LAM) appears to be as effective as the OCT for the eradication of H. pylori infection. The new treatment, however, seems to have advantages in terms of drug tolerance, patient compliance and therapy cost.

Endoscopic aspects of gastroduodenal mucosa due to NSAIDs.

The role of endoscopy in NSAID-related gastroduodenal pathologies is reviewed. If an accepted and largely used algorithm in which the role of endoscopy is exactly identified is not available, current strategy for the management of gastroduodenal toxicity gives indication for endoscopy immediately after the onset of symptoms, anaemia and evidence of bleeding, overt or occult. The endoscopic patterns of lesions in patients taking NSAID are characteristics patterns of erosive and ulcerative lesions. Endoscopy can recognize early lesions, allowing us to prevent a more advanced mucosal damage.

Ultrastructural damage of gastric epithelium in patients taking NSAIDs.

As far as concerns ultrastructural lesions in the gastric epithelium following NSAIDs, a review has been made of existing data and ideas for future research concerning the ultrastructural field are advanced. Specific ultrastructural damage of the gastric epithelial cells has been recognized in patients taking NSAIDs: this pattern of damage appears characterized by a proliferative phenomen of "desquamation" of contiguous epithelial cells. Studies in animal models indicate that the first-level of epithelial damage involves a mitochondrial derangement and an alteration of tight junctions and cytoskeletal. The length of time of local drug action on the gastric mucosa could be the reason for the characteristic morphological presentation seen in vivo. If ulcers are the result of an imbalance between cell necrosis and cell regeneration, the high progression speed of cell necrosis to contiguous cells should play a basic role in the genesis of ulcers.

Therapy of NSAIDs-induced gastropathy.

NSAID-induced gastropathy is the most frequent side effect due to NSAID use. The resulting clinical event is usually of little significance and only in a small percentage of cases results in serious side effects. Nevertheless, the large worldwide use of NSAIDs makes, even a rare side effect, numerically consistent. The pathogenesis of NSAID-induced gastropathy is related to two main mechanisms: an initial topical effect which is pH dependent and a systemic effect which is, more slowly developing, and mainly correlated to the inhibition of prostaglandin synthesis. The therapy of NSAID-gastropathy is almost completely identified with the therapy of NSAID ulceration because of its frequent relation to the development of potentially serious complications. In the case of symptomatic ulcer development the first therapeutic step is NSAID suspension and, in such a case all "antiulcer" drugs are efficient. When the NSAID can not be discontinued, omeprazole seems to be the most efficient drug; H2 blockers can promote ulcer healing but at a slower rate; sucralfate shows an efficacy similar to H2 blockers; misoprostol is useful in the prevention of NSAID-gastropathy. However, it is not so efficient in the treatment of established lesions and shows poor efficacy in the reduction of dyspeptic symptoms. For each one of these drugs it is necessary to obtain further data.

Histological findings in gastric mucosa in patients treated with non-steroidal anti-inflammatory drugs.

AIMS: To identify distinguishing and general histological features related to the use of non-steroidal anti-inflammatory drugs (NSAID). METHODS: Slides from gastric antral biopsies of 50 patients with osteoarthritis taking NSAID were compared with slides from antral biopsies of 50 control cases matched for age, sex, and race. Semithin sections stained with toluidine blue were used. RESULTS: Chronic gastritis was seen in 76% of the patients taking NSAID and in 58% of the control cases; active inflammation was detected in 10% of the NSAID treated patients and in 24% of the control cases, and it appeared closely related with Helicobacter pylori infection. Some histological features common to all slides of patients taking NSAID were recognised. These consisted of focal erosions of the gastric epithelium and macroerosions, and they seemed to represent successive steps of a process of "desquamation". CONCLUSIONS: Some distinguishing morphological aspects appeared prominent; it is suggested that these may be related to the pathogenesis of NSAID linked peptic ulceration. On the other hand, epithelial damage due to NSAID appears very different from that due to Helicobacter pylori, another important factor involved in the aetiopathogenesis of peptic disease.

Ultrastructural patterns of Helicobacter pylori.

Ultrastructural morphology of the bacterial bodies was studied in 40 Helicobacter pylori positive cases. Two bacterial patterns were identified, which were associated with different modes of contact with the epithelial cells and possibly with different stages of the natural history of the infection.