[Treatment of hypertension in a clinical trial. Depot alpha 1 blocker simplifies dosing].
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Adrenergic alpha-Antagonists↗
Biomedical subjects
F Leverkus
Publications and source records attributed to F Leverkus.
Double-blind, multicenter comparative study of sertraline versus amitriptyline in outpatients with major depression.
OBJECTIVE: To compare the efficacy and safety of sertraline and amitriptyline in a German outpatient population. METHODS: Patients with Major Depression (DSM-III-R) and HAM-D (21 items) > or = 21 in 19 German centers received double-blind treatment with sertraline (initial dose 50 mg, titration up to 100 mg) or amitriptyline (75 mg, up to 150 mg) over 6 weeks. HAM-D (21 items), HAM-D Bech, CGI, DSI and SDS were evaluated for the efficacy analysis. FSUCL (Fischer Somatic and Undesired Effects Check List) and spontaneously reported adverse events were used for safety analysis. RESULTS: Of the 240 patients enrolled in the study, 205 (100 sertraline; 105 amitriptyline) were evaluable for efficacy. No statistically significant differences were detected between the two groups in the ITT and ATP efficacy analyses. Response, defined as score 1 (very much improved) or 2 (much improved) of the CGI improvement score, was 76% in the sertraline and 81% in the amitriptyline group (efficacy evaluable patients = ATP population). In the structured FSUCL, the side-effect burden (FSUCL score >2 for drug related symptoms) was significantly higher in the amitriptyline group at all follow up visits (p<0.05). CONCLUSION: Both sertraline and amitriptyline are suitable for the treatment of Major Depression; sertraline is comparable to amitriptyline with regard to efficacy, and offers the additional benefit of a more favorable safety profile.
Adult↗
Intragastric acidity as a predictor of the success of Helicobacter pylori eradication: a study in peptic ulcer patients with omeprazole and amoxicillin.
Omeprazole plus amoxicillin cures Helicobacter pylori infection. The hypothesis was tested that low acidity is a predictor of outcome. Fifty patients with relapsing or complicated, or both H pylori positive duodenal (n = 25) or gastric ulcer (n = 25) were randomly treated with either omeprazole 20 mg twice daily plus amoxicillin 1 g twice daily or with omeprazole 40 mg twice daily plus amoxicillin 1 g twice daily over two weeks. After one week of combined treatment, a 24 hour gastric pH measurement was performed in all patients. H pylori cure rate was 67%. Patients who later turned out to be cured had higher pH values during night time and after meals (p < 0.05). In an explorative analysis drug compliance, smoking, location of the ulcer (duodenum versus stomach), age, and grade of body gastritis were additional predictors of the outcome. Smoking (p = 0.006), compliance (p = 0.037), duodenal ulcer disease (p = 0.065), and young age (p = 0.021) were related to high acidity. In conclusion, the success of eradication treatment with omeprazole and amoxicillin in ulcer patients infected with H pylori depends on intragastric pH. Drug compliance, smoking habits, location of ulcer, age, and activity of body gastritis are other predictors and in part related to intragastric acidity.
Adult↗
Omeprazole plus amoxicillin for cure of Helicobacter pylori infection. Factors influencing the treatment success.
BACKGROUND: Omeprazole plus amoxicillin may cure Helicobacter pylori infection. However, the published results vary rather widely, and the factors influencing the treatment success remain unclear. METHODS: Four hundred and twenty-three H. pylori-positive patients were treated with 1- or 2-week regimens comprising 40 mg or 80 mg omeprazole and amoxicillin in 11 prospective protocols. A complete set of data was available for 405 patients (ulcer disease, n = 383; dyspepsia, n = 22) and was submitted to uni- and multi-variate statistical analyses to elucidate the factors affecting the cure rates of the infection; 18 patients were lost to follow-up. RESULTS: The overall proportion of H. pylori cure was 76%. Insufficient compliance (p < 0.001), a short duration of treatment (p < 0.001), smoking (p = 0.003), and omeprazole pretreatment (p = 0.041) were the significant independent factors predicting treatment failure, whereas advanced age (p = 0.002), high scores of grade and of activity of gastritis (p = 0.035 and p = 0.019, respectively), and gastric ulcer disease (p = 0.058) were independent factors predicting treatment success. CONCLUSIONS: Several patient- and therapy-related factors diminish or increase the rate of H. pylori cure obtained by omeprazole/amoxicillin. These should be considered in future studies comparing different treatment regimens for curing H. pylori infection and also when designing treatment regimens applicable for routine clinical practice.
Adult↗
[Bowel cleansing prior to colonoscopy. A prospective, randomized, blind comparative study].
A randomized, prospective, single blind study was performed in 90 hospital inpatients to compare the effect of three different bowel preparatory regimens prior to total colonoscopy. The extend of bowel cleansing, acceptance by the patients, side effects as well as body weight, blood pressure, pulse rate and various laboratory parameters served as major assessment criteria. Peroral colonic lavage was superior to a senna preparation and a combined laxative agent with regard to the extend of bowel cleansing (p less than 0.001). The study failed to detect significant differences in terms of acceptance by the patients between the three study groups. Minor deviations were found after the combination laxative (slight decrease of serum potassium levels by 0.32 mmol/l), after the senna preparation (minimal decrease of the heart rate), and after peroral lavage (slightly less weight reduction) as compared with the other study groups, respectively. We conclude that peroral lavage is significantly more effective with regard to the extend of bowel cleansing, when compared with two other bowel preparatory regimens, which use a senna preparation or a laxative combination, respectively. Likewise, this study failed to detect significant differences in terms of acceptance by the patients.
Adult↗
Gastrointestinal transit disorders in patients with insulin-treated diabetes mellitus.
Gastric emptying, mouth-to-cecum transit and whole gut transit of a solid-liquid meal were measured in 43 insulin-treated diabetics and in 30 control subjects by using scintigraphic techniques, the hydrogen breath test and stool markers. In the diabetics various parameters including duration of diabetes, gastrointestinal symptoms and complications such as autonomic neuropathy, peripheral neuropathy and proteinuria were determined and related to gastrointestinal transit times. Gastric emptying was significantly prolonged in diabetics as compared to the control group (p less than 0.05) with 35% of the diabetics disclosing abnormally delayed gastric emptying, whereas no significant overall differences were observed between diabetics and controls concerning mouth-to-cecum transit and whole gut transit time. However, abnormally prolonged mouth-to-cecum transit was detected in 23% and delayed whole gut transit in 26% of the diabetics (p less than 0.02 as compared to the control group). There was a significant correlation of dyspeptic symptoms and diarrhea with prolonged gastric emptying (p less than 0.001). Gastric emptying, but not mouth-to-cecum transit or whole gut transit was significantly related to autonomic nerve dysfunction (p less than 0.001) and peripheral neuropathy (p less than 0.02). Furthermore, gastric emptying and WGT were significantly correlated to proteinuria (p less than 0.03). Using a linear regression model, autonomic neuropathy, diarrhea and dyspeptic symptoms were the major parameters in predicting delayed gastric emptying. It is concluded that in diabetics different compartments of the gut are affected by gastrointestinal motor abnormalities and that these segments are probably regulated by independent or different control mechanisms.
Adult↗
Frequency of idiopathic gastric stasis and intestinal transit disorders in essential dyspepsia.
Gastric emptying, mouth-to-cecum transit (MCT), and whole-gut transit of a solid-liquid meal was measured in 30 control subjects and in 43 patients with essential dyspepsia, in whom organic digestive diseases and secondary disorders of gastric emptying had been excluded. The rate of gastric emptying was determined by an anterior gamma camera technique, MCT by the hydrogen breath test, and whole-gut transit by the first appearance of stool makers. Approximately 30% of patients with essential dyspepsia, predominantly women, in whom statistical analysis failed to reveal any specific pattern of symptoms, had significantly delayed gastric emptying suggesting idiopathic gastric stasis. Concerning MCT and whole-gut transit, significant differences between the control and study group could not be detected.
Adolescent↗
[Campylobacter pylori: clinical correlations and prospective comparative studies of various diagnostic techniques].
The diagnostic performance of two different urease tests and of histologic search after modified Giemsa staining to detect Campylobacter pylori (CP) colonization of the upper gastrointestinal tract was prospectively investigated in 215 esophagogastroduodenoscopies, by using a sensitive culture technique as reference. Single antral urease tests had a high specificity of 95-96%, but a limited sensitivity of 78-83%, which increased to 91-94%, when one antral and one additional body biopsy were submitted to the biochemical tests. Giemsa stains were very sensitive, but less specific. The rate of colonization was similar in antrum and body biopsies, and increased with age. There was a close association of Campylobacter pylori colonization with duodenal and to a lower degree with gastric ulcer disease, but especially with gastritic mucosal changes. CP was never detected in patients without gastritis. Therefore, submitting one antral and one body biopsy specimen to validated urease tests represents a sensitive (91-94%) and specific (93%) method to detect Campylobacter pylori colonization, which appears to be a diffuse phenomenon affecting antral and body mucosae with similar frequency.
Biopsy↗
Campylobacter pylori: prospective analysis of clinical and histological factors associated with colonization of the upper gastrointestinal tract.
The association of Campylobacter pylori (C.p.) colonization of the upper gastrointestinal tract with five predefined anamnestic variables, seven symptoms of dyspepsia, and various blindly evaluated histological criteria, was prospectively investigated in a consecutive series of 149 patients submitted to upper gastrointestinal tract endoscopy. Colonization was determined by biopsy urease tests and histological searches. Significant differences (P less than 0.05) between C.p.-positive and C.p.-negative patients were found for smoker status and the frequency of therapy with ulcer-healing drugs (positive association with C.p.) and antibiotics (negative association), but not for any other of the anamnestic data or symptoms. These data were further submitted to stepwise multiple logistic regression analyses. Concerning histological findings, C.p. colonization was significantly associated with the degree of antrum and body gastritis (P less than 0.01), and also with lymphocellular infiltration in antrum and body biopsies and neutrophil cellular grading in gastric antra. We conclude that C.p. colonization of the upper gastrointestinal tract is associated with gastritic change of the antrum and, albeit to a lesser extent, of the body mucosa. However, a specific pattern of symptoms to predict C.p. colonization could not be established.
Adolescent↗
Are dyspeptic symptoms in patients with Campylobacter pylori-associated type B gastritis linked to delayed gastric emptying?
In this paper, the association of gastric Campylobacter pylori (CP) colonization with histologic findings and gastric emptying of a mixed solid-liquid meal was prospectively investigated in 43 consecutive patients with essential non-ulcer dyspepsia (ENUD). Gastric emptying was also measured in 30 symptom-free control subjects. The frequency of CP infection in patients with ENUD was 44.2%. We found a strong association between gastric CP colonization and chronic antral type B gastritis. Although gastric emptying was significantly prolonged in patients with ENUD, compared with the control group (p less than 0.05), we could not detect significant differences of gastric emptying between CP-negative and CP-positive ENUD patients, both groups disclosing a similar proportion of patients with significantly delayed gastric emptying (29.2% vs 31.6%). We therefore conclude that delayed gastric emptying of a mixed solid-liquid meal is not correlated with CP-positive chronic antral type B gastritis, and does not help to explain dyspeptic symptoms, which may possibly arise in relation to gastric CP colonization.
Adult↗
[Prognosis of acute upper gastrointestinal hemorrhage. Univariate and multivariate analysis of 477 episodes of hemorrhage].
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Gastrointestinal Hemorrhage↗
Comparison of biopsy urease test and histologic examination for detection of campylobacter pylori in duodenal, antral and fundic biopsies.
The presence of Campylobacter pylori was investigated in duodenal, antral and fundic biopsies of 149 consecutive patients undergoing upper gastrointestinal tract endoscopy by biopsy urease tests (CLOtest; "CLO test") and histologic examination ("HIST") after modified Giemsa staining. Positive results were obtained rarely in the duodenum (4.7% and 12.8% by CLO test and HIST, respectively), but equally frequently in antral (48.3% and 62.4%) and fundic biopsies (55.0% and 54.4%). Using combined evaluations ("COMB") of both CLO test and HIST results, and disregarding isolated positive histologic grades "1" as C. pylori negative, the detection rates were 6.0, 53.0 and 56.4% in the above order and 63.1% overall at any of the biopsy sites. There was no close correlation between the rapidity of the color conversion of the biochemical test and the microscopic grading of C. pylori density. A positive CLO test in single antral biopsy specimens was an accurate predictor of the presence of C. pylori as compared with HIST (predictive value positive PVpos 0.97), while negative antral BUT results did not rule out C. pylori colonization of the upper GI tract (PVneg 0.52 compared with HIST). An additional negative CLO test from fundic biopsies increases the PVneg to 0.58.
Adolescent↗