[Individualization of exercise load control for inpatient cardiac rehabilitation. Development and evaluation of a HRV-based intervention program for patients with ischemic heart failure]. / Individualisierung der Belastungssteuerung in der kardiologischen stationären Rehabilitation. Entwicklung und Evaluation eines HRV-gesteuerten Interventionsprogramms für Patienten mit ischämisch bedingter Herzinsuffizienz.

BACKGROUND: The effective use of rehabilitation programs is of primary importance in order to improve the physical performance of cardiac disease patients. A modular program has been developed which is intended to structure and individualize conventional, exercise-based rehabilitation programs according to the individual needs and physical condition of each patient. The individualization of the program is based on detailed diagnostics before patients enter the program and daily measurements of heart rate variability (HRV) during cardiac rehabilitation. METHODS: A total of 30 patients with ischemic heart disease were randomly assigned either to the intervention group (IG), completing the modular individualized rehabilitation program [n=15, mean age 54.4±4.2 years and mean left ventricular ejection fraction (LVEF) 28.53±6.25%) or to the control group (CG) taking part in the conventional rehabilitation program (n=15, mean age 56.4±4.4 years and mean LVEF 27.63±5.62). Before and after the intervention, cardiorespiratory fitness was assessed by measurement of maximal oxygen consumption (relative VO2max) during bicycle ergometry and the 6-minute walk test (6-MWT). Pre-post comparisons of cardiorespiratory fitness indicators were used to evaluate the effectiveness of the rehabilitation program. In addition to the results of the basic clinical investigations and the cardiorespiratory testing, results of standardized HRV measurements of 10 min at morning rest served as criteria for program individualization. RESULTS: The relative VO2max increased significantly (p<0.05) in the IG whereas no change was found in the CG. Similar results were found for maximum power output during bicycle ergometry (p<0.01) and for 6-MWT distance (p<0.001). Although patients in the IG completed less aerobic exercise sessions than those in the CG (p<0.001) the physical performance of the IG improved significantly. DISCUSSION: The results prove the effectiveness and efficacy of the modular individualized rehabilitation program. They further suggest the need for an individual program matrix instead of a maximum performance matrix in cardiac rehabilitation. Individualization should be based on clinical and performance diagnostics before and accompanying assessments of training condition, e.g. by HRV measurements, during rehabilitation programs. Each patient should only perform those intervention programs which match the results of the basic clinical investigation and additional analyses during rehabilitation.

[Work-Related Setting Approach with Health Counselling Supports a Healthy Lifestyle of Long-Term Unemployed Persons]. / Arbeitsmarktintegratives Setting mit Gesundheitsberatung unterstützt gesundheitsförderlichen Lebensstil bei Langzeiterwerbslosen.

Unemployment is a major reason for health inequalties. In a pilot study (N=119), the acceptance and effectiveness of a low threshold health promotion intervention for older long-term unemployed persons were evaluated. Health counselling supported the participants in the development of a healthy lifestyle.

[Knowledge of school pupils about the HIV/AIDS topic at selected schools in Mecklenburg-Western Pomerania]. / Der Wissensstand von Schülern über das Thema HIV/AIDS an ausgewählten Schulen in Mecklenburg-Vorpommern.

AIM OF THE STUDY: The increasing numbers of new HIV diagnoses in Germany generate a need to measure the level of knowledge of the young generation about the issue of HIV/AIDS. METHODOLOGY: A survey was conducted of 769 pupils of different age groups and from different schools in Mecklenburg-Western Pomerania. Data analysis was performed using SPSS; statistically significant differences (p<0.05) were tested between the groups using the chi-square test. RESULTS: The level of knowledge within the sample differs: more precise knowledge is demonstrated by pupils following an awareness event (60%) and by pupils interested in HIV (69%) than by those who have attended no awareness event (40%) and those who have little interest in the issue (31%). Moreover, it was noted that grammar school pupils generally achieve better results than pupils from comprehensive and intermediate secondary schools. Furthermore, there are significant differences between the genders: girls give correct answers more frequently than boys and more often show an interest in the HIV/AIDS issue. In addition, age-specific differences are also identifiable: from the age of 14, there is a considerable increase in knowledge, which then remains static at the age of 16. AIDS education in biology lessons is common among pupils and 93% are familiar with this. Over 70% of pupils are unfamiliar with local AIDS awareness teams. CONCLUSIONS: There are significant gaps in the level of knowledge about methods of infection, particularly with respect to questions about the no risk areas, which should thus be particularly dealt with in awareness events. As to knowledge transfer, the pupils' interest should be aroused while taking the type of school, gender and age of the pupils into consideration. In the course of the school career, every pupil should take part in at least one awareness event since our survey showed that only 60% attended such an event. Local AIDS awareness teams should be more frequently active in the schools since 73% stated to be unfamiliar with them in our survey.

Effect of different time intervals between examinations on the reproducibility of ICDAS-II for occlusal caries.

AIM: To evaluate intra- and interexaminer reproducibility of ICDAS-II on occlusal caries diagnosis when different time intervals were allowed to elapse between examinations. A subsidiary aim was to determine whether collapsing the codes would influence this reproducibility. METHODS: The occlusal surfaces of 50 permanent posterior teeth were investigated by 3 trained examiners using ICDAS-II at baseline, 1 day, 1 week and 4 weeks after baseline. RESULTS: Weighted kappa values for intra- and interexaminer reproducibility were 0.76-0.93. CONCLUSION: The time span did not have a major impact on assessing intra- and interexaminer reproducibility. Collapsing ICDAS-II codes had no impact on examiner reproducibility.

Effectiveness of four electronic apex locators to determine distance from the apical foramen.

AIM: To evaluate the accuracy of four electronic apex locators (EAL) in the apical region (0-3 mm short of the foramen) and to compare the precision of the readings on the display with the real position of the file in the root canal. METHODOLOGY: Twenty single-rooted extracted teeth with round root canals were used. The canal orifices were preflared, and the length to the major foramen was determined visually under a microscope. Canals were enlarged, so that a size 15 file fitted well inside the canal. Teeth were mounted in acrylic test tubes filled with physiologic saline solution. Electronic length was determined in the region between the major foramen and 3 mm short of it in 0.5 mm steps with the Dentaport ZX, Root ZX mini, Elements Diagnostic Unit and Apex Locator and Raypex 5 using files of size 10 and size 15. The data were analysed using linear regression between true length and EAL reading, Bland-Altman plots and nonparametric tests at a significance level of alpha = 0.05. RESULTS: The major foramen was detected by all EALs. With a measurement file positioned directly at the major foramen, meter readings were equivalent to a position 0.01-0.38 mm away. For the Dentaport ZX, a better accuracy using the size 15 file for the area 0-1.5 mm short of the apex was found. The differences in measurements between the two files were smaller for the other EALs. In linear regression, a good linearity for Dentaport ZX and Root ZX mini and moderate linearity for Elements Diagnostic Unit and Apex Locator and Raypex 5 were found. The slope of the measurement curve was too low (0.37-0.57) for the Raypex 5 and almost optimal for the Dentaport ZX (1.01-1.05). The Root ZX mini and the Elements Obturation Unit produced lower slope values and especially the Elements Obturation Unit revealed much higher SDs at the different measurement levels. CONCLUSION: Amongst the four EALs, the Dentaport ZX and Root ZX mini had the best agreement between true lengths and meter readings. For the Raypex 5, an interpretation of the colour-coded zones as distance to the foramen cannot be recommended and might lead to erroneous interpretations.

[Sociomedical implications of the inability to commute in patients with cold urticaria]. / Sozialmedizinische Bedeutung der Wegefähigkeit bei der Kälteurtikaria.

One of the important functions of the dermatologist working within a social medicine framework is the determination of social security disability benefits. The primary decision deals with the question which type of work the applicant can be asked to do and to what extent. Depending on the results of the medical assessment, social security disability benefits may be approved given that other insurance criteria specific to the applicant have been met. The following case demonstrates for the first time that a significant idiopathic cold urticaria leads to a severe constraint on keeping employment due to the inability to commute. The scenario shows that the cold urticaria severely restricts social and professional interactions and that the reduced ability to commute to the place of employment must receive special consideration within the context of a sociomedical evaluation.

Extracellular SH3 domain containing proteins--features of a new protein family.

In the year 1994, the protein MIA (melanoma inhibitory activity) was found to be strongly expressed and secreted by malignant melanomas and subsequent studies revealed that MIA has an important function in melanoma development and invasion. Multidimensional NMR-spectroscopy and x-ray crystallography revealed that recombinant human MIA adopts a Src homology 3 (SH3) domain-like fold in solution, a structure with two perpendicular antiparallel three- and five-stranded beta-sheets. SH3 domains are protein modules that are found in many intracellular signalling proteins and mediate protein-protein interactions by binding to proline-rich peptide sequences. Unlike previously described protein structures with SH3 domain folds, MIA is a secreted single-domain protein of 12 kDa that contains an additional antiparallel beta-sheet and two disulfide bonds. Furthermore, the charge surrounding the canonical binding site differs from that of classical SH3 domains. The two disulfide bonds are crucial for correct folding and function as revealed by mutation analysis. Therefore, MIA appears to be the first extracellular protein adopting an SH3 domain-like fold. MIA was shown to interact with fibronectin, and MIA-interacting peptide ligands identified by phage display screening are similar to the consensus sequence of type III human fibronectin repeats, especially FN14. Interestingly, recent data revealed that MIA can also directly bind to integrin alpha 4 beta 1 and alpha 5 beta1 and that it modulates integrin activity negatively. These findings suggest an interesting role of the SH3-domain proteins in the extracellular compartment. Recently, MIA homologous proteins with a sequence identity of 44% and a sequence homology of approximately 80% were determined (TANGO, MIA-2, OTOR). This clearly suggests that this structural device is used more frequently, in processes ranging from developmental changes to the interference of cell attachment in the extracellular matrix. Detailed studies are necessary to determine the exact function of the MIA homologous proteins. It will be interesting to know whether additional protein families can be identified which are secreted and carry SH3 domain-like modules, in addition to elucidate what the specific physiological targets of this protein family are.

Biochemical characterisation of TCTP questions its function as a guanine nucleotide exchange factor for Rheb.

Translationally controlled tumour protein (TCTP) is involved in malignant transformation and regulation of apoptosis. It has been postulated to serve as a guanine nucleotide exchange factor for the small G-protein Rheb. Rheb functions in the PI3 kinase/mTOR pathway. The study presented here was initiated to characterise the interaction between TCTP and Rheb biochemically. Since (i) no exchange activity of TCTP towards Rheb could be detected in vitro, (ii) no interaction between TCTP and Rheb could be detected by NMR spectroscopy, and (iii) no effect of TCTP depletion in cells on the direct downstream targets of Rheb could be observed in vivo, this study shows that TCTP is unlikely to be a guanine nucleotide exchange factor for Rheb.

Design of nanostructured hybrid materials: twin polymerization of urethane-based twin prepolymers.

Organic-inorganic hybrid materials with urethane functionalities were obtained by simultaneous twin polymerization of twin prepolymers in combination with the ideal twin monomer 2,2'-spirobi[4H-1,3,2-benzodioxasiline]. The twin prepolymers consist of a urethane-based prepolymer with reactive terminal groups which can react during the twin polymerization process. Nanostructured hybrid materials with integrated dialkylsiloxane crosslinked urethane structures, phenolic resin and SiO2 are obtained in a one pot process. The effects of the polymerization temperature as well as those of various catalysts and reagent ratios on the polymerization behavior were investigated. The molecular structures of the obtained materials were determined by 13C- and 29Si-{1H}-CP-MAS NMR spectroscopies. HAADF-STEM-measurements were performed to prove the distribution of silicon in the hybrid material.

In vivo characterization of the Saccharomyces cerevisiae centromere DNA element I, a binding site for the helix-loop-helix protein CPF1.

The centromere DNA element I (CDEI) is an important component of Saccharomyces cerevisiae centromere DNA and carries the palindromic sequence CACRTG (R = purine) as a characteristic feature. In vivo, CDEI is bound by the helix-loop-helix protein CPF1. This article describes the in vivo analysis of all single-base-pair substitutions in CDEI in the centromere of an artificial chromosome and demonstrates the importance of the palindromic sequence for faithful chromosome segregation, supporting the notion that CPF1 binds as a dimer to this binding site. Mutational analysis of two conserved base pairs on the left and two nonconserved base pairs on the right of the CDEI palindrome revealed that these are also relevant for mitotic CEN function. Symmetrical mutations in either half-site of the palindrome affect centromere activity to a different extent, indicating nonidentical sequence requirements for binding by the CPF1 homodimer. Analysis of double point mutations in CDEI and in CDEIII, an additional centromere element, indicate synergistic effects between the DNA-protein complexes at these sites.

Handling uncertainties in toxicity modelling using a fuzzy filter.

A fundamental concern in the Quantitative Structure-Activity Relationship approach to toxicity evaluation is the generalization of the model over a wide range of compounds. The data driven modelling of toxicity, due to the complex and ill-defined nature of eco-toxicological systems, is an uncertain process. The development of a toxicity predicting model without considering uncertainties may produce a model with a low generalization performance. This study presents a novel approach to toxicity modelling that handles the involved uncertainties using a fuzzy filter, and thus improves the generalization capability of the model. The method is illustrated by considering a data set dealing with the fathead minnow (Pimephales promelas) toxicity of 568 organic compounds.

Phenolphthalein and bisacodyl: assessment of genotoxic and carcinogenic responses in heterozygous p53 (+/-) mice and syrian hamster embryo (SHE) assay.

Phenolphthalein (800 and 2400 mg/kg/day by gavage and 2400 mg/kg/day by diet) and bisacodyl (800-500, 4000-2000, and 8000 mg/kg/day by gavage) were administered to 15 male and 15 female and 20 male and 20 female p53(+/-) mice respectively for 26 weeks to investigate the potential carcinogenicity of each compound. Toxicokinetic analyses confirmed systemic exposure. p-Cresidine was administered by gavage (400 mg/kg/day) and served as the positive control agent in each study. Dietary phenolphthalein reduced survival in both sexes and early deaths were attributed to thymic lymphoma. No bisacodyl-related neoplasms were observed. Regardless of route of administration to p53(+/-) mice, phenolphthalein but not bisacodyl was unequivocally genotoxic, causing increased micronuclei in polychromatic erythrocytes. In the Syrian hamster embryo (SHE) cell transformation assay, phenolphthalein caused increases in morphologically transformed colonies, thereby corroborating NTP's earlier reports, showing phenolophthalein has potential carcinogenic activity. Bisacodyl was negative in the SHE assay. Results of these experiments confirm an earlier demonstration that dietary phenolphthalein causes thymic lymphoma in p53(+/-) mice and show that (1) phenolphthalein causes qualitatively identical results in this transgenic model regardless of route of oral administration, (2) phenolphthalein shows evidence of micronucleus induction in p53(+/-) mice for up to 26 weeks, (3) phenolphthalein induced transformations in the in vitro SHE assay, and (4) bisacodyl in p53(+/-) mice induces neither drug-related neoplasm, nor micronuclei in polychromatic erythrocytes, and did not induce transformations in the in vitro SHE assay.

Effects of extracellular Mg2+ concentration on intracellular signalling and acid secretion in rat gastric parietal cells.

In the present study, the effects of extracellular magnesium concentration ([Mg2+]ex) on stimulus-secretion coupling processes were investigated in rat gastric parietal cells in vitro. Extracellular magnesium reduction resulted in (1) an increase of basal intracellular free calcium concentration ([Ca2+]in), (2) an enhancement of both carbachol and thapsigargin-induced calcium responses, (3) an improved filling state of intracellular calcium stores, (4) an increase of both basal and carbachol-induced acid secretion, whereas intracellular adenosine 3',5'-cyclic monophosphate (cyclicAMP) levels and histamine stimulated acid secretion were not affected. The effects of high [Mg2+]ex were opposite to the described results, except that high [Mg2+]ex was able to decrease significantly histamine-stimulated cyclicAMP levels and acid secretion. These findings indicate a modulatory role of [Mg2+]ex on the intracellular signalling processes and acid secretory properties in rat parietal cells. These effects seemed to be mediated by regulating (1) calcium loading capacity of intracellular stores, (2) the permeability of the calcium influx pathway, and (3) the formation of cyclicAMP.

A controlled trial of intravenous immune globulin for the prevention of serious infections in adults with advanced human immunodeficiency virus infection.

BACKGROUND: Studies on human immunodeficiency virus-infected children suggest that high-dose immune globulin therapy might be beneficial in reducing the episodes of recurrent infections. In adults, comparable studies are not available. OBJECTIVE: To determine the efficacy of intravenous (IV) immune globulin therapy in preventing infections and reducing days with fever, as well as the duration and frequency of hospitalization for human immunodeficiency virus-infected adults, in a prospective, randomized outpatient clinical trial. METHODS: Adult patients who met Centers for Disease Control and Prevention criteria B and C were randomized to be treated with (n = 70) or without (n = 57) IV immune globulin. Patients who were assigned to treatment with IV immune globulin received 400 and 200 mg/kg of this drug initially and every 21 days thereafter, respectively. Primary end points were the occurrence of laboratory-proved or clinically diagnosed infections and death caused by infection. RESULTS: In comparison with patients in the control group, IV immune globulin treatment significantly increased the time for which the patients who met Centers for Disease Control and Prevention criteria B and C were free from serious infection (P < .001). Twelve (17%) of the patients who received IV immune globulin had infection-related deaths compared with 20 (35%) of the control patients; however, this was not statistically significant (P = .06). Furthermore, immune globulin treatment was associated with an overall reduction in the number and duration of hospitalizations for short-term care (P = .002), days with fever (P < .001), and frequency of diarrhea (P < .001). Because of these results, the study was stopped by the local ethical board. CONCLUSION: Prophylactic IV immune globulin treatment in human immunodeficiency virus-infected adults decreases the frequency of serious infections and is associated with a reduction of hospitalization for short-term care.

The effects of estrone (Ogen) on spinal bone density of postmenopausal women.

The effects of cyclical treatment with estrone sulfate (0.3, 0.625, or 1.25 mg), plus calcium carbonate, on spinal trabecular bone density were compared with placebo in 120 postmenopausal women in this 2-year, multicenter, double-blind study. While the placebo and 0.3-mg treatment groups lost bone density (-3.6% and -5.1%), the 0.625- and 1.25-mg treatment groups experienced no significant change from baseline at 24 months (-0.8% and +0.7%). The 1.25-mg treatment group was significantly different from the placebo group at 12, 18, and 24 months. Although the 0.625-mg treatment group was significantly different from the placebo group only at 18 months, the data suggest that 0.625 and 1.25 mg of estrone sulfate had different effects than placebo and 0.3 mg of estrone sulfate and, given with supplemental calcium, are effective doses for the prevention of spinal bone loss.

Studies of an improved rhesus hematopoietic progenitor cell assay.

We have improved Rhesus monkey marrow cell growth in semisolid media by means of substituting supplemented calf serum for fetal bovine serum. The cloning efficiency of light-density marrow cells separated on 60% Percoll was 126 (+/- 54)/10(5) (n = 12, +/- SD), and for light-density peripheral blood cells 60 (+/- 46)/10(6) (n = 11). Thirty-five percent of the colonies were multilineage, whereas the remainder were unilineage colonies composed of erythrocytes, megakaryocytes, and neutrophilic or monocytic granulocytes. Unilineage megakaryocyte colonies comprised 12% of the total marrow progenitor cells. The [3H]TdR suicide index of marrow progenitor cells was 47% +/- 9% (n = 12). This progenitor cell assay should prove useful in preclinical studies of the effect of recombinant hematopoietic growth factors on the number and cycling status of Rhesus hematopoietic progenitor cells.

Beta-blocking effect of single oral doses of carteolol.

Carteolol is a nonselective beta-adrenergic blocking agent with intrinsic sympathomimetic activity. The duration of beta blockade after single oral doses of carteolol was studied in normal men for 72 hr by determining the heart rate response to an external stimulus, bolus intravenous isoproterenol, and an internal stimulus (graded treadmill exercise designed to achieve 85% of the subjects' maximal heart rate in 12 min). Each subject first received 5 mg of carteolol and then, at 3-wk intervals, 2.5, 15, and 60 mg carteolol and placebo in a randomized, double-blind fashion. Beta blockade was maximal 1 to 2 hr after dosing and the heart rate response to isoproterenol and exercise remained less (P less than 0.05) than placebo responses for the 72 hr after each dose of carteolol. The double product (maximal exercise heart rate x systolic blood pressure during the twelfth minute of exercise) was below (P less than 0.05) baseline values for 24 hr after all doses, for 48 hr after 15 mg, and for 72 hr after 60 mg of carteolol.

Effect of two potent calmodulin antagonists on calcium transport of brush border and basolateral vesicles from human duodenum.

In the present in-vitro study we investigated the possible role of the calmodulin-antagonistic drugs loperamide and calmidazolium in the regulation of transepithelial Ca2+ transport of human duodenum. Brush border membrane vesicles and basolateral membrane vesicles were simultaneously prepared from surgically resected pieces of morphologically intact human duodenum with a modified Percoll-gradient centrifugation method. Brush border and basolateral membrane vesicles were characterized using enzyme marker analysis and electron microscopy: alkaline phosphatase was enriched 20-fold in brush border membrane vesicles, whereas [Na+ + K+]-stimulated adenosine triphosphatase was enriched 15-fold in basolateral membrane vesicles. Calmodulin activity was determined by a specific radioimmunoassay after solubilizing brush border and basolateral membrane vesicles in 1% Triton X-100. In basolateral membrane vesicles, we found no calmodulin activity. In brush border membrane vesicles calmodulin activity was impaired by 50% after pre-incubation with loperamide or calmidazolium. We measured calcium, sodium, D-glucose and D-mannitol uptake with a rapid filtration technique. Before the transport experiments, brush border and basolateral membrane vesicles were pre-incubated with 5 microM loperamide or 5 microM calmidazolium for 60 min at 5 degrees C. In drug-pretreated, brush border membrane vesicles calcium uptake was significantly reduced after 1 min incubation (-25% +/- 5%, P less than 0.05); this effect was completely reversed in the presence of 5 microM calmodulin. In basolateral membrane vesicles, we found two Ca2+ transport systems: (1) Na+/Ca2+ exchange and (2) ATP-dependent Ca2+ transport. In basolateral membrane vesicles loperamide had no effect. Calmidazolium had no effect on Na+/Ca2+ exchange, but significantly inhibited ATP-dependent Ca2+ transport. This effect could not be reversed by calmodulin.

Oral budesonide therapy for steroid-dependent ulcerative colitis: a pilot trial.

BACKGROUND: Budesonide, a corticosteroid with high topical anti-inflammatory activity and low systemic activity, has been shown to prolong time to relapse in Crohn's disease. In the present study, the efficacy of budesonide in an oral pH-modified-release formulation was evaluated for maintenance treatment in patients with steroid-dependent ulcerative colitis. METHODS: Fourteen patients with steroid-dependent ulcerative colitis in the reduction phase of conventional glucocorticosteroids (c-GCS) following a severe attack, were treated with budesonide 3 mg t.d.s. for 6 months. The primary investigation parameters were changes in the clinical activity index (CAI) and in the daily dose of c-GCS. RESULTS: In 11 cases the CAI improved significantly and treatment with c-GCS could be terminated. Three patients experienced relapse and needed further c-GCS treatment. The average daily dose of c-GCS and the average value of the CAI before treatment with budesonide were significantly higher in the relapse group than in the remission group. CONCLUSIONS: In patients with c-GCS-dependent ulcerative colitis, a dose of 9 mg budesonide daily in an oral pH-modified-release formulation was well tolerated, significantly decreased the CAI, and rendered c-GCS unnecessary in the majority of cases.

Eradication of Helicobacter pylori with lansoprazole, roxithromycin and metronidazole--an open pilot study.

BACKGROUND: The most extensively studied Helicobacter pylori eradication regimen comprises omeprazole, clarithromycin and metronidazole. Macrolide antibiotics other than clarithromycin should achieve similar efficacy, but they have not yet been thoroughly tested. AIM: To determine the efficacy and safety of a triple therapy regimen using lansoprazole, roxithromycin, and metronidazole on the basis of multicentre outpatient care in an open pilot study. METHODS: 163 patients with duodenal ulcer and proven H. pylori infection received lansoprazole 30 mg b.d., roxithromycin 300 mg b.d. and metronidazole 500 mg b.d. for 7 days followed by another 7 days of lansoprazole 30 mg once daily. H. pylori status was determined by urease quick test, histology, microbiology and 13C-urea breath test before starting and at least 4 weeks after completing treatment. RESULTS: 150 patients were available for evaluation; H. pylori was successfully eradicated in 84.7% (127/ 150) as determined by urease quick test, 78.0% (117/150) by histology, 81.3% (109/134) by 13C-urea breath test; and in 75.3% (113/150), at least two tests were negative. Side-effects were reported in 34 patients (most commonly diarrhoea and changes in liver function tests), in two cases the study medication was interrupted. Prior to treatment, 23% of the H. pylori isolates were resistant against metronidazole and 3.4% against roxithromycin. After unsuccessful treatment, 84% of the isolates were resistant against metronidazole and 21% against roxithromycin. Primary resistance to metronidazole increased the chance of treatment failure approximately sevenfold (7% vs. 53%). CONCLUSIONS: For H. pylori eradication, the combination of lansoprazole, roxithromycin and metronidazole proved to be as safe as other current triple therapy regimens, while a comparison of efficacy rates yet remains to be assessed in prospective controlled trials. The metronidazole-resistant H. pylori is not rare in Germany and, in the present study, has strongly influenced treatment success.