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H J Trampisch

Publications and source records attributed to H J Trampisch.

At least 19 recordsLinked to original sources
PubMed2007

[Metabolic syndrome and peripheral arterial occlusive disease as indicators for increased cardiovascular risk].

BACKGROUND AND AIMS: The usefulness of the metabolic syndrome (MetS) or a low ankle brachial index (ABI), respectively, to identify patients with high risk for cardiovascular events has repeatedly been postulated. However, robust data on the prevalence and prognosis of such patients are missing in the primary care setting. PATIENTS AND METHODS: In the prospective, non-interventional "German epidemiological trial on Ankle Brachial Index (getABI) at total of 6880 unselected patients > or = 65 years were observed by their General Practitioners over 3 years. Death and cardiovascular events were recorded. The definition of MetS was similar to the one of NCEP ATP III (National Cholesterol Education Program--Adult Treatment Panel III). ABI (ratio of the systolic blood pressures measured at the distal part of the calf and at the upper arm) was measured with Doppler sonography. Peripheral arterial disease (PAD) was defined as ABI <0.9 or peripheral revascularization/amputation owing to PAD. Survival analyses were conducted with a Cox proportional hazard model. Hazard rate ratios (HRR, 95 % confidence intervals, CI) were multvariate adjusted. RESULTS: The observation time for the total cohort was more than 20,000 patient years (PY). Cardiovascular mortality in patients with MetS (n = 3040, 44 %) compared to patients without MetS (n = 3795; 55 %) was doubled (8.5 vs. 4.0 per 1,000 PY; HRR: 2.0; CI 1.3 - 2.9). Concomitant presence of MetS and PAD (n = 651; 9.5 %) increased the mortality risk compared to patients without both conditions (n = 3194; 46.4 %) drastically (21.1 vs. 3.0 per 1000 PY; HRR: 5.7; CI: 3.5 - 9.4). Similar significant risk increases also were noted for all-cause mortality or a combined endpoint of mortality and vascular morbidity. Further, in lower ABI categories cardiovascular event rates increased. CONCLUSIONS: Patients with MetS carry a substantially increased risk of premature death, especially cardiovascular death, and therefore require intensive treatment of their risk factors. This holds especially true if concomitant PAD is present.

Aged↗
PubMed2004

An internal standard for verifying the accuracy of serious adverse event reporting: the example of an acupuncture study of 190,924 patients.

BACKGROUND: Reporting of all serious adverse events (SAEs) is a requirement for regulatory approval of a drug. Can equally rigorous reporting standards be expected in studies of non-drug treatments and how can underreporting, if any, be detected and proven? Using data from our large-scale prospective cohort study of acupuncture on outpatients, we examine the use of an internal standard, a principle taken from laboratory medicine, to quantify real event rates. METHODS: A total of 190,924 patients (68.6% women) seeking treatment for chronic pain (headache, low back pain, coxarthrosis or gonarthrosis) from 12,000 physicians in private practice in Germany were observed during a six-month period ending in May 2002. Most received ten sessions of body acupuncture. Mean treatment time was six weeks. All practitioners were certified in acupuncture and received written instructions on completing forms for basic patient data and SAE monitoring. They were also informed that payment by insurers would be made only upon return of the completed form. All SAEs occurring between start of the first acupuncture session and end of the last one were to be reported, whether causally related to the treatment or not. Multiple minor adverse events (AEs) per single patient were to be reported only once. As the internal standard we chose the expected number of deaths, based on the death rate for the German population, adjusted for age, sex distribution and mean observation time of our study patients. RESULTS: 45 SAEs and 14,404 AEs were reported (i.e. 2.4 SAEs and 754 AEs per 10,000 patients). The number of reported deaths (9) was only 5% of the statistically expected number (180). Applying the resulting correction factor of 20 to all reported SAEs, resulted in 900 expected SAEs (versus 45 reported) or 47 per 10,000 patients. CONCLUSIONS: Without verifying the accuracy of a measurement, results remain speculative. Our internal standard for the first time provides a means of verifying the accuracy of the reported SAE rate and correcting it to the statistically expected SAE rate.

Acupuncture Therapy↗
PubMed2004

High prevalence of peripheral arterial disease and low treatment rates in elderly primary care patients with diabetes.

Representative data on peripheral arterial disease (PAD) in community-based office practice are scarce while at the same time of high interest. Thus, we aimed to determine the prevalence of peripheral arterial disease (PAD), comorbidity of atherothrombotic manifestations, and treatment intensity among elderly diabetic patients in primary care. In this monitored cross-sectional study, 344 general practitioners throughout Germany determined the ankle-brachial index (ABI) of 6880 consecutive, unselected patients aged 65 years or older with bilateral Doppler ultrasound measurements. PAD was defined according to the recent American Heart Association guidelines (using the higher of the 2 systolic ankle pressures: ABI < 0.9) or peripheral revascularisation, or amputation because of PAD. Coronary events (CAD) and cerebrovascular events (CVD) were taken from the patient's history without additional diagnostic measures. Diabetes was defined according to the clinical diagnosis of the physician and/or HbA1c > or = 6.5 % and/or intake of oral antidiabetic medication and/or application of insulin. 1.743 patients were classified as diabetics: the median disease duration was 6 years (1st; 3rd quartile: 2; 11), median HbA1c 6.6 % (5.9; 7.3), mean age 72.5 +/- 5.4 years, and 51.4 % were females. Diabetics had in comparison with non-diabetics a higher prevalence of PAD defined as ABI < 0.9 (26.3 % vs. 15.3 %, univariate odds ratio 2.0 [95 % confidence interval: 1.7; 2.3]), intermittent claudication (5.1 % vs. 2.1 %, OR: 2.5 [1.9; 3.4]), known CAD (16.1 % vs. 10.6 %, OR: 1.6 [1.4; 1.9]), and known CVD (6.8 % vs. 4.8 %; OR: 1.4 [1.2; 1.8]). 57.4 % of the diabetics with previously known PAD (as only atherothrombotic manifestation) received antiplatelet therapy (vs. 75.1 % with CAD and/or CVD only). The ABI was suitable as screening measure in the primary care setting. In elderly diabetics in comparison to non-diabetics, the prevalence of PAD was very high. Despite the known benefits of antiplatelet therapy, PAD patients were less intensively treated than patients with CAD or CVD.

Aged↗
PubMed2003

Are elevated homocysteine plasma levels related to peripheral arterial disease? Results from a cross-sectional study of 6880 primary care patients.

BACKGROUND: It is still unclear whether the strength of the association between elevated plasma homocysteine (HC) levels and peripheral arterial disease (PAD), coronary artery disease (CAD) and cerebrovascular disease (CVD) is similar. METHODS: Fasting homocysteine plasma levels were measured in 6880 unselected primary care patients aged 65 years or older. Presence of PAD was determined with the ankle brachial index, and both CAD and CVD were recorded according to patient history. RESULTS: Median homocysteine levels in the total sample (58.0% females, mean age 72.5 years, mean body mass index 27.3 kg m-2) differed between patients with and without PAD: 15.2 micro mol L-1 (95% confidence interval [CI] 14.8; 15.7, vs. 13.9 micro mol L-1 (CI: 13.8; 14.1; P < 0.001). Peripheral arterial disease prevalence moderately increased from 13.0% in the lowest HC quintile to 24.3% in the highest quintile (crude odds ratio [OR], 2.1 [CI: 1.7; 2.6]). The frequency of atherothrombotic manifestations in the patients' history increased nearly linearly across the homocysteine quintiles in the univariate analysis. However, the association diminished substantially after adjusting for known interfering variables: the ORs between the HC highest fifth vs. lowest fifth (adjusted for age, gender, smoking status, diabetes, hypertension lipid disorders, and estimated glomerular filtration rate levels) for PAD decreased to 1.4, for CAD to 1.0 (NS), and for CVD to 1.1. (NS). CONCLUSIONS: Elevated HC is only slightly more related to PAD than to CAD and CVD. After adjustment for known risk factors, the effect size is small, and an association can no longer be observed between homocysteine and CAD and CVD.

Age Distribution↗
PubMed1998

Practical experience with the design and analysis of a three-armed equivalence study.

OBJECTIVE: While there is a lot of experience with the design, conduct and interpretation of bioequivalence studies, the methodology of trials concerning therapeutic equivalence is still at an early stage of development. Two-armed equivalence studies involve special problems of interpretation, which can be partly solved by the introduction of a third (placebo) arm. We describe a trial in which the therapeutic equivalence of horse chestnut seed extract (HCSE) and compression treatment was to be demonstrated in patients with chronic venous insufficiency (CVI). Compression is regarded as the standard therapy in this field. However, the efficacy of compression in terms of the variable of primary interest, namely oedema reduction, has never been demonstrated according to current methodological rules. Thus, the 'standard' had to be established in the trial itself. This can be achieved by demonstration of relevant superiority in comparison with placebo. METHODS: Two hypotheses had to be tested: (1) the relevant superiority of compression compared with placebo as a precondition for (2) the at most irrelevant inferiority of HCSE in comparison with compression ('equivalence'). For both corresponding statistical tests, the irrelevance criterion -- formulated as standardized difference -- was set to 0.5. RESULTS: Therapeutic equivalence could not be demonstrated following this design, because compression failed to be relevantly superior compared with placebo, even though HCSE was shown to be at most irrelevantly inferior compared with compression. Explorative analyses show that it is not possible to reject simultaneously both null hypotheses with the obtained data when using equal irrelevance limits for both tests. CONCLUSION: Although the primary objective of the trial could not be achieved, the results were encouraging. Thus, a new study was planned and started based on the observed data. The concept of a shifted null hypothesis may be applied to 'routine' clinical trials too; using 'no difference' as the null hypothesis in a trial does not seem to be meaningful when in fact an at least relevant difference is required.

Clinical Trials as Topic↗
PubMed1996

Comparison of leg compression stocking and oral horse-chestnut seed extract therapy in patients with chronic venous insufficiency.

BACKGROUND: Diseases of the venous system are widespread disorders sometimes associated with modern civilisation and are among the major concerns of social and occupational medicine. This study was carried out to compare the efficacy (oedema reduction) and safety of compression stockings class II and dried horse chestnut seed extract (HCSE, 50 mg aescin, twice daily). METHODS: Equivalence of both therapies was examined in a novel hierarchical statistical design in 240 patients with chronic venous insufficiency. Patients were treated over a period of 12 weeks in a randomised, partially blinded, placebo-controlled, parallel study design. FINDINGS: Lower leg volume of the more severely affected limb decreased on average by 43.8 mL (n = 95) with HCSE and 46.7 mL (n = 99) with compression therapy, while it increased by 9.8 mL with placebo (n = 46) after 12 weeks therapy for the intention-to-treat group (95% CI: HCSE: 21.1-66.4; compression: 30.4-63.0; placebo: 40.0-20.4). Significant oedema reductions were achieved by HCSE (p = 0.005) and compression (p = 0.002) compared to placebo, and the two therapies were shown to be equivalent (p = 0.001); in this design, however, compression could not be proven as standard with regard to oedema reduction in the statistical test procedure. Both HCSE and compression therapy were well tolerated and no serious treatment-related events were reported. INTERPRETATION: These results indicate that compression stocking therapy and HCSE therapy are alternative therapies for the effective treatment of patients with oedema resulting from chronic venous insufficiency.

Bandages↗
PubMed1995

Randomised, placebo-controlled, double-blind clinical trial of beta-sitosterol in patients with benign prostatic hyperplasia. Beta-sitosterol Study Group.

Medical treatments have become available for benign hypertrophy of the prostate, including alpha-receptor blocking agents and 5-alpha-reductase inhibitors. Drugs derived from plants, for which no precise mechanism of action has been described, are widely used for this purpose in Europe. In a randomised, double-blind, placebo-controlled multicentre study, 200 patients (recruited between April and October 1993) with symptomatic benign prostatic hyperplasia were treated with either 20 mg beta-sitosterol (which contains a mixture of phytosterols) three times per day or placebo. Primary end-point was a difference of modified Boyarsky score between treatment groups after 6 months; secondary end-points were changes in International Prostate Symptom Score (IPSS), urine flow, and prostate volume. Modified Boyarsky score decreased significantly with a mean of -6.7 (SD 4.0) points in the beta-sitosterol-treated group versus -2.1 (3.2) points in the placebo group p < 0.01. There was a decrease in IPSS (-7.4 [3.8] points in the beta-sitosterol-treated group vs -2.1 [3.8] points in the placebo group) and changes in urine flow parameters: beta-sitosterol treatment resulted in increasing peak flow (15.2 [5.7] mL/s from 9.9 [2.5] mL/s), and decrease of mean residual urinary volume (30.4 [39.9] mL from 65.8 [20.8] mL). These parameters did not change in the placebo group (p < 0.01). No relevant reduction of prostatic volume was observed in either group. Significant improvement in symptoms and urinary flow parameters show the effectiveness of beta-sitosterol in the treatment of benign prostatic hyperplasia.

Aged↗
PubMed1995

How to evaluate measuring methods in the case of non-defined external validity.

In the clinical routine of chronic diseases, a new measurement has to be compared to an established criterion to see whether there is agreement on assessing disease progress. Because of the nonexistence of established criteria for rheumatoid arthritis the evaluation of grading systems for radiological assessment needs an alternative approach. Using the measurement error as a measure for repeatability and rater agreement in comparison to the progress of the grading score might be a solution to this dilemma.

Arthritis, Rheumatoid↗
PubMed1994

[General requirements for study designs].

It is the purpose of this review to outline the principles of biometric methods in clinical research. Several study designs such as cohort studies, case-control studies or randomized controlled trials are explained in detail, and their problems and their interpretation are discussed. It is demonstrated that observational studies may yield valuable information about associations between exposure and outcome variables but that only properly designed randomized clinical trials of adequate sample size make it possible to answer research questions about causal relationships. It is emphasized that good clinical research depends on properly designed studies more than on complicated statistical procedures.

Clinical Trials as Topic↗
PubMed1993

Evaluation of a structured treatment and teaching programme on hypertension in general practice.

OBJECTIVE: Evaluation of a structured hypertension treatment and teaching programme in general practice. DESIGN: Prospective controlled trial; follow-up period 18 months. SETTING: 10 primary health care practices. PRACTICES AND PATIENTS: From each practice 20 patients (30 to 60 years old, mean of the last two blood pressure measurements at or above 160 and/or 95 mmHg) were randomly selected; in 5 practices these patients were to participate in the treatment and teaching programme; in the remaining 5 practices hypertension care was continued without the availability of such a programme (controls). INTERVENTION: Structured treatment and teaching programme based upon four group sessions for patients mainly conducted by paramedical personnel. MAIN OUTCOME MEASURES: Blood pressure, body weight, prescription of antihypertensive drugs - as documented in the patient's records. MAIN RESULTS: Of the 100 control patients 26 and of the 100 intervention patients 14 were lost to observation; 46 patients had agreed to participate in the programme. The mean number of prescribed antihypertensive agents per patient decreased in the intervention group (1.8 +/- 1.3 at baseline, vs 1.2 +/- 1.2 at follow-up) compared to the control group (1.6 +/- 1.3 vs 1.8 +/- 1.6); difference 0.8 (95% CI 0.4 to 1.1), p < 0.0001. In the control group 9% and in the intervention group 33% of patients had documented reductions of body weight (p < 0.0001). Blood pressure decreased in the intervention group (162 +/- 14/100 +/- 7 mmHg at baseline, vs 154 +/- 16/95 +/- 9 mmHg at follow-up) compared to the control group (161 +/- 13/98 +/- 7 mmHg vs 158 +/- 18/96 +/- 11 mmHg); differences for systolic blood pressure 5 (95% CI 0 to 10) mmHg, p = 0.071; for diastolic blood pressure 4 (1 to 7) mmHg, p = 0.018. CONCLUSIONS: The introduction of a structured hypertension treatment and teaching programme in general practice may lead to significant improvements of hypertension care.

Adult↗