Beobachtungsstudien im Rahmen eines naturheilkundlichen Klinikverbunds. teil i: methoden und übersicht der ergebnisse in den beteiligten kliniken.
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Journal Article↗
Biomedical subjects
W Weidenhammer
Publications and source records attributed to W Weidenhammer.
Systematic clinical auditing in complementary medicine: rationale, concept, and a pilot study.
A scientific evaluation of complementary medical practices commonly used in healthcare is urgently required. Although randomized clinical trials are the primary tool for such an evaluation, for a number of conceptual and pragmatic reasons, they should not be the only tool. The authors propose systematic clinical auditing as a concept to (1) provide information on the "epidemiology" of complementary medical practices, (2) make the processes used in the daily practice of these complementary methods clearly intelligible, and (3) give a preliminary estimation of outcomes. Systematic clinical auditing uses mainly observational studies of large samples of patients. A pilot study was conducted to investigate the feasibility of using a systematic clinical audit in a hospital for traditional Chinese medicine in Germany. All 1597 patients admitted between February 1, 1992, and August 31, 1993, were included in the study. Patients' characteristics, diagnoses, and preventive and therapeutic interventions were recorded, and patients were asked to rate the intensity of their main complaints (on scale of 1 to 10) at admission; at discharge; and at 2, 6, and 12 months after admission. About two thirds of all patients had chronic pain complaints; the most common diagnosis was migraine (n = 244). Nearly all patients received acupuncture and Chinese herbal therapy; 61% received tuina massages, and 16% received qigong. The mean intensity of main complaints was 7.0 (2.0, SD) at admission, 4.6 (2.4) at discharge, and 5.5 (2.7) 12 months after admission. In the authors' opinion, systematic clinical auditing is a valuable tool for collecting basic information on structural characteristics, processes, and outcomes in complementary medicine and for determining representative and relevant questions for future randomized clinical trials.
Complementary Therapies↗
St John's wort for depression--an overview and meta-analysis of randomised clinical trials.
OBJECTIVE: To investigate if extracts of Hypericum perforatum (St John's wort) are more effective than placebo in the treatment of depression, are as effective as standard antidepressive treatment, and have fewer side effects than standard antidepressant drugs. DESIGN: Systematic review and meta-analysis of trials revealed by searches. TRIALS: 23 randomised trials including a total of 1757 outpatients with mainly mild or moderately severe depressive disorders: 15 (14 testing single preparations and one a combination with other plant extracts) were placebo controlled, and eight (six testing single preparations and two combinations) compared hypericum with another drug treatment. MAIN OUTCOME MEASURES: A pooled estimate of the responder rate ratio (responder rate in treatment group/responder rate in control group), and numbers of patients reporting and dropping out for side effects. RESULTS: Hypericum extracts were significantly superior to placebo (ratio = 2.67; 95% confidence interval 1.78 to 4.01) and similarly effective as standard antidepressants (single preparations 1.10; 0.93 to 1.31, combinations 1.52; 0.78 to 2.94). There were two (0.8%) drop outs for side effects with hypericum and seven (3.0%) with standard antidepressant drugs. Side effects occurred in 50 (19.8%) patients on hypericum and 84 (52.8%) patients on standard antidepressants. CONCLUSION: There is evidence that extracts of hypericum are more effective than placebo for the treatment of mild to moderately severe depressive disorders. Further studies comparing extracts with standard antidepressants in well defined groups of patients and comparing different extracts and doses are needed.
Antidepressive Agents↗
The integration of natural healing procedures into research and teaching at German universities.
This article describes the activities of the "Münchener Modell," a project for "Integration of Natural Healing Procedures into Research and Teaching" at the Ludwig-Maximilian University in Munich. Its objective is to improve research and teaching of Natural Healing Procedures (NHPs) and to provide the infrastructural and conceptual prerequisites for the establishment of an independent academic institution. In the years 1989 to 1992 the project organized three 1-year pregraduate courses of NHPs for medical students. Parts of the courses have now been integrated in the regular undergraduate education. In 1993 a quality assurance project for postgraduate education was piloted. In a network of clinics using NHPs a comprehensive quality assurance project including observational studies and controlled clinical trials has been implemented and piloted. For evaluating the actual state of knowledge in a transparent way the project performs systematic reviews of published research. Further clinical-experimental research is being done in the area of immunomodulation with natural products.
Complementary Therapies↗
Neurotoxicity of solvent mixtures in spray painters. II. Neurologic, psychiatric, psychological, and neuroradiologic findings.
A multidisciplinary cross-sectional study was performed to examine the chronic neurotoxicity of organic solvents. Participating in the study were 105 persons employed as spray painters and having long-term solvent exposure (10-44 years) and a control group consisting of 58 construction workers, electricians, and plumbers without occupational contact to solvents. Samples were matched for age, preexposure intelligence level, occupation, and socioeconomic status. After controlling for potentially non occupational confounding factors (neuropsychiatric diseases, metabolic disorders, high blood pressure, alcohol intake) 83 spray painters and 42 controls were entered finally into the study. The evaluation included work history, self-rating questionnaire, neurologic investigation, psychiatric analysis using the Present State Examination (PSE), psychological testing, and computerized axial tomography (CAT) of the brain. Physical and neurologic examinations demonstrated no case of overt disorders of the central or peripheral nervous system. An important result of the psychiatric analysis was that the syndromes "special features of depression" and "loss of interest and concentration" occurred significantly more frequently among spray painters than among controls. Further analyses demonstrated an association with chronic exposure over 30 years and repeated acute neurotoxic effects during solvent exposures. Neither psychological nor performance tests demonstrated any statistically significant differences in the performance sets after adjustment according to premorbid intelligence level; this finding supports the presumption of only a low grade of mental dysfunction. Correlation analyses indicated a relationship between subjective health complaints and long-term solvent exposure; however, the effect of age cannot be completely ruled out.(ABSTRACT TRUNCATED AT 250 WORDS)
Adult↗
[Considerations on the use of the construct "Quality of life" as a goal variable in clinical research].
In recent years the importance of the assessment of quality of life increased, especially in palliative therapy. Commonly used concepts of quality of life comprise of several dimensions, e.g. somatic disorders, functional status, well-being and social interaction. We developed an 18-item questionnaire, self-administered by the patients, and compared the results of 66 'healthy' subjects with two clinical samples: 126 patients with inoperable non-small-cell lung cancer and 19 patients under dialysis. The results indicate the questionnaire as a sufficiently reliable and valid method for the assessment of 'quality of life'. On the other hand, there are several problems concerning an adequate interpretation when regarding our clinical data. For example, the cancer patients show a significantly more positive self-assessment concerning well-being and activity, compared to 'healthy' subjects.
Adult↗
Lonidamine versus high-dose tamoxifen in progressive, advanced renal cell carcinoma: results of an ongoing randomized phase II study.
Sixty patients with metastatic renal cell carcinoma were entered into an ongoing randomized phase II study with lonidamine, 350 mg/m2 orally daily (arm A) and high dose tamoxifen, 150 mg/m2 orally daily for 6 months, afterwards 50 mg/m2 (arm B), until tumor progression. All patients had measurable disease and documented tumor progression prior to treatment. There were 1 complete and 1 partial remission among 19 evaluable patients in arm A (10.5%) and 2 complete and 1 partial remission among 25 evaluable patients (12%) in arm B. Objective responses were observed in pulmonary, nodal, and cutaneous metastases. In addition, in 63% and 64% tumor progression could be stopped in arm A and B, respectively. Median response duration was 100 days (range, 20-361) in arm A and 150 days (range, 28-355) in arm B. One year survival rate was 37.5% with lonidamine and 35% with tamoxifen. In arm A patients with tumor progression within 12 weeks after diagnosis of metastatic disease survived significantly shorter than patients with a longer interval (P less than 0.05). Nephrectomy or number and localization of metastatic sites failed to significantly influence probability of remission or survival. Toxicity was mostly mild to moderate. Four patients in the lonidamine arm had to discontinue treatment because of intolerable myalgias, which were immediately reversible. These data suggest that lonidamine and high-dose tamoxifen are moderately effective in widespread renal cell carcinoma where treatment intention is palliative.
Adult↗
[Quality of life as a target variable in oncologic clinical research].
The change of target variables in palliative cancer treatment led to a new evaluation of quality of life. Its use as a target variable to discriminate different therapies is problematic. Investigations with a patient-questionnaire assessing quality of life showed that the validity of this term is difficult to judge. At present it should be used in clinical research as an accompanying variable only.
Adult↗
Cross-sectional epidemiological study on neurotoxicity of solvents in paints and lacquers.
In a multi-disciplinary retrospective study we examined 105 house painters employed for at least ten years (median 27 years, range 10-36 years). Fifty-three workers from various professions (non-painters), who were matched with regard to age, occupational training and socio-economic status served as the control group. In both groups no cases of a clinically manifest polyneuropathy or encephalopathy were found. The neurophysiological examinations (EEG and NCV-measurement) showed no differences in painters and controls that would indicate adverse effects of organic solvents. There were no cases with neuroradiological findings of a diffuse cerebral atrophy. Furthermore the evaluation of certain brain structures (ventricular diameter, cella media index) of the CAT films did not reveal any significant differences. In the neurobehavioral tests significant differences in the results were only found in the subtests "change of personality" and "short term memory capacity" in a subgroup of painters with repeated prenarcotic symptoms at the workplace. Ambient air monitoring measurements at 30 representative workplaces showed that the concentrations of the main components of the solvent-mixtures were well below the MAK-values. The results of the "Erlangen Painter Study" does not confirm former epidemiologic findings from other countries, mainly Denmark. However, there are some aspects, such as minor solvent exposure in German house painters, insufficient diagnostic and etiological procedures as well as misclassifications which may explain the different experiences.
Adolescent↗