Forschende Komplementarmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine最新文献

{"title":"Comparative observational studies in therapeutic research: approach to the development of guidelines for research and reporting. Proceedings of a symposium. Ruttihubelbad, Switzerland, 24-27 August 2003.","authors":"R. Ziegler, W. Gaus","doi":"10.1159/ISBN.978-3-318-01145-6","DOIUrl":"https://doi.org/10.1159/ISBN.978-3-318-01145-6","url":null,"abstract":"","PeriodicalId":80278,"journal":{"name":"Forschende Komplementarmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine","volume":"194 ","pages":"1-55"},"PeriodicalIF":0.0,"publicationDate":"2004-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72553961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomized and double-blind studies--demands and reality as demonstrated by two examples of mistletoe research.","authors":"M Rostock,&nbsp;R Huber","doi":"10.1159/000080571","DOIUrl":"https://doi.org/10.1159/000080571","url":null,"abstract":"<p><strong>Background: </strong>Two examples of clinical research with mistletoe extracts were used to demonstrate essential difficulties in carrying out randomized and placebo-controlled trials. STUDY 1: In a randomized, placebo-controlled, double-blind study investigating the immunological effects of mistletoe extract, healthy subjects were asked to state whether, in their estimation, they had been treated with verum or a placebo. Due to the intrinsic effects of the mistletoe therapy--local inflammatory reactions at the injection site--100% of the subjects treated with verum and 77% of those treated with a placebo made a correct assessment of their therapy. Although double-blind trials are preferable from the methodological point of view--above all in QoL research--this study shows that double blinding is barely achievable when the investigated therapy has obvious (side) effects. STUDY 2: A prospective, randomized, multicenter study of a mistletoe therapy complementary to chemotherapy treatment of breast cancer had to be stopped after a period of 28 months, because it proved impossible to recruit more than 16 patients in six large study centers. With regard to this example and to other failed, GCP-compliant clinical trials on mistletoe therapy we describe which factors interfere with successful clinical trials. One important point, especially in the investigation of complementary cancer treatments, is that cancer patients are unwilling to have their treatment determined by randomization. Many cancer patients in Germany have their own point of view, as to whether a complementary treatment could be of benefit to them or not. Faced with a life-threatening disease they wish to determine this part of their treatment themselves.</p><p><strong>Conclusion: </strong>This background elucidates the need for improving the methodology of non-randomized trials to obtain objective and reliable results even in these fields of clinical research.</p>","PeriodicalId":80278,"journal":{"name":"Forschende Komplementarmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine","volume":"11 Suppl 1 ","pages":"18-22"},"PeriodicalIF":0.0,"publicationDate":"2004-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000080571","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24670106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment outcomes in patients with migraine: an ex-post-facto comparison of two in-patient facilities.","authors":"W Weidenhammer,&nbsp;K Linde,&nbsp;D Melchart","doi":"10.1159/000080573","DOIUrl":"https://doi.org/10.1159/000080573","url":null,"abstract":"<p><strong>Background: </strong>In two hospitals we performed an open, prospective observational study on patients with chronic headache as a measure of internal quality assurance using identical methods. Available data were subordinately analysed in order to compare both studies.</p><p><strong>Questions: </strong>Are the patient samples of both hospitals comparable? If not, which form of statistical adjustment is recommended? Are there differences in the outcome measures of both facilities?</p><p><strong>Methods: </strong>The outcomes were defined as differences between baseline values and values at discharge from hospital, respectively 6 months after. Frequency of headache attacks, intensity of pain, intensity of general complaints as well as of concomitant symptoms, and quality of life were determined in advance as dependent variables. To compare both patient groups univariate analysis of variance without and with inclusion of covariates were used. For calculating propensity scores (conditional probability of belonging to one of two groups) a logistic regression with the same covariates serving as independent variables was performed.</p><p><strong>Patients: </strong>426 patients with the main diagnosis \"Migraine\" and complete data sets concerning the covariates were selected for analysis. 87% of patients are female, the mean age is 45.5 +/- 11.7 years (range 14-73 yrs).</p><p><strong>Results: </strong>4 out of 11 potential covariates show statistically significant differences between the patients of both hospitals. Correct classification of patients by means of the propensity score succeeds in 67%. Comparing the outcomes at discharge from hospital, significant differences between both groups exist which are, with one exception, not affected by controlling for covariates. 6 months after discharge two of the initial differences between both patient groups are no longer present. These findings are independent from the statistical technique of risk adjustment.</p><p><strong>Conclusions: </strong>Because of the observed differences between both patient groups it is recommended to adjust data by regression analysis in order to enhance comparability. The choice for one of the two proposed techniques is secondary. With respect to the analyses clear differences between both hospitals exist in short-term outcomes, disappearing 6 months later.</p>","PeriodicalId":80278,"journal":{"name":"Forschende Komplementarmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine","volume":"11 Suppl 1 ","pages":"30-5"},"PeriodicalIF":0.0,"publicationDate":"2004-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000080573","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24670109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Elements of therapeutic research structure.","authors":"R Ziegler","doi":"10.1159/000080569","DOIUrl":"https://doi.org/10.1159/000080569","url":null,"abstract":"<p><p>For the purpose of comparative therapeutic research, an overview of some basic terms and definitions is given. The main emphasis lies on the time structure of the research and the possible sources of bias and validity. In addition, methods to deal with confounding, effect modification and possible causal inferences are summarized.</p>","PeriodicalId":80278,"journal":{"name":"Forschende Komplementarmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine","volume":"11 Suppl 1 ","pages":"5-12"},"PeriodicalIF":0.0,"publicationDate":"2004-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000080569","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24671225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Coping strategies and the request for a consultation on complementary and alternative medicine -- a cross-sectional survey of patients in a psychosomatic and three medical departments of a german university hospital.","authors":"R Huber,&nbsp;R Lüdtke,&nbsp;I Beiser,&nbsp;D Koch","doi":"10.1159/000080556","DOIUrl":"https://doi.org/10.1159/000080556","url":null,"abstract":"<p><strong>Objective: </strong>To identify factors, predicting which patients of a large German university hospital request for a consultation on complementary and alternative medicine (CAM).</p><p><strong>Patients and methods: </strong>350 patients of 3 medical and a psychosomatic department of the University Hospital Freiburg were consecutively surveyed with respect to their coping strategies, health locus of control, anxiety, depression, and the request for a consultation on CAM. Predicting factors were identified via logistic regression models.</p><p><strong>Results: </strong>The request for a CAM consultation was primarily determined by an active coping strategy (odds ratio 1.66, 95% confidence interval 1.27-2.17, p = 0.0002) and a low Karnofsky index (odds ratio 0.79, 95% confidence interval 0.62-0.99, p = 0.0417). Anxiety, depression or internal health locus of control correlated with each other but could not be proved as independent factors for the request for a CAM consultation.</p><p><strong>Conclusion: </strong>Patients of a university hospital with an active disease coping have a need for information about CAM.</p>","PeriodicalId":80278,"journal":{"name":"Forschende Komplementarmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine","volume":"11 4","pages":"207-11"},"PeriodicalIF":0.0,"publicationDate":"2004-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000080556","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24667695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Research into complementary and alternative medicine across Europe and the United States.","authors":"P Giovannini,&nbsp;K Schmidt,&nbsp;P H Canter,&nbsp;E Ernst","doi":"10.1159/000080558","DOIUrl":"https://doi.org/10.1159/000080558","url":null,"abstract":"<p><strong>Background: </strong>There has been an increase in complementary/ alternative medicine (CAM) research with a wide range of perspectives.</p><p><strong>Objective: </strong>To capture and analyse the diversity of CAM research across 7 European countries (Germany, United Kingdom, Italy, France, Spain, Netherlands, Belgium) and the US. We were predominantly interested in finding out how CAM research differs between countries.</p><p><strong>Study design: </strong>A systematic review of CAM literature published in 2002 and included in Medline, Embase, International Bibliography of the Social Sciences (IBBS) and PsycLit. OUTCOME CRITERIA: Data were extracted regarding country of origin, type of methodology, type of research question, CAM modality, direction of conclusion, setting and type of journal.</p><p><strong>Results: </strong>In total 652 abstracts of articles were assessed (Germany: 137, UK: 183, Italy: 39, France: 47, Spain: 24, Netherlands: 17, Belgium: 22, US: 183). The vast majority of CAM research was of a medical nature and published in medical journals. The majority of articles were nonsystematic reviews and comments, analytical studies and surveys. The UK carried out more surveys than any of the other countries and also published the largest number of systematic reviews. Germany, the UK and the US covered the widest range of interests across various CAM modalities and investigated the safety of CAM.</p><p><strong>Conclusion: </strong>Our data suggest that important national differences exist in terms of the nature of CAM research. This raises important questions regarding the reasons for such differences.</p>","PeriodicalId":80278,"journal":{"name":"Forschende Komplementarmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine","volume":"11 4","pages":"224-30"},"PeriodicalIF":0.0,"publicationDate":"2004-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000080558","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24667697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Naive empiricism?].","authors":"E Ernst","doi":"10.1159/000080560","DOIUrl":"https://doi.org/10.1159/000080560","url":null,"abstract":"Dr. Harald Walach beschuldigt in seinem Editorial «Wider naiven Empirismus und verkleidete Machtansprüche – politische und wissenschaftstheoretische Splitter» (Forsch Komplementärmed Klass Naturheilkd 2004;11:72–75) die heutige medizinische Wissenschaft eines Wissenschaftsund Weltbilds, das «in den seltensten Fällen wirklich begründet und reflektiert» ist sowie auf einem «sachlich falschen und hinderlichen Verständnis von Wissenschaft» beruht. Dies, so meint er, hat dazu geführt, dass sich der «sogenannte Mainstream verrannt hat und in wichtigen Problemen nicht mehr weiter kommt.» Diese und ähnliche Gedanken sind bereits so häufig formuliert worden, dass ihre ursprünglich stimulierende Wirkung deutlich abgenommen hat. Ferner glaube ich, dass Dr. Walach mit vielem Unrecht hat und möchte kurz einige Gegenargumente zu bedenken geben. – Was genau hat die Wissenschaftsforschung dem auf der Anklagebank stehenden Weltbild entgegenzusetzen? In Dr. Walachs Ausführungen finden wir nur vage Hinweise darauf, «dass unsere Wahrnehmung immer gestaltend mit der Wirklichkeit in Wechselwirkung tritt» und dass wir beginnen müssen, «andere Fragen zu stellen». Konkret reicht dies, wie ich fürchte, nicht aus, um effektive Forschung zu betreiben, die das Los der Patienten von morgen verbessert. – Dr. Walach ist Psychologe und daher kann man ihm vielleicht nachsehen, dass er meint, die Medizin würde «alles ausblenden, was nicht ins Bild passt», und sich darauf beschränken, Erreger bei Infektionen abzutöten und Medikamente zu vermarkten, die den Blutdruck senken usw. Jedoch wird seit Jahren wissenschaftlich sehr viel über Immunität gearbeitet, und es existiert eine intensive, jahrzehntelange Forschungsarbeit zur (nicht medikamentösen) Hochdruck-Prävention, etc. Die «anderen Fragen» werden also bereits bearbeitet – auch ohne die Wissenschaftsforscher. – Der Hinweis auf den «medizinisch-pharmazeutischen Komplex», der «bestimmten Interessen» dient, ist ebenfalls nicht neu. Wir alle wissen, dass die medizinische Wissenschaft in erster Linie den (zukünftigen) Patienten dienen sollte. Die Insistenz, dass dies nicht überall und immer in idealer Weise verwirklicht ist, sollte jedoch nicht in Verfolgungswahn ausarten. – Dr. Walach weist wiederholt darauf hin, dass «homöopathische Zauberkünstler» und andere Komplementärmediziner eine bedeutende Rolle in der medizinischen Versorgung spielen könnten, wenn nur die «kurzsichtige» Denkweise der heutigen Medizin ad acta gelegt würde. Wir alle hoffen das natürlich, aber wo sind die Hinoder Beweise, dass wir hier nicht einem Wunschdenken zum Opfer gefallen sind? – Wie alle, die das heutige Wissenschaftsbild anprangern, spricht auch Dr. Walach mehrmals von der Krise in der Medizin («unser Gesundheitssystem [ist] pleite und in Zukunft unbezahlbar...») und einem notwendigen Paradigmenwechsel. Die Medizin befindet sich gemäss dieser Stimmen seit mindestens 150 Jahren in der Krise – und noch nie gab es 150 Jahre in der Medizingeschichte, die g","PeriodicalId":80278,"journal":{"name":"Forschende Komplementarmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine","volume":"11 4","pages":"239; author reply 240"},"PeriodicalIF":0.0,"publicationDate":"2004-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000080560","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24667698","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reasons for caution when evaluating health care interventions using non-randomised study designs.","authors":"B C Reeves","doi":"10.1159/000080575","DOIUrl":"https://doi.org/10.1159/000080575","url":null,"abstract":"<p><p>The key difference between randomised (RCTs) and non-randomised studies (NRS) is their susceptibility to selection bias. Unlike RCTs, groups in non-randomised cohort studies are unlikely to be balanced because of the reasons leading patients to receive one or another treatment, giving rise to \"confounding by clinical indication\" (CCI). Researchers can try to minimise the susceptibility of NRS to selection bias both at the design stage, e. g. by matching participants on key prognostic factors, and during data analysis, e. g. by regression modeling. Nevertheless, because of i) logistical difficulties in matching, ii) imperfect knowledge about the relationships between prognostic factors and between prognostic factors and outcome, and iii) because of measurement limitations, it is inevitable that estimates of effect size derived from NRS will be confounded to some extent. Researchers and users of evidence alike need to be aware of the consequences of residual confounding. CCI need not necessarily lead to systematic bias in favour of one treatment but, if CCI acts in an unpredictable way, it will still give rise to additional, non-statistical \"uncertainty bias\" around the estimate of effect size.</p>","PeriodicalId":80278,"journal":{"name":"Forschende Komplementarmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine","volume":"11 Suppl 1 ","pages":"40-5"},"PeriodicalIF":0.0,"publicationDate":"2004-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000080575","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24670111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomised trials versus observational studies: is the comparative observational study a poor compromise or a perfect synthesis?","authors":"W Gaus","doi":"10.1159/000080568","DOIUrl":"https://doi.org/10.1159/000080568","url":null,"abstract":"<p><p>Overview of some fundamental designs for clinical trials and studies. Some tentative definitions are given in order to stimulate questions and perspectives for further research.</p>","PeriodicalId":80278,"journal":{"name":"Forschende Komplementarmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine","volume":"11 Suppl 1 ","pages":"3-4"},"PeriodicalIF":0.0,"publicationDate":"2004-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000080568","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24671224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Guidelines for reporting non-randomised studies.","authors":"B C Reeves,&nbsp;W Gaus","doi":"10.1159/000080576","DOIUrl":"https://doi.org/10.1159/000080576","url":null,"abstract":"<p><p>Non-randomised studies (NRSs) are useful because they allow interventions to be evaluated that are difficult to investigate by randomised controlled trials (RCTs). However, NRSs are more susceptible to bias. The Consolidated Standards of Reporting Trials (CONSORT) statement was established to ensure that researchers report features of RCTs that must be considered when appraising their quality. CONSORT has improved the reporting of key information, highlighting missing key information for users. Researchers have a responsibility to report essential information that allows users to assess the susceptibility of NRS to selection, performance, detection and attrition bias. This paper considers criteria for reporting cohort studies: the rationale behind the CONSORT criteria for reporting of RCTs will be applied to cohort studies. Many of the criteria need no modification but application of others raise difficult issues for cohort studies, e.g.: description and standardisation of control and intervention treatments; description of the method of allocation; choice of prognostic factors to be collected; distinguishing between intended and provided treatments; collection of data on adverse and longterm outcomes; establishing a priori plans for analysis.</p>","PeriodicalId":80278,"journal":{"name":"Forschende Komplementarmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine","volume":"11 Suppl 1 ","pages":"46-52"},"PeriodicalIF":0.0,"publicationDate":"2004-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000080576","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24670112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}