1999
DOI: 10.1159/000021215
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Probleme von Studiendesigns mit Randomisation, Verblindung und Placebogabe

Abstract: As randomised double-blind trials are not rarely demanded as a prerequisite for the scientific acceptance of complementary medicine, the author has analysed the soundness of this demand on the basis of the international literature. As a result there appeared a number of methodological, practical and ethical problems which question the theoretically deduced primal value of this study design relative to the needs of medical practice and of health insurance issues. The experimental instruments of randomisation, b… Show more

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Cited by 13 publications
(12 citation statements)
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“…Randomisation could ensure internally valid therapeutic studies. However, complementary medicine practitioners are often reluctant to use randomisation, due to the difficulty to ethically, practically and methodologically reconcile their holistic and individualised therapeutic approach with a random allocation to treatment [19]. This might lead to randomised studies on complementary treatments being conducted within conventional medicine institutions, thus hampering the external validity of the generated evidence.…”
Section: Discussionmentioning
confidence: 99%
“…Randomisation could ensure internally valid therapeutic studies. However, complementary medicine practitioners are often reluctant to use randomisation, due to the difficulty to ethically, practically and methodologically reconcile their holistic and individualised therapeutic approach with a random allocation to treatment [19]. This might lead to randomised studies on complementary treatments being conducted within conventional medicine institutions, thus hampering the external validity of the generated evidence.…”
Section: Discussionmentioning
confidence: 99%
“…(5) Welche Untersuchungen zur Wirtschaftlichkeit liegen vor? Methodologische Besonderheiten: In der Komplementärmedi-zin und speziell in der AM wird seit Jahrzehnten ein intensiver Diskurs zur Methodologie klinischer Forschung geführt und auf den begrenzten Erkenntniswert und die limitierten Einsatzmöglichkeiten von randomisierten klinischen Studien (RCTs) sowie auf die Bedeutung einer umfassenden Evidenzgewinnung, speziell auch des wissenschaftlich geschulten ärzt- Kienle/Kiene/Albonico lichen Urteils, für medizinische Hilfeleistung, Erkenntnisgewinnung und Fortschritt verwiesen [3][4][5][6][7][8]. Diese Argumente sind auch in den Kriterien zur Beurteilung des Nutzens von komplementärmedizinischen Methoden («Handbuch zur Standardisierung der medizinischen und wirtschaftlichen Bewertung medizinischer Leistungen» des Schweizerischen Bundesamtes für Sozialversicherung, Ausgabe 2000) thematisiert.…”
Section: Hintergrund Und Fragestellungunclassified
“…Although every new biomedical intervention is being subjected to RCTs in order to prove its safety and efficacy, the quality of the studies and the relevance of their results are generally poor. The same is also true for the CAM interventions that are being scrutinized with the use of RCTs [36,37]. Thus, there is little a priori confidence in population benefit for most interventions.…”
Section: Discussionmentioning
confidence: 99%