Abstract
Evidence-based medicine (EBM) has as its aim and concern the identification and evaluation of the entire body of published evidence concerning a medical problem with a view to making the results available, assessable and easily usable in medical practice. It therefore sees itself first and foremost as an instrument of medical decision-making with the task of supporting physicians in their day-to-day work with patients. EBM’s central stipulation is the provision of external evidence in the form of scientifically verified knowledge.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Agency for Health Care Policy and Research (AHCPR). Acute pain management: operative and medical procedures and trauma. Clinical practice guideline No.1. AHCPR Publication 1992 No. 92–0023, Appendix B. available at: http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat6.table.9286
Alderson P, Green S, Higgins J (2004) Cochrane Reviewers’ Handbook. Handbook 4.2.1. [updated December 2003]. John Wiley & Sons Ltd, Chichester
Altman DG, Bland JM (1995) Absence of evidence is not evidence of absence. BMJ 311 :485
Bornhöft G, Maxion-Bergemann S, Wolf U, Kienle G, Michalsen A, Vollmar H, Gilbertson S, Matthiessen P (2006) Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity. BMC Med Res Methodol 6:56
Bundesamt für Sozialversicherung der Schweiz (ed) (1996)Handbuch zur Standardisierung der medizinischen und wirtschaftlichen Bewertung medizinischer Leistungen, 3rd edn. Bern
Cochrane Collaboration (2002) The Cochrane Collaboration open learning material. 13: Diversity and heterogeneity. Available at: http://www.cochrane-net.org/openlearning/HTML/mod13-4.htm
Crowley T, Low N, Turner A, Harvey I, Bidgood K, Horner P (2001) Antibiotic prophylaxis to prevent post-abortal upper genital tract infection in women with bacterial vaginosis: randomized controlled trial. BJOG Int J Obstet Gynaecol 108:396–402
De Flora S, Grassi C, Carati L (1997) Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment. Eur Respir J 10:1535–1541
Dickersin K (2003) The mammography debate: a crisis for evidence-based medicine? In: 4. Symposion Evidenzbasierte Medizin. 14–15 March, 2003,Freiburg i.Br.
Editorial (2005) The end of homeopathy. Lancet 366:690; DOI:10.1016/S0140-6736(05)67149-8
Ernst E (2004) Author’s reply. Wien Klin Wochenschr 11 6:408
Fisher P, Berman B, Davidson J, Reilly D, Thompson T (2005) Are the clinical effects of homeopathy placebo effects? Lancet 366:2082–2083; DOI:10.1016/S0140-6736(05)67879-8
Gill P, Dowell AC, Neal RD, Smith N, Heywood P, Wilson AE (1996) Evidence-based general practice: a retrospective study of interventions in one training practice. BMJ 312:819–821
Godwin M, Ruhland L, Casson I, MacDonald S, Delva D, Birtwhistle R, Lam M, Seguin R (2003) Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Methodol 3:28. DOI:10.11 86/1471-2288-3-28
Greenhalgh T (1997) Assessing the methodological quality of published papers. BMJ 315:305–308
Habour R, Miller J (2001) A new system for grading recommendations in evidence based guidelines. BMJ 323:334–336
Heusser P (2001) Kriterien zur Beurteilung des Nutzens von komplementärmedizinischen Methoden. Forschende Komplementärmedizin und Klassische Naturheilkunde 8:14–23
Higgins JPT, Thompson SG (2002) Quantifying heterogeneity in a meta-analysis. Stat Med 21:1539–1558
Hogel J, Walach H, Gaus W (1994) Change-to-Open-Label Design. Proposal and discussion of a new design for clinical parallel-group double-masked trials. Arzneimittelforschung 44:97–99
Horn J, de Haan RJ, Vermeulen M, Limburg M (2001) Very early nimodipine use in stroke (VENUS): a randomized, double-blind, placebo-controlled trial. Stroke 32:461–465
Jacobs J, Jimenez LM, Malthouse S, Chapman E, Crothers D, Masuk M, Jonas WB (2000) Homeopathic treatment of acute childhood diarrhea: results from a clinical trial in Nepal. J Altern Complement Med 6:131–139
Jonas WB, Kaptchuk TJ, Linde K (2003) A critical overview of homeopathy. Ann Intern Med 138:393–399
Kaplan MA, Prior MJ, McKonly KI, DuPont HL, Temple AR, Nelson EB (1999) A multicenter randomized controlled trial of a liquid loperamide product versus placebo in the treatment of acute diarrhea in children. Clin Pediatr 38:579–591
Khan KS, ter Riet G, Popay J, Nixon J, Kleijnen J (2001) STAGE II – Conducting the review. PHASE 5 – Study quality assessment. In: Khan KS, ter Riet G, Glanville J, Sowden AJ, Kleijnen J (eds) Undertaking systematic reviews of research on effectiveness. CRD Report Number 4 (2nd edn), York
Kiene H (2001) Komplementäre Methodenlehre der klinischen Forschung. Cognition-based Medicine. Springer, Berlin Heidelberg New York
Kienle G (1974) Arzneimittelsicherheit und Gesellschaft. Eine kritische Untersuchung. Schattauer, Stuttgart New York
Kienle GS (2005) Gibt es Gründe für Pluralistische Evaluationsmodelle? Limitationen der Randomisierten Klinischen Studie. Z Arztl Fortbild Qualität Gesundheitswesen 99:289–294
Kienle GS, Hamre HJ, Portalupi E, Kiene H (2004) Improving the quality of therapeutic reports of single cases and case series in oncology – criteria and checklist. Altern Therapies Health Med 10:68–72
Kienle GS, Kiene H, Albonico HU (2006a) Anthroposophische Medizin in der klinischen Forschung. Schattauer, Stuttgart New York
Kienle GS, Kiene H, Albonico HU (2006b) Anthroposophic medicine. Effectiveness, utility, costs, safety. Schattauer, Stuttgart New York
Labrecque M, Audet D, Latulippe LG, Drouin J (1992) Homeopathic treatment of plantar warts. Can Med Assoc J 146:1749–1753
Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB (1997) Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 350:834–843
Linde K, Jonas W (2005) Are the clinical effects of homeopathy placebo effects? Lancet 366:2081–2082; DOI:10.1016/S0140-6736(05)67878-6
Lüdtke R (ed) (2006) Homöopathie – Zum Stand der klinischen Forschung. Eine Stellungnahme der Karl und Veronica Carstens-Stiftung. KVC, Essen. available at: www.carstens-stiftung.de/wissen/hom/pdf/Stand_der_Forschung_Homeopathie_07MAR06.pdf
Matthiessen PF (2003) Der diagnostisch-therapeutische Prozess als Problem der Einzelfallforschung. In: Ostermann T, Matthiessen PF (eds) Einzelfallforschung in der Medizin. Bedeutung, Möglichkeiten, Grenzen. VAS, Frankfurt
Matthiessen PF (2005) Die Therapieentscheidung des Arztes. Z Arztl Fortbild Qualität Gesundheitswesen 99:269–273
Moher D, Cook DJ, Jadad AR, Tugwell P, Moher M, Jonas A, Pham B, Klassen TP (1999) Assessing the quality of reports of randomized trials: implications for the conduct of meta-analyses. Health Technol Assess 3:i–iv, 1–98
Moller C, Berg IM, Berg T, Kjellman M, Stromberg L (1994) Nedocromil sodium 2% eye drops for twice-daily treatment of seasonal allergic conjunctivitis: a Swedish multicentre placebo-controlled study in children allergic to birch pollen. Clin Exp Allergy 24:884–887
Nicholson KG, Aoki FY, Osterhaus AD, Trottier S, Carewicz O, Mercier CH, Rode A, Kinnersley N, Ward P (2000) Efficacy and safety of oseltamivir in treatment of acute influenza: a randomized controlled trial. Neuraminidase Inhibitor Flu Treatment Investigator Group. Lancet 355:1845–1850
Niroomand F (2004) Evidenzbasierte Medizin: das Individuum bleibt auf der Strecke. Dtsch Ärztebl 101:1870–1874
Ollenschläger G, Helou A, Lorenz W (2000) Kritische Bewertung von Leitlinien. In: Kunz R, Ollenschläger G, Raspe HH (eds). Lehrbuch evidenzbasierte Medizin in Klinik und Praxis. Schriftenreihe Hans Neuffer Stiftung. Deutscher ÄrzteVerlag, Köln, pp 156–176
Papp R, Schuback G, Beck E, Burkard G, Bengel J, Lehrl S, Belon P (1998) Oscillococcinum® in patients with influenza- like syndromes: a placebo-controlled double-blind evaluation. Br Homeopathic J 87:69–76
Penston J (2005) Large-scale randomized trials – a misguided approach to clinical research. Med Hypotheses 64:651–657
Raoult D (2005) Are the clinical effects of homeopathy placebo effects? Authors‘ reply. Lancet 366:2085–2086; DOI:10.1016/S0140-6736(05)67883-X
Resch K (1998) Pragmatic randomized controlled trials for complex therapies. Forschende Komplementärmedizin. 5 [Suppl S1]:S 136–139
Roland M, Torgerson DJ (1998) Understanding controlled trials: What are pragmatic trials? BMJ 316:285
Rottey E, Verleye G, Liagre R (1995) Het effect van een homeopathische bereiding van micro-organismen bij de preventie van griepsymptomen: een gerandomiseered dubbel-blind onderzoek in de huisartspraktijk. Tijdschr Integrale Geneeskunde 11 :54–58
Sackett D, Richardson W, Haynes R (1997) Evidence-based medicine. How to practice and teach EBM. Churchill Livingstone, New York Edinburgh London
Sackett DL (1979) Bias in analytic research. J Chronic Dis 32:51–63
Schmidt JM, Ostermayr B (2002) Does a homeopathic ultramolecular dilution of Thyroidinum 30cH affect the rate of body weight reduction in fasting patients? A randomized placebo-controlled double-blind clinical trial. Homeopathy 91:197–206
Shang A, Huwiler-Muntener K, Nartey L, Jüni P, Dörig S, Sterne JAC, Pewsner D, Egger M (2005a) Are the clinical effects of homeopathy placebo effects? Comparative study of placebo-controlled trials of homeopathy and allopathy. Lancet 366:726–732; DOI:10.1016/S0140-6736(05)67177-2
Shang a, Jüni P, Sterne JAC, Huwiler-Müntener K, Egger M (2005b) Are the clinical effects of homeopathy placebo effects? Authors‘ reply. Lancet 366:2083–2085; DOI:10.1016/S0140-6736(05)67881-6
SIGN 50 (Scottish Intercollegiate Guidelines Network). A guideline developer‘s handbook. Notes on the use of Methodology Checklist 2: Randomized Controlled Trials. available at: http://www.sign.ac.uk/guidelines/fulltext/50/notes2.html
Skandhan KP, Smith A, Avni A (2005) Are the clinical effects of homeopathy placebo effects? Authors’ reply. Lancet 366:2085; DOI:10.1016/S0140-6736(05)67882-8
Vickers AJ, Fisher P, Smith C, Wyllie SE, Rees R (1998) Homeopathic Arnica 30x is ineffective for muscle soreness after long-distance running: a randomized, double-blind, placebo-controlled trial. Clin J Pain 14:227–231
Walach H, Haeusler W, Lowes T, Mussbach D, Schamell U, Springer W, Stritzl G, Gaus W, Haag G (1997) Classical homeopathic treatment of chronic headaches. Cephalalgia 17:11 9–126; discussion: p 1 01
Walach H, Jonas W, Lewith G (2005a) Are the clinical effects of homeopathy placebo effects? Lancet 366:2081; DOI:10.1016/S0140-6736(05)67877-4)
Walach H, Sadaghiani C, Dehm C, Bierman DJ (2005b) The therapeutic effect of clinical trials: understanding placebo response rates in clinical trials – a secondary analysis. BMC Med Res Methodol 5:26
Walach H (2001) Das Wirksamkeitsparadox in der Komplementärmedizin. Forschende Komplementärmedizin und Klassische Naturheilkunde 8:193–195
Wegscheider K (2005) Was sind faire Vergleiche zwischen Therapien? Zeitschrift für ärztliche Fortbildung und Qualität im Gesundheitswesen 99:275–278
Wein C (2002)Qualitätsaspekte klinischer Studien zur Homöopathie. KVC, Essen
Weiser M, Clasen B (1994) Randomisierte plazebokontrollierte Doppelblindstudie zur Untersuchung der klinischen Wirksamkeit der homöopathischen Euphorbium compositum-Nasentropfen S bei chronischer Sinusitis. Forschende Komplementärmedizin 1:251–259
White A, Slade P, Hunt C, Hart A, Ernst E (2003) Individualized homeopathy as an adjunct in the treatment of childhood asthma: a randomized placebo controlled trial. Thorax 58:317–321
World Medical Association (2001) Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organization, 79:373–374. available at: http://whqlibdoc.who.int/bulletin/2001/issue4/79(4)declaration.pdf
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2011 Springer-Verlag Berlin Heidelberg
About this chapter
Cite this chapter
Matthiessen, P.F., Bornhöft, G. (2011). General problems with clinical trials in research. In: Bornhöft, G., Matthiessen, P.F. (eds) Homeopathy in Healthcare – Effectiveness, Appropriateness, Safety, Costs. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-20638-2_5
Download citation
DOI: https://doi.org/10.1007/978-3-642-20638-2_5
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-20637-5
Online ISBN: 978-3-642-20638-2
eBook Packages: MedicineMedicine (R0)