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Homeopathy in Healthcare – Effectiveness, Appropriateness, Safety, Costs pp 27–46Cite as

General problems with clinical trials in research

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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.

Keywords

  • Bacterial Vaginosis
  • Conventional Medicine
  • Nedocromil Sodium
  • Allergic Conjunctivitis
  • Anthroposophic Medicine

These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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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

    Google Scholar 

  • Altman DG, Bland JM (1995) Absence of evidence is not evidence of absence. BMJ 311 :485

    PubMed  CAS  Google Scholar 

  • 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

    PubMed  CrossRef  Google Scholar 

  • Bundesamt für Sozialversicherung der Schweiz (ed) (1996)Handbuch zur Standardisierung der medizinischen und wirtschaftlichen Bewertung medizinischer Leistungen, 3rd edn. Bern

    Google Scholar 

  • 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

    CrossRef  CAS  Google Scholar 

  • 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

    PubMed  CrossRef  Google Scholar 

  • Dickersin K (2003) The mammography debate: a crisis for evidence-based medicine? In: 4. Symposion Evidenzbasierte Medizin. 14–15 March, 2003,Freiburg i.Br.

    Google Scholar 

  • Editorial (2005) The end of homeopathy. Lancet 366:690; DOI:10.1016/S0140-6736(05)67149-8

    Google Scholar 

  • Ernst E (2004) Author’s reply. Wien Klin Wochenschr 11 6:408

    CrossRef  Google Scholar 

  • 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

    PubMed  CrossRef  Google Scholar 

  • 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

    PubMed  CAS  Google Scholar 

  • 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

    PubMed  CrossRef  Google Scholar 

  • Greenhalgh T (1997) Assessing the methodological quality of published papers. BMJ 315:305–308

    PubMed  CAS  Google Scholar 

  • Habour R, Miller J (2001) A new system for grading recommendations in evidence based guidelines. BMJ 323:334–336

    CrossRef  Google Scholar 

  • Heusser P (2001) Kriterien zur Beurteilung des Nutzens von komplementärmedizinischen Methoden. Forschende Komplementärmedizin und Klassische Naturheilkunde 8:14–23

    PubMed  CrossRef  CAS  Google Scholar 

  • Higgins JPT, Thompson SG (2002) Quantifying heterogeneity in a meta-analysis. Stat Med 21:1539–1558

    PubMed  CrossRef  Google Scholar 

  • 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

    PubMed  CAS  Google Scholar 

  • 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

    PubMed  CrossRef  CAS  Google Scholar 

  • 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

    PubMed  CrossRef  CAS  Google Scholar 

  • Jonas WB, Kaptchuk TJ, Linde K (2003) A critical overview of homeopathy. Ann Intern Med 138:393–399

    PubMed  Google Scholar 

  • 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

    CrossRef  CAS  Google Scholar 

  • 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

    Google Scholar 

  • Kiene H (2001) Komplementäre Methodenlehre der klinischen Forschung. Cognition-based Medicine. Springer, Berlin Heidelberg New York

    Google Scholar 

  • Kienle G (1974) Arzneimittelsicherheit und Gesellschaft. Eine kritische Untersuchung. Schattauer, Stuttgart New York

    Google Scholar 

  • Kienle GS (2005) Gibt es Gründe für Pluralistische Evaluationsmodelle? Limitationen der Randomisierten Klinischen Studie. Z Arztl Fortbild Qualität Gesundheitswesen 99:289–294

    Google Scholar 

  • 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

    Google Scholar 

  • Kienle GS, Kiene H, Albonico HU (2006a) Anthroposophische Medizin in der klinischen Forschung. Schattauer, Stuttgart New York

    Google Scholar 

  • Kienle GS, Kiene H, Albonico HU (2006b) Anthroposophic medicine. Effectiveness, utility, costs, safety. Schattauer, Stuttgart New York

    Google Scholar 

  • Labrecque M, Audet D, Latulippe LG, Drouin J (1992) Homeopathic treatment of plantar warts. Can Med Assoc J 146:1749–1753

    CAS  Google Scholar 

  • 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

    PubMed  CrossRef  CAS  Google Scholar 

  • 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

    PubMed  CrossRef  Google Scholar 

  • 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

    Google Scholar 

  • Matthiessen PF (2005) Die Therapieentscheidung des Arztes. Z Arztl Fortbild Qualität Gesundheitswesen 99:269–273

    Google Scholar 

  • 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

    Google Scholar 

  • 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

    PubMed  CrossRef  CAS  Google Scholar 

  • 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

    PubMed  CrossRef  CAS  Google Scholar 

  • Niroomand F (2004) Evidenzbasierte Medizin: das Individuum bleibt auf der Strecke. Dtsch Ärztebl 101:1870–1874

    Google Scholar 

  • 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

    Google Scholar 

  • 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

    CrossRef  Google Scholar 

  • Penston J (2005) Large-scale randomized trials – a misguided approach to clinical research. Med Hypotheses 64:651–657

    PubMed  CrossRef  Google Scholar 

  • 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

    CrossRef  Google Scholar 

  • Resch K (1998) Pragmatic randomized controlled trials for complex therapies. Forschende Komplementärmedizin. 5 [Suppl S1]:S 136–139

    PubMed  CrossRef  Google Scholar 

  • Roland M, Torgerson DJ (1998) Understanding controlled trials: What are pragmatic trials? BMJ 316:285

    PubMed  CAS  Google Scholar 

  • 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

    Google Scholar 

  • Sackett D, Richardson W, Haynes R (1997) Evidence-based medicine. How to practice and teach EBM. Churchill Livingstone, New York Edinburgh London

    Google Scholar 

  • Sackett DL (1979) Bias in analytic research. J Chronic Dis 32:51–63

    PubMed  CrossRef  CAS  Google Scholar 

  • 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

    PubMed  CrossRef  CAS  Google Scholar 

  • 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

    CrossRef  Google Scholar 

  • 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

    CrossRef  Google Scholar 

  • 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

    CrossRef  Google Scholar 

  • 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

    PubMed  CrossRef  CAS  Google Scholar 

  • 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

    CrossRef  Google Scholar 

  • 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)

    CrossRef  Google Scholar 

  • 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

    CrossRef  Google Scholar 

  • Walach H (2001) Das Wirksamkeitsparadox in der Komplementärmedizin. Forschende Komplementärmedizin und Klassische Naturheilkunde 8:193–195

    PubMed  CrossRef  CAS  Google Scholar 

  • Wegscheider K (2005) Was sind faire Vergleiche zwischen Therapien? Zeitschrift für ärztliche Fortbildung und Qualität im Gesundheitswesen 99:275–278

    PubMed  Google Scholar 

  • Wein C (2002)Qualitätsaspekte klinischer Studien zur Homöopathie. KVC, Essen

    Google Scholar 

  • 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

    CrossRef  Google Scholar 

  • 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

    PubMed  CrossRef  CAS  Google Scholar 

  • 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

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Authors and Affiliations

  1. Head of Department for Plurality of Paradigms, Zentrum für Integrative Medizin, Universität Witten/Herdecke gGmbH, Gerhard-Kienle-Weg 6, 58313, Herdecke

    Prof. Peter F. Matthiessen MD, PhD

  2. assistant professor for Medical Theory and Complementary Medicine, Reußstr. 1, 38640, Goslar

    Gudrun Bornhöft MD

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  1. Prof. Peter F. Matthiessen MD, PhD
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Editors and Affiliations

  1. assistant professor for Medical Theory and Complementary Medicine, Reußstr. 1, 38640, Goslar

    Gudrun Bornhöft MD

  2. Head of Department for Plurality of Paradigms, Zentrum für Integrative Medizin, Universität Witten/Herdecke gGmbH, Gerhard-Kienle-Weg 6, 58313, Herdecke

    Prof. Peter F. Matthiessen MD, PhD

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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

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