Download PDF
Aktuelle Neurologie 2005; 32(6): 318-323
DOI: 10.1055/s-2005-866912
Übersicht
© Georg Thieme Verlag KG Stuttgart · New York

Interpretation von Therapiestudien in der Neurologie

Interpretation of Treatment Studies in NeurologyH.-C.  Diener1 , C.  Weimar1 , V.  Limmroth1
  • 1Neurologische Universitäts-Klinik Essen
Further Information

Publication History

Publication Date:
26 July 2005 (online)

Also available at
    Permissions and Reprints

Zusammenfassung

Für weite Bereiche der Neurologie gibt es in der Zwischenzeit eine Vielzahl von kontrollierten klinischen Studien zur Wertigkeit diagnostischer Maßnahmen und zur Therapie. Ein kurzer Blick in Presseverlautbarungen pharmazeutischer Konzerne und in eine kritische Zeitschrift wie das Arzneimittel-Telegramm zeigt schon häufig auf, wie unterschiedlich klinische Studien interpretiert werden. Im Folgenden sollten daher einige wichtige Kriterien bei der Interpretation klinischer Studien dargestellt werden, die dem Leser erleichtern sollen, selbst seine Schlussfolgerungen aus den Studien zu ziehen und zu entscheiden, wie er Studienergebnisse in die tägliche Praxis bei der Therapie seiner Patienten umsetzt. Dieser Artikel stützt sich zum Teil auf eine Serie von fünf Artikeln, die in der Zeitschrift Lancet im Jahr 2005 erschienen sind [1] [2] [3] [4] [5].

Abstract

Numerous studies have investigated the usefulness and efficacy of diagnostic methods and therapies for a number of neurological diseases. Pharmaceutical press releases and critical journals however employ quite a different approach to the interpretation of these studies. This article therefore features some important criteria for the interpretation of clinical studies which will enable the reader to draw his own conclusions from the study results and decide about implications for his daily routine. The recommendations are based on a series of five articles which were published in the Lancet in 2005 [1] [2] [3] [4] [5].

Literatur

  • 1 Rothwell P M, Mehta Z, Howard S C. et al . Treating individuals 3: from subgroups to individuals: general principles and the example of carotid endarterectomy.  Lancet. 2005;  365 256-265
    PubMedGoogle Scholar
  • 2 Rothwell P M. Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation.  Lancet. 2005;  365 176-186
    CrossrefPubMedGoogle Scholar
  • 3 Rothwell P M. External validity of randomised controlled trials: „to whom do the results of this trial apply?”.  Lancet. 2005;  365 82-93
    CrossrefPubMedGoogle Scholar
  • 4 Thompson S G, Higgins J P. Treating individuals 4: can meta-analysis help target interventions at individuals most likely to benefit?.  Lancet. 2005;  365 341-346
    PubMedGoogle Scholar
  • 5 Jackson R, Lawes C M, Bennett D A. et al . Treatment with drugs to lower blood pressure and blood cholesterol based on an individual's absolute cardiovascular risk.  Lancet. 2005;  365 434-441
    CrossrefPubMedGoogle Scholar
  • 6 Die Bundesministerin für Gesundheit und soziale Sicherung .Verordnung über die Anwendung der Guten Klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Arzneimitteln zur Anwendung am Menschen (GCP-Verordnung - GCP-V). Bonn; Bundesgesetzblatt Jahrgang 2004 Teil I Nr. 42 12. August 2004
    Google Scholar
  • 7 Der Bundespräsident Horst Köhler .Zwölftes Gesetz zur Änderung des Arzneimittelgesetzes. Bonn; Bundesgesetzblatt Jahrgang 2004 Teil I Nr. 41 5. August 2004
    Google Scholar
  • 8 Diener H-C, Pfaffenrath V, Pageler L. et al .The fixed combination of acetylsalicylic acid, paracetamol and caffeine is more effective than single substances and dual combination for the treatment of headache: a multi-centre, randomized, double-blind, single-dose, placebo-controlled parallel group study. Cephalalgia 2005, in press 25
    Google Scholar
  • 9 Rothwell P, Eliasziw M, Gutnikov S. et al . Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery.  Lancet. 2004;  363 915-924
    CrossrefPubMedGoogle Scholar
  • 10 Diener H-C, Cuhna L, Forbes C. et al . European Stroke Prevention Study 2. Dipyridamole and acetylsalicylic acid in the secondary prevention of stroke.  J Neurol Sci. 1996;  143 1-13
    CrossrefPubMedGoogle Scholar
  • 11 Keam S J, Goa K L, Figitt D P. Almotriptan. A review of its use in migraine.  Drugs. 2002;  62 387-414
    PubMedGoogle Scholar
  • 12 Tfelt-Hansen P. Sumatriptan for the treatment of migraine attacks - a review of controlled clinical trials.  Cephalalgia. 1993;  13 238-244
    CrossrefPubMedGoogle Scholar
  • 13 Ferrari M D, Roon K I, Lipton R B. et al . Oral triptans (serotonin 5-HT1B/1D agonists) in acute migraine treatment: a meta-analysis of 53 trials.  Lancet. 2001;  358 1668-1675
    CrossrefPubMedGoogle Scholar
  • 14 Hacke W, Donnan G, Fieschi C. et al . Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials.  Lancet. 2004;  363 768-774
    CrossrefPubMedGoogle Scholar
  • 15 Yadav J S, Wholey M H, Kuntz R E. et al . Protected carotid-artery stenting versus endarterectomy in high-risk patients.  N Engl J Med. 2004;  351 1493-1501
    CrossrefPubMedGoogle Scholar
  • 16 Breslau N, Lipton R, Stewart W. et al . Comorbidity of migraine and depression: Investigating potential etiology and prognosis.  Neurology. 2003;  60 1308-1312
    CrossrefPubMedGoogle Scholar
  • 17 Bahra A, Goadsby P J. The comorbidity of migraine and depression: a review.  Neurology and Psychiatry. 1998;  2 23-27
    PubMedGoogle Scholar
  • 18 European Study Group on Interferon β-1b in Secondary Progressive MS . Placebo-controlled multicentre randomised trial of interferon β-1b in treatment of secondary progressive multiple sclerosis.  Lancet. 1998;  352 1491-1497
    CrossrefPubMedGoogle Scholar
  • 19 Kappos L, Weinshenker B, Pozzilli C. et al . Interferon beta-1b in secondary progressive MS: a combined analysis of the two trials.  Neurology. 2004;  63 1779-1787
    CrossrefPubMedGoogle Scholar
  • 20 Executive Committee for the Asymptomatic Carotid Atherosclerosis Study . Endarterectomy for asymptomatic carotid artery stenosis.  JAMA. 1995;  273 1421-1428
    CrossrefPubMedGoogle Scholar
  • 21 Halliday A, Mansfield A, Marro J. et al . Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial.  Lancet. 2004;  363 1491-1502
    CrossrefPubMedGoogle Scholar
  • 22 Rothwell P M, Goldstein L B. Carotid endarterectomy for asymptomatic carotid stenosis: asymptomatic carotid surgery trial.  Stroke. 2004;  35 2425-2427
    CrossrefPubMedGoogle Scholar
  • 23 Paty D, Li D. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. II. MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial. UBC MS/MRI Study Group and the IFNB Multiple Sclerosis Study.  Neurology. 1993;  43 662-667
    CrossrefPubMedGoogle Scholar
  • 24 Matthews P, Arnold D. Magnetic resonance imaging of multiple sclerosis: new insights linking pathology to clinical evolution.  Curr Opin Neurol. 2001;  14 279-287
    CrossrefPubMedGoogle Scholar
  • 25 Miller D, Filippi M, Fazekas F. et al . Role of magnetic resonance imaging within diagnostic criteria for multiple sclerosis.  Ann Neurol. 2004;  56 273-278
    CrossrefPubMedGoogle Scholar
  • 26 Weimar C, Kurth T, Kraywinkel K. et al . Assessment of functioning and disability after ischemic stroke.  Stroke. 2002;  33 2053-2059
    CrossrefPubMedGoogle Scholar
  • 27 Diener H-C, Tfelt-Hansen P, Dahlöf C. et al . Topiramate in migraine prophylaxis: results from a placebo-controlled trial with propranolol as an active control.  J Neurol. 2004;  251 943-950
    PubMedGoogle Scholar
  • 28 EAFT Group . Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke.  Lancet. 1993;  342 1255-1262
    PubMedGoogle Scholar
  • 29 Weise J, Kuschke S, Bahr M. Gender-specific risk of perioperative complications in carotid endarterectomy patients with contralateral carotid artery stenosis or occlusion.  J Neurol. 2004;  251 838-844
    PubMedGoogle Scholar
  • 30 Grotta J. for the US and Canadian Lubeluzole Ischemic Stroke Study Group . Lubeluzole treatment of acute ischemic stroke.  Stroke. 1997;  27 2338-2346
    PubMedGoogle Scholar
  • 31 Diener H-C, Cortens M, Ford G. et al . Lubeluzole in acute ischemic stroke treatment: a double-blind study with an 8-hour inclusion window comparing a 10 mg daily dose of lubeluzole with placebo.  Stroke. 2000;  31 2543-2551
    PubMedGoogle Scholar
  • 32 Barnett H J, Meldrum H E, Eliasziw M. et al . The appropriate use of carotid endarterectomy.  Can Med Ass J. 2002;  166 1169-1179
    PubMedGoogle Scholar
  • 33 North American Symptomatic Carotid Endarterectomy Trial Collaborators . Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis.  N Engl J Med. 1991;  325 445-453
    CrossrefPubMedGoogle Scholar
  • 34 European Carotid Surgery Trialists' Collaborative Group . Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST).  Lancet. 1998;  351 1379-1387
    CrossrefPubMedGoogle Scholar
  • 35 Antithrombotic Trialists' Collaboration . Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients.  BMJ. 2002;  524 71-86
    PubMedGoogle Scholar
  • 36 Algra A, Gijn J van. Cumulative meta-analysis of aspirin efficacy after cerebral ischaemia of arterial origin.  J Neurol Neurosurg Psychiatry. 1999;  65 255
    CrossrefPubMedGoogle Scholar
  • 37 Rothwell P, Warlow C. on behalf of the European Carotid Surgery Trialists . Collaborative Group. Prediction of benefit from carotid endarterectomy in individual patients: a risk-modelling study.  Lancet. 1999;  353 2105-2110
    CrossrefPubMedGoogle Scholar
  • 38 Algra A, Gijn J van. Aspirin at any dose above 30 mg offers only modest protection after cerebral ischaemia.  J Neurol Neurosurg Psychiatry. 1996;  60 197-199
    PubMedGoogle Scholar
  • 39 Steinhubl S R, Berger P B, Mann J T. et al . Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial.  JAMA. 2002;  288 2411-2420
    CrossrefPubMedGoogle Scholar
  • 40 Ringleb P, Kunze A, Allenberg J. et al . The stent-supported percutaneous angioplasty of the carotid artery vs. endarterectomy trial (SPACE).  Cerebrovasc Dis. 2004;  18 66-68
    CrossrefPubMedGoogle Scholar

Prof. Dr. Hans-Christoph Diener

Neurologische Universitäts-Klinik Essen

Hufelandstraße 55

45147 Essen

Email: h.diener@uni-essen.de

      >