Literature DB >> 11417020

Sham neurosurgery in patients with Parkinson's disease: is it morally acceptable?

W Dekkers1, G Boer.   

Abstract

For a few decades, patients with Parkinson's disease (PD) have been treated with intracerebral transplantations of fetal mesencephalic tissue. The results of open trials have been variable. Double blind, placebo-controlled studies have recently been started in order to further investigate the efficacy of this new medical technique. In this paper we challenge the need for sham surgery in neurotransplantation research on PD patients. Considerations regarding the research subjects' informed consent, therapeutic misconception, the integrity of the human body, and the assessment of risks and benefits argue against sham surgery for patients with PD. Moreover, there is an alternative, less harmful mode of research that can provide the same or comparable scientific evidence. A plea is made for intrapatient research based on quantitative measurements of the patient's pre- and post-operative condition combined with similar research on a reference group of patients who have received the standard treatment.

Entities:  

Keywords:  Analytical Approach; Biomedical and Behavioral Research

Mesh:

Substances:

Year:  2001        PMID: 11417020      PMCID: PMC1733414          DOI: 10.1136/jme.27.3.151

Source DB:  PubMed          Journal:  J Med Ethics        ISSN: 0306-6800            Impact factor:   2.903


  16 in total

1.  Dyskinesias assessment: from CAPIT to CAPSIT. Core Assessment Program for Intracerebral Transplantations. Core Assessment Program for Surgical Interventional Therapies.

Authors:  H Widner; G L Defer
Journal:  Mov Disord       Date:  1999       Impact factor: 10.338

Review 2.  Defining and describing benefit appropriately in clinical trials.

Authors:  N M King
Journal:  J Law Med Ethics       Date:  2000       Impact factor: 1.718

3.  Core assessment program for intracerebral transplantations (CAPIT).

Authors:  J W Langston; H Widner; C G Goetz; D Brooks; S Fahn; T Freeman; R Watts
Journal:  Mov Disord       Date:  1992       Impact factor: 10.338

Review 4.  Ethical issues in neurografting of human embryonic cells.

Authors:  G J Boer
Journal:  Theor Med Bioeth       Date:  1999-09

5.  Equipoise and the ethics of clinical research.

Authors:  B Freedman
Journal:  N Engl J Med       Date:  1987-07-16       Impact factor: 91.245

6.  Dopamine release from nigral transplants visualized in vivo in a Parkinson's patient.

Authors:  P Piccini; D J Brooks; A Björklund; R N Gunn; P M Grasby; O Rimoldi; P Brundin; P Hagell; S Rehncrona; H Widner; O Lindvall
Journal:  Nat Neurosci       Date:  1999-12       Impact factor: 24.884

7.  The Polkinghorne Report on Fetal Research: nice recommendations, shame about the reasoning.

Authors:  J Keown
Journal:  J Med Ethics       Date:  1993-06       Impact factor: 2.903

8.  Surgery as a placebo.

Authors:  A G Johnson
Journal:  Lancet       Date:  1994-10-22       Impact factor: 79.321

Review 9.  Improving the survival of grafted dopaminergic neurons: a review over current approaches.

Authors:  P Brundin; J Karlsson; M Emgård; G S Schierle; O Hansson; A Petersén; R F Castilho
Journal:  Cell Transplant       Date:  2000 Mar-Apr       Impact factor: 4.064

10.  Bilateral motor improvement and alteration of L-dopa effect in two patients with Parkinson's disease following intrastriatal transplantation of foetal ventral mesencephalon.

Authors:  M Peschanski; G Defer; J P N'Guyen; F Ricolfi; J C Monfort; P Remy; C Geny; Y Samson; P Hantraye; R Jeny
Journal:  Brain       Date:  1994-06       Impact factor: 13.501

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  16 in total

1.  Unilateral transplantation of human primary fetal tissue in four patients with Huntington's disease: NEST-UK safety report ISRCTN no 36485475.

Authors:  A E Rosser; R A Barker; T Harrower; C Watts; M Farrington; A K Ho; R M Burnstein; D K Menon; J H Gillard; J Pickard; S B Dunnett
Journal:  J Neurol Neurosurg Psychiatry       Date:  2002-12       Impact factor: 10.154

Review 2.  Sham surgery controls: intracerebral grafting of fetal tissue for Parkinson's disease and proposed criteria for use of sham surgery controls.

Authors:  R L Albin
Journal:  J Med Ethics       Date:  2002-10       Impact factor: 2.903

Review 3.  Neural transplantation in patients with Huntington's disease.

Authors:  Anne E Rosser; Stephen B Dunnett
Journal:  CNS Drugs       Date:  2003       Impact factor: 5.749

Review 4.  Sham surgery: an ethical analysis.

Authors:  Franklin G Miller
Journal:  Sci Eng Ethics       Date:  2004-01       Impact factor: 3.525

5.  Sham surgery controls are mitigated trolleys.

Authors:  R L Albin
Journal:  J Med Ethics       Date:  2005-03       Impact factor: 2.903

Review 6.  Randomized surgical trials and "sham" surgery: relevance to modern orthopaedics and minimally invasive surgery.

Authors:  Brian R Wolf; Joseph A Buckwalter
Journal:  Iowa Orthop J       Date:  2006

Review 7.  The role of growth/differentiation factor 5 (GDF5) in the induction and survival of midbrain dopaminergic neurones: relevance to Parkinson's disease treatment.

Authors:  Aideen M Sullivan; Gerard W O'Keeffe
Journal:  J Anat       Date:  2005-09       Impact factor: 2.610

8.  The ethics of sham surgery on research subjects with cognitive impairments that affect decision-making capacity.

Authors:  David B Resnik; Frank Miller
Journal:  Contemp Clin Trials       Date:  2010-06-04       Impact factor: 2.226

Review 9.  Ethics and evidence based surgery.

Authors:  G M Stirrat
Journal:  J Med Ethics       Date:  2004-04       Impact factor: 2.903

10.  Sham surgery trial controls: perspectives of patients and their relatives.

Authors:  Teresa L Swift
Journal:  J Empir Res Hum Res Ethics       Date:  2012-07       Impact factor: 1.742

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