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      Ethical and Scientific Perspectives of Placebo-controlled Trials in Schizophrenia

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          Abstract

          Clinical trials for development of new medications are essential in all fields of medicine. The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. On the other hand, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when the investigational drug may ultimately provide substantial benefit for some patients. At the same time it is the psychiatrist's responsibility to insure that investigators are adequately trained to conduct clinical trials and that stringent regulatory committees supervise the scientific, clinical and ethical aspects of the trials.

          Keywords

          Placebo-control; Schizophrenia; Medical ethics; Clinical trials

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          The continuing unethical use of placebo controls.

          K Michels, K Rothman (1994)
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            Therapeutic potential of bone marrow-derived mesenchymal stem cells on experimental liver fibrosis.

            Mohmamed S. Mahfouz, T. Aziz, H Fouad … (2007)
            To study the effect of mesenchymal stem cells (MSC) on experimental liver fibrosis in rats. MSC were derived from bone marrow obtained from femoral and tibial bones of male albino rats. MSC were separated, grown, and propagated in culture for 4 weeks and were characterized morphologically and by detection of CD29 by RT-PCR. They were then infused into the tail vein of female rats that received CCl4 injection to induce liver fibrosis. Rats were divided into 4 groups: control, CCl4, CCl4 plus MSC, and MSC. Liver tissue was examined histopathologically and liver functions (ALT and serum albumin) were estimated for all groups. Y-chromosome gene (sry) was assessed by PCR in liver tissue of the female rats to confirm uptake of the male stem cells. Hydroxyproline content in liver tissue was assessed by chemical methods and expression of the collagen gene (type I) was detected as a marker for liver fibrosis. Results of the present study showed that MSC have a significant antifibrotic effect as evidenced by the significant decrease in liver collagen gene expression as well as the decrease in hydroxyproline content in the CCl4/MSC group (p 0.05). In conclusion, MSC have a potential therapeutic effect against the fibrotic process through their effect in minimizing collagen deposition in addition to their capacity to differentiate into hepatocytes.
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              The Declaration of Helsinki and clinical trials: a focus on placebo-controlled trials in schizophrenia.

              T. Carpenter, Paul Appelbaum, Gwendolyn Levine (2003)
              The authors' goal was to consider ethical approaches to placebo-controlled clinical trials in the light of the evolving Declaration of Helsinki, with special attention to applications to research on schizophrenia. They review the Helsinki position on placebos, including the 2002 Clarification, exploring the potential negative effects of banning placebos in studies involving conditions for which at least partially effective treatments exist. The Clarification is examined as an approach to this issue that, in contrast to earlier formulations, better acknowledges the complexity of clinical research and the need for protocol-specific determinations. Placebo controls in schizophrenia studies are used to illustrate issues relevant to all clinical research on therapeutic interventions. The Helsinki Clarification provides a basis for operationalizing criteria for review of placebo use in clinical trials. Six criteria are proposed for judging the ethical acceptability of placebo controls, including the likelihood that the intervention being tested will have clinically significant advantages over existing treatments, the presence of compelling reasons for placebo use, subject selection that minimizes the possibility of serious adverse consequences, and a risk-versus-benefit analysis that favors the advantages from placebo use over the risks to subjects. The Helsinki Clarification constitutes an important advance in international approaches to placebo use, requiring protocol-by-protocol judgments on complex issues of clinical research ethics. When operationalized, it provides review boards with a useful methodology for reaching determinations on the appropriateness of placebo controls in particular studies.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Clin Med Res
                Journal ID (iso-abbrev): J Clin Med Res
                Journal ID (publisher-id): Elmer Press
                Title: Journal of Clinical Medicine Research
                Publisher: Elmer Press
                ISSN (Print): 1918-3003
                ISSN (Electronic): 1918-3011
                Publication date (Print): August 2009
                Publication date (Electronic): 03 July 2009
                Volume: 1
                Issue: 3
                Pages: 132-136
                Affiliations
                [a ]Lev-Hasharon Mental Health Center, Netanya, Israel, affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
                Author notes
                [b ]Corresponding author: Deputy Director, Lev Hasharon Mental Health Center. P.O.Box 90000, Netanya 42100, Israel. E-mail: ymelamed@ 123456post.tau.ac.il
                Article
                DOI: 10.4021/jocmr2009.07.1247
                PMC ID: 3318875
                PubMed ID: 22493646
                SO-VID: fa052591-1c0d-492e-b314-eb676365989e
                Copyright © Copyright 2009, Melamed et al.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date accepted : 30 June 2009
                Categories
                Subject: Review

                ScienceOpen disciplines: Medicine
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                ScienceOpen disciplines: Medicine

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