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1.
Box JE 《Science and engineering ethics》2004,10(1):95-101
The UK Medical Research Council, in order to further its mission of maintaining and improving human health, supports a substantial
number of clinical trials on a wide variety of medical questions; some of these trials involve the use of placebos as controls
or to maintain blinding. Before providing support, proposed trials are carefully reviewed to assess scientific quality, and
to determine whether a placebo is required and is ethical — in addition to ethics review by independent Research Ethics Committees.
Some questions such as the choice of placebos in trials in developing countries, in surgical trials and those involving alternative
medicine require consideration of additional, specific issues. Involvement of consumers in MRC work has been increasing and
includes the establishment of a Consumer Liaison Group; members of this group comment on patient information leaflets for
clinical trials, helping to improve patient understanding of trials and ensuring topics like placebo use are explained clearly.
Views differ on the value of placebos in clinical care and on their mechanism of action; continuing research is helping to
clarify the issues.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003. 相似文献
2.
Biller-Andorno N 《Science and engineering ethics》2004,10(1):43-50
The current debate in medical ethics on placebos focuses mainly on their use in health research. Whereas this is certainly
an important topic the discussion tends to overlook another longstanding but nevertheless highly relevant question, namely
if and how the placebo effect should be employed in clinical practice. This paper describes the way the placebo effect is
perceived in modern medicine and offers some historical reflections on how these perceptions have developed; discusses elements
of a definition of the placebo effect; and suggests some conditions under which making use of the therapeutic potential of
the placebo effect can be ethically acceptable, if not warranted.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003.
Nikola Biller-Andorno, MD, PhD, is Assistant Professor in the Dept. of Medical Ethics and History of Medicine, University
of Goettingen, Germany. Dr. Biller-Andorno also serves as an ethicist for the World Health Organization (WHO). This paper
does not necessarily reflect the views of the World Health Organization. 相似文献
3.
Smoak R 《Science and engineering ethics》2004,10(1):9-13
The place for the placebo in human clinical research is addressed in this paper. The World Medical Association which is comprised
of some 80 National Medical Associations uses much of its resources to address medical ethics and human rights issues. It
adopted the Declaration of Helsinki in June 1964 which addressed the protection of individuals in clinical trials. The use
of placebos assumes an important role in this document. Five Revisions of the Declaration of Helsinki have occurred and the
most recent was adopted in October 2000. The provisions on placebo are now in Paragraph 29 which reads as follows:
“The benefit, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic,
diagnostic and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven
prophylactic, diagnostic or therapeutic methods exists.”
The reactions to the newly revised version of the Declaration of Helsinki were numerous and rapid, not the least of which
was the paragraph I quoted above.
At the direction of the WMA Council, a small group of experts together with the WMA workgroup studied the Paragraph 29 to
ensure that no ethically sound research was being restricted by the revision. The outcome was approved by the Council and
later the WMA General Assembly in October 2000. This gives a note of clarification as to the appropriate use of placebos.
Numerous papers and statements over the last several years have described positions very much in line with the Note of Clarification
cited above.
This paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in
Warsaw, Poland on 12–13 April, 2003. 相似文献
4.
Vrhovac B 《Science and engineering ethics》2004,10(1):81-93
The Helsinki Declaration is the ‘gold standard’ — a directive, not a law, on how to conduct controlled studies in humans in
conformity with ethical principles. In spite of many discussions about their unsuitability some articles have remained unchanged
in the most recent (sixth) revision of the Declaration. The demand to use “the best treatment” excludes use of placebo in
the control group and presents an obstacle to the scientific evaluation of a number of drugs and treatments in general. The
use of placebo is justified whenever its use does not cause irreversible damage or considerable suffering to the well informed
patient. It must be, is, and will be used in the controlled clinical trials of treatments of a great number of diseases especially
those which have a tendency to spontaneous improvement, even healing, or have a pronounced psychological component
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003. 相似文献
5.
Huston P 《Science and engineering ethics》2004,10(1):103-117
Part of the National Placebo Initiative in Canada included public consultations, based on the belief that the views of the
public should inform Canadian policy development on what constitutes appropriate placebo use. Public consultations took place
nationally in 2003. A deliberative dialogue approach was used, or a structured discussion format designed to facilitate the
consideration of complex issues and build consensus. The placebo debate was characterized as having 3 distinct approaches
and each were explored. The first approach “Maximize Patient Protection” identified the need for experts to determine appropriate
placebo use and that placebos should only be allowed under very restricted conditions. The second approach “Maximize Medical
Knowledge” identified that placebos give essential information about the safety and efficacy of new drugs, and are appropriate
when the rights, safety and well-being of research participants are ensured. The third approach “Maximize Patient Autonomy”
identified that the current system of regulating placebo use is paternalistic and that patients should be able to define what
is in their best interests and have more leeway to determine for themselves if they wish to participate in a placebo-controlled
trial. Advantages and disadvantages of each approach were considered and feedback on what constitutes appropriate placebo
use was sought. The major findings were that: PCTs were considered a valuable and acceptable part of advancing medical knowledge;
research using placebos must be valid and justifiable; a patient-centred approach needs to be fostered; patient autonomy (choice)
should be a first consideration and take clear precedence in trials of low to medium risk; patient protection (or health)
may need to “trump” patient autonomy at higher levels of risk and/or patient vulnerability; placebos are not a violation of
the duty of care as duty of care is best met by identifying a choice for patients, whenever a choice is available. These consultations
clearly were not designed to produce conclusive evidence, but rather to provide some useful insights into what the public
may think about placebo use; additional studies are indicated.
Funding for the public consultations was provided by Health Canada and the Canadian Institutes of Health Research.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003. 相似文献
6.
The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians
and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The
great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different
clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design
of these studies. One of the most important changes in this field has been the use of placebo groups in double-blind controlled
studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but
also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents
the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and
the use of placebo controls in clinical trials.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003. 相似文献
7.
Marshall MF 《Science and engineering ethics》2004,10(1):37-42
This paper gives an overview of the placebo effect in popular culture, especially as it pertains to the work of authors Patrick
O’Brian and Sinclair Lewis. The beloved physician as placebo, and the clinician scientist as villain are themes that respectively
inform the novels, The Hundred Days and Arrowsmith. Excerpts from the novels, and from film show how the placebo effect, and the randomized clinical trial, have emerged into
popular culture, and evolved over time.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003. 相似文献
8.
Porzsolt F Schlotz-Gorton N Biller-Andorno N Thim A Meissner K Roeckl-Wiedmann I Herzberger B Ziegler R Gaus W Pöppe E 《Science and engineering ethics》2004,10(1):119-132
Using placebos in day-to-day practice is an ethical problem. This paper summarises the available epidemiological evidence
to support this difficult decision. Based on these data we propose to differentiate between placebo and “knowledge framing”.
While the use of placebo should be confined to experimental settings in clinical trials, knowledge framing — which is only
conceptually different from placebo — is a desired, expected and necessary component of any doctor-patient encounter. Examples
from daily practice demonstrate both, the need to investigate the effects of knowledge framing and its impact on ethical,
medical, economical and legal decisions.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003. 相似文献
9.
The quest for effective medicines is very old. In modern times two important tools have been developed to evaluate efficacy
of drugs: superiority and non-inferiority types of clinical trials. The former tests the null hypothesis of μ (the difference
between a tested drug and comparator) ≤ 0 against μ > 0; the latter tests the null hypothesis of μ ≤ - Δ against, μ > - Δ,
where Δ is the clinical difference from the comparator. In a superiority trial, a new drug is tested against a placebo; in
a non-inferiority trial, a new drug is tested against active treatment. In this paper, arguments are presented to show that
a superiority trial against a placebo is scientifically sound but ethically unacceptable, whereas a non-inferiority trial
against active treatment is ethically sound but scientifically not reliable. Switching from a superiority type of trial with
placebo to a non-inferiority trial with an active-control — following the latest revision of Declaration of Helsinki — is
in practice switching from the violation of the uncertainty principle to uncertainty of results. Given human and financial resources, it appears an academic question as to which is more unethical:
to violate patients’ rights or to produce results without scientific value. All presented considerations lead to the conclusion
that the use of a superiority trial of design with an active control instead of placebo will satisfy scientific needs, expectation
of patients, and the ancient quest for effective medicines.
In the era of Good (Clinical, Laboratory, Manufacture) Practice, the attention of those performing clinical trials is focused
on the procedure, not always on its essence. However even the excellent performance of a trial which is not worth doing is
fruitless.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003. 相似文献
10.
A great variety of medical conditions are subject to the placebo effect. Although there is mounting evidence to suggest that
the placebo effect is related to the expectation of clinical benefit, little is still known about the biochemical bases underlying
placebo responses. Positron emission tomography studies have recently shown that the placebo effect in Parkinson’s disease,
pain, and depression is related to the activation of the limbic circuitry. The observation that placebo administration induces
the release of dopamine in the ventral striatum of patients with Parkinson’s disease suggests a link between the placebo effect
and reward mechanisms. In addition to Parkinson’s disease, the placebo-reward model may also apply to other disorders. However,
the relative contribution of the different neurotransmitters and neuropeptides that are known to be involved in modulating
the activity of the limbic system may be disease-specific. Thus, while the placebo-induced clinical benefit observed in Parkinson’s
disease would mostly reflect the release of dopamine in the dorsal striatum, the activation of opioid and serotonin pathways
could be particularly implicated in mediating placebo responses encountered in pain and depression, respectively.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003. 相似文献
11.
Puzyński S 《Science and engineering ethics》2004,10(1):135-142
The paper presents major ethical, legal and methodological problems related to the use of placebo in mental disorders, especially
in depression. It is pointed out that although authoritative groups of experts and numerous publications in the field of psychopharmacology
indicate advisability of the double blind design with placebo in clinical trials of antidepressants, in recent years there
have been more and more voices questioning legitimacy of this method. Objections of an ethical nature are raised, and reliability
of this approach is put into doubt from the methodological viewpoint. These issues are discussed in more detail in the paper.
Available alternative solutions should be implemented in psychotropic drug studies. The author shares these objections and
doubts of an ethical nature, and believes that the placebo procedure is not a necessity in clinical trials of antidepressants.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003. 相似文献
12.
Gefenas E 《Science and engineering ethics》2007,13(3):281-288
This paper attempts to provide a broader view into the ethical issues surrounding the field of emergency medicine (EM) research.
It starts from defining bioethically relevant features of EM and presents this field in the context of different models of
health care provider–patient relationship. The paper also provides a short overview of the “post-Nuremberg” evolution of the
main international research ethics guidelines relevant to EM research which demonstrates a tendency of liberalization of research
on incapable persons. This tendency culminates with the exceptions to informed consent for EM research which is supposed to
be balanced by other research ethics principles, especially a careful rationing of risks and benefits. This finally brings
us towards a critical analysis of the minimal risk standard which is one of the main fundamental safeguards in EM research.
An earlier version of this paper was presented at The 7th International Conference on Bioethics on “The Ethics of Research
in Emergency Medicine”, held on June 2, 2006, Warsaw, Poland. 相似文献
13.
Spier RE 《Science and engineering ethics》2004,10(1):189-197
Conclusion The material presented at this conference pointed to a new dimension in the prosecution of activities that seek to relieve
people of disease. While the simple instrument of the placebo may show those interested in the efficacy of physiologically
active chemicals the extent to which the chemical of interest is actually active, the surprising outcome of such studies is
that the placebo per se is worthy of more general study. This, when taken further, points to the ways in which mind can influence the matter of the
body. Of course, mind itself is an activity of matter, so we may retain the experimental approach that has told us about the
world outside ourselves to examine the world that is inside our brains. New techniques and approaches to these once intractable
problems are now in train. Where they will lead us we cannot predict, but as with the emergence of all new tools, we have
to adopt those ethics that will carry us forward with the expectation that we will maximise benefits and minimise harms.
An International Conference held in Warsaw, April 12–13, 2003, entitled ‘Placebo: Its Action and Place in Health Research
Today’ was attended by some 200 individuals who heard 25 presentations delivered by participants from the wider Europe and
North America. 相似文献
14.
Sugarman J 《Science and engineering ethics》2004,10(1):29-35
There has been considerable debate about the ethical acceptability of using placebo-controls in clinical research. Although
this debate has been rich in rhetoric, considering that much of this research is predicated upon the assumption that data
from this research is vital to clinical decision-making, it is ironic that researchers have introduced little data into these
discussions. Using some published research concerning the use of placebo-controls in clinical research in hypertension and
psychiatric drug trials, I suggest some ways that such data might be incorporated into the ethical analysis concerning placebo
use in clinical trials. This approach promises to be important for enhancing conceptual and scientific understanding as well
as public policy decision-making.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003. 相似文献
15.
Wasilewski BW 《Science and engineering ethics》2004,10(1):179-188
With the example of treatment of menopause-related vegetative and emotional disturbances, the author verifies the effectiveness
of the use of Ignatia amara containing complex homeopathic remedies (IACCHR) as an alternative to placebo. Substantial improvement
in psychological and psychosomatic symptoms was observed. Climacteric complaints diminished or disappeared completely in the
majority of women (95.7% by patient evaluation and 96.2% by physician evaluation). Compared to standard pharmaceuticals, IACCHR
treatment was tolerated better and lower risk of side effects was observed. The results obtained in this work indicate the
significant therapeutic potential of this group of treatments, which is in line with the therapeutic effect of the placebo.
Nevertheless, the showing of specific effects in pharmacological tests disqualifies the investigated treatments from use in
a clinical trial in place of a placebo.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003. 相似文献
16.
An increasing number of drugs removed from the market because of unacceptable toxicity raises concerns regarding preapproval
testing of drug safety. In the present paper it is postulated that the non-inferiority type of trial should be abandoned in
favor of the superiority trial with active controls and less stringent (p<0.1, both for efficacy and toxicity) statistics.
This approach will increase sensitivity of detection of drug-induced adverse effects at the expense of increasing false positive
results regarding the difference in efficacy between the tested and reference drug. Such a move will increase the protection
of future patients. In addition, the proposed design is far more acceptable from the clinical (e.g. no need to specify the
statistically expected “unimportant” number of deaths) and ethical points of view, as well as being favored by the strong
incentive of involved parties. In the second part of this paper arguments are presented in favor of the hypothesis that placebo
(still used in some superiority trials) does not induce adverse effects. The assertion that placebo may induce adverse effects
is probably biased by the nature of the clinical experiment. Such a conclusion is supported by studies indicating that placebo-induced
adverse effects are disease — and treatment — specific. The modification of clinical trials according to the proposed changes
may increase the trials’ sensitivity at detecting adverse effects of drugs.
A lecture on the subject of this paper was presented at the 6th International Bioethics Conference on the subject of ‘The
Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005. 相似文献
17.
Singer EA 《Science and engineering ethics》2004,10(1):51-56
The use of placebo in clinical trials has been repeatedly challenged as being unacceptable from an ethical point of view.
The present paper responds to this criticism by taking up the issue in the light of the pertinent provisions of the Helsinki
Declaration. Examples from different therapeutic areas are given that highlight the importance of placebo in situations in
which its use is acceptable according to the Declaration. Particular emphasis is given to the question of active control trials,
which, under conditions of low assay sensitivity, may become an ethically less acceptable approach than the use of a placebo
control.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003. 相似文献
18.
Mi-Kyung Kim 《Theoretical medicine and bioethics》2009,30(5):367-384
We examine whether the current regulatory regime instituted in South Korea and the United States would have prevented Hwang’s
potential transgressions in oocyte procurement for somatic cell nuclear transfer, we compare the general aspects and oversight
framework of the Bioethics and Biosafety Act in South Korea and the US National Academies’ Guidelines for Human Embryonic
Stem Cell Research, and apply the relevant provisions and recommendations to each transgression. We conclude that the Act
would institute centralized oversight under governmental auspices while the Guidelines recommend politically-independent,
decentralized oversight bodies including a special review body for human embryonic stem cell research at an institutional
level and that the Guidelines would have provided more vigorous protection for the women who had undergone oocyte procurement
for Hwang’s research than the Act. We also suggest additional regulations to protect those who provide oocytes for research
in South Korea. 相似文献
19.
Alzheimer’s disease is the most common form of dementia which is estimated to impact 350,000 people over 65 years of age in
Canada. The lack of effective treatment and the growing number of people who are expected to be diagnosed with Alzheimer’s
disease in the near future are compelling reasons why continued research is in this area is necessary. With additional research,
there needs to be greater recognition of the complexity of seeking ongoing informed consent from those with Alzheimer’s disease.
This complexity is because the impairment of memory and cognitive ability does not diminish in a linear manner, but rather
fluctuates between periods of impairment and relatively normal cognitive lucidness. There is limited discussion in the guidelines
of those progressing from early stages of Alzheimer’s disease who have intermittent cognitive function. Guidelines to research
and Research Ethics Boards require further development to facilitate researcher including those with Alzheimer’s disease while
protecting this growing pool of potential participants. 相似文献
20.
Joerden JC 《Science and engineering ethics》2004,10(1):65-72
This article considers issues concerning cases where the use of placebo is lawful or is not lawful under aspects of German
criminal law. It will differentiate between cases of individual therapy and cases of supervised experiments within the scope
of medical tests. Thereby, it reveals that a medication of placebo with regard to an individual patient seems to be lawful
if there is no alternative possibility of a better treatment using a chemically effective medicine and if the limits of presumed
consent are complied with. On the other hand, in the context of the supervised experiment, the assignment of a patient to
a group treated with placebo is only lawful if the patient has been fully informed about the possibilities of a treatment
and if the patient has given consent to it.
An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research
Today,” held in Warsaw, Poland on 12–13 April, 2003.
The author’s interests include International Criminal Law, Comparative Criminal Law and Philosophy of Law. 相似文献