Sham Procedure and Placebo Medication: What is it about?
How Are Placebos and Shams Utilized in Research?
Researchers use placebos during studies to help them understand what effect a new drug or some other treatment might have on a particular condition. Adding a placebo/sham arm to an experiment helps researchers minimize bias and confounds. Confounders are those variables that if the researchers fail to control or eliminate, would harm the internal validity of the experiment.
What is Placebo Effect?
It is a beneficial effect, produced by a placebo drug or treatment, that cannot be attributed to the properties of the placebo itself, and must therefore be due to the patient’s belief in that treatment. There is evidence that there is a significant placebo effect from surgical procedures and the effectiveness of some accepted procedures is due largely to this placebo effect. There is further evidence that the placebo effect from invasive procedures may be even stronger than the recognized effects of a placebo pill.
Why Is It Ethically Concerning?
Currently, placebo-controlled trials are considered the gold standard design in drug research trials and –despite criticisms– are widely accepted on ethical as well as scientific grounds. But it hasn’t always been clear-cut for sham interventions or surgeries, as it remains a contentious topic.
While critics find sham controls ethically acceptable in research conditions for which there is no standard therapy, most of them argue that it is difficult to justify the use of sham controls when effective standard therapy exists. The reason is that performing a surgical procedure that has no expected benefit other than the placebo effect violates the ethical and regulatory principle that the risk of harm to subjects must be minimized in the conduct of research.14 This is different from the case of a drug trial where the harm comes from withholding a standard medication if has been proved effective.
If you are a researcher
Physicians who engage in biomedical or health research with human participants thus have an ethical obligation to ensure that any study with which they are involved:
(a) Is consistent with the goals and fundamental values of the medical profession.
(b) Addresses research question(s) that will contribute meaningfully to medical knowledge and practice.
(c) Is scientifically well designed to yield valid data to answer the research question(s), including using appropriate population and sampling controls, clear and appropriate inclusion/exclusion criteria, a statistically sound plan for data collection and analysis, appropriate controls, and when applicable, criteria for discontinuing the study (stopping rules).
(d) Minimizes risks to participants, including risks associated with recruitment and data collection activities, without compromising scientific integrity.
(e) Provides mechanisms to safeguard confidentiality.
(f) Does not disproportionately recruit participants from historically disadvantaged populations or populations whose ability to provide fully voluntary consent is compromised. Participants who otherwise meet inclusion/exclusion criteria should be recruited without regard to race, ethnicity, gender, or economic status.
(g) Recruits participants who lack the capacity to give informed consent only when the study stands to benefit that class of participants and participants with capacity would not yield valid results. In this event, assent should be sought from the participant and consent should be obtained from the prospective participant’s legally authorized representative, in keeping with ethics guidance.
(h) Has been reviewed and approved by appropriate oversight bodies.
Federal Stance; Policies and Regulations
EXAMPLES OF CONTENTIOUS SHAM-CONTROLLED CLINCIAL TRIALS
Controversies
Around Informed consent: