Nat Rev Neurosci. Sherman R, Hickner J: Academic physicians use placebos in clinical practice and believe in the mind-body connection. J Gen Intern Med. Bok S: The ethics of giving placebos.
Sci Am. Brody H: The lie that heals: the ethics of giving placebos. Ann Intern Med. Hinks TS: Ends never justify means. PLoS One. Schwartz D, Lellouch J: Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. Cook DJ: Randomized trials in single subjects: the N of 1 study.
Psychopharmacol Bull. A narrative review of the methodological literature. Cochrane Database Syst Rev. PubMed Google Scholar. Spine Phila Pa Article Google Scholar. Ann Pharmacother. Evaluating clinical research. Google Scholar.
Dieppe P: Osteoarthritis of the knee in primary care. Sokol DK: Can deceiving patients be morally acceptable?. J Am Med Assoc. Download references. You can also search for this author in PubMed Google Scholar. Correspondence to Andrew L Avins. AA conceived the original question and the outline of the analysis; wrote the first draft. DC provided essential discussions in the concept development and provided major rewrites of the manuscript.
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Trials 13, 44 Download citation. Received : 11 September Accepted : 27 April Published : 27 April Anyone you share the following link with will be able to read this content:. Sorry, a shareable link is not currently available for this article. Provided by the Springer Nature SharedIt content-sharing initiative. Skip to main content. Search all BMC articles Search. Download PDF. Methodology Open Access Published: 27 April Should we reconsider the routine use of placebo controls in clinical research?
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Previous NCI Directors. NCI Frederick. Advisory Boards and Review Groups. NCI Congressional Justification. Current Congress. Committees of Interest. Legislative Resources. Recent Public Laws. They want to be as certain as possible that the results of the testing show whether or not a treatment is safe and effective. That means volunteers are randomly assigned—that is, selected by chance—to either a test group receiving the experimental intervention or a control group receiving a placebo or standard care.
A placebo is an inactive substance that looks like the drug or treatment being tested. Comparing results from the two groups suggests whether changes in the test group result from the treatment or occur by chance. This is because knowing what treatment participants are taking can affect the results of a clinical trial. For example, if a doctor running the trial strongly believes the new treatment is better than what's available today, he or she might subconsciously try to help sicker patients by putting them into the group that receives the new treatment.
So at the end of the study when the team is looking at the results, it might look like the new treatment didn't work as well as the old treatment, just because patients who received the new treatment were already much sicker than the ones receiving the old one to begin with. This can make the treatment look like it has worse side effects than it does.
To make sure the results are accurate, doctors often use two methods called blinding and random assignment. Blinding is where one or more groups involved with the clinical trial don't know what treatment the participant in the study is receiving. Some of the groups that the researchers might want to prevent from knowing what treatments the patients are on include:.
Two common types of blinding are single-blind and double-blind. In a double-blind study, neither the patients, nor the medical staff treating the patient know which of the possible treatments the patient is taking.
In a single-blind study, the researchers know what medicine each patient is taking but the patient does not. Random assignment can be used to help make sure that the right groups are blinded in the study.
With random assignment, patients are placed into a treatment group randomly. One way that participants are randomized is by using a computer to assign patients to groups. Programs that do this can make sure the investigational group and the control group to be as similar as possible in terms of age, sex, and other features.
Most likely, you won't know during the study if you're in the investigational group or control group, but once the trial is finished, all participants should be informed of which group they were placed in.
In any trial where patients may receive a placebo, they will always be notified of this possibility during the informed consent process before joining a trial.
This will cover any potential risks associated with the control group treatment, and what percent of patients are placed in a group that doesn't receive the study treatment. So while you may not know if you are in a control group, the medical team will provide the details that allow patients to make an informed decision about whether participating is the right choice for their situation.
While the possibility of receiving a placebo can seem scary, remember that trials are designed with patient safety as the first priority.
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