In other words, patients are deprived from an already existing selleck effective therapy. The objective of testing such drugs to establish whether the new drug is better in efficacy or safety when compared to the existing drug/s placebo controlled trial considered unethical. The association of placebo effects with RCTs has caused confusion because the response in the placebo arm is not necessarily a genuine psychosocial response to the simulation of treatment. In fact, the observed response to placebo in RCTs may reflect the natural course of the disease, fluctuations in symptoms, regression to the mean, response bias with respect to the patient’s reporting of subjective symptoms and other concurrent treatments.
[3,4] Clinical equipoise in placebo-controlled trials Another argument proposed against placebo-controlled trials is that they potentially violate the concept of clinical equipoise when proven effective therapy is available. Clinical equipoise refers to the state where clinicians are unsure whether the new treatment or intervention is as good as the standard treatment. Those who reject the use of placebo-controlled trials argue that they violate the therapeutic obligation of physicians to offer optimal medical care. In other words, they compromise the right of the patient to receive the best care possible and violate the ethical principle of therapeutic beneficence. Furthermore, these clinicians have argued that when proven therapy exists, the use of a placebo-controlled trial lacks both scientific and clinical merit.
[21?C23] The use of placebo is also questioned in vulnerable groups like children, psychiatric patients, and patients suffering from cancer. Ethics of placebo in children The use of placebo in children is more restricted than in adults, because children GSK-3 cannot consent. HTC Placebo should not be used when it means withholding effective treatment, particularly for serious and life-threatening conditions. The use of placebo is often needed for scientific reasons, including pediatric trials. The use of placebo may be warranted in children as in adults when evidence for any particular treatment is lacking or when the placebo effect is known to be very variable (e.g., pain, hay fever). As the level of evidence in favor of an effective treatment increases, the ethical justification for the use of placebo decreases. Usefulness of placebo The use of placebo is not equivalent to the absence of treatment, for example, placebo could be used in addition to standard care. In all cases, its use should be associated with measures to minimize exposure and avoid irreversible harm, especially in serious or rapidly evolving diseases. As appropriate, rescue treatment and escape procedures should be set up.