The gold standard for a clinical trial design is the inclusion of a control. A control could be a placebo, active or no treatment. Clinicians use controls in order to give more power for their studies. A placebo control is a vehicle without the active ingredient. The main purpose of using a placebo in clinical trials is to differentiate the background noise from the actual effect of the treatment drug. Regulatory agencies prefer or favor trials that use controls such as placebo since the data obtained will be clear and non-ambiguous .
The use of placebo controlled study has been controversial since it was first introduced (c 1931). In this study, distilled water was used as a control when Sanocrysin was tested as a possible treatment for tuberculosis. The use of placebo control in clinical trials becomes controversial when there are other effective treatments available. It is undeniable that the use of placebo control can be beneficial in giving a strong clinically relevant data .
The recent version of the declaration of Helsinki states that “the benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances :
• The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or
• Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.”
Clinicians, however, have been justifying the use of placebo just because it provides superior data. Yet, there is a possibility that this approach may introduce ethical concerns. The preclusion of an existing therapy or replacing it with a placebo may lead to an irreversible damage over the course of the study and at the same time it would be denying the patient access to a medication that would probably slow down or prevent the progression of a certain disease.
There are opposing views regarding the use of placebo in clinical trials. One group supports the use of placebo as long as it does not expose patients to harm and as long as patients consented to participate and agreed to tolerate the risks. On the contrary, there are groups that oppose the use of placebo in trials when there is a standard treatment available. They argue that the experimental drug should be compared to the standard drug and they strongly feel that it is unethical to use a placebo. The opposing group to the use of placebo also argues that having subjects consent to the use of placebo is the same as transferring the ethical responsibility on them.
Nonetheless, both parties agree that the use of placebo is unacceptable in life-threatening diseases, but the argument remains whether or not it is...