Editorial
Copyright ©2012 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Pharmacol. Feb 9, 2012; 1(1): 4-9
Published online Feb 9, 2012. doi: 10.5497/wjp.v1.i1.4
Design flaws in randomized, placebo controlled, double blind clinical trials
James David Adams Jr
James David Adams Jr, Department of Pharmacology and Pharmaceutical Sciences, University of Southern California, School of Pharmacy, Los Angeles, CA 90089, United States
Author contributions: Adams Jr JD solely contributed to this paper.
Correspondence to: James David Adams Jr, PhD, Associate Professor, Department of Pharmacology and Pharmaceutical Sciences, University of Southern California, School of Pharmacy, 1985 Zonal Avenue, PSC 716, Los Angeles, CA 90089, United States. jadams@pharmacy.usc.edu
Telephone: +1-323-4421362 Fax: +1-323-4421681
Received: May 16, 2011
Revised: October 15, 2011
Accepted: December 20, 2011
Published online: February 9, 2012
Abstract

The hypothesis in drug clinical trials is that the drug is better than a placebo in patients suffering from a disease. The unstated assumption is that the drug cures the disease or is a powerful treatment for the disease. This is an incorrect assumption. Drugs do not cure or treat diseases. The body heals itself; drugs promote this ability of the body to heal itself. Placebos are assumed to be inactive; however, placebos can also promote the ability of the body to heal itself. Placebos are actually treatments that can stimulate endogenous healing mechanisms. The possible place of placebos in health management is controversial. Clinical trial design should be altered. The hypothesis of clinical trials should be that the drug speeds up or improves the healing of the patient, putting patient healing as the first objective. Placebos should not be used as controls but could be tested as drugs in their own right. The control in clinical trials should be no treatment. Alternatively, new drugs could be compared to existing drugs in clinical trials.

Keywords: Randomized clinical trials; Placebo effect; Drug efficacy; Healing