Evidence-based medicine: four fundamental problems with the randomized clinical trial (RCT) used to document chemical medicine

Abstract

Randomized clinical trials (RCT) have been accepted as the golden standard of testing, thus making chemical medicine "evidence based". The RCT is based on four assumptions: 1) The placebo effect is represented by a placebo pill, 2) it is possible to make a double-blind test with biologically active drugs, 3) beneficial and harmful effects of drugs are fairly measured in RCTs, and 4) an appropriate time frame for the test is used. We have found problems with these assumptions: 1) The placebo effect provided by close relationships to a physician is stronger than an inert pill, 2) double-blind tests cannot be made with biologically active drugs, as these leave an internal clue in the patient that destroys the blinding (active placebo), 3) lack of global outcome measures makes toxic effects invisible for the test and magnifies minor effects to make clinically insignificant positive effects look important, and 4) RCTs are used in such a brief time frame that side effects and harm are not properly detected. The four errors combine into a serious error: The RCT-procedure induces a strong bias in favor of any toxic drug tested. RCTs can turn drugs that are only toxic and not beneficial at all into products sold as.useful chemical medicine. Many pharmaceutical drugs on the market today are tested only with this flawed RTC-procedure, and we recommend that these drugs be tested again using a rational method. If drugs are not more helpful than placebo, then we should return to classic psychosocial holistic medicine.