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) doubleblind 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.

Management of Fibromyalgia Syndrome in 2016

“…RCTs, of course, are capable of protecting internal validity of the study by controlling potentially confounding variables. However, reliance on RCTs and p-value-based statistical significance testing has recently been criticized [150][151][152]. In RCT, mean comparisons between groups are the main theme, thus helping us see if the treatment in question benefit 'an average patient,' but it does not tell us whether the treatment would benefit a particular patient who is sitting in your exam room.…”

Review Articles

“…institutions (72). The Cochrane metaanalysis finds systematically less effect and LISTING POSITIVE/NEGATIVE EFFECTS more harm from the pharmaceutical drugs A serious problem in providing accurate than the pharmaceutical industry does, and reliable information about the effects of when it documents its own products.…”

“…It is also important to be aware of the inherent problems of the RCT-test itself not to be over-optimistic of the treatment results from the pharmaceutical drugs (72). The independent meta-analysis is still often based on the industrial RCTs, taking all the bias before statistical analysis with them into the meta-analysis.…”

Proposal of a Holistic Model to Support Local-Level Evidence-Based Practice

“…The emphasis on evidence-based practice shifted attention from appropriate rigorous research methodology to the practice of RCTs. On the other hand, RCTs have a role to play in assessing the effect of a particular treatment in a population, but, in areas where health outcomes are influenced by human behaviour, such as dynamics of disease development, RCTs have no or a limited role to play (e.g., see [24,25,26]). It is plausible that RCT-type activities may have received a higher proportion of resources and funding, thus neglecting research programmes and activities that focus on local knowledge and relevant health issues.…”