2.2.4 – Double-blind randomized placebo-controlled trials have severe limitations.

Contribution: Free Earth Alliance

– To know what is Double-Blind Placebo-Controlled Clinical Trial

Having two control groups, one on placebo and one on the adjuvant, is an over-simplistic model of life. In reality people have options of other paths of medicines and traditional remedies.

So there should be three control groups.
– First Group – Placebo based on an inert pill,
– Second Group – On the adjuvant, and
– Third group – Should be under treatment by various paths of medicine under AYUSH.

Adjuvant should be considered for approval only when it is proven to be better than the results in both the Second and Third group. If research methodology has not considered this possibility then its use as a tool of maximizing Public Health is highly questionable and inappropriate, as there are in-sufficient rationale for assuming that people have no other defenses and paths of medicines to a possible condition. Evidence based thinking, cannot be imposed on everyone.

Mayank Pincha

When Public Health adopts Evidence-Based Medicine (EBM) & Pharmaceutical drugs/ vaccines as the only path of medicine which is based on only two control groups without considering this reality that people have access to other paths of medicine, home remedies, natural immunity, they have already crossed the line and its against Natural & Common Laws, and against Constitutional rights of citizens.

Evidence-based medicine: Four fundamental problems with the randomized clinical trial (RCT) used to document chemical medicine. 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.
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.
4. And RCT’s are used in such a brief time frame that side effects and harm are not properly detected. 

Similar articles that are critical about Double-blind randomized Placebo-controlled tests are –

1. Test-treatment RCTs are susceptible to bias: a review of the methodological quality of randomized trials that evaluate diagnostic tests.
2. Redefining the randomized controlled trial in the context of acupuncture research.
3. The double-blind, randomized, placebo-controlled trial: gold standard or golden calf?

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