Method and System for Addressing the Placebo Effect to Ameliorate its Practical Effect on Drug Testing
A system and method for providing improved therapeutic treatments and improved clinical trials for therapeutic treatments involves the predicting of a placebo response or effect by appreciation of the condition of and variances to the microbiome of individuals involved in drug efficacy studies. The provision of purportedly neutral placebos, such a “sugar pill”, has an effect on the microbes in a person's body, and therefore often has an effect on the person's wellbeing and perception of treatment. An appreciation that there is an actual effect due to the modification of the microbiome, caused by the administration of the placebo, forms a basis for various methods and systems of the present invention, with such appreciation being employed to design and conduct better drug efficacy studies without the prior problems experienced due to the placebo effect.
1 . A method for reducing the likelihood of a placebo effect when determining the activity of a putative therapeutic agent, comprising,
providing a putative therapeutic agent demonstrating positive clinical and/or in vitro results;
identifying a first individual who is a placebo responder by determining whether a purportedly neutral component administered to the individual has a biological effect;
assessing a microbial diversity of a microbiota of said first individual;
correlating the microbial diversity of the first individual to a placebo effect to identify the microbial basis for the placebo effect, wherein the placebo effect is selected from the group of effects consisting of: an improvement in a condition of the first individual in response to administration of the purportedly neutral component, and a deterioration in a condition of the first individual in response to administration of the purportedly neutral component;
identifying a second individual who is a placebo responder by determining whether the purportedly neutral component administered to the second individual has a microbial effect;
assessing a microbial diversity of a microbiota of a second individual;
correlating the microbial diversity of the second individual to a placebo effect to identify the microbial basis for the placebo effect, wherein the placebo effect is selected from the group of effects consisting of: an improvement in a condition of the second individual in response to administration of the purportedly neutral component, and a deterioration in a condition of the second individual in response to administration of the purportedly neutral component;
comparing the microbial diversity of the first individual to the microbial diversity of the second individual;
assessing differences in the first individual's microbial diversity and the second individual's microbial diversity; and
selecting the second individual for a study of the putative therapeutic agent only if the microbial diversity of the second individual is substantially similar to the microbial diversity of the first individual.
2 . The method of claim 1 , further comprising, assessing factors including at least two of the following: diet; ingested drugs; environmental exposure; health history;
intestinal mucosa, the immune system of the first and second individuals.
3 . The method of claim 1 , further comprising, providing a no-treatment control.
4 . The method of claim 1 , further comprising, accounting for microbiota based factors.
5 . The method of claim 1 , further comprising, neutralizing variations in at least the first individual's microbiome by pre-testing at least the first individual for effects they experience after being administered a placebo to determine how the individual microbiome's of the at least first individual is affected.
6 . The method of claim 1 , further comprising, comparing at least a first biological marker of the first individual to said first biological marker for the second individual, correlating the first biological marker to the placebo effect to identify the biological basis for the placebo effect.
7 . The method of claim 1 , wherein the placebo is selected from the group consisting of a suspension, a tablet, and an intravenous injection.