Genetic 'placebo response' marker has trial design implications, say researchers

- Last updated on GMT

Team discovers genetic basis for placebo response
Discovery of the genetic basis for the placebo effect in IBS patients has wider implications for protocol design and trials of personalised medicines say researchers.

Scientists from Beth Israel Deaconess Medical Center (BIDMC) and Harvard Medical School (HMS) claim to have identified​ genetic differences between people who respond to placebos during trials of and those who do not.

The team looked a 2003 trial (NCT00065403​) in which patients ‘treated’ with augmented placebo – combined acupuncture and physician support – showed greater reductions in symptom severity than patients in either the limited placebo group – just acupuncture – or the no treatment arm.

Analysis of blood samples taken at the time showed patients who responded most strongly had two copies of a particular version of a gene encoding catechol-O-methyltransferase (COMT), an enzyme involved in the dopamine pathway, as lead author Kathryn Hall explained.

IBS patients homozygous for the COMT val158met methionine allele were the most responsive to placebo treatment. Heterozygous patients showed an intermediate response, and homozygous valine patients showed essentially no placebo mediated symptom improvement​.”

And while the researchers admit the study was only small scale – 262 adults took part and only 122 allowed blood samples to be taken – they suggest the genetic findings have wider implications for drug research.

To our knowledge, this is the first study to demonstrate genetic modulation of true placebo effects disassociated from changes related to disease natural history and regression to the mean.

Identifying biological characteristics of placebo responders and non-responders could be key to managing underlying placebogenic factors to benefit patients by delivering personalized medicine, for example by adjusting the dose of medication in accordance to the subject's placebo susceptibility or selecting a different class of drugs for the individualized patient​.”

Related topics: Clinical Development, Phase III-IV

Related news

Show more

Related products

show more

What should a clinical metadata repository do?

What should a clinical metadata repository do?

Formedix | 26-Jul-2021 | Technical / White Paper

Choosing a clinical metadata repository (MDR) software can be a tough task as the capabilities and features of your chosen MDR could make or break your...

Adapting supply chains to new ways of working

Adapting supply chains to new ways of working

World Courier | 15-Jul-2021 | Technical / White Paper

COVID-19 has changed the way we operate. We have adapted our supply chain solutions to meet our clients’ requirements while following World Courier standard...

What are the building blocks of DCTs?

What are the building blocks of DCTs?

Medable | 26-Apr-2021 | Technical / White Paper

How to create a seamless experience across eConsent, eCOA and more.

Over the past year, tremendous progress was made toward digitizing and...

How a clinical metadata repository helps with data

How a clinical metadata repository helps with data

Formedix | 22-Mar-2021 | Technical / White Paper

This article covers the various ways a clinical metadata repository helps with data quality, and in turn, with data quality in the clinical trials process....

Related suppliers

Follow us


View more