About Careers Internship MedBlog Contact us
Medindia LOGIN REGISTER
Advertisement

Progesterone Shows No Benefit to Severe TBI Patients: Study

by Himabindu Venkatakrishnan on December 11, 2014 at 5:49 PM
 Progesterone Shows No Benefit to Severe TBI Patients: Study

After five days of treatment with a novel formulation of progesterone acutely administered to patients with severe traumatic brain injury, the study concluded that it showed no clinical benefits.

The paper entitled, "A Clinical Trial of Progesterone for Severe Traumatic Brain Injury," will be published online in The New England Journal of Medicine, December 10, 2014.

Advertisement

This trial, referred to as SyNAPSe, reports on a large prospective randomized clinical trial that investigated the effects of progesterone administered to severe TBI patients," said Raj K. Narayan, MD, executive director, North Shore-LIJ's Cushing Neuroscience Institute and one of the co-authors of the paper. "Despite extensive experimental support in numerous animal models, as well as very promising preliminary data from smaller single center trials, this Phase III study failed to show benefit of progesterone in severe TBI."

In this multinational, placebo-controlled trial, 1195 patients, 16-70 years of age, with severe TBI were randomly assigned to receive progesterone or placebo. Dosing began within eight hours after injury and continued for 120 hours. Analysis showed no treatment effect of progesterone as compared with placebo. The proportion of patients with a favorable outcome on the Glasgow Outcome Scale (the combination of patients with good recovery or moderate disability) was 50.4% with progesterone, as compared with 50.5% with placebo.
Advertisement

Mortality rates in both groups were the same and there were no relevant safety signal differences between progesterone and placebo. "The trial suggests that although promising agents may be found in early experiments, the selection process may still lack the precision for ultimately identifying agents with clinical benefit for this devastating and common disorder for which no proven pharmacological therapies exist," said Brett E. Skolnick, PhD, adjunct associate professor of neurosurgery at the Hofstra North Shore-LIJ School of Medicine and who served as lead author of the paper.

"It also highlights the difficulty in demonstrating the efficacy of any drug in this complex disease since the outcome may be affected by many factors. Animal models usually replicate only one aspect of the injury, but human TBI patients can suffer multiple medical and surgical problems that can affect their ultimate outcome. The need to find better treatments for this severe injury remains as great as ever and what we have learned from this trial will help us better design future trials."

Source: Eurekalert
Font : A-A+

Advertisement

Advertisement
Advertisement

Recommended Readings

Latest Research News

Brain Circuits That Shape Bedtime Rituals in Mice
New study sheds light on the intrinsic, yet often overlooked, role of sleep preparation as a hardwired survival strategy.
NELL-1 Protein Aids to Reduce Bone Loss in Astronauts
Microgravity-induced bone loss in space, can be reduced by systemic delivery of NELL-1, a protein required for bone growth and its maintenance.
Connecting Genetic Variants to the Alzheimer's Puzzle
Researchers establish connections between Alzheimer's-linked genetic alterations and the functioning of brain cells.
Gene Therapy Sparks Spinal Cord Regeneration
Team at NeuroRestore introduces a groundbreaking gene therapy that has effectively promoted nerve regrowth and reconnection, post spinal cord injury.
Unlocking the Gut Microbiome's Influence on Bone Density
Scientists aim to pinpoint particular functional pathways affected by these bacteria that may have an impact on skeletal health.
View All
This site uses cookies to deliver our services.By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use  Ok, Got it. Close
MediBotMediBot
Greetings! How can I assist you?MediBot
×

Progesterone Shows No Benefit to Severe TBI Patients: Study Personalised Printable Document (PDF)

Please complete this form and we'll send you a personalised information that is requested

You may use this for your own reference or forward it to your friends.

Please use the information prudently. If you are not a medical doctor please remember to consult your healthcare provider as this information is not a substitute for professional advice.

Name *

Email Address *

Country *

Areas of Interests