HealthDay News — Researchers in two separate clinical trials found no benefit for progesterone in patients with severe or acute traumatic brain injury (TBI), according to studies published in the New England Journal of Medicine. The results of the multicenter and multinational studies are in stark contrast to the findings of two previous smaller trials.
Brett E. Skolnick, PhD, from the Cushing Neuroscience Institute in Manhasset, N.Y., and colleagues examined the efficacy and safety of progesterone for severe TBI in a multinational placebo-controlled trial. A total of 1,195 patients aged 16 to 70 years with severe TBI were randomized to receive progesterone or placebo. The researchers observed no treatment effect for progesterone versus placebo (odds ratio, 0.96; 95% confidence interval, 0.77 to 1.18). The proportion of patients with a favorable outcome on the Glasgow Outcome Scale was 50.4 and 50.5% in the progesterone and placebo groups, respectively. Mortality was also comparable between the groups.
David W. Wright, MD, from the Emory University School of Medicine in Atlanta, and colleagues conducted a double-blind, multicenter trial involving patients with severe, moderate-to-severe, or moderate acute TBI who were randomized to intravenous progesterone or placebo. After randomization of 882 out of the planned sample of 1,140 patients, the trial was stopped early for futility with respect to the primary outcome. The researchers observed no significant between-group difference in the proportion of patients with a favorable outcome (relative benefit of progesterone, 0.95; 95% confidence interval, 0.85 to 1.06; P = 0.35).
“This clinical trial did not show a benefit of progesterone over placebo in the improvement of outcomes in patients with acute TBI,” Wright and colleagues conclude.
The Skolnick study was funded by BHR Pharma. One of the authors from the Wright study disclosed receiving royalties from a patent related to progesterone for the treatment of TBI, which is licensed to BHR Pharma.