Wednesday, January 19, 2011

PROGESTERONE STUDY

Progesterone
by Kathleen Quinn-Farber on Wednesday, January 19, 2011 at 5:34pm

within hrs of Dannys accident in the early AM of dec 4th, he was being stablized by the trauma team in icu @st lukes, n cuz of his most severe brain injury, diffuse axonal, which is a tearing and shearing of the neurons n their connectors over the entire brain, was selected 2 participate in a study being done on the healing effects of progesterone on the brain. In animals there has been scientific proof that the introduction of this female hormone as quickly as possible after injury, n continuing 4 several days, seems 2 kinda coat n protect the broken nerve endings until they start 2 repair, when normally those endings actually wither n die. The patients chosen recieve either the hormone or a placebo. We wont know which danny got until after the study ends sometime in the next 2 1/2yrs. I got our 1st monthly follow-up call 2day. Very impressive recovery so far she said. I wonder n suspect he recieved the real hormone, n if he did n it made some of the difference, i am grateful and thank God.








Progesterone Called Option for Brain Injury Treatment

By John Gever, Senior Editor, MedPage Today
Published: December 22, 2009
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Progesterone should be considered as treatment option for head trauma -- and perhaps other types of central nervous system injuries, researchers urged.
The hormone's beneficial effects on neuronal survival and functional recovery following traumatic brain injury have been sufficiently documented that its clinical use is now justified, according to Donald G. Stein, PhD, of Emory University, and his recent collaborator there, Iqbal Sayeed, PhD.
"There are now about 100 preclinical studies from laboratories in the U.S. and abroad showing the beneficial effects of progesterone treatment in a number of central nervous system injury models," Stein and Sayeed wrote in a "clinical perspective" article appearing in the January 2010 issue of the American Journal of Roentgenology.
They also pointed to two clinical trials, one in the U.S. and one in China, showing a that short course of progesterone improved function more than placebo in patients with traumatic brain injury. (See Progesterone Cuts 30-Day Mortality from Traumatic Brain Injury and Progesterone Improves Head Injury Recovery)
Stein has been studying the effects of sex hormones on brain function after injury for more than 20 years, primarily in animal models. But he was also an investigator in the U.S. clinical trial, which was led by another Emory colleague, David Wright, MD.
In that study, with 100 patients, 30-day mortality following head trauma was cut to 13% with progesterone compared with 30% in a placebo group. The 159-patient Chinese trial found that six-month mortality was reduced by about 40%.
In these trials, progesterone was given by injection or infusion over several days following injury. No adverse effects attributable to the hormone treatment were reported.
Stein and Sayeed suggested that, given this safety profile and the current lack of effective treatments for severe brain injuries, that it would be appropriate to consider progesterone as a treatment option.
"More than 30 years of testing and 30 trials involving 50 compounds failed to identify an acute-stage treatment for traumatic brain injury that could confer neuroprotection and enhance functional outcomes," they asserted.
They also pointed out the high frequency of brain injuries suffered by troops in Iraq and Afghanistan.
Stroke is also largely untreatable, Stein and Sayeed argued. "Aside from tissue plasminogen activator (tPA), which can be given to only about 3% of stroke victims and only during the first three to four hours after stroke onset, nothing is available for clinical use," they wrote.
No clinical trials of progesterone in stroke are planned, they acknowledged, and stroke differs in important ways from traumatic brain injury.
Progesterone has shown promise in preclinical stroke models but studies of how it behaves in conjunction with tPA should precede clinical application, the researchers recommended.
Stein and Sayeed added that animal studies have found that progesterone may also help in acute spinal cord injury as well as chronic neurodegenerative conditions such as diabetic retinopathy, Niemann-Pick C1 syndrome, and multiple sclerosis.
The exact mechanism for progesterone's neuroprotective effects are unknown, but Stein and Sayeed offered an evolutionary hypothesis for why they might exist.
They noted that progesterone levels are highest in pregnant women and they remain high throughout gestation.
"It is our contention that progesterone's mechanisms of action have evolved primarily to protect the developing fetus against oxidative stress and immune–inflammatory rejection reactions," the researchers wrote, adding that the hormone also helps regulate neuronal development.
"Many of the processes of CNS repair recapitulate the steps taking place during development, and this is why we think that progesterone may also show promise in the treatment of traumatic and degenerative disorders of the brain and CNS."
They concluded, "Given its relatively high safety profile, its ease of administration, and its low cost and ready availability, this hormone and its metabolites should be considered as a viable treatment option -- especially because, in brain injury, so little else is currently available."





Danny went back for a six-month evaluation for this study in early June. All sorts of questions were asked about his recovery so far. I truly think he received the progesterone because his recovery has been dramatically shorter than expected, as well as being significantly complete. The severe memory issues and personality changes, as well as confusion, are the residual effects we are dealing with now...but all in all, Danny is physically ok, except for some tremoring and weakness...his speech is unchanged...and he is doing great. We wont know for 2 more years whether he received the progesterone or the placebo...but i'm convinced he received it :-)













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