Proposed clinical trial of estrogen as a rescue drug in TBI and hypovolemic shock?

Just leaving a conference meeting of an emergency medicine research consortium. We were discussing proposed protocols for new clinical trials to undertake. One proposal included the use of high dose estrogen in subjects with TBI (traumatic brain injury) and/or hypovolemic shock. It would be given to any person that met certain criteria (e.g. low blood pressure, high heart rate w/ evidence of traumatic injury). There are lots of data to suggest that the treatment would increase survival by about 6% in this certain cohort. Finally, to the question: is the use of estrogen, a female sex hormone, as a drug in a clinical trial in the emergency medicine setting (waiver of informed consent) in the general population problematic? Please focus on the use of estrogen rather than other potential philosophical, ethical or scientific issues.

Proposed clinical trial of estrogen as a rescue drug in TBI and hypovolemic shock?
How much estrogen would be used, would it be a one time thing or will the patient have to take it for an extended period of time? You know but most people don't know that even men have a small amount of estrogen in their blood, would the extra amount of the hormone and its effect on the body only work for the brain injury and its "sexual"/"gender" side effects be negligible. Or will a male patient have gynocomastia, for instance, as a side effect?





Of course if the benefits greatly outweigh the side effects then it should be used. So the big question is what are the side effects.








EDIT: Well if there are no adverse side effects and its a one time thing, then there really is not risk of males becoming feminised, as would be some of the issues males would prbly bring up. But I think that any man that is in need of this would want it because its gonna possibly save his life. I think if doctors were more honest with patients on how exactly things work, there wouldn't be as much of an issue. I don't think most people would have an issue with taking a one time dose of estrogen.





Now as far as human trials. Those things go on all the time and I rarely hear of people objecting to it, because humans can actively participate or not. As opposed to people who disagree with animal trials siting that fact that animals don't consent. As long as a person consents to this there shouldn't be an issue.
Reply:Err...what on earth is your question? I can't find one. What does the topic have to do with the ancient fluroride in-the-water conspiracy theory???





Leave it to the experts. You have provided no links so not surprisingly we are lost. My advice is for you not worry too much about it and get on with the rest of your day.
Reply:ditto Emily...


If your concerns are the bad side affects of estrogen, then I would hope more studies would be ran to make sure it is safe, just as any other drug.


If your main concern is that of it being a female hormone, then you would have to deal with that on a personal level. I for one wouldn't have a problem with it, you know what... shoot me full of testosterone if it saves my life!





EDIT: hum, that is interesting that it is beneficial to men and harms women. good question.
Reply:From the clinical trial noted at the site below, this excerpt seems to indicate that estrogen therapy for TBI is beneficial only to males, while may have a negative effect on females. I don't understand the significance of this as I am not a clinician but did find it interesting.





Sex Hormones and TBI Sequelae





An interaction of TBI sequelae with sex hormones may relate to differences in TBI outcome between men and women. Alkayed, et al.,[1] have found that estrogen had a protective effect against ischemia in female rats in which they used an experimental stroke paradigm. However, in an experimental brain trauma study, the authors found a protective effect of estrogen (improvement in free magnesium concentration, cytosolic phosphorylation potential, and motor function) only in male rats. Lowered cytosolic phosphorylation potential after trauma and higher mortality rates were demonstrated in all groups of female rats.[8] Progesterone has also been shown to have a protective effect in reducing brain edema in TBI sequelae in female rats.[37] In progesterone-treated male and female rats a reduction in behavioral impairment and reduced neuronal degeneration 21 days after injury were also demonstrated.[36] A potential negative effect of sex hormones, especially estrogen, may lead to a worse outcome in women after TBI.