The pharmacy and therapeutics committee requested more documented safety data on the nutrition and vitamins I proposed in the study protocol. As a result the study was not approved. I have continued to meet with the pharmacists to review the published literature which is what inspired me to design the nutritional approach which I have taken. These meetings and requests for more information to prove the safety of what I propose in the pilot take time, and patience and a lot of cajoling. As a result I am back to not knowing when the study will be approved, nor do I know how many people we'll be able to enroll in a pilot when it is approved.
In the interim we are getting close to having the original case report accepted for publication. Because we chose to put it into a journal that has open access when it is published I will be able to put a link to the article on this web site so that it can be accessed more readily. Although the pilot study is not approved, the research survey studies about the nutrition and the use of electrical therapy are ongoing. We have 42 responses in the nutritional study and 22 responses in the electrical stimulation study. While I can't talk about the data from those studies in any kind of detail I will comment on what people have reported about the presence of adverse event or complications from nutrition / e stim.
No significant adverse problems associated with the nutrition were reported. For the estim a couple of individuals have reported skin burns and discomfort as problems. One person reported their MS worsened and they discontinued the estim. Although this is not enough to prove safety or efficacy, I consider this good news.
The other thing that is happening is that my physical therapist is writing up a case series reporting on his first 9 patients that he's treated with electrical stimulation. Unfortunately doing a scientific article usually takes several months to a year to go from start to being in print. Science is like that, painfully, arduously slow. I find it maddening too, but that is the nature of the beast.
Like everyone else in the world the recession is affecting the academic world too. We are also being asked to do more for less. That means that we are all picking up more clinic time and have less time to work on unfunded research. The consequence to that is that my partners who are doing this research are also being asked to do more. We have less time to devote to trying find the answers to the questions raised by the pharmacists. So we work at it. That means I choose between putting some time on the blog, or time on getting the pilot going. I've been prioritizing getting the pilot study approved. Of the two, I think that is the more important task. Getting a pilot study so we have preliminary data and can submit a grant for a larger study -- which could then be recognized by the medical community has the greatest impact for everyone.
For those of you who are dismayed that I'm not blogging more frequently I apologize. I also apologize for creating the hope that I'd have a pilot study open in the near future. I do not know when or if it will ever be approved.
That is not in my control, although I do tell myself it can't be harder than getting out of the wheelchair (some days I wonder however!). In the interim I'm working, seeing patients, teaching a couple times each month, working with my team on trying to get a pilot protocol through the review process so it can be approved.