ichisan (in the Oral Sodium Chlorite thread) wrote:
3. The university of Miami conducted an amazing study of hyperbaric oxygen therapy (HBOT) that showed up to 97% improvement in the muscle strength of 4 out five ALS patients. One patient dropped out because of fatigue. Nobody else in the ALS research community considered the study important and nobody else tried to corroborate the study.
4. Two years later, some of the same original researchers who did the first study, conducted a second double-blind trial of HBOT and the results were 100% negative. I find this hard to believe. I suspect foul play.
Louis,
It's not like you have to guess what the pitfalls of the phase I study were. They spelled it out themselves in plain English in the abstract:
"... longer duration ...",
"... placebo controlled ...",
"... larger number of patients ..."
These are crucial factors when assessing the results from a clinical trial, not some minor detail. What you don't seem to understand is that people here have been around long enough to see this happen more than once. Eric V told you that you needed to do your homework, but I guess you were too upset at that point to pay any real attention.
The Italian lithium study is such an obvious parallel that you just can't ignore it.
Long story short: A group of scientists from Pisa, Italy, had previously done some preclinical work with transgenic mice, with the aim to target protein clearing pathways. They put together a phase I randomized trial with low doses of lithium for early stage PALS. 44 patients in total. 16 got lithium and riluzole, the rest just riluzole.
And the results were amazing. Not a single patient in the lithium treated group died during the entire 15 months (vs. 29 percent in the control group). Almost all patients in the lithium group seemed to be progressing at a much slower rate, if at all. Take a good look at the graphs from this study:
You think anyone noticed this? Of course, hundreds and hundreds of PALS begged their doctors for lithium after these results were published. But there were several follow-up studies, including two futility trials in the U.S. and a single-blind randomized dose-finding trial in Italy. Result? Utter failure. One of the studies actually had to be stopped early because of unexpecedly high number of adverse events in the lithium treated group.
So what do you make of that? You think that Big Evil Pharma tried to kill the Lithium "success story" as well? I mean why not? Lithium is a very simple compound, already available and easy to obtain for various purposes. In that sense similar to sodium chlorite. Definitely no blockbuster for Big Pharma. But then again, you would have to be rather bold to suggest foul play when you also have a negative report from
this crowd...
Note that some critics, like Stan Appel, pointed out that the original Italian trial had been weakly designed (and therefore vulnarable to statistical artifacts). Then consider the "amazing" HBOT trial by University of Miami. 5 patients. 8 weeks. No controls. The design of that phase I trial would seem like a horrendous joke, even compared to the first lithium trial, if the purpose had been to evaluate efficacy. But it wasn't. They evaluated this later in the phase II trial (also underpowered, but not as bad as the first one). And it didn't work out. There's no big pharma collusion behind these conflicting results, just bad trial design. What part of this can't you accept?
I agree on one thing though. HBOT has not really been given a fair chance, considering the fcked up Miami trials. Doesn't HBOT sound like a possible DIY trial that could easily be tracked at PLM? It's a non-drug therapy so there are no preparation or dosing issues involved. Pricing example: Forty 50-minute sessions for $2500. I would be willing to make a money donation to any volunteer(s). Maybe others would as well?