The pregabalin study by Crofford was looking at subjective outcome parameters like pain (primary endpoint of the study has been a reduction on the pain numeric rating scale [range 0-10] of at least 50%), but the study didn't adjust for the subjective, confounding parameters like dizziness. 15% of the placebo group patients suffered from dizziness, in the 450 mg verum group of patients (only group that had significantly more patients on a reduction of 50% in the pain scale) about 65% suffered from dizziness, however.
I see an enhanced placebo effect, that the statistics used, cannot detect. Moreover, even in the significant verum group only less than 30% reached the 50% improvement level.
(Somehow I worked ideas out that I already told you about on this blog: http://rheumatologe.blogspot.de/2011/12/what-is-lacking-in-fibromyalgia-studies.html )
04.04.2014:
I've just took the data of the study and put it in chart to compare efficacy with just one side effect (dizziness - in the chart "Schwindel"). Schwindel is the German word for dizziness/vertigo, but it also means fraud. Efficacy rises slowly with increasing the dosage of pregabalin, but the percentage of dizziness rises dramatically.
Very clever, Herr Doktor. I've stolen the Schwindel for my 'Bad Medicine' post, thanx!
ReplyDeleteYou're welcome! And it has been both fun and gain to look at your homepage: http://fnmyalgia.com/.
DeleteThis stopped being funny when a member of our online support group blacked out at the wheel for a second time. Fat, dumb(-ed down), and (un) happy has gone on too long - which is why lawyers associated with the ACCC's anti-competitive action against Pfizer over atorvastatin just received some extra insight on their research ethics.
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