I really want more information before I make judgement on this news release:
“Acupuncture beats drug to hot flashes: study“
But I already have a few flags.
The best outline of the study was at the hospital’s own press release (I could find no peer reviewed published data*, anyone care to point to it).
“Seventy of the 140 patients enrolled in the two-year study will be randomly assigned to receive acupuncture for 12 weeks. The other half will receive Effexor over the same time period. Data will be collected at quarterly intervals in the first year. Researchers will test the effectiveness of acupuncture for reducing hot flashes and if it has fewer side effects than Effexor.” – Henry Ford Health n.d
ZZ: Please note Reuters places the final included patients figure at 47 patients, but still has them split 50:50. Lots of drop outs and exclusions*, or did they just shortfall their expected enrolment.
Now the design almost seems well and good. Patients were selected for meeting criteria, such as having 14 or more flashes per day etc. But while patients are being randomly assigned, it’s not exactly blind* is it? You can’t really hide who your giving medicine too and who you are jabbing acupuncture needles into.
Additionally, where are the controls? There is no placebo* on either treatment. A good study would at least have a third group receiving a placebo version of Effexor. An excellent study would also use placebo acupuncture or at least a placebo CAM (complimentary or alternitive medicine – or “woo”). A mindblowingly overfunded mega-study would have groups receiving both treatments, and combinations of conventional and CAM treatments and conventional and CAM placebos.
Were the patients denied any other treatments while on this study? or after the treatment period, (acupuncture was given 12 weeks out of the 104)? Sometimes clinical studies comparing a new drug’s efficacy allow standard drugs to be used as well. Otherwise you are denying a patient ethical treatment. Sometimes that “standard drugs” used in addition to the treatments on trial may even be the drugs you drawing comparisons with. Perhaps the acupuncture group was taking Effexor or other drugs*. And perhaps in lower doses, explaining their lower levels of side-effects.
So, what exactly is Effexor? Well it’s the proprietery name for venlafaxine (Wyeth must be so happy about this free press). It’s an antidepressant, not an anti-hot flash medication. Now, while not its intended use, there is evidence that low doses of venlafaxine and other antidepressentscan effect relief during hot flashes , but it is not the standard treatment as the news reports are suggesting*. Mayoclinic’s page on hot flashes explains that hormones (oestrogen, progesterone) are what is recommended.
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Rx-ky business
16 06 2009Well, AFM called me up on the Insight post for painting my town¹ a little too apologetic for our phriends in Pharma (possibly due to some comments I made on this post of his, and these over at The Scientist, and also just today on Flickr…) .
So I guess I should make some self-apologetics, that my point has *not* been that Pharma is cute and cuddly and can always be trusted – c’mon they are industry – the wonderful Merck saga unfolds beyond just deceptive journals – this sort of awful ‘hit list’ language to “neutralise” and worse, “discredit”, critical doctors makes me cringe (and if you’re sick of hearing about Vioxx, you can get upset at Lilly’s innapropriate off-label Zyprexa marketing instead). There is nothing I can concoct to attempt to downplay the totally unethical nature of that sort of behaviour, to me it is indefensible. There are bad elements out there. Even if we rule the Vioxx shenanigans as an exceptional exception (which is the closest I can get to a defence) just take a look at the US statistics on Pharma fines and settlements made by over the last 9 years (and that just to the government, does not include private parties, class actions etc.)
Pharmaceutical companies are corporations. And yes, they are motivated by making money. And AFM is right, some guy in marketing will try to put that goal ahead of making quality medicines. But let’s remember that’s also what these companies are about making medicines. Medicines that help people. People do not get into this industry because they want to hurt people.
And that is where I start to get annoyed by anti-Pharma movements.
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