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I really want more information before I make judgement on this news release:
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.
Don’t miss the flip-flop after the break. Read the rest of this entry »
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Tags: acupuncture, anti-depressant, bioethics, breast cancer, cam, clinical study, drugs, effexor, ethics, health, henry ford health, hormones, hot flush, medication, medicine, news, placebo, reuters, side effects, traetment, unanswered, venlafaxine
Categories : From the Newsdesk, In Good Health, MediaWatch, Miss Information, The C Word, Ultimate Showdown