Study: Stabbing ≈ relief?

23 09 2008

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.

Don’t miss the flip-flop after the break.

Ah, someone savvy will point out I’m caught out twisting the facts just then. This study focused on breast cancer patients. Hormones are a bad idea if you are at risk at breast cancer (I’m fairly sure having breast cancer is a risk factor). Mayoclinic again:

Many doctors now consider these antidepressants the treatment of choice if you have troublesome hot flashes and can’t take hormone therapy. However, these medications aren’t as effective as hormone therapy for severe hot flashes and may cause unwanted side effects, such as nausea, dizziness, weight gain or sexual dysfunction.

[At this point, I’ll point out, it really is no surprise that acupuncture does have side effects associated with these drugs. As mentioned earlier, depsite my speculation into possibilities, the acupuncture group does not appear to be taking drugs (or even placebo drugs) so have no reason to suffer from drug-induced side effects.* In other words you need something capable of causing an effect before you even consider having side effects.]

So, admittedly, despite no FDA approval for this particular condition, perhaps venlaflaxine is standard care for this subgroup of patients. But that level of specificity is not the impression I’m getting from press releases. I’m getting something more like : acupuncture is better than a drug ZOMG acupuncture vs breast cancer FTW – ummm, no, acupuncture has been shown to be just as effective as a second rate treatment alleviating a general menopausal condition for those women who can not take the much more effective standard treatment available due to complications.

My last point I want to make was why was this study even being considered. Does the Susan G. Komen Breast Cancer Foundation have just wads of cash to throw around (oh, “$1billion invested to date“, I guess they do). Even we ignore the design flaws I’m seeing (which may be unfounded as they are only media reports) – on what basis was it thought that acupuncture could actually do something. The hospital press release as-matter-of-fact-ly states, “Acupuncture releases endorphins in the body that may affect opioid levels” – this looks like cherry-picking* one explanation of several that matches the one you like.

Despite this “positive” result, could a-quarter-million dollars have been better spent helping actual drugs get developed? Or am I part of the big Pharma conspiracy?

Again: links to peer review material for clarification are welcome.

*marks the flags (total = 6½?)




3 responses

24 09 2008
Bruce McIntire

Thanks for posting the article, was certainly a great read!

30 09 2008

I else have read once 🙂 , very fascinating and interesting article.
Thank you Author. P.S Forgive for my bad english

11 10 2008
One world, many views? « It’s Alive!!

[…] the nonsense are people who should know better; like atheists, scientists and nurses. This is how we can get nonsense acupuncture heals breast cancer studies in the press…  […]

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