Respectful Insolence

I’ve railed on more than one occasion about how much I detest science by press release. For one thing, it bypasses the peer review process and reports results directly to the public, which to me is a strike against any study. Indeed, releasing results by press release or using a press release to tout a study before it’s even published is, as far as I’m concerned, quite dubious, and when I see it I’m automatically way more suspicious of whether the study represents good (or even OK) science.

One form of science by press release that can be a bit more subtle than, say, the cold fusion guys holding a huge press conference to claim that they’ve discovered how to do something that scientists have been trying to achieve for decades, is the press release touting a study that is either ongoing or hasn’t been published yet. Such press releases can serve a valid purpose, for example to encourage recruitment to an ongoing clinical trial or to tout cutting edge research, but it’s very, very easy for such press releases to come across as a bait-and-switch or as a report of success that may not be there because the study isn’t done yet. I came across just such an example of this yesterday in a press release entitled Acupuncture may hold promise for women with hormone disorder. Here’s how it started:

Charlottesville, Va., Sept. 3, 2008 – Getting pregnant with her first child was difficult, but when Rebecca Killmeyer of Charlottesville, Va. experienced a miscarriage during her second pregnancy, she wasn’t sure if she would ever have another baby. When she decided to enter a study testing the impact of acupuncture on women with polycystic ovary syndrome (PCOS) at the University of Virginia Health System, she came out with a miracle.

“To our great surprise we were blessed with a third pregnancy during the PCOS study,” said Killmeyer. “I’m absolutely certain the acupuncture treatments helped me ovulate regularly, which allowed me to become pregnant.”

Lisa Pastore, assistant professor of obstetrics and gynecology at UVA Health System and principle researcher of the study, was hoping for results like this. Her goal has been to help women with PCOS have regular menstrual cycles. PCOS causes a hormonal imbalance, interfering with ovulation and ultimately, fertility. With several women in the study reporting pregnancies, Pastore believes that acupuncture could be an important alternative, non-drug therapy for women with this disorder.

“Over the last year we have seen women who never had a regular menstrual cycle start having regular periods. We can also boast several pregnancies since the study began,” said Pastore. “Now we would like to recruit more people to the study in order to complete the study. It is important for research to have enough participants to ensure that the results are scientifically credible and not due to chance.”

Scared and skeptical was how Killmeyer described her initial feelings towards the experimental treatment, but soon her worries gave way to relaxation.

“When I saw those tiny little needles coming at me I thought to myself, ‘I didn’t sign up for this!’ but I tried it and after a few minutes I was asleep on the table,” Killmeyer said. “The sessions were completely refreshing after awhile.”

After I had seen that headline in my EurekaAlert! newsfeed and then read the press release, I thought Aha! Possible blog material. Let’s go and find the actual study to see if there’s anything to it. So I went looking for the study. After all, I’ve analyzed a number of acupuncture studies before. So I searched PubMed for publications by Lisa M. Pastore.

To my surprise, there was no publication under her name about using acupuncture to treat polycystic ovary syndrome.

My next thought was that maybe it was presented as an abstract or published in a journal not indexed by PubMed. So I searched Google Scholar to see if I could find any evidence of that this study had been published. Nope. Nothing. Nada. Zip. So I did a little more general Googling. The first thing I found was Dr. Pastore’s faculty webpage. I also found other press releases. For example, this one appears to be the one announcing the study. That’s perfectly fine; universities often send out press releases when one of their investigators scores an NIH grant. I have no problem with that. In fact, if (no, when!) I score my next grant, I hope my university will send out a press release about it. Unfortunately, this particular press release was painful to read:

Charlottesville, Va., Nov. 17, 2006 - Can acupuncture normalize hormones in women with irregular periods? The ancient Chinese therapy has long been thought to cure everything from cancer to addictions. Researchers at the University of Virginia Health System have been studying the possibility that acupuncture could stabilize the hormones of women with polycystic ovarian syndrome (PCOS) in the first federally funded acupuncture study at the Medical Center.

PCOS affects 5 percent of reproductive age women. The syndrome is characterized by a hormonal imbalance, interfering with ovulation and ultimately, fertility. Some women with PCOS have small cysts on their ovaries. Others may not have cysts, but may have symptoms such as heavy or irregular vaginal bleeding, male-pattern hair growth and acne. Insulin resistance and pre-diabetes also can occur.

While there are many traditional drugs and therapies that manage this syndrome, acupuncture may succeed in regulating hormones and curing the symptoms of PCOS. In Asian medicine, practitioners believe that everything in the universe forms a unified whole made up of two opposing and complimentary forces called Yin and Yang. Illness is thought to be the result of those forces being out of balance. For the menstrual cycle, that delicate balance of Yin and Yang lies within the kidney meridian. By pricking certain pressure points affecting this region with tiny needles, researchers hope to learn whether acupuncture restores this balance.

Score another one for the Academic Woo Aggregator! The above press release is some serious woo. It has everything you could want in good woo: references to “Asian” or “Eastern” medicine (as opposed, I suppose, to that evil, reductionist, Western, allopathic medicine); a full buy-in to prescientific concepts of Yin and Yang, which, let’s face it, are philosophical and religious concepts, not scientific concepts; and a highly implausible treatment and mechanism. But, wanting to give the benefit of the doubt to Dr. Pastore, I initially assumed that this credulous press release was something put out by the P.R. department at the University of Virginia. Then I read this:

According to Dr. Lisa Pastore, assistant professor of obstetrics and gynecology at UVa Health System, hormones normally go up and down throughout women’s menstrual cycles. In women with PCOS, the hormone levels stay fairly flat.

“In western medicine we tend to think about treatment in terms of making things go up or down and stay there, such as medication to bring down blood pressure or medication to bring estrogen levels back up after menopause,” Pastore said. “But with PCOS patients we want to make those ups and downs happen. We want women to experience their natural cycles and get their rhythm back.”

Ugh. More with the “Western” medicine stuff. Allow me a brief digression here: There is no such thing as “Western” or “Eastern” medicine or “alternative” medicine. There is either medicine that has been shown by science to be effective; medicine that has been shown to be ineffective; and medicine whose efficacy has not yet been demonstrated one way or the other.

There, I feel better now. Back to the topic at hand.

As I said before, I’m not opposed to press releases to announce a study or the award of an NIH grant. The above press release, for all its credulousness and woo, is nothing more than the natural consequence of the NIH funding pseudoscience. When that happens, there really is little reason for universities or the press not to treat press releases about CAM studies the same way they treat any other grants their faculty may obtain that are funded by the NIH. Also, the above press release didn’t really describe results. It was more or less a straight announcement, my dislike of its credulity towards pseudoscience notwithstanding. Again, if the NIH is going to fund stuff like this and accept a rationale like that, then there’s no reason why universities shouldn’t include that rationale in press releases. That’s one reason why I’ve been so disturbed at the sorts of studies that the National Center for Complementary and Alternative Medicine (NCCAM) funds.

Curious, I headed on over to ClinicalTrials.gov to find the study and see how it was designed. As I’ve said before, I used to think there was something to acupuncture; that is, before I actually started reading the scientific literature on acupuncture in depth. One thing I did learn is that the best methodology for studying acupuncture, if study it you must, is to use a double-blinded design. To achieve this the use of sham acupuncture, which involves the use of “sham” needles that do not actually penetrate the skin, the best of which are so well-designed that even the practitioner can’t distinguish them from real. This study appears to use sham acupuncture, although the exact nature of the sham is not described. However, the study is described as “triple-blinded,” which usually means that the researcher, patient, and the person administering the therapy are blinded. (Actually, I don’t like the term “triple-blinded,” because it usually goes without saying in a double-blind study that the researcher and patient are blinded to the.) So, on the surface, this study looks as though it’s probably pretty well-designed, although without details you just can’t tell for sure. Of course, once again, the physiologic mechanism by which acupuncture might modulate hormone levels to correct the symptoms and signs of PCOS is, as far as we can tell, nonexistent, but that’s just par for the course for most CAM therapies.

So what bothered me about the original press release? Certainly there was the dwelling on a single anecdote that made it sound as though acupuncture definitely resulted in Rebecca Killmeyer’s pregnancy. Look at this part of this week’s press release in particular:

Killmeyer learned of her PCOS in 2005. Over the past five years she did not have regular, monthly periods. One month after she started acupuncture treatments she got a period and for the next three months, they continued.

“I had finished all my acupuncture treatments and was in the end stages of the study when I became pregnant,” Killmeyer said. “We had already scheduled our follow-up appt with our fertility doctors when we found out we were pregnant.”

If the study was truly blinded, how did Mrs. Killmeyer know she was getting “true” acupuncture rather than sham acupuncture? Wouldn’t it be ironic if she were in the control group? I’m guessing that, if she’s finished the study, her case was probably unblinded–to her at least. It’s not uncommon to let patients know which group they were in after they have completed the trial. However, having interviewing her for a press release risks unblinding her case to everyone. I just hope the study was designed well enough that the data management system keeps investigators from linking her patient number to her name, something that’s not easy because her clinical history as described in the press release could allow investigators examining the evidence to make an educated guess about her.

In the end, though, the real purpose of this press release appeared to be to recruit more patients to this study. Indeed, the press release says as much. In general, there is rarely anything wrong with trying to promote a study that’s having poor accrual by issuing a press release. However there are some things that should not be in such a press release. This particular release crossed the line when it presented what was, in effect, a glowing testimonial not unlike other testimonials for “alternative” medicine therapies. In doing so the press release strongly implied that acupuncture could do the same thing for patients who might enroll on the study, holding it out as a “carrot” to attract potential recruits. That’s definitely going too far.

In the meantime, I’ll wait for the results of this study to come out to see if it shows anything and whether its conclusions are justified by its methodology and results. I suspect, however, that I’ll wait a long time.

Comments

  1. #1 D. C. Sessions
    September 5, 2008

    Why do I get the impression that Dr. Pastore has had quite a few press releases announcing studies, despite the fact that none of them seem to have progressed to published results?

    Another reason to have profound doubts regarding meta-analyses.

  2. #2 Bryan
    September 5, 2008

    There is another side to the press release thing that you didn’t mention, and one which I personally fear, is media inaccuracy. It’s happened twice in my career despite the fact that we went through a lot of hoops trying to get the info out accurately and in a form easy to understand.

    Once, I was quoted as stating “Hepatitis A is autoimmune, while hepatitis B & C are viral in nature”. Our press release had a point-form introduction which read:

    -Hepatitis can be caused by viruses, such as the hepatitis A, B and C viruses.
    -Hepatitis can also be a result of autoimmunity, when a patients own immune system attacks their liver.

    How they got HepA is autoimmune from that I’ll never know.

    The second time, the media reported we were “curing HIV”, when in fact, we were testing GM-CSF as a hematopoietic “booster” for HIV patients.

    After those experiences, I don’t believe a single thing I read in the media about medicine anymore…

  3. #3 daedalus2u
    September 5, 2008

    I see PCOS as a natural regulatory response to high stress mediated through low NO, so it is something that should be highly amenable to any placebo including acupuncture. The elevated androgen levels are caused by low NO (which disinhibits the cytochrome P450 enzyme which is the rate limiting step in androgen synthesis) and serve to increase androgen sensitive body hair to increase the niche where the bacteria I am working with live. Hirsutism thus causes increased NO/NOx via this feedback mechanism (provided ammonia oxidizing bacteria are present on the skin).

    The spectrum of other symptoms associated with PCOS is consistent with low NO; including hypertension, metabolic syndrome, insulin resistance, obesity, elevated asymmetrical dimethyl arginine, elevated C-reactive protein, increased cardiovascular disease. The main drug used to treat PCOS does seem to normalize to some extent the NO physiology of hyperandrogenized ovaries in a mouse model of PCOS. (open access)

    http://molehr.oxfordjournals.org/cgi/content/full/12/8/475

    I see PCOS as a “normal” mechanism for regulating female fertility under conditions of high stress. A time of high stress was a bad time to have a baby (in “the wild”), better to put it off until times are better. Evolution configured reproductive physiology to do so.

    Women with PCOS if they become pregnant are at high risk for preeclampsia, hypertension, gestational diabetes, miscarriage and preterm birth. I think these are also mediated through low NO.

    I think this is why the Relaxation Response and other relaxation and meditation techniques are useful in helping women to get pregnant. Their NO/NOx physiology has to “be right” for their bodies to undertake what was in “the wild” a risky endeavor. Before modern obstetrical care with antibiotics, the maternal death rate is on the order of 1% per live birth. Any type of relaxation technique, or stress reduction will help by increasing basal NO levels.

    I agree, press releases are a poor way to disseminate scientific results (not that this sounds like a very scientific result). If PCOS is mediated through low NO, any placebo will work, raising the NO level by stress reduction will work, raising the NO level by restoring the bacteria I am working with will work better than anything else because it restores an important and natural pathway for the regulation of NO/NOx physiology which some people have lost (provided the person with PCOS doesn’t have a biofilm of these bacteria).

  4. #4 Zoo Knudsen
    September 5, 2008

    “Scared and skeptical was how Killmeyer described her initial feelings towards the experimental treatment, but soon her worries gave way to relaxation.

    “When I saw those tiny little needles coming at me I thought to myself, ‘I didn’t sign up for this!’ but I tried it and after a few minutes I was asleep on the table,” Killmeyer said. “The sessions were completely refreshing after awhile.”

    Isn’t it funny how every CAM testimonial involves a now true believer who was at first skeptical. Cleverly designed these anecdotes are, providing excellent (to them) ammunition for believers to unleash when discussing such topics with skeptics. Also, if she was able to see the needle coming wouldn’t that dispatch her blindedness. Or was it a sham tecnique involving a needle that draws back into the hub like a stage knife I wonder.

  5. #5 Barbara
    September 5, 2008

    The first thing I try to teach parents looking for treatment for their children is to question the source of their information.*

    Mega agreement with you, Orac, on the problems with media dispersion of ‘research’.

    *See my page called “Reading Reseach”.

  6. #6 sirhcton
    September 5, 2008

    Forgive my ignorance, but would not the study also need to include a group of women who received no treatment? Does PCOS remain permanent or are there periods (so sorry) when a near normal cycle might return? Does the study try to control for such possible confounders?

  7. #7 Bardiac
    September 5, 2008

    She saw the needles? So much for blind, no?

  8. #8 Jim
    September 5, 2008

    The study could easily have been designed such that all subjects saw the needles.
    Why did she fall asleep during the treatment? Was she sediated? Is that normal for acupuncture? Guess we will have to wait for Dr. P. to put out to find out.

  9. #9 DT
    September 5, 2008

    So, according to Dr Pastore’s faculty webpage release:

    “In Asian medicine, practitioners believe that everything in the universe forms a unified whole made up of two opposing and complimentary forces called Yin and Yang.”

    (sic)

    I now have a disturbing vision of Yin challenging Yang to a duel:

    Yin (throwing gauntlet on ground): “You wish to have a fight, beautiful?”
    Yang (blushing): “Why, thank you! Any chance of a roll in the hay instead, you gorgeous hunk?”

  10. #10 Aaron Avalos
    September 5, 2008

    We need you to open an investigation on these matters immediately to prevent further violations of basic and human rights violations.

  11. #11 scicurious
    September 5, 2008

    You know, they actually did a Sex and the City episode (or perhaps it was the movie), where one of the characters undergoes acupuncture for fertility. And it worked for her in the movie. Perhaps she entered the study because of that.

  12. #12 Charlotte
    September 5, 2008

    Jim: I had a few sessions of acupuncture last year. (The government gave me money to spend on woo, so I tried several things. Stop looking at me like that…) My sessions lasted an hour, most of which you spend lying on a couch in a quiet room. Apart from getting needles stuck in you it’s quite relaxing, I nearly drifted off a couple of times and I don’t normally sleep well.

  13. #13 Militant Agnostic
    September 6, 2008

    Zoo – That is exactly how the best sham acupuncture works – the needle retracts into the handle like a stage knife. That way both the practioner and the patient are blinded.

  14. #14 Zoo Knudsen
    September 6, 2008

    What are the odds a true believer like this would have designed a study incorporating the best sham acupuncture methods?

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