In Search of the Holy Grail

By Bill Benda, MD, FACEP, FAAEM

Photo by speckyfish2000 via Flickr, used under the Creative Commons License.

I sat on an NIH panel a couple of weeks ago in Washington, D.C. Our mandate: to determine which of a few dozen grant applications deserved, through purity of methodology and virtue of intent, to be awarded funding by a commercial enterprise whose name I cannot reveal.

In fact, I wish I could tell about you the subject of the grants, or the people who sat on the panel with me, or the amount of monies given away, or how we determined who got the cash. But the NIH is very, very adamant that nothing ever, ever leaks to the outside world on what transpired those two days. Non-disclosure forms are signed, warnings are given, and papers and discs are shredded after the proceedings are completed. I imagine there is a sophisticated surveillance system set up in Bethesda, MD, to watch our every step, and should I inadvertently write the wrong words in this blog, an alarm sounds on the east coast: NIH Central Alert! Reviewer violation! Activate liquidation team! And within the hour an ominous black Prius would pull up in front of my house and bespectacled men in trench coats would emerge.

But I digress from the topic of this article. My time on the panel did serve to reinforce one particular belief I have harbored over the past couple of decades as I have explored the world of scientific investigation – that research, for all of its academic and cultural value, is not health care’s Holy Grail. It is not representative of any irrefutable fact, it is not the courier of absolute truth, and it certainly is nothing close to purity of thought and action.

Now before those of you who spend most of your waking hours in academia start sharpening your ninja swords, let me state firmly that research itself is indeed the best tool we have at our disposal to differentiate reality from fiction in the clinical arena. But it is a fragile tool, and prone to breakage and misuse. And I do hold a touch of credibility on this particular topic - I have conducted and published two randomized control trials (one funded by NCCAM), and have been providing peer review to six medical journals over the past decade or so. So I can state with some authority one thing that I have never seen echoed in any journal, except perhaps on the editorial page or in a letter to the editor, and that is: All research is flawed, and likely quite badly flawed.

Lets take a look at the process of publishing a study, from the first inkling of an idea to the final inking on the journal page. Someone, somewhere, comes up with a hypothesis. After much thinking and mulling, the hypothesis transmogrifies into a research plan–usually in conjunction with other co-investigators–then into a methodology, complete with inclusion and exclusion criteria, plans for statistical analysis, recruitment, carrying out the study, collation of data, actual statistical analysis, final conclusions, writing of the paper, peer review by a journal, revisions as requested by said journal (and perhaps repetition of this step several times), publication of the article, reading and attempted understanding by the subscriber and, finally perhaps, incorporation into clinical use.

There are countless steps where bias and error can creep into the final findings, and this doesn’t take into account influence by industry if the piece happens to be on a pharmaceutical or other medical appliance. And speaking of pharmaceuticals (and supplements), the study usually recruits a narrow demographic of males between this age and that age with this clinical condition but not complicated by that clinical condition (exclusion criteria!) and then treats at a specified dose for a set period of time. And if the positive findings are somewhat higher than the placebo effect, that pharmaceutical (or supplement) is marketed to men and women from 18 to 88 with all sorts of confounding conditions and with each very diverse patient getting pretty much the same dosage. This is part of the reason why, say, hormone replacement therapy protected against heart disease last month, but increases heart attacks this month, while protecting against breast cancer last year, but thought to stimulate breast cancer next year, and on, and on.

OK, I’m going to back up once more and restate a very important point: Research is the best tool we have at our disposal to differentiate reality from fiction in the clinical arena! But it’s simply not as perfect as we, and our media, purport. As I tell my students, no research study, no matter how well done, is the truth; it is simply another finger pointing in the general direction of the truth.

So the next time that your organization wants to put research at the top of its priority list, consider… Wait a minute...

I need to go. A black Prius just pulled up in front of my house.

How Poppy Got Her Name and the Limitations of Evidence-Based Medicine

By Jacob Schor, ND, FABNO

Hamantaschen. Photo by stu_spivack via Flickr, used under the Creative Commons License.

Our dog Poppy was named on the 14^th day of the Hebrew month of Adar in the year 5765. It was Purim, the Jewish holiday that commemorates the deliverance of the Jewish people in the ancient Persian Empire from destruction by an evil advisor to the king, a story recorded in the Book of Esther. Our puppy was about 12 weeks old at the time and still unnamed. We had simply been calling her ‘puppy.’

Part of the celebration of Purim involves the making and sharing of pastries called hamantashen. These triangular shaped pastries traditionally contain fillings made of either poppy seed or prune. How far back the tradition of making them goes is unclear. The holiday of Purim itself has been celebrated for nearly two millennia. As both opium and prunes both originated in the general vicinity in which the Purim story occurred, one might assume the custom of eating hamantashen goes back equally far in time.

In our home, we take making hamantashen seriously. We actually own a special hand crank grinder designed just for crushing the poppy seeds to prepare the filling. And I must admit that my dear wife Rena Bloom makes the best hamantashen I’ve ever tasted.

One cannot, or at least should not, eat poppy seed hamantaschen alone. All poppy plant derivatives have, to a varying degree, the same effect on the intestines. They slow things down. Whether we are talking about opium, heroine, or just poppy seed filling, they all cause constipation.

Alternating the consumption of poppy seed hamantashen with prune filled hamantashen completely solves the problem. Prunes, as we are all well aware, have a laxative action. With ease, one can achieve a balance between the poppy and the prunes’ therapeutic actions.

Let me come back to the story of our dog’s name. Six years ago, during the feast of Purim, as we sat around the dinner table consuming the last plate of homemade hamantashen, my dear wife lifted her last fragment of poppy seed filled hamantashen into the air and declared, “I love poppy.” Our young dog, up to then who had only been referred to as ‘puppy’, assumed Rena was talking about her and came bounding over to us.

This memory came back to me as I was reading a soon-to-be-published study about prunes.

We may all know what eating too many prunes will do but, in truth, this is only anecdotal evidence and until recently an unproven fact. We live in the age of Evidence-Based Medicine (EBM) and according to the rules, we had no way to know whether the laxative effect attributed to prunes was real or merely a placebo effect. That worry is over.

A paper written by researchers from the University of Iowa College of Medicine will be published next month, April 2011, which will tell us that prunes really do help constipation.ⁱ

The researchers fed 40 constipated test subjects either prunes or psyllium powder daily for three weeks in amounts that supplied six grams per day of fiber. After three weeks, the subjects took a week off and then switched therapies. During the course of the experiment, the subjects kept careful diaries, tracking all sorts of details about bowel habits that we don’t really need to discuss here. Suffice to say that when the data were collated and analyzed, it was abundantly clear that prunes had a significant effect in doing what we all know they do.

This was not a perfect study by any means. It was only a single-blinded placebo controlled trial, not the hallmark double-blinded trial that modern medicine considers the gold standard. There were only 40 subjects, 37 of whom were female. One might easily argue that this study is insufficient evidence to base clinical decisions upon.

Still, it may be the first study that clearly demonstrates that prunes do what everyone has known they do since the Book of Esther was written in the third or fourth century BCE.

This points out the weakness of our current reliance on Evidence-Based Medicine (EBM). If we adhere faithfully to the tenets of EBM, we would be obligated to suggest sodium docusate to relieve constipation, a substance that the drug manufacturers have proven works. Or if we insist on a more natural approach, we might consider psyllium, a fiber that research suggests may work better than sodium docusate.ⁱⁱ Up until now, prunes were not evidence-based medicine; they were just food. Now we can say they work better than either of the other two therapies, at least in women.

When we are dealing with serious pharmaceutical agents, it is nice to have evidence that they are beneficial. That’s because they often come with unwanted side effects. It’s nice to know that they will do what they promise. Perhaps we don’t need to require the same degree of caution with simple food therapies such as prunes. And especially with things that have so obvious and well-acknowledged action, we may not need double-blinded, placebo-controlled randomized trials.

Some times we need to preserve a bit of common sense in the practice of medicine.

___
ⁱ Attaluri A, Donahoe R, Valestin J, Brown K, Rao SS. Randomised clinical trial: dried plums (prunes) vs. psyllium for constipation. Aliment Pharmacol Ther. 2011 Apr;33(7):822-8.


ⁱⁱ McRorie JW, Daggy BP, Morel JG, Diersing PS, Miner PB, Robinson M. Psyllium is superior to docusate sodium for treatment of chronic constipation. Aliment Pharmacol Ther. 1998 May;12(5):491-7.

The Circle Game

By Bill Benda, MD, FACEP, FAAEM
2011 Naturopathic Champion Award Winner

Photo by Helen White via Flickr, used under the Creative Commons License.

So. It’s time to find a topic for the next edition of the Physicians Who Listen blog. I know because a week or so ago I received the gracefully worded request from Matthew Santoro, the Communications and Media Associate of the AANP, gently reminding me that Friday is the deadline.

And Friday came and went, bringing to my consciousness the fact that my Integrative Medicine: A Clinician's Journal editorial was also overdue by two weeks, and the Journal of the ACM deadline is only a week or so away, and that my mind is and has been a total blank. It’s not writer’s block—I could blather on for hours about various idiocies inherent to the conventional health-care system or how the emerging theory of basing physician pay on patient satisfaction would be the clinical kiss of death in the Emergency Room.

Nope. I’ve come to the sad conclusion that I really have nothing left to say about the field of integrative/holistic/naturopathic medicine that I haven’t said before, and others’ oft-employed editorial option of describing how the purity of our natural therapies reminds me of the first breath of Spring just isn’t my style. And of course I still do not have the courage to remark on Karen Howard’s leaving or how totally predictable our major conferences have become, as it may hurt some people I still like and admire (but stay tuned).

So I am stuck with nothing to say, and therefore have no choice but to talk about why there is nothing to say. Primarily because this grand experiment of ours is no longer grand or an experiment, at least to me, but simply another chapter in the Big Book of Health-care Tales. Not to sound a discouraging note—this conclusion is simply evidence of an inevitable step in the evolution of all great ideas. First the excitement and purity of discovery (this is so cool and makes so much sense), followed by the heady rise against all odds (from ridicule and ostracization (no, its not a word) to the emergence of Weil, Ornish, NCCAM, IOM reports, and countless billions spent out of pocket), all highly seasoned with the seductive flavor of danger (what if we can’t ever make a living doing this? What if we can’t even find a job?).

But then, with every “victory” comes the inevitable price.

“We can’t prove all of this because the reigning research paradigm was created for reductionistic trials” has become “we must make research a priority because it’s the only way the reigning paradigm will accept us.”

“Should we even consider accepting insurance reimbursement?” has transmogrified into “naturopaths are now on the federal CPT committee!”

Our pioneers are now not only writing even more books but also selling their household products online and hosting daily television shows that remind me of a cross between Oprah and Phil Donahue.

And if I get one more “Dear Bill, this is a personal note to you, and I hope you will join me in an exciting seven-day program to cure you patients and increase your income by 25%,” I’ll have to reach for the Nux Vomica.

It ain’t what it used to be, folks, and I guess that can be considered a good thing in today’s social media/newest/greatest culture. It means we’ve arrived. But it makes me want to leave again, to find whatever the next cutting edge is, the one that will challenge the integrative/holistic/naturopathic model I helped create. To feel the resistance rather than the acquiescence, to worry again that I may not really have a clue as to what I am doing.

I want some new paradigm, fresh idea, brilliant concept - one whose purity will remind me of the first breath of Spring . . .