Respectful Insolence

I don’t recall if I’ve ever mentioned my connection with the Cleveland Clinic Foundation (CCF). I probably have, but just don’t remember it. Longtime readers might recall that I did my general surgery training at Case Western Reserve University at University Hospitals of Cleveland. Indeed, I did my PhD there as well in the Department of Physiology and Biophysics. Up the road less than a mile from UH is the Cleveland Clinic. As it turns out, during my stint in Physiology and Biophysics at CWRU, I happened to do a research rotation in a lab at the CCF, which lasted a few months. OK, so it’s not much of a connection. It was over 20 years ago and only a few months, but it’s something that gives me an obvious and blatant hook to start out this post, particularly given the number of cardiac patients I delivered to the CCF back in the early 1990s when I moonlighted as a flight physician for Metro LifeFlight.

Obvious and clunky introduction aside (hey, they can’t all be brilliant; so I’ll settle for nauseatingly self-deprecating), several of my readers have been sending me a link to a story that appeared in the Wall Street Journal the other day: A Top Hospital Opens Up to Chinese Herbs as Medicines: Evidence is lacking that herbs are effective. I also noticed that Steve Novella blogged about it and was tempted to let it pass, given that I had seemingly lost my window, but then I realized that there’s always something Orac can add to a post, even after the topic’s been blogged by Steve Novella: Insolence. So here we go. Besides, if this article truly indicates a new trend in academic medical centers, it’s—if you’ll excuse the term—quantum leap in the infiltration of quackademic medicine into formerly reputable medical centers. It’s a depressing thing, and it needs to be publicized.

Of course, the Cleveland Clinic has long been a poster child for the evils of quackademic medicine. Indeed, take a look at its Center for Integrative Medicine. Offerings there include acupuncture, chiropractic, something called “holistic psychotherapy,” reiki (of course!), and Chinese herbal therapy. I frequently use the CCF’s woo-ful description of reiki using the “universal life source energy” to heal patients as an example of the utter mystical-religious nonsense that has infiltrated once-proud medical institutions, along with other prime examples carefully curated from selections from other quackademic academic medical centers. So, naturally, it’s not surprising that the CCF would be a “pioneer” (if you can call it that) in bringing traditional Chinese herbal medicine right into the heart of an academic medical center.

The WSJ article isn’t too bad in that it’s not overly credulous and, as the title even proclaims, notes that there isn’t much evidence to support the use of herbal medicine. Of course, herbal medicine is among the most plausible of “complementary and alternative medicine” (CAM) or “integrative medicine” for the simple reason that, for an herb to have a medical effect, there must be a chemical (or chemicals) in it that have pharmacological activity. In other words, there have to be drugs in them thar plants! That’s why pharmaceutical companies and the NIH are so interested in screening natural compounds for chemical properties and pharmaceutical activities that might indicate that they could function as useful drugs. True, much of the low-hanging fruit in terms of naturally occurring chemicals that can make useful drugs has been found and turned into drugs, but there are likely to be lots more where that came from. It just won’t be as easy to identify and characterize them as it was in the past.

As I’ve also described many times and Steve Novella mentioned in his post, the problem with herbal medicines is that they are adulterated drugs (or, as Steve put it, “dirty” drugs). They are not pure. It’s almost impossible to control lot-to-lot consistency with respect to content of active ingredients, given how location, weather, soil conditions, rainfall, and many other factors can affect how the plants from which the medicines are extracted grow and therefore their chemical composition. Let’s just put it this way. It’s much safer and more predictable to administer digoxin to a patient who needs its activity on the heart than it would be for the patient to chew on some foxglove leaves. Given digoxin’s relatively narrow therapeutic window (the difference between the doses needed to produce therapeutic effects and the lowest dose that will cause significant toxicity), that’s critical. There are lots of herbs that can cause significant toxicity, such as Aristolochia, which can cause kidney damage; kava, which can cause liver toxicity; and many others.

The reason physicians moved away from herbal medicine to pharmaceutical drugs is for predictability. Purified active components have a more predictable action because the amount of drug is tightly controlled and known to a very precise degree, while impurities are kept to a minimum. Moreover, these drugs can be combined with various inactive agents to control how fast they are absorbed into the bloodstream, thus providing another level of control. All of these characteristics make the drugs much more predictable than any drugs still contained in dead plant matter. None of this even takes into account the widespread problem with contamination of herbal remedies with heavy metals, such as lead or even arsenic. It’s such a problem that a particularly obnoxious supporter of quackery, has started trying to “distinguish” himself and his supplements from the competition by setting up a lab, measuring heavy metals in his competitors’ products, and then periodically publishing scare stories about “contamination” of various supplements and herbal products. (Yes, I’m referring to Mike Adams.)

So what, exactly, is the CCF doing? Let’s take a look at the patient vignette that begins the WSJ article:

Christina Lunka appeared nervous and excited as she sat in the Chinese herbal therapy center recently opened by the Cleveland Clinic.

The 49-year-old had been to many doctors seeking help for ongoing issues that included joint pain and digestive problems. Now the Kirtland, Ohio, resident was hoping to find relief through herbal remedies.

“Do you have something for inflammation?” Ms. Lunka asked herbalist Galina Roofener during a one-hour consultation.

“Absolutely,” responded Ms. Roofener. “This is for pain, for digestion, for inflammation, all of the above,” she said, handing Ms. Lunka a bottle with capsules of an herbal combination called Xiao Yao San, which translates as free and easy wanderer. The capsules include about eight different herbs, including licorice, mint leaf and white peony root.

This is nonsense. I’d bet a dollar (to steal a cliche) that Ms. Lunka has no solid evidence to support any of these claims. It’d be among the safest of bets, particularly given that this isn’t even a single herb she’s talking about. It’s a bunch of herbs all ground together. Even Dr. Josephine Briggs, the director of the National Center for Complementary and Alternative Medicine (NCCAM), whom we’ve discussed many times before, is quoted in this article characterizing the “evidence base for these approaches using modern rigorous methods of randomized trials” as “quite thin,” which is an understatement. Surprisingly (to me at least) she also apparently admitted that, although NCCAM is looking at the basic science of some herbal products, it is currently not funding any efficacy studies involving humans (i.e., randomized clinical trials) of herbal remedies right now. If NCCAM isn’t even funding clinical trials of herbal medicines, they really must not be showing any promise lately. Actually, they aren’t, and haven’t been for quite some time. There are a number of trials now showing that various herbal remedies thought to be very promising don’t actually work, such as ginkgo biloba for memory, saw palmetto for benign prostatic hypertrophy, or black cohosh for menopausal symptoms.

It’s also some good money. Consultations are $100, and followup visits are $60. True, many visits to real doctors cost more, but in most cases insurance covers them, minus a copay, with all the paperwork that’s required. This sounds as though it’s pure cash on the barrelhead. Add to that the cost of a month’s supply of herbal remedies ($100), and it sounds as though the CCF could easily turn this clinic into a pretty nice profit center, after a slow start. The practitioner, Galina Roofener, is a graduate of the East West College of Natural Medicine in Sarasota, which is largely a school of acupuncture and traditional Chinese medicine (TCM). It seems a bit confused about what TCM is, though. Under a section of its website entitled What is traditional Chinese medicine? it lists electroacupuncture (who knew they had sources of usable electricity in ancient China?), biopuncture (yes, biopuncture), and homeopathy. Who knew? Maybe Samuel Hahnemann was Chinese.

In any case, Roofener worked at clinic called Asian Therapies Acupuncture Clinic before taking a job at CCF. All that’s there now is a message describing how she sold her practice and moved to Cleveland to work for the CCF. However, the Wayback Machine of Archive.org reveals what the website looked like in 2011. There, I found a number of interesting things. Unfortunately, even many of the Archive.org pages are gone, but the titles live on, titles touting the quackery that is thermography for breast cancer, acupuncture for the flu, and lots of evidence that Roofener used homeopathy, which is not surprising given that she’s a naturopath as well, apparently. (Her LinkedIn page also confirms her use of homeopathy.)

Deceptively, Roofener is required by law to invoke the quack Miranda warning as…well, I’ll let the WSJ article explain it to you:

Ms. Roofener’s license doesn’t allow her to claim she treats diseases, a Cleveland Clinic spokeswoman says. She can’t say that Chinese herbs will treat colitis, for instance, but she can say that she can stop diarrhea and pain. She cannot treat arthritis but can alleviate joint pain, the spokeswoman says.

And:

At the Cleveland Clinic’s herbal center, new patients are given a one-hour consultation that may include a battery of questions (How’s your sleep? Body temperature? Ringing in your ears? Headaches?), a physical examination of the tongue, and the traditional Chinese method for pulse-taking (three fingers on each wrist to check different pulses corresponding to various organ systems). They are asked to sign a waiver acknowledging that “herbal supplements are not a substitute for a medical diagnosis.”

Clearly. Still, in another recent story about Galina Roofener and the herbal clinic at the CCF, Roofener is quotes thusly:

The center doesn’t take walk-ins and primarily sees patients with conditions that Western medicine has, for whatever reason, failed to remedy. “For something like acute pneumonia, Western antibiotics may be faster and more cost-effective,” says Roofener. “But if someone has antibiotic resistance, we can strengthen their immune system.”

Egad! “Strengthen the immune system”? Seriously? That’s one of the number one quack claims, regardless of what the quackery is!

Yes, as Steve Novella noted, the CCF is out-and-out admitting in the quack Miranda warning on its consent form for its herbal medicine clinic that the TCM diagnoses Roofener is making and the herbal remedies she is prescribing to treat them are not real medical diagnoses and not real medicine. That’s a staggering admission for an academic medical center to make, that it is offering to its patients medicine that is not real medicine, a system of diagnosis that is not a science-based system of diagnosis. Worse, its physicians are actually referring patients to this clinic, even though they know that there’s no real evidence that it works. For example:

Maged Rizk, a gastroenterologist at Cleveland Clinic who referred Mr. McGeehan, says Chinese herbal medicine is still being critically evaluated. “In the past it wasn’t even considered seriously,” Dr. Rizk says. “At this point there is a thinking, ‘Some of the things we’re doing now aren’t very effective. Should we really be looking at alternatives a little more seriously?’ I think the verdict is still out,” he says.

So, basically, Dr. Rizk seems to be arguing that because current science- and evidence-based treatments for some conditions don’t work as well as we would like we should try treatments with no evidence to support them.

I think I know what’s going on here. I could be wrong, but it sure smells like it. Basically, what we are talking about here are patients with chronic conditions, particularly conditions causing chronic symptoms (there is, for instance, a patient in the story who suffers from chronic nausea), that are not well controlled or well treated with current science- and evidence-based medicine. Understandably, doctors become almost as frustrated as patients when they can’t alleviate their patients’ symptoms. They feel powerless. It’s not surprising that there is a strong temptation to fob the patient off on someone else. It’s also very easy—seductively so—to rationalize a referral to someone like Roofener based on the rationale that maybe she can do something. And if she can’t at least the patient will be someone else’s problem for a while. I know, I know. That’s harsh, but it’s a bit more complicated than that. Few doctors actually want to give up. It’s just that, given an “out” like Roofener’s clinic, it’s not surprising that even good doctors (you have to be good to be on the staff of the CCF) might be tempted to take that out.

Still, we rely on institutions like the CCF to be at the cutting edge of science. We expect that the treatments they offer will be based on the best available science. We do not expect that institutions like the CCF will embrace a prescientific system of medicine that is rooted in what is, in essence, the Asian variant of the humoral theory of medicine in which disease is attributed to imbalances in the five elements rather than the four humors, whose treatments are based on a rationale of somehow channeling or redirecting the flow of a nonexistent “life energy” that has yet to be detected by science and whose medicines are impure mixtures of natural products with nothing resembling what we could consider rigorous evidence of efficacy and safety.

The infiltration of quackademic medicine into medical academia continues apace, to our shame as a profession.

Comments

  1. #1 lilady
    April 24, 2014

    Dr. Oz is featured on (today’s) “Today” Show, discussing the Cleveland Clinic’s CAM and the herbs they prescribe. Oz (naturally), is for all these herbs as natural alternatives to prescribed medicines. The video segment is not up yet on the Today Show website.

    Dr. Oz is also promoting his upcoming show which will have a revealing look at manufacturers who market their supplements which do not deliver the amounts of supplements that they claim, and may be contaminated.

  2. #2 Chris Hickie
    April 24, 2014

    Yeah, herbs are great….look at Oleander and snack on some leaves if you want to take your chance on cardiac glycoside (eg digoxin-like) poisoning. Several years ago in Tucson, a new zoo worker mistakenly fed the giraffes oleander (which they grew all around the perimeter of the zoo). One giraffe died (http://azstarnet.com/news/local/reid-park-zoo-giraffe-dies-nd-seriously-ill/article_12656343-565b-56e6-84a6-6c5f7e24c901.html)

    Yep, go for those unregulated herbs, now that you can get them straight from medical centers that should know better.

  3. #3 Renate
    April 24, 2014

    Herbs are all natural, just like all those vaccine-preventable diseases, so they can’t be bad. Even if they kill you, they are still good, because nature only can be good and only has your best interests in mind.

  4. #4 Denice Walter
    April 24, 2014

    Digoxin? Orac, you cannot be serious!

    I just scanned Wednesday’s archived show @ PRN and Grandmaster Woo revealed ( @ 22-27 minutes in) that doctors know nothing: he’s treated heart patients without meds with supplements and herbs: for arrhythmias, omega-3s, magnesium and hawthorne berry work best.

  5. #5 Lurker
    April 24, 2014

    ‘Always look on the bright side of life (whistle-whistle…)…’

    1) War of the quacks:

    Mike Adams: ‘I have a Science Machine and it says that Joe Quack’s power-placebos are all full of poison!’

    Joe Quack: ‘Oh yeah? Well a friend of mine has a Science Machine and it says that _your_ power-placebos are all full of poison!’

    Back and forth they go, meowing and hissing and scratching at each other. Eventually the major media pick up on the cat fight and splash it all over their health pages & TV. What’s the general public to do? Maybe decide that all of those power-placebos are infested with poison, and opt for taking real medicine that’s made of properly tested compounds that really _are_ 100% natural (and 0% supernatural, with no added poisons).

    I wonder if someone might try to get Dr. Oz interested in joining the fun?

    2) Cleveland:

    Orac, one more possible factor: ‘Ms. So-And-So’s pain is probably psychogenic, and she has a tendency to believe in woo. So we send her _over there_ and she gets her woo indulged and a scrip for some placebos that might do what placebos actually do best, which is symptomatic treatment of pain.’

    Alternately, CCF lets this stuff run for a while and then politely shuts it down whilst publishing something to the effect of ‘we tried, but they couldn’t do it,’ thereby adding one more nail to the coffin of craptastica.

  6. #6 Eric Lund
    April 24, 2014

    Wait, the doctor who is quoted as recommending that some of his patients try remedies he knows haven’t been tested has the surname Rizk?

    Yet another reason why I do not write fiction for a living.

  7. #7 Denice Walter
    April 24, 2014

    Orac calls herbs “dead plant matter”

    But but but aren’t they infused with earth-derived naturally healing phytochemicals and balancing life energies blest by Gaia herself?

  8. #8 Orac
    April 24, 2014

    Of course they are, if you’re an herbalist.

  9. #9 jane
    April 24, 2014

    You’d lose that dollar, or at least, you wouldn’t win mine. I looked up xiao yao san in PubMed and there is a meta-analysis based on 14 human studies – abstract 19702899, which you may reject because it is by Chinese authors – that finds products based on that formula to be substantially better than pharma drugs for functional dyspepsia.

    Indeed, there are hundreds of studies of Chinese herbal formulas that report positive results. You are free to observe that those studies are rarely definitive, or to say that because of your own personal beliefs no number of studies would ever be enough to cause you to use an herb. But your attitude toward this increasingly large body of research approaches that of a climate change denialist: These products have never been studied! And they’ve been proven Worthless! And if all the studies of X product are positive it’s only because all the authors are Woomeisters who must have faked their data! Well, pick one – which is it?

    Sure, digoxin is better than foxglove. It does not follow therefrom that hypericin is better than SJW – in fact, the opposite has been proven – or that any one concentrated molecule from echinacea is as effective as the plant or can match its exceptional safety. Just as not all diseases are cancer, not all herbs are digitalis or aristolochia.

    Your terming plant products “dirty” and “adulterated” is a grotesquely biophobic value judgement that others are free not to share, especially in the era when so many scientific studies showing synergy among plant constituents have been published. In a different form, this very mindset contributes to the supplement use you vilify so furiously: if oranges are just Dirty vitamin C and spinach just Adulterated iron, why shouldn’t you live on junk food and take vitamin pills? They must be even better than real food, which is unavoidably variable and therefore icky, untrustworthy and probably dangerous. Many plants are both foods and medicines. How can it be that ginger in a stir-fry is a tasty and nutritious vegetable precisely because it contains more than cellulose and a single gingerol, whereas the exact same ginger in a tincture or capsule is Dirty and Adulterated?

    • #10 Orac
      April 24, 2014

      That’s a mighty weak meta-analysis ya got there. The authors themselves write:

      However, the evidence remains weak due to publication bias and methodological flaws, which may amplify the therapeutic benefit of MXS.

      One also notes that none of the 14 clinical trials in the meta-analysis were blinded. From the paper:

      All studies were of poor methodological quality and are at high risk of bias. All studies were described as ‘randomized’, but none of the studies mentioned allocation concealment. No study mentioned blinding of participants or of outcome assessors. None of the studies provided any data on dropouts.

      In other words, it’s a meta-analysis of crap, and for meta-analyses, garbage in = garbage out. One wonders why they even bothered. (Heck, if they weren’t going to blind at least the patients to treatment group, one wonders why the investigators who did those 14 clinical trials even bothered.) A meta-analysis is not suddenly going to make the conclusions from a bunch of crappy studies more scientifically convincing.

      Your terming plant products “dirty” and “adulterated” is a grotesquely biophobic value judgement that others are free not to share, especially in the era when so many scientific studies showing synergy among plant constituents have been published.

      Cite a couple.

      You see, I’ve looked. That’s a common (and old) argument of herbalists, but in reality it’s very difficult to demonstrate such synergy in a biochemically rigorous manner, so much so that I’m only aware of one or two studies that even make me think that something might be going on.

      In other words, for the overwhelmingly vast majority of cases, the “synergy” argument is also crap.

  10. #11 Eric Lund
    April 24, 2014

    abstract 19702899

    Journal citation, please. If this is a conference presentation, it is unlikely to have been peer reviewed, which is sufficient reason to discount the study regardless of the nationality of the authors.

  11. #12 Denice Walter
    April 24, 2014

    *biophobic*- that’s a new one.

  12. #13 Denice Walter
    April 24, 2014

    The biophobic Orac, replete behind his stanchion…

  13. #14 anthrosciguy
    April 24, 2014

    “can alleviate joint pain” is a good one. It’s literally the very same sort of statement made by back of the wagon Doctor Feelgoods about their various alcohol and labdanum laced nostrums back in the bad old days. The Doctor Feelgoods had the advantage that their nostrums could actually do it.

  14. #15 Mike
    April 24, 2014

    I have heard organic leaders say they were chemophobes before, but biophobic is a new one on me. But the big problem is that “bio” is made up only of lots of “chemo.”

  15. #16 Anton P. Nym
    Koobikal Hel
    April 24, 2014

    “Biophobic.” Hah. I think I preferred the original term, “Goodlife”, as proposed by Fred Saberhagen. http://en.wikipedia.org/wiki/Berserker_(Saberhagen)

    (“Goodlife” is also the name of a chain of gyms here, one I have not joined for some mysterious reason or other…)

    — Steve

  16. #17 Narad
    April 24, 2014

    Your terming plant products “dirty” and “adulterated” is a grotesquely biophobic value judgement that others are free not to share

    As PMID 22320084 is not open-access (there are 38 hits for “xiao yao san” OR “xiaoyao san”, 24 in Medline; your meta-analysis comes up under the latter term), let us resort to this:

    “The results demonstrate that the contents of saikosaponin A, ferulic acid, and paeoniflorin among samples for the pharmaceutical manufacturers of A–E were situated between 0.116 to 0.351 mg/g, 0.046 to 0.140 mg/g, and 2.128 to 3.497 mg/g, respectively. However, the herbal ingredient of saikosaponin D was detectable only in the samples from pharmaceutical manufacturers B and D.”

  17. #18 Narad
    April 24, 2014

    ^ For clarification, “modified” (or “augmented”) xiaoyao san appears to be jiawei xiaoyao san.

  18. #19 Narad
    April 24, 2014

    Journal citation, please.

    Journal of Gastroenterology and Hepatology. York critical review here:

    “The quality of the trials was assessed, using appropriate criteria, but it was described as poor, suggesting that the data might not be reliable. Trials using different comparator groups were pooled together, but there was no evidence of significant statistical heterogeneity between them.

    “Despite the poor quality of the data and the risk of publication bias, the authors’ cautious conclusions are likely to be reliable….

    “The authors did not state any implications for practice.”

  19. #20 Narad
    April 24, 2014

    “Absolutely,” responded Ms. Roofener. “This is for pain, for digestion, for inflammation, all of the above,” she said….

    BTW, there are zero hits for ‘(“xiao yao san” OR “xiaoyao san”) AND (inflammation OR pain)’. This is mildly interesting:

    “Patients using CHPs [in Taiwan] were generally female and middle-aged, made more outpatient visits, had fewer hospitalizations and consumed more medical resources than non-users of CHPs.”

  20. #21 Narad
    April 24, 2014

    Ah, here we go. The underlying work appears to be mostly in vitro, with some rodents thrown in for good measure in the Chinese-language literature.

  21. #22 Chris Hickie
    April 24, 2014

    git yer stamens off me, you damned dirty grapes!

  22. #23 Irène Delse
    April 24, 2014

    Jane:
    Your terming plant products “dirty” and “adulterated” is a grotesquely biophobic value judgement that others are free not to share, especially in the era when so many scientific studies showing synergy among plant constituents have been published. In a different form, this very mindset contributes to the supplement use you vilify so furiously: if oranges are just Dirty vitamin C and spinach just Adulterated iron, why shouldn’t you live on junk food and take vitamin pills?

    But precisely, oranges and spinach are NOT just a source of this and that chemical ingredient, they are food. And eating food satisfies various needs: fuel for our metabolism, but also pleasure of flavor, texture, etc., plus all the social and psychological aspects of sharing a meal, or trying new recipes, or indulging in comfort food… Taking a drug when you are sick is another thing entirely. In fact it strikes me as problematic to envision food and cooking from a narrowly medicalistic perspective, as if it was just a source of the correct nutrients. Plus it’s too simplistic to say: eat oranges because vitamin C. Oranges and other fruits contain also fiber, moisture, sugars, other vitamins and micronutrients… Not easy to mimic with substitutes. And alas, the bioavailability of spinach iron is pathetic: the body can’t use much of it. Other foods are better in that respect (meat, of course, and also pulses like lentils). That’s one reason variety is good in a diet: it’s complicated to calculate, so better eat a little of many things than a lot of one thing.

  23. #24 Eric Lund
    April 24, 2014

    The quality of the trials was assessed, using appropriate criteria, but it was described as poor, suggesting that the data might not be reliable. Trials using different comparator groups were pooled together, but there was no evidence of significant statistical heterogeneity between them.

    This sounds like a roundabout way of saying, “The data were tortured until they confessed.” Of course, the reviewer probably isn’t allowed to say that in so many words.

  24. #25 herr doktor bimler
    April 24, 2014

    git yer stamens off me, you damned dirty grapes!

    You feeling stigmatised?

  25. #26 Taryn Kotze
    South Africa
    April 25, 2014

    herbal medicine is by far the better option when it comes to small scale sicknesses, but i think it’s a good idea to use modern medicine when dealing with life threatening diseases? anyone agree?

  26. #27 RichardHunter
    England
    April 25, 2014

    I agree. We need to use modern medicine to its greatest advantage. Herbal medicine is seen as the “weaker” option because it wont always work.

  27. #28 Nick K
    April 25, 2014

    #26: In other words, herbal medicine is fine when you’re not actually ill.

  28. #29 Narad
    April 25, 2014

    In other words, herbal medicine is fine when you’re not actually ill.

    And aren’t particularly concerned about what you’re consuming.

  29. #30 Pareidolius
    April 25, 2014

    Oh, Jane, you keep leaving all your ammo lying around for us biophobes to use . . .

  30. #31 Reality
    April 25, 2014

    The CCF’s (who’s motto apparently is – “Back to the 11th century!”) latest alt-med profit center:
    http://www.bubblews.com/assets/images/news/1152567411_1393340369.jpg
    This is based on TWCPD Medicine:
    Traditional Western Children Playing Doctor Medicine.

    It’s just down the hall from the Whole-ist-icky patient cafeteria:
    http://www.plioz.com/wp-content/images/vintage-play-kitchen-gives-a-wide-range-of-imaginary-cooking-playing-experience1.jpg

    Advances are being made in reducing patient disposable income.

  31. #32 JGC
    April 25, 2014

    In fact, jane, the authors of the review you’re citing to support the efficacy of xiaoyao san for functional dyspepsia state explicitly the evidence isn’t sufficient to demonstrate this:

    The poor evidence does not allow any conclusion regarding the effectiveness of MXS per se
    and none of the included studies were ideally suited to investigate the effectiveness of MXS in treating FD.

    (bold for emphasis)

    I don’t think it can be stated any more explicitly than that.

  32. #33 Shay
    April 25, 2014

    #26 — going to bed with a cup of hot tea and a trashy novel works just as well as any herbal medicine. I’ll go with the tea and trash.

  33. #34 herr doktor bimler
    April 25, 2014

    Hot tea *is* herbal medicine!

  34. #35 Nick K
    April 26, 2014

    #29 Narad: Yes, but remember that the heavy metals, hepatotoxic alkaloids and so forth in herbal medicines are entirely *natural*. They must be good for you!

  35. #36 Krebiozen
    April 26, 2014

    jane,

    I looked up xiao yao san in PubMed and there is a meta-analysis based on 14 human studies – abstract 19702899, which you may reject because it is by Chinese authors – that finds products based on that formula to be substantially better than pharma drugs for functional dyspepsia.

    Functional dyspepsia is another of those somewhat vague, subjectively assessed conditions with a variable course that we know are very responsive to placebos and for which there isn’t a very effective conventional treatment. Given the lack of any blinding, this result wouldn’t be at all surprising even if the herbs were completely inactive.

    Indeed, there are hundreds of studies of Chinese herbal formulas that report positive results.

    Incidentally, your veiled accusation of racism is both offensive and inaccurate: it isn’t because the authors are Chinese that these results are rejected, it’s because of the poor study design and risk of bias. There’s a pile of very poor quality evidence, that’s true, but the quality of evidence doesn’t improve with quantity, especially when that evidence is being generated by people who are very strongly motivated to get a positive result. By analogy, hundreds of fuzzy out-of-focus UFO photos are no more convincing than one fuzzy photo.

    If you filter out the poor quality studies, using Cochrane’s criteria, for example, there’s little of substance left. Here’s a flavor of the first few studies that come up in a search for Chinese herbs on Cochrane:

    further trials are needed before the effects of TCM for people with breast cancer can be evaluated with any real confidence […]

    Although some studies investigating traditional Chinese herbs for were found for chronic fatigue syndrome, no studies met the inclusion criteria. […]

    Though some Chinese medicinal herbs appear to be safe for people with asymptomatic, mild, or moderate disease, they have not been conclusively shown to have curative effects on gallstones due to the low methodological quality (high risk of bias) of the included trials. […]

    However, since these included studies were of poor quality, the evidence does not support or reject the use of any Chinese herbal preparations for influenza. […]

    The review authors found a large number of clinical studies providing evidence of Chinese herbal medicines in the treatment of measles. Some of these reports claimed to be randomised controlled trials. However, after telephone interviewing 32 trial authors, we found that none of them used acceptable randomisation procedures to allocate participants and 34 studies included participants with measles complicated with other diseases, for example, pneumonia. Ten trials were non-randomised controlled studies and four trials require further classification. In this update, we were unable to include any randomised controlled trial for assessment.

    And so it goes on. I find it hard to believe that if these herbal treatments have any real positive effects no one has managed to produce any high quality evidence to demonstrate this. It isn’t as if the criteria for such studies is a secret.

    What I see here is mostly noise, just like all those studies of acupuncture and homeopathy. I see nothing that gives me any confidence that any of these Chinese herbal treatments are safe and effective. Railing against sceptics for refusing to accept this mass of lousy data seems a little irrational to me.

  36. #37 Helianthus
    April 26, 2014

    From jane #9

    especially in the era when so many scientific studies showing synergy among plant constituents have been published.

    Orac rightfully answered (#10):

    In other words, for the overwhelmingly vast majority of cases, the “synergy” argument is also crap.

    To add my 2 cents, jane’s argument on synergy is flawed at the origin:
    Even if synergy effects were found between some plant constituents, this does not invalidate our argument that plants extracts are a complex mixture of many ingredients in unknown -and highly variable – quantities.

    That’s the meaning of “dirty” and “adulterated”: there is nothing pure about extracts of a whole organism, from a chemical (i.e. actual content) point-of-view. Unless you mean “pure” as in “single source” (e.g. “pure orange juice”); i.e. a processing/packaging qualifier, but with little relation to the actual chemical content. You know what was not added, but you don’t know what’s in it in the first place.

    Tangential note: when a biologist gives a chemist a “pure” sample for analysis, there is a high chance the chemist will come back with a long list of unwanted compounds. Different fields, different meanings. Been here, done that on both sides… So yeah, for a chemist, a unrefined biological extract is deserving to be named dirty or crude. He certainly could need a few hours or even days to clean his instruments after injecting a “pure” sample.

    tl;dr: even in cases of synergy within plant extracts, there is still a high incentive to isolate the individual compounds, if only to be sure to get this synergy effect by having the appropriate proportions.

  37. #38 Renate
    April 26, 2014

    @ Nick K
    I prefer to take my heavy metals in another way.

  38. #39 Denice Walter
    April 26, 2014

    “there are hundreds of studies”

    This appears to be the way alt med advocates appeal to their followers’ belief in science:
    they support their beliefs about supplements’ or herbs’ efficacy by quoting hundreds- even thousands** in some cases- of “peer-reviewed studies”.. “in scientific journals”..

    But then when you look a little closer, you’ll find what Krebiozen did:
    small, uncontrolled/ inadequately controlled, unblinded/ inadequately blinded, insufficiently thought-out studies with various methodological problems, un-reviewed, having barely significant results, many of them in difficult to access sources, periodicals that no one has ever heard of or in well-known woo outlets ( like Medical Hypotheses).

    OBVIOUSLY we’ve heard this all before- a bad study ( e.g. Wakefield’s- and those of his followers’ which support it) is held up as “proof” of a particular belief about vaccines even though it’s been considered worthless fraud for years; Seralini is often quoted as “proving” that GMOs cause cancer. Similarly for accupuncture, homeopathy working effectively etc. Psychiatric meds don’t work.

    But here’s how this works and gains converts to alt med:
    -their audience didn’t study research design and statistical analysis ( few people do) or study life science
    – their believe that their source is an expert, honest and understands the consensus science at the time. They don’t.
    – people are motivated to believe in magic- simple, easy cures for serious conditions.
    – people may have axes to grind against SBM

    I just heard ( quoted above) how herbs and supplements are superior to meds fo cardiac arrhythmias- this is supported by tales of blissful success as well as “studies”
    I’d take that with MANY grains of salt if I were you ( but not if you have an arrhythmia)

    ** Gary Null says that there are “5000 studies” showing how ginseng works.

  39. […] An herbal medicine clinic at the Cleveland Clinic: Quackademia triumphant [Respectful Insolence] […]

  40. #41 brewandferment
    April 26, 2014

    Could one of the RDs or other true nutrition researchers please help clear up one area of confusion for me:

    I regularly see comments to the effect of “get vitamins from food because supplements don’t work as well (if at all)” and indeed the synergy argument is usually made in conjunction with this statement. How does this differ? This is an earnest question and NOT a defense of Jane’s comments.

    As a (barely) related aside, I did the math on trying to get the RDA of potassium and it would require vast caloric overload due to the sheer number of sweet potatoes and bananas that would need to be consumed. Even half the RDA would require the intake of at least one sweet potato (the richest source of potassium) daily just to get enough. I like them, I really do–but not daily!!!

    So: please explain why food and not supplements? (or some combo??) What am I missing in this seemingly contradictory example?

  41. #42 Narad
    April 26, 2014

    Even half the RDA would require the intake of at least one sweet potato (the richest source of potassium) daily just to get enough.

    Sweet potatoes aren’t even close, at 400 mg/100 kcal. Tomatoes are 1200 mg/100 kcal, leafy greens 1500 mg. The median potassium intake for non-Hispanic White American men here (PDF) is 2.8–3.3 mg against an adequate intake (there is no RDA) of 4.7 mg.

    One reason for food is that fruits and nongrain vegetables are going to be giving you bicarbonate forms, and a quick survey of potassium bicarbonate and citrate supplements suggests that they all come in at 99 mg. How many of those do you want to be horking down day in and day out? An ounce of hazelnuts will give you 755 mg.

  42. #43 tf
    US
    April 26, 2014

    Interesting article Orac. I sent it along plus the WSJ article to a colleague who is interested in traditional medicines as a source of pharmaceuticals. My argument was essentially you need the pure compounds to ensure efficacy and reproducibility, and he sent back these two articles, one a lay article and one primary literature:
    http://online.wsj.com/news/articles/SB10001424052702304177104577313821796467932
    http://stm.sciencemag.org/content/2/45/45ra59.abstract

    Essentially the guts of the story is that a mixture of four plant extracts used in traditional medicine were effective at alleviating some intestinal toxicity / side effects from chemotherapy. The mixture is currently in phase II clinical trials (as far as I can tell). According to the lay article, they identified 62 bioactive compounds from the mixture, and did observe synergistic effects when reductively analyzing the mixture. So that establishes the efficacy (if you buy it), but they also argue that with modern plant science in controlled environments with LC/MS metabolite quality control you actually *can* make reproducible mixtures. How much would it cost to make a pill of 62 pure compounds? What would it cost if some of the compounds had to be made synthetically or semi-synthetically? Essentially, I was quite excited to see what to me is real as rigorous science around a “dubious” modality which I usually ignore out of derision! Very interested to hear what people’s reactions to this are, especially given the high profile of the work. Perhaps it has already been dissected ruthlessly somewhere?

  43. #44 Helianthus
    April 26, 2014

    @ brewandferment

    I regularly see comments to the effect of “get vitamins from food because supplements don’t work as well (if at all)” and indeed the synergy argument is usually made in conjunction with this statement.

    Disclaimer: not a nutritionist here. Just general knowledge I acquired.

    It’s not right to say that nutrient supplements are not working. Most of us here say that they are generally useless, but it’s not the same thing: that we mean is that they are redundant.
    Competent nutritionists (i.e. not the ones selling their miracle hypervitamined complexes) are regularly saying that; if you have a balanced and varied diet, you will get all your nutrients from it and don’t need to swallow expansive pills on top of it.

    There are cases where supplements are justified. If you don’t have access to oranges, apples, or sauerkraut, vitamin C pills may very well be what you need. And there is a on-going legitimate debate about the correct level of vitamin D you should have (anything from 200 to 2000 units daily), which could be an issue if you don’t see much daylight and don’t drink milk (although 15 min a day outdoor, sleeveless, is deemed enough by some nutritionists – not indoor, the right UV sun rays are blocked by ordinary glass) .
    Similarly, there are very good scientific reasons for pregnant women to increase their uptakes of vitamin B12. Or to give a shot of vitamin K to newborn babies.

    We do say that vitamins don’t work when quacks claim that an overdose of them (like, 10 times or 100 times the RDA) will cure cancer, HIV, and baldness. Because, from all the evidence available, they don’t.

    Now, why take vitamins and other micronutrients from food rather than from pills?
    To repeat something a previous commenter wrote, it’s important to distinguish between food and medical drugs, for all a variety of reasons. You eat food daily, and it should bring you some sense of pleasure, or at least satiety, both for psychological balance and the sake of your body mass index. It’s also an important occasion for socializing (another disclaimer: I’m French. We tend to be religious on such matters).
    Popping a pill or a dozen, especially if you are not ill… It’s a bad habit. A medicament should not be a candy.

    There is another reason why concentrated nutrients could be of limited value: the quantities which your body is accepting to carry around are strictly limited.
    First off, a number of vitamins and other special molecules won’t go through the intestines’ wall unassisted. Specialized proteins will act either as passive canals or active pumps and transport these molecules from the intestines to the bloodstream. There is only so many of these transporters, and the food you ate will only stay so long inside your intestines. So, for some nutrients, only a finite quantity could be absorbed every day. The rest is wasted.
    To complicate matters, some nutrients could be in competition with others. Too much of one present, and more of the other will be ignored. Conversely, some pumps transport two specific, different molecules at the same time, like a sodium ion and a sugar. Increasing the swallowed amount of one molecule won’t do anything if the co-transported one isn’t present (note: the sodium-glucose pump is just an example. For most people in developed countries, if anything, there is too much sodium salts and sugar in their diet)
    I don’t know if we can truly call this synergy, but in the regard of these mechanisms, a mixed bunch of many nutrients, spread out over the course of a meal, may individually have a higher uptake than a concentrated spike of a few vitamins as delivered by a pill. Less risk of overloading the transporters. Less risk also to forget a class of nutrients or to trigger detrimental effects due to a high dose.
    However, as I said above, if you are lacking some nutrients, supplement pills can perfectly do an adequate job in providing them to you. Even if not all of the provided nutrients are absorbed, the true objective is that enough of them are.

    A similar limiting process happens with the kidneys: they are cleaning our blood by actually first dumping out the plasma and everything it contains – salts, sugars, vitamins, and very importantly, urea and uric acid – and then fishing back useful compounds, including water. Again, using specialized pumps or canals, in limited numbers, for a limited time. That’s why diabetics have sugar in urine – there is too much of it in the bloodstream and part of it is not reabsorbed. Similarly, people taking big doses of vitamins B will have blue urine: that’s the B12 in excess.

    tl;dr: nutrient supplements could be useful. But it’s better to focus on a varied and enjoyable diet, if possible, to avoid to blur the line between food and medical drugs, and because doing so easily covers a broad range of nutrients without having to pay for expansive pills. Because the amounts you can absorb and keep are limited, taking a big pill of vitamins could easily be wasteful, as much of it won’t stay in your body.

  44. #45 squirrelelite
    United States
    April 26, 2014

    @tf,

    I did a quick check of one of the protein powder supplements one of my sons likes to take, and it already has 24 vitamins and minerals as well as 18 amino acids.
    These powders sell for $12-15 per pound on line, so the cost for a pill with 62 ingredients shouldn’t be too much more.
    The 2010 paper you referenced is interesting, but very preliminary. They’ve only studied this combination of 4 herbs in lab mice and embryonic kidney cells, not in humans.
    They seem to be jumping into a Phase II study in human cancer patients. However, just considering this as a non-chemist, non-medical researcher, it seems they are taking a lot for granted in making that jump.
    The abstract refers to 4 specific effects.
    If I were writing a research proposal, I would want to find out which herb or herbs cause which effect(s). Also, I would test different ratios of the herbs to determine an ideal mixture. (maybe there’s too much oregano http://www.imdb.com/title/tt0245513/
    or not enough basil in the marinara sauce.)
    Then I would want to learn which of the 62 compounds produces each of the 4 identified effects. There might be 2 or 3 for a specific effect, but it’s highly unlikely that all 62 are needed for each effect.
    Then I would want to test for dose/toxicity/absorption in humans (probably a phase I study). Then, I would move on to phase II testing with some identified combination of the useful chemical ingredients.

  45. #46 squirrelelite
    April 26, 2014

    @brewandferment,
    I second Helianthus’ comment about nutritional benefits of foods versus just supplements.
    I like to think of this as the Kelvan Paradox, from the classic Star Trek episode, “By Any Other Name”.
    In this episode, the Enterprise is captured by invading aliens from the Andromeda galaxy. The Kelvans have synthesized a pill that contains all the nutrients needed by humans.

    One of the Kelvans, Tomar, chides the remaining crew about their use of “bulk material” instead of the nutritional supplement pills the Kelvins use. Dr. McCoy responds: “Don’t knock it ’til you try it.” Tomar orders the doctor to assist him in sampling human cuisine which he ends up enjoying.

    Specifically, while there is pretty good evidence that a diet with certain nutritional factors like low saturated fat, high Omega-3 fatty acids, antioxidants like Vitamin C, E and minerals like selenium, etc. has health benefits; tests on those nutritional ingredients themselves show inconsistent or even negative effects.
    So, there seems to be some benefit from the overall diet that is independent of or in addition to the effects of the identified important ingredients. In this case, I think, more research is needed.
    But, food is more than just the vitamins and minerals it contains. It provides energy to fuel the body, raw materials such as proteins to convert into muscles and other tissues. And, even non-nutritional components such as fiber have value. Fiber helps produce a satisfying fullness so we don’t overeat. It moderates the flow of nutrients through the digestive system so there is a longer, more steady intake of those ingredients into the bloodstream. And, it has benefits to the colon such as reducing the risk of colon cancer.
    And, like Helianthus, I enjoy a good meal with different textures, flavors and aromas.

  46. #47 tf
    April 27, 2014

    @squirrelelite #45

    The multivitamin is an interesting counter argument, perhaps yes the cost of a 62 component pharmaceutical wouldn’t be prohibitive. I suppose I was coming from the angle of complex metabolites which would be tricky to synthesize, but there isn’t necessarily any support for that in the article. The assumption that only a handful of compounds would be needed isn’t unreasonable I’ll admit. Occams razor and the general state of known pharmaceuticals would argue that only a few metabolites could have a large therapeutic effect. That being said, the lay article states 62 compounds was the least complex efficacious mixture (Whether or not that is an authoritative statement is a different story). Additionally, synergy in drugs is not a unproven effect: see combinatorial therapies in cancer chemotherapies. In fact, I have seen examples where order and time of dosing in a combinatorial therapy has a massive difference in therapeutic effect. This sort of complex response is in essence the idealogical basis behind “systems biology”, if you buy that. Anyway, I suppose my overall point was that despite that the vast majority of typical herbal remedies stuff is complete unscientific BS, but here is at least one interesting example of it being tested in a scientifically rigorous manner. In principle, if a mixture is efficacious, and can be reproduced in a standardized way, then perhaps it could be adapted into an actual clinical treatment. I’m reminded of the current state of bacteriophage therapy for bacterial infection, which involves poorly characterized mixtures of “bioactive” bacteriophage. Clearly there is a scientific basis for killing bacteria with bacteriophage, but using it clinically requires the “standardization” of a complex mixture with poorly characterized mechanism. But it does work, and given the choice between serious illness from an antibiotic resistant bacteria, and potentially efficacious treatment with a poorly understood but complex mixture, I’d go with the mixture. Perhaps an aside, but I suppose the overall point is that while purified compounds and directed therapies are fantastic, there is the potential for efficacious treatment from complex and mechanistically poorly characterized therapies.

  47. #48 AnnB
    April 27, 2014

    Agreed. This is nonsense. I only had to go to a naturopath a couple of times to figure out that all they offer is a sympathetic ear and some supplements for sale. By them.

    However, I can’t shake my skepticism of what “real” medicine offers today either Most medical research is flawed, says leading medical editor.

  48. […] B, with each column containing a list of modalities ranging from pure quackery like homeopathy and traditional Chinese medicine to mundane modalities that naturopaths embrace, “rebrand” as “alternative,” […]

  49. #50 Calli Arcale
    http://fractalwonder.wordpress.com
    April 28, 2014

    AnnB — well, it’s been said that science-based medicine is the worst form of health care there is, except for all the others that have been tried. ;-) It has a long litany of failures. But it is through failure that we find successes. Only the intellectual rigor needed to systematically test propositions and ruthlessly discard the failures can get us where we want to be, ultimately. Any other system lets us deceive ourselves, and that’s just a waste.

  50. #51 emilenolde
    May 1, 2014

    Regarding synergy in herbs:
    1. Cannabis research provides some evidence that CBD and terpenes in the flower buds interact in interesting ways with THC. This may explain why synthetic THC is less effective than cannabis. I can dig up the studies if you like.
    2. I’ve heard herbalists make the claim that herbs that contain salicylic acid (meadowsweet and willow bark) are superior to aspirin because they also contain tannins and cox-2 inhibitors which heal and prevent stomach ulceration. Thoughts?

  51. […] posted a short (for me) piece about something that disturbed both Steve Novella and myself, namely An herbal medicine clinic at the Cleveland Clinic: Quackademia triumphant Steve had blogged about it as well a couple of days earlier. To my surprise, Maithri Vengala over […]

  52. […] months ago, I wrote about how the Cleveland Clinic had recently opened a clinic that dispensed herbal medicine according to […]

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