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Another Acupuncture Study – On Heartburn

Blogging on Peer-Reviewed ResearchPatients with heartburn are often diagnosed with GERD (gastroesophageal reflux disease) and treated with a drug called a proton pump inhibitor (PPI) to reduce stomach acid production. It is pretty effective, but it doesn’t always work. When it doesn’t, standard practice has been to double the dose of PPI. Doubling the dose only improves symptoms in 20-25%. Most patients who fail the single dose turn out to have normal esophageal acid exposure, or “functional” heartburn. In other words, the symptoms appear to be due to something other than excess acid – so it really may not make much sense to double the PPI dose. What else could doctors try?

How about acupuncture? A recent clinical trial compared acupuncture to doubling the proton pump inhibitor dose in refractory heartburn.

There were 30 patients randomized into two comparable groups. Patients in the PPI doubling group got no intervention but a doubling of the PPI dose. Patients in the acupuncture group remained on the original dose of PPI but also got acupuncture. The acupuncture protocol was developed using Traditional Chinese Medicine (TCM) pattern diagnosis and five acupuncture points were chosen. A sixth point was used if the patient had any characteristics of “dampness” such as loose stools or sensation of gastric heaviness. 10 sessions of traditional acupuncture according to TCM principles were scheduled over 4 weeks. Acupuncturists told patients to expect a unique needle sensation known as “de qi.” They conducted a thorough TCM evaluation, decided whether to include the 6th acupuncture point, and then took patients to a quiet treatment room. They stimulated the needle and adjusted the depth of insertion until the patient reported a “de qi” sensation. This was repeated every 5 minutes for 20 minutes total. Otherwise, they tried to minimize patient-provider interactions. The end points were subjective (self-reported heartburn and acid regurgitation). There was no improvement in the group that got a double dose of PPI, but the acupuncture group reported significant improvements in symptoms and in mean general health score.

They concluded that adding acupuncture to PPI is significantly more effective in relieving symptoms than doubling the PPI dose.

Research methodologist R. Barker Bausell, in Snake Oil Science, offers some simplified guidelines to see if a study could be considered credible scientific evidence. Let’s see how this study measures up.

(1) Random assignment and a credible placebo control group. Random assignment – yes. Placebo – no (more about this later).

(2) At least 50 subjects in each group. No, only 15.

(3) Less than 25% dropout rate. Yes, everyone completed the study protocol.

(4) Published in a high-quality, prestigious, peer-reviewed journal. This was published in Alimentary Pharmacology & Therapeutics which according to its website is ranked 14/48 in Gastroenterology and Hepatology and 47/199 in Pharmacology and Pharmacy, with an overall impact factor of 3.287. For comparison, the New England Journal of Medicine has an impact factor of 34.83.

So Bausell would probably have a few doubts about this study right off the bat.

But what completely discredits this study for me is the authors’ flawed reasoning in the discussion section. Here is the most offensive paragraph in its entirety:

“We did not add a sham acupuncture arm to this study because of the increasing recognition in the acupuncture literature that superficial (needling of the skin), sham (needling of non-acupuncture points) and placebo (needling with blunt tip that does not penetrate the skin) acupuncture also provide an active therapeutic effect.37 This is particularly the case in pain conditions that are predominantly associated with an affective component.38–40 A recent study demonstrated that a system of slow-conducting unmyelinated (C) afferents responds to light touch.41 By using functional magnetic resonance imaging, the authors showed that stimulation of C tactile afferents after light touch results in activation of the insular region but not of the somatosensory cortex. Activation of the C tactile afferents results in a ‘limbic touch’ that may underlie emotional and hormonal responses commonly seen following caressing, for example.41 Thus, it is likely that control procedures used in many acupuncture studies aimed at being inert may activate the C tactile afferents that alleviate unpleasantness and re-establish patients’ sense of well-being.37 Therefore, neither minimal, superficial, sham acupuncture nor placebo needles may be regarded as placebo, because they are not inert.37″

I could hardly believe my eyes when I read this. The authors are aware of the research showing that acupuncture is no better than placebo, but instead of accepting the obvious, they are trying to rationalize that the placebos are therapeutic too! This hypothesis has been refuted by other research showing that patients get more pain relief when they believe they have gotten conventional acupuncture, regardless of whether they got the conventional or sham or placebo acupuncture! Patients who believed they were receiving true acupuncture had a mean pain level VAS score of 21.0 (range 17.2-24.8), and patients who believed they were receiving a sham or placebo acupuncture treatment had a level of 40.4 (range 31.9-48.8). There was not even any overlap between the groups. It doesn’t matter what you do to the patient; all that matters is what the patient believes you did.

Then, think about the implications of their rationalizations about C tactile afferents. What they are saying is that maybe any kind of light touching of the skin can produce the effects traditionally attributed to acupuncture. If this were true, it would completely destroy any reason to use acupuncture. Why on earth would anyone bother with TCM methods, needles, or “de qi” if it works just as well to caress the skin?

Another small thing that bothers me is that in previous studies, 20-25% of patients improved after the PPI dose was doubled, and in this study there was no improvement whatsoever. They don’t say whether their subjects had previous experience with acupuncture. One possible explanation might be that patients volunteered for this study because they believed acupuncture worked, and assignment to the PPI-doubling group disappointed them and made them think they would not improve.

This study falls into the category of what I call Tooth Fairy science. You could measure how much money the Tooth Fairy leaves under the pillow, whether she leaves more cash for the first or last tooth, whether the payoff is greater if you leave the tooth in a plastic baggie versus wrapped in Kleenex. You can get all kinds of good data that is reproducible and statistically significant. Yes, you have learned something. But you haven’t learned what you think you’ve learned, because you haven’t bothered to establish whether the Tooth Fairy really exists.

These researchers learned something, but not what they think they learned. They learned that doubling the PPI dose is pretty much useless, and that providing a placebo intervention is much more effective. To my mind, the next logical step would be to find the simplest, most effective method to help the patient in the same way that they were helped by acupuncture placebo, but without any make-believe about imaginary meridians and qi. If the authors’ speculations about light touch are correct, it’s quite possible that some form of light massage would be equally effective. And perhaps personal attention, relaxation, and reassurance would do even more good.

We may be able to learn a great deal from alternative medicine practices, but not necessarily what they would like to teach us. All the acupuncture research to date is compatible with the hypothesis that it’s nothing more than an elaborate placebo with maybe a touch of counter-irritant thrown in. No one has seen a meridian or measured the qi. Isn’t it time to stop doing junk science and Tooth Fairy research, to discard needles and meridians and mystical nonsense, and to try reality-based approaches to improving patient comfort and satisfaction?

Posted in: Acupuncture, Clinical Trials, Energy Medicine

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20 thoughts on “Another Acupuncture Study – On Heartburn

  1. Henrik says:

    Great post! If you change “Gastrointestinal…” to “GastroEsophageal Reflux Disease”, the acronym makes more sense (sorry to be a nitpick). Keep up the good work.

  2. Harriet Hall says:

    Thanks, Henrik. for pointing out the error. I have already corrected it. I’m a fellow nitpicker and truly appreciate your assistance.

  3. humgums says:

    I really like your “tooth fairy science” analogy.

  4. Sastra says:

    It’s time for “Alternative Medicine” to be replaced by “Alternative Health Caring.”

    In “Alternative Health Caring,” a trained professional comes to your house when you are sick or ill. They listen to your complaints, asking you to explain symptoms in more detail and describe the entire history of your malady. As much as you want, for as long as you want.

    They then give you some home-made soup. They say “I don’t know how you do it, I really don’t.” They proceed to tell you about someone they know who had a similar problem, but it was either worse (“you’ve got such a strong constitution”) or better (“you’ve got such mental fortitude.”) They rub your back or feet a bit, make you some tea, maybe straighten up the place. You are informed that you are very easy to talk to, there’s such a comfortable connection they can really feel, and that’s not true about all sick people, some of them just don’t seem to be able to cope the way you do. It must be so hard for you, and yet you still have so much vigor and a good attitude, despite everything.

    They charge by the hour. And it is worth it.

    Alternative Health Caring would not conflict with Science Based Medicine. As far as I can tell, it provides all the benefits of CAM, and none of the drawbacks. You really could integrate it into traditional standard treatment, no problem.

    Sooner or later I think someone is going to hit on this for real, and make the Big Bucks.

  5. Freddy the Pig says:

    “We did not add a sham acupuncture arm to this study because of the increasing recognition in the acupuncture literature that superficial (needling of the skin), sham (needling of non-acupuncture points) and placebo (needling with blunt tip that does not penetrate the skin) acupuncture also provide an active therapeutic effect.”

    In other words “We did not do a placebo arm because it would have shown that our woo is poo”

    And completely off topic, but in response to Pec’s claim that Science Based Medicine should leave Cancer Treatment to sCAM, I ran into someone who has Brain Cancer at the grocery store. He was diagnosed long before I met him (over 6 years ago) and he looked quite healthy (just over a year ago, he could barely walk). Any one who tells you that “Conventional Medicine” can not treat cancer, they are full of shit.

  6. drval says:

    I love the Tooth Fairy paragraph. Great analogy. Nicely done. Sastra’s point about the importance of caring is also really good. Love the blog! Keep it up, team!

  7. BlazingDragon says:

    It wouldn’t hurt if actual doctors could adopt a few of the practices that Sastra outlined too (of course, we’d actually have to convince insurance companies to pay for longer visits and to put considerable value on “general practitioner” visits, neither of which they currently do… quite the opposite in fact).

    If medical doctors did this kind of “kindness therapy,” they’d be able to spot “real” problems earlier and initiate treatment. Right now, people are often brushed off as “somatic” when they sometimes have very early and/or atypical presentations of treatable problems… Having someone trained to make one “feel better” would probably miss important early diagnoses (and probably result in legal nightmares). These “kindness therapy” practitioners wouldn’t be able to fall back on a huge body if “literature” to justify their missing something important and would be subject to the full weight of the law… unlike the woo practitioners who seem to “get away with” missing important things (or outright fraud).

  8. Michael X says:

    I just read a cover piece in Chicago’s Red Eye (a free publication by the Tribune, with huge distribution) that basically worked as an advertisement for acupuncture, as it has no skeptical opinions in the article and at best only offered testimonials as evidence. Yet they had the balls to title the article “Acupuncture, Fab or Fad?” as if such a question was actually being considered.

    I wrote in, and I’m being considered for publication in the reader feedback. Though, this is little consolation. Until, the reader feedback gets a cover story, such pandering will continue, and peoples money will be spirited away, not to mention nonsense being taken as supported fact.

  9. Antono says:

    When confronted with evidence that acupuncture is no better that placebo, acupuncture supporters twist it around saying that placebo is jut as efficacious.

    If they really believe that, then they should abandon Chinese tradition and start performing sham acupuncture only. After all, it’s got the same efficacy with a lot less cost and side-effects. Their “science” would then be known as “Needling-with-Blunt-Tip-that-does-not-Penetrate-the-Skin Therapy”!

    Otherwise this would be analogous to a pharma contending that “no, it’s just that saline water is just as potent as our medicine” but then go right ahead and sell their expensive drug instead of saline water for that indication.

    On depressing side-note, here is how David A. Johnson, MD, President of the American College of Gastroenterology commented about this article on Journal Watch Gastroenterology.

    “Naysayers might dismiss acupuncture as “voodoo medicine,” but scientific data support its therapeutic benefit for some conditions. Acupuncture has been reported to alter gastric acid secretion, enhance esophageal peristalsis, and alter visceral hypersensitivity. Although the lack of a sham control and questions about durability of acupuncture’s effect limit the validity of this trial, its findings clearly warrant further study.”

  10. wertys says:

    This has got to be the funniest and most comprehensive shot in the foot yet for the NCCAM, the best part being it is self-inflicted.

    Goldman RH, Stason WB, Park SK, Kim R, Schnyer RN, Davis RB, Legedza AT, Kaptchuk TJ.Acupuncture for treatment of persistent arm pain due to repetitive use: a randomized controlled clinical trial.Clin J Pain. 2008 Mar-Apr;24(3):211-8.

    The last couple of paragraphs are worth the price of admission…

  11. joel_grant says:

    Is it too late to comment on this article? I love the methodology but I am a layman; applying it to impressive-sounding articles makes my head spin.

    Personally, I find it difficult to credit acupuncture for anything, given the seemingly impossible claims relating to ‘chi’ energy made to explain its effects.

    I just ran across this article:

    http://www.biomedcentral.com/imedia/5418761701003291_manuscript.pdf

    The gist of it is that acupuncture seems to be efficacious in the treatment of post-thoracotomy pain. Rather an astonishing claim, if true.

    But is it true? What give?

  12. Harriet Hall says:

    Not an astonishing claim at all. Placebos are effective for even severe pain. This was a pilot study with no controls. it was designed to assess the feasibility of doing a later RCT. It was testing a new way of providing acupuncture that would not interfere with post-thoracotomy care. It just demonstrated once again that acupuncture is a good placebo system.

    We have no acceptable evidence that acupuncture is more effective than placebo, and this study adds nothing to our knowledge. Except maybe to our knowledge of how to administer placebos efficiently in the post-op setting. This is a good example of research that should not have been funded.

  13. joel_grant says:

    Dr. Hall, thank you for checking this out and offering your professional opinion.

    Of course, I should have made clear, not that I thought a placebo effect was extraordinary, but that acupuncture as such might be helpful.

    It simply does not seem possible to me that acupuncture per se could possibly be useful. It appears that is very much the case.

  14. BillyJoe says:

    If you look at the recent systematic review on the use of acupucture in the prophylaxis of migraine in the Cochrane Database, the authors conclude that true acupuncture is as effective as sham acupuncture! They then suggest that in any future studies of acupuncture a sham acupuncture placebo group should “not have high priority”!

    http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001218/frame.html

    (you will need to click on “Authors conclusions” in the left hand column and scroll down to “Implications for research”)

    BillyJoe

  15. Spudman says:

    I love it when the same allopathic filth who kill 100′s of 1000′s a people a year and then drive to the golf club in their Lexus’s take shots at alternative medicine. One study doesn’t prove anything conclusively; there are also studies showing that Prozac had no better than placebo effect. But hey, you ghouls can make money off of Prozac, much more than you can make off of alternative medicine, right?? So shhhhhhhhhhhhhhh about Prozac, right? And that was only ONE study that showed the ineffectiveness of your standard “medicine.”

    Acupuncture works – try finding studies that demonstrate that. You probably won’t, though. You can’t buy a townhouse on the hill and pay for your drug habit on an acupuncturist’s pay, can you.

    Go kill another 700, 000 people a year with your heartless, atomistic, UNPROVEN (only about 15% of what you do has any scientific “provability”) therapies per year and take another sip from your Martini.

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