Patients 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 theybelieve 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?
This article was originally published in the Science-Based Medicine Blog.