Clinical trials Complementary and alternative medicine Medicine Quackery Science

An acupuncture bait and switch on hypertension

Acupuncture is a theatrical placebo, but it’s hard not to grudgingly admire just how—shall we say?—malleable or adaptable a placebo it is. What I mean by this is that, if you believe its practitioners and adherents, acupuncture can treat almost literally any disease or health problem. Any! Pain? Acupuncture. Allergies? Acupuncture. Biliary colic? Acupuncture. Infertility? Acupuncture. Menstrual problems? Acupuncture. Prostate problems? Acupuncture. Asthma? Acupuncture.

Well, maybe not asthma, but that doesn’t stop acupuncturists from claiming that acupuncture can treat it.

Oh, and if you’re a middle aged white dude with a touch of hypertension like me, a new study claims that acupuncture can help you, particularly if your antihypertensive medications are causing side effects. I’ve been fortunate enough that this is not the case for me (indeed, I’ve been amazed at how side effect-free my treatment has been), but, sadly, that’s not the case for everyone. Maybe some of those people would find having needles stuck into them on a regular basis preferable to pharmacology, diet changes, and exercise.

First, let’s take a look at the press release on EurekaAlert!. It’s full of tropes about traditional Chinese medicine that drive me crazy:

Irvine, Calif., Aug. 19, 2015 — Patients with hypertension treated with acupuncture experienced drops in their blood pressure that lasted up to a month and a half, researchers with the Susan Samueli Center for Integrative Medicine have found.

Their work is the first to scientifically confirm that this ancient Chinese practice is beneficial in treating mild to moderate hypertension, and it indicates that regular use could help people control their blood pressure and lessen their risk of stroke and heart disease.

“This clinical study is the culmination of more than a decade of bench research in this area,” said Dr. John Longhurst, a University of California, Irvine cardiologist and former director of the Samueli Center. “By using Western scientific rigor to validate an ancient Eastern therapy, we feel we have integrated Chinese and Western medicine and provided a beneficial guideline for treating a disease that affects millions in the U.S.”

Here we go again. Note the appeal to antiquity, as acupuncture is referred to as an “ancient Chinese practice” when in fact acupuncture as we know it today is far more a phenomenon that arose during the 20th century. It was popularized in China by Chairman Mao Zedong and brought to the West with the help of credulous reporters. Indeed, traditional Chinese medicine, of which acupuncture is a major part, was the very first example of a conscious attempt to “integrate” quackery with real scientific medicine. Back before, say, the 20th century, acupuncture resembled a practice common in the “West” as well as the “East,” namely bloodletting—and a particularly crude and barbaric form of bloodletting. Indeed, until well into the 20th century, no attempt was made to insert needles near acupuncture points; needles were simply inserted near the point of pain.

And, of course, unless the ancient Chinese were considerably more advanced than we knew, there was no electricity, which makes Dr. Longhurst’s boasting of “using Western scientific rigor to validate an ancient Eastern therapy” so utterly risible that reading his weasel words of woo (as Kimball Atwood liked to call them) makes my head feel as though it’s about to explode. Doesn’t he realize how silly he sounds? Does he realize how racist he sounds? As I’ve said so many times before, the “East” versus “West” dichotomy assumed by advocates of quackademic medicine with respect to many forms of alternative medicine that they seek to “integrate” into “Western” medicine in that it assumes that the “East” (i.e., Asians) are more “wholistic,” touchy-feely, and mystical, while the “West” (i.e., those of us descended from Europeans) are cold, scientific, and reductionist. If I were Asian, I’d be insulted by the construct.

In examining any study of acupuncture, there are several things to look for. Indeed, there are several general categories of deficiencies that apply to nearly all of them, particularly the “positive” studies like this one:

  • Inadequate or no blinding
  • The “bait and switch” of using electroacupuncture instead of acupuncture
  • Small sample size
  • Improper or inadequate controls
  • Statistical problems
  • “Soft” subjective outcomes measured

There are others, but these are the most common.

So which of these apply to this study? Let’s take a look.

The investigators studied 65 subjects. Subjects stopped taking their antihypertensive medications for at least 72 hours before the electroacupuncture (EA) treatments began, and during the study they underwent 24 hour ambulatory blood pressure monitoring. They were also instructed to start taking their antihypertensive medications if their average systolic BP went over 180 or their average diastolic BP went over 110. They noted that none of them had to do this, which tells me that they didn’t have particularly severe hypertension.

Right here, though, is a problem with this study that shows just how ineffective institutional review boards are at evaluating the ethics of clinical trials of “complementary and alternative medicine” (CAM). Taking subjects with hypertensive off of their antihypertensive medications is not without risk. Sure, if they don’t run blood pressures over 180 systolic or 110 diastolic, the risk is very low, but it is not nonexistent. Weigh this against a fantastical therapy with minimal chance of benefit, and if I were on the IRB for this study there’d be no way I would vote to approve it.

Study design for acupuncture (electroacupuncture) versus hypertension
Study design for acupuncture (electroacupuncture) versus hypertension

On to the design, which is summarized in the figure above. This study, for some reason, randomized patients into two different acupuncture groups, one receiving 30-minutes of EA at acupuncture points PC 5-6 + ST 36-37 or at LI 6-7 + GB 37-39 once weekly for 8 weeks. How these were decided upon appears to be based on animal experiments. (Lovely.) The PC 5-6 acupuncture points iares located above proximal to the wrist between the tendons of the palmaris longus and flexor carpi radialis muscles. The ST 36-37 acupuncture points have been discussed here before, being located on the leg lateral to the anterior border of the tibia. The LI 6-7 acupuncture points are on the thumb side of the arm above the wrist, while the GB 37-39 acupuncture points are on the lateral part of the lower leg, above the ankle.

Basically, the 33 patients receiving EA at PC 5-6 and ST 36-37 were the experimental group, while the rest were the controls. This is better than the average acupuncture study in that at least the investigators tried to evaluate “irrelevant” points (based on what, who knows) as controls. Unfortunately, certain other controls are notably absent, namely a sham EA control for PC 5-6, which could be accomplished quite simply by sticking the needles in, but not actually applying electricity, the machine being set up so that the practitioner doesn’t know whether current is being applied or not.

Speaking of blinding, another big problem with this study becomes rapidly evident when you look at the methods. The study was only single blinded (the patients). True, the data analysis was also blinded, but practitioners were not blinded. Also, there was no post-study assessment of blinding to see how effectively patients were blinded to their study group. At the very least, post-study assessment of subjects to make sure that their assessment of which group they were in is consistent with random guesses, suggesting that they didn’t know what group they were in. If you really wanted to make sure the patients were blinded, you’d stick the needles in all four acupoints and then only two of them would receive current.

So what were the reported results? After eight weeks, the experimental group showed decreased peak and average SBP in 70% of the participants, an average of 6 to 8 mmHg for systolic blood pressure and 4 mmHg for diastolic blood pressure. These improvements reportedly persisted for a month and a half. There was no detectable change in either systolic or diastolic blood pressure in the control group. Also, reportedly, After treatment, the plasma concentration of norepinephrine (which increases blood pressure), which was initially elevated, declined 41%. Similarly, the renin-angiotensin system activity, which increases blood pressure (indeed was reduced, with renin decreased by 67% and aldosterone by 22%. Blood pressure is commonly treated with angiotensin converting enzyme (ACE) inhibitors like lisinopril, which lower the activity of the same system.

The reported decreases in blood pressure were small, with peak and average systolic BP decreasing by 8 and 6 mmHG, respectively, and diastolic BP decreased by 4 mmHg. The authors claim that this is clinically significant. I suppose that might be possible, but only if a patient has some incredibly mild hypertension, so that such a small reduction would bring blood pressure down to target levels as described in clinical practice guidelines.

So let’s assume for the moment that the findings are “correct” (in other words, EA really does reduce systolic BP by around 8 mmHg and diastolic BP by 4 mmHg). This requires weekly treatments. Hypertension is a chronic condition. Are people really going to undergo EA treatments at least weekly for the rest of their lives, hundreds and hundreds of treatments? Is that really better than taking a pill. The assumption is that it is better, but I’m not so sure, particularly given that the longer one regularly sticks needles into one’s skin the greater the chance that one of those uncommon acupuncture complications will occur.

Overall, this study is just not that convincing. It has small numbers, inadequate controls, and, of course, the classic bait and switch substituting EA for acupuncture. Even if its results are totally valid, it does not validate acupuncture, but rather transcutaneous electrical stimulation (TENS), which is a science-based treatment for some conditions. In the end, acupuncture is a modality that is touted as being able to treat everything. In reality, it is based on a prescientific understanding of how the human body works and requires a lot of “help” in the form of electricity even to give the appearance of working.

Basically, acupuncture is to CAM as words were to Humpty-Dumpty. When acupuncturists use the word “acupuncture” it means what they choose it to mean, neither more nor less, and the most important thing is to be master of what it means. Unfortunately, the very malleability of acupuncture is what makes it so unconvincing as a treatment. A treatment that is claimed to be able to treat anything in the end probably treats nothing effectively.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]


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