Dr. Carlo Giovanardi: Spinning another negative acupuncture study

I write about acupuncture a lot because it’s a form of quackery that I once sort of believed in. Well, not exactly. I’m exaggerating a bit. Rather, it was a form of quackery that I wasn’t as skeptical of as, for example, homeopathy or energy medicine, both of which are examples of the most magical of magical thinking, with as close to zero biological plausibility as I can imagine, plausibility so close to zero as to be, for all practical purposes, indistinguishable from zero. Acupuncture, on the other hand, actually involves physically sticking needles into the skin. Of course, I never bought the idea that acupuncture somehow works because its needles redirect the flow of qi, a magical life force energy, to some sort of healing effect. I did, however, leave open the possibility that somehow do…something. Then, I actually started delving deeply into the acupuncture literature and found, not entirely to my surprise, that there’s just no “there” there to acupuncture. It’s a theatrical placebo. Such were my thoughts when reading this letter by Carlo Maria Giovanardi, MD, President of the Italian Federation of Acupuncture Societies (FISA), President of the Association of Medical Acupuncturists of Bologna (AMAB), What is the Scientific Contribution when the Study Methodology has so Many Limitations?

Dr. Giovanardi is referring to a randomized clinical trial published in JAMA in May testing whether acupuncture increases pregnancy rates after in vitro fertilization (IVF). As I noted at the time when I discussed it in my usual inimitable fashion, it was, unlike most acupuncture trials, large and well designed and that, not surprisingly, it was negative. Of course, as I like to say, if a treatment is claimed to work for almost everything, it probably works for nothing, and acupuncture is just such a treatment. While I can imagine potential biological mechanisms through which acupuncture might decrease the perception of pain, no matter how tenuous and unlikely, they’re not homeopathy-level implausible. On the other hand, there’s no even remotely plausible known mechanism by which acupuncture could have an effect on IVF success rates. Indeed, I even mocked the section of the paper that speculated about potential biological mechanisms as “woo babble” (like Star Trek technobabble, but with woo instead of science and technology).

In any event, Dr. Giovanardi wrote a letter to JAMA about the study and why he thought it had so many flaws that its conclusion that acupuncture doesn’t increase IVF success rates. Indeed, he’s peeved, and peeved that JAMA didn’t publish his letter:

The authors themselves identify five limitations to their study; however, in spite of them, they reach a definite and clearly stated conclusion (‘These findings do not support the use of acupuncture when administered at the time of oviarian stimulation and embryo transfer to improve the rate of live births’) which leaves no doubt as to the total inefficacy of acupuncture to improve birth outcomes among women undergoing IVF. Such a strong statement, therefore, is being supported by a trial, the limitations of which have been identified but not overcome.

I am sure we all agree on one point, namely that a methodologically incorrect article brings about misleading results which affect the choices of both medical doctors and patients; that’s why I wonder how the conclusions reached can be useful to acupuncturists and patients who decide to choose acupuncture as a therapy.

Methinks Dr. Giovanardi doth protest too much. When a study is negative, as this study was, this is what you write in the conclusion, that your study doesn’t support the use of the intervention for the condition for which it was tested in the clinical trial—because it doesn’t. That’s the conclusion for that one study. In general, such a statement doesn’t show the “total inefficacy” of any intervention, just the failure to find efficacy for that intervention in that study. Dr. Gionavardi appears to be reading more into the conclusion than a normal doctor would, mainly because, of course, he’s not just a physician but an acupuncturist. Hell, he’s the president of not just one, but two, Italian acupuncture associations! He also seems not to notice that the authors basically twist themselves into pretzels to try to make excuses for their result.

Indeed, Dr. Giovanardi latches on to the issue of the placebo control. In this particular study, non-penetrating sham acupuncture needles known as the Park sham needle. It’s a device with a retractable needle shaft and blunt tip. The sham needles were also placed in non-acupuncture points for the same duration as the “true” or “verum” acupuncture. Now here’s what Dr. Gionavardi doesn’t like about this:

My analysis starts with the generally accepted principle that no skin stimulation is inert, which implies that ‘sham acupuncture’ cannot be inert: any skin stimulation brings about central and peripheral responses (Birch S., A review and analysis of placebo treatments, placebo effects, and placebo controls in trials of medical procedures when sham is not inert, J Altern Complement Med, 2006). Effects have been observed when using non-needle sham, penetrating sham needles and non-penetrating sham needles, although they were different in size (MacPherson H., Influence of control group on effect size in trials of acupuncture for chronic pain: a secondary analysis of an individual patient data meta-analysis, PLos One, 2014).

The authors say that sham acupuncture can lead to weak physiological effects and the sham needle has been shown to stimulate different brain activity than acupuncture: this means, they recognize and accept the fact that sham treatment is not inert.

This argument amuses me to no end. The reason is simple. Dr. Giovanardi basically making the same point that skeptics have been making about acupuncture all along. It doesn’t matter where you stick the needles or even if you stick the needles in. That’s basically what he’s arguing by criticizing the use of sham needles as placebo control, particularly in this case because not only were these sham needles placed in nonacupuncture points but didn’t penetrate the skin. Accepting Dr. Giovanardi’s argument basically requires accepting what skeptics say about acupuncture; i.e., that it is nonspecific and nothing but a theatrical placebo.

Dr. Giovanardi then goes on with a bit of prestidigitation:

At the same time, their study addressed whether acupuncture was more efficacious than a placebo. This appears to be a contradiction in terms: how can sham acupuncture be defined as a placebo treatment? Placebo means being inert, by definition, whereas sham acupuncture is not, according both to the literature and to the article. Effects may be minimal, as researchers assume, but as a matter of fact such outcomes cannot be assessed, and therefore any speculation is possible.

Again, Dr. Giovanardi is basically arguing against the precepts of acupuncture here. Acupuncture claims that there are “meridians” through which “qi” flows and whose flow is redirected by the needles to healing effect. He’s in essence denying the results of the study by denying that there’s anything to the precepts of acupuncture. Seemingly realizing this, he quickly pivots:

First, if they decide to ‘minimize’ the effects, they admit that the effects are not only present but also remarkable and – let me repeat it –their impact cannot be assessed. Second, according to the Traditional Chinese Medicine, there are no points with no function, the whole skin being able to trigger physiological responses, as it is clearly revealed by the functions of the cutaneous regions called pí bù in Chinese (Maciocia G., The foundations of Chinese medicine: a comprehensive text for acupuncturists and herbalists, 1989; Ching N., The fundamentals of acupuncture, 2016).

This is the first I’ve learned of this. Acupuncturists will argue endlessly over which acupuncture points are best for what condition and which system of meridians to use; yet here Dr. Giovanardi seems to be admitting that even acupuncture itself teaches that it doesn’t matter where you stick the needles, all of which makes me wonde: Why do we need acupuncturists, anyway, then? Obviously, we don’t, because acupuncture remains quackery, but even if it weren’t I’m learning here that there’s no skill needed. Acupuncture is a pseudo-skill; that is, unless you count the theatrics needed for its theatrical placebo effect.

It’s a principle of clinical trials that you try to do your best to isolate the specific intervention being studied. In the case of acupuncture, the intervention is, well, acupuncture. But how does one define acupuncture? If it’s just sticking needles somewhere in the skin, then anyone can do it. Therefore, anything we consider “acupuncture” must conform to what acupunctures say it is and where they say the needles should be placed. The way to isolate acupuncture, then, must involve some form of “sham acupuncture,” be it needles placed in nonacupuncture points or sham needles that don’t penetrate the skin. In this case, the investigators chose both. Now, one can argue that it’s still worthwhile to include a no-needle “usual care” control, and if this were a study for which the primary outcome were not such a “hard measure” (i.e., pregnancy versus no pregnancy, live birth versus no live birth), I’d be more inclined to agree. Also, the authors had a pretty good reason for not including an “usual care” control, noting that their pilot study indicated that women would decline randomization in a trial that included a no-acupuncture, no sham acupuncture group. Personally, I have no problem with including such an additional control, except that it would add to the cost of the trial.

Of course, I’m also neglecting to note that I have a problem with even doing this trial to begin with, given all the negative evidence, some of which I’ve discussed over the years going back to 2008, that acupuncture has any effect on the success rates of IVF procedures. Remember that, according to the Declaration of Helsinki, it is unethical to do a clinical trial without robust preclinical evidence in basic science and animal studies to justify doing it.

But Dr. Gionavardi isn’t done yet. Oh, no:

Minimal, superficial, sham, or ‘placebo’ acupuncture have been thoroughly investigated: it has been demonstrated that light touch of the skin stimulates mechanoreceptors coupled to slow conducting unmyelinated (C) afferents resulting in activity in the insular region, but not in the somatosensory cortex. Activity in these C tactile afferents has been suggested to induce a ‘limbic touch’ response resulting in emotional and hormonal reactions. It is likely that, in many acupuncture studies, control procedures that are meant to be inert are in fact activating these C tactile afferents.

Perhaps, but Dr. Gionavardi neglects to present any evidence that these effects result in any detectable effect on the outcome being studied, namely IVF success rates. Of course, his concern is, not surprisingly given the utterly negative study he’s criticizing, this:

Sham acupuncture may introduce bias against the treatment being tested and I share Lund’s point of view when she affirms that minimal acupuncture is not valid as an inert placebo-control despite its conceptual brilliance (Lund I., Minimal acupuncture is not a valid placebo control in randomised controlled trials of acupuncture: a physiologist’s perspective, Chin Med, 2009).

In conclusion, an important risk of bias exists in this study and what it actually lacks is a true control group (a care alone group). As already suggested by Zheng (Zheng C.H., Effects of acupuncture on pregnancy rates in women undergoing in vitro fertilization: a systematic review and meta-analysis, Fertil Steril, 2012), sham acupuncture (Streitberger control) may not be an inactive control. More positive effects from using acupuncture in IVF can be expected if an appropriate control and more reasonable acupuncture programs are used.

Sure, and the Tooth Fairy might actually exist.

Basically, as we see all too often whenever a rigorously designed acupuncture trial produces a negative result, true believers find a way to discount it. Their belief is total, and, in their minds, there is no way that a result as resoundingly negative as this one could be correct. So they always find a rationale to discount the study, even if their rationale contradicts the rationale for their own “specialty” of acupuncture.

Theatrical placebo, indeed. Same as it ever was. Sadly, that doesn’t stop academic medical centers from selling this quackery, including the one where I did my general surgery training. That’s the same as it ever was, too.