CAM, placebos, and the new paternalism

Three and a half years ago, I bought a new car. The reason why I mention this as a means of beginning this post is because that car had something I had never had in a car before, namely Sirius XM satellite radio preinstalled. Curious, I subscribed, and I now barely listen to regular radio anymore. A couple of years after I had bought the car, a new channel was added to the lineup, a channel called Radio Classics. I don’t know how I discovered it, but I rapidly became hooked on what’s commonly referred to as old time radio. Basically, that’s classic radio of the sort that was broadcast between the 1920s until around 1962, when the last of the scripted radio dramas and comedies that were so popular went the way of the dodo with the final broadcast of a couple of my now favorite old time radio shows, Suspense and Yours Truly, Johnny Dollar. (For any other geeks like me, my favorite episodes were the ones starring Bob Bailey as Johnny Dollar.) It’s true that some of these shows were truly cheesy (how on earth anyone could think The Shadow anything other than pure silliness, I don’t know, but I was shocked to learn that Orson Wells played Lamont Cranston, a.k.a. The Shadow, in quite a few episodes), but some were really, really good, such as the aforementioned Yours Truly, Johnny Dollar, as well as Gunsmoke, Dragnet, The Six Shooter, The Adventures of Sam Spade (the Howard Duff episodes, of course), and The Whistler. I also learned that Abbot and Costello had a hilarious radio series in the 1940s and that Jack Benny was actually quite funny as well.

Another thing I learned as I explored this decades-old world is how much medicine has changed. Primarily I learned this from listening to old episodes of The Story of Dr. Kildare, a radio show that ran in the 1950s. The way medicine is practiced these days might well have many, many problems, but listening to how Dr. Kildare was represented one thing I learned was that paternalism was far more prevalent in the 1950s than it is now. Yes, I know, big surprise (although it was refreshing to hear physicians call a quack a quack), but listening to some of these episodes is very jarring to a physician practicing in 2012. For instance, I recall one episode where a patient was not told she had a terminal cancer until the end was near and there was no choice. The other aspect of the series that’s amazing to a physician practicing in 2012 is how little concern is given to the discussion of alternatives, informed consent, or anything else having to do with patient autonomy. In general, doctors told patients what needed to be done and they did it, with little questioning. How much of this was due to how the writers perceived how medicine was practiced and how much of this was a seemingly accurate portrayal of how medicine was practiced is hard to say (after all, how much of Grey’s Anatomy is accurate?), but there is other evidence. For example, until around 40 or 50 years ago, it was considered ethical to prescribe placebos. In general, it no longer is.

Which brings me back to “alternative medicine,” “complementary and alternative medicine” (CAM), “integrative medicine” (IM), or whatever you want to call non-science-based medicine that has infiltrated scientific medicine and academia over the last couple of decades. Last week, I mentioned how we’ve seen a rash of credulous reporting about placebo responses over the last month or so. I singled out one article in particular, but that was not the only article. In any case, what I lamented was the “rebranding” of pseudoscientific CAM remedies as means of “harnessing the placebo effect,” noting that one shouldn’t need pseudoscience to maximize placebo effects if they are real. There is, however, another consideration that I see, and that’s paternalism. And I’m starting to agree with Kimball Atwood when he proclaims that CAM is the “new paternalism.” I’ve already alluded to such concepts before, such as when I countered an attack against science-based medicine as being paternalistic because of its reliance on science or when I pointed out the “misinformed consent” that antivaccine activists and CAM boosters seem to be advocating in the name of a false “health freedom” that actually subverts patient autonomy. A couple of weeks ago, there was a rather interesting study published that led me to think on these matters again.

Power and authority versus empathy in placebo effects

All too often, “placebo” seems to mean exactly what people choose it to mean, no more, no less (apologies to Lewis Carroll). In reality, a placebo is nothing more than “a substance or procedure a patient accepts as medicine or therapy, but which has no specific therapeutic activity” or, as Wikipedia now defines it, “simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient.” This strikes me as a better definition than the old definition because it emphasizes that placebos are medically ineffectual and that they involve deceiving the patient. Indeed, the necessity of deception is part and parcel of placebo use, which is one key reason why using placebos has fallen out of favor. Using placebos outside of a clinical trial is now generally considered at best paternalistic and at worst downright unethical, because it violates informed consent and patient autonomy. Sixty or seventy years ago, it was considered acceptable for physicians to deceive patients that way. in 2012, not so much.

In any case, what we call the “placebo effect” is not a single effect, and it has many components. Placebos are actually best viewed as a rather artificial tool used in clinical trials to control for nonspecific effects. There are expectation effects, in which patients experience what they are led to expect to experience. There are effects due to observation. Patients in clinical trials almost always do better than those not in clinical trials, thanks to the closer attention and more rigorous treatment protocols. This has sometimes been referred to as the “clinical trial effect,” and both patients and doctors often unconsciously modify their behavior based on their knowledge that they are being observed, an effect known as the Hawthorne effect. Then there are effects due to reporting, which can introduce bias. There are effects due to regression to the mean, which describes how patients interact with the natural waxing and waning of their symptoms. When their symptoms are at their worst is when patients will tend to try a treatment. Because most symptoms will wax and wane, even if nothing is done there’s a good chance that a patient’s symptoms will “regress to the mean” on their own even if the patient does nothing. However, if a patient has taken a remedy, even a placebo like homeopathy, at a time when their symptoms are at their worst, it’s very common for them to attribute their improvement to the medication. Correlation, of course, does not equal causation. In any case, depending on the timing of the clinical trial’s measurement, regression to the mean can play a role in placebo effects.

Given how complex placebo effects are and how many different variables determine the magnitude of placebo effects, it should not be surprising are a whole host of other factors that determine how strong a placebo effect will occur in any situation. Surgery and invasive procedures are more powerful placebos than pills, for instance. More expensive placebos tend to produce stronger apparent effects. Indeed, there’s a whole hierarchy of placebos, and placebo effects can be enhanced by things like empathy and the doctor-patient relationship. Traditionally, it’s been believed, based on a number of lines of evidence, that practitioner empathy has a major effect on placebo effects.

Just last month a group out of the University of Southhampton published a rather intriguing study that somewhat challenges that paradigm. The study, which was published as an E-pub ahead of print last month is entitled Practice, practitioner, or placebo? A multifactorial, mixed-methods randomized controlled trial of acupuncture. Its conclusions are a mixture of the provocative and the mundane (i.e., in line with what we already know). It’s a rather complicated study to explain because its design is rather complex, which opens it up to concerns on my part that it’s a bit too complicated to draw firm conclusions from. Let’s start with the abstract:

The nonspecific effects of acupuncture are well documented; we wished to quantify these factors in osteoarthritic (OA) pain, examining needling, the consultation, and the practitioner. In a prospective randomised, single-blind, placebo-controlled, multifactorial, mixed-methods trial, 221 patients with OA awaiting joint replacement surgery were recruited. Interventions were acupuncture, Streitberger placebo acupuncture, and mock electrical stimulation, each with empathic or nonempathic consultations. Interventions involved eight 30-minute treatments over 4 weeks. The primary outcome was pain (VAS) at 1 week posttreatment. Face-to-face qualitative interviews were conducted (purposive sample, 27 participants). Improvements occurred from baseline for all interventions with no significant differences between real and placebo acupuncture (mean difference −2.7 mm, 95% confidence intervals −9.0 to 3.6; P = .40) or mock stimulation (−3.9, −10.4 to 2.7; P = .25). Empathic consultations did not affect pain (3.0 mm, −2.2 to 8.2; P = .26) but practitioner 3 achieved greater analgesia than practitioner 2 (10.9, 3.9 to 18.0; P = .002). Qualitative analysis indicated that patients’ beliefs about treatment veracity and confidence in outcomes were reciprocally linked. The supportive nature of the trial attenuated differences between the different consultation styles. Improvements occurred from baseline, but acupuncture has no specific efficacy over either placebo. The individual practitioner and the patient’s belief had a significant effect on outcome. The 2 placebos were equally as effective and credible as acupuncture. Needle and nonneedle placebos are equivalent. An unknown characteristic of the treating practitioner predicts outcome, as does the patient’s belief (independently). Beliefs about treatment veracity shape how patients self-report outcome, complicating and confounding study interpretation.

It’s probably easier to borrow the figure in the paper that explains how this study was laid out (click on the image to enlarge):

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Note how this design results in eighteen different experimental groups, based on three practitioners treating patients either with the “empathic protocol” or the “non-empathic” protocol, each of which is further divided into groups of real acupuncture, sham acupuncture (Streitberger placebo acupuncture technique), or mock electrical stimulation. It is these groups that were analyzed in different combinations (for example, empathic versus non-empathic, sham versus real acupuncture, practitioner 1 versus practitioner 2 versus practitioner 3). In the end, there were 221 patients randomized, and each small experimental group ended up with between 5 and 20 subjects, for a total of 221 patients. To assess for possible confounding factors, investigators also recorded “attitudes towards complementary medicine holistic complementary and alternative medicine questionnaire (HCAMQ),” empathy consultation and relational empathy (CARE) questionnaire, analgesic intake (tablet count), and needling sensation. Patients were also given a daily pain diary (100 mm visual analogue scale VAS) to complete for 7 (pretreatment) days and during treatment. Finally, patients were asked at treatment completion, “Do you think the treatment you had was real” and required to give a simple yes or no answer. One strength of the study is that high percentages of subjects believed (75% to 96%, depending on group) that they were receiving “real” treatments.

Let’s start with the unsurprising result of the study. Basically, it was found that all three main groups, real acupuncture, sham acupuncture, and mock electrical current, all experienced a decrease in pain and that there was no difference between them. This result is, of course, completely consistent with what studies have found time and time again about acupuncture, namely that it performs no better than placebo. Similarly, the observation that belief in the therapy (i.e., belief that the subject was receiving “real” therapy and that that therapy would be effective) was correlated with improved outcomes in pain was expected and consistent with previous literature about placebo responses. The result that was surprising was that there was no reported difference between patients receiving empathic and non-empathic treatment. This finding the authors reported, was unexpected. But what does it mean?

In this study, empathic treatments were described thusly:

Empathic (EMP) consultations were deemed to be normal pragmatic treatment sessions. Patients were greeted in a friendly, warm manner and were free to enter into conversation with their practitioner, who in turn would willingly do so. Practitioners did their utmost to comply with participants’ wishes, providing detailed answers to questions and emphasising patient comfort and well-being.

Non-empathic interactions consisted of this:

This encounter was more “clinical” in nature. Patients were greeted in an efficient manner and quietly shown to the treatment cubicle. Practitioners would only discuss matters directly relating to the treatment to enable them to effectively carry out that treatment, e.g., pattern of pain and side effects. Necessary explanations were kept as short as possible, and if patients attempted to enter into any discussion, the practitioner would respond using the words “I’m sorry but because this is a trial I am not allowed to discuss this with you.” Between needle stimulations, patients were left on their own in a curtained cubicle.

Based on previous results, we would expect beforehand that patients receiving the empathic consultations would report more pain relief, but such was not the case in this study. The authors speculated quite a bit about why this was, from their questionnaire not reflecting empathy adequately to a rather interesting potential confounder in which patients made excuses for the non-empathic interactions:

Participants in empathic consultations described practitioners as caring, friendly, and communicative. Those in nonempathic consultations undertook a little more work to explain their similarly positive views of their practitioners. Thus interviewees who had received nonempathic consultations talked about how they colluded with the practitioner to obey the study rules and have limited personal interactions. They suggested that the practitioners were not really nonempathic, they were just acting that way for the sake of the trial. For example, “I had the feeling that she sort of felt that you know, not being able to converse properly, that she felt a bit awkward about it” (Betty, nonempathic).

To me this suggests that patients really, really want to believe that their practitioners care about them and will go to great lengths to align their interpretations of observed behavior with that belief so that perhaps empathy isn’t as powerful an inducer of the placebo effect as we might expect.

Another intriguing result of this study was the observation of a definite practitioner effect independent of consultation type. Specifically, one practitioner (Practitioner 3) produced consistently better outcomes across all treatment and consultation types. The investigators report that this was observed “in spite of all the meticulous care and planning taken to ensure consistency of treatment delivery among the three practitioners.” Why was this? It wasn’t empathy, but rather it was something that wasn’t being measured in the study design, something unknown. The authors couldn’t identify it, but they did speculate that it has to do with patients viewing Pracitioner 3 as being more authoritative, expert, and confident:

The qualitative data suggested that the interviewees perceived practitioner 3 as a paternalistic male authority figure. Practitioner 3, as the primary investigator, might have been seen by patients as the expert, consequently establishing higher expectations of success, which in turn influenced outcome. Although this is consistent with previous research [10] and [29] a larger explanatory study involving many practitioners is needed.

This was in contrast to Practitioner 1:

Interviewees referred to Practitioner 1 by her first name and as a “girl” and a “young lady,” and some described her using affectionate terms such as “sweet.” Practitioner 3 was referred to as “Doctor,” was never referred to by his first name, and was typically described in more respectful than affectionate terms, including “courteous” and “formal but friendly.” Participants seem to have seen practitioner 3 as more authoritative than practitioner 1.

This is, of course, an observation that opens a can of worms that will be very difficult to deal with. Clearly, more research needs to be done to confirm and expand on these results, but it shouldn’t be surprising that a more authoritative practitioner, who can project an air of confidence and expertise, might be better at affecting a patient’s perception of his or her illness. As I mentioned above, Kimball Atwood once referred to integrative medicine and patient-centered care as the “new paternalism.” I chuckled when I read Atwood’s take on the issue, but I have to admit that he is probably more correct than I had wanted to admit. Certainly, the “health freedom” movement, as much as it cloaks itself in rhetoric suggesting that it is trying to “empower” patients to “take control” of their health, in actuality denies them the most important tool to do that: An honest, science-based appraisal of the rationale behind a proposed treatment, along with an assessment of its potential benefits and risks based on science, not fantasy. Instead, it substitutes tooth fairy science, pre-scientific vitalism, and utter faith in the practitioner for science and reason.

It’s hard not to wonder whether the more modern constructs in medicine that involve truly informed consent and respect for patient autonomy are now coming into direct conflict with the apparent vision of proponents of “harnessing the placebo effect,” such as Ted Kaptchuk and Daniel Moerman, who apparently see physicians as shamans whose interactions with patients are as powerful at healing as the medications and procedures they have at their disposal. Their vision of what medicine should be would fit quite nicely in an old episode of The Story of Dr. Kildare.