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Acupuncture for Depression

One of the basic principles of science-based medicine is that a single study rarely tells us much about any complex topic. Reliable conclusions are derived from an assessment of basic science (i.e prior probability or plausibility) and a pattern of effects across multiple clinical trials. However the mainstream media generally report each study as if it is a breakthrough or the definitive answer to the question at hand. If the many e-mails I receive asking me about such studies are representative, the general public takes a similar approach, perhaps due in part to the media coverage.

I generally do not plan to report on each study that comes out as that would be an endless and ultimately pointless exercise. But occasionally focusing on a specific study is educational, especially if that study is garnering a significant amount of media attention. And so I turn my attention this week to a recent study looking at acupuncture in major depression during pregnancy. The study concludes:

The short acupuncture protocol demonstrated symptom reduction and a response rate comparable to those observed in standard depression treatments of similar length and could be a viable treatment option for depression during pregnancy.

Plausibility

The study compared acupuncture designed specifically to treat depression, and in fact tailored to the individual patient, according to principles of Traditional Chinese Medicine (TCM). This was compared to two control groups – a control acupuncture that was not specific to depression and massage. The comparison to massage was obviously not blinded and therefore, in my opinion, of very little value as depression is highly susceptible to non-specific therapeutic effects and both interventions – acupuncture and massage – would be likely to create such non-specific effects.

The interesting aspect of this study is the comparison between treatment acupuncture (targeted for depression) and control acupuncture (not targeted for depression). The purpose of the study was to control, as much as possible, for any other variables so as to determine if the underlying TCM principles have any validity – does it matter where the needles are placed?

We can really only put this study into context if we first consider the prior probability of this claim. I would argue that there is already a large body of acupuncture research that collectively shows needle placement as a variable has no effect on clinical outcome. This one study does little to alter the balance of that evidence.

Further, from a basic science point of view, the TCM principles have essentially no plausibility. The underlying theory is that there is an undetected life force (chi) that is partly responsible for health and illness, that acupuncture needles placed in specific acupuncture points alters the flow and strength of this energy, resulting in a clinical outcome. Chi has no existence in science, however. Vitalistic philosophies such as chi were discarded over a century ago as both unnecessary and without any empirical foundation.

Any modern attempts to explain acupuncture effects with known physiological phenomena might explain non-specific needling effects, but cannot explain any differences due to needle placement, and do not provide any explanation for the location of alleged acupuncture points.

Therefore, given the extremely low prior probability of the claims of this study, nothing short of a large rigorous and replicated study would alter our assessment of validity of acupuncture as a specific intervention.

The Current Study

This new study, published in the Obstetrics and Gynecology, is not of sufficient quality to justify the conclusions of the authors. The authors did do a decent job of trying to rigorously control the comparison between the two acupuncture groups. Subjects were blinded to which group they were in, as were those evaluating the outcome. Standard depressions scales were used. They even made a reasonable attempt to blind the acupuncturists, using a novel method (to my knowledge).

They had experienced acupuncturists design a treatment and control acupuncture regimen for each subject, and then had a “junior acupuncturist” (less than two years experience) perform the treatment without being told which one they were giving.

This, in my opinion, in the crux of the methodology – were the treating acupuncturists properly blinded. The study authors took the very useful step of assessing the degree of blinding of the acupuncturists and the subjects. Unfortunately for the validity of the study, they found that the treating acupuncturists were significantly more likely to have positive expectations for the treatment group than the control group – so their blinding methods failed with respect to the treating acupuncturists. The study was therefore, at best, single blinded. Test subjects did not have any significant difference in expectations.

Because depression is so amenable to non-specific therapeutic effects, the expectations of the treating acupuncturist can plausibly have had a significant effect on the final outcomes. This is the primary weakness of the study – but there are other worth mentioning.

The author also, for some reason, did not stratify the test subject according to race, and there turned out to be significantly more African Americans in the control acupuncture group than the treatment group. Cultural beliefs can have a significant effect on responses to different kinds of placebos, particularly needles. This is therefore a potential, if unknown, confounder.

The results were also not impressive. The study used the Hamilton Rating Scale for depression:

Interpretation of Hamilton Rating Scale for Depression scores is as follows: less than 7, nondepressed; 8–13, mild depression; 14–18, moderate depression; 19–22, severe depression; more than 23, very severe depression.

At 8 weeks the control acupuncture groups has about a 9 point drop in the scale, while the treatment acupuncture group dropped 11.5 points. On this scale that is a modest clinical effect. There was also no difference in remission rates among the three groups. In addition this was a relatively small study (141 treated in total, divided among the three groups) with a 23% drop out rate.

Conclusion

Therefore we have a small and improperly blinded and randomized study showing a modest clinical effect. This does not significantly alter the low prior probability of a treatment effect from needle placement.

This study should also be considered in the context of other trials looking at acupuncture and depression. This very recent Cochrane review concluded:

We found insufficient evidence to recommend the use of acupuncture for people with depression. The results are limited by the high risk of bias in the majority of trials meeting inclusion criteria.

Specifically – there was no difference between verum acupuncture and sham acupuncture in the clinical trials reviewed.

Given the low plausibility and overall negative character of the clinical evidence, it is reasonable to conclude that no further research into acupuncture for any indication is warranted. However, acupuncture is a modality with dedicated practitioners (acupuncturists) and proponents (by contrast, for example, there is no medical specialty dedicated to a particular drug – there are no penicillinists). And therefore it is likely that further research will be conducted.

In that event, given existing research, it would be useful to conduct only highly rigorous trials, using sham and/or placebo acupuncture (where the needle or fake needle does not penetrate the skin) with adequate blinding. Such trials would need to be large with consistent replicated positive results in order to have sufficient weight to overturn the current mass of basic and clinical evidence.

Posted in: Acupuncture, Clinical Trials, Neuroscience/Mental Health, Obstetrics & gynecology

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144 thoughts on “Acupuncture for Depression

  1. ceekay says:

    Re plausibility of acupuncture meridians and points:

    there are some interesting studies by Langevin suggesting acupuncture meridians and points have unique physiological properties including location at intramuscular connective tissue planes.

    And the actually effect of needle rotation in an acupuncture point elicits very specific surprising effects on connective tissue remodelling that may initiate broader signalling cascades.

    The significance of these findings is still unclear but the authors are also looking at the broader question of signalling in the connective tissue fascial system in a manner that might be analogous to glia in the brain, since some connective tissue cells play a similar structural role to glia in providing scaffolding for nerve cells in the periphery (glia have recently been associated with surprisingly robust calcium signalling functions in the brain).

  2. Ian says:

    (Re: the conclusion) Isn’t one of the tenets of SBM that it doesn’t make sense to do a study to test a treatment which has no plausible method to work.

  3. I didn’t read the whole study but I felt the massage group was unnecessary at best and deceptive at worst. It seems that they frequently focused on the comparison of the treatment group to the “combined control” group rather than to the control acupuncture group, which makes me think they are trying to enhance their results by dragging the control numbers down by including the totally unblinded massage group.

    It seems obvious that there is very great potential for the unblinded massage group to influence the control group results up or down.

    At the very least, including an unblinded “control” like massage introduces an unknown confounder. You can’t expect the placebo response for massage to be similar to control acupuncture, and you can’t expect the massage group to not have an actual therapeutic response either.

    I’ve seen this before where an acupuncture study included an extra, unblinded and seemingly unneeded “control” group to their study. The last study I saw like that used the extra group to conclude that their “control” was also effective rather than their treatment was no more effective than placebo.

  4. ceekay – these kinds of studies amount to little more than anomaly hunting – yeah, stuff changes when you stick a needle in it. But these do not provide plausible mechanisms for the claimed clinical effects. Also, there is no plausible connection between TCM acupuncture points and physiology.

  5. Harriet Hall says:

    From anatomy classes in medical school, I know that the exact location of things like the end branches of nerves and blood vessels is highly variable from one individual to the next. The same spot on two people’s legs can be innervated by L4 in one person and by L5 in the other. I can’t believe that practitioners could be capable of finding exact acupuncture points with any degree of accuracy. If the “de qi” sensation is important in verifying the proper location, I would expect many failures to find it, requiring many re-insertions.

    I love the analogy with “penicillinists”!

  6. Noelley B says:

    Massage sounds like a horrible control group. As someone with rather crippling depression, I have to say that getting a massage on a regular basis sounds like a heavenly way of combating my anxiety and low mood. Anecdotal evidence and all that, but it certainly sounds like a better time than getting poked with tiny needles.

  7. I love the analogy with “penicillinists.”

    Exactly my response. “CAM” begins with interventions and looks for indications; real medicine begins with diagnoses and chooses the most appropriate interventions, and biomedical research searches for better interventions. That’s why all but one of the NIH sub-institutions and centers are named for diseases or organ systems (cancer, diabetes, infectious disease, heart/lung/blood, etc.). The exception is the NCCAM. Imagine the hue and cry from anti-modern medicine paranoiacs if an NIH affiliate were named “the National Institute of Coronary Artery Bypass Surgery” or the “National Center for Electroconvulsive Therapy.”

    What I find particularly impressive about this article is a gem of a phrase right out of the Weasel Words of Woo: “acupuncture specific for depression.” Hmmm: I can’t find “depression” in the Yellow Emperor’s Classic of Internal Medicine.

  8. ceekay says:

    Steve: “Also, there is no plausible connection between TCM acupuncture points and physiology.”

    Steve, I’ve just offered what may be a plausible account: mechanical changes in connective tissue may initiate specific changes in neural and immune measures (and these, btw, may be related to inflammatory cytokines that are implicated in depression). Obviously, this is only a hypothesis that requires empirical testing. Any test of the hypothesis requires a complex progression of studies involving in vitro, animal and human studies.

    But, given that we don’t know what sorts of answers these studies might find, are you asking us to prejudge them in advance?

    Harriet: “The exact location of things like the end branches of nerves and blood vessels is highly variable from one individual to the next… I can’t believe that practitioners could be capable of finding exact acupuncture points with any degree of accuracy.”

    Harriet, I agree. Many studies have shown that acupuncturists only achieve rough agreement on point location. I guess the question is whether acupoints are broad target zones (in which case, exact topographical agreement might not matter) or are very exact point locations. My guess is that acupuncturists exaggerate somewhat the specificity of their needling techniques in order to burnish their apparent skills.

    My own hunch is that the effect of acupuncture may be derived from an enhanced placebo effect (that includes pulse-diagnosis as healing touch along with empathic interaction) along with some non-exact real acupuncture needling effect that comes from a connective tissue signalling mechanism.

    You can dismiss the components of acupuncture+placebo package as containing too much placebo to be treated seriously. When you add the entire treatment is does seem to produce positive outcomes in some people (and that is all the patient cares about).

  9. ceekay on what matters in acupuncture:
    “I guess the question is whether acupoints are broad target zones (in which case, exact topographical agreement might not matter) or are very exact point locations.”

    The fact that after 2200 years this question has still not been answered strongly suggests to me that none of it matters.

  10. Jayhox says:

    While I completely agree with Steve’s assessment of the article, his comparison between acupuncturists and “penicillinists” isn’t completely valid. For example, an oral surgeon defines him/herself by a treatment modality as opposed to a specific disease. The key is for said practitioner to ascertain which diseases/conditions are best treated or managed by the modality in which they are trained. Taking out a wisdom tooth won’t do much for appendicitis, but it’s great for getting rid of a wisdom tooth infection!

  11. ceekay says:

    “The fact that after 2200 years this question has still not been answered strongly suggests to me that none of it matters.”

    This seems like a superstitious attitude…. Imagine if we approached cancer or alzheimers this way, “no answer yet… must not matter”…

    What if Prusiner had approached Kuru, the prion disease afflicting Papua New Guinea tribesmen, this way?

    Traditional accounts of acupuncture matter. But why should our scientific understanding of mechanism be bound to these earlier ideas?

  12. ceekay,

    I don’t know how long we’ve been clubbing seal pups in Canada but I do know that crushing their skulls is universally acknowledged to kill them. There is no debate as to whether crushing the tail might work as well. It’s the head. I suspect it didn’t take seal-pup clubbers very long to figure out the best spot because the outcomes were so obvious. Say, less than an hour.

    If acupuncturists have been trying to figure out the best spot to aim their needles at for 2200 years and still haven’t managed to, that suggests that the outcome they are looking at is so subtle as to be nonexistent.

    There is no evidence that the placement of acupuncture needles matters in the least. There is no evidence that puncturing the skin matters in the least. Tapping people randomly with toothpicks seems to work just fine to help them feel better. Ditto waving your hands around in the air and calling it Reiki. Ditto supplying them with complicated homeopathic regimes to keep themselves busy.

  13. Looking for a mechanism seems premature when there is no compelling evidence acupuncture works beyond placebo.

    An alleged connective tissue mechanism would not explain why there are supposed to be different acupuncture points relating to different symptoms – that is my point.

    Jayhox – I agree that some specialists have areas of treatment expertise. For example – surgeons use surgery – although no particular surgical procedure, and they can also prescribe medicine or any other intervention. Broad areas of treatment expertise are fine.

    The only specialty I know of that is tied to a specific intervention is that of radiation oncology.

    But further keep in mind – treatment modality specialists are not primary care practitioners. They are not the first people making treatment decisions. Rather they have patients referred to them when their treatment may be indicated.

    This is all distinctly different from acupuncturists, homeopaths, and chiropractors.

  14. Jayhox says:

    I agree Steve. Thanks for clarifying and amplifying.

  15. EricG says:

    off topic, but whats the difference between chiro and acupuncture anyway…?

    http://www.guardian.co.uk/science/2010/mar/01/simon-singh-libel-case-chiropractors

    Anyone know any more about this? Looks like the evidence/science based community may enjoy some vindication after all

  16. Transmogrifier says:

    @ceekay

    If indeed there is some sort of inflammatory response to acupuncture, why is it such a panacea? The cytokine release is supposed to fix back pain, relieve depression, lower blood pressure, and everything else all at once? Certainly the medications we give often have effects on multiple systems, but very predictable, identifiable, and consistent effects. Random induction of inflammation doesn’t seem to fit there.

  17. Kausik Datta says:

    I saw this paper this past weekend and found several problems with it (I apologize if these have already been mentioned; I haven’t read through all the comments upthread yet). In addition to the problems Steven mentioned, I had a problem with the differentiation of acupuncture into specific and non-specific for depression. If I assume that sticking needles into the body actually does something (i.e. if I consciously set aside Steven’s prior plausibility criterion), it is not clear to me how the study ensured that needles stuck in “non-specifically” did not evoke physiological responses that “specific” needling produced. This seems to be corroborated by the rather modest outcome difference in the Hamilton scale, ~(-)11.5 in the specific, and ~(-)9.0 in the non-specific, or for that matter,
    ~(-)9.5 in the massage group, as well as by a Cohen’s d of 0.39 (which is in the range of a ‘small’ change) between specific acupuncture and combined controls. Yes, the authors have shown a statistically significant difference between specific and combined controls, but statistics is a function of numbers. The question is: is that significance biologically
    relevant?

    Secondly, their practice of combining the control groups (non-specific acupuncture with massage) is dubious. The modality of the massage has nothing in common with that of the acupuncture; why club those as a group and subject them to statistical tests that depend upon the sample size, unless both of the controls are expected to be completely ineffective and thereby provide a sharp contrast to the treatment group? This seems to be corroborated by the lack of any difference in outcome between the controls at week 4
    and very slight difference at week 8.

    Thirdly, the results section of the article was very poorly reviewed and edited, leaving very ambiguous statements that seem to mean quite different from what the authors intended. Two examples are:

    Exploratory mixed model analyses revealed a greater reduction in Hamilton Rating Scale for Depression scores in those receiving acupuncture specific for depression than in those receiving acupuncture not specific for depression (P<.05; Cohen’s d=0.46,
    95% CI 0.01-0.92) but no difference from those receiving prenatal massage (P=.13; Cohen’s d=0.33; 95% CI -0.10 to 0.76).

    This seems to indicate that the specific group had no difference with the massage group (Freudian slip?)

    …and

    Exploratory analysis revealed that the group receiving acupuncture specific for depression had a greater response rate than the group receiving acupuncture not specific for depression (P<.05; number needed to treat 3.9; 95% CI 2.2-19.8) but was not different from the group receiving acupuncture not specific for depression and prenatal massage (P=.20; number needed to treat 7.7).

    Look at the underlined group
    descriptions and tell me if it makes sense!!

    The authors indicate that the remission rates were not significantly different between the treatment and control groups. Besides, if one goes by the numbers in Table 3, the ‘specific’ acupuncture group reported a lot more of the side effects compared to the other groups. I didn’t see any effect size statistics on that!

    I was surprised (and oddly pleased) to see the use of effect size as a statistic in this study. Effect size is a descriptive statistic that measures the magnitude of relationship between two variables in a sample-based estimate of that parameter, without making a statement about the representation of that relationship in the population. While it effectively complements inferential statistics, such as p-values, and is useful in exploratory studies (which is what this study was billed
    as) and in meta-analyses, it does not prima facie indicate whether the observations are generalizable to the population or not. Standardized effect size measures, such as Cohen’s d (which is difference of two group means divided by pooled standard deviation; used in this study), may not have any biological significance when used in individual studies. Besides, the authors provided no justification for setting their study standard to a moderate/medium effect (defined as Cohen’s d of 0.5). For effect size measures, I would have liked to see Odd’s ratio and/or Relative Risk measures, which are standard for case-control studies and RCTs.

    In summary, despite a lot of fancy statistics (what David aptly
    described as statistical legerdemain), the study suffers from
    inadequacies (for instance, the insufficient blinding), and more
    devastatingly, absence of a strong and reliable outcome. Sadly,
    though, this study would be touted as proof positive of efficacy of acupuncture as therapy by hordes of pseudoscience-worshippers.

  18. Tsuken says:

    Thank you Dr Novella for writing about this – and thanks also to commenters for very useful comments. – Not that it’s surprising at all; I wouldn’t have expected acupuncture to be a helpful treatment, for all the reasons Dr Novella mentions.

    No doubt part of the impetus for this study is anxiety about pharmacological treatments during pregnancy. The thing is, there is much more anxiety about that than there is evidence for harm. A recent paper from American Psychiatric Association and the American College of Obstetricians and Gynecologists (my summary here: http://www.tsuken.co.nz/midweek-medicine-antidepressants-in-pregnancy/ ) goes through the available evidence – and highlights the gaps). Overall, we can do a lot that is safe and effective (recent flawed and over-generalising meta-analyses notwithstanding) to treat depression in pregnancy, without resorting to something like acupuncture.

  19. pmoran says:

    ceeekay: “Steve, I’ve just offered what may be a plausible account: mechanical changes in connective tissue may initiate specific changes in neural and immune measures (and these, btw, may be related to inflammatory cytokines that are implicated in depression). Obviously, this is only a hypothesis that requires empirical testing. Any test of the hypothesis requires a complex progression of studies involving in vitro, animal and human studies.”
    ———————————————

    As indicated by Steve, a scientific hypothesis has worth only so far as it provides the best explanation for generally replicable phenomena. A fail on that, I think.

    But I mainly wanted to remind you of strong contrary evidence for such a hypothesis, from a well-explored model of connective tissue “connections” i.e. surgical patients.

    We surgeons have been disrupting acupuncture points and meridia, in connective tissues or wherever else they may hide unfelt and unseen, for centuries. We have cut into them, excised them, widely disconnected them and even amputated them in large numbers, without producing the health effects that we might reasonably expect such actions to have under TCM theory.

    There are indeed physiological responses to surgical trauma, but they are very stereotyped. They lack the anatomical specificity TCM requires with both site of the stimulus and the target organ. They are invoked mainly by known humoral mechanisms, and they are specific for need to survive and to recover from tissue trauma.

    Some, such as endorphin release, may have broader roles in other contexts, even possibly explaining some of the responses to acupuncture and to placebos generally.

  20. Wallace Sampson says:

    “The study compared acupuncture designed specifically to treat depression, and in fact tailored to the individual patient, according to principles of Traditional Chinese Medicine (TCM)…

    Geting down to basics…Just what is the evidence for the existence of “acupuncture designed specifically to treat depression”?

    As hinted by Kim Atwood, one need not have gone through the entire writings of the Inner Canan of the Yellow Emperor, or through all the writings of those who preceded and followed, for that matter, for reference to specifically directed acupuncture.

    There isn’t any. Nor has there been a TCM claim for any.

    It should no longer be necessary to point out here that neither acupuncture, Chinese herbs, or any other TCM method was designed to treat any specific condition. TCM did not categorize diseases, let alone attempt to determine specific causes and specific treatments. [TCM methods are directed toward restoring a balance between the cosmos, the Earth, and the person - "nothing more, nothing less."]

    Specific assumptions have been made up by mostly European and No. American proponents, followed by immigrant Chinese to those areas. (As has been pointed out frequently by Unschuld, David Ramey, Bob Imrie, and lately here by Ben Kavoussis. And grudgingly, I’ve taught about this at Stanford for some 20 years, and have the honor of never having been called by the NCCAM and NCI awardees at Stanford, some of whom conceived and produced this worthless paper.

    Worthless? Well, maybe worth something, because…given 1) the high implausibility of acupuncture and 2) the lack of proof of prior existence of verum acupuncture, any difference between verum and controls should be assumed to be due to systematic or random error in the experiment.

    Thus the authors should search for the source of experimental error, not look for other ways to prove acupuncture efficiacy.
    WS

  21. BillyJoe says:

    “I’ve seen this before where an acupuncture study included an extra, unblinded and seemingly unneeded “control” group to their study. The last study I saw like that used the extra group to conclude that their “control” was also effective rather than their treatment was no more effective than placebo.”

    Yes, I remember the headline “True Acupuncture as Effective as Sham Acupuncture in the Prophylaxis of Migraine” which, of course, should have read: “Acupuncture No More Effective Than Placebo in the Prophylaxis of Migraine”.

  22. rork says:

    Yet again an SBM article reviews a paper but utterly fails to summarize the weight of the evidence of the study.
    You gave us the means of the treatment effects but no idea of the variability. It gives the impression of utter cluelessness/incompetence about how to judge evidence. I have to read the paper or rely on commenters like Datta to be told what the data actually looked like.

    Your statistics – it sucks. Get it together.

  23. apteryx says:

    The claim that acupuncture is “all placebo” depends on the assumption that if it did have any purely mechanistic, not culturally mediated biological activity, that activity would not be present in sham acupuncture, which often (though not always) provides similar results in clinical trials. However, I’ve seen on TV a generally anti-CAM program depicting the practice of sham acupuncture on a sample patient, who thought based on the sensation that she was being stuck with a penetrating needle. Clearly, there was some kind of stimulation of nerve endings going on, and I don’t think we know enough to rule that out as a biological source of pain relief. The fact that animal studies often show benefit for acupuncture hints that it might be.

    The other quibble I have is that doctrinaire SBM supporters speak of “placebo” as if all placebos were alike in their (limited) activity. We know that a sugar pill will produce less relief of arthritis pain than an analgesic, which provides both the placebo relief of the sugar pill plus a mechanistic pharmacological effect. However, it has been found repeatedly that acupuncture provides more relief of certain painful conditions than analgesic treatment. If the former is indeed “all placebo,” it must therefore have a super-duper-placebo effect, strong enough to exceed both the sugar pill’s placebo effect and the drug effect put together. If the only biological change you’re after is pain relief, and a super-placebo treatment may provide the greatest available relief (without any risk of wrecking your stomach or kidneys), why is that not the best option? Seems to me that your reasons for refusing to consider it are philosophical rather than practical/scientific, and my philosophy – I care about how well my pain is relieved, not about how that happens – is just as valid for me as yours is for you.

  24. Scott says:

    The claim that acupuncture is “all placebo” depends on the assumption that if it did have any purely mechanistic, not culturally mediated biological activity, that activity would not be present in sham acupuncture, which often (though not always) provides similar results in clinical trials. However, I’ve seen on TV a generally anti-CAM program depicting the practice of sham acupuncture on a sample patient, who thought based on the sensation that she was being stuck with a penetrating needle. Clearly, there was some kind of stimulation of nerve endings going on, and I don’t think we know enough to rule that out as a biological source of pain relief. The fact that animal studies often show benefit for acupuncture hints that it might be.

    Not really relevant. When the same effects may be obtained by random tapping with toothpicks, it’s completely unacceptable and unethical to penetrate the skin for the same end, as that’s a riskier operation.

    So the argument you’re making cannot justify the use of acupuncture.

  25. apteryx says:

    Certainly it can. Let us suppose for the sake of argument that the benefits of acupuncture are entirely psychological/cultural (i.e., “placebo”). Placebos are of course far safer than drugs. The rationale for automatically rejecting the use of placebos is that they are presumed to be less effective than standard treatments, which have the same placebo activity as well as (we hope) a mechanistic benefit. But in some cases, that’s not true: if your goal is relief of joint pain, acupuncture may be more potent than analgesics.

    And it is certainly less “risky”; tens of thousands of Americans die annually from using analgesic drugs as instructed, whereas I know of one death from acupuncture (some bizarre offshoot method that apparently used small skewers). It is simply ludicrous to suggest that acupuncture could be more dangerous than long-term analgesic use.

    If the CAM treatment is more effective AND safer than the standard treatment, a consumer’s choice to use it is adequately “justified.” Could acupuncture be made even safer still by switching to non-penetrating needles, acupressure, etc., without losing any of the benefit? Maybe, but to determine that it would be necessary to conduct studies that focused more on patient-centered efficacy than on blinding.

  26. pmoran says:

    Apteryx, yes, I agree! What you are suggesting is within the bounds of present scientific knowledge. In fact, studies are emerging as we speak suggesting that procedural placebos (with associated care) may perform as well as or better than drugs in real-world cost/risk/benefit terms. It will be at least a close-run thing in some settings, I think.

    The same methods don’t perform better than sham in other studies but that is asking a different question.

    The only reservation I have is that we don’t yet know whether “placebo responders” (a horrible term for an integral, unavoidable, nurturing aspect of medical care), including those who describe dramatic responses to dubious alternative methods are “really, really” better or whether they are exaggerating or lying or misinterpreting, for a number of plausible reasons.

    That aside, I think the evidence is suggestive enough to make us cautious, especially if we value patient autonomy to the degree we profess when condemning placebo use by doctors.

  27. Tsuken says:

    To a large extent I would argue that depends on what you mean by “placebo use by doctors”. I make a conscious effort whenever proposing a treatment plan, to try to maximise the non-specific effects of treatment. I try to instill hope, raise expectations, increase support, project confidence, and so on. Givewn that I do that while embarking on treatments that have evidence for specific efficacy, I don’t see there’s anything wrong with that. I’m not sure however that I would be so happy about doing all that while prescribing a pill or procedure (or whatever) that demonstrably lacked specific effect.

    … despite acknowledging that a good chunk of people who get better with the pills and potions are actually doing so through those non-specific effects, rather than the pills (or whatever) themselves. The thing is, we don’t know which of our patients will respond to the non-spcific (ok, placebo) effects, and which will need the physiological treatment. I submit in that instance it’s better to use an active treatment – while maximising all the rest of it as well.

  28. BillyJoe says:

    How is it any longer acupuncture when you can stick the needles in wherever you like and not even stick them in. Surely we need a different name here.

    But the problem is that it is unethical for a doctor (well anyone) to use a placebo and not inform the patient of this fact. This may not eliminate the placebo effect but it can compromise it.

    The other issue is the inadvertent (or deliberate) promotion of pseudoscience and the resultant conditioning of the population to accept pseudoscience of any type including those that are useless or even harmful.

  29. apteryx:
    “Placebos are of course far safer than drugs.”

    I see. So a chiropractic neck-cracking makes you feel better though non-specific effects, and even with the risk of stroke is far safer than which drug for which problem?

    Placebo surgery is of course far safer than… ?

  30. pmoran says:

    Alison, you are correct, but I was explicitly talking “in cost/risk/benefit terms”. That would preclude neck manipulation for headache, but not necessarily as a late resort for disabling neck pain not responding to other treatments with no otherwise clearly correctable pathology abd with fully informed consent. I am sure apteryx means somethign similar.

    Tsuken, it is taken for granted that there should be no superior evidence-based treatment on the same cost/risk/benefit standard.

    Billyjoe, there are benefits to patients having access to simple safe placebos, which you need to allow for when you start to weigh up the risks.

    There are also already certain safeguards, in that the public are demonstrably not as indiscriminate in the use of placebo CAM medicines as skeptics tend to think. In fact they do mainly use them where the mainstream lacks simple, safe, cheap and wholly reliable treatments.

    But this is strange territory for SBM, I know.

  31. rork says:

    Does this “shopping for placebos” attitude say we should take efforts to study which placebos or near-placebos are most effective? In this study you folks were complaining about comparing to massage, but that’s seems where you are going now (I had no trouble with making that comparison, it’s the conclusion where you need to watch your socks).

    How do we stop folks who want to offer very expensive placebos, which they never compare to cheaper ones?

    What claims do you make for the placebos? “Here’s a list of things you might want to consider, and I’ll just say nothing about the effectiveness, since your beliefs will lead you to the placebo best suited to you. I personally like shaman who calls herself Sofonda. She’s $300/hr.”

    I’m not being completely sarcastic, I want education. Is there a famous position paper?

  32. micheleinmichigan says:

    Boy, it would be nice if there were two separate words for placebo.

    One to describe the social/psychological effect of instilling hope, raising expectations, increasing support, projecting confidence, etc.

    One to describe a procedure or “sugar pill” that a doctor would recommend knowing it was a sham in order to illicit a placebo effect.

    It would make conversations much clearer or at least more brief.

    Regarding the social/psychological effect of a placebo, It is not inconcievable to me that different procedural placebos would have different pain response effects.

    For instance, a caring gentle massage could trigger hormones that signal relaxation, lower stress hormones. It’s possible being poked with needles may trigger more of a slight “thrill” or cortisol response (mild roller coaster exhilaration). Could one be more useful than the other in pain control?

  33. Scott says:

    One to describe the social/psychological effect of instilling hope, raising expectations, increasing support, projecting confidence, etc.
    One to describe a procedure or “sugar pill” that a doctor would recommend knowing it was a sham in order to illicit a placebo effect.

    Might I suggest “placebo effect” vs. “placebo treatement”, respectively?

  34. micheleinmichigan says:

    Oh, I didn’t see rork’s comment before I posted mine. Mine is not a response to his/her’s. Although reading it, it may seem so.

  35. micheleinmichigan says:

    # rorkon 05 Mar 2010 at 9:30 am

    “Does this “shopping for placebos” attitude say we should take efforts to study which placebos or near-placebos are most effective? In this study you folks were complaining about comparing to massage, but that’s seems where you are going now (I had no trouble with making that comparison, it’s the conclusion where you need to watch your socks).”

    I guess I don’t understand why you would approach it differently than other SBM medicine. You see an effect, you try to understand it. Perhaps with understanding you can increase positive results, lower risk. You look at risk, benefit, cost. You try to set up criteria for who will benefit and hierarchy of methods most likely to least likely to help.

    Just because it is a psychological response does not make it unscientific or completely unpredictable.

  36. micheleinmichigan says:

    scott said “Might I suggest “placebo effect” vs. “placebo treatement”, respectively?”

    Sounds good to me.

  37. apteryx says:

    Alison, I dislike the common habit of yelling “straw man” to dispose of disliked counterarguments, but there’s no other term for your argument above. Neck-cracking certainly has biological effects (including, sometimes, tearing arteries). I was speaking not of “things that have a placebo effect” – which include ALL medical treatments, even mechanistically effective drugs and surgeries – but of “placebos” specifically, i.e., a sugar pill as compared head-to-head against a pharmaceutical drug. Since the sugar pill has no significant bioactivity, it can have no significant side effects, and therefore it’s got to be safer than the drug (as virtually all drugs have side effects for some users).

  38. Fifi says:

    michele – “Regarding the social/psychological effect of a placebo, It is not inconcievable to me that different procedural placebos would have different pain response effects.

    For instance, a caring gentle massage could trigger hormones that signal relaxation, lower stress hormones. It’s possible being poked with needles may trigger more of a slight “thrill” or cortisol response (mild roller coaster exhilaration). Could one be more useful than the other in pain control?”

    You’re right in some ways, though what you’re actually proposing in the second instance isn’t really a placebo effect or a psychological effect. What you’re describing is a physiological effect, where the experience/psychological effect follows a physiological effect (rather than the other way around).

    I’d have to do some digging to find studies but I remember reading (and have seen) that eople who are very effected by the placebo effect tend to have a bigger response to a more dramatic treatment (this doesn’t mean more or less gentle or painful, it just means more ritual and bigger symbolic ojects/tools). We can’t entirely disentangle the placebo effect/response from ritual because it’s the ritual that creates the placebo response a lot of the time. Relaxation can be useful in pain management but for reasons that aren’t directly related to placebo effects and it’s much more useful for a patient to know why relaxation helps with pain management (and not everyone relaxes when being massaged, for some people it’s invasive and tension inducing to have people touching them).

  39. Scott says:

    Since the sugar pill has no significant bioactivity, it can have no significant side effects, and therefore it’s got to be safer than the drug

    There’s still some non-zero risk, though – contamination, for instance. And that’s entirely disregarding the point regarding the ethics – are you suggesting that doctors should tell patients it’s a placebo (in which case it will be less effective), or are you suggesting that doctors should lie to patients (please explain how that would be ethical, and simply not mentioning it is lying by omission)?

    Plus, the discussion was originally about acupuncture, which certainly has significant risks – puncturing the skin always has the potential for infection, and acupuncture generally does not include proper measures to guard against that.

  40. micheleinmichigan says:

    Whoops, I referred to pain management because of another set of comments in “Press Release” This post is regarding pregnant women and depression.

    So, some anti-depressants have a good history of showing no negative effects on fetuses. But some women either do not feel comfortable taking anti-depressant, may not want to tolerate the side-effects on top of pregnancy or are not lucky enough to respond to the saver medications.

    To re-orient my comments in that context any placebo effect treatment option would have to have some benefit over CBT or show some evidence to have benefit in addition to CBT.

  41. Fifi says:

    scott – “…are you suggesting that doctors should tell patients it’s a placebo (in which case it will be less effective)…”

    Actually, you can tell people that a treatment has no proven effect and is not better than a placebo but if they still believe it “works” then it will. Cognitive dissonance doesn’t effect everyone, some people don’t experience any dissonance when holding two contradictory ideas (or, they make up narratives to bridge the gaps or smooth over the contradictions).

    As we’ve seen here, people who desperately want to believe that their faith-based ideas or subjective beliefs are actually scientifically viable and objectively true will go to great lengths to create narratives that support their subjective beliefs (and this is very much the source of psuedoscience, people who are simply honest about their faith don’t need to construct pseudoscientific narratives to justifying their faith or calm the cognitive dissonance caused by the conflict between their faith, science and their own desire to consider themselves entirely rational). For instance, quantum woo is clutching at straws (and erecting strawmen) to try to build a viable scientific concept to support faith-based beliefs. It’s used by gurus and conmen to manipulate people who want the reassurance of faith and neat answers for life, the universe and everything but that don’t actually have the capacity to have faith (hence the pseudorational aspects so that people can pretend they’re not just indulging in magical thinking and a slightly more sophisticated sounding version of The Secret).

  42. micheleinmichigan says:

    “You’re right in some ways, though what you’re actually proposing in the second instance isn’t really a placebo effect or a psychological effect. What you’re describing is a physiological effect, where the experience/psychological effect follows a physiological effect (rather than the other way around).”

    Yes, you are right, or to add another layer here is how I imagined the process I’m describing: Fear of a potential danger (psych) Cortisol response (physio) Thrill sensation (psych).

    For example: I used to do martial arts. Sparring is somewhat frightening/thrilling even with a partner you know that is not trying to hurt you and wearing gloves. You know you might catch an elbow, knee or knuckle in the nose, etc. The low fear has a thrill effect that is invigorating and can lift a dark mood. But of course in Martial Arts it is impossible to separate the thrill effect from the exercise effect from the mental focus effect. And if my doctor told me to do it, the placebo effect. :)

  43. micheleinmichigan says:

    FiFi “(and not everyone relaxes when being massaged, for some people it’s invasive and tension inducing to have people touching them).”

    Yes, I can relate, not a big massage fan myself. Although I will tolerate it in the case of deep tissue massage for muscle spasms. But that is a purely physiological response.

  44. Fifi says:

    michele – “To re-orient my comments in that context any placebo effect treatment option would have to have some benefit over CBT or show some evidence to have benefit in addition to CBT.”

    Michele, you keep associating CBT with placebo effects and I think there’s a very important distinction to be made (plus I suspect it may be helpful for you to better understand what each is and how they function). I mean no offense but I suspect you don’t quite understand what CBT or a placebo effect is because CBT is almost the opposite of a placebo effect! This may get in your way of better understanding both and some of the features of placebo effects and CBT.

    In very simple terms, CBT involves becoming conscious of how our thoughts, feelings and actions are interconnected and cause each other. It’s a mindfulness technique that’s about becoming more aware so that one can change unconstructive habits/rituals. A placebo response is somatized, meaning it’s unconscious (even if someone is aware they’re getting a placebo, they remain unconscious of the interconnection between their thoughts, feelings and the actions involved). It’s all about ritual/habit.

    Now, interpersonal therapies (which are about the relationship between the therapist and the patient) can certainly have a somatic element and work on an unconscious level and this is where you see a psychosocial aspect to placebo effects (how relationship and/or interaction between the therapist/doctor and patient influences the perception of a treatment). This doesn’t mean that interpersonal psychotherapies are just a placebo effect, it just means that part of the process can be unconscious on the patient’s part (the therapist would be conscious of the transference and counter-transference – and this ability is essential to being a good psychotherapist or psychiatrist).

    I hope pointing out this distinction is useful for you :-)

  45. Fifi says:

    michele – “to add another layer here is how I imagined the process I’m describing: Fear of a potential danger (psych) Cortisol response (physio) Thrill sensation (psych).”

    I don’t think most people are afraid of their acupuncturists though or think acupuncture is dangerous! I think I get what you’re saying vis a vis being in certain states – relaxed or excited – but I’m not sure they apply to the placebo effect in quite the way you think they may. However, that said, when some people have chronic pain they do tend to start to live in a heightened state of alertness/tension and to protect the injury (whether it need to be protected or not). And, obviously, chronic pain can also interfere with sleep and relaxation. That’s why both relaxation exercises and also zen and mindfulness practices can be useful for pain management. (Though zen meditation has a physiological effect on on neuroanatomy, there’s a different thing going on than simply learning how to relax.) Like depression, there are many interrelated psychosocial aspects to chronic pain (though that doesn’t mean we may not one day come up with a procedure or medication that can bypass these aspects and deliver relief…apart from massive doses of narcotics, which are very effective at providing pain relief but they can reduce functionality and we have some very weird social beliefs – that are entirely moral in nature – about both pain and addiction that have made effective pain treatment increasingly difficult in some places).

  46. rork says:

    I saw a list of CAM alternatives occupying a whole page in handouts to folks considering joint replacement (U of Michigan), and I was appalled. It came after weak weasel-words expressing doubt of the evidence of effectiveness, but then explained each ah, er, modality, in not unflattering terms.

    Doesn’t an authority condoning shamanism have the de facto effect of advocating it? Doesn’t it permit ever further multiplication of the absurd, and increased money inducing folks to invent further absurdities? The slope seems icy to me. Show me how to draw a line.

    I thought a common point was that it deflects folks from methods with evidence too (if any).

    I’m not comfortable yet, but am off conjuring some new form of Bose-Einstein visualization therapy (BEVT) to sell the weak-minded cancer patients, since y’all seem ready to help me line my pockets (as long as I do little harm). Good for autism too.

  47. apteryx says:

    Scott – saying that acupuncture has “significant risks” implies not just that it’s conceivably possible to get an infection from it, but that a meaningful proportion of users actually suffer real harm. If the chances that a treatment will cause me serious illness or injury are less than the chances that I will be killed by lightning, I don’t consider the risk “significant.” Do flu shots have “significant risks” if one in twenty million people die of them?

    I will “explain” that science does not and cannot support your personal ethics as being superior to anyone else’s. Again imagining for the moment that the benefits of acupuncture had been proven to be all psychological, a doctor could still honestly say: “Studies have found that acupuncture may relieve your elbow pain as well as or better than an analgesic, with less risk of side effects.” What the patient cares about is the degree of relief, not the mechanism of relief, and so recommending the treatments with the best combination of safety and efficacy in practice would be entirely ethical. I have never seen a doctor who showed any interest in explaining the mechanisms of action of every treatment prescribed. However, if you were a doctor and felt that to be a moral necessity across the board – good luck with that – you would need to add: “Studies show that acupuncture relieves pain through psychological mechanisms alone, rather than through direct biological effects on the skin or nerves.”

  48. micheleinmichigan says:

    Michele, you keep associating CBT with placebo effects and I think there’s a very important distinction to be made (plus I suspect it may be helpful for you to better understand what each is and how they function).”

    Sorry FiFi, I was trying to be brief, but maybe I was not clear. The only association I have between CBT and placebo is that I was talking about things that MAY have some positive benefit on depression (regardless of the mechanism.)

    So if you can’t take anti-depressants, (or if you can) CBT is shown to have a clinically significant benefit. So, in the end, one would have to compare the results and reliability of ANY potential treatment against the results of CBT (and/or exercise for that matter, which I think has some clinical evidence of benefit.)

    I do not believe I confuse the two separate mechanisms, But, I can see how in my first comment it would look that way, since I was rather sloppily grouping placebo effect in with a hypothetical psycho/physio effect.

    “(plus I suspect it may be helpful for you to better understand what each is and how they function). I mean no offense but I suspect you don’t quite understand what CBT or a placebo effect is because CBT is almost the opposite of a placebo effect! This may get in your way of better understanding both and some of the features of placebo effects and CBT.”

    I’m sure you don’t mean to sound patronizing in this paragraph. I suspect it is just your habitual style of writing. But, other posters do seem to be able to make a point or correct a fact without a paragraph on why the previous commenter needs to hear or listen to that point.

    Just let me assure you, I am perfectly happy to read any comment or information in response to mine (time allowing) without first seeing the argument that it will correct a deficit in my knowledge. :)

  49. Scott says:

    Do flu shots have “significant risks” if one in twenty million people die of them?

    Yes, I would consider that to be significant.

    Again imagining for the moment that the benefits of acupuncture had been proven to be all psychological, a doctor could still honestly say: “Studies have found that acupuncture may relieve your elbow pain as well as or better than an analgesic, with less risk of side effects.”

    Based on previous discussions, my understanding of the current consensus of medical ethicists is that no, a doctor CANNOT honestly say that.

  50. apteryx says:

    Scott – I don’t know if that’s true – even if it is, though, a group of medical professionals disproportionately from one culture are not the only people whose ethical perspectives matter. Again assuming that acupuncture beats drugs solely due to its superior psychological effects, if it does beat the drug, from my perspective (and that of probably a large majority of the world’s population) it is perfectly ethical for anyone to admit to that fact. Conversely, I would regard it as unethical for a doctor to tell a patient that acupuncture could not possibly help him, if studies show that in practice it may be the best available source of the effect desired by the patient!

    Your view of “significant risks” illustrates that individuals’ value judgements vary, and that science cannot tell us whose are “right” or “wrong.” If five people per year die of getting a flu shot, if I otherwise desire to get a flu shot I will not consider that a reason to change my mind or make out my will ahead of time. I consider such risks too small to worry about. If you consider it worth worrying about, you have a right to that perspective. But your use of the quasi-scientific word “significant” to describe the risk implies that there’s an objective reason why the people who aren’t worried about it really ought to be, which is just not true.

  51. micheleinmichigan says:

    I’m not comfortable yet, but am off conjuring some new form of Bose-Einstein visualization therapy (BEVT) to sell the weak-minded cancer patients, since y’all seem ready to help me line my pockets (as long as I do little harm). Good for autism too.

    I’m sorry, perhaps if you did a pull quote, I’d understand. I do not see who here is encouraging a sham cure for cancer or autism.

  52. micheleinmichigan says:

    sorry, pull quote error myself

    rork said “I’m not comfortable yet, but am off conjuring some new form of Bose-Einstein visualization therapy (BEVT) to sell the weak-minded cancer patients, since y’all seem ready to help me line my pockets (as long as I do little harm). Good for autism too.”

    I’m saying – I’m sorry, perhaps if you did a pull quote, I’d understand. I do not see who here is encouraging a sham cure for cancer or autism.

  53. BillyJoe says:

    apteryx,

    ” Since the sugar pill has no significant bioactivity, it can have no significant side effects”

    Please allow me to expand the definition of “side effect” to include the following:
    - the “nocebo effect”.
    - the dumbing down of the science literacy of the population.
    - the harm to the doctor patient relationship when the patient finds out he’s been lied to or taken for a fool.
    - the increased tendency of the patient to accept other atlmed modalities that may be harmful in themselves or prevent him form getting a proper diagnosis hence delaying proper treatment.

    “a doctor could still honestly say: “Studies have found that acupuncture may relieve your elbow pain as well as or better than an analgesic, with less risk of side effects.””

    No, that is dishonest. Period. It’s not the acupuncture. It is the placebo effect. And most patients now understand what is meant by the placebo effect – if not, please do them and society a favour and explain it to them.

    “Conversely, I would regard it as unethical for a doctor to tell a patient that acupuncture could not possibly help him”

    No, because the plain fact of the matter is that acupuncture cannot possibly help you. But you will probably get a placebo effect especially if it’s just pain relief and not cure that you are after.
    It is unethical, and there is no excuse, to lie to patients.
    (There are exceptions but this has no relevance to the present discussion)

  54. rork says:

    Ok, micheleinmichigan, I’ll leave off my last sentence quipping from now on, since it detracts from my (ignored) main questions. Sorry.

  55. pmoran says:

    Billyjoe: “No, because the plain fact of the matter is that acupuncture cannot possibly help you.”

    You do NOT know that. You only know that it doesn’t work obviously better than sham versions. In the above study of major depression all groups were quite dramatically better (8 points on a 23 point scale within four weeks) with the various “treatments” used. We expect many of those would have improved naturally, but how many would have with no treatment at all, or with drug use? Do you know?

    Such findings don’t even place an upper limit on what non-specific medical nurture including a placebo can achieve, because we expect that to be dependent upon the world view of individual patients and characteristics of a particular practitioner and of any “treatment” used.

    This discussion ALWAYS stalls at the “it is unethical for doctors to consciously use placebos” stage when there are, to me, a number of equally important questions that need answering.

    With my seriously limited word-power, compared to some writers here, I am trying to convey a dilemma that I see in relation to science’s right to have a final say about alternative methods. That right is limited wherever we are unable to reliably predict how any individual will react. It is also never absolute.

  56. micheleinmichigan says:

    “Doesn’t an authority condoning shamanism have the de facto effect of advocating it?”

    From a patient’s prospective:

    I would look to my doctor to inform me on the evidence to any common procedure (SBM, CAM or another specialty) that is related to my condition. I do want them to “advocate” for a particular treatment, but I do respect their need to re-explain any consequences of a treatment or non treatment if they believe I don’t understand. I also respect that they can’t know it all outside their specialty. They can say they do not know and offer a referral, reference or caution as they see fit.

    If the doctor thinks a prominent CAM method is dangerous or is safe, but works only as a placebo. They should say so and explain. I think that will increase the trust between doctor and patients.

    I deal with health professional a reasonable amount. I recently had a provider who seemed to feel that they had to “advocate” for one SBM choice over another SBM choice. I have no doubt that their intentions were good, but their preference was so obvious, I could not trust that they were giving me ALL the facts. So I had to switch providers.

    But, it is not unusual for me to ask a provider who I trust what they would do when the decision is difficult, with conflicting evidence or procedures that have equal pro/cons. I have to be pretty impressed with a provider to do this.

    I believe that the provider should give the patients all the honest information they can and accept that the patient will make the final decision AND deal with the consequences. But, I do not expect a doctor to perform procedures they can not condone and I feel it is their right to discontinue service to a patient if they are too frustrated with the patients choices.

    Regarding placebo treatment. I think if my doctor prescribed a placebo pill or treatment without informing me it was a placebo, they would lose credibility with me. I probably would switch doctors. If knowing undermines the placebo effect, so be it.

    A tip regarding using good bedside manner to bring about the placebo effect. I would remind doctor’s to be as genuine as possible. The first time a doctor told me “You’re doing everything right. You are asking all the right questions.” at the end of a consultation regarding a surgery for my son, I felt competent and happy. The fourth time I heard the same line (from three different providers), I began to suspect the line was in the hospital manual under “dealing with parents who ask too many questions.” :)

    Regarding research funds – whether we like it or not, I think research has to be done on popular CAM methods. If they are common we need to know more about them. If this is hard to swallow, think of them as a potentially invasive species like emerald ash borer.

    rork, This is my attempt to address your question. But I suspect I have probably missed some viable concerns that a doctor may have.

  57. BillyJoe says:

    Billyjoe: “No, because the plain fact of the matter is that acupuncture cannot possibly help you.”

    pmoran”You do NOT know that. You only know that it doesn’t work obviously better than sham versions.”

    Okay let me substitute then:
    Acupuncture doesn’t work better than placebo.

  58. BillyJoe says:

    micheleinmichigan,

    “If the doctor thinks a prominent CAM method is dangerous or is safe, but works only as a placebo. They should say so and explain. I think that will increase the trust between doctor and patients.”

    “I think if my doctor prescribed a placebo pill or treatment without informing me it was a placebo, they would lose credibility with me. I probably would switch doctors. If knowing undermines the placebo effect, so be it.”

    I can only agree. :)

  59. Fifi says:

    michele – “The only association I have between CBT and placebo is that I was talking about things that MAY have some positive benefit on depression (regardless of the mechanism.)”

    The way you’d associated CBT and placebo on more than one occasion makes it appear you believe they’re the same thing. Sorry if I offended you by responding but this is a topic that brings out my inner nerd and you seem quite interested in the subject. I find a lot of people are very, very confused about what a placebo is and how CBT, meditation and different therapies that exploit neuroplasticity work, so even if you’re not confused yourself you’re unintentionally perpetuating a general confusion. Certainly there are still a lot of unknowns, both about depression and how the mind/brain function, but it’s worth being clear on what we do know – if only because there are so many gray areas and some of the reality of cognition is quite counterintuitive.

  60. Fifi says:

    apteryx – “a group of medical professionals disproportionately from one culture are not the only people whose ethical perspectives matter.”

    That’s just ignorant and downright racist. People from all different “cultures” (nations, ethnicities, etc) go to medical school, practice SBM and engage in medical research. (And have throughout history.)

  61. daedalus2u says:

    Whether CBT is a placebo or not depends on what the definition of “placebo” is.

    The definition of “placebo” that I like to use is an effective treatment that is not pharmacologically or physically active, i.e. is not a physiologically active chemical or surgery. Under that definition, CBT is a placebo because it does not involve the use of drugs or surgery and it has positive therapeutic effects.

    You have to come up with the definition of “placebo” first, and then see if a treatment modality is a placebo or not. You can’t decide which treatments are not placebos first and then look at the common characteristics of those treatments to figure out your placebo definition.

    The reason you can’t decide which treatments are placebos first is because all effective treatments have a placebo component. Even opiates for pain relief have a placebo component that is different depending on how they are administered. Injected morphine provides more pain relief than does oral morphine. In my blog on the placebo effect I quote a resident saying that there is something about putting cold steel into someone while saying “this is going to make you feel better” that really works.

    Dr Novella is exactly right, first you have to determine if there is an effective therapeutic effect, and then determine what the physiology is. If you get a therapeutic effect that is no different from a known placebo, then your treatment is indistinguishable from placebo. If a treatment is indistinguishable from placebo, it is a placebo.

    All placebos are not equivalent. Hitting someone on the head with a hammer, might relieve a headache (in a very small class of people with headaches). If it does work, it is through a placebo effect. Acupuncture might work better for headache for most people than hitting them on the head with a hammer. That does not make acupuncture a non-placebo.

  62. micheleinmichigan says:

    Sorry if I offended you by responding but this is a topic that brings out my inner nerd and you seem quite interested in the subject.

    That’s okay FiFi. I understand. We all forget our manner sometimes when we are excited about a topic.

  63. pmoran says:

    Billyjoe: “Okay let me substitute then:
    Acupuncture doesn’t work better than placebo.”

    Actually acupuncture works better than sugar-pill type placebos, at least to the satisfaction of many patients.

    This is why we have to go to desperate lengths when blinding patients as to what “treatment” they are receiving in controlled clinical trials.

    Might it also work better than some weakly active drugs?

    We should be thinking this through, folks. There is nothing very reassuring in the current research.

    I emphasise again that this is about certain niches within medicine. For many or most medical purposes placebos are useless, although they may be capable to bring additional comfort to many.

  64. The Blind Watchmaker says:

    Dr. Atwood said, “CAM” begins with interventions and looks for indications..”

    This is the Texas Sharpshooter Fallacy. We need to teach critical thinking in the elementary schools. Maybe someday we won’t have to waste time with arguments like these.

  65. BillyJoe says:

    BillyJoe said: “Okay let me substitute then:
    Acupuncture doesn’t work better than placebo.”

    pmoran replied: “Actually acupuncture works better than sugar-pill type placebos”

    A sugar pill is not the appropriate placebo for acupuncture.
    So, my statement stands:
    Acupuncture doesn’t work better than placebo.

  66. pmoran says:

    “BillyJoe said: “Okay let me substitute then:
    Acupuncture doesn’t work better than placebo.”

    pmoran replied: “Actually acupuncture works better than sugar-pill type placebos”

    A sugar pill is not the appropriate placebo for acupuncture.
    So, my statement stands:
    Acupuncture doesn’t work better than placebo.”

    =====================
    Like most skeptics, and myself at one time, your mind is fully focused upon what you think is THE question i.e. “does this method have the intrinsic medical efficacy that is being claimed?”.

    It does not undermine the prime importance of that question in many medical settings to say that the studies intended to study it, using comparisons with sophisticated sham treatments, tell us very little about what placebos/sham treatments can do on their own. Nothing at all, in fact, if the study doesn’t include an “untreated” or waiting list group and probably only a lowish approximation when it does.

    So it remains quite feasible that acupuncture and other procedural placebos could perform better than some accepted drugs for some conditions. There are already studies that suggest that the former performs as well as and safer than usual medical treatment in migraine prophylaxis, in studies where the fairly objective outcomes recorded in migraine diaries are being measured.

    Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, White AR. Acupuncture for migraine prophylaxis. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD001218. DOI: 10.1002/14651858.CD001218.pub2

    An extract: — “In the previous version of this review, evidence in support of acupuncture for migraine prophylaxis was considered promising but insufficient. Now, with 12 additional trials, there is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care. There is no evidence for an effect of ‘true’ acupuncture over sham interventions, though this is difficult to interpret, as exact point location could be of limited importance. Available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects. Acupuncture should be considered a treatment option for patients willing to undergo this treatment.”

    Even this does not establish potent effects for placebo per se. Perhaps the drugs used in these comparisons are further examples of the second-rate crap occasionally foisted on us by drug companies. Perhaps the enforced relaxation/meditation of 20 min acupuncture sessions two or three times a week is the active agency, perhaps sometimes along with counterirritant effects or endorphin release. If so, it is not a placebo in the usual sense of being a completely inert medical activity.

    Note that those ways of evading the question of “placebo power” also fail to confer on us the right to condemn acupuncture’s use under all circumstances and they can hardly justify too aggressive a pot-kettle-black stance when we state that “it cannot work”.

    I am not asking you to go all the way with this (yet). There is merely sufficient uncertainty about some matters as to make some of our rhetoric over-the-top for a supposedly science-based group.

  67. micheleinmichigan says:

    pmoran – I found and interesting article on the AMA ethics report for placebos.
    http://www.medpagetoday.com/MeetingCoverage/AMA/3555

    You might be interested. One part I found intriguing.

    “Dr. Sade said that a permissible single-patient clinical trial approach may be useful in making a diagnosis when the physician is faced with significant clinical uncertainty. Patients should be told that they will be alternately given a substance that is “not pharmacologically specific for the condition being treated” but may be helpful and in any case will not worsen the condition.”

    The original report is here. http://www.ncbi.nlm.nih.gov/pubmed/18552054

    But I could not access even a summary.

  68. pmoran says:

    “pmoran – I found and interesting article on the AMA ethics report for placebos.”

    There is no unanimity of opinion.

    There cannot be when there are occasions when doing what is almost certainly best for the individual patient, and must be admitted to be so when properly argued out, conflicts with concerns about interfering with patient autonomy.

    The concerns about patient autonomy do not prevent some from wanting to extend a sometimes shaky but always patronising scientific hegemony over which treatment methods patients should have access to at their own volition, even developing a derogatory name for any who feel some unease concerning that — the despised “shruggie”.

  69. BillyJoe says:

    pmoran,

    ” There are already studies that suggest that the former performs as well as and safer than usual medical treatment in migraine prophylaxis, in studies where the fairly objective outcomes recorded in migraine diaries are being measured.

    Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, White AR. Acupuncture for migraine prophylaxis. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD001218. DOI: 10.1002/14651858.CD001218.pub2″

    No, you have misread the review.

    When you study the write up of a clinical trial – or a systematic review as in the above – the first thing to do is to ignore the authors’ conclusions. Especially when the authors have a conflict of interest as do these authors. Because the authors’ conclusions are often not supported by the results, as in this case, or a spin on the results. Instead you need to read the actual results (well, the methodology as well but in this case there does not seem to be a problem with methodology).

    What I am saying here is: don’t take the authors’ word for it. This systematic review does not say what they say it says and I see no reason to change my conclusion about acupuncture which is:

    Acupuncture is no better than placebo.

  70. BillyJoe says:

    pmoran,

    “It does not undermine the prime importance of that question in many medical settings to say that the studies intended to study it, using comparisons with sophisticated sham treatments, tell us very little about what placebos/sham treatments can do on their own. Nothing at all, in fact, if the study doesn’t include an “untreated” or waiting list group and probably only a lowish approximation when it does.”

    If you want to study the effect of placebos then use a non-treatment or waiting-list control.
    If you want to study the effect of acupuncture use a sham control.
    Acupunturists love the non-treatment control so if all else fails – as it usually does – they can at least say that acupuncture works better than doing nothing.

  71. BillyJoe says:

    pmoran,

    “perhaps sometimes along with counterirritant effects or endorphin release. If so, it is not a placebo in the usual sense of being a completely inert medical activity.”

    Any supposed mechanism for acupuncture is trumped by the consistently negative trials (counting only the methodloogically sound trials of course)

  72. BillyJoe says:

    pmoran,

    “The concerns about patient autonomy do not prevent some from wanting to extend a sometimes shaky but always patronising scientific hegemony over which treatment methods patients should have access to at their own volition even developing a derogatory name for any who feel some unease concerning that — the despised “shruggie”

    You don’t have to be patronising and you don’t have to be derogatory. Patients can choose acupuncture if they want to, just don’t pretend that it works any better than placebo.

  73. apteryx says:

    Fifi wrote:

    “apteryx – “a group of medical professionals disproportionately from one culture are not the only people whose ethical perspectives matter.”

    That’s just ignorant and downright racist. People from all different “cultures” (nations, ethnicities, etc) go to medical school, practice SBM and engage in medical research. (And have throughout history.)”

    Fifi – Watch with the reading comprehension, please. I was responding to Scott’s claim regarding “the views of medical ethicists,” in response to which your comment is senseless. There most certainly have not been professional medical ethicists “throughout history” – or medical schools, for that matter; the former in particular is a recent occupational niche. And you are not free to conflate culture with race. I’m sure there are African-American and Asian-American professional medical ethicists, but how many medical ethicists are there from Zaire or Cambodia? Are there any Jivaro or Kikuyu professional ethicists? If there should be any, they were trained in Western or Westernized university systems, and their current opinions would be likely to conform to those considered acceptable by the faculty at those institutions, making their values no longer representative of the values of others from their native culture – just as Dr. Arthur Caplan and his less famous colleagues are not necessarily representative of ordinary Americans’ values.

    If you don’t mind my saying so, I would have thought SBM’s recent Dr. Amy fiasco would have taught you a lesson about spewing unwarranted personal insults towards those whom you view as inferior because they disagree with you on some point. You consider yourself to be one of the skeptical elite, but the minute you questioned Dr. Amy, you wound up on the receiving end of that treatment, didn’t you? Didn’t like it, did you? Then you might refrain from dishing it out.

  74. pmoran says:

    Billyjoe: “You don’t have to be patronising and you don’t have to be derogatory. Patients can choose acupuncture if they want to, just don’t pretend that it works any better than placebo.”

    Do you not see a bit of a tension between those two sentences? ‘OK, go ahead, but know that if it should help with your problem it is “just placebo”‘, with the unjustified implication that that would be somehow not real, not of any true value.

    I am a little offended that you should htink that I should not udnerstand the significance of the clinica

  75. pmoran says:

    Sorry for the incomplete post.
    ——————————————-
    I was saying that I was offended by your assumption that I did not understand the clinical study data I quoted.

    I am trying to get across some subtle but important matters. Let’s try another tack.

    Patients mostly don’t care “how it works” and will approach the question of efficacy of dubious methods with far less certainty than we will, even when knowing that doctors and scientists don’t believe in them. That is their right. It is even sensible, by their lights, when they have an unresolved medical problem.

    For them acupuncture and the like is simply something else to try when when the doctors are not helping enough or they don’t like what is on offer from them, often on reasonable grounds if you stand back and look at pharmaceuticals and their potential for ill effects dispassionately. With most everyday complaints they are going to be better within a few weeks whatever treatments they may choose to use, and most have a sense of when it is best that they consult a doctor.

    So I think that in some contexts we as doctors should be wishing them well from any benefits they may derive from placebo and other non-specific effects of CAM. It is deeply counterproductive to react with what can so easily look like spite, even somewhat dog in the mangerish.

    The information we should be getting across to the public is that acupuncture is useless as a treatment for most defined diseases but it can ease symptoms for some. That is firm ground, and all that the available evidence allows us to say.

  76. Harriet Hall says:

    A useful concept is “comfort measures.” I think this is what pmoran is gettiing at. Comfort measures don’t do anything objective to shorten the illness, but they are a humane addition that make the patient’s experience of illness less unpleasant, and they can include measures as simple as holding a hand or covering with a warm blanket. I have no objection to acupuncture or any other “ineffective” treatment being used as a comfort measure – as long as it doesn’t carry enough risk to outweigh the benefits and the patient isn’t lied to.

  77. micheleinmichigan says:

    pmoran – “There is no unanimity of opinion. ” regarding placebo ethics AMA article

    Yes, the article I linked says that. That is why I linked to it. I thought some might find the different opinions interesting, but I did not want to cut and paste the whole article in the comment box.

  78. pmoran says:

    Yes, Harriet, comfort medicine is part of it, but there are many elements. Even just satisfying that deeply implanted urge to “do something” when sick can have merit. Not all patients will follow or respond positively to careful explanations as to why treatment is being withheld fro some complaints.

    Sometimes a placebo/symptomatic treatment can buy time, while an unclear diagnostic situation clarifies itself, or the patient gets better by themsleves, leaving the practitioner still in play and not risking the loss of the patient to someone with less knowledge of them and less medical savvy.

    Why are we so shy about allowing that just sometimes, possibly, highly trained and experienced professionals who know the patient very well do know what’s best, in the many fringe situations that arise within medicine?

    And there may be more serious medical applications. Who knows for sure whether or not the addition of acupuncture to other management might enable susceptible patients to need less narcotics for their cancer pain? No one. There are no suitable studies that I can find, but one is I think planned by the NCCAM.

    The “working better than placebo” model of medical practice precludes us even trying to find that out. As usually applied, it would also reject any positive studies as just showing placebo effects. Hmmmh!

    I say again, this all refers to situations where there is no entirely satisfactory medical treatment.

  79. BillyJoe says:

    pmoran,

    “Do you not see a bit of a tension between those two sentences? ‘OK, go ahead, but know that if it should help with your problem it is “just placebo”‘, with the unjustified implication that that would be somehow not real, not of any true value.”

    I said “don’t pretend that acupuncture is any better than placebo”.
    If a patient asks you about acupuncture are you going to lie and say: “acupuncture works” [and under your breath "but no better than placebo"] or are you going to be upfront and honest and say “there is no evidence that acupuncture works better than placebo”.

    In my experience, once you lie to people you are always on the back foot, you have to keep lying to cover up your initial lie. Also you’re promoting ineffective altmed treatment and perhaps unwittingly pushing your patient to try other – and maybe this time dangerous – altmed treartments.

  80. BillyJoe says:

    pmoran,

    “I was offended by your assumption that I did not understand the clinical study data I quoted. ”

    Okay, I misread your post.
    On second read, it is clear that you understand that systematic review pretty well.
    Apologies to you, and embarrassment for me :(

    But I wasn’t suggesting that patients choosing acupuncture be condemned – just not lied to. Especially if they come to you for information. Maybe the placebo effect of acupuncture works better than some medical treatments (because they aren’t accompanied by the ritual that produces the placebo effect of acupuncture).

    But it’s the ritual that works, not the acupuncture. The acupuncture itself does not work (you can stick the needles in anywhere you like, and you don’t even have to stick them in), and there’s no getting away from that. I could even say that, because sham acupuncture works just as well as true acupuncture and is safer, you should be recommending sham acupuncture.
    I suppose, though, that sham acupuncturists might be in fairly short supply.

  81. Fifi says:

    BillyJoe – Outside of the context of a clinical trial, there’s absolutely no need to lie to people about things that work no better than a placebo – be they acupuncture or certain kinds of knee surgery that are no better than placebo surgery. It’s quite possible to tell the truth and say to a patient, “clinical trials have shown that this procedure is no better than a placebo – some people find it makes them feel a bit better and others don’t.” In areas like chronic pain or depression, the placebo effect can sometimes be quite powerful. My only caveat is that it’s always best to be teaching a patient how their own mind works and how to create these experiences for themselves (rather than becoming dependent upon a practitioner, though sometimes a period of dependency before transitioning to being more self managing is part of the treatment process so it’s really about having self management as the ultimate goal).

  82. BillyJoe says:

    Fifi,

    I largely agree with what you say.

    However I’m finding it hard to imagine someone performing acupuncture on themselves knowing that it is a placebo treatment getting the same effect as someone who believes in acupuncture attending a skilled acupunturist who also believes in acupuncture.

    Also there is the down side that I have mentioned several times.

  83. apteryx says:

    Trouble is, we really don’t know how acupuncture works, whether it has a mechanistic nervous-system effect or a super-placebo effect or both, and if the latter, what accounts for its extraordinary activity. If it has been adequately demonstrated that acupuncture relieves a particular condition better than drugs, the fact that some people believe acupuncture is functionally equivalent to “poking yourself with toothpicks” does not mean that poking yourself with toothpicks will likewise be more effective than drug treatment. Someone who tried that and found that it was ineffective might wrongly conclude that acupuncture would likewise not benefit them.

  84. pmoran says:

    Billyjoe: ” But it’s the ritual that works, not the acupuncture. The acupuncture itself does not work (you can stick the needles in anywhere you like, and you don’t even have to stick them in), and there’s no getting away from that. I could even say that, because sham acupuncture works just as well as true acupuncture and is safer, you should be recommending sham acupuncture.”

    That is roughly my view, too. Acupuncture, being a somewhat invasive procedure involving periods of enforced ‘time out” while being cared for in a sympathetic environment has some additional plausible reasons for having medical activity over some other healing rituals. And, of course, the whole therapeutic envirnement is critical. Perfunctory treatment by a surly practitioner may not “work”.

  85. BillyJoe says:

    apteryx,

    Sorry to nitpick your post, but I think the nitpick is necessary.

    “Trouble is, we really don’t know how acupuncture works”

    Acupunture doesn’t work.

    “…whether it has a mechanistic nervous-system effect or a super-placebo effect or both…”

    There is a super placebo effect associated with acupuncture.

    “and if the latter, what accounts for its extraordinary activity.”

    The ritual.

    ” If it has been adequately demonstrated that acupuncture relieves a particular condition better than drugs…”

    It hasn’t and it doesn’t.

    ” the fact that some people believe acupuncture is functionally equivalent to “poking yourself with toothpicks””

    Yes, they are both useless.

    “does not mean that poking yourself with toothpicks will likewise be more effective than drug treatment.”

    It isn’t (see above)

    “Someone who tried that and found that it was ineffective might wrongly conclude that acupuncture would likewise not benefit them.”

    It wouldn’t.

    Poking yourself with toothpicks doesn’t work at all.
    The ritual associated with “poking yourself with toothpicks” probably doesn’t work very well.
    Acupuncture doesn’t work either.
    But the ritual associated with acupuncture works pretty well in certain conditions.

  86. apteryx says:

    Sorry BillyJoe, but like many issues, the definition of words like “works” and “useless” seems to be a philosophical question and not a scientific one. If studies show, let’s say, that patients with elbow pain randomized to acupuncture have less pain and regain more range of motion than those randomized to drug treatment, I would conclude that acupuncture works for that specific use and hence is not useless. You conclude the opposite. To me, if I were to declare that acupuncture was useless, I would also have to declare that the drugs, which provided less relief and have many more side effects (including, according to a new study, increased risk of hearing loss), were useless. Science offers no reason to believe that your personal definitions are superior to mine.

    As a scientific issue, it has not been proven that the effects of acupuncture are entirely due to “ritual,” as the only studies that show equivalence to “sham” acupuncture involve dermal stimulation probably comparable to that of real acupuncture. There are modern alternative practices, such as reiki and “therapeutic touch”, that likewise involve plenty of ritual, caring treatment of the patient, the opportunity for the patient to rest and relax for periods of time, etc., but that (based on both clinical trials and human experience) seem clearly to be less effective than either acupuncture or drugs at relieving pain. If the pain relief of acupuncture is all due to ritual, why are those other practices not just as good? (There is also the issue that, though highest-quality studies are few in number, there is some evidence that acupuncture and similar methods affect animals. Animals, of course, are not susceptible to culturally mediated placebo effects.)

  87. BillyJoe says:

    “If studies show, let’s say, that patients with elbow pain randomized to acupuncture have less pain and regain more range of motion than those randomized to drug treatment, I would conclude that acupuncture works for that specific use and hence is not useless.”

    If that study included a sham acupuncture control group and the effect in the true acupuncture group was no better than that in the sham acupunture group, then the conclusion is that acupuncture is no better than placebo. If something is no better than palcebo, that means it does not work.

    “As a scientific issue, it has not been proven that the effects of acupuncture are entirely due to “ritual,” as the only studies that show equivalence to “sham” acupuncture involve dermal stimulation probably comparable to that of real acupuncture.”

    Acupuncture is the placement of needles at specified acupuncture points to a depth of about 1cm (there are variations of course but they all have there own problems). This has been shown to work no better than putting the needles in wherever you like and, in fact, not putting them in at all – as in sham acupuncture. Sham acupuncture is the ritual of acupuncture without the acupuncture. It is the ritual of acupuncture, not the acupuncture itself (which is the placement of needles at specidfied point to a depth of 1cm) that has the effect. This ritual of acupuncture is the placebo effect of acupuncture.

    “If the pain relief of acupuncture is all due to ritual, why are those other practices not just as good?”

    Because all rituals (ie placebo effects) are not equivalent. It seems that actually touching the skin has a greater placebo effect that nearly touching the skin (as with TT and Reiki). Just as an injection of normal saline works better than a sugar pill as a placebo.

    “there is some evidence that acupuncture and similar methods affect animals. Animals, of course, are not susceptible to culturally mediated placebo effects.”

    They don’t need to respond to the placebo effect. In fact, there is little evidence that they do. Their owners, on the other hand, are ready to swear that their animals have been helped when clearly they haven’t.

  88. BillyJoe says:

    …sorry, that was in reply to apteryx.

  89. Fifi says:

    BillyJoe – “However I’m finding it hard to imagine someone performing acupuncture on themselves knowing that it is a placebo treatment getting the same effect as someone who believes in acupuncture attending a skilled acupuncturist who also believes in acupuncture.”

    Can someone even perform acupuncture on themselves? It seems quite unlikely and I’ve never even seen it suggested or advocated (acupressure, yes, but not acupuncture). The problem is that you’re proposing two entirely different things and contexts here – doing something to oneself that one doesn’t believe in and someone else doing something to you that you both believe in. Surely you can see how these aren’t equivalent at all in any sense in regards to acupuncture and particularly in terms of the placebo effect?

    Speaking to apertyx’s point that he believes acupuncture to be superior to reiki and TT and the effects not due to ritual… It’s been shown that the placebo effect is amplified by having a more dramatic ritual or procedure…bigger needles equals bigger placebo effect, for instance, when a placebo injection is being given. So, with this understanding, it makes perfect sense that the more dramatic and “medical” intervention of being stuck with needles (or believing that one is being stuck with needles in the case of sham acupuncture) will have a more pronounced placebo effect for those prone to the placebo effect and who like dramatic interventions. (It’s a bit like how some people tend to believe that only medicine that tastes bad works. You see this bad tasting version of the placebo effect all the time regarding medicines – both herbal and pharmaceutical.)

  90. daedalus2u says:

    Apteryx, what basis do you have for saying that placebos do not work on animals? Animals can be conditioned to do all sorts of things, everything that humans can be conditioned to do. Why can’t animals be conditioned to respond to acupuncture too?

  91. apteryx says:

    BillyJoe – you are simply repeating your definition of “does not work”, with no apparent willingness to understand that other people have a different definition that they can equally well justify by rational argument based on observed facts.

    There are various modern “energy healing” or chiropractic-offshoot practices that involve gently physically touching people. (I recently had the joyous experience of listening to a small swarm of chiropractors yack about this at some length.) Have any of these been observed to improve pain and range of motion better than pharmaceuticals? I don’t think so, therefore, I remain unconvinced that acupuncture’s benefit is all due to “ritual.” Even if it were, I, like many people, care only about getting maximum relief with minimum risk. If I could really do that through ritual, that’s fine with me; according to my values, the mechanism of relief is a matter for intellectual curiosity but not a basis for decision-making.

    daedalus2u – I don’t think there is incontrovertible evidence that acupuncture benefits animals, but if it does, I would not believe that that was a placebo effect. Placebo effects are culturally mediated: you have to have positive expectations of a treatment in order to benefit. How do the animals learn that acupuncture is supposed to relieve their pain? It just happens to be annual vaccination time for my cat, and though she does demonstrate understanding of a very limited English vocabulary, I have never been able to get across the concept that she’s being hauled to the vet and stuck with a needle for her own good. She’ll sit still for it, but she clearly thinks that she’s being ill used. I suspect she would react the same way to acupuncture.

  92. squirrelelite says:

    When we talk about treatments like acupuncture and other methods that show variable or limited utility, much of the disagreement seems to come down to confusion about what exactly is the “placebo effect” and whether any benefits observed from the placebo treatment or the test treatment (if its results aren’t significantly superior to placebo) are “real”.

    For understanding this problem, I found Dr Novella’s article from last October to be illuminating even though it only got 12 comments. I think I have looked it up 2 or 3 times in preparing comments for other blog posts such as this one.

    Here is the link:

    http://www.theness.com/neurologicablog/?p=1130#more-1130

    I especially like his definition/description:

    “What most people mean when they say “the” placebo effect is a real physiological effect that derives from belief in the effects of a treatment – a mind-over-matter effect. However, the placebo effect, as it is measured in clinical trials, has a very specific operational definition. It is any and all measured effects other than a physiological response to the treatment itself.

    This includes any physiological responses to belief in the treatment, but also a host of psychological factors such as reporting bias, confirmation bias, risk justification, and assessment bias. It also includes non-specific effects of being in a clinical trial – people treat themselves better when they are being observed, when they are being reminded of their illness because of frequent attention, and when they are encouraged by the hope of benefit. Such things actually affect compliance with other treatments and healthy lifestyles – in other words, people will be more compliant with other medications they may be on, and may eat better and exercise more, etc.

    These variables and others are the reason for double-blinding experiments. Without doubling blinding, these placebo effects will be mixed in with the physiological effects of the treatment, if any.”

    For diseases like HIV/AIDS or the severe forms of cancer with a relatively straight-forward and prompt progression to death, it is fairly easy to see (at least for most people) that standard therapies like HAART or surgery/chemotherapy/radiation therapy are significantly superior in most cases to complete placebos like a sugar pill (not that that would be an ethically valid study) or even some pharmacologically active substances such as aspirin.

    However, for diseases without a good medical “cure” or even a satisfactory treatment that can reduce the condition to the nuisance level, we are stuck with looking for slight or marginal improvements over existing therapies. Because these are slight, they are hard to distinguish from the random variation in results that is simply part of the normal process of trying to conduct a study (i.e., the placebo effect). Chronic pain and depression are two major targets for this category of studies.

    Because a lot of people suffer from these conditions, even slight positive results can be interesting and worthy of follow-up. But, unless those results can be repeatably and reliably replicated, there just isn’t sufficient basis to call for an immediate change in the standard of care. This is where the popular media and most CAM advocates jump the gun.

    Some people think of the placebo effect as a real, beneficial therapeutic effect that we just don’t understand yet. I think this is misleading and it makes more sense to me to think of the placebo effect as the random variation in the standard response that we are trying to use as a basis for comparison to look for a real or significant improvement.

    Thus, for acupuncture, even if it has a slight but real beneficial effect (which is dubious), the best studies show that it does not work the way its proponents say it does. It does not matter where you stick the needles (proponents say it does) and it does not matter if the needles even penetrate the skin (proponents say it does). So, in the absence of a definable or measurable mechanism, we are left with only the simple participation in the treatment process (the “ritual”) as the source of any improvement (in other words, the placebo effect).

    If the person being treated for depression wants to get their back poked and prodded and hopes that it will help, I think that I can ethically recommend (even as a non-medical practictioner) that they keep their money, avoid the risk of infection from getting needles stuck through their skin, and get their spouse or partner to give them a good back scratching (and vice versa) and see what happens.

    If nothing else, the results may help to mitigate a side effect of a common medical treatment for depression.

    http://www.johnshopkinshealthalerts.com/reports/depression_anxiety/130-1.html

  93. BillyJoe says:

    BillyJoe said: “However I’m finding it hard to imagine someone performing acupuncture on themselves knowing that it is a placebo treatment getting the same effect as someone who believes in acupuncture attending a skilled acupuncturist who also believes in acupuncture.”

    Fifi replied: ” Surely you can see how these aren’t equivalent at all in any sense in regards to acupuncture and particularly in terms of the placebo effect?”

    That was exactly my point.
    It was apteryx who bought this up when he said something about comparing acupuncture with sticking toothpicks into yourself as somhow demonstrating that acupuncture is effective. My point was that they are both placebo efffects and it’s just that the second placebo effect is much stronger than the first.

  94. BillyJoe says:

    Fifi, my response is in moderation so you’ll have to wait.
    I wish they would fix the damn thing.

  95. BillyJoe says:

    apteryx,

    “BillyJoe – you are simply repeating your definition of “does not work”, with no apparent willingness to understand that other people have a different definition that they can equally well justify by rational argument based on observed facts.”

    If your definition leads to you saying – incorrectly – that acupuncture works when it clearly does not and all you mean is that it has a placebo effect – albeit a powerful one – then your definition is misleading and you should discard it. That’s all I’m trying to say.
    (If you followed the discussion about the use of the word “observer” in quantum physics, you’d understand what I mean)

    “I remain unconvinced that acupuncture’s benefit is all due to “ritual.””

    Then I think you just don’t want to be concinced, because I’ve already explained that “sham acupuncture” encompases the ritual (which is the placebo effect of acupuncture) and “true acupuncture” is the placebo effect + the effect of acupuncture itself (which is the placement of needles at specific acupuncture points to a depth of 1cm). All clinical trials comparing “sham acupuncture” and “true acupuncture” show that there is no difference. The logical and inescapable conclusion is that acupuncture does not work.

    “Even if it were, I, like many people, care only about getting maximum relief with minimum risk. If I could really do that through ritual, that’s fine with me; according to my values, the mechanism of relief is a matter for intellectual curiosity but not a basis for decision-making.”

    I prefer to know the truth of the matter, the benefits come second.
    If the truth means I don’t get the benefit so be it, I’m not going to sacrifice the truth.

  96. I read a nice little takedown of the concept of the placebo effect as a “thing” a while ago. I don’t know whether it was after Wired’s article in September or whether I had read it earlier, so of course I can’t locate it. Perhaps someone here has an online reference to something similar.

    Anyway. The article pointed out that a placebo effect isn’t necessarily — or even usually — a benefit someone is actually getting from a placebo treatment. It’s a benefit that they are recorded to have reported getting. It includes many sources of bias, including the subject’s wanting to please someone who has invested a certain amount of effort in them, and saying they feel better than they actually do.

    Unless you have a way of taking apart all the different contributors to the placebo effect, you don’t know how much is real but nonspecific effects (from social contact, from being touched) and how much is just saying Yes I feel better, now leave me alone — and without that you can’t justify saying that placebo “works.”

  97. Oh goody — what squirrelelite already said at 1:15 pm.

    Thanks, squirrelelite!

  98. apteryx says:

    There’s a whole book on the placebo effect that was published several years ago; you might look it up. A number of elegant studies have made it clear that there is a “placebo effect” for pain relief, which can be influenced by both patient and caregiver expectations, and which operates in part through the activity of endogenous opioids in the brain. If people think they are getting a drug for pain, though they are really getting IV sugar water, they report less pain than if they don’t think they are. However, if they are also secretly given naltrexone, an opioid antagonist, they report much less pain reduction. If a sizeable component of the “placebo effect” is due to the poor silly sheeple putting on a brave face to please the investigator, this implies that suppressing the activity of endogenous opioids makes people enormously less eager to please. I’d have to see some substantive evidence before I accepted that presumption.

    This please-the-doctor hypothesis also raises the question of how then anyone could conduct any kind of study of pain, or any other symptom that exists solely in a patient’s perceptions. You can’t consider reports of change on standardized pain scales to be reliable and meaningful only when you approve of the treatment being tested.

  99. Regarding this “mysterious” placebo effect: Irvin Yalom studied the factors that providers and patients believed had led to improvements from group psychotherapy. He arrived at a list of 11: instillation of hope, universality, imparting of information, altruism, corrective recapitulation of the primary family group, development of socializing techniques, imitative behavior, interpersonal learning, cohesiveness, catharsis, existential factors. These are reported in the ubiquitous, readable text, “Theory and practice of group psychotherapy.” A few of these would obviously be operating for someone recruited into any psychiatric drug study. Study staff would typically be friendly and encouraging, and likely portray cautious optimism toward any treatment arm. Also, the clincal / research setting itself probably contributes toward some of these effects.

    In a drug study, you would get: instillation of hope, universality, imparting of information, and interpersonal learning.

    Carl Rogers, another research-evidence-driven psychologist, noted the “necessary and sufficient conditions” for a person to benefit from psychotherapy. To some degree, these conditions can be invoked in a drug trial, regardless of drug efficacy per se. These include: an obvious, perceived therapeutic relationship, in which the provider has unconditional positive regard for the patient; this regard includes genuineness / honesty / transparency. This could be communicated by the drug trial personnel through the entire process of participation. Rogers believed that these therapeutic effects normally happen when human beings have these sorts of relationships, anyway, with others – it is not limited to mental health professionals. An example of benefit from such a realtionship is the classic positive influence that a school teacher can have on a student.

    In the field of psychotherapy research, we have known this for decades, and it is part and parcel of our research. A term for these factors is “nonspecific therapeutic factors,” as opposed to specific factors such as cognitive therapy striving to challenge and replace maladaptive thoughts, behavioral therapy striving to provide classical exposure-and-extinguishing experiences, and psychodynamic therapy striving to re-create a significant powerful interpersonal experience with one in which there is a corrective emotional experience.

    You can act like these therapeutic influences are some sort of black box mystery if you want. If you are in the field of mental health / psychiatry research, that is being woefully ignorant of decades’ worth of major bodies of knowledge. This is bread-and-butter in psychology research and practice. We all have Yalom’s book on our shelves. Sadly, when I read these medication studies, this ignorance of nonspecific therapeutic factors is the status quo.

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