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What do we do about placebo?


ResearchBlogging.org
Body in Mind recently featured a piece on the ‘Moral Dilemma of Offering a Known Placebo’ in which Neil O’Connell talks about how the ‘placebo effect … in part rests on the effects of expectation, belief in the treatment and possibly a re-evaluation by the patient of their symptoms’. He was referring to treatments like acupuncture, electrotherapy and so on, and calls them ‘magic kisses’ because they work in a similar fashion to the ‘Mummy will kiss it better’ treatment I’ve given to my kids when they were younger.  The dilemma lies in the fact that placebo is simply an inert, inactive ‘intervention’ given as if it was active – inevitably requiring deception on the part of the practitioner, and what this can do to things like trust and informed choice by the patient.

So much of what we do as clinicians, particularly physical and occupational therapies, has a limited evidence base.  At the same time, some of the ‘active ingredients’ that have been identified in ‘placebo’ are the very things we are taught to develop – like active listening, instilling positive expectations, helping people re-evaluate their situation.  It’s incredibly difficult to disentangle the ‘active’ from the inactive components of the treatment.

Like Neil, I have concerns about encouraging, even inadvertently, any belief in a mystical, magical ingredient – chi anyone?  I also have concerns about any intervention that suggests the need for an ongoing relationship with a clinician – six-weekly ‘adjustments’ sir?  Or interventions that leave the power (or locus of control to be pedantic) with a gadget or device or substance that someone else needs to operate – three monthly infusions madam?

Dan Moerman’s view of health interventions suggests that every treatment inevitably contains culturally-based elements.  These are the result of an interaction between the person seeking treatment, the social environment in which they live, the treatment setting, the ritual associated with the treatment process, and the interpersonal relationship with the practitioner – everything we do in any healthcare encounter will influence the ‘healing’ or ‘meaning response’ of the patient.

Along with the placebo effect (meaning response), we sometimes forget the nocebo effect – the ill effects that people develop as a result of receiving an inactive treatment.  Take a look at any of the randomised, double-blinded, placebo controlled studies, and in a good one, you’ll see listed all the side effects that people developed when receiving the active treatment – and if you look carefully, you’ll also see the side effects that people developed when receiving the inactive treatment.  It’s entirely likely that along with our very effective, evidence-based treatments, some people will also either fail to respond, or will develop side effects that negate the positive effects of the intervention.

So what on earth do we do about this placebo thing?

Putting my ‘patient’ hat on for a moment, and remember that we are ALL patients at some point in our lives, I know that I want honesty from the practitioner I’m seeing.  I want to choose whether I have a certain treatment – or not.  And I want to know my options.  I’d like to be told about both the side effects and the hopefully positive effects of the treatment.  I want to know the evidence-base for the treatments I get (and if I don’t get told, you can bet, like many of our patients, I’ll be onto the internet and into the journals quick as a flash to find out!)

I don’t want to have a long-term relationship with a practitioner who will want to see me every six weeks or three months, and I don’t want chi (or woo).  I’m not into magic, superstition or intuition.

I’m inevitably going bring all my socially-shaped judgements and beliefs and prejudices into the treatment setting, and I know this is going to influence the outcome.

I’m likely to decide on a particular practitioner on the basis of word of mouth (reputation), what I’ve read from the literature (call that advertising if you will), and I’ll probably decide to return (or not) depending on his or her interpersonal skills – and because I too am influenced by the superficial – I’ll probably be influenced by the decor in his or her rooms and the cost of the treatment!

You see, we’re all influenced by these meaning responses.

So… what to do about placebo?  I, like Neil, hope that as the evidence accumulates, I will throw out the treatments that don’t have solid support from well-constructed RCT’s.  I will be mindful of my reputation and hope to have one that means I’m recognised by my adherence to an evidence-based approach to pain management.  I also hope I’ll always focus on helping people to help themselves, so I don’t inadvertently foster dependence on me.  I won’t be incorporating woo, chi or crystals (at least, not on the basis of current evidence!)  I won’t be using gadgets except as part of helping someone develop their own skills.  If I ask someone to come back after a bit of a break, it will be only to review how they’re going with their own goals, and to help them re-jig their plan for the future.

And I will try to recognise that some people will come to see me and will not ‘get better’ – not because of my approach, but because they have come into treatment with their own beliefs and expectations, their own ‘meaning response’ might interfere with what I’m doing.  Above all, I hope I’ll be honest about what I’m doing and be prepared to change my approach on the basis of science.

That darned placebo – whatever do we do about it? Learn more I hope!

Moerman DE (2002). The meaning response and the ethics of avoiding placebos. Evaluation & the health professions, 25 (4), 399-409 PMID: 12449083
Moerman, D., (2003). Doctors and patients: The role of clinicians in the placebo effect. Advances in Mind-Body Medicine. Vol.19(1), pp. 14-22.
Moerman, D., (2003). “Placebo” versus “meaning”: The case for a change in our use of language. Prevention & Treatment. Vol.6(1), pp. No Pagination Specified

15 comments

  1. It appears your approach to providing a placebo treatment is to place yourself in the shoes of the patient, and then provide service in conformity with your own expectations. And you appear to be typical of doctors: trained to make decisions as scientists, disdainful of superstition, and desirous to personally weigh the possible consequences of various courses of action.

    While you and I may not like woo, many patients clearly do. Some people look to doctors or other experts not for information and choices, but answers.

    Why not provide treatment based on the patient’s preferences, not your own? You could provide each patient, prior to being diagnosed or treated, with information regarding the placebo effect and ask whether they would like placebo-like treatments to be incorporated where appropriate.

    Recognizing the limits of medical understanding the and the real effects of placebo treatments doesn’t mean you need to take advantage of patients by seeing them three times a week. As noted in the Mind and Body article, you can suggest relatively inexpensive acts that are otherwise beneficial to a patient–taking a vitamin, eating green leafy vegetables, walking 30 min. a day–even if there is no evidence these acts will help the specific problem at issue.

    Give patients information and let them decide–even on the issue of whether they should be given further information. The alternative may be that patients without adequate information will simply seek out expensive placebo treatments on their own.

    1. Hmm, I’m not sure that you’ve read any of my other blog posts, because I totally agree that it’s vital to give patients information and let them decide – what I’ve said in this post is that what I offer will aim to be honest and based on empirical findings rather than woo or mysticism, or treatments with limited support in evidence. If, however, people want to know what else is available to them, then I think the provenders of woo have that market well-covered via advertising. I guess I have a question as to how you would select the ‘placebo-like treatments’ that you suggest could be incorporated, and how you would judge them to be ‘appropriate’? If you’re not using a scientific basis for deciding this, how do you decide, or is this simply about the preference of either the clinician or the patient? I’d hope that some underlying principles would be present – mine are to minimise ongoing dependence on clinicians or procedures that mean the person needs to come into a health care facility, to be able to maintain and increase activity, self reliance, participation in valued activities/roles and to reduce distress.
      The majority of the strategies I provide are quite simple – living well with chronic pain is pretty much the same as living well generally, with just a bit more rigour in terms of managing energy.
      I agree that it’s unnecessary to take advantage of patients by over-servicing them, but beware of simplistic thinking: even simple ‘reassurance’ is not always reassuring!
      Linton, S. J., McCracken, L. M., & Vlaeyen, J. W. (2008). Reassurance: Help or hinder in the treatment of pain. Pain, 134(1-2), 5-8.

  2. Placebo/nocebo is of no serious clinical value or significance, and lying to patients is never acceptable (perhaps with a tiny handful of short term exceptions, like when dealing with a parent who is strongly suspected of abusing their child, or patients who are tipping over into psychosis and need hospitalising).

    (Of course, this effect should always be controlled for in formal studies. But beyond that, meh.)

    1. Hi Ronny, I’m not so sure that nocebo/placebo is of no serious clinical value – it’s those reported side effects on which people decide to stop taking medications, and as Benedetti and others have shown, there is a significant opioid effect that can be countered with opioid antagonists, suggesting that placebo can provoke very real and clinically important effects. I totally endorse never deceiving patients, honesty is paramount in a health situation.

      1. Hi adiemusfree

        Should have said I was making a general comment on the placebo/nocebo effect. I agree that it probably does have some clinically significant (though generally modest) effect with pain and nausea. But these are probably the only symptoms it does.

        Also, achieving a reduction in levels of medication use is not necessarily direct evidence for placebo effect. It may be that standard levels for at least some medications are a bit too high to start with (erring a little on the high side to ensure a good effect, under dosing can be just as problematic as over dosing).

        There is also the question of exactly what we mean by placebo effect. For example, it is hard to distinguish clearly between placebo and just simple distraction, or even tell if they are different processes. Obviously if you have some rewarding interactions going on, say with an old and much loved friend visiting for the first time in a while, then your neuro-psychology is going to be less swamped by pain (or other distressing symptoms you may have), simply due to it having other and pleasurable things to do, within limits of course.

        Another issue is the short term nature of placebo effects. Might be fine to help get somebody through a bad hour or day, but beyond that its effect and value seems to rapidly diminish.

        I used to have the conventional view of placebo, but since the solid meta-analytical work of over the last decade, I have become a lot more sceptical of its power and importance and its nature (though not its reality, I don’t doubt it exists in some form). At the very least, the claims made about it, including by mainstream medicine, need to be much more closely scrutinised and cut down to size. I have always been troubled by how casually various clinical presentations are characterised as some form of placebo/nocebo. It is just too convenient, and frankly lazy and sloppy clinical practice. We are seeing exactly these problems at the moment with a lot of claims about various forms of somatisation, (the flavour of the decade it sometimes seems). But these are diagnoses all too often based on little more than a lack of known organic disease, (coupled with some rather weak and selective inferences about usually subjectively measured psycho-social correlates). I hardly need point out the logical fallacy in that line of thinking, including the unfalsifiability of the diagnostic method, and the serious potential consequences for the patient if it is wrong (and it quite clearly often is). It has a long and troubled history, that does not look like ceasing any time soon.

        OTOH, we have the Whitehall studies (among others) which clearly show that social ranking alone has a very measurable impact on overall health, including simple physical health. But this is only measurable at the population level, ie statistically. My big problem comes when we try to definitively ascribe placebo based processes to individual patients. Virtually impossible to be sure in the vast majority of situations, which rather reduces the value of such interpretations.

        BTW, good blog. Very interesting, if often troubled area of medicine.

      2. Ronny you make some great points. I’m still weighing up all the bits and pieces on placebo and I guess it’s a bit early to really apply it to daily clinica practice (although my feeling is that those ‘meaning responses’ are already influencing expectancies). I’m reflecting on Benedetti and Colloca’s work and the very ‘hard’ evidence they have found about endogenous opioid systems. I am truly wary of anyone pointing to an individual’s response as ‘placebo’ – although it’s incredibly tempting when one person I know received an invasive intervention, used the device 10 minutes a day for a month then stopped using it stating she was completely pain free. The device ordinarily is used intermittently throughout the day – but of course, this could be distress reduction with an external locus of control (ie the device controls) that she could push whenever she felt distressed, quite a powerful conditioning effect.
        It’s plausible that along with the meaning response there are also situations in which conditioning occurs, as well as natural regression to the mean, reduced distress by ‘taking control’, and the occasional miraculous healing! Distraction, or working with attention management is still, IMHO, neurobiologically driven – in which case I’m really interested to know more about how this works.
        I’m worried by your suggestion that clinical presentations without the presence of known organic disease being sloppy. Firstly, declaring my own hand here, what about fibromyalgia, and all the other central sensitisation syndromes? It’s pretty difficult to find objective ‘organic’ findings in mTBI and yet it produces profound disturbance of cognition, affect and behaviour especially in some vulnerable individuals. I personally think ‘somatization’ can represent the worst of the mind/body dichotomy that pain has neatly blurred. I wonder at the utility of diagnosis in these cases, and this is why I’d prefer to use a case formulation approach that develops specific hypotheses about how and why aspects of the individuals presentation are being maintained, and from this, treatment strategies can be developed. My concern about the ongoing search for a specific diagnosis is that the process itself is intrusive, can lead to iatrogenic disability (especially because the more obscure the diagnosis, the more high-tech the investigation – the more catastrophic the interpretation by the individual!), and delays in the person feeling ready to engage in living life well.
        I think it’s important that placebo/nocebo isn’t thought of as ‘just psychological’ because to me it’s both, and the mechanisms are something we need to know more about and then harness as much as we can in clinical practice. But at the moment the best we can do is be mindful of the aspects we do know about, and ensure we are open and honest with our patients about what we do and don’t know.
        Thanks for your thoughtful comments! Pain management is a passion of mine (in case you hadn’t guessed!)

  3. I chuckled when you admitted that the decor might play a role in your perception of a practitioner.
    Seriously though, I really started thinking about the ethics of the nocebo effect particularly when I caught
    myself mentally entertaining the thought of forwarding an email to a friend with graphic pictures of a particularly
    ghastly outcome from a repetitive behavior. I did not take this action because of course this is manipulation –trying to influence my friend to stop a behavior that I have ever so helpfully identified as being inimical to her health and well-being. And that frankly –TRUTH now–I find irritating and annoying.

    The stupidest use of nocebo IMHO are those chain-mail emails that have magical benefits if only one forwards to the certain stipulated number of recipients; otherwise if one breaks the chain, whamm-o the curse is upon thee.

    Slightly more subtle, in the past I have had a doctor use the “if you do not take this medicine as prescribed, you
    could die” exhortation. I would have preferred a candid tempered discussion of limits of knowledge about the consequences of not treating the condition. Since I did not die when I stopped the taking medication and my test results came back within normal ranges, I unfortunately came to harbor some cognitive beliefs about doctors in my early twenties such as “doctors lie and exaggerate to ensure patient compliance ” and “doctors always minimize how painful a procedure really is so you will agree that the benefit surely outweighs such modest discomfort.” ha!

    I did not think doctors were EVIL or malicious. Seemed to me that they were rationalizing that the end justifies the mean (and they did not believe that they could present evidence to me and expect me to make a rational decision ) so they needed to employ some extreme emotional motivation.

    Fortunately, I have had many more encounters and opportunities to interact with doctors and I realize that those human beings, many of whom have discarded the white coat and are willing to share evidence and discuss options, are not homogeneous in their orientations.

    I have also come to realize that many alternative remedies are marketed in a weird kind of nocebo-fashion as non-existing illnesses are invoked so that the “remedies” can alleviate or cure them. ” A Toxic system filled with free radicals is the underlying cause of all illness….sip on acai juice while experiencing the health benefits of chelation therapy combined with a colonic.” Yup time to exorcize that demon “toxicity”

    Coming back to what you are saying so well in your post: the problem with placebos is the Dumbo’s magic feather conundrum. Dumbo can fly without the feather, and we as patients actually generate our own neurotransmitters which modulate our own systems. I really like your emphasis on interacting with your patients so that they can fly on their own (metaphorically speaking of course😉

    1. “Slightly more subtle, in the past I have had a doctor use the “if you do not take this medicine as prescribed, you
      could die” exhortation.”

      So did I, for an emergency asthma medication. Which is why, no matter how terrible I felt, I never, ever took it. Rather than make an error on taking the follow-up tapered dosage.

      Somehow I doubt that was the effect the doctor and pharmacist wanted their warning to have.

  4. Great post Bronnie (thanks for the mention) and I couldn’t agree more. I think patient choice is a difficult concept here because it is very difficult for patients to access or distinguish good health information. There is so much misdirection, anecdote and outright fraud out there and when you are in desperate need you become vulnerable to the peddlers of false hope. I guess it boils down to “keep what works, keep the care and dump the magic”.

    1. Hi Neil and thank you for the trigger to this post! Patient choice is an incredibly difficult thing to manage – I see people who have spent thousands of dollars on treatments, both ‘conventional’ and not, that have failed to address their concerns about their pain. Many of these people have never been informed about self management, despite the strong support for a cognitive behavioural approach for self managing chronic pain. By being very upfront about my adherence to evidence-based practice – that also tries to help people live lives full of things they value – and posting as I do, I hope to inform and enthuse practitioners and patients of things that do seem to help, given the current status of the science!

  5. Its a difficult issue, ethically prqctically and economically (for both private providers and patients) in many ways. However, positively if we can enhance meaning ,facilitate a persons own process of restitution and understand what may move a person towards this state than this has to be a good thing? Spaces and places where treament takes place for example have been studied by the Rheumatologist Esther Sternberg. Often complex cases of distress and disabilty are shunted into stark clnical rooms with rushed appointments (this was my experience of several pain clinics).
    I fully endorse pain managment , enhancing self efficacy and minimising disability. However in Neils terms a few ‘kisses’ probably will not go amiss. A good narrative which looks at a patients journey dealing occupational therapy following an elbow fracture and secondary neurogenic pain is the Sociologist Ann Oakley’s Fracture. The response Ann obtained through the enhanced treatment effect cultivated by the acupuncturist (environment ,demenour , care ) was in stark contrast to the orthopaedic clinic . People often seek care, reasurance and an ‘individualised’ approach –this is often lacking in many protocol led clinics.
    I disagree with the post that suggest placebo and nocebo are of no clinical importance. For many people nocebo is a feature of many health care interactions and according to Benedetti may have strong negative physiological consequencies. As biomechancial explanations of pain are dominant many people are told or interpret the results of tests,scans etc in often maladpative ways ….you have the spine of a 70 year old often leads to catastrophisation and disability for example.
    I think for some people ‘chi’ used as a metaphorical explanation is not too bad… metaphors used wisely may indeed enchance meaning and downregulate threat. I suggest tai chi and use the principles all the time–it does not mean that I think chi,prana etc are ‘real’ but perhaps these metaphors may improve a persons self image /intereoception (especially if they learn to do things themself) .The danger perhaps is if these things are relied upon too much …..’Peddlars of false hope’ …yes a big problem and it is easy for those in the scientific medicla community to sit on a pedastal casting stones on CAM etc when many interventions offered by the medical profession offer little and in many cases are iatrogenic. I would have no problem suggesting certain ‘woo’ therapies offered by some caring people I know over and above an interventional pain clinc or rheumatology clinic for example . Allowing a stressed out person with often complex social issues a little respite seems fine in some circumstances . It may be a better use of resources than the mri/ct multiple health professional pharmacology route which tends to be a frequent occurrence.
    Sometimes I just think we live in a overly medicalised culture and placebo treatments will just evolve to meet the demands of the population seeking care and attention!

    1. Hmmm, more food for thought Ian! But if we can learn about what it is about these nonscientific interactions that is helpful then surely we can transplant this into evidence-based practice? That’s part of the reason I’m teaching 5th year medical students about psychosocial ‘yellow flags’, so they can develop awareness and then skills to be compassionate and to listen – hopefully when they graduate these skills will remain with them and they’ll be far more capable of providing appropriate individualised attention.
      The problem with using words like ‘chi’ is that they are tied up in a belief system with all the same problems inherent in the biomedical system – like unintended nocebic effects. And while we may acknowledge them as being metaphoric, I’m not so sure that patients will, and there are most definitely practitioners who do believe in these things literally. The combination of an enthusiastic, passionate, caring person who genuinely believes in something mystical is undoubtedly powerful. You see while I think there are definitely some woo peddlars who are fully aware of the lack of effectiveness of their approach, there are many more who are genuine in their belief – even though it is only a belief – and the expectations they engender simply because they’re passionate are possibly a good part of their ‘success’. Wouldn’t it be fabulous if that same passion and instilling of hope was delivered by someone who is using evidence-based practice?
      This isn’t a treatment dichotomy – either biomedical or mystical. Maybe a referral to an interventional pain clinic or a rheumatology clinic where only pharmacological or invasive treatments are recommended isn’t the best for someone with psychosocial concerns – but the alternative isn’t just to suggest palliative ‘woo’ input. There’s enough evidence to support the cognitive behavioural approach including ACT, CBT and others for a referral to an interdisciplinary pain management centre to be as wholistic as what the woo provenders say they are!

      1. Its late here and I have 2 weeks off now to head off to the wilds of the N Isles of Scotland ! Briefly I agree with you re evidence and in an ideal way this would be the best bet . Pragmatically however,the reality in the interventionist led clinics where I have worked , the dominant issues are psychosocial ‘distress’, iatrogenic disability, ‘trauma’ /ptsd issues etc etc . The spaces where ‘treatments’ occur tend not to be like the ones Sternberg recommends and treatment ‘acts’ tend on the whole to be unimodal . Pain management is not at all integrated or for that matter valued that much. I have read widely in these areas. I practice meditation , have learned to teach mindfulness principles and apply CBT principles daily. It is not that I do not value evidence , far from it! Minimal ‘treatment’ with the dominant message of education and self reliance is my approach. I think my main role and only real role actually in the GP clinic is to act as a health coach and demedicalise the vast majority of people with vague non specific ailments that get sent my way…Most if not all of the modalities that I was trained to use are placebo ……Touch and movement are the main things I ‘believe’ in —both are often lacking in many peoples lives –especially those in persistent pain . Touch as a form of empathic communication and education is different from a mechanist fix which may cause dependency and I try to avoid the latter…

        ian

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