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The use of the placebo effect in clinical practice

Discussion in 'General Issues and Discussion Forum' started by Craig Payne, Jan 31, 2008.

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  1. Craig Payne

    Craig Payne Moderator

    Articles:
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    Been doing some thinking and looking up some literature today. The placebo effect of "sham" foot orthotics in RCT has been well shown which means that at least some of the effect of "real" orthotics must be due to the placebo effect.

    What got me thinking was just how much of the placebo effect is specific to randomised clinical trial and was not an issue in actual clinical practice? A superficial review of the literature turned up a lot on the placebo effect in clinical practice, in particular, the full text of this article is available online:

    Using the placebo response in clinical practice
    Hyland, Michael E.
    Journal of the Royal College of Physicians, Volume 3, Number 4, 1 July 2003 , pp. 347-350(4)
    Link to article

    What say you?
     
  2. Admin2

    Admin2 Administrator Staff Member

  3. davidh

    davidh Podiatry Arena Veteran

    Hi Craig,

    As clinicians what we are interested in is a beneficial physiological manifestation of any psychological changes brought about by placebo effect.

    Apart from the obvious "targets" (homeopathy and acupuncture), there are probably beneficial physiological effects to the patient from simply walking into a clean clinic, being greeted by a clinician wearing white coat, and being listened to.

    Difficult to measure, I know, but there are some studies which show physiological changes due to placebo effect, so not too hard to extrapolate those out.

    Cheers,

    David
     
  4. Aren't we mixing placebo and Hawthorn effects here?
     
  5. Fiona Hawke

    Fiona Hawke Member

    Dear All,

    I investigated the role of the placebo effect in podiatry as part of my honours project, a systematic review of custom-made foot orthoses for the treatment of foot pain (protocol available online: http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD006801/frame.html). The full review is being peer reviewed.

    As a quick introduction, the placebo effect is the impact of psychosocial context surrounding an intervention (e.g. attitudes and expectations) on therapy outcomes.

    For those interested in the placebo effect, I recommend reading:

    Hróbjartsson, A., & Gøtzsche, P. (2004). Placebo interventions for all clinical conditions. Cochrane Database of Systematic Reviews. Issue 2. Art. No.: CD003974. DOI: 10.1002/14651858.CD003974.pub2.
    Available online within countries with national provision open access: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD003974/frame.html

    In summary, Hróbjartsson attempted to determine whether or not the placebo effect actually exists. From meta-analysis, he did not detect a statistically significant placebo effect in trials for binary and objective outcomes; however, he did detect a moderate placebo effect for self-reported continuous outcomes. This effect was even stronger for self-reported pain outcomes, however, could not be clearly distinguished from systematic bias.

    Very interestingly, brain functional imaging has located the neuro-chemical circuitry activated when participants expect they will receive, or believe they are receiving, a pain relieving intervention (Kuehn, 2005; Ramos, 2007). The changes in brain activity are similar to those occurring when genuine interventions are delivered (Colloca & Benedetti, 2005; Haour, 2005; Kuehn, 2005).

    Overall, it appears likely that placebo plays a role in the treatment of pain within podiatry. It is even possible that clinically important benefits can be achieved by intentionally maximizing the placebo effect in clinical practice. More research is needed to determine if (and if so, how) we can achieve this.

    Take home messages:
    1. ‘Placebo’ is not a dirty word. We humans appear to have an endogenous capability to voluntarily and/or involuntarily regulate our response to the treatment of pain. This is exciting. The mechanical effects of interventions we prescribe for what we believe are mechanical stress induced injuries can be supplemented by patients’ psychological responses to treatment. Excellent.
    2. What the patient thinks, matters.



    Kind regards,


    Fiona Hawke


    Please note, the placebo effect is distinctly different to the Hawthorne effect.
    Hawthorne effect: changes that occur as a result of a participant/patient knowing that they are under observation. It is unclear whether or not the Hawthorne effect actually exists (Kompier, 2006).


    Colloca, & Benedetti. (2005). Nat Rev Neurosci, 6, 545-552.
    Haour, F. (2005). Mechanisms of placebo effect and of conditioning: neurobiological data in human and animals. Medecine Sciences 21(3), 315-319.
    Kompier, M. A. J. (2006). The "Hawthorne effect" is a myth, but what keeps the story going? Scandinavian Journal of Work, Environment & Health, 32(5), 402-412.
    Kuehn, B. M. (2005). Pain studies illuminate the placebo effect. Journal of the American Medical Association, 294(14).
    Ramos, J. (2007). Placebo effect and pain: brain bases. Neurologia, 22(2), 99-105.
     
  6. Atlas

    Atlas Well-Known Member



    It matters, but only in conjuction and in context of clinically measurable findings.

    That is why measures (such as the lunge for ankle rehab) are a vital assessment (and reassessment tool) to help judge whether what we do works and to what degree.


    Patient x, 6 months post-ankle surgery (excluding triple fusion), who can only regain 40% of lunge range, means that surgery and/or rehab has not been successful. It would be hard to justify 'success' if the lunge has not moved, the patient is obviously limping; but the placebo effect convinces the patient and/or therapist of otherwise.


    Over the past 12 years of clinical practice, I am surprised how much patients do know, and how much they don't know. In other words, be careful with what you include and exclude in relation to subjective information.


    Even if the placebo effect exists, it is a one-percenter that makes us feel good for 30 seconds. Let's worry about the things that we can significantly and truly change objectively.

    Because if we delude ourselves that the placebo effect is anything more than icing on a cake, then insurance companies should just make a DVD using an actor dressed up as a clinician who continually 'empathises' with "How are you today?", with a long pause and nodding following. They can save a lot of money and dramatically lower their health expenditures.
     
  7. Fiona Hawke

    Fiona Hawke Member

    Dear Atlas,

    If the video works, we should get it out there. However, I doubt it would. The placebo effect encompasses the entire treatment context. For example, expectations of treatments are very important. If you think orthoses might work, they might work a little better for you than for they do bloke next door who thinks they’re rubbish and wears them to prove it.

    In regards to your case study of patient x, the success of the ankle surgery depends on the goals of surgery. If the goal was to regain 70% of lunge, then the surgery was not a success. If the surgery was to reduce pain levels to a point where daily function was not limited, then regardless of any increase in % lunge, the surgery could be a success.

    Objective outcomes are clean, however, they aren’t always of upmost important to the patient. E.g. pain and comfort are extremely important to most podiatry patients, yet these are almost as subjective as they come.

    Hróbjartsson’s review found that the placebo effect probably does exist for subjective, self-reported outcomes such as pain and comfort. The effect size was moderate; large enough to produce clinically important improvements for patients.

    It is a very interesting topic and I expect many people have some thoughts to share.

    All the best,

    Fiona
     
  8. peter96

    peter96 Member

    I think this approach has many pitfalls, are we talking about misleading, and exaggerating the affect of treatments to patients in the hope of improving outcomes. Many practitioners unrealistically talk up their therapy, or give patients the hard sell, in the end patients are paying a fee for this service. I often hear people say um well maybe i feel a little bit better, or i felt good last thursday arvo. Patients who are suffering, often interpret any change in symptoms, or fluctuation in their condition, as evidence their treatment is working. This belief is usually only sustained temporarily, unless their treatment is truly effective in reducing symptoms, due to physiological reasons. Patients who get a pep talk on how good their therapy is going to be in the hope of soliciting a placebo effect, may in the short term feel better, but three or six months down the road might feel that they have been fooled, and develop a negative opinion about the therapy that they have been receiving, and feel hopeless about their situation.


    I am not dismissing the placebo effect, but i think that some of the research on this subject it is over estimating it.
     
  9. Fiona Hawke

    Fiona Hawke Member

    Dear Peter,

    Thanks for your post. I think you touched on some very important issues regarding the placebo effect.

    I do not advocate misleading patients regarding the potential benefits of treatment. Patients need to consent to treatment only when adequately informed about the treatment and alternative treatments etc. The placebo effect encompasses the ENITRE treatment context, not just what the clinician might tell their patient. I suspect that patients often approach certain treatments with so much emotional baggage that the makings of a placebo effect are already in place.



    I couldn’t agree more. But patients aren’t the only ones liable to be fooled by this initial reduction in symptoms. Clinician should stay aware of this possibility and keep focused on long-term goals for patients. Also, since the placebo effect is strongest for subjective outcomes (such as self reported pain), it might help clinically to supplement pain measurement with objective measures including functioning ability.

    Similarly, patients and clinicians alike can falsely attribute long-term reductions in symptoms due to natural progression of pathology to a physiological effect of the treatment. It is incredibly difficult (perhaps even impossible) to isolate the physiological effect of a treatment on outcomes such as pain in the clinical setting. This is where well-designed clinical trials should jump on board and provide some light.

    I might add here that since pain is a subjective experience, it is often perpetuated by the fear of pain. In fact, a view of pain as mysterious is one of the five predictors of poor health-related quality of life in chronic pain sufferers (Dysvik, Lindstrøm, Eikeland, & Natvig, 2004). The initial reduction in symptoms that you see and attribute to the placebo might help patients in their emotional struggle with pain. They might feel as though they regain control over the situation.



    In a case where the physiological effect of the treatment is minimal and the placebo effect is the sole reason for symptom reduction, any emotional benefit derived from a placebo effect should not be left to slowly fizzle out, leaving the patient once again in fear of their pain (‘why would it suddenly come back like this???’ panic mode). The ball might be rolling, but it can come to a stop.


    Currently, we know very little about the impact of the placebo effect on the treatment of foot pain. We don’t know who it affects, how long it lasts, how strong it is (and is it stronger for some types of treatments) and if it can be intentionally modified. Until we know these things, all I will do is keep an eye out for it and where possible try to ensure it does less harm than good.

    Sincerely,

    Fiona

    Dysvik, E., Lindstrøm, T. C., Eikeland, O.-J., & Natvig, G. K. (2004). Health-related quality of life and pain beliefs among people suffering from chronic pain. Pain Management Nursing, 5(2), 66-74.
     
  10. Atlas

    Atlas Well-Known Member



    Fiona, when I buy a car, I would be a little worried if the manufacture has spent 60% of its time and resources on the paint job.

    Same with the musculo-skeletal clinician!

    I recall an honours project at university regarding placebo callous removal. Personally, I think there a better avenues to advance the student, the profession, and the academic library.

    The placebo effect is icing on the cake at best. Until podiatrists are clinically proficient at assessing and treating (the cake) ankle sprains etc., only then, should we concern ourselves with the superfluous IMO.



    Ron.
     
  11. Shane Toohey

    Shane Toohey Active Member

    Dear Ron, Fiona et al,

    I just came across this thread while using the Arena for insomnia.

    My strongest thought is that the clinician who is thorough, confident and listens with empathy is most likely to produce a positive placebo.
    The smart talker only needs to say one thing out of line and has lost.
    Also, be aware that your results may sometimes be helped by the effect and remain humble.

    Cheers
    Shane
     
  12. Like one of my teachers said... The name of "PLACEBO" disappear when the treatment for example the ACUPUNCTURE run successfully in children and no rational animals :)
     
  13. Trent Baker

    Trent Baker Active Member

    I remember attending a NSW state conference in Albury a few years back and listening to a presentation on research that found a positive placebo affect involving podiatrists using orthoses.

    Forgive me for not being able to quote the name of the study or the researcher, however if memory serves me well, it found that 60% of orthotic patient outcomes are due to practitioner confidence. The main crux of it was as Shane has noted above, "My strongest thought is that the clinician who is thorough, confident and listens with empathy is most likely to produce a positive placebo."

    Trent
     
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