It is summer, the kids are off, and time to write dwindles in the face of sun and golf.  Nonsense knows no season, and in my readings this week I came across the phrase “the undeniable power of the placebo.”  I will do my best to deny that power at least three times before the I crow my conclusion.

One of my first entries for SBM, back in the mists of time, was the Placebo Myth (0), where I argued that the placebo has no clinical effects,  has clinically irrelevant alleged physiology and at most leads to a slight change in perception on the part of the patient that they have less pain. Essentially placebo does nothing. It has no power.

Two studies this month continue that argument: demonstrating that placebo has no practical benefit and the crowing in the media mistakenly trumpets that it does. The headline on Medscape (1) reads “Placebo Effects Modest in Treating the Common Cold.” How modest?719 patients with new-onset common cold were randomly assigned to  no pills, placebo, blinded to echinacea, and open-label echinacea. Illness duration and  severity were the main study endpoints, and neutrophil count and interleukin 8 levels from nasal wash at enrollment and 2 days later were secondary endpoints.

No surprise that for the hard endpoint, WBC and interleukin levels, the sciency part of the study, there was no difference. Placebo and echinacea (as if there were a difference) had no effect on measurable reality.

There were no difference in the severity scores in any of the groups as well.

Those who thought they received eccinacea thought they were better faster (2.58 days, not statistically significant) than those who did not know they were getting echinacea.  As is usual with CAM studies, only when the patient believed they were getting a potentially effective treatment did the subjective aspects of their illness improve.

The authors said “Participants randomized to the no-pill group tended to have longer and more severe illnesses than those who received pills.”  What was the difference between 3 placebos and no treatment over an illness that lasted a week?

The  difference was 0.16 days.  Two decimal points.  That’s accurate. That would be 3 hours, 50 minutes, and 24 seconds faster improvement.  Seriously.  That is a clinically relevant number?  Is there anyone who can mark both the onset and end of a cold with that kind of precision? Over a week they improved  2.2% faster.  That is modest.  Is such an ‘improvement’ likely to be a real effect or part of random clustering seen in all studies.

So another study that demonstrates that the only effect of placebo is to change the perceptions of illness, not the illness itself.  Placebos of all kinds, and all CAM is placebo, do nothing for objective findings, only change the perception of diseases.  It is a curious phenomena.  If someones perceptions convinces them that they were abducted by aliens, or see ghosts, or witnessed a UFO,  or psychic phenomena, many would say, and rightly so, that perceptions are unreliable and that they are being mislead and misinterpreting what has occurred.  If the same thing happens with SCAM, we fund studies by the NCCAM.

The second study was the NEJM asthma report, already discussed at length at this blog.  Patients with mild asthma had no objective changes in their lung function, but were subjectively better if they had a placebo inhaler or sham acupuncture when compared to no treatment. Again, no objective change, only subjective change.

If a patient says they are subjectively better, then they are better even if they are objectively unchanged, right?

It is an interesting question, almost a Zen koan, the sound of one hand clapping, or if a tree falls in the forest and no one is there to hear it, does it make a sound  (2)?  If there was an over arching theme to TAM 9, it was that humans have an amazing ability to convince themselves that phenomena that have no basis whatsoever in reality are in fact real.  It may be UFO’s, or ghosts, or psychic abilities or libertarianism (3);  people believe these phenomena are real but they are only fooling themselves.  The placebo effect is not an effect,  but only a change in perception. Illness appears better through the beer goggles of placebo and CAM.  But in the morning, when you wake up, the disease is unchanged.

Virtually all SCAM’s have no effect beyond that of placebo. So I hearby declare a new law:  Since SCAM  effect= placebo  and Placebo effect = nothing, therefore  the SCAM effect= nothing.  Lets call it Crislip’s Law of the CAM Transitive Relationship ™, as I do so want something named after me, and, as Hanneman demonstrated, by declaring a random concept a Law, it imbues it with a fundamental validity.   Get it on the wikipedia this week, OK?

Both the AFP and NEJM have the same duh moment:  these studies “support the general idea that beliefs and feelings about treatments may be important and perhaps should be taken into consideration when making medical decisions.”

Of course it is important to take into consideration the patients beliefs and feelings when treating them.  The more involved the patient is with their treatment plan, the better the outcome.  A huge part of the practice of medicine is just that interaction.  After 25 years, most of the time my practice is not that difficult.    Most consults would take at most 15 minutes from start to finish if only my clinical needs were the issue: Me find bug, me kill bug, me go home.  It is really not that hard anymore.  The time in a consult is not in making the diagnosis and starting the treatment plan, its is talking with the patient and their family about all the ramifications of their diseases.

The NEJM, however, bordered on the ludicrous.  Most busy clinicians do not have the time or inclinations to read most articles critically.  We rely on a hierarchy of trust, and know from prior experience that some journals are more trusted than others.  The Annals of Internal Medicine lost my trust years ago, and I always read their articles with a grain of salt substitute, knowing that they can publish gullible nonsense.  First the acupuncture article, now the current asthma article, and the NEJM has fallen from trusted journal to read with suspicion.  I long ago was taught that you judge a person by the company they keep, and the NEJM has now been frequently spotted in the company of nonsense.

Look at the abstract, which is all most people will read:

“Although albuterol, but not the two placebo interventions, improved FEV1 in these patients with asthma, albuterol provided no incremental benefit with respect to the self-reported outcomes. Placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma. However, from a clinical- management and research-design perspective, patient self-reports can be unreliable. An assessment of untreated responses in asthma may be essential in evaluating patient-reported outcomes. (Funded by the National Center for Complementary and Alternative Medicine.)”

Placebo effects can be clinically meaningful.  You are receiving a SCAM based/placebo based therapy.  You think you are better.  Your tumor, your HIV, your rheumatoid arthritis, your asthma is unchanged and the basic pathophysiology, with its physiological consequences, metastasis, immune destruction, joint damage, lung inflammation,  continues unabated and unchecked.  That is good?

The accompanying editorial has what has to be the most dumb ass straw man in the history of the NEJM.

“What is the more important outcome in medicine: the objective or the subjective, the doctor’s or the patient’s perception?  This distinction is important, since it should direct us as to when patient-centered versus doctor-directed care should take place.”

I am rarely insulted by the SCAM world; mostly I roll my eyes and give a snort of laughter.  However, this is the NEJM, a formally respected journal.

The goal of medicine always has been and always well be about both.  The heart of patient care is establishing a therapeutic relationship, and everything that is the placebo ‘effect’ is part of the patient -HCW interaction.  To suggest otherwise is both disingenuous and insulting.  The issue for as long as I have been in medicine is the best way, within time and financial constraints,  to apply and nurture the non-objective parts of medicine. What is not needed is to wrap up the patient-physician interaction in pseudomystical nonsense, lies or non reality based therapies that are SCAM.

“Maybe it is sufficient simply to show that a treatment yields significant improvement for the patients, has reasonable cost, and has no negative effects over the short or long term. This is, after all, the first tenet of medicine: “Do no harm.”

They are advocating for a form of Fernando medicine:  it is better to feel improved than to be improved.

I suppose not being effective is not considered a ‘negative effect over the short term or long term.’  And I always though the first tenet of medicine was “Heal the patient.”  If you can to that without harm, so much the better.

A positive subjective response plus no objective response yields nothing.
A negative subjective response plus a positive objective response yields a suboptimal clinical outcome.
A positive subjective response plus a positive objective response yields the best of clinical outcomes. It is what we, in real medicine, strive for.

SBM at its best offers the last, SCAM at its best offers only the first.  It offers nothing but beer goggles.

Footnotes

(0). Have I really been writing for this blog for over three years?  Where does the time go?

(1).  I am a paid Infectious Disease blogger for Medscape, and I realized during an interview with Rachael Dunlop that since Medscape is supported by pharmaceutical advertising, and I am paid by Medscape, I am, in fact, a paid Big Pharma Shill once removed.

(3) We know from the work of Elliot and Goulding that in fact it does not.

(3) The last is a joke. Please, do not send me copies of the Watchtower in an attempt to convince me of the righteousness of your cause.

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