Placebo Treatment of Fibromyalgia

There is much ado in the popular press as well as the blogosphere concerning a recent study in the BMJ concerning the use of placebo in the treatment of fibromyalgia.  The authors set out to explore the use of placebo amongst american internists and rheumatologists but in order to do so without actually bringing up the P word, they couched the key questions within a questionnaire on alternative and complementary treatments.  The actual questions about placebo use were introduced in the following manner.

The first set of three items began with a hypothetical scenario in which a dextrose tablet was shown in clinical trials to be superior to a no treatment control group (thus establishing its efficacy as a placebo treatment). To avoid biasing responses these three questions did not use the term "placebo," "placebo treatment," or "placebo effect." Respondents were then asked to rate the likelihood of their personally recommending this treatment to non-diabetic patients with fibromyalgia; how often they recommend a therapy "primarily because you believe it will enhance the patient’s expectation of getting better";and whether recommending treatments in this manner was "obligatory,""permissible," "permissible in rare circumstances," or "never permissible." Respondents were then asked to indicate which of several treatments they had used within the past year primarily as a placebo treatment, defined as a treatment whose benefits derive from positive patient expectations and not from the physiological mechanism of the treatment itself; and how they typically described placebo treatments to patients. By asking these five questions both without the term "placebo" and then using the term, we aimed to assess physicians’ practices as accurately as possible.

The results in brief:

58% of rheumatologists responded to the survey.  57% of internists.

58% would give the sugar pill given the scenario proposed.

46% personally prescribed treatments primarily to promote patient expectations.

59% believed it was permissible to give this kind of treatment, another 30% said it was okay in rare           circumstances.

Of those that prescribed expectation promoting treatments, the products given included:

    over the counter analgesics 41%

    vitamins 38%

    sedatives 13%

    antibiotics 13%

    saline 3%

    sugar pills 2%

Much has already been written about this study, including at the blogs: Terra Sigillata,and Pure Pedantry 

 but as a practising rheumatologist who treats fibromyalgia, I have to make a few observations. 

First of all, how hard up are american rheumatologists that 58% take the time to respond to questionnaires about alternative medicine for 20 bucks?  Though it may have taken a crew of psychologists and statisticians months to prepare their deviously worded questions, much of the subtlety may have been lost as busy clinicians rocketed through the questions.(Of course, this may have been the objective, did I mention that they were devious?)   The results themselves make me wonder if the survey responders were really tapped for their belief in placebo,  or rather  their use of non-evidence based treatments.  This is the only explanation for the ridiculously high use of  antibiotics.  Surely someone thinking of placebo would choose from any other of the hundreds of more innocuous products available.  MDs aren't that clued out.  I think this may well represent that small group of physicians who believe that fibromyalgia and chronic fatigue are chronic Lyme or Candida infections. Might these physicians also be more likely to respond to a survey on alternative treatments?  Sedatives are also an unlikely choice for placebo.  Why make your patient drowsy when fatigue is a major complaint.  What they are likely doing is treating the anxiety, and hoping it will help the overall condition, even though there is little evidence that it will do so.  The results as a whole make me wonder whether the authors weren't just a little too cute with their subterfuge and netted opinions only obliquely related to placebo.

    The original scenario about a sugar pill proving superior to no treatment may also have created confusion.  The last two decades have been defined by the tyranny of evidence-based medicine.  Clinicians have been brow-beaten into a reflex submission before the  blinded, controlled study, no matter how dubious the source.  The sugar pill study sounds a lot like the many recent acupuncture studies which have been published in reputable peer-reviewed journals, their legitimacy based on their double-blind protocol.How is it that a journal allowed the authors of an acupuncture trial to conclude that sham acupuncture was effective treatment?  If the scientific community seems content to equate double blind with respectability, why would clinicians think otherwise.  With this in mind, I don't doubt that many physicians skimming through the sugar pill protocol didn't simply go with their well trained reflex, if it's blinded and controlled, it's probably okay. 

    Controlled studies can actually function as enablers for placebo treatment. In some respects, ALL pharmacological fibromyalgia treatments are placebo treatments.  There are almost no studies which show a good result in treating these patients.  The most recent addition, pregabalin (Lyrica) did show improvement, but only 43% obtained 30% improvement while  35% of controls did so also.  The studies lasted only 13 wks.  The doses required to obtain this modest result were about 300-600mg/day, doses which in practice are virtually impossible to maintain because of side effects.  So when a clinician prescribes pregabalin at doses of 150mg/day (a dose which is itself not always tolerated)  and expects results, he/she is either wildy optimistic, or hoping for a placebo effect.  The double-blind studies in hand, however, do legitimize the whole endeavour. 

    Lastly, some would somehow equate the use of placebo in fibromyalgia to the use of alternative to medicine treatments.  The big difference is that MDs resort to these measure out of desperation, not out of conviction.  Those that do use placebo, or untested, or alternative treatments almost always do so when known treatments have failed.  I personally do not prescribe placebos but I have the luxury of returning patients to their primary physicians once I've exhausted all my tools.  If the clinicians in this study are in fact the primary physicians, they are following a large population of suffering, distressed, desperate patients with nowhere else to go.    Try to walk a mile in their shoes.

     

    

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