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Medical Forum / Diseases and Disorders / Sinusitis / January 2008

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Chronic Sinus Problems Require Treatment (JAMA got it wrong)

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joe@freakyacres.com - 20 Dec 2007 12:56 GMT
http://www.consumeraffairs.com/news04/2007/12/sinus_treatment2.html

or

http://tinyurl.com/3dwrr7
truehawk - 22 Dec 2007 05:28 GMT
I don't know the authors of the study, but if they are not idiots they
are paid flunkies of the insurance industry.
judy.n - 22 Dec 2007 13:31 GMT
YOU'RE BACK!!!!
I posted at least twice that people need to read the abstract: only
240 patients/4 years with flawed clincial criteria. (Each practice
contributed one or less patient.The four arms studied 60 people.)
 The JAMA editorial blasted the study: poorly designed, underpowered,
selection bias, and said it proved nothing, except they likely studied
people with early URI's and --go figure--antibiotics and steroids
weren't helpful in those situations. Duh.
 It was done in the UK--no idea if they're all in the pocket of
pharma there, but bottom line, lousy study and the press misunderstood
it--deliberately??--and ran the sensationalist headline.
 Glad you're back, we needed your cutting edge, scientific input.
 Hope all is well with you and your family.
Judy

> I don't know the authors of the study, but if they are not idiots they
> are paid flunkies of the insurance industry.
Steven L. - 23 Dec 2007 00:18 GMT
> YOU'RE BACK!!!!
> I posted at least twice that people need to read the abstract: only
> 240 patients/4 years with flawed clincial criteria. (Each practice
> contributed one or less patient.The four arms studied 60 people.)
>   The JAMA editorial blasted the study: poorly designed, underpowered,
> selection bias, and said it proved nothing,

Where did he say that???  In the part of the editorial I saw, Dr.
Lindbaek said this:

“The study by Williamson et al has implications for clinicians who treat
patients with acute sinusitis–like symptoms. This study reinforces the
lack of benefit from antibiotics shown in a number of other studies that
recruited patients based on clinical symptoms and findings. Most
patients with acute purulent sinusitis recover without antibiotic
treatment, as was also observed in a study that used sinus computed
tomography scans as the diagnostic standard. But some patients with
sinusitis are more ill than others with fever, malaise, and deteriorated
general condition. These patients still are in need of antibiotics,
although they are relatively uncommon in general practice. So far there
is no reliable way to distinguish viral sinusitis from bacterial
sinusitis in the general practice setting, and a point of care test that
could single out patients who could benefit from antibiotic treatment is
not available.”

JAMA would never have accepted a paper for publication that "proved
nothing."  They just wouldn't publish it, not publish it and then attack
it as worthless in an editorial.

Signature

Steven L.
Email:  sdlitvin@earthlinkNOSPAM.net
Remove the NOSPAM before replying to me.

judy.n - 23 Dec 2007 00:47 GMT
Did you read when it was qualified as useful, with significant
limitations:
"....his study is a useful contribution to the evidence on the effect
of antibiotics and topical steroids in treating sinusitis but has some
limitations. First, an objective reference standard was not used.
Patients were included who had at least 2 of 4 Berg and Carenfeldt
criteria,11 which have not been validated in a primary care setting.
Second, the positive likelihood ratio of 6.75 is fairly high, but
depends on a high pretest probability of patients with purulent
sinusitis. With a possible pretest probability of 20%, the proportion
of purulent sinusitis would be 65%, leaving 35% with a possible viral
infection. Therefore, it cannot be ruled out that a number of viral
cases were included in the study. Third, the recruitment of patients
for each clinician was low, around 1 case per primary care physician
during 1 year, whereas most primary care physicians might be expected
to see as many as 50 cases of sinusitis per year. This may imply a
selection bias and limits the external validity of the study."

Clearly I over-simplified when I called the study worthless: but the
press and this group have over-simplified the study without reading
it, or the editorial.

Antibiotics are over-prescribed, in some settings (I would argue more
in urgent care than primary care settings, where there is continuity)
and should not be used to treat viral infections, but we have limited
clinical ability to determine which patients will benefit from
antibiotics, and which won't.

This was a very limited study, of a few patients with an isolated
illness: it doesn't address recurrent sinusitis, chronic sinusitis,
patients who are quite ill with their illness. Most likely, as stated
above, a significant number of the subjects had an isolated viral
illness.

The editorial pointed out the weaknesses of the study, and basically
said it continues the dialogue, but doesn't offer the solution of
determining which patients require antibiotics. It suggested other
forms of diagnosis: C reactive protein, and other, larger studies.

It is not the last word.

How do you know JAMA"s agenda? You need to read articles carefully and
completely to fully understand them: the abstract isn't sufficient.

Judy

> > YOU'RE BACK!!!!
> > I posted at least twice that people need to read the abstract: only
[quoted text clipped - 29 lines]
> Email:  sdlit...@earthlinkNOSPAM.net
> Remove the NOSPAM before replying to me.
judy.n - 22 Dec 2007 13:38 GMT
YOU'RE BACK !!!!!
  I tried to post earlier, but it didn't work.
  It was a lousy study, and the editorial in JAMA blasted it:
underpowered, poor clinical criteria, 240 patients studied over 4
years with obvious selection bias--one or less patient from each
participating practice.
 The criteria they used for inclusion had poor predictive value--they
most likely studied people with early viral infections, and--surprise--
antibiotics and steroids were'nt helpful.
 The press was so biased: they ignored the editorial which said it
was a lousy study, and ran with the sensationalized headline.
 I've posted this before.
 Hope all is well with you and your family.
 The editorial said that clearly there are patients who require
antibiotics to treat their sinusitis, and this study did not clarify
how to select those patients.
Judy

> I don't know the authors of the study, but if they are not idiots they
> are paid flunkies of the insurance industry.
judy.n - 22 Dec 2007 13:39 GMT
Oops, the post did go through, just not for a while.
Still glad you're back.
Judy

> YOU'RE BACK !!!!!
>    I tried to post earlier, but it didn't work.
[quoted text clipped - 16 lines]
> > I don't know the authors of the study, but if they are not idiots they
> > are paid flunkies of the insurance industry.
truehawk - 22 Dec 2007 23:08 GMT
> Oops, the post did go through, just not for a while.
> Still glad you're back.
[quoted text clipped - 20 lines]
> > > I don't know the authors of the study, but if they are not idiots they
> > > are paid flunkies of the insurance industry.

Glad to hear from you too Judy.
Happy Holidays.

Elizabeth
ellen - 23 Dec 2007 16:12 GMT
> I don't know the authors of the study, but if they are not idiots they
> are paid flunkies of the insurance industry.

elizabeth!  so glad to hear from you again.  missed you & hope all is
well.

ellen
truehawk - 29 Dec 2007 03:40 GMT
> > I don't know the authors of the study, but if they are not idiots they
> > are paid flunkies of the insurance industry.
[quoted text clipped - 3 lines]
>
> ellen

Ellen:
All is miserable to outstanding!
Life, generally grand in it's complexity and cussedness!!!!!!

Judy:
I don't know that I agree that antibiotics are over proscribed.
If you prescribe antibotics which prevent bacteria from moving into
the area where a viral infection has killed off or seriously
comprimised the cillia and it saves the person from years of goo, then
I would argue that those antibotics were highly effective.
I did not have the kind or quanity of mucus that completly blocked my
breathing until I had the flu and was refused antibotics.
(And let us not forget that all antibotics are not created equal by a
long shot, the fact that a penicillian is not effective for CHRONIC
sinusitis,  says nothing about what macrolides, sulfa drugs, or
floroquinolones would do.)
judy.n - 29 Dec 2007 14:50 GMT
Elizabeth: I agree with you. I find the movement to restrict
antibiotics is pervasisve theme, and some people are being really
dogmatic about it, and getting very "holier than thou" about
withholding antibiotics for the patient's own good.
 I don't see people begging for unnecessary antibiotics.
 I have seen physicians and mid-levels refusing to prescribe, and
calling it evidence based.
 It scares me. Because one size does not fit all, and the move to
withhold antibiotics in response to increased resistance focuses on
people, not all the farm animals who are the primary cause of the
resistance--IMO.
Judy

> > > I don't know the authors of the study, but if they are not idiots they
> > > are paid flunkies of the insurance industry.
[quoted text clipped - 20 lines]
> sinusitis,  says nothing about what macrolides, sulfa drugs, or
> floroquinolones would do.)
truehawk - 30 Dec 2007 06:31 GMT
> Elizabeth: I agree with you. I find the movement to restrict
> antibiotics is pervasisve theme, and some people are being really
[quoted text clipped - 3 lines]
>   I have seen physicians and mid-levels refusing to prescribe, and
> calling it evidence based.

Yes and that evidence is almost always a trial done with
amoxicillian.

They don't have any trials saying that clindiamycian (Biaxin) is
ineffective for sinusitis.
aroberts - 12 Jan 2008 18:19 GMT
>> Elizabeth: I agree with you. I find the movement to restrict
>> antibiotics is pervasisve theme, and some people are being really
[quoted text clipped - 9 lines]
> They don't have any trials saying that clindiamycian (Biaxin) is
> ineffective for sinusitis.

I know one thing empirically:  When I'm taking Biaxin, both my sinusitis and
asthma improve.  I am lucky to have both an excellent ENT and pulmo.  They
are familiar with the studies and potential of macrolides, and have not been
reluctant to prescribe when necessary.  As Judy says, many doctors are
dogmatic about their fear of resistance, and unfamiliar with the work that
has been done with macrolides.  The media have had their role in this as
well, with their frenzied and often uninformed reporting about resistance.
Of course, they're in the Panic Profession.
judy.n - 14 Jan 2008 02:19 GMT
Well put: you are lucky to have physicians who get it. Macrolides are
anti-inflammatory and don't allow viruses and bacteria to stick--they
interfere with the CAM-1 protein, at doses below antimicrobial
levels.
 I like the term Panic Profession. And, the need to over simplify is
pervasive.
Judy

> >> Elizabeth: I agree with you. I find the movement to restrict
> >> antibiotics is pervasisve theme, and some people are being really
[quoted text clipped - 18 lines]
> well, with their frenzied and often uninformed reporting about resistance.
> Of course, they're in the Panic Profession.
truehawk - 14 Jan 2008 05:21 GMT
> Well put: you are lucky to have physicians who get it. Macrolides are
> anti-inflammatory and don't allow viruses and bacteria to stick--they
[quoted text clipped - 30 lines]
> > well, with their frenzied and often uninformed reporting about resistance.
> > Of course, they're in the Panic Profession.

And staph A has the superantigens to keep the neighborhood inflamed
without having to resort to any theory of
autoimmunity.  Just like staph A has the an enzyme that destroys
CFTMCF, it is one vicious little animalcule.

Role of staphylococcal superantigens in upper airway disease.
   Bachert C, Zhang N, Patou J, van Zele T, Gevaert P.

   Upper Airway Research Laboratory, Ear Nose and Throat Department,
University Hospital Ghent, Ghent, Belgium.

   PURPOSE OF REVIEW: Chronic rhinosinusitis with nasal polyps often
represents a chronic severe inflammatory disease of the upper airways
and may serve as a model for lower airway diseases such as late-onset
intrinsic asthma. Enterotoxins derived from Staphylococcus aureus have
been implicated in the pathophysiology of nasal polyps as disease-
modifying factors; recent findings using therapeutic proof-of-concept
approaches support this hypothesis. RECENT FINDINGS: Nasal polyps
(chronic rhinosinusitis with nasal polyps) are characterized by a T-
helper-2 dominated cytokine pattern that includes interleukin-5 and
formation of immunoglobulin E. This is in contrast to chronic
rhinosinusitis without polyps, which exhibits T-helper-1 biased
cytokine release. It is now evident that the cytokine environment is
decisive regarding the impact of S. aureus derived enterotoxins, which
function as superantigens. S. aureus enterotoxin B further shifts the
cytokine pattern in nasal polyps toward T-helper-2 cytokines
(increases greater than twofold for interleukin-2, interleukin-4 and
interleukin-5), but it disfavours the T-regulatory cytokines
interleukin-10 and transforming growth factor-beta1. Furthermore, S.
aureus derived enterotoxins influence local immunoglobulin synthesis
and induce polyclonal immunoglobulin E production, which may
contribute to severe inflammation via activation of mast cells.
SUMMARY: From this new understanding of chronic rhinosinusitis with
nasal polyps, new therapeutic approaches emerge such as anti-
interleukin-5, anti-immunoglobulin E, and antibiotic treatment. These
may enlarge the nonsurgical armentarium.

   PMID: 18188015 [PubMed - in process]
Michael - 14 Jan 2008 09:33 GMT
> > Well put: you are lucky to have physicians who get it. Macrolides are
> > anti-inflammatory and don't allow viruses and bacteria to stick--they
[quoted text clipped - 69 lines]
>
>     PMID: 18188015 [PubMed - in process]

"Elizabeth: I agree with you. I find the movement to restrict
antibiotics is pervasisve theme, and some people are being really
dogmatic about it, and getting very "holier than thou" about
withholding antibiotics for the patient's own good.
 I don't see people begging for unnecessary antibiotics.
 I have seen physicians and mid-levels refusing to prescribe, and
calling it evidence based.  ..."

I am very glad to see some one else say this -- I am surprised how
angry i am still at a physician who five years ago refused to continue
to prescribe me antibiotics after five months off and on 10 day
courses - clearly did not listen when I talked (too busy reading
notes)  - got angry when I gave him  typed notes because I said he was
clearly more comfortable reading than listening and alluded to reading
literature which suggested long courses of antibiotics were in order
-  had decided I had an allergy despite there being no evidence on
RAST tests and at that stage the area of secretion only affected one
part of one sinus and promptly declared me in need a therapist ... and
I might need a therapist everyone can benefit from sessions with a
good one (he did not get the joke when I said I had been married in
Manhattan so that there would have been something wrong with me had I
not consulted a Psychiatrist) But I had an observable physical problem
that differed from his conclusions.  I was shocked by the simple
stupidity -- even if the man had only 15/20 minutes of time to spend
with me couldn't he at least review evidence in front of him and see
that his "'allergy' affected only one part of one mucous membrane on
only one side of the body and I was describing multiple symptoms
(lethargy, poor cognition, loss of mental focus, gastric problems,
frequent 'colds' that would not go away, swollen glands on the one
side, etc., etc.)

My only prior experiences with the US medical profession had been
collaborating on a project with a group at a major research
institution all highly competent (some MD some not).  They as a group
did not take the medical profession seriously, one joke about the MD/
Phd program was that the degree after MD was really BMW! I did not
take them seriously until my encounters as an ordinary retail consumer
of medicine.  Obviously I realize every trade has its variables and by
definition 50% are going to be worse than average but I am shocked
that after a significant number of years of training the average
competence in my experience now is so low.

My only consolation has been thinking about the member of the public
who consults an average 'professional' in my own trade with anything
the slightest bit unusual, frankly God help em -- and often she does
not !

Apologies for the rant and consequent emotional self indulgence.
Apologies also to the MD members of this forum  for any offense, its
very clear to me from your posts that you are exceptional for the
trade and I only wish I had encountered  physicians like
yourselves!

Michael
truehawk - 15 Jan 2008 04:55 GMT
> > > Well put: you are lucky to have physicians who get it. Macrolides are
> > > anti-inflammatory and don't allow viruses and bacteria to stick--they
[quoted text clipped - 124 lines]
>
> Michael

Michael;
I blame the medical schools.
I am an engineer and see multispecies biofilms in on surfaces water
systems and biologically accelerated corrosion all the time.
It never occurred to me that the medical community had let the handy
simplification of growing bacteria in pure cultures in planktonic
( free floating)  form conceptually get away from them to the point
they forgot that this  is a simplification.  It led them to believe
that this is how bacteria normally live and do business as single
cells.
I have tremendous respect for the rigors of medical education and the
complexity of the systems, but teaching them that most bacteria live
as colonies of single free floating individuals produces a number of
clinical conclusions that have nothing to do with the reality of
lichen-like multispecies communities living in extracellular
polysacride of their own making with some species like e-coli
providing the anchor, fungi the strength, and staph the hyaluronase to
spread the host cell walls apart to allow access to host plasma.
Michael - 15 Jan 2008 08:55 GMT
> > > > Well put: you are lucky to have physicians who get it. Macrolides are
> > > > anti-inflammatory and don't allow viruses and bacteria to stick--they
[quoted text clipped - 143 lines]
> providing the anchor, fungi the strength, and staph the hyaluronase to
> spread the host cell walls apart to allow access to host plasma.

Thanks for the acknowledgment.

I should add as a contrast that with some trepidation  I recently
asked the physician I am seeing currently (whose attitude has been
try this, lets try that and see what happens -- and was the first to
schedule regular follow up appointments to see if his suggestions were
working rather than me having to call up & eventually feeling that I
had failed as a 'good patient' rather than the treatment had failed)
-- if he minded since treatment had reached a stasis  if I put
together a review of what's gone on, what the situation is now and
treatment possibilities (with supporting literature)  to consider
pursuing in the future.  He said he would be delighted to take a look
at same and encouraged me.

So despite a run of bad experiences there are good and serious MD
people out there  in my universe also!

Michael
judy.n - 15 Jan 2008 15:56 GMT
Michael,
 When you find the people who are willing to admit to uncertainity,
and that this is a partnership, you stick with them.
 I teach at medical school, but I"m a clinician, so I teach how to
talk to patients, not hard science like Elizabeth. Personally, I blame
the whole climate of medicine--driven by third party payors, with
nonsense quality evaluations (how many of your patients get a pap
smear--those who are willing and who don't have a prohibitive
deductible--but insurance companies measure the percentage as a
quality parameter.)
 Judy

> > > > > Well put: you are lucky to have physicians who get it. Macrolides are
> > > > > anti-inflammatory and don't allow viruses and bacteria to stick--they
[quoted text clipped - 162 lines]
>
> Michael
neil0502@yahoo.com - 15 Jan 2008 16:26 GMT
> Michael,
>   When you find the people who are willing to admit to uncertainity,
[quoted text clipped - 7 lines]
> quality parameter.)
>   Judy

ObThat: I met with a Kaiser psychologist yesterday.  Just joined
Kaiser on 1/1, and wanted to know what sort of support they offered
for chronic pain and/or chronic illness.

The psychologist told me that Kaiser HAD a pretty darned good program,
but ... [wait for it] ... it was killing their "efficacy numbers."

They weren't curing people.  Patients required ongoing visits,
virtually in perpetuity, so it made them look bad.

Chronic pain patients.  Chronic illness patients.

Can you /stand/ it?
judy.n - 16 Jan 2008 02:13 GMT
Kaiser, the institution where my younger sister is an upper level
adminstrator, (I once asked if it bothered her to have a parasitic
job--I was post-call was my only excuse) and who had a program where
high school educated receptionists were paid a bonus if they got
patients off the phone in less than a minute AND refused them an
appointment.
 They settled the ensuing law suit.
 On the other hand, they provided my mother with liver transplant at
USCF--I think she's the reason they're cutting other programs...
 I coach my other sister on what to say to get an appointment. After
years of frustration, she does work the system to get what she needs:
including chronic biaxin--I just emailed her doctor with articles, and
she found a receptive PCP.
 Neil, it makes me sick that the fact that the chronicity of an
illness is an excuse not to provide services. I can't stand it.
Judy

On Jan 15, 11:26 am, neil0...@yahoo.com wrote:

> > Michael,
> >   When you find the people who are willing to admit to uncertainity,
[quoted text clipped - 21 lines]
>
> Can you /stand/ it?
aroberts - 14 Jan 2008 17:38 GMT
>> Well put: you are lucky to have physicians who get it. Macrolides are
>> anti-inflammatory and don't allow viruses and bacteria to stick--they
[quoted text clipped - 75 lines]
>
>    PMID: 18188015 [PubMed - in process]

Very interesting citation.  Thanks.
judy.n - 15 Jan 2008 02:17 GMT
Elizabeth, When you think about how staph is considered a fairly
common colonizer of nasal mucosa, it really makes you wonder.
 Very interesting article.
  Clearly the answer isn't "to cut is to cure": it's so much more
complex, and medical.
 I once did some preliminary research on back pain when I was working
at the residency, and was amazed at how little was known: there was
some thoughts that it's not just simply mechanical--the disc pushes on
the nerve,etc--but more of an inflammatory process. And this was
several years ago. I was shocked at the lack of studies.
Judy

> >> Well put: you are lucky to have physicians who get it. Macrolides are
> >> anti-inflammatory and don't allow viruses and bacteria to stick--they
[quoted text clipped - 77 lines]
>
> Very interesting citation.  Thanks.
truehawk - 15 Jan 2008 03:42 GMT
> Elizabeth, When you think about how staph is considered a fairly
> common colonizer of nasal mucosa, it really makes you wonder.
[quoted text clipped - 93 lines]
>
> > Very interesting citation.  Thanks.

Judy:
It gives me hope that there is so much to know.
I think a lot of things we associate with ageing are the result of
bacterially injected DNA, bacteria (not viruses but little tiny nano-
bacteria) locating themselves inside our cells and the like.  All this
is "controversial" because the limits for the minimum size of bacteria
are much smaller than thought. Why this should be so controversial
when they can be  observed by anyone skilled in the art with a desire
and an instrument powerful enough to look, is I guess a measure of how
much easier it is to talk and speculate than to go through the 15
months of proposals and permission requests and begging to get money
and samples to do the work for just a small study of surgical
pathology samples.
judy.n - 15 Jan 2008 12:05 GMT
Elizabeth, there was a horrifying article in the New Yorker, called
"guinea pigs" about the current state of drug testing: often phase 1
trials are done on homeless people, in run down motels, and indigent
people will make a risky living partipating in these trials which
involve only risk. If they suffer an adverse event, they are kicked
out of the trial, with no compensation. A study in England of
monoclonal antibodies resulted in multiple deaths and irreversible
disabiliy. Really scary stuff.
 This is the stage of current drug trials. The IRB boards are
corporate. University/Academic trials are a small minority, because
the IRB's are so much tougher.
  So, it makes me understand why trials aren't done.
Judy

> > Elizabeth, When you think about how staph is considered a fairly
> > common colonizer of nasal mucosa, it really makes you wonder.
[quoted text clipped - 107 lines]
> and samples to do the work for just a small study of surgical
> pathology samples.
 
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