E-DRUG: Re: E-DRUG Demazin Syrup Response

[Mark Dunn <markdunn@tassie.net.au>]

Dear e-druggers,

In response to Richard Laing and others:

"Moderators comment: I remain surprised at how many people feel that
personal series of two or three cases are valid or even relevant to a
discussion of the efficacy or safety of a drug. The fact that two or
three people took the drug without ill effects is meaningless when
compared to a well controlled trial in which a lack of efficacy was
shown. Such is the basis of evidence based medicine. Richard Laing
Co-Moderator"

Richard, 
The principal point I was hoping to make in my post regarding Demazin was
that in Australia it is possible that pharmacists are acting unethically
if not illegally in selling a product that has little or no evidence
available to suggest it does what the manufacturers claims it does or
provides any benefit to the patient. My personal observation re my own
kids was added to provide a bit of perspective - one other side of the
coin, so to speak. My comments were, I believe, relevant to the broader
issues involved, not to considerations of efficacy and safety.


I read with interest James McCormack's response to my post as well Peter
Mansfield's comments on behalf of MaLAM and his personal comments
regarding his own children. I am a MaLAM subscriber, although only for
about the last year, hence my not being aware of some of MaLAM's
representations to the various drug companies re cough and cold
preparations. Many thanks to you Peter for your prompt and detailed
response, and also to James.


I am a community pharmacist who works at the coalface. I see many
patients each winter seeking products to relieve the symptoms of "the
common cold". I am as committed to the notion of evidence based medicine
as most e-druggers but clinical experience still compels me to sell
products that appear to do more or less what is claimed of them by the
manufacturers, principally cough suppressants and nasal decongestants,
either alone or in combination. These preparations appear consistently to
make patients more comfortable; in most instances they do not speed up
recovery or otherwise aid in the process of recovery, except by
symptomatic relief. I make sure my patients are aware of this.


A recent experience with a GP friend springs to mind in regard to a
Cochrane Collaboration statement, selected parts appear below:


Antibiotic versus placebo for acute otitis media in children

Objectives: To assess the effectiveness of antibiotics in
the clinical management of children with acute otitis media.

Main results: Our primary interests were in 

(a) short-term relief of symptoms and 

(b) subsequent complications. 


Results: The eight trials, all in developed countries,
suggest no reduction in pain at 24 hours, but a 41% relative reduction in
pain at 2-7 days. Since approximately 80% of patients will have settled
spontaneously in this time, this means an absolute reduction of about 8%,
that is about 12 children must be treated with antibiotics to prevent 1
child having some pain after 2 days. There was no effect of
antibiotics on complication rates, as measured by subsequent tympanometry
or recurrence. However, there were few serious complications seen in
these trials: only one case of mastoiditis occurred (in a penicillin
treated group).

Conclusions: Antibiotics provide a real but small benefit in
acute otitis media in children. As most cases will resolve spontaneously,
this poses a difficult decision for clinicians when weighed against the
possible adverse reactions. For populations or subgroups at risk of
suppurative complications such as mastoiditis, e.g., in developing
countries, antibiotics would be strongly advised.


 ______________



It could be argued that this (evidence) would appear to support the
notion that antibiotics have little place in the initial therapy of acute
otitis media in most children in developed countries such as Australia. I
brought this particular Cochrane statement to the attention of my GP
friend, who in my opinion, is a top notch GP, and is very much aware of
the issues involved, principally that of antibiotic overuse. 


His comment was that<bold> he would not have the courage to withhold
(usually) amoxycillin from such patients, </bold>a view shared by many of
his colleagues in Australia and elsewhere in developed countries, I
suspect. Perhaps the child from whom he withheld the amoxycillin would be
the child who developed some serious complication as a result of not
being given the amox.

Just another demonstration of the point that hard evidence is not
always the only factor considered. Perhaps it should be, but I think we
have a way to go yet, before we are all practising our various crafts by
the book.

Thanks for allowing my self indulgence if this note actually makes it out
into the ether.

Cheers...............Mark 
                                                  

Mark Dunn  B Pharm  MPS  MACPP  JP                  
Dover 7117                                      
Tasmania AUSTRALIA                            
Ph: and Fax: 61 2 03 6298 1517                  
WWW: http://www.tassie.net.au/~mdunn             
e-mail: markdunn@tassie.net.au                         

[discussion closed - WB moderator]                                               
  
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