I was a bit perplexed by a recent study on a new treatment for alcohol
withdrawal.  Ordinarily, I am in favor of new treatment
options, based on the supposition that nothing works for everyone, and
having more options is good.  This counterbalances, to some
extent, the anti-pharma screed about “me-too” drugs, but that is
another story.

href="http://www.aafp.org/afp/20040315/1443.html" rel="tag">Alcohol
withdrawal is a significant clinical problem.  While
most people who drink alcohol can simply stop, with no danger, people
who routinely drink too much may go into withdrawal.  That is
dangerous, and can be fatal.  

class="image" title=""> class="inset"
src="http://upload.wikimedia.org/wikipedia/commons/thumb/c/c9/Diazepam-3D-balls.png/180px-Diazepam-3D-balls.png"
alt="diazepam" longdesc="/wiki/Image:Diazepam-3D-balls.png"
align="left" border="0" height="155" width="180">Alcohol
withdrawal typically href="http://www.aafp.org/afp/20050201/495.html">is treated
with href="http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/202084.html"
rel="tag">benzodiazepines or with href="http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a682007.html"
rel="tag">phenobarbital.  The FDA has
approved the use of href="http://en.wikipedia.org/wiki/Chlordiazepoxide" rel="tag">chlordiazepoxide (Librium),
oxazepam
(Serax) and rel="tag">diazepam (Valium) for this purpose.
 The approval is based upon evidence that these drugs can
avert the most serious consequences of alcohol withdrawal.  
Such withdrawal typically produces autonomic symptoms such as rapid
heat rate, high blood pressure, sweating, tremor, and the like.
 The elevation of blood pressure, in particular, can be
dangerous.  More serious cases progress to href="http://en.wikipedia.org/wiki/Delirium_tremens" rel="tag">delirium
tremens. Delirium tremens is href="http://www.asam.org/publ/detoxification.htm">reported
to have a mortality rate of 1 to 5%.  

But what about baclofen?
 Some people object to the use of benzodiazepines or
phenobarbital, because they do have some potential for abuse.
 Baclofen, on the other hand, is rarely abused and does not
cause physical dependence.  Would that be preferable?

Naturally, we prefer to use evidence-based treatments, especially in
conditions that could have a fatal outcome.  Plus, I’ve never
been too impressed by the worry over giving people benzodiazepines for
alcohol withdrawal.  After all, we are not going to turn them
into addicts.  They are already addicts,
otherwise we wouldn’t be treating them.  

That is why I was perplexed to see this article:
href="http://www.sciencedirect.com/science?_ob=ArticleURL&_aset=V-WA-A-W-B-MsSAYZA-UUA-U-AAVZEWEVCD-AAVVCAUWCD-DYAABEBBZ-B-U&_rdoc=1&_fmt=summary&_udi=B6TDC-4J9MXY7-P&_coverDate=03/31/2006&_cdi=5195&_orig=search&_st=13&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=20613e04ea71f0a3989f6ef64d7f1fb4">

href="http://www.sciencedirect.com/science?_ob=ArticleURL&_aset=V-WA-A-W-B-MsSAYZA-UUA-U-AAVZEWEVCD-AAVVCAUWCD-DYAABEBBZ-B-U&_rdoc=1&_fmt=summary&_udi=B6TDC-4J9MXY7-P&_coverDate=03/31/2006&_cdi=5195&_orig=search&_st=13&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=20613e04ea71f0a3989f6ef64d7f1fb4">Baclofen
in the Treatment of Alcohol Withdrawal Syndrome: A Comparative Study vs
Diazepam
The American Journal of Medicine
Volume 119, Issue 3 , March 2006, Pages 276.e13-276.e18

Purpose Benzodiazepines are the drugs of choice in
the treatment of alcohol withdrawal syndrome (AWS). Recent data have
shown that baclofen may reduce AWS symptoms. At present, no comparative
studies between baclofen and any benzodiazepine used in AWS treatment
are available. Accordingly, the present study was designed to compare
efficacy, tolerability and safety of baclofen versus diazepam in the
treatment of AWS.

Subjects and methods Thirty-seven patients with
AWS were enrolled in the study and randomly divided into 2 groups.
Baclofen (30 mg/day for 10 consecutive days) was orally administered to
18 patients (15 males, 3 females; median age: 46.5 years). Diazepam
(0.5-0.75 mg/kg/day for 6 consecutive days, tapering the dose by 25%
daily from day 7 to day 10) was orally administered to 19 patients (17
men, 2 women; median age: 42.0 years). The Clinical Institute
Withdrawal Assessment (CIWA-Ar) was used to evaluate physical symptoms
of AWS.

Results Both baclofen and diazepam significantly
decreased CIWA-Ar score, without significant differences between the 2
treatments. When CIWA-Ar subscales for sweating, tremors, anxiety and
agitation were evaluated singly, treatment with baclofen and diazepam
resulted in a significant decrease in sweating, tremors and anxiety
score, without significant differences between the 2 drug treatments.
Both treatments decreased the agitation score, although diazepam was
slightly more rapid than baclofen.

Conclusion The efficacy of baclofen in treatment
of uncomplicated AWS is comparable to that of the “gold
standard” diazepam. These results suggest that baclofen may
be considered as a new drug for treatment of uncomplicated AWS.

The study shows that, in a sample of 37 patients, baclofen worked as
well as diazepam.  That is fair, and it is even a little bit
interesting.  But is it going to change anyone’s clinical
practice?  I hope not.  

First of all, it generally is unwise to change your clinical practice
on the basis of any one study.  There are exceptions: some
large, comprehensive, multi-site studies are sufficiently conclusive to
warrant changes in practice.  But even those have to be
interpreted in the context of all the other research that has been done
on the subject at hand.

Second, if you are dealing with a condition that is potentially fatal,
you need to be even more cautious than usual.  You certainly
are not going to drop the “gold standard” treatment in favor of
something that was tested on 18 patients.  

Third, if you are working in a hospital setting, there is another
potential problem.  Although most patients going through
withdrawal are not put in the hospital, about 10-20% are.  In
a hospital, the admitting physician writes the orders, almost always
using a pre-established protocol.  The nurses and other health
care providers then carry out those orders.  

There are very good reasons to have a protocol.  One reason is
that people are less likely to make mistakes if they have a protocol
that they use over and over.  I have a lot of respect for the
nurses who routinely handle alcohol withdrawal, and I trust that they
can do a good job.  The absolute last
thing I want to do is throw them a curve ball, so to speak, and ask
them to drop a protocol they’ve been using successfully for years, and
try something new.  That is just asking for trouble.  

Sure, we do need to review these protocols from time to time, and we
need to be open-minded about it.  If there is a problem, we
have to be willing to change the protocol.  But that is not
something one undertakes lightly.  

Sure, sometimes the medical establishment is too conservative, and
continues to use protocols for too long.  But there is a
reason that physicians are reluctant to change their practice, and more
often than not, it is a good reason.

To their credit, the authors of the baclofen study did not say anyone
should change their practice; what they said was:

The efficacy of baclofen in treatment of
uncomplicated AWS is comparable to that of the “gold
standard” diazepam. These results suggest that baclofen may
be considered as a new drug for treatment of uncomplicated AWS.

But I personally think even that is too strong of a statement.
 I’d prefer something to the effect of “the results suggest
that further study may be warranted.”  

It would take a great deal of further study to supplant a
well-established practice, and without demonstrating a need, it would
be hard to justify such an effort.