The Corpus Callosum

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:

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.