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Role of Steroids in Spinal Cord Inj

Bjorn, Pret pbjorn at emh.org
Mon Nov 8 13:08:09 GMT 2010


Kind of you to invite Dr. Bracken to the conversation; but in the interests of transparency, the list should be aware that Dr. Bracken's methods and behavior have been central to the NASCIS controversy.  

The following is from Geisler, Fred H. (2008-03-22). "Excessively closed science hurts". BMJ 336 (7645): 629-a.

<Snip.>

Excessively closed science hurts

I would like to add to Lenzer and Brownlee's reporting of my comments on how excessively closed science can hurt physicians and patients.[1]

Statistician Michael Bracken led the NASCIS 2 and 3 studies of high dose steroids in acute spinal cord injury.[2] The National Institute of Neurological Disorders and Stroke conducted a public campaign in advance of the scientific publication of NASCIS 2 on 17 May 1990. The institute sent a fax on 13 April 1990 to some 19 000 emergency room physicians and hospitals, after a press release had resulted in coverage by the New York Times and the Chicago Tribune on 31 March 1990, by Science News on 7 April 1990, by Newsweek on 9 April 1990.

This led to widespread use of steroids, off label. No application for regulatory approval for this indication was completed, and no agency ever approved it. Surgeons report that methylprednisolone is administered from fear of litigation, not belief in efficacy.[3] Bracken reinforced this fear by testifying against physicians; he was deposed on 9 June 1998 in Civil Action File No 96A-7768-6, Superior Court of Fulton County, GA.

We have criticised NASCIS science.4 The later guidelines for the management of acute cervical spine and spinal cord injuries from the American Association of Neurological Surgeons and the Congress of Neurological Surgeons (AANS/CNS)[5] rated the NASCIS publications as evidence class III, citing flaws in study design, data presentation, interpretation, and analysis. They listed steroid treatment only as an "option."

The lack of demonstrated benefit must be weighed against documented risks. The CRASH trial showed a 3% greater mortality when corticosteroids were given to a multitrauma group with head injury.[6] If this increased death rate held in SCI, then 5000 extra patients may have died in the US since 1990.

Yet it's difficult to stop the momentum-especially when primary data are unavailable for independent review.

Fred H. Geisler, Director, Illinois Neuro-Spine Center

References
Lenzer J, Brownlee S. Antidepressants. An untold story? BMJ 2008;336:532. (8 March.)[Free Full Text]
Bracken MB, Shepard MJ, Collins WF Jr, Holford TR, Baskin DS, Eisenberg HM, et al. A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury. Results of the second national acute spinal cord injury study. N Engl J Med 1990;322:1405-11.
Eck JC, Nachtigall D, Humphreys SC, Hodges SD. Questionnaire survey of spine surgeons on the use of methylprednisolone for acute spinal cord injury. Spine 2006;31:E250-253.
Coleman WP, Benzel E, Cahill DW, Ducker T, Geisler F, Green B, et al. A Critical appraisal of the reporting of the NASCIS II and III studies of MPSS in acute spinal cord injury. J Spinal Disord 2000;13:185-99.
Hadley MN, Walters BC. Pharmacological therapy after acute cervical spinal cord injury. In: Guidelines for the management of acute cervical spine and spinal cord injuries. Neurosurgery 2002;50:S63-S72.
Edwards P, Arango M, Balica L, Cottingham R, El-Sayed H, Farrell B. Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury-outcomes at 6 months. Lancet 2005;365:1957-9.





-----Original Message-----
From: trauma-list-bounces at trauma.org [mailto:trauma-list-bounces at trauma.org] On Behalf Of listasmsd
Sent: Sunday, November 07, 2010 8:12 AM
To: michael.bracken at yale.edu
Cc: *TRAUMA LIST
Subject: Role of Steroids in Spinal Cord Inj

Dear Dr. Bracken
There is been a discussion going on in the www.trauma.org list about the role of Role of Steroids in Spinal Cord Injuries. This list is free to sign in and it will be interesting that you share a word about your papers in this subject. The main stream of the list members believed that steroids have no place in in Spinal Cord injury. I have not taken a stand yet, mainly because all studies don´t show a clear and clean cut of statistics. Initially in your papers (Cochrane Plus in Spanish ) in the ´80 you conclude there is no benefit but after the late ´80, ´90 and 2001 you change your conclusions.Why?  The CRASH trial protocol on the other hand from 2001 concludes the opposite from a placebo-controlled trial.
Could you share your opinion in this list? 

Sincerely
Manuel Sotelo MD
Caracas
Venezuela
   



----- Original Message ----- 
From: Robert Smith 
To: Trauma-List [TRAUMA.ORG] 
Sent: Sábado, 06 de Noviembre de 2010 09:33 a.m.
Subject: Re: Role of Steroids in Spinal Cord Inj


Meta-analysis is the definition of Garbage In/Garbage Out


On Nov 6, 2010, at 9:57 AM, Pret Bjorn wrote:

> Meta-analysis is overrated, and highly conditional.
> 
> Pret
> 
> 
> Clumsily sent from my cell phone.
> 
> -----Original Message-----
> From: listasmsd <listasmsd at gmail.com>
> Sent: Friday, November 05, 2010 23:00
> To: Trauma-List [TRAUMA.ORG] <trauma-list at trauma.org>
> Subject: Re: Role of Steroids in Spinal Cord Inj
> 
> If it did not say "Cochrane" I would not take it so seriously
> 
> Regards
> Manuel Sotelo MD
> Caracas
> 
> 
> 
> --------------------------------------------------------------------------------
> Cochrane Database Syst Rev. 2002;(3):CD001046.
> 
> Steroids for acute spinal cord injury.
> Bracken MB.
> 
> Department of Epidemiology and Public Health, Yale School of Medicine, 60 College street, Box 20834, New Haven, Connecticut, 06520-8034, USA. > 
> Comment in: 
> 
>  a.. Ann Emerg Med. 2003 Mar;41(3):410-3. 
> 
> Update of: 
> 
>  a.. Cochrane Database Syst Rev. 2000;(2):CD001046. 
> 
> Abstract
> BACKGROUND: Acute spinal cord injury is a devastating condition typically affecting young people with a preponderance being male. Steroid treatment in the early hours of the injury is aimed at reducing the extent of permanent paralysis during the rest of the patient's life.
> 
> OBJECTIVES: To review randomized trials of steroids for acute spinal cord injury.
> 
> SEARCH STRATEGY: The review draws on the search strategy developed by the Cochrane Injuries Group. In addition, files of the National Acute Spinal Cord Injury Study have been reviewed and a Medline search conducted.
> 
> SELECTION CRITERIA: All published or unpublished randomized controlled trials of steroid treatment for acute spinal cord injury in any language.
> 
> DATA COLLECTION AND ANALYSIS: Data have been abstracted from original trial reports. For the NASCIS, Japanese and French trials, additional data (e.g. SDs) have been obtained from the original authors.
> 
> MAIN RESULTS: There are few trials in this area of medical care. Only one steroid has been extensively studied, methylprednisolone sodium succinate, which has been shown to improve neurologic outcome up to one year post injury if administered within eight hours of injury and in a dose regimen of: bolus 30mg/kg administered over 15 minutes with a maintenance infusion of 5.4 mg/kg per hour infused for 23 hours. The initial North American trial was replicated in a Japanese trial but not in the one from France. Data has been obtained from the latter studies to permit appropriate meta-analysis of all three trials. This analysis indicates significant recovery in motor function after methylprednisolone therapy when administration commences within eight hours of injury. A more recent trial indicates that if methylprednisolone therapy is given for an additional 24 hours (for a total of 48 hours), additional improvement in motor neurologic function and functional status is observed. 
 Th
> is is particularly observed if treatment cannot be started until between three to eight hours after injury. The same methylprednisolone therapy has been found effective in whiplash injuries and a modified regimen found to improve recovery after surgery for lumbar disc disease.
> 
> REVIEWER'S CONCLUSIONS: High dose methylprednisolone steroid therapy is the only pharmacological therapy shown to have efficacy in a Phase Three randomized trial when it can be administered within eight hours of injury. A recent trial indicates additional benefit by extending the maintenance dose from 24 to 48 hours if start of treatment must be delayed to between three and eight hours after injury. There is an urgent need for more randomized trials of pharmacological therapy for acute spinal cord injury.
> 
> 
> --------------------------------------------------------------------------------
> 
> 
>      Do not believe in anything simply because you've heard it. 
> 
>      Do not believe in traditions because they have been handed down for many generations. 
> 
>      Do not believe in anything because it is spoken and rumored by many. 
> 
>      Do not believe in anything simply because it is found written in your religious books. 
> 
>      Do not believe in anything merely on the authority of your teachers and elders. 
> 
>      But after observation and analysis, when you find anything agrees with reason and is conducive to the good and benefit of one and all then accept it and live up to it. 
> 
> 
>     Lord Gautam Buddha
> 
>      2600 BC 
> 
>      Anguttara Nikaya III, 65, 
> 
>      Quoted in: British Medical Journal, 
> 
>      BMJ 2003;326:737 ( 5 April )
> 
> 
> 
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