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Thread: Why Do You Prescribe Methylprednisolone for Acute Spinal Cord Injury? A Canadian Perspective and a Position Statement

  1. #1
    Senior Member Max's Avatar
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    Why Do You Prescribe Methylprednisolone for Acute Spinal Cord Injury? A Canadian Perspective and a Position Statement

    Why Do You Prescribe Methylprednisolone for Acute Spinal Cord Injury? A Canadian Perspective and a Position Statement

    R.J. Hurlbert, R. Moulton

    Abstract: Objective: To determine the practice patterns for methylprednisolone administration for patients with acute spinal cord injury (SCI) within the spinal surgery community across Canada, and the reasons behind these patterns. Methods: Canadian neurological and orthopedic spine surgeons were surveyed at their respective annual meetings with a questionnaire asking seven questions with respect to their practice standards. Results: Sixty surgeons completed the survey representing approximately two-thirds of surgeons treating acute SCI within Canada. The NASCIS III dosing regimen is the most commonly prescribed steroid protocol. However, one-quarter of surgeons do not administer steroids at all. Of those who administer methylprednisolone, most do so because of peer pressure or out of fear of litigation. Conclusions: The vast majority of spine surgeons in Canada either do not prescribe methylprednisolone for acute SCI, or do so for what might be considered the wrong reasons. These results demonstrate the need for an evidence-based practice guideline. The Candian Spine Society and the Canadian Neurosurgical Society fully endorse the recommendations of the steroid task force (see preceding paper).

    Résumé: Pourquoi prescrire de la méthylprednisolone dans les cas de lésion aiguë de la moelle épinière? Perspective canadienne et déclaration de principe. Objectif: Déterminer les modalités d'administration de la méthylprednisolone chez les patients présentant une lésion aiguë de la moelle épinière (LMÉ) en chirurgie de la moelle épinière au Canada et les raisons sous-jacentes Ã* ces pratiques. Méthodes: Nous avons fait un sondage auprès des neurochirurgiens et des orthopédistes lors de leur congrès annuel respectif au moyen d'un questionnaire incluant sept questions sur leurs standards de pratique. Résultats: Soixante chirurgiens ont complété le sondage, soit environ les deux tiers des chirurgiens qui traitent des LMÉ au Canada. Le régime posologique NASCIS III est le protocole d'administration de stéroïdes le plus couramment prescrit. Cependant, le quart des chirurgiens ne prescrivent pas du tout de stéroïdes. Parmi ceux qui administrent de la méthylprednisolone, la plupart le font Ã* cause de la pression des pairs ou par crainte d'une poursuite. Conclusions: La grande majorité des chirurgiens qui traitent des traumatisés de la moelle au Canada ne prescrivent pas de méthylprednisolone pour une LMÉ ou le font pour ce qui pourrait être considéré comme de mauvaises raisons. Ces résultats démontrent qu'il existe un besoin quant Ã* l'établissement de lignes directrices basées sur des données probantes. La Canadian Spine Society et la Canadian Neurosurgical Society appuient entièrement les recommandations du groupe de travail sur les stéroïdes (voir l'article précédent).

    Can. J. Neurol. Sci. 2002; 29: 236-239

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    "With every scientific advance, we grow closer to unlocking the mysteries of life and creation. But what have we gained if in the process, we lose our humanity. The most powerful thing we pass along to our children may not reside in the genes, but in the soul."
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    Senior Member Max's Avatar
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    that's why

    me & many after me did not get it!!!

    What a criminal stupidity

    ==============================
    "With every scientific advance, we grow closer to unlocking the mysteries of life and creation. But what have we gained if in the process, we lose our humanity. The most powerful thing we pass along to our children may not reside in the genes, but in the soul."
    The Outer Limits(Criminal Nature)



  3. #3
    Senior Member Max's Avatar
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    High-Dose Methylprednisolone for Acute Closed Spinal Cord Injury - Only a Treatment Option
    H. Hugenholtz, D.E. Cass, M.F. Dvorak, D.H. Fewer, R.J. Fox, D.M.S. Izukawa,
    J. Lexchin, S. Tuli, N. Bharatwal, C. Short

    Abstract: Background: A systematic review of the evidence pertaining to methylprednisolone infusion following acute spinal cord injury was conducted in order to address the persistent confusion about the utility of this treatment. Methods: A committee of neurosurgical and orthopedic spine specialists, emergency physicians and physiatrists engaged in active clinical practice conducted an electronic database search for articles about acute spinal cord injuries and steroids, from January 1, 1966 to April 2001, that was supplemented by a manual search of reference lists, requests for unpublished additional information, translations of foreign language references and study protocols from the author of a Cochrane systematic review and Pharmacia Inc. The evidence was graded and recommendations were developed by consensus. Results: One hundred and fifty-seven citations that specifically addressed spinal cord injuries and methylprednisolone were retrieved and 64 reviewed. Recommendations were based on one Cochrane systematic review, six Level I clinical studies and seven Level II clinical studies that addressed changes in neurological function and complications following methylprednisolone therapy. Conclusions: There is insufficient evidence to support the use of high-dose methylprednisolone within eight hours following an acute closed spinal cord injury as a treatment standard or as a guideline for treatment. Methylprednisolone, prescribed as a bolus intravenous infusion of 30 mg per kilogram of body weight over fifteen minutes within eight hours of closed spinal cord injury, followed 45 minutes later by an infusion of 5.4 mg per kilogram of bodyweight per hour for 23 hours, is only a treatment option for which there is weak clinical evidence (Level I- to II-1). There is insufficient evidence to support extending methylprednisolone infusion beyond 23 hours if chosen as a treatment option.

    Résumé: Méthylprednisolone Ã* haute dose dans les traumatismes aigus fermés de la moelle épinière -une option thérapeutique.
    Introduction: Une revue systématique des données concernant l'infusion de méthylprednisolone suite Ã* un traumatisme aigu de la moelle épinière a été effectuée afin de clarifier la confusion qui règne sur l'utilité de ce traitement Méthodes: Un comité formé de spécialistes en neurochirurgie et en chirurgie orthopédique de la colonne vertébrale, d'urgentologues et de physiatres en pratique clinique active a procédé Ã* une recherche électronique de bases de données pour identifier des articles sur les traumatismes aigus de la moelle épinière et l'administration de stéroïdes, du 1er janvier 1966 Ã* avril 2001. Une recherche manuelle de listes de références, la quête d'informations additionnelles non publiées, la traduction de références en langues étrangères et le protocole d'étude de l'auteur d'une Cochrane systematic review et de Pharmacia inc. ont été utilisés comme sources d'informations d'appoint. Les données ont été pondérées et des recommandations ont été développées par consensus. Résultats: Cent cinquante-sept citations qui traitaient spécifiquement de traumatisme de la moelle épinière et de méthylprednisolone ont été identifiées et soixante-quatre ont été revues. Les recommandations ont été basées sur une revue systématique Cochrane, six études cliniques de niveau I et sept études de niveau II qui traitaient de modifications de la fonction neurologique et de complications suite au traitement par la méthylprednisolone. Conclusions: Il n'y a pas suffisamment de données pour appuyer l'utilisation de la méthylprednisolone Ã* haute dose en dedans de huit heures après un traumatisme aigu fermé de la moelle épinière comme traitement standard ou comme ligne directrice de traitement. La méthylprednisolone prescrite en infusion intraveineuse en bolus de 30 mg par kilogramme de poids corporel sur une période de quinze minutes en dedans de huit heures d'un traumatisme fermé de la moelle, suivie 45 minutes plus tard d'une infusion de 5,4 mg par kilogramme de poids Ã* l'heure pendant 23 heures est seulement une option thérapeutique en faveur de laquelle il n'y a que des données cliniques faibles (Niveau I Ã* II-1). Il n'y a pas suffisamment de données pour recommander de prolonger l'infusion de méthylprednisolone au delÃ* de vingt-trois heures si on choisit cette option thérapeutique.


    Can. J. Neurol. Sci. 2002; 29: 227-235

    ==============================
    "With every scientific advance, we grow closer to unlocking the mysteries of life and creation. But what have we gained if in the process, we lose our humanity. The most powerful thing we pass along to our children may not reside in the genes, but in the soul."
    The Outer Limits(Criminal Nature)



  4. #4
    It is difficult to address the criticism in these articles because the authors are basing their criticism on a misunderstanding of the clinical trials that were carried out and some artificial standard of what consistutes sufficient evidence to justify use of a drug. Perhaps some of the people who wrote these articles would come to this site and help clarify.

    Most of these articles claim that NASCIS 2 and 3 were based on post-hoc analyses of data. The term post-hoc is a Latin word that indicates that the analyses were concocted after the study was done. Post-hoc analyses are frowned upon in clinical trials because one can always make up some kind of analysis that shows positive results after the trial. But, NASCIS analysis was not post-hoc. It was our original hypothesis that timing of therapy made a difference and the trial was designed to test this. For this reason, the trial compared patients that were treated before and after the median time of treatment (median time means half of the patients were treated before and half were treated after the time). In NASCIS 2, the median time of treatment was 8 hours. As it turns out, only those patients that were treated within 8 hours showed a statistically significant effect of methylprednisolone. The main criticism is not that the data is not significant but that the analysis was post-hoc. In my opinion, this criticism is not valid because the hypothesis and the design of the trial before the trial started was that there would be a difference due to timing.

    Some people thought that the trial was invalid because the analysis segregated complete and incomplete patients. This was also part of the trial design because we knew that the recovery patterns of these patients would be very different. Therefore, the trial was designed to stratify these patients into two groups. Incidentally, the analysis also separated patients into cervical and thoracic spinal cord injuries because we thought that these patients may have different recovery patterns. These were also part of the trial design and should not be considered post-hoc.

    The critiques threw out the studies based on their erroneous assumption that the trial analysis was post-hoc. Because they threw out the data and of course the data that remains is not sufficient to prove that the methylprednisolone is effective, they are claiming that the treatment is not effective and therefore should not be used. This is circular reasoning. When clinicians or scientists disbelieve a particular study, it is their obligation to collect new data that shows that the previous data is wrong and propose a better alternative. Rather than fulfilling this obligation (because none of the critics have suggested a better treatment or carried out a trial that is valid), they have chosen to attack methylprednisolone rather than coming out with a better one.

    Some of the critics have suggested that because methylprednisolone is now the standard therapy, this is discouraging further clinical trials since they must compare all new therapies against methylprednisolone. My answer to this is that they can't have their cake and eat it, too. If they believe the methylprednisolone is ineffective, then it is the perfect placebo against which to compare their new treatment. If their new treatment is not as effective as methylprednisolone, this means that methylprednisolone should be used. This is common sense.

    If methylprednisolone poses a considerable risk to the patients, perhaps the criticism would be justified. However, to date, there has not been any convincing evidence that a 30 mg/kg bolus of methylprednisolone followed by 23 hours of 5.4 mg/kg/hour increases morbidity or mortality after spinal cord injury. Over the past 10 years, probably over a million people have received this treatment (methylprednisolone is not only use for spinal cord injury but for multiple sclerosis). If the drug has serious side-effects, it certainly would have been reported by now. By the way, there is some evidence (from NASCIS 3) to suggest that a 48-hour course of methylprednisolone does increase the severity of pneumonia. This was the main reason that the 48-hour course of the treatment should not be used unless patients were treated between 3 to 8 hours after injury. NASCIS 3 showed that the 48-hour course of the drug is significantly superior to the 24-hour course of the drug when the drug is started more than 3 hours after injury.

    Finally, I question the motivation of clinicians who are spending so much of their time attacking a 10-year old drug. Why are they doing this? There is currently no alternative to methylprednisolone for acute spinal cord injury. There has been unanimous agreement amongst all the clinicians and scientists in the field that we need a therapy that is better than methylprednisolone. Instead of spending all their time attacking an old therapy, they should be developing and testing a better treatment approach. All this squabbling should stop.

    Wise.

    [This message was edited by Wise Young on Aug 22, 2002 at 02:09 PM.]

  5. #5
    Senior Member kate's Avatar
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    Dr. Young, it makes me dizzy to think that if we lived 200 miles north, in British Columbia, my husband would not have been given MP a year and a half ago. Thank you for putting up with all of it, and for keeping on keeping on! You made our lives possible.

    Kate

  6. #6
    It enrages me that my daughter was not given Methylprednisolone within 8 hours of her injury. It was not until after she was transferred to a bigger/better Hospital that she was given it for 24 hours. What can be done about informing these Emergency Doctors how important it is??? This isn't acceptable!

    Darlene

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    Senior Member dogger's Avatar
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    not given methylpridnisolone !

    Karen'sMom , i never got MP at all . i've put the full circumstances in another post . basically my local Doctor wouldn't call in the Air Ambulance , so what should have been a less than 4 hour trip to hospital [ including waiting for the aircraft } turned into a 14 hour trip by road . then it was too late to bother about MP . however my specialist sent out a letter to all hospital superintendants [ doctors] outside of the state capital that air retrieval was to be used in all suspected SCI cases . this would then ensure they got MP in time . the thing that really annoys me about not getting MP is that i am an incomplete C5/6 and can walk , what extra function may have returned if i had received MP .
    thank you
    dogger

  8. #8
    The benefits of methylprednisolone are modest. If started more than 8 hours after injury, NASCIS 2 suggests that it is not only not beneficial but may reduce recovery. However, if started within 8 hours, on average, it improves motor recovery from 8% (if not treated) to 21% of what people had lost (usually 2-3 segments below the injury site) in "complete" spinal cord injury and from 59% (if not treated) to 75% of what a person with "incomplete" spinal cord injry. NASCIS 3 showed no difference between people given a bolus dose of 30 mg/kg methylprednisolone with 3 hours followed by 24 hours of 5.4 mg/kg/hour of methylprednisolone, 48 hours of 5.4 mg/kg/hour of methylprednisolone, or 6 mg/day of tirilazad mesylate (an antioxidant steroid). However, in people that were treated more than 3 hours after injury, people receiving the 48 hour course of methylprednisolone had significantly better motor recovery.

    The current recommendation is that people get a 30 mg/kg bolus of methylprednisolone as soon as possible within 8 hours and a 24-hour course of the drug at 5.4 mg/kg/hour if they are treated within 3 hours, and a 48-hour course of the drug at 5.4 mg/kg/hour if they are treated between 3 and 8 hours. People who come in later than 8 hours should not be treated with the drug.

    I believe that people should be decompressed as soon as possible after spinal cord injury. Many animal studies have now shown that continued compression of the cord even for an hour or two after injury greatly increases the severity of the injury. Despite that, most patients are not decompressed until several hours and many not until 24-48 hours. Many neurosurgeons have been calling for a clinical trial to compare early and late decompression to gather the evidence for the beneficial effects of early decompression so that this could be used to improve emergency transportation and staffing of level 1 trauma centers to do immediate decompression of spinal cord injury.

    When I was in Indonesia, I heard a wonderful talk by a group of neurosurgeons from Budapest. What they do there really put American trauma centers to shame. They are routinely getting their patients into the operating room and definitively decompressing and stabilizing both cervical and thoracic spinal cord injury within 1-2 hours after injury. That is an amazing feat, considering the limited resources that they have. Switzerland, likewise, is another country that rapidly treats all their patients with methylprednisolone and decompression.

    Wise.

  9. #9
    Senior Member Jeff's Avatar
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    Oh man

    The more I learn about the acute phase of SCI the more I realize why I recovered so little. If early decompression is a good thing then I was totally hosed by my neurosurgeon. I wasn't operated on until TWO WEEKS after injury. They put a halo on me right away and traction on my skull to keep my neck straight but waited a full two weeks to fix my broken neck. When they finally operated they did an anterior fusion to stabilize the vertebrae. I wonder if I was definitively decompressed or not.

    I was hurt June 12, 1980. It was still a very dark age for SCI.

    ~See you at the SCIWire-used-to-be-paralyzed Reunion ~

  10. #10

    At the local hospital...

    where I wa brought after my crash my doctor started MP, and I was on it for about 8 hours while I waited for the Air Ambulance to come and fly me to a larger center. As soon as I as brought to the emergency here in Edmonton the doctor commented that MP 'was only used in rural areas' and disconnected my IV....

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