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Eur J Orthop Surg Traumatol Current use of methylprednisolone for acute spinal cord injuryin Poland: survey study Grzegorz Miekisiak • Wojciech Kloc •Witold Janusz • Jacek Kaczmarczyk •Dariusz Latka • Daniel Zarzycki Received: 28 September 2013 / Accepted: 26 January 2014Ó Springer-Verlag France 2014 was fear of litigation (36.7 %), 30.4 % declared it is as an The controversial practice of methylpredniso- institutional standard, nearly one-third believed in the lone (MP) application in acute spinal cord injury (ASCI) is effectiveness of drug in improving neurological outcomes.
gradually decreasing. This is a survey study designed to The subgroup analyses revealed no statistically significant assess the current use of MP in ASCI in Poland.
interaction for specialty, age, personal involvement in care The questionnaire comprised of five questions and institutional case volume.
was distributed among 251 spinal surgeons, members of As opposed to the literature data from sim- the Polish Society of Spinal Surgery. One hundred and ten ilar studies performed in other countries, the rate of use of (43.8 %) responded, and data from 108 were included in MP in ASCI remains high.
the study.
Results Majority of respondents (73.1 %) declared the Spinal cord injury
Methylprednisolone
use of MP in ASCI. Most of them (41.7 %) adhered to the Steroids
Neuroprotection NASCIS II protocol, and 24.1 % rather used the NASCISIII protocol. Predominant rationale for the use of steroids Spinal cord injury (SCI) remains a devastating condition Department of Neurosurgery, Specialist Medical Center, often affecting young, otherwise healthy individuals. In ul. Jana Pawla II 2, 57-320 Polanica-Zdroj, Polande-mail: [email protected] Poland, the annual incidence of SCI is approximately 14.5per 1 million population Intensive research over the years has led to a comprehensive understanding of its Department of Neurology and Neurosurgery, Faculty of Medical mechanisms; however, these advances have not translated Sciences, University of Varmia and Masuria, Olsztyn, Poland into improved neurological outcomes. Though many new methods of treatment have been proposed to manage acute Department of Neurosurgery, Medical University of Lublin, spinal cord injury (ASCI) over the last few decades, only one treatment regimen based on the high-dose methyl- prednisolone (MP) was widely introduced into clinical Department of Orthopaedics and Rehabilitation, Medical University of Poznan, Poznan, Poland The publications of results from NASICIS II and III trials in early 90s ] resulted in international recognition D. LatkaDepartment of Neurosurgery, Regional Medical Center, Opole, of this therapy as a standard for the treatment of ASCI, but soon it became a subject of much controversy and criti-cism. Many reports pointed to numerous flaws of NASCIS series trials such as improper randomization, inadequate Department of Orthopaedics and Rehabilitation,Jagiellonian University, Zakopane, Poland assessment of outcomes, incomplete reporting of results Eur J Orthop Surg Traumatol Table 1 Questions included in the booklet spinal surgeons associated with the PSoSS. In particular, itaimed to determine which is the prevalent protocol and 1. My specialty is what is the rationale for this therapy.
Board certified orthopedic surgeon Board certify neurosurgeon Orthopedic surgeon in training Neurosurgeon in training The questionnaire comprised of five questions. The ques- tions were pertained to the specialty, use of steroids in SCI I use MP therapy, initial bolus than the maintaining dose for 24 h including the protocol favored, rationale for its use, vol- if 8 h from trauma ume/number of SCI cases in his/her institution and the I use MP therapy, initial bolus than the maintaining dose for 24 or 48 h depending whether the trauma occurred within last 8 or extent of personal involvement in SCI patient care 8–24 h, respectively (Table The questionnaire was similar to the one I use MP therapy regardless of the timing of administration designed by Eck et al. The demographic section of the I use dexamethasone or other steroid drug form included only one question about the age of the I do not use steroids at all respondent (B45 or [45 years old). A self-validating web 3. I use MP in the ASCI because: form was provided for data acquisition, allowing only clean I believe it is an efficient drug improving the outcomes and correct data, without missing values. The survey It is a standard in my institution questionnaire was distributed to all the 251 spinal surgeons, I am concerned about medicolegal consequences members of the PSoSS, between March and May 2013. The results were presented as descriptive statistics. The Pear-son's Chi-square test was used to assess the significance of 4. How many patients with SCI are treated in you institution per differences among defined subgroups.
5. What percentage of all SCI cases in your institution is operated Out of 251 members of the PSoSS, 110 (43.8 %) responded.
Data from two respondents were excluded, as they were practicing outside Poland. Thus, the final number of par- ticipating surgeons was 108. The resulting data are shown inTable There were 44 orthopedic surgeons (nine intraining) and 64 neurosurgeons (12 in training). Seventy of and, most of all, drawing conclusions from the post hoc them were aged 45 years or less, and 38 were more than analysis []. However, despite heavy critique from many 45 years old at the time of application. Nearly three quarters authors, MP remained in use even if the rationale has (73.1 %) of all the respondents declared the use of steroids, changed over time. A survey study in 2006 by Eck et al. and majority (41.7 %) of them followed the NASCIS II revealed that majority of respondents used MP out of fear protocol. Twenty-six (24.1 %) surgeons adhered to the of litigation. With the increasing evidence of serious side NASCIS III protocol, four used steroids regardless of the effects far exceeding the potential benefits, MP use in timing of administration, and four used steroids other than ASCI started to decrease worldwide In the second MP. The differences among specialties were statistically not iteration of guidelines for the management of ASCI by the significant (p = 0.90). Likewise, the use of steroids was AANS/CNS Joint Section on Disorders of the Spine and independent of other factors, such as the age, and the annual Peripheral Nerves published in 2013, there is a level I volume of SCI patients treated in respondents' institution.
recommendation against the use of MP in ASCI Within In terms of rationale for treatment, the replies were almost a few months, similar recommendations were issued by the equally distributed among the three available options.
Polish Society of Spinal Surgery (PSoSS), a nonprofit Nearly 33 % of respondents claim that their primary moti- medical association comprising of about 300 members, vation for the use of steroids was their belief in the effec- mostly, spine surgeons [].
tiveness of drug in improving the neurological outcomes.
PSoSS is the largest organization in this field in Poland Institutional standard is a rationale in 30.4 %, but a majority and is affiliated with the EuroSpine, the Spine Society of (36.7 %) of the respondents used steroids for medicolegal Europe. This survey study was designed to assess the reasons. Orthopedic surgeons believe that clinical benefit is current status of MP use in SCI in Poland among practicing seen in 40.6 % in MP users compared to 27.7 % in Eur J Orthop Surg Traumatol Eur J Orthop Surg Traumatol nonusers. Thirty-four percent of neurosurgeons claimed that As a result of prolonged international dispute, a steady they used the MP therapy as an institutional standard. A decline in the use of MP in ASCI is observed. Other articles quarter of orthopedic surgeons marked this option. The similar to this have also shown this trend in several countries differences in rationales for treatment among specialties across the globe. A Canadian study in 2008 by Hurlbert and were not statistically significant (p = 0.46).
Hamilton compared the survey data from 2001 to 2006and showed a complete reversal of practice. The number ofrespondents using MP dropped from 76 % in 2001 to 24 % in 2006. In another survey in 2012 of neurosurgeons practicingin the United Kingdom from ], only 21 % recommended After publication of the results of NASCIS II trial MP the use of glucocorticoids in an incomplete SCI (16 % instantaneously became an unofficial standard of treat- patients). Felleiter et al. retrospectively analyzed the ment. The lack of viable treatment options targeted to changes in adherence to MP therapy in ASCI between the abate secondary injury, together with a tremendous pres- two study periods, 2001–2003 and 2008–2010, in Switzer- sure from the society, propelled the acceptance of this land's largest center dealing with SCI. The rate of patients new standard of care. This hasty validation of a new treated with MP dropped from 96 % in 2001–2003 to 23 % in treatment did not go unnoticed by the professional com- 2008–2010. Interestingly, the pooled data showed a better munity. Soon, articles criticizing the NASCIS series were rate of neurological improvement in MP users (32 vs 28 %), published. Although these studies were well prepared and although the differences were statistically not significant. A executed, the conclusions were drawn up upon the ret- national study on current practice of MP administration in rospective analysis of data, as the primary data failed to ASCI in Germany [revealed that 55 % of surveyed show significant differences in motor outcomes between departments still use MP. It is noteworthy that respondents the treatment groups. Thus, these trials cannot be classi- from 14 departments (9.7 %), 11 of them from academic fied as level I, but rather level III. Other authors point to institutions, declared that they used an obsolete protocol numerous other flaws, such as improper randomization from the NASCIS I trial.
[], lack of compelling data and failure to include func- There are certain limitations in this study. The most tional outcomes important to the patients [Overall, important one was its reliance on self-report data on these studies do not provide sufficiently strong evidences respondents' typical practice not the facts from medical to justify the use of MP in ASCI. Furthermore, the NA- records. Thus, the exact prevalence of MP use is not SCIS studies were not followed by other trials of adequate known. However, the intention of this study was to analyze size and quality supporting the use of MP. On the con- current opinions in response to the publication of new trary, there is mounting clinical evidence that MP in high recommendations. Another limitation comes from the lack doses has a potential for major complications, such as of precise information on incidence of SCI in Poland in sepsis, pneumonia, urinary tract infection, gastrointestinal recent years, and it would allow to estimate to what extent ulcer/bleeding and pulmonary embolism –]. Corti- the results are representative at the national level.
costeroid Randomization after Significant Head injury Our results show that despite available clinical evidence, (CRASH) was a large international trial designed to the rate of practitioners using MP in Poland remains even assess the safety and efficacy of the corticosteroids for the higher (73.1 %) than in previously published studies.
treatment of traumatic brain injury ]. Initially planned Moreover, more than one-third of respondents choose to to enroll 20,000 patients, it was terminated halfway use MP because of the fear of litigation. This is rather a through when the interim analysis revealed significantly increased mortality in the MP treated group. Although ‘‘defensive medicine'' practices are very popular in Poland this study did not address the SCI patients directly, it as formal recommendations are rarely formulated by further heated up the debate on the safety of MP responsible agencies often leading to actions contrary to administration as the protocol of MP administration was patients' best interest. Noteworthy is a greater percentage similar to that of NASCIS III study.
of more experienced surgeon refusing the MP treatment, In 2013, an important set of guidelines were published albeit not statistically significant. The plausible explanation by the AANS/CNS Joint Section on Disorders of the Spine is that it is likely a consequence of greater confidence and and Peripheral Nerves For the first time, level I rec- hence lower fear of litigation related to more frequent ommendation was made against the use of MP in ASCI.
exposure to SCI patients. We hope that the formulation of The authors stated that there are sufficient Class I, Class II new relevant standards supported with subsequent infor- and Class III evidences and that high-dose steroids are mation will help surgeons reject the harmful practice of MP associated with harmful side effects including death.
application in ASCI.
Eur J Orthop Surg Traumatol 7. Hurlbert RJ, Hamilton MG (2008) Methylprednisolone for acute spinal cord injury: 5-year practice reversal. Can J Neurol Sci35(1):41–45 This study concurs with previously published studies, that 8. Hurlbert RJ, Hadley MN, Walters BC, Aarabi B, Dhall SS, Gelb despite overwhelming evidence against the use of steroids DE, Rozzelle CJ, Ryken TC, Theodore N (2013) Pharmacologi- in ASCI, this potentially harmful practice remains com- cal therapy for acute spinal cord injury. Neurosurgery 72:93–105 mon. An informative campaign should be implemented to 9. Miekisiak G, Kloc W, Janusz W, Kaczmarczyk J, Latka D, Zarzycki D (2013) The use of methylprednisolone in the acute promote adherence to current standards, as the fear of lit- phase of spinal cord injury. The official position of the Polish igation and lack of feasible options make the application of Society of Spinal Surgery. J Spine Surg 5(1):11–24 MP difficult to eradicate.
10. Hurlbert RJ (2000) Methylprednisolone for acute spinal cord injury: an inappropriate standard of care. J Neurosurg Spine Conflict of interest 11. Ito Y, Sugimoto Y, Tomioka M, Kai N, Tanaka M (2009) Does high dose methylprednisolone sodium succinate really improveneurological status in patient with acute cervical cord injury?: a prospective study about neurological recovery and early com-plications. Spine 34(20):2121–2124 1. Pietraszkiewicz F, Tysiewicz-Dudek M (2010) Epidemiology of 12. Chikuda H, Yasunaga H, Takeshita K, Horiguchi H, Kawaguchi spinal injuries in Lubuskie Province. Ortop Traumatol Rehabil H, Ohe K, Fushimi K, Tanaka S (2013) Mortality and morbidity after high-dose methylprednisolone treatment in patients with 2. Bracken MB, Shepard MJ, Collins WF, Holford TR, Young W, acute cervical spinal cord injury: a propensity-matched analysis Baskin DS, Eisenberg HM, Flamm E, Leo-Summers L, Maroon J using a nationwide administrative database. Emerg Med J. (1990) A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury: results of 13. Matsumoto T, Tamaki T, Kawakami M, Yoshida M, Ando M, the Second National Acute Spinal Cord Injury Study. N Engl J Yamada H (2001) Early complications of high-dose methyl- Med 322(20):1405–1411 prednisolone sodium succinate treatment in the follow-up of 3. Bracken MB, Shepard MJ, Holford TR, Leo-Summers L, Aldrich acute cervical spinal cord injury. Spine 26(4):426–430 EF, Fazl M, Fehlings M, Herr DL, Hitchon PW, Marshall LF 14. Roberts I, Yates D, Sandercock P, Farrell B, Wasserberg J, Lo- (1997) Administration of methylprednisolone for 24 or 48 hours mas G, Cottingham R, Svoboda P, Brayley N, Mazairac G (2004) or tirilazad mesylate for 48 hours in the treatment of acute spinal Effect of intravenous corticosteroids on death within 14 days in cord injury results of the third national acute spinal cord injury 10008 adults with clinically significant head injury (MRC randomized controlled trial. JAMA 277(20):1597–1604 CRASH trial): randomised placebo-controlled trial. Lancet 4. Coleman WP, Benzel E, Cahill DW, Ducker T, Geisler F, Green B, Gropper MR, Goffin J, Madsen PW III, Maiman DJ (2000) A 15. Werndle MC, Zoumprouli A, Sedgwick P, Papadopoulos MC critical appraisal of the reporting of the National Acute Spinal (2012) Variability in the treatment of acute spinal cord injury in Cord Injury Studies (II and III) of methylprednisolone in acute the United Kingdom: results of a national survey. J Neurotrauma spinal cord injury. J Spinal Disord Tech 13(3):185–199 5. Eck JC, Nachtigall D, Humphreys SC, Hodges SD (2006) 16. Druschel C, Schaser K-D, Schwab JM (2013) Current practice of Questionnaire survey of spine surgeons on the use of methyl- methylprednisolone administration for acute spinal cord injury in prednisolone for acute spinal cord injury. Spine 31(9):E250–E253 Germany: a national survey. Spine 38(11):E669–E677 6. Felleiter P, Mu¨ller N, Schumann F, Felix O, Lierz P (2012) Changes in the use of the methylprednisolone protocol for trau-matic spinal cord injury in Switzerland. Spine 37(11):953–956

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