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. 2017 Sep 5;7(3 Suppl):116S–137S. doi: 10.1177/2192568217706366

Table 3.

Study Characteristics*.

Author (Year), Design, Risk of Bias Sample and Characteristics Treatment Inclusion Criteria Severity (on Admission) Outcome Measures Follow-up Time (%) Funding
Bracken (1990/92)22,23 RCT Low N = 487 MPSS: Male: 86.4% Age: 13-29: 55.5% 30-44: 27.2% ≥45: 17.3% Naloxone: Male: 80.5% Age: 13-29: 63.6% 30-44: 18.7% ≥45: 17.6% Placebo: Male: 84.8% Age: 13-29: 52.6% 30-44: 28.7% ≥45: 18.8% MPSS: n = 162 IV bolus dose of 30 mg/kg body weight over a 15-minute period followed by a 45-minute pause, then infusion at 5.4 mg/kg/h for 23 hours Naloxone: n = 154 IV bolus dose of 5.4 mg/kg body weight over a 15-minute period followed by a 45-minute pause, then infusion at 4.0 mg/kg/h for 23 hours Placebo: n = 171 IV bolus dose and then an infusion given—no other info given as to the time or amount Inclusion:

  • SCI

  • Randomized ≤12 hours of injury

  • Consent

Exclusion:

  • Nerve root involvement

  • Cauda equina alone

  • Gunshot wounds

  • Life-threatening morbidity

  • Pregnancy

  • Narcotic addiction

  • Other steroid usage

  • <13 years of age

  • Receiving 100 mg MPSS or naloxone before admission

  • Difficulty with following-up

  • Quadriplegic: 228/484 (47.1%)

  • Paraplegic: 159/484 (32.9%)

  • Quadriparetic: 49/484 (10.1%)

  • Paraparetic: 12/484 (2.5%)

  • Normal: 36/484 (7.4%)

 Motor score: 0-5 (no contraction to normal function) for 14 muscles—range from 0 to 70 Response to pinprick and light touch: 1-3 (absent, dysfunction, or normal) in 29 segments—range 29 to 87 6 weeks: 477/487 (97.9%) 6 months: 470/487 (96.5%) 1 year: 427/487 (87.7%)a National Institute of Neurological Disorders and Stroke (Grant NS 15078)
Otani (1994)b,24 RCT Moderately high N = 117 Male: 76.1% Age: 40-49: 14.5% 50-59: 26.5% 60-69: 18.8% MPSS: n = 70 IV bolus dose of 30 mg/kg of body weight over a 15-minute period followed by a 45-minute pause and then an infusion at 5.4 mg/kg/h for 23 hours Control: n = 47 Drug therapies without a corticosteroid and surgical treatment Inclusion:

  • SCI with motor/sensory loss

  • Treated ≤8 hours after injury

  • Consent

  • 16-65 years of age

  • Available for 6 month follow-up

Exclusion: Patients with:

  • Spinal root and/or cauda equina lesions only

  • Serious comorbidity

  • 100 mg MPSS between injury and treatment initiation

  • Other steroid use

  • Congenital or previous spinal cord illness/injury

  • Pregnant, nursing, or suspect pregnancy

  • Hypersensitivity to corticosteroids

  • Physician decision

  • Quadriplegic: 39/117 (33.3%)

  • Paraplegic: 25/117 (21.4%)

  • Quadriparetic: 20/117 (17.1%)

  • Paraparetic: 5/117 (4.2%)

  • Normal: 28/117 (23.9%)

 Frankel Classification:

  • A = complete lesion; B = sensory only; C = motor useless; D = motor useful; E = recovery

  • Changes in classification were compared from baseline to each time point

 6 months: 117/158 (74.1%) NR
Bracken (1997-8)29,40 RCT Low N = 499 MPSS 24 hours: Male: 85.5% Age: 14-29: 42.3% 30-44: 29.5% ≥45: 28.3% TM 48 hours: Male: 86.8% Age: 14-29: 47.4% 30-44: 31.2% ≥45: 21.6% MPSS 48 hours: Male: 81.9% Age: 14-29: 45.9% 30-44: 32.5% ≥45: 21.6% MPSS 24 hours: n = 166 IV bolus dose of 30 mg/kg body weight followed by 5.4 mg/kg/h for 24 hours, then placebo given every hour for next 24 hours TM 48 hours: n = 167 IV bolus dose of 30 mg/kg body weight followed by 2.5 mg/kg every 6 hours for 48 hours MPSS 48 hours: n = 166 IV bolus dose of 30 mg/kg body weight followed by 5.4 mg/kg/h for 48 hours Inclusion:

  • SCI

  • Consent

  • ≥14 years old

Exclusion: Patients:

  • Pregnant

  • Illegal immigrants

  • Indicted criminals

  • Serious comorbidity

  • More than 109 kg (242 lb)

  • Gunshot wounds

  • Previous spinal injury

  • Previous MPSS treatment

  • Quadriplegic: ∼35.2%

  • Paraplegic: ∼30.9%

  • Quadriparetic: ∼13.4%

  • Paraparetic: ∼4.0%

  • Normal: ∼16.5%c

Motor score: 0-5 (no contraction to normal function) for 14 muscles—range from 0 to 70 Response to pinprick and light touch: 1-3 (absent, dysfunction or normal) in 29 segments—range 29 to 87 Functional Independence Measure (FIM): 18-126 (need for assistance in all areas to complete independence) 6 weeks: 465/499 (93.2%) 6 months: 444/499 (89.0%) 1 year: 431/499 (86.4%)d National Institute of Neurological Disorders and Stroke (Grant NS-15078)
Pointillart (2000); Petitjean (1998)e,25 RCT Low N = 106 % Male: NR MPSS: Age: 32 (25-44) NP: Age: 32 (26-47) MPSS and NP: Age: 28 (20-39) Placebo: Age: 28 (25-42)f MPSS: n = 27 IV bolus dose of 30 mg/kg over 1 hour, then 5.4 mg/kg/h for 23 hours NP: n = 27 NP dose of 0.15 mg/kg/h for 2 hours, then 0.03 mg/kg/h for 7 days MPSS and NP: MPSS and NP at the same doses Placebo: n = 25 Neither medication received Inclusion:

  • 15-65 years

  • Consent

  • Hospitalized ≤8 hours of injury

Exclusion:

  • Nerve-root involvement

  • Cauda equina syndrome

  • Open spinal lesions

  • Pregnancy

  • Multiple trauma

  • Head injury with Glasgow score <13

  • Pulmonary contusion

  • Persistent hemodynamic instability

  • MAP <60 mm Hg

  • Previous corticosteroids or calcium channel blockers

  • History of diabetes mellitus

  • Stomach ulcer

  • Liver failure

  • Cardiovascular disorders

  • Paraplegia: 48/106 (45.3%)

  • Tetraplegia: 58/106 (54.7%)

 ASIA motor, pinprick sensation, and pain scores: Neurological examination at admission and 1 year later 1 year: 100/106 (94.3%) 5 patients lost to death NR
Matsumoto (2001)27 RCT Moderately high N = 46 Male: 91.3% Mean age (range): 60.6 (20-84) MPSS: Male: 91.3% Mean age (range): 60.9 (41-84) Placebo: Male: 91.3% Mean age (range): 60.4 (20-84) MPSS: n = 23 IV bolus dose of 30 mg/kg of body weight over a 15-minute period followed by a 45-minute pause and then an infusion at 5.4 mg/kg/h for 23 hours Placebo: n = 23 15-minute bolus of 30 mg/kg followed by a 45-minute pause, and then a 23-hour maintenance infusion of 5.4 mg/kg Inclusion:

  • Cervical SCI, 1993-1999

  • Randomized ≤8 hours of injury

  • Consent

Exclusion:

  • Involvement of ≥1 nerve root

  • Gunshot wounds

  • Life-threatening morbidity

  • Pregnancy

  • Narcotic addiction

  • Other steroid usage

  • Operative treatment

  • MPSS or equivalent before admission

  • Difficult follow-up

  • Ankylosing spondylitis

 Frankel grade

  • A: 15/46 (32.6%)

  • B: 16/46 (34.8%)

  • C: 7/46 (15.2%)

  • D: 8/46 (17.4%)

 Frankel Classification:

  • A = complete lesion; B = sensory only; C = motor useless; D = motor useful; E = recovery

  • Changes in classification were compared from baseline to each time point

 2 months, 46/46 (100%) NR
Wilson (2012)28 STASCIS trial, prospective cohort Moderately high N = 411 Mean age: 44.4 ±17.0 Male: 308/411 (74.9%) MPSS: 233/411 (56.7%) 24-hour, low-dose MPSS regimen from the NASCIS II study Inclusion:

  • Patients with SCI

  • ≥16 years of age

  • Presented to one of the participating institutions

  • AIS Grade of A-D

  • A cervical neurological level of injury (C2-T1)

  • Radiographic evidence of spinal cord compression

  • Documented neurological examination <24 hours of injury and follow-up available at acute care discharge

 AIS Grade: e

  • A: 144/411 (35.0%)

  • B: 66/411 (16.1%)

  • C: 86/411 (20.9%)

  • D: 115/411 (28.0%)

ISS Score:

  • 12.5 ± 10.5

  • Complications: 160/411 (38.9%)

 NR Christopher and Dana Reeve Foundation, Cervical Spine Research Society, AANS/CNS Section on Disorders of the Spine and Peripheral Nerves, and Rick Hansen Institute
Evanview (2015)26 Prospective cohort RHSCIR Moderately low N = 88 MPSS: Male: 81.8% Mean age: 45.4 ± 16.2 No MPSS: Male: 93.2% Mean age: 45.5 ± 16.6 MPSS: n = 44 MPSS regimen from the NASCIS II study given within 8 hours of injury and administered for 24 or 48 hours Control: n = 44 Propensity matched SCI patients with no MPSS administration Inclusion:

  • Traumatic SCI

  • ≥18 years of age

Exclusion:

  • SCI due to infection, neoplasm, iatrogenic or vascular causes

 AIS Grade:

  • A: 40/88 (45.5%)

  • B: 66/411 (12.51%)

  • C: 86/411 (15.9%)

  • D: 115/411 (26.1%)

 Motor score: International Standards for Neurologic Classification of Spinal Cord Injury (ISNCSCI) In-hospital complications Median number of days: 127 (MPSS) and 117 (no MPSS) 44/46 (95.7%) Rick Hansen Institute, Health Canada, Western Economic Diversification Canada, and the Governments of Alberta, British Columbia, Manitoba, and Ontario

Abbreviations: AANS, American Association of Neurological Surgeons; ASIA, American Spinal Injury Association; CNS, Congress of Neurological Surgeons; IV, intravenous; MAP, mean arterial pressure; MPSS, methylprednisolone sodium succinate; NP, nimodipine; NR, not reported; RCT, randomized controlled trial; RHSCIR, Rick Hansen Spinal Cord Injury Registry; SCI, spinal cord injury; TM, tirilazad mesylate.

*Bracken studies are reported as a primary report and then a follow-up report 1 year later; 6-week and 6-month follow-up information are based on primary reports; 1-year follow-up is based on the follow-up report.

aBracken (1990/1992): Measured in 161 patients in the methylprednisolone group, 153 in the naloxone group, and 170 in the placebo group.

bEnglish translation of an article originally published in Japanese.

cBracken (1997/98): Motor function percentages are averaged from percentages of each treatment group in Table 2.

dBracken (1984/5): 330 refers to number of patients randomized, 24 patients were excluded from analysis after randomization, n = 306.

ePetitjean 1998 was published in a French journal, and Pointillart 2000 was published in an English journal.

fPetitjean 1998: Age values expressed as averages with 25th and 75th percentiles in parentheses.