Table 2.
Summary of Findings: Methylprednisolone vs. Placebo or No Treatment for Patients With Acute Traumatic Spinal Cord Injuries
| Outcome | Follow-up | Data source | No. of participants | Quality of evidencea(GRADE) | Anticipated effects |
|---|---|---|---|---|---|
| Motor score | Short | RCT | 414 (2 studies)6,38 |
LOW Risk of bias, imprecision |
No significant difference between groups (MD, 1.19; 95% CI, −2.33 to 4.71; p = 0.51) |
| OBS | 308 (5 studies)1,47,49,51,52 |
VERY LOW Study design, risk of bias, imprecision |
No significant difference between groups (MD, 3.04; 95% CI, −2.81 to 8.90; p = 0.31) | ||
| Long | RCT | 335 (2 studies)6,39 |
LOW Risk of bias, imprecision |
No significant difference between groups (MD, −1.11; 95% CI, −4.75 to 2.53; p = 0.55) | |
| OBS | 528 (2 studies)44,46 |
VERY LOW Study design, risk of bias, imprecision |
No significant difference between groups (MD, 1.37; 95% CI, −3.08 to 5.83; p = 0.55) | ||
| Improvement by ≥1 Frankel/AIS grade | Short | OBS | 675 (4 studies)42,43,48,49 |
VERY LOW Study design, risk of bias, imprecision, inconsistency |
No significant difference between groups (RR, 1.27; 95% CI, 0.75−2.17; p = 0.37) |
| Long | OBS | 383 (3 studies)41,44,50 |
VERY LOW Study design, risk of bias, imprecision |
No significant difference between groups (RR, 0.84; 95% CI, 0.53−1.33; p = 0.46) | |
| Total adverse Eventsb | Up to 24 months | RCT | 595 (4 studies)6,38,39,40 |
LOW Risk of bias, imprecision, |
No significant difference between groups (RR, 1.65; 95% CI, 0.62−4.41; p = 0.32) |
| Up to 56 months | OBS | 3347 (14 studies)1,19,20,41,43–45,47–51,53,54, |
VERY LOW Study design, risk of bias |
No significant difference between groups (RR, 1.23; 95% CI, 1.00–1.52; p = 0.05) |
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.
Composite of total adverse events: mortality, sepsis, pneumonia, gastrointestinal bleeding, decubitus ulcer, urinary tract infection, venous thromboembolism, and surgical site infection.
AIS, ASIA Impairment Scale; RCT, randomized, controlled trial; OBS, observational study; GRADE, Grades of Recommendation, Assessment, Development, and Evaluation; MD, mean difference; RR, relative risk; CI, confidence interval.