In moderate-severe traumatic brain injury, Cerebrolysin improved the functional and neuropsychological ensemble versus saline at Day 30.
In plain wordsIn patients with brain injury, Cerebrolysin improved combined functional and psychological outcomes more than saline at Day 30.
- Peptide
- Cerebrolysin
- Outcome
- IncreaseFunctional and neuropsychological ensemble at Day 30
- Study
n = 185
- Comparator
- Physiological saline solution
- Analysis
- Primary
- Outcome group
- Neuroprotection · Nervous system and cognition
- Studied dose
- 50 mL per day for ten days, followed by two cycles of 10 mL per day for 10 daysAs given in this study (human).
Measurements
- MW combined
- 0.6
- Day 30
- SMD
- 0.31
- Day 30
- OR
- 1.69
- Day 30
- 95% confidence interval for MW combined
- 0.52 to 0.66
- Cerebrolysin versus saline, Day 30
- p value for functional and neuropsychological ensemble
- 0.0156
- Cerebrolysin versus saline, Day 30
Source sentences
The primary endpoint, a multidimensional ensemble of functional and neuropsychological outcome scales indicated a "small-to-medium" sized effect in favor of Cerebrolysin, statistically significant at Day 30 and at Day 90
3 context sentences(design, population, supporting numbers)
(Day 30: MWcombined = 0.60, 95%CI 0.52 to 0.66, p = 0.0156; SMD = 0.31; OR = 1.69;
The study included two phase IIIb/IV prospective, randomized, double-blind, placebo-controlled clinical trials.
Eligible patients with a Glasgow Coma Score (GCS) between 6 and 12 received study medication (50 mL of Cerebrolysin or physiological saline solution per day for ten days, followed by two additional treatment cycles with 10 mL per day for 10 days) in addition to usual care.