Table 1. Characteristics of Included Studies.
| Author (Year) | Sample Size(Type of Study) | Acute/Chronic TBI | Severity of Patients’ Condition | Intervention | Duration of Intervention (Follow up) | Outcome Assessment |
|---|---|---|---|---|---|---|
| Leon-Carrion (2000) | 10(RCT intervention vs. placebo) | Chronic TBI | Patients with severe memory deficits | Oral 1 gram Daily |
3 months in conjunction to neuropsychological treatment to both study groups(No further follow up after 3 months) | Before/After assessment of attention, vigilance, memory, verbal fluency and visoconstrictive abilities. |
| Maldonado (1991) | 216(RCT Single-Blinded Case-Control) | Acute TBI | Patients with moderate or severe TBI | Intravenous (During admission) Days 1-2: 1 gram Q6hrs Days 3-4: 1 gram Q8hrs Then until discharge patients who wore phleoclisis received 1 gram Q8hr, and who didn’t received 1 gram Q12hrs Oral (After Discharge) 200mg Q8hr |
The total duration of treatment was variable, depending on the evolution of the patient(3 months) | Comparing the evolution of patients who received conventional treatment with the evolution of those treated with citicoline using GOS. |
| Shokouhi (2014) | 58 (RCT Double-Blinded Case-Control) | Acute TBI | Patients with moderate or severe TBI | Intravenous Citicoline (500 mg) Q6hr |
15 Days(No further follow up after day 15) | 1- Serum levels of fetuin-A and MGP: Days 6,12 2- Physical examination and GCS evaluation: Daily |
| Zafonte (2012) | 1213 (RCT Phase-III) | Acute TBI | Patients with complicated mild, moderate or severe | Enteral or oral Citicoline (2000 mg) Daily | 90 Days (Outcomes assessment in Days 30,90,180) | 1- Functional and cognitive status assessed at day-90 using TBI-Clinical Trials Network Core Battery. 2- Days 30, 90,180 assessments for functional and cognitive improvement using GOS and long-term maintenance of treatment effects. |