3- Results
The statistical package for social sciences (SPSS) software for Windows version 18 (IBM Inc., Chicago, IL, USA) was used for data analysis. Between-group comparison of nominal or the categorical variables was ascertained with the use of chi-square test or Fisher’s exact test. After determining normality using the Shapiro-Wilk test, the between-group comparison of continuous variables was ascertained using independent sample T or Mann-Whitney U Test (non-normal distribution). Analysis of covariance (ANCOVA) test was used to determine the mean change and effect size with the adjustment for sex and age. P-value <0.05 was considered statistically significant.
A total of 67 consecutive patients with TBI were admitted to the ICU from October 2018 to August 2019; twenty patients met all eligibility criteria and then underwent randomization and were followed until hospital discharge. All patients received either standard or anti-inflammatory formula for 14 days. The trial groups were well matched in terms of demographic characteristics. The majority of patients were male, all patients in the intervention group and 8 of the control group (P-value: 0.47). The mean (±SD) age and weight were 36.40 ± 18.72 and 38.50 ± 16.83 years and 76.30 ± 6.06 and 73.50 ± 11.27 kg in the intervention and control group, respectively. In each trial group, 30% and 20% of participants had subarachnoid and intracranial haemorrhage, respectively. Subdural haemorrhage was present in 30% of the control group but in only 20% of the intervention group and other participants had contusion (P-value: 0.30). The comparison of the clinical, nutritional, and laboratory characteristics at the baseline showed no significant differences between the trial groups (Table 3, 4).
The mean of total calorie intake during the 7 and 14 days of the intervention was 8295 ± 1567 and 18655 ± 2976 Kcal in the intervention group and 8615±1583 and 19115 ± 2118 Kcal in the control groups, respectively. The trial groups did not differ significantly in terms of energy intake. Adjusted mean changes (95% CI) in laboratory characteristics from baseline to 7- and 14-day intervention are summarized in Table 5. Serum TC concentration and PLT count increased significantly, whereas serum hs-CRP and creatinine concentrations and WBC count decreased significantly in the intervention group during the first week of the intervention. The serum BUN, LDL-c, and TC concentrations and PLT count during the first week of the intervention increased significantly in the control group. Other parameters did not significantly change in either group during this period. The two groups did not differ significantly with respect to laboratory parameters within the first week of intervention. The serum hs-CRP and FBS concentrations and PLT and WBC count in the intervention group and the serum TNF-α, FBS, LDL-c, and creatinine concentrations and PLT count in the control group changed significantly from baseline to 14-day intervention. Other parameters did not significantly change in either group during this period. Among these variables, only hs-CRP, FBS, and LDL-c showed a significant reduction in the intervention group compared with the control group.
Multivariable-adjusted mean changes (95% CI) in clinical characteristics are summarized in Figure 2. Within-group comparisons showed that only MAC decreased significantly in both groups and GCS scores increased significantly in the intervention group during the first 7 days of the intervention. The between-group comparison demonstrated that only the average increase in GCS score was significantly higher in the intervention group compared to the control group during this period (P value=0.032). The mean of APACHE II and SAPS II scores and MAC during the 14 days of the intervention decreased and GCS increased significantly in the intervention group. On the other hand, in the control group, MAC decreased and NUTRIC scores increased significantly. The comparison of the changes in clinical parameters between the study groups following 14 days of intervention demonstrated that the average change in GCS score was significantly higher and also change in APACHE II, SAPS II, and NUTRIC scores were significantly lower in the intervention group compared with the control group. Moreover, the adjusted mean (95% CI) for hospital length of stay (LOS) was 73.21 (55, 91.4) days for the control group and 41.99 (23.80, 60.18) days for the intervention group (Figure3).