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).