Shirin Hassanizadeh, Babak Alikiaii, Mohammad Hossein Rouhani, Shokoofeh Talebi, Zeinab Mokhtari, Manoj Sharma, Mohammad Bagherniya
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引用次数: 0
Abstract
Background: Critically ill patients suffering from sepsis are at an increased risk of morbidity and mortality due to its serious complications. Saffron as an herbal medicine has been proven to have anti-inflammatory and anti-oxidative stress effects previously. Hence, this study aimed to determine how saffron supplementation affected inflammatory and hematological factors in patients admitted to the intensive care unit (ICU) with sepsis.
Methods: In this double-blind clinical trial, 90 ICU sepsis patients with GCS lower than 13 were randomized to receive either an intervention tablet containing 100 mg of saffron or a placebo tablet containing 100 mg of corn starch for seven days. Before and after the intervention, clinical, inflammatory, hematological, and mortality parameters were assessed.
Results: After seven days, the saffron group showed a significantly decline from baseline compared to the placebo group in inflammatory markers, including CRP (-24.58 ± 22.16 vs. -2.42 ± 30.86; P < 0.001), ESR (-5.36 ± 28.75 vs. 24.29 ± 28.24; P < 0.001), IL-6 (-22.09 ± 25.22 vs. -4.02 ± 20.04; P < 0.001), IL-18 (-9.56 ± 9.31 vs. -0.89 ± 3.38; P < 0.001), and TNF-α (-2.52 ± 3.79 vs. -0.035 ± 2.35; P < 0.001). Regarding clinical outcomes, significant improvements were observed in APACHE II (-2.55 ± 5.47 vs. 0.78 ± 3.37; P = 0.003), SOFA (-1 ± 1.07 vs. -0.05 ± 1.53; P < 0.001), NUTRIC score (-1.2 ± 1.01 vs. 0.2 ± 0.87; P < 0.001), and WBC count (-4176.34 ± 4063.01 vs. 61.57 ± 4118.97; P < 0.001). Moreover, the effect sizes (Cohen's d) for these factors ranged from moderate to large, except for IL-6, which had a small effect size (d = -0.38). However, no significant differences were found between the groups in the Glasgow Coma Scale, FOUR Score, 28-day and 90-day mortality rates, or other hematological parameters (P > 0.05).
Conclusions: Saffron administration in sepsis patients admitted to the ICU led to significant improvements in inflammatory markers and some clinical parameters. However, the clinical significance of these findings remains to be fully established.
Trial registration: Iranian Registry of Clinical Trials: IRCT20201129049534N8. It was registered on 17 March 2024.
期刊介绍:
Nutrition Journal publishes surveillance, epidemiologic, and intervention research that sheds light on i) influences (e.g., familial, environmental) on eating patterns; ii) associations between eating patterns and health, and iii) strategies to improve eating patterns among populations. The journal also welcomes manuscripts reporting on the psychometric properties (e.g., validity, reliability) and feasibility of methods (e.g., for assessing dietary intake) for human nutrition research. In addition, study protocols for controlled trials and cohort studies, with an emphasis on methods for assessing dietary exposures and outcomes as well as intervention components, will be considered.
Manuscripts that consider eating patterns holistically, as opposed to solely reductionist approaches that focus on specific dietary components in isolation, are encouraged. Also encouraged are papers that take a holistic or systems perspective in attempting to understand possible compensatory and differential effects of nutrition interventions. The journal does not consider animal studies.
In addition to the influence of eating patterns for human health, we also invite research providing insights into the environmental sustainability of dietary practices. Again, a holistic perspective is encouraged, for example, through the consideration of how eating patterns might maximize both human and planetary health.