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Background <p>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.</p> Methods <p>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&#xa0;mg of saffron or a placebo tablet containing 100&#xa0;mg of corn starch for seven days. Before and after the intervention, clinical, inflammatory, hematological, and mortality parameters were assessed.</p> Results <p>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; <i>P</i> &lt; 0.001), ESR (-5.36 ± 28.75 vs. 24.29 ± 28.24; <i>P</i> &lt; 0.001), IL-6 (-22.09 ± 25.22 vs. -4.02 ± 20.04; <i>P</i> &lt; 0.001), IL-18 (-9.56 ± 9.31 vs. -0.89 ± 3.38; <i>P</i> &lt; 0.001), and TNF-α (-2.52 ± 3.79 vs. -0.035 ± 2.35; <i>P</i> &lt; 0.001). Regarding clinical outcomes, significant improvements were observed in APACHE II (-2.55 ± 5.47 vs. 0.78 ± 3.37; <i>P</i> = 0.003), SOFA (-1 ± 1.07 vs. -0.05 ± 1.53; <i>P</i> &lt; 0.001), NUTRIC score (-1.2 ± 1.01 vs. 0.2 ± 0.87; <i>P</i> &lt; 0.001), and WBC count (-4176.34 ± 4063.01 vs. 61.57 ± 4118.97; <i>P</i> &lt; 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 (<i>P</i> &gt; 0.05).</p> Conclusions <p>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.</p> Trial registration <p>Iranian Registry of Clinical Trials: IRCT20201129049534N8. It was registered on 17 March 2024.</p>

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The effects of saffron supplementation on inflammation and hematological parameters in patients with sepsis: a randomized controlled trial

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  • 发表日期：

    2025年5月9日

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  • Shirin Hassanizadeh,
  • Babak Alikiaii,
  • Mohammad Hossein Rouhani,
  • Shokoofeh Talebi,
  • Zeinab Mokhtari,
  • Manoj Sharma,
  • Mohammad Bagherniya

摘要

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.