Ruolan Huang1, Zhong Zhang, Mujuan Xu, Xiao Chang, Qiujie Qiao, Ling Wang, Xinke Meng. 1. Department of Critical Care Medicine, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen 518033, Guangdong, China. Corresponding author: Meng Xinke, Department of Emergency, Shenzhen Second People's Hospital, Shenzhen 518035, Guangdong, China, Email: minimi007@126.com.
Abstract
OBJECTIVE: To investigate the effects of Sini decoction on function of hypothalamic-pituitary-adrenal axis in patients with sepsis. METHODS: A prospective single-blind randomized controlled trial was conducted. 60 septic patients were divided into three groups with the method of random number table, 20 cases in the control group, 20 in the Chinese herb group, and 20 in corticoid group. All of them received routine treatment. Patients in Chinese herb group were given Sini decoction in addition (decoction of monkshood 15 g, dried ginger 15 g, honey-fried licorice 10 g) 100 mL/d orally or by nasal feeding, while patients in corticoid group were given hydrocortisone 200 mg/d intravenously instead, both for 7 days. Before the treatment, 3 days and 14 days after treatment, blood was collected to determine the levels of adrenocorticotropic hormone (ACTH) and cortisol, and the result of ACTH stimulating test was observed. At the same time, acute physiology and chronic health evaluation II (APACHEII) score was recorded, and 3-day shock recovery rate and 28-day death rate were also compared among these groups. RESULTS: None of the three groups showed different result in ACTH stimulating test (χ(2)=1.101, P=0.605). ACTH in three groups was gradually decreased. Compared with that before treatment, ACTH in Chinese herb group and corticoid groups began to decrease obviously on day 3 (29.90±3.31 ng/L vs. 33.10±3.31 ng/L, 28.20±2.45 ng/L vs. 33.30±3.84 ng/L, both P<0.01), while in control group declined ACTH appeared later (on day 14) compared with before treatment (29.40±5.63 ng/L vs. 33.50±4.89 ng/L, P<0.05). No obvious difference in ACTH level was showed between the Chinese herb group and the cortical group (both P>0.05). Cortisol level in both Chinese herb and cortical groups showed a raise-fall biphase trend while there was no change in the control. The cortical levels on day 3 in Chinese herb and cortical groups were much higher than that before treatment (343.04±31.20 μg/L vs. 294.70±42.10 μg/L, 331.25±42.80 μg/L vs. 280.36±38.10 μg/L, both P<0.01) and that of control group (291.61±41.50 μg/L, both P<0.01), though no significant statistical difference was observed between two groups (both P>0.05). APACHEII score on day 14 in control, Chinese herb and cortical groups was significantly lower than that before treatment (16.8±5.1 vs. 20.1±4.3, 13.4±3.2 vs. 18.3±3.8,15.1±2.5 vs. 19.5±4.0, all P<0.01), and the score was much lower in Chinese herb group comparing with that of control group (P<0.05). No statistical difference was observed among control, Chinese herb and cortical groups in lowering 28-day death rate [35.0% (7/20), 25.0% (5/20), 20.0% (4/20)] and improving 3-day shock recovery rate [40.0% (8/20), 70.0% (14/20), 60.0% (12/20), all P>0.05]. CONCLUSIONS:Sini decoction could elevate cortisol while lower ACTH at the early stage of sepsis. Sini decoction could also effectively improve symptoms and hypothalamic-pituitary-adrenal axis function in septic patients without affecting death rate.
RCT Entities:
OBJECTIVE: To investigate the effects of Sini decoction on function of hypothalamic-pituitary-adrenal axis in patients with sepsis. METHODS: A prospective single-blind randomized controlled trial was conducted. 60 septic patients were divided into three groups with the method of random number table, 20 cases in the control group, 20 in the Chinese herb group, and 20 in corticoid group. All of them received routine treatment. Patients in Chinese herb group were given Sini decoction in addition (decoction of monkshood 15 g, dried ginger 15 g, honey-fried licorice 10 g) 100 mL/d orally or by nasal feeding, while patients in corticoid group were given hydrocortisone 200 mg/d intravenously instead, both for 7 days. Before the treatment, 3 days and 14 days after treatment, blood was collected to determine the levels of adrenocorticotropic hormone (ACTH) and cortisol, and the result of ACTH stimulating test was observed. At the same time, acute physiology and chronic health evaluation II (APACHEII) score was recorded, and 3-day shock recovery rate and 28-day death rate were also compared among these groups. RESULTS: None of the three groups showed different result in ACTH stimulating test (χ(2)=1.101, P=0.605). ACTH in three groups was gradually decreased. Compared with that before treatment, ACTH in Chinese herb group and corticoid groups began to decrease obviously on day 3 (29.90±3.31 ng/L vs. 33.10±3.31 ng/L, 28.20±2.45 ng/L vs. 33.30±3.84 ng/L, both P<0.01), while in control group declined ACTH appeared later (on day 14) compared with before treatment (29.40±5.63 ng/L vs. 33.50±4.89 ng/L, P<0.05). No obvious difference in ACTH level was showed between the Chinese herb group and the cortical group (both P>0.05). Cortisol level in both Chinese herb and cortical groups showed a raise-fall biphase trend while there was no change in the control. The cortical levels on day 3 in Chinese herb and cortical groups were much higher than that before treatment (343.04±31.20 μg/L vs. 294.70±42.10 μg/L, 331.25±42.80 μg/L vs. 280.36±38.10 μg/L, both P<0.01) and that of control group (291.61±41.50 μg/L, both P<0.01), though no significant statistical difference was observed between two groups (both P>0.05). APACHEII score on day 14 in control, Chinese herb and cortical groups was significantly lower than that before treatment (16.8±5.1 vs. 20.1±4.3, 13.4±3.2 vs. 18.3±3.8,15.1±2.5 vs. 19.5±4.0, all P<0.01), and the score was much lower in Chinese herb group comparing with that of control group (P<0.05). No statistical difference was observed among control, Chinese herb and cortical groups in lowering 28-day death rate [35.0% (7/20), 25.0% (5/20), 20.0% (4/20)] and improving 3-day shock recovery rate [40.0% (8/20), 70.0% (14/20), 60.0% (12/20), all P>0.05]. CONCLUSIONS: Sini decoction could elevate cortisol while lower ACTH at the early stage of sepsis. Sini decoction could also effectively improve symptoms and hypothalamic-pituitary-adrenal axis function in septic patients without affecting death rate.
Authors: M Volbeda; J Wetterslev; C Gluud; J G Zijlstra; I C C van der Horst; F Keus Journal: Intensive Care Med Date: 2015-06-23 Impact factor: 17.440