Fuling Zexie Decoction Combined with Lifestyle for the Intervention of Metabolic Syndrome of Dampness Syndrome:A Clinical Randomized Trial
10.19378/j.issn.1003-9783.2024.10.001
- VernacularTitle:茯苓泽泻汤联合生活方式干预湿证代谢综合征的临床试验
- Author:
Shaoqin LIN
1
;
Chengcheng WANG
;
Qing XU
;
Fei TAN
;
Zhimin YANG
;
Xinyan CHEN
Author Information
1. 广州中医药大学第二临床医学院,广东广州 510006
- Keywords:
Metabolic syndrome;
dampness syndrome of TCM;
Fuling Zexie Decoction;
randomized controlled trial (RCT);
metabolic related indexes;
inflammation related indexes
- From:
Traditional Chinese Drug Research & Clinical Pharmacology
2024;35(10):1453-1461
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the clinical efficacy of Fuling Zexie Decoction combined with lifestyle intervention in patients with metabolic syndrome (MetS) of dampness syndrome. Methods A total of 40 patients with MetS of dampness syndrome were randomly divided into experimental group (n=20) and control group (n=20) according to a randomized double-blind placebo-controlled design. The experimental group was given oral administration of Fuling Zexie Decoction,the control group was given placebo,150 mL each time,twice a day. Both groups were given healthy lifestyle(healthy eating habits and exercise mode) education. The intervention period was 16 weeks. Traditional Chinese medicine dampness syndrome scale score and the diagnostic indexes of MetS,including waist circumference (WC),systolic blood pressure (SBP),diastolic blood pressure (DBP),triglyceride (TG),high density lipoprotein cholesterol (HDL-C) and fasting blood glucose (FBG),were evaluated before and after treatment. Other metabolic indexes such as body mass index(BMI),total cholesterol(TC),low density lipoprotein cholesterol(LDL-C),homeostasis model assessment of insulin resistance(HOMA-IR),uric acid(UC),as well as inflammation related indexes including C-reactive protein (CRP),interleukin-6 (IL-6) and tumor necrosis factor(TNF-α) were also evaluated. Results A total of 33 people completed the trial,including 17 people in the experimental group and 16 people in the control group. Compared to the baseline period,FBG,BMI,LDL-C and dampness syndrome scale score in the experimental group were significantly decreased at the 8th and 16th week of intervention(P<0.05). WC was significantly decreased at the 8th week of intervention(P<0.05). CRP showed a downward trend at the 16th week of intervention(P<0.05). Moreover,SBP and IL-6 in control group decreased significantly at the 8th and 16th week of intervention(P<0.05). WC,DBP and HOMA-IR decreased significantly at the 8th week of intervention (P<0.05). There was no significant difference in other outcome indexes between the two groups at the 8th and 16th week of intervention (P>0.05). The safety indexes of all patients before and after intervention were not significantly abnormal,and no serious adverse events occurred. Conclusion This study initially shows the positive regulatory effect of Fuling Zexie Decoction combined with lifestyle on metabolism and inflammation-related indexes in people with MetS of dampness syndrome,which helps to improve the level of dampness syndrome and provides a basis for further research.
