Beneficial effects of Huanglian Jiedu decoction (黄连解毒汤 ) on metabolic syndrome: a prospective randomized controlled clinical trial

doi:10.19852/j.cnki.jtcm.2026.02.013

Abstract

Abstract:

OBJECTIVE: To evaluate the clinical efficacy of Huanglian Jiedu decoction (黄连解毒汤, HLJDD) in patients with metabolic syndrome (MS) and to elucidate its potential underlying mechanisms.

METHODS: A total of 132 participants were enrolled and randomly divided into the HLJDD group and the control group. Participants in the HLJDD group received a 3-month HLJDD treatment in addition to lifestyle guidance, while the control group received only lifestyle guidance. Anthropometric indices, blood lipid profiles, liver function indices, glucose homeostasis, insulin sensitivity, inflammatory profiles, and the brown adipokine fibroblast growth factor 21 (FGF-21) were measured both at baseline and at the end of the trial.

RESULTS: The study demonstrated that administering HLJDD for three months significantly reduces the body weight [8.91% (6.03%-10.22%) vs5.58% (3.31%-8.70%), P<0.01], body mass index [8.55% (6.08%-10.16%) vs5.37% (3.27%-8.54%), P<0.01], waist circumference [9.56% (6.63%-14.41%) vs 7.43% (3.11%-11.69%), P <0.01] as well as the metabolic profiles of patients with metabolic syndrome. Additionally, it was observed that the HLJDD regimen led to lower serum levels of inflammatory cytokines IL-6 (-45.03% vs-22.90%, P < 0.01), IL-17A (-23.34% vs -9.13%, P < 0.05), TNF-α (-33.78% vs-11.02%, P < 0.01) and FGF-21 (P < 0.05) when compared to the control group.

CONCLUSION: It can be concluded that HLJDD contributes to ameliorating metabolic disorders in individuals suffering from metabolic syndrome. The data also imply that the beneficial effects of HLJDD on metabolism might be attributed to its role in enhancing FGF-21 secretion, which is otherwise compromised due to metabolic inflammation.

Key words: metabolic syndrome, fibroblast growth factors, inflammation, Huanglian Jiedu decoction

XU Pingyuan, ZHU Heng, ZHOU Ruonan, WEI Yaping, ZHU Ziwei, XU Fangyuan, XIANG Yingying, CAO Yue, SHEN Lixuan, WANG Ziwei, XUE Yingying, YU Xizhong, FANG Penghua, SHANG Wenbin. Beneficial effects of Huanglian Jiedu decoction (黄连解毒汤 ) on metabolic syndrome: a prospective randomized controlled clinical trial[J]. Journal of Traditional Chinese Medicine, 2026, 46(2): 411-417.

Figures/Tables 6

References 23.

1.	Engin A. The definition and prevalence of obesity and metabolic syndrome. Adv Exp Med Biol 2017; 960: 1-17. DOI PMID
2.	Saklayen MG. The global epidemic of the metabolic syndrome. Curr Hypertens Rep 2018; 20: 12. DOI PMID
3.	Nilsson P, Tuomilehto J, Rydén L. The metabolic syndrome-What is it and how should it be managed? Eur J Prev Cardiol 2019; 26: 33-46. DOI PMID
4.	Ge H (East Jin dynasty). Zhou Hou Bei Ji Fang. Beijing: People's Medical Publishing House, 2016: 25-48.
5.	Xu P, Zhu Z, Wei Y, Shang W. The emerging role of Huanglian Jiedu decoction in metabolic syndrome treatment. Shi Zhen Guo Yi Guo Yao 2023; 34: 938-40.
6.	Wu H, Tian J, Dai D, et al. Efficacy and safety assessment of Traditional Chinese Medicine for metabolic syndrome. BMJ Open Diabetes Res Care 2020; 8: e001181.
7.	Zhang X, Deng Y, Shi Q, He M, Chen B, Qiu X. Hypolipidemic effect of the Chinese polyherbal Huanglian Jiedu decoction in type 2 diabetic rats and its possible mechanism. Phytomedicine 2014; 21: 615-23. DOI URL
8.	Chen M, Liao Z, Lu B, et al. Huang-Lian-Jie-Du-decoction ameliorates hyperglycemia and insulin resistant in association with gut microbiota modulation. Front Microbiol 2018; 9: 2380. DOI PMID
9.	IDF Clinical Guidelines Task Force. Global guideline for type 2 diabetes: recommendations for standard, comprehensive, and minimal care. Diabet Med. 2006; 23: 579-93. DOI URL
10.	Rohm T, Meier D, Olefsky J, Donath M. Inflammation in obesity, diabetes, and related disorders. Immunity 2022; 55: 31-55. DOI PMID
11.	Kawai T, Autieri M, Scalia R. Adipose tissue inflammation and metabolic dysfunction in obesity. Am J Physiol Cell Physiol 2021; 320: C375-91. DOI URL
12.	Bianchi V. Weight loss is a critical factor to reduce inflammation. Clin Nutr ESPEN 2018; 28: 21-35. DOI PMID
13.	Hotamisligil G. Inflammation and metabolic disorders. Nature 2006; 444: 860-7. DOI
14.	Kunz H, Hart C, Gries K, et al. Adipose tissue macrophage populations and inflammation are associated with systemic inflammation and insulin resistance in obesity. Am J Physiol Endocrinol Metab 2021; 321: E105-21. DOI PMID
15.	Lin S, Zhang A, Yuan L, et al. Targeting parvalbumin promotes M2 macrophage polarization and energy expenditure in mice. Nat Commun 2022; 13: 3301. DOI PMID
16.	Locati M, Curtale G, Mantovani A. Diversity, mechanisms, and significance of macrophage plasticity. Annu Rev Pathol 2020; 15: 123-47. DOI PMID
17.	Sang W, Sang G, Zhao X. Effect of Huanglian Jiedu decoction on carotid atherosclerotic plaque and inflammatory factors in patients with coronary heart disease. Zhong Yao Cai 2014; 37: 356-8.
18.	li L, Yang W. Effect of modified Huanglian Jiedu decoction on pancreatic islet function and serum inflammatory factors in newly obese type 2 diabetes patients. Guangxi Zhong Yi Yao Da Xue Xue Bao 2013; 16: 25-7+44.
19.	Li C, Li X, Chen Y, et al. Huang-lian-jie-du-tang protects rats from cardiac damages induced by metabolic disorder by improving inflammation-mediated insulin resistance. PLoS One 2013; 8: e67530.
20.	Douris N, Stevanovic D, Fisher F, et al. Central fibroblast growth factor 21 browns white fat via sympathetic action in male mice. Endocrinology 2015; 156: 2470-81. DOI URL
21.	Geng L, Lam K, Xu A. The therapeutic potential of FGF 21 in metabolic diseases: from bench to clinic. Nat Rev Endocrinol 2020; 16: 654-67. DOI
22.	Yang M, Liu C, Jiang N, et al. Fibroblast growth factor 21 in metabolic syndrome. Front Endocrinol 2023 ;14: 1220426.
23.	Guo C, Zhao L, Li Y, Deng X, Yuan G. Relationship between FGF21 and drug or nondrug therapy of type 2 diabetes mellitus. J Cell Physiol 2021; 236: 55-67. DOI URL

Item	HLJDD group (n = 60)				Control group (n = 64)			Differences between groups
Item	Baseline	After intervention		P value	Baseline	After intervention	P value	P value
Weight (kg)	85.75 (78.25-93.88)		80.00 (72.00-82.75)^a	<0.0001	86.00 (77.30-95.00)	80.70 (72.41-88.38)^c	<0.0001	0.189
BMI (kg/m²)	31.18 (28.55-32.99)		28.01 (25.79-30.12)^ab	<0.0001	31.40 (29.40-34.10)	29.00 (27.33-31.60)^c	<0.0001	-0.009
WC (cm)	105.50 (100.00-110.75)		93.50 (88.00-98.00)^a	<0.0001	103.00 (96.50-109.75)	94.00 (88.25-99.75)^c	<0.0001	0.317

Item	HLJDD group (n = 60)				Control group (n = 64)			Differences between groups
Item	Baseline	After intervention		P value	Baseline	After intervention	P value	P value
Weight (kg)	85.75 (78.25-93.88)		80.00 (72.00-82.75)^a	<0.0001	86.00 (77.30-95.00)	80.70 (72.41-88.38)^c	<0.0001	0.189
BMI (kg/m²)	31.18 (28.55-32.99)		28.01 (25.79-30.12)^ab	<0.0001	31.40 (29.40-34.10)	29.00 (27.33-31.60)^c	<0.0001	-0.009
WC (cm)	105.50 (100.00-110.75)		93.50 (88.00-98.00)^a	<0.0001	103.00 (96.50-109.75)	94.00 (88.25-99.75)^c	<0.0001	0.317

Item	HLJDD group (n = 60)			Control group (n = 64)			Differences between groups
Item	Baseline	After intervention	P value	Baseline	After intervention	P value	P value
TC (mmol/L)	4.98±1.23	4.31±0.81^ab	<0.0001	4.80±0.76	4.69±0.75	0.245	0.02
TG (mmol/L)	2.34±0.81	1.40±0.46^a	<0.0001	1.98±0.83	1.41±0.62^c	<0.0001	NA
HDL-C (mmol/L)	1.04±0.18	1.16±0.21^a	<0.0001	1.06±0.20	1.11±0.20^c	0.048	0.137
LDL-C (mmol/L)	2.92±0.88	2.43±0.62^ab	<0.0001	2.96±0.68	2.83±0.63	0.100	<0.0001
FFA (μmol/L)	531.00±195.17	554.88±196.10	0.149	582.38±191.13	571.59±203.05	0.725	NA

Item	HLJDD group (n = 60)			Control group (n = 64)			Differences between groups
Item	Baseline	After intervention	P value	Baseline	After intervention	P value	P value
TC (mmol/L)	4.98±1.23	4.31±0.81^ab	<0.0001	4.80±0.76	4.69±0.75	0.245	0.02
TG (mmol/L)	2.34±0.81	1.40±0.46^a	<0.0001	1.98±0.83	1.41±0.62^c	<0.0001	NA
HDL-C (mmol/L)	1.04±0.18	1.16±0.21^a	<0.0001	1.06±0.20	1.11±0.20^c	0.048	0.137
LDL-C (mmol/L)	2.92±0.88	2.43±0.62^ab	<0.0001	2.96±0.68	2.83±0.63	0.100	<0.0001
FFA (μmol/L)	531.00±195.17	554.88±196.10	0.149	582.38±191.13	571.59±203.05	0.725	NA

Item	HLJDD group (n = 60)			Control group (n = 64)			Differences between groups
Item	Baseline	After intervention	P value	Baseline	After intervention	P value	P value
FBG (mmol/L)	6.05 (5.53-6.44)	5.20 (5.10-5.60)^a	<0.0001	5.28 (4.98-5.72)	5.03 (4.68-5.21)^c	<0.0001	NA
HbA1c (%)	6.10 (5.73-6.58)	5.89 (5.40-6.00)^ab	<0.0001	6.10 (5.90-6.90)	5.90 (5.70-6.50)^c	<0.0001	0.025
Insulin (μU/mL)	28.63 (15.81-34.00)	11.25 (7.23-14.85)^ab	<0.0001	24.65 (18.06-34.00)	16.18 (10.30-24.39)^c	<0.0001	<0.0001
HOMA	4.03 (2.85-6.60)	2.59 (1.84-2.97)^a	<0.0001	4.48 (2.92-6.22)	2.71 (1.68-3.74)^c	<0.0001	0.227

Home

Online First

Author Center

Reviewer Center

Issues

Announcement

About Us