Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2013, Vol. 11 ›› Issue (3): 175-183.doi: 10.3736/jintegrmed2013032

• Research Article • Previous Articles     Next Articles

Effects of Chinese herbal medicine Yiqi Huaju Qingli Formula in metabolic syndrome patients with microalbuminuria: a randomized placebo-controlled trial

Tian-zhan Wanga, Yu Chenb,c, Yan-ming Heb, Xiao-dong Fua, Yi Wangb, Yan-qiu Xub, Hong-jie Yangb, Hong-li Xueb, Yi Liua, Xiao-tao Fengd, Teng Zhangb,c, Wen-jian Wanga,c   

  1. a. Institute of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China
    b. Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University ofTraditional Chinese Medicine, Shanghai 200437, China
    c. Clinical Research Institute of Integrative Medicine, Shanghai University of Traditional Chinese Medicine,Shanghai 200437, China
    d. Guangxi Scientifc Experimental Center of Traditional Chinese Medicine, Guangxi University of ChineseMedicine, Nanning 530001, Guangxi Zhuang Autonomous Region, China
  • Received:2013-03-18 Accepted:2013-04-15 Online:2013-05-10 Published:2013-05-15


Microalbuminuria (MAU) is a key component of metabolic syndrome (MetS) and is an early sign of diabetic nephropathy as well. Although routine Western medicine treatments are given to MetS patients to control high blood pressure, hyperglycemia and dyslipidemia, some patients still experience progressive renal lesions and it is necessary to modify and improve the treatment strategy for MetS patients.


To investigate the efficacy of Yiqi Huaju Qingli Herb Formula, a compound traditional Chinese herbal medicine, in MetS patients with MAU when it is combined with routine Western medicine treatment.

Design, setting, participants and interventions

Sixty patients with MetS were randomized into the Chinese herbal formula group (CHF, Yiqi Huaju Qingli formula treatment in combination with Western medicine) and control group (placebo in combination with Western medicine). All treatments were administered for 12 weeks.

Main outcome measures

Urinary microalbumin (MA), urinary albumin-to-creatinine ratio (UACR), 24-hour total urine protein (24-hTP), body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2-hPPG), glycosylated hemoglobin (HbA1c), homeostasis model assessment for insulin resistance (HOMA-IR), blood lipid profile and blood pressure were observed.


Compared with the control group, CHF treatment significantly decreased BMI (P<0.05), WC (P<0.01) and WHR (P<0.01). Both groups had significant decreases in FPG, 2-hPPG, HbA1c, HOMA-IR, MA, and UACR, with CHF treatment showing better effects on these parameters compared with the control treatment (P<0.05). Both treatments significantly reduced the levels of total cholesterol, low-density lipoprotein cholesterol and triacylglycerol (TAG), and a greater reduction in TAG was observed with CHF treatment (P<0.05). The level of high-density lipoprotein cholesterol did not change in the control group after treatment (P>0.05), whereas it significantly increased with CHF treatment (P<0.01). Compared with before the treatment, significant decreases in systolic blood pressure, diastolic blood pressure and mean arterial blood pressure were observed in both groups (P<0.01). However, there was no significant difference between the two groups (P>0.05).


Combined treatment of Yiqi Huaju Qingli Formula and Western medicine significantly alleviated MAU, which may correlate with the improvement of insulin sensitivity and glucose and lipid metabolism.

Trial registration identifier

This trial was registered in the Chinese Clinical Trial Registry with the identifier ChiCTR-TRC-11001633.

Key words: Metabolic syndrome X, Microalbuminuria, Insulin resistance, Drugs, Chinese herbal, Randomized controlled trials







Figure 1

Flowchart of the patients in the trial"

[1] Alberti KG, Zimmet PZ . Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation[J]. Diabet Med, 1998,15(7):539-553
doi: 10.1002/(ISSN)1096-9136
[2] Schrijvers BF, De Vriese AS, Flyvbjerg A . From hyperglycemia to diabetic kidney disease: the role of metabolic, hemodynamic, intracellular factors and growth factors/cytokines[J]. Endocr Rev, 2004,25(6):971-1010
doi: 10.1210/er.2003-0018
[3] Khosla N, Sarafidis PA, Bakris GL . Microalbuminuria[J]. Clin Lab Med, 2006,26(3):635-653
doi: 10.1016/j.cll.2006.06.005
[4] He CY, Wang WJ, Li B, Xu DS, Chen WH, Ying J, He YM . Clinical research of Yiqi Sanju Formula in treating central obese men at high risk of metabolic syndrome[J]. J Chin Integr Med, 2007,5(3):263-267
doi: 10.3736/jcim
[5] Lou SY, Liu Y, Ma YY, Chen HY, Chen WH, Ying J, He YM, Wang WJ . Effects of Yiqi Sanju Formula on non-alcoholic fatty liver disease: a randomized controlled trial[J]. J Chin Integr Med, 2008,6(8):793-798
doi: 10.3736/jcim
[6] Wang WJ . Inspection of the relationship between disease and syndrome complex: analogous syndrome complex in the same disease[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2011,31(8):1023-1024
[7] Xue HL, Zhang Z, Wang WJ, Chen WH, Ying J . Effects of “Yiqi Zengmin Recipe” on microalbuminuria and insulin resistance of type 2 diabetic in rats[J]. Zhongguo Lao Nian Xue Za Zhi, 2011,( 31):4213-4215
[8] Joint Committee for Developing Chinese Guidelines on Prevention and Treatment of Dyslipidemia in Adults. Chinese guidelines on prevention and treatment of dyslipidemia in adults[J]. Zhonghua Xin Xue Guan Bing Za Zhi, 2007,35(5):390-419
[9] Esteghamati A, Rashidi A, Khalilzadeh O, Ashraf H, Abbasi M . Metabolic syndrome is independently associated with microalbuminuria in type 2 diabetes[J]. Acta Diabetol, 2010,47(2):125-130
doi: 10.1007/s00592-009-0131-6
[10] Klausen KP, Scharling H, Jensen G, Jensen JS . New definition of microalbuminuria in hypertensive subjects: association with incident coronary heart disease and death[J]. Hypertension, 2005,46(1):33-37
doi: 10.1161/01.HYP.0000169153.78459.50
[11] Abdul-Ghani M, Nawaf G, Nawaf F, Itzhak B, Minuchin O, Vardi P . Increased prevalence of microvascular complications in type 2 diabetes patients with the metabolic syndrome[J]. Isr Med Assoc J, 2006,8(6):378-382
[12] Parvanova AI, Trevisan R, Iliev IP, Dimitrov BD, Vedovato M, Tiengo A, Remuzzi G, Ruggenenti P . Insulin resistance and microalbuminuria: a cross-sectional, case-control study of 158 patients with type 2 diabetes and different degrees of urinary albumin excretion[J]. Diabetes, 2006,55(5):1456-1462
doi: 10.2337/db05-1484
[13] Chan JC, Tomlinson B, Nicholls MG, Swaminathan R, Cheung CK, Woo J, Cockram CS . Albuminuria, insulin resistance and dyslipidaemia in Chinese patients with non-insulin-dependent diabetes(NIDDM)[J]. Diabet Med, 1996,13(2):150-157
doi: 10.1002/(ISSN)1096-9136
[14] Mykk?nen L, Zaccaro DJ, Wagenknecht LE, Robbins DC, Gabriel M, Haffner SM . Microalbuminuria is associated with insulin resistance in nondiabetic subjects: the insulin resistance atherosclerosis study[J]. Diabetes, 1998,47(5):793-800
doi: 10.2337/diabetes.47.5.793
[15] Kurella M, Lo JC, Chertow GM . Metabolic syndrome and the risk for chronic kidney disease among nondiabetic adults[J]. J Am Soc Nephrol, 2005,16(7):2134-2140
doi: 10.1681/ASN.2005010106
[16] Adler AI, Stevens RJ, Manley SE, Bilous RW, Cull CA, Holman RR; UKPDS GROUP . Development and progression of nephropathy in type 2 diabetes: the United Kingdom Prospective Diabetes Study(UKPDS 64)[J]. Kidney Int, 2003,63(1):225-232
doi: 10.1046/j.1523-1755.2003.00712.x
[17] Lane JT . Microalbuminuria as a marker of cardiovascular and renal risk in type 2 diabetes mellitus: a temporal perspective[J]. Am J Physiol, 2004,286(3):F442-F450
[18] Hillege HL, Fidler V , Diercks GF, van Gilst WH, de Zeeuw D, van Veldhuisen DJ, Gans RO, Janssen WM, Grobbee DE, de Jong PE; Prevention of Renal and Vascular End Stage Disease (PREVEND) Study Group.Urinary albumin excretion predicts cardiovascular and noncardiovascular mortality in general population[J]. Circulation, 2002,106(14):1777-1782
[19] Wahba IM, Mak RH . Obesity and obesity-initiated metabolic syndrome: mechanistic links to chronic kidney disease[J]. Clin J Am Soc Nephrol, 2007,2(3):550-562
doi: 10.2215/CJN.04071206
[20] Hernandez AV, Usmani A, Rajamanickam A, Moheet A . Thiazolidinediones and risk of heart failure in patients with or at high risk of type 2 diabetes mellitus: a meta-analysis and meta-regression analysis of placebo-controlled randomized clinical trials[J]. Am J Cardiovasc Drugs, 2011,11(2):115-128
doi: 10.2165/11587580-000000000-00000
[21] Wang WJ . Foundation and application of aggregation syndrome theory in traditional Chinese medicine[J]. J Chin Integr Med, 2007,5(2):111-114
doi: 10.3736/jcim
[22] Wang WJ . Pay more attention to “analogous syndrome complex in the same disease and treating the same disease with analogous methods”[J]. J Chin Integr Med, 2008,6(5):441-445
doi: 10.3736/jcim
[23] Wang SH, Wang WJ, Wang XF, Chen WH . Effect of Astragalus polysaccharides and berberine on carbohydrate metabolism and cell differentiation in 3T3 L1 adipocytes[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2004,24(10):926-928
[24] Liu Y, Lou SY, He YM, Chen WH, Ying J, Wang WJ . Effects of berberine on cell proliferation, peroxisome proliferation activated receptor gamma, CAAT/enhancer binding protein mRNA and protein expression in 3T3-L1 pre-adipocytes[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2008,28(11):1005-1009
[25] He YM, Wang WJ, Chen WH, Ying J . Effects of Pollen Typhae total flavones on mRNA expressions of peroxisome proliferator-activated receptors in 3T3-L1 adipocytes[J]. J Chin Integr Med, 2008,6(9):939-941
doi: 10.3736/jcim
[26] Feng XT, Wang TZ, Leng J, Chen Y, Liu JB, Liu Y, Wang WJ . Palmitate contributes to insulin resistance through downregulation of the Src-mediated phosphorylation of Akt in C2C12 myotubes[J]. Biosci Biotechnol Biochem, 2012,76(7):1356-1361
doi: 10.1271/bbb.120107
[27] Feng XT, Wang TZ, Chen Y, Liu JB, Liu Y, Wang WJ . Pollen Typhae total flavone improves insulin-induced glucose uptake through the beta-arrestin-2-mediated signaling in C2C12 myotubes. Int J Mol Med, 2012; 30(4):914-922.
doi: 10.3892/ijmm.2012.1061
[28] Zhang Z, Xue HL, Liu Y, Wang WJ . Yi-Qi-Zeng-Min-Tang, a Chinese medicine, ameliorates insulin resistance in type 2 diabetic rats[J]. World J Gastroenterol, 2011,17(8):987-995
[1] Shu-yi Chen, Qun-wei Chen, Liu-mei Shou, Hong Pan, Shan-ming Ruan, Zhe-hao Liang, Qi-jin Shu. Stevens-Johnson syndrome/toxic epidermal necrolysis successfully treated with Chinese herbal medicine Pi-Yan-Ning: A case report. Journal of Integrative Medicine, 2021, 19(6): 555-560.
[2] Xin Yin, Shu-bin Cai, Lan-ting Tao, Lu-ming Chen, Zhong-de Zhang, Su-hong Xiao, Arthur Yin Fan, Xu Zou. Recovery of a patient with severe COVID-19 by acupuncture and Chinese herbal medicine adjuvant to standard care. Journal of Integrative Medicine, 2021, 19(5): 460-466.
[3] Qing-lan Wang, Yan-yan Tao, Hong-dong Xie, Cheng-hai Liu, Ping Liu. Fuzheng Huayu recipe, a traditional Chinese compound herbal medicine, attenuates renal interstitial fibrosis via targeting the miR-21/PTEN/AKT axis. Journal of Integrative Medicine, 2020, 18(6): 505-513.
[4] Ming-sheng Lyu, De-ying Li, Shao-zhong Zhou, Cheng-jun Ban, Jun Yan. Adult-onset Still's disease successfully treated with Chinese herbal medicine: A case report with 15-month follow-up. Journal of Integrative Medicine, 2020, 18(6): 530-534.
[5] Jafar Abolghasemi, Mohammad Ali Farboodniay Jahromi, Mohammad Hossein Sharifi, Zohreh Mazloom, Leila Hosseini, Nasrindokht Zamani, Majid Nimrouzi. Effects of Zataria oxymel on obesity, insulin resistance and lipid profile: A randomized, controlled, triple-blind trial. Journal of Integrative Medicine, 2020, 18(5): 401-408.
[6] Arthur Yin Fan, Sherman Gu, Sarah Faggert Alemi, Research Group for Evidence-based Chinese Medicine. Chinese herbal medicine for COVID-19: Current evidence with systematic review and meta-analysis. Journal of Integrative Medicine, 2020, 18(5): 385-394.
[7] Esmaeil Yousefi Rad, Behzad Nazarian, Somayeh Saboori, Ebrahim Falahi, Azita Hekmatdoost. Effects of L-arginine supplementation on glycemic profile: Evidence from a systematic review and meta-analysis of clinical trials. Journal of Integrative Medicine, 2020, 18(4): 284-291.
[8] Bin Lan, Jin-wen Ge, Shao-wu Cheng, Xi-long Zheng, Jun Liao, Chao He, Zheng-qing Rao, Guo-zuo Wang. Extract of Naotaifang, a compound Chinese herbal medicine, protects neuron ferroptosis induced by acute cerebral ischemia in rats. Journal of Integrative Medicine, 2020, 18(4): 344-350.
[9] Deng-hai Zhang, Kun-lun Wu, Xue Zhang, Sheng-qiong Deng, Bin Peng. In silico screening of Chinese herbal medicines with the potential to directly inhibit 2019 novel coronavirus. Journal of Integrative Medicine, 2020, 18(2): 152-158.
[10] Sonia Chew Wen Phang, Uma Devi Palanisamy, Khalid Abdul Kadir. Effects of geraniin (rambutan rind extract) on blood pressure and metabolic parameters in rats fed high-fat diet. Journal of Integrative Medicine, 2019, 17(2): 100-106.
[11] Mehranghiz Ebrahimi-Mameghani, Mohammad Asghari-Jafarabadi, Khatereh Rezazadeh. TCF7L2-rs7903146 polymorphism modulates the effect of artichoke leaf extract supplementation on insulin resistance in metabolic syndrome: A randomized, double-blind, placebo-controlled trial. Journal of Integrative Medicine, 2018, 16(5): 329-334.
[12] Carola Analía Torres, Cristina Marisel Pérez Zamora, María Beatriz Nuñez, Ana María Gonzalez. In vitro antioxidant, antilipoxygenase and antimicrobial activities of extracts from seven climbing plants belonging to the Bignoniaceae. Journal of Integrative Medicine, 2018, 16(4): 255-262.
[13] Shui-jie Shen, Yong-hong Zhang, Xiao-xia Gu, Shui-ju Jiang, Ling-jun Xu. Yangfei Kongliu Formula, a compound Chinese herbal medicine, combined with cisplatin, inhibits growth of lung cancer cells through transforming growth factor-β1 signaling pathway. Journal of Integrative Medicine, 2017, 15(3): 242-251.
[14] Liliana Zazueta-Beltrán, Lorena Medina-Aymerich, Nadia Estela Díaz-Triste, Aracely Evangelina Chávez-Piña, Gilberto Castañeda-Hernández, Leticia Cruz-Antonio. Evidence against the participation of a pharmacokinetic interaction in the protective effect of single-dose curcumin against gastrointestinal damage induced by indomethacin in rats. Journal of Integrative Medicine, 2017, 15(2): 151-157.
[15] Nazli Samadi, Hassan Mozaffari-Khosravi, Masoud Rahmanian, Mohsen Askarishahi. Effects of bee propolis supplementation on glycemic control, lipid profile and insulin resistance indices in patients with type 2 diabetes: A randomized, double-blind clinical trial. Journal of Integrative Medicine, 2017, 15(2): 124-134.
Full text



[1] Jin-zhou Tian, Jing Shi, Xin-qing Zhang, Qi Bi, Xin Ma, Zhi-liang Wang, Xiao-bin Li, Shu-li Shen, Lin Li, Zhen-yun Wu, Li-yan Fang, Xiao-dong Zhao, Ying-chun Miao, Peng-wen Wang, Ying Ren, Jun-xiang Yin, Yong-yan Wang, Beijing United Study Group on MCI of the Capital Foundation of Medical Developments. An explanation on "guiding principles of clinical research on mild cognitive impairment (protocol)". Journal of Chinese Integrative Medicine, 2008, 6(1): 15-21
[2] Yi-ting He, Qing-lin Zha, Jian-ping Yu, Yong Tan, Cheng Lu, Ai-ping Lv. Principal factor analysis of symptoms of rheumatoid arthritis and their correlations with efficacy of traditional Chinese medicine and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 32-36
[3] Jun Cai, Hua Wang, Sheng Zhou, Bin Wu, Hua-rong Song, Zheng-rong Xuan. Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(1): 37-40
[4] Wei Zhang, Xiang-feng Lu, Xiao-mei Zhang, Jian-jun Wu, Liang-duo Jiang. A rat model of pulmonary fibrosis induced by infusing bleomycin quickly through tracheal intubation. Journal of Chinese Integrative Medicine, 2008, 6(1): 60-67
[5] A-gao Zhou, Yong Zhang, Gang Kui, De-Yun Kong, Hai-liang Ge, Qiu-hua Ren, Jia-rong Dong, Sheng Hong, Xu-ming Mao, Yin Wang, Hui-zheng Zhang, Shu-jun Wang. Influence of traditional Chinese compound recipes with different efficacy on body weight, tumor weight and immune function in H22 cancer-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 77-82
[6] Guo-hong Yuan, Xiao-jing Pang, He-chao Ma. Synergic effects of Danggui Buxue Decoction in reducing toxicity of cytoxan in tumor-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 83-88
[7] Li Zhou, Hong-xing Zhang, Ling-guang Liu, Wen-jun Wan. Effect of electro-acupuncture at Fenglong (GV 16) on nitric oxide and endothelin in rats with hyperlipidemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 89-92
[8] Jin-zhou Tian, Jing Shi, Xin-qing Zhang, Qi Bi, Xin Ma, Zhi-liang Wang, Xiao-bin Li, Shu-li Shen, Lin Li, Zhen-yun Wu, Li-yan Fang, Xiao-dong Zhao, Ying-chun Miao, Peng-wen Wang, Ying Ren, Jun-xiang Yin, Yong-yan Wang, Beijing United Study Group on MCI of the Capital Foundation of Medical Developments. Guiding principles of clinical research on mild cognitive impairment (protocol). Journal of Chinese Integrative Medicine, 2008, 6(1): 9-14
[9] Xin-jun Wang, Ling-ling Wang . A mechanism of endogenous opioid peptides for rapid onset of acupuncture effect in treatment of depression. Journal of Chinese Integrative Medicine, 2010, 8(11): 1014-1017
[10] Bo Wang , Wei Yan , Li-hui Hou, Xiao-ke Wu. Disorder of Tiangui (kidney essence) and reproductive dysfunction in patients with polycystic ovary syndrome. Journal of Chinese Integrative Medicine, 2010, 8(11): 1018-1022