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Journal of Chinese Integrative Medicine ›› 2013, Vol. 11 ›› Issue (3): 184-194.doi: 10.3736/jintegrmed2013031

• Research Article • Previous Articles     Next Articles

Effects of Chinese herbal medicine Yiqi Huaju Formula on hypertensive patients with metabolic syndrome: A randomized, placebo-controlled trial

Yi Chena, De-yu Fub, Yu Chenb,c, Yan-ming Heb, Xiao-dong Fua, Yan-qiu Xub, Yi Liua, Xiao-tao Fenga, 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
  • Received:2013-03-20 Accepted:2013-04-23 Online:2013-05-10 Published:2013-05-15


Patients with hypertension coupled with metabolic syndrome (MetS) are among the high risk population in cardiovascular and cerebrovascular diseases. To reduce the prevalence of cardiovascular and cerebrovascular diseases, it is essential to appropriately control blood pressure together with other cardiovascular risk factors.


The current study was designed to investigate the therapeutic effects on blood pressure, blood pressure variability and other cardiovascular risk factors by giving Yiqi Huaju Formula, a compound traditional Chinese herbal medicine, in addition to routine treatment to hypertensive patients coupled with MetS.

Design, setting, participants and interventions

A total of 43 patients with hypertension coupled with MetS were recruited into this study. The enrolled patients were randomly divided into the Chinese herbal formula group (anti-hypertensive drugs plus Yiqi Huaju Formula, CHF) and the control group (anti-hypertensive drugs plus placebo). The CHF group enrolled 22 patients while the control group received 21 cases. Treatments were given for 12 weeks in both groups.

Main outcome measures

Parameters examined include 24-hour ambulatory blood pressure monitoring, body mass index, waist circumference, waist-to-hip ratio, homeostatic model assessment for insulin resistance (HOMA-IR), fasting glycosylated hemoglobin (HbA1c), fasting plasma glucose, 2-hour postprandial plasma glucose (PPG), fasting plasma insulin, serum lipid, etc.


Compared with the control group, the CHF group had significant improvement (P<0.01) in anthropometric parameters, FPG, HOMA-IR, blood pressure amplitude, blood pressure variability and blood pressure load.


This study showed that integrated traditional Chinese and Western medicine treatment can achieve better results in controlling blood pressure as well as other cardiovascular risk factors. The mechanism of controlling of blood pressure may be associated with the improvement of insulin sensitivity due to the Yiqi Huaju intervention.

Trial registration identifier


Key words: Metabolic syndrome, Hypertension, Ambulatory blood pressure monitoring, Blood pressure variability, Drugs, Chinese herbal, Therapies, Investigational


Figure 1

Flow chart of this trial24-h ABPM: 24-hour ambulatory blood pressure monitoring; MetS: metabolic syndrome."







[1] Scholze J, Alegria E, Ferri C, Langham S, Stevens W, Jeffries D, Uhl-Hochgraeber K . Epidemiological and economic burden of metabolic syndrome and its consequences in patients with hypertension in Germany, Spain and Italy; a prevalence-based model[J]. BMC Public Health, 2010,10:529
doi: 10.1186/1471-2458-10-529
[2] Andreadis EA, Tsourous GI, Tzavara CK, Georgiopoulos DX, Katsanou PM, Marakomichelakis GE, Diamantopoulos EJ . Metabolic syndrome and incident cardiovascular morbidity and mortality in a Mediterranean hypertensive population[J]. Am J Hypertens, 2007,20(5):558-564
doi: 10.1016/j.amjhyper.2006.12.001
[3] Schillaci G, Pirro M, Vaudo G, Gemelli F, Marchesi S, Porcellati C, Mannarino E . Prognostic value of the metabolic syndrome in essential hypertension[J]. J Am Coll Cardiol, 2004,43(10):1817-1822
doi: 10.1016/j.jacc.2003.12.049
[4] Obesity in Asia Collaboration . Is central obesity a better discriminator of the risk of hypertension than body mass index in ethnically diverse populations?[J] Hypertens. 2008; 26(2):169-177.
doi: 10.1097/HJH.0b013e3282f16ad3
[5] 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
[6] 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
[7] Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial Collaborative Research Group. Diuretic versus alpha-blocker as first-step antihypertensive therapy: final results from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial(ALLHAT)[J]. Hypertension, 2003,42(3):239-246
doi: 10.1161/01.HYP.0000086521.95630.5A
[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] Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure[J]. Hypertension, 2003,42(6):1206-1252
doi: 10.1161/01.HYP.0000107251.49515.c2
[10] Bianchi C, Penno G, Daniele G, Benzi L, Del Prato S, Miccoli R . Optimizing management of metabolic syndrome to reduce risk: focus on life-style[J]. Intern Emerg Med, 2008,3(2):87-98
doi: 10.1007/s11739-008-0122-6
[11] Zhang X, Sun Z, Zhang X, Zheng L, Li J, Liu S, Xu C, Li J, Zhao F, Hu D, Sun Y . Prevalence of metabolic syndrome in Han and Mongolian rural population with hypertension[J]. J Int Med Res, 2007,35(5):597-599
doi: 10.1177/147323000703500503
[12] Cheung BM, Wat NM, Man YB, Tam S, Cheng CH, Leung GM, Woo J, Janus ED, Lau CP, Lam TH, Lam KS . Relationship between the metabolic syndrome and the development of hypertension in the Hong Kong Cardiovascular Risk Factor Prevalence Study-2(CRISPS2)[J]. Am J Hypertens, 2008,21(1):17-22
doi: 10.1038/ajh.2007.19
[13] Ho JS, Cannaday JJ, Barlow CE, Mitchell TL, Cooper KH , FitzGerald SJ.Relation of the number of metabolic syndrome risk factors with all-cause and cardiovascular mortality[J]. Am J Cardiol, 2008,102(6):689-692
doi: 10.1016/j.amjcard.2008.05.010
[14] Ong KL, Cheung BM, Man YB, Lau CP, Lam KS . Prevalence, awareness, treatment, and control of hypertension among United States adults 1999-2004[J]. Hypertension, 2007,49(1):69-75
doi: 10.1161/01.HYP.0000252676.46043.18
[15] Li W, Lu WL, Wang Y, Li YL, Sun YM, Huang GW, Wang Z, Wang JH . Association between blood pressure control and risk factor in community hypertensive patients[J]. Zhongguo Gong Gong Wei Sheng, 2012,28(2):154-156
[16] Wang WJ, Liu Y . Differentiation on “spleen-deficiency resulting in obstacle of transport” and “spleen-deficiency resulting in obstacle of transformation”[J]. Shanghai Zhong Yi Yao Da Xue Xue Bao, 2013,27(1):8-10
[17] Liu Y, Wang WJ, Chen WH, Yin J . Effects of Astragalus polysaccharides on proliferation and differentiation of 3T3-L1 preadipocytes[J]. J Chin Integr Med, 2007,5(4):421-426
[18] 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
[19] Liu Y, Lou SY, He YM . 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
[20] Rothwell PM, Howard SC, Dolan E , O’Brien E, Dobson JE, Dahl?f B, Sever PS, Poulter NR.Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension[J]. Lancet, 2010,375(9718):895-905
doi: 10.1016/S0140-6736(10)60308-X
[21] Tatasciore A, Renda G, Zimarino M, Soccio M, Bilo G, Parati G, Schillaci G, De Caterina R . Awake systolic blood pressure variability correlates with target-organ damage in hypertensive subjects[J]. Hypertension, 2007,50(2):325-332
doi: 10.1161/HYPERTENSIONAHA.107.090084
[22] Parati G, Pomidossi G, Albini F, Malaspina D, Mancia G . Relationship of 24-hour blood pressure mean and variability to severity of target-organ damage in hypertension[J]. J Hypertens, 1987,5(1):93-98
doi: 10.1097/00004872-198702000-00013
[23] Ievleva GI, Teslia EF, Biktimirova DM, Kiklevich AV, Erdakova TK . Parameters of 24-hour arterial pressure in patients with metabolic syndrome[J]. Klin Med (Mosk), 2009,87(6):15-18
[24] Dahl?f B, Sever PS, Poulter NR, Wedel H, Beevers DG, Caulfield M, Collins R, Kjeldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O’Brien E, Ostergren J; ASCOT Investigators . Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm(ASCOT-BPLA): a multicentre randomised controlled trial[J]. Lancet, 2005,366(9489):895-906
doi: 10.1016/S0140-6736(05)67185-1
[25] Aalbers J . Reduced blood pressure variability in ASCOT-BPLA trial favours use of amlodipine/perindopril combination to reduce stroke risk[J]. Cardiovasc J Afr, 2010,21(2):115
[26] Webb AJ, Fischer U, Mehta Z, Rothwell PM . Effects of antihypertensive-drug class on interindividual variation in blood pressure and risk of stroke: a systematic review and meta-analysis[J]. Lancet, 2010,375(9718):906-915
doi: 10.1016/S0140-6736(10)60235-8
[27] Clement DL, De Buyzere M, Duprez DD . Influence of drugs on blood pressure variability[J]. J Hypertens Suppl, 1994,12(8):S49-S53
[28] Mancia G, Casadel R, Mutti E, Trazzi S, Parati G . Ambulatory blood pressure monitoring in the evaluation of antihypertensive treatment. Am[J] Med. 1989; 87(6B):64S-69S.
doi: 10.1016/S0002-9343(89)80933-7
[29] Mulè G, Nardi E, Andronico G, Cottone S, Raspanti F, Piazza G, Volpe V, Ferrara D, Cerasola G. Relationships between 24 h blood pressure load and target organ damage in patients with mild-to-moderate essential hypertension[J].Blood Press Monit, 2001,6(3):115-123
[30] Falqui V, Viazzi F, Leoncini G, Ratto E, Parodi A, Conti N, Tomolillo C, Deferrari G, Pontremoli R . Blood pressure load, vascular permeability and target organ damage in primary hypertension[J]. J Nephrol, 2007,20(Suppl 12):S63-S67
[31] Mancia G, Di Rienzo M, Parati G . Ambulatory blood pressure monitoring use in hypertension research and clinical practice[J]. Hypertension, 1993,21(4):510-524
doi: 10.1161/01.HYP.21.4.510
[32] Chen Y, Wang WJ . Relationships between insulin resistant and hypertension and traditional Chinese medicine intervention[J]. J Chin Integr Med, 2010,8(12):1114-1118
doi: 10.3736/jcim201012
[33] Miura Y, Matsui H . Triphenyltin impairs a protein kinase A(PKA)-dependent increase of cytosolic Na+ and Ca2+ and PKA-independent increase of cytosolic Ca2+ associated with insulin secretion in hamster pancreatic beta-cells[J]. Toxicol Appl Pharmacol, 2006,216(3):363-372
doi: 10.1016/j.taap.2006.05.017
[34] Sievers C, Schneider HJ, Stalla GK . Insulin-like growth factor-1 in plasma and brain: regulation in health and disease[J]. Front Biosci, 2008,13:85-99
doi: 10.2741/2662
[35] Usukura M, Zhu A, Yoneda T, Karashima S, Yagi K, Yamagishi M, Takeda Y . Effects of a high-salt diet on adipocyte glucocorticoid receptor and 11-beta hydroxysteroid dehydrogenase 1 in salt-sensitive hypertensive rats[J]. Steroids, 2009,74(12):978-982
doi: 10.1016/j.steroids.2009.07.006
[36] Wang XL, Zhang L, Youker K, Zhang MX, Wang J , LeMaire SA, Coselli JS, Shen YH.Free fatty acids inhibit insulin signaling-stimulated endothelial nitric oxide synthase activation through upregulating PTEN or inhibiting Akt kinase[J]. Diabetes, 2006,55(8):2301-2310
doi: 10.2337/db05-1574
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