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Table 2 Characteristics of the included studies

From: Efficacy of Chinese herbal medicine for stroke modifiable risk factors: a systematic review

Author
Country Study period
Stroke risk factor Participants Intervention groups Results Side effects Limitations
Treatment group(s) Control group(s)
Lin et al. [18] China Sep 2001–Sep 2002 (Primary) Hypertension Sample size n = 102
CHM group n = 52; 41 males and 11 females; mean age: 55 years
Control group n = 50; 41 males and 9 females; mean age: 54 years
Inclusion criteria SBP: 140–179 mmHg or DBP: 90–109 mmHg; TCM diagnosed for hyperactivity of the liver-yang syndrome
Tianma gouteng decoction 150 ml/time, twice daily, 4 weeks
Formulas Tianma, Niuxi, Sangjisheng, Yimucao, Yejiaoteng, Huangqi, et al.
Nitrendipine 10 mg/time, 3 times daily, 4 weeks Baseline balance Yes
Significantly decreased SBP and DBP of both CHM and control groups before and after treatment, without significant difference between these two groups after treatment
No side effects N/A
Li [19] China No information on study period (Primary) Hypertension Sample size n = 72
CHM group n = 46; 18 males and 28 females; mean age: 54 years
Control group: n = 26; 11 males and 15 females; mean age: 53 years
Both groups have cases with coronary heart disease, hyperlipemia, and diabetes
Inclusion criteria SBP: 140–179 mmHg or DBP: 90–109 mmHg; TCM diagnosed for flaming-up of the liver-fire syndrome
During the intervention, no other drugs Baseline balance Yes
An effective rate (return to the normal range of BP or ≥20 mmHg but not in the normal range) at 60.9% of hypertension in the CHM group and 15.4% in the control group; Significantly decreased cholesterol, TG, blood sugar of the CHM group before and after treatment, without significant difference compared to the control group after treatment
CHM group: Vomiting and distension (n = 1); Slight abdominal pain and diarrhea (n = 3) N/A
Huanglian fire-purging mixture 30 ml/time, twice daily, 4 weeks
Formulas Huanglian, Gouteng, Zexie, Luhui
Niuhuang Bolus 1–2 bolus/time, 2–3 times daily, 4 weeks
Ye et al. [20] China Feb 2004–Dec 2004 (Primary) Hypertension Sample size n = 55
CHM group n = 28
Control group n = 27
Inclusion criteria SBP: 140–179 mmHg or DBP: 90–109 mmHg; normal LDL-C level; currently no antihypertensive medications or using antihypertensive medications for at least 6 months before screening
Xuezhikang with Nifedipine (20 mg/time, twice daily) 1200 mg daily, 72 weeks
Formulas Red yeast rice
Placebo with Nifedipine (20 mg/time, twice daily) 1200 mg daily, 72 weeks Baseline balance Yes
No significant differences in BP between the CHM and placebo groups after treatment; 92.8% of the CHM group and 88.9% of the placebo group reached the target BP (<140/90 mmHg)
N/A N/A
Zhao et al. [21] China No information on study period (Primary) Hypertension Sample size n = 79
CHM group n = 40; 17 males and 23 females; mean age: 52 years
Control group n = 39; 18 males and 21 females; mean age: 52 years
Inclusion criteria SBP: 140–159 mmHg or DBP: 90–99 mmHg; no antihypertensive drugs or stopped taking antihypertensive drugs for 2 weeks; TCM diagnosed for stagnation of phlegm, blood stasis and hyperactivity of the liver-yang syndrome; age: 40–60 years
Yinian Jiangya Yin 100 ml/time, twice daily, 15 days
Formulas Gouteng, Shijueming, Yimucao, Guijia, Banxia, Zhike, et al.
Tianma Gouteng Yin 100 ml/time, twice daily, 15 days
Formulas Tianma, Gouteng, Huangqin, Yejiaoteng, Fushen, Duzhong, et al.
Baseline balance Yes
Significantly decreased SBP and DBP of both CHM and control groups before and after treatment; Significantly decreased SBP and DBP in the CHM group than those in the control group after treatment; The total effective rate at 95.0% of BP control in the CHM group, while 87.2% in the control group
No side effects N/A
Zhong et al. [22] China Jan 2006–Dec 2008 (Primary) Hypertension Sample size n = 57
CHM group n = 31
Control group n = 26
Inclusion criteria SBP: 140–179 mmHg or DBP: 90–109 mmHg; daytime BP > 135/85 mmHg or nighttime BP > 120/70 mmHg; age: 18 years and older
During the intervention, no antiplatelet or lipid-lowering drugs and other Chinese patent medicines Baseline balance Yes
Significantly decreased SBP and DBP in both CHM and control groups before and after treatment, without significant difference between these two groups after treatment
N/A N/A
Jiangya capsule with Nimodipine simulation (1 capsule simulation/time, 3 times daily) 4 capsules/time, 3 times daily, 4 weeks
Formulas Dilong, Nuxi, Haizao, Tianma, Chuanxiong
Control group 1: Integrative medicine 4 Jiangya capsule with 1 nimodipine capsule 3 times daily, 4 weeks
Control group 2: Western medicine 4 Jiangya capsule simulation with 1 nimodipine capsule 3 times daily, 4 weeks
Yang et al. [23] Taiwan Sept 2008–Aug 2009 (Uncontrolled primary) Hypertension Sample size n = 55
CHM group n = 30
Control group n = 25
Inclusion criteria sitting SBP ≥ 140 mmHg or sitting DBP ≥ 90mHg despite the conventional antihypertensive treatment; TCM diagnosed for hyperactivity of the liver-yang syndrome; age: 18–80 years
Fufang Danshen capsule 1000 mg/time, twice daily, 12 weeks
Formulas Gegen, Juhua, Danshen, Hongjingtian
Placebo 12 weeks Baseline balance Yes
BP control rate (SBP < 140 mmHg and DBP < 90 mmHg) at 25.5% in the CHM group and 7.3% in the placebo group; More significant decrease of SBP in the CHM group than that of the placebo group after treatment
Mild side effects (e.g. diarrhea, fatigue, common cold) (CHM: n = 13; Control: n = 15) Small sample size; Short study period
Tong et al. [24] China Mar 2010–Sep 2010 (Mild to moderate) Hypertension Sample size n = 219
CHM group n = 106; 61 males and 45 females; mean age: 52 years
Control group n = 113; 62 males and 51 females; mean age: 52 years
Inclusion criteria SBP: 140–180 mmHg or DBP: 90–110 mmHg; age: 18–65 years; WC ≥ 85 cm (male)/80 cm (female); plus one of the following: (1) TG ≥ 1.7 mmol/l or have received antidyslipidemia treatment; (2) HDL-C < 0.9 mmol/l (male)/1.1 mmol/l (female), or have received the related treatment; (3) FPG ≥ 5.6 mmol/l, diagnosed Type 2 diabetes, or have received glycemiccontrol treatment; (4) TCM diagnosed for liver and stomach damp-heat syndrome
Jiangzhuoqinggan 170 ml/time, twice daily, 4 weeks
Formulas Huanglian, Huangbai, Gouteng, Yinyanghuo
Irbesartan 150 mg/time, once daily, 4 weeks Baseline balance Yes
Significantly decreased BP in both CHM and control groups before and after treatment, without significant difference between these two groups after treatment; More significant decrease of daytime and nighttime SBP and DBP in the CHM group than those in the control group after treatment; Significantly decreased WC in the CHM group before and after treatment
N/A Short study period; No placebo group; Small sample size
Wu et al. [25] China Jan 2010–May 2012 (Primary) Hypertension Sample size n = 137
CHM group 1 n = 45; 31 males and 14 females; mean age: 50 years
CHM group 2 n = 47; 33 males and 14 females; mean age: 48 years
Control group n = 45; 29 males and 16 females; mean age: 48 years
Inclusion criteria diagnosed primary hypertension for at least 3 months prior to screening; age: 18–75 years; 24 h MBP ≥ 130/80 mmHg, MBP ≥ 135/85 mmHg during waking hours, or MBP ≥ 120/70 mmHg during sleeping hours; or SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg
CHM group 1: Bushen Qinggan granule with amlodipine (5 mg/time, twice daily) Twice daily, 8 weeks
CHM group 2: Bushen Qinggan decoction with amlodipine (5 mg/time, twice daily) Twice daily, 8 weeks
Formulas Tianma, Gouteng, Duzhong, Huangqin, Kudingcha
Placebo with amlodipine (5 mg/time, twice daily) Twice daily, 8 weeks Baseline balance Yes
Significantly decreased BP in all three groups before and after treatment; Significant decrease in the daytime SBP in the CHM group 2 than that in the other two groups after treatment; More significant decrease of BP variability in the two CHM groups than those in the placebo group, without significant difference between these two CHM groups after treatment
N/A N/A
Li et al. [26] China Jun 2007–Jan 2008 (Isolated systolic) Hypertension Sample size n = 241; 98 males and 143 females; mean age: 67 years
CHM group n = 80
Control group 1 n = 76
Control group 2 n = 85
Inclusion criteria diagnosed hypertension; after 1-week elution period, sitting SBP: 140–180 mmHg and sitting DBP < 90 mmHg; age: 60–80 years
During the intervention, no other antihypertensive drugs Baseline balance Yes
Significantly decreased SBP in all three groups before and after treatment; More significant decrease of SBP in the control group 1 than that in the CHM group and control group 2, without significant difference between the CHM group and control group 2 after treatment
Stomach discomfort (CHM: n = 2; Control 2: n = 2); Facial flush and dizziness (Control 2: n = 1) N/A
Jiangya capsule with Nimodipine simulation (1 capsule simulation/time, 3 times daily) 4 capsules/time, 3 times daily, 4 weeks
Formulas Dilong, Nuxi, Haizao, Tianma, Chuanxiong
Control group 1: Integrative medicine 4 Jiangya capsule with 1 nimodipine capsule 3 times daily, 4 weeks
Control group 2: Western medicine 4 Jiangya capsule simulation with 1 nimodipine capsule 3 times daily, 4 weeks
Chen et al. [27] China 2006–2010 (Polarized) Hypertension Sample size n = 125
CHM group n = 66
Control group n = 59
Inclusion criteria SBP > 140 mmHg and DBP < 70 mmHg; age: 60 years and older
Diet, exercise, smoking/alcohol advices were provided; no other Western medicine affecting BP Baseline balance Yes
Significantly decreased SBP and pulse pressure in the CHM group before and after treatment; Significantly decreased SBP in the control group before and after treatment; No significant difference of DBP between the two CHM capsule groups after treatment
Dizziness and weakness (CHM: n = 5; Control: n = 4); Pretibial edema (CHM: n = 4; Control: n = 4); Facial flushing and headache (CHM: n = 4; Control: n = 4); Severe side effects (Control: n = 21) N/A
Shiyiwei Shenqi capsule or Dengzhan Shengmai capsule with Amlodipine Besylate tablets and Irbesartan tablets 3-5 capsules/time, 2–3 times daily, 6 weeks
Formulas Shiyiwei Shenqi capsule-Danggui, Xixin, Gouqi, Huangqi, Juemingzi, Lurong, et al.
Dengzhan Shengmai capsule-Wuweizie, Xixin, Ginseng, Maidong
Amlodipine Besylate tablets and Irbesartan tablets 5 mg/time, once or twice daily, 6 weeks
Gong et al. [28] China Apr 2007–Apr 2009 Hypertension with cardiac damage Sample size n = 90
CHM group n = 32; 19 males and 13 females; mean age: 59 years
Control group 1 n = 30; 18 males and 12 females; mean age: 56 years
Control group 2 n = 28; 15 males and 13 females; mean age: 59 years
Inclusion criteria SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg
Co-administered medications: aspirin, β-blockers, calcium antagonists, diuretics Baseline balance Yes
Significantly decreased SBP, DBP in all three groups before and after treatment; More significant decrease of SBP, DBP, TO, LVMI in the CHM group and control group 1 than those in the control group 2 after treatment
Nausea and gastric discomfort (CHM: n = 3; Control 1:n = 1; Control 2: n = 2); Skin rash (Control 1: n = 1) N/A
Xuezhikang capsule with Valsartan (80 mg/time, once daily) 600 mg/time, twice daily, 24 months
Formulas Red yeast rice
Control group 1: Valsartan 80 mg/time, once daily, 24 months
Control group 2: No intervention
Xu et al. [29] China Jan 2006–Apr 2006 Hypertension, hypertension with diabetes, hypertension with coronary heart disease Sample size n = 108
CHM group n = 55
Control group n = 53
Both groups have cases with diabetes and cases with coronary heart disease
Inclusion criteria SBP > 140 mmHg or DBP > 90 mmHg; age: 40–80 years
Qian Yang He Ji with antihypertensive angiotensin II receptor blocker therapy 35 ml/time, twice daily, 6 months
Formulas Gouteng, Shengdihuang, Jili, Nvzhenzi
Antihypertensive angiotensin II receptor blocker No information of usage Baseline balance Yes
Significantly decreased SBP, DBP, pulse pressure, cardioankle vascular index of both CHM and control groups before and after treatment; More significant decrease of SBP, DBP, cardioankle vascular index in the CHM group than those in the control group after treatment
CHM group: serious side effects (n = 5) N/A
Chao et al. [30] China Sep 2006–Nov 2007 Type 2 diabetes Sample size n = 43; age range: 18–70
Inclusion criteria newly diagnosed Type 2 diabetes; FPG ≥ 7 mmol/l and/or OGTT 2hPG ≥ 11.1 mmol/l; BMI: 23–35 kg/m2 with poor glucose level after a 1-month diet control (i.e., FPG: 7–10 mmol/l); no antidiabetic drugs before
Diet and exercise advices were provided. During the intervention, no antidiabetic medications Baseline balance Yes
Significantly decreased FPG, PPG, HbA1c, BMI in the CHM group before and after treatment, without significant difference between these two groups after treatment
Moderate constipation (CHM: n = 2; Placebo: n = 2) N/A
CHM compound 3 times daily, 3 months
Formulas Huanglian, Huangqi, Rendongteng
Placebo 3 times daily, 3 months
Ji et al. [31] China Dec 2007–Oct 2008 Type 2 diabetes Sample size n = 627
(1) Drug naïve group; mean age: 54 years
CHM group n = 153
Control group n = 150
(2) Metformin group; mean age: 55 years
CHM group n = 164
Control group n = 160
Inclusion criteria diagnosed Type 2 diabetes; age: 21–70 years; BMI: 18–28 or 18–35 kg/m2 using metformin at 750 mg/day (or more) for at least 3 months before screening; stable body weight within at least 3 months before screening; FPG: 7.0–13.0 mmol/l and HbA1c >7%
Diet and exercise advices were provided Baseline balance Yes
In drug naı¨ve group: Significant 38% lower any hypoglycemia rate and 41% lower mild hypoglycemic episode in the CHM group than those in the control group after treatment; In Metformin group: Significant 24% lower hypoglycemia rate in the CHM group than that in the control group, without significant difference between these two groups in the mild hypoglycemic episode after treatment; In both drug naı¨ve group and Metformin groups, no significant difference of the rate of reducing HbA1c <6.5% between the CHM and control groups
Urinary tract infection; Upper respiratory tract infection; Elevated ALT/AST; Dyslipidemia N/A
Drug naïve group
Xiaoke pill 5–30 pills daily (according to FPG level), 48 weeks
Formulas N/A
Glibenclamide 1.25–7.5 mg daily (according to FPG level), 48 weeks
Metformin group:
Xiaoke pill with Metformin (250 mg/tablet) 5 tablets daily, 48 weeks
Formulas N/A
Glibenclamide with Metformin
1.25 mg daily, 48 weeks
Tong et al. [32] China May 2009–Dec 2009 Type 2 diabetes Sample size n = 480
CHM group n = 360
Control group n = 120
Inclusion criteria early diabetic status; BMI ≥ 24 kg/m2; HbA1c ≥ 7.0%; FPG: 7.0–13.9 mmol/l or 2hPG > 11.1 mmol/l; age: 35–65 years
During the intervention, antihyperlipidemia or antihypertensive drugs remain stable Baseline balance statistically different in HbA1c and 2hPG between groups
Significantly decreased HbAlc, FPG, 2hPG and increased HOMA-β in both CHM and placebo groups before and after treatment; Significant higher proportion of the HbA1c reversed to normal (HbA1c ≤ 6.5%) in the CHM group (47.6%) than that in the placebo group (35.5%) after treatment; More significant decrease of HbAlc, FPG, 2hPG, body weight, BMI, WC and increase of HOMA-β in the CHM group than those in the placebo group after treatment
Mild side effects (CHM: n = 24; Placebo: n = 7); Transient slight ALT elevation (CHM: n = 2); Transient slight AST elevation (CHM: n = 2) Short study period; No follow-up
Tang-Min-Ling-Wan 6 g/time, 3 times daily, 12 weeks
Formulas Huangqin, Huanglian, Baishao, Chenpi, Dahuang
Placebo 6 g/time, 3 times daily, 12 weeks
Tu et al. [33] China No information on study period Type 2 diabetes Sample size n = 80
CHM group n = 41
Control group n = 39
Inclusion criteria diagnosed Type 2 diabetes; FPG: 7.0–13.3 mmol/l or 2hPG: 11.1–22.9 mmol/l; age: 18–70 years; normal renal function
Diet and exercise advices were provided Baseline balance statistically different in gender between groups
No significant difference of FPG, PPG, HbA1c between the CHM and control groups after treatment
Side effects (CHM: n = 1) Short study period; Not double blind trial
Wumei Wan 3 packages daily, 12 weeks
Formulas Huanglian, Huangbai, Ganjiang, Ginseng, Danggui, Huajiao, et al.
Metformin 500 mg/time, twice daily, 12 weeks
Wu and Fan [34] China Oct 2012–Jan 2013 Type 2 diabetes Sample size n = 152
CHM group n = 76; 48 males and 28 females; age: 48–66 years
Control group n = 76; 35 males and 41 females; age: 47–68 years
Inclusion criteria diabetes symptoms and any plasma glucose ≥ 11.1 mmol/l; FPG ≥ 7.0 mmol/l; 2hPG ≥ 11.1 mmol/l during OGTT
Self-proposed Chinese herbal medicines with insulin 1 dose daily, 2 weeks
Formulas Guijianyu, Zhimu, Gegen, Jineijin, Zexie, Ginseng, et al.
Insulin injection Novolin 30R before breakfast and lunch, 2 weeks Baseline balance Yes
Significant more 20% decrease of insulin use in the CHM group than that in the control group after treatment; Significant less treatment days and frequency of hypoglycaemia in the CHM group than those in the control group after treatment
N/A N/A
Cai et al. [35] China No information on study period Type 2 diabetes Sample size n = 67
CHM group n = 37
Control group n = 30
Inclusion criteria diabetes course < 5 years, fasting serum glucose > 7.0 mmol/l and/or 11.1 mmol/l after meal
Diet and exercise advices were provided Baseline balance Yes
Significantly decreased serum glucose and increased insulinogenic index in the CHM group before and after treatment; Significantly increased HDL in the CHM group than that in the placebo group after treatment
No side effects Small sample size; Short follow-up
Lycium barbarum Poly-saccharide capsule 300 mg/day, twice daily, 3 months
Formulas Gouqi
Placebo 300 mg/day body weight, twice daily, 3 months
Lian et al. [36] China Apr 2013–Oct 2013 Type 2 diabetes Sample size n = 186
CHM group n = 92
Control group n = 94
Inclusion criteria diagnosed type 2 diabetes; standard diet control and exercise therapy; taking metformin in a steady dose for over 3 months; HbA1c ≥ 7.0%; FPG: 7.0–13.9 mmol/l or 2hPG ≥ 11.1 mmol/l; BMI: 18–40 kg/m2; age: 18–70 years
Diet and exercise advices were provided Baseline balance Yes
Significantly decreased HbA1c and increased HOMA-β in the CHM group before and after treatment; More significant decrease of HbA1c, FPG, 2hPG in the CHM group than those in the placebo group after treatment
N/A Short study period; Small sample size
Jinlida with metformin (1500 mg/kg/day) 1 granule/time, 3 times daily, 12 weeks
Formulas Shuweicao, Yinyanghuo, Ginseng, Huangjing, Cangzhu, Kushen, et al.
Placebo with metformin (1500 mg/kg/day) 1 granule/time, 3 times daily, 12 weeks
Zhang et al. [37] China Jan 2011–Dec 2013 Type 2 diabetes Sample size n = 219; 112 males and 107 females; age: 38–74 years
CHM group n = 109
Control group n = 110
Inclusion criteria diagnosed type 2 diabetes treated with insulin alone; FPG ≥ 7.0 mmol/l or 2hPG ≥ 11.1 mmol/l; age: 18 years and older; standard food containing100 g of carbohydrate during intervention
Shen-Qi-Formula with insulin injection (300 IU, twice daily before breakfast and dinner) 100 ml/time, 3 times daily, 12 weeks
Formulas Shengdihuang, Huangqi, Zhidahuang, Ginseng, Shanzhuyu, Shuweicao, et al.
Insulin injection 300 IU, twice daily before breakfast and dinner, 12 weeks Baseline balance: Yes
Significantly decreased FPG, HbA1c in both CHM and control groups before and after treatment; Significantly decreased HOMA-IR and insulin usage level in the CHM group, while significantly increased insulin usage level in the control group, before and after treatment after treatment; More significant decrease of FPG, PPG, HbA1c in the CHM group than those in the control group after treatment
Transient hypoglycemia (Control: n = 1) N/A
Hu et al. [38] China No information on study period Type 2 diabetes Sample size n = 112
CHM group n = 59
Control group n = 53
Inclusion criteria newly diagnosed type 2 diabetes (illness course ≤5 years); only taking metformin for treatment; age: 18–75 years; HbA1c: 6.5–9.0% despite taking two 500 mg metformin tablets daily
Diet and exercise advices were provided Baseline balance Yes
Significantly decreased FPG, HbA1c in both CHM and placebo groups before and after treatment; More significant decrease of FPG, HbA1c in the CHM group than those in the placebo group after treatment
No side effects Small sample size; No group without lifestyle intervention; Almost 25% participants lost from both groups
Jianyutangkang tablet with Metformin (1.5 g/time, 3 times daily) 3 tablets/time, 3 times daily, 26 weeks
Formulas Ciwujia, Zhimu, Guijianyu
Placebo with Metformin 1.5 g/time, 3 times daily, 26 weeks
Li et al. [39] China Jun 2014–Dec 2014 Type 2 diabetes Sample size n = 38
CHM group n = 23
Control group n = 15
Inclusion criteria diagnosed Type 2 diabetes; not on a regimen of antidiabetic medical treatment at least 3 months before screening, or on a regimen of antidiabetic treatment no more than 3 months at any time in the past, or on a stable regimen of metformin monotherapy for at least 8 weeks; age:18–70 years; HbA1c: 7.0–10.0%; FPG ≤ 13 mmol/l; BMI: 19–30 kg/m2
During the intervention, metformin remains stable Baseline balance Yes
Significantly decreased 1 h and 2 h PPG, HbA1c in the CHM group before and after treatment without significant difference between these two groups after treatment; No significant difference of FPG between the CHM and control groups after treatment
Gastrointestinal side effects (lower in the CHM group than control group)
Slightly higher liver and kidney function indices in the CHM group than those in the control group
Short study period; Small sample size; Missing data of BMI in follow-up period
Mulberry twig alkaloid tablet with Acarbose placebo (50 mg/time, 3 times daily) 50 mg-100 mg/time, 3 times daily, 24 weeks
Formulas Sangzhi
Placebo with Acarbose (50–100 mg/time, 3 times daily) 50 mg/time, 3 times daily, 24 weeks
Wang et al. [40] China No information on study period Hyperlipidemia Sample size n = 446
CHM group n = 324; 188 males and 136 females; mean age: 56 years
Control group n = 122; 73 males and 49 females; mean age: 56 years
Inclusion criteria serum TC ≥ 5.95 mmol/l, LDL-C ≥ 3.41 mmol/l, or TG: 2.26-4.52 mmol/l; HDL-C ≤ 1.04 mmol/l (male)/1.16 mmol/l (female); no medication for hyperlipidemia for more than 4 weeks and received dietary advice for 2–4 weeks
During the intervention, no medications affecting serum lipids Baseline balance Yes
Significantly decreased TC, LDL-C, TG in both CHM and control groups before and after treatment; More significant decrease of TC, LDL-C, TG and increase of HDL-C in the CHM group than those that in the control group after treatment; Significant higher total effective rate in the CHM group (93.2%) than that in the control group (50.8%)
CHM group: Heartburn; flatulence; Dizziness; Exacerbation of preexisting stomachache N/A
Monascus purpureus rice preparation 3 tablets (600 mg)/time, twice daily, 8 weeks
Formulas Red yeast rice
Jiaogulan 3 tablets (600 mg)/time, twice daily, 8 weeks
Formulas Jiaogulan
Yang et al. [41] China Feb 2002–May 2004 Hyperlipidemia Sample size n = 96
CHM group n = 56; 31 males and 25 females; mean age: 69 years
Control group n = 40; 29 males and 11 females; mean age: 68 years
Both groups have cases with coronary heart disease, hypertension, and cerebral vascular disease
Inclusion criteria TC > 5.7 mmol/l and/or TG > 1.7 mmol/l; TCM diagnosed for phlegm-damp and blood stasis syndrome
During the intervention, no other drugs Baseline balance Yes
Significantly decreased TC, LDL-C in both CHM and control groups before and after treatment; Significantly decreased TG in the CHM group before and after treatment; More significant decrease of TC, LDL-C in the CHM group than those in the control group after treatment
No side effects N/A
Danshen Jueming granules 24 g/time, twice daily
Formulas Taizishen, Danshen, Juemingzi, Shanzha, Zexie, Chenpi, et al.
Xuezhikang capsules 0.8 g/time, 3 times daily
Ai et al. [42] China No information on study period Hyperlipidemia Sample size n = 60
CHM group n = 30
Control group n = 30
Inclusion criteria BMI < 35 kg/m2; TC ≥ 5.72 mmol/l and TG > 4.52 mmol/l; age: 18 years and older
During the intervention, no other lipid-modulating drugs Baseline balance statistically different in the serum TG level between groups
Significantly decreased in the TC, LDL-C in both CHM and control groups before and after treatment; More significant decrease of TC, LDL-C in the control group than those in the CHM group after treatment
Diarrhea (CHM: n = 8); Myalgia and epigastric discomfort (Control: n = 2) N/A
Daming capsule 2 g/time, twice daily, 6 weeks
Formulas Dahuang, Ginseng, Juemingzi, Danshen
Pravastatin 10 mg/time, once daily, 6 weeks
Xu et al. [43] China No information on study period Hyperlipidemia Sample size n = 77
CHM group n = 37; 17 males and 20 females; mean age: 59 years
Control group n = 40; 20 males and 20 females; mean age: 61 years
Inclusion criteria TC ≥ 5.72 mmol/l or TG ≥ 1.70 mmol/l or HDL-C ≤ 1.04 mmol/l (male)/1.17 mmol/l (female); TCM diagnosed for phlegm-damp and blood stasis syndrome
During the intervention, no drugs affecting the blood lipid metabolism Baseline balance Yes
Significantly decreased TC, TG, LDL-C, BMI in the CHM group and significantly decreased LDL-C, BMI in the control group, before and after treatment; More significant decrease of TC, TG in the CHM group than those in the control group after treatment; Significantly lower recurrence rate in the CHM group than that in the control group after treatment
No side effects N/A
Antihyperlipidemic decoction 150 ml/time, twice daily, 8 weeks
Formulas: Yiyiren, Shengpuhuang, Zexie, Shengshanzha, Huangqi, Juemingzi, et al.
Zhinbiticose 1050 mg/time, 3 times daily, 8 weeks
Hu et al. [44] Hong Kong No information on study period Hyperlipidemia Sample size n = 40
CHM group n = 20; 6 males and 14 females; mean age: 58 years
Control group n = 20; 10 males and 10 females; mean age: 55 years
Inclusion criteria diagnosed dyslipidemia with lipid-lowering therapy or fasting LDL-C ≥ 4.1 mmol/l or TG ≥ 1.7 mmol/l; plasma LDL-C ≥ 2.6 mmol/l or ≥ 1.8 mmol/l for those with high cardiovascular risk following lipid-lowering treatment and diet or plasma TG ≥ 1.7 mmol/l following a lipid-lowering diet; age: 18 years and older
A multiherb formula 4 capsules in the morning and 4 capsules in the evening, 12 weeks
Formulas Shanzha, Zexie, Yumixu, Sangye, Lingzhi, Heshouwu
Placebo 4 capsules in the morning and 4 capsules in the evening, 12 weeks Baseline balance statistically different in the LDL-C level between groups
More significant decrease of LDL-C in the CHM group than that in the placebo group after treatment; No significant difference of LDL-C in the CHM group before and after treatment
CHM group: n = 11, including one stomach upset; Placebo group: n = 12, including one acid reflux Not balanced baseline data of the two groups; Small sample size; Lack of consideration of the different types of dyslipidemia
Moriarty et al. [45] USA and China Apr 2011–Aug 2012 Hyperlipidemia Sample size n = 116
CHM group 1 n = 36; 6 males and 30 females; mean age: 58 years
CHM group 2 n = 42; 13 males and 29 females; mean age: 56 years
Control group n = 38; 11 males and 27 females; mean age: 56 years
Inclusion criteria TC ≥ 13.3 mmol/l; LDL-C: 8.9-12.2 mmol/l; TG < 22.2 mmol/l; BMI < 36 kg/m2; age: 18 years and older
During the intervention, no lipid-lowering drugs, investigational agent, medications promoting weight loss, agents affecting lipid metabolism Baseline balance Yes
Significantly decreased LDL-C in both two CHM groups before and after treatment, without significant difference between these two groups after treatment; The total effective rates at about 48% of LDL-C by ≥30% in the two CHM groups before and after treatment, without significant difference between these two groups
CHM groups 1, 2: n = 5, not CHM-related side effects (thyroid cancer, pulmonary embolism, fractured leg)
Placebo group: n = 3
Not representative data; More females than males; Short treatment period
CHM group 1: Xuezhikang 1200 mg 2 capsules (300 mg) and 2 placebo daily, 12 weeks
CHM group 2: Xuezhikang 2400 mg 4 capsules (300 mg) daily, 12 weeks
Formulas Red yeast rice
Placebo 4 placebo capsules daily, 12 weeks
Heber et al. [46] USA No information on study period Hyperlipidemia Sample size n = 83; 46 males and 37 females; age: 34–78 years
Inclusion criteria LDL-C > 4.14 mmol/l and TG < 2.94 mmol/l; no treatment for hypercholesterolemia before; normal liver and renal function
Diet advices were provided Baseline balance Yes
Significantly decreased TC, TG, LDL-C in the CHM group before and after treatment; More significant decrease of TC, LDL-C in the CHM group than those in the placebo group after treatment
Placebo group: Rash (n = 1); Headaches (n = 1); Concurrent development of pneumonia (n = 1) N/A
Red yeast rice capsule 1 capsule (600 mg), 2.4 g daily, 12 weeks
Formulas Red yeast rice
Rice powder placebo capsule 1 capsule (600 mg), 2.4 g daily, 12 weeks
Lin et al. [47] Taiwan Dec 2001–Jan 2003 Hyperlipidemia Sample size n = 79
CHM group n = 39; 23 males and 16 females; mean age: 46 years
Control group n = 40; 22 males and 18 females; mean age: 47 years
Inclusion criteria TC ≥ 6.22 mmol/l; LDL-C ≥ 4.14 mmol/l; TG ≤ 4.52 mmol/l; age: 18–65 years; BMI < 30 kg/m2; no lipid-lowering drugs 4 weeks before screening
Diet advices were provided Baseline balance Yes
Significantly decreased TC, TG, LDL-C in the CHM group before and after treatment; More significant decrease of TC, TG, LDL-C in the CHM group than those in the placebo group after treatment
CHM group: Drug-related side effects (n = 6) No record of diets of the participants
Monascus purpureus Went rice 1 capsule (600 mg)/time, twice daily, 8 weeks
Formulas Red yeast rice
Rice powder placebo 1 capsule (600 mg)/time, twice daily, 8 weeks
Wei et al. [48] China Mar 2006–Sep 2007 Impaired glucose tolerance Sample size n = 140
CHM group n = 70; 31 males and 39 females; mean age: 51 years
Control group n = 70; 32 males and 38 females; mean age: 51 years
Inclusion criteria 2hPG: 7.8–11.1 mmol/l; age: 25–70 years; BMI: 18.5–35.0 kg/m2; no IGT treatment before; TCM diagnosed for spleen-stomach dampness-heat syndrome
Tang No.1 granule with IGT knowledge education 2 packets/time, twice daily, 6 months
Formulas: Dangshen, Fushen, Huangqi, Shanyao, Huangqin, Huanglian, et al.
IGT knowledge education Baseline balance Yes
Significantly decreased FPG, 2hPG, HbA1c, TG, HOMA-IR in the CHM group before and after treatment;More significant decrease of FPG, 2hPG, HbA1c, TG, HOMA-IR in the CHM group than those in the control group after treatment;More patients with IGT reversed to normal in the CHM group (19.1%) than that in the control group (3.1%)
No side effects N/A
Gao et al. [49] China No information on study period Impaired glucose tolerance Sample size n = 510
CHM group n = 255; 110 males and 145 females; mean age: 49 years
Control group n = 255; 112 males and 143 females; mean age: 51 years
Inclusion criteria 2hPG: 7.8–11.1 mmol/l after OGTT and FPG > 7.0 mmol/l; age: 25–75 years; BMI: 20–35 kg/m2
Co-administered medications: calcium antagonists, α blockers or ACE antagonists, or β-blockers or thiazide for hypertension control Baseline balance Yes
Significantly decreased 2hPG, HbA1c, BMI, FIN, HOMA-IR in the CHM group before and after treatment; More significant decrease of FPG, 2hPG, HbA1c, FIN, HOMA-IR in the CHM group than those in the control group after treatment; More patients with IGT reversed to normal in the CHM group (29.1%) than those in the control group (13.6%) after treatment; Lower risk of IGT patients progressing to Type 2 diabetes in the CHM group (22.2%) than that in the placebo group (43.9%)
Mild abdominal distension (CHM: n = 4; Control: n = 3) Small sample size; Short follow-up
Tangzhiping granule with Standard health care advice 5 g/time, twice daily, 5 days a week
Formulas Huanglian, Sangbaipi, Gegen
Standard health care advice
Fang et al. [50] China No information on study period Impaired glucose tolerance Sample size n = 514
CHM group n = 257; 136 males and 121 females; mean age: 55 years
Control group n = 257; 142 males and 115 females; mean age: 55 years
Inclusion criteria 2hPG: 7.8–11.1 mmol/l and FPG < 7.0 mmol/l; TCM diagnosed for spleen deficiency and dampness syndrome; age: 25–70 years; no IGT treatment before; no participation in clinical trials within the 3 months before screening
Shenzhu Tiaopi granule with lifestyle intervention 8.8 g/time, twice daily, 12 months
Formulas N/A
Lifestyle intervention Baseline balance Yes
More patients with IGT reversed to normal in the CHM group (42.2%) than that in the control group (32.9%); Lower risk of IGT patients progressing to Type 2 diabetes in the CHM group (8.5%) than that in the placebo group (15.3%)
CHM group: n = 9
Placebo group: n = 5
Gastrointestinal reactions were the most common side effects
Short follow-up; No consensus about efficacy of the CHM approach
Lian et al. [51] China Aug 2008–Mar 2010 Impaired glucose tolerance Sample size n = 420
CHM group n = 210; 98 males and 112 females; mean age: 53 years
Control group n = 210; 106 males and 104 females; mean age: 52 years
Inclusion criteria 2hPG: 7.8–11.1 mmol/l after OGTT and FPG > 7.0 mmol/l; age: 25–70 years; no IGT treatment before; no participation in clinical trials within the 3 months before screening
Diet and exercise advices were provided Baseline balance Yes
More patients with IGT reversed to normal in the CHM group (63.1%) than that in the control group (46.6%); Lower risk of IGT patients progressing to Type 2 diabetes in the CHM group (18.2%) than that in the placebo group (29.3%)
CHM group: n = 15
Placebo group: n = 11
Gastrointestinal reactions were the most common side effects
Short study period; No data on plasma insulin and HbA1c; Small sample size
Tianqi capsule 5 capsules/time, 3 times daily, 12 months
Formulas Huangqi, Nvzhenzi, Huanglian, Tianhuafen, Shihu, Jixueteng, et al.
Placebo 5 capsules/time, 3 times daily, 12 months
Huang et al. [52] China Mar 2013–Jul 2015 Impaired glucose tolerance Sample size n = 120
CHM group n = 60; 31 males and 29 females; mean age: 52 years
Control group n = 60; 35 males and 25 females; mean age: 51 years
Inclusion criteria 2hPG: 7.8–11.1 mmol/l and FPG < 7.0 mmol/l; age: 30–70 years; no diabetes history; normal blood test, urine, stool, liver and renal function
Tangyiping granules with lifestyle intervention 10 g/time, twice daily, 12 weeks
Formulas Huangqi, Baishao, Huanglian, Danshen, Banxia, Gegen
Lifestyle intervention Baseline balance Yes
Significantly decreased 2hPG, HbA1c, HOMA-IR, TG in the CHM group before and after treatment; More significant decrease of 2hPG, HbA1c, HOMA-IR, TG in the CHM group than those in the control group after treatment; More patients with IGT reversed to normal in the CHM group (58.3%) than that in the control group (26.7%); Lower risk of IGT patients progressing to Type 2 diabetes in the CHM group (16.7%) than that in the placebo group (31.7%)
No severe side effects Small sample size; Short follow-up; Insufficient outcome measures
Shi et al. [53] China Apr 2014–Oct 2014 Impaired glucose tolerance Sample size n = 61
CHM group n = 32; 17 males and 15 females; mean age: 47 years
Control group n = 29; 14 males and 15 females; mean age: 50 years
Inclusion criteria 2hPG: 7.8–11.1 mmol/l after OGTT and FPG < 7.0 mmol/l; age: 20–80 years; BMI: 18–30 kg/m2
Diet, exercise, smoking/alcohol consumption advices were provided; no other CHM products with similar function Baseline balance Yes
Significantly decreased FPG, 2hPG, HbA1c, HOMA-IR, BMI in the CHM group before and after treatment; More significant decrease of HbA1c, 2hPG, HOMA-IR in the CHM group than those in the control group after treatment; Lower risk of IGT patients progressing to Type 2 diabetes in the CHM group (6.2%) than that in the placebo group (17.2%); More patients with IGT reversed to normal in the CHM group (43.8%) than that in the control group (6.9%)
Gastrointestinal reactions (n = 2) Short study period; Small sample size
Jinlida granule 1 granule (9 g)/time, 3 times daily, 12 weeks
Formulas Ginseng, Fuling, Cangzhu, Gegen, Huangjing, Zhimu, et al.
No drug intervention
Grant et al. [54] Australia Jun 2007–Dec 2009 Impaired glucose tolerance Sample size n = 71
CHM group n = 39; 15 males and 24 females; mean age: 58 years
Control group n = 32; 18 males and 14 females; mean age: 60 years
Inclusion criteria FPG < 7.0 mmol/l and 2hPG: 7.8–11.0 mmol/l; age: 18 years and older
Jiangtang Xiaozhi 3 capsules/time, 3 times daily, 16 weeks
Formulas Nvzhenzi, Huangqi, Huanglian, Kunbu, Lizhihe, Jianghuang
Placebo 3 capsules/time, 3 times daily, 16 weeks Baseline balance Yes
More significant decrease of fasting insulin, HDL in the CHM group than those in the placebo group after treatment; No information on the efficacy of CHM before and after treatment
CHM group: moderate dizziness (n = 1) Short study period; Small sample size
Pan et al. [55] China Jul 2003–Aug 2003 Obesity Sample size n = 78
CHM group n = 40; 18 males and 22 females; mean age: 41 years
Control group n = 38; 17 males and 21 females; mean age: 41 years
Inclusion criteria BMI ≥ 25 kg/m2; age: 20–50 years
Dietary powder 1 package (9 g)/time, twice daily, 7 weeks
Formulas Lotus rhizome, Green tea, Sanqi
Placebo 1 package (9 g)/time, twice daily, 7 weeks Baseline balance Yes
Significantly decreased body mass, percentage of body fat, BMI, WC, HC in the CHM group before and after treatment; More significant decrease of body mass, percentage of body fat, BMI, WC, HC in the CHM group than those in the placebo group
Irritability (CHM: n = 1; Placebo: n = 1); Nausea (CHM: n = 2; Placebo: n = 1); Constipation (Placebo: n = 2) N/A
Zhou et al. [56] China May 2010–Feb 2011 Obesity Sample size n = 134
CHM group n = 70; 31 males and 39 females; mean age: 40 years
Control group n = 64; 29 males and 35 females; mean age: 40 years
Inclusion criteria BMI: 28–40 kg/m2; WC ≥ 85 cm (male)/80 cm (female); age: 18–60 years; TCM diagnosed for qi and phlegm stasis syndrome
Xin-Ju-Xiao-Gao-Fang (full-dose) 170 ml decoction/time, twice daily, 24 weeks
Formulas Dahuang, Zhishi, Huanglian, Juemingzi
Xin-Ju-Xiao-Gao-Fang (10% of full-dose) 170 mL decoction/time, twice daily, 24 weeks Baseline balance Yes
More significant decrease of body weight, WC, HC, FIN in the CHM group than those in the control group after treatment
Minor side effects (e.g. skin rash) (CHM: n = 4; Control: n = 3) Short study period; No follow-up; No true placebo group
Lenon et al. [57] Australia No information on study period Obesity Sample size n = 117
CHM group n = 59; 10 males and 49 females; mean age: 39 years
Control group n = 58; 10 males and 48 females; mean age: 40 years
Inclusion criteria BMI ≥ 30 kg/m2; age: 18–60 years
During the intervention, no other medications for obesity management Baseline balance Yes
Significantly decreased body weight, BMI, body fat in the CHM group and increased body weight, BMI, body fat in the placebo group, before and after treatment; More significant decrease of body weight, BMI in the CHM group than those in the placebo group after treatment
Nausea (CHM: n = 4)
Headache (CHM: n = 9)
Decrease of appetite (Placebo: n = 2)
N/A
Chinese herbal medicine formula RCM-104 4 capsules/time, 3 times daily, 12 weeks
Formulas Green tea, Juemingzi, Huaihua
Placebo 4 capsules/time, 3 times daily, 12 weeks
Hioki et al. [58] Japan No information on study period Obesity and impaired glucose tolerance Sample size n = 81; mean age: 54 years
CHM group n = 41
Control group n = 40
Inclusion criteria FPG < 7.0 mmol/l and 2hPG: 7.8–11.1 mmol/l after OGTT
Diet and exercise advices were provided Baseline balance Yes
Significantly decreased body weight, WC, HC, TC,TG, LDL-C in both CHM and placebo groups before and after treatment; Significantly decreased fasting insulin, HOMA-IR in the CHM group before and after treatment; More significant decrease of WC in the CHM group than that in the placebo group after treatment
CHM group: Loose bowels (n = 3) N/A
Bofu-tsusho-san 3 times daily, 24 weeks
Formulas Jingjie, Bohe, Shigao, Gancao, Lianqiao, Mahuang, et al.
Placebo 3 times daily, 24 weeks
Gao & Hu [59] China No information on study period Type 2 diabetes and hyperlipidemia Sample size n = 80
CHM group n = 40; 22 males and 18 females; mean age: 59 years
Control group n = 40; 20 males and 20 females; mean age: 59 years
Inclusion criteria FPG > 7.0 mmol/l and blood PG > 6.1 mmol/l
During the intervention, hypoglycemic agents remain stable Baseline balance Yes
Significantly decreased TC, TG, LDL-C and increased HDL-C in the CHM group before and after treatment, without significant difference compared to the control group after treatment
Control group: Slight elevation of ALT (n = 2) N/A
Taizhi’an capsule with Simvastatin (10 mg daily) 0.9 g/time, 3 times daily, 12 weeks
Formulas N/A
Simvastatin 20 mg daily, 12 weeks
Poppel et al. [60] Netherlands May 2012–Mar 2013 Hyperlipidemia and hypertension Sample size n = 20; 14 males and 6 females; mean age: 58 years
CHM group n = 9
Control group n = 11
Inclusion criteria fasting LDL-C > 3.5 mmol/l and/or TG > 1.7 mmol/l; age: 40–70 years; SBP > 140 mmHg and/or DBP > 90 mmHg despite taking antihypertensive drugs
Danshen capsules 4 capsules (500 mg)/time, 3 time daily, 4 weeks
Formulas Danshen
Placebo 4 capsules (500 mg)/time, 3 time daily, 4 weeks Baseline balance Yes
Significantly increased LDL-C in the CHM group before and after treatment, without significant difference compared to the placebo group; No significant difference of BP between the CHM and placebo groups after treatment after treatment
CHM group: Headache (n = 5); Dizziness (n = 3); Change in stool frequency (n = 3); Flatulence (n = 2); Peripheral facial nerve paralysis (n = 1) Carry-over effect
Chu et al. [61] China Jan 2008–Dec 2009 Metabolic syndrome Sample size n = 90
CHM group n = 60; 28 males and 32 females; mean age: 51 years
Control group n = 30; 13 males and 17 females; mean age: 50 years
Inclusion criteria diagnosed central obesity; WC > 90 cm (male)/80 cm (female) and/or BMI > 25 kg/m2; fasting blood glucose ≥ 6.1 mmol/l and/or 2hPG ≥ 7.8 mmol/l or having diabetes history; TG > 1.7 mmol/l and/or HDL-C < 0.9 mmol/l(male)/1.0 mmol/l (female); age: 18–70 years
Diet and exercise advices were provided; During the intervention, no other CHM with hypoglycemic, lipid-lowering and antihypertensive effects Baseline balance Yes
Significantly decreased BMI, waist-to-hip ratio, TC, TG, LDL-C, 2hPG and increased HDL-C in the CHM group before and after treatment; More significant decrease of BMI, TC, LDL-C, 2hPG and increase of HDL-C in the CHM group than those in the placebo group after treatment
CHM group: Diarrhea (n = 1) N/A
Pu’er tea extract capsules 4 capsules/time, twice daily, 3 months
Formulas Pu’er tea
Placebo 4 capsules/time, twice daily, 3 months
Chen et al. [62] China Oct 2011–Oct 2012 Hypertension and metabolic syndrome Sample size n = 43
CHM group n = 22; 14 males and 8 females; mean age: 49 years
Control group n = 21; 14 males and 7 females; mean age: 49 years
Inclusion criteria diagnosed metabolic syndrome; average BP > 135/85 mmHg when awake and > 120/75 mmHg during sleep or SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg; age: 18–65 years
Diet and exercise intervention were provided Baseline balance Yes
Significantly decreased body weight, WC, BMI, FPG, 2hPG, FIN, HOMA-IR, SBP, DBP, daytime SBP, daytime DBP, nighttime SBP in the CHM group before and after treatment; More significant decrease of WC, waist-to-hip ratio, 2hPG, HOMA-IR, FIN, SBP, DBP, daytime SBP and DBP than those in the placebo group after treatment
CHM group: Skin allergy (n = 2) N/A
Yiqi Huaju formula 1 bag/time, twice daily, 12 weeks
Formulas Huangqi, Zexie, Huanglian, Yinchen, Puhuang
Placebo 12 weeks
Azushima et al. [63] Japan Jun 2010–Mar 2013 Hypertension and obesity Sample size n = 106
CHM group n = 54; 28 males and 26 females; mean age: 59 years
Control group n = 52; 29 males and 23 females; mean age: 60 years
Inclusion criteria diagnosed hypertension with a history of antihypertensive treatment more than 4 weeks; BMI > 25 kg/m2; age: 20–79 years
Diet and exercise advices were provided Baseline balance Yes
Significantly decreased daytime SBP, daytime DBP, body weight, BMI in the CHM group before and after treatment; More significant decrease of daytime SBP, body weight, BMI in the CHM group than those in the control group after treatment
CHM group: Gastric irritation (n = 1); Constipation (n = 1); Elevation of serum hepatic enzyme level (n = 1) Not a double-blinded placebo-controlled study; Short study period
Bofu-tsusho-san with Antihypertensive therapy 2.5 g/time, once daily, 24 weeks
Formulas Jingjie, Bohe, Shigao, Mahuang, Gancao, Lianqiao, et al.
Antihypertensive therapy No further information
  1. 2hPG 2-hour postprandial glucose, BP blood pressure, BMI body mass index, DBP diastolic blood pressure, FIN fasting plasma insulin, FPG Fasting plasma glucose, HbA1c glycated hemoglobin, HC hip circumferences, HDL high-density lipoprotein, HDL-C high-density lipoprotein cholesterol, HOMA-β homeostatic model assessment β-cell function, HOMA-IR homeostatic model assessment insulin resistance, IGT Impaired glucose tolerance, LDL-C low-density lipoprotein cholesterol, LVMI left ventricular mass index, MBP mean blood pressure, OGTT oral glucose tolerance test, PPG postprandial plasma glucose, SBP systolic blood pressure, TC total cholesterol, TG triglyceride, TO original heart rate, WC waist circumference