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 | ||||||