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Table 3 Major findings of the RCTs included in the review

From: Efficacy and safety of traditional Chinese medicines for non-alcoholic fatty liver disease: a systematic literature review of randomized controlled trials

No. Authors, year Test group Control group Duration Primary outcome Secondary outcome
TCMs Behavioral interventions Pharmacological interventions Behavioral interventions TCM syndrome score Adverse reactions Radiological response Liver function Body weight Blood sugar Blood lipid Others
1 Wu et al., 2020 [43] Jianpi Qingzhi prescription Diet and exercise Polyene Phosphatidylcholine capsules Diet and exercise 12 weeks Yes N/A BU, CT ALT, AST, GGT N/A FBG, FINs, HOMA-IR, TG, TC DAO, LPS, d-lactic acid, Claudin-1, Claudin-4
2 Lyv et al., 2020 [47] Shenge formula Diet and exercise N/A Diet and exercise 6 months Yes N/A N/A ALT, AST N/A N/A TG, TC N/A
3 Yang et al., 2019 [59] Yanggan Jieyu granule Diet and exercise Polyene phosphatidylcholine capsules Diet and exercise 24 weeks Yes N/A CT ALT, AST, GGT N/A N/A TG, TC, LDL-C N/A
4 Yang et al., 2019 [97] Qinjiang Baoling decoction Diet and exercise N/A Diet and exercise 3 months Yes N/A BU, CT ALT, GGT BMI HOMA-IR TC, HDL-C N/A
5 Li et al., 2018 [62] Qutan Huoxue decoction N/A Silibinin capsules N/A 24 weeks Yes Yes CT ALT, AST, GGT N/A N/A TG, TC N/A
6 Chen et al., 2017 [98] Shuangqing granule Diet and exercise Xuezhikang capsules Diet and exercise 12 weeks Yes N/A BU AST, ALT N/A N/A TG, TC, HDL-C, LDL-C N/A
7 Hu et al., 2017 [31] Jianpishugan and Huoxuehuatan formula Diet and exercise Polyene Phosphatidylcholine capsules Diet and exercise 3 months Yes Yes BU ALT, AST, GGT BMI N/A TG, TC, HDL-C, LDL-C N/A
8 Jiang et al., 2017 [41] Dahuang Lidan capsule Diet and exercise Polyene Phosphatidylcholine capsules Diet and exercise 12 weeks Yes Yes BU ALT, AST, GGT N/A N/A TG, TC, HDL-C, LDL-C N/A
9 Yang et al.,2017 [53] Cigu Xiaozhi capsule Diet and exercise Polyene Phosphatidylcholine capsules Diet and exercise 8 weeks Yes N/A BU ALT, AST, ALP, GGT BMI N/A TG, TC, HDL-C, LDL-C N/A
10 Jeong et al., 2017 [28] Test group 1—HL tablet—high dose N/A Placebo N/A 12 weeks N/A Yes N/A ALT, AST BMI HOMA-IR TG, TC, HDL-C, LDL-C MRS, free fatty acid
Test group 2—HL tablet—low dose N/A Placebo N/A 12 weeks N/A
11 Sun et al., 2017 [68] Jianpi Qushi prescription Diet and exercise N/A Diet and exercise 3 months Yes N/A BU ALT, AST N/A FPG, FINs TG, TC N/A
12 Niu 2016 [48] Shugan Jianpi Huatan decoction Diet and exercise Atorvastatin calcium tablets Diet and exercise 3 months Yes N/A N/A ALT, AST N/A FBG, FNIs, HOMA-IR TG, TC N/A
13 Zhang et al., 2016 [99] Yiqi Qizhu decoction Diet and exercise Polyene phosphatidylcholine capsules Diet and exercise 3 months Yes Yes BU ALT, AST, GGT N/A N/A TG, TC N/A
14 Zhang et al., 2016 [34] Jiang Zhi granules N/A Ursodeoxycholic acid capsules N/A 24 weeks Yes N/A BU N/A N/A N/A N/A N/A
15 Qi et al., 2016 [63] Jiangpi Shugan Huoxue Huatan decoction Diet and exercise Silibinin capsules N/A 3 months Yes N/A BU ALT, AST, GGT N/A N/A TG, TC, HDL-C, LDL-C N/A
16 Tan et al., 2016 [100] Shugan Jianpi decoction Diet and exercise Pioglitazone N/A 3 months Yes Yes BU ALT, AST BMI, WHR FBG, FNIs, HOMA-IR TG, TC N/A
17 Yu et al., 2016 [69] Qinggan Jiangzhi decoction Diet and exercise Polyene phosphatidylcholine tablet and Dangfei Liganning capsule Diet and exercise 24 weeks Yes N/A BU ALT, AST, GGT BMI, BM N/A TG, TC N/A
18 Yin et al., 2016 [35] Danxia Zhifang decoction; simulated Zhiganxiao capsule N/A Qianggan capsule N/A 3 months Yes N/A BU, CT ALT, AST, GGT,TB, DB, TP, ALB, A/G, N/A N/A TG, TC N/A
19 Zhu 2015 [33] Qingdan Jiangzhi decoction Diet and exercise Tiopronin enteric-coated tablets Diet and exercise 12 weeks Yes N/A BU N/A N/A N/A N/A N/A
20 Li 2015 [64] Huatan Lishi Huoxue granule combined granule decoction Diet and exercise Polyene phosphatidylcholine capsules Diet and exercise 3 months Yes Yes CT ALT N/A N/A TG N/A
21 Chen et al., 2015 [101] Zaozhu Yinchen decoction N/A Silymarin meglumine tablet N/A 2 months Yes Yes BU ALT, AST N/A N/A TG, TC N/A
22 Yu et al., 2015 [52] Tiaogan Lipi recipe Diet and exercise Placebo Diet and exercise 12 weeks Yes Yes CT ALT, AST, GGT N/A N/A TG, TC N/A
23 Li et al., 2015 [58] Qinghua decoction Diet and exercise N/A Diet and exercise 6 months Yes N/A BU ALT, AST, GGT, TB BMI, WHR N/A TG, TC N/A
24 Liu et al., 2014 [49] Heze lipid-lowering oral liquid N/A Polyene phosphatidylcholine capsules N/A 4 months Yes N/A CT ALP, AST, GGT, GLP, ALB BMI N/A TG, TC, HDL-C, LDL-C N/A
25 Liu et al., 2014 [50] Ruangan Jiangzhi capsule Diet and exercise Polyene phosphatidylcholine capsules Diet and exercise 12 weeks Yes Yes BU ALT, GGT N/A N/A TG, TC N/A
26 Li et al., 2014 [51] Jianpi Shugan recipe Diet and exercise Polyene phosphatidylcholine capsules Diet and exercise 3 months Yes Yes CT ALT N/A N/A N/A N/A
27 Zhu et al., 2014 [102] Zhigan pill N/A Placebo N/A 3 months Yes N/A BU N/A N/A N/A N/A N/A
28 Wen et al., 2014 [60] Jiangan Xiaozhi granule Diet and exercise Hedan tablet Diet and exercise 3 months Yes Yes CT ALT, AST, GGT N/A N/A TG, TC, HDL-C, LDL-C N/A
29 Deng, 2013 [103] Jiangan Sanqing decoction N/A Polyene Phosphatidylcholine capsules N/A 3 months Yes N/A BU ALT, AST N/A N/A TG, TC N/A
30 Li et al., 2013 [54] Jianpi Huatan Zhuyu prescription N/A Qianggan capsule N/A 3 months Yes Yes BU ALT, AST, GGT N/A N/A TG, TC N/A
31 Song et al., 2013 [104] Modified Linggui Zhugan decoction N/A Polyene phosphatidylcholine capsules N/A 3 months Yes N/A CT ALT, AST N/A N/A TG, TC N/A
32 Li et al., 2013 [42] Qushi Huayu decoction N/A Polyene phosphatidylcholine capsules N/A 24 weeks Yes Yes BU ALT, AST N/A N/A TG, TC, HDL-C, LDL-C N/A
33 Wong et al., 2013 [26] Phyllanthus urinaria Diet and exercise Placebo Diet and exercise 24 weeks N/A Yes N/A ALT, AST N/A HbA1 HDL-C, LDL-C N/A
34 Pan et al., 2013 [27] Jiang Zhi granule Diet and exercise Placebo Diet and exercise 24 weeks N/A Yes CT N/A BMI N/A TG, TC N/A
35 Chen et al., 2012 [45] Jindanwang mixture Diet Ursodeoxycholic acid capsules Diet 24 weeks Yes N/A BU, CT ALT, AST N/A N/A TG, TC N/A
36 Zhao et al., 2012 [30] Huatan Xiezhuo recipe Diet and exercise Polyene phosphatidylcholine capsules Diet and exercise 3 months Yes Yes N/A ALT BMI N/A TG N/A
37 Wang et al., 2012 [65] Yigan Jiedu decoction Diet and exercise Silymarin Diet and exercise 2 months Yes N/A N/A ALT, AST, GGT N/A N/A TG, TC N/A
38 Pei et al., 2012 [70] Qinggan Huatan Huoxue recipe Diet and exercise Danning tablet Diet and exercise 3 months Yes Yes BU ALT, AST, GGT BMI FBG, FNIs, HOMA-IR TG, TC, HDL-C, LDL-C N/A
39 Wu 2012 [83] Jianpi Huatan formula N/A Vitamin E N/A 3 months N/A Yes BU ALT, AST N/A FBG, FNIs, HOMA-IR TG, TC, HDL-C, LDL-C N/A
40 Tong et al., 2011 [105] Jiedu Jianpi Tongluo decoction N/A Silibinin capsules N/A 12 weeks Yes Yes BU ALT, AST, GGT, TB N/A N/A TG, TC, HDL-C, LDL-C N/A
41 Zhang et al., 2011 [66] Kangzhi decoction N/A Tiopronin enteric-coated tablets N/A 6 months Yes Yes BU, CT ALT, AST, GGT N/A N/A TG, TC N/A
42 Gu et al., 2011 [61] Zhigan capsule Diet and exercise Polyene phosphatidylcholine capsules Diet and exercise 3 months Yes Yes BU ALT, AST, GGT BMI FBG TG, TC, LDL-C N/A
43 Zhao et al., 2010 [46] Qiyin tea N/A Polyene phosphatidylcholine capsules N/A 2 months Yes N/A BU AST, ALP, AST, GGT N/A N/A TG, TC N/A
44 Ding et al., 2010 [88] Pingganjian decoction Diet and exercise Silymarin, Ultivarietas Oryzae Saltlicae Et Monasci Diet and exercise 3 months Yes Yes CT ALT, AST BMI,WHR FBG, FNIs, HOMA-IR TG, TC N/A
45 Pan et al., 2010 [32] Tiaozhiji granules N/A Hedan tablet N/A 3 months Yes Yes BU, CT ALT, AST, GGT N/A N/A TG, TC N/A
46 Liu et al., 2008 [67] Qiyin granules Diet and exercise Polyene phosphatidylcholine capsules Diet and exercise 2 months Yes N/A BU ALT, AST N/A N/A TG, TC N/A
47 Ji et al., 2008 [25] Danning tablet Diet and exercise Ursodeoxycholic acid tablet Diet and exercise 24 weeks Yes Yes CT ALT, AST, GGT BMI N/A TG, TC N/A
48 Chen et al., 2008 [29] Xiaoyao San decoction and Danggui Shaoyao San decoction Diet Anethol trithione Diet 3 months Yes N/A BU ALT, AST N/A N/A TG, TC N/A
49 Lou et al., 2008 [44] Yiqi Sanju formula N/A Placebo N/A 3 months Yes Yes CT ALT, AST BMI FBG, FNIs, HOMA-IR TG, TC, HDL-C, LDL-C hs-CRP, TNF-α
50 Li et al., 2007 [55] Jianpi Bushen decoction N/A Silibinin N/A 8 weeks Yes Yes BU ALT, AST, GGT,TB N/A N/A TG, TC, HDL-C, LDL-C N/A
51 Yang et al., 2007 [56] Yigan Jiangzhi capsule N/A Dongbao Gantai tablet N/A 3 months N/A N/A BU, CT ALT, AST, GGT N/A N/A TG, TC, HDL-C, LDL-C N/A
52 Gu et al., 2007 [24] Tiaozhi Yanggan decoction Diet and exercise Thiola tablet Diet and exercise 12 weeks Yes Yes N/A ALT, AST, GGT N/A N/A TG, TC, HDL-C, LDL-C N/A
53 Chen et al., 2006 [57] Qianggan capsule Diet and exercise Tiopronin Diet and exercise 3 months N/A N/A BU ALT, GGT N/A N/A TG N/A
No. Authors, year Overall findings
Efficacy Safety
Overall efficacy rate of test group Overall efficacy rate of control group Difference between the 2 groups Non-serious Serious
1 Wu et al., 2020 [43] 93.33% 80.00% Test group (P < 0.05) N/A N/A
2 Lyv et al., 2020 [47] 100.00% 48.39% Test group (P < 0.05) N/A N/A
3 Yang et al., 2019 [59] 86.67% 73.33% Test group (P < 0.01) N/A N/A
4 Yang et al., 2019 [97] 64.00% 52.00% Test group (P < 0.05) N/A N/A
5 Li et al., 2018 [62] 84.13% 56.45% Test group (P < 0.01) None None
6 Chen et al., 2017 [98] 89.7% 84.0% Test group (P < 0.05) N/A N/A
7 Hu et al., 2017 [31] 94.28% 77.14% Test group (P < 0.01) None None
8 Jiang et al., 2017 [41] Specific outcome readings Specific outcome readings Test group (P < 0.01) ADR1 None
9 Yang et al., 2017 [53] 93.02% 68.18% Test group (P < 0.01) N/A N/A
10 Jeong et al., 2017 [28] Specific outcome readings Specific outcome readings High dose group (P = 0.033) ADR2 None
Specific outcome readings Specific outcome readings Low dose group (P = 0.386)
11 Sun et al., 2017 [68] 93.33% 61.67% Test group (P < 0.01) N/A N/A
12 Niu 2016 [48] 95.00% 76.60% Test group (P < 0.05) N/A N/A
13 Zhang et al., 2016 [99] 92.31% 78.85% Test group (P < 0.05) None None
14 Zhang et al., 2016 [34] 33.80% 23.39% Test group (P < 0.05) N/A N/A
15 Qi et al., 2016 [63] 93.30% 62.20% Test group (P < 0.05) N/A N/A
16 Tan et al., 2016 [100] 87.23% 71.11% Test group (P < 0.05) ADR3 None
17 Yu et al., 2016 [69] Specific outcome readings Specific outcome readings Test group (P < 0.01) N/A N/A
18 Yin et al., 2016 [35] 81.63% 62.5% Test group (P < 0.05) N/A N/A
19 Zhu, 2015 [33] Specific outcome readings Specific outcome readings Test group (P < 0.05) N/A N/A
20 Li, 2015 [64] 98.10% 80.80% Test group (P < 0.05) None None
21 Chen et al., 2015 [101] 87.50% 73.68% Test group (P < 0.05) None None
22 Yu et al., 2015[52] Specific outcome readings Specific outcome readings Test group (P < 0.05) None None
23 Li et al., 2015 [58] 58.33% 30.51% Test group (P < 0.01) N/A N/A
24 Liu et al., 2014 [49] 52.94% 29.09% Test group (P < 0.05) N/A N/A
25 Liu et al., 2014 [50] 91.67% 56.67% Test group (P < 0.05) ADR4 None
26 Li et al., 2014 [51] 84.09% 75.00% Test group (P < 0.05) ADR5 None
27 Zhu et al., 2014 [102] 85.83% 63.16% Test group (P < 0.05) N/A N/A
28 Wen et al., 2014 [60] 78.40% 55.60% Test group (P < 0.05) None None
29 Deng, 2013 [103] 90.00% 70.00% Test group (P < 0.05) N/A N/A
30 Li et al., 2013 [54] 86.60% 66.60% Test group (P < 0.05) None None
31 Song et al., 2013 [104] 91.70% 69.00% Test group (P < 0.01) N/A N/A
32 Li et al., 2013 [42] specific outcome readings specific outcome readings Test group (P < 0.01) ADR6 None
33 Wong et al., 2013 [26] Specific outcome readings Specific outcome readings Not siginificant ADR7 ADR8
34 Pan et al., 2013 [27] Specific outcome readings Specific outcome readings Test group (P < 0.05) ADR9 None
35 Chen et al., 2012 [45] 94.00% 92.00% No siginificant differences (P > 0.05) N/A N/A
36 Zhao et al., 2012 [30] Specific outcome readings Specific outcome readings Test group (P < 0.01) None None
37 Wang et al., 2012 [65] 75.56% 51.11% Test group (P < 0.01) N/A N/A
38 Pei et al., 2012 [70] 87.20% 73.60% Test group (P < 0.05) ADR10 None
39 Wu 2012 [83] 83.30% 46.67% Test group (P < 0.05) None None
40 Tong et al., 2011 [105] 86.67% 76.09% Test group (P < 0.05) None None
41 Zhang et al., 2011 [66] 86.90% 67.70% Test group (P < 0.05) None None
42 Gu et al., 2011 [61] 90.00% 72.00% Test group (P < 0.05) ADR11 None
43 Zhao et al., 2010 [46] 87.60% 83.90% No siginificant differences (p = 0.873) N/A N/A
44 Ding et al., 2010 [88] 83.33% 45.10% Test group (P < 0.05) ADR12 None
45 Pan et al., 2010 [32] Specific outcome readings Specific outcome readings Test group (P < 0.05) None None
46 Liu et al., 2008 [67] Specific outcome readings Specific outcome readings Test group (P < 0.05) N/A N/A
47 Ji et al., 2008 [25] Specific outcome readings Specific outcome readings Test group (P < 0.05) ADR13 None
48 Chen et al., 2008 [29] 96.77% 83.87% Test group (P < 0.05) N/A N/A
49 Lou et al., 2008 [44] 94.87% 32.14% Test group (P < 0.01) ADR14 None
50 Li et al., 2007 [55] 87.23% 71.11% Test group (P < 0.05) None None
51 Yang et al., 2007 [56] 88.20% 71.70% Test group (P < 0.05) N/A N/A
52 Gu et al., 2007 [24] 81.19% 68.97% Test group (P < 0.05) ADR15 None
53 Chen et al., 2006 [57] 79.69% 62.07% Test group (P < 0.05) N/A N/A
  1. ALB albumin, ALP alkaline phosphatases, ALT aminotransferase, AST aspartate aminotransferase, A/G albumin/globulin ratio, BU B-ultrasound, CT computed tomography, DAO diamine oxidase, DB direct bilirubin, FBG fasting blood glucose, FINS fasting plasma insulin, GGT gamma-glutamyl-transpeptidase, GLB globulin, HDL high density lipoprotein-cholesterol, HFC hepatic fat content, HOMA-IR homeostasis model assessment-estimated insulin resistance, hs-CRP high sensitivity C-reactive protein, L/S ratio liver to spleen ratio, LDL low density lipoprotein-cholesterol, MRS magnetic resonance spectroscopy, TB total bilirubin, TC total cholesterol, TG triglyceride, TP total serum protein, TNF-α tumor necrosis factor-α, VLDL very low density lipoprotein, WHR waist/hip ratio
  2. ADR1: one patient in the control group had a mild prothrombin time
  3. ADR2: high dose group: abdominal pain upper(1 patient); low dose group: dizziness(1 patient); Palcebo group: nausea (1 patient)
  4. ADR3: one case in the control group had mild edema of both lower limbs
  5. ADR4: 4 patients in the test group had different degrees of diarrhea
  6. ADR5: 1 case in test group; 3 cases in control group(not specified)
  7. ADR6: in the test group, 3 cases developed nausea and 2 cases of gastric cavity discomfort; in the control group, 2 cases of gastric cavity discomfort
  8. ADR7: dyspepsia, diarrhea, per-rectal bleeding, chest pain, cough, headache, blurred vision, toothache, gum bleeding, flu-like symptoms
  9. ADR8: hospitalization occurred in two patients in the Phyllanthus group (back pain, stroke) and one patient in the placebo group (acute appendicitis)
  10. ADR9: 16 patients with 19 cases of adverse events were reported in the test group, and 14 patients with 19 cases were reported tn the control group (no mention of the mild adverse name). 1 case exhaustion/dizziness and 1 case sloppy stool were related the study
  11. ADR10: 3 cases in the test group had loose stools; In the control group, 2 cases had nausea and 5 cases had loose stools
  12. ADR11: 5 patients in the test group had different degrees of diarrhea symptoms
  13. ADR12: in the test group, 3 patients had mild diarrhea, gastrointestinal discomfort and reduced appetite, 1 case of hypertension; In the control group 2 cases of hypertension
  14. ADR13: in test group, most of pat ients showed diarrhea. There was one patient with skin rash and three patients with nausea
  15. ADR14: in the test group, 3 patients developed mild diarrhea, recovered and decreased appetite
  16. ADR15: 21 cases of diarrhea, 22 of gastric discomfort or light pain, 15 of abdominal discomfort or dull pain, and 11 cases of nausea