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Journal of Chinese Integrative Medicine ›› 2008, Vol. 6 ›› Issue (8): 793-798.doi: 10.3736/jcim20080805

• Original Clinical Research • Previous Articles     Next Articles

Effects of Yiqi Sanju Formula on non-alcoholic fatty liver disease: a randomized controlled trial

Shao-ying Lou, Yi Liu, Yu-ying Ma, Hai-ying Chen, Wei-hua Chen, Jian Ying, Yan-ming He, Wen-jian Wang()   

  1. Institution of Chinese Integrative Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China
  • Received:2008-01-30 Online:2008-08-20 Published:2008-08-15

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Objective: To observe the therapeutic effects of Yiqi Sanju Formula (YQSJF), a compound traditional Chinese herbal medicine, in treatment of non-alcoholic fatty liver disease (NAFLD).
Methods: Sixty-seven patients diagnosed with NAFLD was randomly divided into two groups: YQSJF-treated group (39 cases) and placebo group (28 cases). The NAFLD patients in the two groups were treated with YQSJF and placebo respectively for 3 months. Clinical symptoms, the CT ratio of liver-spleen, body mass index (BMI), waist circumference, homeostatic model assessment for insulin resistance (HOMA2-IR) and the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), tumor necrosis factor-α (TNF-α), high sensitivity C-reactive protein (hs-CRP), triglyceride (TG), total cholesterol (TC), high-density lipoprotein (HDL) and low-density lipoprotein (LDL) were evaluated before and after treatment.
Results: After treatment, the clinical symptoms were improved and the levels of BMI, waist circumference, HOMA2-IR, ALT, AST, TG and TC were decreased significantly in the YQSJF-treated group (P<0.05). The CT ratio of liver-spleen in the YQSJF-treated group was increased significantly as compared with the placebo group (P<0.01).
Conclusion: YQSJF has reliable and definite therapeutic effects on NAFLD.

Key words: fatty liver, Yiqi Sanju Formula, spiral CT, insulin resistence, ranomized controlled trials

CLC Number: 

  • R589

Table 1

Changes of CT ratio of liver-spleen, BMI, waist circumference and HOMA2-IR before and after treatment in two groups (x±s)"

Group n CT ratio BMI Waist circumference (cm) HOMA2-IR
Placebo
Before treatment 28 0.80±0.15 27.88±1.53 94.51±9.02 3.97±1.33
After treatment 28 0.86±0.14 26.76±1.64 91.50±10.10* 3.91±0.93
YQSJF-treated
Before treatment 39 0.78±0.21 27.29±3.07 95.43±9.03 3.59±1.67
After treatment 39 1.23±0.11**△△ 23.25±2.59**△ 85.21±8.82**△△ 2.21±0.64**△△

Table 2

NAFLD grade before and after treatment in two groups"

Group n Light Mid Heavy Normal Recovering ratio (%)
Placebo
Before treatment 28 18 8 2 0
After treatment 28 18 5 2 3 10.71
YQSJF-treated
Before treatment 39 24 11 4 0
After treatment 39 1 2 0 36 92.31△△

Figure 1

CT ratio of liver-spleen before and after treatment in YQSJF-treated group A: Before treatment (mid-grade fatty liver); B: After treatment (normal); C: Before treatment (light-grade fatty liver); D: After treatment (normal). A and B are from one patient, and C and D from another patient."

Figure 2

CT ratio of liver-spleen before and after treatment in placebo group A: Before treatment (light-grade fatty liver); B: After treatment (normal). A and B are from one patient."

Table 3

Changes of ALT, AST, TNF-α and hs-CRP before and after treatment in two groups （x±s）"

Group n ALT (U/L） AST (U/L） TNF-α (ng/L) hs-CRP (mg/L)
Placebo
Before treatment 28 73.56±41.04 39.88±23.42 118.20±81.00 4.59±2.48
After treatment 28 70.38±19.69 36.70±29.87 115.30±58.10 4.67±1.62
YQSJF-treated
Before treatment 39 75.44±47.74 42.75±20.15 120.10±85.10 4.71±1.89
After treatment 39 33.75±11.38**△△ 23.13±4.29**△△ 87.10±55.20**△△ 2.25±1.53*△

Table 4

Levels of TG, TC, HDL and LDL before and after treatment in two groups（x±s, mmol/L）"

Group n TG TC HDL LDL
Placebo
Before treatment 28 2.15±1.19 5.40±0.94 1.08±0.25 3.23±0.25
After treatment 28 2.02±0.50 5.51±0.41 1.10±0.15 3.65±0.60
YQSJF-treated
Before treatment 39 2.34 ±0.68 5.75 ±1.00 1.05±0.18 3.32±0.75
After treatment 39 1.43 ±0.37*△ 4.42 ±1.05*△ 1.30±0.62*△ 2.26± 0.35*△
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