| Objective: Fatty liver disease (FLD) is arising rapidity, it's high risk factor to became many severe illness. Therefore, curing FLD by using Traditional Chinese Medicine is becoming the most affordable job. In this study, observing the effectiveness and safety of using Zhi Gan Fang (Fatty liver formula)to cure spleen deficiency with damp-phlegm type FLD. It is attempting to seek a way to cure FLD by using differentiation of Zang fu (Zang Fu Bian Zh-eng) .Method: This study is chose spleen deficiency with damp-phlegm type patients as research group, used randomized control trial, it was used randomized control trial on the time of the patients visited in the clinic, In our clinical research study were divided into two groups by simply randomly. The treatment group (Zhi Gan Fang) and the comparison group (Lipitor) have equal numbers of 30 cases. One group of the FLD patients was treated with Zhi Gan Fang (Fatty Liver Formula) , while the other group was administrated with Lipitor orally, 4 weeks as the treatment period.Result: 60 cases divided into the two groups, criteria before treatment that included age, sex, the age of the disease, family history, ultrasound scan, lipaemia and clinical symptoms study was used, there has no significant difference (P>0. 05), two groups are comparable.The effectiveness of decrease in symptoms after treatment according to ni mo de ping fa evaluation method to evaluate Chinese syndrome treatment effectiveness on before and after treatment. Zhi Gan Fang (Fatty Liver Formula)group has total effective rate of 83.33%, but the Lipitor group has only effective rate of 56.67%, two groups have the significant difference (P< 0.05), Zhi Gan Fang group is better than the Lipitor group. In the study, the symptom criteria compared Zhi Gan Fang group has decrease of the symptom of manifested as loss of appetite, abdominal distention, diarrhea,, fatigue, lassitude and sleepy, the effective rate of (p<0. 05) Therefore, it can proof that Zhi Gan Fang (Fatty Liver Formula) is effectiveness, and it can improve the quality of FLD patient' s life. On the other hand, Lipitor group has no changed in symptom criteria, there are no significant changes, no significant difference of (p>0. 05) .According to blood serum lipid changes after treatment of the both groups, both groups of TC\ TG & LDL-C have effective improved, compare to both groups, there are no significant difference ( P > 0. 05 ) , compare to before the treatment : TG & TC have a significant difference (p<0. 05);HDL-C has a significant difference ( P < 0.01 ) . Therefore, both treatments are significant effective to improve blood serum lipid.Submitted to an ultrasound scan of the liver to confirm fatty deposition, both groups have improve the fatty deposition on the liver function, both have comparable, and there is no significant difference of (P>0. 05) .Conclusions: The study of the Zhi Gan Fang (Fatty Liver Formula) cure FLD (spleen deficiency with damp-phlegm type) patients with randomized control trial indicates: Zhi Gan Fang group can improved the patient' s syndrome, blood serum lipid & ultrasound scan of the fatty deposition. The comparison on the both group after treatment, Zhi Gan Fang group is better than the Lipitor group on the patient' s syndrome, both groups have significant effective, but between both group have no significant difference on the lipaemia and ultrasound scan result. On this clinical study indicates that according to traditional Chinese syndrome' s improvement evaluation, Zhi Gan Fang group has the effective rate of 83.33%, Lipitor group has effective rate of 56, 67%, both groups have significant difference (P<0. 05), Zhi Gan Fang group is better than the Lipitor group.
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