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Journal of Chinese Integrative Medicine ›› 2008, Vol. 6 ›› Issue (2): 128-133.doi: 10.3736/jcim20080205

• Original Clinical Research • Previous Articles     Next Articles

Effectiveness of Danning Tablet in patients with non-alcoholic fatty liver of damp-heat syndrome type: A multicenter randomized controlled trial

Guang Ji1(), Jian-gao Fan2, Jian-jie Chen3, Lun-gen Lu4, Lian-jun Xing1, Pei-yong Zheng5, Hong-gang Gu1, Hua-feng Wei1, Sheng-fu You1, Pei-ting Zhu1   

  1. 1. Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
    2. Department of Gastroenterology, Shanghai First Peoples Hospital, Shanghai Jiaotong University, Shanghai 200080, China
    3. Department of Hepatology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
    4. Shanghai Institute of Digestive Diseases, Shanghai 200000, China
    5. Evaluation Center of Clinical Efficacy, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
  • Received:2007-04-11 Online:2008-02-20 Published:2008-02-15
  • Contact: JI Guang E-mail:jiliver@vip.sina.com

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Objective:To evaluate the efficacy and safety of Danning Tablet (DNT) in patients with non-alcoholic fatty liver disease (NAFLD) of damp-heat syndrome type.

Methods:A multicenter, randomized, double-blinded and positive drug parallel controlled trial was performed. One hundred and thirty-five patients were enrolled into the study and divided into two groups: DNT-treated group (n=102) and ursodeoxycholic acid (UDCA)-treated group (n=33). Body mass index (BMI), principal symptoms, liver function, blood lipids, iconographic, and compositional parameters were measured before and after treatment, respectively.

Results:In the two groups, BMI, distress in hepatic region, fatigue, anorexia, liver function, blood lipids and iconographic parameters were significantly improved, and the improvements of BMI, distress in hepatic region were better in DNT-treated group than in UDCA-treated group. The histological study also showed that DNT had positive effect in treatment of NAFLD.

Conclusion:DNT is an effective drug to treat patients with NAFLD of damp-heat syndrome type and is more effective than UDCA.

Key words: fatty liver, dampness-heat (traditional Chinese medicine), treatment effectiveness, randomized controlled trial

CLC Number: 

  • R657.31

"

Group n Main symptom score Body mass index
DNT-treated
Pre-treatment 107 7.28±4.31 26.38±4.33
Post-treatment 107 5.09±3.98 24.65±3.86
Difference 107 2.19±1.30* 1.73±0.84*
UDCA-treated
Pre-treatment 33 7.14±4.66 25.94±6.36
Post-treatment 33 5.58±4.32 25.08±3.47
Difference 33 1.56±1.50 0.86±0.92

"

Group n ALT (U/L) AST (U/L) GGT (U/L) TG (mmol/L) TC (mmol/L)
DNT-treated
Pre-treatment 102 71.19±41.00 55.31±23.86 86.41±47.96 3.20±1.76 5.32±1.25
Post-treatment 102 40.54±21.29* 31.16±11.92* 46.50±27.68* 2.46±1.40* 5.03±0.83
UDCA-treated
Pre-treatment 33 74.13±39.21 61.7726.09 81.2346.84 3.502.29 5.391.44
Post-treatment 33 48.69±25.20* 33.94±16.43* 56.13±38.30* 2.65±1.20* 5.22±1.32

"

Group n Degree of improvement in B-ultrasound image n Degree of improvement in CT image
– + ++ +++ – + ++ +++
DNT-treated 102 11 68 19 4 52 2 30 18 22
UDCA-treated 33 5 22 6 0 18 2 10 6 0
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