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Journal of Chinese Integrative Medicine ›› 2005, Vol. 3 ›› Issue (3): 191-193.doi: 10.3736/jcim20050307

Special Issue: Traditional Chinese Medicine

• Original Clinical Research • Previous Articles     Next Articles

Discussion on design and quality control of clinical trials of traditional Chinese medicine on the basis of Fuhuang Tablets clinical study

Jin-gen Lu1,Yi-bin Pan1,Yong-qing Cao1,Wei Yang2,Xin-lin Zhang3   

  1. 1. Shanghai Municipal Clinical Medicine Center for Chinese Traditional Surgery, Shanghai 200032, China
    2. Department of Anorectal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200021
    3. Department of Anorectal Surgery, Shanghai Hospital of Traditonal Chinese Medicine, Shanghai 200071, China
  • Received:2005-03-08 Online:2005-05-20 Published:2005-05-20
  • Contact: Jin-gen Lu E-mail:lujingen@longhua.net

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Objectives

To assess the efficacy of Fuhuang Tablets in treating internal hemorrhoid hemorrhage and discussing the design and quality control of clinical trials of traditional Chinese medicine. 

Methods

According to two-center, randomized, blinded and controlled study, 144 patients with internal hemorrhoids were divided into 2 groups. Seventy-two patients were treated with Fuhuang Tablets (4 tablets t.i.d. per os) and the other 72 patients were treated with Zhining Tablets (4 tablets t.i.d. per os). Symptoms and signs of the patients were recorded and evaluated at the third and seventh day of treatment respectively.

Results

At the third day of treatment, the overall response rates of Fuhuang Tablets-treated group and Zhining Tablets-treated group were 58.57% and 27.78% respectively, with statistic difference between the two groups (P<0.05). At the seventh day of treatment, the overall response rates of Fuhuang Tablets-treated group and Zhining Tablets-treated group were 91.43% and 81.94% respectively, with no statistic difference between the two groups. The laboratory test results and life signs of the 144 patients were normal before and after the treatment.

Conclusion

Fuhuang Tablets are effective and safe in treating internal hemorrhoid hemorrhage.

Key words: Fuhuang Tablets, Clinical research, Research design, Quality control

CLC Number: 

  • R954.73

Tab 1

Comparison of therapeutic effects between 2 groups n (%)"

Group N Recovery Significant effect Partial response Nonresponse Overall response
rate (%)
Fuhuang Tablets-treated group
At the third treatment day 70 0 (0) 0 (0) 41 (58.57) 29 (41.43) 58.57
At the seventh treatment day 70 4 (5.71) 21 (30.00) 39 (55.71) 6 (8.57) 91.43
Zhining Tablets-treated group
At the third treatment day 72 0(0) 0(0) 20(27.78) 52(72.22) 27.78*
At the seventh treatment day 72 3(4.16) 12(16.67) 44(61.11) 13(18.06)* 81.94
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