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

Abstract

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.

• Authors: Jin-Gen Lu, Yi-Bin Pan, Yong-Qing Cao, Wei Yang, Xin-Lin Zhang
• Journal: Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine (Zhong Xi Yi Jie He Xue Bao) Vol. 3 Issue 3 Pg. 191-4 (May 2005) ISSN: 1672-1977 [Print] China
• PMID: 15885165 (Publication Type: English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Drugs, Chinese Herbal
• Tablets

Topics

• Adolescent
• Adult
• Aged
• Drugs, Chinese Herbal (therapeutic use)
• Female
• Hemorrhoids (drug therapy)
• Humans
• Male
• Medicine, Chinese Traditional
• Middle Aged
• Phytotherapy
• Quality Control
• Research Design
• Single-Blind Method
• Tablets
• Treatment Outcome