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Chinese Journal of Integrative Medicine

, Volume 24, Issue 3, pp 171–177 | Cite as

Efficacy and Safety of Quxie Capsule (祛邪胶囊) in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial

  • Tong Zhang
  • Yu-fei Yang
  • Bin He
  • Dan-hui Yi
  • Jie Hao
  • Da Zhang
Original Article

Abstract

Objective

To verify the efficacy and safety of Quxie Capsule (祛邪胶囊) in patients with metastatic colorectal cancer (mCRC).

Methods

The present study was a randomized, double-blind, placebo-controlled trial. Sixty patients with mCRC were randomized into two groups at a 1:1 ratio by sealed envelope. The treatment group received conventional therapy combined with Quxie Capsule for 3 months. The control group was treated with conventional therapy combined with placebo for 3 months. Main outcome measures were overall survival (OS) and progression-free survival (PFS). Subgroup analysis was performed according to age, right or left-sided disease, and second-line therapy to determine the differences in PFS and OS between the two groups. Patients were followed up every 3 months until Dec 31st 2016.

Results

The median OS was 23 months in the treatment group [95% confidence interval (CI): 15–not calculated] vs. 14 months in the control group (95% CI: 11–22, P=0.060). The OS of the treatment group tended to be longer than that of the control group (P>0.05). In the subgroups of patients <65 years old, left-sided colon, and 2nd-line therapy, the treatment group showed a significant survival benefit compared with the control group (P=0.006, 0.038, 0.013, respectively). There were no significant differences between the two groups in PFS (P>0.05). Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group.

Conclusions

Quxie Capsule showed good safety and efficacy, and could prolong the OS of patients with mCRC. (Registration No. ChiCTR-IOR-16009733)

Keywords

Chinese medicine Quxie Capsule metastatic colorectal cancer randomized controlled trial 

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Copyright information

© Chinese Association of the Integration of Traditional and Western Medicine 2017

Authors and Affiliations

  • Tong Zhang
    • 1
  • Yu-fei Yang
    • 1
  • Bin He
    • 1
  • Dan-hui Yi
    • 2
  • Jie Hao
    • 1
  • Da Zhang
    • 1
  1. 1.Department of Oncology, Xiyuan HospitalChina Academy of Chinese Medical SciencesBeijingChina
  2. 2.School of StatisticsRenmin University of ChinaBeijingChina

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