Article Abstract

Using single-patient (n-of-1) trials to determine effectiveness of traditional Chinese medicine on chemotherapy-induced leukopenia in gastric cancer: a feasibility study

Authors: Jiang Li, Junqiang Niu, Min Yang, Peizhi Ye, Jingbo Zhai, Wenzhen Yuan, Li Feng, Guihua Tian, Jiayuan Hu, Yaohan Wang, Hongcai Shang


Background: Gastric cancer has been the second cause of cancer death worldwide. Chemical comprehensive treatment programs primarily were the main therapy method with modest efficacy to gastric cancer. Traditional Chinese medicine (TCM) has been reported to alleviate adverse events induced by chemotherapy, but has not yet developed clinical trials to test and needs scientific evidence for making policy. Single-patient (N-of-1) trials might be an eligible study design for TCM since it well represented the individualized treatment philosophy of TCM. The aim of this study is to obtain information necessary to design a more series trial.
Methods: Individuals who underwent gastrectomy were included. Each patient suffered 3-week standard chemotherapy and 3-day treatment periods (decoction with Astragalus mongholicus and Semen Cuscutae or placebo: decoction without Astragalus mongholicus and Semen Cuscutae). Each trial lasted up to a maximum of 30 weeks or a minimum of 20 weeks. Staffs and participants were blinded to the randomization. This study was approved by Ethics Committee of First Hospital, Lanzhou University in November, 2014.
Results: From August, 2014 to March, 2015, 6 participants were included. There were 16 cycles compared between intervention and control decoction (2.28, 95% CI: 1.24–5.47), P<0.0001. The quality of life (QoL) score after the trial was reported is a little higher than before, t=3.87, P=0.01. Two participants reported symptoms had improved after taken trial decoction.
Conclusions: This is the first N-of-1 trials of testing the effectiveness of TCM decoction on alleviative treatment to gastric cancer. The feasibility study will help to develop a practical design for the more series trial.