A randomized controlled pilot trial of "Feiji Recipe" on quality of life of non-small cell lung cancer patients.

In order to pilot a study observing the feasibility of applying the Core Quality of Life Questionnaire (QLQ-C30) version 2.0 to assess the quality of life (QOL) of patients with NSCLC treated with Feiji Recipe, a randomized, parallel controlled clinical trial was conducted in the university-affiliated hospital. Seventy inpatients who met the inclusion criteria were randomized into the study, and 60 cases were available as subjects for QOL data analysis. The subjects were randomly assigned to one of three groups: the Feiji Recipe group (A); the Feiji Recipe combined with chemotherapy group (B); and the chemotherapy group (C) in which the patients were treated with vinorelbine plus cisplatin (NP) or gemcitabine plus cisplatin (GP). QOL was assessed with the Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. Sixty cases that finished the questionnaires were analyzed, and we found that patients who received chemotherapy had low QOL, in terms of their global health, role, emotional, social, economic status and symptom burden including fatigue, nausea and vomiting, dyspnea, loss of appetite and abnormal bowel movements. Simultaneous treatment with Feiji Recipe and chemotherapy was able to prevent the worsening of function in terms of role, social, fatigue and global health. The Core Quality of Life Questionnaire (QLQ-C30) version 2.0 can be used to evaluate the QOL of patients with NSCLC treated by Chinese herbal medicine. Feiji Recipe might partially improve the QOL of NSCLC patients when administered alone or in combination with chemotherapy. No unexpected side effects were observed. However, further double-blinded placebo controlled studies are strongly recommended.

[Effects of Feiji Formula on lung cancer metastasis in mice].

OBJECTIVE: To observe the effects of Feiji Formula, a compound traditional Chinese herbal medicine, on lung cancer metastasis in mice. METHODS: The lung cancer metastasis model of mice was established in this experiment study. Twenty-four mice were randomly divided into three groups: untreated group, cisplatin group and Feiji Formula group. Mice in the Feiji Formula group were treated with Feiji Formula decoction; in cisplatin group, with cisplatin by intraperitoneal injection; and in the untreated group, with normal saline (NS). After twenty-day treatment, the body and tumor weights as well as the number of metastatic tumors in both lungs of each mouse were measured. RESULTS: The body weight of mice in cisplatin group was significantly less than that of Feiji Formula group and untreated group (P<0.01); the tumor weight of mice in cisplatin group and Feiji Formula group was markedly lower than that of untreated group (P<0.01); and the number of metastatic tumors in cisplatin group and Feiji Formula group was markedly lower than that of the untreated group (P<0.01), no significant difference between the Feiji Formula group and cisplatin group in terms of the weights and the numbers of metastatic tumors in bilateral lungs. CONCLUSION: Feiji Formula can suppress tumor growth and decrease the number of lung metastatic tumors in the mice, and maintain the body weight of the mice.

[Intervention effect of Feiji Recipe on immune escape of lung cancer].

OBJECTIVE: To evaluate the intervention effect of Feiji Recipe (FJR) on tumor immune escape. METHODS: In the prospective randomized control study, 60 cases of middle stage and advanced non-small cell lung cancer (NSCLC) with qi-yin deficiency syndrome were randomly assigned to the treatment group and the control group, 30 in each group. The levels of CD+ CD25+ Tr, interleukin-10 (IL-10), vascular endothelial growth factor (VEGF), sCD44v6 and transforming growth factor-beta1 (TGF-beta1) of peripheral blood were observed before and after treatment, and the clinical efficacy of FJR was evaluated depending upon the changes in tumor size, Karnofsky Performance scoring (KPS) and TCM syndrome. RESULTS: (1) The levels of CD4+ CD2+Tr, VEGF, sCD44v6, TGF-beta1, and IL-10 decreased, in the treatment group as compared with those in the control group, respectively. (2) The stabilization rate of tumor in the treatment group was superior to that in the control group (78.26% vs 50.00%, P < 0.05). (3) The stabilization rate of KPS increasing in the treatment group and the control group was 76.67% and 43.33% respectively, suggesting the improvement of KPS in the treatment group was superior to that in the control group (P < 0.01). (4) Improvement in TCM qi-yin deficiency syndrome was more significant in the treatment group than that in the control group. CONCLUSION: FJR can stabilize the tumor body, improve the clinical symptoms of middle stage and advanced NSCLC with qi-yin deficiency syndrome, promote patients' quality of life, and is effective in recovering immuno-surveillance and intervening immune escape of lung cancer through multi-pathway to enhance the clinical therapeutic efficacy.

[Evaluation on effect of feiji recipe on quality of life of patients with non-small cell lung cancer by adopting international questionnaire of QOL].

OBJECTIVE: To evaluate the effect of Feiji Recipe (FJR) on quality of life (QOL) of patients with non-small cell lung cancer (NSCLC). METHODS: One hundred and two patients with NSCLC were randomly assigned into 2 groups. The 61 patients in the combined treated group were given FJR and chemotherapy and the 41 patients in the control group were treated with chemotherapy alone. They were observed for two treatment courses with QOL estimated by EORTC QLQ-C43 questionnaire and FACT-L questionnaire, the two international questionnaires as the tools for measurement, and referred to the traditional evaluating indexes of clinical efficiency. RESULTS: QOL in the combined treated group was improved after treatment with the improvement of scores in all domains, including functional and symptom sub-domain, while it in the control group deprived significantly, showing significant difference between the two groups (P < 0.05). Similar results were also shown in the evaluation of physical performance by Eastern Cooperative Oncology Group (ECOG) and Karnovfsky performance scoring. The gastrointestinal reaction and myelo-suppression were slighter in the combined treated group than those in the control group (P < 0.05), and no significant difference was shown between the response rate of the two groups (P > 0.05). CONCLUSION: FJR can improve QOL of patients with NSCLC, reduce the adverse reaction of chemotherapy, and improve patients' physical performance.

[Study on the relationship among the international scales for quality of life evaluation in patients with lung cancer, the East Cooperative Oncology Group Status and Lung Cancer Symptoms Lists of TCM].

OBJECTIVE: To investigate the relationship among international scales for quality of life (QOL), physical performance assessment and Lung Cancer Symptoms Lists of Traditional Chinese Medicine (LCSL) from the viewpoint of clinical observation. METHODS: QOL of 363 patients with lung cancer was estimated with two international scales, the European Organization for Research and Treatment of Cancer QOL Questionnaire LC-43 (EORTC QLQ-LC43) and the Functional Assessment of Cancer Therapy General and Lung (FACT-L). In the same time, scores calculated by Karnofsky Performance Status (KPS), East Cooperative Oncology Group Status (ECOG) and LCSL were recorded. Correlation and consistency among them were analyzed. RESULTS: EORTC QLQ-C43, FACT-L were correlated with KPS, ECOG and LCSL, but the correlation coefficient was small. All these indexes were consistent. CONCLUSION: QOL should be assessed by QOL questionnaire, not by physical performance indexes, although they can be the simply forecast indexes of QOL. There is certain consistency between LCSL, QOL and physical performance.