Impact of complementary mistletoe extract treatment on quality of life in breast, ovarian and non-small cell lung cancer patients. A prospective randomized controlled clinical trial.

Standardized aqueous mistletoe extracts have been applied to cancer patients for several decades as complementary medicine. A multicentric, randomized, open, prospective clinical trial was conducted in three oncological centers in the People's Republic of China in Bejing, Shenyang and Tianjin. Following the guidelines of "Good Clinical Practice" (GCP) this study was performed to get information on efficacy safety and side-effects of the standardized mistletoe extract (sME). Two hundred and thirty-three patients with breast (n=68), ovarian (n=71) and non-small cell lung cancer (NSCLC; n=94) were enrolled into this study. Two hundred and twenty-four patients fulfilled the requirements for final analysis (n=115 treated with sME HELIXOR A; n=109 comprising the control group being treated with the approved immunomodulating phytopharmacon Lentinan). All patients were provided with standard tumor-destructive treatment schedules and complementarily treated with sME or Lentinan during chemotherapy according to treatment protocol. Biometrically, the patients of the control and sME treatment group were comparable regarding distribution, clinical classification (WHO) and treatment protocols. Analysis was performed according to the "Intention to treat principle". Quality of life (QoL) was significantly (p<0.05) improved for patients who were complementarily treated with sME, as determined by the questionnaires FLIC (Functional Living Index-Cancer), TCM (Traditional Chinese Medicine Index) and the KPI (Karnofsky Performance Index) in comparison to the control group. Additionally, the occurrence of adverse events (AEs) was less frequent in the sME than in the control group (total number of AEs 52 versus 90 and number of serious AEs 5 versus 10 in study and control group, most of them due to chemotherapy). Only one serious AE was allocated to complementary treatment in each group (1 angioedema in sME group). All other side-effects of the sME (7 harmless local inflammatory reactions at subcutaneous injection site, 4 cases with fever) were self-limiting and did not demand therapeutic intervention. This study showed that complementary treatment with sME can beneficially reduce the side-effects of chemotherapy in cancer patients and thus improve quality of life.

Clinical and experimental studies on stomach carcinoma treated with Yangwei Kangliu granules.

AIM: To study the anti-cancer mechanism of Yangwei Kangliu (YWKL) granules from the view point of red blood cell (RBC) immunity and to investigate the relationship between RBC immunity and T lymphocyte immunity. METHODS: Fifty patients with advanced gastric carcinoma were treated with a combination of YWKL granules and chemotherapy. Venous blood samples were obtained before treatment and after one course of treatment. The rosette rate of c-3b-receptor (RBC-C-3bRR), tumor and red cell (RRTR) and RBC immune complex (RBC-ICR) were measured under microscopy by counting the rosettes formed by sensitized or unsensitized yeast adherence. The T lymphocyte subset was observed by the method of APAAP. Control patients were treated with chemotherapy alone (n = 20). In addition, mouse tumor studies were performed to investigate the dynamic changes of RBC-C-3bRR, RRTR and RBC-ICR in response to treatment with YWKL granules (n = 30). Mice treated with chemotherapy alone (n = 30) or water alone (n = 30) were used as controls. RESULTS: The clinical therapeutic effect of combination treatment with YWKL granules and chemotherapy (i.e. the treatment group) was markedly superior to that of chemotherapy alone (i.e. the control group) (P < 0.01). In the treatment group, the rosette rates of RBC-C-3bRR and of RRTR were significantly increased (P < 0.01) after treatment, the rate of RBC-ICR was markedly decreased (P < 0.01), and the ratio of CD4 to CD8 was obviously elevated (P < 0.01). Moreover, CD8 was much lower (P < 0.01) and the ratio of CD4 to CD8 was much higher (P < 0.01) than that in the control group. The RRTR rate was positively correlated with the ratio of CD4 to CD8. In mice, on day 9 of bearing cancer, the tumor weight in the group treated with YWKL granules alone was much lower than that of the tumors in the control mice groups; in addition, the YWKL treated mice showed higher RBC immune function than the mice of the two control groups. On day 13 of bearing cancer, however, the differences in both tumor weight and RBC immune function had disappeared. CONCLUSION: The anti-cancer mechanism of YWKL granules may involve enhancement of RBC immunity and of T lymphocyte immune function, which is supported by the finding of RBC immune function being correlated with T lymphocyte immune function.