Shenyi Capsule Prolongs Postoperative Survival of Patients with Nonsmall Cell Lung Cancer: A Multicenter, Randomized, Controlled Trial

Objective:The objective of this study was to examine the effect of the postsurgical administration of Shenyi capsules on the outcome and overall survival of patients with nonsmall cell lung cancer(NSCLC).Materials and Methods:This was a multicenter,randomized,placebo-controlled,double-blind clinical trial.Patients with stages I–IIIA NSCLC were randomized to Shenyi or placebo groups(treatment duration:6 months)and followed up for 10 years.One-year,2-year,5-year,and 10-year survival rates and survival times were calculated.Symptoms,quality of life,traditional Chinese medicine(TCM)syndrome,and recurrence were evaluated.Results:A total of 361 patients(treatment group,n=185;placebo group,n=176)were randomized and followed up for 10 years.The two groups had similar baseline demographic and clinical characteristics.Among all 361 patients,the treatment group had significantly longer median survival(31 months,respectively)than the placebo group(22.3 months,P<0.01).In stage II or III patients,recurrence and metastasis rates in the treatment group were lower than those in the placebo group(P<0.05).The treatment group also had significantly longer 1-year and 2-year survival rates based on the full analysis set and per-protocol set;however,there was no statistically significant difference in the 5-year and 10-year survival rates(P<0.01 for all comparisons).Multivariate analysis of variance showed that the interaction between stage and age had a significant impact on overall survival(P<0.05).Compared with the placebo group,the treatment group showed a significant decrease in TCM syndrome(P<0.01)and a significant increase in the Karnofsky Performance Score(P<0.01)and body weight(P<0.05).Conclusions:Adjunctive therapy with Shenyi capsules significantly prolonged the 1-year and 2-year survival rates after surgery and improved the quality of life.Moreover,none of the patients experienced severe adverse effects.These results suggest that Shenyi capsules may have clinical applications in treating patients with NSCLC.

Shenyi Capsule(参一胶囊) plus Chemotherapy versus Chemotherapy for Non-Small Cell Lung Cancer:A Systematic Review of Overlapping Meta-Analyses

Objective：To assist decision-makers interpret and choose among conflicting meta-analyses,as well as to offer treatment recommendations based on current best evidence by performing a systematic review of overlapping meta-analyses regarding Shenyi Capsule（参一胶囊,SC） plus chemotherapy versus chemotherapy of non-small cell lung cancer（NSCLC）.Methods：A literature search was conducted to select systematic reviews comparing SC plus chemotherapy with chemotherapy for NSCLC.Meta-analyses only composed of randomized controlled trials（RCTs） met the inclusion criteria.Two authors individually estimated the quality of meta-analysis and extracted data.The Jadad decision algorithm was applied to guarantee which meta-analysis provided the best original evidence.Results：A total of 5 meta-analyses were included.All the studies composed of RCTs or quasi-RCTs and were regarded as level-Ⅱ evidence.The scores of the Assessment of Multiple Systematic Reviews ranged from 3 to 6（median 4）.A high-quality meta-analysis with more RCTs was chosen,which suggested that SC plus chemotherapy could increase incidence of short-term efficacy,improve the quality of life and survival rate in comparison to chemotherapy.However,there was no statistically significant difference between SC plus chemotherapy and chemotherapy regarding chemotherapy-induced side effect,such as liver and kidney function obstacle,leukopenia,hemoglobin decrement and gastrointestinal adverse reaction.Conclusions：Based on the best available evidence,treatment effect of SC plus chemotherapy was better than chemotherapy and did not increase side effects.Therefore,SC plus chemotherapy may be superior to chemotherapy for treating NSCLC.However,due to some limitations,SC plus chemotherapy should be cautiously considered,and further high-quality meta-analyses are needed.

Effect and Mechanism of Ginsenoside Rg3 on Postoperative Life Span of Patients with Non-Small Cell Lung Cancer

Objective： To explore the effect and mechanism of ginsenoside Rg3 （Shenyi Capsule, 参一胶囊） on the postoperative life span of patients with non-small cell lung cancer （NSCLC）. Methods： The prospective, randomized, controlled method was adopted. One hundred and thirty- three patients with NSCLC were randomly assigned to 3 groups： Shenyi Capsule group （43 cases）, combined therapy group （Shenyi Capsule plus chemotherapy, 46 cases）, and chemotherapy group （44 cases）. The survival rates, immune function and the correlation between vascular endothelial growth factor （VEGF） expression and clinical effect were analyzed in the three groups. Results： （1） The 1-year survival rate in the Shenyi group, the combined group and the chemotherapy group was 76.7% （33/43）, 82.6% （38/46）, and 79.5% （35/44）, respectively; the 2-year survival rate was 67.4% （29/43）, 71.7% （33/46）, and 70.5% （31/44）, respectively; and the 3-year survival rate was 46.5% （20/43）, 54.3% （25/46）, and 47.7% （21/44）, respectively. There was no significant difference among the 3 groups （P〉0.05）. （2） NK cells were increased to different degrees and the ratio of CD4/CD8 was normal in the Shenyi Capsule group and the combined group, while the ratio of CD4/CD8 was disproportional in the chemotherapy group. （3） In the chemotherapy group, the 3-year survival rate was lower in patients with positive expression of VEGF than in patients with negative expression （37.0% vs 64.7%, χ^2=17.9, P〈0.01）, but no significant statistical difference was shown in the other two groups （53.6% vs 55.6%, P〉0.05; 44.4% vs 50.0%, P〉0.05）. Conclusion： Shenyi Capsule, especially in combination with chemotherapy, can improve the life span of patients with NSCLC after operation. The mechanism might be correlated with improving the immune function and anti-tumor angiogenesis.