title: Injectable Chinese herbal formula Kang'ai for nonsmall cell lung cancer: Trial sequential analysis of 2,259 participants from 31 randomized controlled trials.
abstract: OBJECTIVE
  The aim was to evaluate the efficacy and safety of Kang' ai (KA) injection for patients with nonsmall cell lung cancer (NSCLC). Furthermore, to identify if more trials are needed before reliable conclusions could be drawn with regard to these outcomes.
  
  
  METHODS
  We searched the Cochrane library, PubMed, EMBASE, VIP, CBMdisc, and CNKI in September 2012, and then an additional updated search was conducted in January 2013. Only relevant randomized controlled trials (RCTs) on KA injection plus first-line cisplatin-based chemotherapy in the treatment of NSCLC were identified. Trials' data was reviewed and extracted by two reviewers independently. The quality of included studies was assessed according to a statement from Cochrane Handbook. RevMan 5 Software and Trial sequential analysis (TSA) software were applied for data analyses.
  
  
  RESULTS
  A total of 31 RCTs involving 2259 patients were included. The results of meta-analysis showed that compared with chemotherapy alone, the combination of KA injection plus chemotherapy had a statistically significant benefit in improving clinical response rate (relative risk [RR] =1.29, 95% confidence interval [CI]: 1.17-1.41, P < 0.00001), clinical benefit rate (RR = 1.19, 95% CI: 1.14-1.25, P < 0.00001) and quality of life (RR = 1.79, 95% CI: 1.63-1.98, P < 0.00001); hematological toxicity (white blood cell) (RR = 0.71, 95% CI: 0.66-0.76, P < 0.00001) and nonhematological toxicity (nausea and vomiting) (RR = 0.73, 95% CI: 0.65-0.83, P < 0.00001) were improved as well. TSA showed that all cumulative Z-score crossed their monitoring boundaries, demonstrating that no more trials are needed before reliable conclusions could be drawn.
  
  
  CONCLUSIONS
  Current evidence presented that KA injection might improve the therapeutic effect when combined with chemotherapy. Moreover, no more trials are needed in future according to TSA. Nevertheless, additional randomized studies investigating KA injection are needed to be further evaluated.
authors.affiliation: Department of Integration of Traditional Chinese and Western Medicine, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University School of Oncology, Peking University Cancer Hospital and Institute, Beijing 100142, China.
authors.forename: Xi-Ran
authors.initials: XR
authors.lastname: He
authors.affiliation: Department of Integration of Traditional Chinese and Western Medicine, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University School of Oncology, Peking University Cancer Hospital and Institute, Beijing 100142, China.
authors.forename: Shu-Yan
authors.initials: SY
authors.lastname: Han
authors.affiliation: Department of Integration of Traditional Chinese and Western Medicine, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University School of Oncology, Peking University Cancer Hospital and Institute, Beijing 100142, China.
authors.forename: Ping-Ping
authors.initials: PP
authors.lastname: Li
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D017594:Publication Bias; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D004365:Drugs, Chinese Herbal