title: A systematic review and meta-analysis on the use of traditional Chinese medicine compound kushen injection for bone cancer pain.
abstract: OBJECTIVE
  Bone cancer pain presents a clinical challenge with limitations of current treatments. Compound kushen injection (CKI) is a well-known traditional Chinese medicine (TCM) formulation in treatment of patients with bone cancer pain. The objective of this study is to assess the efficacy and safety of CKI for bone cancer pain.
  
  
  METHODS
  A systematic literature search was conducted in nine databases until December 2012 to identify randomized controlled trials (RCTs) of CKI versus current western therapies for bone cancer pain. The primary outcome was total pain relief rate. The secondary outcomes were the quality of life and adverse events at the end of treatment course. The methodological quality of RCTs was assessed independently using six-item criteria according to the Cochrane Collaboration, and the level of evidence was assessed by the GRADE approach. All data were analyzed using Review Manager 5.1.0.
  
  
  RESULTS
  Seven RCTs with 521 patients from 2010 to 2012 were identified. Compared with radiotherapy or bisphosphonates, seven RCTs showed significant effects of CKI for improving pain relief in patients with bone cancer pain (n = 521, risk ratio (RR) = 1.25, 95 % CI (95 % confidence intervals (CI)), 1.13 to 1.38, p < 0.0001)), three RCTs for improving Karnofsky scoring (KPS) increase rate (n = 305, RR = 1.62, 95 % CI, 1.32 to 1.99, p < 0.00001), 1 RCT for increasing KPS scores (n = 78, mean difference (MD) = 10.43, 95 % CI 4.76 to 16.10, p = 0.0003). 4 RCTs reported adverse effects in both the treatment and control groups. The patients treated with CKI achieved statistically significant reductions of incidences of leukopenia (n = 276, RR = 0.32, 95 % CI, 0.21 to 0.47, p < 0.00001) and nausea (n = 78, RR = 0.15, 95 % CI, 0.06 to 0.34, p < 0.00001). No severe adverse events were found and no treatment was stopped because of adverse events of CKI in the treatment groups. However, the studies were deemed to have a high risk of bias.
  
  
  CONCLUSIONS
  This systematic review showed positive but weak evidence of CKI for bone cancer pain because of the poor methodological quality and the small quantity of the included trials. Future rigorously designed RCTs are required.
authors.affiliation: Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beixiange 5, Xicheng District, Beijing, 100053, China, baoyanju@126.com.
authors.forename: Bao
authors.initials: B
authors.lastname: Yanju
authors.forename: Liping
authors.initials: L
authors.lastname: Yang
authors.forename: Baojin
authors.initials: B
authors.lastname: Hua
authors.forename: Wei
authors.initials: W
authors.lastname: Hou
authors.forename: Zhan
authors.initials: Z
authors.lastname: Shi
authors.forename: Weidong
authors.initials: W
authors.lastname: Li
authors.forename: Conghuang
authors.initials: C
authors.lastname: Li
authors.forename: Cihui
authors.initials: C
authors.lastname: Chen
authors.forename: Rui
authors.initials: R
authors.lastname: Liu
authors.forename: Yinggang
authors.initials: Y
authors.lastname: Qin
authors.forename: Wenliang
authors.initials: W
authors.lastname: Lv
mesh_terms: D000328:Adult; D000368:Aged; D001859:Bone Neoplasms / Q000503:physiopathology*; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic
chemical_list: D004365:Drugs, Chinese Herbal; C494416:kushen