The efficacy of compound kushen injection in preventing and treating radiation-induced oral mucositis: a systematic review and meta-analysis

Naijun Yuan, Guijuan Zhang, Xianxin Yan, Xuefeng Jiang, Min Ma, Yi Ma, Xiaoqian Hao, Yanhong Lv, Chunxin Lu, Yunbo Chen
2017 Int J Clin Exp Med   unpublished
Oral Mucositis (OM) is a common complication of head and neck cancer with radiotherapy. Given the intractable complication with the radiotherapy of cancer, many patients seek additional prevention and treatment methods that may reduce the incidence, decrease pain, and improve the quality of life. Several random-ized controlled trials (RCTs) have reported that Compound Kushen Injection (CKI), a traditional Chinese medicine injection, is efficient in OM. The purpose of this meta-analysis was to
more » ... aluate the clinical evidence for or against CKI as a treatment for OM. Methods: Our research registered in PROSPERO (International prospective register of systematic reviews). The registration number is CRD42016049460. We searched the following electronic databases: PubMed, Web of Science, EMBASE, CENTRAL, CNKI, CBM, VIP and Wan-fang Data databases from their inception to September 2016. Searchers were restricted to randomized controlled clinical studies of CKI to intervention for the treatment of OM and without language restrictions. The outcome measures were the grade of radioactive-stomatitis, the pain degree of radiation-induced oral mucositis; Healing time of impaired oral mucosal; The improvement rate for the quality of life, recent therapeutic evaluation of tumor. Used the Cochrane risk of bias to assess the methodological quality of all RCTs. Meta-analysis, sensitivity analysis, publication bias of data was applied RevMan 5.3 software (Cochrane Collaboration) and Stata software. Also, this meta-analysis is reported according to the Preferred Reporting Items or Systematic Reviews and Meta-Analyses (PRISMA) guideline strictly, and the level of evidence assessed by the GRADE approach. Results: We included 18 RCTs (n=1,647). All studies used an active control group. The quality for methodological of included studies was limited. We analyzed data from 18 studies reporting on the grade of radioactive-stomatitis (Relative Risk [RR] of 0.50, 95% CI (0.44, 0.57), P<0.0001). The degree of pain in radioactive-stomatitis included 4 studies, (RR=0.47, 95% CI (0.36, 0.61), P<0.0001). The healing time of oral mucosa included two studies, (RR=1.92, 95% CI (1.15, 2.68), P<0.0001). The improvement rate for the quality of life for adopting CKI described in all five included studies, (RR=1.36, 95% CI (1.17, 1.57), P<0.0001). The recent therapeutic evaluation of solid tumour included 9 studies, (RR=1.14, 95% CI (1.01, 1.30), P<0.0001). Conclusion: Current evidence considering insufficient to show that CKI is an effective treatment of radiation-induced oral mucositis. Such as limited patient numbers, the high risk of bias in the included studies, and reports on adverse effects. But it still provides a clinical choice for the prevention and treatment of OM. More precise studies are required.