Abstract��
OBJECTIVE To assess the methodological quality of clinical studies using Shenqi Fuzheng injection as an adjunct therapy to tumor chemotherapy and to evaluate its safety. METHODS Randomized controlled trials (RCTs) were identified from MEDLINE (1989 to Dec.2008)�� EMBASE (1989 to Dec.2008)�� Cochrane Controlled Trials Register�� Chinese Cochrane Centre Database�� CBMdisc (1989 to Feb.2009)�� and TCMLRS (1989 to Feb.2009). We handsearched the related published and unpublished data and their . All trials about comparing Shenqi Fuzheng injection plus routine chemotherapy versus routine chemotherapy alone were included. Data were extracted and evaluated by two reviewers independently with designed extraction form. RevMan 4.2.8 software was used for data analysis. RESULTS Sixteen RCTs met the inclusion criteria. methodological quality was poor(all the trials included were level C).Compared with the control group��the combined outcome of Shenqi Fuzheng injection increased the safety of chemotherapy[OR 1.67��95��CI 1.30��2.15]�� P<0.000 1]��reduced the side effect of bone marrow inhibition[OR 0.23��95��CI (0.14�� 0.37)�� P<0.000 01 in WBC counting�� OR 0.71��95��CI(0.39��1.29)�� P=0.26 in PLT count�� OR 0.25��95��CI(0.14��0.43)�� P<0.000 1 in HB count.]And Shenqi Fuzheng injection relieved the symptoms of nausea and vomiting [OR0.27��95��CI(0.13�� 0.58)�� P=0.000 7]�� and alleviated the quality of life[OR 3.92��95��CI(2.77��5.57)��P=0.000 7]. CONCLUSION The methodological quality of the trails using Shenqi Fuzheng injection should be improved. Based on the results of the review and the meta-analysis�� Shenqi Fuzheng injection may have positive effects on chemotherapy in patients with malignant tumor�� although the evidence is weak. No serious adverse events are reported.Further welldesigned clinical trials should be performed.
2010, Vol. 45 
