Systematic Evaluation And Meta-analysis Of Oral Chinese Medicine Intervention For Esophageal Cancer Chemotherapy

[Research backgroud]Esophageal cancer is one of the most frequent malignant tumors of digestive tract in China.Chemotherapy is the main treatment for advanced esophageal cancer,because of its concealment of onset and poor surgical opportunity.At present,the chemotherapy regimens of esophageal cancer mainly include fluorouracil + platinum,paclitaxel + platinum and irinotecan + platinum.The side effects of chemotherapy are mainly nausea and vomiting,diarrhea,myelosuppression,peripheral neurotoxicity,liver and kidney dysfunction,alopecia and so on.The incidence of adverse reactions such as nausea and vomiting and myelosuppression is still high,and supportive treatment is the main treatment in mordem medicine.Chinese medicine is relatively inexpensive,safe and effective,which can improve the curative effect of esophageal cancer and reduce the incidence of side effects.In clinical reports,Chinese Medicine supplementing chemotherapy intervenes in the treatment of esophageal cancer mainly by supplementing qi and nourishing Yin,strengthening spleen and tonifying kidney,resolving phlegm and dispersing stagnation,activating blood and eliminating disease,detoxifying and dispersing knots.In recent years,the clinical research has achieved satisfactory results in the intervention of traditional Chinese medicine supplementing chemotherapy in the treatment of esophageal cancer.However,most of the methodological quality of literatures is not high,and the efficacy and safety of oral Chinese medicine supplementing chemotherapy in the treatment of esophageal cancer has not been confirmed by systematic reviews[Research objective]The purpose of this study is to evaluate the efficacy and safety of oral Chinese medicine supplementing chemotherapy in the treatment of esophageal cancer to improve the efficacy of chemotherapy,reduce the incidence of side effects,and provide evidence for clinical practice.To provide a reference for future clinical studies,a systematic evaluation of the methodological quality of the randomized controlled clinical trials on the treatment of esophageal cancer by oral Chinese medicine supplementing chemotherapy was conducted.[Research methods]We performed a literature search on Chinese Biomedical database(CBM)?China National Knowledge Infrastructure(CNKI)Chinese VIP journal database(VIP)?WanFang Database?Medline(PubMed)?Embase?and The Cochrane Library.Then we screened literatures according to inclusion and excluding criteris,extracted data,evaluated methodological quality,and used Revman5.3 software for data analysis.[Research results]After screening the literature,52 researchs were finally included,and the number of total samples was 3829.All patients were treated with chemotherapy for esophageal cancer,and the patients in experimental group were given traditional Chinese medicine on the basis of chemotherapyMethodological quality evaluation:In the 52 researchs included,14 researchs used low risk random methods.all studies did not mention random hidden and blinding.2 studies had fallen cases,with no selective reporting outcome.There was no clear evidence of other sources of bias.The results of the Meta analysis:Recent efficiency:38 studies reported the recent efficiency(I2=0%,RR=1.36,95%CI 1.26 to 1.46,P<0.00001),which suggesting that oral Chinese medicine can significantly improve the short-term efficacy of chemotherapy for esophageal cancer.Survival period:3 studies reported half a year survival period(I2=91%,RR=1.18,95%CI 0.79 to 1.76,P=0.43);6 studies reported 1 year survival period(I2=0%,RR=1.43,95%CI 1.22 to 1.68,P<0.0001);3 studies reported the 2 years survival period(I2=0%,RR=1.80,95%CI 1.24 to 2.60,P=0.002);3 studies reported 3 years survival period(12=0%,RR=2.30,95%CI 1.46 to 3.61,P=0.0003),which showed that the half a year survival period of the esophageal cancer patients with the treatment of chemotherapy and oral Chinese medicine was not significantly improved,and the survival period of 1,2 and 3 years was obviously improved.KPS score:12 studies reported the changes of the KPS score(I2=72%,MD=7.29,95%CI 5.3 to 9.28,P<0.00001),and 17 studies report the numbers of KPS scores improved and stabilized(I2=59%,RR=1.23,95%CI 1.13 to 1.35,P<0.00001).It indicates that oral Chinese medicine can significantly improve the quality of life of esophageal cancer patients undergoing chemotherapy.Digestive reaction:25 studies reported the number of CINV cases(I2=96%,RR=0.57,95%CI 0.43 to 0.75,P<0.00001).7 studies reported the number of CID cases(I2=0%,RR=0.51,95%CI 0.39 to 0.66,P<0.00001).It shows that oral Chinese medicine can obviously reduce the occurrence of CINV and CID.Myelosuppression:29 studies reported the number of cases of leukocyte reduction(I2=68%,RR=0.67,95%CI 0.62 to 0.73,P<0.00001);17 studies reported the number of anaemic cases(I2=0%,RR=0.67,95%CI 0.57 to 0.80,P<0.00001);and 22 studies reported the number of thrombocytopenia(I2=14%,RR=0.54,95%CI 0.46 to 0.65,P<0.00001),indicating that the incidence of leukenia,anemia and thrombocytopenia could be significantly reduced by oral Chinese medicine for esophageal cancer patients undergoing chemotherapy.Liver and kidney function:13 studies reported the number of liver dysfunction cases(I2=0%,R=0.69,95%CI 0.52 to 0.93,P=0.01),and 16 studies reported the number of cases of renal dysfunction(I2=0%,RR=0.63,95%CI 0.45 to 0.90,P=0.01).It shows that oral Chinese medicine can reduce the incidence of abnormal liver function and renal dysfunction of esophageal cancer patients undergoing chemotherapy.[Research conclusion]Traditional Chinese medicine can improve the curative effect of chemotherapy of esophageal cancer,prolong the survival time,and reduce the occurrence of digestive tract reaction,myelosuppression and liver function abnormality.It is safe and effective without renal toxicity.So,it is worthy of clinical promotion.However,the quality of literatures is generally not high,which leads to a low level of evidence.In the future clinical researchs,we should strictly standardize the design and implementation of randomized controlled trials,so as to provide high-level evidence-based medical evidences.