| Objective:To explore the effect of traditional Chinese medicine on the nutritional status of chronic kidney disease and the current status of related experimental research.Methods:Search CNKI,WanFang,VIP,Sinomed,Pubmed,Cochrane library,Web of Science,EMBASE database for the literature of randomized controlled experiments related to traditional Chinese medicine(TCM)intervention in chronic kidney disease(CKD)which mentioned nutritional status.The wanted literature are RCT tails that observe serum albumin level in adult CKD patients with TCM intervention measures(including oral,intravenous and external use of Chinese medicine,acupuncture,qigong,dietary intervention,etc.),and the control group do not contain TCM relevant content.The retrieval date is from November 2010 to November 2020.All search results were imported to Endnote 20 to rule out duplicates automatically.Two independent researchers read the title and abstract separately to excluded those that fail to meet the inclusion criteria.The full text of the remaining literature were obtained and reviewed by two independent researchers separately to select the potential qualified ones,followed by discussion and integration of the including list.Disputation were arbitrated by a third researcher.The quality of the included literature were evaluated by two researchers independently using both Cochrane Risk Assessment Tool and JADAD Scale,disagreements were solved by discussion or arbitration of the third researcher.For literature which cannot be determined during quality evaluation,we contacted the original authors by email or telephone,the verification process ceased after two rounds of email inquiries and 1 round of telephone inquiries that received no response.The literature with JADAD scores below 3 were ruled out.The whole process and all the excluding reasons were documented.Two researchers extracted and cross-checked the data of included literature,which included basic research information(researcher and research date,patient demographic characteristics,experimental design,intervention methods,intervention period)and outcomes.Stata 14.0 was used for data analysis,I2 test was used to judge the research heterogeneity,and meta regression and clinical heterogeneity factors were applied for subgroup analysis.If there was homogeneity among the studies within the subgroup(P≥0.1,I2≤50%),the fixed effects model was used in meta analysis;randomized effect analysis model were used if the studies within the subgroup had clinical homogeneity,but showed statistical heterogeneity.For continuous variable,mean difference(MD)or standardized mean difference(SMD)were used to combine statistics.Each effect size is given a 95%confidence interval(CI)with a test level(a)of 0.05.When necessary,sensitivity analysis was applied to evaluate the stability and reliability of the meta-analysis results.If the number of included studies was more than 10,the funnel chart was used to judge publication bias.Results:Most of the studies on the nutritional status intervened by TCM were focused on the final stage of CKD.The observational indicators of nutritional status are quite different from study to study,and the diagnostic criteria for CKD malnutrition are diverse.22 domestic study were included for meta analysis with 1,718 patients,including 861 in treatment group and 857 in the control group.Laboratory indicators:1)Alb:The influence of TCM intervention on Alb has no significant correlation with TCM syndromes and intervention measures compared with the control group,but it has a high correlation with CKD stage and nutritional status comprehensive grouping.Only subgroup of stage 5 CKD which did not mention the nutritional status meets the criteria of meta-analysis,MD:0.54,95%CI:[0.261.0.81],P=0.008<0.05,suggesting that in this specific subgroup,traditional Chinese medicine has a better effect on improving Alb level compared with the control group.The high heterogeneity between groups suggests that traditional Chinese medicine has different effects on patients with different stages of CKD and different nutritional status.2)PA:The efficacy of TCM compared with the control group has a lower correlation with CKD staging and intervention measures,while having high correlation with nutritional status,comprehensive grouping,and TCM syndrome types.The effect of TCM on the malnutrition group and the group not mentioning the nutritional status are better than that of control group;Subgroup of malnutrition,MD:1.27,95%CI:[0.88,1.66],P=0.008<0.05;Subgroup with unmentioned nutritional status,MD:0.47,95%CI:[0.21,0.74],P=0.027<0.05,the differences are statistically significant.Subgroup of CKD stage 2-4 with malnutrition,MD:1.37,95%CI:[1.013,1.727],P=0.084>0.05;CKD stage 5 with mild to moderate malnutrition subgroup,MD:2.539,95%CI:[2.015,3.064],P=0.067>0.05.The differences are not statistically significant.MD of the right-qi deficiency group:0.42,95%CI:[0.11,0.74],P=0.033<0.05,the difference is statistically significant;For no TCM syndrome tagged subgroup,MD:1.34,95%CI:[0.94,1.74],P=0.097>0.05.The effect of TCM on PA was related to the TCM syndrome type.3)TF:The degree of effect of Chinese medicine on TF has no obvious correlation with CKD staging,nutritional status,comprehensive grouping,TCM syndrome type,or intervention measures.4)CHO:Nutritional status,TCM syndrome,intervention measures all have low correlation with the combined MD of CHO,whereas CKD staging had a high correlation,but the effect of TCM on CHO of CKD stage 5 patients is not significantly different than that of the control group.5)BUN:The nutritional status,TCM syndrome type and the effect of BUN have low correlation with MD.CKD staging and intervention measures are highly correlated with it,but due to the high heterogeneity within the subgroups,meta-analysis cannot be performed.6)Scr:The change of Scr by traditional Chinese medicine has low correlation with intervention measures and TCM syndrome type,and has high correlation with CKD staging.CKD stage 2-4 subgroup,MD:-0.69,95%CI:[-0.95,-0.43],P=0.035<0.05,the difference is statistically significant,suggesting that TCM has a significant effect on reducing Scr in patients with CKD2-4 Better than the control group.7)HGB:After deleting 2 highly heterogeneous studies,a total number of 1329 patients were finally included,and the data was merged using a random effects model,MD:0.54,95%CI:[0.34,0.74],P=0.000<0.05,The results are statistically significant,suggesting that compared with the control group,TCM can effectively improve the HGB level of CKD patients,regardless of stages,nutritional status,syndromes.However,the funnel chart test suggests that there is publication bias,so the research conclusions are limited.Anthropometric signs and scales:BMI,MAC,MAMC and scores of scales are all heterogeneous among studies,consequently meta-analysis cannot be performed.Adverse reactions:The adverse reactions caused by the intervention of TCM are relatively small,and there are no serious adverse reactions.Conclusion:Traditional Chinese medicine interventions have different effects on different CKD nutritional status indicators.About laboratory indicators,firstly,the effect on Alb of different comprehensive group which divided by CKD stages and nutritional status is quite different;Besides,TCM can significantly improve the PA level of CKD patients,and the degree of effect is affected by nutritional status,comprehensive grouping and TCM syndrome type;Meanwhile,large discrepancy of TCM’s efficacy are found on patients’ TC level of different CKD stages;Adding to that,most research show that TCM can improve the HGB level of CKD patients.Lastly,there is no clear conclusion on the efficacy of traditional Chinese medicine on TF,BUN,and Scr,thus further research and observation are needed.As for anthropometric indicators of BMI,MAC,MAMC,also SGA and MQSGA scales,no clear conclusion can be achieved.Finally,according to this study,the adverse reactions caused by traditional Chinese medicine interventions are relatively mild,and there are no serious adverse events. |
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