| ObjectiveA systematic review and meta-analysis was carried out to study the efficacy and safety of traditional Chinese herbal medicine prescriptions for thyroid associated ophthalmopathy(TAO)of active period or(and)moderate to severe state,therefore to provide supportive evidence and reference for future original research.MethodsAfter conducting a background study of TAO,we formulated the inclusion and exclusion criteria.A systematic literature search was carried out using the approach of searching subject words+free words from 7 databases(Pubmed,Embase,Cochrane library,CNKI,Wanfang,VIP,SinoMed)to obtain RCTs on this topic.According to the inclusion and exclusion criteria,the literature was screened.And features of the included studies were extracted to form a feature table.The Cochrane bias risk assessment tool in Review Manager(version 5.4)was used to evaluate the methodological quality of the included studies.We also used this software to conduct meta-analysis and test the heterogeneity between research.We conducted meta-analysis in studies with low heterogeneity,and qualitative analysis when high heterogeneity occurred or when data was unsuitable for meta-analysis.Lastly,we summarized the evidence and drew conclusions.Results1.Inclusion of literature:10 studies were included with a total of 576 patients,including 290 patients in treatment groups,and 286 patients in control group,all the general information between two groups(age,gender,course of illness,etc.)are comparable(p>0.05).2.Risk of bias of studies:According to the Cochrane Bias Risk Assessment Tool,all 10 studies included had high risk of bias.3.Analysis of the outcome indicator(1)Exophthalmos:We extracted data of exophthalmos from a total of 7 studies(n=366),there was no obvious heterogeneity between these studies(heterogeneity:chi-square-3.58,P=-0.73,I2=0%).Compared to the control group that received only immunosuppressive intervention,the experimental group with intervention of Chinese herbal prescription showed better improvement in exophthalmos(WMD-1.25,95%CI-1.56 to-0.95,z=8.11,p<0.00001).(2)Clinical Activity Score(CAS):Data of CAS were extracted from 9 studies(n=525).The experimental group with intervention of Chinses herbal prescription compared favourably in terms of CAS with the control group(WMD-0.9,95%CI-1.34 to-0.46,z=4.02,p<0.0001),the heterogeneity was high(heterogenity:chi-square=57.54,p<0.00001,I2=86%).According to the differences between studies in intervention and course of treatment,1 study was excluded and subgroup analysis was conducted with the remaining studies.After subgroup analysis,the heterogeneity was greatly decreased and the result remained positive.(3)NOSPECS rating:after synthesizing the data of 3 studies(n=186),we found that the treatment group with intervention of Chinese herbal prescription had a lower NOSPECS rating than that in the control group(WMD-0.58,95%CI-0.87 to-0.30,z=3.98,p<0.0001),and the heterogeneity between studies was relatively low(heterogeneity:chi-square=2.60,p=0.27,12=23%).(4)Safety analysis:5 studies(n=282)reported the occurrence of adverse events.Overall,the number of adverse events occurred in treatment group was less than that in the control group,but there was no significant difference.ConclusionThrough systematic review and meta-analysis of the included studies,we found that Chinese herbal prescription had certain efficacy in reducing exophthalmos,CAS and NOSPECS rating in patients with active or/and moderate-to-severe Graves’ orbitopathy,no obvious superiority in overall safty was found. |
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