| Objective:The objectives of this study are to comprehensively search clinical trials on Traditional Chinese Medicine(TCM)as a treatment to myasthenia gravis(MG),summary and analyze the current status of clinical studies on TCM for MG,understand their trend,characteristics and limitation,in order to provide evidence-based support for future clinical application of TCM for MG and researches on this.In addition,based on the clinical trials of myasthenia gravis in Chinese medicine we’ve got,randomized controlled trial was selected to evaluate the efficacy and safety of TCM as treatment for myasthenia gravis.Method:A bibliometric research was conducted for clinical trials of TCM for myasthenia gravis.The author conducted a comprehensive literature search,data extraction,data analysis and results report.Search method:A comprehensive search was conducted for all clinical trials on TCM for MG in China National Knowledge Infrastructure(CNKI),Chinese Scientific Journal Database(VIP),Sino-Med,Wanfang Database,PubMed,and the Cochrane Library from their inception to November 2016.Inclusion criteria:Participants:Patients with myasthenia gravis.Intervention/expose:Traditional Chinese treatment,for example,Chinese herbal medicine,acupuncture,moxibustion,Tuina,Gua Sha,cupping,and qigong.Study type:Randomized controlled trial(RCT),clinical controlled trial(CCT),cohort study,case-control study,case series,and case report.Besides,we also included studies which contain information about the case of MG but don’t belong to any type of studies above.If the literature has other important outcomes also can be included.Data extraction and analysis:Three authors participated in the extraction of data,and were reviewed and summarized by key investigators.Epidata3.1 software was used to designed data extraction form.The following information was extracted:publication information;patient information;disease/condition;TCM treatment information.Data analysis was conducted using SPSS 22.0,presenting as counts,percentage and frequency.Quality assessment of study:The risk of bias tool which recommended by Cochrane handbook was used to evaluated methodological quality of RCT.Methodological index for non-randomized studies(MINORS)was used to evaluated methodological quality of CCT.Cohort study and case-control study were using the Newcastle-Ottawa scale assess the risk of bias.Case series quality evaluation items which recommended by the National Institute for Clinical Hospital(NICE)was used to evaluate methodological quality of case series.Case report evaluate by TCM case report writing entries which proposed by Yang H.Effectiveness evaluation:We included the RCT from bibliometric research.But only studies which compared TCM with non-treated or placebo or conventional western medicine were included.Outcomes:mortality;recurrence rate;symptom evaluation indicators,quality of life,safety indicators,immune function indicators;incidence rate of myasthenia crisis.RevMan 5.3 software was used to perform data analysis which contains heterogeneity test,pooled analysis,subgroup analysis,and sensitivity analysis.Relative risk(RR)and 95%confident index(CI)were used to estimate the effect size of dichotomous data,and mean difference(MD)or standardized mean difference(SMD)for continuous variable.According to the results of heterogeneity test and I2 value select the fixed effect model or random effect model.Subgroup conducted according to the course,or TCM syndrome differentiation.When the number of studies included in the meta-analysis is more than 10,the funnel plot is used to estimate the publication bias.Result:A total of 484 literatures were included in this study,including 88 randomized clinical trials,12 non-randomized controlled clinical studies,109 case series and 275 case reports.The main findings are as follows:(1)Clinical research about TCM as treatment of myasthenia gravis has been published in large numbers.This study collected randomized clinical trials,non-randomized controlled clinical studies,case series and case reports.There is no cohort study and case-control study included.(2)The number and trend of different studies were different.The number of randomized controlled trials and case reports showed a steady increase year by year.The number of cases series and non-randomized clinical trials was declining.(3)The type of myasthenia gravis treated with TCM treatment covers all types,including typel/eye type and Ⅱb.The studies about type V and type of muscle atrophy were rare because of the incidence is low.A total of 336(336/538,62.45%)studies reported the classification of TCM syndrome,which Deficiency is the most commonly syndrome.(4)Chinese medicine treatment measures for myasthenia gravis are quite a lot.A total of 178 treatment measures were reported in studies we include.Drug treatment measures 169 species which contain 9 kinds of dosage form.The top three frequently dosage form are decoction,pills,and capsules.A total of 455 decoctions were used.The highest frequency decoction is researchers combined themselves based on syndrome differentiation(148/455,32.53%).Besides,top three frequently used decoctions are Buzhong Yiqi decoction(116/455,25.49%),Sijunzi decoction(11/455,2.42%)and Astragalus compound(7/455,1.54%).Non-drug intervention measures 6 species:acupuncture(118/144,81.94%),Tuina(8/144,5.56%),and acupoint injection(8/144,5.56%)and so on.(5)The quality of clinical research TCM for myasthenia gravis is generally low.The biggest problem is the report of selection process of the study object and the intervention process is unclear which leading to information insufficient and researchers are inability to evaluate the details of the study.A total of 70 trials and 5395 participants were included in last part.Seventy trials included 12 types of intervention controls type.Twenty-seven meta-analyses have been performed.And 20 meta-analyses had significant statistical difference:effective rate,QMG scores in Chinese herbal medicine versus anticholinesterase;effective rate of TCM syndrome,scores of TCM syndrome,TNF,CD8+、CD4+/CD8+ in Chinese herbal medicine plus anticholinesterase versus anticholinesterase;Effective rate of TCM syndrome in Chinese herbal medicine versus glucocorticoid;recurrence rate,effective rate,clinical absolute scores in Chinese herbal medicine plus glucocorticoid versus glucocorticoid;clinical absolute scores,scores of TCM syndrome,CD4+,CD8+,CD4+/CD8+,TNF-α,recurrence rate in Chinese herbal medicine plus anticholinesterase plus glucocorticoid versus anticholinesterase plus glucocorticoid;effective rate in acupuncture plus anticholinesterase plus glucocorticoid versus anticholinesterase plus glucocorticoid.29 studies reported safety index,no studies report laboratory specific values.Six studies reported no abnormalities in the two groups.The rest of the study reported abnormalities and adverse events in varying degrees,including gastrointestinal reactions,centripetal obesity,etc.And the results of pool analysis suggest that TCM may have the effect of reducing gastrointestinal reaction and hormone obesity.Conclusion:The number of clinical studies of TCM for myasthenia gravis increased year by year,covering a variety of clinical research types,interventions are diverse.But the quality of research is generally low,mainly in the lack of research and design related information.Meta analysis showed that the treatment group may better than control group in reducing the recurrence rate,improving the clinical symptoms and regulating the immune function.TCM may be effective in reducing the incidence of muscle weakness crisis and improving the quality of life,but the report is less research and the conclusion is uncertain.The incidence of adverse effect may be reducing by the addition of TCM.But due to low quality of evidence and the complication of Chinese herbal medicine selection,meta-anlysis could not provided indirect evidence to elaborate the effectiveness of TCM.The results need further validated in the future. |
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