| Background and objectiveDiabetic foot ulcer is one of the main complications of diabetes.The cost of health and economic resources in the treatment process is enormous,which brings great burden to the patient family and the whole society.If the treatment fails,it needs amputation or even loss of life.There are many ways for Western medicine to treat diabetic foot ulcers,but there are also some shortcomings of contraindications and obvious side effects,and the clinical effect is not optimistic.Although Chinese medicine does not explicitly mention the name of diabetic foot ulcer,it has a profound understanding of its etiology,pathogenesis and dialectical classification.It has a long history in the treatment of sores,and it is rich in therapeutic methods in clinical applications,often using Chinese medicine orally.Treatment or internal and external coherence,but the efficacy is controversial.Systematically collating,evaluating and synthesizing randomized controlled trials based on evidence-based methods,critically evaluating the efficacy and safety of clinical evidence for the treatment of diabetic foot ulcers with traditional Chinese medicine preparations,providing a scientific basis for current medical practice.And guide the research and development of diabetic foot ulcer in the field of Chinese medicine in the futureThe value of clinical trials lies not only in the scientific and rational design of the research,but also in the quality control of the research process.It also relies on the results of the research to be clearly and transparently reported.A complete and clear research report can help the reader to correctly evaluate the feasibility and trial of the intervention.Consolidated Standards of Reporting Trials(CONSORT)and its Chinese Medicine Compound Extension Statement(2017 version)were used to evaluate the quality of randomized controlled trials of traditional Chinese medicine preparations for the treatment of diabetic foot ulcers,to obtain missing information by telephone interview,and to investigate the included literature.The current status of the CONSORT statement of relevant j ournals provides an improved basis and direction for the development and publication of high-quality clinical research in the future MethodsEligibility criteria:Type of study:RCTs that evaluate the effects of CHM for treating foot ulcers in people with diabetes were included.Type of participants:Adults(18 years or older)with clearly diagnosed Type 1 or Type 2 diabetes and a related foot ulcer,with or without infection were concerned as participants in this review.Other types of foot ulcers,such as ulcers caused by venous disease,vasculitis,or any conditions other than diabetes were excluded.Type of interventions:Interventions of this review were grouped as follows:Single Chinese herb;Chinese proprietary herbal medicine,a kind of fixed formulation of herbs produced by a pharmaceutical company;Chinese Herbal mixture prescribed by herbalist(so called individualized treatment)and is usually tailored based on individual's pattern of symptoms.The control intervention included placebo,non-medical treatment(such as dressings and hot water foot bath)or other interventions used with the intention of glycemic control,promotion of healing,or wound care.Studies with co-interventions were considered as long as all arms of the trial receive the same co-intervention(s).Type of outcome:Main outcomes:?Amputation rate caused by diabetic foot;?ulcer healing 100%healing;?Quality of life;Secondary outcome:?although not complete but reached more than 50%healing;?ulcer healing time(days);?ulcer area after treatment(cm2);?number of adverse events;?treatment costs(yuan).Search strategy:Published studies were comprehensively searched from seven major Chinese and English electronic databases from their inception to November 2018:PubMed,the Cochrane Library,EMBASE,Chinese National Knowledge Infrastructure Database(CNKI),VIP Chinese Science and Technique Journals Database,Wanfang Database and Sino-Med Database.Study selection and data extraction:A total of six researchers used NoteExpress 3.2 software for literature management,designed data extraction tables based on the research content,and used Excel 2010 for literature extraction.Any disagreement shall be settled through consultation with a third people,and all data shall be screened and extracted for verification and summary.Quality assessment and quality of evidence by GRADE:According to Cochrane risk of bias in any of risk assessment tools to evaluate the methodological quality of RCTs,with GDT online tools(GRADEpro Guideline Development Tool,GDT)for quality GRADE assessment evidence,eventually all quality checks and summary evaluation and assessment results.Data analysis:The Review Manager5.3 software was used to summarize and synthesize the data in terms of heterogeneity testing,combined statistics,sensitivity analysis,subgroup analysis,and publication bias.Before merging statistic need to include a number of different original research results are different size,if more than one study has homogeneity,and the difference of clinical heterogeneity and methodology heterogeneity,just can effect the amount of merger,according to the I2 value range to select the corresponding fixed effects model or random effects model.The combined effect was expressed as a risk ratio(RR),and the 95%confidence intervals(CI)was calculated.Standardized mean difference(MD)or standardized mean difference(SMD)was standardized for continuous variables,and a 95%confidence interval was calculated.Literature report quality evaluation:Referring to CONSORT statement(2010 edition),the two researchers conducted literature evaluation on the quality of literature report and negotiated with a third people to decide if there were uncertainties.Finally,all evaluation results were checked and summarized,the number of literature conformance of each report and its percentage were calculated,and the report rate of included research items was statistically analyzed.Telephone interview to original author:An interview outline was developed,which mainly involved the way of random grouping,the method of random allocation and hiding,the calculation of sample size,the implementation of the blind method,whether there is shedding or missing visit,the registration of the experiment and the source of funding.According to the work unit of the author at that time shown in the article,look up the phone Numbers of all the authors.If the author can be contacted,conduct a phone interview and record the answers.If the author refuses to answer,ask and record the reasons.If the call is not received and three attempts to contact the author within two weeks are unsuccessful,further contact with the author is waived.To investigate the application status of CONSORT Statement:Search the official website of the journal of the literature eventually included in this study,check whether the submission requirements clearly propose to report the contents of the RCTs according to 25 items of CONSORT Statement,and record the resultsResults3.1 The effects of Chinese herbal medicines for treating diabetic foot ulcers:A systematic review of 49 randomized controlled trialsA total of 49 trials were included,including 3,646 patients with diabetic foot ulcers Among them,45 studies were published in Chinese,and the remaining 4 studies were implemented in China but published in English.Most of the included trials had an unclear or high bias risk and the overall methodological quality was low.Twenty-six studies were combined into five meta-analyses and found that traditional Chinese medicine preparations combined with other treatments were compared with other treatments alone,such as traditional Chinese medicine oral decoction group(RR=1.52,[1.21,1.90])and Chinese medicine foot bath group(RR=1.58,[1.25,2.00]),traditional Chinese medicine oral decoction combined with traditional Chinese medicine external application agent(RR=1.60,[1.22,2.10]),traditional Chinese medicine oral decoction combined with traditional Chinese medicine foot bath(RR=1.76,[0.87,3.55]),can make More ulcers in patients with diabetic foot ulcers were completely healed;traditional Chinese medicine foot bath combined with conventional treatment compared with hot foot bath combined with conventional treatment,the 100%healing rate of ulcer in Chinese medicine foot bath group was better than that in hot water group(RR=1.42,[1.19,1.70])Subgroup analysis was performed to verify whether the treatment of traditional Chinese medicine before and after foot bath had an effect on the treatment of diabetic foot ulcers.The results showed that there was no significant difference between the two groups.Sensitivity analysis,the data missing in the study was reasonably filled and then re-analyzed,and no difference was found before or after.The above results should be treated with caution in light of the low quality of the research methodology includedOf the 10 items,adverse events were mentioned,6 of which reported no adverse reactions,and the remaining 4 reported upper abdominal pain,dry mouth,ulcer-related pain,diarrhea,coagulopathy,leg swelling,and constipation.Four studies reported amputation of diabetic foot ulcers.One study reported deaths3.2 Quality evaluation of randomized controlled trials of traditional Chinese medicine preparations for treating diabetic foot ulcersFinally,49 randomized controlled trials were included.According to the CONSORT entry,the random sequence generation method,allocation scheme concealment,blind method,sample size calculation,shedding or rejection,outcome index,adverse reaction,and study protocol registration reporting rate were 44.9%,6.1%,4.1%,2.0%,8.2%,30.6%,18.4%,4.1%.According to the extended version of CONSORT Chinese Medicine Compound,the reporting rate of topics and abstracts is very high.The reporting rates in the fixed composition of Chinese medicine compound,individualized Chinese medicine compound and Chinese patent medicine list are 94.7%,93.3%,100%,respectively.The topic and abstracts reflect the TCM syndromes of Western medicine.The reporting rate of the introduction and background is also very high.The reporting rates in the above three lists are 92.1%,93.3%,and 100%,respectively.The production rate,dosage and route of administration of the compound in the intervention were 100%in the first two lists;the reporting principles,basis and solution in the first two lists were 81.6%and 86.7%,respectively;their names,provenances and dosage forms of the compound were reported in the first two lists at 23.7%and 20%respectively.There were no studies to clearly report the TCM syndromes of diabetic foot ulcers,nor did the study report detailed diagnostic criteria and inclusion exclusion criteria for subjects enrolled in specific TCM syndromes.Only one(2.6%)intervention was a study of a fixed Chinese herbal compound that reported the names,origins,methods,and dosages of all constituent drugs in the combination.One of the 49 studies was published in the dissertation,and the remaining 48 studies were published in 45 journals.After finding the submission requirements for each magazine,it was found that there were three magazines that used the CONSORT statement as a randomized controlled trnal report standard,all of which were English-language magazines,accounting for 6.7%of the magazines covered by the study.The remaining 45 studies(one published in English and 44 published in Chinese)were published in 42 journals,and none of the drafts mentioned the CONSORT statement.Only one(2.0%)trial was successfully contacted by the original author and interviewed by the author.It is difficult to study the telephone interview.The main reasons are as follows:? The article has been published for a long time,the author has changed the work unit or retired.? The contact information provided by the author to the magazine is not specific enough.When contacting the author,it is to find the hospital switchboard on the Internet,and then transfer to the department for inquiry.The information is not enough to increase the difficulty of the contact.? The author refuses to answer and is unwilling to cooperate,but he cannot doubt the authenticity of his research.? can not accurately determine the authenticity of the author's answer.If the author has a certain methodological knowledge,even if the research is not really carried out,the author can give an answer according to the norm.Conclusion:The potential advantages of traditional Chinese medicine preparations for treating diabetic foot ulcers are to promote complete healing of the ulcer,shorten the t'ime required for complete healing of the ulcer,reduce the ulcer wound area,and save treatment costs.However,due to the small sample size of the included studies,the methodological and evidence quality evaluations are not high,and the research details are not comprehensive,so we can not directly draw a positive conclusion on the efficacy and safety of traditional Chinese medicine preparations for the treatment of diabetic foot ulcers.In the future,more large-scale,methodologically more rigorous trials will be needed to validate this finding,provide a scientific basis for current medical practice,and guide the research and development of diabetic foot ulcers in the Chinese medicine field in the future.The CONSORT statement for the randomized controlled trial of traditional Chinese medicine preparations for the treatment of diabetic foot ulcers and the report of the Chinese medicine compound expansion statement are of low quality.The CONSORT statement has not been widely adopted in Chinese journals in this field of study.The success rate of telephone interviews is very low and it is difficult to obtain test reports.The missing information suggests that Chinese journals should pay attention to the report of clinical trials in accordance with the CONSORT statement in the future. |
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