| ObjectivesTo systematically review the evidence status of randomized controlled trial(RCT)of Chinese medicine in the treatment of ulcerative colitis(UC),sort out the list of existing interventions and the types of outcomes of clinical concern.The research areas need to be strengthened are determined to provide reference for future research.At the same time,the efficacy and safety of Chinese patent medicine in the treatment of mild to moderate ulcerative colitis was evaluated by using the network meta-analysis method.MethodsIn study 1,we systematically searched China National Knowledge Infrastructure(CNKI),Wanfang,Sino-Med,Chinese Scientific Journal Database(VIP),Cochrane Library,PubMed databases.The search date was updated to March 2021.Interventions included drug therapy under the guidance of traditional Chinese medicine theory,and do not distinguish between dosage form and route of administration.Control measures,dosage form,and route of administration are not restricted.Outcome indicators included clinical effectiveness,safety outcome,TCM symptom score,and inflammatory factor levels,immunological indicators,blood indicators,electronic colonoscopy performance,intestinal flora.We used the Mapping review method to map the distribution of evidence included in this work.AMSTAR 2 was assessed the quality of the methodological report in the included systematic reviews.In study 2,we systematically searched CNKI,Wanfang,Sino-Med,VIP,Cochrane Library,PubMed databases from the establishment of each database to June 2020.We included randomized controlled trial(RCT)for the treatment of UC with Chinese herbs.We conducted literature screening,data extraction,and analyzed its methodology and clinical characteristics.In study 3,we systematically searched CNKI,Wanfang,Sino-Med,VIP,Cochrane Library,PubMed,Embase Databases from the establishment of each database to October 2020.We included RCTs of Chinese patent medicines in the treatment of mild to moderate UC,used a network meta-analysis method under the Bayesian framework,the risk of bias was assessed using the Cochrane ROB scale,and Revman 5.3 was used for direct comparison analysis,we used ADDIS 1.16.5 and STATA 16 software to compare indirect evidence.Each outcome will form a networkplot and a RANK probality diagram.The research protocol was registered on the PROSPERO platform with the registration number of CRD420213867 in October 2020.ResultsIn study 1,of which 73 systematic reviews(SRs)met the inlusion criteria.The quality of methodological reports of all included SRs were extremely low.1.4%(1/73)of the patients in the SRs were limited to disease active stage,1.4%(1/73)to remission stage,1.4%(1/73)to non acute ulcerative colitis outbreak stage,and 13.7%(10/73)to disease severity.46.6%(34/73)of the intervention in the SRs were Chinese medicine alone,and the rest were integrated traditional Chinese and Western medicine intervention.The administration route of intervention measures included oral,enema,suppository anal,intravenous injection,acupoint application and ultrasound induction.Control measures usually include Western medicine,such as Mesalazine,Sulfasalazine,Hormone preparation,Intestinal probiotics,Placebo,etc.No SRs used no-treatment control.58.9%(43/73)of the SRs reported funding information,and 39.7%(29/73)of the SRs did not report the diagnostic criteria of the patients.In Study 2,of which 410 RCTs involving 35727 patients met the inclusion criteria.In terms of methodological design features,single center trials accounted for the largest proportion(337/410,82%),and 10.9%(45/412)trials did not report the source of research objects.There were 18 double center trials,7 three center trials,1 four center trial,1 nine center trial,1 13 center trial,and 118 center trial.5.1%(21/410)of the trials were blinded to patients and researchers,no trial with triple blind.7%(7/410)of trials with random allocation concealment.64.9%(266/410)of the trials did not report detailed random sequence generation method,29.5%(121/410)used simple random method,among which random number table method was the most commonly used(n=109),random lot method(n=9),coin toss method(n=1),one trial only reported using simple random method without specific method;in addition,central random method(n=3),software random method(n=13)were also included Interval random method(n=1).One trial reported sample size estimates.0.5%(2/410)of the test reports were registered.8.5%(35/410)of the trials reported missing data,and 27.1%(111/410)of the trials were supported by funds.The average sample size was(84.2±40.3).In terms of clinical features.59.3%(243/410)of the trials were for active UC patients,2.2%(9/410)were for remission patients,one trial was for active+remission patients,and the rest 38.3%(157/410)did not report disease stages.265 interventions were involved,of which 21 were proprietary Chinese medicines.There are more than 10 trials of three intervention measures,including 18 traditional Chinese medicine dosage forms.In the intervention group,there were 7 routes of administration of traditional Chinese medicine,the first three frequencies were oral administration(n=214),enema(n=128),oral combined enema(n=86),followed by anal medication(n=4),intravenous drip(n=1),oral combined application(n=1),oral combined intravenous drip(n=1).The most reported outcome index in the included literature was clinical comprehensive efficacy index,followed by safety outcomes and TCM symptom score.In Study 3,the databased search identified 3222 citations,of which 33 RCTs involving 2862 patients met the inclusion criteria.Male subjects were more than female subjects(1209 males and 960 females).The baseline characteristics of each group were comparable in characteristics.Among 33 RCTs,42.4%(14/33)did not report the method of random number generation.Three studies were used double blind.18.2%(6/33)of the trials were supported by funding.19 interventions were involved in the study 3,most of which were the combination of Chinese patent medicine and mesalazine.There are few studies on the application of Chinese patent medicine alone.The results of NMA showed that Xilei powder plus mesalazine might be better than mesalazine alone in the disappearance rate of purulent stool/abdominal pain,and its safety might be better than other interventions;Kangfuxin solution plus mesalazine might be better than mesalazine alone in the disappearance rate of diarrhea/tenesmus.ConclusionThere are a large number of RCTs and SRs on the treatment of UC with Chinese medicine preparations.However,there are some deficiencies in the reporting of methodology and clinical characteristics.The overall quality of included studiesn is low.Placebo is rarely used as a control measure.At present,the positive outcomes of Chinese patent medicine in the treatment of mild-moderate UC can not be regarded as a confirmatory conclusion.Researchers need to pay attention to the outcomes of health economics,quality of life,safety indicators and other outcome for UC patients,as well as the intervention for the treatment of patients with remission UC.Targeted clinical trials with more quantity.more rigorous methodology design and higher quality of research report should be carried out. |
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