Current Status Of Randomized Controlled Trials Of Traditional Chinese Medicine In The Treatment Of Ulcerative Colitis And Evaluation Of Acupuncture Efficacy And Quality

ObjectivesThe purpose of this study is to comprehensively and systematically search the current research status of randomized controlled trials of traditional Chinese medicine in the treatment of ulcerative colitis,sort out the current status of randomized controlled trials of traditional Chinese medicine in the treatment of ulcerative colitis,analyze and summarize the existing randomized controlled trials of traditional Chinese medicine in the treatment of ulcerative colitis,and provide a reliable reference for the future clinical application and research development of traditional Chinese medicine in the field of ulcerative colitis.Based on the literature review of randomized controlled trials of traditional Chinese medicine in the treatment of ulcerative colitis,randomized controlled trials of acupuncture in the treatment of ulcerative colitis were selected to evaluate the efficacy and safety of acupuncture in the treatment of ulcerative colitis.MethodsComprehensive and systematic search of randomized controlled trials of traditional Chinese medicine in the treatment of ulcerative colitis,strict screening,and the final included literature for data extraction,data analysis and result reporting,and select the experimental group intervention measures for acupuncture research.Search methods:China National Knowledge Infrastructure,Wanfang Data,Chinese Biomedical Literature Database,VIP Chinese Science and Technology Journal Database,Cochrane Library and PubMed Database were searched.The search dates ranged from database construction to January 2020 for each database.Literature inclusion criteria:Study subjects:patients with ulcerative colitis;Intervention measures:various treatment measures under the guidance of traditional Chinese medicine theory,including traditional Chinese medicine decoction,traditional Chinese medicine formula granules,traditional Chinese medicine extract,various Chinese patent medicines,traditional Chinese medicine injections,acupuncture(such as conventional body acupuncture,warm needle,fire needle,electroacupuncture,scalp acupuncture,auricular acupuncture,abdominal acupuncture,etc.),moxibustion,massage,scraping,cupping,acupoint application,acupoint catgut embedding,etc.;Control measures:conventional western medicine treatment;Study type:randomized controlled trial.Data extraction:Excel 2019 was used to design the literature data extraction table,and the extraction contents included the basic information of the included studies,patient information,intervention measures information,and quality evaluation items.The data extraction part was independently conducted by two investigators,and then checked after completion.The inconsistent parts were discussed and negotiated,or arbitrated by a third party.Quality evaluation:The Cochrane risk of bias assessment tool was used for quality evaluation of randomized controlled trials.These include six items:random sequence generation,allocation concealment,blind method,incomplete outcome reporting,selective outcome reporting,and other biases,i.e.The randomized controlled trials collected in the first part were screened to select the literature on acupuncture treatment of ulcerative colitis.The Cochrane risk of bias assessment tool,CONSORT non-drug trial extension statement,and STRICTA checklist were used to evaluate the quality of the literature on acupuncture treatment of ulcerative colitis,respectively.Data analysis:RevMan 5.3 software was used for data analysis.Mean(MD)and 95%confidence interval(CI)were used to describe continuous variables.Relative risk(RR)and 95%CI were used to describe binary variables.Data were meta-analyzed using a fixed-effects model or a random-effects model,and the quality of evidence grade was evaluated using GRADE.ResultsA total of 2191 randomized controlled trials were finally included,which covered 36 provinces and municipalities in China,of which more than 100 RCT studies were carried out in Henan Province(238s 11.31%),Jiangsu Province(178,8.46%),Shandong Province(162,7.70%),Guangdong Province(159,7.56%),Hebei Province(144,6.84%),Hunan Province(117,5.56%)and Hubei Province(110,5.23%).Only one study was published in English,and the rest were in Chinese.About one-third(632,30.04%)of the studies had a treatment duration of less than 28 days,and nearly three-quarters(1639,74.33%)of the studies did not report the severity of ulcerative colitis in the study subjects.Of the 2191 included studies,2000(91.28%)used drug therapy,54(2.46%)used non-drug therapy,and 137(6.25%)used drug combined with non-drug therapy.Among them,drug therapy includes 12 kinds of traditional Chinese medicine dosage forms,which are decoction,tablet,powder,capsule,granule,pill,suppository,ointment,injection,gel,oral liquid,and tea on behalf of each other according to the order of frequency of use.There were 10 non-pharmacological interventions,which were acupuncture,moxibustion,bloodletting,ear beans,acupoint catgut embedding,acupoint injection,scraping,massage,acupoint application,and five-tone therapy in order of frequency of use.A total of 12 randomized controlled trials of acupuncture for ulcerative colitis involving a total of 970 subjects were included.All studies were conducted in China and published in Chinese.Seven studies compared the efficacy of acupuncture alone and conventional western medicine treatment,and five studies compared the efficacy of acupuncture and combined conventional western medicine treatment versus conventional western medicine treatment.Among them,1 patient was treated with head acupuncture and 11 patients were treated with body acupuncture.The duration of treatment varied from 14 to 60 days.Subjects were between 20 and 78 years of age.The disease duration was 9 days to 8 years.Two of these studies(16.67%)reported random sequence generation methods,one study(8.33%)reported allocation concealment,and eight studies(66.67%)had a high risk of other bias.One study(8.33%)described the trial design in detail and one study(8.33%)reported baseline data as required in CONSORT.In the description of the intervention,none of the included studies described the reasons for the choice of acupuncture method and the background of the therapist.ConclusionsRandomized controlled trials of traditional Chinese medicine for ulcerative colitis involve a variety of treatments and routes of administration,which have received much attention from researchers,but their research quality is not ideal.Future research needs to improve the quality of research,using rigorous methods when conducting trials to ensure that high-quality research evidence is obtained.Acupuncture has a certain effect on the treatment of ulcerative colitis.Due to the limited number of clinical trials and the unsatisfactory methodological quality of the included studies,there is a need for high-quality studies to further verify the effectiveness and safety of acupuncture treatment.