| ObjectivesTo explore the application of Sequential Multiple Assignment Randomized Trial(SMART)to study the efficacy of Zexie decoction in synopsis of Golden Chamber in treating phlegm-dampness Benign Paroxysmal Positional Vertigo(BPPV),proving the feasibility of SMART design in clinical trials of Traditional Chinese medicine(TCM).Methods1.Theory research:Download the literature data from CNKI database,next use CiteSpace data conversion and literature measurement analysis,draw in Zexie decoction in synopsis of Golden Chamber for treatment of vertigo in China as the theme of knowledge map,as shown in the information from the multiple dimension analysis map,visually display the knowledge structure and academic evolution,so as to track the development and research in the field of hot spots.2.Clinical trial research:Based on SMART design,this project took patients with phlegm-dampness BPPV as the research objects and carried out a study consisting of two treatment stages.The first stage was a randomized control study of adding flavor of Zexie decoction and Merislon,and the enrolled patients were randomly assigned to the control group(C)and the experimental group(TZ)to receive the treatment of Merislon and aadding flavor of Zexie decoction,respectively.After taking the medicine for 2 weeks,according to the main therapeutic index(Dizziness Handicap Inventory,DHI)to evaluate whether the treatment was effective to determine the treatment plan of the second stage.Stage 2:Patients who had previously received Merislon(C)were evaluated to be effective and continued to receive Merislon(C),while those who had no effect were replaced with Zexie decoction(TZ).Patients who had previously received Zexie Decoction(TZ)received Zexie Decoction(TZ)after effective evaluation,while patients who had no effect were randomized into Lingguizhugan Decoction(TL)or increase the dose(TZ increase).DHI was taken as the main efficacy index and the score of vertigo phlegm-dampness syndrome evaluation Scale was taken as the secondary efficacy index to evaluate the effectiveness.Adverse events were used as safety evaluation index.Results(1)Theory research:①Treatment of Zexie decoction in vertigo related research papers published in the overall trend of rising,after 2010 the increase is more obvious,2020～2021 issued a number of 47,it can be seen that Zexie decoction treatment of vertigo research has still being a hot spot of clinical research.②Through the study of the research institutions of Zexie Decoction in treating vertigo in China,it is found that the research institutions are scattered,the cooperation between institutions is less,and the degree of cooperation is low.It can be seen that Zexie Decoction in treating vertigo is in a relatively closed state,and there is a lack of leading figures and institutions in this field.③Research focus on the treatment of vertigo by Zexie decoction:based on the observation of the curative effect of Zexie decoction in the treatment of auricular vertigo,the following in-depth exploration of the use of Zexie decoction,flavoring,and identification and combined application with other classical decoctions in Treatise on Febrile and Miscellaneous Diseases(Banxiabaizhutianma decoction,Lingguizhugan Decoction,Wuling Powder,etc.);and towards the development of modern medical disease spectrum of vertigo,Zexie decoction used in the treatment of BPPV,essential hypertension,vertebrobasilar artery insufficiency,vestibular migraine effect observation is the focus of research.④Zexie decoction treatment of vertigo main hot research content:Zexie decoction treatment of vertigo curative effect observation,Zexie decoction to add the law of medicine,Zexie decoction treatment of otogenic vertigo clinical effect.(2)Clinical trial research:①Enrollment:From January 2022 to April 2022,a total of 88 cases were screened,86 cases were enrolled,and 61 cases were included in FAS set,including 42 cases in Zexie Decoction group and 19 cases in Merislon group.49 cases were included in PPS set,including 31 cases in Zexie Decoction group and 18 cases in Merislon group.The SS set had the same number of cases as the FAS set.ITT and PPS analysis were used for main efficacy indicators,and SS set was used for safety analysis.②Baseline analysis:There was no significant difference in the main efficacy indicators between baseline groups(P>0.00001),which was comparable.③Effectiveness analysis:Taking DHI 4 weeks after treatment as the main effect index,a consumption function method was used to conduct statistical analysis of the main efficacy indexes.When α<0.00001,there was a significant difference in efficacy between the two groups and the trial could be terminated ITT analysis and PP analysis showed that there was no significant difference in effective rate between DHI groups(P=0.000606>0.00001,P=0.001160>0.00001),so the trial could not be terminated.④Safety analysis:There was 1 case of adverse event in Zexie Decoction group,which was manifested as systemic fatigue;no adverse events occurred in Merislon group,and no statistical difference was found in the incidence of adverse events between the two groups(P>0.05).No serious adverse events or adverse reactions occurred in the two groups during the treatment period.⑤Adjustment of test parameters:MCID is DHI reduction value≥ 5 points,the effective rate of Zexie decoction group and Merislon group for 2 weeks(90.48%and 78.95%,respectively),and the effective rate for 4 weeks of treatment(95.24%and 94.74%,respectively)are higher.The parameter design is unreasonable,and it is difficult to evaluate the effectiveness of the treatment plan.Taking the DHI reduction value≥15 points,the effective rates of the Zexie decoction group and the Merislon group were treated for 2 weeks(71.43%and 42.11%,respectively),and the effective rates of 4 weeks of treatment(85.71%and 68.42%,respectively),is more reasonable.ConclusionThe trial continued,and the MCID will be adjusted to 15 points for DHI reduction.The results of the first phase of SMART design clinical trial on the treatment of phlegm-dampness BPPV by Zexie Decoction showed that it can improve the core symptoms of vertigo.SMART design clinical trial,according to the response of patients after taking medicine to adjust the prescription,medication and dose,close to the clinical practice of TCM increasing and decreasing with the disease,it is preliminarily believed that SMART design can be applied to TCM clinical trial. |
PDF Full Text Request