A Clinical Research On N-of-1 Trial For Grade 1 HyPertension(Yin Deficiency Yang HyPeractivity Syndrome) By Xiaxi Sanshi Formula

Objective: Through the research method of N-of-1 trial,the clinical efficacy of Xiaxi Sanshi Formula on patients with grade 1 hyPertension(yin deficiency yang hy Peractivity syndrome)was observed,and the new idea of traditional Chinese medicine treatment of grade 1 hyPertension(yin deficiency yang hy Peractivity syndrome)was explored.Methods:This study used N-of-1 trial with a single case itself as a controlled,randomized,multiple-crossover trial.By the run-in period,the intervention period was 3weeks,and the drug wash-out period was 1 week.As 16 patients needed to be observed,to prevent the loss of patients by 20%,20 patients were included.The trial design is divided into three rounds,each patient will go through three rounds of trial,each round is divided into two periods,and they are the experimental period and the control period(patients will be given Xiaxi Sanshi Formula during the experimental period,and will be given placebo during the control period).The order of intervention was randomized.The intervention period is 3 weeks;There was a 1-week drug washout period between each intervention period.Drug was Dispensed was in a random order designed in advance.Patients are single-blind.Three rounds for a total of 24 weeks.The changes of clinic blood pressure,24 h average ambulatory blood pressure,The Duchenne Hypertension Quality of Life Scale score and Traditional Chinese medicine symptom score of all the patients were recorded when patients at enrollment,after experimental period and after the control period,so that the clinical efficacy of Xiaxi Sanshi Formula on grade 1 hyPertension(yin deficiency yang hy Peractivity syndrome)was objectively evaluated.Results: Of the 20 patients participating in the study,4 patients did not complete the trial due to personal reasons,and 16 patients completed 3 rounds completely.In the overall efficacy evaluation of 16 patients(n=48),Comparing the experimental period with the control period,The changes of clinic blood pressure,24 h average ambulatory blood pressure,The Duchenne Hypertension Quality of Life Scale score and Traditional Chinese medicine symptom score were significantly ameliorated,with significant difference(P <0.05).In the 3 rounds of 16 patients(n=48),Comparing the experimental period with the When enrolled,The changes of clinic blood pressure,24 h average ambulatory blood pressure,The Duchenne Hypertension Quality of Life Scale score and Traditional Chinese medicine symptom score were significantly ameliorated,with significant difference(P <0.05).In the 3 rounds of 16 patients(n=48),Comparing the control period with the When enrolled,The changes of clinic blood pressure,24 h average ambulatory blood pressure,The Duchenne Hypertension Quality of Life Scale score and TCM symptom score were not significantly ameliorated,with no significant difference(P > 0.05).All patients had no adverse effects throughout the trial.Conclusion: The treatment of grade 1 hyPertension(yin deficiency yang hy Peractivity syndrome)can effectively reduce blood pressure,relieve the symptoms of traditional Chinese medicine,improve the quality of life of patients,and have high safety.