ABSTRACT
Objectives@#Vitex negundo is an endemic shrub in the Philippines which has been clinically tested for the symptomatic treatment of cough in syrup and tablet formats. However, the effectiveness and safety of the capsule have not been formally documented in a clinical trial setting. Therefore, in compliance with the Philippine FDA directive, this study compared the efficacy and safety of the capsule and tablet formats after three days of treatment among Filipinos with acute uncomplicated cough. @*Methods@#This is a Phase 3b randomized, open-label, parallel-group non-inferiority study with 335 subjects using improvement based on Global Rating of Change Scale scores as primary efficacy endpoint and several secondary endpoints. Descriptive and inferential analyses were performed. The Farrington-Manning Method of Z-test with -10% non-inferiority margin was used for the primary outcome. Appropriate inferential tests were used for the secondary outcomes. @*Results@#Of 335 enrolled subjects, 170 were randomized to the capsule group and 165 to the tablet group with comparable baseline characteristics. The proportion of success based on the Global Rating of Change Scale rated by patients was 95.71% and 91.19% for the capsule and tablet groups, respectively. Based on doctors’ ratings, they were 96.93% and 94.34%, respectively. In addition, the Farrington-Manning Method of Z-test revealed the capsule was not inferior to the tablet based on patients’ and doctors’ ratings (90% Confidence Intervals: -0.0086 to 0.0988 and -0.0228 to 0.0747, respectively). The intention-to-treat analysis also showed non-inferiority, indicating robust results. Significant and similar improvements in cough severity and quality of life were observed in both groups based on Cough Severity Diary scores and Leicester Cough Questionnaire for acute cough, respectively. There were also improvements in the Forced Expiratory Volume at 1 second [FEV1] (capsule group) and Peak Expiratory Flow Rate [PEFR] (both groups), but these were not clinically significant. The safety profiles were also comparable (p= 0.4437) with 1.23% and 2.52% incidence of adverse events, respectively, all of which were mild and assessed as not related to the drug. @*Conclusion@#In terms of efficacy, Ascof® Forte capsule was non-inferior to Ascof® Forte tablet in treating acute uncomplicated cough among Filipinos based on Global Rating of Change Scale scores as rated by patients and doctors. Both treatments showed significant and similar improvements in cough severity and quality of life. They were also comparable in safety with few adverse events in both groups, all mild and assessed unrelated to drug intake.
Subject(s)
CapsulesABSTRACT
Objective:To evaluate the performance, efficacy and safety of a novel portable endoscopy system for upper gastrointestinal examination.Methods:A multicentered, open-label, randomized, non-inferiority controlled study was conducted in 3 clinical research centers from June 2019 to June 2020, and a total of 90 outpatients admitted to Department of Gastroenterology were randomly assigned to the trial group ( n=44) undergoing portable endoscopy and the control group ( n=46) undergoing Olympus endoscopy. The examination success rate, image quality, performance, overall operation satisfaction rate, biopsy success rate and adverse events of the two groups were compared. Results:The examination success rates of the trial group and the control group were 97.73% (43/44) and 100.00% (46/46) respectively with a difference of -2.27% (95% CI: -6.68%-2.13%), higher than the set non-inferiority margin of -10%. Rates of good and excellent image quality were 100% in both groups, and the difference of 0 was higher than the set non-inferiority margin of -10%. There was no significant difference in the rate of good and excellent performance of the operating system between the two groups [97.67% (42/43) VS 100.00% (46/46), P=0.483]. There was significant difference in the overall satisfactory rate of the operation between the two groups [86.05% (37/43) VS 100.00% (46/46), P=0.011]. A total of 9 cases underwent endoscopic biopsy, including 5 cases in the trial group and 4 cases in the control group. The biopsy channels in both groups were smooth and the biopsy were successfully completed. There was no significant difference in adverse event rate between the two groups [25.00% (11/44) VS 10.87%(5/46), χ2=3.07, P=0.080]. All adverse events disappeared in 48 hours, and no severe adverse events or device defect events occurred. Conclusion:The novel portable endoscopic system is comparable to Olympus endoscopic system in terms of the operating performance, the image quality and safety. Therefore, this system is safe and effective for upper gastrointestinal examination.
ABSTRACT
Objective:To explore the effect of kangaroo care for mothers and fathers on preterm infants' heart rate, blood oxygen, body temperature and so on, and to explore the influence of kangaroo care on the anxiety of the implementers.Methods:Totally 132 cases of preterm infants and their parents from September 2017 to September 2018 in Shengjing Hospital of China Medical University were randomly divided into mother group (67 cases) and father group (65 cases) by envelope method. The intervention lasted for two hours. State Anxiety Inventory(SAI) was used to evaluate the anxiety status of the implementers before and after the intervention, and the heart rate, oxygen saturation and body temperature of preterm infants were recorded 15 minutes before and at the end of the intervention.Results:Before the intervention, the SAI scores of the two groups were 35.00(30.00, 45.00) in the mother group and 33.00(30.00, 43.00) in the father group, with no significant difference ( Z value was -0.645, P>0.05); after the intervention, the SAI score of the mother group was 29.00(23.00, 32.00) and that of the father group was 25.00(21.50, 28.00), with significant difference ( Z value was -3.518, P<0.01). Before and after the intervention, the changes of heart rate ( δ1=- 4.25), blood oxygen saturation ( δ2=1.45), body temperature ( δ3=0.20) of preterm infants before and after the intervention were tested by non inferiority test, and the difference was statistically significant ( t values were -6.370, 5.343, 12.612, P<0.01). Conclusions:The effect of kangaroo care on preterm infants' heart rate, blood oxygen and body temperature are no less than that of mothers. Compared with mother, kangaroo care can reduce father's anxiety better.