Hui Luo1, Gui-Hua Song2, Xiao-Jian Ma3, Meng-Meng Sun2, Man Zhang4, Jian-Rong Xie5, Shao Peng6. 1. Institute for Tibetan Medicine, China Tibetology Research Center, Beijing, 100101, China. 2. Department of Pediatrics, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, China. 3. Department of Pediatrics, Huaihe Hospital of Henan University, Zhengzhou, 450000, China. 4. Department of Pediatrics, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, 475000, China. 5. School of Statistics, Renmin University of China, Beijing, 100872, China. 6. Department of Pediatrics, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, 475000, China. Pengshaodh630@126.com.
Abstract
OBJECTIVE: To assess the effectiveness of Jiuwei Zhuhuang Powder (JWZH), a Tibetan patent medicine in treating upper respiratory tract infection (URTI) associated cough in children. METHODS: The study was a multicenter, randomized, open-label, controlled trial. A total of 142 children aged 2 to 14 years old, with URTI-associated cough within 48 h of onset, were randomly assigned to two groups at a 1:1 ratio by computer-generated randomization sequence. Children were treated with JWZH (1 to 1.5 g, twice to thrice daily) in the treatment group or conventional treatment (Pediatric Paracetamol, Artificial Cow-bezoar and Chlorphenamine Maleate Granules, 0.25 to 1 g, thrice daily) in the control group for 5 days. The primary endpoints were the time to cough resolution and 4-day cough resolution rate. The secondary endpoints were the daily improvement in symptom scores and cough resolution rate during the study period. RESULTS: A total of 138 children were included in the intention-to-treat analysis, with 71 cases in the treatment group and 67 cases in the control group. Compared with the conventional treatment, the children receiving JWZH had a shorter time to cough resolution [hazard ratio, 2.10; 95% confidence interval (CI), 1.29-3.40; P=0.003]. The median time to cough resolution for children receiving JWZH was shorter than that of the conventional treatment (2 days vs. 3 days; P<0.001). The 4-day cough resolution rate in the JWZH group was higher than that of the control group (94.4% vs. 74.6%; risk difference: 19.8%, 95% CI: 8.1%-31.5%; relative risk: 1.265, 95% CI: 1.088-1.470; P=0.001). There were no statistically significant differences in the improvement of other symptoms caused by URTI (P>0.05). Adverse events was reported in 5.6% (4/71) and 4.5% (3/67) in participants of JWZH and PPACCM groups (P>0.05), respectively, which were all mild and resolved without treatment. CONCLUSION: JWZH seemed to be a safe and effective therapy for URTI-associated cough in children. (Trial registration No. ChiCTR2000039421).
OBJECTIVE: To assess the effectiveness of Jiuwei Zhuhuang Powder (JWZH), a Tibetan patent medicine in treating upper respiratory tract infection (URTI) associated cough in children. METHODS: The study was a multicenter, randomized, open-label, controlled trial. A total of 142 children aged 2 to 14 years old, with URTI-associated cough within 48 h of onset, were randomly assigned to two groups at a 1:1 ratio by computer-generated randomization sequence. Children were treated with JWZH (1 to 1.5 g, twice to thrice daily) in the treatment group or conventional treatment (Pediatric Paracetamol, Artificial Cow-bezoar and Chlorphenamine Maleate Granules, 0.25 to 1 g, thrice daily) in the control group for 5 days. The primary endpoints were the time to cough resolution and 4-day cough resolution rate. The secondary endpoints were the daily improvement in symptom scores and cough resolution rate during the study period. RESULTS: A total of 138 children were included in the intention-to-treat analysis, with 71 cases in the treatment group and 67 cases in the control group. Compared with the conventional treatment, the children receiving JWZH had a shorter time to cough resolution [hazard ratio, 2.10; 95% confidence interval (CI), 1.29-3.40; P=0.003]. The median time to cough resolution for children receiving JWZH was shorter than that of the conventional treatment (2 days vs. 3 days; P<0.001). The 4-day cough resolution rate in the JWZH group was higher than that of the control group (94.4% vs. 74.6%; risk difference: 19.8%, 95% CI: 8.1%-31.5%; relative risk: 1.265, 95% CI: 1.088-1.470; P=0.001). There were no statistically significant differences in the improvement of other symptoms caused by URTI (P>0.05). Adverse events was reported in 5.6% (4/71) and 4.5% (3/67) in participants of JWZH and PPACCM groups (P>0.05), respectively, which were all mild and resolved without treatment. CONCLUSION: JWZH seemed to be a safe and effective therapy for URTI-associated cough in children. (Trial registration No. ChiCTR2000039421).
Authors: Vitalia Murgia; Sara Manti; Amelia Licari; Maria De Filippo; Giorgio Ciprandi; Gian Luigi Marseglia Journal: Pediatr Allergy Immunol Pulmonol Date: 2020-03 Impact factor: 1.349
Authors: Gian Luigi Marseglia; Sara Manti; Elena Chiappini; Ilaria Brambilla; Carlo Caffarelli; Mauro Calvani; Fabio Cardinale; Claudio Cravidi; Marzia Duse; Alberto Martelli; Domenico Minasi; Michele Miraglia Del Giudice; Giovanni Pajno; Diego G Peroni; Maria Angela Tosca; Amelia Licari; Giorgio Ciprandi Journal: Allergol Immunopathol (Madr) Date: 2021-03-01 Impact factor: 1.667