Xiaoli Shang1, Tippawan Liabsuetrakul2, Pasuree Sangsupawanich3, Xiaoling Xia1, Ping He4, Hong Cao5, Edward McNeil2. 1. Department of Pediatrics, the 2nd Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, 650000, China. 2. Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand. 3. Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand. 4. Department of Pediatrics, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, Yunnan, 650000, China. 5. Department of Pediatrics, Yan'an Hospital of Kunming City, Kunming, Yunnan, 650000, China.
Abstract
INTRODUCTION:Laggera pterodonta, a traditional Chinese medicine, has been commonly used in respiratory tract infections for more than hundreds of years without any randomized controlled trials to evaluate its efficacy and safety. OBJECTIVES: To evaluate the efficacy and safety of Laggera pterodonta in hospitalized children aged 3-24 months with acute bronchiolitis. METHODS: A double-blind, randomized-controlled trial was conducted in three tertiary hospitals of Kunming, China. A total of 133 acute bronchiolitis children with an initial episode of wheezing were randomly assigned to a control mixture or Laggera pterodonta mixture. All recruited patients were given three doses of the mixture every 24 h for 5 days. Clinical symptoms and responses including adverse events in both groups were assessed and laboratory tests were done at enrolment and then after 120 h. Analysis was performed based on an intention-to-treat principle. RESULTS: Significantly more hospitalized children fulfilled the discharge criteria at 96 h and 120 h in the Laggera pterodonta mixture group compared to the control group (97% vs 75.8% P < 0.001 and 98.5% vs 89.4% P = 0.03), respectively. Better responses on clinical severity score, respiratory rate, oxygen saturation, wheezing and heart rate were also detected in the Laggera pterodonta mixture group along with lower white blood cell count, platelet count and aspartate aminotransferase. Vomiting and diarrhea were more common in the control group. CONCLUSION:Laggera pterodonta mixture is effective and safe to be prescribed in hospitalized children with acute bronchiolitis.
RCT Entities:
INTRODUCTION:Laggera pterodonta, a traditional Chinese medicine, has been commonly used in respiratory tract infections for more than hundreds of years without any randomized controlled trials to evaluate its efficacy and safety. OBJECTIVES: To evaluate the efficacy and safety of Laggera pterodonta in hospitalized children aged 3-24 months with acute bronchiolitis. METHODS: A double-blind, randomized-controlled trial was conducted in three tertiary hospitals of Kunming, China. A total of 133 acute bronchiolitischildren with an initial episode of wheezing were randomly assigned to a control mixture or Laggera pterodonta mixture. All recruited patients were given three doses of the mixture every 24 h for 5 days. Clinical symptoms and responses including adverse events in both groups were assessed and laboratory tests were done at enrolment and then after 120 h. Analysis was performed based on an intention-to-treat principle. RESULTS: Significantly more hospitalized children fulfilled the discharge criteria at 96 h and 120 h in the Laggera pterodonta mixture group compared to the control group (97% vs 75.8% P < 0.001 and 98.5% vs 89.4% P = 0.03), respectively. Better responses on clinical severity score, respiratory rate, oxygen saturation, wheezing and heart rate were also detected in the Laggera pterodonta mixture group along with lower white blood cell count, platelet count and aspartate aminotransferase. Vomiting and diarrhea were more common in the control group. CONCLUSION:Laggera pterodonta mixture is effective and safe to be prescribed in hospitalized children with acute bronchiolitis.