Objective To verify the efficacy and safety of Bangbo Ruexiao granule in the treatment of children with acute tonsillitis (external wind?heat syndrome). Methods This study was a multicenter, randomized, double?blind, double?dummy, positive drug parallel control design. A total of 520 children with acute tonsillitis (external wind?heat syndrome) treated in Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Jiangsu Province Hospital of Traditional Chinese Medicine, Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine, Yunnan Province Hospital of Traditional Chinese Medicine and Hubei Province Hospital of Traditional Chinese Medicine from January 2010 to March 2012 were selected and randomly divided into observation group and control group by 3∶1. The observation group was treated with Bangbo Ruexiao granule, and the control group was treated with Xiaoer Qingyan granule. The course of treatment was 5 days. The following items were observed: clinical efficacy, TCM disease and syndrome efficacy, the disappearance rate of single symptoms and signs (pharyngalgia or odynophagia, tonsil swelling and congestion, pharyngeal mucosa congestion, fever, cough, aversion to wind and headache), the onset time of the effect on pharyngalgia, the disappearance time of pharyngalgia, the negative conversion rate of C-reactive protein and safety indicators. Results (1) There were 509 patients in the intention?to?treat set(ITTS), 491 patients in the per?protocol set(PPS), and 515 patients in the safety set(SS). (2) Effectiveness evaluation: the total effective rate of the observation group was 85.9%(329/383), which was significantly better than that of the control group (58.7%, 74/126), and the difference was statistically significant(P<0.001). The total rate of significant effect of TCM disease and syndrome was 89.8%(344/383) in the observation group, which was significantly better than 64.3% (81/126) in the control group, and the difference was statistically significant (P<0.001). The disappearance rate of sore throat or odynophagia, the disappearance rate of tonsil swelling and congestion, and the disappearance rate of pharyngeal mucosa congestion in the observation group were significantly higher than those in the control group, and the differences were statistically significant(P<0.05). There was no significant difference in the disappearance rate of other symptoms and signs(fever, cough, aversion to wind, headache) between the two groups(P>0.05). The median onset time of the effect on pharyngalgia and the median time of pharyngalgia disappearance in the observation group were lower than those in the control group, and the differences were statistically significant(P<0.001). There was no significant difference in the negative conversion rate of C-reactive protein between the two groups(P>0.05). (3) Safety evaluation: there were no significant differences in the incidence of adverse events, the incidence of combined medication or medication compliance between the two groups(P>0.05). Conclusions Bangbo Ruexiao granule has a good clinical effect in the treatment of children with acute tonsillitis(external wind?heat syndrome), which can improve the efficacy of TCM syndromes, shorten the duration of sore throat, and has good safety. It can provide a new alternative treatment for children with acute tonsillitis(external wind?heat syndrome).
