Clinical Effectiveness and Safety of Bairui Granules （百蕊颗粒） in Treating Patients with Acute Pharyngitis with Wind-Heat Syndrome： A Multi-Center， Double-Blind， Double-Simulation， Randomized Controlled Trial
10.13288/j.11-2166/r.2024.11.009
- VernacularTitle:百蕊颗粒治疗急性咽炎风热证患者临床疗效及安全性的多中心、双盲、双模拟、随机对照试验
- Author:
Siming LIU
1
;
Hui ZHOU
2
;
Qiang LI
3
;
Min ZHOU
4
;
Qixiang WU
5
;
Shanjun YANG
6
;
Jun WANG
7
;
Jingjing YUAN
1
;
Ying ZHANG
1
;
Ziqi ZHU
1
;
Jingyi HU
1
;
Shuang WU
1
;
Mengting LI
1
;
Zhanfeng YAN
1
Author Information
1. Dongzhimen Hospital， Beijing University of Chinese Medicine， Beijing， 100700
2. Affiliated Hospital of Chengdu University
3. Luohe Hospital of Traditional Chinese Medicine， Henan Province
4. Luoyang Third People's Hospital， Henan Province
5. Kaifeng Hospital of Traditional Chinese Medicine，Henan Province
6. The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
7. The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
- Publication Type:Journal Article
- Keywords:
acute pharyngitis;
wind-heat syndrome;
sore throat;
Bairui Granules （百蕊颗粒）;
randomised controlled trial
- From:
Journal of Traditional Chinese Medicine
2024;65(11):1139-1145
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the clinical effectiveness and safety of Bairui Granules （百蕊颗粒） in the treatment of acute pharyngitis with wind-heat syndrome. MethodsA multicenter， double-blind， double-simulation， randomised controlled trial was conducted， in which 162 patients with acute pharyngitis and wind-heat syndrome from 7 centers were recruited， and each center was divided into trial group and control group on the ratio of 2∶1. In the trial group， 108 cases were orally administered with Bairui Granules plus Reyanning Granules （热炎宁颗粒） simulant， and in the control group， 54 cases were orally administered with Reyanning Granules plus Bairui Granules simulant for 5 days， with a follow-up visit on the 6th day. Full analysis set （FAS） analysis and per protocol set （PPS） were used for analysis， respectively. The primary efficacy index was the disappearance rate of sore throat after 5-day treatment； the secondary efficacy indexes were the disappearance rate of sore throat after 3-day treatment， as well as the visual analogue score （VAS） of sore throat before treatment， every day during the treatment， and follow-up on day 6， and the traditional Chinese medicine （TCM） syndrome score was performed before treatment and at the follow-up on day 6. The effectiveness on TCM syndrome was evaluated at the follow-up on day 6， and the changes of vital signs， blood routine， urine routine， liver functions， kidney function， the adverse events before and after the treatment were recorded， and safety analysis set （SS） was analysed. Results162 patients entered the FAS and SS analyses， and 158 cases （105 cases in the trial group and 53 cases in the control group） entered the PPS analysis. FAS analysis showed that the disappearance rate of sore throat after 5-day treatment was 80.56% （87/108） in the trial group and 64.81% （35/54） in the control group， and the difference between groups was statistically significant （χ2 = 5.10， P = 0.0239）. PPS analysis showed that the disappearance rate of sore throat after 5-day treatment was 80.00% （84/105） in the trial group and 64.15% （34/53） in the control group， and the difference between groups was statistically significant （χ2 =4.85， P = 0.0277）. FAS and SS analyses both showed that the difference in disappearance rate of sore throat between groups on 3-day treatment was not statistically significant （P＞0.05）. Compared with those before treatment， the VAS scores of sore throat were lower in both groups during treatment on day 2， 3， 4， 5， and follow-up on day 6 （P＜0.01）， but the difference between groups at each time point was not statistically significant （P＞0.05）. TCM syndrome scores of both groups at the follow-up were lower than that before treatment， and those of the trial group were lower than those of the control group （P＜0.01）. The cure rate and effective rate of TCM syndrome of the trial group were significantly higher than those of the control group （P＜0.01）. There was no significant difference in blood routine， urine routine， liver function， kidney function between groups before and after treatment （P＞0.05）， and no serious adverse events occured in both groups. ConclusionBairui Granules showed clinical effectiveness in the treatment of acute pharyngitis of wind-heat syndrome， and it could significantly improve the clinical symptoms， accelerate the disappearance time of sore throat with good safety.
