A Randomized Controlled Trial On Therapeutic Efficacy And Safety Of No.1Decoction For Common Cold

Objective:The morbidity of common cold in millitary troops especially in recruits are relatively high because of the dense population,heavy training,and the change of life styel. A herb develpoed by the General Hospital of Beijing PLA named No.1Decoction for Common Cold, after years of application, has got a good public praise on its efficacy and inexpensive price. This study aims at to evaluate the efficacy and safty of No.1Decoction by compare it with Ganmao Qingre Keli(by Tongrentang) through a A randomize controlled trial, by doing this, this study will explore the feasibility and effectiveness No.1Decotion for Common Cold treatment in millitary.Methods:A randomized controlled trial was conducted to study225male military officers and soldiers who were suffering from common cold for less than48hours, we used pharyngeal recess secretions taken by throat swabs to preform GICA tests for Flu A/B and LP, while6of them who showed positive results were excluded(0for FluA/B,6for LP). The remaining219patients we included and asked to fill out The First Questionnarie of Influenza-like Illness (Table1), after that they were randomly allocated either to receive No.1Decoction (study group, n=111,1pakage/12hours, drink after slightly heated)or Ganmao Qingre Keli (control group, n=108,1pakage/12hours,drink with warm water) for3days. Grading quantization form for symptoms of common cold were filled for all patients. Clinical response rate, significant response rate and complete cure rate were analyzed by SPSS. Adverse events were also observed and recorded.Results:In this trial,2patients in test group and1in study group were lost in follow-up,13cases with incomplete data were excluded (5in study group,8in control group).219patients were included in FAS set and SS set, and data of203cases were observed in the PP set. In FAS set, the study group had a higher clinical recovery rate and effective rate than the control group (14.41%vs12.96%, p=0.755;72.97%vs64.81%, p=0.192), and had a lower significant effective rate than control group (36.94%vs43.52%, P=0.321). In PP the study group also had a higher clinical recovery rate and effective rate thatn the control group(15.38%vs14.14%,p=0.311;75%vs68.69%, p=0.317), and a lover significant effective rate than control group(39.42%vs49.46%,p=0.311).The95%confidence interval for the difference between the effective rates of study group and control group was (-4.06%—20.38%,△=-10%), suggesting No.1Decoction might be as effective as Ganmao Qingre Keli. The results of PP set were similar to that of FAS set. In SS set,study group reported3cases of side effects,all of them suffered from slight nausea which stopped after the therapy,0cases of side effects were reported from the control group, the rates were calculated and compared(2.88%vs0%,p=0.085)Conclusion:This study confirmed the efficacy and safety of No.1Decoction for common cold.