ObjectiveThe RCT was focused on the short-term curative effect and safety of subsiding internal wind & regulating lung decoction (Ning Feng Li Fei decoction) in curing cough variant asthma (CVA) of liver-fire invading lung type and also on the curing regulation of subsiding internal wind & regulating lung decoction (Ning Feng Li Fei decoction). This RCT was to explore the clinical effects and advantages of subsiding internal wind & regulating lung decoction (Ning Feng Li Fei decoction) therapy in curing cough variant asthma (CVA) of liver-fire invading lung type.MethodAll the selected CVA participants was from the outpatients of the Traditional Chinese Medicine (TCM) internal medicine department in Wangjing Hospital of Chinese Academy of Medical Sciences (CACMS) during from October 2013 to October 2014. The 66 patients, in total, was randomly divided into experimental group (34 patients) and control group (32 patients). For experimental group, the patients were given a dose of Ning Feng Li Fei decoction, which is divided into two parts. For control group, the patients were given Budesonide and Formoterol Fumarate Powder for Inhalation (Symbicort Turbuhaler) 160 μg/4.5 μg*60 dose twice a day, and they administrated 1-2 does for each time. The whole course last for 6 weeks, and the pulmonary function or peak expiratory flow rate variation (PEFRV) of the patients were reexamined on the 28th day. If the examination results have been normal and the symptom of the patients have disappeared, the patients would stop using any drugs and be home interviewed in two weeks. All patients filled the case report form (CRF). As planned, the change or improvement of the CVA symptom or TCM syndrome pattern was recoded.The statistics was analyzed in descriptive statistical method. The qualitative analysis was described in frequency distribution table and percentage. For quantitative analysis, if the statistic have matched the normal distribution, it would be described by Mean±SD, or it will be in percentage. The significance of the statistical difference between two groups was verified by t-test. And the relationship between intervention and effects was tested by chi-square test. The statistic was processed by SPSS 19.0.Results1 Baseline analysisThe baseline of age, gender, stature, body weight, BP, HR, pulse, breathe, cough VAS, cough symptom scores, Leicester cough questionnaire score and TCM syndrome pattern scores had no significant difference (P>0.05).2 Curative effects2.1 The improvement in TCM syndrome patternThe curative effects in bitter taste, rib pain, vexation, irritability, insomnia, and dreamful sleep syndrome of experimental group is better than control group in the third day. The statistic began to have significant difference on the first week (P<0.05).2.2 The effective rateAt the end of the course, the effective rate of experimental group is 9.56% higher than control group (P<0.05).2.3 The improvement in cough symptomOn the 1 st,3rd and 7th day, the experimental group has a better improvement in cough VAS and cough symptom scores (P>0.05). On the 14th,21st,28th, and 42nd day, the cough VAS, cough symptom scores, Leicester cough questionnaire score of experimental group had a better performance than control group (P<0.05).ConclusionSubsiding internal wind & regulating lung decoction (Ning Feng Li Fei decoction) therapy was proved effective in curing cough variant asthma (CVA) of liver-fire invading lung type, whose function was stable. The bitter taste, rib pain, vexation, irritability, insomnia, and dreamful sleep syndrome of the liver-fire invading lung pattern were improved by subsiding internal wind & regulating lung decoction (Ning Feng Li Fei decoction) obviously. |