Multi-center randomized controlled study on the effect of syndrome differentiation therapy on clinical symptoms and signs score and quality of life in patients with AECOPD
Objective:To evaluate the effect of syndrome differentiation therapy on clinical symptoms and signs score and quality of life of patients with AECOPD.Methods:A multicenter,randomized,double-blind,placebo-controlled parallel trial design was used and 378 participants with AECOPD from eight centers were randomly divided into experimental group and control group,189 respectively.On the basis of conventional medicine,the experimental group was given TCM syndrome differentiation treatment:Sanhanhuayin granule for a syndrome of external cold and internal fluid,Qingrehuatan granule for a syndrome of phlegm-heat congesting lung and Zaoshihuatan granule for a syndrome of phlegm-damp amassing in the lung.The control group was given corresponding placebo granules;10 g each time,twice a day;14 days of treatment and 12 weeks of follow-up.The COPD patient-reported outcome scale(CAP-CRO)was measured at baseline,4days,7days,10days,14 days(end of treatment),28 days,42 days(after a follow-up of 4 weeks),and 98 days(after a follow-up of 12 weeks).The MOS item short from health survey(SF-36)was measured at baseline,14 days,42 days,and 98 days.Results:There were significant differences between the two groups in terms of symptoms score and total score of symptoms and signs in CAP-CRO scale(P＜0.05).After 14 days of treatment,the experimental group outperformed the control group in reducing symptom scores and total symptom and sign scores(P＜0.01).There were significant differences between the two groups in terms of Physical Functioning score,Role-Physical score,Vitality score,Social Functioning score,Mental Health score and Reported Health Transition score in SF-36 scale(P＜0.05).After 14 days of treatment,the experimental group outperformed the control group in improving scores in all other areas except for Bodily Pain(P＜0.05,P＜0.01).Conclusion:The treatment of AECOPD with syndrome differentiation therapy has a good effect in reducing clinical symptoms and improving quality of life.
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