Clinical Efficacy Observation Of Shengxian Decoction For Treating Autonomic Dysfunction With Qi Deficiency Syndrome In Early Parkinson's Disease

Objective:1.To evaluate the difference of Unified Parkinson Disease Rating Scale(UPDRS),Scale for Outcomes in PD for Autononmic Symptoms(SPOCA-AUT),Traditional chinese medicine Symptoms of Parkinson's disease(PD-TCMS)in patients with Parkinson's disease(PD)before and after treatment.2.To investigate the efficacy and safety of shengxian decoction for the treatment of autonomic dysfunction with Qi deficiency syndrome in early Parkinson's disease.Method:80 patients wih Parkinson's disease were randomly divided into a Traditional chinese medicine(TCM)group of 40 cases and a control group of 40 cases.The patients were treated with Shengxian decoction granules in TCM group and the control group was given a placebo,containing 1/10 liters of broth and the same smell and color with TCM group.The two groups of patients took 1 pack each time,taking them 2 times a day in the morning and evening.The treatment session course will continue until they begin to use Western medicine for Parkinson's disease.This study was performed to evaluate the changes of UPDRS,SCOPA-AUT and PD-TCMS between these two groups of the patients,and to observe the efficacy and safety of Shengxian decoction for the treatment of autonomic dysfunction with Qi deficiency syndrome in early Parkinson's disease.Results:Among 80 patients included,because two patiens in the TCM group and threes in the control group were missing.Eventually,75 patients(38 cases in the TCM group,37 cases in the control group)completed the follow-up.The results are listed below:1.The UPDRS score before and after treatment: Although the UPDRS score of the two groups increased than before treatment,there was no statistical difference before and after treatment(P >0.05).There was no significant difference between two group(P>0.05).2.The SCOPA-AUT score before and after treatment: the score of the TCM group was significantly decreased than before treatment(P<0.05),the score of the control group was notably increased than before treatment(P<0.05).The TCM group significantly improved the functions of the digestive system,urinary system and body temperature regulation compared with the control group(P<0.05).No significant differences were found between two groups for Cardiovascular system,pupillomotor domains and sexual function.The score of constipation,drooling,urinary frequency,urgency,Sweating heavily during the day in SCOPA-AUT of the TCM group were significantly better than those of the control group(P< 0.05).3.The comparison of the main symptom of PD-TCMS score before and after treatment: the score of the TCM group decreased than before treatment(P >0.05),the score of the control group increased than before treatment(P >0.05).There was no significant difference between two groups(P>0.05).4.The comparison of the secondary symptom of PD-TCMS score before and after treatment: the score of the TCM group was significantly decreased before treatment(P<0.05).The score of the control group was notably increased before treatment(P<0.05).The score of constipation,spontaneous sweat,short of breath and tired and its total score in the secondary symptom of PD-TCMS of the TCM group were better than those of the control group(P< 0.05).5.The comparison of the total score of PD-TCMS before and after treatment: the score of the TCM group was significantly decreased than before treatment(P< 0.05),The score of the control group was notably increased than before treatment(P<0.05).There was significant difference between two groups(P<0.05).6.The comparison of the time of taking chinese medicine: The TCM group was177.50±34.92 days and the control group 156±30.37 days.Significant difference was found between two groups(P<0.05).7.Adverse reaction: No significant adverse reactions occurred in these two groups after treatment.Conclusion:1.Shengxian decoction may effectively improve the autonomic dysfunction in early Parkinson's disease and have significant effects on constipation,drooling,urinary frequency,urgency and Sweating heavily during the day.2.Shengxian decoction can effectively improve the symptoms of PD-TCMS in early Parkinson's disease such as constipation,spontaneous sweat,short of breath and tired.3.Shengxian decoction can delay the time to start taking Western medicine for early Parkinson's disease.Which may have the effect of delaying the progression of PD.4.There was no significant adverse reactions after treatment in two groups,suggesting that Shengxian decoction is safe and effective.