Effectiveness of Congrong Shujing Granules on Expression of Substantia Nigra Metabolites in Parkinson's Disease Patients:A Randomized Controlled Trial
Objective To evaluate the clinical efficacy and safety of Congrong Shujing Granules on substantia nigra metabolites in the treatment of Parkinson's disease(PD).Methods According to the double-center stratified randomization,30 PD patients meeting the enrollment criteria were randomly divided into 2 groups,15 patients in the observation group were treated with Congrong Shujing Granules plus basic Western medicine,and 15 patients in the control group were treated with placebo plus basic Western medicine.The course of treatment lasted for 12 weeks.The scores of Movement Disorder Society-Unified Parkinson Disease Rating Scale(MDS-UPDRS),magnetic resonance spectroscopy(MRS),electromyography(EMG),39-item Parkinson's Disease Quality of Life Questionnaire(PDQ-39)and non-Motor Symptom Rating Scale(NMSS)were determined before and after treatment.Blood and urine routine,liver and kidney function,electrocardiogram were detected,and adverse events were recorded.Results There were 60 cases in ITT group,60 cases in safety group,53 cases of MRS Per-Protocol(PP)and 45 cases of EMG PP in the two centers.Compared with the same group before treatment,the MDS-UPDRS Ⅰ,PDQ-39 and NMSS scores were all reduced in the control group(P＜0.05).And in the observation group,the scores of each domain and total score of MDS-UPDRS scale,PDQ-39 and NMSS scores were all reduced,and the N-acetylaspartate/creatine(NAA/Cr)value in substantia nigra of mild side was increased(P＜0.05).Compared with the control group at the same time,MDS-UPDRS Ⅰ,MDS-UPDRS Ⅲ,PDQ-39 and NMSS scores were decreased,and the NAA/Cr value in substantia nigra of mild side was increased in the observation group(P＜0.05).During the treatment period,there was 1 case of adverse reaction in the control group,and the symptoms were reduced to disappear after observation.Compared with baseline,there was no significant change in the safety index of all patients(P＞0.05).Conclusions Congrong Shujing Granules can improve the motor symptoms and non-motor symptoms of PD patients,improve the quality of life,promote the proliferation of glial cells.It has good safety in the treatment of PD.(Chinese Clinical Trial Registry,No.ChiCTR2000034107)
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