Guo-hua Zhao1, Fei Sun, Xue-gong Feng, Min Gao. 1. Inpatient Department, Beijing Tongrentang Hospitalof Traditional Chinese Medicine, Beijing, China. ghzhao318@126.com
Abstract
OBJECTIVE: To observe the therapeutic efficacy of guiling pa'an granule (GPG) in treating non-motor symptoms of Parkinson's disease (PD) patients of Gan-Shen deficiency syndrome (GSDS). METHODS: A multi-center,third party-central online, network randomized, double-blinded, double-dummy, and placebo controlled clinical trial was conducted. Totally 121 patients with confirmed diagnosis of PD by Western medicine and of GSDS by syndrome typing were assigned to the control group and the treatment group. Under the premise of the same treatment baseline, the placebo and GPG at the same dose was respectively administered to patients in the control group and the treatment group. The therapeutic course was 6 months for all. The changes of 8 non-motor symptoms (including witless expression, seborrhea, sialorrhea, cognitive impairment, constipation, hyperhidrosis, insomnia and dreaminess, and psychosis) were observed in the two groups, when compared with the baseline. RESULTS:Satisfactory effectiveness in the 8 non-motor symptoms of PD patients were obtained in the treatment group (P<0.01). Besides, less adverse reactions occurred. CONCLUSION:GPG could improve the non-motor symptoms of PD patients.
RCT Entities:
OBJECTIVE: To observe the therapeutic efficacy of guiling pa'an granule (GPG) in treating non-motor symptoms of Parkinson's disease (PD) patients of Gan-Shen deficiency syndrome (GSDS). METHODS: A multi-center,third party-central online, network randomized, double-blinded, double-dummy, and placebo controlled clinical trial was conducted. Totally 121 patients with confirmed diagnosis of PD by Western medicine and of GSDS by syndrome typing were assigned to the control group and the treatment group. Under the premise of the same treatment baseline, the placebo and GPG at the same dose was respectively administered to patients in the control group and the treatment group. The therapeutic course was 6 months for all. The changes of 8 non-motor symptoms (including witless expression, seborrhea, sialorrhea, cognitive impairment, constipation, hyperhidrosis, insomnia and dreaminess, and psychosis) were observed in the two groups, when compared with the baseline. RESULTS: Satisfactory effectiveness in the 8 non-motor symptoms of PDpatients were obtained in the treatment group (P<0.01). Besides, less adverse reactions occurred. CONCLUSION: GPG could improve the non-motor symptoms of PDpatients.