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| Clinical Efficacy and Transcriptomic Analysis of Congrong Shujing Granules (苁蓉舒痉颗粒) in Patients with Parkinson's Disease of Shen (Kidney) Essence Deficiency Syndrome |
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| KeyWord:Congrong Shujing Granules, Parkinson's disease, randomized controlled trial, RNA-sequencing, transcriptomics, Chinese medicine |
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| Abstract: |
| Objective: To evaluate the clinical efficacy and safety of Congrong Shujing Granules (苁蓉舒痉颗粒, CSGs) in treating patients with Parkinson's disease (PD) and Chinese medicine (CM) syndrome of Shen (Kidney) essence deficiency, and to investigate the potential mechanism involving efficacy through a transcriptome sequencing approach. Methods: Eligible PD patients with syndrome of Shen essence deficiency were randomly assigned to a treatment group or a control group by a random number table, and were treated with CSGs combined with Western medicine (WM), or placebo combined with WM, respectively. Both courses of treatment lasted for 12 weeks. The Unified Parkinson's Disease Rating Scale (UPDRS) score, the PD Question-39(PDQ-39) score, CM Syndrome Scale score, and drug usage of all patients were evaluated before and after treatment. Safety was evaluated by clinical laboratory tests and electrocardiographs. Blood samples from 6 patients in each group were collected before and after the trial and used for transcriptomic analysis by gene ontology analysis and Kyoto Encyclopedia of Genes and Genomes pathway analysis. Differentially expressed genes were validated using reverse transcription-polymerase chain reaction. Results: A total of 86 PD patients were selected from the Third Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine between January 2017 and December 2017. Finally, 72 patients completed the trial, including 35 in the treatment group and 37 in the control group. When compared with the control group after treatment, patients in the treatment group showed significant decreases in UPDRS sub-Ⅱ score, PDQ-39 score, CM syndrome score, and Levodopa equivalent dose (P<0.05). During the treatment course, no significant changes were observed in safety indicators between the two groups (P>0.05). A possible mechanism of clinical efficacy was proposed that involved regulating cell metabolism-related processes and ribosome-related pathways. Treatment with CSGs had shown to affect relevant gene loci for PD, including AIDA, ANKRD36BP2, BCL2A1, BCL2L11, FTH1P2, GCH1, HPRT1, NFE2L2, RMRP, RPS7, TGFBR1, WIPF2, and COX7B. Conclusions: CSGs combined with WM can be used to treat PD patients with CM syndrome of Shen essence deficiency with a good safety. The possible mechanism of action and relevant gene loci were proposed. (Registration No. ChiCTR-IOR-16008394) |
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