RESUMEN
Objective To observe the clinical efficacy of Zishen Pingchan Granules in treating non-motor symptoms (NMS) of Parkinson disease (PD). Methods A randomized, double-blind, placebo-controlled trial was used. 124 patients with PD were randomly divided into the treatment group (n=62) and the control group (n=62). Patients not yet taking Western medicine were suspended the application of Western medicine, receiving direct TCM treatment. Patients who had already taken Western medicine were added TCM on the basis of original medicine dosage and method. The treatment group was given Zishen Pingchan Granules, while the control group was treated with placebo granule, once a bag, twice a day. The treatment lasted for 12 weeks. The clinical efficacy was assessed by using unified PD rating scale (UPDRSⅡ–Ⅲ), the scale for outcomes in PD for autonomic symptoms (SCOPA-AUT), Parkinson disease sleep scale (PDSS) and dosage of levodopa. Results The UPDRSⅡ and UPDRS Ⅲscores of the treatment group and the control group after 4, 8, and 12 week of treatment had no difference at each time point compared with before treatment (P>0.05). There was no statistical significance in scores of UPDRSⅡ and UPDRSⅢ after treatment (P>0.05). Efficacy of SCOPA-AUT in treatment group after treatment was significantly better than the control group; There was statistical significance in constipation, salivation, nocturia and sweating in SCOPA-AUT between the two groups after treatment (P<0.05). Compared with before treatment, PDSS scores in treatment group after 8 and 12 weeks of treatment increased significantly (P<0.05). After 4, 8, and 12 weeks of treatment, PDSS scores in treatment group were much higher than control group (P<0.01). By comparing PDSS score in the two groups before and after treatment, it showed that treatment group had better efficacy in extending the time to sleep, reducing nocturia, nightmares, and hallucinations (P<0.05). After 12 weeks of treatment, dosage of levodopa in control group increased significantly, which treatment group was much lower than the control group (P<0.05). Conclusion Zishen Pingchan Granules can improve the autonomic dysfunctionin and sleep quality of PD patients, and can significantly reduce the dosage of levodopa.