Efficacy of Wuling capsule for depressive symptoms in patients with Parkinson's disease——a multicenter,randomized,double-blind,placebo-controlled study
Objective To observe the therapeutic effect and safety of Wuling capsule on depressive symptoms in patients with Parkinson's disease(PD).Methods We conducted a multicenter,randomized,double-blind,placebo-controlled clinical trial(Clinical Trials Registration Number:NCT03195231).Patients with PD and depressive symptoms who had a Hamilton Depression Scale(HAMD-17)score ≥13 were screened from four tertiary hospitals in China.Randomization was performed by four hospitals.The PD patients were randomly assigned to either Wuling group or placebo group,and were taken Wuling capsule or placebo three capsules three times a day for 12 weeks.The primary efficacy outcome was the difference in the total HAMD-17 scores from baseline to week 12.Results Eighty-two eligible patients were randomized into two groups,and 66 patients completed all follow-up,including 28 cases in the placebo group and 38 cases in the Wuling capsule group.After 12 weeks of treatment,the total score of HAMD-17 decreased in both placebo group[-3.0(-0.3,-6.0)in the median difference(quartile)]and Wuling capsule group[-6.0(-3.0,-8.3)in the median difference(quartile)],and the decrease was more significantly in Wuling capsule group(Z=1.321,P=0.036).The total score of Parkinson's disease sleep scale(PDSS)increased in both placebo group[2.0(-2.8,12.8)points in the median difference(quartile)]and Wuling capsule group[7.5(0.0,17.3)points in the median difference(quartile)],and the increase of score was more significantly in Wuling capsule group(Z=1.753,P=0.048).No serious adverse reaction events were reported during the study.Conclusions Wuling capsules could improve depressive symptoms and sleep disturbances in PD patients,and show good medication safety.
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