Pingchan granule for depressive symptoms in parkinson's disease: A randomized, double-blind, placebo-controlled trial / 中西医结合学报

ABSTRACT

BACKGROUND@#Depression in Parkinson's disease (dPD) is closely related to quality of life. Current studies have suggested that Pingchan Granule (PCG) might be effective for treating dPD.@*OBJECTIVE@#This study determines the efficacy of PCG for depressive symptoms in Parkinson's disease (PD).@*DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS@#This was a randomized, double-blind, placebo-controlled trial, conducted in Longhua Hospital, Shanghai, China. Patients diagnosed with idiopathic PD and clinically significant depressive symptoms (defined by a 24-item Hamilton Rating Scale for Depression [HAM-D] score ≥ 8) were included in this study, randomly assigned to PCG or placebo group in a 11 ratio and followed for 24 weeks.@*MAIN OUTCOME MEASURES@#The primary outcome was the change from baseline to week 24 in HAM-D score among the set of patients who completed the study following the treatment protocol (per-protocol set). Secondary outcomes included changes in scores on the Unified Parkinson's Disease Rating Scale (UPDRS) part 2 (UPDRS-II), UPDRS part 3 (UPDRS-III), Parkinson's Disease Sleep Scale (PDSS) and Hamilton Rating Scale for Anxiety (HAM-A), between baseline and week 24.@*RESULTS@#Eighty-six patients were enrolled, and 85 patients were included in the per-protocol set. HAM-D scores decreased by an adjusted mean of 11.77 (standard error [SE] 0.25) in the PCG group and 3.86 (SE 0.25) in the placebo group (between-group difference = 7.91, 95% confidence interval [7.22, 8.80], P < 0.001), in the multivariable linear regression. Improvements in scores on the UPDRS-II, UPDRS-III, PDSS, and HAM-A scales were also observed.@*CONCLUSION@#Treatment with PCG was well tolerated and improved depressive symptoms and motor and other non-motor symptoms in PD.@*TRIAL REGISTRATION@#Chinese Clinical Trial Register ChiCTR-INR-17011949.