Zishenpingchan granules for the treatment of Parkinson＇s disease：a randomized,double-blind,placebo-controlled clinical trial

Levodopa preparations remain the preferred drug for Parkinson＇s disease.However,long-term use of levodopa may lead to a series of motor complications.Previous studies have shown that the combination of levodopa and Zishenpingchan granules（consisting of Radix Rehmanniae preparata,Lycium barbarum,Herba Taxilli,Rhizoma Gastrodiae,Stiff Silkorm,Curcuma phaeocaulis,Radix Paeoniae Alba,Rhizoma Arisaematis,Scorpio and Centipede） can markedly improve dyskinesia and delay the progression of Parkinson＇s disease,with especially dramatic improvements of non-motor symptoms.However,the efficacy of this combination has not been confirmed by randomized controlled trials.The current study was approved by the Hospital Ethics Committee and was registered in the Chinese Clinical Trial Register（registration number：Chi CTR-INR-1701194）.From December 2014 to December 2016,128 patients（72 males and 56 females,mean age of 65.78 ± 6.34 years） with Parkinson＇s disease were recruited from the Department of Neurology of Longhua Hospital and Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine in China.Patients were equally allocated into treatment and control groups.In addition to treatment with dopamine,patients in treatment and control groups were given Zishenpingchan granules or placebo,respectively,for 24 weeks.Therapeutic efficacy was assessed using the Unified Parkinson＇s Disease Rating Scale,on-off phenomenon,Hoehn-Yahr grade,Scales for Outcomes in Parkinson＇s disease–Autonomic,Parkinson＇s disease sleep scale,Hamilton Anxiety Scale,Hamilton Depression Scale,Mini-Mental State Examination,and the Parkinson＇s Disease Quality of Life Questionnaire.Artificial neural networks were used to determine weights at which to scale these parameters.Our results demonstrated that Zishenpingchan granules significantly reduced the occurrence of motor complications,and were useful for mitigating dyskinesia and non-motor symptoms of Parkinson＇s disease.This combination of Chinese and Western medicine has the potential to reduce levodopa dosages,and no obvious side effects were found.These findings indicate that Zishenpingchan granules can mitigate symptoms of Parkinson＇s disease,reduce toxic side effects of dopaminergic agents,and exert synergistic and detoxifying effects.

Pingchan granule for depressive symptoms in parkinson’s disease:A randomized,double-blind,placebo-controlled trial

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 1:1 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(SE0.25)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.