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ObjectiveTo observe the clinical efficacy and safety of Chinese medicinal mixture for dispelling stasis and resolving phlegm combined with western medicine in the treatment of epilepsy combined with cognitive impairment by randomized， double-blind， placebo-controlled， parallel-group trial. MethodA total of 123 inpatients and outpatients with epilepsy complicated with cognitive impairment admitted to the department of neurology at Longhua Hospital from October 2020 to October 2021 were randomly assigned into a control group （62 cases， carbamazepine + placebo） and a treatment group （61 cases， carbamazepine + Quyu Dingxian Zhengtong mixture） by random number table method. In the treatment group， 4 cases were exfoliated and eliminated. In the control group， 3 cases fell off. Finally， 57 cases in the treatment group and 59 cases in the control group were included. The total course of treatment for both groups was 12 weeks. The clinical efficacy， efficacy for traditional Chinese medicine （TCM） syndromes， and incidence of adverse reactions were compared between two groups. The changes of seizure frequency， abnormal rate of electroencephalogram （EEG）， cognitive function score， serum homocysteine （HCY）， folic acid， and vitamin B12 （B12） were measured and compared before and after treatment. ResultAfter 12 weeks of treatment， the treatment group had higher clinical efficacy ［92.98% （53/57） vs 79.66% （47/59）， χ2=4.327， P<0.05］ and efficacy for TCM syndromes ［96.49% （55/57） vs 84.75% （50/59）， χ2=4.660， P<0.05］ than the control group. The treatment group was superior to the control group in reducing the seizure frequency （Z=-3.938， P<0.01） and improving the Montreal cognitive assessment （MoCA） score （t=4.333， P<0.01） and mini-mental state examination （MMSE） score （t=9.531， P<0.01）. The variations in serum HCY， folic acid， and B12 in the treatment group were less than those in the control group （t=-7.233， t=-7.972， t=-6.871， P<0.01）. After treatment， the abnormal rate of EEG in the treatment group was lower than that in the control group （χ2=4.437， P<0.05）. The incidence of adverse reactions in the treatment group （1.75%， 1/57） was lower than that （13.56%， 8/59） in the control group （corrected χ2=4.116， P<0.05）. ConclusionChinese medicinal mixture for dispelling stasis and resolving phlegm in combination with western medicine had better efficacy and safety than western medicine alone in the treatment of epilepsy complicated with cognitive impairment. Specifically， the combination outperformed western medicine alone in terms of clinical efficacy， efficacy for TCM syndromes， reduction in seizure frequency， abnormal rate of EEG， adverse reactions， improvement of cognitive function， and variations in serum folic acid， B12， and HCY values. Chinese medicinal mixture for dispelling stasis and resolving phlegm may improve the clinical efficacy and safety by changing the metabolism of folic acid， B12， and HCY in serum of the patients with epilepsy complicated with cognitive impairment.
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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 (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.