平颤颗粒治疗帕金森病抑郁症状的随机、双盲、安慰剂对照试验。

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

机构信息

Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.

出版信息

J Integr Med. 2021 Mar;19(2):120-128. doi: 10.1016/j.joim.2020.12.006. Epub 2020 Dec 29.

DOI:10.1016/j.joim.2020.12.006

PMID:33446472

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 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.

摘要

背景

帕金森病（PD）伴发的抑郁与生活质量密切相关。目前的研究表明，平颤颗粒（PCG）可能对治疗 PD 伴发的抑郁有效。

目的

本研究旨在确定 PCG 治疗帕金森病伴发抑郁症状的疗效。

设计、地点、参与者和干预措施：这是一项在中国上海龙华医院进行的随机、双盲、安慰剂对照试验。将符合特发性 PD 且存在临床显著抑郁症状（24 项汉密尔顿抑郁量表[HAM-D]评分≥8 分）的患者纳入本研究，按 1∶1 比例随机分配至 PCG 或安慰剂组，随访 24 周。

主要结局测量指标

主要结局是根据治疗方案完成研究的患者（意向性治疗集）基线至 24 周时 HAM-D 评分的变化。次要结局包括从基线至 24 周时统一帕金森病评定量表（UPDRS）第 2 部分（UPDRS-II）、第 3 部分（UPDRS-III）、帕金森病睡眠量表（PDSS）和汉密尔顿焦虑量表（HAM-A）评分的变化。

结果

共纳入 86 例患者，85 例患者纳入意向性治疗集。PCG 组 HAM-D 评分降低 11.77（标准误 0.25），安慰剂组降低 3.86（标准误 0.25）（组间差异 7.91，95%置信区间 7.22~8.80，P＜0.001）。在多变量线性回归分析中也观察到 UPDRS-II、UPDRS-III、PDSS 和 HAM-A 评分的改善。