Li Min, Yang Hui Ming, Luo Dong Xiao, Chen Jian Zong, Shi Heng Jun
Institute o f Traditional Chinese Medicine, General Hospital of People s Liberation Army, Beijing 100853, China.
Institute o f Traditional Chinese Medicine, General Hospital of People s Liberation Army, Beijing 100853, China.
Complement Ther Med. 2016 Dec;29:116-120. doi: 10.1016/j.ctim.2016.09.008. Epub 2016 Sep 14.
To preliminarily assess the effects of Bushen Huoxue Granule (BHG) on Parkinson's Patients with Parkinson's Disease Questionnaire-39 (PDQ-39)and to provide data for further research.
A randomized, double-blinded, placebo controlled study with a 3-month intervention period and a 6-month follow-up.
Participants were patients with Parkinson's Disease (PD) of age ranging from 50 to 80 years and Hoehn and Yahr (H-Y) stage I-IV of the disease.120 participants were allocated to BHG group or placebo group at a 1:1 ratio. The BHG group received BHG twice a day for 3 months, and was followed-up for 6 months after treatment; the placebo group did not receive any Chinese Herb treatment for 9 months. All the patients were given the conventional therapy of levodopa (Madopar).
Primary outcome measure was PDQ-39 comprises 39 questions with five different options of answer related to the frequency of the disease manifestation.
Significant statistical difference appeared in the following PDQ-39 dimensions: mobility; emotional well-being; stigma; cognition (P<0.01) and bodily discomfort (P<0.05).There was no statistical difference in the dimensions of social support, ADL and communication between the data of these two group patients (P≥0.05). We found that the sum index of PDQ-39 was significantly different between two groups.
The results of this study show that BHG treatment makes significant effects in most domains of PD patients life quality,especially in mobility, emotional well-being, stigma and cognition. The affected factors should be confirmed in larger studies.
初步评估补肾活血颗粒(BHG)对帕金森病患者帕金森病问卷-39(PDQ-39)的影响,为进一步研究提供数据。
一项随机、双盲、安慰剂对照研究,干预期为3个月,随访期为6个月。
参与者为年龄在50至80岁之间、疾病 Hoehn 和 Yahr(H-Y)分期为 I-IV 期的帕金森病(PD)患者。120名参与者按1:1的比例分配到BHG组或安慰剂组。BHG组每天服用两次BHG,持续3个月,并在治疗后随访6个月;安慰剂组9个月内未接受任何中药治疗。所有患者均接受左旋多巴(美多芭)的常规治疗。
主要观察指标为PDQ-39,包括39个问题,有五个与疾病表现频率相关的不同答案选项。
在以下PDQ-39维度上出现了显著的统计学差异:运动能力;情绪健康;耻辱感;认知(P<0.01)和身体不适(P<0.05)。两组患者在社会支持、日常生活活动能力和沟通维度的数据上没有统计学差异(P≥0.05)。我们发现两组之间PDQ-39的总和指数有显著差异。
本研究结果表明,BHG治疗对PD患者生活质量的大多数领域有显著影响,尤其是在运动能力、情绪健康、耻辱感和认知方面。这些影响因素应在更大规模的研究中得到证实。