The Effects Of "the Seven Acupoints Of The Cranial Base" On Health Related Quality Of Life For Patients With Parkinson’s Disease:a Randomized Controlled Trial

Objectives:To observe and evaluate the curative effects and the safety of "the Seven Acupoints of the Cranial Base"(SACB) in improving quality of life (QOL)of patients with PD.Methods:①Design:The study design was a randomized controlled trial of acupuncture compared with a western medicine control group.②Setting:The study was conducted at Department of Acupuncture of Wangjing Hospital.③Subjects: Seventy-two(72) patients with diagnosis of Parkinson’s disease, who met the inclusion criteria.④Interventions:The study subjects were randomly divided into two groups, i. e., a test group(acupuncture group) and a control group(drug group). The former was treated by SACB (DU15, GB20, GB12, BL10) every two days, while the latter took Levodopa and Benserazide (Madopar)250mg tid.The subjects all received a six month treatment.⑤Outcome measures:Parkinson’s disease questionnaire-39(PDQ-39), Unified Parkinson’s Disease Rating Scale Ⅱ (UPDRSⅡ) and Parkinson’s disease sleep scale(PDSS) were adopted to measure health related quality of life at four time points, i. e., at baseline, after1months of treatment, after3months of treatment and after6months of treatment.⑥Statistical method:Microsoft Excel2003and SPSS18.0were adopted to process the test data. According to different type of the test data,t-test, chi-square test and rank sum test were adopted to process measurement data, count data and level informationResult:1The baseline data in the two groupsAmong the subjects, two2cases are dropped out.Among the70evaluated cases,36are male and34are female, with an average age of61.5years old and an average PD history of4.36years.The total scores of Mini-Mental State Examination(MMSE), Parkinson’s disease questionnaire-39(PDQ-39), Unified Parkinson’s Disease Rating Scale Ⅱ (UPDRS Ⅱ) and Parkinson’s disease sleep scale(PDSS)of patients in the treatment group were24.89±2.30,35.62±7.23,16.91±2.55,111.54±10.43, the control group were25.43±2.15,34.88±6.62,15.97±2.47,113.17±10.71.There was no statistical difference between the two groups in the distribution of demographic characteristics such as age, gender, clinical course and scores of MMSE, PDQ-39, UPDRS Ⅱ and PDSS, P>0.05. Baseline data of the two groups were comparable.2The clinical curative effects in the two groupsThe total effective rate of the treatment group was85.71%(30/35), the control group was71.43%(25/35).And there was a statistical difference of level distribution between the two groups(Z=-3.929, P<0.01).The movement of the index of lab:The movement of total score of PDQ-39, UPDRS II and PDSS of patients in the treatment group were significantly improved compared with the control groupfthe movement in the treatment group:15.22±9.76,7.83±4.27,14.77±11.31, the control group:7.40±4.73,5.66±4.21,-3.23±6.49, P<0.01].The treatment group has statistical improvements of seven dimensions of PDQ-39scale, i. e., mobility, activities of daily living, the emotions, stigma, cognitions, communication and bodily discomfort. While the control group only has statistical improvements of two dimensions of PDQ-39scale, i. e., mobility, activities of daily living.The movement of the8total dimension score in PDQ-39scale of mobility, activities of daily living, emotional well-being, stigma, Social support,cognitions, communication and bodily discomfort of patients in the treatment group:7.97±6.01,4.74±3.53,3.46±6.70,2.03±2.41,0.40±1.22,3.83±2.42,2.40±2.04,1.40±2.26, the control group:7.97±5.60,4.97±3.84,3.46±6.70, 2.03±2.41,0.34±1.08,3.83±2.42,2.40±2.04,1.40±2.26. The scores of the total dimension score in PDQ-39scale of emotional well-being, stigma, cognitions, communication and bodily discomfort of patients in the treatment group were significantly improved compared with the control group, while the control group had no curative effects in this5dimension. And there was a statistical difference between the two groups in the movement of this5dimension, P<0.05or P<0.01.The movement of the item score in UPDRSⅡ scale of salivating, swallowing, speech and turning in bed of patients in the treatment group were significantly improved compared with the control group[the movement in the treatment group:0.66±0.59,0.80±0.80,0.74±0.82,0.51±0.61, the control group:0.09±.0.70,0.20±0.63,0.20±0.93,0.20±0.53.P<0.01or P<0.05]Actually, the control group had no curative effects in salivating, swallowing and speech, P>0.05.Conclusion:"The Seven Acupoints of the Cranial Base" can markedly and multi-dimensionally improve the quality of life of patients with PD, especially in respects of sleep, cognitions, emotions, stigma, communication, bodily discomfort and4items of activities of daily living, including speech, swallowing, salivating, turning in bed.