Multi-dimensional analysis on Parkinson's disease questionnaire-39 in Parkinson's patients treated with Bushen Huoxue Granule: A multicenter, randomized, double-blinded and placebo controlled trial.

OBJECTIVES: 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. DESIGN: A randomized, double-blinded, placebo controlled study with a 3-month intervention period and a 6-month follow-up. INTERVENTIONS: 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). MAIN OUTCOME MEASURES: Primary outcome measure was PDQ-39 comprises 39 questions with five different options of answer related to the frequency of the disease manifestation. RESULTS: 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. CONCLUSION: 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.

Analysis of clinical evaluation of response to treatment of Parkinson's disease with integrated Chinese and Western medicine therapy.

OBJECTIVE: To analyze the clinical evaluation of Parkinson's disease (PD) patients receiving integrated Chinese and Western medicine therapy. METHODS: One hundred and twenty patients were enrolled and randomly allocated to a control group or treatment group. Patients in the two groups received placebo and Bushen Huoxue Granule (, BHG), respectively. Both groups received baseline levodopa and benserazide (Madopar). The effects of treatment were assessed monthly during the 9-month treatment. Means of evaluation included Unified PD Rating Scale (UPDRS) scores (II and III), sleep scale score, 10 m turn back test (getting up time, 10 m×2 times, and turning time), timing motor test (TMT)-left and TMT-right, which were treated as the dependent variables; and age, sex, duration of PD, Hoehn and Yahr (H-Y) stage and Madopar dosage of admitted PD patients were as the independent variables. Multiple linear regression was used to analyze these factors. RESULTS: H-Y stage significantly affected UPDRS II score, UPDRS III score, and getting up time (P<0.01). Madopar dosage and H-Y stage significantly affected the 10 m×2 times (P<0.05 or <0.01). Madopar dosage significantly affected the sleep scale score (P<0.05). There were also significant correlations between age and TMT-left or TMT-right (P<0.01), and duration of PD and TMT-right (P<0.05). CONCLUSIONS: The six assessed means of clinical evaluation (including UPDRS II and UPDRS III scores, sleep scale score, getting up time, 10 m×2 times, and turning time) are sensitive indexes in all PD patients. H-Y stage and Madopar dosage are the major factors influencing means of clinical assessment of PD treatment.

[Effects of Bushen Huoxue Granule on motor function in patients with Parkinson's disease: a multicenter, randomized, double-blind and placebo-controlled trial].

BACKGROUND: The main clinical symptoms of Parkinson's disease (PD) are resting tremor, muscle rigidity, bradykinesia, and so on. There is no effective treatment for PD yet, and dyskinesia symptoms affect the life qualities of PD patients. The therapy used for reinforcing kidney and activating blood circulation in treatment of PD can achieve good clinical effects. OBJECTIVE: To evaluate the efficacy and safety of Bushen Huoxue Granule (BSHXG), a compound traditional Chinese herbal medicine for reinforcing kidney and activating blood circulation in treatment of PD. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: A multi-center, randomized, double-blind, placebo-controlled clinical study was undertaken. A total of 120 PD patients from Outpatient Department of General Hospital of People's Liberation Army, Guangdong Provincial Hospital of Traditional Chinese Medicine, and Xijing Hospital and Tangdu Hospital in Xi'an, were randomly divided into BSHXG group and placebo group. There were 55 cases in BSHXG group, for 5 cases lost to follow-up, and 51 cases in placebo group, for 1 case was excluded and 8 cases lost to follow-up. The patients in two groups were all treated for three months. MAIN OUTCOME MEASURES: The movement scale, exercise testing, and muscle tension were observed before and after treatment to make a comprehensive evaluation for clinical efficacy. One month follow-up was also made. RESULTS: At three different times (one, two and three months) after treatment, the score of Unified Parkinson's Disease Rating Scale (UPDRS) III, rise time of 10-meter back and forth exercise and resting muscle tension in BSHXG group were improved as compared with before treatment (P<0.05, P<0.01), and there was an interaction between treatment time and intervention (P<0.05, P<0.01). There were no differences in evaluation results of chronograph movement (times of left and right hand movement in one minute), and walking time and turn around time of 10-meter back and forth exercise between BSHXG group and placebo group, and no interaction existed between treatment time and intervention. BSHXG showed a better efficacy than the placebo (P<0.01) in improving motor function, shortening rise time of 10-meter back and forth test and relieving muscle tension. No adverse effects were found in this trial. CONCLUSION: BSHXG plus Western medicine is effective and safe in improving motor dysfunction of PD patients.