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.