[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.


METHODS
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.


METHODS
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.


CONCLUSIONS
BSHXG plus Western medicine is effective and safe in improving motor dysfunction of PD patients.
Yang
Ming-hui
MH
Institute of Traditional Chinese Medicine, General Hospital of People's Liberation Army, Beijing 100853, China.
Li
Min
M
Dou
Yong-qi
YQ
Liu
Yi
Y
Luo
Xiao-dong
XD
Chen
Jian-zong
JZ
Shi
Heng-jun
HJ
D000368:Aged; D000369:Aged, 80 and over; D000978:Antiparkinson Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009068:Movement / Q000187:drug effects; D010300:Parkinson Disease / Q000188:drug therapy* / Q000503:physiopathology*; D008517:Phytotherapy; D016896:Treatment Outcome
D000978:Antiparkinson Agents; D004365:Drugs, Chinese Herbal; C527851:bushen huoxue