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Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (3): 231-237.doi: 10.3736/jcim20100306

• Original Clinical Research • Previous Articles     Next Articles

Effects of Bushen Huoxue Granule on motor function in patients with Parkinson’s disease: A multicenter, randomized, double-blind and placebo-controlled trial

 Ming-hui Yanga, Min Lia, Yong-qi Doia, Yi Liua, Xiao-dong Luob, Jian-zong Chenc, Heng-jun Shic   

  1. a Institute of Traditional Chinese Medicine, General Hospital of People’s Liberation Army, Beijing 100853, China;
    b Department of Internal Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou 510310, Guangdong Province, China
    c Department of Traditional Chinese Medicine, Xijing Hospital, Forth Military Medical University, Xi’an 710032,Shaanxi Pro vine, China
  • Received:2009-10-16 Accepted:2010-01-24 Online:2010-03-20 Published:2010-03-15
  • Contact: Min Li E-mail:kittenlee1115@126.com

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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.

Key words: Parkinson’s disease, Reinforcing kidney, Activating blood circulation, Chinese herbal drugs, Randomized controlled trial, Double blind method, Placebo, Multicenter study

Figure 1

Flow diagram of this randomized trial"

Table 1

UPDRSⅢ scores before and after treatment in two groups (x±s)"

Group n UPDRSⅢ score
Placebo
Before treatment 51 35.1±2.0
One-month treatment 51 34.7±2.0
Two-month treatment 51 34.4±2.0
Three-month treatment 51 33.9±2.0
BSHXG group
Before treatment 55 41.3±1.9
One-month treatment 55 40.1±1.9**
Two-month treatment 55 38.7±1.9**
Three-month treatment 55 36.9±1.9**

Table 2

Evaluation of chronograph movement before and after treatment in two groups (x±s, times)"

Group n Left hand Right hand
Placebo
Before treatment 51 84.1±5.1 93.5±5.5
One-month treatment 51 89.8±5.4 96.0±5.6
Two-month treatment 51 90.8±5.5 97.8±5.7
Three-month treatment 51 91.6±5.4 98.1±5.7
BSHXG group
Before treatment 55 84.1±5.1 86.2±5.3
One-month treatment 55 87.0±5.2* 88.8±5.3*
Two-month treatment 55 86.9±5.2* 89.0±5.5*
Three-month treatment 55 88.4±5.2* 91.0±5.5*

Table 3

Evaluation of 10-meter back and forth movement before and after treatment in two groups (x±s, s)"

Group n Rise time Walking time Turn around time
Placebo
Before treatment 51 2.3±0.2 26.6±2.1 3.9±0.7
One-month treatment 51 2.3±0.2 26.0±2.0 3.8±0.7
Two-month treatment 51 2.3±0.2 26.6±1.9 4.0±0.7
Three-month treatment 51 2.3±0.2 27.1±1.9 4.0±0.7
BSHXG group
Before treatment 55 2.9±0.2 31.8±2.0 3.4±0.7
One-month treatment 55 2.8±0.2* 31.0±1.9 3.4±0.6
Two-month treatment 55 2.7±0.2* 30.0±1.8 3.2±0.7
Three-month treatment 55 2.6±0.2* 29.1±1.8 3.1±0.7

Table 4

Biceps brachii muscle tension at resting state and maximal voluntary contraction before and after treatment in two groups (x±s, kg/mm)"

Group n Resting state Maximal voluntary contraction
Left Right Left Right
Placebo
Before treatment 26 12.3±0.3 13.6±0.4 10.5±0.3 11.2±0.3
One-month treatment 26 12.3±0.3 13.6±0.4 10.6±0.3 11.2±0.3
Two-month treatment 26 12.3±0.3 13.6±0.4 10.8±0.3 11.1±0.3
Three-month treatment 26 12.3±0.3 13.4±0.3 10.9±0.3 11.1±0.4
BSHXG group
Before treatment 29 12.0±0.3 12.9±0.4 10.40±0.3 10.9±0.3
One-month treatment 29 12.2±0.3** 13.0±0.3** 10.46±0.3 11.0±0.3
Two-month treatment 29 12.4±0.3** 13.1±0.3** 10.5±0.3 13.1±0.3
Three-month treatment 29 13.5±0.3** 13.8±0.3** 10.5±0.3 13.8±0.3

Table 5

Quadriceps femoris muscle tension at resting state and maximal voluntary contraction before and after treatment in two groups (x±s, kg/mm)"

Group n Resting state Maximal voluntary contraction
Left Right Left Right
Placebo
Before treatment 26 11.7±0.4 11.7±0.4 8.9±0.3 8.5±0.2
One-month treatment 26 11.6±0.4 11.7±0.3 8.9±0.3 8.5±0.2
Two-month treatment 26 11.6±0.4 11.7±0.3 8.9±0.3 8.5±0.2
Three-month treatment 26 11.7±0.3 11.8±0.3 8.9±0.3 8.5±0.2
BSHXG group
Before treatment 29 11.7±0.4 12.5±0.3 8.5±0.3 9.2±0.2
One-month treatment 29 11.9±0.3** 12.7±0.3** 8.6±0.3 9.2±0.2
Two-month treatment 29 12.1±0.4** 12.8±0.3** 8.8±0.3 9.2±0.2
Three-month treatment 29 13.0±0.3** 13.2±0.3** 8.5±0.3 9.2±0.2
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