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Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (3): 310-317.doi: 10.3736/jcim20120310

• Original Clinical Research • Previous Articles     Next Articles

Effects of Chinese herbal medicine Bushen Huoxue Granule on quality of life of patients with Parkinson disease: a randomized, double-blinded and placebo-controlled trial

Li Min(),Yang Ming-hui,Liu Yi   

  1. Institute of Traditional Chinese Medicine, General Hospital of the People’s Liberation Army, Beijing 100853, China
  • Received:2011-07-06 Accepted:2011-08-01 Online:2012-03-20 Published:2018-10-10

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BACKGROUND: The main clinical symptoms of Parkinson disease (PD) are resting tremor, muscle rigidity and bradykinesia. There is currently no effective treatment for PD, and dyskinesia symptoms affect the quality of life of patients with PD. The Chinese medicine therapy used for reinforcing kidney and activating blood circulation in treatment of PD was reported to achieve good clinical effects.
OBJECTIVE: To study the effects of Bushen Huoxue Granule, a compound traditional Chinese herbal medicine, on the quality of life of patients with PD.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: A total of 120 patients were enrolled from General Hospital of the People’s Liberation Army in China and divided into two groups randomly. Patients in the control group were treated with a placebo and in the treatment group with Bushen Huoxue Granule based on treating with levodopa. A double-blinded clinical trial was adopted over a 3-month treatment with a follow-up period lasting 6 months.
MAIN OUTCOME MEASURES: Unified Parkinson Disease Rating Scale Ⅱ (UPDRSⅡ), questionnaire-39 (PDQ-39) and Parkinson’s disease sleep scale (PDSS) were adopted to measure the quality of life at baseline, after 3 months of treatment and at a 6-month follow-up.
RESULTS: Bushen Huoxue Granule showed a higher efficacy than the control in improving life quality of patients with PD by improving scores of UPDRSⅡ, PDQ-39 and PDSS (P<0.05). No adverse effects were found in this trial.
CONCLUSION: Bushen Huoxue Granule can markedly improve the quality of life of patients with PD.

Key words: Parkinson disease, drugs, Chinese herbal, quality of life, randomized controlled trials, double-blinded method, placebos

Table 1

Characteristics of patients of two groups"

Group n Sex (Male/female) Age (x±s, years) Period of PD (x±s, years) H-Y stage (x±s) Levodopa (x±s, mg)
BSHXG 60 31/27 66.6±1.2 5.2±0.4 2.5±0.1 494.38±19.43
Control 60 42/20 67.3±1.2 5.1±0.5 2.3±0.1 475.00±19.43

Figure 1

Flow diagram of this randomized trial"

Table 2

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

Group n UPDRSⅡ score
Before treatment One-month treatment Two-month treatment Three-month treatment
Control 51 15.41±0.90 14.98±0.87 15.02±0.90 14.71±0.87
BSHXG 55 16.49±0.87 15.98±0.84 15.38±0.87 14.62±0.84

Table 3

UPDRSⅡ scores before and after treatment in two groups in follow-up period (x±s)"

Group n UPDRSⅡ score
Before treatment After 6-month treatment After 9-month treatment
Control 51 15.41±0.90 15.22±0.81 16.88±0.83
BSHXG 55 16.49±0.87 14.13±0.77 12.86±0.78

Table 4

The changes of UPDRSⅡ scores after treatment in two groups (x±s)"

Group n The changes of UPDRSⅡ score
One-month treatment Two-month treatment Three-month treatment Six-month treatment Nine-month treatment
Control 51 2.38±0.29 1.96±0.44 2.22±0.17 1.20±0.56 0.04±0.93
BSHXG 55 2.77±0.32 2.89±0.57 4.68±0.21 5.07±0.28 8.33±0.19

Table 5

PDQ-39 scores before and after treatment in two groups (x±s)"

Group n PDQ-39 score
Before treatment After 1-month
treatment		 After 2-month
treatment		 After 3-month
treatment		 After 6-month
treatment		 After 9-month
treatment
Control 51 29.28±1.20 28.95±1.99 28.23±1.99 28.34±2.05 29.81±1.93 32.82±1.85
BSHXG 55 33.57±1.89 32.53±1.88 30.89±1.88 29.36±1.93 26.85±1.82 23.23±1.75

Table 6

The changes of PDQ-39 scores after treatment in two groups (x±s)"

Group n The changes of PDQ-39 score
After 1-month
treatment		 After 2-month
treatment		 After 3-month
treatment		 After 6-month
treatment		 After 9-month
treatment
Control 51 1.28±0.27 1.48±0.49 1.77±1.82 3.38±1.22 7.20±2.30
BSHXG 55 1.33±1.20 4.92±1.78 6.75±2.04 7.89±1.33 12.80±1.04

Table 7

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

Group n PDSS score
Before treatment After 1-month treatment After 2-month treatment After 3-month treatment
Control 51 98.14±4.11 101.84±3.40 103.06±3.80 102.61±3.78
BSHXG 55 89.02±3.96 94.29±3.85 99.06±3.66 101.46±3.64

Table 8

PDSS scores before and after treatment in two groups in follow-up period （x±s)"

Group n PDSS score
Before treatment After 6-month treatment After 9-month treatment
Control 51 98.14±4.11 96.69±3.35 91.49±2.97
BSHXG 55 89.02±3.96 103.76±3.17 110.56±2.80

Table 9

The changes of PDSS scores after treatment in two groups （x±s)"

Group n The changes of PDSS score
One-month treatment Two-month treatment Three-month treatment Six-month treatment Nine-month treatment
Control 51 6.07±0.45 7.29±1.44 6.12±0.97 2.12±1.39 5.13±1.47
BSHXG 55 10.70±1.01 17.96±1.38 19.27±2.09 23.18±0.24 38.21±2.16
[1] Hely MA, Morris JG, Reid WG, Trafficante R . Sydney Multicenter Study of Parkinson' disease: non- L-dopa-responsive problems dominate at 15 years. Mov Disord. 2005; 20(2):190-199.
doi: 10.1002/(ISSN)1531-8257
[2] Siderowf A, McDermott M, Kieburtz K, Blindauer K, Plumb S, Shoulson I; Parkinson Study Group . Test- retest reliability of the unified Parkinson’s disease rating scale in patients with early Parkinson's disease: results from a multicenter clinical trial. Mov Disord. 2002; 17(4) : 758-763.
doi: 10.1002/(ISSN)1531-8257
[3] Gibb WR, Lees AJ . The relevance of the Lewy body to the pathogenesis of idiopathic Parkinson’s disease. J Neurol Neurosurg Psychiatry. 1988; 51(6):745-752.
doi: 10.1136/jnnp.51.6.745
[4] Hoehn MM, Yahr MD . Parkinsonism: onset, progression and mortality. Neurology. 1967 ; 17(5) : 427-442.
doi: 10.1212/WNL.17.5.427
[5] Li M, Yang MH . Effects of strengthening kidney and activating circulation therapy on symptoms of TCM in Parkinson's patients. Zhonghua Zhong Yi Yao Za Zhi. 2010 ; 25 (12): 2346-2351. Chinese with abstract in English.
李敏, 杨明会 . 补肾活血法对帕金森患者中医证候的影响.中华中医药杂志. 2010; 25(12):2346-2351.
[6] Ministry of Health of the Peopled Republic of China. Clinical guideline of new drugs for traditional Chinese medicine (trial implementation) . Beijing: China Medical Science Press. 1993 : 91-94. Chinese.
中华人民共和国卫生部. 中药新药临床研究指导原则 (试行).北京: 中国医药科技出版社. 1993: 91-94.
[7] Bian ZX, Li YP, Moher D, Dangenais S, Liu L, Wu TX, Miao JX, Kwan AKL, Song L . Improving the quality of randomized controlled trials in Chinese herbal medicine, part I : clinical trial design and methodology. J Chin Integr Med. 2006; 4(2): 120-129. Chinese with abstract in English.
卞兆祥, 李幼平, Moher D, Dangenais S, 刘良,吴泰相,缪江霞,关家伦,宋丽 .提髙中草药随机对照试验的质量I :临床试验设计和方法学.中西医结合学报. 2006; 4(2) : 120-129.
[8] Peto V, Jenkinson C, Fitzpatrick R . PDQ-39 : a review of the development, validation and application of a Parkinson’s disease quality of life questionnaire and its associated measures. J Neurol. 1998; 245(Suppl 1):S10-S14.
doi: 10.1007/PL00007730
[9] Chaudhuri KR . Nocturnal symptom complex in PD and its management. Neurology. 2003; 61(6 Suppl 3):S17-S23.
doi: 10.1212/WNL.61.6_suppl_3.S17
[10] Den Oudsten BL, Van Heck GL, De Vries J . Quality of life and related concepts in Parkinson’s disease: a systematic review. Mov Disord. 2007 ; 22(11) : 1528-1537.
doi: 10.1002/(ISSN)1531-8257
[11] Porter B, Macfarlane R, Walker R . The frequency and nature of sleep disorders in a community-based population of patients with Parkinson's disease. Eur J Neurol. 2008; 15(1) : 50-54.
[12] Souza RG, Borges V, Silva SM, Ferraz HB . Quality of life scale in Parkinson’s disease PDQ-39 —(Brazilian Portuguese version) to assess patients with and without levodopa motor fluctuation. Arq Neuropsiquiatr. 2007; 65(3B) : 787-791.
doi: 10.1590/S0004-282X2007000500010
[13] Cornelia CL . Sleep disturbances and excessive daytime sleepiness in Parkinson disease: an overview. J Neural Transm Suppl. 2006; ( 70):349-355.
[14] Dzirasa K, Ribeiro S, Costa R, Santos LM, Lin SC, Grosmark A, Sotnikova TD, Gainetdinov RR, Caron MG, Nicolelis MA . Dopaminergic control of sleep-wake states. J Neurosci. 2006; 26(41):10577-10589.
doi: 10.1523/JNEUROSCI.1767-06.2006
[15] Yang MH, Li M, Dou YQ, Liu Y, Luo XD, Chen JZ , Shi HJ. Effects of Bushen Huoxue Granule on motor function in patients with Parkinson’s disease. J Chin Integr Med. 2010; 8(3): 231-237. Chinese with abstract in English.
杨明会, 李敏, 窦永起, 刘毅, 雒晓东, 陈建宗, 史恒军 . 补肾活血颗粒对帕金森病患者运动功能的影响.中西医结合学报. 2010; 8(3):231-237.
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