SUBSCRIBE
Search JIM Advanced Search

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

RichHTML

2

PDF (PC)

110

Like

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
[1] Chen SD, Le WD, Chen XW. Parkinson’s disease[M]. Beijing: People’s Medical Publishing House, 2006: 59-73
陈生弟, 乐卫东, 陈先文 . 帕金森病[M]. 北京: 人民卫生出版社, 2006: 59-73
[2] Gibb UR, Lees AJ . The relevance of the Lewy body to the pathogenesis of idiopathic Parkinson’s disease[J]. J Neurol Neurosurg Psychiatry, 1988,51(6):745-752
doi: 10.1136/jnnp.51.6.745
[3] Yang MH, Dou YQ, Liu Y, Zhao GY, Luo Y . Contrast clinical observation in the treatment of Parkinson’s disease with Yichan decoction[J]. Zhongguo Zhong Xi Yi Jie He Ji Jiu Za Zhi, 2002,9(5):256-257
杨明会, 窦永起, 刘毅, 赵冠英, 罗毅 . 抑颤汤治疗帕金森病临床对照观察[J]. 中国中西医结合急救杂志, 2002,9(5):256-257
[4] Dou YQ, Yang MH, Liu Y, Wei ZM . Curative effect of integrated traditional Chinese medicine and Western medicine for treatment of patients with Parkinson’s disease: a control study[J]. Zhongguo Lin Chuang Kang Fu, 2006,10(19):6-8
窦永起, 杨明会, 刘毅, 魏正茂 . 中西医结合治疗PD疗效的对照观察[J]. 中国临床康复, 2006,10(19):6-8
[5] Leonard CT, Deshner WP, Romo JW, Suoja ES, Fehrer SC, Mikhailenok EL . Myotonometer intra- and interrater reliabilities[J]. Arch Phys Med Rehabil, 2003,84(6):928-932
doi: 10.1016/S0003-9993(03)00006-6
[6] Zheng XY. Guidelines for clinical research on Chinese new herbal medicines(trial implementation)[M]. Beijing: Medical Science and Technology Publishing House of China, 1993: 91-94
郑筱萸 . 中药新药临床研究指导原则(试行)[M]. 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, Miu JX, Song L . Improving the quality of randomized controlled trials in Chinese herbal medicine, Part Ⅰ: clinical trial design and methodology[J]. J Chin Integr Med, 2006,4(2):120-129
卞兆祥, 李幼平, Moher D, Dangenais S, 刘良, 吴泰相, 缪江霞, 宋丽 .提高中草药随机对照试验的质量Ⅰ: 临床试验设计和方法学[J]. 中西医结合学报, 2006,4(2):120-129
[8] Gu XZ . Clinical observation of the effects of Dingchan Yin combined with Western medicine in treatment of 30 cases of Parkinson’s disease[J]. Nanjing Zhong Yi Yao Da Xue Xue Bao Zi Ran Ke Xue Ban, 2002,18(5):275-277
顾锡镇 . 西药加定颤饮治疗帕金森病30例临床观察[J]. 南京中医药大学学报: 自然科学版, 2002,18(5):275-277
[9] Zhang YH . Significance of motor function test on early stage patients with Parkinson’s disease[J]. Nao Yu Shen Jing Ji Bing Za Zhi, 2005,13(2):155-156
张燕辉 . 运动功能检测对帕金森病早期诊断的意义[J]. 脑与神经疾病杂志, 2005,13(2):155-156
[1] Sherman Gu, Arthur Yin Fan. Controversial conclusions from two randomized controlled trials for acupuncture's effects on polycystic ovary syndrome or in vitro fertilization support. Journal of Integrative Medicine, 2020, 18(2): 89-91.
[2] Gerli E.G. Herr, Fábio Goulart da Silva, Francisco José Cidral-Filho, Fabricia Petronilho, Lucinéia Gainski Danielski, Mariana Pereira de Souza Goldim, Afonso Shiguemi Inoue Salgado, Franciane Bobinski, Daniel Fernandes Martins, Eliane R. Winkelmann. Effects of the use of bioceramic wraps in patients with lower limb venous ulcers: A randomized double-blind placebo-controlled trial. Journal of Integrative Medicine, 2020, 18(1): 27-.
[3] Xin-yu Yue, Zhuo-qi Feng, Xi-yi Yu, Jia-min Hu, Xiao-Jing He, Shi Shu. Fire-needle acupuncture for upper limb spastic paralysis after stroke: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 167-172.
[4] Ya-ru Huangfu, Wei Peng, Bao-jun Guo, Zhi-fu Shen, Li Li, Shi-wei, Liu, Hui Zheng, You-ping Hu. Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 161-167.
[5] Pádraic J.Dunne, Julie Lynch, Lucia Prihodova, Caoimhe O'Leary, Atiyeh Ghoreyshi, Sharee A. Basdeo, Donal J.Cox, Rachel Breen, Ali Sheikhi, Áine Carroll, Cathal Walsh, Geraldine McMahon, Barry White. Burnout in the emergency department: Randomized controlled trial of an attention-based training program. Journal of Integrative Medicine, 2019, 17(3): 173-180.
[6] J.M. Oliver-Baxter, H.S. Whitford, D.A. Turnbull, M.J. Bond. Effects of vitamin supplementation on inflammatory markers and psychological wellbeing among distressed women: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(5): 322-328.
[7] Xu-xia Bao, Hui-han Ma, Hao Ding, Wen-wei Li, Min Zhu . Preliminary optimization of a Chinese herbal medicine formula based on the neuroprotective effects in a rat model of rotenone-induced Parkinson’s disease. Journal of Integrative Medicine, 2018, 16(4): 290-296.
[8] Nobuari Takakura, Miho Takayama, Morihiro Nasu, Masako Nishiwaki, Akiko Kawase, Hiroyoshi Yajima . Patient blinding with blunt tip placebo acupuncture needles: Comparison between 1 mm and 2 mm skin press. Journal of Integrative Medicine, 2018, 16(3): 164-171.
[9] Parunkul Tungsukruthai, Preecha Nootim, Wiwan Worakunphanich, Nareerat Tabtong. Efficacy and safety of herbal steam bath in allergic rhinitis: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(1): 39-44.
[10] Zahra Hajmohammadi, Mojtaba Heydari, Majid Nimrouzi, Pouya Faridi, Mohammad Javad Zibaeenezhad, Gholamhossein Ranjbar Omrani, Mesbah Shams . Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels: A double-blind placebo-controlled randomized clinical trial. Journal of Integrative Medicine, 2018, 16(1): 45-50.
[11] Laura Belland, Laura Rivera-Reyes, Ula Hwang. Using music to reduce anxiety among older adults in the emergency department: A randomized pilot study. Journal of Integrative Medicine, 2017, 15(6): 450-455.
[12] Hilal Yuksel, Yasemin Cayir, Zahide Kosan, Kenan Tastan. Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: A randomized controlled trial. Journal of Integrative Medicine, 2017, 15(6): 456-461.
[13] Yoshiharu Motoo, Takashi Hakamatsuka, Nobuo Kawahara, Ichiro Arai, Kiichiro Tsutani. Standards of Reporting Kampo Products (STORK) in research articles. Journal of Integrative Medicine, 2017, 15(3): 182-185.
[14] Maria T.Chao, AlexandraChang, SanjayReddy, James D.Harrison, JosephAcquah, MiriaToveg, TrilceSantana, Frederick M.Hecht. Adjunctive acupuncture for pain and symptom management in the inpatient setting: Protocol for a pilot hybrid effectiveness-implementation study. Journal of Integrative Medicine, 2016, 14(3): 228-238.
[15] Nouran A. Aleyeidi, Khaled S. Aseri, Shadia M. Matbouli, Albaraa A. Sulaiamani, Sumayyah A. Kobeisy. Effects of wet-cupping on blood pressure in hypertensive patients: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(6): 391-399.
Viewed
Full text


Abstract

Cited
  Shared   
  Discussed   
[1] Hao Li, Ming-jiang Yao, Wen-ming Zhao, Jie Guan, Lin-lin Cai, Ling Cui. A randomized, controlled, double-blind trial of Huannao Yicong capsule in senile patients with mild cognitive impairment. Journal of Chinese Integrative Medicine, 2008, 6(1): 25-31
[2] Jun Cai, Hua Wang, Sheng Zhou, Bin Wu, Hua-rong Song, Zheng-rong Xuan. Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(1): 37-40
[3] Zhi-chun Jin. Problems in establishing clinical guideline for integrated traditional Chinese and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 5-8
[4] SUN Ming-yu, ZUO Jian, DUAN Ji-feng, HAN Jun, FAN Shi-ming, ZHANG Wei, ZHU Li-fang, YAO Ming-hui. Antitumor activities of kushen flavonoids in vivo and in vitro. Journal of Chinese Integrative Medicine, 2008, 6(1): 51-59
[5] Wei Zhang, Xiang-feng Lu, Xiao-mei Zhang, Jian-jun Wu, Liang-duo Jiang. A rat model of pulmonary fibrosis induced by infusing bleomycin quickly through tracheal intubation. Journal of Chinese Integrative Medicine, 2008, 6(1): 60-67
[6] Guo-hong Yuan, Xiao-jing Pang, He-chao Ma. Synergic effects of Danggui Buxue Decoction in reducing toxicity of cytoxan in tumor-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 83-88
[7] Bo Wang , Wei Yan , Li-hui Hou, Xiao-ke Wu. Disorder of Tiangui (kidney essence) and reproductive dysfunction in patients with polycystic ovary syndrome. Journal of Chinese Integrative Medicine, 2010, 8(11): 1018-1022
[8] Hong Liu , Guo-liang Zhang, Li Shen , Zhen Zeng, Bao-luo Zhou, Cheng-hai Liu, Guang Nie . Application and evaluation of a pseudotyped virus assay for screening herbs for anti-H5Nl avian influenza virus. Journal of Chinese Integrative Medicine, 2010, 8(11): 1036-1040
[9] Ya-bing Zhou, Jian-er Yu, Jie Wu, Li Bai, Li-li Huo, Xin-guang Zhang, Li-qing Li . Effects of Chinese herbal medicine Bushen Gubiao Recipe on toll-like receptor 4 and CD4 +CD25 +foxp3 +regulatory T cells in mice with recurrent respiratory tract infections. Journal of Chinese Integrative Medicine, 2010, 8(11): 1053-1059
[10] Ya-hui Liang , Ping Li, Jing-xia Zhao, Xin Liu, Qi-fu Huang. Acetyl-11-keto-beta-boswellic acid and arsenic trioxide regulate the productions and activities of matrix metalloproteinases in human skin fibroblasts and human leukemia cell line THP-1. Journal of Chinese Integrative Medicine, 2010, 8(11): 1060-1069
Journal of Integrative Medicine, ISSN: 2095-4964 CN 31-2083/R
Copyright © Journal of Integrative Medicine
Powered by Beijing Magtech Co. Ltd
沪公网安备31010602003416号      沪ICP备18017633号-3