Evaluation on the efficacy and safety of Chinese herbal medication Xifeng Dingchan Pill in treating Parkinson’s disease: Study protocol of a multicenter, open-label, randomized active-controlled trial

doi:10.3736/jintegrmed2013035

Abstract

Background

Parkinson’s disease (PD) is a complicated disease, commonly diagnosed among the elderly, which leads to degeneration of the central nervous system. It presently lacks an effective therapy for its complex pathogenesis. Adverse effects from Western drug-based medical intervention prevent long-term adherence to these therapies in many patients. Traditional Chinese medicine (TCM) has long been used to improve the treatment of PD by alleviating the toxic and adverse effects of Western drug-based intervention. Therefore, the aim of this study is to evaluate the efficacy and safety of Xifeng Dingchan Pill (XFDCP), a compound traditional Chinese herbal medicine, taken in conjunction with Western medicine in the treatment of PD patients at different stages in the progression of the disease.

Methods and design

This is a multicenter, randomized controlled trial. In total, 320 patients with early- (n = 160) and middle-stage PD (n = 160) will be enrolled and divided evenly into control and trial groups. Of the 160 patients with early-stage PD, the trial group (n = 80) will be given XFDCP, and the control group (n = 80) will be given Madopar. Of the 160 patients with middle-stage PD, the trial group (n = 80) will be given XFDCP combined with Madopar and Piribedil, and the control group (n = 80) will be given Madopar and Piribedil. The Unified Parkinson’s Disease Rating Scale scores, TCM symptoms scores, quality of life, change of Madopar’s dosage and the toxic and adverse effects of Madopar will be observed during a 3-month treatment period and through a further 6-month follow-up period.

Discussion

It is hypothesized that XFDCP, combined with Madopar and Piribedil, will have beneficial effects on patients with PD. The results of this study will provide evidence for developing a comprehensive therapy regimen, which can delay the progress of the disease and improve the quality of life for PD patients in different stages.

Trial Registration

This trial has been registered in the Chinese Clinical Trial Registry with the identifer ChiCTR-TRC-12002150.

Key words: Parkinson disease, Levodopa, Drugs, Chinese herbal, Drug toxicity, Randomized controlled trial, Clinical protocols

Jie Zhang, Yun-zhi Ma, Xiao-ming Shen. Evaluation on the efficacy and safety of Chinese herbal medication Xifeng Dingchan Pill in treating Parkinson’s disease: Study protocol of a multicenter, open-label, randomized active-controlled trial. Journal of Chinese Integrative Medicine, 2013, 11(4): 285-290.

/ / Recommend

Add to citation manager EndNote| Reference Manager|ProCite|BibTeX|RefWorks

URL: http://www.jcimjournal.com/EN/10.3736/jintegrmed2013035

http://www.jcimjournal.com/EN/Y2013/V11/I4/285

[1]	Zhang ZX, Roman GC, Hong Z, Wu CB, Qu QM, Huang JB, Zhou B, Geng ZP, Wu JX, Wen HB, Zhao H, Zahner GE . Parkinson’s disease in China: prevalence in Beijing, Xian, and Shanghai[J]. Lancet, 2005,365(9459):595-597 doi: 10.1016/S0140-6736(05)70801-1
[2]	Dorsey ER, Constantinescu R, Thompson JP, Biglan KM, Holloway RG, Kieburtz K, Marshall FJ, Ravina BM, Schifitto G, Siderowf A, Tanner CM . Projected number of people with Parkinson disease in the most populous nations, 2005 through 2030[J]. Neurology, 2007,68(5):384-386 doi: 10.1212/01.wnl.0000247740.47667.03
[3]	Wang Y, Yin S, Liu WG, Bian Y, Wang BM, Ye M, Lin XJ, Zhang L . Investigation on economic burden of disease and its related influence factors in patients with Parkinson disease[J]. Lin Chuang Shen Jing Bing Xue Za Zhi, 2011,24(6):427-430
[4]	Bai QL, Feng Z . Effect of nourishing liver-kidney and extinguishing wind on Parkinson’s disease of liver-kidney deficiency symptom[J]. Liaoning Zhong Yi Za Zhi, 2010,37(5):846-849
[5]	Ma YZ, Liu J, Wang BQ, Li SF, Fu AM, Fang J, Lu SL, Lü FZ, Shen XM, Jia K, Zuo QX, Zhuang ZJ, Zhang M, Zhou XQ , Liu SS. Study on the effects of Xifeng Dingchan Pill in improving the efficiency and alleviating the toxicity symptoms of Madopar in patients with Parkinson’s disease. National Achievement of Science and Technology. ( 2004[ 2012-12-14]. .
[6]	Bai QL, Ma YZ . Effect of Xifeng Dingchan Pill on syndrome of liver and kidney deficiency of Parkinson’s disease: a report of 30 cases[J]. Zhong Yi Za Zhi, 2010,51(2):125-127, 131
[7]	Ma YZ, Li SF, Shen XM, Jia K . Research on efficiency of traditional Chinese and Western medicine in treating 30 patients with Parkinson disease[J]. Xin Zhong Yi, 2005,37(10):55-56
[8]	Ma L . A study on effects of Xifeng Dingchan Pill in treating 40 patients with Parkinson’s disease[J]. Zhong Yi Yan Jiu, 2008,21(3):39-42
[9]	Chen CH, Ma YZ, Ma L, Wang JF . Study on the effects of Xifeng Dingchan Pill on the Madopar dosage on Parkinson’s disease[J]. Shanxi Zhong Yi, 2007,23(1):35-36
[10]	Gelb DJ, Oliver E, Gilman S . Diagnostic criteria for Parkinson disease[J]. Arch Neurol, 1999,56(1):33-39 doi: 10.1001/archneur.56.1.33
[11]	Movement Disorder and Parkinson’s Disease Group of Chinese Society of Neurology. Guidelines for the treament of Parkinson’s disease[J]. Zhonghua Shen Jing Ke Za Zhi, 2009,42(5):352-355
[12]	China Association of Traditional Chinese Medicine for Senile Encephalopathy. Diagnosis and efficacy evaluation criteria for senile tremor disease of traditional Chinese medicine[J]. Beijing Zhong Yi Xue Yuan Xue Bao, 1992,15(4):39-41
[13]	Zheng XY. Clinical guideline of new drugs for traditional Chinese medicine(Draft)[M]. Beijing: China Medical Science Press, 2002,5
[14]	Sun ZQ. Medical statistics.3rd ed[M]. Beijing: People’s Medical Publishing House, 2011, 541-543
[15]	Bian ZX, Li YP, Moher D, Dagenais S, Liu L, Wu TX, Miao JX, Guan JL, 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 doi: 10.3736/jcim
[16]	Palacios N, Gao X, Schwarzschild M, Ascherio A . Declining quality of life in Parkinson disease before and after diagnosis[J]. J Parkins Dis, 2012,2(2):153-160
[17]	Gao HM, Hong JS . Why neurodegenerative diseases are progressive: uncontrolled inflammation drives disease progression[J]. Trends Immunol, 2008,29(8):357-365 doi: 10.1016/j.it.2008.05.002
[18]	Poewe W, Antonini A, Zijlmans JC, Burkhard PR, Vingerhoets F . Levodopa in the treatment of Parkinson’s disease: an old drug still going strong[J]. Clin Interv Aging, 2010,5:229-238
[19]	Olanow W, Schapira AH, Rascol O . Continuous dopamine-receptor stimulation in early Pakinson’s disase[J]. Trends Neurosci, 2000,23(10 Suppl):S117-S126 doi: 10.1016/S1471-1931(00)00030-6

Related Articles 15

[1]	Chiung-Hui Huang, Mei-Ling Yeh, Fang-Pey Chen, Daphne Wu. Low-level laser acupuncture reduces postoperative pain and morphine consumption in older patients with total knee arthroplasty: A randomized placebo-controlled trial. Journal of Integrative Medicine, 2022, 20(4): 321-328.
[2]	Keat Lam Ho, Phaik Har Yong, Chee Woon Wang, Umah Rani Kuppusamy, Chek Tung Ngo, Festo Massawe, Zhi Xiang Ng. Peperomia pellucida (L.) Kunth and eye diseases: A review on phytochemistry, pharmacology and toxicology. Journal of Integrative Medicine, 2022, 20(4): 292-304.
[3]	Lu Yin, Yun An, Xiao Chen, Hui-xin Yan, Tao Zhang, Xin-gang Lu, Jun-tao Yan. Local vibration therapy promotes the recovery of nerve function in rats with sciatic nerve injury. Journal of Integrative Medicine, 2022, 20(3): 265-273.
[4]	Maryam Azimi, Hanieh Niayesh, Mahboobeh Raeiszadeh, Sedigheh Khodabandeh-shahraki. Efficacy of the herbal formula of Foeniculum vulgare and Rosa damascena on elderly patients with functional constipation: A double-blind randomized controlled tria. Journal of Integrative Medicine, 2022, 20(3): 230-236.
[5]	Ubiratan Cardinalli Adler, Maristela Schiabel Adler, Ana Elisa Madureira Padula, Livia Mitchiguian Hotta, Amarilysde Toledo Cesar, José Nelson Martins Diniz, Helen de Freitas Santos, Edson Zangiacomi Martinez. Homeopathy for COVID-19 in primary care: A randomized, double-blind, placebo-controlled trial (COVID-Simile study). Journal of Integrative Medicine, 2022, 20(3): 221-229.
[6]	Zeinab Vafaeipour, Bibi Marjan Razavi, Hossein Hosseinzadeh. Effects of turmeric (Curcuma longa) and its constituent (curcumin) on the metabolic syndrome: An updated review. Journal of Integrative Medicine, 2022, 20(3): 193-203.
[7]	Jia-yi Zhao, Jin Pu, Jian Fan, Xin-yu Feng, Jian-wen Xu, Rong Zhang, Yan Shang. Tanshinone IIA prevents acute lung injury by regulating macrophage polarization. Journal of Integrative Medicine, 2022, 20(3): 274-280.
[8]	Marisa Casal. Improving the health and treatment success rates of in vitro fertilization patients with traditional chinese medicine: need for more robust evidence and innovative approaches. Journal of Integrative Medicine, 2022, 20(3): 187-192.
[9]	Ning Guo, Fei Wu, Mei Wu, Yuan Wang, Qing Lang, Xiao Lin, Yi Feng. Progress in the design and quality control of placeboes for clinical trials of traditional Chinese medicine . Journal of Integrative Medicine, 2022, 20(3): 204-212.
[10]	Xin Wang, Wen-juan Song, Yi Ruan, Bing-chu Li, Can Lü, Nian Huang, Fan-fu Fang, Wei Gu. Core muscle functional strength training for reducing the risk of low-back pain in military recruits: An open-label randomized controlled trial. Journal of Integrative Medicine, 2022, 20(2): 145-152.
[11]	Yan-jun Lin, Kun-li Jiao, Bo Liu, Lu Fang, Shu Meng. Antiplatelet and myocardial protective effect of shexiang tongxin dropping pill in patients undergoing percutaneous coronary intervention: A randomized controlled trial. Journal of Integrative Medicine, 2022, 20(2): 126-134.
[12]	Peter Bablis, Henry Pollard, Anthony L. Rosner. Stress reduction via neuro-emotional technique to achieve the simultaneous resolution of chronic low back pain with multiple inflammatory and biobehavioural indicators: A randomized, double-blinded, placebo-controlled trial. Journal of Integrative Medicine, 2022, 20(2): 135-144.
[13]	Jose Antonio Castilla-Jimena, Isabel Ruiz-Pérez, Jesús Henares-Montiel. Impact of socioeconomic and health-related factors on consumption of homeopathic and natural remedies in Spain in 2006, 2011 and 2017. Journal of Integrative Medicine, 2022, 20(1): 52-56.
[14]	Jun-peng Yao, Li-ping Chen, Xian-jun Xiao, Ting-hui Hou, Si-yuan Zhou, Ming-min Xu, Kai Wang, Yu-jun Hou, Lin Zhang, Ying Li. Effectiveness and safety of acupuncture for treating functional constipation: An overview of systematic reviews. Journal of Integrative Medicine, 2022, 20(1): 13-25.
[15]	Ofer Baranovitch, Meirav Wolff-Bar, Meora Feinmesser, Chen Sade-Zaltz, Ilan Tsarfaty, Victoria Neiman. Searching for the emotional roots of breast cancer: A cross-disciplinary analysis integrating psychology, Chinese medicine, and oncology biomarkers. Journal of Integrative Medicine, 2022, 20(1): 57-64.

Metrics

Viewed

Full text

Abstract

Cited

Shared

Discussed

Comments

Recommended 10

[1]	Wei-xiong Liang. Problems-solving strategies in clinical treatment guideline for traditional Chinese medicine and integrative medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 1-4
[2]	Zhao-guo Li. Discussion on English translation of commonly used sentences in traditional Chinese medicine: part one. Journal of Chinese Integrative Medicine, 2008, 6(1): 107-110
[3]	Jun Hu, Jian-ping Liu. Non-invasive physical treatments for chronic/recurrent headache. Journal of Chinese Integrative Medicine, 2008, 6(1): 31
[4]	Xue-mei Liu, Qi-fu Huang, Yun-ling Zhang, Jin-li Lou, Hong-sheng Liu, Hong Zheng. Effects of Tribulus terrestris L. saponion on apoptosis of cortical neurons induced by hypoxia-reoxygenation in rats. Journal of Chinese Integrative Medicine, 2008, 6(1): 45-50
[5]	. Uniform requirements for manuscripts submitted to biomedical journals: Writing and editing for biomedical publication (Chinese version, part two). Journal of Chinese Integrative Medicine, 2010, 8(11): 1001-1005
[6]	Daniel Weber, Janelle M Wheat, Geoffrey M Currie. Inflammation and cancer: Tumor initiation, progression and metastasis,and Chinese botanical medicines. Journal of Chinese Integrative Medicine, 2010, 8(11): 1006-1013
[7]	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
[8]	Zhao-guo Li . A discussion of English translation of 1995 and 1997 Chinese National Standards of Traditional Chinese Medical Terminologies for Clinical Diagnosis and Treatment. Journal of Chinese Integrative Medicine, 2010, 8(11): 1090-1096
[9]	Rui Jin, Bing Zhang. A complexity analysis of Chinese herbal property theory: the multiple formations of herbal property (Part 1). Journal of Chinese Integrative Medicine, 2012, 10(11): 1198-1205
[10]	Hui-min Liu, Xian-bo Wang, Yu-juan Chang, Li-li Gu. Systematic review and meta-analysis of randomized controlled trials of integrative medicine therapy for treatment of chronic severe hepatitis. Journal of Chinese Integrative Medicine, 2012, 10(11): 1211-1228