Skip to main content
Top
Published in: BMC Complementary Medicine and Therapies 1/2023

Open Access 01-12-2023 | Parkinson's Disease | Study protocol

Moxibustion treatment for Parkinson’s disease: study protocol for a randomized controlled trial

Authors: Chunxiao Wu, Lijun Zhao, Yuelin Guo, Xiaoqian Hao, Yaohua Fan, Peipei Wu, Jiajun Han, Qinglian Li, Xiaoling Wang, Qizhang Wang, Xiaodong Luo, Meiling Zhu

Published in: BMC Complementary Medicine and Therapies | Issue 1/2023

Login to get access

Abstract

Background

Parkinson’s disease (PD) is the second most common neurodegenerative disorder and seriously affects quality of life globally. Moxibustion is widely used to treat neurodegenerative diseases in the clinic and has achieved a beneficial clinical effect. However, strict control and high-quality randomized controlled trials are still lacking. Therefore, this trial aims to evaluate the clinical efficacy and safety of moxibustion in patients with PD and preliminarily explore the underlying mechanism.

Methods

This is a randomized, single-blind and placebo-controlled trial design in which 70 eligible participants will be randomly divided into a moxibustion group and a sham moxibustion group. Baihui (DU20) and Sishenchong (EX-HN1) are selected for both groups. The treatment will be performed for 30 min per session, two sessions a week for 8 weeks. The mean change in MDS-UPDRS scores (including MDS-UPDRS II, III subscale scores and total scores) from baseline to the observation points will be the primary outcome. The secondary outcomes will include scores on the Parkinson’s Disease Questionnaire-39 (PDQ-39), Fatigue Severity Scale (FSS), Parkinson Disease Sleep Scale (PDSS), Montreal Cognitive Assessment (MoCA), and Self-Rating Depression Scale (SDS) as well as the Wexner constipation score. All the above outcomes will be assessed at 4 and 8 weeks. Laboratory blood biochemical analysis and functional magnetic resonance imaging (fMRI) will be conducted at baseline and at the end of treatment to explore the potential mechanisms of moxibustion in regulating PD.

Discussion

In conclusion, the results of this trial will reveal whether moxibustion is effective for treating motor and nonmotor symptoms in PD. This trial will also preliminarily explore the underlying mechanism of the regulatory effect of moxibustion in PD, which will contribute to providing a theoretical basis for the treatment of PD.

Trial registration

ClinicalTrials.gov ChiCTR2000029745. Registered on 9 August 2021.
Literature
1.
go back to reference Kalia LV, Lang AE. Parkinson’s disease. Lancet. 2015;386(9996):896–912. Kalia LV, Lang AE. Parkinson’s disease. Lancet. 2015;386(9996):896–912.
2.
go back to reference Collaborators GBDPsD. Global, regional, and national burden of Parkinson’s disease, 1990–2016: a systematic analysis for the global burden of disease study 2016. Lancet Neurol. 2018;17(11):939–53.CrossRef Collaborators GBDPsD. Global, regional, and national burden of Parkinson’s disease, 1990–2016: a systematic analysis for the global burden of disease study 2016. Lancet Neurol. 2018;17(11):939–53.CrossRef
3.
go back to reference Grimes D, Fitzpatrick M, Gordon J, Miyasaki J, Fon EA, Schlossmacher M, et al. Canadian guideline for Parkinson disease. CMAJ. 2019;191(36):E989–1004.CrossRefPubMedPubMedCentral Grimes D, Fitzpatrick M, Gordon J, Miyasaki J, Fon EA, Schlossmacher M, et al. Canadian guideline for Parkinson disease. CMAJ. 2019;191(36):E989–1004.CrossRefPubMedPubMedCentral
4.
go back to reference Rogers G, Davies D, Pink J, Cooper P. Parkinson’s disease: summary of updated NICE guidance. BMJ. 2017;358:j1951.CrossRefPubMed Rogers G, Davies D, Pink J, Cooper P. Parkinson’s disease: summary of updated NICE guidance. BMJ. 2017;358:j1951.CrossRefPubMed
5.
go back to reference Armstrong MJ, Okun MS. Diagnosis and treatment of Parkinson disease: a review. JAMA. 2020;323(6):548–60.CrossRefPubMed Armstrong MJ, Okun MS. Diagnosis and treatment of Parkinson disease: a review. JAMA. 2020;323(6):548–60.CrossRefPubMed
6.
go back to reference Li BD, Bi ZY, Liu JF, Si WJ, Shi QQ, Xue LP, et al. Adverse effects produced by different drugs used in the treatment of Parkinson’s disease: a mixed treatment comparison. CNS Neurosci Ther. 2017;23(10):827–42. Li BD, Bi ZY, Liu JF, Si WJ, Shi QQ, Xue LP, et al. Adverse effects produced by different drugs used in the treatment of Parkinson’s disease: a mixed treatment comparison. CNS Neurosci Ther. 2017;23(10):827–42.
7.
go back to reference Zhang JF, Sun GS, Zhao GH. Observation on therapeutic effect of herbs-partitioned moxibustion on Parkinson disease of 54 cases. Zhongguo Zhen Jiu. 2005;25(9):610–2.PubMed Zhang JF, Sun GS, Zhao GH. Observation on therapeutic effect of herbs-partitioned moxibustion on Parkinson disease of 54 cases. Zhongguo Zhen Jiu. 2005;25(9):610–2.PubMed
9.
go back to reference Huang Z, Si W, Li X, Ye S, Liu X, Ji Y, et al. Moxibustion protects dopaminergic neurons in Parkinson’s disease through antiferroptosis. Evid Based Complement Alternat Med. 2021;2021:6668249.PubMedPubMedCentral Huang Z, Si W, Li X, Ye S, Liu X, Ji Y, et al. Moxibustion protects dopaminergic neurons in Parkinson’s disease through antiferroptosis. Evid Based Complement Alternat Med. 2021;2021:6668249.PubMedPubMedCentral
10.
go back to reference Lu J, Liu X, Tian Y, Li H, Ren Z, Liang S, et al. Moxibustion exerts a neuroprotective effect through antiferroptosis in Parkinson’s disease. Evid Based Complement Alternat Med. 2019;2019:2735492.CrossRefPubMedPubMedCentral Lu J, Liu X, Tian Y, Li H, Ren Z, Liang S, et al. Moxibustion exerts a neuroprotective effect through antiferroptosis in Parkinson’s disease. Evid Based Complement Alternat Med. 2019;2019:2735492.CrossRefPubMedPubMedCentral
11.
go back to reference Liu J. Chinese diagnostic criteria for Parkinson’s disease (2016 edition). Chin J Neurol. 2016;49(04):268–71. Liu J. Chinese diagnostic criteria for Parkinson’s disease (2016 edition). Chin J Neurol. 2016;49(04):268–71.
12.
go back to reference Zhong P, Xu F, Hou YR, Fu WB. Efficacy of moxibustion combined with drugs in the treatment of Parkinson’s disease with liver and kidney insufficiency. Chin J Gerontol. 2012;32(13):2720–1. Zhong P, Xu F, Hou YR, Fu WB. Efficacy of moxibustion combined with drugs in the treatment of Parkinson’s disease with liver and kidney insufficiency. Chin J Gerontol. 2012;32(13):2720–1.
14.
go back to reference Zahoor I, Shafi A, Haq E. Pharmacological Treatment of Parkinson’s Disease. In: Stoker TB, Greenland JC, editors. Parkinson's disease: pathogenesis and clinical aspects. Brisbane (AU). 2018. Zahoor I, Shafi A, Haq E. Pharmacological Treatment of Parkinson’s Disease. In: Stoker TB, Greenland JC, editors. Parkinson's disease: pathogenesis and clinical aspects. Brisbane (AU). 2018.
15.
16.
go back to reference Shen EY, Chen FJ, Chen YY, Lin MF. Locating the acupoint Baihui (GV20) beneath the cerebral cortex with MRI reconstructed 3D neuroimages. Evid Based Complement Alternat Med. 2011;2011:362494.CrossRefPubMedPubMedCentral Shen EY, Chen FJ, Chen YY, Lin MF. Locating the acupoint Baihui (GV20) beneath the cerebral cortex with MRI reconstructed 3D neuroimages. Evid Based Complement Alternat Med. 2011;2011:362494.CrossRefPubMedPubMedCentral
17.
go back to reference Kwon S, Seo BK, Kim S. Acupuncture points for treating Parkinson’s disease based on animal studies. Chin J Integr Med. 2016;22(10):723–7. Kwon S, Seo BK, Kim S. Acupuncture points for treating Parkinson’s disease based on animal studies. Chin J Integr Med. 2016;22(10):723–7.
18.
go back to reference Mao H, Zhao Y, Li H, Lei L. Ferroptosis as an emerging target in inflammatory diseases. Prog Biophys Mol Biol. 2020;155:20–8.CrossRefPubMed Mao H, Zhao Y, Li H, Lei L. Ferroptosis as an emerging target in inflammatory diseases. Prog Biophys Mol Biol. 2020;155:20–8.CrossRefPubMed
19.
go back to reference Kim YK, Lim HH, Song YK, Lee HH, Lim S, Han SM, et al. Effect of acupuncture on 6-hydroxydopamine-induced nigrostratal dopaminergic neuronal cell death in rats. Neurosci Lett. 2005;384(1–2):133–8.CrossRefPubMed Kim YK, Lim HH, Song YK, Lee HH, Lim S, Han SM, et al. Effect of acupuncture on 6-hydroxydopamine-induced nigrostratal dopaminergic neuronal cell death in rats. Neurosci Lett. 2005;384(1–2):133–8.CrossRefPubMed
20.
go back to reference Li Z, Chen J, Cheng J, Huang S, Hu Y, Wu Y, et al. Acupuncture modulates the cerebello-thalamo-cortical circuit and cognitive brain Regions in patients of Parkinson’s disease with tremor. Front Aging Neurosci. 2018;10:206.CrossRefPubMedPubMedCentral Li Z, Chen J, Cheng J, Huang S, Hu Y, Wu Y, et al. Acupuncture modulates the cerebello-thalamo-cortical circuit and cognitive brain Regions in patients of Parkinson’s disease with tremor. Front Aging Neurosci. 2018;10:206.CrossRefPubMedPubMedCentral
21.
go back to reference Liu XL, Lu J, Tian Y, Zhang GY, Zhao CP, Wang TT, et al. Effect and mechanism of moxibustion on oxidative stress injury in rats with Parkinson’s disease by activating Nrf2/ARE pathway. Zhongguo Zhen Jiu. 2020;40(8):857–62.PubMed Liu XL, Lu J, Tian Y, Zhang GY, Zhao CP, Wang TT, et al. Effect and mechanism of moxibustion on oxidative stress injury in rats with Parkinson’s disease by activating Nrf2/ARE pathway. Zhongguo Zhen Jiu. 2020;40(8):857–62.PubMed
22.
go back to reference Zhao B, Wang X, Lin Z, Liu R, Lao L. A novel sham moxibustion device: a randomized, placebo-controlled trial. Complement Ther Med. 2006;14(1):53–60. discussion 1.CrossRefPubMed Zhao B, Wang X, Lin Z, Liu R, Lao L. A novel sham moxibustion device: a randomized, placebo-controlled trial. Complement Ther Med. 2006;14(1):53–60. discussion 1.CrossRefPubMed
23.
go back to reference Bao C, Zhang J, Liu J, Liu H, Wu L, Shi Y, et al. Moxibustion treatment for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2016;16(1):408.CrossRefPubMedPubMedCentral Bao C, Zhang J, Liu J, Liu H, Wu L, Shi Y, et al. Moxibustion treatment for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2016;16(1):408.CrossRefPubMedPubMedCentral
24.
go back to reference Xu H, Zhao H, Kang L, Huang S, Shi Y, Su W, et al. Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial. Trials. 2018;19(1):403.CrossRefPubMedPubMedCentral Xu H, Zhao H, Kang L, Huang S, Shi Y, Su W, et al. Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial. Trials. 2018;19(1):403.CrossRefPubMedPubMedCentral
25.
go back to reference Pach D, Brinkhaus B, Willich SN. Moxa sticks: thermal properties and possible implications for clinical trials. Complement Ther Med. 2009;17(4):243–6.CrossRefPubMed Pach D, Brinkhaus B, Willich SN. Moxa sticks: thermal properties and possible implications for clinical trials. Complement Ther Med. 2009;17(4):243–6.CrossRefPubMed
26.
go back to reference Kim SY, Yi SH, Cho JH, Yin CS, Lee H, Park HJ. Heat stimulation on the skin for medical treatment: can it be controlled? J Altern Complement Med. 2011;17(6):497–504.CrossRefPubMed Kim SY, Yi SH, Cho JH, Yin CS, Lee H, Park HJ. Heat stimulation on the skin for medical treatment: can it be controlled? J Altern Complement Med. 2011;17(6):497–504.CrossRefPubMed
27.
go back to reference Wu L, Liu M, Liang J, Li N, Yang D, Cai J, et al. Ferroptosis as a new mechanism in Parkinson’s disease therapy using traditional Chinese medicine. Front Pharmacol. 2021;12:659584.CrossRefPubMedPubMedCentral Wu L, Liu M, Liang J, Li N, Yang D, Cai J, et al. Ferroptosis as a new mechanism in Parkinson’s disease therapy using traditional Chinese medicine. Front Pharmacol. 2021;12:659584.CrossRefPubMedPubMedCentral
28.
go back to reference Mahoney-Sanchez L, Bouchaoui H, Ayton S, Devos D, Duce JA, Devedjian JC. Ferroptosis and its potential role in the physiopathology of Parkinson’s disease. Prog Neurobiol. 2021;196:101890.CrossRefPubMed Mahoney-Sanchez L, Bouchaoui H, Ayton S, Devos D, Duce JA, Devedjian JC. Ferroptosis and its potential role in the physiopathology of Parkinson’s disease. Prog Neurobiol. 2021;196:101890.CrossRefPubMed
Metadata
Title
Moxibustion treatment for Parkinson’s disease: study protocol for a randomized controlled trial
Authors
Chunxiao Wu
Lijun Zhao
Yuelin Guo
Xiaoqian Hao
Yaohua Fan
Peipei Wu
Jiajun Han
Qinglian Li
Xiaoling Wang
Qizhang Wang
Xiaodong Luo
Meiling Zhu
Publication date
01-12-2023
Publisher
BioMed Central
Published in
BMC Complementary Medicine and Therapies / Issue 1/2023
Electronic ISSN: 2662-7671
DOI
https://doi.org/10.1186/s12906-023-03995-w

Other articles of this Issue 1/2023

BMC Complementary Medicine and Therapies 1/2023 Go to the issue