Effectiveness And Safety Of A Herbal Medication Hh368 For Clinical Symptoms Of Idiopathic Parkinsons Disease: A Randomized Controlled Pilot Trial Protocol
KH. Cho, SW. Kwon, C. Jin, WS. Jung, SK. Moon, SH. Lee
Session Time: 1:45pm-3:15pm
Location: Agora 3 West, Level 3
Objective: This study aims to assess feasibility of a herbal medication, HH368 for idiopathic Parkinsons disease patients who are in Hoehn & Yahr stage 2 to 3 grades and have been taking levodopa agents for more than 5 years.
Background: PD is a chronic neurodegenerative disease which requires long-term management strategy. Dopaminergic agents have been shown prominent clinical improvement but dyskinesia, wearing-off phenomena, psychosis are well-known symptoms related to long-term usage of these agents . As alternative and complementary treatment options, various herbal medications have been used in East-Asian society, but clinical evidence was not established well .
Results: The study protocol of this study was approved by institutional review board of Kyunghee University Korean Medicine Hospital and by Ministry of Food and Drug Safety of Republic of Korea . The study protocol was registered at Clinical Research Information Service . Currently study participants are recruited, and clinical trial is ongoing in Kyunghee University Korean Medicine Hospital.
This study results will present basic data for assessing feasibility and designing future confirmative clinical trial.
To cite this abstract in AMA style:
Mov Disord.
Effects Of Acupuncture According To Updrs
We conducted a meta-analysis of the study results based on the UPDRS used to the effects of acupuncture plus conventional treatment versus conventional treatment alone .2). UPDRS I had no significant effect on PD symptoms in two studies ).2). UPDRS II had a significant effect on PD symptoms in 2 studies ).2). UPDRS III had a significant effect on PD symptoms in 5 studies ).2). UPDRS IV had no significant effect on PD symptoms in 2 studies ).2). In 7 studies that used the UPDRS total score to compare the effects of acupuncture plus conventional treatment versus conventional treatment alone, it was seen that combined treatment had a significant effect on PD symptoms ).
Massage Therapy For Parkinsons
While data analyzing the role of acupuncture in treatment of PD symptoms is fairly limited, the data on the role of massage in the treatment of PD symptoms is even more so. One clinical trial was done assessing the effects of a 40-minute massage session, with some participants then continuing to receive seven weekly sessions. The control group was not blinded to their status . Despite these limitations, the study showed that massage was helpful in improving quality of life for people with PD.
All of the above begs the question should a person with PD try acupuncture or massage to help their PD symptoms? The bottom line is that there is little formal evidence that either treatment is truly effective. Larger and better designed clinical trials are necessary before these treatments will be routinely recommended.
For now, people with PD can choose to make their own assessments about whether these practices improve their well-being and whether to incorporate acupuncture or massage into their weekly routine. In general there is minimal risk in trying acupuncture or massage, aside from perhaps disappointment if they do not work for you. If you plan to try acupuncture and/or massage, be sure to go to reputable practitioners, preferably ones with experience in treating people with PD.
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Efficacy Of Acupuncture For Motor Symptoms
UPDRS III is the most commonly used score for measuring motor performance. An RCT with 15 participants conducted by Lei et al. evaluated improvement in motor performance due to electroacupuncture in 15 participants . They found that electroacupuncture significantly decreased UPDRS scores and improved gait speed. To the best of our knowledge, this is the first experiment using an objective task for evaluating the effects of acupuncture, which may provide rigorous evidence for evaluation of the efficacy of acupuncture. These results were in accordance with those of other studies by Cho et al. and Lee et al. . Only one study found no efficacy. A meta-analysis by Liu et al. that analyzed two RCTs with 240 participants did not found any efficacy of acupuncture in improving UPDRS scores . Their explanation was that the high heterogeneity influenced the reliability of the results .
Effect Of Acupuncture On The Motor And Nonmotor Symptoms In Parkinson’s Diseasea Review Of Clinical Studies
Corresponding Author
Bai-Yun Zeng
Neurodegenerative Disease Research Group, Institute of Pharmaceutical Science, Faculty of Life Sciences and Medicine, King’s College London, London, UK
Correspondence
Bai-Yun Zeng, Neurodegenerative Disease Research Group, Institute of Pharmaceutical Science, Faculty of Life Sciences and Medicine, King’s College London, London SE1 1UL, UK.
Tel.: +44-20-88842987
Corresponding Author
Bai-Yun Zeng
Neurodegenerative Disease Research Group, Institute of Pharmaceutical Science, Faculty of Life Sciences and Medicine, King’s College London, London, UK
Correspondence
Bai-Yun Zeng, Neurodegenerative Disease Research Group, Institute of Pharmaceutical Science, Faculty of Life Sciences and Medicine, King’s College London, London SE1 1UL, UK.
Tel.: +44-20-88842987
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Data Sources And Search Strategy
For English publications, data were gathered from four separate electronic databases, including Medline , Embase , the Cochrane Library , and PubMed. For Chinese articles, online databases such as the China National Knowledge Infrastructure , China Biology Medicine disc, Chinese Scientific Journals Full-Text Database , and Wanfang Database were searched. Searches were confined to publications in the English and Chinese languages. No restrictions were imposed on publication years. The reference lists of the included studies were also manually searched to identify relevant articles. The obtained studies were further evaluated by review of titles and abstracts to exclude those not meeting the criteria, and the full text was then read to determine eligibility. Detailed search strategies are described in Appendix 1.
Study Shows Acupuncture Is Effective For Treating Parkinsons Disease
Lee, S.-H., & Lim, S. . Clinical effectiveness of acupuncture on Parkinson disease: A PRISMA-compliant systematic review and meta-analysis. Medicine, 96, e5836. http://doi.org/10.1097/MD.0000000000005836 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5279085/
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About the Author: Vanessa Vogel Batt, L.Ac., MSTOM, studied at the Pacific College of Oriental Medicine, and practiced acupuncture and Oriental medicine in New York for several years. Vanessa enjoys traveling the world, and has published articles on acupuncture and Oriental medicine and related health topics for websites and publications in both the U.S. and abroad.
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Quality Assessment Of Included Studies
We assessed the quality of the included studies with a Jadad scale and an Overview Quality Assessment Questionnaire .
The primary limitations of the included RCTs were small sample size and unreported adverse events. One progress compared with previous acupuncture studies was that placebo acupuncture was performed in four studies and objective behavioral assessment tool was used in one study Figure 1B.
Characteristics Of Included Literature
A total of 11 studies were included, comprising 4 meta-analysis studies and 7 RCTs. The characteristics of the included studies are shown in Table 1. Subjective behavioral assessments employed in this study include the Unified Parkinson’s Disease Rating Scale , the Webster Scale , the Tension Assessment Scale , the Parkinson’s Disease Sleep Scale , the Postural Instability Gait Disorder , the Parkinson’s Disease Quality of Life Questionnaire , the Beck Depression Inventory , the Modified Fatigue Impact Scale , the 39-Item Parkinson’s Disease Questionnaire , and the Pittsburgh Sleep Quality Index . One RCT used gait speed as an objective assessment . Besides motor symptoms, non-motor symptoms, such as sleep , quality of life , and fatigue , were also evaluated. Objective evaluation and evaluation of non-motor symptoms are increasingly emphasized for evaluation of the efficacy and safety of acupuncture for PD. No serious adverse events were reported.
Table 1. Efficacy and safety in the current acupuncture study.
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Contact Metro Detroit Acupuncture
Do you suffer from Parkinsons disease? Are you looking for a more natural way to treat your worsening symptoms? Get in touch with Metro Detroit Acupuncture today at 248-432-2846. We are the premier acupuncture clinic in Southeast Michigan, owned and operated by Marino Moutafis, nationally certified acupuncturist.
Effect Of Acupuncture On Motor Symptoms Of Parkinson’s Disease
In a large clinical study , 80 PD subjects were divided into treatment group and control group , it was found that acupuncture treatment for 4 weeks produced a significant improvement in motor function including tremor and gait disturbance compared to control group however, the study did not mention how the motor functions were assessed . Using functional magnetic resonance imaging technique, Chae et al. explored the neural mechanism of specific effect of acupuncture stimulation on the motor function of patients with PD. When acupuncture stimulation at acupoint GB34 on patients with PD, fMRI revealed the activation of the putamen and primary motor cortex. The patients experienced a significant improvement of motor function, finger-tapping tasks of affected hand following acupuncture . This suggested that acupuncture exerted its beneficial effect via its ability to modulate neuronal activities in the specific motor-related brain regions in patients with PD.
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Effectiveness Of Acupuncture For Parkinson’s Disease: A Systematic Review
Complementary Medicine, Peninsula Medical School, Universities of Exeter & Plymouth, Exeter, United Kingdom
Department of Medical Research, Korea Institute of Oriental Medicine, Daejeon, South Korea
Jae Cheol Kong OMD, MSc
Department of Oriental Rehabilitation Medicine, College of Oriental Medicine, Wonkwang University, Iksan, South Korea
Edzard Ernst MD, PhD, FRCP, FRCPEd
Complementary Medicine, Peninsula Medical School, Universities of Exeter & Plymouth, Exeter, United Kingdom
Complementary Medicine, Peninsula Medical School, Universities of Exeter & Plymouth, Exeter, United Kingdom
Department of Medical Research, Korea Institute of Oriental Medicine, Daejeon, South Korea
Jae Cheol Kong OMD, MSc
Department of Oriental Rehabilitation Medicine, College of Oriental Medicine, Wonkwang University, Iksan, South Korea
Edzard Ernst MD, PhD, FRCP, FRCPEd
Complementary Medicine, Peninsula Medical School, Universities of Exeter & Plymouth, Exeter, United Kingdom
The Evidence For Effectiveness
Introduction
Acupuncture has been used to treat many conditions in China for more than 3000 years. Acupuncture is now one of the most popular complementary medicines, and is used for the treatment of a variety of disorders worldwide. In general, acupuncture needle inserted at the specific acupoint stimulates nerve receptors both directly or indirectly, through mechanical coupling via the connective tissues surrounding the needle, then through the local reflex and the central nervous system, induces endocrine, neuroendocrine, autonomic and systemic behavioural responses This suggests that acupuncture therapy beneficially affects a whole body even if it stimulates, through the fine needles, only limited sites on the body. Within past a few decades acupuncture has become increasingly popular with both public and medical professionals, and it has been reported to be a very safe and welltolerated therapy with only minor side effects . Many patients with PD are reported using acupuncture as an alternative treatment at some points of their life. Indeed, it has been estimated that more than a quarter of PD patients in the United State , Britain , Sweden , Singapore , and Argentina have used at least one form of complementary medicine, while 7-49% of them have used acupuncture as an alternative therapy Many patients with PD experienced improvement of their conditions after acupuncture.
Literature Search
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Effect Of Acupuncture On Nonmotor Symptoms Of Parkinson’s Disease
Nonmotor symptoms of PD are common but are often under-recognized in clinic practice due to the lack of spontaneous complaints from patients. NMS in PD was systematically reviewed for the first time by Chaudhuri et al. . NMS ranges from autonomic dysfunction, neuropsychiatric disorders, sleep disturbance, sensory symptoms to gastrointestinal syndromes, fatigue, and many others and are often under-treated . NMS occurs throughout the course of the disease. Some of them, such as depression, fatigue, and smelling dysfunction, may appear at the earliest stage of the disease in un-treated patients. Others appear at the advanced stage of the disease. At the time of diagnosis, the prevalence of NMS among patients with PD was 21% and went up to 88% after 7-year disease progression , . Indeed, nonmotor aspects of PD had greater impact on quality of life and cause higher institutionalization rates and healthcare cost .
Recommendations For Future Studies
Based on the recent acupuncture studies summarized here, we make several recommendations for future studies.
1. The quality assessments suggested that some studies were of low quality and some items provided inconsistent results in different studies. Thus, it is time to organize large, multicenter, well-designed RCTs to evaluate the efficacy of acupuncture. Although many RCTs have provided evidence for the efficacy of acupuncture, flaws of methodology have reduced the value of the evidence. Acupuncture needs authoritative evidence to step into the mainstream of medical academia. Once acupuncture has been authoritatively proved to be efficacious and accepted by clinicians, it should be considered as a method of peripheral stimulation to treat PD . Peripheral stimulation has no surgical risks, which will greatly benefit PD patients in the world.
2. Objective assessments using novel computerized technologies, such as wearable devices, virtual reality, and augmented reality technologies and robot assistant technology, which can realize real-time, programmable, and safe measurements of the motor fluctuations in PD, should be developed and used in future acupuncture studies to provide more powerful evidence for the efficacy of acupuncture, since it may bring great revolutionary in the behavioral assessments in PD .
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Study Selection And Data Extraction
The titles and abstracts of collected studies were scanned to select potential reference. Relevant articles with potential for eligible studies were selected after reviewing full text, and then, data describing patients, duration and severity of condition, treatment, control groups, and outcomes were extracted.
A total of 176 studies were identified from the electronic databases and hand searching. After searching titles and abstracts, 142 studies were excluded due to the following reasons: the studies were nonclinical the studies were irrelevant to PD the studies were irrelevant to acupuncture the studies were case report patients included were not typical idiopathic PD and the studies did not show valid outcome measures. Having evaluated full text of remaining 34 literatures, 14 were selected for this study based on predefined criteria. Among the selected studies, four were conducted in the United States, two originated from Korea, and eight were from China . The screen process was summarized in a flow diagram .
Figure 1
Characteristics Of Included Reviews
The characteristics of the 11 SRs/MAs included in our final analysis are summarized in Table 2. They were published between 2010 and 2019, and 9 of them were published since 2015 . The number of primary studies included in each review ranged from 8 to 42, and the sample sizes ranged from 474 to 2,625. The interventions in the therapy groups were mainly acupuncture or acupuncture plus medication, and the interventions in the control groups were mainly medication and sham placebo acupuncture. The conclusions from these reviews differed: 10 reviews reached the conclusion that acupuncture was effective in relieving PD symptoms, while the remaining 1 reached the opposite conclusion.
Table 2. Characteristics of the included reviews.
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Efficacy Of Acupuncture For Global Evaluation
For global evaluation, we used the total UPDRS score and the Webster Scale. UPDRS is the most widely used scale for evaluation of the PD symptoms. The classic UPDRS has six parts: UPDRS I- mentation, behavior and mood Part IIactivities of daily life Part IIImotor evaluation Part IVcomplications of therapy Part Vstaging of severity of PD and Part VISchwab and England ADL scale. This is a clinician-report scale. Most items have scores ranged from 0 to 4 . The Webster Scale is another commonly used self-report scale, which is briefer than UPDRS. It has 10 items . The scores range from 0 to 3 . We found that all the measurements using the total UPDRS score showed good efficacy of acupuncture, regardless of whether the protocol acupuncture + classical treatment vs. classical treatment or acupuncture vs. classical treatment was used. A meta-analysis by Lee and Lim analyzed seven RCTs with 425 participants and found that the protocol acupuncture + classical treatment showed superior efficacy to classical treatment . These results are similar to those of Liu et al. from 11 RCTs with 831 participants = 1.15 95% CI, 1.63 to 0.67 P< 0.001] , of Noh from five RCTs with 407 participants , and of Lee from two RCTs with 60 participants .
How Acupuncture Helps Relieve Parkinsons Disease Symptoms
More than one million people in this country suffer from Parkinsons disease. It strikes 50 percent more men than women, with an average age of onset of 60 years old. PD is a chronic and progressive neurodegenerative disease that has no cure currently. Many patients take medication to suppress symptoms, such as involuntary shaking. However, more and more people are seeking complementary therapies to relieve their symptoms.
In particular, acupuncture has been found to be very helpful in alleviating PD symptoms. A study appearing in Medicine analyzed the clinical effectiveness of acupuncture on Parkinsons disease, taking the results of nearly 1,000 articles and studies that showed favorable results for acupuncture in conjunction with conventional treatment compared with conventional treatment alone in the treatment of PD symptoms.
This particular studys researchers performed a systematic review and meta-analysis to find out if acupuncture did indeed relieve PD symptoms. The result? Acupuncture was found to have significant positive effects. Its generally considered to be a combination treatment with conventional treatment.
Despite the many positive findings over the years, acupuncture remains difficult to study. Why? Well, it faces many limitations in the research setting, such as being associated with a high placebo effect as is the case with many complementary therapies, according to The Michael J. Fox Foundation for Parkinsons Research.
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