Objective: This study aims to assess feasibility of a herbal medication, HH368 for idiopathic Parkinson’s disease (PD) 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 [1]. As alternative and complementary treatment options, various herbal medications have been used in East-Asian society, but clinical evidence was not established well [2].

Method: Forty participants will be assigned into one of two groups, herbal medicine and acupuncture treatment group or single acupuncture treatment group. In the treatment group, 4 g of HH368 (Eoggansangahubagjisil 4g) will be administered twice a day (8 g) for a total of 42 days, and acupuncture and physician consultation will be offered twice a week. In the control group, acupuncture treatment and physician consultation will be offered twice a week without herbal medication. All the study participants need to continue their dopaminergic medication during the participation. Movement disorder society-unified Parkinson’s disease rating scale (MDS-UPDRS), Berg balance test, Schwab & England ADL score, Parkinson’s Disease Questionnaire (PDQ-39), doses of levodopa agent consumption, EuroQol(EQ-5D)-5D-5L and safety will be assessed up to 12 weeks of participation period [3-10]. Along with this clinical trial, cost-effectiveness analysis will be conducted for evaluating economic impact of this herbal medication.

Results: The study protocol of this study was approved by institutional review board (IRB) of Kyunghee University Korean Medicine Hospital (IRB approval number: KOMCIRB-17-717-HR-021) and by Ministry of Food and Drug Safety of Republic of Korea (Approval number: 31858). The study protocol was registered at Clinical Research Information Service (registration number: KCT0003444). Currently study participants are recruited, and clinical trial is ongoing in Kyunghee University Korean Medicine Hospital.

Conclusion: This study results will present basic data for assessing feasibility and designing future confirmative clinical trial.

References: [1] M.F. Bastide, W.G. Meissner, B. Picconi, et al. “Pathophysiology of L-dopa-induced motor and non-motor complications in Parkinson’s disease,” Progress in neurobiology, vol. 132, pp. 96-168. [2] CHO, Ki-Ho, et al. Complementary and Alternative Medicine for Idiopathic Parkinson’s Disease: An Evidence-Based Clinical Practice Guideline. Frontiers in aging neuroscience, 2018, 10: 323. [3] “http://www.movementdisorders.org/MDS-Files1/PDFs/Rating-Scales/MDS-UPDRS_Korean_Official_Translation_FINAL.pdf, currenlty assessed at June 26, 2017.” [4] D. Podsiadlo and S. Richardson. “The timed “Up & Go”: a test of basic functional mobility for frail elderly persons,” Journal of the American geriatrics Society, vol. 39, no. 2, pp. 142-148. [5] C. McRae, G. Diem, A. Vo, C. O’Brien, and L. Seeberger. “Reliability of measurements of patient health status: a comparison of physician, patient, and caregiver ratings,” Parkinsonism & related disorders, vol. 8, no. 3, pp. 187-192. [6] H. Wang, Y. Pan, B. Xue, et al. “The antioxidative effect of electro-acupuncture in a mouse model of Parkinson’s disease,” PLoS One, vol. 6, no. 5, p. e19790. [7] D.-Y. Kwon, J.W. Kim, H.-I. Ma, et al. “Translation and validation of the Korean version of the 39-item Parkinson’s disease questionnaire,” Journal of Clinical Neurology, vol. 9, no. 1, pp. 26-31. [8] H.-J. Park, K.-Y. Sohng, and S. Kim. “Validation of the Korean version of the 39-Item Parkinson’s Disease Questionnaire (PDQ-39),” Asian nursing research, vol. 8, no. 1, pp. 67-74. [9] O. Suchowersky, S. Reich, J. Perlmutter, T. Zesiewicz, G. Gronseth, and W. Weiner. “Practice Parameter: Diagnosis and prognosis of new onset Parkinson disease (an evidence-based review) Report of the Quality Standards Subcommittee of the American Academy of Neurology,” Neurology, vol. 66, no. 7, pp. 968-975. [10] D.K. Whynes. “Correspondence between EQ-5D health state classifications and EQ VAS scores,” Health and quality of life outcomes, vol. 6, no. 1, p. 94.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/effectiveness-and-safety-of-a-herbal-medication-hh368-for-clinical-symptoms-of-idiopathic-parkinsons-disease-a-randomized-controlled-pilot-trial-protocol/