Table of Contents Author Guidelines Submit a Manuscript
Evidence-Based Complementary and Alternative Medicine
Volume 2017, Article ID 4363716, 10 pages
https://doi.org/10.1155/2017/4363716
Research Article

A Herbal Medicine, Gongjindan, in Subjects with Chronic Dizziness (GOODNESS Study): Study Protocol for a Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial for Effectiveness, Safety, and Cost-Effectiveness

1Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea
2Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea
3Department of Korean Medical Ophthalmology & Otolaryngology & Dermatology, School of Korean Medicine, Pusan National University, 20 Geumo-ro, Mulgeum-eup, Yangsan, Gyeongsangnam-do 50612, Republic of Korea
4Department of Sasang Constitutional Medicine, College of Oriental Medicine, Semyung University, 65 Semyung-ro, Jecheon, Chungcheongbuk-do 27136, Republic of Korea
5Department of Korean Rehabilitation Medicine, College of Korean Medicine, Kyung Hee University, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea
6Department of Oriental Medicine Ophthalmology & Otolaryngology & Dermatology, College of Oriental Medicine, Dongguk University, 27 Dongguk-ro, Ilsandong-gu, Goyang, Gyeonggi-do 10326, Republic of Korea
7Department of Sasang Constitutional Medicine, College of Korean Medicine, Kyung Hee University, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea

Correspondence should be addressed to Seung-Ug Hong; ten.liamnah@ushtneeh and Euiju Lee; ten.muad@nignasas

Received 16 July 2017; Accepted 19 October 2017; Published 13 December 2017

Academic Editor: Carmen Mannucci

Copyright © 2017 Seungwon Shin et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. K. A. Kerber and R. W. Baloh, “The evaluation of a patient with dizziness,” Neurology: Clinical Practice, vol. 1, no. 1, pp. 24–33, 2011. View at Publisher · View at Google Scholar · View at Scopus
  2. D. K. Lee, “Clinical understanding to dizziness in the elderly,” Korean Journal of Clinical Geriatrics, vol. 15, no. 2, pp. 45–55, 2014 (Korean). View at Google Scholar
  3. K. K. Lee, “Psychogenic dizziness for psychiatrists in Korea,” Korean Journal of Psychosomatic Medicine, vol. 24, no. 1, pp. 9–19, 2016 (Korean). View at Google Scholar
  4. S. Y. Kwon and S. K. Hong, “Evaluation and treatment of Meniere’s disease,” Research in Vestibular Science, vol. 11, Supplement 1, pp. 4–8, 2012 (Korean). View at Google Scholar
  5. K. Kroenke, C. A. Lucas, M. L. Rosenberg et al., “Causes of persistent dizziness: A prospective study of 100 patients in ambulatory care,” Annals of Internal Medicine, vol. 117, no. 11, pp. 898–904, 1992. View at Publisher · View at Google Scholar · View at Scopus
  6. S. Y. Oh, “Diagnosis and treatment of chronic dizziness,” Research in Vestibular Science, vol. 9, pp. 65–71, 2010 (Korean). View at Google Scholar
  7. Review Assessment Service, Healthcare Bigdata Hub, Wonju: Health Insurance Review Assessment Service (Republic of Korea, Health Insurance, Wonju, 2017.
  8. L. Sokolova, R. Hoerr, and T. Mishchenko, “Treatment of vertigo: a randomized, double-blind trial comparing efficacy and safety of ginkgo biloba extract EGb 761 and betahistine,” International Journal of Otolaryngology, vol. 2014, Article ID 682439, 6 pages, 2014. View at Publisher · View at Google Scholar
  9. J. M. Oh, T. M. Eom, and K. E. Choi, “Study of the patients with dizziness who visited the Korean medicine hospital,” Korean Journal of Oriental Physiology Pathology, vol. 29, no. 5, pp. 378–385, 2015 (Korean). View at Publisher · View at Google Scholar
  10. J. Heo, Dongeuibogam, Namsandang, Seoul, South Korea, 2014.
  11. J. H. Lee, D. C. Jo, C. G. Kim et al., “A literature review of effectiveness on the Gongjin-dan (Gongchen-dan),” Journal of Korean Medicine Rehabilitation, vol. 23, no. 3, pp. 69–78, 2013 (Korean). View at Google Scholar
  12. E. Moon, Y. Her, J. B. Lee et al., “The multi-herbal medicine Gongjin-dan enhances memory and learning tasks via NGF regulation,” Neuroscience Letters, vol. 466, no. 3, pp. 114–119, 2009. View at Publisher · View at Google Scholar · View at Scopus
  13. J.-S. Lee, S.-S. Hong, H.-G. Kim et al., “Gongjin-Dan enhances hippocampal memory in a mouse model of scopolamine-induced amnesia,” PLoS ONE, vol. 11, no. 8, Article ID e0159823, 2016. View at Publisher · View at Google Scholar · View at Scopus
  14. S.-S. Hong, J.-Y. Lee, J.-S. Lee et al., “The traditional drug Gongjin-Dan ameliorates chronic fatigue in a forced-stress mouse exercise model,” Journal of Ethnopharmacology, vol. 168, pp. 268–278, 2015. View at Publisher · View at Google Scholar · View at Scopus
  15. K. H. Choi and C. S. Park, “An analysis of the Gongjindan`s ingredients and its efficacy on anti-oxidation,” The Korean Journal of Herbology, vol. 22, no. 2, pp. 51–63, 2007 (Korean). View at Google Scholar
  16. Y. Y. Sunwoo, S. I. Park, and Y. A. Chung, “A pilot study for the neuroprotective effect of Gongjin-dan on transient middle cerebral artery occlusion-induced ischemic rat brain,” Evidence-Based Complementary and Alternative Medicine, vol. 2012, Article ID 682720, 11 pages, 2012. View at Publisher · View at Google Scholar
  17. S. M. Hwang and D. K. Chung, “The effects of KongJin-dan (KJD) on the Alzheimer's disease model induced by CT105,” Journal of Oriental Neuropsychiatry, vol. 15, no. 2, pp. 103–118, 2004 (Korean). View at Google Scholar
  18. Y. H. Kim and M. J. Bae, “The effect of Gongjindan on the lipid metabolism in rats fed high fat-diet,” The Journal of East-West Medicines, vol. 14, no. 2, pp. 61–78, 1989 (Korean). View at Google Scholar
  19. H. C. Jung, H. J. Jang, W. Y. Sung, S. H. Lee, J. H. Son, and S. H. Han, “A study of Gongjin-dan in patients with mild dementia of Alzheimer type,” Journal of Oriental Neuropsychiatry, vol. 15, no. 2, pp. 141–148, 2004 (Korean). View at Google Scholar
  20. D. S. Lee and D. W. Kim, “A effect of Gongchen-dan to anemia,” Journal of Kyungwon University Korean Medicine Institution, vol. 7, pp. 97–107, 2004 (Korean). View at Google Scholar
  21. M. J. Son, H.-J. Im, Y.-E. Kim, B. Ku, J.-H. Lee, and C.-G. Son, “Evaluation of the anti-fatigue effects of a traditional herbal drug, Gongjin-dan, under insufficient sleep conditions: Study protocol for a randomised controlled trial,” Trials, vol. 17, no. 1, article no. 418, 2016. View at Publisher · View at Google Scholar · View at Scopus
  22. A. W. Chan, J. M. Tetzlaff, D. G. Altman et al., “SPIRIT 2013 statement: defining standard protocol items for clinical trials,” Annals of Internal Medicine, vol. 158, no. 3, pp. 200–207, 2013. View at Publisher · View at Google Scholar · View at Scopus
  23. J. J. Gagnier, H. Boon, P. Rochon, D. Moher, J. Barnes, and C. Bombardier, “Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement,” Annals of Internal Medicine, vol. 144, no. 5, pp. 364–367, 2006. View at Publisher · View at Google Scholar · View at Scopus
  24. Z. Xue, C.-Z. Liu, G.-X. Shi et al., “Efficacy and safety of acupuncture for chronic dizziness: Study protocol for a randomized controlled trial,” Trials, vol. 14, no. 1, article no. 429, 2013. View at Publisher · View at Google Scholar · View at Scopus
  25. Association of department of pathology in Korea medicine, Pathology in Korean Medicine, Iljungsa, Seoul, Korea, 1998.
  26. G. P. Jacobson and C. W. Newman, “The development of the Dizziness Handicap Inventory,” JAMA Otolaryngology–Head & Neck Surgery, vol. 116, no. 4, pp. 424–427, 1990. View at Publisher · View at Google Scholar · View at Scopus
  27. G. C. Han, E. J. Lee, J. H. Lee et al., “The study of standardization for a Korean adaptation of self-report measures of dizziness,” Journal of the Korean Balance Society, vol. 3, no. 2, pp. 307–325, 2004 (Korean). View at Google Scholar
  28. M. Novotný, R. Kostŕica, and Z. Círek, “The efficacy of Arlevert therapy for vertigo and tinnitus,” International Tinnitus Journal, vol. 5, no. 1, pp. 60–62, 1999. View at Google Scholar
  29. M. Novotný and R. Kostřica, “Fixed combination of cinnarizine and dimenhydrinate versus betahistine dimesylate in the treatment of Meniere's disease: a randomized, double-blind, parallel group clinical study,” International Tinnitus Journal, vol. 8, no. 2, pp. 115–123, 2002. View at Google Scholar
  30. A. W. Scholtz, M. Schwarz, W. Baumann, D. Kleinfeldt, and H.-J. Scholtz, “Treatment of vertigo due to acute unilateral vestibular loss with a fixed combination of cinnarizine and dimenhydrinate: A double-blind, randomized, parallel-group clinical study,” Clinical Therapeutics, vol. 26, no. 6, pp. 866–877, 2004. View at Publisher · View at Google Scholar · View at Scopus
  31. Z. Cirek, M. Schwarz, W. Baumann, and M. Novotny, “Efficacy and tolerability of a fixed combination of cinnarizine and dimenhydrinate versus betahistine in the treatment of otogenic vertigo: A double-blind, randomised clinical study,” Clinical Drug Investigation, vol. 25, no. 6, pp. 377–389, 2005. View at Publisher · View at Google Scholar · View at Scopus
  32. J. Pytel, G. Nagy, A. Tóth, S. Spellenberg, M. Schwarz, and G. Répassy, “Efficacy and tolerability of a fixed low-dose combination of cinnarizine and dimenhydrinate in the treatment of vertigo: A 4-week, randomized, double-blind, active- and placebo-controlled, parallel-group, outpatient study,” Clinical Therapeutics, vol. 29, no. 1, pp. 84–98, 2007. View at Publisher · View at Google Scholar · View at Scopus
  33. A. Hahn, I. Sejna, B. Stefflova, M. Schwarz, and W. Baumann, “A fixed combination of cinnarizine/dimenhydrinate for the treatment of patients with acute vertigo due to vestibular disorders: A randomized, reference-controlled clinical study,” Clinical Drug Investigation, vol. 28, no. 2, pp. 89–99, 2008. View at Publisher · View at Google Scholar · View at Scopus
  34. V. Otto, B. Fischer, M. Schwarz, W. Baumann, and R. Preibisch-Effenberger, “Treatment of vertebrobasilar insufficiency-associated vertigo with a fixed combination of cinnarizine and dimenhydrinate,” The International Tinnitus Journal, vol. 14, no. 1, pp. 57–67, 2008. View at Google Scholar
  35. A. Hahn, M. Novotný, P. M. Shotekov, Z. Cirek, I. Bognar-Steinberg, and W. Baumann, “Comparison of cinnarizinedimenhydrinate fixed combination with the respective monotherapies for vertigo of various origins: A randomized, double-blind, active-controlled, multicentre study,” Clinical Drug Investigation, vol. 31, no. 6, pp. 371–383, 2011. View at Publisher · View at Google Scholar · View at Scopus
  36. M. Toupet, E. Ferrary, and A. B. Grayeli, “Visual analog scale to assess vertigo and dizziness after repositioning maneuvers for benign paroxysmal positional vertigo,” Journal of Vestibular Research, vol. 21, no. 4, pp. 235–241, 2011. View at Google Scholar
  37. C. W. Chiu, T. C. Lee, P. C. Hsu et al., “Efficacy and safety of acupuncture for dizziness and vertigo in emergency department: a pilot cohort study,” BMC Complementary and Alternative Medicine, vol. 15, article 173, 2015. View at Publisher · View at Google Scholar
  38. S. A. Reid, D. A. Rivett, M. G. Katekar, and R. Callister, “Sustained natural apophyseal glides (SNAGs) are an effective treatment for cervicogenic dizziness,” Manual Therapy, vol. 13, no. 4, pp. 357–366, 2008. View at Publisher · View at Google Scholar · View at Scopus
  39. S. A. Reid, D. A. Rivett, M. G. Katekar, and R. Callister, “Efficacy of manual therapy treatments for people with cervicogenic dizziness and pain: Protocol of a randomised controlled trial,” BMC Musculoskeletal Disorders, vol. 13, article no. 201, 2012. View at Publisher · View at Google Scholar · View at Scopus
  40. S. A. Reid, D. A. Rivett, M. G. Katekar, and R. Callister, “Comparison of mulligan sustained natural apophyseal glides and maitland mobilizations for treatment of cervicogenic dizziness: A randomized controlled trial,” Physical Therapy in Sport, vol. 94, no. 4, pp. 466–476, 2014. View at Publisher · View at Google Scholar · View at Scopus
  41. S. A. Reid, R. Callister, S. J. Snodgrass, M. G. Katekar, and D. A. Rivett, “Manual therapy for cervicogenic dizziness: Long-term outcomes of a randomised trial,” Manual Therapy, vol. 20, no. 1, pp. 148–156, 2015. View at Publisher · View at Google Scholar · View at Scopus
  42. K. Berg, S. Wood-Dauphinee, J. I. Williams, and D. Gayton, “Measuring balance in the elderly: preliminary development of an instrument,” Physiotherapy Canada, vol. 41, no. 6, pp. 304–311, 1989. View at Publisher · View at Google Scholar · View at Scopus
  43. K. Berg, S. Wood-Dauphinee, and J. I. Williams, “The balance scale: reliability assessment with elderly residents and patients with an acute stroke,” Scandinavian Journal of Rehabilitation Medicine, vol. 27, no. 1, pp. 27–36, 1995. View at Google Scholar
  44. K. O. Berg, S. L. Wood-Dauphinee, J. I. Williams, and B. Maki, “Measuring balance in the elderly: validation of an instrument,” Canadian Journal of Public Health, vol. 83, supplement 2, pp. S7–S11, 1992. View at Google Scholar
  45. L. D. B. Thorbahn and R. A. Newton, “Use of the Berg balance test to predict falls in elderly persons,” Physical Therapy in Sport, vol. 76, no. 6, pp. 576–585, 1996. View at Publisher · View at Google Scholar · View at Scopus
  46. H. Y. Jung, J. H. Park, J. J. Shim, M. J. Kim, M. R. Hwang, and S. H. Kim, “Reliability test of Korean version of berg balance scale,” Annals of Rehabilitation Medicine, vol. 30, no. 6, pp. 611–618, 2006. View at Google Scholar
  47. S. Hewlett, E. Dures, and C. Almeida, “Measures of fatigue: Bristol rheumatoid arthritis fatigue multi-dimensional questionnaire (BRAF MDQ), Bristol rheumatoid arthritis fatigue numerical rating scales (BRAF NRS) for severity, effect, and coping, Chalder fatigue questionnaire (CFQ), checklist individual strength (CIS20R and CIS8R), fatigue severity scale (FSS), functional assessment chronic illness therapy (Fatigue) (FACIT-F), multi-dimensional assessment of fatigue (MAF), multi-dimensional fatigue inventory (MFI), pediatric quality of life (PedsQL) multi-dimensional fatigue scale, profile of fatigue (ProF), short form 36 vitality subscale (SF-36 VT), and visual analog scales (VAS),” Arthritis Care and Research, vol. 63, supplement 11, pp. S263–S286, 2011. View at Google Scholar
  48. S. J. Kamper, R. W. J. G. Ostelo, D. L. Knol, C. G. Maher, H. C. W. de Vet, and M. J. Hancock, “Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status,” Journal of Clinical Epidemiology, vol. 63, no. 7, pp. 760–e1, 2010. View at Publisher · View at Google Scholar · View at Scopus
  49. J. P. Staab and M. J. Ruckenstein, “Chronic dizziness and anxiety: Effect of course of illness on treatment outcome,” Archives of Otolaryngology—Head and Neck Surgery, vol. 131, no. 8, pp. 675–679, 2005. View at Publisher · View at Google Scholar · View at Scopus
  50. M. K. Rhee, Y. H. Lee, H. Y. Jung et al., “A standardization study of beck depression inventory II - Korean version (K-BDI): validity,” The Korean Journal of Psychopathology, vol. 4, no. 1, pp. 96–104, 1995 (Korean). View at Google Scholar
  51. M. K. Rhee, Y. H. Lee, S. H. Park et al., “A standardization study of beck depression inventory I - Korean version (K-BDI): reliability and factor analysis,” The Korean Journal of Psychopathology, vol. 4, no. 1, pp. 77–95, 1995 (Korean). View at Google Scholar
  52. L. J. Julian, “Measures of anxiety,” Arthritis Care and Research, vol. 63, supplement S11, pp. S467–S472, 2011. View at Publisher · View at Google Scholar
  53. H. Woo, S. Kim, S. Lee, M. Choi, Y. Kim, and J. Lee, “Development of questionnaires for differentiation of qì-xū, xuè-xū, yang-xū, yīn-xū analysis,” The Journal of Internal Korean Medicine, vol. 29, no. 4, pp. 856–870, 2008 (Korean). View at Google Scholar
  54. J. H. Kim, B. C. Ku, J. E. Kim, Y. S. Kim, and K. H. Kim, “Study on reliability and validity of the “qi blood yin yang deficiency questionnaire”,” Korean Journal of Oriental Physiology & Pathology, vol. 28, no. 3, pp. 346–354, 2014 (Korean). View at Google Scholar
  55. J. Kim, B. Ku, and K. H. Kim, “Validation of the qi blood yin yang deficiency questionnaire on chronic fatigue,” Chinese Medicine, vol. 11, p. 24, 2016. View at Google Scholar
  56. H. Bang, L. Ni, and C. E. Davis, “Assessment of blinding in clinical trials,” Controlled Clinical Trials, vol. 25, no. 2, pp. 143–156, 2004. View at Publisher · View at Google Scholar · View at Scopus
  57. T. H. Kim, Validity and reliability evaluation for EQ-5D in the general population of South Korea, College of Medicine, Ulsan University, Ulsan, South Korea, 2012 (Korean).
  58. X. Wu, Clinical research on traditional acupuncture manipulation combined with the moxibustion on BaiHui of Meniere’s disease, Guangzhou University of Chinese Medicine, Guangdong Sheng, China, 2011 (Chinese).