DOI QR코드

DOI QR Code

Efficacy and Safety of Cheong-A-Won Gagambang (JCE003) on Knee Osteoarthritis: Randomized Controlled Pilot Trial

  • Kong, Haejin (17th Fighter Wing of Republic of Korea Air Force) ;
  • Kang, Jaehui (Department of Acupuncture and Moxibustion Medicine, Cheonan Korean Medicine Hospital of Daejeon University) ;
  • Lee, Hyun (Department of Acupuncture and Moxibustion Medicine, Cheonan Korean Medicine Hospital of Daejeon University)
  • 투고 : 2022.01.26
  • 심사 : 2022.05.18
  • 발행 : 2022.08.31

초록

Background: The aim of this study was to evaluate the effectiveness and safety of Cheong-A-Won Gagambang (JCE003) treatment for degenerative knee osteoarthritis. Methods: This was a single-center, randomized, double-blind, placebo-controlled pilot clinical trial. There were 36 adults with degenerative knee osteoarthritis who were randomly allocated into JCE003 1,000 mg, JCE003 2,000 mg, or the placebo group (in a 1:1:1 ratio). The participants received 12 weeks of treatment and had scheduled tests every 6 weeks. The primary outcomes were measured using the Korean Western Ontario and McMaster Universities scale, and the secondary outcomes were measured using the visual analog scale, European quality of life-5-dimensions, patient global impression of change, C-reactive protein, and erythrocyte sedimentation rate. Changes between baseline scores and scores following study completion were analyzed. Results: There were 29 participants whose data were analyzed in this study. The change of Korean Western Ontario and McMaster Universities, visual analog scale, European quality of life-5-dimensions scores showed significant improvement in the JCE003 1,000 mg group. The change of patient global impression of change was significantly improved in the placebo group. There were 14 adverse events, but there was no clinically significant relationship with the intake of JCE003 compared with the placebo. Conclusion: Taking JCE003 may be effective at improving knee pain in patients with degenerative knee osteoarthritis and appears to be safe. Based on this study, the concentration and feasibility of the test group may be used when conducting a large-scale clinical trial of degenerative knee osteoarthritis in the future.

키워드

참고문헌

  1. Han TR, Bang MS, Chung SG. Rehabilitation medicine, 6th ed. Seoul (Korea): Koonja publishing; 2019. p. 501-524. [in Korean].
  2. Wen DY. Intra-articular hyaluronic acid injections for knee osteoarthritis. Am Fam Physician 2000;62:565-570.
  3. Bruyere O, Cooper C, Pelletier JP, Branco J, Brandi ML, Guillemin F et al. An algorithm recommendation for the management of knee osteoarthritis in Europe and internationally: A report from a task force of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Semin Arthritis Rheum 2014;44:253-263. https://doi.org/10.1016/j.semarthrit.2014.05.014
  4. Laine L. Gastrointestinal effects of NSAIDs and coxibs. J Pain Symptom Manage 2003;25:32-40. https://doi.org/10.1016/S0885-3924(02)00629-2
  5. Habib GS, Saliba W, Nashashibi M. Local effects of intra-articular corticosteroids. Clin Rheumatol 2010;29:347-356. https://doi.org/10.1007/s10067-009-1357-y
  6. Seo BK, Ryu SR, Kang JW, An K, Lee SH, Choi DY et al. Clinical study of the efficacy and safety of Jetongdan on patients with osteoarthritis of the knee. J Korean Med 2005;26:231-240. [in Korean].
  7. Park MJ, Lee KY, Park KH, Chung AK, Shin DH. The clinical study on the effect of Sulguanjul-bang No. 1 on osteoarthritis of knee joint. J Acupunct Res 2004;21:249-264. [in Korean].
  8. Lim JA, Kim SN, Lee SY, Moon HC, Shin MS, Kim HJ et al. The clinical study on bee venom acupuncture treatment on osteoarthritis of knee joint. J Pharmacopuncture 2005;8:29-37. [in Korean]. https://doi.org/10.3831/KPI.2005.8.2.029
  9. Park MS, Oh SJ, Lee JH, Jun SA, Gong HM, Choi SH et al. Miniscalpel acupuncture treatment on a knee degenerative osteoarthritis patient, who does not respond to acupuncture treatment. J Acupunct Res 2016;33:161-168. [in Korean]. https://doi.org/10.13045/acupunct.2016043
  10. Min WK, Yeo S, Kim EH, Song HS, Koo S, Lee JD, et al. Comparison of warm-needling and acupuncture for knee osteoarthritis: A randomized controlled trial. J Acupunct Res 2013;30:64-72.
  11. Kim TY, Kim JH, Park JH, Lee JK, Han C, Kum CJ, Oh JW. The domestic trends of traditional Korean medicine treatments on degenerative knee arthritis. J Korea Chuna Man Med Spine Nerves 2014;9:69-79. [in Korean].
  12. Kim JH, Yoon YS, Lee WJ, Ko HJ, Kim SJ. A systematic review of herbal medicine treatment for knee osteoarthritis. J Korean Med Rehabil 2019;29:47-60. [in Korean]. https://doi.org/10.18325/jkmr.2019.29.4.47
  13. Kim YH, Seo BI. A philological study on poisoning and side effects of Psoraleae Fructus. J Jeahan Orient Med Acad 2012;10:55-62. [in Korean].
  14. Oh SY [Dissertation]. Effects of herbal complex extract (JCE003) on MIA-induced osteoarthritis rats. Daejeon (Korea): Daejeon University; 2019. [in Korean].
  15. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat 2005;4:287-291. https://doi.org/10.1002/pst.185
  16. Rosnow RL, Rosenthal R, Rubin DB. Contrasts and correlations in effect-size estimation. Psychol Sci 2000;11:446-453. https://doi.org/10.1111/1467-9280.00287
  17. Ryu HY, Lee H, Kong HJ, Kang JH. Anti-inflammatory effects of complex extract including Eucommia ulmoides in LPS-induced RAW 264.7 cells. J Acupunct Res 2019;36:256-263. https://doi.org/10.13045/jar.2019.00276