Efficacy and Safety of Herb Medication According to Cold-heat Tendency of Knee Osteoarthritis Patients

퇴행성 슬관절염 환자의 한열 성향에 따른 한약 제제의 유효성과 안전성 비교

  • Song, Ji-Yeon (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University) ;
  • Kim, Min-Jung (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University) ;
  • Sung, Won-Seok (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University) ;
  • Kim, Pil-Kun (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University) ;
  • Goo, Bon-Hyuk (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University) ;
  • Kwak, Hyun-Young (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University) ;
  • Kim, Ji-Hye (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University) ;
  • Kim, Dong-Hyuk (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University) ;
  • Park, Yeon-Cheol (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University) ;
  • Seo, Byung-Kwan (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University) ;
  • Baek, Yong-Hyeon (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University) ;
  • Choi, Do-Young (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University) ;
  • Lee, Jae-Dong (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University) ;
  • Park, Dong-Suk (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Kyung Hee University)
  • 송지연 (경희대학교 한의과대학 침구의학교실) ;
  • 김민정 (경희대학교 한의과대학 침구의학교실) ;
  • 성원석 (경희대학교 한의과대학 침구의학교실) ;
  • 김필군 (경희대학교 한의과대학 침구의학교실) ;
  • 구본혁 (경희대학교 한의과대학 침구의학교실) ;
  • 곽현영 (경희대학교 한의과대학 침구의학교실) ;
  • 김지혜 (경희대학교 한의과대학 침구의학교실) ;
  • 김동혁 (경희대학교 한의과대학 침구의학교실) ;
  • 박연철 (경희대학교 한의과대학 침구의학교실) ;
  • 서병관 (경희대학교 한의과대학 침구의학교실) ;
  • 백용현 (경희대학교 한의과대학 침구의학교실) ;
  • 최도영 (경희대학교 한의과대학 침구의학교실) ;
  • 이재동 (경희대학교 한의과대학 침구의학교실) ;
  • 박동석 (경희대학교 한의과대학 침구의학교실)
  • Received : 2012.09.10
  • Accepted : 2012.10.06
  • Published : 2012.10.20

Abstract

Objectives : To demonstrate the importance of syndrome differentiation in clinical research of herb medication, through the comparative study on efficacy and safety of herb medication according to cold-heat tendency of OA knee patients. Methods : During December 2010 to July 2011, 138 knee OA patients were randomly assigned to WIN-34B 600mg(300mg, b.i.d.), 1,200mg(600mg, b.i.d.) and placebo b.i.d. for 8 weeks. Patient were re-classified into cold-heat tendency group according to cold-heat questionnaires. To investigate efficacy and safety, we assessed the 100mm pain VAS at baseline and 8 weeks later, and we monitored adverse event of patients during treatment period. Results : 1. Efficacy study : In WIN-34B 1,200mg group, VAS mean changes of heat tendency group showed slightly increase than those of cold tendency, but no significant difference within two groups. In heat tendency group, WIN-34B 1,200mg group showed a significant decrease of VAS compared to placebo group. but there were no significant difference in cold tendency group. 2. Safety study; In WIN-34B 600mg group, incidence of adverse events of cold tendency group was higher than those of heat tendency, but not in WIN-34B 1,200mg group. Conclusions : This study suggests that WIN-34B tend to have more efficacy in heat tendency-knee OA patients and WIN-34B is safe drug relatively, regardless of cold-heat tendency. In further clinical research on efficacy and safety of WIN-34B, stratification using syndrome differentiation is required.

Keywords

References

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