The Journal of Internal Korean Medicine (대한한방내과학회지)

The Society of Internal Korean Medicine (대한한방내과학회)
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Research on Outcome Indicators in Clinical Trials of Asthma, Cough, and Sputum by Reviewing Papers Searched from PubMed

해외논문고찰을 통한 천식 및 기침${\cdot}$가래 치료제의 유효성 평가지표 개발연구

  • Oh, Mi-Hyune (Herbal Medicinal Products Team, Korea Food and Drug Administration) ;
  • Lee, Ji-Hyung (Center for Clinical Research and Genomics, Institute of Oriental Medicine, Kyunghee University, Department of Preventive Medicine, College of Oriental Medicine, Kyunghee University) ;
  • Jang, Bo-Hyoung (Center for Clinical Research and Genomics, Institute of Oriental Medicine, Kyunghee University, Department of Preventive Medicine, College of Oriental Medicine, Kyunghee University) ;
  • Jung, Sung-Ki (Department of Internal Medicine, College of Oriental Medicine, Kyunghee University) ;
  • Sun, Seung-Ho (Department of Internal Medicine, College of Oriental Medicine, Sangji University) ;
  • Ko, Ho-Yeon (Department of Internal Medicine, College of Oriental Medicine, Semyung University) ;
  • Jun, Chan-Yong (Department of Internal Medicine. College of Oriental Medicine, Kyungwon University) ;
  • Park, Jong-Hyeong (Department of Internal Medicine. College of Oriental Medicine, Kyungwon University) ;
  • Ko, Seong-Gyu (Center for Clinical Research and Genomics, Institute of Oriental Medicine, Kyunghee University, Department of Preventive Medicine, College of Oriental Medicine, Kyunghee University)
  • 오미현 (식품의약품안전청 생약제제팀) ;
  • 이지형 (경희대학교 한의학임상연구 및 유전체센터, 경희대학교 한의과대학 예방의학과) ;
  • 장보형 (경희대학교 한의학임상연구 및 유전체센터, 경희대학교 한의과대학 예방의학과) ;
  • 정승기 (경희대학교 한의과대학 내과) ;
  • 선승호 (상지대학교 한의과대학 내과) ;
  • 고호연 (세명대학교 한의과대학 내과) ;
  • 전찬용 (경원대학교 한의과대학 내과) ;
  • 박종형 (경원대학교 한의과대학 내과) ;
  • 고성규 (경희대학교 한의학임상연구 및 유전체센터, 경희대학교 한의과대학 예방의학과)
  • Published : 2007.09.30
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Abstract

Objectives : The purpose of this study was to develop outcome indicators in clinical trials of herbal drugs effective for asthma. cough and sputum. To accomplish the objective, this study collected outcome indicators developed and used according to conventional medical concepts. Methods : Our research group reviewed SCI papers concerned with developing outcome indicators to evaluate amelioration of asthma, cough and sputum. We also reviewed clinical trials of herbal drugs effective for them. Results : To evaluate asthma, objective as well as subjective methods were chosen according to the purpose of each trial. Objective methods were PEF, FEVl, serum IgE, peripheral eosinophil counts, and so on. Subjective methods were symptom scores, symptom diaries, quality of life measures, etc. To evaluate cough and sputum, objective and subjective methods were also chosen. Objective methods were tussigenic challenges, sputum induction and computerized methodology, and subjective methods were similar to the methodology evaluating asthmatic symptoms. Conclusions : It is desirable for a clinical trial evaluating herbal drugs for asthma, cough and sputum to use objective and subjective outcome indicators together. However, biological outcome indicators, a kind of objective methods, can not be chosen as the purpose of trial. Valid and reliable subjective outcome indicators are needed to develop good clinical trials of herbal drugs effective for asthma, cough and sputum.

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