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The Journal of Internal Korean Medicine > Volume 28(3); 2007 > Article
The Journal of Internal Korean Medicine 2007;28(3): 519-530.
해외논문고찰을 통한 천식 및 기침,가래 치료제의
오미현1, 이지형2,3, 장보형2,3, 정승기4, 선승호5, 고호연6, 전찬용7, 박종형7, 고성규2,3
1식품의약품안전청 생약제제팀
2경희대학교 한의학임상연구 및 유전체센터
3경희대학교 한의과대학 예방의학과
4경희대학교 한의과대학 내과
5상지대학교 한의과대학 내과
6세명대학교 한의과대학 내과
7경원대학교 한의과대학 내과
Research on Outcome Indicators in Clinical Trials of Asthma, Cough, and Sputum by Reviewing Papers Searched from PubMed
Mi-hyune Oh1, Ji-hyung Lee2,3, Bo-hyoung Jang2,3, Sung-ki Jung4, Seung-ho Sun5, Ho-yeon Ko6, Chan-yong Jun7, Jong-hyeong Park7, Seong-gyu Ko2,3
1Herbal Medicinal Products Team, Korea Food and Drug Administration
2Center for Clinical Research and Genomics, Institute of Oriental Medicine, Kyunghee University
3Department of Preventive Medicine, College of Oriental Medicine, Kyunghee University
4Department of Internal Medicine, College of Oriental Medicine, Kyunghee University
5Department of Internal Medicine, College of Oriental Medicine, Sangji University
6Department of Internal Medicine, College of Oriental Medicine, Semyung University
7Department of Internal Medicine, College of Oriental Medicine, Kyungwon University
Correspondence  Seong-gyu Ko ,Tel: 02-961-0329, Fax: 02-966-1165, Email: epiko@khu.ac.kr
  Published online: September 30, 2007.
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, FEV1, 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.
Key words: Clinical Trial, Outcome Indicators, Asthma, Cough, Sputum
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