마황복용 후 사상체질별 이상반응에 관한 임상연구 : 무작위배정 이중맹검시험
Adverse Effects of Ephedra According to Sasang Typology in Healthy Adults : A Double-Blind Randomized Controlled Trial
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Background : Ephedra (Ephedra sinica) has been widely used to treat respiratory disease in traditional medicine of east Asia for over a hundred years. Despite safety concerns raised by some, but, it has been a long time more than 1,800 years that the use of Ephedra in traditional medicine. It is well established that Ephedra is one of the famous medicine, in Korean ‘Sasang Constitution' medicine. In Sasang Constitution medicine, all of human could be divided into four types: Soeumin, Soyangin, Taeumin and Taeyangin, and each constitution has their own typical characteristics. Accordingly, it is estimated that the adverse effects of Ephedra differ from the Sasang Constitution Classification. Objectives : The aim of this study is to determine adverse effects of Ephedra that is classified into Taeumin herb, show whether the response is different or not, according to Sasang Constitution Classification. Methods : The study design was a double-blind randomized controlled trial. The subjects were healthy adults 20 - 50 years old who were agreed to participate in this study. They were allocated through randomization either Ephedra group (N=55) or placebo group (N=24), where Ephedra extract(6 g of dried Ephedra) and placebo with similar opaque capsules were given twice for one day. To compare the adverse events of Ephedra according to Sasang constitution classification, we analyzed blood pressure (systolic and diastolic), pulse rate, the morning questionnaire, patient's global assessment scale score for adverse events were well known: palpitation, headache, sweating, tiredness, dyspepsia, and dry mouth. Results : After ingestion of Ephedra, the pulse rate had a significant increase in all kinds of constitution. The changes of diastolic pressure in Soeumin and the changes of pulse rate in Soeumin, Soyangin and Taeumin had a significant increase in Ephedra than in control group. In Ephedra group, the palpitation and dyspepsia score of Patients global assessment scale had a significant increase in Soeumin, and, palpitation and sweating score in Soyangin. Others contents were insignificant results. Conclusion : The results of this study may confirm that the physical responses or adverse effects of herbs are differ from each type of Sasang constitution. Future studies using other herbs will be required to ascertain the herbal drug reaction of Sasang constitution.
Abstract
Background : Ephedra (Ephedra sinica) has been widely used to treat respiratory disease in traditional medicine of east Asia for over a hundred years. Despite safety concerns raised by some, but, it has been a long time more than 1,800 years that the use of Ephedra in traditional medicine. It is well established that Ephedra is one of the famous medicine, in Korean ‘Sasang Constitution' medicine. In Sasang Constitution medicine, all of human could be divided into four types: Soeumin, Soyangin, Taeumin and Taeyangin, and each constitution has their own typical characteristics. Accordingly, it is estimated that the adverse effects of Ephedra differ from the Sasang Constitution Classification. Objectives : The aim of this study is to determine adverse effects of Ephedra that is classified into Taeumin herb, show whether the response is different or not, according to Sasang Constitution Classification. Methods : The study design was a double-blind randomized controlled trial. The subjects were healthy adults 20 - 50 years old who were agreed to participate in this study. They were allocated through randomization either Ephedra group (N=55) or placebo group (N=24), where Ephedra extract(6 g of dried Ephedra) and placebo with similar opaque capsules were given twice for one day. To compare the adverse events of Ephedra according to Sasang constitution classification, we analyzed blood pressure (systolic and diastolic), pulse rate, the morning questionnaire, patient's global assessment scale score for adverse events were well known: palpitation, headache, sweating, tiredness, dyspepsia, and dry mouth. Results : After ingestion of Ephedra, the pulse rate had a significant increase in all kinds of constitution. The changes of diastolic pressure in Soeumin and the changes of pulse rate in Soeumin, Soyangin and Taeumin had a significant increase in Ephedra than in control group. In Ephedra group, the palpitation and dyspepsia score of Patients global assessment scale had a significant increase in Soeumin, and, palpitation and sweating score in Soyangin. Others contents were insignificant results. Conclusion : The results of this study may confirm that the physical responses or adverse effects of herbs are differ from each type of Sasang constitution. Future studies using other herbs will be required to ascertain the herbal drug reaction of Sasang constitution.
참고문헌 (24)
- 전국한의과대학 본초학교실, "본초학", pp.154~156 (2004), 영림사
- 한종현, "한방약리학", pp.88~96 (2004), 의성당
- 김호철, "한약약리학", pp.63~66 (2001), 집문당
- Haller CA, "Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids", N Engl J Med, 343(25), pp.1833~1838 (2000)
- Soni MG, "Safety of ephedra: lessons learned", Toxicol Lett, 150(1), pp.97~110 (2004)
- Shekelle PG, "Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis", JAMA, 289(12), pp.1537~1545 (2003)
- 전국한의과대학사상의학교실, "사상의학", pp.479~489 (1998), 집문당
- Morgan PJ, "Evaluation of zolpidem, triazolam, and placebo as hypnotic drugs the night before surgery", J Clin Anesth, 9(2), pp.97~102 (1997)
- Buysse DJ, "The Pittsburgh sleep quality index: A new instrument for psychiatric and research", Psychiatry Res, 28, pp.192~213 (1988)
- Andraws R, "Cardiovascular Effects of Ephedra Alkaloids: A Comprehensive Review", Prog Cardiovasc Dis, 47(4), pp.217~225 (2005)
- 한국약학대학협의회 약전분과회, "대한약전: 제7개정해설서 의약품각조 제2부", pp.1044~1045 (1998), 문성사
- Blanck HM, "Use of nonprescription weight loss products: results from a multistate survey", JAMA, 286(8), pp.930~935 (2001)
- Charatan F, "Ephedra supplement may have contributed to sportsman's death", BMJ, 326(7387), pp.464~ (2003)
- Scheindlin S, "Ephedra: once a boon, now a bane", Mol Interv, 3(7), pp.358~360 (2003)
- 박해모, "국내에서 보고된 한약 및 민간요법, 건강식품 관련 약인성간손상에 대한 체계적 고찰", 대한한의학회지, 26(2), pp.152~165 (2005), 대한한의학회
- 장인수, "최근 독성 문제가 제기된 한약재에 대한 고찰", 대한한의학회지, 28(1), pp.1~10 (2007), 대한한의학회
- 장인수, "약인성간손상의 진단기준 및 원인산정법", 대한한방내과학회 추계학술대회초록집, pp.12~18 (2005)
- 형례창, "마황용량에 따른 이상반응에 관한 예비연구:무작위배정이중맹검시험", 대한한방내과학회지, 27(1), pp.188~196 (2006), 대한한방내과학회
- 장인수, "마황의 안전성에 대한 논란과 한방 임상에서의 마황 사용 지침의 필요성", 대한한방비만학회지, 7(1), pp.23~29 (2007)
- 양병무, "東武遺稿(國譯韓醫學大系 15券)", pp.21~98 (1999), 海東醫學社
- Ryu S-R, "Effect of ephedrine on locomotor activity and self administration", National Institute of Toxicological Research, pp.12~14 (2000)
- El Hemaly AK, "Nocturnal enuresis: pathogenesis and treatment", Int Urogynecol J Pelvic Floor Dysfunct, 9(3), pp.129~131 (1998)
- White LM, "Pharmacokinetics and cardiovascular effects of Mahuang(Ephedra sinica) in normotensive adults", J Clin Pharmacol, 37(2), pp.116~122 (1997)
- 김정열, "뇌졸중환자 소변실금에 대한 마황효과", 대한한방내과학회 춘계학술대회, pp.114~124 (2003)