| 마황복용 후 사상체질별 이상반응에 관한 임상연구 : 무작위배정 이중맹검시험 |
| 이태호1,3, 형례창1,4, 양창섭1, 김락형2, 서의석1, 장인수1 |
1우석대학교 한의과대학 한방내과학교실
2우석대학교 한의과대학 한방신경정신과학교실
3유림한의원
4전북대학교 의학전문대학원 |
| Adverse Effects of Ephedra According to Sasang Typology in Healthy Adults
: A Double-Blind Randomized Controlled Trial |
| Tae-ho Lee1,3, Li-chang Hsing1,4, Chang-sop Yang1, Lak-hyung Kim2, Eui-seok Seo1, In-soo Jang1 |
1Dept. of Internal medicine, Woo-suk University
2Dept. of Oriental Neuropsychiatry College of Korean Medicine, Woo-suk University
3Yu-rim Korean Medical Clinic
4School of Medicine, Chon-buk National University |
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Published online: March 30, 2009. |
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| 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, the use of ephedra in traditional medicine is documented over more than 1,800 years. It is well established that ephedra is one of the central medicines in Korean ‘Sasang constitution' medicine. In Sasang constitution medicine, all humans can be divided into one of four types: Soeumin, Soyangin, Taeumin or Taeyangin, and each constitution type has their own typical characteristics. Accordingly, it is hypothesized that the adverse effects of ephedra differ depending on the Sasang constitution classification.
Objectives:
The aim of this study was to determine adverse effects of ephedra which is classified as a Taeumin herb, and to observe whether the response differs 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 agreed to participate in this study. They were allocated through randomization to either ephedra group (N=55) or placebo group (N=24), where ephedra extract (6 g of driedephedra) 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, and patient's global assessment scale score for well known adverse events: palpitation, headache, sweating, tiredness, dyspepsia, and dry mouth.
Results:
After ingestion of ephedra, the pulse rate had a significant increase in all constitution types. The changes of diastolic pressure in Soeumin and the changes of pulse rate in Soeumin, Soyangin and Taeumin had a significant increase in the ephedra over the control group. In the ephedra group, the palpitation and dyspepsia score of the patients' global assessment scale had a significant increase in Soeumin, with palpitation and sweating score increasing in Soyangin. Others observations were insignificant results.
Conclusion:
The results of this study may confirm that the physical responses or adverse effects of herbs differ for each type of Sasang constitution. Future studies using other herbs will be required to ascertain the herbal drug reaction of Sasang constitutions. |
| Key words:
Ephedra, Mahuang, Sasang constitution, Typology, Adverse effects |
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