1 Investigation of Reasons for Discontinuance of Kampo and Improvement of Continuance through Better Instructions to Patients 8 조 - 김용범, 박현우, 송상윤, 최보은 Sung-Joon Kim, Miyuki Mizusawa, Chiaki Ogata, Koji Sakata, Toshihiko Hanawa and Haruki Yamada Oriental Medicine Research Center, the kitasato Institute Kitasato Institute for Life Sciences Kitasato University Received May 16, 2005 Accepted October 12, 2005

2 Introduction  To investigate the reasons for discontinuance of Kampo medicines  To discuss the relationship between Kampo medicines and the reasons  To examine how to improve continuance of Kampo medicines through the proper patient instruction

3 Methods - 1  Period and Subject of Investigation  May 2000 ~ December 2003 (44months)  At the outpatient Kampo clinic of Oriental Medicine Research Center of Kitasato Institute

4 Methods - 2  Classification of Reasons for Discontinuance  Symptoms found after taking Kampo medicines  The tastes and smell of Kampo medicines  others

5 Methods - 3  The prescriptions related to the discontinuance and the source herbal medicine  Analyze the prescriptions and the herbal medicines considered as the reason for adverse effects  JTDM : Japanese Traditional Drug’s Name

6 Methods - 4  Prevention measures based on the investigation results  Examine the necessary countermeasures for patient instruction to prevent the discontinuance

7 Results - 1  The Number of Cases of Discontinuance of Kampo Medicine  351/119,000 outpatients (0.29%)  No relation between treatment periods and discontinuance

8 Results - 2  Classification of reason for discontinuance

9 Results - 2  Classification of reason of the Occurrence of symptoms after taking the medicines

10 Results – 2A  Main Complaint Aggravation (Total 109)

11 Results – 2B  Upper Digestive Track Symptoms (Total 72)

12 Results – 2C  Lower Digestive Track Symptoms(Total 54)

13 Results – 2D  Skin Symptoms (Total 44)

14 Results – 2E  Psychological Nervous System Symptoms(Total 44)

15 Results – 2F  Respiratory Organs Symptoms(Total 27)

16 Results – 2G  Others(Total 79)

17 Result - 3  The prescriptions related to the discontinuance and the source herbal medicines  Adverse Effects of Herbal Medicines  Relation to the Adverse Effects of Herbal Medicines and their Composition.

18 Side EffectsHerbal MedicinesNumber of the adverse effect (incidence rate) Blood pressure rise, Edema, Lassitude, General fatigue, Paralysis Glycyrrhizae Radix( 감초 ) 10 (3.8%) Rash Cinnamoni Cortex( 육계 ), Ginseng Radix( 인삼 ) 2 (0.8%) Skin red. Itch Cinnamoni Cortex( 육계 ) 14 (5.3%) Nausea Rehmaniae Radix( 지황 ), Cnidii Rhizoma( 천궁 ), Angelicae Radix( 백지 ), Aconiti Tuber( 부자 ), Ephedrae Herba( 마황 ) 4 (1.5%) Diarrhea Gardeniae Frucrus( 치자 ), Zizyphi Spinosi Semen( 산조 인 ), Rehmaniae Radix( 지황 ), Gypsum Fibrosum( 석고 ), Cnidii Rhizoma( 천궁 ), Rhei Rhizoma( 대황 ), Angelicae Radix( 백지 ), Natrium Sulfuricum( 5 (1.9%) Labial paralysis, Palpitation, Flush Aconiti Tuber( 부자 ) 2 (0.8%) Table 1. Adverse Effects of Herbal Medicines 참고 - 한의과대학 본초학 편찬위원회 (2006), 본초학, 영림사

19 Disease(n)Symptom( n) Prescription(n)Cause of Adverse Effect A. Primary Complaint (106) Skin symptoms (66) Rash and/or Itch (66) Orengedokuto added to Jumihaidokuto (4), Unseiin (3), Keishikaogito (3), Saikokeishito (3), Juzentaihoto (3), Orengedokuto added to Yokukansan (2) Schizonepetae Spica( 형개 ), Cinnamoni Cortex( 육계 ), Bupleuri Radix( 시호 ), Cnidii Rhizoma( 천궁 ), Araliae Cordatae Rhizoma( 독활 ), Ginseng Radix( 인삼 ), Saposhnikoviac Radix( 방풍 ) Digestive Symptoms (17) Diarrhea (8) Kamishoyosan added to Kososan (2) Gardeniae Fructus( 치자 ) Table 2. Relation to the Adverse Effects of Herbal Medicines and their Composition. 참고 - 한의과대학 본초학 편찬위원회 (2006), 본초학, 영림사

20 Result - 4  Prevention measures based on the investigation results  “discontinuance sheet”  Record the “forbidden/allergy” column & pharmaceutical history  Medical history questionnaire  Explain the tastes of new prescription

21 Discussion  the reasons for discontinuance  Skin symptom aggravation  Digestive track symptoms(diarrhea, nausea, vomitting)  Respiratory organ symptoms(fever, dry cough, dyspnea)  Taste, smell  Food allergy

22 Discussion  How to improve the continuance of Kampo medicines  Offer information about the adverse effects and explain the meanings to patients  Write a “discontinuance sheet”  Clear the patient instructions

23 Discontinuance Sheet