The efficacy and safety of a Huanglian-jie-du decoction on Hwa-byung patients: A study protocol for a randomized controlled trial
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Objective: Hwa-byung is one of the cultural concept of distress in Korea resulted from chronic accumulated anger. It is characterized by various symptoms like stuffy in the chest, hot or heat sensation, something pushing up in the chest, feeling of mortification, and a flush of anger. This protocol aims to explore the efficacy and safety of Huanglian-jie-du decoction on various somatic symptoms and insomnia in patients with Hwa-byung. Methods: This is study protocol for a randomized, double-blind, placebo-controlled trial. A total of 44 patients will be randomly assigned to the experimental group or the placebo group in a 1:1 ratio. All medications will be taken orally 3 times per day for 7 consecutive days. The primary outcomes are the mean changes in Patient Health Questionnaire of physical symptoms (PHQ-15) and Insomnia Severity Index (ISI) after the 7 days of administration. The secondary outcomes include the scales to assess stress response, symptoms of Hwabyung, and state anger. Conclusion: The results of this study will provide high quality and explorative evidence to investigate the effect of Huanglian-jie-du decoction on Hwa-byung.
Abstract
Objective: Hwa-byung is one of the cultural concept of distress in Korea resulted from chronic accumulated anger. It is characterized by various symptoms like stuffy in the chest, hot or heat sensation, something pushing up in the chest, feeling of mortification, and a flush of anger. This protocol aims to explore the efficacy and safety of Huanglian-jie-du decoction on various somatic symptoms and insomnia in patients with Hwa-byung. Methods: This is study protocol for a randomized, double-blind, placebo-controlled trial. A total of 44 patients will be randomly assigned to the experimental group or the placebo group in a 1:1 ratio. All medications will be taken orally 3 times per day for 7 consecutive days. The primary outcomes are the mean changes in Patient Health Questionnaire of physical symptoms (PHQ-15) and Insomnia Severity Index (ISI) after the 7 days of administration. The secondary outcomes include the scales to assess stress response, symptoms of Hwabyung, and state anger. Conclusion: The results of this study will provide high quality and explorative evidence to investigate the effect of Huanglian-jie-du decoction on Hwa-byung.
참고문헌 (27)
- Kohrt BA, "Cultural concepts of distress and psychiatric disorders: Literature review and research recommendations for global mental health epidemiology", Int J Epidemiol, 43(2), pp.365~406 (2014)[DOI]
- 민성길, "Clinical Correlates of Hwa-Byung and a Proposal for a New Anger Disorder", PSYCHIATRY INVESTIGATION, 5(3), pp.125~141 (2008), 대한신경정신의학회
- Lin KM, "Hwa-byung: A community study of Korean Americans", J Nerv Ment Dis, 180(6), pp.386~391 (1992)[DOI]
- Lee J, "A Review of the Korean Cultural Syndrome Hwa-Byung: Suggestions for Theory and Intervention", Asia Taepyongyang Sangdam Yongu, 4(1), pp.49~ (2014)
- Ninnemann K, "Hwa-Byung: In Encyclopedia of Immigrant Health", pp.862~863 (2012), Springer New York
- Park YJ, "A survey of Hwa-Byung in middle-age Korean women", J Transcult Nurs, 12(2), pp.115~122 (2001)[DOI]
- 민성길, "Symptoms to Use for Diagnostic Criteria of Hwa-Byung, an Anger Syndrome", PSYCHIATRY INVESTIGATION, 6(1), pp.7~12 (2009), 대한신경정신의학회
- 이진규, "HBDIS를 이용한 강원도 지역주민의 화병 유병률에 대한 연구", 동의신경정신과학회지, 19(2), pp.133~140 (2008), 대한한방신경정신과학회
- Kim J, "Clinical guideline for Hwa-Byung" (2013)
- Chon K, "Relationship between hwabyung and emotional stress", Korean J Health Psychology, 2, pp.170~180 (1997)
- Kim SH, "The effect of Bunsimgi-eum on Hwa- byung: randomized, double blind, placebo controlled trial", J Ethnopharmacol, 144(2), pp.402~407 (2012)[DOI]
- 최우창, "화병의 불안 증상에 대한 시호가용골모려탕의 효능 임상연구 중간보고", 동의신경정신과학회지, 23(4), pp.133~152 (2012), 대한한방신경정신과학회[DOI]
- 이고은, "화병환자의 불면증상에 대한 침치료 유효성 평가연구: 환자-평가자 눈가림, 무작위배정, 일반대조군 임상시험", 동의신경정신과학회지, 23(1), pp.31~48 (2012), 대한한방신경정신과학회[DOI]
- 정인철, "화병의 핵심증상에 대한 사암침 심정격 치료의 효과", 동의신경정신과학회지, 19(1), pp.1~18 (2008), 대한한방신경정신과학회
- 정덕진, "화병환자의 불안증 해소에 대한 침치료의 유효성 평가를 위한 단일군, 공개, 단일기관 임상시험", 동의신경정신과학회지, 23(1), pp.49~58 (2012), 대한한방신경정신과학회[DOI]
- Suh JW, "Anxiety and Anger Symptoms in Hwabyung Patients Improved More following 4 Weeks of the Emotional Freedom Technique Program Compared to the Progressive Muscle Relaxation Program: A Randomized Controlled Trial", Evidence-based complementary and alternative medicine : eCAM, 2015, pp.203612~ (2015)
- Hwang EY, "Effects of a brief Qigong-based stress reduction program (BQSRP) in a distressed Korean population: a randomized trial", BMC complementary and alternative medicine, 13, pp.113~ (2013)[DOI]
- Ye Y, "Huanglian-Jie-Du-Tang extract protects against chronic brain injury after focal cerebral ischemia via hypoxia-inducible-factor- 1alpha-regulated vascular endothelial growth factor signaling in mice", Biological & pharmaceutical bulletin, 35(3), pp.355~361 (2012)[DOI]
- Ye YL, "Huanglian-Jie-Du-Tang Extract Ameliorates Depression-Like Behaviors through BDNF-TrkB-CREB Pathway in Rats with Chronic Unpredictable Stress", Evidence-based complementary and alternative medicine : eCAM, 2017, pp.7903918~ (2017)
- 김종우, "화병면담검사의 신뢰도와 타당도", 한국심리학회지: 건강, 9(2), pp.321~332 (2004), 한국건강심리학회
- Han C, "Psychometric properties of the Patient Health Questionnaire-15 (PHQ-15) for measuring the somatic symptoms of psychiatric outpatients", Psychosomatics, 50(6), pp.580~585 (2009)
- Bastien CH, "Validation of the Insomnia Severity Index as an outcome measure for insomnia research", Sleep medicine, 2(4), pp.297~307 (2001)[DOI]
- Koh KB, "Development of the stress response inventory and its application in clinical practice", Psychosomatic medicine, 63(4), pp.668~678 (2001)[DOI]
- Spielberger CD, "Manual for the state-trait anxiety inventory" (1970)
- Kleiger RE, "Heart rate variability: measurement and clinical utility", Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc, 10(1), pp.88~101 (2005)[DOI]
- Morin CM, "The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response", Sleep, 34(5), pp.601~608 (2011)[DOI]
- Mi Kyoung Hong, "Korean medicine for Hwa-byung: a systematic and meta-analysis", Oriental Pharmacy and Experimental Medicine, 16(4), pp.251~257 (2016), 융합한의과학연구소[DOI]