Effect of Traditional East Asian Medicinal herbal tea (HT002) on insomnia: a randomized controlled pilot study

Background: Complementary and alternative medicine treatment for insomnia has been sought due to the possible adverse effects of conventional pharmacotherapies. We performed a preliminary evaluation of the feasibility of using, and of the effect of a herbal tea (HT002), based on Traditional East Asi...

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Main Authors: Sujeong Mun, Siwoo Lee, Kihyun Park, Sang-Jae Lee, Byung-Hee Koh, Younghwa Baek
Format: Article
Language:English
Published: Elsevier 2019-03-01
Series:Integrative Medicine Research
Online Access:http://www.sciencedirect.com/science/article/pii/S2213422018302087
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author Sujeong Mun
Siwoo Lee
Kihyun Park
Sang-Jae Lee
Byung-Hee Koh
Younghwa Baek
author_facet Sujeong Mun
Siwoo Lee
Kihyun Park
Sang-Jae Lee
Byung-Hee Koh
Younghwa Baek
author_sort Sujeong Mun
collection DOAJ
description Background: Complementary and alternative medicine treatment for insomnia has been sought due to the possible adverse effects of conventional pharmacotherapies. We performed a preliminary evaluation of the feasibility of using, and of the effect of a herbal tea (HT002), based on Traditional East Asian Medicine, in mild-to-moderate insomnia. Methods: Patients (n = 40) with mild-to-moderate insomnia were randomized to the HT002 (n = 20) or waitlist (n = 20) groups. The HT002 group consumed HT002 twice daily for 4 weeks. Outcomes were assessed using the Insomnia Severity Scale (ISI), Pittsburgh Sleep Quality Index (PSQI), and 12-item Short Form Health Survey (SF-12) at baseline and after 4 and 8 weeks. Results: The ISI score differences from baseline at weeks 4 and 8 were significantly greater in the HT002 than that in the waitlist group (week 4: −4.0 ± 0.8 vs. −0.4 ± 0.8, p < 0.05; week 8: −4.8 ± 0.7 vs. −0.9 ± 0.7, p < 0.05). Changes in PSQI and SF-12 physical component scores in the HT002 group were significantly greater at weeks 4 and 8 (p < 0.05), while SF-12 mental component scores were only significantly larger at 4 weeks (p < 0.05). HT002 was well-tolerated, with only one (5.0%) dropout, and no significant mean liver and renal function test changes post-treatment. Conclusion: Our preliminary results suggest that a 4-week treatment with HT002 may reduce the severity of insomnia symptoms and improve the quality of life. Further studies devoid of the limitations of our protocol may provide stronger conclusions. Trial registration: Clinical Research Information Service (CRIS), KCT0001900. Keywords: Herbal medicine, Herbal tea, Insomnia, Randomized controlled trial
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spelling doaj-art-1eec4f7d88c446538c610c5a2f07ddf02025-08-20T03:17:35ZengElsevierIntegrative Medicine Research2213-42202019-03-0181152010.1016/j.imr.2018.11.004Effect of Traditional East Asian Medicinal herbal tea (HT002) on insomnia: a randomized controlled pilot studySujeong Mun0Siwoo Lee1Kihyun Park2Sang-Jae Lee3Byung-Hee Koh4Younghwa Baek5Future Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaFuture Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaFuture Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaDivision of Longevity and Biofunctional Medicine, School of Korean Medicine, Pusan National University, Pusan, Republic of KoreaDepartment of Sasang Constitutional Medicine, School of Korean Medicine, Kyung Hee University, Seoul, Republic of KoreaFuture Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; Corresponding author at: Future Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon 305-811, Republic of Korea.Background: Complementary and alternative medicine treatment for insomnia has been sought due to the possible adverse effects of conventional pharmacotherapies. We performed a preliminary evaluation of the feasibility of using, and of the effect of a herbal tea (HT002), based on Traditional East Asian Medicine, in mild-to-moderate insomnia. Methods: Patients (n = 40) with mild-to-moderate insomnia were randomized to the HT002 (n = 20) or waitlist (n = 20) groups. The HT002 group consumed HT002 twice daily for 4 weeks. Outcomes were assessed using the Insomnia Severity Scale (ISI), Pittsburgh Sleep Quality Index (PSQI), and 12-item Short Form Health Survey (SF-12) at baseline and after 4 and 8 weeks. Results: The ISI score differences from baseline at weeks 4 and 8 were significantly greater in the HT002 than that in the waitlist group (week 4: −4.0 ± 0.8 vs. −0.4 ± 0.8, p < 0.05; week 8: −4.8 ± 0.7 vs. −0.9 ± 0.7, p < 0.05). Changes in PSQI and SF-12 physical component scores in the HT002 group were significantly greater at weeks 4 and 8 (p < 0.05), while SF-12 mental component scores were only significantly larger at 4 weeks (p < 0.05). HT002 was well-tolerated, with only one (5.0%) dropout, and no significant mean liver and renal function test changes post-treatment. Conclusion: Our preliminary results suggest that a 4-week treatment with HT002 may reduce the severity of insomnia symptoms and improve the quality of life. Further studies devoid of the limitations of our protocol may provide stronger conclusions. Trial registration: Clinical Research Information Service (CRIS), KCT0001900. Keywords: Herbal medicine, Herbal tea, Insomnia, Randomized controlled trialhttp://www.sciencedirect.com/science/article/pii/S2213422018302087
spellingShingle Sujeong Mun
Siwoo Lee
Kihyun Park
Sang-Jae Lee
Byung-Hee Koh
Younghwa Baek
Effect of Traditional East Asian Medicinal herbal tea (HT002) on insomnia: a randomized controlled pilot study
Integrative Medicine Research
title Effect of Traditional East Asian Medicinal herbal tea (HT002) on insomnia: a randomized controlled pilot study
title_full Effect of Traditional East Asian Medicinal herbal tea (HT002) on insomnia: a randomized controlled pilot study
title_fullStr Effect of Traditional East Asian Medicinal herbal tea (HT002) on insomnia: a randomized controlled pilot study
title_full_unstemmed Effect of Traditional East Asian Medicinal herbal tea (HT002) on insomnia: a randomized controlled pilot study
title_short Effect of Traditional East Asian Medicinal herbal tea (HT002) on insomnia: a randomized controlled pilot study
title_sort effect of traditional east asian medicinal herbal tea ht002 on insomnia a randomized controlled pilot study
url http://www.sciencedirect.com/science/article/pii/S2213422018302087
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