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

다국어 초록 (Multilingual Abstract)

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.

참고문헌 (Reference)

1 Bastien CH, "Validation of the Insomnia Severity Index as an outcome measure for insomnia research" 2 : 297-307, 2001

2 조용원, "Validation of a Korean Version of the Insomnia Severity Index" 대한신경과학회 10 (10): 210-215, 2014

3 Seung Il Sohn, "The reliability and validity of the Korean version of the Pittsburgh Sleep Quality Index" Springer Science and Business Media LLC 16 (16): 803-812, 2012

4 Qi-Hui Zhou, "Suanzaoren Formulae for Insomnia: Updated Clinical Evidence and Possible Mechanisms" Frontiers Media SA 9 : 2018

5 Kathryn J. Reid, "Sleep: A Marker of Physical and Mental Health in the Elderly" Elsevier BV 14 (14): 860-866, 2006

6 Byung Hoon Han, "Sedative activity and its active components of Zizyphi fructus" Springer Science and Business Media LLC 10 (10): 208-211, 1987

7 Ru-Xue Zhang, "Rehmannia glutinosa: Review of botany, chemistry and pharmacology" Elsevier BV 117 (117): 199-214, 2008

8 Hwang SJ, "Prescriptions of Chinese herbal medicines for insomnia in Taiwan during 2002" 2011 : 2011

9 Michael T. Smith, "Measures of sleep: The Insomnia Severity Index, Medical Outcomes Study (MOS) Sleep Scale, Pittsburgh Sleep Diary (PSD), and Pittsburgh Sleep Quality Index (PSQI)" Wiley 49 (49): S184-S196, 2003

10 Min Yang, "Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference" Informa Healthcare 25 (25): 2487-2494, 2009

11 Roth T, "Insomnia: definition, prevalence, etiology, and consequences" 3 : 3-6, 2007

12 Julieta Scalo, "Insomnia, hypnotic use, and health-related quality of life in a nationally representative sample" Springer Science and Business Media LLC 24 (24): 1223-1233, 2015

13 Nancy J. Pearson, "Insomnia, Trouble Sleeping, and Complementary and Alternative Medicine" American Medical Association (AMA) 166 (166): 1775-, 2006

14 Charles M. Morin, "Insomnia disorder" Springer Science and Business Media LLC 1 (1): 1-18, 2015

15 Chung-Soo Kim, "Herbs for the Treatment of Insomnia" 한국응용약물학회 19 (19): 274-281, 2011

16 Emerson M. Wickwire, "Health economics of insomnia treatments: The return on investment for a good night's sleep" Elsevier BV 30 : 72-82, 2016

17 Taeko Sasai, "Effects of insomnia and sleep medication on health-related quality of life" Elsevier BV 11 (11): 452-457, 2010

18 T. B. Huedo-Medina, "Effectiveness of non-benzodiazepine hypnotics in treatment of adult insomnia: meta-analysis of data submitted to the Food and Drug Administration" BMJ 345 (345): e8343-e8343, 2012

19 L.-C. Chen, "Drug-use pattern of Chinese herbal medicines in insomnia: a 4-year survey in Taiwan" Wiley 34 (34): 555-560, 2009

20 Barbara Gandek, "Cross-Validation of Item Selection and Scoring for the SF-12 Health Survey in Nine Countries" Elsevier BV 51 (51): 1171-1178, 1998

21 Melody A. Hertzog, "Considerations in determining sample size for pilot studies" Wiley 31 (31): 180-191, 2008

22 Célyne H. Bastien, "Cognitive-Behavioral Therapy for Insomnia: Comparison of Individual Therapy, Group Therapy, and Telephone Consultations" American Psychological Association (APA) 72 (72): 653-659, 2004

23 Damien Léger, "Chronic insomnia, quality-of-life, and utility scores: Comparison with good sleepers in a cross-sectional international survey" Elsevier BV 13 (13): 43-51, 2012

24 Kazuo Toriizuka, "Anxiolytic effect of Gardeniae Fructus-extract containing active ingredient from Kamishoyosan (KSS), a Japanese traditional Kampo medicine" Elsevier BV 77 (77): 3010-3020, 2005

25 D. Leger, "An international survey of insomnia: under-recognition and under-treatment of a polysymptomatic condition" Informa Healthcare 21 (21): 1785-1792, 2005

26 C. Jenkinson, "A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies?" Oxford University Press (OUP) 19 (19): 179-186, 1997

27 Ware J, "A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity" 34 : 220-233, 1996