A combination of Eschscholtzia californica Cham. and Valeriana officinalis L. extracts for adjustment insomnia: A prospective observational study

10.1016/j.jtcme.2019.02.003

Samira Ait Abdellah；Aurélie Berlin；Claude Blondeau；Isabelle Guinobert；Angèle Guilbot；Marc Beck；François Duforez

Valerian ； Eschscholtzia ； Insomnia disorders ； Adjustment insomnia

Journal of Traditional and Complementary Medicine

10卷2期（2020 / 03 / 01）

116 - 123

英文

Eschscholtzia californica Cham. and Valeriana officinalis L. have long been used for the management of sleep disorders and anxiety. Use of a fixed combination of these two plant extracts (Phytostandard® d'Eschscholtzia et de Valériane, PiLeJe Laboratoire, France) was investigated in an observational study. Adults with adjustment insomnia according to the criteria of the International Classification of Sleep Disorders and with an insomnia severity index (ISI) score ＞7 enrolled by GPs took a maximum of four tablets of the eschscholtzia and valerian combination every night for four weeks. Within one month, ISI score decreased by approximately 30% (from 16.09 ± 3.67 at inclusion (V1) to 11.32 ± 4.78 at 4 weeks (V2); p ＜ 0.0001). Night sleep duration significantly increased between the first and the fourth week of supplement intake, sleep efficiency increasing from 78.4% ± 12.5 to 84.6% ± 10.2 (p = 0.002). There was no improvement in sleep latency. The number of awakenings decreased by approximately 25% and their total duration by approximately 25 min. Anxiety score significantly decreased by 50% from 13.9 ± 7.3 at V1 to 6.7 ± 6.3 at V2 (p ＜ 0.0001). The supplement was well tolerated. These results suggest that the tested combination of eschscholtzia and valerian extracts could be beneficial for the management of insomnia in adults and deserves further investigation.

1. Caudal, D,Guinobert, I,Lafoux, A(2017).Skeletal muscle relaxant effect of a standardized extract of Valeriana officinalis L. after acute administration in mice.Journal of Traditional and Complementary Medicine,8(2),335-340.
   連結：
2. (2004).PDR for Herbal Medicines.Montvale:Thomson PDR.
3. The Epworth Sleepiness Scale. http://epworthsleepinessscale.com/about-the-ess/. Accessed February 4, 2019.
4. (2006).Recommandations pour la pratique clinique: Prise en charge du patient adulte se plaignant d’insomnie en médecine générale.Revue de Pneumologie Clinique,62,283-284.
5. American Academy of Sleep Medicine(2014).International Classification of Sleep Disorders.
6. Baldacci, R(1984).Contribution à l’utilisation en médecine de ville de l’Eschscholtzia californica.Phytotherapy,9,31-32.
7. Bastien, C(2001).Validation of the Insomnia Severity Index as an outcome measure for insomnia research.Sleep Med,2,297-307.
8. Bent, S,Padula, A,Moore, D,Patterson, M,Mehling, W(2006).Valerian for sleep: a systematic review and meta-analysis.Am J Med.,119,1005-1012.
9. Bertisch, SM,Wells, RE,Smith, MT,McCarthy, EP(2012).Use of relaxation techniques and complementary and alternative medicine by American adults with insomnia symptoms: results from a national survey.J Clin Sleep Med.,8,681-691.
10. Boonstra, E,Kleijn, R de,Colzato, LS,Alkemade, A,Forstmann, BU,Nieuwenhuis, S(2015).Neurotransmitters as food supplements: the effects of GABA on brain and behavior.Front Psychol,6,1520.
11. Bothelius, K,Kyhle, K,Espie, CA,Broman, J-E(2013).Manual-guided cognitive-behavioural therapy for insomnia delivered by ordinary primary care personnel in general medical practice: a randomized controlled effectiveness trial.J Sleep Res,22,688-696.
12. Cavadas, C,Araujo, I,Cotrim, MD(1995).In vitro study on the interaction of Valeriana officinalis L. extracts and their amino acids on GABAA receptor in rat brain.Arzneim Forsch,45,753-755.
13. Cho, YW,Song, ML,Morin, CM(2014).Validation of a Korean version of the insomnia severity index.J Clin Neurol,10(3),210-215.
14. Culpepper, L,Wingertzahn, MA(2015).Over-the-Counter agents for the treatment of occasional disturbed sleep or transient insomnia: a systematic review of efficacy and safety.Prim Care Companion CNS Disord,17
15. Ellis, JG,Gehrman, P,Espie, CA,Riemann, D,Perlis, ML(2012).Acute insomnia: current conceptualizations and future directions.Sleep Med Rev,16,5-14.
16. European Medicines Agency. European Union herbal monograph on Valeriana officinalis L., radix. Published http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_HMPC_assessment_report/2016/04/WC500205373.pdf; 2016. Accessed February 15, 2019.
17. European Medicines Agency. European Union herbal monograph on Eschscholzia californica Cham., herba. Published http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_HMPC_assessment_report/2015/05/WC500186550.pdf; 2015. Accessed February 15, 2019.
18. Fernández, S,Wasowski, C,Paladini, AC,Marder, M(2004).Sedative and sleepenhancing properties of linarin, a flavonoid-isolated from Valeriana officinalis.Pharmacol Biochem Behav,77,399-404.
19. Fernández-San-Martín, MI,Masa-Font, R,Palacios-Soler, L,Sancho-Gómez, P,Calbó-Caldentey, C,Flores-Mateo, G(2010).Effectiveness of Valerian on insomnia: a meta-analysis of randomized placebo-controlled trials.Sleep Med,11,505-511.
20. Gagnon, C,Bélanger, L,Ivers, H,Morin, CM(2013).Validation of the insomnia severity index in primary care.J Am Board Fam Med,26,701-710.
21. Hamilton, M(1959).The assessment of anxiety states by rating.Br J Med Psychol,32,50-55.
22. Hanus, M,Lafon, J,Mathieu, M(2004).Double-blind, randomised, placebo-controlled study to evaluate the efficacy and safety of a fixed combination containing two plant extracts (Crataegus oxyacantha and Eschscholtzia californica) and magnesium in mild-to-moderate anxiety disorders.Curr Med Res Opin,20,63-71.
23. Kaldo, V,Jernelöv, S,Blom, K(2015).Guided internet cognitive behavioral therapy for insomnia compared to a control treatment - a randomized trial.Behav Res Ther,71,90-100.
24. Kay, R(1998).Statistical principles for clinical trials.J Int Med Res,26,57-65.
25. Leach, MJ,Page, AT(2015).Herbal medicine for insomnia: a systematic review and meta-analysis.Sleep Med Rev,24,1-12.
26. Lee, JY,Oh, HK,Ryu, HS,Yoon, SS,Eo, W,Yoon, SW(2017).Efficacy and safety of the traditional herbal medicine, gamiguibi-tang, in patients with cancer-related sleep disturbance: a prospective, randomized, wait-list-controlled, pilot study.Integr Canc Ther,524-530.
27. Machado, FdS,Souza, RCdS,Poveda, VB,Costa, ALS(2017).Non-pharmacological interventions to promote the sleep of patients after cardiac surgery: a systematic review.Rev Lat Am Enfermagem,25
28. Maroo, N,Hazra, A,Das, T(2013).Efficacy and safety of a polyherbal sedative-hypnotic formulation NSF-3 in primary insomnia in comparison to zolpidem: a randomized controlled trial.Indian J Pharmacol,45,34-39.
29. Morin, CM(1993).Insomnia: Psychological Assessment and Management.New York:Guilford Press.
30. Morin, CM,Belleville, G,Bélanger, L,Ivers, H(2011).The insomnia severity index: psychometric indicators to detect insomnia cases and evaluate treatment response.Sleep,34,601-608.
31. Ohayon, MM(2002).Epidemiology of insomnia: what we know and what we still need to learn.Sleep Med Rev.,6(2),97-111.
32. Palmieri, G,Contaldi, P,Fogliame, G(2017).Evaluation of effectiveness and safety of a herbal compound in primary insomnia symptoms and sleep disturbances not related to medical or psychiatric causes.Nat Sci Sleep,9,163-169.
33. Reed, DL,Sacco, WP(2016).Measuring sleep efficiency: what should the denominator Be?.J Clin Sleep Med,12,263-266.
34. Riemann, D,Baglioni, C,Bassetti, C(2017).European guideline for the diagnosis and treatment of insomnia.J Sleep Res
35. Rolland, A,Fleurentin, J,Lanhers, MC(1991).Behavioural effects of the American traditional plant Eschscholzia californica: sedative and anxiolytic properties.Planta Med,57,212-216.
36. Rolland, A,Fleurentin, J,Lanhers, MC,Misslin, R,Mortier, F(2001).Neurophysiological effects of an extract of Eschscholzia californica Cham. (Papaveraceae).Phytother Res,15,377-381.
37. Schäfer, HL,Schäfer, H,Schneider, W,Elstner, EF(1995).Sedative action of extract combinations of Eschscholtzia californica and Corydalis cava.Arzneim Forsch,45,124-126.
38. Schroeck, JL,Ford, J,Conway, EL(2016).Review of safety and efficacy of sleep medicines in older adults.Clin Ther,38,2340-2372.
39. Vincieri, FF,Celli, S,Mulinacci, N,Speroni, E(1988).An approach to the study of the biological activity of Eschscholtzia californica Cham.Pharmacol Res Commun,20,41-44.
40. Wong, SY-S,Zhang, D-X,Li, CC-K(2017).Comparing the effects of mindfulnessbased cognitive therapy and sleep psycho-education with exercise on chronic insomnia: a randomised controlled trial.Psychother Psychosom,86,241-253.
41. World Health Organization.The ICD10 classification of mental and behavioural disorders: diagnostic criteria for research.
42. World Health Organization(1999).WHO Monographs on Selected Medicinal Plants -Volume 1: Radix Valerianae.
43. Yilmaz, CK,Kapucu, S(2017).The effect of progressive relaxation exercises on fatigue and sleep quality in individuals with COPD.Holist Nurs Pract,31,369-377.
44. Yuan, C-S,Mehendale, S,Xiao, Y,Aung, HH,Xie, J-T,Ang-Lee, MK(2004).The gammaaminobutyric acidergic effects of valerian and valerenic acid on rat brainstem neuronal activity.Anesth Analg,98,353-358.
45. Zhou, ES,Gardiner, P,Bertisch, SM(2017).Integrative medicine for insomnia.Med Clin,101,865-879.