Draft list of references supporting the
Transcription
Draft list of references supporting the
7 July 2015 EMA/HMPC/150847/2015 Committee on Herbal Medicinal Products (HMPC) List of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum Draft The European Medicines Agency acknowledges that copies of the underlying works used to produce this monograph were provided for research only with exclusion of any commercial purpose. Albrecht M, Berger W, Laux P, Schmidt U, Martin C. Psychopharmaka und Verkehrssicherheit. Der Einfluss von Euvegal - Dragees forte auf die Fahrtüchtigkeit und Kombinationswirkungen mit Alkohol. Z. Allg. Med. 1995, 71: 1215-1225 [German] Al-Majed AA. Effect on valerian on spermatogenic, genotoxic, reproductive and biochemical changes in sex cells after chronic treatment in male Swiss albino mice. J. Med. Sci. 2007, 7(2): 276-283 Al-Majed AA, Al-Yahya AA, Al-Bekairi AM, Al-Shabanah OA, Qureshi S. Studies on the cytological and biochemical effects of valerian in somatic and germ cells of Swiss albino mice. Food Chem Toxicol. 2006, 44(11): 1830-1837 Anderson GD, Elmer GW, Taibi DM, Vitiello MV, Kantor E, Kalhorn TF et al. Pharmacokinetics of valerenic acid after single and multiple doses of valerian in older women. Phytother Res. 2010 , 24(10): 1442-1446 Ammer K, Melnizky P. Medicinal baths for treatment of generalized fibromyalgia Forsch Komplementarmed. 1999 ,6(2): 80-85 [German] Angst J, Borbely A, Engel RR, Ferner U, Gaszner P, Hippius H et al. Report on the sixth consensus conference on the methodology of clinical trials with hypnotic drugs. Pharmacopsychiatry 1995, 28(1):2-7 Balderer G, Borbely AA. Effect of valerian on human sleep. Psychopharmacol. 1985, 87: 406-409 Balduini W, Cattabeni F. Displacement of [3H] N6-cyclohexyladenosine binding to rat cortical membranes by an hydroalcoholic extract of Valeriana officinalis. Med. Sci Res. 1989, 17: 639-640 Barton DL, Atherton PJ, Bauer BA, Moore jr. DF, Mattar BI, LaVasseur BI et al. The use of Valeriana officinalis (Valerian) in improving sleep in patients who are undergoing treatment for cancer: A Phase 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged. III randomized, placebo-controlled, double-blind study (NCCTG Trial, N01C51). J Support Oncol. 2011, 9(1): 24–31 Benedum J, Loew D, Schilcher H. Arzneipflanzen in der traditionellen Medizin. 3rd ed. Kooperation Phytopharmaka, Bonn 2000, 162 Benke D, Barberis A, Kopp S, Altmann KH, Schubiger M, Kaspar E et al. GABA A receptors as in vivo substrate for the anxiolytic action of valerenic acid, a major constituent of valerian root extracts. Neuropharmacology 2009, 56(1): 174-181 Bent S, Padula A, Moore D, Patterson M, Mehling W. Valerian for sleep: a systematic review and metaanalysis. Am J Med. 2006, 119(12): 1005-1012 Block KI, Gyllenhaal C. Clinical corner: herb-drug interactions in cancer chemotherapy: theoretical concerns regarding drug metabolizing enzymes. Integr Cancer Ther. 2002, 1(1): 83–89 Bodesheim U, Hoelzl J. Isolierung, Strukturaufklärung und Radiorezeptorassay von Alkaloiden und Lignanen aus Valeriana officinalis L. Pharmazie 1997, 52: 386-391 [German] Bos R, Woerdenbag HJ, De Smet PAGM, Scheffer JJC. Valeriana Species. In: De Smet PAGM, Keller K, Haensel R, Chandler RF, editors. Adverse Effects of Herbal Drugs. Vol 3. Springer-Verlag, Berlin Heidelberg 1997, 165-180 BHP (British Herbal Pharmacopoeia). British Herbal Medicine Association, Bournemouth 1976, 219 BP (British Pharmacopoeia). Vol 4. The Stationary Office, London 2015, 397-398 Braun R (editor) Standardzulassungen für Fertigarzneimittel - Baldrianwurzel. 11th supplemental set, Deutscher Apotheker Verlag, Stuttgart 1996 [German] Braun R (editor) Standardzulassungen für Fertigarzneimittel - Baldriantinktur. 16th supplemental set, Deutscher Apotheker Verlag, Stuttgart 2005 [German] Cavadas C, Araújo I, Cotrim MD, Amaral T, Cunha AP, Macedo T et al. In vitro study on the interaction of Valeriana officinalis L. extracts and their amino acids on GABA-A receptor in rat brain. Arzneim.Forsch./Drug Res. 1995, 45(II)(7): 753-755 Chow NK, Fretz M, Hamburger M, Butterweck V. Telemetry as a tool to measure sedative effects of a valerian root extract and its single constituents in mice. Planta Med. 2011, 77(8): 795-803 Coxeter PD, Schluter PJ, Eastwood HL, Nikles CJ, Glasziou PP. Valerian does not appear to reduce symptoms for patients with chronic insomnia in general practice using a series of randomised n-of-1 trials. Complement Ther Med. 2003, 11: 215-222 Cropley M, Cave Z, Ellis J, Middleton RW. Effect of kava and valerian on human physiological and psychological responses to mental stress assessed under laboratory conditions. Phytother Res. 2002, 16: 23-27 Culbreth DMR. A manual of materia medica and pharmacology comprising the organic drugs which are or have been recognized by the United States Pharmacopoeia and national formulary. 7th ed. Lea & Febiger, Philadelphia 1927, 213-214 DAB 6 (Deutsches Arzneibuch 6) Oleum Valerianae. 6th ed., Arbeitsgemeinschaft Medizinischer Verlage, Berlin 1947 (reprint of Deutsches Arzneibuch 6th ed. R. v. Decker’s Verlag G. Schenk 1926), 264 [German] List of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum EMA/HMPC/150847/2015 Page 2/13 Decocq G, Gras-Champel V, Vrolant-Mille C, Delcenserie R, Sauvé L, Masson H et al. Pancréatites aiguës induites par les médicaments dérivés de l'acide 5-aminosalicylique: un cas et revue de la littérature. [Acute pancreatitis induced by drugs derived from 5-aminosalicylic acid: case report and review of the literature.] Therapie. 1999, 54(1): 41-48 [French] Del Valle-Mojica LM, Cordero-Hernández JM, González-Medina G, Ramos-Vélez I, Berríos-Cartagena N, Torres-Hernández BA et al. Aqueous and ethanolic Valeriana officinalis extracts change the binding of ligands to glutamate receptors. Evid Based Complement Alternat Med. 2011, doi: 10.1155/2011/891819 Del Valle-Mojica LM, Ortíz JG. Anxiolytic properties of Valeriana officinalis in the zebrafish: a possible role for metabotropic glutamate receptors. Planta Med. 2012, 78(16): 1719-1724 Diaper A, Hindmarch I. A double-blind, placebo-controlled investigation of the effects of two doses of a valerian preparation on the sleep, cognitive and psychomotor function of sleep-disturbed older adults. Phytotherapy Res 2004, 18: 831-836 Dietz BM, Mahady GB, Pauli GF, Farnsworth NR. Valerian extract and valerenic acid are partial agonists of the 5-HT5a receptor in vitro. Brain Res Mol Brain Res. 2005, 138(2): 191-197 Donath F, Quispe S, Diefenbach K, Maurer A, Fietze I, Roots I. Critical evaluation of the effect of valerian extract on sleep structure and sleep quality. Pharmacopsych. 2000, 33: 47-53 Donovan JL, DeVane CL, Chavin KD, Wang J-S, Gibson BB, Gefroh HA et al. Multiple night time doses of valerian (Valeriana officinalis) had minimal effects on CYP 3A4 activity and no effect on CYP 2D6 activity in healthy volunteers. Drug Metab Dispos. 2004, 32(12): 1333-1336 Dorn M. Wirksamkeit und Verträglichkeit von Baldrian versus Oxazepam bei nichtorganischen und nichtpsychiatrischen Insomnien: Eine randomisierte, doppelblinde klinische Vergleichsstudie. [Valerian versus oxazepam: efficacy and tolerability in non-organic and non-psychiatric insomnias: a randomized, double-blind, clinical, comparative study.] Forsch Komplementarmed Klass Naturheilkd. 2000, 7: 79-84 [German] Douros A, Bronder E, Andersohn F, Klimpel A, Thomae M, Sarganas G et al. Drug-induced liver injury: results from the hospital-based Berlin Case-Control Surveillance Study. Br J Clin Pharmacol. 2014, doi: 10.1111/bcp.12565 Dragendorff G. Die Heilpflanzen der verschiedenen Völker und Zeiten. Werner Fritsch, München 1967 (reprint of Dragendorff G. Die Heilpflanzen der verschiedenen Völker und Zeiten. Ferd. Enke, Stuttgart 1898), 643 [German] ESCOP (European Scientific Cooperative on Phytotherapy). ESCOP Monograph: Valerianae radix – Valerian root. European Scientific Cooperative on Phytotherapy, Exeter 1997 European Pharmacopoeia 8 th ed (8.5). Valerian root – Valerianae radix. Council of Europe. th ed (8.5). Valerian root, cut – Valerianae radix minutata. Council of 07/2015:0453; 4957-4958 European Pharmacopoeia 8 Europe. 07/2015:2526; 4958-4959 European Pharmacopoeia 8 th ed (8.0). Valerian tincture – Valerianae tinctura. Council of Europe. th ed (8.0). Valerian dry aqueous extract – Valerianae extractum aquosum 07/2010:1899; 1416-1417 European Pharmacopoeia 8 siccum. Council of Europe. 07/2010:2400; 1412 List of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum EMA/HMPC/150847/2015 Page 3/13 European Pharmacopoeia 8 th ed (8.2). Valerian dry hydroalcoholic extract – Valerianae extractum hydroalcoholicum siccum. Council of Europe. 07/2014:1898; 3974 Fachinetto R, Villarinho JG, Wagner C, Pereira RP, Avila DS, Burger ME et al. Valeriana officinalis does not alter the orofacial dyskinesia induced by haloperidol in rats: role of dopamine transporter. Prog Neuropsychopharmacol Biol Psychiatry. 2007, 31(7): 1478-1486 Fehri B, Aiache JM, Boukef K, Memmi A, Hizaoui B. Valeriana officinalis et Crataegus oxyacantha: Toxicité par administrations réitérées et investigations pharmacologiques. J. Pharm. Belg. 1991, 46(3): 165-176 [French] Férnandez S, Wasowski C, Paladini AC, Marder M. Sedative and sleep-enhancing properties of linarin, a flavonoid-isolated from Valeriana officinalis. Pharm Biochem Behav. 2004, 77: 399-404 Ferreira F, Santos MS, Faro C, Pires E, Carvalho AP, Cunha AP et al. Effect of extracts of Valeriana officinalis on [³H]GABA. Rev Port Farm. 1996, 46(2): 74-77 Fields AM, Richards TA, Felton JA, Felton SK, Bayer EZ, Ibrahim IN et al. Analysis of responses to valerian root extract in the feline pulmonary vascular bed. J Altern Complement Med. 2003, 9(6):909918 Fintelmann V, Weiss RF. Lehrbuch Phytotherapie. 12th ed. Stuttgart 2009, Hippokrates Verlag, 249 [German] Francis AJ, Dempster RJ. Effect of valerian, Valeriana edulis, on sleep difficulties in children with intellectual deficits: randomised trial. Phytomedicine. 2002, 9(4): 273-279 Garges HP, Varia I, Doraiswamy PM. Cardiac complications and delirium associated with valerian root withdrawal. JAMA 1998, 280: 1566-1567 Gerhard U, Linnenbrink N, Georghiadou C, Hobi V. Vigilanzmindernde Effekte zweier pflanzlicher Schlafmittel. Schweiz. Rundsch. Med. (Praxis) 1996, 85(15): 473-481 [German] Glass JR, Sproule BA, Herrmann N, Streiner D, Busto UE. Acute pharmacological effects of temazepam, diphenhydramine and valerian in healthy elderly subjects J Clin Psychopharmacol. 2003, 23(3): 260268 Gurley BJ, Gardner SF, Hubbard MA, Williams DK, Gentry WB, Khan IA et al. In vivo effects of goldenseal, kava kava, black cohosh, and valerian on human cytochrome P450 1A2, 2D6, 2E1, and 3A4/5 phenotypes. Clin Pharmacol Ther. 2005, 77(5): 415-426 Haffner F. (editor) Normdosen gebräuchlicher Arzneistoffe und Drogen. 8th ed. Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart 1991, 221 [German] Hahnemann S. Apothekerlexikon. Karl F Haug Fachbuchverlag, Heidelberg 1986 (reprint of Hahnemann S. Apotherkerlexikon bei Siegfried Lebrecht Crusius, Leipzig 1793-1799), 476-477 [German] Hallam KT, Olver JS, McGrath C, Norman TR. Comparative cognitive and psychomotor effects of single doses of Valeriana officinalis and triazolam in healthy volunteers. Hum Psychopharmacol. 2003, 18: 619-625 Hänsel R, Keller K, Rimpler H, Schneider G. (editors) Hagers Handbuch der Pharmazeutischen Praxis. Vol. 6: Drogen P-Z. 5th ed. Springer Verlag, Berlin Heidelberg New York 1994, 1067-1095 Hänsel R, Sticher O, Steinegger G. (editors) Pharmakognosie - Phytopharmazie, 6th ed. Springer Verlag, Berlin Heidelberg New York 1999, 457-464 List of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum EMA/HMPC/150847/2015 Page 4/13 Hendriks H, Bos R, Allersma DP, Malingré TM, Koster AS. Pharmacological screening of valerenal and some other components of essential oil of Valeriana officinalis. Planta Med. 1981, 42: 62-68 Hendriks H, Bos R, Woerdenbag HJ, Koster AS. Central nervous depressant activity of valerenic acid in the mouse. Planta Med. 1985, 51: 28-31 Herberg KW. Fahrtüchtig trotz Einnahme eines Sedativums? Randomisierte, doppelblinde Untersuchung versus Plazebo. Therapiewoche 1991, 41: 1039-1042 [German] Herberg KW. Psychotrope Phytopharmaka im Test: Alternative zu synthetischen Psychopharmaka? Therapiewoche 1994b, 44(12): 704-713 [German] Hiller KO, Kato G. Anxiolytic Activity of Psychotropic Plant Extracts. I. Test of Ethanolic Valeriana Extract STEI Val. 44th Annual Congress of the Society for Medical Plant Research, Prague 1996, Poster P 65 Hiller KO, Zetler G. Neuropharmacological studies on ethanol extracts of Valeriana officinalis L.: behavioral and anticonvulsant properties. Phytotherapy Res. 1996, 10: 145-151 Hintelmann C. Einschlafstörungen bei Kindern unter 12 Jahren – Anwendungsbeobachtung mit hochdosiertem Baldrianextrakt. Schweiz Z Ganzheitsmedizin 2002, 14: 404-407 [German] Holm E, Kowollik H, Reinecke A, v. Henning GE, Behne F, Scherer HD. Vergleichende neurophysiologische Untersuchungen mit Valtratum/Isovaltratum und Extractum Valerianae an Katzen. Med. Welt. 1980, 31(26): 982-990 [German] Hölzl J: Baldrianwurzel. Z. Phytotherapie 1998, 19:47-54 [German] Holst L, Nordeng H, Haavik S. Use of herbal drugs during early pregnancy in relation to maternal characteristics and pregnancy outcome. Pharmacoepidemiol Drug Saf. 2008, 17(2): 151-159 Izzo AA. Interactions between herbs and conventional drugs: overview of the clinical data. Med Princ Pract. 2012, 21(5): 404-428 Jacob TC, Moss SJ, Jurd R. GABA(A) receptor trafficking and its role in the dynamic modulation of neuronal inhibition. Nat Rev Neurosci. 2008, 9(5): 331-343 Jacobo-Herrera NJ, Vartiainen N, Bremner P, Gibbons S, Koistinaho J, Heinrich M. NF-kappaB modulators from Valeriana officinalis. Phytother Res. 2006, 20(10): 917-919 Jacobs BP, Bent S, Tice JA, Blackwell T, Cummings SR. An internet-based randomized, placebocontrolled trial of kava and valerian for anxiety and insomnia. Medicine 2005, 84(4): 197-207 Kammerer E, Brattström A, Herberg KW. Einfluss einer Hopfen-Baldrian-Kombination auf Leistungsfähigkeit und Verkehrssicherheit. Der Bayerische Internist 1996, 16: 32-36 [German] Kamm-Kohl AV, Jansen W, Brockmann P. Moderne Baldriantherapie gegen nervöse Störungen im Senium. Med. Welt 1984, 35: 1450-1454 [German] Kelber O, Nieber K, Kraft K. Valerian: no evidence for clinically relevant interactions. Evid Based Complement Alternat Med. 2014a, doi: 10.1155/2014/879396 Kelber O, Wegener T, Steinhoff B, Staiger C, Wiesner J, Knöss W et al. Assessment of genotoxicity of herbal medicinal products: application of the "bracketing and matrixing" concept using the example of Valerianae radix (valerian root). Phytomedicine. 2014b, 21(8-9): 1124-1129 List of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum EMA/HMPC/150847/2015 Page 5/13 Khom S, Baburin I, Timin E, Hohaus A, Trauner G, Kopp B et al. Valerenic acid potentiates and inhibits GABA(A) receptors: molecular mechanism and subunit specificity. Neuropharmacology. 2007, 53(1): 178-187 Kohnen R, Oswald WD. The effects of valerian, propanolol, and their combination on activation, performance and mood on healthy volunteers under social stress conditions. Pharmacopsychiat. 1988, 21: 447-448 Kommission B8 (German Commission B8): Baldrian-Bäder. BAnZ 1989; 212 (10.11.1989): 5276 [German] Kommission E (German Commission E): Baldrianwurzel. BAnZ 1985; 90 (15.05.1985): 4955 [German] Kommission E (German Commission E): Baldrianwurzel. BAnZ 1990; 50 (13.03.1990): 1215 [German] Kuhlmann J, Berger W, Prodzuweit H, Schmidt U. The influence of valerian treatment on „reaction time, alertness and concentration“ in volunteers. Pharmacopsychiat. 1999, 32: 235-241 Lacher SK, Mayer R, Sichardt K, Nieber K, Müller CE. Interaction of valerian extracts of different polarity with adenosine receptors: identification of isovaltrate as an inverse agonist at A1 receptors. Biochem Pharmacol. 2007, 73(2): 248-258 Leathwood PD, Chauffard F. Quantifying the effects of mild sedatives. J. Psychiatr. Res. 1982/83, 17(2): 115-122 Leathwood PD, Chauffard F: Aqueous extract of valerian reduces latency to fall asleep in man. Planta Med. 1985; 51: 144-148 Leathwood PD, Chauffard F, Heck E, Munoz-Box R. Aqueous extract of valerian Root (Valeriana officinalis L.) improves sleep quality in man. Pharmacol. Biochem. Behav. 1982, 17: 65-71 Lefèbre T, Foster BC. In vitro activity of commercial valerian root extracts against human cytochrome P450 3A4. J Pharm Pharmaceut Sci 2004, 7: 265-273 Leuschner J, Müller J, Rudmann M. Characterisation of the central nervous depressant activity of a commercially available valerian root extract. Arzneim.-Forsch./Drug Res. 1993, 43(1): 638-641 List PH, Hoerhammer L, Roth HJ, Schmid W (editors). Hagers Handbuch der Pharmazeutischen Praxis. Vol. 6: Chemikalien und Drogen. 4th ed. , Springer Verlag, Berlin Heidelberg New York 1979, 375-382 Madaus G. Lehrbuch der biologischen Heilmittel. Vol. 2. Georg Olms Verlag, Hildesheim New York 1976 (reprint of Madaus G. Lehrbuch der biologischen Heilmittel. Georg Thieme Verlag, Leipzig, 1938), 1267-1278 [German] Mahmoudian A, Rajaei Z, Haghir H, Banihashemian S, Hami J. Effects of valerian consumption during pregnancy on cortical volume and the levels of zinc and copper in the brain tissue of mouse fetus. Zhong Xi Yi Jie He Xue Bao. 2012, 10(4): 424-429 Malva JO, Santos S, Macedo T. Neuroprotective properties of Valeriana officinalis extracts. Neurotox Res. 2004, 6(2): 131-140 Marder M, Viola H, Wasowski C, Fernández S, Medina JH, Paladini AC. 5-Methylapigenin and hesperidin: new valeriana flavonoids with activity on the CNS. Pharm Biochem Behav. 2003, 75: 537545 Markwardt S, Overstreet-Wadiche L. GABAergic signalling to adult-generated neurons. J Physiol. 2008, 586(16): 3745-3749 List of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum EMA/HMPC/150847/2015 Page 6/13 Martindale The Extra Pharmacopoeia. 25th ed. Percy Lund, Humphries & Co. Ltd, London Bradford 1967, 2046-2047 Mennini T, Bernasconi P, Bombardelli E, Morazzoni P. In vitro study on the interactions of extracts and pure compounds from Valeriana officinalis roots with GABA, benzodiazepine and barbiturate receptors in rat brain. Fitoterapia. 1993, 64(4): 291-300 Miyasaka LS, Atallah AN, Soares BG. Valerian for anxiety disorders. Cochrane Database Syst Rev. 2006; Issue 4: CD004515, doi: 10.1002/14651858.CD004515.pub2 Mkrtchyan A, Panosyan V, Panossian A, Wikman G, Wagner H. A phase I clinical study of Andrographis paniculata fixed combination Kan Jang versus ginseng and valerian on the semen quality of healthy male subjects. Phytomedicine 2005, 12(6-7): 403-409 Mohamed MF, Tseng T, Frye RF. Inhibitory effects of commonly used herbal extracts on UGT1A1 enzyme activity. Xenobiotica 2010, 40(10): 663–669 Morin CM, Benca R. Chronic insomnia. Lancet 2012, 379: 1129–1141 Müller CE, Schumacher B, Brattstroem A, Abourashed EA, Koetter U . Interactions of valerian extracts and a fixed valerian-hop extract combination with adenosine receptors. Life Sciences 2002, 71: 19391949 Müller SF, Klement S: A combination of valerian and lemon balm is effective in the treatment of restlessness and dyssominia in children. Phytomedicine 2006; 13(6): 383-387 Nam SM, Choi JH, Yoo DY, Kim W, Jung HY, Kim JW et al. Valeriana officinalis extract and its main component, valerenic acid, ameliorate D-galactose-induced reductions in memory, cell proliferation, and neuroblast differentiation by reducing corticosterone levels and lipid peroxidation. Exp Gerontol. 2013, 48(11): 1369-1377 Neamati A, Chaman F, Hosseini M, Boskabady MH. The effects of Valeriana officinalis L. hydro-alcoholic extract on depression like behavior in ovalbumin sensitized rats. J Pharm Bioallied Sci. 2014, 6(2): 97103 Neuhaus W, Trauner G, Gruber D, Oelzant S, Klepal W, Kopp B et al. Transport of a GABAA receptor modulator and its derivatives from Valeriana officinalis L. s.l. across an in vitro cell culture model of the blood-brain barrier. Planta Med. 2008, 74(11): 1338-1344 Nowack R, Ballé C, Birnkammer F, Koch W, Sessler R, Birek R. Impact of food and herbal medication on calcineurin inhibitor dose in renal transplant patients: a cross-sectional study. J Med Food 2011, 14(7-8): 756–760 NTP (National Toxicology Program). Chemical Information Review Document for Valerian (Valeriana officinalis L.) [CAS No. 8057-49-6] and Oils [CAS No. 8008-88-6], National Toxicology Program U.S. Department of Health and Human Services, 2009 Occhiuto F, Pino A, Palumbo DR, Samperi S, De Pasquale R, Sturlese E, et al. Relaxing effects of Valeriana officinalis extracts on isolated human non-pregnant uterine muscle. J Pharm Pharmacol. 2009, 61(2): 251-256 Ortiz JG, Nieves-Natal J, Chavez P. Effects of Valeriana officinalis extracts on [3H]flunitrazepam binding, synaptosomal [3H]GABA Uptake, and hippocampal [3H]GABA Release. Neurochem Res. 1999, 24: 1373-1378 List of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum EMA/HMPC/150847/2015 Page 7/13 Ortiz JG, Rassi N, Maldonado PM, González-Cabrera S, Ramos I. Commercial valerian interactions with [3H]Flunitrazepam and [3H]MK-801 binding to rat synaptic membranes. Phytother Res. 2006, 20(9): 794-798 Oxman AD, Flottorp S, Håvelsrud K, Fretheim A, Odgaard-Jensen J, Austvoll-Dahlgren A et al. A televised, web-based randomised trial of an herbal remedy (valerian) for insomnia. PLoS One. 2007, 2(10): e1040 Pakseresht S, Boostani H, Sayyah M. Extract of valerian root (Valeriana officinalis L.) vs. placebo in treatment of obsessive-compulsive disorder: a randomized double-blind study. J Complement Integr Med. 2011, 8(1), doi: 10.2202/1553-3840.1465 Paoletti A, Gallo E, Benemei S, Vietri M, Lapi F, Volpi R et al. Interactions between natural health products and oral anticoagulants: spontaneous reports in the Italian surveillance system of natural health products. Evid Based Complement Alternat Med. 2011, doi: 10.1155/2011/612150 Pereira RP, Fachinetto R, de Souza Prestes A, Wagner C, Sudati JH, Boligon AA et al. Valeriana officinalis ameliorates vacuous chewing movements induced by reserpine in rats. J Neural Transm. 2011, 118(11): 1547-1557 Perlis M, Shaw PJ, Cano G, Espie CA. Models of insomnia. In: Kryger MH, Roth T, Dement WC. Principles and practice of sleep medicine. 5th ed. Elsevier Saunders, Philadelphia 2011, 850-865 Pinheiro ML, Alcântara CE, de Moraes M, de Andrade ED. Valeriana officinalis L. for conscious sedation of patients submitted to impacted lower third molar surgery: A randomized, double-blind, placebocontrolled split-mouth study. J Pharm Bioallied Sci. 2014, 6(2): 109-114 Rezvani ME, Roohbakhsh A, Allahtavakoli M, Shamsizadeh A. Anticonvulsant effect of aqueous extract of Valeriana officinalis in amygdala-kindled rats: possible involvement of adenosine. J Ethnopharmacol. 2010, 127(2): 313-318 Riedel E, Hänsel R, Ehrke G. Inhibition of -Aminobutyric Acid by Valerenic Acid Derivatives. Planta Med. 1982, 46: 219-220 Romero-Jiménez M, Campos-Sánchez J, Analla M, Munoz-Serrano A, Alonso-Moraga A. Genotoxicity and anti-genotoxicity of some traditional herbs. Mutat. Res. 2005, 585: 147-155 Rosecrans JA, Defeo JJ, Youngken HW Jr. Pharmacological investigation of certain Valeriana officinalis L. extracts. J Pharm Sci. 1961, 50: 240-244 Rücker G, Tautges J, Sieck A, Wenzl H, Graf E. Untersuchungen zur Isolierung und pharmakodynamischen Aktivität des Sesquiterpens Valeranon aus Nardostachys jatamansi DC. Arzneim.-Forsch./Drug Res. 1978; 28(I) (1): 7-13 [German] Sack RL, Auckley D, Auger RR, Carskadon MA, Wright KP Jr, Vitiello MV et al. Circadian rhythm sleep disorders: part I, basic principles, shift work and jet lag disorders. An American Academy of Sleep Medicine review. Sleep 2007a, 30(11): 1460-1483 Sack RL, Auckley D, Auger RR, Carskadon MA, Wright KP Jr, Vitiello MV, et al. Circadian rhythm sleep disorders: part II, advanced sleep phase disorder, delayed sleep phase disorder, free-running disorder, and irregular sleep-wake rhythm. An American Academy of Sleep Medicine review. Sleep 2007b, 30(11): 1484-1501 Sampath C, Haug K, Thanei S, Hamburger M, Derendorf H, Frye R et al. Pharmacokinetics of valerenic acid in rats after intravenous and oral administrations. Planta Med. 2012, 78(6): 575-581 List of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum EMA/HMPC/150847/2015 Page 8/13 Santos MS, Ferreira F, Cunha AP, Carvalho AP, Macedo T. An aqueous extract of valerian influences the transport of GABA in synaptosomes. Planta Med. 1994a. 60: 278-279 Santos MS, Ferreira F, Cunha AP, Carvalho AP, Ribeiro CF, Macedo Tl. Synaptosomal GABA release as influenced by valerian root extract-involvement of the GABA carrier. Arch Int Pharmacodyn Ther. 1994b, 327(2): 220-231 Santos MS, Ferreira F, Faro C, Pires E, Carvalho AP, Cunha AP et al. The amount of GABA present in aqueous extracts of valerian is sufficient to account for [3H]-GABA release in synaptosomes. Planta Med. 1994c, 60: 475-476 Sayre LE. A manual of organic materia medica and pharmacognosy. 4th ed. P Blakiston´s Son & Co, Philadelphia 1917, 66-69 Schulz H, Jobert M. Die Darstellung sedierender/tranquilisierender Wirkungen von Phytopharmaka im quantifizierten EEG. Z. Phytotherapie, 6. Phytotherapiekongress, Berlin 1995; Abstractband: 10 [German] Schulz H, Jobert M, Huebner WD. The quantitative EEG as a screening instrument to identify sedative effects of single doses of plant extracts in comparison with diazepam. Phytomedicine 1998, 5: 449-458 Schulz H, Stolz C, Mueller J. The effect of valerian extract on sleep polygraphy in poor sleepers: A pilot study. Pharmacopsychiat. 1994, 27: 147-151 Schumacher B, Scholle S, Hoelzl J, Khudeir N, Hess S, Mueller CE. Lignans isolated from valerian: identification and characterization of a new olivil derivative with partial agonistic activity at A1 receptors. J Nat Prod 2002, 65: 1479-1485 Sichardt K, Vissiennon Z, Koetter U, Brattström A, Nieber K. Modulation of postsynaptic potentials in rat cortical neurons by valerian extracts macerated with different alcohols: involvement of adenosine A(1)- and GABA(A)-receptors. Phytother Res. 2007, 21(10): 932-937 Simmen U, Saladin C, Kaufmann P, Poddar M, Wallimann C, Schaffner W. Preserved pharmacological activity of hepatocytes-treated extracts of valerian and St. John's wort. Planta Med. 2005, 71(7): 592598 Steinhoff B. Current perspectives on herb-drug interactions in the European regulatory landscape. Planta Med. 2012, 78(13): 1416–1420 Stevinson C, Ernst E. Valerian for insomnia: a systematic review of randomized clinical trials. Sleep Med. 2000, 1(2): 91-99 Taibi DM, Vitiello MV, Barsness S, Elmer GW, Anderson GD, Landis CA . A randomized clinical trial of valerian fails to improve self-reported, polysomnographic, and actigraphic sleep in older women with insomnia. Sleep Med. 2009, 10(3): 319-328 Torrent MT, Iglesias J, Adzet T. Valoración experimental de la actividad sedante de la tintura de Valeriana officinalis L. Circular Farmacéutica. 1972, 30:107-112 [Spanish] Trauner G, Khom S, Baburin I, Benedek B, Hering S, Kopp B. Modulation of GABAA receptors by valerian extracts is related to the content of valerenic acid. Planta Med. 2008, 74(1): 19-24 Tufik S, Fujita K, Seabra Mde L, Lobo LL. Effects of a prolonged administration of valepotriates in rats on the mothers and their offspring. J Ethnopharmacol. 1994, 41(1-2): 39-44 List of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum EMA/HMPC/150847/2015 Page 9/13 USP (The United States Pharmacopeia). The National Formulary 32 Vol.4. Valerian. The United States Pharmacopeial Convention, 2014, 5574-5576 Usmanghani K, Saeed A, Alam MT. Indusyunic medicine. Traditional medicine of herbal, animal and mineral origin in Pakistan. University of Karachi, Faculty of Pharmacy, Karachi 1997, 436-437 von der Hude W, Scheutwinkel-Reich M, Braun R. Bacterial mutagenicity of the tranquilizing constituents of Valerianaceae roots. Mutat.Res. 1986, 169: 23-27 von Skramlik E. Über die Giftigkeit und Verträglichkeit von ätherischen Ölen. Pharmazie 1959, 14:435445 [German] Vorbach EU, Goertelmeyer R, Brüning J. Therapie von Insomnien. Wirksamkeit und Verträglichkeit eines Baldrianpräparates. Psychopharmakotherapie 1996, 3: 109-115 [German] Wagner H, Jurcic K. In vitro- and in vivo-Metabolism of 14 C-Didrovaltrate. Planta Med. 1980, 38: 366- 376 Ward H. Herbal manual. L N Fowler & Co LTD, London 1936, 94 Wasowski C, Marder M, Viola H, Medina JH, Paladini AC. Isolation and identification of 6methylapigenin, a competitive ligand for the brain GABAA receptors, from Valeriana wallichii. Planta Med. 2002, 68: 934-936 Weiss RF. Lehrbuch der Phytotherapie. Hippokrates Verlag, Stuttgart 1944, 310-312 WHO (World Health Organistaion). WHO monographs on selected medicinal plants. Vol.1. Radix Valeriana. World Health Organization. Geneva 1999, 267-276 Wiener SW, Hoffmann RS, Nelson LS. Withdrawal symptoms after valerian cessation. Clin Tox. 2003, 41: 721 Wichtl M. Teedrogen und Phytopharmaka. 5th ed. Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart 2009, 692-696 Willey LB, Mady SP, Cobaugh DJ, Wax PM. Valerian overdose: a case report. Vet Human Toxicol. 1995, 37: 364-365 Yuan CS, Mehendale S, Xiao Y, Aung HH, Xie JT, Ang-Lee MK. The gamma-aminobutyric acidergic effects of valerian and valerenic acid on rat brainstem neuronal activity. Anesth Analg. 2004, 98: 353358 Ziegler G, Ploch M, Miettinen-Baumann A, Collet W. Efficacy and tolerability of valerian extract LI 156 compared with oxazepam in the treatment of non-organic insomnia – a randomized, double-blind, comparative clinical study. Eur J Med Res. 2002, 7: 480-486 References assessed by not sighted in the assessment report Andreatini R, Sartori VA, Seabra ML, Leite JR. Effect of valepotriates (valerian extract) in generalized anxiety disorder: a randomized placebo-controlled pilot study. Phytother Res. 2002 ,16(7):650-654 Awad R, Levac D, Cybulska P, Merali Z, Trudeau VL, Arnason JT. Effects of traditionally used anxiolytic botanicals on enzymes of the gamma-aminobutyric acid (GABA) system. Can J Physiol Pharmacol. 2007 , 85(9):933-942 List of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum EMA/HMPC/150847/2015 Page 10/13 Block KI, Gyllenhaal C, Mead MN. Safety and efficacy of herbal sedatives in cancer care. Integr Cancer Ther. 2004, 3(2): 128-148 Brattström A. Wirksamkeitsnachweis von Phytopharmaka am Beispiel einer Hopfen-BaldrianKombination. Forsch Komplementärmed. 1996, 3: 188-195 [German] Bühring U. Praxislehrbuch Heilpflanzenkunde 4th ed. Haug Verlag, Stuttgart 2014, 598 [German] Chamisso, A. von: Illustriertes Heil-,Gift- und Nutzpflanzenbuch. Ed. Schneebeli-Graf R, Berlin 1987 Carrasco MC, Vallejo JR, Pardo-de-Santayana M, Peral D, Martín MA, Altimiras J. Interactions of Valeriana officinalis L. and Passiflora incarnata L. in a patient treated with lorazepam. Phytother Res. 2009, 23(12): 1795-1796 Circosta C, De Pasquale R, Samperi S, Pino A, Occhiuto F. Biological and analytical characterization of two extracts from Valeriana officinalis. J Ethnopharmacol. 2007, 112(2): 361-367 Consolini AE, Ragone MI. Patterns of self-medication with medicinal plants and related adverse events-a South American survey. Curr Drug Saf. 2010, 5(4): 333-341 Cravotto G, Boffa L, Genzini L, Garella D. Phytotherapeutics: an evaluation of the potential of 1000 plants. J Clin Pharm Ther. 2010, 5(1): 11-48 Czeizel A, Szentesi I, Szekeres I, Molnár G, Glauber A, Bucski P. A study of adverse effects on the progeny after intoxication during pregnancy. Arch Toxicol. 1988;, 62(1): 1-7 Dimpfel W, Suter A. Sleep improving effects of a single dose administration of a valerian/hops fluid extract - a double blind, randomized, placebo-controlled sleep-EEG study in a parallel design using electrohypnograms. Eur J Med Res. 2008; 13(5): 200-204 Do KH, Choi YW, Kim EK, Yun SJ, Kim MS, Lee SY et al. Pinoresinol-4,4'-di-O-beta-D-glucoside from Valeriana officinalis root stimulates calcium mobilization and chemotactic migration of mouse embryo fibroblasts. Phytomedicine. 2009, 16(6-7): 530-537 de Oliveria DM, Barreto G, De Andrade DV, Saraceno E, Aon-Bertolino L et al. Cytoprotective effect of Valeriana officinalis extract on an in vitro experimental model of Parkinson disease. Neurochem Res. 2009, 34(2): 215-220 Devesa Jordà F, Pellicer Bataller J, Ferrando Ginestar J, Borghol Hariri A, Bustamante Balén M; Ortuno Cortés J et al. Consumption of medicinal herbs in patients attending a gastroenterology outpatient clinic. Gastroenterol Hepatol. 2004, 27(4): 244-249 [Spanish] Dimpfel W, Suter A. Sleep improving effects of a single dose administration of a valerian/hops fluid extract - a double blind, randomized, placebo-controlled sleep-EEG study in a parallel design using electrohypnograms. Eur J Med Res. 2008;, 13(5): 200-204 Ernst E. Herbal medications for common ailments in the elderly. Drugs Aging. 1999, 15(6): 423-428 Faustino TT, de Almeida RB, Andreatini R. Plantas medicinais no tratatmento do transtorno de ansiedade generalizada : uma revisão dos estudos clínicos controllados. [Medicinal plants for the treatment of generalized anxiety disorder: a review of controlled clinical studies.] Rev Bras Psiquiatr. 2010, 32(4): 429-436 [Portuguese] Feldmeier Ch, Kapp W. Comparative clinical studies with midazolam, oxazepam and placebo. Br J Clin Pharmacol 1983, 16: 151-155 Fintelmann V, Weiss RF. Lehrbuch Phytotherapie. 12th ed. Haug Verlag, Stuttgart 2009, 249 [German] List of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum EMA/HMPC/150847/2015 Page 11/13 Goldstein SE, Birnbom F, Lancee WJ, Darke AC. Comparison of oxazepam, flurazepam and chloral hydrate as hypnotic sedatives in geriatric patients. J Am Geriatr Soc 1978, 26(8): 366-371 Gutierrez S, Ang-Lee MK, Walker DJ, Zacny JP. Assessing subjective and psychomotor effects of the herbal medication valerian in healthy volunteers. Pharmacol Biochem Behav 2004, (78): 57-64 Hadley S, Petry JJ. Valerian. Am Fam Physician. 2003, 67(8): 1755-1758 Hazelhoff B, Malingré TH M, Meijer DKF. Antispasmodic Effects of Valeriana Compounds. An in-Vivo and in-Vitro Study on the Guinea-Pig Ileum. Arch. Int. Pharmacodyn. 1982, 257: 274-287 Herber KW. Fahrtüchtig trotz Einnahme eines Sedativums? Therapiewoche 1991, 41: 1039-1042 [German] Herrera-Arellano A, Luna-Villegas G, Cuevas-Uriostegui ML, Alvarez L, Vargas-Pineda G, ZamilpaAlvarez A, et al. Polysomnographic evaluation of the hypnotic effect of Valeriana edulis standardized extract in patients suffering from insomnia. Planta Med. 2001, 67(8): 695-699 Houghton PJ. The scientific basis for the reputed activity of Valerian. J Pharm Pharmacol 1999;, 51(5): 505-512 Kennedy DO, Little W, Haskell CF, Scholey AB. Anxiolytic effects of a combination of Melissa officinalis and Valeriana officinalis during laboratory induced stress. Phytother Res. 2006, 20(2): 96-102 Koetter U, Schrader E, Käufeler R, Brattström A. A randomized, double blind, placebo-controlled, prospective clinical study to demonstrate clinical efficacy of a fixed valerian hops extract combination (Ze 91019) in patients suffering from non-organic sleep disorder. Phytother Res. 2007; 21(9): 847851 Lindahl O, Lindwall L. Double blind study of a valerian preparation. Pharmacol Biochem Behav. 1989, 32(4): 1065-1066 Maroo N, Hazra A, Das T, 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. 2013, 45(1): 34-39 Muedra V, Moreno L. Estudio sobre el conocimiento del riesgo perioperatoriode las plantas medicinales. [Knowledge of perioperative risk associated with use of medicinal plants] Rev Esp Anestesiol Reanim. 2009, 56(8): 467-473 [Spanish] Müller SF, Klement S. A combination of valerian and lemon balm is effective in the treatment of restlessness and dyssominia in children. Phytomedicine 2006, 13(6): 383-387 Mueller CE. A1 adenosine receptors and their ligands: overview and recent developments. Farmaco. 2001, 56(1-2): 77-80 Posadzki P, Watson LK, Ernst E. Adverse effects of herbal medicines: an overview of systematic reviews. Clin Med. 2013, 13(1): 7-12 Plushner SL. Valerian: Valeriana officinalis. Am J Health Syst Pharm. 2000, 57(4):328, 333, 335 Richardson GS. Human physiological models of insomnia. Sleep Med 2007. 8(4): 9-14 Schaefer D, Schaefer R, Schaefer W. Untersuchungen zu pharmakologischen Wirkungen eines Baldrianbades. Z Phys Med Baln Med Klim 1982, 11: 391-395 [German] Schilcher H, Kammerer S. Leitfaden Phytotherapie. 3rd ed. Urban & Fischer, München 2007, 902 List of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum EMA/HMPC/150847/2015 Page 12/13 Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med 2008, 4(5): 487–504 Spinella M. The importance of pharmacological synergy in psychoactive herbal medicines. Altern Med Rev. 2002, 7(2): 130-137 Sudati JH, Fachinetto R, Pereira RP, Boligon AA, Athayde ML, Soares FA et al. In vitro antioxidant activity of Valeriana officinalis against different neurotoxic agents. Neurochem Res. 2009, 34(8): 13721379 Sudati JH, Vieira FA, Pavin SS, Dias GR, Seeger RL, Golombieski R et al. Valeriana officinalis attenuates the rotenone-induced toxicity in Drosophila melanogaster. Neurotoxicology. 2013, 37: 118-126 Toth LA, Bhargava P. Animal models of sleep disorders. Comp Med. 2013, 63(2): 91-104 Walter G, Rey JM. The relevance of herbal treatments for psychiatric practice. Aust N Z J Psychiatry. 1999, 33(4): 482-489; discussion 490-493 Weeks BS. Formulations of dietary supplements and herbal extracts for relaxation and anxiolytic action: Relarian. Review. Med Sci Monit. 2009, 15(11): 256-262 Wheatley D. Medicinal plants for insomnia: a review of their pharmacology, efficacy and tolerability. J Psychopharmacol. 2005, 19(4): 414-421 Williamson EM. Synergy and other interactions in phytomedicines. Phytomedicine 2001, 8(5): 401-409 Zadoyan G, Fuhr U. Phenotyping studies to assess the effects of phytopharmaceuticals on in vivo activity of main human cytochrome p450 enzymes. Planta Med. 2012, 78(13): 1428-1457 List of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum EMA/HMPC/150847/2015 Page 13/13