Übersicht wichtiger Publikationen
- Monographie: Valeriana radix (Baldrianwurzel)
Die im Bundesanzeiger Nr. 90 vom 15.5.1985 publizierte und im Bundesanzeiger Nr. 50 vom 13.3.1990 berichtigte Monographie der Kommission E des Bundesgesundheitsamtes
(veröffentlicht im Bundesanzeiger Nr. 90 vom 15.5.1985 mit Berichtigung im Bundesanzeiger Nr. 50 vom 13.3.1990) - Baldrian-Melisse-Extrakt zeigt keine Beeinträchtigung der Verkehrssicherheit oder Wirkungsverstärkung von Alkohol
Eine experimentelle Untersuchung an 54 Probanden, durchgeführt von der Forschungsgemeinschaft für Verkehrssicherheit in Köln.
(Quelle: M. Albrecht, W. Berger, P. Laux, U. Schmidt, C. Martin: Psychopharmaka und Verkehrssicherheit. ZFA 16, 71. Jhg, 20. 8. 1995: 1215-1228) - Insomnie: Baldrian-Trockenextrakt erweist sich als effiziente Behandlungsoption
Randomisierte Doppelblindstudie mit 121 ambulanten Patienten, die von der Klinik für Psychiatrie und Psychotherapie am Evangelischen Krankenhaus Elisabethstift in Darmstadt durchgeführt wurde
(Quelle: E.U. Vorbach, R. Görtelmeyer, J. Brüning: Therapie von Insomnien. PPT Psychopharmakotherapie, Heft 3, 3. Jhrg, März 1996., S. 109-115) - Hochdosierte Baldrian-Melisse-Kombination verbessert die Schlafqualität
Eine doppelblinde randomisierte placebokontrollierte Studie an 68 Patienten, die am Zentralinstitut für seelische Gesundheit in Mannheim durchgeführt wurde
(Quelle: H. Dreßing, S. Köhler, W. E. Müller: Verbesserung der Schlafqualität mit einem hochdosierten Baldrian-Melisse-Präparat. Psychopharmakotherapie 3, 3. Jhg., 1996: 123-130) - Baldrianwurzel-Extrakt: I-Hydroxypinoresinol hat in vitro eine starke Affinität zum 5-HAT 1A-Rezeptor
Eine experimentelle Untersuchung vom Institut für Pharmazeutische Biologie der Universität Marburg
(U. Bodesheim, J. Hölzl: Isolierung, Strukturaufklärung und Radiorezeptorassays von Alkaloiden und Lignanen aus Valeriana officinalis L..erschienen in Pharmazie 1997; 52: 386 – 391) - Auch Langzeiteinnahme von Baldrian-Extrakt zeigt keinen Einfluss auf Reaktionszeit und Konzentrationsfähigkeit
Eine Doppelblindstudie mit 102 Probanden, durchgeführt von der Gesellschaft für Interdisziplinäre medizinische Forschung in Köln
(Quelle: J. Kuhlmann, W. Berger, H. Podzuweit, U. Schmidt: The Influence of Valerian Treatment on Reaction-Time, Alertness and Concentration in volunteers. Pharmacopsychiatry 32 (1999): 235-241 - Wirksamkeit von Baldrianwurzel-Trockenextrakt ist bei Schlafstörungen der von Oxazepam ebenbürtig
Eine doppelblinde Vergleichsstudie an 75 Patienten
(Quelle: Dr. med. Martin Dorn: Wirksamkeit und Verträglichkeit von Baldrian versus Oxazepam bei nicht-organischen und nicht-psychiatrischen Insomnien. Eine randomisierte, doppelblinde, klinische Vergleichsstudie, Forsch Komplementärmed Klass Naturheilkd 2000;7:79-84) - Neues Wirkprinzip im Baldrian entdeckt: Hydrophiles Derivat von Olivil wirkt am Adenosin-1-Rezeptor
Eine experimentelle Arbeit der Arbeitsgruppe von Prof. Müller vom Institut für Pharmazeutische Chemie der Universität Bonn.
(Quelle: B. Schumacher, S. Scholle, J. Hölzl, N. Khudeir, S. Hess, C. Müller: Lignans isolated from Valerian: Identification and characterization of a new Olivil Derivative with partial agonistic activity at A-1 Adenosine rezeptors. J of Natural Products 2002; 65:1479-1485)
Bibliographie Baldrian
GABA(A) receptors as in vivo substrate for the anxiolytic action of valerenic acid, a major constituent of valerian root extracts.
Valerian extracts have been used for centuries to alleviate restlessness and anxiety albeit with unknown mechanism of action in vivo. We now describe a specific binding site on GABA(A) receptors with nM affinity for valerenic acid and valerenol, common constituents of valerian. Both agents enhanced the response to GABA at multiple types of recombinant GABA(A) receptors. A point mutation in the beta2 or beta3 subunit (N265M) of recombinant receptors strongly reduced the drug response. In vivo, valerenic acid and valerenol exerted anxiolytic activity with high potencies in the elevated plus maze and the light/dark choice test in wild type mice. In beta3 (N265M) point-mutated mice the anxiolytic activity of valerenic acid was absent. Thus, neurons expressing beta3 containing GABA(A) receptors are a major cellular substrate for the anxiolytic action of valerian extracts.
Institute of Pharmacology and Toxicology, University of Zurich, Winterthurerstrasse 190, CH-8057 Zurich, Switzerland.
(Quelle: Benke D, Barberis A, Kopp S, Altmann KH, Schubiger M, Vogt KE, Rudolph U, Möhler H., Neuropharmacology, 2009 Jan;56(1):174-81. Epub 2008 Jun 17.)
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.
Repetitive administrations of valerian/hops combinations have been widely used for self-administered therapy of sleep disturbances. This investigation focuses on the question if a single administration can be an effective sleep aid. Two parallel groups of n = 20 (verum) and n = 22 (placebo) were tested. Each subject spent two consecutive nights in the lab (reference night and medication night). Medication consisted in giving verum or placebo to poor sleepers identified by a validated sleep questionnaire (Schlaffragebogen SF-B). Two ml of the liquid ex?tract or similar smelling placebo were diluted in 50 ml water (flavoured with honey) and administered 15 minutes before EEG recording during the medication night. The data analysis is based on the electrohypnogram – a method derived from a validated computer assisted automatic analysis for depth of sleep. Differences between the reference nights and medication nights were evaluated and tested for significance. Time spent in sleep (values of the sleep frequency index “SFx” of the electrohypnogram of 74% or lower) was significantly higher for the verum group in comparison to the placebo group (p<0.01). The difference with respect to time spent in deeper sleep (i.e. 68% and lower or 62% and lower) between reference and medication night was also statistically significant at p<0.01. This parameter correlated with the difference in quality of sleep between the two consecutive nights as derived from the sleep inventory SF-A sub-score (subjects evaluation) with r = 0.48 at p<0.0001. The EEG derived parameter “sleep quantity” as calculated from the electrohypnogram proved superiority of the valerian/hops combination over placebo. Thus, the present investigation has shown evidence that a valerian/hops fluid extract can be used successfully using a single administration.
Justus-Liebig-University Giessen, c/o NeuroCode AG, Sportparkstr. 9, 35578 Wetzlar, Germany. w.dimpfel@neurocode-ag.com
(Quelle: Dimpfel W, Suter A., Eur J Med Res.; 2008 May 26;13(5):200-4.).
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.
Valerian and hops are traditionally used as sleep aids. Since the fixed extract combination (Ze 91019) as a whole is considered the active compound, the clinical efficacy must be demonstrated for this extract combination. The present clinical study aimed to demonstrate superiority of the fixed extract combination in comparison with placebo in patients suffering from non-organic insomnia (ICD 10, F 51.0-51.2). Objective sleep parameters were registered by means of a transportable home recorder system (QUISI). The primary outcome was the reduction in sleep latency (SL2) which had to be prolonged at baseline (>/=30 min) as an inclusion criteria. The treatment period lasted for 4 weeks with either placebo, single valerian extract (Ze 911) or the fixed valerian hops extract combination (Ze 91019). The amount of the single valerian extract was identical to that amount contained in the fixed extract combination, i.e. 500 mg valerian extract siccum. In the extract combination 120 mg hops extract siccum was added. Both the extracts were prepared with 45% methanol m/m with a drug-extract ratio of 5.3:1 (valerian) and 6.6:1 (hops), respectively. The fixed extract combination was significantly superior to the placebo in reducing the sleep latency whilst the single valerian extract failed to be superior to the placebo. The result underlined the plausibility for adding hops extract to the valerian extract.
Max Zeller Söhne AG, CH-8590 Romanshorn, Switzerland.
(Quelle: Koetter U, Schrader E, Käufeler R, Brattström A., Phytother Res.; 2007 Sep;21(9):847-51.)
Interaction of valerian extracts of different polarity with adenosine receptors: identification of isovaltrate as an inverse agonist at A1 receptors.
A series of extracts of valerian roots (Valeriana officinalis L.) was prepared with solvents of different polarity. Polar as well as nonpolar extracts were found to interact with adenosine A(1) receptors. While polar extracts activated A(1) receptors (partial agonistic activity), nonpolar extracts showed antagonistic or inverse agonistic activity at A(1) receptors, as demonstrated by GTPgammaS binding assays at human recombinant A(1) receptors stably expressed in Chinese hamster ovary (CHO) cells. Guided by radioligand binding assays, fractionation of a lipophilic petroleum ether:diethyl ether (1:1) extract led to the isolation of isovaltrate, which was characterized as a potent, highly efficacious inverse agonist at adenosine A(1) receptors (K(i) rat A(1): 2.05 microM). In experiments at rat brain slices measuring post-synaptic potentials (PSPs) in cortical neurons, isovaltrate at least partly reversed the reduction in the PSPs induced by the adenosine A(1) receptor agonist N(6)-cyclopentyladenosine (CPA). Isovaltrate may serve as a new lead structure for the development of inverse agonists at adenosine A(1) receptors. The common use of hydrophilic, but not lipophilic valerian extracts as mild sleep-inducing agents is consistent with the opposite actions of hydrophilic and lipophilic extracts on adenosine receptors.
Pharmaceutical Institute, Pharmaceutical Chemistry I, University of Bonn, Bonn, Germany.
(Quelle: Lacher SK, Mayer R, Sichardt K, Nieber K, Müller CE., Biochem Pharmacol.; 2007 Jan 15;73(2):248-58. Epub 2006 Oct 6.)
Valerian-hops combination and diphenhydramine for treating insomnia: a randomized placebo-controlled clinical trial.
CONTEXT: Insomnia is a prevalent health complaint associated with daytime impairments, reduced quality of life, and increased health-care costs. Although it is often self-treated with herbal and dietary supplements or with over-the-counter sleep aids, there is still little evidence on the efficacy and safety of those products. OBJECTIVE: To evaluate the efficacy and safety of a valerian-hops combination and diphenhydramine for the treatment of mild insomnia. DESIGN AND SETTING: Multicenter, randomized, placebo-controlled, parallel-group study conducted in 9 sleep disorders centers throughout the United States. PATIENTS: A total of 184 adults (110 women, 74 men; mean age of 44.3 years) with mild insomnia. INTERVENTIONS: (1) Two nightly tablets of standardized extracts of a valerian (187-mg native extracts; 5-8:1, methanol 45% m/m) and hops (41.9-mg native extracts; 7-10:1, methanol 45% m/m) combination for 28 days (n = 59), (2) placebo for 28 days (n = 65), or (3) 2 tablets of diphenhydramine (25 mg) for 14 days followed by placebo for 14 days (n = 60). OUTCOME MEASURES: Sleep parameters measured by daily diaries and polysomnography, clinical outcome ratings from patients and physicians, and quality of life measures. RESULTS: Modest improvements of subjective sleep parameters were obtained with both the valerian-hops combination and diphenhydramine, but few group comparisons with placebo reached statistical significance. Valerian produced slightly greater, though nonsignificant, reductions of sleep latency relative to placebo and diphenhydramine at the end of 14 days of treatment and greater reductions than placebo at the end of 28 days of treatment. Diphenhydramine produced significantly greater increases in sleep efficiency and a trend for increased total sleep time relative to placebo during the first 14 days of treatment. There was no significant group difference on any of the sleep continuity variables measured by polysomnography. In addition, there was no alteration of sleep stages 3-4 and rapid eye movement sleep with any of the treatments. Patients in the valerian and diphenhydramine groups rated their insomnia severity lower relative to placebo at the end of 14 days of treatment. Quality of life (Physical component) was significantly more improved in the valerian-hops group relative to the placebo group at the end of 28 days. There were no significant residual effects and no serious adverse events with either valerian or diphenhydramine and no rebound insomnia following their discontinuation. CONCLUSIONS: The findings show a modest hypnotic effect for a valerian-hops combination and diphenhydramine relative to placebo. Sleep improvements with a valerian-hops combination are associated with improved quality of life. Both treatments appear safe and did not produce rebound insomnia upon discontinuation during this study. Overall, these findings indicate that a valerian-hops combination and diphenhydramine might be useful adjuncts in the treatment of mild insomnia.
Universite Laval, Ecole de Psychologie, Sainte-Foy, Quebec, Canada. cmorin@psy.ulaval.ca
(Quelle: Morin CM, Koetter U, Bastien C, Ware JC, Wooten V., Sleep.; 2005 Nov 1;28 (11):1465-71)