Article

Efficacy and tolerability of Baldrian versus oxazepam in non-organic and non-psychiatric insomniacs: a randomised, double-blind, clinical, comparative study

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Abstract

To show better improvement of sleep quality when treating non-organic insomniacs with extractum Valerianae radix siccum instead of oxazepam. Randomised, double blind, comparative study. Out-patients of 8 general practitioners. Non-organic and non-psychiatric insomniacs aged between 18 and 70 years were included into the trial. Persons with known hypersensitivity to valerian or benzodiazepines, other psychotropic drugs and various contraindications/limitations for benzodiazepines were excluded. 75 patients were randomly allocated either to the index group (2 x 300 mg extractum Valerianae radix siccum dragées LI 156) or control group (2 x 5 mg oxazepam dragées). The patients took study medication daily over a period of 28 days 30 min before going to bed. The factor sleep quality of the SF-B was defined as primary outcome. Secondary outcomes were other sleep characteristics of the SF-B, well-being (Bf-S) and anxiety (HAMA). Controls were performed before treatment as well as after 1, 2 and 4 weeks. Vital and laboratory parameters as well as unexpected events were assessed for safety and tolerability. For all outcomes effect sizes between groups were calculated. For the main outcome criteria significance was tested by repeated-measures ANOVA considering all cases for which data of at least one follow-up existed (n = 70). Baseline characteristics were well balanced. 70% (54/75) of the patients were females, over 53% (40/75) reported insomnia for more than 1 year. Mean age was 52 +/- 12 years. In both groups sleep quality improved significantly (p <0.001), but no statistically significant difference could be found between groups (p = 0.70). Effect sizes between groups varied between 0.02 and 0.25. Five persons withdrew due to possibly adverse drug reactions (2 ( valerian, 3 ( oxazepam). No serious adverse events happened. The study showed no differences in the efficacy for valerian and oxazepam. Because of the more favourable adverse effect profile of valerian compared to oxazepam, this hypothesis should be analysed confirmatorily in an equivalence study.

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... Using subacute treatment regimes, an extract made with 70% v/v ethanol affected different sleep parameters in a positive manner as well (Donath et al., 2000;Vorbach et al., 1996). Furthermore an improvement of sleep quality comparable to treatment with 10 mg oxazepam was observed for the same ethanolic extract in two comparative studies (Dorn, 2000;Ziegler et al., 2002). ...
... Additionally, several observations indicate a putative efficacy of valerian preparations in the treatment of anxiety and stress-related symptoms. In a comparative study a 4 week treatment with a 70% v/v ethanolic extract led, amongst others, to a reduction of the Hamilton-scores similar to the oxazepam treated group (Dorn, 2000). Furthermore, after a treatment period of 1 week using the same extract a diminished response to mental stress under laboratory conditions was reported by Cropley et al. (2002). ...
Article
Extracts of Valeriana officinalis L. s.l. are used for treating mild sleep disorders and nervous tension. Despite intensive research efforts, the pharmacological actions accounting for the clinical efficacy of valerian remain unclear. Thus, it was the aim of this study to evaluate CNS-related effects of different valerian extracts using behavioral paradigms (mice and rats). Following oral administration two commercially available preparations (extraction solvents: 45% methanol m/m and 70% ethanol v/v), a 35% ethanolic v/v extract and a refined extract derived from it (patented special extract phytofin Valerian 368) were tested for sedative (locomotor activity, ether-induced anaesthesia) and anxiolytic (elevated plus maze) activity. Using the forced swimming and the horizontal wire test the latter two extracts were additionally tested for antidepressant and myorelaxant properties. Up to maximum dosages of 500 or 1000 mg/kg bw none of the valerian extracts displayed sedative effects. Neither spontaneous activity was reduced nor the duration of ether-induced narcosis was prolonged. In contrast, results obtained in the elevated plus maze test revealed a pronounced anxiolytic effect of the 45% methanolic and 35% ethanolic extract as well as of phyotofin Valerian 368 in a dose range of 100-500 mg/kg bw. Additionally and different from its primary extract (35% ethanolic extract) phytofin Valerian 368 showed antidepressant activity in the forced swimming test after subacute treatment. Myorelaxant effects were not observed in dosages up to 1000 mg/kg bw. Due to these findings it is proposed that not sedative but anxiolytic and antidepressant activity, which was elaborated particularly in the special extract phytofin Valerian 368, considerably contribute to the sleep-enhancing properties of valerian.
... In two double-blind and placebo-controlled studies, single doses between 400 and 900 mg significantly improved sleep latency and sleep quality when compared with placebo [34,35]. In two randomized, double-blind studies, the effects of Valeriana (600 mg/d) on insomnia were comparable to those of Oxazepam [36,37]. Interestingly, a high dosage of Valeriana (1500 mg Valeriana in combination with 360 mg hops) particularly increased δ-waves in human subjects [38]. ...
... In two double-blind and placebocontrolled studies, single doses between 400 and 900 mg significantly improved sleep latency and sleep quality when compared with placebo [34,35] . In two randomized , double-blind studies, the effects of Valeriana (600 mg/d) on insomnia were comparable to those of Oxazepam [36,37]. Interestingly, a high dosage of Valeriana (1500 mg Valeriana in combination with 360 mg hops) particularly increased δ-waves in human subjects [38]. ...
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Background Various medications of natural origin have effectively treated stress-related disorders, such as sleep disturbances and agitated conditions. The efficacy of Neurexan, a multicomponent, low-dose medication, has been demonstrated in observational studies, but its exact mechanism of action has not been determined. Methods To characterize the effects of Neurexan on the central nervous system, we analyzed the spectral frequencies of field potentials in four rat brain areas after a single oral administration of Neurexan. Different doses of Neurexan were tested within a crossover design, and effects were compared with vehicle control. Results Significant effects were observed with 0.5 tablets of Neurexan, predominantly on δ- and θ-waves in the frontal cortex and reticular formation (P < 0.01). In the reticular formation, significant changes of δ- and θ-waves occurred as early as during the first hour after administration. The time course revealed a significant and longer-lasting increase of δ- and θ-waves in the frontal cortex and reticular formation, whereas other spectral frequencies were only transiently affected in the frontal cortex, reticular formation, and striatum. Conclusion In conclusion, this study demonstrated that the low-dose medication Neurexan influences central nervous system activity in rats. The resulting electroencephalographic profile of Neurexan shows several similarities with those of other calming agents, such as Valeriana and Passiflora, suggesting a potential benefit of Neurexan for patients with stress-related disorders. Moreover, this report demonstrates that electroencephalographic signatures are also valid biomarkers for the assessment of low-dose medications, such as Neurexan.
... There are no substantial long-term studies of safety or benefit. 199,200 • Lemon balm, hops, passion flower and skullcap are other less well-studied herbs that might have value for sleep and that are sometimes combined with Valerian. ...
... TABLE 1. (continued) Symptom CAM Therapy Evidence in Pediatrics Evidence in Adults Nonsignificant Findings Dominquez, 2000 195 Dorn, 2000 196 Ziegler, 2002 197 Wheatley, 2001 114 Passion flower Akhonzadeh et al, 2001 115 Kava Kava Gurley et al, 2005 112 Wheatley, 2001 114 Pittler and Ernst, 2003 200 Lehmann, 1996 201 Volz and Kieser, 1997 202 Emser and Bartylla, 1991 203 German Chamomile Gould, 1973 (tea), 204 Masago et al (aromatherapy), 2000 119 ...
Article
The use of complementary/alternative medicine (CAM) has been well documented among children with cancer. This report summarizes the research evidence on the role of CAM therapies for prevention and treatment of the most commonly reported cancer-related symptoms and late effects among children with cancer. Small clinical trials document evidence of effectiveness for select therapies, such as acupuncture or ginger for nausea and vomiting, TRAUMEEL S for mucositis, and hypnosis and imagery for pain and anxiety. Several relatively small clinical trials of varying quality have been conducted on these CAM therapies in children with cancer. Some herbs have demonstrated efficacy in adults, but few studies of herbs have been conducted in children. Larger randomized clinical trials are warranted for each of these promising therapies. Until the evidence is more conclusive, the providers' role is to assess and document the child's use of CAM, critically evaluate the evidence or lack of evidence, balance the potential risks with possible benefits, and assist the family in their choices and decisions regarding use of CAM for their child with cancer.
... Its efficacy has been demonstrated in a number of animal and clinical studies; however, the constituents, efficacy, and adverse effects have yet to be studied (Houghton, 1999 ). A randomized, doubleblinded , clinical study comparing valerian and oxazepam on treatment of nonorganic causes of insomnia demonstrated no differences in the efficacy of these two drugs (Dorn, 2000 ). Another study utilizing quantitative topographical electroencephalogram (EEG) showed slight but clear visible effects on the central nervous system, especially after intake of a high-dose valerian-hops mixture in healthy young adults compared to placebo (Vonderheid-Guth et al., 2000 ). ...
Article
This study was undertaken to investigate pulmonary vascular response to valerian (Valeriana officinalis) in the feline pulmonary vasculature under constant flow conditions. In separate experiments, the effects of NG-L-nitro-L-arginine methyl ester (L-NIO), a nitric oxide synthase inhibitor, glibenclamide, an adenosine triphosphate (ATP)-sensitive potassium (K+) channel blocker, meclofenamate, a nonselective cyclooxygenase (COX) inhibitor, bicuculline, a GABA(A) receptor antagonist, and saclofen, a GABA(B) antagonist, were investigated on pulmonary arterial responses to various agonists in the feline pulmonary vascular bed. These agonists included valerian, muscimol, a GABA(A) agonist, SKF-97541 a GABA(B) agonist, acetylcholine (ACh), and bradykinin, both inducers of nitric oxide synthase, arachidonic acid, a COX substrate, and pinacidil, an ATP-sensitive K+ channel activator, during increased tone conditions induced by the thromboxane A2 mimic, U46619. Settings/location: Laboratory investigation. Mongrel cats of either gender. Injections of the abovementioned agonists and antagonists were given. Baseline pulmonary tone, responses to the agonists, and responses to the agonists after injections of antagonists were all measured via a pulmonary catheter transducer and recorded. Valerian root extract is a potent smooth muscle dilator in the feline pulmonary vascular bed. The vasodilatory effects of valerian root extract were unchanged after the administration of L-NIO, glibenclamide, and meclofenamate. These effects were ablated, however, by both saclofen and bicuculline. The ability of saclofen and bicuculline to modulate the dilatory effects of valerian root extract was not statistically different. The vasodilatory effects of valerian root extract are mediated by a nonselective GABA mechanism.
... Dorn reported on a double-blind, randomized trial of valerian extract LI 156 versus oxazepam in 75 patients with nonorganic, nonpsychiatric insomnia, 90 in which 600 mg valerian extract or 10 mg oxazepam were given daily for a month. Results of the German Sleep Questionnaire B indicated that sleep quality improved for both groups and that no differences in degree of improvement between groups were seen. ...
Article
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Insomnia and other sleep disturbances are common in cancer patients. Insomnia is a multifactorial health concern that currently affects at least 1 in 3 cancer patients, and yet most insomnia sufferers do not consult their physician regarding pharmaceutical options for relief. Use of hypnotic drugs (primarily benzodiazepines) is associated with increasing tolerance, dependence, and adverse effects on the central nervous system. While hypnotic drug use declined substantially in the past decade, the use of herbal sedatives appeared to increase. Mostly self-prescribed by lay people, herbal sedatives hold widespread appeal, presumably because of their lower cost and higher margin of safety when compared to pharmaceuticals. Studies of better-known herbal sedatives, notably valerian and kava, showed moderate evidence for both safety and efficacy for valerian while revealing disturbing toxicity concerns for kava. Milder sedatives or anxiolytics in need of clinical study include German chamomile, lavender, hops, lemon balm, and passionflower; St. John's wort may have anxiolytic effects with relevance to sleep. Herb-drug interactions are a possibility for some of these species, including St. John's wort. Although sufficient evidence exists to recommend some of these agents for short-term relief of mild insomnia, long-term trials and observational studies are needed to establish the safety of prolonged use as well as overall efficacy in the context of cancer treatment and management.
... It is often taken to help alleviate insomnia. There are several clinical studies to evaluate the evidence of efficacy of valerian as a treatment for insomnia [131][132][133][134]. ...
Article
The extensive use of herbal drugs and their multiple components and modes of action suggests that they may also cause drug interactions by changing the activity of human cytochrome P450 enzymes. The purpose of the present review is to present the available data for the top 14 herbal drug sales in the U. S. Studies describing the effects of herbal drugs on phenotyping substrates for individual CYPs were identified by a comprehensive MEDLINE search. Drugs included Allium sativum (Liliaceae), Echinacea purpurea (Asteraceae), Serenoa repens (Arecaceae), Ginkgo biloba (Ginkgoaceae), Vaccinium macrocarpon (Ericaceae), Glycine max (Fabaceae), Panax ginseng (Araliaceae), Actea racemosa (Ranunculaceae), Hypericum perforatum (Hypericaceae), Silybum marianum (Asteraceae), Camellia sinensis (Theaceae), Valeriana officinalis (Valerianaceae), Piper methysticum (Piperaceae), and Hydrastis canadensis (Ranunculaceae) preparations. We identified 70 clinical studies in 69 publications. The majority of the herbal drugs appeared to have no clear effects on most of the CYPs examined. If there was an effect, there was mild inhibition in almost all cases, as seen with garlic or kava effects on CYP2E1 and with soybean components on CYP1A2. The most pronounced effects were induction of CYP3A and other CYPs by St. John's wort and the inhibitory effect of goldenseal on CYP3A and CYP2D6, both being borderline between mild and moderate in magnitude. With the exceptions of St. John's wort and goldenseal, the information currently available suggests that concomitant intake of the herbal drugs addressed here is not a major risk for drugs that are metabolized by CYPs.
... Using subacute treatment regimes, an extract made with 70% v/v ethanol affected different sleep parameters in a positive manner as well [39]. Furthermore an improvement of sleep quality comparable to treatment with 10 mg oxazepam was observed for the same ethanolic extract in two comparative studies [40,41]. Another in vivo experiment revealed a significant shortening of sleep latency in sleep-disturbed rats after treatment with a 70% ethanolic preparation [42]. ...
Article
The genus Valeriana (Valerianaceae) contains over 250 species distributed around the world and used in traditional medicines of many cultures. The main compds. isolated from Valeriana species are essential oils, valerenic acid and its derivs. and iridoids, accumulated mainly in the roots and rhizomes. This review lists 135 chem. constituents as well as their biosynthesis and bioactivity as reported by the end of 2008 (80 refs.). [on SciFinder(R)]
... Using subacute treatment regimes, an extract made with 70% v/v ethanol affected different sleep parameters in a positive manner as well [39]. Furthermore an improvement of sleep quality comparable to treatment with 10 mg oxazepam was observed for the same ethanolic extract in two comparative studies [40,41]. Another in vivo experiment revealed a significant shortening of sleep latency in sleep-disturbed rats after treatment with a 70% ethanolic preparation [42]. ...
Article
The genus Valeriana (Valerianaceae) contains over 250 species distributed around the world and used in traditional medicines of many cultures. The main compounds isolated from Valeriana species are essential oils, valerenic acid and its derivatives and iridoids, accumulated mainly in the roots and rhizomes. This review lists 135 chemical constituents as well as their biosynthesis and bioactivity as reported by the end of 2008 (80 references).
... 75 Valerian extract LI 156 (600 mg) was as effective as oxazepam 10 mg for improving sleep quality when given 30 minutes before bedtime to 74 patients with insomnia for 28 days. 76 Valerian is generally well-tolerated, although some clinical trials have reported morning sedation. Unlike flunitrazepam (1 mg), a single dose 600 mg of LI 156 did not impair reaction abilities, concentration, and coordination. ...
Article
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Safety and efficacy issues surrounding the use of the most popular herbs are discussed. The various herbs classified under the general heading "ginseng" are compared and contrasted. Echinacea is commonly used for treating colds and flu. St. John's Wort is among the best studied herbs in terms of efficacy in treating depression and drug interactions. Saw palmetto is used to treat benign prostatic hypertrophy with a minimum of side effects and drug interactions. Garlic has a wide range of uses, including hyperlipidemia, hypertension, and infections. Kava kava shows promise as an alternative for mild anxiety disorders. Valerian has been used with some success to treat insomnia. Ginkgo has gained acceptance for treating dementia, memory loss, and intermittent claudication. Goldenseal is a popular but probably ineffective antiseptic and agent for masking drug screens. Milk thistle may have a role in treating liver disease of various origins. Aloe is used as a laxative and to treat wounds. Black cohosh is a popular herb for treating the symptoms of menopause.
... In two studies on small numbers of subjects, insomniacs rated valerian and oxazepam as being equally effective. 57,58 In another trial, valerian was used to control insomnia that arose after benzodiazepine withdrawl. 59 It is hard to ascertain the incidence of side effects of valerian from observations with such a limited number of subjects. ...
Article
Insomnia is a frequent problem among the elderly, for which patients often self-medicate. The use of alternative medicine by individuals worldwide, including the elderly, is increasing and insomnia is a common reason for its use. Conventional treatments do not benefit all, and there is uncertainty about the effects of their long-term use. Many alternative therapies have been considered for the treatment of sleep disorders in published medical reports. These consist of pharmacological therapies, including melatonin, valerian, lavender, hops, kava, Chinese and Japanese herbal compounds, pyridoxine, St John's wort and German chamomile, and non-pharmacological therapies, including massage, acupuncture, music therapy, tai chi, magnetism and white noise. Comparison of these treatments, either with each other or with conventional therapies, is difficult because many studies inadequately define insomnia, have few subjects or lack randomization or controls. Many have not been tested specifically on elderly subjects. As a result of the problems in the trials of these treatments, drawing a definitive conclusion about the effectiveness of these therapies is difficult. Melatonin appears to be the most promising. It has been shown to produce some limited benefit by studies to date, although it has not been investigated in enough appropriate subjects to definitively conclude that there is a benefit at a sufficiently low risk. A promising role for melatonin might be in the treatment of elderly people with sleep-phase disorders. Other pharmacological treatments with potential await well-designed studies on the elderly. There are many non-pharmacological therapies that offer the potential advantages of a low side-effect profile, but the investigations of these have been even less rigorous.
... Comparison with a Benzodiazepine Dorn 43 reported the result of a double-blind, comparative study, in outpatients from eight general practitioners. Seventyfive patients between 18 and 70 years of age were randomly assigned either to the test group (2 doses of 300 mg valerian extract, LI 156) or the control group (2 doses of 5 mg oxazepam for 28 days, 30 min before bed). ...
Article
The World Health Organization estimates that 80% of the world’s population relies on herbal medicine, with the use of herbs in the United States expanding significantly in the past decade. Alternative and herbal medicines—such as St. John’s wort, kava, ginkgo biloba, and valerian, among others—have become increasingly popular treatments for nervous and sleep disorders including stress, anxiety, dementia, and forgetfulness. This article reviews the use of ginkgo, kava, passionflower, and valerian in psychiatric practice, summarizing existing research on these major botanicals. Herbal remedies are compared with pharmaceuticals, and dosages, benefits, adverse effects, and drug–herb interactions are discussed for each herb.
... This study suggests that valerian's effects may be cumulative, with optimal effects occurring with persistent use over a period of at least one month. @BULLET Dorn et al (2000)-Well-designed double blind trial (n=75) comparing a dry ethanolic valerian extract (Sedonium, 600mg/day) with benzodiazepine oxazepam (10mg/day). The sample included primarily older female patients who had complained of insomnia for over one year. ...
Data
Full-text available
Herbal medicines fact sheets. The four herbal medicines fact sheets developed, implemented, and evaluated in this study.
... IVA is also a component of valerian root, an herbal medicine used since ancient Greek and Roman times to treat insomnia, and since medieval times in Europe specifically to treat seizures 34,35 . Valerian root extract is still used extensively today for anxiety and insomnia, although randomized controlled trials evaluating its efficacy have achieved mixed results [43][44][45] . It has been estimated that 10 g of valerian root might yield as much as 100 mg of IVA, and that valerian root doses of 30-50 g per day would have the potential for anticonvulsant activity 46 . ...
Article
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Epilepsy has been treated for centuries with herbal remedies, including leaves of the African shrub Mallotus oppositifolius, yet the underlying molecular mechanisms have remained unclear. Voltage-gated potassium channel isoforms KCNQ2-5, predominantly KCNQ2/3 heteromers, underlie the neuronal M-current, which suppresses neuronal excitability, protecting against seizures. Here, in silico docking, mutagenesis and cellular electrophysiology reveal that two components of M. oppositifolius leaf extract, mallotoxin (MTX) and isovaleric acid (IVA), act synergistically to open neuronal KCNQs, including KCNQ2/3 channels. Correspondingly, MTX and IVA combine to suppress pentylene tetrazole-induced tonic seizures in mice, whereas individually they are ineffective. Co-administering MTX and IVA with the modern, synthetic anticonvulsant retigabine creates a further synergy that voltage independently locks KCNQ2/3 open. Leveraging this synergy, which harnesses ancient and modern medicines to exploit differential KCNQ isoform preferences, presents an approach to developing safe yet effective anticonvulsants.
... The studies showed that V. officinalis root improved sleep quality [168], reduced sleep latency and improved the subjective sleep rating [169], decreased insomnia symptoms [170] and also improved sleep quality with results comparable to those obtained by the administration of 10 mg of oxazepam but with fewer side effects [171]. Conversely, subsequent randomized double-blind studies based on sleep parameters evaluated objectively with polysomnographic techniques detected no substantial differences on any of the measurements in comparison to the placebo group except for only one parameter [172]. ...
Article
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Valerianaceae, the sub-family of Caprifoliaceae, contains more than 300 species of annual and perennial herbs, worldwide distributed. Several species are used for their biological properties while some are used as food. Species from the genus Valeriana have been used for their antispas-modic, relaxing, and sedative properties, which have been mainly attributed to the presence of valepotriates, borneol derivatives, and isovalerenic acid. Among this genus, the most common and employed species is Valeriana officinalis. Although valerian has been traditionally used as a mild sedative, research results are still controversial regarding the role of the different active compounds, the herbal preparations, and the dosage used. The present review is designed to summarize and critically describe the current knowledge on the different plant species belonging to Valerianaceae, their phytochemicals, their uses in the treatment of different diseases with particular emphasis on the effects on the central nervous system. The available information on this sub-family was collected from scientific databases up until year 2020. The following electronic databases were used: PubMed,
... Dies bestätigt eine Meta-Analyse randomisierter, placebokontrollierter Studien, die eine subjektive Verbesserung der Insomnie feststellte [47]. Baldrian verbesserte den Schlaf und Angstsymptome vergleichbar wirksam wie Oxazepam [48,49]. Aufgrund seiner milden sedierenden Effekte und schlaffördernden Wirkung stellt Baldrian eine verträgliche Alternative und einen möglichen Ersatz für synthetische Sedativa dar [31]. ...
Article
Depressive disorders in comorbidity with anxiety disorders represent an frequently diagnostic and therapeutic problem. The studies quoted here prove that the symptoms associated with anxiety that severely afflict patients can be clearly improved more quickly with a combination therapy of St John's wort extract and valerian extract than with St John's wort monotherapy. The combination therapy was well tolerated, no significant side-effects occurred. Further studies are necessary to compare the combination treatment with other forms of therapy (serotonin- and noradrenalin re-uptake inhibitors).
Article
Valerian is an herb that is widely available in a variety of commercial preparations and is commonly used as a sleep aid. A recent systematic review and meta-analysis of valerian concluded that evidence in support of the effectiveness of the herb was inconclusive. Therefore, in an effort to more closely examine this issue, a systematic review was conducted to examine the evidence on the efficacy of valerian as a sleep aid with specific attention to the type of preparations tested and the characteristics of the subjects studied. A comprehensive search of studies investigating valerian was conducted through computerized databases and hand searches of reference lists. Standardized forms were used to summarize findings and standardized criteria were used to assess study quality. Out of 592 articles initially identified, a total of 36 articles describing 37 separate studies met criteria for review: 29 controlled trials evaluated for both efficacy and safety, and eight open-label trials evaluated for safety only. Most studies found no significant differences between valerian and placebo either in healthy individuals or in persons with general sleep disturbance or insomnia. None of the most recent studies, which were also the most methodologically rigorous, found significant effects of valerian on sleep. Overall, the evidence, while supporting that valerian is a safe herb associated with only rare adverse events, does not support the clinical efficacy of valerian as a sleep aid for insomnia.
Article
Sleep disruption is common in the long-term care setting. This article discusses the available literature on 2 herbal approaches to sleep problems in long-term care. The largest body of evidence exists for the use of the dietary/herbal supplements valerian and melatonin. While these agents appear to have a modest positive effect on sleep quality among older adults, most studies were small in size and included only subjective assessments of sleep quality. In addition, it is unclear whether these agents pose risks to long-term care residents because of potential drug interactions. Additional research is needed before making conclusive recommendations about the use of these interventions for sleep in the long-term care setting.
Article
Efficacy and tolerability of a combined valerian/lemon balm preparation were investigated in an open, multicentre study in children less than 12 years suffering from restlessness and nervous dyskoimesis. Patients were dosed individually by the investigators. In total, 918 children were evaluated for therapeutic efficacy and tolerability. A distinct and convincing reduction in severity was found for all symptoms in the investigators' and parents' ratings. The core symptoms dyssomnia and restlessness were reduced from "moderate/severe" to "mild" or "absent" in most of the patients. In total, 80.9% of the patients who suffered from dyssomnia experienced an improvement for this symptom and 70.4% of the patients with restlessness improved clearly. For the other listed symptoms the total improvement was 37.8% on average. Both, parents and investigators assessed efficacy as to be "very good" or "good" (60.5% and 67.7%, respectively). The tolerability of Euvegal forte was considered as "good" (in 96.7% of the patients it was judged to be "very good" or "good"). No study medication-related adverse events occurred. In conclusion, Euvegal forte was effective in the treatment of younger children with restlessness and dyssomnia and it was very well tolerated.
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The use of complementary medicines in those with mental health problems is well documented. However, their effectiveness is often not established and they may be less harmless than commonly assumed. To review the complementary medicines routinely encountered in psychiatric practice, their effectiveness, potential adverse effects and interactions. Electronic and manual literature search on the effectiveness and safety of psychotropic complementary medicines. Potentially useful substances include ginkgo and hydergine as cognitive enhancers, passion flower and valerian as sedatives, St John's wort and s-adenosylmethionine as antidepressants, and selenium and folate to complement antidepressants. The evidence is less conclusive for the use of omega-3 fatty acids as augmentation treatment in schizophrenia, melatonin for tardive dyskinesia and 18-methoxycoronaridine, an ibogaine derivative, for the treatment of cocaine and heroin addiction. Systematic clinical trials are needed to test promising substances. Meanwhile, those wishing to take psychotropic complementary medicines require appropriate advice.
Article
Insomnia is the most frequently encountered sleep complaint worldwide. While many prescription drugs are used to treat insomnia, extracts of valerian (Valeriana officinalis L., Valerianaceae) are also used for the treatment of insomnia and restlessness. To determine novel mechanisms of action, radioligand binding studies were performed with valerian extracts (100% methanol, 50% methanol, dichloromethane [DCM], and petroleum ether [PE]) at the melatonin, glutamate, and GABA(A) receptors, and 8 serotonin receptor subtypes. Both DCM and PE extracts had strong binding affinity to the 5-HT(5a) receptor, but only weak binding affinity to the 5-HT(2b) and the serotonin transporter. Subsequent binding studies focused on the 5-HT(5a) receptor due to the distribution of this receptor in the suprachiasmatic nucleus of the brain, which is implicated in the sleep-wake cycle. The PE extract inhibited [(3)H]lysergic acid diethylamide (LSD) binding to the human 5-HT(5a) receptor (86% at 50 microg/ml) and the DCM extract inhibited LSD binding by 51%. Generation of an IC(50) curve for the PE extract produced a biphasic curve, thus GTP shift experiments were also performed. In the absence of GTP, the competition curve was biphasic (two affinity sites) with an IC(50) of 15.7 ng/ml for the high-affinity state and 27.7 microg/ml for the low-affinity state. The addition of GTP (100 microM) resulted in a right-hand shift of the binding curve with an IC(50) of 11.4 microg/ml. Valerenic acid, the active constituent of both extracts, had an IC(50) of 17.2 microM. These results indicate that valerian and valerenic acid are new partial agonists of the 5-HT(5a) receptor.
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The use of complementary medicines for mental health problems generates wide public interest. Patients, particularly when suffering from chronic mental health problems such as anxiety and depression, may use complementary medicines for a variety of reasons. Some may feel that a complementary approach is more “integrative” balancing mind and body; others may wish to gain control of their mental health problems. Again others may have been disappointed by conventional treatments.1 With the ubiquitous availability of knowledge in today’s high tech world, patients are increasingly well informed about treatment options. They may even be more knowledgeable about complementary medicines than clinicians whose experience in this area of practice is usually quite limited. Indeed, current professional regulations may make it extremely difficult for doctors to practise complementary medicine. Very rarely conventional treatment options, which a clinician is professionally bound to give preference, cannot be identified. Pharmacological complementary medicines are not subject to the same strict licensing requirements as conventional medicines, and commonly complementary remedies are just registered as food supplements rather than as medicinal substances.2 The range of complementary medicines is huge. Pharmacological options include herbal medicines and food supplements. These are further reviewed in this article in regard to the most common psychiatric problems encountered. Countless non-pharmacological options also exist, including acupuncture, transcutaneous electric nerve stimulation (TENS), aromatherapy, homeopathy, yoga, biofeedback, relaxation, meditation, hypnosis, reiki/therapeutic touch and reflexology. However, a review of all treatments would be beyond the scope of this review. Evaluating the effectiveness of complementary medicines can be a daunting task. Perceived effectiveness may originate from anthropological sources describing the use of folk remedies over hundreds and sometimes even thousands of years. Many remedies have percolated this way, but systematically derived clinical evidence often remains limited (table 1). Regarding mental health problems, most of the evidence is …
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