kava and Anxiety-Disorders

Exploration of new drugs targeting anxiety treatment is a major concern worldwide. Medicinal plants are being used as a potential source of novel drugs for anxiety disorders. The objective of this review is to provide information about the healing outcomes of anxiety treatment with natural products. Valeriana officinalis, Citrus aurantium, Commelina benghalensis, Achyranthes aspera, Mimosa pudica, Achillea millefolium, Nymphaea alba, Leonurus cardiac, Camellia sinensis, Turnera aphrodisiaca, Crataegus oxyacantha and Piper methysticum showed promising effects on anxiety in animal models. In clinical studies, passion flower, kava, valerian, St John's wort, and hwagandha showed the most positive results. More studies are needed for the exploration of the antianxiety of medicinal plants. In drugs derived from natural sources have explored many components that are playing an essential role in curing anxiety disorders and associated complications.

Topics: Animals; Anxiety; Anxiety Disorders; Hypericum; Kava; Phytotherapy; Plant Extracts; Plants, Medicinal; Valerian

Generalized anxiety disorder (GAD) is a chronic and debilitating condition characterized by persistent and overpowering anxiety. Treatment of GAD with antidepressants and benzodiazepines is only moderately effective and not free from side effects. Kava (Piper methysticum) has been explored as a potential phytotherapeutic option for GAD.. To perform a systematic review and meta-analysis of the available evidence on Kava as a treatment for GAD.. Systematic search of English-language publications from major databases for clinical trials reporting the effects of Kava for the treatment of GAD.. Twelve articles were included in this review. Evidence supporting Kava as an effective treatment for GAD was found in two placebo-controlled trials and a reference-controlled trial. One negative trial demonstrated that Kava was not more effective than placebo. Meta-analyses of the results of three placebo-controlled trials (n = 130) favored Kava for GAD treatment with effect sizes between 0.59 and 0.99 (standard mean difference) without reaching statistical significance. Kava is an appealing treatment option to GAD patients who are more attune to natural remedies or lifestyle approaches to reduce stress. Positive patient experiences and improvement of vagal cardiac control due to Kava treatment were also reported in the literature. Kava is safe and well tolerated for short-term (4-8 weeks) therapeutic use at a dosage of 120-280 mg per day of Kavalactones, regardless of dosage schedule.. Current evidence, although promising, is insufficient to confirm the effect of Kava for GAD treatment beyond placebo. New evidence is expected from a large, multisite ongoing trial.

Topics: Anxiety Disorders; Female; Humans; Kava; Male; Phytotherapy; Plant Extracts

Kava (Piper methysticum) is a South Pacific psychotropic plant medicine that has anxiolytic activity. This effect is achieved from modulation of GABA activity via alteration of lipid membrane structure and sodium channel function, monoamine oxidase B inhibition, and noradrenaline and dopamine re-uptake inhibition. Kava is available over the counter in jurisdictions such as the USA, Australia and New Zealand. Due to this, a review of efficacy, safety and clinical recommendations is advised.. To conduct a comprehensive review of kava, in respect to efficacy, psychopharmacology, and safety, and to provide clinical recommendations for use in psychiatry to treat generalized anxiety disorder (GAD).. A review was conducted using the electronic databases MEDLINE, CINAHL, PsycINFO and the Cochrane Library during mid 2010 of search terms relating to kava and GAD. A subsequent forward search was conducted of key papers using Web of Science cited reference search.. The current weight of evidence supports the use of kava in treatment of anxiety with a significant result occurring in four out of six studies reviewed (mean Cohen's d = 1.1). Safety issues should however be considered. Use of traditional water soluble extracts of the rhizome (root) of appropriate kava cultivars is advised, in addition to avoidance of use with alcohol and caution with other psychotropic medications. Avoidance of high doses if driving or operating heavy machinery should be mandatory. For regular users routine liver function tests are advised.. While current evidence supports kava for generalized anxiety, more studies are required to assess comparative efficacy and safety (on the liver, cognition, driving, and sexual effects) versus established pharmaceutical comparators.

Topics: Anti-Anxiety Agents; Anxiety Disorders; Humans; Kava; Phytotherapy; Plant Extracts; Plants, Medicinal; Treatment Outcome

Over the past several decades, complementary and alternative medications have increasingly become a part of everyday treatment. With the rising cost of prescription medications and their production of unwanted side effects, patients are exploring herbal and other natural remedies for the management and treatment of psychological conditions. Psychological disorders are one of the most frequent conditions seen by clinicians, and often require a long-term regimen of prescription medications. Approximately 6.8 million Americans suffer from generalized anxiety disorder. Many also suffer from the spectrum of behavioural and physical side effects that often accompany its treatment. It is not surprising that there is universal interest in finding effective natural anxiolytic (anti-anxiety) treatments with a lower risk of adverse effects or withdrawal.. An electronic and manual search was performed through MEDLINE/PubMed and EBSCO. Articles were not discriminated by date of publication. Available clinical studies published in English that used human participants and examined the anxiolytic potential of dietary and herbal supplements were included. Data were extracted and compiled into tables that included the study design, sample population, intervention, control, length of treatment, outcomes, direction of evidence, and reported adverse events.. A total of 24 studies that investigated five different CAM monotherapies and eight different combination treatments and involved 2619 participants met the inclusion criteria and were analyzed. There were 21 randomized controlled trials and three open-label, uncontrolled observational studies. Most studies involved patients who had been diagnosed with either an anxiety disorder or depression (n = 1786). However, eight studies used healthy volunteers (n = 877) who had normal levels of anxiety, were undergoing surgery, tested at the upper limit of the normal range of a trait anxiety scale, had adverse premenstrual symptoms or were peri-menopausal, reported anxiety and insomnia, or had one month or more of elevated generalized anxiety. Heterogeneity and the small number of studies for each supplement or combination therapy prevented a formal meta-analysis. Of the randomized controlled trials reviewed, 71% (15 out of 21) showed a positive direction of evidence. Any reported side effects were mild to moderate.. Based on the available evidence, it appears that nutritional and herbal supplementation is an effective method for treating anxiety and anxiety-related conditions without the risk of serious side effects. There is the possibility that any positive effects seen could be due to a placebo effect, which may have a significant psychological impact on participants with mental disorders. However, based on this systematic review, strong evidence exists for the use of herbal supplements containing extracts of passionflower or kava and combinations of L-lysine and L-arginine as treatments for anxiety symptoms and disorders. Magnesium-containing supplements and other herbal combinations may hold promise, but more research is needed before these products can be recommended to patients. St. John's wort monotherapy has insufficient evidence for use as an effective anxiolytic treatment.

Topics: Anti-Anxiety Agents; Anxiety; Anxiety Disorders; Arginine; Depressive Disorder; Humans; Hypericum; Kava; Lysine; Magnesium; Passiflora; Phytotherapy; Randomized Controlled Trials as Topic; Vitamin B 6

Natural remedies have been widely used and generally accepted as established treatments of depressive disorders, leading to the investigation of their potential role and efficacy in the treatment of the various anxiety disorders.. Numerous case reports, open-label, and placebo-controlled trials investigating the use of natural remedies in the treatment of anxiety disorders have yielded some encouraging results.. Overall, these studies have indicated a potential role for natural remedies in the treatment of anxiety and suggest that such agents may possess a safer side effects profile when compared to conventional agents. However, these early findings, albeit promising, are yet to be supported by further investigation in large-scale, placebo-controlled studies.. This article reviews past and present research being performed in this area of clinical interest, while also revealing a remarkable paucity of data.

Topics: Anti-Anxiety Agents; Antioxidants; Anxiety Disorders; Humans; Hypericum; Inositol; Kava; Melatonin; Obsessive-Compulsive Disorder; Panic Disorder; Passiflora; Phytotherapy; Valerian

There is well documented evidence for the increasing widespread use of complementary and alternative medicine in the treatment of physical and psychiatric symptoms and disorders within Western populations. Here we provide a review of the recent literature on evidence for using such interventions in the treatment of anxiety and depression.. With regard to herbal treatments, kava is effective in reducing anxiety symptoms and St John's wort in treating mild to moderate depression. The association of kava with hepatotoxicity, however, is a significant concern. Promising data continue to emerge for the use of omega-3 fatty acids in managing depression. Evidence for the use of acupuncture in treating anxiety disorders is becoming stronger, although there is currently minimal empirical evidence for the use of aromatherapy or mindfulness-based meditation.. The evidence base for the efficacy of the majority of complementary and alternative interventions used to treat anxiety and depression remains poor. Recent systematic reviews all point to a significant lack of methodologically rigorous studies within the field. This lack of evidence does not diminish the popularity of such interventions within the general Western population.

Topics: Acupuncture Therapy; Anxiety Disorders; Aromatherapy; Cognitive Behavioral Therapy; Combined Modality Therapy; Complementary Therapies; Depressive Disorder; Evidence-Based Medicine; Humans; Hypericum; Kava; Meditation; Phytotherapy; Plant Extracts; Randomized Controlled Trials as Topic

Use of complementary and alternative medicine has increased over the past decade. A variety of studies have suggested that this use is greater in persons with symptoms or diagnoses of anxiety and depression. Data support the effectiveness of some popular herbal remedies and dietary supplements; in some of these products, particularly kava, the potential for benefit seems greater than that for harm with short-term use in patients with mild to moderate anxiety. Inositol has been found to have modest effects in patients with panic disorder or obsessive-compulsive disorder. Physicians should not encourage the use of St. John's wort, valerian, Sympathyl, or passionflower for the treatment of anxiety based on small or inconsistent effects in small studies. Although the evidence varies depending on the supplement and the anxiety disorder, physicians can collaborate with patients in developing dietary supplement strategies that minimize risks and maximize benefits.

Topics: Anti-Anxiety Agents; Anxiety Disorders; Dietary Supplements; Humans; Hypericum; Kava; Phytotherapy; Plant Preparations; Randomized Controlled Trials as Topic; Self Medication

The herbal medicinal product kava-kava, used for treating anxiety disorders, was assessed positively by the Cochrane Review. However, it was withdrawn from the market in Switzerland and Germany due to cases of liver failure and 'unproven' efficacy.. A protocol for the meta-analysis based on patient source data was written, a literature search was done, and six placebo-controlled, randomized trials with the kava extract WS1490 were identified. The endpoints were the change in HAMA during treatment (continuous and binary).. WS1490 has an effective success rate of OR=3.3 (95% confidence interval of 2.09-5.22) in patients with non-psychotic anxiety disorders. The continuous outcome supports this result: mean improvement with WS1490 by 5.94 (95% confidence interval -0.86 to 12.8) points on the HAMA scale better than placebo. Kava seems to be more effective in females and in younger patients.. This meta-analysis has no publication bias, no remarkable heterogeneity and is based on trials with high methodological standards. It is concluded that WS1490, and possibly other kava extracts, are effective. Therefore they remain alternatives to benzodiazepines, selective serotonin re-uptake inhibitors (SSRIs) and other antidepressants in the treatment of non-psychotic anxiety disorders.

Topics: Anti-Anxiety Agents; Anxiety Disorders; Humans; Kava; Phytotherapy; Plant Extracts; Randomized Controlled Trials as Topic

Topics: Anti-Anxiety Agents; Antidepressive Agents; Anxiety Disorders; Benzodiazepines; Buspirone; Carbolines; Cognitive Behavioral Therapy; Humans; Hydroxyzine; Kava; Phytotherapy

Topics: Anti-Anxiety Agents; Antidepressive Agents; Anxiety Disorders; Benzodiazepines; Buspirone; Cognitive Behavioral Therapy; Humans; Hydroxyzine; Kava; Phytotherapy

Topics: Adrenergic beta-Antagonists; Anti-Anxiety Agents; Antidepressive Agents; Antipsychotic Agents; Anxiety Disorders; Carbolines; Cognitive Behavioral Therapy; Humans; Hydroxyzine; Kava; Relaxation Therapy

Anxiety disorders are among the most common psychiatric disorders that affect all age groups of the general population. Currently, the preferred treatment is with pharmacological drugs that have antidepressant or anti-anxiety properties. However, these agents have numerous and often serious adverse effects, including sedation, impaired cognition, ataxia, aggression, sexual dysfunction, tolerance and dependence. Withdrawal reactions on termination after long-term administration are also a major limiting factor in the use of these agents. Herbal remedies, including kava (Piper methysticum), have been shown to be effective as alternative treatments, at least in mild to moderate cases of anxiety. Kava is a social and ceremonial herb from the South Pacific. It is available in the west as an over-the-counter preparation. Its biological effects, due to a mixture of compounds called kavalactones, are reported to include sedative, anxiolytic, antistress, analgesic, local anaesthetic, anticonvulsant and neuroprotective properties. The pharmacological properties of kava are postulated to include blockade of voltage-gated sodium ion channels, enhanced ligand binding to gamma-aminobutyric acid (GABA) type A receptors, diminished excitatory neurotransmitter release due to calcium ion channel blockade, reduced neuronal reuptake of noradrenaline (norepinephrine), reversible inhibition of monoamine oxidase B and suppression of the synthesis of the eicosanoid thromboxane A(2), which antagonises GABA(A) receptor function. Clinical studies have shown that kava and kavalactones are effective in the treatment of anxiety at subclinical and clinical levels, anxiety associated with menopause and anxiety due to various medical conditions. Until recently, the adverse effects attributed to kava use were considered mild or negligible, except for the occurrence of a skin lesion. This disorder, called kava dermopathy, occurs only with prolonged use of large amounts of kava and is reversible on reduced intake or cessation. Rare cases of interactions have occurred with pharmaceutical drugs that share one or more mechanisms of action with the kavalactones. In the past few years, about 35 cases of severe liver toxicity associated with kava intake have been reported in Europe and the US. However, a direct causal relationship with kava use has been difficult to establish in the majority of the cases, and there is insufficient evidence to implicate kava as the responsible agent. Nevertheless,

Topics: Animals; Anti-Anxiety Agents; Anxiety Disorders; Brain; Clinical Trials as Topic; Cognition; Drug Interactions; Humans; Ion Channels; Kava; Monoamine Oxidase Inhibitors; Neurotransmitter Agents; Phytotherapy; Plant Extracts; Psychomotor Performance; Thromboxane A2; Treatment Outcome

Topics: Administration, Oral; Anxiety Disorders; Evidence-Based Medicine; Humans; Kava; Plant Extracts; Randomized Controlled Trials as Topic; Research Design; Sample Size; Severity of Illness Index; Treatment Outcome

Kava-kava (Piper methysticum), a shrub which grows on the islands of the Pacific Ocean, contains the so-called kavapyrones as active substances; these have been pharmacologically investigated in detail and are comparable with the benzodiazepine tranquilizers with regard to their mode and strength of action. The good tolerance and absence of both the soporific effect and risk of dependence should be emphasized. The present article describes the origin and history of the kava plant as well as its pharmacology, action, possibilities for therapeutic use, and significance in medical practice. Also discussed are the advantages of the standardized kavapyrone complex of active substances as a modern phyto-anxiolytic and daily tranquilizer for nervous anxiety, tension, and agitation states.

Topics: Anti-Anxiety Agents; Anxiety Disorders; Clinical Trials as Topic; Humans; Kava; Plants, Medicinal; Stress, Psychological; Treatment Outcome

Generalised Anxiety Disorder (GAD) is a prevalent, chronic mental health disorder. The measurement of regional brain gamma-aminobutyric acid (GABA) offers insight into its role in anxiety and is a potential biomarker for treatment response. Research literature suggests

Topics: Adult; Anti-Anxiety Agents; Anxiety Disorders; Biomarkers; Gyrus Cinguli; Humans; Kava; Neuroimaging; Phytotherapy; Plant Extracts

Generalised anxiety disorder (GAD) is a chronic and pervasive condition that generates high levels of psychological stress, and it is difficult to treat in the long term. Current pharmacotherapeutic options for GAD are in some cases only modestly effective, and may elicit undesirable side effects. Through targeted actions on the gamma-aminobutyric acid (GABA) pathway, the South Pacific medicinal plant kava (Piper methysticum) is a non-addictive, non-hypnotic anxiolytic with the potential to treat GAD. The evidence for the efficacy of kava for treating anxiety has been affirmed through clinical trials and meta-analyses. Recent research has also served to lessen safety concerns regarding the use of kava due to hepatotoxic risk, which is reflected in a recent German court overturning the previous kava ban in that country (which may in turn influence a reinstatement by the European Union). The aim of current research is to assess the efficacy of an 'aqueous noble cultivar rootstock extract' of kava in GAD in a larger longer term study. In addition, we plan to investigate the pharmacogenomic influence of GABA transporters on response, effects of kava on gene expression, and for the first time, the neurobiological correlates of treatment response via functional and metabolic imaging.. This clinical trial is funded by the Australian National Health and Medical Research Council (APP1063383) and co-funded by MediHerb (Integria Healthcare (Australia) Pty. Ltd). The study is a phase III, multi-site, two-arm, 18-week, randomised, double-blind, placebo-controlled study using an aqueous extract of noble kava cultivar (standardised to 240 mg of kavalactones per day) versus matching placebo in 210 currently anxious participants with diagnosed GAD who are non-medicated. The study takes place at two sites: the Centre for Human Psychopharmacology (Swinburne University of Technology), Hawthorn, Melbourne, Australia; and the Academic Discipline of Psychiatry (The University of Queensland) based at the Royal Brisbane and Women's Hospital, Herston, Brisbane, Australia. Written informed consent will be obtained from each participant prior to commencement in the study. The primary outcome is the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). The secondary outcomes involve a range of scales that assess affective disorder symptoms and quality of life outcomes, in addition to the study of mediating biomarkers of response (assessed via genomics and neuroimaging).. If this study demonstrates positive findings in support of the superiority of kava over placebo in the treatment of GAD, and also is shown to be safe, then this plant-medicine can be considered a 'first-line' therapy for GAD. Genomic and neuroimaging data may reveal clinical response patterns and provide more evidence of the neurobiological activity of the plant extract.. ClinicalTrials.gov: NCT02219880 Date: 13 August 2014:.

Topics: Adolescent; Adult; Aged; Anti-Anxiety Agents; Anxiety Disorders; Brain; Clinical Protocols; Double-Blind Method; Female; Functional Neuroimaging; GABA Plasma Membrane Transport Proteins; Humans; Kava; Male; Middle Aged; Pharmacogenetics; Phytotherapy; Plant Extracts; Plant Roots; Plants, Medicinal; Polymorphism, Genetic; Psychiatric Status Rating Scales; Queensland; Registries; Research Design; Surveys and Questionnaires; Time Factors; Treatment Outcome; Victoria; Young Adult

Kava (Piper methysticum) is a plant-based medicine, which has been previously shown to reduce anxiety. To date, however, no placebo-controlled trial assessing kava in the treatment of generalized anxiety disorder (GAD) has been completed. A total of 75 participants with GAD and no comorbid mood disorder were enrolled in a 6-week double-blind trial of an aqueous extract of kava (120/240 mg of kavalactones per day depending on response) versus placebo. γ-Aminobutyric acid (GABA) and noradrenaline transporter polymorphisms were also analyzed as potential pharmacogenetic markers of response. Reduction in anxiety was measured using the Hamilton Anxiety Rating Scale (HAMA) as the primary outcome. Intention-to-treat analysis was performed on 58 participants who met inclusion criteria after an initial 1 week placebo run-in phase. Results revealed a significant reduction in anxiety for the kava group compared with the placebo group with a moderate effect size (P = 0.046, Cohen d = 0.62). Among participants with moderate to severe Diagnostic and Statistical Manual of Mental Disorders-diagnosed GAD, this effect was larger (P = 0.02; d = 0.82). At conclusion of the controlled phase, 26% of the kava group were classified as remitted (HAMA ≤ 7) compared with 6% of the placebo group (P = 0.04). Within the kava group, GABA transporter polymorphisms rs2601126 (P = 0.021) and rs2697153 (P = 0.046) were associated with HAMA reduction. Kava was well tolerated, and aside from more headaches reported in the kava group (P = 0.05), no other significant differences between groups occurred for any other adverse effects, nor for liver function tests. Standardized kava may be a moderately effective short-term option for the treatment of GAD. Furthermore, specific GABA transporter polymorphisms appear to potentially modify anxiolytic response to kava.

Topics: Adult; Anti-Anxiety Agents; Anxiety Disorders; Chi-Square Distribution; Double-Blind Method; Female; GABA Plasma Membrane Transport Proteins; Humans; Kava; Male; Pharmacogenetics; Phytotherapy; Plant Extracts; Plants, Medicinal; Polymorphism, Genetic; Psychiatric Status Rating Scales; Time Factors; Treatment Outcome; Victoria; Young Adult

Presently, little is known about a number issues concerning kava (Piper methysticum), including (i) whether kava has any withdrawal or addictive effects; (ii) if genetic polymorphisms of the cytochrome (CYP) P450 2D6 liver enzyme moderates any potential adverse effects; and (iii) if medicinal application of kava has any negative or beneficial effect on sexual function and experience. The study design was a 6-week, double-blind, randomized controlled trial (n = 75) involving chronic administration of kava (one tablet of kava twice per day; 120 mg of kavalactones per day, titrated in non-response to two tablets of kava twice per day; 240 mg of kavalactones) or placebo for participants with generalized anxiety disorder. Results showed no significant differences across groups for liver function tests, nor were there any significant adverse reactions that could be attributed to kava. No differences in withdrawal or addiction were found between groups. Interesting, kava significantly increased female's sexual drive compared to placebo (p = 0.040) on a sub-domain of the Arizona Sexual Experience Scale (ASEX), with no negative effects seen in males. Further, it was found that there was a highly significant correlation between ASEX reduction (improved sexual function and performance) and anxiety reduction in the whole sample.

Topics: Adult; Anti-Anxiety Agents; Anxiety Disorders; Cytochrome P-450 CYP2D6; Double-Blind Method; Female; Humans; Kava; Lactones; Liver; Liver Function Tests; Male; Middle Aged; Phytotherapy; Sexual Dysfunction, Physiological; Young Adult

We report the first randomised controlled trial (RCT) using a combination of St. John's wort (SJW) and Kava for the treatment of major depressive disorder (MDD) with comorbid anxiety.. Twenty-eight adults with MDD and co-occurring anxiety were recruited for a double-blind RCT. After a placebo run-in of 2 weeks, the trial had a crossover design testing SJW and Kava against placebo over two controlled phases, each of 4 weeks. The primary analyses used intention-to-treat and completer analyses.. On both intention-to-treat (p = 0.047) and completer analyses (p = 0.003), SJW and Kava gave a significantly greater reduction in self-reported depression on the Beck Depression Inventory (BDI-II) over placebo in the first controlled phase. However, in the crossover phase, a replication of those effects in the delayed medication group did not occur. Nor were there significant effects on anxiety or quality of life.. There was some evidence of antidepressant effects using SJW and Kava in a small sample with comorbid anxiety. Possible explanations for the absence of anxiolysis may include a potential interaction with SJW, the presence of depression, or an inadequate dose of Kava.

Topics: Adolescent; Adult; Antidepressive Agents; Anxiety Disorders; Cross-Over Studies; Depressive Disorder, Major; Dose-Response Relationship, Drug; Double-Blind Method; Drug Interactions; Drug Therapy, Combination; Female; Humans; Hypericum; Kava; Male; Middle Aged; Pilot Projects; Plant Extracts; Psychometrics; Quality of Life; Young Adult

To report on the design, significance and potential impacts of the first documented human clinical trial assessing the anxiolytic and thymoleptic efficacy of an aqueous mono-extract of Piper methysticum (kava). The significance of the qualitative element of our clinical trial is also explored. The Kava Anxiety Depression Spectrum Study (KADSS) is a 3-week placebo-controlled, double-blind, cross-over trial involving 60 adult participants (18-65) with elevated stable anxiety and varying levels of depressive symptoms.. The aims of KADSS are: (1) to determine whether an aqueous standardised extract of kava is effective for the treatment of anxiety; (2) to assess the effects of kava on differing levels of depression; and (3) to explore participants' experience of taking kava via qualitative research. The study also provides preliminary assessment of the safety of an aqueous extract of kava in humans.. If results reveal that the aqueous kava preparation exerts significant anxiolytic effects and appears safe, potentially beneficial impacts may occur. Data supporting a safe and effective kava extract may encourage a re-introduction of kava to Europe, UK and Canada. This may provide a major socioeconomic benefit to Pacific Island nations, and to sufferers of anxiety disorders.

Topics: Adolescent; Adult; Aged; Anti-Anxiety Agents; Anxiety; Anxiety Disorders; Depression; Double-Blind Method; Humans; Kava; Middle Aged; Patient Satisfaction; Phytotherapy; Plant Extracts; Young Adult

In this study, we evaluated the efficacy and safety of kava kava (Piper methysticum) in generalized anxiety disorder. Data were analyzed from three randomized, double-blind, placebo-controlled trials of kava, including one study with an active comparator (venlafaxine), in adult outpatients with DSM-IV generalized anxiety disorder. The pooled sample (n=64) included the following number of participants: kava, n=28; placebo, n=30; and venlafaxine, n=6. Given the comparability of the study designs, the data comparing kava and placebo were then pooled for further efficacy and safety analyses. No significant differences were observed between the treatment groups in any of the trials. In the pooled analyses, no effects were found for kava, while a significant effect in favor of placebo was observed in participants with higher anxiety at baseline. No evidence of hepatotoxicity was found with kava, and all of the treatments were well tolerated. Findings from these three controlled trials do not support the use of kava in DSM-IV generalized anxiety disorder.

Topics: Anxiety Disorders; Cyclohexanols; Double-Blind Method; Female; Humans; Kava; Male; Middle Aged; Phytotherapy; Plant Preparations; Selective Serotonin Reuptake Inhibitors; Venlafaxine Hydrochloride

A need exists to understand illness attribution and treatment beliefs among those seeking botanical treatment for anxiety. The objectives of this study are to evaluate explanatory beliefs about reasons for generalized anxiety disorder (GAD), and to evaluate the extent to which subjects thought different approaches might be most helpful, in a study of botanical treatment.. Post hoc analysis of data from two similarly randomized controlled clinical trails.. Psychiatric research clinic in an academic medical center.. Fifty-one (51) outpatients participating in two randomized, double-blinded, placebo-controlled trials of kava in GAD.. Kava and placebo.. Hamilton Anxiety Scale and Global Improvement Scale.. Subjects thought their conditions were largely related to personality factors, stressful life experiences, or cognitive patterns. These beliefs correlated positively with treatment response, whereas endorsement of belief in an energy imbalance or biologic abnormality correlated negatively with improvement.. Subjects felt more strongly that cognitive patterns, personality and stress were causative of their GAD and of greatest relevance to recovery. Biologic/genetic factors were somewhat relevant, whereas the importance of energy imbalance and spiritual/religious factors were minimal. When treating patients, it is important to consider the patient's belief systems regarding the disorder, as well as credibility of treatment.

Topics: Adult; Anti-Anxiety Agents; Anxiety; Anxiety Disorders; Attitude to Health; Double-Blind Method; Female; Humans; Kava; Male; Middle Aged; Phytotherapy; Plant Extracts; Quality of Life; Spirituality; Surveys and Questionnaires; Time Factors; Treatment Outcome

An 8-week randomized, reference-controlled, double-blind, multi-centre clinical trial investigated Kava-Kava LI 150 in Generalized Anxiety Disorder (GAD; ICD-10: F41.1).. 129 out-patients received either 400 mg Kava LI 150, 10 mg Buspirone or 100 mg Opipramol daily for 8 weeks. At week 9, subjects were seen to check for symptoms of withdrawal or relapse. Primary outcome measures comprised the HAMA scale and the proportion of responders at week 8. Secondary measures were the Boerner Anxiety Scale (BOEAS), SAS, CGI, a self-rating scale for well-being (Bf-S), a sleep questionnaire (SF-B), a quality-of-life questionnaire (AL) and global judgements by investigator and patients.. In 127 patients (ITT) no significant differences could be observed regarding all efficacy and safety measures. About 75% of patients were classified as responders (50% reduction of HAMA score) in each treatment group, about 60% achieved full remission.. Kava-Kava LI150 is well tolerated and as effective as Buspirone and Opipramol in the acute treatment of out-patients suffering from GAD.

Topics: Adult; Aged; Anti-Anxiety Agents; Anxiety Disorders; Buspirone; Double-Blind Method; Drug Administration Schedule; Female; Germany; Humans; Kava; Male; Manifest Anxiety Scale; Middle Aged; Opipramol; Phytotherapy; Plant Extracts; Quality of Life; Sleep; Surveys and Questionnaires; Treatment Outcome

The efficacy and tolerability of 150 mg/d Kava special extract WS 1490 were investigated in a randomized, placebo-controlled, double-blind multicenter study in patients suffering from neurotic anxiety (DSM-III-R diagnoses 300.02, 300.22, 300.23, 300.29, or 309.24). 141 adult, male and female out-patients received 3 x 1 capsule of 50 mg/d WS 1490 or placebo for four weeks, followed by two weeks of observation without study-specific treatment. During randomized treatment the total score of the Anxiety Status Inventory (ASI) observer rating scale showed more pronounced decreases in the WS 1490 group than in the placebo group. Although a treatment group comparison of the post-treatment ASI scores was not significant (p > 0.05), an exploratory analysis of variance across the differences between treatment end and baseline, with center as a second factor, showed superiority of the herbal extract over placebo (p < 0.01, two-sided). 73% of the patients treated with WS 1490 exhibited ASI score decreases > 5 points versus baseline, compared to 56% for placebo. Significant advantages for WS 1490 were also evident in a structured well-being self-rating scale (Bf-S) and the Clinical Global Impressions (CGI), while the Erlangen Anxiety, Tension and Aggression Scale (EAAS) and the Brief Test of Personality Structure (KEPS) showed only minor treatment group differences. Although the results show consistent advantages for WS 1490 over placebo in several psychiatric scales and indicate significant improvements in the patients' general well-being, the differences versus placebo were not as large as in previous trials which employed 300 mg/d of the same extract. WS 1490 was well tolerated, with no influence on liver function tests and only one trivial adverse event (tiredness) attributable to the study drug.

Topics: Administration, Oral; Adolescent; Adult; Aged; Anti-Anxiety Agents; Anxiety Disorders; Double-Blind Method; Female; Germany; Humans; Kava; Male; Middle Aged; Personality Inventory; Phytotherapy; Plant Extracts; Psychomotor Agitation; Severity of Illness Index; Treatment Outcome

We assessed the efficacy and safety of a botanical anxiolytic, Kava kava (Piper methysticum), in treating generalized anxiety disorder (GAD). Thirty-seven adults with DSM-IV GAD were randomly assigned to 4 weeks of double-blind treatment with kava or a matching placebo. Weekly efficacy assessments [Hamilton Anxiety Scale, Hospital Anxiety and Depression Scale (HADS), Self Assessment of Resilience and Anxiety (SARA)] and safety evaluations were conducted. Improvement was observed with both treatments but no differences were found in the principal analysis. Post-hoc analyses revealed significant differences based on baseline anxiety severity, whereby kava was superior on the SARA in low anxiety and placebo was superior on the HADS and SARA in high anxiety. Both treatments were well tolerated. Although kava was not superior to placebo, it would be premature to rule it out as efficacious in GAD.

Topics: Anxiety Disorders; Double-Blind Method; Female; Humans; Kava; Male; Middle Aged; Outpatients; Phytotherapy; Psychiatric Status Rating Scales

101 outpatients suffering from anxiety of non-psychotic origin (DSM-III-R criteria: agoraphobia, specific phobia, generalized anxiety disorder, and adjustment disorder with anxiety) were included in a 25-week multicenter randomized placebo-controlled double-blind trial with WS 1490, a special extract of kava-kava. In the main outcome criterion, the Hamilton Anxiety Scale (HAMA), there was a significant superiority of the test drug starting from week 8 on. WS 1490 was also found to be superior with respect to the secondary outcome variables. HAMA subscores somatic and psychic anxiety, Clinical Global Impression, Self-Report Symptom Inventory-90 Items revised, and Adjective Mood Scale. Adverse events were rare and distributed evenly in both groups. These results support WS 1490 as a treatment alternative to tricyclic antidepressants and benzodiazepines in anxiety disorders, with proven long-term efficacy and none of the tolerance problems associated with tricyclics and benzodiazepines.

Topics: Anti-Anxiety Agents; Anxiety Disorders; Double-Blind Method; Female; Humans; Kava; Male; Middle Aged; Outpatients; Plant Extracts; Plants, Medicinal; Psychiatric Status Rating Scales; Treatment Outcome

Clinical Efficacy of a Kava Extract in Patients with Anxiety Syndrome/Double-blind placebo controlled study over 4 weeks. In a randomized, placebo-controlled double-blind study two groups each containing 29 patients with anxiety syndrome not caused by psychotic disorders were treated for a period of 4 weeks with kava extract WS 1490 (Laitan) 3 x 100 mg/day or a placebo preparation. Therapeutic efficacy was assessed by the Hamilton-Anxiety-Scale (main target variable), the Adjectives-List and the Clinical-Global-Impression-Scale (secondary target variables) after 1, 2 and 4 weeks of treatment. The HAMA overall score of anxiety symptomatology revealed a significant reduction in the drug receiving group already after one week of treatment. This difference between the two groups of patients increased in the course of the study. The results of the secondary target variables were in agreement with the HAMA-score and demonstrate the efficacy of WS 1490 in patients with anxiety disorders. No adverse experiences caused by the medication were noted during the 4 week administration of WS 1490.

Topics: Adolescent; Adult; Anxiety Disorders; Double-Blind Method; Female; Humans; Kava; Male; Middle Aged; Plant Extracts; Plants, Medicinal; Psychiatric Status Rating Scales

Kava is a neuroactive medicinal herb that can induce pharmacological effects when ingested. As an herbal remedy, kava exhibits sedative, anesthetic, euphoriant, and entheogenic effects. Kava is used as a relaxant, pain reliever, and remedy for anxiety and insomnia. In the United States, kava is marketed as a safe dietary supplement. Kava's popularity is on the rise due to heightened awareness and interest in natural plant-based health alternatives. Although meta-analyses and systematic reviews of kava use in treating anxiety are favorable, results remain inconsistent. Due to poor quality control, diversity of kava products, and lack of standardization, health care professionals, such as nurses, advanced practice nurses, physicians, physician assistants, and pharmacists, need to be familiar with the pharmacology, possible polydrug interactions, and management of kava use as a remedy for anxiety-related conditions. The purpose of the current article is to provide an overview of kava and its use as a remedy for psychological issues, such as anxiety and nervousness. [

Topics: Anti-Anxiety Agents; Anxiety; Anxiety Disorders; Humans; Hypnotics and Sedatives; Kava

Prior to the kava ban of 2002, the indication for kava (. Documentation was available from 156 patients. Twelve typical symptoms of nervous anxiety, tension and restlessness were assessed on a five-item rating scale, together with the therapeutic context, the perceived time of onset of effects and the safety of application.. The median duration of treatment was 28 days. All individual symptoms showed significant and clinically relevant improvements. The most effective results were seen for nervous tension and restlessness, with better effects in patients with acute versus chronic complaints. The safety of the treatment was found to be excellent, which included the assessment of laboratory data.. Overall, the study confirms the effective and safe short-term use of kava in the Commission E-defined indication of "nervous anxiety, tension and restlessness", especially in other than chronic cases. The clinical use of kava might be translated into context-related phobias according to ICD-10 F40, or to nervous tension (ICD10 R45.0) or restlessness and excitation (ICD-10 R45.1).

Topics: Anti-Anxiety Agents; Anxiety; Anxiety Disorders; Female; Germany; Humans; Kava; Male; Middle Aged; Phytotherapy; Plant Extracts; Prospective Studies

Kava (Piper methysticum) is an effective anxiolytic that has been withdrawn from various consumer markets in European countries due to concerns over its hepatotoxicity. It is plausible that the reported hepatotoxicity may be due in part to plant substitution, or an incorrect cultivar, or plant parts being used (such as leaves or bark); thus both the plant chemotype and the plant part used may be critical factors. If re-institution of kava in the EU is to occur, more evidence is required to determine its safety and efficacy. Furthermore, according to current evidence, the study of traditional water soluble rhizome extracts using a noble cultivar of kava may be advised. The Kava Anxiety-Lowering Medication (KALM) project is due to start in late 2010 to address these considerations. The KALM project uses an aqueous rhizome extract of a noble cultivar of kava in participants with generalised anxiety and Generalised Anxiety Disorder (GAD). The project comprises of 1) an acute RCT, kava (180 mg of kavalactones) versus oxazepam and placebo in 20 anxious people, testing effects on cognition, mood, anxiety, and driving; 2) an 8-week RCT comparing kava (120 mg kavalactones) versus placebo in 100 patients with GAD. To assess differences between dosages, non-responders at 3 weeks will be titrated to 240 mg of kavalactones. The project will also assess the effects of kava on liver function tests and its side effects profile. A novel component of the project is the pharmacogenomic exploration of phenotypical responses (GABA system and cytochrome P450 markers). The results of the study may be of benefit to sufferers of anxiety and the future economy of the Pacific islands, potentially providing an important step in the way forward with kava.

Topics: Anti-Anxiety Agents; Anxiety; Anxiety Disorders; Europe; Humans; Kava; Liver; Pacific Islands; Phytotherapy; Plant Extracts; Plant Preparations; Plants, Medicinal; Safety; Time Factors

Topics: Anxiety Disorders; Herb-Drug Interactions; Humans; Kava; Liver; Phytotherapy; Plant Extracts

Resilience may be an important component of the prevention of neuropsychiatric disease. Resilience has proved to be quantifiable by scales such as the Connor-Davidson Resilience Scale (CD-RISC). Here, we introduce a two-item version of this scale, the CD-RISC2. We hypothesize that this shortened version of the scale has internal consistency, test-retest reliability, convergent validity, and divergent validity as well as significant correlation with the full scale. Additionally, we hypothesize that the CD-RISC2 can be used to assess pharmacological modification of resilience. We test these hypotheses by utilizing data from treatment trials of post-traumatic stress disorder, major depression, and generalized anxiety disorder with setraline, mirtazapine, fluoxetine, paroxetine, venlafaxine XR, and kava as well as data from the general population, psychiatric outpatients, and family medicine clinic patients.

Topics: Antidepressive Agents; Anxiety Disorders; Clinical Trials as Topic; Cyclohexanols; Depressive Disorder, Major; Fluoxetine; Humans; Kava; Mianserin; Mirtazapine; Paroxetine; Psychometrics; Sertraline; Stress Disorders, Post-Traumatic; Surveys and Questionnaires; Venlafaxine Hydrochloride

For normally distributed data, determination of the appropriate sample size requires a knowledge of the variance. Because of the uncertainty in the planning phase, two-stage procedures are attractive where the variance is reestimated from a subsample and the sample size is adjusted if necessary. From a regulatory viewpoint, preserving blindness and maintaining the ability to calculate or control the type I error rate are essential. Recently, a number of proposals have been made for sample size adjustment procedures in the t-test situation. Unfortunately, none of these methods satisfy both these requirements. We show through analytical computations that the type I error rate of the t-test is not affected if simple blind variance estimators are used for sample size recalculation. Furthermore, the results for the expected power of the procedures demonstrate that the methods are effective in ensuring the desired power even under initial misspecification of the variance. A method is discussed that can be applied in a more general setting and that assumes analysis with a permutation test. This procedure maintains the significance level for any design situation and arbitrary blind sample size recalculation strategy.

Topics: Anxiety Disorders; Clinical Trials as Topic; Humans; Kava; Plant Extracts; Research Design; Sample Size

Topics: Anxiety Disorders; Humans; Kava; Phytotherapy; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome

Topics: Anxiety Disorders; Chemical and Drug Induced Liver Injury; Drug Interactions; Humans; Kava

Topics: Anxiety Disorders; Drug Interactions; Female; Humans; Kava; Male; Phytotherapy; Plants, Medicinal

Topics: Anti-Anxiety Agents; Anxiety; Anxiety Disorders; Female; Humans; Kava; Male; Menopause; Phytotherapy; Plant Extracts; Plants, Medicinal