Valerian Group Research Articles

Efficacy of Valerian Extract on Sleep Quality after Coronary Artery bypass Graft Surgery: A Triple-Blind Randomized Controlled Trial.

To assess the effect of valerian root extract on the sleep quality of patients after coronary artery bypass graft (CABG) surgery. The patients who participated in this triple-blind clinical trial were selected by permuted block randomization. The participants were assigned to the valerian (n=36) and placebo (n=36) groups. The valerian group received 530 mg of valerian capsules for 30 nights after CABG surgery, and the placebo group received 530 mg of the placebo capsules containing wheat flour. The Pittsburgh Sleep Quality Index (PSQI), the prothrombin time (PT) and partial thromboplastin time (PTT) were assessed on four occasions, including the baseline, the 3rd, 14th and 30th days following intervention. The odds ratio of worsened sleep quality significantly varied over time (the interaction of time and group) in the valerian group compared to the placebo group in various dimensions including total sleep quality (P=0.001), sleep latency (P<0.01), sleep duration (P=0.020), sleep efficiency (P=0.001) and daytime dysfunction (P=0.025). No significant difference was observed in the alterations of the odds ratio of PT in the two groups over time. (P=0.371). The consumption of oral valerian root extract over 30 nights could significantly improve the patients' sleep quality safely after CABG surgery.

The Effect of Valerian and Ginger on Dysmenorrhea: A Randomized Clinical Trial

Objectives: Dysmenorrhea is a frequent complaint in young females. In recent years, researchers have grown an interest in the use of herbal drugs to decrease menstrual pain given the side effects of chemical drugs. This project was conducted to evaluate the effect of valerian and ginger on the duration of pain and analgesic use in dysmenorrhea. Materials and Methods: This triple-blind randomized clinical trial was performed on 210 dormitory females who were randomly divided into valerian, ginger, and control groups after opening an envelope. In this study, 250 and 350 mg of ginger and valerian in each capsule were administered, respectively, and 250 mg sugar was used as a placebo. The number of days with pain and analgesic use were evaluated as well. Finally, descriptive (percentage and mean) and inferential (t test, post hoc, and chi-square at a significance level of 0.05) statistics were used to analyze the data. Results: The results of the study showed a marginally significant difference in the duration of pain between ginger (1.61±0.64 days) and control (2.12±0.81 days) groups (P=0.052), and significant difference between ginger (1.61±0.64 days) and valerian (2.53±1.43 days) groups (P=0.001). The mean days of analgesic use among the three groups were not different significantly (P&gt;0.05). However, the mean severity of symptoms significantly differed between ginger (0.73±0.28) and control (0.3±0.04) groups and increased in the ginger group (P=0.003). Conclusions: In general, the administration of valerian and ginger at the doses used in this study failed to produce desirable analgesic effects and thus could not decrease the symptoms associated with dysmenorrhea

The Effects of Lavender, Valerian, and Oxazepam on Anxiety Among Hospitalized Patients with Coronary Artery Disease

Background and Objectives: Patients with coronary artery disease (CAD) experience different levels of anxiety during their hospital stay. Untreated anxiety among these patients can increase the risk of further cardiac events. The current study aimed at comparing the effects of lavender, valerian, and oxazepam on anxiety among hospitalized patients with CAD. Methods: As a double-blind, randomized, placebo-controlled, clinical trial, the current study was conducted in 2016 on 120 patients with CAD hospitalized in the cardiac care unit (CCU) of Valiasr (PBUH) Hospital, Birjand, Iran. Patients were conveniently recruited and randomly allocated to 30-patient lavender, valerian, oxazepam, and placebo groups using the permuted-block randomization method. Patients in these groups orally received 80 mg of lavender essential oil, 400 mg of valerian essential oil, a 10-mg oxazepam tablet, and 5 mL of distilled water, respectively, 1 hour before bedtime in 3 consecutive nights. Data were collected before and after the intervention via a demographic questionnaire and the Spielberger state-trait anxiety inventory. The data were analyzed with SPSS version 21.0 based on descriptive statistics measures (such as mean, standard deviation, and frequency distributions) using inferential statistics (such as the Chi-square test, the paired-samples t test, the one-way analysis of variance (ANOVA), and Tukey range test). The level of significance was set to 0.05). However, the mean score of total anxiety significantly decreased in all groups, with the greatest decrease in the lavender group, followed by the valerian, oxazepam, and placebo groups (P < 0.05). The pretest-posttest mean differences of state anxiety were significantly greater in the valerian and the lavender groups than the oxazepam and the placebo groups. Moreover, the pretest-posttest mean difference of trait anxiety was significantly greater in the lavender group than the other groups. In addition, the pretest-posttest mean difference of total anxiety was significantly greater in the lavender group than the other groups and in the valerian group it was significantly greater than the oxazepam and the placebo groups (P < 0.05). Conclusions: Oral intake of lavender and valerian essential oils was as effective as oxazepam in alleviating anxiety among patients with coronary artery disease. Of course, the anxiolytic effects of lavender were stronger than those of valerian. These medicinal plants can be good substitutes for chemical anxiolytic medications. Of course, further studies are needed to produce more reliable evidence in this realm.

The effect of Valerian on the severity and frequency of hot flashes: A triple-blind randomized clinical trial

ABSTRACTValerian is one of the most widely used herbal supplements and a phytoestrogenic herb. The aim of this study was to determine the effect of Valerian on the severity and frequency of hot flashes. This triple-blind, randomized, controlled clinical trial was conducted during a three-month period in Hamadan, Iran, in 60 postmenopausal women aged 45–55 years. Participants were randomly assigned to one of two groups– either placebo or Valerian. An oral Valerian 530 mg capsule was given twice per day for two months. An oral placebo 530 mg capsule (starch) was similarly administered. The severity and frequency of hot flashes were determined by the Kupperman index, before the intervention, one month after, and two months after initiation of the intervention. The severity of hot flashes in the Valerian group was significantly lower than that in the placebo group at one (p = .048) and two months (p = .020) after initiation of the intervention. Compared with the placebo group, the mean frequency of hot flashes was significantly reduced two months after initiating the use of Valerian (p = .033). Health-care providers should consider Valerian to be effective for menopausal women with hot flashes.

Effect of Valerian in Preventing Neuropsychiatric Adverse Effects of Efavirenz in HIV-Positive Patients: A Pilot Randomized, Placebo-Controlled Clinical Trial.

Several neuropsychiatric adverse effects of efavirenz are known. Preventing these adverse effects may improve patients' adherence to antiretroviral therapy (ART). To evaluate the efficacy and safety of valerian in preventing neuropsychiatric adverse effects of efavirenz in HIV-positive patients. In this pilot randomized, double-blinded, placebo-controlled, clinical trial, 51 HIV-positive patients who were receiving efavirenz were recruited into the valerian (n = 25) or placebo (n = 26) group. Patients received valerian (530 mg) or placebo nightly 1 hour before sleep for 4 weeks. The neuropsychiatric status (sleep, anxiety, depression, suicidal thought, and psychosis) of patients was assessed at baseline and week 4 using validated questionnaires. Sleep ( P ≤ 0.001) and anxiety ( P = 0.001) significantly improved in the valerian group compared with the placebo group. Dizziness was the most common complaint of patients in first days of the intervention. In the valerian and placebo groups, 92% and 84.6% of patients experienced dizziness, respectively ( P = 0.35). Nausea was the second common adverse effect that 84% and 76.9% of patients in the valerian and placebo groups experienced ( P = 0.39). In the first 4 weeks of ART including efavirenz, valerian significantly improved sleep and anxiety in HIV-positive patients. Valerian may be considered as a potential option in preventing neuropsychiatric adverse effects of efavirenz in HIV-positive patients.

Comparison of valerian extract and diazepam on anxiety before orthopedic surgery

Introduction: anxiety has a negative effect on healing and tissue repair and spending too much mental and physical energy during prolonged stress can cause hospitalization and delay in discharge of patients. One method of reducing anxiety is the use of medicinal plants that in this study the effects of valerian root on the anxiety was examined. The aim of this study was to Comparison of valerian extract and diazepam on anxiety before orthopedic surgeryMaterials and Methods: In this double blind clinical trial study, 60 patients 15-60 years old referred to Imam Ali (AS) hospital of Bojnoord were selected as available and were also randomly divided into two groups of 30 individuals. At 21 pm before surgery, group 1 received 10 drops of valerian edible oil and group 2 received diazepam (5 mg) mixed in 50 ml of tap water. The Spielberger questionnaire was used to assess anxiety before intervention and one hour before initiation of surgery was recorded. Data was analyzed using statistical tests . The level of significance was measured 0/05 in this study.Results: In this study, in the valerian group there were 83.8% male and 16.7%% female while diazepam group included 23.3% male and 76.7 females. The Difference score of overt and covert anxiety in valerian group was 10.1±1.0 and 12.4±1.3 and in the diazepam group was 9.3±1.1 and 10.7±.03. Comparison of two groups showed no significant difference .Conclusion: Valerian has a good anti-anxiety and can be a substitute for chemical medicines after enough studies

Modulation of corticospinal excitability by valerian officinalis root extract: A neuropharmacological Transcranial Magnetic Stimulation (TMS) study

IntroductionValerian officinalis roots extract is a popular medication for insomnia and anxiety treatment. Sedative effect of Valerian is mainly attributed to the modulation of gabaergic transmission, but its pharmacodynamics has not been fully elucidated.ObjectsTo investigate the acute effects of Valerian Officinalis extracts intake on corticoexcitability as measured by TMS.AimsTo obtain further data on Valerian pharmacodynamics.MethodsTwelve healthy volunteers participated in a double-blind randomized crossover placebo-controlled study. They were required to take either 900 mg of Valerian officinalis extract (valerenic acid 0.8%) or placebo. Focal TMS of the hand area of left motor cortex was used to test Resting motor threshold (RMT), Motor evoked potentials (MEPs) amplitude and silent period duration (SP). We also tested Short-interval Intracortical Inhibition (SICI), Intracortical facilitation (ICF), Short and Long afferent Inhibition (SAI and LAI). All parameters were investigated at baseline, 1 hour and 6 hours after drug intake. After a 3-week washout period the subjects switched to the alternate arm of the study.ResultsA mixed RMANOVA revealed a significant main effect of “time” [F(1,22) = 4.03, P = 0.02] and a significant “treatment × time” interaction [F(1,22) = 6.3, P = 0.003]. Post-hoc analysis indicated that the amount of ICF was significantly reduced 1 hour after Valerian intake (P = 0.01) returning to baseline values after 6 hours. No significant changes between the Valerian and placebo groups were observed for the other parameters investigated.ConclusionsThe modulation of ICF induced by Valerian officinalis is likely due to glutamatergic antagonism and might underlie the anti-anxiety therapeutic effects.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Valerian inhibits rat hepatocarcinogenesis by activating GABA(A) receptor-mediated signaling.

Valerian is widely used as a traditional medicine to improve the quality of sleep due to interaction of several active components with the γ-aminobutyric acid (GABA) A receptor (GABA(A)R) system. Recently, activation of GABA signaling in stem cells has been reported to suppress cell cycle progression in vivo. Furthermore, possible inhibitory effects of GABA(A)R agonists on hepatocarcinogenesis have been reported. The present study was performed to investigate modulating effects of Valerian on hepatocarcinogenesis using a medium-term rat liver bioassay. Male F344 rats were treated with one of the most powerful Valerian species (Valeriana sitchensis) at doses of 0, 50, 500 and 5000 ppm in their drinking water after initiation of hepatocarcinogenesis with diethylnitrosamine (DEN). Formation of glutathione S-transferase placental form positive (GST-P+) foci was significantly inhibited by Valerian at all applied doses compared with DEN initiation control rats. Generation of 8-hydroxy-2′-deoxyguanosine in the rat liver was significantly suppressed by all doses of Valerian, likely due to suppression of Nrf2, CYP7A1 and induction of catalase expression. Cell proliferation was significantly inhibited, while apoptosis was induced in areas of GST-P+ foci of Valerian groups associated with suppression of c-myc, Mafb, cyclin D1 and induction of p21Waf1/Cip1, p53 and Bax mRNA expression. Interestingly, expression of the GABA(A)R alpha 1 subunit was observed in GST-P+ foci of DEN control rats, with significant elevation associated with Valerian treatment. These results indicate that Valerian exhibits inhibitory effects on rat hepatocarcinogenesis by inhibiting oxidative DNA damage, suppressing cell proliferation and inducing apoptosis in GST-P+ foci by activating GABA(A)R-mediated signaling.

Can Valeriana officinalis root extract prevent early postoperative cognitive dysfunction after CABG surgery? A randomized, double-blind, placebo-controlled trial.

We hypothesized that valerian root might prevent cognitive dysfunction in coronary artery bypass graft (CABG) surgery patients through stimulating serotonin receptors and anti-inflammatory activity. The aim of this study was to evaluate the effect of Valeriana officinalis root extract on prevention of early postoperative cognitive dysfunction after on-pump CABG surgery. In a randomized, double-blind, placebo-controlled trial, 61 patients, aged between 30 and 70years, scheduled for elective CABG surgery using cardiopulmonary bypass (CPB), were recruited into the study. Patients were randomly divided into two groups who received either one valerian capsule containing 530mg of valerian root extract (1,060mg/daily) or placebo capsule each 12h for 8weeks, respectively. For all patients, cognitive brain function was evaluated before the surgery and at 10-day and 2-month follow-up by Mini Mental State Examination (MMSE) test. Mean MMSE score decreased from 27.03 ± 2.02 in the preoperative period to 26.52 ± 1.82 at the 10th day and then increased to 27.45 ± 1.36 at the 60th day in the valerian group. Conversely, its variation was reduced significantly after 60days in the placebo group, 27.37 ± 1.87 at the baseline to 24 ± 1.91 at the 10th day, and consequently slightly increased to 24.83 ± 1.66 at the 60th day. Valerian prophylaxis reduced odds of cognitive dysfunction compared to placebo group (OR = 0.108, 95% CI 0.022-0.545). We concluded that, based on this study, the cognitive state of patients in the valerian group was better than that in the placebo group after CABG; therefore, it seems that the use of V. officinalis root extract may prevent early postoperative cognitive dysfunction after on-pump CABG surgery.

2363 – Effect of valerian on sleep quality in menopausal women: a randomized placebo- controlled clinical trial

Sleep problems, can lead to low quality of life in Menopausal women. There are a wide variety of pharmacologic and nonpharmacologic methods for solving it. Some of Herbal Medicine, which have low side effect, may be useful for management of sleep disturbance during this time. Aim To evaluate effects of valerian extract on improvement of sleep quality in menopause women. Material and methods In this randomized, triple- blind, controlled trials 100 volunteer menopause women with age 50–60, who had insomnia and selected from 250 volunteers, had been visited in Public clinics of West of Tehran. Instrument includes demographic form and Pittsburg sleep quality index (PSQI). Samples randomly divided to two groups. Each group received twice a day for four weeks 530 mg of concentrated Valerian extract or 50 mg Starch as placebo in capsules. Results Equality of personal characteristics and sleep quality before intervention were checked and there were no differences in two groups. Valerian led to significant decrease in average of PSQI in compared to placebo (Valerian before intervention: 9.8 ± 3.6, after one month intervention: 6.02 ± 2.6) (Placebo before intervention: 11.14 ± 4.3, after one month intervention: 9.4 ± 3.9) (p = 0.000). Also 30% of valerian group and 4% of placebo group had important improvement in sleep quality, which was decreasing of 5 score of PSQI. There were significant difference between two groups (p = 0.00). Conclusion Findings from this study add to the scientific evidence that support use of valerian in the clinical management of insomnia especially in menopausal women.

Effects of valerian on the severity and systemic manifestations of dysmenorrhea

Objective To evaluate the impact of valerian—a herb with sedative effects and antispasmodic effects on smooth muscles—on the severity of dysmenorrhea. Methods In a double-blind, randomized, placebo-controlled trial, 100 students were randomly assigned to receive valerian (n = 49) or placebo (n = 51). Valerian (dose 255 mg) was given 3 times daily for 3 days beginning at the onset of menstruation, for 2 consecutive menstrual cycles. At baseline and during the intervention cycles, the pain severity was evaluated with a visual analog scale and the systemic manifestations were assessed using a multidimensional verbal scale. Results The pain severity at baseline did not differ significantly between the groups. After the intervention, the pain severity was significantly reduced in both groups ( P < 0.001), but the extent of the reduction was larger in the valerian group, with the difference between the 2 groups being statistically significant ( P < 0.05). The total scores of the systemic manifestations associated with dysmenorrhea decreased after the intervention, but there was no significant difference between the groups, with the exception for syncope ( P < 0.05). Conclusion Valerian seems to be an effective treatment for dysmenorrhea, probably because of its antispasmodic effects.

Effect of valerian extract treatment on experimental pulmonary fibrosis in rats

Objective To evaluate the effects and mechanism of valerian extract treatment on bleomycin-induced pulmonary fibrosis of rats. Methods After healthy Wistar rats(irrespective of sex)were given diethyl ether inhalation anesthesia, giving a single intratracheal instillation of bleomycin at a dose of 5 mg/kg to make a pattern of pulmonary fibrosis. 65 survival rats were randomly divided into four groups: Valerian high-dose groups(n = 16), Valerian low-dose groups(n = 16), Colchicine group(n = 16)and Model group (n = 17).Each group was given a dose of 100 mg/kg valeian extract everyday, a dose of 20 mg/kg valeian extract Valeian extract , a dose of 100μg/kg colchicine and a dose of 10ml/kg after second day. And in each groups, 6 rats were killed on day 7, 10 rats were killed on day 28 after instillation respectively. Rats in control group (n = 8) were instilled with saline intractracheally and saline was given everyday with a dose of 10ml/kg. Control group was killed on day 28. After rats were killed, The right lower pulmonary lobes were harvested for HE-staining, Masson-staining was used to observe the transformation of pulmonary tissue and immunohistochemistry was used to examine transforming growth factor-β1 (TGF-β1) which was analyzed by image analysis system. Results No obvious transformation were found in control group. The alveolitis in valerian and colchicine groups were ameliorated, compared with model group on day 7. The expressions of TGF-β1 in control group were lower than that in model group, and the mean integrated optical densities of TGF-β1 in control group were lower than that in mod-el group(P<0.05). The pulmonary fibrosis in valerian and colchicine group were ameliorated, compared with model group on day 28. The expressions of TGF-β1 in valerian and colchicine group were lower than that in model group. There were no significant differences between the valerian group and the colchicine group. Conclusion Valerian extract could reduce the degree of alveolitis and fibrosis induced by bleo-mycin through suppressing of TGF-β1. Key words: Valeriana officinali △/PD; Pulmonary fthrosis; Transforming growth factor beta

Effectiveness of the Homeopathic Preparation Neurexan®Compared with that of Commonly used Valerian-Based Preparations for the Treatment of Nervousness/Restlessness – an Observational Study

Mild anxieties, nervousness, and restlessness are common in the general population and are commonly treated by complementary and alternative medical (CAM) therapies. A prospective, nonrandomized, noninterventional, observational study, using conventional or CAM practices, was conducted in 49 German practices. Each practice could include up to 15 subjects treated with either the homeopathic preparation Neurexan® or with combination formulations based on valerian extracts. There was no placebo group. Choice and doses of study therapies were at the respective physician's discretion. The planned treatment duration was 2 weeks. A total of 826 subjects were included in the study and 777 (553 Neurexan and 224 valerian) subjects were available for the final examination. Subjects receiving Neurexan tended to weigh less, to have fewer concomitant illnesses and slightly milder severity of nervousness/restlessness, and were likelier to be female than the subjects receiving valerian therapies. The summary score for nervousness/restlessness was reduced from 19.0 ± 6.1 at baseline to 7.4 ± 6.8 at the end of the observation period in the Neurexan group, a reduction of 11.5 ± 7.3 score units. In the valerian group, the summary score was reduced from 21.4 ± 6.0 to 12.6 ± 7.3, a reduction of 9.0 ± 6.6 score units. The changes from baseline and the differences between the groups were statistically significant. Similar significant differences in effects were seen on the subscores and on the subjects' assessments of effectiveness. Both study therapies were well tolerated. Neurexan appears to be an effective and well-tolerated alternative to valerian-based combination therapies for the treatment of nervousness/restlessness in subjects favorable towards a CAM-based therapy.

Potentially adverse interactions between haloperidol and valerian

This study was designed to determine whether the treatment with haloperidol (HP), valerian or both in association impairs the liver or kidney functions. Valerian alone did not affect oxidative stress parameters in the liver or kidney of rats. HP alone only increased glutathione (GSH) depletion in liver, but not in kidney. However, when HP was associated with valerian, an increase in lipid peroxidation levels and dichlorofluorescein (DCFH) reactive species production was observed in the hepatic tissue. Superoxide dismutase (SOD) and Catalase (CAT) activities were not affected by the HP plus valerian treatment in the liver and kidney of rats. HP and valerian when administered independently did not affect the activity of hepatic and renal δ-aminolevulinate dehydratase (δ-ALA-D), however, these drugs administered concomitantly provoked an inhibition of hepatic δ-ALA-D activity. The δ-ALA-D reactivation index was higher in rats treated with HP plus valerian than other treated groups. These results strengthen the view that δ-ALA-D can be considered a marker for oxidative stress. Serum aspartate aminotransferase (AST) activity was not altered by any treatment. However, serum alanine aminotransferase (ALT) activity was higher in the HP group and HP plus valerian group. Our findings suggest adverse interactions between haloperidol and valerian.

The Homeopathic Preparation Neurexan® vs. Valerian for the Treatment of Insomnia: An Observational Study

Insomnia is prevalent and complementary therapies are common, but data are lacking on the effectiveness and tolerability of preparations beyond valerian. Here we report on an open-label, prospective cohort study in 89 German centers offering both conventional and complementary therapies. Subjects received the homeopathic preparation Neurexan® or valerian for 28 days. Doses were at physicians' judgments. Sleep duration and latency were evaluated based on patients' sleep diaries over 14 days; sleep quality was evaluated at 28 ± 1 days. A total of 409 subjects were enrolled. The groups were balanced at baseline for age, sex, weight, and sleep disturbances. At day 14, both groups reported improved sleep latency and duration; latency was reduced from baseline by 37.3 ± 36.3 min with Neurexan and by 38.2 ± 38.5 min with valerian. The duration of sleep increased by 2.2 (±1.6) h in the Neurexan group and by 2.0 (±1.5) h in the valerian group. Differences between the groups in improvement on sleep duration were significantly in favor of Neurexan therapy at days 8, 12, and 14. At day 28, quality of sleep was improved in both groups with no significant differences between the treatments. Significantly more patients reported lack of daytime fatigue with Neurexan than with valerian therapies (49% vs. 32%; p < 0.05 for the comparison). For patients favorable towards a CAM-based therapy, Neurexan might be an effective and well-tolerated alternative to conventional valerian-based therapies for the treatment of mild to moderate insomnia.

A televised, web-based randomised trial of an herbal remedy (valerian) for insomnia.

BackgroundThis trial was conducted as part of a project that aims to enhance public understanding and use of research in decisions about healthcare by enabling viewers to participate in research and to follow the process, through television reports and on the web. Valerian is an herbal over-the-counter drug that is widely used for insomnia. Systematic reviews have found inconsistent and inconclusive results about its effects.MethodsParticipants were recruited through a weekly nationally televised health program in Norway. Enrolment and data collection were over the Internet. 405 participants who were 18 to 75 years old and had insomnia completed a two week diary-keeping run-in period without treatment and were randomised and mailed valerian or placebo tablets for two weeks. All participants and investigators were blind to treatment until after the analysis was completed.FindingsFor the primary outcome of a minimally important improvement in self-reported sleep quality (≥0.5 units on a 7 point scale), the difference between the valerian group (29%) and the placebo group (21%) was not statistically significant (difference 7.5%; 95% CI-0.9 to 15.9; p = 0.08). On the global self-assessment question at the end of the treatment period 5.5% (95% CI 0.2 to 10.8) more participants in the valerian group perceived their sleep as better or much better (p = 0.04). There were similar trends favouring the valerian group for night awakenings (difference = 6.0%, 95% CI-0.5 to 12.5) and sleep duration (difference = 7.5%, 95% CI-1.0 to 16.1). There were no serious adverse events and no important or statistically significant differences in minor adverse events.InterpretationBased on this and previous studies, valerian appears to be safe, but with modest beneficial effects at most on insomnia compared to placebo. The combined use of television and the Internet in randomised trials offers opportunities to answer questions about the effects of health care interventions and to improve public understanding and use of randomised trials.Trial RegistrationControlled-Trials.com ISRCTN72748991

An Internet-Based Randomized, Placebo-Controlled Trial of Kava and Valerian for Anxiety and Insomnia

The herbal extracts kava and valerian are the leading dietary supplements used in the self-management of anxiety and insomnia, respectively. There is limited evidence to support their effectiveness for these common symptoms. The Internet has been used to a limited extent for research, but it is not known whether randomized controlled trials can be conducted entirely using Internet technology. We performed a randomized, double-blind, placebo-controlled trial using a novel Internet-based design to determine if kava is effective for reducing anxiety and if valerian is effective for improving sleep quality. E-mail recruitment letters and banner advertisements on websites were used to recruit a large pool of interested participants (1551) from 45 states over an 8-week period. Participants were first asked to read study information, complete an online informed consent process, and undergo electronic identity verification. In order to be eligible for the study, participants were required to have 1) anxiety as documented by scores of at least 0.5 standard deviations above the mean on the State-Trait Anxiety Inventory State subtest (STAI-State) on 2 separate occasions, and 2) insomnia, defined as a "problem getting to sleep or staying asleep over the past 2 weeks." We randomly assigned 391 eligible participants to 1 of the following 3 groups, and mailed 28 days' supply: kava with valerian placebo (n = 121), valerian with kava placebo (n = 135), or double placebo (n = 135). The primary outcome measures were changes from baseline in anxiety (STAI-State questionnaire) and insomnia (Insomnia Severity Index [ISI]) compared with placebo. Participants receiving placebo had a 14.4 point decrease in anxiety symptoms on the STAI-State score and an 8.3 point decrease in insomnia symptoms on the ISI. Those receiving kava had similar reductions in STAI-State score (2.7 point greater reduction in placebo compared with kava; 95% confidence interval [CI], -0.8 to +6.2). Those receiving valerian and placebo had similar improvements in sleep (0.4 point greater reduction in the placebo than the valerian group; 95% CI, -1.3 to +2.1). Results were similar when limited to the 83% of participants who adhered to study compounds for all 4 weeks. Neither kava nor valerian relieved anxiety or insomnia more than placebo. This trial demonstrates the feasibility of conducting randomized, blinded trials entirely via the Internet.

The Effect of Valerian Extract on Sleep Polygraphy in Poor Sleepers: A Pilot Study

The effect of acute and repeated treatment (seven days) with a valerian extract (Valdispert forte, 405 mg t.i.d.) on objective and subjective measures of sleep was studied. Polysomnography was conducted in 14 elderly poor sleepers on three nights, at one-week intervals (N0, N1, N2). N0 was an adaptation night, N1 and N2 the first and last night under treatment. Six subjects received placebo and eight subjects valerian. Subjects in the valerian group showed an increase in slow-wave sleep (SWS) and a decrease in sleep stage 1. Density of K-complexes was increased under active treatment. There was no effect on sleep onset time or time awake after sleep onset. REM sleep was unaltered. There was also no effect on self-rated sleep quality. We hypothesize that valerian increases SWS in subjects with low baseline values.