[The safety of herbal medicines in the psychiatric practice].

The use of alternative medicines is increasing world-wide and in Israel. These drugs, considered by the Ministry of Health as food supplements, are to be obtained at pharmacies and health stores and are being sold freely, without any professional advice. Many of the herbs are used by patients to treat psychiatric disorders. These herbs have a pharmacological activity, adverse effects and interactions with conventional drugs, which can produce changes in mood, cognition, and behavior. We present the most commonly used herbal drugs, and discuss their safety and efficacy in psychiatric practice. Hypericum--used as an antidepressant and as an antiviral medicine, was reported in 23 randomized clinical trials reviewed from the MEDLINE. It was found to be significantly more effective than placebo and had a similar level of effectiveness as standard antidepressants. Recent studies almost clearly prove that this herb, like most of the conventional antidepressants, can induce mania. Valerian--is used as an anti-anxiety drug, and reported to have sedative as well as antidepressant properties. In contrast to the significant improvement in sleep that was found with the use of valerian, compared to placebo, there are several reports on the valerian root toxicity. This includes nephrotoxicity, headaches, chest tightness, mydriasis, abdominal pain, and tremor of the hands and feet. Ginseng--another plant that is widely used as an aphrodisiac and a stimulant. It has been associated with the occurrence of vaginal bleeding, mastalgia, mental status changes and Stevens-Johnson syndrome after it's chronic administration. It has interactions with digoxin, phenelzine and warfarin. Ginkgo--in clinical trials the ginkgo extract has shown a significant improvement in symptoms such as memory loss, difficulties in concentration, fatigue, anxiety, and depressed mood. Long-term use has been associated with increased bleeding time and spontaneous hemorrhage. Ginkgo should be used cautiously in patients receiving aspirin, NSAIDs, anticoagulants or other platelet inhibitors. Health care professionals can no longer ignore the widespread use of alternative medicines and cannot continue with the "don't ask, don't tell" policy. Clinicians should ask the patients about their use of herbs in a non-judgmental way, and should document the patient's use of these drugs. Finally, we must be more aware of the side effects and the potential drug interactions of these herbs, and advise our patients to avoid long term use of these drugs due to lack of information regarding the safety of these medicines.

Medicinal herbs: answers and advice, part 1.

Many herbal medicines have been used for centuries but have only recently been subjected to rigorous scientific scrutiny. Fever-few, milk thistle, tea tree oil, and valerian are considered safe for use by most patients. All four appear to provide some benefits in treating or preventing illness, but the supporting evidence is inconclusive in some cases.

[Phytochemicals as means to induce sleep]. / Phytopharmaka als Mittel zur Schlafförderung.

Phytopharmacons are widely used in Germany. Whereas St. John's wort extracts are prescribed for the treatment of mild forms of depression and kava-kava for unspecified anxiety syndromes, hop, balm, lavender, passiflora and valerian are traditionally administered against nervousness and sleep disturbances. Controlled clinical trials are only available for valerian. However, no sleep inducing potential of valerian was observed, only a certain positive effect on daytime mood. Therefore, the mentioned phytopharmacons cannot be recommended for the treatment of sleep disturbances.

Síndrome de déficit de atención e hiperactividad infantil / Attention deficit and Hyperactivity disorder

La hiperactividad es un trastorno bastante común en niños, considerado actualmente como un síndrome clínico por la medicina científica. La A.P.A. establece 10 síntomas de diagnóstico que se resumen en tres características básicas: impulsividad, distracción e hiperactividad. Existen diversas vías de tratamiento, pero la medicación psiquiátrica supone riesgos considerables. La medicina complementaria ayuda cambiando los patrones dietéticos y mediante la suplementación dietética. Mientras que el azúcar, golosinas, aditivos, etc. se suponen perjudiciales para estos niños, puede resultar muy beneficiosa la suplementación con lípidos ricos en AGPI, vitaminas del grupo B, magnesio, cobre, calcio... al tiempo que también pueden utilizarse plantas sedantes, como por ejemplo, la valeriana, la pasiflora o la melisa. También el regaliz, el hinojo o las bayces se utilizan para acciones fisiológicas diferentes (AU)

Valerian as a hypnotic for Hispanic patients.

Valerian is a botanical used for its sedative effects whose central nervous system activity is ascribed to multiple constituents. Twenty-three established outpatient symptomatic Hispanic volunteers receiving mental health services at a large urban hospital participated in this case study. All complained of insufficient sleep. They were asked to try a popular national brand of valerian ("Nature's Way", 470 mg valerian root) and completed sleep questionnaires at baseline and at the end of Weeks 1 and 2. They were instructed to take 1 capsule each night before retiring and were allowed to increase their dose to a maximum of 3 capsules after Week 1. Twenty patients completed the trial. On an ordinal scale of 1 (no effect), 3 (moderately helpful), and 5 (extremely helpful), 16 patients rated their insomnia as at least "moderately improved" at the end of Week 1. By Week 2, 16 still rated themselves at least "moderately improved," but 15 of them now described their response as either a 4 or a 5. Global improvement at Week 2 was significantly better than at Week 1 (Wilcoxon ranks test p = .005), perhaps reflecting a time-dependent or dose-response relationship. This case study suggests that valerian can be a supplement for improving insomnia in a symptomatic population.

Who uses over-the-counter psychotropics? Characteristics, functioning, and (mental) health profile.

As part of a population study on the prevalence of psychopathology, users of "Over-The-Counter" Psychotropics (OTC-Ps) were studied. First, their mental health profile was examined by a number of subjective and objective assessments. Second, the medical consumption of the users was studied with special attention to the psychotropic drugs prescribed. The prevalence of psychological problems and symptoms of psychological distress was higher among OTC-P users than among non-users. Somatic problems and symptoms were comparable in the two groups; social support was better in the OTC-P users. Half of the users were known to have mental health problems by their Primary Care Physician (PCP). The DSM IV Axis I disorders were mostly mood and anxiety disorders. A benzodiazepine had been prescribed to one-third of the OTC-P users. No other psychotropic drugs had been prescribed, and the medical consumption was comparable in the two groups. PCPs should be aware of concomitant OTC-Ps use.

Critical evaluation of the effect of valerian extract on sleep structure and sleep quality.

A carefully designed study assessed the short-term (single dose) and long-term (14 days with multiple dosage) effects of a valerian extract on both objective and subjective sleep parameters. The investigation was performed as a randomised, double-blind, placebo-controlled, cross-over study. Sixteen patients (4 male, 12 female) with previously established psychophysiological insomnia (ICSD-code 1.A.1.), and with a median age of 49 (range: 22 to 55), were included in the study. The main inclusion criteria were reported primary insomnia according to ICSD criteria, which was confirmed by polysomnographic recording, and the absence of acute diseases. During the study, the patients underwent 8 polysomnographic recordings: i.e., 2 recordings (baseline and study night) at each time point at which the short and long-term effects of placebo and valerian were tested. The target variable of the study was sleep efficiency. Other parameters describing objective sleep structure were the usual features of sleep-stage analysis, based on the rules of Rechtschaffen and Kales (1968), and the arousal index (scored according to ASDA criteria, 1992) as a sleep microstructure parameter. Subjective parameters such as sleep quality, morning feeling, daytime performance, subjectively perceived duration of sleep latency, and sleep period time were assessed by means of questionnaires. After a single dose of valerian, no effects on sleep structure and subjective sleep assessment were observed. After multiple-dose treatment, sleep efficiency showed a significant increase for both the placebo and the valerian condition in comparison with baseline polysomnography. We confirmed significant differences between valerian and placebo for parameters describing slow-wave sleep. In comparison with the placebo, slow-wave sleep latency was reduced after administration of valerian (21.3 vs. 13.5 min respectively, p<0.05). The SWS percentage of time in bed (TIB) was increased after long-term valerian treatment, in comparison to baseline (9.8 vs. 8.1% respectively, p<0.05). At the same time point, a tendency for shorter subjective sleep latency, as well as a higher correlation coefficient between subjective and objective sleep latencies, were observed under valerian treatment. Other improvements in sleep structure - such as an increase in REM percentage and a decrease in NREM1 percentage - took place simultaneously under placebo and valerian treatment. A remarkable finding of the study was the extremely low number of adverse events during the valerian treatment periods (3 vs. 18 in the placebo period). In conclusion, treatment with a herbal extract of radix valerianae demonstrated positive effects on sleep structure and sleep perception of insomnia patients, and can therefore be recommended for the treatment of patients with mild psychophysiological insomnia.

Dietary supplements and natural products as psychotherapeutic agents.

Alternative therapies are widely used by consumers. A number of herbs and dietary supplements have demonstrable effects on mood, memory, and insomnia. There is a significant amount of evidence supporting the use of Hypericum perforatum (St. John's wort) for depression and Ginkgo biloba for dementia. Results of randomized, controlled trials also support the use of kava for anxiety and valerian for insomnia. Although evidence for the use of vitamins and amino acids as sole agents for psychiatric symptoms is not strong, there is intriguing preliminary evidence for the use of folate, tryptophan, and phenylalanine as adjuncts to enhance the effectiveness of conventional antidepressants. S-adenosylmethionine seems to have antidepressant effects, and omega-3 polyunsaturated fatty acids, particularly docosahexaenoic acid, may have mood-stabilizing effects. More research should be conducted on these and other natural products for the prevention and treatment of various psychiatric disorders.

The scientific basis for the reputed activity of Valerian.

The underground organs of members of the genus Valeriana (Valerianaceae), as well as related genera such as Nardostachys, are used in the traditional medicine of many cultures as mild sedatives and tranquillizers and to aid the induction of sleep. V. officinalis is the species most commonly used in northern Europe and still retains its official pharmacopoeial status although it is most commonly encountered as an ingredient of herbal medicines. This plant is still the subject of considerable research aimed at establishing the chemical and pharmacological basis of the activity which has been clearly shown in a number of animal and clinical studies. The constituents of the volatile oil are very variable due to population differences in genetics and to environmental factors. The major constituents include the monoterpene bornyl acetate and the sesquiterpene valerenic acid, which is characteristic of the species, in addition to other types of sesquiterpene. Some of these have been shown to have a direct action on the amygdaloid body of the brain and valerenic acid has been shown to inhibit enzyme-induced breakdown of GABA in the brain resulting in sedation. The non-volatile monoterpenes known as valepotriates were first isolated in 1966 and contribute to the overall activity by possessing sedative activity based on the CNS although the mode of action is not clearly known. The valepotriates themselves act as prodrugs which are transformed into homobaldrinal which has been shown to reduce the spontaneous motility of mice. More recent studies have shown that aqueous extracts of the roots contain appreciable amounts of GABA which could directly cause sedation but there is some controversy surrounding the bioavailability of this compound. Another recent finding is the presence of a lignan, hydroxypinoresinol, and its ability to bind to benzodiazepine receptors. Valerian is a good example of both the negative and positive aspects of herbal drugs. The considerable variation in its composition and content as well as the instability of some of its constituents pose serious problems for standardization but the range of components which contribute to its overall activity suggest that it may correct a variety of underlying causes of conditions which necessitate a general sedative or tranquilizing effect.

[Medicinal baths for treatment of generalized fibromyalgia]. / Medizinalbader zur therapie der generalisierten fibromyalgie.

OBJECTIVE: We studied whether whirl baths with plain water or with water containing pine oil or valerian have a different influence on pain, disturbed sleep or tender point count. METHODS: A randomized, comparative and investigator-blinded study was performed. Out-patients with generalized fibromyalgia were randomized into three treatment groups. INTERVENTIONS: Therapy consisted of either whirl bath with plain water or with the addition of pine oil or valerian. The baths were carried out 10 times, three times a week. MAIN OUTCOME MEASURES: General pain, change of pain intensity during the day, general well-being and occurrence of disturbed sleep were recorded before and after the therapy. The number of tender points was assessed by digital palpation, the pain threshold on the shinbone and the middle part of the deltoid muscle was measured by the dolorimeter of A. Fischer. The same instrument was used for recording pain threshold and pain tolerance of both trapezius muscles. The tissue compliance of these muscles was measured as well. RESULTS: 30 out of 39 patients included in the study were evaluated statistically. After treatment with valerian bath (n = 12) well-being and sleep were significantly improved and also the tender point count decreased significantly. Pine oil added to the bath water (n = 7) resulted in a significant improvement of well-being, but unfortunately also in a significant decrease of pain threshold of the shinbone and the right deltoid muscle. Whirl bath in plain water (n = 11) reduced general and maximum pain intensity significantly. CONCLUSIONS: Our cautious conclusion of this study is - with respect to the small number of treated patients - that different effects of whirl baths with or without medicinal bath oils can be detected in fibromyalgia patients. Plain water baths modify the pain intensity, medicinal baths improve well-being and sleep.

Herbal remedies in psychiatric practice.

Patients' use of alternative and complementary health services has created a need for physicians to become informed about the current literature regarding these treatments. Herbal remedies may be encountered in psychiatric practice when they are used to treat psychiatric symptoms; produce changes in mood, thinking, or behavior as a side effect; or interact with psychiatric medications. English-language articles and translated abstracts or articles (where available) found on MEDLINE and sources from the alternative/complementary health field were reviewed. Each herb was assessed for its safety, side effects, drug interactions, and efficacy in treating target symptoms or diagnoses. A synopsis of the information available for each herb is presented. In many cases the quantity and quality of data were insufficient to make definitive conclusions about efficacy or safety. However, there was good evidence for the efficacy of St John's wort for the treatment of depression and for ginkgo in the treatment of memory impairment caused by dementia. More research is required for most of the herbs reviewed, but the information published to date is still of clinical interest in diagnosing, counseling, and treating patients who may be taking botanical remedies.

Over-the-counter psychotropics: a review of melatonin, St John's wort, valerian, and kava-kava.

Use and availability of alternative healthcare products have revived in the last few years. The prevalence of supplement use in the United States is largely unknown but is thought to be widespread. In this article, four of the common substances used to treat emotional problems are reviewed. The plant or substance description, clinical indications, evidence of therapeutic efficacy, mechanisms of therapeutic actions, dosages and regimens, different commercially available preparations, and adverse effects and toxicities are described for melatonin, St John's wort, valerian, and kava-kava. That a product is "natural" does not mean that it is either safe or effective. Many supplements are potent drugs that lack sufficient data on safety, dose-response relationships, drug interactions, and purity.

A comparison of two methods for adaptive interim analyses in clinical trials.

Recently, two methods for planning and conducting two-stage procedures were proposed (Bauer and Köhne, 1994, Biometrics 50, 1029-1041; Proschan and Hunsberger, 1995, Biometrics 51, 1315-1324). Both procedures allow the termination of the trial with the early acceptance of H0 in the absence of a treatment effect after performing the first stage of the study. Furthermore, the observed treatment effect at stage I can be used for planning and redesigning the second stage of the study in a way that protects the Type I error rate. The exact Type I error rate of the Proschan and Hunsberger approach is derived. It is shown that the two methods lead to similar decision rules with negligibly small differences in power and expected sample size. In terms of providing design tools and practical applicability, however, they differ. The practical performance of the procedures is discussed and recommendations for their use are given.

Beyond benzodiazepines: alternative pharmacologic agents for the treatment of insomnia.

OBJECTIVE: To review the epidemiology, etiology, and classification of insomnia and provide an overview of the pharmacologic therapy of insomnia. Novel nonbenzodiazepine hypnotics including zolpidem, zopiclone, and zaleplon, as well as nonprescription products such as valerian and melatonin, are reviewed in detail. DATA SOURCES: A MEDLINE search was performed to identify relevant clinical studies, case reports, abstracts, and review articles published between April 1992 and December 1997. Key search terms included insomnia, benzodiazepines, zolpidem, zopiclone, zaleplon, Cl 284,846, melatonin, and valerian. Additional references were obtained from the lists of review articles and textbooks. DATA EXTRACTION AND SYNTHESIS: Data concerning the safety and efficacy of the hypnotic agents were extracted from all available clinical trials and abstracts. Background information regarding insomnia, benzodiazepines, and other hypnotics was extracted from the most current literature, including review articles and textbooks. CONCLUSIONS: New developments in benzodiazepine receptor pharmacology have introduced novel nonbenzodiazepine hypnotics that provide comparable efficacy to benzodiazepines. Although they may possess theoretical advantages over benzodiazepines based on their unique pharmacologic profiles, they offer few, if any, significant advantages in terms of adverse effects. Over-the-counter agents such as valerian and melatonin may be useful in alleviating mild, short-term insomnia, but further clinical trials are required to fully evaluate their safety and efficacy.

Enfermedades crónicas, reflexión y formación de subjetividad / Chronic illnesses, reflection and formation of subjectivity

En el arduo trabajo de conceptualizar una epistemología homeopática, uno de los temas a tratar debe ser el de la formación de la subjetividad homeopática, ésta es parte importante y supuestamente natural en el acto médico-paciente. Una manera de no naturalizarla y por ende ignorarla, es su estudio crítico, como intenta en este artículo