FWD 2 Expanded Commission E: Valerian root

Herbal Medicine: Expanded Commission E

Valerian root

Latin Name: Valeriana officinalis
Pharmacopeial Name: Valerianae radix
Other Names: garden valerian, Mexican valerian, garden heliotrope, Pacific valerian, Indian valerian

Overview

Valerian is an extremely polymorphous perennial herb represented by a complex of sub-species with natural populations dispersed over temperate and sub-polar Eurasian zones, naturalized in northeastern America, now extensively cultivated in Holland, Belgium, France, Germany, eastern Europe, Japan, and the United States(Bradley, 1992; Wichtl and Bisset, 1994).New sub-species evolve by the mechanism of polyploidy (changes in chromosome number). Twelve mainly European sub-species, such as exaltata (diploid), nitida (tetraploid), and procurrens (octaploid), and some transitional types have been defined (Bradley, 1992; Titz et al., 1982, 1983). Valerian is one of Germany's most important medicinal plant crops (Lange and Schippmann, 1997).The material of commerce is obtainedfrom Belgium and France, the former U.S.S.R., and China (BHP, 1996; Leung and Foster, 1996; Wichtl and Bisset, 1994).

Its modern day therapeutic uses in Germany and the United States stem from traditional Greek medicine, originally documented by Hippocrates (ca. 460–377 B.C.E.) and later by Dioscorides (first century C.E.), author of De Materia Medica. Galen (ca. 130–200 C.E.) prescribed valerian for insomnia. Dioscorides and Galen referred to the drug as "phu"as an expression of aversion from its offensive odor. The current genus name, Valeriana, first came into use around the tenth century C.E. In the medical texts of that period, the names "Valeriana," "phu," and "fu" are used synonymously (Bown, 1995; Brown, 1995; Grieve, 1979). Although the sedative properties of valerian have been recognized for at least two thousand years, the constituents responsible for this effect and their mode of action remain unknown, despite considerable pharmacological and clinical studies confirming the empirically recognized sedative effect (ESCOP, 1997; Tyler, 1998). Today, valerian root (Valeriana officinalis L.s.l.) is official in the national pharmacopeias ofAustria,France,Germany,Great Britain,Hungary, Russia, Switzerland, and the European Pharmacopoeia, among others(BP, 1988; Bradley, 1992; DAB, 1997; Newall et al., 1996; AB, 1981; Ph.Eur.3, 1997; Ph.Fr.X, 1990; Ph.Helv.VII, 1987; Ph.Hg.VII, 1986; USSR X, 1973; Wichtl and Bisset, 1994). Japanese valerian root (V. fauriei Briquet) is official in the national pharmacopeia of Japan (JP XII, 1993). Indian valerian root (V. jatamansi Jones; syn. V. wallichii DC) is used in Indian Ayurvedic, Tibetan Buddhist, and traditional Chinese medicines (Clifford, 1984; Kapoor, 1990; Leung and Foster, 1996; Nadkarni, 1976).

In Germany, valerian isofficial in the German Pharmacopoeia, approved in the Commission E monographs, and licensed as both a standard medicinal tea infusion and as a standard medicinal tincture, 66.3 vol.% alcohol(BAnz, 1998; Bradley, 1992; Braun et al., 1997; DAB, 1997; Meyer-Buchtela, 1999; Schilcher, 1997; Wichtl and Bisset, 1994). It is used by itself in fresh pressed juice, drops, tea, and coated tablets (e.g., Baldrian-Pflanzensaft Nerventrost® and Valdispert®Drage) but more often used in manysedative and nerve teas (e.g., Nerven- und Schlaf-Tee N and Species Sedativae AB). Valerian is used in approximately sixty hypnotic/sedative drugs (Kneipp®, 1996; Schilcher, 1997; Wichtl and Bisset, 1994).For example, valerian is a main component in the licensed drug Beruhigungstee I (Sedative Tea I), composed of 40% valerian root, 20% hop strobile, 15% lemon balm leaf, 15% peppermint leaf, and 10% orange peel (Braun et al., 1997). It is also a main component in an approved Commission E "Sedative Tea," composed of 40% valerian root, 30% passion flower herb, and 30% lemon balm leaf (BAnz, 1998; Schilcher, 1997). InGerman pediatric medicine, valerianaqueous infusions, alcoholic tinctures diluted in milk or fruit juice, and cold macerates are used. In popular medicine, the cold macerate is considered the most efficacious (Schilcher, 1997). In the United States, valerian root is widely used in sleep aids and sedatives in alcoholic tincture, aqueous infusion, and capsules and tablets. Crude valerian root, fluidextract, alcoholic tincture, and ammoniated tincture were formerly official in the United States Pharmacopoeia and National Formulary (Grieve, 1979; Leung and Foster, 1996).

In 1992, the European-American Phytomedicines Coalition (EAPC) formally petitioned the U.S. Food and Drug Administration to review and approve valerian as an over-the-counter drug in the night-time sleep aid category (Pinco and Israelsen, 1994). At the time of publication of this book (Fall, 1999) the FDA had not yet responded to this petition. In 1998, the USP stated in a consumer information bulletin that the USP Advisory Panel did not recommend or support the use of valerian because it believed that there have not been an adequate number of clinical studies of sufficient size or duration to adequately support valerian's reported uses, although its overall safety was recognized by the USP (USP, 1998).

Modern human studies have investigated valerian's use by itself and in combination with other herbs for a variety of conditions: in combination with hops (Humulus lupulus) as an alternative to benzodiazepine to treat nonchronic and non-psychiatric sleep disorders (Schmitz and Jackel, 1998), its use in combination with hops as a sedative to treat disturbed sleep (M ller-Limmroth and Ehrenstein, 1977), its effects in combination with hops on vigilance (Gerhard et al., 1996), its use in combination with St. John's wort (Hypericum perforatum) as an alternative to diazepam to treat symptoms of anxiety (Panijel, 1985), its use in combination with camphor (Cinnamomum camphora), night-blooming cereus (Echinocereus grandiflorus), and hawthorn (Crataegus spp.) to treat functional cardiovascular disorders, hypotension, or meteorosensitivity (Busanny-Caspari et al., 1986), its effect on sleep latency and sleep quality in patients suffering from insomnia (Kamm-Kohl et al., 1984; Leathwood et al., 1982; Leathwood and Chauffard, 1982–1983, 1985), its effectiveness and tolerability in patients with insomnia (Vorbach et al., 1996), its effect on poor sleep (Lindahl and Lindwall, 1989), its effect on human sleep in healthy, young subjects (Balderer and Borbely, 1985), its effect on sleep polygraphy in poor sleepers (Schulz et al., 1994), its ability to treat nervous sleep disorders (Schmidt-Voigt, 1986), and its ability to treat control disorders of the autonomic nervous system (Boeters, 1969).

One randomized, double-blind, controlled clinical trial in parallel group design investigated the efficacy and tolerability of a hop-valerian preparation compared with a benzodiazepine preparation in patients suffering from sleep disorders according to DSM-IV criteria. (The DSM-IV is the Diagnostic and Statistical Manual of Mental Disorders. 1995. Washington: American Psychiatric Press). Sleep quality, fitness, and quality of life were determined by psychometric tests, psychopathologic scales, and sleep questionnaires at the beginning of the therapy, end of therapy (duration two weeks), and one week after therapy. The patient's state of health improved during therapy with both substances and a deterioration after cessation was reported for both preparations. Withdrawal symptoms were only reported in the benzodiazepine group. The authors concluded that the hop-valerian preparation in an appropriate dose is a sensible alternative to benzodiazepine for the treatment of nonchronic and non-psychiatric sleep disorders (Schmitz and Jackel, 1998).

In one double-blind, placebo-controlled, crossover study with 128 volunteers, the effects of a valerian root aqueous dry extract (approx. 3:1) on sleep latency and sleep quality were investigated. For nine nights, 400 mg of valerian extract or placebo were taken in crossover design. Compared to placebo, the extract produced significant improvements in sleep latency and in sleep quality, particularly in relatively poor sleepers (ESCOP, 1997; Leathwood and Chauffard, 1982–1983; Leathwood et al., 1983).

In a double-blind, placebo-controlled randomized study, 27 adult males and females suffering from insomnia compared a valerian extract preparation (ValerinaNatt®) with placebo on successive nights. ValerinaNatt® tablets (Pharbio Medical Sverige, Oslo, Sweden) contain 100 mg valerian extract (4:1), corresponding to 400 mg dried root, 45 mg hops extract (8.5:1), corresponding to 382 mg dried strobile, 25 mg lemon balm leaf (Melissa officinalis) extract (6.5:1), corresponding to 162 mg dried leaf, and 275 mg of excipient materials. The investigators stated that the valerian root extract, contained in this preparation, is composed mainly of sesquiterpenes as opposed to valepotriates. The subjects ingested either 400 mg of drug (4 tablets) or placebo each night for two nights. The results were based on a subjective evaluation method using a self-reporting scale. By comparison with placebo, the valerian preparation demonstrated a good and statistically significant effect on poor sleep (p<0.001). In the drug group, 89% reported improved sleep, 78% rated the valerian preparation better than placebo, and 44% reported perfect sleep. No adverse side effects were reported for either group (ESCOP, 1997; Lindahl and Lindwall, 1986, 1989; NetDoktor.dk, 1999; Pharbio Medical, 1999).

In a double-blind, placebo-controlled, parallel-group study, the effects of acute and repeated treatment with a valerian extract preparation (Valdispert forte®) were studied in 14 elderly female patients suffering from insomnia over a seven day period. Valdispert® forte coated tablets (Solvay Arzneimittel, Hannover, Germany) contain 45 mg valerian root dry aqueous alkaline extract (5–6:1), corresponding to 225–270 mg of dried root, and are standardized to contain 0.05 mg valerenic acid and acetoxyvalerenic acid. A daily dose of 405 mg of the valerian preparation (3 tablets, three times daily) was administered to eight subjects and the other six received placebo. Objective and subjective sleep parameters were investigated using methods including polysomnography for recording the electroencephalogram (EEG) and a self-reporting scale. Polysomnography was conducted on three nights, at one-week intervals (N0, N1, N2). N0 was one week prior to treatment, N1 was one hour before first night of treatment, and N2 was on the last night of treatment. Increased short-wave-sleep (SWS) was reported for the valerian group as well as a decrease in sleep stage 1. Rapid eye movement (REM) sleep was unaltered. Based on the EEG data, there were no significant changes in sleep latency, waking time, or sleep quality. The authors hypothesized that the valerian extract preparation increased SWS in subjects with low baseline values, which implies that sleep quality may be improved only under certain conditions (ESCOP, 1997; NetDoktor.dk, 1999; Schulz et al., 1994; Solvay Pharma, 1998; Upton, 1999).

The approved modern therapeutic applications for valerian appear to be supportable based on its history of use in well established systems of traditional and conventional medicine,extensive phytochemical investigations, many in vitro and in vivo pharmacological experiments in animals,and some human clinical studies.

Pharmacopeial grade valerian root consists of the rhizome, root, and stolons of V. officinalis L.s.l., dried carefully at a temperature below 40?C. The fresh undried root must contain not less than 5% (v/m) volatile oil and the dried pulverized rootmust contain not less than 15% water- and alcohol-soluble (40% water and 60% ethanol) extractive. Botanical identity must be confirmed by thin-layer chromatography (TLC), macroscopic and microscopic examinations, and organoleptic evaluation(DAB 10, 1993; Ph.Eur.3, 1997;Wichtl and Bisset, 1994).The ESCOP valerian root monograph requires that the material comply with the European Pharmacopoeia (ESCOP, 1997).

Pharmacopeial grade valerian root dry extract is composed of the native extractive yielded from DAB-grade valerian root manufactured in accordance with the DAB Extracta monograph. The drug-to-extract ratio ranges from 3:1 to 6:1 (w/w). Identification is confirmed with TLC and organoleptic evaluation (DAB, 1997).

Description

Valerian root, consisting of fresh underground plant parts, or parts carefully dried below 40?C, of the species V. officinalis L. [Fam. Valerianaceae] and its preparations in effective dosage. The roots contain essential oil with monoterpenes and sesquiterpenes (valerenic acids). Preparations of valerian used therapeutically (infusion, extract, fluidextract, and tincture) no longer contain the thermolabile and chemically unstable valepotriates.

Chemistry and Pharmacology

Constituents include valtrates, didrovaltrates, and isovaltrates (Leung and Foster, 1996). Other constituents include 0.4–1.4 % monoterpenes and sesquiterpenes, caffeic, gamma-aminobutyric (GABA), and chlorogenic acids, b-sitosterol, methyl,2-pyrrolketone, choline, tannins, gum, alkaloids, and resin (Bradley, 1992; ESCOP, 1997; Newall et al., 1996).

The Commission E reported sedative and sleep-promoting activities.

Uses

The Commission E approved the internal use of valerian for restlessness and sleeping disorders based on nervous conditions.

Valerian has been reported to relieve pain, reduce spasms, and stimulate appetite (Newall et al., 1996).

The World Health Organization notes the following uses for valerian that are supported by clinical data: mild sedative and sleep-promoting agent, often used as a milder alternative or a possible substitute for stronger synthetic sedatives, e.g., benzodiazepines, in the treatment of states of nervous excitation and anxiety-induced sleep disturbances (WHO, 1999).

Contraindications

None known.

Side Effects

None known.

Use During Pregnancy and Lactation

No restrictions known.

Interactions with Other Drugs

None known.

Dosage and Administration

Unless otherwise prescribed:

Infusions: 2-3 g of fresh or dried root per cup, once to several times per day.

Tincture: 1/2-1 teaspoon (1-3 ml), once to several times per day.

Extracts: Amount equivalent to 2-3 g of preparation, once to several times per day.

External use: 100 g for one full bath; equivalent preparations.

Infusion: 2-3 g in 150 ml water.

References

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.1989. Double blind study of a valerian preparation. Pharmacol Biochem Behav 32(4):10651066.

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Nadkarni, K.M. 1976. Indian Materia Medica. Bombay: Popular Prakashan. 12601261.

NetDoktor.dk. 1999. Naturlaegemidler. Denmark: NetDoktor.dk. Available at: www.netdoktor.dk/naturlaegemidler/fakta/valerianen.htm

Newall, C.A., L.A. Anderson, J.D. Phillipson. 1996. Herbal Medicines: A Guide for Health-Care Professionals. London: The Pharmaceutical Press.

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Pharbio Medical. 1999. Vra produkter. Oslo, Sweden: Pharbio Medical AS. Available at: www.pharbio.cederroth.com

Ph.Eur.3. See Europäisches Arzneibuch.

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Pinco, R.G. and L.D. Israelson. 1994. European-American Phytomedicines Coalition Citizen Petition to Amend FDA's Monograph on Nighttime Sleep-aid Drug Products for Over-the-Counter ('OTC') Human Use to Include Valerian. Jun 7.

Schilcher, H. 1997. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart: Medpharm Scientific Publishers. 59, 62.

Schmidt-Voigt, J. 1986. Die Behandlung nervser Schlafstrungen und innerer Unruhe mit einem rein pflanzlichen Sedativum. Therapiewoche 36:663667.

Schmitz, M. and M. Jackel. 1998. [Comparative study for assessing quality of life of patients with exogenous sleep disorders (temporary sleep onset and sleep interruption disorders) treated with a hops-valerian preparation and a benzodiazepine drug] [In German]. Wien Med Wochenschr 148(13):291298.

Schulz, H., C. Stolz, J. M ller. 1994. The effect of valerian extract on sleep polygraphy in poor sleepers: A pilot study. Pharmacopsychiat 27(4):147151.

Solvay Pharma. 1998. Beruhigungsmittel and Antidepressiva. Hannover, Germany: Solvay Arzneimittel. Available at: www.solvay.com/de/gesundh.htm

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Additional Resources

Boss, R. et al. 1997. Valeriana species. In: De Smet, P.A., K. Keller, R. Hnsel, R.F. Chandler, (eds.). Adverse Effects of Herbal Drugs, Vol. 3. New York: Springer Verlag.

Bravo, S.Q. et al. 1996. Polysomnographic and subjective findings in insomniacs under treatment with placebo and valerian extract (LI 156). (Proceedings of the 2nd International Congress on Phytomedicine, Munich, Germany.) Eur J Clin Pharmacol 50(6):552.

Diefenbach, K. et al. 1997. Valerian effects on microstructure of sleep in insomniacs. (2nd Congress of the European Assoc. for Clinical Pharmacology and Therapeutics, Berlin, Germany, Sept. 1720.) Eur J Clin Pharmacol 52 (suppl.):A169.

Donath, F. and I. Roots.1996. Effects of valerian extract (Sedonium) on EEG power spectrum in male healthy volunteers after single and multiple application. (6th Annual Meeting of the German Society for Clinical Pharmacology and Therapeutics, Dresden, Germany, Sept. 57.) Eur J Clin Pharmacol 50(6):541.

DreBring, H., 1992. Insomnia: are valerian/balm combinations of equal value to Benzodiazepine? Therapiewoche 42:726.

Fauteck, J.D., B. Pietz, H. Winterhoff, W. Wittowski. 1996. Interaction of Valeriana officinalis with melatonin receptors: a possible explanation of its biological action. (Proceedings of the 2nd International Congress on Phytomedicine, Munich, Germany.)

Kohnen, R., W.D. Oswald. 1988. The effects of valerian, Propranolol and their combination on activation, performance and mood of healthy volunteers under social stress conditions. Pharmacopsychiat 21(6):447448.

Lindahl, O. and L. Lindwall. 1992. Double-blind study of valopotriates by hairy root cultures of Valeriana officinalis var. sambucifolia. Planta Med 58(7):A614.

Quispe, B.S. et al. 1997. The influence of valerian on objective and subjective sleep in insomniacs. (2nd Congress of the European Assoc. for Clinical Pharmacology and Therapeutics, Berlin, Germany, Sept. 1720.) Eur J Clin Pharmacol 52 (suppl.):A170.

Sanner, B., A. Strum. 1997. Treatment of sleep disorders in the elderly. DMW (Deutsche Medizinische Wochenschrift) 122(5152):15991604.

Santos, M.S. et al. 1994. Synaptosomal GABA release as influenced by valerian root extractinvolvement of the GABA carrier. Arch Int Pharmacodyn 327(2):220231.

Santos, M.S. et al. 1994. The amount of GABA present in aqueous extracts of valerian is sufficient to account for [3H]GABA release in synaptosomes. Planta Med 60(5):475476.

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This material was adapted from The Complete German Commission E MonographsTherapeutic Guide to Herbal Medicines. M. Blumenthal, W.R. Busse, A. Goldberg, J. Gruenwald, T. Hall, C.W. Riggins, R.S. Rister (eds.) S. Klein and R.S. Rister (trans.). 1998. Austin: American Botanical Council; Boston: Integrative Medicine Communications.

1) The Overview section is new information.

2) Description, Chemistry and Pharmacology, Uses, Contraindications, Side Effects, Interactions with Other Drugs, and Dosage sections have been drawn from the original work. Additional information has been added in some or all of these sections, as noted with references.

3) The dosage for equivalent preparations (tea infusion, fluidextract, and tincture) have been provided based on the following example:

  • Unless otherwise prescribed: 2 g per day of [powdered, crushed, cut or whole] [plant part]
  • Infusion: 2 g in 150 ml of water
  • Fluidextract 1:1 (g/ml): 2 ml
  • Tincture 1:5 (g/ml): 10 ml

4) The References and Additional Resources sections are new sections. Additional Resources are not cited in the monograph but are included for research purposes.

This monograph, published by the Commission E in 1994, was modified based on new scientific research. It contains more extensive pharmacological and therapeutic information taken directly from the Commission E.

Excerpt from Herbal Medicine: Expanded Commission E Monographs
Copyright 2000 American Botanical Council
Published by Integrative Medicine Communications
Available from the American Botanical Council.