No. 34 February 2010 Herbs & Nutrients for the Treatment of Anxiety & Insomnia Magnolia & Zizyphus Lemon Balm Magnolia officinalis bark is used in traditional Chinese Leaf or aerial parts of Lemon Balm (Melissa officinalis) are used in western traditional medicine for sleep disorders of nervous origin, neurasthenia and dyspepsia associated with anxiety or depression.8,9 Weiss described the main indications as a nervous heart, a nervous stomach and difficulties in going to sleep.10 It was highly regarded by Paracelsus, who believed it would "completely revivify a man", and would be of great use in "all complaints supposed to proceed from a disordered state of the nervous system".11 medicine (TCM) for abdominal pain and distention, dyspepsia and asthma.1 Magnolia bark has been an important component of formulations in traditional Japanese medicine (Kampo) for the treatment of psychological and neurological conditions, including anxiety, insomnia and depression. In this case it is Magnolia obovata bark that is used, although both species are used in TCM.2 Zizyphus spinosa seed is used in TCM to quieten the spirit, for dream-disturbed sleep, insomnia, irritability, palpitations with anxiety and spontaneous or night sweats.3,4 Suanzaorentang is a TCM formula containing mainly Zizyphus spinosa seed. It has been investigated in controlled trials. One study of patients with anxiety found that it significantly improved mood, decreased sympathetic nervous system symptoms and improved performance.5 Another study of patients with sleep disorders found a significant improvement in sleep quality and well-being without side effects.6 Clinical Study: Magnolia & Zizyphus A blend of Magnolia officinalis bark and Zizyphus spinosa seed was evaluated in an open study in the United States, which involved 295 volunteers with mild to moderate sleep difficulties.7 The daily dosage corresponded to Magnolia officinalis bark (1.2 g) and Zizyphus spinosa seed (1.3 g), taken one hour before going to bed, every night for at least 2 weeks. The volunteers were assessed by questionnaire at baseline and after treatment. Of the 145 participants that returned one questionnaire, • 86.9% found the herbal treatment to be relaxing, • 82.8% rated it as assisting in a restful sleep, • 82.8% rated it as effective in reducing fatigue. In the group of volunteers that returned two or more questionnaires (treatment was extended to average of 4.2 months in total) the scores were higher. Overall, the herbal treatment was well tolerated: 18 participants (6%) reported mild complaints; the most common (in 8 individuals) was feeling groggy the next morning. Clinical Studies Three placebo-controlled clinical studies investigated the acute administration (single doses) of Lemon Balm in healthy volunteers. Increased calmness was observed.12-14 In one study, the most notable effects were observed at a dosage of 1.6 g of dried leaf.12 In a double-blind trial, 30 patients with anxiety and sleep difficulties were randomised to receive Lemon Balm extract or placebo for a period of 15 days. The daily dosage corresponded to 3.9 g of Lemon Balm leaf. Compared to placebo, patients treated with Lemon Balm extract experienced:15 • 49% less anxiety, • 72% fewer anxiety-associated symptoms (12 symptoms measured including emotional instability, mental confusion, asthenia, difficulty with food), • 39% less insomnia. Lavender Oil The flower and essential oil of the flower of Lavender (Lavandula angustifolia (L. officinalis)) have been used traditionally, in oral doses, in France for a range of conditions including irritability, physical and mental debility, melancholia, anxiety, nervous crises, insomnia, sluggish digestion and spasm. The essential oil, when taken internally, is given in a dose of 2 to 5 drops, 2 to 3 times a day.16 The Commission E advises Lavender flower and its essential oil for restlessness, insomnia and abdominal complaints. For these indications, Lavender oil is prescribed in a daily dose of 1–4 drops, about 20-80 mg.9 Lavender oil was administered in an aqueous solution of honey or alcohol, or on a sugar cube.9,16 © Copyright 2010 MediHerb. Not for Public Distribution. For Education of Health Care Professionals Only. 1 Clinical Trials A 4-week randomised, double-blind trial found a combination of imipramine (a tricyclic antidepressant) and Lavender tincture was more effective than imipramine alone for the treatment of mild to moderate depression. The combination produced a better and earlier improvement. The administered dosage of Lavender 1:5 tincture was 60 drops per day.17 The essential oil is an important component of Lavender flower tincture. Based on this dose, 12 to 18 mg of Lavender oil per day is adequate. Oral administration of essential oil of the flower of Lavandula angustifolia was as effective as lorazepam (0.5 mg/day, a benzodiazepine) in adults with generalised anxiety disorder. Seventy-seven patients were randomised and received treatment for 6 weeks. Hamilton Anxiety Rating Scale scores decreased from baseline by 45% in the Lavender oil group and 46% in the lorazepam group. Other measures of anxiety, worry, severity of illness and sleep disturbance improved to a similar extent in both groups. Serious adverse events did not occur. A causal assessment of adverse events indicated: 9 of 11 mild to moderate adverse events in the Lavender oil group were gastrointestinal (nausea, burping, dyspepsia); and 6 of 7 patients experienced fatigue in the lorazepam group.18 The preparation is insufficiently defined but the dosage is likely to be 80 mg/day of Lavender oil.19 In an open trial, the same preparation and dosage reduced anxiety, restlessness and depression in patients with neurasthenia and posttraumatic stress disorder.19,20 Magnesium Due to its role as a cofactor in more than 300 enzyme systems, deficiency of magnesium can result in a wide variety of symptoms, including many of a neurological, neuromuscular or neuropsychiatric nature. Physically, these may include lethargy, insomnia, tremors, and spasms and/or weakness of the muscles. Additional psychological and emotional symptoms may include depression, mental confusion, decreased attention span, hyperirritability or hyperexcitability and varying degrees of personality change.21-25 Deficiency of magnesium is surprisingly widespread, with dietary surveys showing that the average daily consumption of the mineral by Australian adults is 10-20% below the recommended dietary intake (RDI).21,26 These dietary deficits may be compounded by prolonged stress and/or sleep deprivation, both of which deplete magnesium levels (perhaps because excretion is promoted as a consequence of the increased secretion of catecholamines such as epinephrine, norepinephrine and dopamine).24,27 In a vicious cycle, some substances popularly used to aid stress coping (such as fatty foods, alcohol, soft drinks and coffee) may exacerbate the situation by inhibiting the absorption of magnesium or further enhancing its excretion.24,28,29 Low magnesium levels have been observed in a wide range of mood and mental health disorders, from premenstrual syndrome (PMS), seasonal affective disorder and age-related insomnia and memory decline through to severe depression and acute schizophrenia.25,29-32 Even when no underlying pathology is present, magnesium levels have a significant correlation with mood and well-being. In research published in 2008, healthy women without psychiatric disorders who had low serum magnesium levels were found to have a significantly greater risk of depressed moods than women with high serum magnesium.33 In other supplementation studies, taking magnesium has been shown to improve premenstrual mood swings, symptoms of depression in older people (specifically those newly diagnosed with diabetes) and insomnia and disturbed sleep related to restless leg syndrome.24,34,35 Vitamin B6 is required for magnesium absorption, and the two nutrients are co-factors in the conversion of tryptophan to serotonin, which is in turn converted to melatonin. The metabolic pathway involved may be inhibited by deficiency of either nutrient, as well as by stress, increasing age and/or insulin resistance.25,28 Vitamin B6 Vitamin B6 is involved in an enormous number of bodily functions. After consumption, pyridoxine is metabolised into the metabolically active form of vitamin B6 pyridoxal 5’-phosphate (P5P, sometimes also referred to as PLP). P5P is a co-enzyme in nearly 100 enzymatic reactions.22 In addition to its role in the conversion of tryptophan (and subsequently to serotonin, melatonin and niacin), P5P is a co-factor in the synthesis of other neurotransmitters involved in stress coping, including gamma-aminobutyric acid (GABA) and dopamine (which is in turn converted into epinephrine and norepinephrine).22,28 Vitamin B6 deficiency may consequently have a significant impact on brain function; low levels of these neurotransmitters may be linked to the development of depression and other neuropsychological disorders including Parkinson’s disease and tardive dyskinesia.36 Levels of vitamin B6 may also influence the ability to cope with emotional stressors. For example, men with deficient vitamin B6 levels who have been recently bereaved show greater levels of depression, fatigue and confused moods than men who have adequate vitamin B6. It is hypothesised that this effect may be due to the negative impact of inadequate vitamin B6 on serotonin and GABA levels.24,37 © Copyright 2009 MediHerb. Not for Public Distribution. For Education of Health Care Professionals Only. 2 Aside from depression, other nervous system symptoms of vitamin B6 deficiency may include weakness, sleeplessness, irritability, confusion and an inability to concentrate.21-23,25,36 Marginal deficiency of vitamin B6 is very common. In some studies, 71–100% of subjects have not obtained the RDI from their diets.24 Older people are considered at particular risk.36 Dietary shortfall may be exacerbated by gastric atrophy, alcohol abuse, liver dysfunction and smoking.22,23,25 Use of the oral contraceptive pill has also been associated with low vitamin B6 levels, and in the 1970s, several clinical studies found treatment with vitamin B6 to be an effective treatment for depression that occurred as an adverse effect of the pill.25 Vitamin B6 is also used to relieve premenstrual depression and a range of other PMS symptoms, and in this context may work in part by enhancing cellular uptake of magnesium.24,25 Synergistic Formulation These herbs and nutrients would complement each other in a very potent formulation with anxiolytic, mild sedative and mood-elevating activity. Cyracos Product Information. Available online: http://www.npicenter.com/images/profile/naturex/Cyracos_503078 _Marketing_brochure_03.pdf. Accessed November 2009. 16 Valnet J. The Practice of Aromatherapy, translated from the French by Campbell R and Houston L, edited by Tisserand RB. Saffron Walden, Daniel, 1982. 17 Akhondzadeh S et al. Prog Neuropsychopharmacol Biol Psychiatry 2003; 27: 123 18 Woelk H, Schlafke S. Phytomedicine 2010; 17: 94 19 Dienell A, Noldner M, inventor. Use Of Lavender Oil For The Prophylaxis And Treatment Of Neurasthenia, Somatization Disorders And Other Stress-Associated Diseases. United States Patent Application Publication No. 20080124410. 2008 May 29. 20 Stange R et al. Focus Alternat Complement Ther 2007; 12(Suppl): 46 21 National Health and Medical Research Council. Nutrient reference values for Australia and New Zealand, including recommended dietary intakes. Commonwealth of Australia, Canberra, 2006. 22 Shils ME et al. Modern nutrition in health and disease, 9th Edn. Williams and Wilkins, Pennsylvania, 1999. 23 Mahan LK, Escott-Stump S. Krause’s food, nutrition and diet therapy, 10th Edn. WB Saunders, Pennsylvania, 2000. 24 Braun L, Cohen M. Herbs and natural supplements: an evidence-based guide, 2nd Edn. Churchill Livingstone Elsevier, Sydney, 2007. 25 Pizzorno JE, Murray MT. Textbook of natural medicine, 3rd Edn. Churchill Livingstone Elsevier, Missouri, 2006. 26 McLennan W, Podger A. National nutrition survey: Nutrient intakes and physical measures, Australia, 1995. Commonwealth of Australia, Canberra, 1998. 27 Tanabe K et al. Jpn Circ J 1998; 62: 341 28 Head KA, Kelly GS. Altern Med Rev 2009; 14: 114 29 Johnson S. Med Hypotheses 2001; 56: 163 30 Durlach J et al. Magnes Res 2002; 15: 263 31 Killalea DW, Maier JAM. Magnes Res 2008; 21: 77 32 Nechifor M. Magnes Res 2008; 21: 97 33 Jung KI et al. Biol Trace Elem Res 2010; 133: 153 34 Barragán-Rodríguez L et al. Magnes Res 2008; 21: 218 35 Hornyak M et al. Sleep 1998; 21: 501 36 Malouf R, Grimley Evans J. Cochrane Database Syst Rev 2003, (4): CD004393 37 Baldewicz T et al. Psychosom Med 1998; 60: 297 Authors: Michelle Morgan, Jayne Tancred © Copyright 2010 MediHerb. Indications • • • • • • Anxiety. Insomnia, sleeplessness, restlessness. Nervous tension, stress. Depression, irritability. Gastrointestinal upset due to anxiety. Premenstrual anxiety and moodiness. Cautions and Contraindications Magnolia bark should be used with caution in pregnancy. REFERENCES 1 Chang HM, But PP (eds). Pharmacology and Applications of Chinese Materia Medica. Vol 2. World Scientific, Singapore, 1987. 2 Maruyama Y, Kuribara H. CNS Drug Rev 2000; 6: 35 3 Pharmacopoeia Commission of the People’s Republic of China. Pharmacopoeia of the People’s Republic of China, English Edn, Volume I. Chemical Industry Press, Beijing, 1997. 4 Bensky D, Clavey S, Stoger E. Chinese Herbal Medicine: Materia Medica, 3rd Edn. Eastland Press, Seattle, 2004. 5 Chen HC et al. Int J Clin Pharmacol Ther Toxicol 1986; 24: 646 6 Chen HC, Hsieh MT. Clin Ther 1985; 7: 334 7 Unpublished data. A proprietary blend of Magnolia and Zizyphus extracts assists with sleep: an open-label assessment. Available online: www.nextpharmaceuticals.com/stage/pdfs/Seditol_Open2008.pdf. Accessed November 2009. 8 British Herbal Medicine Association’s Scientific Committee. British Herbal Pharmacopoeia. BHMA, Bournemouth, 1983. 9 Blumenthal M et al (eds). The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. American Botanical Council, Austin, 1998. 10 Weiss RF. Herbal Medicine, translated by Meuss AR from the 6th German Edition of Lehrbuch der Phytotherapie. Gothenburg, AB Arcanum, Sweden, 1988. 11 Grieve M. A Modern Herbal. First published 1931, reprinted Dover Publications, New York, 1971. 12 Kennedy DO et al. Neuropsychopharmacology 2003; 28: 1871 13 Kennedy DO et al. Pharmacol Biochem Behav 2002; 72: 953 14 Kennedy DO et al. Psychosom Med 2004; 66: 607 15 Unpublished data. © Copyright 2009 MediHerb. Not for Public Distribution. 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