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Many women experience hormonal imbalances, which can lead to symptoms that can impact their quality of life. Some of these symptoms include irritability, moodiness, fatigue, insomnia, bloating and hot flashes. These symptoms can affect women of all ages but especially during the transition into menopause and during monthly menstruation. In most cases there is an imbalance in estrogen and progesterone levels along with an over-taxed adrenal system, due to high levels of stress.
Fem Calm is a unique formula that addresses both inadequate levels of progesterone and a depleted adrenal system. It provides chasteberry extract which supports progesterone production, adaptogenic herbs rhodiola and ashwagandha which support the adrenal system and select B-vitamins to provide support during premenstrual syndrome (PMS) and menopause. Fem Calm helps relieve some of the mental and emotional changes as well as mild physical symptoms experienced prior to and during the menstrual cycle and in menopause due to hormone fluctuations.
For more complete relief of the physical symptoms associated with menstruation, Fem Calm is best combined with AOR’s Fem Ease for painful periods or with Fem Adapt for menopausal symptoms such as hot flashes.
Fem Calm is used in herbal medicine as a hormone normalizer to help stabilize menstrual cycle irregularities and to help relieve premenstrual symptoms. It is also used as an adaptogen to help temporarily relieve symptoms of stress (such as mental fatigue and sensation of weakness).
|Serving Size: 2 Capsules||Amount||% Daily|
|Chasteberry extract (Vitex agnus-castus 12:1)||20 mg|
|Rhodiola rosea extract (3% rosavin, 1% salidroside)||144 mg|
|Ashwagandha extract (Withania somnifera 10:1)||300 mg|
|Vitamin B6 (Pyridoxal-5’-phosphate)||30 mg|
|Vitamin B12 (Methylcobalamin)||1 mg|
|Folic acid (calcium L-5-MTHF)||300 mcg|
silicon dioxide, microcrystalline cellulose, sodium stearyl fumarate, maltodextrin. Capsule: hypromellose.
AOR™ guarantees that all ingredients have been declared on the label. Contains no wheat, gluten, peanuts, sulphites, soy, dairy, eggs, fish, shellfish or any animal byproduct.
Take 2 capsules once daily with/without food, or as directed by a qualified health care practitioner. Do not take immediately before bed. Use for a minimum of 3 months to see beneficial effects for menstrual cycle irregularities.
Consult a health care practitioner prior to use if you are taking hormone containing medication such as progesterone preparations, oral contraceptives or hormone replacement therapy (HRT), antidepressant medication, or if you are pregnant or breastfeeding. Consumption with alcohol, drugs or natural health products with sedative properties is not recommended. May cause irritability and insomnia, in which case discontinue use. Consult a health care practitioner if symptoms persist or worsen. Do not use if you have bipolar spectrum disorder.
The information and product descriptions appearing on this website are for information purposes only, and are not intended to provide or replace medical advice to individuals from a qualified health care professional. Consult with your physician if you have any health concerns, and before initiating any new diet, exercise, supplement, or other lifestyle changes.
Feel Better with Fem Calm
Fem Calm contains powerful nutrients and botanical ingredients that have proven to be beneficial for potentially relieving some of the mental and physical discomforts experienced prior to and during the menstrual cycle and in menopause due to hormone fluctuations. Some of these symptoms include irritability, mood imbalances, fatigue, insomnia, and hot flashes. Fem Calm primarily helps to provide an emotional and mental calming effect while also assisting in balancing hormones and regulating the menstrual cycle. This product may be used in combination with Fem Ease for best results. Fem Ease offers additional pain and inflammation fighting ingredients to naturally help relieve the physical symptoms of PMS and menstrual related pain.
Natural Ingredients to Ease Menstrual Related Problems
Vitex agnus, also known as chasteberry, has traditionally been used for the treatment of PMS. It has also been used for menopause symptom relief and for female hormone balancing; it is considered a “progesteronic” herb. Vitamin B6 or Pyridoxal-5-phosphate has been well studied for reducing the mood imbalance symptoms of PMS. Rhodiola rosea has been shown in a number of positive studies to benefit concentration and in coping with stress. Ashwagandha or Withania somnifera helps to normalize cortisol, acts as an anti-inflammatory, and improves mood as it functions as a calming adaptogen. Ashwagandha also helps balance out the buzz that some people feel when taking Rhodiola. Vitamin B12 (Methylcobalamin) and L-5-MTHF, the active form of folate, are necessary in order for proper methylation to occur in the body, a process that is essential in order to live. Ineffective methylation has been associated with mood imbalances and neuropsychiatric disorders.
Premenstrual Syndrome and Mood Disturbance
Premenstrual syndrome (PMS) refers to a collection of emotional symptoms that may or may not be accompanied by physical symptoms, and which are related to a woman’s menstrual cycle. A severe form of PMS called premenstrual dysphoric disorder (PMDD) is characterized by a poor mood, anxiety, irritability and decreased interest in daily activities during the menstrual cycle. The causes of PMDD are not well understood. Natural substances such as chasteberry, ashwagandha, rhodiola, vitamins B6, B12 and folate have been proven effective in relieving the physical and emotional symptoms associated with the menstrual cycle.
Chasteberry Reduces Physical PMS and Menopausal Symptoms
Chasteberry can activate dopamine receptors, which works to counteract the excessive release of prolactin that is a prominent sign of PMDD, and thus mitigate the unpleasant physical effects of this more severe form of PMS. It acts as a hormone normaliser to help stabilise menstrual cycle irregularities, and to help relieve symptoms associated with menopause, such as hot flashes. A randomized double blinded placebo controlled study published in the British Medical Journal in 2001 investigated the treatment of PMS symptoms with chasteberry. The extract of chasteberry was given to 86 women, while another 84 women were given a placebo. The duration of the randomized and double blind study was three months, thus covering 3 menstrual cycles. The study results demonstrated that chasteberry was superior to the placebo at relieving the symptoms of PMS including mood changes, irritability, headaches, anger, breast enlargement and bloating. A similar study in 2012 provided comparable results and proved that chasteberry was safe and effective at relieving PMS symptoms but not the duration of it.
Ashwagandha and Rhodiola Reduce Stress, Fatigue, Anxiety and Insomnia
Ashwagandha has been shown to be effective in reducing various aspects of stress including anxiety and insomnia, both symptoms that can occur before and during the menstrual cycle. Stress, either physical or mental, leads to the enhancement of adrenocorticotropic hormone (ACTH) secretion which in turn increases cortisol levels. Ashwagandha root extract, in addition to successfully reducing raised levels of serum cortisol, can improve an individual’s resistance towards stress. A single center, prospective, double-blind, randomized, placebo-controlled trial.
involving a total of 64 subjects with a history of chronic stress were given a high-concentration full-spectrum ashwagandha root extract at a dosage of one capsule twice a day for a period of 60 days. It was found that ashwagandha root safely and effectively improves an individual’s resistance towards stress and thereby improves self-assessed quality of life.
Rhodiola acts as an adaptogen by counteracting any adverse physical, chemical or biological stressors. It has been traditionally used in Herbal Medicine to help relieve symptoms of stress such as mental fatigue and sensation of weakness and to support cognitive function including mental focus and mental stamina. Rhodiola extracts improve the organism’s capacity to handle a wide variety of stressors. Studies suggest that Rhodiola can help prevent symptoms associated with intense physical or mental strain such as a decline in work performance, sleep difficulties, poor appetite, irritability, blood pressure imbalances, headaches and fatigue. In a human clinical trial, a Rhodiola rosea extract along with a combination of vitamins and minerals was given to 120 adults with physical and cognitive deficiencies in a 12 week drug monitoring study. There was a significant improvement in these deficiencies, with observed improvements in symptoms such as exhaustion, decreased motivation, daytime sleepiness, sleep disturbances, concentration deficiencies, forgetfulness, susceptibility to stress and irritability. This is likely due to Rhodiola’s ability to influence the levels of several neurotransmitters in the brain.
Vitamin B6 for PMS Related Mood Disturbances
Vitamin B6 is known to benefit those who suffer from mood imbalance, also a symptom that some women experience prior to and during the menstrual cycle. Premenstrual syndrome (PMS) can cause dissociation of familial relationships, abnormalities in the daily work and inter-personal relationships in the patients, and bring about direct and indirect economic burden for the society. One study compared the effects of a combination of magnesium and vitamin B6 on mood imbalances in PMS patients versus magnesium only or a placebo. The study was carried out for four months in ten selected health centers in Isfahan. The study’s findings indicated that magnesium plus vitamin B6 had the greatest effect on the mean PMS score and the placebo had the least effect.
Improving Methylation and Lowering Homocysteine Levels to Improve Mood
The methylation cycle involves the process of taking a single carbon and three hydrogens, known as a methyl group, and using it for numerous critical functions in your body such as thinking, repairing DNA, turning on and off genes, fighting infections and getting rid of environmental toxins to name a few. Vitamin B12 and folate (the active form is known as L-5-MTHF or L-5-methyltetrahydrofolate ) are nutrients required for methylation to occur properly and to lower homocysteine levels. Elevated homocysteine levels have been demonstrated to be related to mood disturbances. One study found that patients with low folate levels were more likely to suffer with mood imbalances and were also less likely to respond to medical treatment for mood imbalances with the drug fluoxetine (a popular type of SSRI or selective serotonin reuptake inhibitor). Another study found that both folate and vitamin B12 deficiencies were more likely to cause mood disorders, cognitive disorders and neurological disorders such as demyelinating myelopathy.
Folate and vitamin B12 are required both in the methylation of homocysteine to methionine and in the synthesis of S-adenosylmethionine. S-adenosylmethionine is involved in numerous methylation reactions involving proteins, phospholipids, DNA, and neurotransmitter metabolism. A current theory proposes that a defect in the methylation processes is closely related to the biochemical basis of the neuropsychiatric disorders. Folate deficiency may specifically aggravate mood disorders. In addition, the neurotoxic effects of homocysteine may also play a role in the neurologic and psychiatric disturbances that are associated with folate and vitamin B12 deficiency.
Many women simply suffer in silence or turn to conventional drugs or hormone therapies to manage the symptoms of PMS and menopause. Many of these therapies have side effects and other associated health risks.
Fem Calm provides natural adaptogens, botanicals, and nutrients that help to normalize hormones and reduce the unpleasant emotional symptoms of the menstrual cycle and during menopause. These ingredients may also help to reduce physical discomfort experienced prior to and during menstruation and in menopause. To help reduce the physical symptoms of PMS, Fem Calm is best used with AOR’s Fem Ease.
Atmaca, M., Kumru, S., and Tezcan, E. 2003. Fluoxetine versus Vitex agnus castus extract in the treatment of premenstrual dysphoric disorder. Human Psychopharmacology. 18:191-195
Chandrasekhar, K., Kapoor, J., and Anishetty, S. 2012. A Prospective, Randomized Double-Blind, Placebo-Controlled Study of Safety and Efficacy of a High-Concentration Full-Spectrum Extract of Ashwagandha Root in Reducing Stress and Anxiety in Adults. Indian Journal of Psychological Medicine. 34(3):255-262
De Bock K, Eijnde BO, Ramaekers M, Hespel P. Acute Rhodiola rosea intake can improve endurance exercise performance. Int J Sport Nutr Exerc Metab. 2004 Jun;14(3):298-307.
Döll M. [The premenstrual syndrome: effectiveness of Vitex agnus castus]. Med Monatsschr Pharm. 2009 May;32(5):186-91.
Fathizadeh N, Ebrahimi E, Valiani M, Tavakoli N, Yar MH. Evaluating the effect of magnesium and magnesium plus vitamin B6 supplement on the severity of premenstrual syndrome. Iran J Nurs Midwifery Res. 2010 Dec;15(Suppl 1):401-5.
Olsson EM, von Schéele B, Panossian AG. A randomised, double-blind, placebo-controlled, parallel-group study of the standardised extract shr-5 of the roots of Rhodiola rosea in the treatment of subjects with stress-related fatigue. Planta Med. 2009 Feb;75(2):105-12.
Rege, N.N., Thatte, U., M., and Dahanukar, S., A. 1999. Adaptogenic Properties of Six Rasayana Herbs Used in Ayurvedic Medicine. Phytotherapy Research. 13:275-291
Schellenberg R. Treatment for the premenstrual syndrome with agnus castus fruit extract: prospective, randomised, placebo controlled study. BMJ. 2001 Jan 20;322(7279):134-7.
Shevtsov VA, Zholus BI, Shervarly VI, Vol’skij VB, Korovin YP, Khristich MP, Roslyakova NA, Wikman G. A randomized trial of two different doses of a SHR-5 Rhodiola rosea extract versus placebo and control of capacity for mental work. Phytomedicine. 2003 Mar;10(2-3):95-105.
Spasov, A.A., Wikman, G.K., Mandrikov, V.B., Mironova, I.A., and Neumoin, V.V. 2000. A double-blind , placebo-controlled pilot study of the stimulating and adaptogenic effect of Rhodiola rosea SHR-5 extract on the fatigue of students caused by stress during an examination period with a repeat low-dose regimen. Phytomedicine. 7(2):85-89
van Die MD, Burger HG, Bone KM, Cohen MM, Teede HJ. Hypericum perforatum with Vitex agnus-castus in menopausal symptoms: a randomized, controlled trial. Menopause. 2009 Jan-Feb;16(1):156-63.
van Die MD, Burger HG, Teede HJ, Bone KM. Vitex agnus-castus (Chaste-Tree/Berry) in the treatment of menopause-related complaints. J Altern Complement Med. 2009 Aug;15(8):853-62.
Wuttke W, Jarry H, Christoffel V, Spengler B, Seidlová-Wuttke D. Chaste tree (Vitex agnus-castus)–pharmacology and clinical indications. Phytomedicine. 2003 May;10(4):348-57.
Therapeutic effect of Vitex agnus castus in patients with premenstrual syndrome.
Acta Med Iran. 2012;50(2):101-6.
Zamani M, Neghab N, Torabian S.
Medical therapies have been widely used for premenstrual syndrome (PMS), but in all of them side effects are predominant. Herbal remedies rarely have side effects and people have more tendencies toward them than chemical therapies. In this study the therapeutic effect of Vitex agnus castus on women who had the PMS, in comparison with placebo, were investigated. In this randomized, placebo-controlled, double-blind study, from 134 selected patients 128 women suffered from PMS were evaluated (active 62, placebo 66). All patients answered to a self assessment questionnaire about their headache, anger, irritability, depression, breast fullness and bloating and tympani during the premenstrual period before the study. Forty drops of Vitex agnus extract or matching placebo, administrated for 6 days before menses for 6 consecutive cycles. Patients answered the self-assessment questionnaires after 6 menstrual cycles, again. Each item rated using a visual analogue scale (VAS). The mean age was 30.77 (SD=4.37) years in the active group and 30.89 (SD=4.02) years in the placebo group.Rank of variables had significantly difference in active and placebo group before and after the study (P<0.0001) also we noticed significant differences on the use of Vitex agnus in comparison with placebo (P<0.0001). Vitex agnus can be considered as an effective and well tolerated treatment for the relief of symptoms of mild and moderate PMS.
A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults.
Indian J Psychol Med. 2012 Jul;34(3):255-62.
Chandrasekhar K, Kapoor J, Anishetty S.
CONTEXT: Stress is a state of mental or emotional strain or tension, which can lead to underperformance and adverse clinical conditions. Adaptogens are herbs that help in combating stress. Ayurvedic classical texts, animal studies and clinical studies describe Ashwagandha as a safe and effective adaptogen.
AIMS: The aim of the study was to evaluate the safety and efficacy of a high-concentration full-spectrum extract of Ashwagandha roots in reducing stress and anxiety and in improving the general well-being of adults who were under stress.
SETTINGS AND DESIGN: Single center, prospective, double-blind, randomized, placebo-controlled trial.
MATERIALS AND METHODS: A total of 64 subjects with a history of chronic stress were enrolled into the study after performing relevant clinical examinations and laboratory tests. These included a measurement of serum cortisol, and assessing their scores on standard stress-assessment questionnaires. They were randomized to either the placebo control group or the study drug treatment group, and were asked to take one capsule twice a day for a period of 60 days. In the study drug treatment group, each capsule contained 300 mg of high-concentration full-spectrum extract from the root of the Ashwagandha plant. During the treatment period (on Day 15, Day 30 and Day 45), a follow-up telephone call was made to all subjects to check for treatment compliance and to note any adverse reactions. Final safety and efficacy assessments were done on Day 60.
STATISTICAL ANALYSIS: t-test, Mann-Whitney test.
RESULTS: The treatment group that was given the high-concentration full-spectrum Ashwagandha root extract exhibited a significant reduction (P<0.0001) in scores on all the stress-assessment scales on Day 60, relative to the placebo group. The serum cortisol levels were substantially reduced (P=0.0006) in the Ashwagandha group, relative to the placebo group. The adverse effects were mild in nature and were comparable in both the groups. No serious adverse events were reported.
CONCLUSION: The findings of this study suggest that a high-concentration full-spectrum Ashwagandha root extract safely and effectively improves an individual’s resistance towards stress and thereby improves self-assessed quality of life.
Evaluating the effect of magnesium and magnesium plus vitamin B6 supplement on the severity of premenstrual syndrome.
Iran J Nurs Midwifery Res. 2010 Dec;15(Suppl 1):401-5.
Fathizadeh N, Ebrahimi E, Valiani M, Tavakoli N, Yar MH.
BACKGROUND: Since premenstrual syndrome (PMS) can cause suicide, dissociation of familial relationships, abnormalities in the daily work and inter-personal relationships in the patients, and bring about direct and indirect economic burden for the society, it is important to resolve the problems of the patients. The objective of the current study is to determine the effect of magnesium (Mg), combination of vitamin B6 and Mg, and the placebo on the severity of PMS in the patients affected by the disease referred to the health centers of Isfahan University of Medical Sciences during 2009-2010.
METHODS: The participants were randomly assigned to two intervention groups and one control group. The study was carried out for four months in ten selected health centers in Isfahan. To confirm the PMS diagnosis in patients, they were asked to fill out the PMS daily symptom record form for two months and then, when the diagnosis was confirmed, the participants were randomly assigned to one of the three groups of the study (Mg, Mg plus vitamin B6, and placebo). Medical intervention was carried out in two menstrual cycles and the results of pre- and post-test were compared.
RESULTS: After the intervention, the mean score of PMS significantly decreased in all the three groups (p < 0.05). The decrease was the greatest in the Mg plus vitamin B6 group, and was the least in the placebo group.
CONCLUSIONS: The findings indicated that Mg plus vitamin B6 and placebo has the greatest and the least effect on the mean score of PMS, respectively.
[The premenstrual syndrome: effectiveness of Vitex agnus castus].
Med Monatsschr Pharm. 2009 May;32(5):186-91.
Premenstrual syndrome (PMS) is a complex combination of a variety of symptoms including mood swings, anxiety, depression, tender breasts and food cravings. For some women the physical pain and emotional stress are severe enough to affect their daily routines and activities. The causes of the premenstrual syndrome have not yet been understood clearly, but have been attributed to hormonal and neuronal dysbalance, diet and lifestyle. Hyperprolactinemia seems to be an important factor which is considered to be part of the endocrine disorder. Different clinical investigations and double blind trials have shown that preparations containing Vitex agnus castus fruit extract are a useful tool to decrease pathophysiologicaly increased prolactin serum levels and though could be an effective treatment for women suffering from premenstrual syndrome.
Vitex agnus-castus (Chaste-Tree/Berry) in the treatment of menopause-related complaints.
J Altern Complement Med. 2009 Aug;15(8):853-62.
van Die MD, Burger HG, Teede HJ, Bone KM.
BACKGROUND: The origin of the current practice of administering Vitex agnus-castus in menopause-related complaints is uncertain, but appears to be relatively recent. Here we review the evidence for this application of Vitex based on evidence from pharmacological studies and clinical research.
METHODS: The mechanisms of potential relevance in the context of menopause are explored with reference to the current understanding of the endocrinology and neuroendocrinology of menopause and associated symptoms.
CONCLUSIONS: We conclude that, while evidence from rigorous randomized controlled trials is lacking for the individual herb in this context, emerging pharmacological evidence supports a role for V. agnus-castus in the alleviation of menopausal symptoms and suggests that further investigation may be appropriate.
Hypericum perforatum with Vitex agnus-castus in menopausal symptoms: a randomized, controlled trial.
Menopause. 2009 Jan-Feb;16(1):156-63.
van Die MD, Burger HG, Bone KM, Cohen MM, Teede HJ.
OBJECTIVE: To evaluate the effectiveness of a phytotherapeutic intervention comprising a combination of Hypericum perforatum (St. John’s wort) and Vitex agnus-castus (Chaste tree/berry) in the management of menopausal symptoms.
DESIGN: A double-blind, randomized, placebo-controlled, parallel trial was performed over 16 weeks in 100 eligible late-perimenopausal or postmenopausal women experiencing hot flushes and other menopausal symptoms. Herbal combination therapy or placebo tablets were administered twice daily. The primary endpoint was hot flush episodes. Secondary endpoints included Greene Climacteric Scale scores, Hamilton Depression Inventory scores, and Utian Quality of Life Scale scores.
RESULTS: Ninety-three women completed the study. Data analysis on an intent-to-treat basis found no significant differences between the two groups for any of the endpoints. Analyses performed at interim data time points revealed no significant differences at week 4, 8, or 12 for daily weighted flushes or scores on the Greene Climacteric Scale or Hamilton Depression Inventory. However, significant improvements across the treatment phase were observed in both the placebo and active treatment groups for these endpoints. No significant change was found for either group on quality of life.
CONCLUSION: The herbal combination of H. perforatum and V. agnus-castus was not found to be superior to placebo for the treatment of menopausal symptoms. The herbal combination was well tolerated with no significant adverse events noted in the short term. Robust findings from quality studies such as this are important for informing the community, healthcare providers, and regulatory authorities.
A randomised, double-blind, placebo-controlled, parallel-group study of the standardised extract shr-5 of the roots of Rhodiola rosea in the treatment of subjects with stress-related fatigue.
Planta Med. 2009 Feb;75(2):105-12.
Olsson EM, von Schéele B, Panossian AG.
The aim of the study was to assess the efficacy of the standardised extract SHR-5 of roots of Rhodiola Rosea L. in the treatment of individuals suffering from stress-related fatigue. The phase III clinical trial took the form of a randomised, double-blind, placebo-controlled study with parallel groups. Participants, males and females aged between 20 and 55 years, were selected according to the Swedish National Board of Health and Welfare diagnostic criteria for fatigue syndrome. A total of 60 individuals were randomised into two groups, one ( N = 30) of which received four tablets daily of SHR-5 extract (576 mg extract/day), while a second ( N = 30) received four placebo tablets daily. The effects of the extract with respect to quality of life (SF-36 questionnaire), symptoms of fatigue (Pines’ burnout scale), depression (Montgomery -Asberg depression rating scale – MADRS), attention (Conners’ computerised continuous performance test II – CCPT II), and saliva cortisol response to awakening were assessed on day 1 and after 28 days of medication. Data were analysed by between-within analyses of variance. No serious side effects that could be attributed to the extract were reported. Significant post-treatment improvements were observed for both groups (placebo effect) in Pines’ burnout scale, mental health (SF-36), and MADRS and in several CCPT II indices of attention, namely, omissions, commissions, and Hit RT SE. When the two groups were compared, however, significant effects of the SHR-5 extract in comparison with the placebo were observed in Pines’ burnout scale and the CCPT II indices omissions, Hit RT SE, and variability. Pre- VERSUS post-treatment cortisol responses to awakening stress were significantly different in the treatment group compared with the control group. It is concluded that repeated administration of R. ROSEA extract SHR-5 exerts an anti-fatigue effect that increases mental performance, particularly the ability to concentrate, and decreases cortisol response to awakening stress in burnout patients with fatigue syndrome.
Acute Rhodiola rosea intake can improve endurance exercise performance.
Int J Sport Nutr Exerc Metab. 2004 Jun;14(3):298-307.
De Bock K, Eijnde BO, Ramaekers M, Hespel P.
PURPOSE: The purpose of this study was to investigate the effect of acute and 4-week Rhodiola rosea intake on physical capacity, muscle strength, speed of limb movement, reaction time, and attention.
METHODS: PHASE I: A double blind placebo-controlled randomized study (n= 24) was performed, consisting of 2 sessions (2 days per session). Day 1: One hour after acute Rhodiola rosea intake (R, 200-mg Rhodiola rosea extract containing 3% rosavin 1% salidroside plus 500 mg starch) or placebo (P, 700 mg starch) speed of limb movement (plate tapping test), aural and visual reaction time, and the ability to sustain attention (Fepsy Vigilance test) were assessed. Day 2: Following the same intake procedure as on day 1, maximal isometric knee-extension torque and endurance exercise capacity were tested. Following a 5-day washout period, the experimental procedure was repeated, with the treatment regimens being switched between groups (session 2). PHASE II: A double blind placebo-controlled study (n = 12) was performed. Subjects underwent sessions 3 and 4, identical to Phase I, separated by a 4-week R/P intake, during which subjects ingested 200 mg R/P per day.
RESULTS: PHASE I: Compared with P, acute R intake in Phase I increased (p < 0.05) time to exhaustion from 16.8 /- 0.7 min to 17.2 /- 0.8 min. Accordingly, VO2peak (p < 0.05) and VCO2peak (p< 0.05) increased during R compared to P from 50.9 /- 1.8 ml x min(-1) x kg(- )1 to 52.9 /- 2.7 ml x min(-10) x kg(-1) (VO2peak) and from 60.0 /- 2.3 ml x min(-1) x kg(-1) to 63.5 /- 2.7 ml x min(-1) x kg(-1) (VCO2peak). Pulmonary ventilation (p = 0.07) tended to increase more during R than during P (P: 115.9 /- 7.7 L/min; R: 124.8 /- 7.7 L/min). All other parameters remained unchanged.
CONCLUSION: Acute Rhodiola rosea intake can improve endurance exercise capacity in young healthy volunteers. This response was not altered by prior daily 4-week Rhodiola intake.
A randomized trial of two different doses of a SHR-5 Rhodiola rosea extract versus placebo and control of capacity for mental work.
Phytomedicine. 2003 Mar;10(2-3):95-105.
Shevtsov VA, Zholus BI, Shervarly VI, Vol’skij VB, Korovin YP, Khristich MP, Roslyakova NA, Wikman G.
A randomized, double-blind, placebo-controlled, parallel-group clinical study with an extra non-treatment group was performed to measure the effect of a single dose of standardized SHR-5 Rhodiola rosea extract on capacity for mental work against a background of fatigue and stress. An additional objective was to investigate a possible difference between two doses, one dose being chosen as the standard mean dose in accordance with well-established medicinal use as a psychostimulant/adaptogen, the other dose being 50% higher. Some physiological parameters, e.g. pulse rate, systolic and diastolic blood pressure, were also measured. The study was carried out on a highly uniform population comprising 161 cadets aged from 19 to 21 years. All groups were found to have very similar initial data, with no significant difference with regard to any parameter. The study showed a pronounced antifatigue effect reflected in an antifatigue index defined as a ratio called AFI. The verum groups had AFI mean values of 1.0385 and 1.0195, 2 and 3 capsules respectively, whilst the figure for the placebo group was 0.9046. This was statistically highly significant (p < 0.001) for both doses (verum groups), whilst no significant difference between the two dosage groups was observed. There was a possible trend in favour of the lower dose in the psychometric tests. No such trend was found in the physiological tests.
Fluoxetine versus Vitex agnus castus extract in the treatment of premenstrual dysphoric disorder.
Hum Psychopharmacol. 2003 Apr;18(3):191-5.
Atmaca M, Kumru S, Tezcan E.
Clinical trials have demonstrated that serotonin reuptake inhibitors (SRIs) and the extract of Vitex agnus castus are effective for the treatment of premenstrual dysphoric disorder (PMDD). However, to the best of our knowledge, there has been no study comparing the efficacy of the SRIs with Vitex agnus castus (AC) extract. Therefore, the aim of the present study was to compare the efficacy of fluoxetine, a selective serotonin reuptake inhibitor (SSRI), with that of the AC extract, a natural choice. After a period of 2 screening months to screen the patients for suitability, 41 patients with PMDD according to DSM-IV were recruited into the study. The patients were randomized to fluoxetine or AC for 2 months of single-blind, rater- blinded and prospective treatment period. The outcome measures included the Penn daily symptom report (DSR), the Hamilton depression rating scale (HAM-D), and the clinical global impression-severity of illness (CGI-SI) and -improvement (CGI-I) scales. At endpoint, using the clinical criterion for improvement, a similar percentage of patients responded to fluoxetine (68.4%, n = 13) and AC (57.9%, n = 11). There was no statistically significant difference between the groups with respect to the rate of responders. This preliminary study suggests that patients with PMDD respond well to treatment with both fluoxetine and AC. However, fluoxetine was more effective for psychological symptoms while the extract diminished the physical symptoms.
Chaste tree (Vitex agnus-castus)–pharmacology and clinical indications.
Phytomedicine. 2003 May;10(4):348-57.
Wuttke W, Jarry H, Christoffel V, Spengler B, Seidlová-Wuttke D.
Extracts of the fruits of chaste tree (Vitex agnus castus = AC) are widely used to treat premenstrual symptoms. Double-blind placebo-controlled studies indicate that one of the most common premenstrual symptoms, i.e. premenstrual mastodynia (mastalgia) is beneficially influenced by an AC extract. In addition, numerous less rigidly controlled studies indicate that AC extracts have also beneficial effects on other psychic and somatic symptoms of the PMS. Premenstrual mastodynia is most likely due to a latent hyperprolactinemia, i.e. patients release more than physiologic amounts of prolactin in response to stressful situations and during deep sleep phases which appear to stimulate the mammary gland. Premenstrually this unphysiological prolactin release is so high that the serum prolactin levels often approach heights which are misinterpreted as prolactinomas. Since AC extracts were shown to have beneficial effects on premenstrual mastodynia serum prolactin levels in such patients were also studied in one double-blind, placebo-controlled clinical study. Serum prolactin levels were indeed reduced in the patients treated with the extract. The search for the prolactin-suppressive principle(s) yielded a number of compounds with dopaminergic properties: they bound to recombinant DA2-receptor protein and suppressed prolactin release from cultivated lactotrophs as well as in animal experiments. The search for the chemical identity of the dopaminergic compounds resulted in isolation of a number of diterpenes of which some clerodadienols were most important for the prolactin-suppressive effects. They were almost identical in their prolactin-suppressive properties than dopamine itself. Hence, it is concluded that dopaminergic compounds present in Vitex agnus castus are clinically the important compounds which improve premenstrual mastodynia and possibly also other symptoms of the premenstrual syndrome.
Treatment for the premenstrual syndrome with agnus castus fruit extract: prospective, randomised, placebo controlled study.
BMJ. 2001 Jan 20;322(7279):134-7.
OBJECTIVES: To compare the efficacy and tolerability of agnus castus fruit (Vitex agnus castus L extract Ze 440) with placebo for women with the premenstrual syndrome.
DESIGN: Randomised, double blind, placebo controlled, parallel group comparison over three menstrual cycles.
SETTING: General medicine community clinics. Participants: 178 women were screened and 170 were evaluated (active 86; placebo 84). Mean age was 36 years, mean cycle length was 28 days, mean duration of menses was 4.5 days.
INTERVENTIONS: Agnus castus (dry extract tablets) one tablet daily or matching placebo, given for three consecutive cycles.
MAIN OUTCOME MEASURES: Main efficacy variable: change from baseline to end point (end of third cycle) in women’s self-assessment of irritability, mood alteration, anger, headache, breast fullness, and other menstrual symptoms including bloating. Secondary efficacy variables: changes in clinical global impression (severity of condition, global improvement, and risk or benefit) and responder rate (50% reduction in symptoms).
RESULTS: Improvement in the main variable was greater in the active group compared with placebo group (P<0.001). Analysis of the secondary variables showed significant (P<0.001) superiority of active treatment in each of the three global impression items. Responder rates were 52% and 24% for active and placebo, respectively. Seven women reported mild adverse events (four active; three placebo), none of which caused discontinuation of treatment.
CONCLUSIONS: Dry extract of agnus castus fruit is an effective and well tolerated treatment for the relief of symptoms of the premenstrual syndrome.
Folate, vitamin B12, and homocysteine in major depressive disorder.
Am J Psychiatry. 1997 Mar;154(3):426-8.
Fava M, Borus JS, Alpert JE, Nierenberg AA, Rosenbaum JF, Bottiglieri T.
OBJECTIVE: The authors examined the relationships between levels of three metabolites (folate, vitamin B12, and homocysteine) and both depressive subtype and response to fluoxetine treatment in depressed patients.
METHOD: Fluoxetine, 20 mg/day for 8 weeks, was given to 213 outpatients with major depressive disorder. At baseline, depressive subtypes were assessed, and a blood sample was collected from each patient. Serum metabolite levels were assayed. Response to treatment was determined by percentage change in score on the 17-item Hamilton Depression Rating Scale.
RESULTS: Subjects with low folate levels were more likely to have melancholic depression and were significantly less likely to respond to fluoxetine. Homocysteine and B12 levels were not associated with depressive subtype or treatment response.
CONCLUSIONS: Overall, the results are consistent with findings linking low folate levels to poorer response to antidepressant treatment. Folate levels might be considered in the evaluation of depressed patients who do not respond to antidepressant treatment.
Folate, vitamin B12, and neuropsychiatric disorders.
Nutr Rev. 1996 Dec;54(12):382-90.
Folate and vitamin B12 are required both in the methylation of homocysteine to methionine and in the synthesis of S-adenosylmethionine. S-adenosylmethionine is involved in numerous methylation reactions involving proteins, phospholipids, DNA, and neurotransmitter metabolism. Both folate and vitamin B12 deficiency may cause similar neurologic and psychiatric disturbances including depression, dementia, and a demyelinating myelopathy. A current theory proposes that a defect in methylation processes is central to the biochemical basis of the neuropsychiatry of these vitamin deficiencies. Folate deficiency may specifically affect central monoamine metabolism and aggravate depressive disorders. In addition, the neurotoxic effects of homocysteine may also play a role in the neurologic and psychiatric disturbances that are associated with folate and vitamin B12 deficiency.
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