B-Calm is used to facilitate stress adaptation in
those who are described as being stressedout,
in order to reduce or eliminate the feelings and adverse effects
associated with chronic
stressfulness.
B-Calm is also used to modulate cortisol secretion in periods of
chronic stressfulness to
reduce the risk for cortisol toxicity associated with chronic adaptation
to stressfulness.
* Please Note: This information is based partly on Traditional Medicine which uses natural materials to support health. This information has not been evaluated or approved by the FDA. These statements have not been evaluated by the Food and Drug Administration (FDA). These products are intended to support general well being and are not intended to treat, diagnose, mitigate, prevent, or cure any condition or disease. If conditions persist, please seek advice from your medical doctor.
Description
Adverse Side Effects
Mishra et. al. provide a summary of acute and long-term toxicity data taken from pharmaceutical toxicity studies of ashwagandha.(1) They conclude that ashwagandha appears to be a safe plant substance, exhibiting a variety of therapeutic effects with little or no associated toxicity. Human oral use of ashwagandha has been well tolerated for centuries in Ayurvedic medicine, the traditional medical system of India.(1)
The Sensoril ® ashwagandha root and leaf extract in oral subchronic toxicity studies in mice was without adverse effects in doses up to 300 mg/kg for 90 days and the LD50 tests on mice demonstrated that doses as high as 5000 mg/kg did not cause mortality in any animals tested.(2)
Large doses of the root are reported to be able to induce irritation of the mucous and serous membranes with gastrointestinal upset, diarrhea, and vomiting.(3,4)
The amount of root content in B-Calm is not expected to cause membrane irritation. However, people with a sensitive stomach, gastritis, or peptic ulcer may find ashwagandha root preparations to be irritating.
Interactions
Ashwagandha extracts may potentiate the effects of barbiturates, other sedatives, and anxiolytics.(3,4,5) There is preliminary evidence that ashwagandha might have an additive effect with benzodiazepines.(3)
The action of immunosuppressant drugs may be reduced by the immunostimulatory capacity of ashwagandha extract.(1)
Ashwagandha extract may be able to cause immunostimulation in autoimmune disorders.(3) Animal studies indicate that cyclophosphamide cytotoxicity against cancer may be reduced by the antioxidant capacity of ashwagandha extract.(6)
Interestingly, while ashwagandha extract might reduce cyclophosphamide cytotoxicity in cancer chemotherapy, it also may be useful in significantly reducing the leucopenia associated with cyclophosphamide (CTX) treated cancer. In one animal study, Davis and Kuttan found that the total WBC count on day-12 was 65% greater in the animal group receiving CTX and ashwagandha extract (6120 cells/mm3) than in the group receiving only CTX (3720 cells/mm3).(7) Treatment with CTX and ashwagandha extract was associated with a bone marrow cellularity of 13.1 x 106 cells/femur, while treatment with CTX alone was associated with a bone marrow cellularity of 8 x 106 cells/femur (p < 0.0001).
Precaution / Cautions
Ashwagandha has abortifacient effects.(3) There is insufficient reliable information available to indicate the safety of ashwagandha extract use during pregnancy, and during the breast feeding period.
Contraindications
In myeloproliferative disorders, the use of ashwagandha extract should be provisionally contraindicated.
Mice studies demonstrate the ability of ashwagandha extract to significantly increase hemoglobin concentration, red blood cell count, white blood cell count, and platelet count.(8,9)
Pharmaceutical Commentary
Probably for the majority of North Americans, modern living is fast, complex, and demanding, fostering unavoidable pressures and strains that impact the body-mind as physical, mental, and emotional stressfulness. More than likely, much of this stressfulness is experienced chronically, rather than as intermittent episodes of acute stress. Chronic stressfulness attracts attention because it is associated with adverse physiological and psychological feelings and effects that are collectively described as being stressed-out, often including sleep deprivation.(10-12)
As well, chronic stress is associated with long-term body-mind adversities by an insidious cortisol-related promotion of key degenerative disease processes, an effect often referred to as cortisol toxicity.(13-16) The body-mind copes with stressfulness by metabolic adaptations that affect physiological and psychological domains.
The state of being stressed-out is thought to be related to excessive demands on the stress system and resulting dysregulation of body-mind systems.(11,12,17) The adverse feelings and effects and the risk for cortisol-related toxicity associated with chronic stress can be favorably modulated by an enhanced capacity for adaptation.
B-Calm provides the adaptogenic ashwagandha extract, Sensoril®, and all of the B vitamins to support adaptation metabolism. While the development of stress-managing life-skills, regular moderate aerobic exercise, relevant life-style adjustments, and psychosocial support can contribute meaningfully to adaptation to stressfulness, these supportive modalities are often difficult for a person to effectively implement. Thus, B-Calm is offered as an important herbal/nutritional interventional complement for direct metabolic enhancement of adaptation capacity.
Stress System Concepts Foundational to understanding stress, chronic stress, and stress-related health issues, is the concept of homeostasis.
This term is used to convey the idea of "no net disruptions of state", in which metabolic balance or equilibrium remains intact despite disruptive forces. Bruce S. McEwen from the Laboratory of Neuroendocrinology at Rockefeller University in New York refers to homeostasis as, "maintaining stability through change".(18) The "change" in mind is metabolic changes as exquisite reactive metabolic adaptation to the day to day confluence of pressures and strains. Medical experts in stress medicine recognize metabolic homeostasis to be part of the obligatory biological condition for physical, mental, and emotional well being and performance.(11)
It is conventional to refer to the physical, mental, and emotional strains and pressures in life as stressors. Stressors range in degree of intensity and whether they are positive or negative in nature. A positive stressor is illustrated in the process of commitment to purchase one's first house, a commitment to added financial and custodial pressures and strains that are otherwise overshadowed by joy of ownership and accomplishment. An example of a negative stressor is illustrated in the abusive language of a work place associate. Each stressor imposes a burden on the body-mind to some degree, and this burden ultimately has metabolic representation and confluence in the pathways affecting homeostasis. The combined affects of positive and negative stressors is related to their number, duration, and intensity, which descriptions define the overall dynamic stressor load. An important dimension in the intensity of a stressor is whether there is belief that it can be understood and overcome. If not adequately adapted to, stressor loads increase risk for developing stressor-related health problems.(12)
The stress system is the biological answer to the stressor load. Technically, stress is an adaptation response to stressors, whereby the body rises to the occasion to reestablish or maintain homeostasis.(10-12,19) Hans Selye's final definition of the stress term was that stress is the nonspecific response of the body to any demand made upon it.(20) Seen in this light, stress is a positive concept, and is fundamentally about self preservation. However, constant ongoing exposure to stressors, even of low intensity, can wear-out most people, exceeding normal adaptation capacity. So stress is good, but too much of a good thing can have adversity attached to it.
Stress is mediated by the brain through very complicated and integrated neurological and endocrine coping mechanisms, equally encompassing physical and psychological domains.(21) Epinephrine, norepinephrine, and cortisol are the hormones most associated with mediating stress. The hypothalamic-pituitary-adrenal (HPA) axis and the central nervous system with peripheral components of the autonomic nervous system constitute the two main physiological pillars that mediate the stress-response, that is, adaptation.(17) The brain's goal is to quickly identify what is homeostatically disrupting through all domains of conscious and unconscious experience and what is required in response, and then to respond with physiological and psychological strategies to maintain homeostasis.(17)
Stress can be conceptualized as being acute or chronic. In acute stress, the stressor load is relatively quickly resolved (full adaptation within hours to days) and disruptions to homeostasis are limited, and without health impact for most people.
Acute stress may be associated with minor stressors or more intense stressors as in the classic fight or flight scenario. Acute stressfulness is the idea that the stressor load elements of number, duration, and intensity can be accommodated without exceeding adaptation capacity. Under acute stress, ongoing homeostatic balance is virtually assured and health is not or is minimally challenged. The body-mind is built to function well within a life of acute stress, but few people would characterize their experience of stress as acute. Indeed, stressfulness has become a widespread topic of medical and social concern because of chronic stress, not acute stress.
In chronic stress, a weighty dynamic stressor load is constantly or chronically driving the stress system to adequately adapt to stressfulness to preserve homeostasis. The number, duration, and intensity of stressors combine to impose chronic metabolic adaptation hyperactivity. Living in chronic stress, the risk is high for developing the feelings and effects that are referred to as being stressed-out.(12,17,22) These can include:
inappropriate fatigue
low endurance
sleep deprivation
inability to cope
inordinate worrying
short-term memory problems
reduced sex drive
reduced immunity
a reduction in well-being
a reduction in physical and mental performance capacity
Being stressed-out means that stressor adaptation capacity is overwhelmed, leading to maladaptation or dysfunctional effects in many metabolic controls.(11,12,17)
Cortisol secretion is of particular importance in chronic stress adaptation. Cortisol facilitates chronic stress-adaptation by becoming the principal agent for mobilizing stored sugar and fat for meeting the energy requirements that fund stress-adaptation. In the case of acute stress adaptation, the role for cortisol is short-lived, with relatively quick adaptation and the reestablishment of homeostasis, and a return to the normal circadian blood level of cortisol. However, under chronic stress cortisol is maintained at relatively high and protracted levels, leading to the opportunity for cortisol toxicity effects.(10) Furthermore, chronic adaptation-related secretion of cortisol over a long period can lead to cortisol injury to the hypothalamic tissue leading to dysregulation of cortisol feedback and control, a condition that increases the risk of cortisol toxicity.(10,23)
Apart from the day-to-day unpleasant feelings and effects of being stressed-out, chronic stress is scientifically and clinically associated with an insidious cortisol-related toxicity that comprises an added promotional component in the progression of degenerative diseases.(10) Adverse effects of cortisol toxicity associated with chronic stress-adaptation are illustrated below in four major health domains:
1. Promotion of metabolic syndrome:(11,19,24)
Increases in appetite and cravings for high calorie foods that promote obesity, especially abdominal obesity
Promotion of insulin resistance
Increases in the risk for, or worsening of, type 2 diabetes
Increases in LDL-cholesterol
Increases in hypertension
Increases risk for heart disease
2. Promotion of compromised immune function:(22,25,26)
Cortisol destruction of the thymus gland mass
Inhibition of white blood cell production and activity
In some cases, promotion of allergies and auto-immune diseases [MS, lupus, fibromyalgia, and rheumatoid arthritis]
Decreases in as much as 50% of the natural killer cell population that otherwise resolves virus infections and destroys cancer cells
Increases risk for cancer promotion
3. Promotion of neurological deficits:(13,14,15)
Increases damage and death to brain cells
Increases cognitive deficits
Increases in forgetfulness
Accelerates full-blown memory loss
Predisposes to depression and mood disorders
Possibly an adverse factor in Alzheimer's disease
4. Promotion of connective, muscle, and skin tissue failure:(27,28)
Increases bone, cartilage, and muscle losses, promoting osteoporosis, osteoarthritis, and manual weakness
Increases losses in skin elasticity and hydration
How does B-Calm Offer Help?
B-Calm provides the patented proprietary ashwagandha extract, Sensoril® and all of the B vitamins. Ashwagandha, also called Indian ginseng, has been an important adaptogenic herb in Ayurvedic medicine for over 3000 years.(5) Studies indicate ashwagandha possesses anti-inflammatory, anti-tumor, anti-stress, antioxidant, immunomodulatory, hemopoietic, rejuvenating properties, and appears to exert a positive influence on the endocrine, cardiopulmonary, and central nervous systems.(1)
B-Calm is intended for use in those living under chronic stress to:
Overcome or diminish a stressed-out state while living under chronic stress, and
Modulate cortisol secretion to minimize the risk for cortisol toxicity associated with chronic stress-adaptation
The ashwagandha extract Sensoril® is incorporated in B-Calm because it has achieved U. S. patented status, has received human clinical research evaluation, and provides a standardized extract with optimal concentrations and ratios of relevant bioactive constituents that together provide the most effective stress adaptogenic support. Sensoril® is the registered trade mark of Natreon, Inc., a company specializing in the research and development of proprietary nutraceutical ingredients and headquartered in New Brunswick, NJ. Global sales and marketing for Sensoril® is provided by Nutragenesis LLC of Brattleboro, Vermont. The ashwagandha extract bioactives are described in the following manner:
Glycowithanolides, standardized to a minimum concentration of 8%. These are comprised of fully characterized withanolide glycosides, which include the sitoindosides VII to X. These glycosides are key to the traditional benefits associated with ashwagandha use in chronic stress-adaptation.
Oligosaccharides, (mol Wt < 2000 Daltons), standardized to a minimum concentration of 32%. Oligosaccharides play an essential role in the bioavailability of the bioactive constituents in Sensoril®, acting as carriers for the glycowithanolides to prevent their premature destruction, thus enhancing bioavailability.
Withaferin-A (withanolide aglycone), standardized to a maximum concentration of 2%, for maintaining targeted ratios between Withaferin-A and oligosaccharides, and to act as an immunomodulator for compensating stress-related immunosuppression.
Sensoril® has been shown in a 2005-2006 multi-phase randomized, double-blind, placebo-controlled clinical trial to demonstrate efficacy in modulating the negative effects associated with chronic stress.(2) Sensoril® treatment was evaluated in terms of the subjective feelings and effects associated with the stressed-out state, and in terms of objective serum cortisol levels and cortisol-related lipid and glycemic effects, as well as the DHEA level. The treatment group demonstrated statistically significant improvements in both objective and subjective criteria compared to the placebo group.(2)
Subjective features associated with Sensoril® treatment included:
Increased energy
Reduction in fatigue
Better sleep
Less irritability
Enhanced cognition
Enhanced overall feeling of well being
Objective features associated with Sensoril® treatment included:
Serum cortisol levels reduced by up to 30.5% (P<0.001 vs placebo)
Reduction in fasting blood sugar
Reductions in total cholesterol, LDL, VLDL, and triglycerides
Increase in HDL cholesterol
Increase in serum DHEA up to 32.5% (P<0.001 vs placebo)
These adaptogenic ashwagandha results support the use of B-Calm for avoiding or minimizing the stressed-out state when living under chronic stress, thus providing an enhanced quality of life. The ashwagandha-related reduction in cortisol of up to 26 percent offers significant modulation of chronic stress cortisol, reducing the risk for cortisol toxicity associated with chronic stress. DHEA is the natural hormone for metabolically counterbalancing cortisol action and the ashwagandha induced increase in serum DHEA serves to further modulate cortisol action and lower cortisol toxicity risk.
The Role of B Vitamins in Chronic Stress
The B vitamins are indispensable facilitators of metabolism. In times of high stressfulness and periods of chronic stressfulness, the increase in adaptation metabolism in turn places greater emphasis on the availability of nutritional factors involved in adaptation to stressor loads. However, stressful lives frequently are not associated with the dietary opportunity or focus that is required to adequately support adaptation metabolism with deliberate excellent food choices, especially plant food choices. People who chose this product will at least also obtain B vitamin nutrition as background assistance.
References 1. Mishra, Lakshmi-Chandra, et al, Scientific basis for the therapeutic use of Withania somnifera (Ashwagandha): A review, Alternative Medicine Review, 5(4):334-346, 2000 2. Auddy, Biswajit, et al, A standardized Withania Somnifera extract significantly reduces stress-related parameters in chronically stressed humans: A double-blind, randomized, placebo-controlled study, J Am Nutraceutical Asso, 11(1):43-49, 2008 3. Natural Medicines Comprehensive Database; www.naturaldatabase.com 4. Upton, R., editor, Ashwagandha Root (Withania somnifera): Analytical, quality control, and therapeutic monograph, American Herbal Pharmacopoeia, Santa Cruz, CA, 2000, pp1-25 5. Monograph, Withania somnifera, Alternative Medicine Review, 9(2):211-214, 2004 6. Davis, L., Kuttan, G., Effect of Withania somnifera on Cyclophosphamide-induced urotoxicity, Cancer Letters, Jan 1; 148(1):9-17, 2000 7. Davis, L., Kuttan, G., Suppressive effect of cyclophosphamide-induced toxicity by Withania somnifera in mice, J Ethnopharmacol, Oct; 62(3):209-214, 1998 8. Davis, L., Kuttan, G., Suppressive effect of cyclophosphamide-induced toxicity by Withania somnifera extract in mice, J Ethnopharmacol, Oct; 62(3):209-14, 1998 9. Ziauddin, M., et al, Studies on the immunomodulatory effects of Ashwagandha, J Ethnopharmacol, Feb; 50(2):69-76,1996 10. Talbott, Shawn M., The Cortisol Connection, Hunter House Publishers, Alameda, CA, 2002 11. Hjemdahl, Paul, Stress and the metabolic syndrome: An interesting but enigmatic Association, Circulation, 106:2634-36, 2002 12. McEwen, Bruce S., Protective and damaging effects of stress mediators, NEJM, 338(3):171-179, 1998 13. Solpolsky, R.M., Glucocorticoids and hippocampal atrophy in neuropsychiatric disorders, Archives in General Psychiatry, 57(10):925-35, 2000 14. Lupien, Sonia, et al, Basal cortisol levels and cognitive deficits in human aging, Journal of Neuroscience, May, 14(5 Pt 1), 2893-903, 1994 15. McEwen, B.S., Glucocordicoids, depression, and mood disorders: structural remodeling in the brain, Metabolism, 54(5 Suppl 1):20-23, 2005 16. Leproult, R., et al, Sleep loss results in an elevation of cortisol levels the next evening, Sleep, Oct; 20(10):865-70, 1997 17. Kyrou, I., Tsigos, C., Stress mechanisms and metabolic complications, Horm Metab Res, Jun; 39(6):430-438, 2007 18. McEwen, B.S., Interacting mediators of allostasis and allostatic load: towards an understanding of resilience in aging, Metabolism, Oct; 52(10 Supple):10-16, 2003 19. Kelly, Gregory S., Nutritional and Botanical Interventions to Assist with the Adaptation to Stress, Alternative Medicine Review, 4(4):249-265, 1999 20. Tatum, John, Psychosocial Influences, in Textbook of Functional Medicine, David S Jones, Editor in Chief, The Institute for Functional Medicine, Gig Harbor, WA, 2005, p138 21. McEwen, B.S., Physiology and neurobiology of stress and adaptation: central role of the brain, Physiol Rev, Jul; 87(3):873-904, 2007 22. Vidovic, A., et al, Circulating lymphocyte subsets, natural killer cell cytotoxicity, and components of hypothalamic-pituitary-adrenal axis in Croatian war veterans with posttramactic stress disorder: cross-sectional study, Croat Med J, Apr; 48(2):198-206, 2007 23. Rosmond, R., Stress induced disturbances of the HPA axis: a pathway to Type 2 diabetes, Med Sci Monit, Feb; 9(2):RA35-9, 2003 24. Kyrou, I., et al, Stress, visceral obesity, and metabolic complications, Ann N Y Acad Sci, Nov; 1083:77-110, 2006 25. Cohen, F., et al, Immune function declines with unemployment and recovers after stressor termination, Psychosom Med, April; 69(3):225-234, 2007 26. Vig, R.S., et al, The role of stress in asthma: insights from studies on the effect of acute and chronic stressors in models of airway inflammation, Ann NY Acad Sci, Nov; 1088:65-77, 2006 27. Neporada, K.S., et al, Chronic stress impairs structural organization of organic matrix in bone tissue of rat periodontium, Bull Exp Biol Med, Jun; 135(6):543-545, 2003 28. Parniapour, M., et al, Environmentally induced disorders of the musculoskeletal system, Med Clin North Am, Mar; 74(2):347-359, 1990
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Directions
Use 1 capsule daily, or as directed by a physician.
These statements have not been evaluated by the Food and Drug Administration (FDA). Products are intended to support general well being and are not intended to treat, diagnose, mitigate, prevent, or cure any condition or disease. If conditions persist, please seek advice from your medical doctor. The essence of the current American rule on Traditional Uses is, as stated by FTC, "Claims based on historical or traditional use should be substantiated by confirming scientific evidence, or should be presented in such a way that consumers understand that the sole basis for the claim is a history of use of the product for a particular purpose."
