From the Practice - International Academy of Homotoxicology
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From the Practice - International Academy of Homotoxicology
d 2.00 • US $ 2.00 • CAN $ 3.00 Biomedical Therapy J o urnal o f Volume 3, Number 1 ) 2009 Integrating Homeopathy and Conventional Medicine Neuroendocrine Dysfunction • Psychogenic Factors in Gastrointestinal Pathology • Bioregulatory Treatment of Dysautonomia ) Contents I n Fo c u s Applied Bioregulation in Neuroendocrine Disease: Chronic Stress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 W h a t E l s e I s N e w ? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 From the Practice Metabolic and Endocrine Disorders Associated With Pseudarthrosis: Presentation of a Clinical Case . . . . . . 10 Around the Globe Verona – More Than Just Romeo and Juliet ... . . . . . . . . . . . . .15 Practical Protocols Bioregulatory Treatment of Dysautonomia . . . . . . . . . . . . . . 16 In memoriam Professor Michael F. Kirkman . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Re f r e s h Yo u r H o m o t ox i c o l o g y Psychogenic Factors in Gastrointestinal Pathology . . . . . . . 18 M a r ke t i n g Yo u r P r a c t i c e Communication in Your Practice . . . . . . . . . . . . . . . . . . . . . . . 20 Specialized Applications The Acupuncture Approach to the Hypothalamus-Pituitary-Adrenal Axis . . . . . . . . . . . . . . . . . . 22 Making of ... Manufacturing of Traumeel Injection Solution Part I: From Work Preparation to Filling . . . . . . . . . . . . . . . . .26 Meet the Expert Dr. Arturo O’Byrne . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Re s e a r c h H i g h l i g h t s Cover photograph © Sebastian Kaulitzki/Fotolia.de )2 Nervoheel N vs. Lorazepam for Mild Nervous Disorders . . . 30 Published by/Verlegt durch: International Academy for Homotoxicology GmbH, Bahnackerstraße 16, 76532 Baden-Baden, Germany, e-mail: [email protected] Editor in charge/verantwortlicher Redakteur: Dr. Alta A. Smit Print/Druck: VVA Konkordia GmbH, Dr.-Rudolf-Eberle-Straße 15, 76534 Baden-Baden, Germany © 2009 International Academy for Homotoxicology GmbH, Baden-Baden, Germany ) Stress and the Immune System Dr. Alta A. Smit P sychoneuroimmunology (PNI) has come a long way since Walter Cannon’s early work with animals. Cannon observed that any change in emotional state (such as anxiety, distress, or rage) was accompanied by total cessation of stomach movements. Cannon’s research culminated in his seminal work, Bodily Changes in Pain, Hunger, Fear and Rage, published in 1915.1 Hans Selye then drew on Cannon’s research for his own animal experiments. Selye subjected animals to a variety of adverse physical and mental conditions and observed consistent adaptations that allow the body to heal and recover. The General Adaptation Syndrome Selye described is still important in bioregulatory medicine today.2 Even conventional medicine increasingly recognizes the mind-brain connection and psychoneuroendocrinoimmunology (PNEI). For instance, stress at work is associated with cardiovascular risk factors such as BMI, hypertension, and lipid levels. The Whitehall studies examined this possible larger relationship between work stress and cardiovascular disease in depth.3 Bioregulatory medicine recognizes and tests for autonomic dysfunction as one of the main obstacles to regulatory ability in patients. For example, heart rate variability is one of the main risk factors for cardiac disease.4 In this issue, we present a variety of articles on the effects of stress on the immune system, which have been well-known for decades. In the focus article, Dr. Jesús Agudo gives a general introduction to the subject. Dr. Mónica Name presents a case study demonstrating the effect of bioregulatory medicines on bone healing. Dr. Butch Levy examines the role of acupuncture in the treatment of autonomic dysfunction, and Dr. Bert Hannosset contributes a treatment protocol for dysautonomia. In Research Highlights, we present the results of a study investigating the effectiveness of Nervoheel in mild nervous disorders, and our marketing specialist offers tips on successful communication with your patients. We also examine how ampoule medications are manufactured (Part 1) and continue our Meet the Expert Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 series with an introduction to Dr. Arturo O’Byrne of Colombia. It is with great sadness that we remember another expert, Professor Michael Kirkman. His sudden death this year leaves a huge void in the world of homotoxicology. Dr. Damir Shakambet, who worked closely with Professor Kirkman in the UK, contributes a heartfelt obituary. Dr. Alta A. Smit References 1. Quick JC, Spielberger CD. Walter Bradford Cannon: Pioneer of stress research. International Journal of Stress Management. 1994;1(2):141-143. 2. Selye H. A syndrome produced by diverse nocuous agents. Nature. 1936;138(3479):32. 3. Marmot M. UCL Department of Epidemiology and Public Health: Whitehall II Study. 2008. UCL web site. http://www.ucl.ac.uk/ whitehallII/. Updated February 27, 2008. Accessed July 14, 2009. 4. Institute of HeartMath Research Staff. Science of the heart: exploring the role of the heart in human performance. Institute of HeartMath web site. http://www.heartmath. org/research/research-science-of-the-heart. html. Accessed July 14, 2009. )3 ) I n Fo c u s Applied Bioregulation in Neuroendocrine Disease Chronic Stress By Jesús Agudo, MD Chronic stress is often a reaction to the stimuli of a more or less hostile environment, to which most people living in the 21st century have succumbed. With increasing clarity, chronic stress is shown to be a causative agent of numerous diseases, especially those of neuroendocrine origin. A new cross-functional medical specialization is appearing, propelled by increasingly detailed knowledge about the biological foundations of the relationship between stress and a variety of diseases: psychoneuro immunology. T )4 he history of medicine has been a constant struggle between monism and dualism, between those researchers who consider the human being to be a unit and those who see in the individual the confluence of 2 separate entities: physical and spiritual, material and immaterial, metabolism and emotions, body and soul. If we go back some 2,600 years, Hippocrates had already declared that health was a state inherent to the individual, whom nature had endowed with self-healing abilities. Furthermore, while a person lived in harmony with nature, his or her health would be maintained or, were it lost, could easily be recovered. Disease was only an imbalance resulting from a failure to observe the rules of Hygeia. Thus, the physi- cian’s mission would be to help individuals recover the lost equilibrium and teach them to live in accordance with the laws of nature (vis medicatrix naturae). In contrast, students of the school of Aesculapius believed that for every disease there was a determined cause, a separate treatment, and some organs or systems involved, and that the most prestigious physician was the one who made the diagnosis and prescribed the correct treatment. This compartmentalized and highly specialized vision is that which now dominates “modern” medicine, one in which the idea of the individual is, incorrectly, not considered to be an indivisible entity, a single unit with one material component and another apparently immaterial component. Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 Fortunately, in the second half of the 20th century, the development of that highly specialized and fragmented medicine, with an impressive ability to delve into the core of the most subtle physiological processes, converged with the other, more humanist medicine descended from Hippocrates, which pays attention to the psycho-emotional aspects of humankind. We could say that the more cartesian-reductionist and more fiercely material medicine has discovered the influence of the human soul on physiopathological processes. It is, therefore, absolutely fascinating that more than 2,000 years ago, the pineal gland was described by Galen, who credited it with the ability to regulate the flow of thought; in the 17th century, it was described by Descartes as the seat of the rational soul. What is surprising is the insight, from ancient times, that this area would be the gateway between body and soul and the approximation of what was being described to what we know today about the interrelationships between emotions and their physical responses. The study of the relationships between mind and body has been termed psychoneuroimmunology, and what we are truly faced with is the most refined, holistic concept of medical science. ) I n Fo c u s Stress Brain ACh+ 5-HT+ IL-1+ CRH+ GABA- NA+/– – IL-1 RA + Hypothalamus CRH+ – IL-1, IL-6, TNF-a AVP+ – Pituitary NA/A+ Monocytes Macrophages A Adrenaline NA Noradrenaline ACh Acetylcholine GABA γ-Aminobutyric acid 5-HT 5-Hydroxytryptamine IL-1 RA Interleukin 1 receptor antagonist TNF Tumor necrosis factor IL Interleukin ACTH Corticotropin ACTH+ Adrenal gland Cortisol +/– AVP Arginine vasopressin CRH Corticotropinreleasing hormone Figure 1: Relationship between the cortex, hypothalamus, pituitary gland, and adrenal glands (after Lack and Wright1) The hypothalamicpituitary-adrenal system The stimuli generated in the cerebral cortex by adverse situations such as stress or various pathological mental processes will create a response in the limbic system that triggers the release of several neurotransmitters (e.g., acetylcholine, 5-hydroxytryp tamine, interleukin [IL] 1, corticotropin-releasing hormone [CRH], γ-aminobutyric acid [GABA], and noradrenaline). These neurotransmitters will ultimately activate the hypothalamic-pituitary-adrenal axis according to the cascade described later (Figure 1). Corticotropin-releasing hormone and arginine vasopressin (AVP) are produced in the paraventricular nuclei of the hypothalamus. These substances are carried to the anterior pituitary gland, where they regulate the secretion of adrenocorticotropic hormone (ACTH or corticotropin). Adrenocorticotropic hormone travels through the bloodstream to the cortex of the adrenal glands, where it stimulates the synthesis and release of glucocorticoids (GCs). In turn, these GCs exert a negative feedback on several targets, including the adrenal cortex, inhibiting their own secretion; the pituitary gland, inhibiting ACTH production; and even the hypothalamus itself, down-regulating the release of ACTH and AVP. Glucocorticoids also act on the hypothalamus through the production of GABA, which ultimately inhibits this organ’s synthesis of CRH and AVP. Another intermediate feedback regulator of the release of CRH in this process would be the one exerted on the noradrenergic and serotonergic neurons.2 Finally, we must not forget that the brain will also exert an influence on the sympathetic and endocrine system by means of the CRH that regulates the sympathetic nervous system. This has nerve endings in the bone marrow, thymus, and spleen, which are the cell factories responsible for cellular and humoral immunity. Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 The psychoneuroimmunology of stress It is now clear that CRH plays a fundamental role in the response to stress. Administration of CRH produces a broad suppression of immune functions similar to that observed in depression or chronic stress. Corticotropin-releasing hormone regulates immune functions through a central pathway and a peripheral pathway. By means of the central pathway, it notably suppresses the proliferation of lymphocytes and phagocytosis by neutrophils while increasing the number of neutrophils and cellular aggregation. It al so decreases the quantity and activity of natural killer (NK) cells and IgG levels. In the peripheral pathway, its activity is based on the CRH receptors that exist on macrophages, monocytes, and helper lymphocytes. Corticotropin-releasing hormone reduces the replication and survival of spleen cells while simultaneously encouraging the migration of monocytes. )5 ) I n Fo c u s We have already seen how stress activates the production of CRH directly in the hypothalamus and indirectly through noradrenergic and serotonergic neurons. However, it also activates the autonomic nervous system. For these tasks, mediation by intermediaries such as acetylcholine, IL-1, and serotonin is required. Meanwhile, to balance this reaction, stress-inhibiting substances are also present, such as GABA; opioid peptides, whose producing neurons are closely related to CRH-producing neurons to establish an equilibrium; and a third group (e.g., adrenaline/ noradrenaline) that acts on various senses. With respect to the sympathetic nervous system, we could say that in states of stress it will be activated by CRH, and on being stimulated, it will produce adrenaline and noradrenaline. Peripherally, these substances will trigger a series of actions, such as an increase in blood pressure, blood glucose, heart rate, alertness, and vigilance, and inhibit the sensation of hunger and growth through the suppression of growth hormone (GH). Stress affects various vital areas )6 The immune system According to recent studies, the role of cortisol in the inhibition of the immune system appears to consist of suppressing the ability of immune cells to activate their own telomerase to reproduce their telomeres each time the cell divides. The telomere would, therefore, be shortened, a characteristic observed in pathological conditions, such as human immunodeficiency virus infection, osteoporosis, coronary heart disease, and even aging.3 Cancerous diseases Stress significantly reduces the activity of NK cells.4 In laboratory experiments on animals subjected to stress, the rate of pulmonary metastases from induced breast cancers doubled. Studies of women who underwent surgery for carcinoma of the breast have also shown a significantly reduced NK cell count in patients with high stress levels compared with those who controlled their stress, resulting from uncertainty about the treatment or prognosis of their disease.5 Infectious diseases In laboratory experiments on animals subjected to stress conditions, their response to the flu virus decreased significantly. Along with high levels of plasma corticosterone, a decrease in the mononuclear cell population and a 60% to 95% decrease in IL-2 production in lymphoid organs were observed. In preschool-aged children subjected to various situations of environmental stress, several changes in the CD4, CD8, and NK cell counts were observed, which have been correlated with respiratory diseases.4 Another experiment conducted on astronauts found that during periods of stress, there was a decrease in antibodies to the Epstein-Barr virus nuclear antigens, along with an increase in adrenaline and noradrenaline in the urine and a decrease in virus-specific T lymphocytes. This led to the reactivation of the Epstein-Barr virus in 11 of 28 astronauts.6 Wound healing There also appears to be evidence from in vitro studies showing that fibroblasts would be less effective in matrix repair for recovery from inju- Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 ries and wounds in situations of psychological stress, precisely because of the presence of high tissue levels of corticosteroids. In one study of student volunteers who underwent small incisions on mucous membranes, the healing time was 40% longer during examination periods than during vacation periods. This longer duration was associated with a 30% decrease in IL-1 levels during examination periods.7 Stress and allergies In a joint experiment, physicians and psychologists studied the relationship between stressful situations and an increase in the most common signs of allergies (rhinitis, sneezing, coughing, and conjunctivitis), along with the peculiarity that the allergic symptoms worsened in the following days while the stress stimulus continued. Analytically, this translates to a significant increase in IL-6 and catecholamines in the blood of stressed patients with symptoms of allergies. There is another mediator, vasoactive intestinal polypeptide, that has been found in increased quantities in children who have experienced significant stress (typically parental separation) and that is closely linked to sensitization and the onset of allergic phenomena.9 In another recent experiment performed in Canada,10 it was found that maternal stress in the first 7 years of the child’s life has a significant influence on the rates of childhood asthma because mothers in this situation are less likely to interact with and show affection to their children. This is recognized by the child’s immune system, which could be considered an “affective” transmission of stress. ) I n Fo c u s Systemic lupus erythematosus, depression, and stress Distinct immunological changes have been found in patients with depressive syndromes of various degrees and clinical manifestations.11 In contrast to healthy control subjects, an increase in B lymphocytes, antinuclear antibodies, and serum immunoglobulins can be observed in patients with depressive syndromes. Thus, depressive illnesses can demonstrate a certain relationship to autoimmunity. Also, many autoimmune diseases are characterized by major episodes of depression, especially systemic lupus erythematosus, regardless of treatment with GCs. With depression in general, prolonged activity in the adrenal cortex is a factor that makes recovery notably difficult. These are patients in whom the administration of corticosteroids does not exert a negative feedback on their own cortisol levels.12 Bioregulatory approach to stress A fascinating opportunity remains open for bioregulatory medicine to establish treatment protocols consisting of immune regulatory medicines (e.g., Echinacea compositum and Engystol), medicines supporting brain function (e.g., Cerebrum compositum, Thalamus compositum, Ypsiloheel, Neuro-Injeel, Tonico-Injeel, Nervoheel, and IgnatiaHomaccord), and the classic organoregulators, such as Ovarium compositum, Pulsatilla compositum, Coenzyme compositum, Hepar compositum, Testis compositum, Thyreoidea compositum, GaliumHeel, and Ubichinon compositum. Neurexan, a medication for nervousness and insomnia, has recently been shown in preliminary studies to be possibly useful in anticipatory an xiety.15| Growth and stress As previously mentioned, sustained stress causes high levels of CRH, which in turn inhibits GH and insulinlike growth factor 1. The circulating corticosteroids also exert a negative feedback on GH production by the pituitary gland.2 Stress and sleep Patients experiencing stress have a poor quality of sleep as a cause and a result of stress.5,13 Failure to follow circadian rhythms due to a lack of sleep reduces the amount of melatonin in the blood to below required levels. It is, therefore, presumed that its antioxidant activity cannot be performed. Also, melatonin’s likely activity of promoting immunity by inhibiting the production of gonadotropins is inhibited.1,14 References 1. Lack LC, Wright HR. Chronobiology of sleep in humans. Cell Mol Life Sci. 2007;64(10):1205-1215. 2. Rosales Estrada M. Síndrome de inflamación de las mucosas: tratamiento antihomotóxico. Colombia: M. Rosales Estrada; 2005. 3. Choi J, Fauce SR, Effros RB. Reduced telomerase activity in human T lymphocytes exposed to cortisol. Brain Behav Immun. 2008;22(4):600-605. 4. Song C, Leonard BE. Fundamentals of Psychoneuroimmunology. Chichester, England: Wiley & Sons; 2000. 5. Andersen BL, Farrar WB, Golden-Kreutz D, et al. Stress and immune responses after surgical treatment for regional breast cancer. J Natl Cancer Inst. 1998;90(1):30-36. 6. Stowe RP, Pierson DL, Barrett AD. Elevated stress hormone levels relate to Epstein-Barr virus reactivation in astronauts. Psychosom Med. 2001;63(6):891-895. 7. Glaser R, Kiecolt-Glaser JK. Stress-induced immune dysfunction: implications for health. Nat Rev Immunol. 2005;5(3):243-251. 8. Stress, anxiety can make allergy attacks even more miserable and last longer. ScienceDaily Web site. http://www.sciencedaily.com/ releases/2008/08/080814154327.htm. Published August 17, 2008. Accessed July 14, 2009. 9. Stress during childhood increases the risk of allergies. e! Science News Web site. http:// esciencenews.com/articles/2008/06/18/ stress.during.childhood.increases.risk.allergies. Published June 18, 2008. Accessed July 14, 2009. 10. Kozyrskyj AL, Mai XM, McGrath P, Hayglass KT, Becker AB, Macneil B. Continued exposure to maternal distress in early life is associated with an increased risk of childhood asthma. Am J Respir Crit Care Med. 2008;177(2):142-147. 11. Eiguchi K, Soneira SG. Psiconeuroinmunoendocrinología en enfermedades autoinmunes (LES). Archivos de Alergia e Inmunología Clínica. 2002;33(suppl 1):S8-S16. 12. McEwen BS. Physiology and neurobiology of stress and adaptation: central role of the brain. Physiol Rev. 2007;87(3):873-904. 13. Zisapel N. Sleep and sleep disturbances: biological basis and clinical implications. Cell Mol Life Sci. 2007;64(10):1174-1186. 14. Plant TM. Hypothalamic control of the pituitary-gonadal axis in higher primates: key advances over the last two decades. J Neuroendocrinol. 2008;20(6):719-726. 15. Dimpfel W. Psychophysiological effects of neurexan on stress-induced etropsychograms: a double blind, randomized, placebo-controlled study in human volunteers. NeuroCode-AG Web site. http://www. neurocode-ag.com/Poster%20Stresskongress%20Teil%20A.pdf and http://www. neurocode-ag.com/Poster%20Stresskongress%20Teil%20B.pdf. Accessed July 14, 2009. )7 Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 Hearing voices when there is nobody around? A recent study suggests that high caffeine consumption may increase a pre-existing tendency to hallucinate. Getting a good night’s sleep reduces the risk of catching a viral infection. )8 Link between caffeine and hallucinations? The more expensive the better? For good health, get enough sleep A new research study, conducted at Durham University, UK, examines a possible link between high caffeine consumption and an increased tendency to hallucinate. The study assessed typical caffeine consumption of 200 students, along with stress levels and proneness to common hallucinatory experiences such as hearing voices when no one is present. “High caffeine users” consuming more than the equivalent of seven cups of instant coffee a day were three times more likely to hear voices than “low users” consuming less than one cup-equivalent. What’s the theory behind this research? As a result of traumatic events in their past, many hallucination-prone individuals respond to current stress by producing increased amounts of the stress hormone cortisol. Caffeine consumption further increases release of the stress hormone, and this extra cortisol boost might exacerbate a pre-existing tendency to hallucinate. The authors call the findings a first step in better understanding how nutrition affects hallucinations. More research is needed to see if changes in caffeine intake might help people to better cope with distressing hallucinations or reduce the frequency of these experiences. “If it’s not expensive, it can’t be any good.” Many people seem to approach medical care with this attitude. In an American study, 82 healthy volunteers were given what they thought was a new pain reliever. In reality, all of the subjects received identical placebos, but half of them were told that the price per tablet was $2.50, while the others were allowed to believe the medication was very lowpriced. The analgesic effects of the fake medication were then tested using mild electrical shocks to induce pain. Subjective sensations of pain were significantly reduced in the group receiving the supposedly more expensive medication in comparison to the other group. People who sleep well and long enough are less susceptible to viral infections, according to a study of 153 healthy men ranging in age from 21 to 55 years. The subjects were surveyed about the quantity and quality of their sleep over a 14day period, after which they were infected by administering nose drops containing rhinoviruses. Researchers found that subjects who slept longer and better got sick less often than participants who slept less. For example, participants who got eight hours of sleep or more were approximately 2.94 times less likely to catch colds than those who slept for seven hours or less. The effects of sleep efficiency (actual sleeping time as a percentage of total time in bed) were even greater: Participants with 92 percent efficiency or less were 5.5 times more likely to develop a cold than those with 98 percent efficiency or more. The immune system appears to need adequate sleep to effectively fend off germs. Personality and Individual Differences. 2009;46(4):562-564. JAMA. 2008;299:1016-1017 Enjoy food and lose weight Eating rapidly to the point of satiety increases the risk of obesity. When 3,287 Japanese women and men were surveyed about their eating habits, respondents who said they tended to eat fast until they felt full were three times more likely to be overweight than people who ate slowly and enjoyed their food. It seems that weightwatchers should not only pay attention to what they eat but also to how they eat. BMJ. 2008;337:a2002 Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 Arch Intern Med. 2009;169(1):62-67 ) What Else Is New? During a coughing attack, airborne pathogens will be propelled into the surrounding air for about four meters. Sexy women wear red “Red-light” districts and sexy red lingerie suggest that the color red has long been associated with male sexual drive, but this connection had never been scientifically confirmed. To test men’s responses to the color red in relationship to women’s sexual attractiveness, participants were shown photos of women in front of different colored backgrounds. Other pictures showed the women wearing different colored tops. The study found that men saw women posing in front of a red background or wearing red tops as sexually more desirable than the same women in other photos. Red had no effect on the men’s assessment of the women’s other qualities such as intelligence or kindness. Women shown the same photos seemed to be colorblind when it came to rating the attractiveness of other women. Communicating with patients through positive images We humans still think best in images, and abstract numbers are difficult for most of us to remember. Health care practitioners should also use this fact to their advantage and enhance their communication with patients by using pictures and graphic elements. Researchers from New Zealand recently investigated the best way to convey important information about treatments to patients. Two-thirds of the patients questioned preferred graphically presented information to pure numbers and percentages. Positive formulations were also considered helpful. In other words, it is generally better to emphasize the benefits of a particular therapy instead of stressing the possible risks of leaving a condition untreated. Keep your distance to stay healthy Many diseases are transmitted by airborne drops. At work, in the subway, while shopping – wherever we meet other people, we are bombarded with germs. People who are already sick and coughing are especially likely to contaminate the air with germ-filled spray. A recent study investigated how fast this cloud spreads around a cougher. Scientists from the USA calculated the speed of spread at up to eight meters per second over a period of approximately half a second. This means that an attack of coughing propels germs into the surroundings for about four meters. Anyone who wants to make it through cold season unscathed would do well to keep their distance from other people. N Engl J Med. 2008;359(15):e19 J Pers Soc Psychol. 2008;95(5):11501164 Ann Fam Med 2008;6(3):213-217 F O R P RO F E S S I ONA L U S E ON LY The information contained in this journal is meant for professional use only, is meant to convey general and/or specific worldwide scientific information relating to the products or ingredients referred to for informational purposes only, is not intended to be a recommendation with respect to the use of or benefits derived from the products and/or ingredients (which may be different depending on the regulatory environment in your country), and is not intended to diagnose any illness, nor is it intended to replace competent medical advice and practice. IAH or anyone connected to, or participating in this publication does not accept nor will it be liable for any medical or legal responsibility for the reliance upon or the misinterpretation or misuse of the scientific, informational and educational content of the articles in this journal. The purpose of the Journal of Biomedical Therapy is to share worldwide scientific information about successful protocols from orthodox and complementary practitioners. The intent of the scientific information contained in this journal is not to “dispense recipes” but to provide practitioners with “practice information” for a better understanding of the possibilities and limits of complementary and integrative therapies. Some of the products referred to in articles may not be available in all countries in which the journal is made available, with the formulation described in any article or available for sale with the conditions of use and/or claims indicated in the articles. It is the practitioner’s responsibility to use this information as applicable and in a manner that is permitted in his or her respective jurisdiction based on the applicable regulatory environment. We encourage our readers to share their complementary therapies, as the purpose of the Journal of Biomedical Therapy is to join together like-minded practitioners from around the globe. Written permission is required to reproduce any of the enclosed material. The articles contained herein are not independently verified for accuracy or truth. They have been provided to the Journal of Biomedical Therapy by the author and represent the thoughts, views and opinions of the article’s author. Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 )9 ) From the Practice Metabolic and Endocrine Disorders Associated With Pseudarthrosis Presentation of a Clinical Case Mónica Name Guerra, MD Bone fatigue is a considerable risk factor causing fractures in high-performance athletes, as a result of many extrinsic and intrinsic factors. This article describes a 13-year-old girl, a professional skater with a fracture of the femur and atrophic pseudarthrosis 10 months after initial surgical treatment. A metabolic disturbance was found at the biological medical consultation; this was managed holistically, and the patient’s fracture healed after 2 months of antihomotoxic and integrative treatment. T he use of unsuitable equipment, very intensive training schedules, and inappropriate diets are among the external risk factors that predispose towards bone pathology in athletes. Age; mechanical biophysical factors arising from the bone-muscle relationship, which alter physiological alignment; bone density; and metabolic or hormonal imbalances are intrinsic causes of stress fractures and pseudarthrosis. Prepubertal girls and women, as a result of the physiological changes inherent to their sexual development and monthly hormonal fluctuation, are a population especially at risk.1 In 1986, the US Food and Drug Administration defined pseudar throsis as nonhealing of a fracture Figure 1: Fracture Figure 2: Intramedullary pin (June 26, 2004) ) 10 Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 9 months after injury. However, depending on the bone and the site of the injury, this period may vary. In fractures of the long bones in the middle third of the femur, a waiting period of 6 months is allowed, whereas neck fractures should heal within 3 months after the trauma.2 Although the exact cause of pseudar throsis is not clear, it is believed that local factors (e.g., infection and poor vascularization) and systemic factors (e.g., nutritional state and hormonal balance) contribute to nonhealing of fractures. Although there are opposing opinions, there is considerable bibliographic evidence implicating nonsteroidal anti-inflammatory drugs and corticoids as important factors in fractures that are not healing.3 Pseudarthrosis can be hypertrophic or hypervascularized and atrophic or avascular. Figure 3: Pseudarthrosis at follow-up ) From the Practice Figure 4: Second operative procedure Figure 5: Postoperative view 5 months after the second operative procedure Clinical case The patient is a 13-year-old sports person who, on June 25, 2004, experienced a displaced fracture in the middle third of the right femur (Figure 1), which required surgical treatment with an intramedullary pin (Figure 2). A 5-month postoperative followup X-ray showed pseudarthrosis (Figure 3). Thus, from an orthopedic viewpoint of the mechanical instability and hypertrophic pseudar throsis, a further intervention changing the pin for one of a larger diameter with double distal locking was performed on November 17, 2004 (Figure 4). Five months after the second operative procedure, the fracture was classified as atrophic pseudarthrosis (Figure 5), and the treating orthopedic surgeon proposed a third intervention. The patient decided to consult a biological medicine specialist to obtain a second opinion. Laboratory test The consultation on April 13, 2005, showed that the patient was in pain, with no support from the lower right limb, and had a high consumption of nonsteroidal anti-inflammatory drugs. The results of the Meridian Stress Assessment (developed by Reinhold Voll) were pancreatic and splenic dysfunction (Table 1); therefore, clinical laboratory tests were performed to complete the investigation (Table 2). These test results showed a state of hypercortisolism with a normal basal insulin level (no postprandial insulin test result was available). The postprandial glucose response at 30 minutes was normal; however, at 1 hour, it was very low. The thyrotropin level was in the normal range, the free thyroxine level was normal, and the triiodothyronine level was not obtained. The parathyroid hormone level was normal; the result of bone densitometry showed osteopenia. Patient value Reference value Urinary cortisol, µg/24 h 60.86 5-55 Basal blood glucose, mg/dL 79 70-105 Postprandial blood glucose at 30 min, mg/dL 125 > 110 Postprandial blood glucose at 1 h, mg/dL 74 120-170 Postprandial blood glucose at 2 h, mg/dL 94 70-120 Thyrotropin, µUI/mL 2.40 0.35-5.50 Free thyroxine, ng/dL 1.06 0.93-1.70 Parathyroid hormone, pg/mL 31.3 11.0-79.5 Basal insulin, µU/mL 5.02 2.60 -24.90 Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 Organ Right side Left side Lymphatic deg. 48 46 Lung 54 46 Large intestine 34 56 Central nervous system deg. 42 46 Circulation 46 48 Allergy deg. 42 42 Parenchyma deg. 34 42 Endocrine 46 46 Heart 52 46 Small intestine 44 58 Pancreas 18 Spleen 16 Liver 44 46 Joint deg. 46 36 Stomach 54 52 Fibroid deg. 58 48 Skin deg. 66 58 Fat deg. 56 58 Gallbladder 70 52 Kidney 54 52 Bladder 48 56 Uterus/prostate 48 54 Table 1: Meridian Stress Assessment results* Table 2: Clinical laboratory results * Normal values, 40-60; Irritation, 61-80; Inflammation, 81-100; Weakness, 31-39; Degeneration, < 30 ) 11 ) From the Practice Figure 6: Consolidated fracture (June 23, 2005) Treatment was started as follows: • Osteoheel, 1 tablet 4 times per day • Strumeel, 1 tablet 4 times per day • Momordica compositum, 1 ampoule twice weekly, 10 doses • Placenta compositum, 1 ampoule twice weekly, 10 doses • Acidum citricum-Injeel, 1 ampoule twice weekly, 10 doses • Lymphomyosot, 1 ampoule twice weekly, 10 doses Nutritional changes reducing the intake of rapidly absorbed carbohydrates (refined sugars) and avoiding high-sodium processed foods (ready meals and fast food) were recommended. At the 2-month clinical follow-up, pain was absent, normal electrical measurements of the pancreas (44) and spleen (48) were noted, and radiography showed healing of the fracture (Figure 6); therefore, the intramedullary pin was removed (Figure 7). Laboratory findings at the end of treatment were normal. ) 12 Discussion According to the Meridian Stress Assessment, this patient had an abnormality of the pancreas. Her low glucose level, using the result of the oral glucose tolerance test at 60 minutes, indicates hypoglycemia and a state of chronic hypercortisolism. This state of transitory hypoglycemia leads to a functional imbalance of the hypothalamus-pituitary-adrenal cortex axis4-6; therefore, the response is an increase in β-adrenergic activity in the hypothalamus, with the release of the growth hormones somatotrophin and corticotropin and increased secretion of cortisol and epinephrine.5,6 The cortisol acts like a counterregulating hormone and induces the production of glucose, activating the gluconeogenesis pathway. If the hypoglycemia persists, the level of cortisol rises, conforming a state of chronic hypercortisolism. The increased cortisol levels in this patient could be secondary to the hypoglycemia and stress produced by competitive exercise and the influence of interleukin 6 as a chronic inflammatory cytokine.7 Intense exercise by high-performance athletes suppresses the function of the T cells and natural killer cells and increases the release of cortisol and interleukin 6 proinflammatory factors.7 Cortisol causes a reduction in bone formation and an increase in re sorption by various mechanisms (Figure 8).8 Cortisol antagonizes the action of 1,25-dihydroxyvitamin D3 or calcitriol, which acts on the osteoblast by increasing the synthesis of tissue growth factor β (TGF-β) and raising the number of insulinlike growth Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 factor receptors, whose anabolic effect regulates bone growth and tissue repair.8-12 Vitamin D3 increases the synthesis of osteocalcin and osteopontin by improving the mineralization of the collagen fibrils of the bone when they are depleted.9-12 The formation of hydroxyapatite alters with sodium/calcium interchange in the renal distal tubules, where phosphorus and magnesium are also lost. Each gram of sodium ion in urine corresponds to 26.3 mg of lost calcium; therefore, salty and fast food diets are not recommended.13 Ingesting oily seeds and extra virgin vegetable oils rich in polyunsaturated fatty acids and conjugated lin oleic acid increases the absorption rate of calcium in the cells and reduces osteoclastogenesis.14 Acidification secondary to the ingestion of refined sugar and proteins with sulfur atoms (methionine and cysteine) alters the mineralization and metabolism of the bone.9 The concentration of protons in the plasma and in the extracellular fluid is about 40 nM, corresponding to a pH of 7.4; to stabilize and alkalize this, there are systems that include balancing phosphate with calcium and magnesium ions originating from the bone matrix at the expense of weakening the bone.9 According to the personal analysis that I have made of this clinical case, ) From the Practice Figure 7: Fracture without intramedullary pin (November 28, 2006) antihomotoxic medications could hypothetically have acted in the following manner in healing the fracture: 1. Antihomotoxic medications, which contain low doses of antigens, could have stimulated the production of TGF-β from the lymphocyte line T-helper cell 3. This TGF-β intervenes in the reconstruction of the bone matrix by inhibiting the activation of the osteoclasts and stimulating the action of the osteoblasts, promoting the healing of the tissue and the resolution of the inflammation.15-18 2. The bioregulatory effect of Momordica compositum in the pancreas in controlling hypoglycemia and secondary hyper cortisolism could be the result of a possible improvement in the expression of glucotransporters in the cells and hypothetically might increase the secretion of amylin and preptin. These 2 polypeptides are cosecreted with insulin from the β cells of the pancreas; their function is to stimulate osteoblastic proliferation, reduce osteoblastic apoptosis, and inhibit osteoclastic activity.19-25 3. Possibly, Acidum citricum-Injeel, a Krebs cycle catalyst and calcium metabolism regulator that improves the absorption of vitamin D, could act in the renal tubule cells by stimulating the mitochondrial 1a-hydroxylase responsible for transforming 25hydroxycholecalciferol (inactive) into 1,25-dihydroxycholecalciferol (active) or calcitriol. Figure 8: Effects of cortisol on bone8 GI Ca absorption Renal Ca absorption Bone resorption LH – FSH Testosterone Estrogen Cortisol Osteoporosis Osteoprotegerin Muscle strength Osteoblastic apoptosis Bone formation Growth factors Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 GI Gastrointestinal Ca Calcium LH Luteinizing hormone FSH Follicle-stimulating hormone ) 13 ) From the Practice Conclusion Antihomotoxic treatment drains the matrix (Lymphomyosot), regulates the endocrine function of the pancreas (Momordica compositum), regulates thyroid function (Strumeel), solves the problem of avascular atrophic pseudarthrosis (Placenta compositum), and re-establishes the metabolic balance of bone, the intrinsic calcium metabolism, and vitamin D absorption (Osteoheel and Acidum citricum-Injeel). Pseudarthrosis is not an exclusively mechanical problem. It must be confronted integrally, from the profession or lifestyle to the metabolism of the organism, the diet, the neuroendocrine system, and immunological modulation. “The whole organism suffers with the fracture of a long bone.”26| ) 14 References 1. DeFranco MJ, Recht M, Schils J, Parker RD. Stress fractures of the femur in athletes. Clin Sports Med. 2006;25(1):89-103, ix. 2. Cleveland KB. Delayed union and nonunion of fractures. In: Canale ST, Beaty J, eds. Campbell’s Operative Orthopaedics. 11th ed. Philadelphia, PA: Mosby; 2007:chapter 56. 3. Koester MC, Spindler KP. Pharmacologic agents in fracture healing. Clin Sports Med. 2006;25(1):63-73, viii. 4. Fruehwald-Schultes B, Kern W, Born J, Fehm HL, Peters A. Hyperinsulinemia causes activation of the hypothalamus-pituitary-adrenal axis in humans. Intern J Obes. 2001;25(suppl1):S38-S40. 5. Arias P, Arzt E, Bonet E. Estrés y procesos de enfermedad. Buenos Aires, Argentina: Biblos; 1998. 6. Suliman AM, Freaney R, McBrinn Y, et al. Insulin-induced hypoglycemia suppresses plasma parathyroid hormone levels in patients with adrenal insufficiency. Metabolism. 2004;53(10):1251-1254. 7. Rosales Estrada M. Síndrome de inflamación de las mucosas: tratamiento antihomotóxico. 2nd ed. Colombia: M. Rosales Estrada; 2005. 8. Rubin MR, Bilezikian JP. The role of parathyroid hormone in the pathogenesis of glucocorticoid-induced osteoporosis: a reexamination of the evidence. J Clin Endocrinol Metab. 2002;87(9):4033-4041. 9. Koolman J, Röhm K. Bioquímica: texto y atlas. 3rd ed. Stuttgart, Germany: Panamericana; 2004. 10. Clark R. The somatogenic hormones and insulin-like growth factor-1: stimulators of lymphopoiesis and immune function. Endocr Rev. 1997;18(2):157-179. 11. Kurtz A, Matter R, Eckardt KU, Zapf J. Erythropoiesis, serum erythropoietin, and serum IGF-I in rats during accelerated growth. Acta Endocrinol (Copenh). 1990;122(3):323328. 12. Gómez JM. The role of insulin-like growth factor I components in the regulation of vitamin D. Curr Pharm Biotechnol. 2006;7(2):125132. 13. Shortt C, Madden A, Flynn A, Morrissey PA. Influence of dietary sodium intake on urinary calcium excretion in selected Irish individuals. Eur J Clin Nutr. 1988;42(7):595-603. 14. Bhattacharya A, Banu J, Rahman M, Causey J, Fernandes G. Biological effects of conju- Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 gated linoleic acids in health and disease. J Nutr Biochem. 2006;17(12):789-810. 15. Abbas AK, Lichtman AH, Pillai S. Inmunología celular y molecular. 6th ed. Barcelona, Spain: Elsevier Saunders; 2008:3-16, 243263, 267-301. 16. Heine H. Homotoxicología: Una síntesis de las orientaciones médicas basadas en las ciencias naturales. 3rd ed. Baden-Baden, Germany: Aurelia-Verlag; 2004:79-85. 17. Weiner HL, Mayer LF. Oral tolerance: mechanisms and applications. Ann N Y Acad Sci. 1996;778:1-451. 18. Weiner HL, Friedman A, Miller A, et al. Oral tolerance: immunologic mechanisms and treatment of animal and human organspecific autoimmune diseases by oral administration of autoantigens. Annu Rev Immunol. 1994;12:809-837. 19. Cornish J, Callon KE, Bava U, et al. Preptin, another peptide product of the pancreatic β-cell, is osteogenic in vitro and in vivo. Am J Physiol Endocrinol Metab. 2007;292(1): E117-E122. 20. Dacquin R, Davey RA, Laplace C, et al. Amylin inhibits bone resorption while the calcitonin receptor controls bone formation in vivo. J Cell Biol. 2004;164(4):509-514. 21. Valenzano KJ, Heath-Monnig E, Tollefsen SE, Lake M, Lobel P. Biophysical and biological properties of naturally occurring high molecular weight insulin-like growth factor II variants. J Biol Chem. 1997;272(8):48044813. 22. Buchanan CM, Phillips AR, Cooper GJ. Preptin derived from proinsulin-like growth factor II (proIGF-II) is secreted from pancreatic islet β-cells and enhances insulin secretion. Biochem J. 2001;360(pt 2):431-439. 23. Alam AS, Moonga BS, Bevis PJ, Huang CL, Zaidi M. Amylin inhibits bone resorption by a direct effect on the motility of rat osteoclasts. Exp Physiol. 1993;78(2):183-196. 24. Cornish J, Callon KE, Cooper GJ, Reid IR. Amylin stimulates osteoblast proliferation and increases mineralized bone volume in adult mice. Biochem Biophys Res Commun. 1995;207(1):133-139. 25. Cornish J, Callon KE, King AR, Cooper GJ, Reid IR. Systemic administration of amylin increases bone mass, linear growth, and adiposity in adult male mice. Am J Physiol Endocrinol Metab. 1998;275(4, pt 1):E694-E699. 26. Sodi-Pallares D. Magnetoterapia y tratamiento metabólico. Publisher unknown; 1994:84. ) Around the Globe Verona – More Than Just Romeo and Juliet ... By Anita Bania, MD F human body and the loss of normal matrix functions in the course of the aging process. Professor Sergio Serrano introduced the therapeutic use of biophotons and singlet oxygen and demonstrated their practical applications in traditional mesotherapy and biomesotherapy to the group. Dr. Bianchi is a seasoned expert on Krebs cycle catalysts and enthusiastically endorses their use in therapy, both in his youngest patients (such as low birth-weight babies) and in mature and elderly patients. We analyzed individual clinical case studies under Dr. Bianchi’s guidance. From the perspective of conventional medicine, all of these cases were at least very interesting and often very challenging. All of Dr. Bianchi’s patients had undergone very thorough diagnosis, often in university hospitals, and their discharge summaries and hospitalization information were available. Dr. Bianchi conducted detailed repertorization of each individual patient, applying the rules of classical homeopathy and homotoxicology, and determined the position of each patient’s condi- rom November 6 to 8, 2008, in Verona, Italy, the International Academy for Homotoxicology presented a practice-based training for Polish doctors whose practices combine conventional medical training with elements of homeopathy, homotoxicology, acupuncture, homeosiniatry, and mesotherapy. The small group of students, all experienced clinicians, included three internal medicine specialists and two pediatricians. The training took place in Dr. Ivo Bianchi’s private medical practice, which he runs together with his wife and daughter. Dr. Bianchi sees patients of virtually all ages, ranging from infants to geriatric patients. The group had close contact with selected patients, had access to their histories, and was able to examine them. Each patient was then discussed in detail to determine individually optimized therapies and recommendations. Dr. Bianchi had invited two guest speakers to contribute to the training. Dr. Lugero Graziolli gave a lecture and practical demonstrations on “Esthetic Biological Medicine: Diagnosis and Therapies,” placing particular emphasis on biochemical and electromagnetic homeostasis in the At the end of the training, the Sightseeing in Verona tion on a neurovegetative outline he has developed and enriched with additional elements drawn from homotoxicology, Chinese medicine, and conventional medicine. The training itself was very intense but well-organized, and the sessions were just the right length. Between sessions, we were also able to enjoy the charming sights of the town of Verona and see the international horse show gala HORSELYRIC, for which Verona is now famous. We found participating in this training to be highly rewarding and recommend it to all practitioners interested in homotoxicology and holistic medicine.| For more information on practice-based training in bioregulatory medicine, please contact the International Society of Homotoxicology and Homeopathy at [email protected] ) 15 participants received certificates (far left and right: Dr. Ivo Bianchi and his wife Marina). Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 ) Practical Protocols Bioregulatory Treatment of Dysautonomia By Bert Hannosset, MD D ic nervous system, is much more common. In this disorder, the human body fails to properly regulate blood pressure (e.g., orthostatic hypotension), heart rate (e.g., postural orthostatic tachycardia syndrome), temperature, vascular constriction/ dilation, and blood supply to the brain. The results are unpredictable fainting, low blood pressure, lightheadedness, dizziness, problems with concentration (“brain fog”), headaches, fatigue, heart palpitations, exercise intolerance, insomnia, ysautonomia, formerly called neurasthenia, exists in two forms: familial dysautonomia and non-familial dysautonomia. Familial dysautonomia is an autosomal recessive genetic disease, the result of mutation in the IKBKAP gene on chromosome 9. It occurs exclusively in Ashkenazi Jews; there are currently 350 known living cases worldwide. To date, the disease remains incurable. Non-familial dysautonomia, a disease or malfunction of the autonom- DET-phase Basic and/or symptomatic Sympathicodermal Impregnation • Ignatia Homaccord D&D hot flashes, chills, weakness, seizures, pain, and disability. The causes of non-familial dysautonomia are not fully understood but are thought to include viral infections, exposure to toxic chemicals, genetic factors (a variation in the angiotensin II type I receptor gene), autoimmune disorders (antibodies to neuronal nicotinic acetylcholine receptors of the autonomic ganglia), adrenal disorders, and trauma (injury or emotional trauma, which damages the autonomic nervous system). (See protocol in Table 1.)| Regulation therapy* Optional • Advanced supportive detoxification and drainage followed by the • Vertigoheel (dizziness) • Detox-Kit IM • Tonsilla compositum OR • Sympathicus suis-Injeel if available; if not, use • Tonico-Injeel (exhaustion) • Cralonin (cardiac weakness) • Aurumheel (low blood pressure) • Traumeel (injury) • Engystol (post-viral) • Cerebrum compositum Notes: Ignatia and Moschus = basic homeopathic treatment for dystonia. Advanced supportive detoxification and drainage consists of Hepar compositum (liver), Solidago compositum (kidneys), and Thyreoidea compositum (connective tissue; also regulates glandular functions [e.g., pineal body, thyroid, and adrenals]); Coenzyme compositum and Ubichinon compositum for cellular detoxification and drainage. The Detox-Kit consists of Lymphomyosot, Nux-vomica-Homaccord, and Berberis-Homaccord. Tonsilla compositum downregulates the Th-2 pathway and supports adrenals. Sympathicus suis-Injeel supports the autonomic nervous system. Cerebrum compositum supports the central nervous system and improves blood flow. Dosages: Ignatia-Homaccord: 15 drops 3 times per day. Regulation therapy: 1 ampoule of each medication 1-3 times per week. Detox-Kit: 30 drops o f each medication in 1.5 liters of water; drink throughout the day. ) 16 Table 1: Protocol for dysautonomia * Antihomotoxic regulation therapy consists of a three-pillar approach: detoxification & drainage (D&D), immunomodulation (IM), and organ regulation (OR) Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 In memoriam P rofessor Michael F. Kirkman died on Saturday, January 18 on the Isle of Wight, United Kingdom. He had lectured at St. Andrew’s Medical School; his medical knowledge ranged from pathology and tropical diseases to homeopathy, homotoxicology, and nutrition. He was one of the first doctors to apply an integrative concept of medicine that included environmental factors and detoxification. He had the courage to challenge medical conventions and found himself in the first line of attack for his use of homeopathic sarcodes and nosodes. Like Drs. Reich, Gerson, Bach, and Reckeweg before him, his dogged persistency, academic ability, and zeal to advance the “art of medicine” enabled him to carry on with his mission. He wrote a textbook on tissue microenvironment and lectured and published articles worldwide. He was one of the first certified lecturers of the International Academy for Homotoxicology (IAH) and won an award for the best lecture at the first IAH rollout in BadenBaden, Germany in April 2003. He founded not only one of the first nutritional colleges in the UK (the European College of Nutrition at the Royal Society for Public Health) but also the first College of Homotoxicology in the UK; with colleagues, he started the first postgraduate course in bioregulatory medicine. Last but not least, he was involved in teaching a course in bioregulatory medicine at the Biomedic Centre in the UK in collaboration with two colleagues, Drs Shakambet and Bosh. Professor Michael F. Kirkman (1936 – 2009) His guidance and support were crucial to those following this path, and he was full of warmth and enthusiasm for new projects. His mentorship, wise guidance, and friendship, along with his witty and creative mind, will be greatly missed. His funeral was held on February 4, 2009 on the Isle of Wight. Professor Kirkman is survived by his wife Muriel. Damir A. Shakambet, MD Hans-Heinrich Reckeweg Award 2010 Join in – have your experience rewarded Heel annually honors outstanding scientific research in the field of a unique homeotherapeutic system (homotoxicology) with the Hans-Heinrich Reckeweg Award. The main award (€ 10,000) is presented for scientific work of fundamental theoretical and/or practical significance in antihomotoxic medicine in the fields of human and veterinary medicine. The incentive award (€ 5,000) is presented for promising results arising from clinical, case-based or fundamental research in antihomotoxic medicine in the fields of human and veterinary medicine. The prize money is intended to fund further research. Both prizes are awarded for research carried out in a laboratory or registered practice. All results must be new, convincing and previously unpublished, and research should not have involved animal testing. The deadline for submissions is May 31, 2010. For more information contact: Biologische Heilmittel Heel GmbH, Department of Research, 76532 Baden-Baden, Germany Phone +49 7221 501-227, Fax +49 7221 501-660, [email protected], www.heel.com Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 ) 17 ) Re f r e s h Yo u r H o m o t ox i c o l o g y Psychogenic Factors in Gastrointestinal Pathology By Bruno Van Brandt Medical Education Manager of the IAH Is half a glass of water half full or half empty? Although the reality remains the same, the way individuals look at it will definitely change their emotional state. Half full or half empty makes the difference between positivism and negativism, between stress and inner peace, between psychogenic factors that will, over the ideomotorical rule in psychology,* enhance or inhibit physical condition or strength. E ) 18 motional triggers of immune disorders are very well-known in modern medicine, especially where psycho-neuro-endocrino-immunological (PNEI) effects are seen as a major trigger within psychosomatic diseases.1 Serotonin, adrenaline, dopamine, and glutamate are major neurotransmitters in the central nervous system. Serotonin and adrenaline especially are secreted in response to stress and emotion. All 4 neurotransmitters mentioned are also present in a second, almost prehistorical, and often forgotten brain, called the enteric brain. This enteric nervous system, located in the gastrointestinal (GI) tract (more precisely in the epithelial lining of the esophagus, stomach, and small and large intestines), is a major subject in the study of neurogastroenterology and plays an important role in irritable bowel syndrome (IBS). According to some researchers, up to 95% of the serotonin available in the body is located in the GI tract; of this 95%, 90% is in the enterochromaffin cells, and the remaining 10% can be found in enteric neurons. Serotonin plays a key role in the initiation of peristaltic and secretory reflexes.2 Although the enteric brain is described as part of the peripheral nervous system, it is also defined as the second brain,3 in addition to the primary central brain. The central nervous system can influence the enteric brain and vice versa.3 This could be a possible explanation as to why an emotional stressor or anxiety can indirectly induce IBS. During stress, the brain will induce, over the brain-gut axis, mast cell degranulation in the intestinal tract. By this degranulation, histamine and phospholipids are set free in large numbers, inducing inflammatory pathways. Activation of the gut immune system may disrupt normal gut motility, leading to common symptoms such as diarrhea, cramping, and bloating.4 The inflamed tissues render the enteric nerves overly sensitive and overactive, deregulating the production of serotonin. Both low and high levels of serotonin can cause problems. The same molecule, when available in a too low or a too high concentration, may induce the same clinical symptom: cramps. As Paracelsus already stated centuries ago, “the dose makes the poison.” Low levels of serotonin are not only associated with depression, shortterm memory, and concentration deficits, but also, at the level of the enteric nervous system, with bowel problems such as constipation with spasm (IBS-C). Emotional stress, over the PNEI system, can thus induce changes within serotonin levels at the level of the GI tract and can induce spasms (Figure 1). A stressrelated nervous or anxious state will increase the prevalence or intensity of intestinal spasm over the braingut axis.5 Increased levels of serotonin are associated with intestinal problems too, such as is seen in diarrhea accompanied by cramps (IBS-D).6 Selective serotonin reuptake inhibitor package inserts often mention both symptoms as possible adverse effects because of the medicationinduced decreased reuptake of serotonin and thus the increased serotonin availability and activity levels. * Every thought or idea makes the body gravitate to fulfill that thought or idea. William James, The Principles of Psychology (1890) Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 ) Re f r e s h Yo u r H o m o t ox i c o l o g y The conventional medical approach to IBS is often the use of antispasmodic agents, such as hyoscine butylbromide, to relieve spasms and cramps. Research in conventional medicine also reports the symptomrelieving effects of benzodiazepines in patients with IBS,7,8 pointing at the psychogenic factors that increase the physical symptoms over the brain-gut axis. A combination therapy of an antispasmodic medication with a benzodiazepine seems to have synergic therapeutic effects in the relief of IBS symptoms.9 Treatments aimed at the gut-brain interface are in development, but have been difficult to establish because of adverse effects.10 Bioregulatory treatment It is thus interesting to look at a bioregulatory approach in these patients. In a comparative study, Nervoheel was found to be noninferior to lorazepam, a benzodiazepine prescribed worldwide, in the treatment of mild nervous disorders.11 Spascupreel is a bioregulatory antispasmodic medication that will induce symptomatic relief of spasmodic conditions of the intestinal tract. In a comparative study versus hyoscine butylbromide, it was shown to possess a noninferior therapeutic effect in treating intestinal cramps.12 This effect of Spascupreel can be used in conditions such as IBS, and, if it is applied together with a psychogenic relaxing drug such as Nervoheel, a synergistic action on the gut-brain axis may be possible. In this way, a bioregulatory alternative can be offered for the combination of antispasmodic agent–tranquilizer in conventional therapy of IBS. Given the PNEI link between the central and enteric brain and the experience in conventional medicine (i.e., antispasmodic drugs in combination with tranquillizers have a stronger symptom-relieving effect in IBS), it can be stated that Nervoheel might play an important therapeutic role in the bioregulatory relief of IBS symptoms. Although some benzodiazepines are known to be addictive,13 to my knowledge, no such risk has ever been reported for Nervoheel. Thus, Nervoheel is a safe alternative to benzodiazepines. In the same way, Spascupreel is a safe and effective alternative to hyoscine butylbromide in the symptomatic relief of patients with IBS. Known adverse effects of hyoscine butylbromide include constipation, dry mouth, trouble urinating, and nausea. Other adverse effects, which are very unlikely but reported, include rash, itching, swelling of the hands or feet, trouble breathing, increased pulse, dizziness, diarrhea, vision problems, and eye pain. To my knowledge, none of these adverse effects have ever been reported with Spascupreel. In conclusion, bioregulatory treatment may offer a viable alternative Stress Mood disturbances • Anxiety • Depression Central nervous system (brain) Autonomic nervous system Enteric nervous system Intestines Smooth muscle Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 in the management of conditions in which the gut-brain interface causes deregulation of the enteric nervous system, the second brain.| References: 1. Sivik T, Byrne D, Lipsitt D, Christodoulou G, Dienstfrey H, eds. Psycho-Neuro-EndocrinoImmunology (PNEI). Amsterdam, the Netherlands: Elsevier; 2002. Excerpta Medica International Congress Series 1241. 2. Grider JR, Kuemmerle JF, Jin JG. 5-HT released by mucosal stimuli initiates peristalsis by activating 5-HT4/5-HT1p receptors on sensory CGRP neurons. Am J Physiol. 1996;270(5 pt 1):G778-G782. 3. Gershon MD. The enteric nervous system: a second brain. Hosp Pract (Minneap). 1999;34(7):31-32, 35-38, 41-42 passim. 4. Törnblom H, Lindberg G, Nyberg B, Veress B. Full-thickness biopsy of the jejunum reveals inflammation and enteric neuropathy in irritable bowel syndrome. Gastroenterology. 2002;123(6):1972-1979. 5. Taché Y. Stress and irritable bowel syndrome: unravelling the code. International Foundation for Gastrointestinal Disorders Web site. http://www.iffgd.org/store/viewproduct/211. Accessed July 14, 2009. 6. Singh RK, Pandey HP, Singh RH. Correlation of serotonin and monoamine oxidase levels with anxiety level in diarrhea-predominant irritable bowel syndrome. Indian J Gastroenterol. 2003;22(3):88-90. 7. Tollefson GD, Luxenberg M, Valentine R, Dunsmore G, Tollefson SL. An open label trial of alprazolam in comorbid irritable bowel syndrome and generalized anxiety disorder. J Clin Psychiatry. 1991;52(12):502-508. 8. Leventer SM, Raudibaugh K, Frissora CL, et al. Clinical trial: dextofisopam in the treatment of patients with diarrhoea-predominant or alternating irritable bowel syndrome. Aliment Pharmacol Ther. 2008;27(2):197-206. 9. Ritchie JA, Truelove SC. Treatment of irritable bowel syndrome with lorazepam, hyoscine butylbromide, and ispaghula husk. Br Med J. 1979;1(6160):376-378. 10. Sanger GJ. 5-Hydroxytryptamine and the gastrointestinal tract: where next? Trends Pharmacol Sci. 2008;29(9):465-471. 11. van den Meerschaut L, Sünder A. The homeopathic preparation Nervoheel N can offer an alternative to lorazepam therapy for mild nervous disorders. Evid Based Complement Alternat Med. Published October 25, 2007. doi:10.1093/ecam/nem144. 12. Müller-Krampe B, Oberbaum M, Klein P, Weiser M. Effects of Spascupreel versus hyoscine butylbromide for gastrointestinal cramps in children. Pediatr Int. 2007;49(3):328-334. 13. Cappell H, Busto U, Kay G, Naranjo CA, Sellers EM, Sanchez-Craig M. Drug deprivation and reinforcement by diazepam in a dependent population. Psychopharmacology (Berl). 1987;91(2):154-160. Figure 1: Stress alters the function of the gastrointestinal tract via the brain-gut axis. ) 19 ) M a r k e t i n g Yo u r P r a c t i c e Communication in Your Practice By Marc Deschler Marketing specialist An American study shows that faulty communication is management’s biggest problem. As a physician, you probably spend 90 percent of your working time communicating, both consciously and unconsciously. In the long term, miscommunication that leads to actual misunderstandings can put your practice at risk. R ) 20 eview the requirements of good communication and make improvements as needed: 1. Good communicators are made, not born. Every day brings new opportunities to practice and refine this ability. 2. We communicate even when we’re not saying anything. For example, if you keep your eyes fixed on the patient’s chart, you’re giving him the (mistaken) impression you are not really interested in his problem – his most important problem, otherwise he wouldn’t be there! Pay careful attention not only to what you say, but also to what you do. 3. Most of the information that gets stored in the brain is received through visual channels, and you can take advantage of this fact by using written information to supplement your words. Informational materials give patients a second chance – if they didn’t understand something completely, they can read about it later. Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 An additional tip: To reinforce your competence in your patients’ minds, print all informational materials on your own letterhead. 4. Assume that anything you’re trying to say can always be misunderstood. This will lead to better communication on your part, since you will choose your words differently and observe reactions more closely. 5. Not everything you say has to be print-ready and error-free. It’s more important that your patients understand what you’re saying. Avoid pretentious technical jargon. 6. Defining an illness is no help to the patient. She wants to know what it means for her, and she needs to be able to interpret your message correctly. 7. It’s not what you say, but how you say it. Pay attention to how you say something and to how you reinforce it with body language because nonverbal communication is by far the most important contributing factor. 8. On the phone, nonverbal communication is eliminated, so you and your team should make a special effort to use visual imagery when you speak. Repeatedly monitor the communication behavior of your staff and offer training and suggestions for improvements as needed. A clear structure, whether in communication, documentation, or filing, will save you time and money. The answering machine No one likes talking to a machine. Not surprisingly, according to one study, almost 60 percent of callers hang up when they get a machine, and of those who do leave a message, only 16 percent are identifiable. Clearly, though, your answering machine is one of the most important advertisements for your practice. What do you need to keep in mind when recording your message? 1. Include your name in your greeting. For example, “Hello, this is John Sample at XYZ practice.” 2. Meet the caller halfway: “Thank you for calling. Even though we can’t answer the phone right now, we’re still here for you.” 3. Suggest an action: “Please don’t hang up, but …” 4. In closing, thank them again for calling. Your phone message should be wellprepared, not just an afterthought. Write out an appropriate text and read it in a clear and friendly voice, quietly and not too slowly. Your message should flow, so concentrate on what you’re saying but don’t rush it. Check your machine now and then by calling yourself. Your voice will sound different over the phone than it does when you’re recording. The tapes in analog machines eventually wear out; replace them periodically. To make sure you get the information you need from your callers, try handing out cards to your patients with the most important “W” questions you need in order to return their calls: • Who is calling? (name) • What are you calling about? • Where can you be reached? (phone number? E-mail address?) • When is a good time to reach you? Even if you choose not to offer patients the option of leaving a message, your recorded statement should be appropriate and convincing and leave them with a professional impression of your practice. Optimizing record-keeping It’s always worth looking for opportunities to improve the organization of your practice, including patient chart management, which can be a half-time job in itself if poorly designed. To avoid unnecessary expense to your practice, follow these rules for chart management: 1. The fewer files you have, the faster you can find any individual chart. Make sure to keep all of each patient’s information together in one place! 2. Sort through the files regularly. Inactive folders simply slow down your search. 3. Alphabetization is almost always the best filing system. Using as many index cards/tabs as possible makes it easier to find what you need quickly. Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 4. Re-file charts as soon as possible after adding to them. Don’t leave them lying around for someone to deal with later. 5. Formats and labeling should be kept consistent so you know where to look for what you need without searching. 6. More than three identifying cha racters (first and second letter of last name, first letter of first name) get unwieldy. Color coding (for example, for year of treatment) can speed up access. 7. File tabs or insert cards should be used to indicate status. 8. Documentation should be completed immediately after a service is rendered. Here, too, a well-conceived and consistent structure is important. 9. For preparing patient charts, you’ll need a date stamp, a stamp for diagnostic reports, etc. Charts prepared for house calls must also include a blank prescription form. 10.A quick glance before re-filing the chart should be enough to ensure that all necessary entries have been made. If you have the equipment and technical know-how, by all means get rid of paper charts a.s.a.p. You will eliminate a lot of administrative work, and that expensive EDP system will finally pay for itself ! In many cases, the improved work flow even makes additional investment in new EDP work stations worthwhile.| ) 21 ) Specialized Applications The Acupuncture Approach to the Hypothalamus-Pituitary-Adrenal Axis and Its Interaction With the Sympathetic and Parasympathetic Systems By Butch Levy, MD, LAc In contemplating this article, I was struck by the opportunity to connect and integrate an approach to a Western anatomical/physiological concept while reflecting on the use of Chinese medicine and homotoxicology. The sympathetic/parasympathetic system, or autonomic nervous system (ANS), can be translated into paradigms of activity and interaction using the Oriental construct of acupuncture tsubos, or holes, and using homeopathic combinations as therapeutic interventions. This combined usage is called homeosiniatry*. I ) 22 n the US perception of acupuncture, points reflect an anatomical location where a needle is inserted. Changing the rotation of the needle infers a method of enhancing or diminishing its effect (i.e., clockwise is tonification and counterclockwise is sedation). The Japanese approach to needling technique views acupuncture locations as specific holes. The needle is inserted along a vector, with a direction and depth. This requires palpatory acumen that translates into a precise connection into the path of flow desired. The extracellular matrix (ECM) is the common conduit for therapy, be it physiological stimulation of the nervous system, the Yin and Yang energies of Asian medicine, or the electrical signature of natural molecules, as is seen in homeopathy.1 Within the ECM lie the biological features that allow nerve impulses to signal and transmit information for homeostasis. Layered on that, the similar concepts of Yin and Yang theory are reflected within the same ECM, with cylindrical spirals of acupuncture holes acting as a transit system, via the meridian system, for similar information transmission concerning the body’s balance.2 Within the Oriental system, the ECM represents an equivalent concept, expressed as the Triple Heater. It is said to convey the Qi that is essential in energy transformation and metabolism. It is considered to be the fluid interface surrounding cells; in modern interpretation, it is considered to be the extracellular environment of the cell. The importance of these statements is to act as the starting point to treating patients with problems of the sympathetic/parasympathetic system, by being able to act in creative ways based on the practitioner’s assessment of the patient. It is often the situation that a single paradigm of therapy is inadequate to treat the complexity of issues generated within the body. This certainly is true regarding the sympathetic/parasympathetic system influences within us. To integrate these unique therapies requires a brief review of the connections that make them compatible for the treatment of sympathetic/parasympathetic, or ANS, imbalance. Autonomic nervous system The aspect of the nervous system that is involved in our discussion is the ANS. Originating in the hypothalamus, fiber tracts from the various nuclei (e.g., medial, lateral, anterior) travel from the hypothalamus into the intermediate brain and through the lower brain, making connections with multiple other nuclei there before descending into the spinal cord. These other nuclei also contribute essential information for ANS regulation. These pathways are called the hypothalamospinal tract * “Homeo” from homeopathy, “sin” from sinology = study of Chinese culture, and “-iatry” from Greek iatros = healer (figuratively: medicine) Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 © iStockphoto.com/Wolfgang Amri ) Specialized Applications Acupuncture needles are inserted into specific points on the body in order to relieve pain and/or restore health and well-being. (HST) and carry information that activates, stimulates, inhibits, or balances sympathetic and parasympathetic signals. The sympathetic system dominates during activity in the body and is energy consuming. The parasympathetic system dominates when the organism is in resting phases, including digestion and sleep cycles. The sympathetic nervous system is under the direct control of corticotrophin-releasing hormone (CRH) in the hypothalamus. Its stimulation creates an excitatory response in the sympathetic system while turning off parasympathetic responses, in preparation for the fight, fright, or flight response. Some of the direct effects seen via increased norepinephrine (adrenaline) are stimulation of cardiac muscle, an increase in heart rate and breathing, an increase in blood glucose, sweating, and vasoconstriction. At the same time, blood volume is expanded via the CRH activation of the renin-angiotensin-aldosterone system. When situations of perceived threat occur, anticipatory readiness is also reflected in increased muscle activity and visual acoustic startle, reduced appetite, and an inherent protective anxiety to “get out of town” or leave the scene quickly. To assist these preparations, the visceral tissues become quiescent, until the danger has passed. The spinal parasympathetic system is composed of the cranial division (cranial nerves III, VII, IX, and X) and the sacral division (S2-S4). These cranial nerves interconnect with the HST fibers via their nuclei, located in the midbrain, pons, and brainstem. The principal HST parasympathetic functions include pupillary and lens adjustments, salivation, heart rate, movement and secretions in the gastrointestinal tract, urination, defecation, and erection. Specifically, cranial nerve IX influences the carotid body and sinus and the pharyngeal mucosa. Cranial nerve X is related to the larynx and trachea and the thoracoabdominal viscera to the level of the splenic flexure. The sacral plexus involves the colon distal to the splenic flexure, the rectum, and the bladder. The HST of the sympathetic system extends from T1 to L2/3. The fibers exit the spinal cord as preganglionic fibers that release acetylcholine, which innervates their nearby preaortic and paravertebral postganglionic receptors, which then release norepinephrine. These chemical transmitters then affect the pupils, sweat glands, blood vessels, lungs, abdominal viscera, and gastrointestinal tract. The ANS helps coordinate and regulate stimuli coming from the external and internal environment. Asian medicine The seemingly opposite parts of the ANS imply energies of mutual dependence when considered within Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 the paradigm of Asian medicine. It is the Yin and Yang that are considered as the framework of movement and stillness, night and day, light and dark, with each aspect requiring a comparison to its counterpart to make sense. Although the final step for our consideration of homeosiniatry is specific injection of tsubos, or holes, there are essential constructs in Asian practice that themselves can act to create an enhancement of energy or the opposite effect of reducing or dampening energetic effects. The movement of energy, or Qi, is considered to travel unidirectional under normal circumstances, along each specific meridian pathway. Needling a tsubo along this direction of flow is considered tonifying or sympathetically stimulating. Needling techniques that are in the direction opposite or counter to established meridian flow will slow or reduce the energy flow, are considered sedating or quieting to the system, and would be considered parasympathetic. In protocols using electrical stimulation, a sympathetic or parasympathetic effect can be created via the circuits used. Electrical charge travels from negative (silver needle or black grip) to positive (gold needle or red grip), and electrical flows can be used to augment or diminish energy solely by adjusting the direction of flow of the electricity. Practitioners can also influence the activation of sympathetic activity by ) 23 ) Specialized Applications Figure 1: Back Shu points used in treating disorders of the hypothala- mus-pituitary-adrenal–sympathetic/ parasympathetic system. low-frequency electrical stimulation in the range of 2 to 10 Hz. These frequencies are used, for example, in facial nerve palsies and for historic treatments that were designed to upregulate, so to speak, weak energy systems within the body. To create a parasympathetic flow, high-frequency electrical stimulation can be used, ranging from 100 to 200 Hz for local myofascial injury to 1500 Hz for sedation of the central nervous system, thereby affecting higher brain centers for pain regulation (and a down-regulation of pain). BL 13 Lung BL 14 Pericardium BL 15 Heart BL 16 Governing vessel BL 17 Conception vessel BL 18 Liver BL 19 Gall bladder BL 20 Spleen BL 21 Stomach ) 24 Injection sites The classic choices for acupuncture holes that may be integrated to synergistically relate to homeosiniatry might include the 8 extra vessels, back Shu points (Figure 1), and source and auricular points. The extra vessel meridians of Yin/Yang Wei (Pericardium 6 and Triple Heater 5) connect and distribute all the Yin and Yang, respectively. The Yin/ Yang Qiao vessels (Kidney 6 and Urinary Bladder 62) balance all the Yin and Yang for muscle coordination in the body. Also, the Du Mai channel, the source of all Yang Qi, or sympathetic energy, can be augmented by needling from the lower spine up and can be quieted or sedated by needling from the scalp down. For the sympathetic concept, this would mean increasing the movement in the Yang organs; for the parasympathetic concept, the Qi BL 22 Triple heater BL 23 Kidney BL 25 Large intestine BL 27 Small intestine energy would be augmented in the Yin organs. The use of auricular points adds an essential synergism for balance within the brain and ANS. Using a point locator allows exact locations for treatment. Traditional interpretations used to imply that when one Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 aspect of the ANS was on, the other was off, and vice versa. Our society today creates levels of continuing stressors, and often the continued pressure on both aspects of the ANS results in imbalances that do not fit conventional rules. Using such a testing device, areas such as the pi- ) Specialized Applications In homeosiniatry, bioregulatory © iStockphoto.com medications are injected into tuitary, hypothalamus, preganglionic and postganglionic nerves, vagus, parasympathetic nerves, and amyg dala can be accessed and therapeutically used. The back Shu points represent a level of interaction that would be used to affect the individual organs that are influenced by the hypothalamus-pituitary-adrenal–sympathetic/parasympathetic system. The first line relates to organ dysfunction, whereas the second line has great benefits in emotional issues that affect its adjacent organ. Practical application Some practical examples of homeosiniatry that have application in the clinic would include the following. Starting at the hypothalamus, it would be ideal to directly affect its function! Tonsilla compositum contains hypothalamus and can act toward directly targeting at the hypothalamic level. Its effect would, therefore, generalize to the entire system. Points of injection should be ones that have general regulatory ability, such as Stomach 36 or Spleen 6. More often, therapy must be designed to indirectly affect the system, at the feedback loop to the hypothalamus or at the organ itself. Because hypothalamic CRH controls the production of cortisol, the negative feedback loop to CRH is activated when the hypothalamus senses increased cortisol. Therefore, using medications that contain acupuncture points. cortisol will reduce the production of CRH and slow or regulate the fight or flight response (i.e., sympathetic outflow). Tonsilla compositum (for overall immune stimulation), Thyreoidea compositum (for connective tissue metabolism), and Pulsatilla compositum (for support during chronic inflammation) all contain cortisone in dilution and can be used to reduce the output of CRH and with it sympathetic activity. Major organs that are activated by sympathetic stimulation are the heart, lungs, and the associated circulatory system. To affect these organs, especially in chronic conditions, the back Shu points can be injected. Because fight or flight is an excess condition, the points chosen on the Urinary Bladder line (Urinary Bladder 14, Pericardium; and Urinary Bladder 15, Heart) are tight and tense, indicating overactivity. Chronic myocardial weakness or coronary circulatory problems can be treated with Cactus compositum. Cor compositum can be used for palpitations, and Cralonin can be used for chest pains. The lung area, Urinary Bladder 13, can receive treatment for bronchospasm, using Mucosa compositum for wheezing and cough, Traumeel for inflammation, or Engystol for immune stimulation. In contrast, when sympathetic activation is quieted down, ideally the parasympathetic system is activated. Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 Their innervations primarily involve smooth muscle contraction and movement within many hollow organs. The Master Point of the Yin Qiao, Kidney 6, is considered regulatory of the Vagus, and Atropinum compositum is very useful for cramping and imbalanced peristalsis. Point choices might also include the source points or back Shu points for the large and small intestines, the spleen and stomach, and the urinary bladder and gallbladder. Spascupreel is effective for intestinal cramps and bladder spasm and irritability. In conclusion, any discussion regarding the hypothalamus-pituitary-adrenal–ANS really requires chapters to credibly explain each of the topics mentioned in this brief discussion. What I have attempted to relate is that the complexity of disease and our rapidly expanding technology have created a need to look beyond individual areas of focus and embrace a new holism of care. It is necessary to integrate multiple disciplines, concepts, and images to achieve results that succeed. | References 1. Oschman J. Energy Medicine. Dover, NH: Churchill Livingstone; 2008:141. 2. Pischinger A. The Extracellular Matrix and Ground Regulation. Berkeley, CA: North Atlantic Books; 2007:106. ) 25 ) Making of … Manufacturing of Traumeel Injection Solution Part I: From Work Preparation to Filling By Larissa Wörthwein-Mack To minimize the risk of contamination with microorganisms, special requirements apply to the manufacture of sterile medications. The standards are high, both for spatial and technical conditions and for employee qualifications. For example, manufacturing must take place in so-called cleanrooms of the appropriate classes, and spatial separation of the different production steps is required. M odern homeopathic combination products like Traumeel (which is used to treat inflammation and injuries) contain multiple ingredients. In Traumeel injection solution, there are 14 different active ingredients, primarily plant substances such as arnica, chamomile, and calendula. These raw materials are processed into mother tinctures and single potencies in accordance with current regulations of the German Homeopathic Pharmacopeia (HAB) and the European Pharmacopeia (Ph. Eur.). Production of a sterile dosage form ) 26 All manufacturing steps involving open containers must take place in Class C cleanrooms, which can be accessed only through airlocks and in appropriate protective clothing. High performance filters reduce the particulate count in the air, and the rooms are under positive pressure Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 with more than 20 air exchanges per hour. Pressure differentials of 10-15 Pa between cleanrooms of different classes ensure that when the door of a cleaner room is opened, the air streams out and contaminated air cannot flow in. The air is tested at regular intervals for particulate counts and microbiological loads. All exposed surfaces in the cleanrooms must be smooth and easy to clean. The special requirements that apply to employees engaged in manufacturing sterile products include regular training in sterile manufacturing, hygiene, and microbiology. Of course high standards of personal hygiene are also a must, and inside the cleanroom, employees are not allowed to wear jewelry or make-up! Regular medical checkups are also required. The steps in the production of sterile ampoules are: work preparation, bulk production, filtration, filling, sterilization, inspection, labeling, and packaging. Each individual production step takes place in accordance with clearly defined procedures and current GMP (Good Manufacturing Practice) guidelines. Written production instructions for each product detail all of the individual steps in its production. The production instructions are based on the company’s manufacturing specifications, the CTD-HD (Common Technical Document – Manufacturing Documentation), which is submitted to the regulatory agency. ) Making of … Producing potency mixtures from individual potencies according to manufacturing specifications Specially trained employees conduct in-process controls (IPC) at regular intervals during production. These controls serve to monitor and direct the production process, ensuring high quality and compliance with all requirements at every stage of processing. The production process The first step takes place in the Work Preparation department, where batch-specific production instructions are drawn up. In these documents, employees will record every detail of the processes involved in producing the batch. In the Bulk Production department, the 14 active ingredients (mother tinctures, single potencies, and triturations) are manufactured in accor- dance with the production guide. Ethanol-water mixtures in varying concentrations are used as the potentizing medium. The next step is production of the so-called bulk solutions. The individual potencies and triturations are combined into potency mixtures, which are then further potentized with water for injection. The resulting intermediate products are then mixed in large stainless steel tanks, and a specific amount of sodium chloride is added to produce an isotonic solution. IPC workers take samples of the finished bulk solution and test for a variety of parameters including pH, isotonicity, and appearance. The bulk solution is released for further processing only if all values fall within the required ranges. This step Manual potentization of a potency mixture Stainless steel batching tank for producing the solution Filtering the bulk solution through a sterile membrane ) 27 Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 ) Making of … Interim storage of the bulk solution in sterile disposable containers is followed by bulk filtration, which removes suspended matter and reduces germs. The filter is a sterile membrane filter with a pore size of 0.22 µm. The filtered solution is filled into sterile, flexible, disposable containers. The used filter is then tested for integrity, and if it passes the test, the filtered batch of bulk solution is transported to the filling equipment in disposable containers with capacities ranging from 10 to 50 liters. The containers are connected to the filling equipment, and the required quantities of glass ampoules are prepared. Before the actual filling takes place, a test run of a certain number of ampoules is filled to check for accuracy of the fill quantity. If the fill quantities match the target value, the machine is cleared for filling. Precisely measured fill quantities are then pumped into the sterile glass ampoules through six filling nozzles. Finally, a blowpipe is used to seal the open ampoules by melting their necks to create a closure. Each machine can fill up to 18,000 ampoules per hour. In the next issue, you will learn about the further steps required to produce a finished, customer-ready product.| ) 28 Photos by Sonja Bell Filling and heat sealing the sterile glass ampoules Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 ) Meet the Expert Dr. Arturo O’Byrne By Catherine E. Creeger A Back in Colombia, he studied sports medicine and nutrition in Cali, where he later also held professorships in biology and physiology. From 1987 to 1989, as medical director of the professional cycling team “Caf é de Colombia,” he based the athletes’ training and maintenance program on biological medicine. During this time, the team achieved international standing in particular in mountain racing, resulting in first places in the 1987 Vuelta a España and the 1988 Dauphiné Libéré and a third place in the 1988 Tour de France. His work with other sports teams had similar results and generated considerable interest in biological therapies in sports medicine in Colombia. In 1989, Dr. O’Byrne founded the teaching hospital “Centro de Medicina Biológica Dr. O’Byrne” in Cali and began giving courses and talks for doctors. Since then, his ongoing efforts in disseminating homotoxicology and biological medicine have led him to travel widely, rturo O’Byrne was born in 1951 in Cali, Colombia, into a long line of medical doctors. He received his first practical instruction in surgery from his father in their family-owned clinic. Young Arturo was very interested in photography and designing educational materials, and in college he collaborated with many of his professors on audiovisual presentations for classes. This skill in developing innovative educational tools would later become one of the foundations of his professional activities. He graduated from the Universidad del Cauca in Popayán, Colombia in 1976 with a diploma in surgery. During his student years, the climate in Popayán aggravated the asthma he had suffered from since childhood. His search for better health led him to the Colombian physician Dr. Germán Duque, who pioneered biological medicine in South America. Duque’s treatments produced a lasting cure within a few months. This introduction to alternative therapeutic methods, including homeopathy and homotoxicology, marked a radical and irrevocable turning point in Dr. O’Byrne’s life. On Duque’s advice, Dr. O’Byrne travelled to Europe to learn about integrative biological medicine firsthand. (Later, as medical director of Santa Margarita Hospital in La Cumbre, he would become the first to obtain authorization for a pilot program in biological medicine in a National Health Service hospital.) especially in Latin America. Over the course of seventeen years, he has logged more than four million flight miles and given more than 650 seminars! Throughout this time, he has remained dedicated to producing state-of-the-art educational material. In 2007, with his son Daniel, he founded BioMD-SA, an academic services center focusing on professional production of high-definition 3D animation, medical illustration, etc. His home workstation has three LCD screens (internet, PowerPoint, and Photoshop) in use simultaneously. For entertainment on his long trips, he downloads music of all genres to his I-pod. (The airlines serve vanilla ice cream with Baileys Irish Cream, which also helps to pass the time!) Dr. O’Byrne enjoys playing guitar at family gatherings and is a natural at salsa dancing, but he is always eager to get back to his medical projects as soon as the festivities are over. This is the mark of a true scientist!| ) 29 Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 ) Re s e a r c h H i g h l i g h t s Nervoheel N vs. Lorazepam for Mild Nervous Disorders ) 30 Introduction Complementary and alternative medicine (CAM) is being used more often, both in Europe and in the United States. One of the main reasons for the increase in CAM is the adverse effects seen with conventional medications, leading to the withdrawal of some of these drugs from the market. It is believed that CAM medications are better tolerated than conventional medications. One of the frequent uses of CAM is for treatment of functional nervous disorders, including insomnia, distress, anxiety, restlessness, and burnout. In this study, Nervoheel N, a CAM medication, was compared with lorazepam, a conventional benzodiazepine, for the treatment of functional nervous disorders. Specifically, the effectiveness and tolerability of the 2 medications were compared. The purpose of the study was to show the noninferiority of Nervoheel N vs. lorazepam. Nervoheel N is a preparation based on the principles of homotoxicology. Lorazepam has a relatively short half-life and is favored over longacting benzodiazepines for the short-term relief of anxiety. Benzodiazepines are contraindicated for long-term use because of their addictiveness and adverse effects. The present study was a preliminary open-label prospective nonrandomized cohort investigation. To our knowledge, it is the first study to By Mary A. Kingzette evaluate the effectiveness of Nervoheel N in a clinical setting. Methods This study was performed in 39 centers in Belgium and the Netherlands; these centers offer both conventional and CAM therapy. Patients enrolled were18 years or older and suffered from headache, heart palpitations, backache, indigestion, lack of appetite, mild sexual dysfunction, fatigue, listlessness, sleep disturbances, restlessness, or lack of concentration. Patients excluded were those who were unable or did not want to participate in the study and those taking both Nervoheel N and lorazepam. The study duration was a maximum of 4 weeks. Patients were examined at the start of treatment, after 2 weeks of treatment, and after 4 weeks of treatment. Physicians decided the treatment used for each patient (after discussion with the patient), and any other medications taken were not changed during the study. The dose of Nervoheel N given was 1 tablet 3 times a day; the dose of lorazepam given was 2 to 3 mg daily for sedation and anxiety and 2 to 4 mg nightly for insomnia. Variations in the dose were allowed if determined to be in the patient’s best interest. The effects of treatment were determined in conversation between the practitioner and the patient. The se- Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 verity of symptoms was evaluated on a 4-point scale (0 indicates asymptomatic; 1, mild; 2, moderate; and 3, severe). The overall effect of the therapies was evaluated on a 5-point scale (excellent, good, satisfactory, no improvement, and worsening of symptoms). Tolerability was determined by patient-reported adverse events evaluated by the physician. Overall tolerability of the treatments was evaluated as excellent, good, moderate, or poor. Results A total of 248 patients were included in this study (136 in the Nervoheel N group and 112 in the lorazepam group). After 2 weeks of treatment, 128 patients in the Nervoheel N group and 106 patients in the lorazepam group were examined. At the final 4-week examination, the numbers of patients included were 134 and 111, respectively. There were several differences between the 2 groups at enrollment: Patients in the lorazepam group were older and were more likely to be men, to smoke, and to use alcohol or coffee regularly than patients in the Nervoheel N group. However, none of these differences were statistically significant. There was also no significant difference in the number of nervous disorders between the 2 groups (predominately 2-4 disorders). In both groups, the most common com- ) Re s e a r c h H i g h l i g h t s © cherie/Fotolia.de Sepia, one of the ingredients of plaints included emotional distress, jitteriness, and anxiety; and the most common reasons given for the complaints included work-related anxiety, stress, and family-related anxiety. Most patients in both groups (> 70%) had not received previous treatment for their condition. In both groups, there were significant differences from baseline: The sum of symptom scores improved by 4.4 points in the Nervoheel N group and by 4.2 points in the lorazepam group. However, there was not a significant difference between the 2 groups. For both groups, the greatest symptom improvement was seen at the 2-week examination, with slight continued improvement until the 4-week examination. Even though most patients chose to maintain treatment for longer than 4 weeks, less than 10% did so for longer than 6 weeks. The average duration of treatment was 31 days in the Nervoheel N group and 29 days in the lorazepam group. There was no significant difference between the 2 groups in overall therapeutic results (rated as excellent to good by 72.1% of the Nervoheel N group and 73.7% of the lorazepam group; P = 0.84). The tolerability of both treatments was very good, with only one patient in each group experiencing an adverse event (both considered unlikely to be treatment related). Nervoheel N, is prepared from the secretion of the inkgland of the cuttlefish (Sepia officinalis). Notably, the overall patient-assessed tolerability was significantly better for the Nervoheel N group vs. the lorazepam group: Tolerability was rated as excellent in 81.9% vs. 45.5% of patients (P < 0.001). There was no significant difference between the 2 groups in compliance scores (P = 0.35), with compliance ratings of excellent or good for approximately 90% of both groups. Discussion This study showed that Nervoheel N, a homotoxicological medication, can effectively treat mild nervous disorders, including aches, palpitations, indigestion, lack of appetite, mild sexual dysfunction, fatigue, listlessness, sleep disturbances, restlessness, and lack of concentration. The study indicated that Nervoheel N was better tolerated than lorazepam, a traditional benzodiazepine medication used to treat these disorders. This being an open-label observational trial, there are limitations to such a study that are inherent in the design. First, the enrollment criteria for mild nervous disorders are somewhat subjective because there are no standardized rating scales for these disorders. Second, the evaluations were left mostly to the physician’s discretion, which could result in greater physician bias. However, the fact that the enrolling centers offer both comple- Journal of Biomedical Therapy 2009 ) Vol. 3, No. 1 mentary and conventional medicine may reduce this factor in this case. Third, baseline differences between groups are inherent in the design of observational studies, as was also found in the present study. There were also other differences between the 2 treatment groups (older patients and more male patients, with different lifestyle habits, in the lorazepam group), which were addressed with propensity score analysis but would not exclude all bias. However, the strength of observational studies is not so much to show efficacy, but to show effectiveness in a practice-based setting and to demonstrate tolerability, in which this study succeeded. In conclusion, this 4-week study showed that Nervoheel N (a homeopathic treatment) was not inferior to lorazepam (a conventional ben zodiazepine treatment) for the short-term relief of mild nervous symptoms. In addition, significantly more patients rated the tolerability of Nervoheel N as excellent compared with the tolerability of lora zepam. | Reference van den Meerschaut L, Sünder A. The homeopathic preparation Nervoheel N can offer an alternative to lorazepam therapy for mild nervous disorders. Evid Based Complement Alternat Med. Published October 25, 2007. doi:10.1093/ ecam/nem144. ) 31 IAH Abbreviated Course An e-learning course leading to certification in homotoxicology from the International Academy for Homotoxicology in just 40 hours. 1 Access the IAH website at www.iah-online.com. Select your language. 2 Click on Login and register. 3 Go to Education Program. 4 Click on The IAH abbreviated course. 5 When you have finished the course, click on Examination. After completing it successfully, you will receive your certificate by mail. For MDs and licensed healthcare practitioners only ) 32 www.iah-online.com Free of charge