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2.00 Euros 2.00$ US 3.00 $ CAN Winter 2005 JOURNAL OF BIOMEDICAL THERAPY Integrating Homotoxicology and Mainstream Medicine Infectious diseases Gripp-Heel in the treatment of upper respiratory infections Plantar warts Official publication of SOHNA Euphorbium compositum® for the safe and natural relief of: • Sinus congestion • Chronic nasal drip • Dry nasal membranes • Rhinitis & sinusitis Euphorbium compositum® is available as a nasal spray, oral drops, and oral vial solution. Physicians have been recommending Euphorbium compositum® as a safe and effective prescription-free alternative to habit-forming nasal sprays for more than 40 years. • Non habit-forming or addictive • For the whole family (including infants, children, pregnant and nursing women) • Very well tolerated • Free from side effects even with long-term use • No tachyphylaxis, rebound effect or burning sensation • Metered dose pump spray without propellant • Isotonic sodium chloride solution base prevents desiccation and promotes cleansing of the nasal mucosa ® Euphorbium compositum is a unique natural nasal spray that possesses a proven antiviral and anti-inflammatory action. No adverse events reported worldwide for over 2.5 million packages sold in one year by the Medical Writer Practical Protocols Acute viral influenza . . . . . . . . . . . . . . . . . 5 Boils and Furuncles . . . . . . . . . . . . . . . . . . 6 The Winter Cough . . . . . . . . . . . . . . . . . . 6 Medical Studies Symptomatic Treatment of Acute Upper Respiratory Infections: A Comparison of Homeopathic and Conventional Therapies . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Medical Summaries • Treatment of infections of the upper respiratory tract; comparison of a homeopathic remedy with Xylometazoline . . . . . . . . . . . . . . . . . . . 11 • Experience of using antihomotoxic preparations Hepar compositum and Engystol in the treatment of patients suffering from viral hepatitis . . . . . . . . 11 In Your Practice Recurrent infections: the problem of low cellular immunity . . . . . . . . . . . . . 12 Podiatric Column Podiatric management of viral warts with special reference to antihomotoxic medicine . . . . . . . . . . . . . . . . . . . . . . . . . . 14 This approach has dire consequences, apart from the emergence of these super bugs, due to the overuse of antibiotics. In natural medicine, we have always seen banal infection as part of nature’s way to ‘train’ the immune system and keep it on its toes. That thinking which is correct, is now reflected in the writings on the so-called hygiene hypothesis, where it is thought that we have created a population who has cellular immune deficiency (a lack of Th1 helper cell responsiveness), which boils down to an increase in conditions like allergy, recurrent viral disease and even cancer. This is further discussed under practical protocols. According to Homotoxicology, infections can be classified on the sixphase table of disease. Most infections seen in practice fall in the inflammatory phase of the six-phase table, while other chronic infections represent an underlying regulation rigidity in the patient, such as chronic recurrent viral disease. For example, the acute infection of mononucleosis is not classified in the impregnation phase, but rather, in the inflammatory phase. Only when a patient cannot clear the infection and it becomes a chronic recurrent situation as whenever the patient is stressed, for instance, will it be classified in the impregnation phase. Examples of both will be discussed in this issue, as the treatment of diseases found in the impregnation phase is more complicated. Viral warts is such a condition, which is often the concern of podiatrists. In this issue we invite a prominent podiatrist and one of our speakers, Dr. Klebe, to give his practical protocol for this condition. Several botanicals have been used over time to stimulate the immune system, or to function as natural antibiotics by themselves. It is important to note that full strength substances have a pharmacological action and are associated with side effects, and lead to interactions that should be observed. Homeopathic preparations, on the other hand, work on a regulatory level and generally are exempt of these interactions. Finally, you will also find in this issue a recent paper on Gripp-Heel, one of the most well-known antihomotoxic products used to treat symptoms of upper respiratory infections. MEDICAL EDITOR/WRITER: Dr. Alta A. Smit Dr. Alta Smit is a qualified physiotherapist, medical doctor and homeopath, who is particularly interested in the regulation therapy of modern immune diseases and metabolic diseases, as they are overlapping so rapidly. MANAGING EDITOR: Karina-Marie Tomasino GRAPHIC DESIGN: Phaneuf Design Graphique To reach us, log on to our website: If you wish to download this issue, visit our website at @ www.heel.ca (Canada) or www.heelusa.com (USA) 3 AGREEMENT NUMBER: 40016492 Since this is an international publication, names and availability of the products mentioned in this journal may vary from one country to another. Please note that certain jurisdictions do not allow injectable homeopathics. PROOFREADING: Andy Moss, Dr. Rüdiger Schneider, Dr. Bruce H. Shelton CIRCULATION: 11,145 Made and printed in Canada RETURN ADDRESS: 11025 L.H. Lafontaine Montreal, Quebec, Canada H1J 2Z4 FOR PROFESSIONAL USE ONLY The information contained in this document is meant for professional use only and is not intended to diagnose any illness, nor is it intended to replace competent medical advice and practice. Heel/SOHNA or anyone connected to, or participating in this publication will not accept any medical or legal responsibility for misinterpretation or misuse of the informational and educational content of the present document. The intention of the Journal of Biomedical Therapy is to inspire practitioners who wish to evolve their holistic practice. The purpose is to share information about successful protocols from orthodox and complementary practitioners. The intent of the information contained in this journal is not to “dispense recipes”, but to encourage learning about complementary therapies. It is the practitioner’s responsibility to take this information in stride and, if they so choose to apply it to their practice, to do so within the spectrum of their knowledge and experience with integrity and competence, and within the scope of their practice. 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 required to reproduce any of the enclosed material. Winter 2005 Homotoxicology In Brief Ivonne Kraft came in under the top ten in Cross Country World Championships in Les Gets, France. Homeopathics were packed in the suitcase. . . . . . . . . . . . . . . . 4 Infection in biological medicine has a special significance. Infections have seem to become more life threatening in some cases, like in the so-called nosocomial infections we see in hospitals where super bugs seem to be resistant to even the strongest antibiotics. However, on the other hand, we seem to have taken the quest against infection too far, and thus started treating banal infections in a very aggressive way. Journal of Biomedical Therapy J O U R N A L O F B I O M E D I CA L T H E R A P Y SUMMARY • EDITORIAL Homotoxicology IN BRIEF Ivonne Kraft came in under the top ten in Cross Country World Championships in Les Gets, France. Homeopathics Original article German* were packed in the suitcase. Les Gets, France “Sport is one of the most wonderful hobbies in the world - except for mountain biking” points out Ivonne Kraft, the world’s number four in Cross Country Mountain biking, to the crowds at the neck-breaking cross country track in Les Gets, France. The 34 year old woman from Mittelbaden, Germany, managed a ninth place in the tournament at Les Gets, and in Athens she achieved seventh place, despite an unfortunate collision and some bike trouble which prevented her from taking home the coveted gold medal. In fact, cycling, whether on the street or in the country, counts as one of the most dangerous sports in general; the accident rates are comparable with boxing. Optimal preparation, mental strength and a maximum of concentration are therefore essential requirements for Ivonne in order to minimize the risks. For treatment of the inevitable contusions, sprains and abrasions the cyclist relies on Traumeel, making use of tablets and ointment at the same time to get fit as soon as possible after an injury. Homeopathics do not interfere with concentration or performance and entail no danger of doping. 4 Winter 2005 Journal of Biomedical Therapy Elite sportsmen and women are also subject to other health risks, as Kraft has seen from her own experience. They are more at risk of infections, which are the result of the stress that is placed on the immune system during training and competing. These changes in the immune system can be seen in the laboratory as increasing white blood cells and changes in the cytokines. In fact, on average, every second athlete will get flu-like illness after a major competition. With regards to these infections, the top cyclist also falls back on homeopathic medicine as treatment, or as prophylaxis. She takes the so-called ‘Flu Cocktail’, which consists of a combination of Gripp-Heel, Engystol, and Echinacea compositum, as a prophylactic once a year over four weeks. She also uses the ‘Flu Cocktail’ in case of an acute infection, which will complement the treatment for a sore throat, and takes Angin-Heel and Euphorbium compositum Nasal Spray for the treatment of a cold. When she has fever, Ivonne sits out a training session or a tournament, to protect her heart from viral damage. She also suggests this to hobby sportsmen and women, who are seldom aware of the dangerous connection between acute viral disease and physical exertion. *Free translation Acute viral influenza By the Medical Writer Babies are born with a relatively immature immune system, and it seems that the banal diseases of childhood are necessary to train the immune system and especially the Th1 cells. When we generate fever, we activate these cells and if we have a reactive organism, and the little ones learn to regulate the immune system back to a balance between the inflammatory system and the anti-inflammatory system, the immune system functions optimally for the rest of the individual’s life. If we keep suppressing the attempt of the body to mount a Th1 response, by firstly preventing any acute infection (vaccination) and then giving anti-fever medication at the slightest attempt of the body to mount a Th1 response, the body will not be as responsive to acute infections in the future. If this carries on long enough, we see people handling infection poorly, or individuals that are not able to get acute infections at all. This is not a good state to be in, as this constellates the non-reactive population as seen from an immune system perspective. Parmenides (540-480 BC) wrote the famous words: “Give me the power to create a fever, and I shall cure all disease.” This was practiced by the German contemporaries of Hans-Heinrich Reckeweg, who would induce malaria in their cancer patients to generate fever. It is always difficult to decide when to treat infection with suppressive medicines, and there are instances where one is forced to do so, for instance when the process is threatening to overwhelm the patient, or when the infection is not treatable through regulation therapy. However, in most cases of banal infection and also in the case of certain infections where no definitive treatment is available, as in many viral diseases, the treatment of choice should be that of increasing the innate defenses of the body. This always implies a biological approach and mostly a regulatory one such as Homotoxicology. Although viral flu can be severe and fatal in selective groups of patients, notably those with a pre-existing immune suppression or in the elderly, in most patients it is a self-limiting disease. However, treating it with homeopathic medicine can shorten recovery time and minimize symptoms. We want the patient to have a reaction to the virus, not suppress this, and in reactive patients, this will include the effects of cytokine activity such as fever (Interleukin 1), feeling of illness and light depression (Interleukin 6), muscle pain and weakness (Interferon γ). If the flu entails long recovery time, we can use some “mop up” remedies. Postviral fatigue is normal in most people, but in general should not last longer than two weeks. Time of onset Main symptoms covered / Reason Acute onset (at the first appearance of symptoms) Practical PROTOCOLS Dose Acute massive initial dose Gripp-Heel Shivering, bone pain, fever, sore throat Engystol Antiviral action and stimulation of the non-specific defenses Gelsemium-Homaccord Muscle pain and weakness 5 1 tablet every 10 minutes for 8 doses 10 drops every 10 minutes for 8 doses BED REST AND LOTS OF FLUIDS SHOULD ALSO BE ADVISED Sub-acute Gripp-Heel As above As above Echinacea compositum forte* Increase phagocytosis, antiviral and antibacterial In severe cases, 1 tablet 3 times a day, or 1 oral vial 3 times daily, otherwise once daily for 3 days Lymphomyosot/Lyphosot For swollen glands and drainage 1 tablet or 10 drops 3 times a day Slow recovery “mop up” remedies Gelsemium-Homaccord Gelsemium for post-viral fatigue 10 drops 3 times a day Viscum compositum or Visceel For patients staying too long in a TH2 state 1 ampoule daily or one tablet 3 times daily of Viscum compositum, or 10 drops of Visceel 3 times per day *Note: Nosodes are generally used sparingly and not in acute diseases. The exception is the bacterial and flu nosodes, as contained in Echinacea compositum forte, which have an intense immune stimulating effect. This is generally only used for short periods of time to avoid over stimulation. Journal of Biomedical Therapy Engystol Winter 2005 1 tablet 3 times a day Practical PROTOCOLS Boils and Furuncles The treatment of these are of special importance, as they are often seen when we treat patients with antihomotoxic remedies and the patient vicariates from one of the matrix phases into the inflammation phase. We thus often welcome their appearance as signs of reactivity in patients who were stuck in the non-reactive part of the equation and as such, these should not be suppressed. Incision and drainage of a boil is a means of artificially inducing the excretion phase of the six-phase table and is generally allowed. Often applying the remedies mentioned below, we see “ripening” of the boil and spontaneous drainage, the so-called “homeopathic incision” where the boil will start draining by itself. Subcutaneous spreading (cellulitis) and swollen lymph nodes are generally signs that conventional antimicrobial medication may be needed, except in the hands of experienced homeopathic practitioners. Medication Reason Dose Belladonna-Homaccord Erythema, throbbing pain 10 drops every 15 minutes for 8 doses, thereafter 3 times a day Traumeel Works on every aspect of inflammation, promotes wound healing and restitution after drainage 10 drops or 1 tablet 3 times a day until drainage or resolution. Use for a further 5 days to promote granulation and wound healing Echinacea compositum forte* (see note p.5) Infectious processes, especially in skin infections due to the Staphylococcus and Streptococcus nosodes. Also contains Lachesis, which helps for bluish colored boils 1 tablet or 1 oral vial 3 times a day for the first 3 days, thereafter one oral vial per day or 3 tablets a day until complete recovery Arnica-Heel Comp./ Arnica-Heel NP For severe infections with toxicity (Baptisia tinctoria and Solanum nigrum) and for swelling (Apis mellifica) 10 drops every 15 minutes for 8 doses, then 3 times a day Lymphomyosot/Lyphosot Add when there is much swelling 10 drops or 1 tablet 3 times a day 6 Winter 2005 Journal of Biomedical Therapy The Winter Cough Remedy Indication Husteel Bronchiolitis, irritating cough, catarrh Drosera-Homaccord Spasmodic cough, laryngitis, pseudocroup Tartephedreel Bronchospasm, expectoration, descending catarrh Droperteel Congestive cough, spasmodic cough Belladonna-Homaccord Barking cough Bronkeel / Bronchalis-Heel To loosen cough Practical note: Sometimes we see mixed coughs in practice and it is difficult to determine which preparation to give. Some experienced practitioners in Germany (Dr. Anselm Graf von Ingelheim) mix two or more preparations together in the following fashion: 30 ml of each preparation below for a total of 90 ml Husteel (drops) Tartephedreel (drops) Drosera-Homaccord (drops) give 10 drops of mixture 3 times a day Symptomatic Treatment of Acute Upper Respiratory Infections: A Comparison of Homeopathic and Conventional Therapies Medical STUDIES By Andreas Rabe, M.D. Reprint from: Der Allgemeinarzt 2003;25(20):1522-3 This multicenter, prospective cohort study with parallel groups compared the efficacy of the homeopathic medication Gripp-Heel® to that of conventional allopathic therapy for acute upper respiratory infections (URIs). In both treatment groups, the severity of clinical symptoms declined significantly over the course of the study. Upon conclusion of therapy, 77% of patients in the test group were symptom-free, as compared to 49% of the reference group. No adverse drug events occurred in patients treated with the homeopathic medication, while the rate of adverse effects under conventional therapy was 5.8%. This study confirms that Gripp-Heel®, as used to treat acute URIs in daily practice, is just as effective as conventional allopathic medications. Furthermore, participating physicians reported better patient Common cold, upper respiratory tolerance of the homeopathic medication. infections (URIs), allopathy, A common cold or other typical upper homeopathy respiratory infection (URI) is usually caused by one of approximately 200 types of viruses, the most common of which are rhinoviruses and adenoviruses. Other pathogens that cause URIs include the coronaviruses, respiratory syncytial viruses, and parainfluenza viruses. In a high percentage of cases, these viruses affect the organs of the upper respiratory tract and symptoms are confined to these organs. As the most common type of acute illness, URIs are responsible for many absences from work, school, and kindergarten. Epidemiological studies confirm that approximately 25% of the German population, for example, comes down with an upper respiratory infection three to six times each year, and 75% of all survey respondents reported having a cold at least once a year.1 Infants and toddlers typically suffer from as many as eight feverish infections per year, most of which affect the upper respiratory tract. For young children, predisposing factors include not only immature immune systems and anatomical conditions such as tonsillar hypertrophy, but also noninfectious environmental factors such as exposure to tobacco smoke or other noxae.2 Keywords: 7 FOCUS ON SYMPTOM ALLEVIATION Patients who take medication for URIs do so in the hope of achieving rapid symptom abatement. At the very least, they hope to avoid the worst by beginning treatment at the first sign of symptoms. Thus the therapeutic value of cold remedies lies in: relieving subjectively bothersome symptoms such as rhinitis or cough controlling difficulty in breathing or swallowing reducing malaise Hence, any treatment of URIs focuses primarily on symptomatic relief and on strengthening the immune system. HOMEOPATHY ALSO SUPPORTS THE IMMUNE SYSTEM Chemical decongestants are a common and effective treatment for URIs. Other medications are often not helpful; antibiotics, for example, are useless unless secondary bacterial infections are present. For over 200 years, homeopathic treatment of acute upper respiratory infections has been based on a variety of medicinal herbs and other components. Phytotherapeutic ingredients used for this purpose include garden monkshood (Aconitum napellus), bryony (Bryonia spp.), and boneset (Eupatorium perfoliatum). For decades, Gripp-Heel® (a combination of these botanical ingredients plus Lachesis and phosphorus) has been used therapeutically to activate the body’s endogenous defenses in upper respiratory infections. The purpose of this study was to investigate the efficacy and tolerability of Gripp-Heel® as compared to conventional allopathic treatments in patients with acute upper respiratory infections. Age (years) Gender Height (cm) Weight (kg) Stressful job or family situation Risk factors Duration of illness < 1 week Test Group (N = 82) Reference (N = 181) Statistics Median (min/max) Male N/% Female N/% M (SD) M (SD) N/% 34 (3/78) 33 (0/82) p = 0.750 (ns) 36/43.9 46/56.1 161.99 (2.35) 61.99 (2.17) 7/8.5 82/45.3 99/54.7 153.02 (2.51) 57.51 (1.94) 20/11.0 p = 0.894 (ns) p = 0.2249 (ns) p = 0.4759 (ns) p = 0.545 (ns) N/% 15/18.3 20/11.0 p = 0.122 (ns) N/% 77/93.9 151/83.3 p = 0.005 (s) M = mean; SD = standard deviation, ns = not significant, s = significant Journal of Biomedical Therapy Criteria Winter 2005 Table 1: Patient demographics Medical STUDIES METHODS For purposes of this study, patients with acute URIs were treated by family practitioners, internists, or otolaryngologists, some of whom were also licensed to practice homeopathy and/or naturopathy. New or returning patients were admitted to the study, but patients receiving ongoing long-term treatment were excluded. The patients in the test group (homeopathic medication) were not allowed to supplement their treatment with either conventional (allopathic) drugs or other homeopathic medicines. For the reference group, each physician selected analogous patients to receive a conventional therapy. STUDY DESIGN This investigation was conceived as a multicenter, prospective, noninterventional cohort study with parallel groups. 263 patients participated. The test group took Gripp-Heel®; the reference group took either a conventional single medication or a combination, with dosages selected by the attending physicians. IMPLEMENTATION Upon conclusion of treatment, data on individual patients were anonymized and documented in coded form in accordance with ICD-10/WHO. For each patient, the physician rated the initial severity (scale: symptom-free, mild, moderate, severe) of the patient’s two most important clinical symptoms (primary/secondary pathognomonic symptoms) as well as the change in these symptoms over the course of therapy. Any adverse effects were also recorded, along with the physician’s assessment of the patient’s tolerance of the homeopathic or reference therapy (scale: very good, good, satisfactory, poor). The physicians also rated therapeutic outcome (scale: symptom-free, significant improvement, moderate improvement, symptoms unchanged, symptoms worsened) and patient compliance (scale: very good, good, fair, poor) in each case. Table 2: Type, frequency, and initial severity of primary pathognomonic symptoms (N/%) 8 Type and frequency Test group (N = 82) Reference (N = 181) Statistics Cough/rhinitis/hoarseness Headache/muscle aches Fever Other Severity Mild Moderate Severe 33/40.3 28/34.1 19/23.2 2/2.4 100/55.2 40/22.1 29/16.0 12/6.7 p = 0.028 (ns) 12/14.6 45/54.9 25/30.5 9/5.0 96/53.0 76/42.0 p = 0.017 (ns) ns = not significant Table 3: Type, frequency, and initial severity of secondary pathognomonic symptoms (N/%) Type and frequency Test group (N = 82) Reference (N = 181) Statistics Cough/rhinitis/hoarseness Headache/muscle aches Fever Other Severity Mild Moderate Severe No secondary symptom 37/45.1 25/30.5 18/22.0 2/2.4 98/54.1 28/15.5 19/10.5 36/19.9 p < 0.001 (s) 19/23.2 48/58.5 15/18.3 – 22/12.2 99/59.7 51/28.1 9/5.0 p = 0.040 (ns) Winter 2005 Journal of Biomedical Therapy ns = not significant, s = significant TARGET CRITERIA The primary criterion of efficacy was the percentage of cases in which primary/secondary pathognomonic symptoms abated completely. Secondary criteria of efficacy were: - time elapsed before onset of symptomatic improvement - physicians’ rating of therapeutic outcome/efficacy Primary criteria of safety were: - the number of patients experiencing adverse effects (reported were: type, number, severity, duration, relationship to treatment, measures taken, and outcome) - physicians’ rating of tolerability and patient compliance STATISTICAL EVALUATION After monitoring and query processing, data was entered and subjected to quality and plausibility tests, followed by descriptive analysis (which included between-group comparison of patients’ master data and initial illness status and of group homogeneity). Logistic regression procedures were used to adjust for heterogeneities in initial status and for confounders, followed by hypothesis testing. The effect size of the adjusted rate of symptom abatement was calculated with 95% CI of the odds ratio. (Adjusted) time elapsed before onset of symptom abatement was evaluated using the Cox proportional hazard regression method (HR 95% CI). Medical STUDIES RESULTS – TREATMENT GROUPS In total, 263 patients (82 in the test group and 181 in the reference group) ranging in age from 0 to 82 years were included in the study. Analysis of patients’ master data indicated that the treatment groups were largely comparable (Table 1). The physicians rated initial severity of the URI as “moderate to severe” in 85% of the patients in the Gripp-Heel® group and 95% of the reference group, indicating a tendency toward more severe illness in the reference group. With regard to clinical symptomatology, the pathognomonic symptoms cough, rhinitis, hoarseness, fever, and headache/body ache predominated in both groups (Tables 2-3). Most patients in both groups had been ill for less than one week (94% of the Gripp-Heel® group and 83% of the reference group, p = 0.005). DOSAGES In 95% of cases, Gripp-Heel® was prescribed in tablet form, with 55% of these patients taking the standard dosage of 1 tablet 3-5 times per day. The remaining 5% of patients in the Gripp-Heel® group received injections (i.m. or s.c.) of the medication at the standard dosage of 1-3 ampoules per week. In the reference group, treatment of symptoms usually consisted of either a single drug or a combination of any of the following types: cough suppressants, analgesics, antibiotics, decongestants, or cold/flu combination remedies. Choice of medication, dosage, and duration of treatment were left to the discretion of the physician in each case. Table 4: Frequency of complete abatement of the primary pathognomonic symptom / Time elapsed before onset of abatement (not adjusted) (N/%) Frequency Test group (N = 82) Yes 63/76.8 No or n/a 19/23.2 Multivariate adjusted Odds ratio (95% CI) Time elapsed before onset of abatement (not adjusted) (N/%) < 4 days 58/70.7 4-7 days 16/19.5 1-2 weeks 5/6.1 2-4 weeks – > 4 weeks – No improvement – n/a 3/3.7 Multivariate adjusted Cox proportional hazard regression (95% CI) Reference (N = 181) Statistics 114/63.0 67/37.0 P = 0.019 (s) 9 P (Wald) = 0.162 (ns) OR (95% CI) = 0.62 (0.31-1.21) 98/54.0 55/30.4 19/10.5 2/1.1 3/1.7 1/0.6 3/1.7 P(< 4 days) = 0.001(s) P(total) = 0.109 (ns) P (Wald) = 0.008 (s) HR (95% CI) = 1.57 (1.13-2.20) ns = not significant, s = significant Table 5: Frequency of complete abatement of the secondary pathognomonic symptom / Time elapsed before onset of abatement (not adjusted) (N/%) Yes 62/75.6 No or n/a 20/24.4 Multivariate adjusted Odds ratio (95% CI) Time elapsed before onset of abatement (not adjusted) (N/%) < 4 days 59/77.2 4-7 days 17/20.6 1-2 weeks 3/3.7 2-4 weeks – > 4 weeks – No improvement – n/a 3/3.7 Multivariate adjusted Cox proportional hazard regression (95% CI) ns = not significant, s = significant Reference (N = 181) 14/57.5 77/42.5 Statistics P = 0.009 (s) P (Wald) = 0.224 (ns) OR (95% CI) = 0.66 (0.34-1.29) 91/50.4 44/24.3 26/14.4 5/2.8 – 3/1.7 12/6.6 P(< 4 days) = 0.001(s) P(total) = 0.004 (s) P (Wald) = 0.170 (ns) HR (95% CI) = 1.27 (0.90-1.79) Winter 2005 Test group (N = 82) Journal of Biomedical Therapy Frequency Medical STUDIES THERAPEUTIC EFFICACY In the symptomatic treatment of acute URIs, therapy with the homeopathic medication proved to be as effective as reference therapies with conventional drugs (adjusted for initial symptom severity). The chance of a patient becoming completely symptom-free within the test period, however, was 34-38% greater (depending on the individual symptom) for the GrippHeel® group than for the conventionally treated group. The median elapsed time before symptom abatement was 2 days for the test group versus 5.5 days for the reference group. With regard to the primary pathognomonic symptom, the difference in favor of the homeopathic medication was statistically significant (Table 4). The chance of a shorter elapsed 80 time before symptom abatement occurred was 57% 60 higher (statistically significant) for the test group than for the reference group with 40 regard to the primary pathognomonic symptom and 27% 20 higher with regard to the secondary pathognomonic symp0 tom (Table 5). Upon conclusion of therapy, the physicians rated 77% of the test patients and only 49% of the referFig. 1: Physicians’ ratings of therapeutic outcomes (efficacy of treatment) ence group as symptom-free (p<0.001) (Figure 1). TOLERABILITY In general, the homeopathic medication was very well tolerated by the patients; no adverse drug events occurred in the test group. In the reference group, the incidence of adverse effects (most common were gastrointestinal symptoms) was 5.8%. A similar difference was reflected in global assessments of tolerability. The physicians rated patient tolerance of the medication “very good” for 85% of the test group but for only 37% of the reference group (p < 0.001). Similar differences in patient compliance were also observed. Physicians reported “very good” compliance for approximately 70% of patients treated with the homeopathic medication, but for only 44% of the reference group (p < 0.001). 10 Winter 2005 Journal of Biomedical Therapy DISCUSSION In Germany, Gripp-Heel® has been marketed in its current formulation for several decades. More recently, several clinical studies have investigated its efficacy in adults and children with URIs.3-5 All of these studies confirm the clinically relevanttherapeutic efficacy of Gripp-Heel® in treating upper respiratory infections, and risk-benefit assessment based on their results supports the conclusion that this homeopathic medication is not only reliably effective, but also well tolerated by both adults and children. Because of the primarily viral genesis of URIs, symptom alleviation is the focus of any therapy. Therefore, symptomatic relief and more rapid symptom abatement can serve as criteria for assessing the therapeutic efficacy of pharmaceuticals prescribed for this indication. The present study proves that this homeopathic medication is at least as effective in reducing symptoms as the conventional reference therapy. The interval before onset of symptom abatement was shorter in the test group than in the reference group. Gripp-Heel®’s mechanism of action in the body has not yet been definitively explained, but in vitro studies indicate that it stimulates phagocytosis, which suggests activation of the non-specific endogenous defense system.6 In conclusion, it can be said that the results of this present study not only corroborate those of previous studies, but also confirm the product’s excellent safety profile. In the current study, no adverse drug events were experienced by the test group. In comparison, a total of ten incidents of adverse effects were reported in the reference group, whose members were treated with various conventional medications (including cough suppressants, analgesics, antibiotics, decongestants, or cold/flu combination medications). In view of the efficacy and tolerability ratings supplied by the participating physicians, it is not surprising that “very good” compliance was significantly higher in the test group (70%) than in the reference group (44%). References 1. Turner RB. Epidemiology, pathogenesis, and treatment of the common cold. Ann Allergy Asthma Immunol 1997,78:531-40 2. Kreuder J. Kleinkinder erleiden jährlich bis zu acht fieberhafte Infektionen. Forschung und Praxis 1994,173:8-12 3. Gottwald R, Weiser M. Homöopathische Behandlung von grippalen Infekten bei Kindern. Ärztezeitschrift für Naturheilverfahren 1999,40:348-53 4. Weiser M, Gottwald R. Therapie von Grippe und grippalen Infekten mit einem Homöopathikum. NaturaMed 2000,15:15-8 5. Maiwald L, Weinfurtner T, Mau J, Connert WD. The therapy of the common cold with a combination homeopathic preparation, compared with treatment with acetylsalicylic acid. J Biomedical Ther 2001, Medical abstracts 6. Wagner H, Jurcic K et al. Influence of homeopathic drug preparations on the phagocytosis capability of granulocytes. Biol Ther 1993,3:43-9 Treatment of infections of the upper respiratory tract; comparison of a homeopathic remedy with Xylometazoline Medical SUMMARIES By Dr. Ammerschläger, original German publication in preparation Introduction: The primary objective of a treatment of inflammatory processes and diseases of the upper respiratory tract by local rhinologics is the relief of nasal congestion and improvement of associated symptoms. Restoration of uninhibited respiration and drainage of the nasal sinuses reduce the risk of further complications and consecutive symptoms. Objective: Is the homeopathic remedy Euphorbium compositum SN nasal spray therapeutically equivalent to xylometazoline with respect to efficacy and tolerability? Methods: Open, multicenter, prospective and reference-controlled cohort study. It was intended to statistically demonstrate non-inferiority of the homeopathic remedy in comparison with the reference medication. Results: During therapy, a clinically relevant reduction in the intensity of each disease-specific symptom was observed. In each case, the lower bound of the 95% confidence interval was greater than the margin of equivalence, thus proving therapeutical equivalence of the homeopathic remedy and the reference medication with statistical significance. Positive assessments of tolerability were obtained for both therapies. Conclusion: The results of this cohort study indicate a comparable efficacy profile of the homeopathic remedy Euphorbium compositum SN nasal spray and the reference substance xylometazoline in the treatment of patients with inflammatory processes and disease of the upper respiratory tract. Experience of using antihomotoxic preparations Hepar compositum and Engystol in the treatment of patients suffering from viral hepatitis 11 Reprint from Biologiceska Terapia, Ukraine, No. 1, 2003, p. 17 - Vovk A.D., Solyanik I.V. Gromashevsky Institute of epidemiology and transmissible diseases AMS of Ukraine, Kiev Original article in Ukrainian* Summary: This study is aimed at demonstrating the use of the antihomotoxic preparations Hepar compositum and Engystol in complex treatment of patients suffering from viral hepatitis. Results and conclusion: The use of the antihomotoxic preparations in the acute stage of the disease led to improvement of the quality of life of patients during the recovery period, and removed the manifestation of post-hepatitis residual syndromes. The combination of Hepar compositum and Engystol in the treatment of hepatitis is more effective than only using Hepar compositum alone. Moreover, this combination is more useful in the treatment of patients of a mature age. It is thought that these antihomotoxic preparations allow preservation of the structure of hepatocytes and produce a therapeutic effect. There were no cases of withdrawal of test subjects due to allergic reactions or adverse events. *Free translation Journal of Biomedical Therapy Treatment with antihomotoxic preparations was started in the acute period of the disease, after the confirmation of diagnosis. Hepar compositum was prescribed in the dosage of 2.2 ml (1 ampoule) once every three days i.v. for a total of 10 injections; Engystol – 1 tablet 3x/day sublingually. The duration of the treatment was 30 days. Winter 2005 Methodology: 60 patients ranging from 17 to 65 years of age were included in the study. They were distributed into three groups: two test groups (20 patients each) and the control group (20 patients). Patients of the control group received detoxification therapy (5% glucose solution i.v., 0.9% natrium chloride), and when needed, additional symptomatic therapy. Patients of the test groups received complex antihomotoxic preparations: The first test group (1): Hepar compositum The second test group (2): Hepar compositum and Engystol In Your PRACTICE Recurrent infections: the problem of low By the Medical Writer cellular immunity VIRAL INFECTIONS: THE FAMILY OF HERPETIC VIRUSES The Herpetic group of viruses includes a large family such as the Herpes simplex viruses (HSV) I and II and the Varicella Zoster virus making up the α group, the Epstein Barr Virus (EBV) and Kaposi’s sarcoma virus making up the β group and the Cytomegalovirus (CMV), HSV 6 and 7 making up the γ group. These are DNA-enveloped viruses, which produce intracellular inclusion bodies in the cells they infect. They are notoriously difficult to eradicate from the body and can stay latent in the cell for years. Cellular immunity keeps them in check throughout the rest of the individual’s life. Things which impair cellular immunity such as psychological stress as well as certain drugs, notably recreational drugs, such as alcohol and Ecstasy used on a constant basis will cause a recurrence of these viruses at various stages of life. Interestingly enough, UV light from the sun also impairs our cellular immunity, which explains the typical outbreak of cold sores after sun exposure in some individuals. One of these viruses, EBV, is highly contagious and is often seen as a mini-epidemic in young teenagers. It is therefore often referred to as the “kissing disease”. New evidence also suggests that aphtous ulceration and oral leukoplakia are signs of such viral recurrences. It is thus no wonder that we often get them when we are “run down”. Another feature of these viruses is that they will induce states of intense fatigue if they become systemic. EBV, CMV and Human Herpes Virus 6 (HHV 6) are seen as reactivating viruses in conditions like Chronic Fatigue Syndrome (a condition of cellular immune deficiency), genital and oral herpes as well as in Herpes Zoster. The treatment of first time infections is that of any acute infection, thus support of the autoregulatory system and symptomatic treatment. If the disease is self-limiting, it falls into the inflammation phase on the six-phase table. However, when recurrence sets in, this implies that the patient is experiencing problems with cellular immunity, and this means in terms of Homotoxicology that the patient has crossed the biological division and is now in the impregnation phase. In immunological terms it means that the patient is in a so-called TH2 rigidity and cannot mount an adequate TH1 response long enough to keep the virus latent. It is thus important to treat more than just what is happening at that moment. This is the time when we employ the three pillars of Homotoxicology, namely detoxification and drainage, cellular activation and organ regulation with specific emphasis on the immune regulation. For most of these viral infections, the conventional treatment is symptomatic, except for the HSV group, where antivirals are employed. It is, however, also important to treat the biological terrain, so that the immune rigidity is addressed and the matrix is cleared of toxins. Therefore, the antihomotoxic treatment can stand alone in non-complicated cases or be part of an adjuvant therapy in cases with complications. 12 TREATMENT Winter 2005 Journal of Biomedical Therapy Phase: Acute Phase Condition Medication Reason Dose Oral and genital herpes, Varicella Zoster Euphorbium compositum Nasal Spray Antiviral action 2 sprays directly onto the lesion, up to 5 times a day Engystol Antiviral action, supporting endogenous defense mechanism 1 tablet 3 times a day or 1 oral vial per day Traumeel Anti-inflammatory, also helps for neuralgia 1 tablet or 10 drops 3 times a day Mezereum-Homaccord Add for secondary infection in the lesions, pus-filled blisters 10 drops 3 times a day or 1 oral vial per day Ranunculus-Homaccord Especially in Zoster for post-neuralgia in the thoracic area 10 drops 3 times a day, but also as neural therapy (s/c) with the ampoule in the distribution of the intercostal nerve, as wheals (Quaddles) about 2 cm apart Condition Medication Reason In Your PRACTICE Dose Acute glandular fever (can be caused by Epstein Barr and Cytomegalovirus) Angeel / Angin-Heel Sore throat, an early sign of this condition. NB: to exclude septic tonsillitis Acute massive initial dose possible: 1 tablet every 15 minutes for 8 doses Lymphomyosot / Lyphosot Glandular swelling 10 drops or 1 tablet 3 times daily or 1 oral vial daily China-Homaccord Fatigue and weakness 10 drops 3 times a day or 1 oral vial daily Engystol Antiviral and to increase general defenses 1 tablet 3 times a day or 1 oral vial daily Tonsilla compositum or combination of Glandula suprarenalis suis-Injeel and Funiculus umbilicalis suis-Injeel Matrix and adrenal support, also to prevent post-viral fatigue 1 oral vial 3 times per week Tonico-Heel / Tonico-Injeel Add in case of neurasthenia and depression 1 oral vial 3 times per week or 1 tablet 3 times daily Nervoheel / Nereel If patient is very anxious with neurasthenia 1 tablet 3 times per day 13 Phase: Chronic recurrent infection: after acute infection, to prevent further recurrences Pillar II: Cellular regeneration Pillar III: Organ regeneration and Immunomodulation Hepar compositum + Solidago compositum or Berberis-Homaccord or Equisetum arvense-Injeel + Thyreoidea compositum or Pulsatilla compositum 1 oral vial of each 3 times per week Coenzyme compositum or Ubicoenzyme Achieved here with the advanced detoxification remedies in pillar I 1 tablet or 10 drops 3 times a day or 1 oral vial 3 times per week Drainage Cellular regeneration Organ regeneration and immunomodulation Nux vomica-Homaccord + Berberis-Homaccord + Lymphomyosot/Lyphosot or Detox-Kit 30 drops of each in a bottle of water, to be sipped throughout the day Ubichinon compositum or Ubicoenzyme Viscum compositum forte 1 ampoule 2 times per week or Visceel 10 drops 3 times a day + Psorinoheel 10 drops 3 times a day or Tuberculinum-Injeel 1 oral vial 2 times per week 1 tablet or 10 drops 3 times a day or 1 oral vial 3 times per week + Glyoxal compositum 1 oral vial 2 times per week or 1 tablet 3 times a day Winter 2005 Weeks 8-12 Pillar I: Detoxification Journal of Biomedical Therapy Weeks 1-7 Column PODIATRIC Podiatric management of VIRAL WARTS with special reference to antihomotoxic medicine By Dr. Lester Klebe, DPM Warts of the feet, especially those that are plantar, are one of those pathologies that physicians find most difficult to treat. It has been postulated that this is because the bottom skin of the foot is so thick that the virus particles can interweave themselves into the fabric of the dense connective tissue of the skin or that the body simply does not recognize, for whatever reason, that there is an infection present. Realizing that one is limited in the capacity to directly kill viruses, for years doctors have tried to create treatments based on developing ways to stimulate the body's own defense mechanisms. Besides, this is probably a more logical approach. Such treatments include acids applied in various media, cantherone, formaldehyde, liquid nitrogen, etc. Used along with appropriate debridement procedures the results are generally effective. Surgical excision is also an option, yet not without potential negatives. 14 The accepted approach is a combination of the above plus additional considerations, such as treating the patient's environment and use of oral medications. ENVIRONMENTAL TREATMENT: It is important to use an insole that reduces the coefficient of friction on the skin. This is usually a "flat" insole. If an orthopedic correction is needed this insole can be placed over a functional orthotic. Spenco® is an example. An antifungal spray should be used in the shoes each night and a shoe-tree then placed inside the shoe as it dries out from the day's foot perspiration. (The insole can be left inside the shoe.) Note: Clinically, I have often seen a concomitant fungal/yeast infection along with the wart. Washing the socks or nylons with hot water, chlorine bleach and detergent (color-safe bleach can be used for colored items). Spray the shower floor with an antiseptic like Lysol® spray, before and after the shower. Be certain to let this spray dry prior to showering, to prevent it from making the patient slip on the floor or to be caustic to the skin. Winter 2005 Journal of Biomedical Therapy TOPICAL TREATMENT: Euphorbium Sinus Relief / Euphorbium compositum drops applied directly to the wart, 10 drops, two times a day, followed by the doctor's topical treatment, i.e., an acid patch, etc. (Debridement is generally performed every two weeks.) A topical cream with an acid component (such as lactic acid) is to be rubbed all over both feet two times a day in order to lower the pH of the skin. Column PODIATRIC ORAL TREATMENT: General detoxification of the matrix is important for proper immune function of the body. Berberis-Homaccord, Nux vomica-Homaccord and Lymphomyosot/Lyphosot oral drops, each at 15 drops three times a day are to be utilized up to three bottles of each, depending on the results of the treatment. Dr. Alta Smit has recently revised the detoxification protocol and one may also wish to try this approach.* Engystol tablets, one tablet three times a day or two tablets twice a day, generally for the duration of treatment. Euphorbium Sinus Relief/Euphorbium compositum, Psorinoheel/Sorinoheel, Graphites-Homaccord and Galium-Heel oral drops, each at 15 drops three times a day, generally for the duration of treatment. As treatment continues, Gripp-Heel and/or BHI Inflammation oral tablets may be added to this treatment regimen as indicated. (Same dosage as the other oral tablets.) 15 Oral Vitamin A pills, 20,000 units, once a day, for six weeks, followed by 10,000 units a day for two months. The dosage may then be reduced to 5,000 units daily. Warts can be a significant challenge to any physician. However, with the integration of the homeopathic and allopathic approaches, one's success rate can be nicely increased. * See proposed protocol on page 13, under “Phase: Chronic recurrent infection: after acute infection to prevent further recurrences” Journal of Biomedical Therapy Thuja-Injeel oral vials and injection of Engystol medication directly into the wart have been proposed as additional treatments, for which, however, I have no experience. Winter 2005 OTHER TREATMENTS: Susceptibility to infections depends upon the status of the immune system. The goal of treatment with a homeopathic combination preparation such as Engystol is to activate and support the defense mechanisms of the body. Many European clinical studies have demonstrated Engystol’s efficacy. In vitro tests have demonstrated that Engystol stimulates the phagocytic activity of human granulocytes up to 30% above control cultures. A randomized, placebo-controlled double-blind trial demonstrated that the administration of an immunomodulator such as Engystol can enable favorable effects to be achieved in the prophylaxis of uncomplicated virus disorders of the upper respiratory passages. Moreover, Engystol has been effectively used in the treatment of mild infections. Activate your immune system today… Engystol is available in ampoule form as well as tablets. Both medicinal forms exhibit excellent tolerability and efficacy. It is recommended for the entire family (including children and infants) and is compatible with other medication. Gripp-Heel strengthens the immune system by stimulating phagocytic activity of human granulocyte preparations up to 30% more than placebo. This results in less severe symptoms and shorter recovery time. Gripp-Heel is as good as acetylsalicylic acid. A study using 3 tablets of Gripp-Heel 3 times daily produced the same improvement after 4 days of treatment as 1 tablet (500 mg) of acetylsalicylic acid 3 times daily. Gripp-Heel improves symptoms within 3 days. A drug monitoring trial demonstrated that 70% of patients treated with Gripp-Heel exhibited initial improvement of symptoms as early as 1 to 3 days after initiation of therapy. Gripp-Heel has an excellent safety profile. The innocuousness of Gripp-Heel has been established by over 40 years of worldwide therapeutic use, clinical studies and drug monitoring trials. Over 3 million packages of Gripp-Heel have been sold in the last 5 years with no side effects reported during this period. Ease through the cold and flu season with Gripp-Heel ®