GUNA – ANTI IL 1 INGREDIENTS: Anti-interleukin 1 alpha 4CH; Anti-interleukin 1 beta 4CH. DILUTION: 4CH BIOLOGICAL FUNCTIONS: Regulates the immune response in inflammatory conditions. USES: • acute pain and fever relief • inflammation DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
GUNA -INTERFERON ALFA DILUTION: 4CH BIOLOGICAL FUNCTIONS: Antiviral activity. USES: • recurrent viral infection • joint pain • asthenia • sudden pain with numbness • painful muscle spasm DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
GUNA -INTERFERON GAMMA DILUTION: 4CH BIOLOGICAL FUNCTIONS: Antiviral activity. NK cell activation. Macrophage activation. Anti-proliferative effects. Enhancing the activity of T lymphocytes. USES: Rapid activation of the immune system(activation of the antigen presentation). Stimulation of antiviral defenses. Treatment of autoimmune diseases with risk of viral super-infection. Treatment of hepatitis C and B. • chronic viral infection • allergic syndrome • complementary cancer therapy • asthenia • painful muscle spasm DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
GUNA -INTERLEUKIN 1 BETA DILUTION: 4CH BIOLOGICAL FUNCTIONS: Fever induction, as alert against attack (endogenous pyrogen). USES: Acute immune attack. During the first hours of fever on a viral basis. • asthenia • sleep disorders • eating disorders (excessive hunger) It must be used intermittently, for a time necessary to induce fever. DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
GUNA -INTERLEUKIN 2 DILUTION: 4CH BIOLOGICAL FUNCTIONS: T lymphocyte differentiation. B lymphocyte and NK cell stimulation. USES: Regulation of cell-mediated immune response. • immune deficiency • general malaise • sub-acute painful syndromes • localized inflammation • aging • complementary cancer therapy • prostration, adynamia • burning mouth • susceptibility to viral infections DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
GUNA -INTERLEUKIN 3 DILUTION: 4CH BIOLOGICAL FUNCTIONS: Stimulation of mast cell growth. Stimulation of hematopoiesis. USES: Treatment of hematopoiesis disorders. Treatment of the side effects due to chemotherapy, radiotherapy and of treatment with allopathic antiviral drugs. • hemopoiesis disorders • side effects due to chemotherapy, radiotherapy and antiviral treatments • early aging • memory impairment • digestive disorders • dizziness with vomiting • skin rashes • migrating pain DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
GUNA -INTERLEUKIN 4 DILUTION: 4CH BIOLOGICAL FUNCTIONS: B lymphocyte proliferation. IgG and IgE synthesis. Inhibition of proinflammatory cytokines. USES: Modulation of inflammation. It improves the individual response to vaccine therapy. • basic treatment of autoimmune diseases • chronic inflammatory diseases • cramps and spasm • mental exhaustion DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
GUNA -INTERLEUKIN 5 DILUTION: 4CH BIOLOGICAL FUNCTIONS: Eosinophil and basophil differentiation, growth and maturation. USES: • intestinal parasites • pain caused by contusion • constipation and tympanites • abdominal pain (cramps) • RRI with IgA deficit DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
GUNA -INTERLEUKIN 6 DILUTION: 4CH BIOLOGICAL FUNCTIONS: B lymphocyte growth and differentiation. Co-stimulation of T lymphocyte. Hepatic stimulation. Endocrine factor of the cytokine Network. USES: Complications in the clinical evolution of a patient affected by autoimmune disease. Stimulation of general immunity in cancer patients. • general malaise • complementary cancer therapy • eating disorders (excessive hunger) DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
GUNA -INTERLEUKIN 7 DILUTION: 4CH BIOLOGICAL FUNCTIONS: Thymocyte and T lymphocyte proliferation. USES: • recurrent infections • asthenia • disorders of childhood growth and development • throbbing pain • exhaustion and fatigue DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
GUNA -INTERLEUKIN 8 DILUTION: 4CH BIOLOGICAL FUNCTIONS: Phagocyte, T lymphocyte and platelet chemotaxis. USES: • chemotaxis activation • wet cough • phlegm • acute and chronic stress DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
GUNA -INTERLEUKIN 9 DILUTION: 4CH BIOLOGICAL FUNCTIONS: Lymphocyte stimulation. Synergism with Erythropoietin in the development of erythroid proliferation. USES: Induction of specific immune response. • asthenia and drowsiness • nerve pain • chronic phlegm • water retention DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
GUNA -INTERLEUKIN 10 DILUTION: 4CH BIOLOGICAL FUNCTIONS: Immunosuppressive and inhibiting action on the cytokine Network.Modulation of physiological reactivity. USES: Modulation of the immune tolerance mechanisms. Modulation of inflammation. • chronic inflammatory diseases • itch and sting • mucosal inflammation • chronic pain syndromes • vomiting-loss of appetite DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
GUNA -INTERLEUKIN 11 DILUTION: 4CH BIOLOGICAL FUNCTIONS: Regulation of the growth and the differentiation of hematopoietic cells. Control of the proliferation of other interleukins. USES: Induction of specific immune response. • heartburn • memory disorders • hematopoiesis disorders • psoriasis • abdominal bloating • general regulation in patients under immunotherapy • disorders of childhood growth and development • throbbing pain • exhaustion and fatigue DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
GUNA -INTERLEUKIN 12 DILUTION: 4CH BIOLOGICAL FUNCTIONS: NK cell and T lymphocyte stimulation. USES: Regulation of cell-mediated immune response. Complementary treatment of allergy. • allergy • food intolerance • complementary cancer therapy • recurrent night-time cough • nasal congestion and nasal itching • paroxysmal sneezing • watery eyes due to allergy • skin swelling and skin inflammation DIRECTIONS: 15-20 drops two times a day (standard dosage). PACKAGE SIZE: 30 ml/1.0 fl. Oz. bottle with dropper. For oral use.
Results of a Randomized, Controlled, Clinical Trial
in Comparison to Hyaluronic Acid
ABSTRACT
This multicentric, randomized, singleblind, controlled study compared the efficacy and tolerance of Zeel® compositum and Hyalart brand of hyaluronic acid in the treatment of patients wich osteoarthritis of the knee. Over the five week course of the study, each patient received either 10 injections of Zeel compositum (two 2 ml intra-articular injections per week) or 5 injections of Hyalartt (one 2 ml intrarticular injection per week). Key parameters were the intensity of pain in the arthritic joint during active movement, and the glnbal assessment nf tolerance, both as reported by the patient. Out of a total of 121 patients, the data on 114 (2 treatment groups of 57 patients each) were suitable for stacistical analysis. Zeel® compositum and Hyalarr® proved to be equally efficacious in treating patients wich either milder or more severe pain. Undesirable incidents occurred in 6 patients receiving Zeel® compositum and in 13 of those receiving Hyalart®.In both treatment groups, the most fre- quencly reported side effects were signs of local inflammation or irritation after the intra-articular injections.
INTRODUCTION
Osreoarthritis of the knee is a painful, degenerative joint disease that occurs in approximately 10% of all individuals over the age of 65 and in approximately 2% of the total adult population. At present there is no effective means of treating the cause. Depending on the stage of the illness, however, good therapeutic results can be achieved with non-steroidal anti-inflammatories, corticosteroids, hyaluronic acid, homeopathic remedies, and organ lysates. Age-related cartilage degeneration is a crucial Factor in the development of arthritis, since all bradytrophic tissues due in large part ro the fact that they are poorly supplied with blood vessels are subject to regressive aging processes with increasing loss of elasticity. Because of the chronic and generally progressive nature of the disease,the best possible ratio of therapeutic efficacy to risk of undesirable side effects is a prime consideration in the selection of pharmaceutical cherapy.
The goal of this multicenter, randomized, controlled, singleblind, clinical equivalence study was to prove the therapeutic efficacy of Zeel® compositum in treating knee arthritis. According to the symptom pictures of its individual ingre- dients (Rhus toxicodendron, Arnica montana, Solanum dulcamara, Sanguinaria canadensis, and Sulphur), Zeel® compositum, a combinacion homeopathic preparation, is appropriate for effectively alleviating arthricic symptonms with little risk. Hyalart® brand of hyaluronic acid (a polysaccharide and a natural component of synovial fluid) was selected as the comparative drug. Controlled studies have demonstrated the therapeutic efficacy of Hyalart in treating arthritis. Because Hyalart®is visibly more viscous than Zeel compositum and because the manufacturer recommends less frequent applications than are recommended for Zeel® compositum, it was not possible to conduct this trial on a strict double-blind basis, so it was conducted as a single-blind study. Additional injections of a placebo to equalize application frequencies berween the two drugs were rejected as unethical.
Editor’s note: The formula of the complex bomeopathic preparation featured in this study, Zeel® compositum, is not avail- able in the U.S. In the U.S. Zeel is distributed ointment, tablets, and oral vials, all of which contain the same ingredients of Zeel® compositum,plus others.
METHODOLOGY
Between July 1994 and February 1995,12 orthopedic physicians in active practice in Germany and Austria accepted a total of 121 patients of boch sexes with primary osteoarthritis of the knee into this clinical trial.
Criteria for inclusion were:
presence of primary (idiopathic) arthritis, verified by:
a typical X-ray (medial narrowing of the joint cavity, peripheral osteo- phyte development, compact ossifi- cation of subchondral bone)
chronic pain in one or both knee joints for at least three months, with no sign of acure inflammation
Written statement of patient consent. Criteria for exclusion were:
age <35 or>85 years
arthritis resulting from prior deforma- tions, injuries, or metabolic causes (secondary arthritis)
other ailments with symptoms similar to arthricis of the knece, such as archri- tis of the hip, varicosis, bone and muscle disorders, rheumatoid archritis
signs of acute inflammation (acure active arthritis)
non-ambulatory or bedridden patients ·patients who stated their intention to change their level of physical activity during the study
probable surgical treatment of the arthritic joint in the near furure
intra-articular corticosteroid treatment of the arthricic joint within the past 2 months
low-grade pain (<75 mm on the 100 mm visual analog scale)
a history of allergic reactions to Zeel® compositum or Hyalart®
serious liver or kidlney disease
long-term treatment wih immuno- suppressives during the last month
ongoing concomitant therapy with analgesics/anti-inflammatories
Random assignment to one of the two
treatment groups was accomplished with the help of a special EDP program (Rancode,IDV), which also sorted the patients into subgroups on the basis of pain intensity during active movement of the arthritic joint. Less severe pain was defined as 25-60 mm on the VAS-SB, severe pain as 61-100 mm. Treatment proceeded according to the manufactur- ers’ recommendations. Over the five- week course f the study, each patient received eicher 10 injections of Zeele compositum (two 2 ml intra-articular injections per week) or 5 injections of Hyalart® (one 2 ml intra-articular injection per week). To ensure that the parients did not know which medication they were receiving,the physicians were requested to prepare and administer the injections in such a way that the patients could not see the packaging and to make sure that participants in the study were not in the same room at the same time.
Primary parameters were:
subjective experience of pain in the arthritic knee joint during active movement, measured on a standard- ized visual analog scale(VAS) 100 mm in length (0 mm =pain-free,100 mm =worst pain to date)
the patients’ final assessment of toler- ance ar the end of five weeks of treat- ment,measured on the 100 mm VAS (0 =extremely poorly tolerated, 100=extremely well tolerated)
Secondary parameters were:
pain in the arthritic knee joint during the night,measured on the 100 mm VAS (0 mm = pain-free,100 mm= worst pain to dare)
duration of moming stiffness (in minutes)
maximum distancc the patient was capable of wallcing (as a functional criterion for assessing the severity of the arthritis)
time required (in seconds) to walk up and down a standard series (one flight) of stairs (relative change)
final assessment of efficacy by physician and patienc ac the end of five weeks of rreatment,measured on the 100 mm VAS (0 mm = no improvement,100 mm =extreme improvement)
final assessment of tolerance by physician and patient ar the end of five weeks of treatment,measured on che 100 mm VAS (0 mm = cxtremely poorly tolerated,100=extremely well tolerated)
drop-out rate in both groups resulting from inadequate product efficacy
reporting of undesired side effects dur- ing treatment(recorded weekly)
All of the compiled data were recorded on standardized questionnaires. The study was conducted in accordance witl the European Union’s Good Clinical Practice guidelines and German and Austrian national laws.
Data Preparation and Statistical Analysis
A two-tailed Wilcoxon’s rank-sum test (=0.05 and =0.20) was used to analyze the differences between the treatment groups with regard to efficacy and tolerance. In calculating required sample size, the efficacy or tolerance of the two forms of treatment was assumed to be therapeutically equivalent if the absolute dif- ference in therapeutic efficacy (defined as reduction in pain during active move- ment after five weeks of treatment, as measured on the VAS) or tolerance (defined as final assessment after five weeks of treatment, as measured on the VAS) between Zeel® compositum and Hyalart® was no greater than 33%. Minimum group size was calculated ar nl=n2=51, without including dropouts amounting to approximarely 10%. Comparabilicy of treatment groups with regard to baseline characteristics was cested by means of either the Wilcoxon test (pain during active movement or during the night when the study began) or the chi-square test.(number of affected knee joints); the difference in frequency of side effects was tesred by means of the chi-square tesr. Taking into account the patierics’ subjective experierce of pain intensity during active movcinent when the study began (as per VAS-SB), therapeutic efficacy and tolerance in each trearment group were compared by means of either covariance analysis or the Wilcoxon test (patiencs with more or less severe pain were assigned to subgroups). A descriptive statistical analysis of baseline characteristics and all secondary parameters was performed wich a chosen level of significance of =0.05.
Results
In accordance wich the intent-to-treat principle, all available analyzable dara on 114 parients, including dropouts and protocol violators, were used in analyzing efficacy and tolerance. Of a total of 121 randomly selected patients, three did not meer the minimum pain requirement (at least 25 mm on the VAS-SB). Four patients who had been mistakenly treated with both products (in different knees)were studied only with respect to undesired incidents and excluded from the analysis of efficacy, resulting in 114 assessable patients (Table 1). The two treacment groups (n=57) were comparable both with regard to all baseline characteristics (age, gender, height and weight, concomitant illnesses and medications) and with regard to anamnestic data on the artchricis (duration of illness, intensity of pain,and morning stiffness ar the inception of the study, Table 2). In accordance with the exclusion criteria, concomitant use of analgesics and antinflammatories was prohibited. Protocol violations on this count occurred in one patient receiving Zeel® compositum and in three receiving Hyalart®. Other protocol violations were premature termina- tion of therapy for non-medical reasons (one patient), failure to adhere to trear- ment schedule (one parient),and prema- ture termination of therapy because of inadequate improvement (two patients receiving Zeel® compositum and one receiving Hyalart®).
a) Therapeutic Efficacy
The patients’ arthritic symptoms clearly decreased both under treatment with Zeel® compositum and under treatment with Hyalart.® In boch treatment groups there was a roughly linear decrease in pain due to active movement of the arthricic joint.This decrease aver- aged 36 mm for Zeel® compositum (from 67 mm to 31 mm) and 37 mm for Hyalart®(from 63 mm to 26 mm).The reduction in nocturnal joint pain fol- lowed a similar pattern, with a linear decrease during treatment (from 33 mm ro 9 mra for Zeel® compositum and from 35″mm to 7 mm for Hyalart). Duration of morning stiffness in the arthricic joint was reduced from 5 min- utes to 2 minutes for Zeel® compositum and to 1 minute for Hyalare®(Table 3). According to analysis of the difference in therapeutic efficacy berween Zeel® compositum and Hyalart® by means of a two-tailed Wilcoxon’s rank-sum test, these two forms of treatment can be seen as therapeutically equivalent (pain during movement: p = 0.4298; pain during the night:p=0.3077;duration of morning stiffness:p=0.9211).An increase in functional ability was associated with pain reduction during treatment.After five weeks of treatment, the percentage of patients who were able to walk more than 1 km increased from 55% to 67% for Zeel® compositum and from 68% to 79% for Hyalart®. In 3 out of 5 pacients in the Zeel® compositum group and 1 out of 3 patients in the Hyalart® group, symptoms improved so much that they were able to do without the cane they had needed when treatment began.The time needed to climb one flight of stairs also decreased by an average of 18% for patients treated with Zeel compositum and by an average of 9% for those treated with Hyalart®.
Table 1Table 2Table 3
The results of the final assessment confirmed the comparable therapeutic efficacy of the two products (Table 4). Noticeable improvement in symptoms was reported for 87.3% of the patients treated with Zeel® compositum and 93.0% of those treared wich Hyalart®.In boch treatment groups, The patients’ subjective assessment was slighdy more favorable than that of the physicians who treated them. VAS values assigned by patients were 2 mm greater for Zeel® compositum and 4 mm greater for Hyalart® than the values assigned by the physicians.In both treatment groups, co-variance analysis reveals that the suc- cess of treatment depends significanly on pain intensity at the inception of the study (p =0.0060).When initial pain was considered as a co-variable, no significant difference between Zeel® compositum and Hyalart which regard to therapeutic success could be derermined (p =0.7555). This means that the effica- cy of Zeel® compositum must be seen as equivalent to that of Hyalart® boch in patients witch less severe pain (25 to 60 mm as per VAS) and in cases of more severe pain (61 to 100 mm as per VAS). The fundamental character of the results is not changed if, instead of conducting che assessment according to the intent- to-treat principle, the analysis comprises only the data on the 103 patients who completed the study according to plan.
Table 4
b) Tolerance
In terms of tolerance, the trend favored Zeel® compositum.A total of 6 patients(11%)treated wich Zeel° compositum and 13 patients (23%) treated with Hyalart® developed undesirable side effects (chi-square test: p=0.079). While receiving twice-weekly injections of Zeel® compositum 3 patients developed low-grade joint effusions that had tapped. Renewed applications of Zeel® compositum induced new effu- sions in 2 of these 3 patients, and as a result treatment was prematurely termi- nated(after 9 injections) in one case. The two other patients completed the study according to plan in spite of intermittent joint effusions. One patient reported a temporary sensation of heaviness in the leg after the first injection of Zeel® composicum Another Zeel® compositum patient terminated treatment prematurely after two weeks because of headaches and insomnia. Two patients from the Zeel® compositum group and 9 from the Hyalart group complained of increased pain in the knee joint after the intra-articular injections; the pain lasted from 3 to 7 days. One patient from the Hyalart® group had to terminate therapy after the first injection because of an allergic reaction (pain, swelling and redness from the knee to the mid thigh). In contrast to Zeel® compositum, no joint effusions were observed in the Hyalart group, but one patient complained of a hot burning sensation in the knee joint that appeared 24 hours after cach of the first two Hyalart®injections and Iasted approximately 24 hours. Another Hyalart® patient reported a mild sensation of pressure and fullness in the joint for about 15 minutes after the third injection. In one patient, nausea and repeated vertigo were experienced after intra-articular applications of Hyalart®. The physicians of two additional patients from the Hyalart® group reported that side effects had appeared but they failed to specify further. In all of these cases, the side effects subsided without medication during the course of the study.
The final assessment of tolerance (as per VAS) upon conclusion of treatment indicated very good tolerance of both ested products wichout significant differences berween the two treatment groups. According to the Wilcoxon tesc: patients’ assessment of tolerance p=0.1213; physicians’ assessment p=0.7287; in the great majority of cases, the physicians’ assessments coincided with those of their patients. (The difference between physician and pacient assessments was 2mm for both treatment groups; Table 4).
Discussion
Many studies restrict themselves to statistically substantiating improvement over the course of therapy in comparison to the starting point (pre-post comparison). However, since symptom patterns do not remain constant over the course of an illness, patients generally tend to see a physician only when the pain has already increased. As a result, there is a high degree of probability that the pain will revert spontaneously to its previous level. This is also known as ‘regression to the mean.” Thus analyses based on pre-post comparisons are not always reliable because, taken by themselves, they cannot separate spontaneous improvement from stricly therapeutic effects. A different route was chosen in the context of this present study, namely comparison of improvement in the two treatment groups at the end of a predefined course of therapy (post-post comparison). The definition of therapeutic equivalence that was used here was not purely statistical but primarily clinical, namely a certain range within which the improvement in one group would be considered equivalent to that in the other. In this study, equivalence was assumed if the maximum difference in decrease in pain between the two groups was no more than 33% (pain at inception of study= 100%). In fact, this investigation showed the difference to be only five percentage points (59% for Hyalart vs. 54% for Zeel® compositum),meaning thac wich regard to therapeutic efficacy, Zeel”compositum and Hyalart” are equivalent. There is a linear correlation between improvemenc in pain and duration of treatment. The criterion ‘pain during movement’ yields a coefficient of r=- 0.80 while the criterion ‘pain during the night’ yields a coefficient of=-0.69. A similarly linear relationship was also found in a recently compleced prospective study in which 446 patients wich knee arthritis were treated with Zeel® compositum.
In addition, it is especially interesting to note that the therapeutic efficacy of Zeel® compositum was found to be equivalent to that of Hyalart® not only in the subgroup wich less severe pain but also in the group which more severe pain. Analysis of the assessments of functional capacity(climbing stairs, distance patients were able to walk) that also contributed to improving the patients’ quality of life.
In this trial, a trend in Favor of Zeel® compositum was noted with regard to tolerance. Although Zeel® compositum was injected twice as often as Hyalart and the probabilicy of complications was therefore greater, Zeel® compositum had only half as many undesired incidents. While one patient terminated treatment prematurely because of a suspected allergic reaction after being injected with Hyalart®, no allergic reactions of any kind appeared in the Zeele composirum group.
The results of this clinical study and of the prospective study of Zeel® compositum confirm the favorable empirical reports of this homeopachic preparation that have accumulated over the years. A 1992 prospective study of Zeel® P (which has 10 more ingredients than Zeel® compositum) involved 1845 patients with osteoarthritis of the knee. That study also documented a significant linear decrease in pain symptoms. Like Zeelr compositum, Zeel® P was also found to be therapeutically effective for mild, moderate, and severe symptoms, wich 93.1% of the patients rating the therapeutic success as positive, i.e. satisfactory to very good.
A summary abstract, original by: Werner Frase, M.D.
Reprint from Medicina Biologica, Vol. 2, April-June 2002, 52-54.
SUMMARY
The basis of antihomotoxic preparations in allergic respiratory conditions is to stabilize the mucous membranes, thereby normalizing their response to allergens. In general, an oral treatment combines Tartephedreel, Drosera-Homaccord and Husteel. Seven (7) drops of each in a little water 3x/day before meals is a general protocol. The use of this protocol for bronchial problems contributes a broncodilating effect by acting in a spasmolytic capacity. The frequent use of such a protocol can greatly diminish the need for conventional medicine and reduce the frequency and/or duration of the condition. You will find below a list of recommended preparations along with their respective properties and indications.
ANTIHOMOTOXIC MEDICATION PROPERTIES & INDICATIONS
BRONCHALIS-HEEL/BRONKEEL Bronchitis, catarrh, chronic bronchitis COENZYME COMP/UBICOENZYME Dysfunction of the Krebs cycle DROSERA-HOMACCORD Cough, bronchitis, spasm with cough ECHINACEA COMPOSITUM Immune stimulation, bacterial infections ENGYSTOL Immune modulator, viral infections GALIUM-HEEL Activates immune system in chronic cases HISTAMIN-INJEEL Modulates histamine release in allergic mechanism of the mucous membranes HUSTEEL Cough from varied pathology, spastic bronchitis IGNATIA-HOMACCORD Reduces symptoms, sedative MUCOSA COMPOSITUM Drainage of mucous membranes PSORINOHEEL/SORINOHEEL Stimulating agent TARTEPHEDREEL Bronchial conditions with spasm TRAUMEEL Localized inflammation from various etiology UBICHINON COMPOSITUM Enzymatic dysfunction, stimulation of oxygen metabolism URTICA-INJEEL Conditions of the mucous membranes, urticaria
Allergic reactions and symptoms are extremely com- plex in their origins and not yet fully understood.
Allergies can be divided into three major types:
delayed reaction allergies caused by sensitized lymphocytes
antigen-antibody allergies caused by a reaction between immunoglobulin G (IgG) antibodies and antigens and
atopic or inherited allergies which are characterized by the presence of large amounts of sensitizing antibodies called IgE antibodies.
Examples of delayed reaction allergies, also called cell-mediated hypersensitivity allergies, include contact dermatitis or skin eruptions resulting from exposure to causative agents such as drugs, chemicals and the toxins of poison oak or poison ivy.
Antigen-antibody allergies occur when an individual has built up a high titer of antibodies following exposure to a specific antigen.Examples of antigen-antibody reactions include transfusion reactions and autoimmune disease.
Atopic allergies affect roughly 10% of the population. The hypersensitivity involves the production of excessive amounts of IgE antibodies. Allergens which react specifically in this way include pollen,dust, foods as well as bee,wasp and hornet venoms.Reactions of this type include hay fever, asthma, urticaria (hives) and potentially fatal anaphylaxis. Contact with an allergen by a person with an atopic allergy triggers a local inflammatory reaction with accompanying tis- sue damage.
At the metabolic crossroads of all these allergic reactions is histamine. An excess of histamine is apparently re- leased when the body comes into contact with substances to which is it sensitive.Histamine acting as a mediator of hypersensitivity triggers the inflammatory process.
A remedy which lends itself exceptionally well to the antihomotoxic treatment of various allergies is BHI Allergy, which has been specifically formulated for the treatment of allergic reactions and symptoms.
Focusing Ingredient:
Histamine hydrochloride 8x:
specific antiallergy effectiveness
Accompanying Ingredients:
Arnica 6x:
inflammations, tissue traumas, neurodermatitis
Ignatia amara 6x:
constrictive sensation in larynx and trachea,cough,dif- ficult breathing,fluent coryza, catarrh
Lycopodium clavatum 6x:
throbbing headache, cough, inflammation of the eyes, violent catarrh, difficult breathing, sore throat
constrictive oppression of the chest,suffocative breathing arrest, cough, painful respiration
Antimonium crudum 10x:
affections of the mucous membranes, nasal and bronchial catarrh, eczema, skin eruptions with itching
Embryo bouis 10x:
detoxicating factor for all tissues
Graphites 10x:
skin disorders with eczematous eruptions, scrofulous affections
Pix liquida 10x:
eczemas of the hands, itching, eruptions
Tellurium metallicum 10x:
eczema scrofulous conditions, eruptions and pain
Selenium 12x:
nasal catarrh, cough with mucus and expectoration, straining in the chest, skin inflammations, blisters, itching
Sulphur 12x:
skin conditions, eruptions,mucous membranes of the bronchi,allergic reactions
Psorinum nosode 15x:
nosode for skin infections, eczemas and inflammations
This combination of ingredients works together to mutually strengthen their effects on the histamine metabolismand allergic symptoms.
The respiratory symptoms associated with allergies such as sneezing,cough, itching, burning watery eyes, catarrh and difficult breathing respond well to treatment with BHI Allergy. Skin inflammations due to chemical or food allergies as well as poison oak or ivy and insect bites and stings may also be treated in this way.
The recommended dosage is one tablet taken six (6) to ten (10) times daily, or about every two hours at the onset of symptoms.This dosage should then be decreased to three (3) times daily upon improvement. In cases where symptoms are severe due to reexposure to causative agents, BHI Allergy may be administered, one tablet every 8-10 minutes to relieve the immediate discomfort. Once relief is observed, the normal dosage schedule is resumed.
This remedy combines well with other BHI remedies when,additional symptoms are present. For example:
Hay fever, catarrh:
BHI Sinus
Asthma:
BHI Asthma
Skin inflammations:
BHI Skin
Healing of skin lesions:
BHI Hair & Skin
These accompanying remedies should be administered six (6) to eight (8) times daily, every 2-2/2 hours, alternating with BHI Allergy.
For example:
For asthma with difficult breathing administer BHI Asthma upon rising, BHI Allergy one hour later, BHI Asthma one hour following Allergy and so on throughout the waking day until symptoms improve. For acute asthmatic attacks administer one tablet of BHI Asthma every eight (8) minutes until symptoms improve and then return to the previous schedule.
Reprint and translated from: Rosales-Estrada M. El syndrome de inflamación de las mucosas en la enfermedad alérgica. Revista Colombiana de Pediatría. 2003;38(3):201-5.
INTRODUCTION It is common to find allergic patients with simultaneous clinical signs or symptoms of the respiratory and/or gastrointestinal and/or genitourinary mucosal membranes. In the present study the common denominator was allergic rhinitis. Simultaneous clinical involvement, circumscribed to the aforementioned mucosal tissues (mucosae) clearly suggests common physiopathological factors in allergic disease; accordingly, alterations of one type of membrane affect the others, or alterations of two or more mucosae may be explained on the basis of a common mechanism.
Hypothesis. Allergic disease can give rise to simultaneous clinical manifestations of the respiratory, gastrointestinal and genitourinary mucosal membranes.
Objective. To determine whether allergic disease can give rise to simultaneous clinical manifestations of these mucosae.
Summary. Patients who have allergies can have simultaneous respiratory, digestive and genitourinary mucosal disease. I performed a retrospective study in 30 patients; 24 children and 6 women. The children were between 5 and 9 years old, and the women were between 26 to 40 years old. All of them suffer from allergic diseases.
Results. 100% had clinical respiratory diseases like rhinitis, asthma, arithenoids or vocal cord inflammation, tonsillectomy, and/or frequent respiratory viral infections. 100% of the patients had clinical digestive diseases such as gastro-esophageal reflux, gastroduodenitis, constipation and diarrhea. 87% of the female patients had clinical genitourinary diseases such as vulvovaginitis and urinary infections.
The results of this study are very important because they provide information regarding the clinical behaviour of allergic diseases, which can be systemic. According to this concept, its treatment should be holistic and individual because each patient can have one or more mucosae involved. The most recent articles of medical literature refer to rhinitis and asthma only as a like process.
MATERIALS AND METHODS A retrospective analysis was made of 30 deliberately selected allergic patients with clinical manifestations of allergic rhinitis that coincided with clinical manifestations of the respiratory and/or gastrointestinal and/or genitourinary mucosal membranes. These clinical manifestations were: asthma, sinusitis, otitis media, acute and recurrent viral respiratory infections, adenotonsillar hypertrophy, inflammation of the vocal cords and arytenoiditis, esophagitis, gastroesophageal reflux (GERD), gastritis, duodenitis, diarrhea, constipation, vaginitis and urinary infections.
The study series comprised 24 children and 6 adult women. Of the pediatric patients, 10 were girls and 14 were boys. The patient age varied from 5-9 years among the children and from 26-40 years in the case of the adults. Three of the women were nulliparous. The study period was from April 30, 2002 to April 30, 2003.
Allergic patient classification was based on an evident clinical history of rhinitis, with or without simultaneous asthma and/or total immunoglobulin E (IgE) levels above normal or specific IgE positivity for a given antigen. Clinical antecedents of adenoid removal or tonsillectomy in a large proportion of cases contributed to establish the diagnosis. Thus, the sum of these clinical events undoubtedly would classify these patients as allergic subjects.
The definition of rhinitis was based on a clinical history of abnormally increased and chronic nasal itching, marked sneezing particularly in the morning, nasal congestion and rhinorrhea of variable intensity according to the severity of the clinical process. Almost all these patients had previously used local steroids applied to the nasal mucosa, prescribed by a physician unrelated to the present study.
Asthmatic patients in turn were defined as those with two or more asthmatic episodes a year on average, in the previous three years, with frequent beta-2-adrenergic and/or inhalatory steroid use.
Esophago- and/or gastro- and/or duodenitis were diagnosed in the presence of endoscopic and histological findings corresponding to such disorders.
Recurrent acute viral respiratory infection (ARI) was diagnosed when the patient suffered one or more infections a month.
Clinical gastritis in turn was defined by clinical signs of acute gastritis – the latter being established by acute epigastric pain accompanied or not by vomiting and relief following antacid administration.
Chronic cough was defined as cough persisting for more than 20 days in different episodes, with a cause not different from allergy of the upper airways.
Gastroesophageal reflux (GERD) in turn was diagnosed by gammagraphy or a history of chronic vomiting in a child, or – in the case of adults – chronic heartburn.
Arytenoiditis and inflammation of the vocal cords was accepted when laryngoscopy confirmed inflammation of these structures.
Mucosal inflammation index
Chronic diarrhea was defined as two or more daily depositions, with diarrheic consistency on one or more occasions – all with colic type abdominal pain.
Constipation was defined as an absence of bowel movement for over 48 hours, with hard stools and a large fecal bolus.
Vulvovaginitis was described as an episode of vaginal secretion, itching or inflammation of the skin of the vulva and vaginal mucosa.
Urinary infection in turn was considered for those patients presenting at least one episode of clinical signs and symptoms of urinary infection and positive urine culture for a microorganism known to cause such disorders (bacterial count: 100,000 CFUs or more).
Likewise, 100% had clinical manifestations of the gastrointestinal mucosa. These manifestations may or may not correspond to allergic physiopathological processes of the membranes. Many of these patients presented clinical signs and symptoms of gastritis in the presence of acute respiratory infection (ARI); 5 of them presented gastric ulcer as established at endoscopy, coinciding with an acute episode of viral respiratory infection.
On the other hand, 61.9% of the female patients, regardless of age, showed clinical alterations of these mucosae, manifesting as vulvovaginitis and/or urinary infection.
CONCLUSION The selected allergic patients with clinical manifestations of the respiratory tract were seen to possibly present simultaneous alterations of the gastrointestinal and/or genitourinary mucosal membranes.
DISCUSSION The following syndromic manifestations simultaneously affect the mucosal membranes of the respiratory and/or gastrointestinal and/or genitourinary tracts, and partially or completely confirm the different clinical manifestations of MUCOSAL INFLAMMATION SYNDROME, as described for the first time in the present article. These observations were made in allergic outpatients or allergic individuals admitted to hospital, and their detection merits attention and sensitivity on the part of the supervising physician.
Girls with sinusitis and/or allergic rhinitis and/or pharyngitis, with concomitant vaginitis. Eventual ascending urinary tract infection.
Nursing infant (age under 3 months) with gastroesophageal reflux (GERD) (or underlying gastroenteritis) and nasal congestion (noisy nasal breathing) – this latter symptom often being observed before manifestations of GERD become apparent.
Rhinitis, sinusitis and asthma.
Upper respiratory tract allergy and esophago-gastroduodenitis.
Acute viral respiratory tract infection and gastritis and/or exacerbation of gastritis.
Immediate recurrence of GERD (or underlying gastroenteritis), associated with acute viral respiratory infections.
Sinusitis and soft stools with mucus and sometimes of a foul-smelling nature, in children under three years of age.
Acute viral respiratory tract infections with soft stools, and sometimes diarrhea.
Concurrence of tonsillitis with right iliac fossa pain simulating appendicitis or diffuse abdominal pain.
Viral respiratory infections and so-called mesenteric adenitis (diffuse abdominal pain concomitant to viral respiratory infection).
GERD (or underlying gastroenteritis) and chronic cough and/or asthma.
GERD and recurrent airway infections.
Geographic tongue and manifestations of upper respiratory allergy and/or gastroduodenitis.
Reappearance of geographic tongue with acute viral respiratory infections.
Posterior laryngitis (edema, leveling and erythema of the inter-arytenoid mucosa) and edema of Reinke (vocal cord edema), associated with GERD.
Urinary infection and/or vulvovaginitis associated with constipation.
Urinary infection and/or vulvovaginitis associated with allergic enteropathy.
Endometriosis in allergic women and allergic enteropathy and/or constipation.
While GERD of the nursing infant (generally under 6 months of age) reflects gastrointestinal mucosal disorders, it has been seen to exacerbate if the mother consumes dairy products, suffers inflammatory enteric disease (constipation, diarrhea), asthma crises, or acute viral respiratory infections.
The medical literature reports the partial concurrence of these manifestations: • 77% of the adult asthmatic population experience symptoms of GERD. • 43% of asthmatic patients subjected to digestive tract endoscopy present esophagitis or Barrett’s esophagus. • 20% of children with rhinitis develop asthma. • 50% of children with asthma develop rhinitis. • Marked association of sinusitis, asthma, laryngitis, pneumonia and bronchiectasia in patients with GERD (patients aged 2-18 years). • Clinical association of tonsillitis and right iliac fossa pain simulating acute appendicitis (involving patients needlessly subjected to appendectomy). The importance of focusing attention on the global involvement of the mucosal membranes in a given patient is that the diagnostic and management approach should be holistic and individualized. A lack of response to treatment on the part of pathology related to a given mucosal membrane in the context of allergic disease is seen on a daily basis in medical practice when necessary attention is not focused on other simultaneously affected mucosal membranes. The following may serve as examples:
A lack of surgical intervention to correct important adenoid hypertrophy implies frequent respiratory infections (viral, otitis, sinusitis).
Torpid course of asthma in patients with uncontrolled GERD (or underlying gastroenteritis).
Acute respiratory infections and the presence of GERD (or underlying gastroenteritis).
A lack of response in allergic patients with uncontrolled rhinitis.
Persistent asthma due to undiagnosed bacterial sinusitis.
Persistence of vaginal secretion and/or urinary infections in patients with constipation or allergic enteropathy.
In order to begin to modify old paradigms, allergic disease seen from this perspective would not be exclusive to the different subspecialties, determined by the affected body organ. In effect, such conditions could be treated by all physicians, regardless of their specialty, provided thorough knowledge is gained in all spheres where allergy as a systemic disorder produces its devastating effects. Neglect in this context would be a sign of incompetence.
STUDY
As an example, an ear, nose and throat (ENT) specialist could not treat rhinitis if the intestinal alterations are not first dealt with. Gynecologists or urologists likewise would not be able to treat a large percentage of cases of vulvovaginitis and urinary tract infections without first treating the respiratory allergies and intestinal disorders. In turn, pneumologists would not diagnose gastritis if not intentionally explored. The same considerations apply to the other medical specialties that deal with allergic processes.
This clinical approach involving physiopathological dependency of the mucosae in allergic disease would fully reorientate the current treatment established by conventional medicine; each mucosal membrane deals with somewhat different immunological information, though with crossed immune data among different membranes. As an example, a food allergen can produce digestive tract and respiratory symptoms at the same time.
Food allergies can coincide with allergy produced by aeroallergens in up to 70% of cases, which increases the possibility of crossreactions between foods with aeroallergens. This data implicates the intestine as an important antigen generating source – a fact that must be taken into account when treating an allergic patient, regardless of where the allergic process manifests. It is our experience that once a patient starts a correct diet, with good intestinal hygiene and environmental control, allergic processes largely disappear.
Another mistake in medical practice is to consider these symptoms as a disease. Such manifestations are actually symptoms or signs of allergic disease, and the correct diagnosis of an allergic patient should be based on the following premises: allergic disease with manifestations of esophagitis, gastritis, rhinitis, asthma, vulvovaginitis, etc. The practice of considering an organ isolatedly from the rest of the organism fails to take into account that the mucosal membranes share immunological information, and that alterations of one membrane can affect others.
Lastly, another aspect that deserves mention on the basis of the findings of the present study is that ascending urinary tract infection and vulvovaginitis may be related to alterations of nearby mucosal membranes – such as constipation or allergic enteropathy – or more distant mucosae, such as in the case of allergic rhinosinusitis. A number of studies already mention allergic disease as a cause of vulvovaginitis, and even establish a relation to dust mite allergy.10 In my opinion, this problem is very common, though the medical literature does not yet report the situation as such.
It is hoped that the present study may serve as motivation for investigators to clarify the prevalence of this syndrome in allergic disease, to establish a new definition for the latter, and to explore the association between allergic pathology and other mucosal disorders such as GERD in the adult, vesicoureteral reflux, interstitial cystitis in the adult, constipation and endometriosis.
As a general conclusion, I am of the opinion that a clinical syndrome exists in allergic disease, which from the physiopathological perspective may partially or fully implicate the respiratory, gastrointestinal and genitourinary tracts, and that the medical literature has not yet recognized its relevance.
The scientific bases explaining the physiopathology of mucosal inflammation syndrome in allergic disease are based on the new concept of modern psycho-neuro-endocrino-immunology, which we hope to develop in the following issue pending publication.
The latest publications referring to allergies only view rhinitis and asthma as manifestations of one same process. The corroboration by other investigators of the simultaneous involvement of the mucosal membranes in the allergic patient would help confirm a new definition of allergic disease, and thus also promote a new approach to management.
The urinary symptoms give the keynotes for this remedy. Piles with much itching.
Urinary.–Burning, tingling, from perineum throughout whole urethra; sudden urging, to urinate; frequent, voluptuous tickling in fossa navicularis. Gonorrhœa; sudden, irresistible desire to urinate; intense biting, itching, deep in urethra; milky discharge.
Stomach.–Thirsty and hungry, but desire fails on beginning to eat or drink.
Relationship.–Compare: Apiol-the active principle of Parsley–(in dysmenorrhœa); Canth; Sars.: Cannab; Merc.
Has distinct diuretic properties; hence its use in dropsies. Asthmatic conditions, with bronchial catarrh.
Head.–Boring pain behind right ear in mastoid process (Caps). Violent pulsation of arteries (Pothos; Glonoine). Painful pressure above the root of nose.
Stomach.–Persistent pressure in cardiac orifice. Vomiting.
Abdomen.–Distended; meteorism; very severe colic.
Urine.–Cutting, burning in urethra. Tenesmus of bladder and rectum, with absence of stool and urine.
A Vermifuge-Nausea and vomiting, vertigo, prćcordial anxiety slowing and irregular pulse, subdelirium and collapse. Rapid and extreme prostration. To expel tapeworm.
Dose.–1/2 oz. Mix with warm water and let stand 15 minutes; stir well and administer. May be preceded by a little lemon juice (Merrell).
Relationship.–Compare: Mallotus-Kamala-An efficient remedy for tapeworm in 30-60 minims of tincture taken in cinnamon water.