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Background: Severe acute respiratory syndrome due to coronavirus 2 (SARS CoV-2) is a novel infectious disease, which has quickly developed into a pandemic. The spectrum of COVID-19 symptoms is broad, ranging from a mild, self-limiting respiratory tract illness to severe progressive pneumonia, multi-organ failure and possible death. Despite much effort and multiple clinical trials, there are, to date, no specific therapeutic agents to treat or cure the coronavirus infection. Case Reports: The present paper presents 5 cases of patients with moderate to severe COVID-19 infections, 2 of them hospitalized in the intensive care unit, who were successfully treated with homeopathy. Results: All 5 patients responded to homeopathic treatment in an unexpectedly short time span, improving both physically and mentally. Conclusion: The present case series emphasizes the rapidity of response among moderate to severely ill patients to homeopathic treatment, when conventional medical options have been unable to relieve or shorten the disease. The observations described should encourage use of homeopathy in treating patients with COVID-19 during the acute phase of the disease.

Successful homeopathic prescriptions are based on careful individualization of symptoms, either for an individual patient or collectively in the case of epidemic outbreaks. The ongoing COVID-19 pandemic was initially represented as a severe acute respiratory illness, with eventual dramatic complications. However, over time it revealed to be a complex systemic disease with manifestations derived from viral-induced inflammation and hypercoagulability, thus liable to affect any body organ or system. As a result, clinical presentation is variable, in addition to variations associated with several individual and collective risk factors. Given the extreme variability of pathology and clinical manifestations, a single, or a few, universal homeopathic preventive Do not split medicine(s) do not seem feasible. Yet homeopathy may have a relevant role to play, inasmuch as the vast majority of patients only exhibit the mild form of disease and are indicated to self-care at home, without standard monitoring, follow-up, or treatment. For future pandemics, homeopathy agencies should prepare by establishing rapid-response teams and efficacious lines of communication.

SARS-CoV-2 Omicron variant has been characterized by decreased clinical severity, raising the question of whether early variant-specific interactions within the mucosal surfaces of the respiratory tract could mediate its attenuated pathogenicity. Here, we employed ex vivo infection of native human nasal and lung tissues to investigate the local-mucosal susceptibility and innate immune response to Omicron, compared to Delta and earlier SARS-CoV-2 variants of concern (VOC). We show that the replication of Omicron in lung tissues is highly restricted compared to other VOC, whereas it remains relatively unchanged in nasal tissues. Mechanistically, Omicron induced a much stronger antiviral interferon response in infected tissues compared to Delta and earlier VOC - a difference which was most striking in the lung tissues, where the innate immune response to all other SARS-CoV-2 VOC was blunted. Our data provide new insights to the reduced lung involvement and clinical severity of Omicron.

Coronavirus disease 2019 (COVID-19), caused by a new coronavirus, first appeared in late 2019. What initially seemed to be a mild influenza quickly revealed itself as a serious and highly contagious disease, and the planet was soon faced with a significant morbidity and mortality associated with this pathogen. For homeopathy, shunned during its 200 years of existence by conventional medicine, this outbreak is a key opportunity to show potentially the contribution it can make in treating COVID-19 patients. This should be done through performance of impeccably controlled, prospective, randomized clinical trials, with publication of their findings in well-ranked conventional medicine journals. If the homeopathy community fails to take advantage of this rare opportunity, it might wait another century for the next major pandemic.

Background In a double-blind placebo-controlled randomized trial with parallel groups, the efficacy of individually prescribed homeopathic medicines was evaluated in women with premenstrual syndrome (PMS). Methods In an outpatient department of a university clinic in Jerusalem, Israel (1996–1999), women with PMS, aged 18 to 50 years, entered a 2-month screening phase with prospective daily recording of premenstrual symptoms by the Menstrual Distress Questionnaire (MDQ). They were included after being diagnosed with PMS. A reproducible treatment protocol was used: women received a homeopathic prescription based on symptom clusters identified in a questionnaire. The symptoms were verified during a complementary, structured, interview. Only women whose symptoms matched the symptom profile of one of 14 pre-selected homeopathic medicines were included. Each participant was administered active medicine or placebo via random allocation. Primary outcome measures were differences in changes in mean daily premenstrual symptom (PM) scores by the MDQ. Analysis was by intention-to-treat. Results A total of 105 women were included: 49 were randomized to active medicine and 56 to placebo. Forty-three women in the active medicine group and 53 in the placebo group received the allocated intervention with at least one follow-up measurement and their data were analyzed. Significantly greater improvement of mean PM scores was measured in the active medicine group (0.443 [standard deviation, SD, 0.32] to 0.287 [SD, 0.20]) compared to placebo (0.426 [SD, 0.34] to 0.340 [SD, 0.39]); p = 0.043. Conclusions Individually prescribed homeopathic medicines were associated with significantly greater improvement of PM scores in women with PMS, compared to placebo. Replication, with larger sample size and other refinements, is recommended to confirm the efficacy of this treatment in other settings.

Purpose The novel coronavirus, SARS-CoV-2, emerged from Wuhan, China, causing a pandemic. Access to outpatient psychiatric care was limited. We conducted a pilot study of telepsychiatry during a national shutdown. Adult patients with post-traumatic stress disorder (PTSD) participated via Zoom. Patient preference comparing televisits to face-to-face visits was assessed. Recent findings Telemedicine has emerged as new technological tool in the evolution of the patient-physician relationship, changing the way we interact. Physicians and patients now have access to the electronic medical record, remote point-of-care testing, and each other. The present epidemic allows us to test the limits of technology in combating limited access to care for patients with psychiatric illness. Summary Twenty (90% male) patients with PTSD participated. Most (90 %) were moderately to severely depressed, and 50% used medical cannabis and increased their dosage during the study period. Patients preferred face-to-face meetings for its ease of use (p < .01) and general satisfaction from therapy (p < .01). However, given continued outbreak-limiting access to care, most patients stated they would continue with telepsychiatry. While most patients preferred face-to-face visits, telepsychiatry can be used during times of outbreak-limiting access to care. Future research and development should be directed at improving technological ease of use.

The nasal mucosa constitutes the primary entry site for respiratory viruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). While the imbalanced innate immune response of end-stage coronavirus disease 2019 (COVID-19) has been extensively studied, the earliest stages of SARS-CoV-2 infection at the mucosal entry site have remained unexplored. Here, we employed SARS-CoV-2 and influenza virus infection in native multi-cell-type human nasal turbinate and lung tissues ex vivo, coupled with genome-wide transcriptional analysis, to investigate viral susceptibility and early patterns of local mucosal innate immune response in the authentic milieu of the human respiratory tract. SARS-CoV-2 productively infected the nasal turbinate tissues, predominantly targeting respiratory epithelial cells, with a rapid increase in tissue-associated viral subgenomic mRNA and secretion of infectious viral progeny. Importantly, SARS-CoV-2 infection triggered robust antiviral and inflammatory innate immune responses in the nasal mucosa. The upregulation of interferon-stimulated genes, cytokines, and chemokines, related to interferon signaling and immune-cell activation pathways, was broader than that triggered by influenza virus infection. Conversely, lung tissues exhibited a restricted innate immune response to SARS-CoV-2, with a conspicuous lack of type I and III interferon upregulation, contrasting with their vigorous innate immune response to influenza virus. Our findings reveal differential tissue-specific innate immune responses in the upper and lower respiratory tracts that are specific to SARS-CoV-2. The studies shed light on the role of the nasal mucosa in active viral transmission and immune defense, implying a window of opportunity for early interventions, whereas the restricted innate immune response in early-SARS-CoV-2-infected lung tissues could underlie the unique uncontrolled late-phase lung damage of advanced COVID-19. IMPORTANCE In order to reduce the late-phase morbidity and mortality of COVID-19, there is a need to better understand and target the earliest stages of SARS-CoV-2 infection in the human respiratory tract. Here, we have studied the initial steps of SARS-CoV-2 infection and the consequent innate immune responses within the natural multicellular complexity of human nasal mucosal and lung tissues. Comparing the global innate response patterns of nasal and lung tissues infected in parallel with SARS-CoV-2 and influenza virus, we found distinct virus-host interactions in the upper and lower respiratory tract, which could determine the outcome and unique pathogenesis of SARS-CoV-2 infection. Studies in the nasal mucosal infection model can be employed to assess the impact of viral evolutionary changes and evaluate new therapeutic and preventive measures against SARS-CoV-2 and other human respiratory pathogens.

The case presented discusses a prisoner, Y, in his mid-sixties with longstanding medical conditions, who was sentenced to prolonged incarceration. Y refused conventional medicine because he believed that his medical condition was exacerbated by this treatment and only complementary alternative medicine (CAM) would be helpful. He therefore demanded to be treated only by CAM. He was ready to pay for the treatment out of his own pocket. In the prison where Y was previously incarcerated over the course of 12 years, he had access to CAM remedies which were purchased by his family. After being transferred to the current facility, Y was denied access to these remedies by the prison physicians. He appealed in court against this decision and was supported by a CAM specialist, who ascertained that the remedies under consideration were not hazardous to Y's health. This case report discusses the ethical aspects of a prisoner's autonomy to choose medical treatment even when his/her autonomy has been severely curtailed by virtue of the incarceration.

The initial events of viral infection at the primary mucosal entry site following horizontal person-to-person transmission have remained ill defined. Our limited understanding is further underscored by the absence of animal models in the case of human-restricted viruses, such as human cytomegalovirus (HCMV), a leading cause of congenital infection and a major pathogen in immunocompromised individuals. Here, we established a novel ex vivo model of HCMV infection in native human nasal turbinate tissues. Nasal turbinate tissue viability and physiological functionality were preserved for at least 7 days in culture. We found that nasal mucosal tissues were susceptible to HCMV infection, with predominant infection of ciliated respiratory epithelial cells. A limited viral spread was demonstrated, involving mainly stromal and vascular endothelial cells within the tissue. Importantly, functional antiviral and proleukocyte chemotactic signaling pathways were significantly upregulated in the nasal mucosa in response to infection. Conversely, HCMV downregulated the expression of nasal epithelial cell-related genes. We further revealed tissue-specific innate immune response patterns to HCMV, comparing infected human nasal mucosal and placental tissues, representing the viral entry and the maternal-to-fetal transmission sites, respectively. Taken together, our studies provide insights into the earliest stages of HCMV infection. Studies in this model could help evaluate new interventions against the horizontal transmission of HCMV. IMPORTANCE HCMV is a ubiquitous human pathogen causing neurodevelopmental disabilities in congenitally infected children and severe disease in immunocompromised patients. The earliest stages of HCMV infection in the human host have remained elusive in the absence of a model for the viral entry site. Here, we describe the establishment and use of a novel nasal turbinate organ culture to study the initial steps of viral infection and the consequent innate immune responses within the natural complexity and the full cellular repertoire of human nasal mucosal tissues. This model can be applied to examine new antiviral interventions against the horizontal transmission of HCMV and potentially that of other viruses.

Background: The comprehensive systematic review of randomised placebo-controlled trials (RCTs) in homeopathy requires examination of a study's model validity of homeopathic treatment (MVHT) as well as its risk of bias (extent of reliable evidence). Objective: To appraise MVHT in those RCTs of non-individualised homeopathy that an associated investigation had judged as ‘not at high risk of bias’. Design: Systematic review. Methods: An assessment of MVHT was ascribed to each of 26 eligible RCTs. Another 49 RCTs were ineligible due to their high risk of bias. Main outcome measures: MVHT and the prior risk of bias rating per trial were merged to obtain a single overall quality designation (‘high’, ‘moderate’, ‘low’), based on the GRADE principle of downgrading. Results: The trials were rated as ‘acceptable MVHT’ (N = 9), ‘uncertain MVHT’ (N = 10) and ‘inadequate MVHT’ (N = 7); and, previously, as ‘reliable evidence’ (N = 3) and ‘non-reliable evidence’ (N = 23). The 26 trials were designated overall as: ‘high quality’ (N = 1); ‘moderate quality’ (N = 18); ‘low quality’ (N = 7). Conclusion: Of the 26 RCTs of non-individualised homeopathy that were judged ‘not at high risk of bias’, nine have been rated ‘acceptable MVHT’. One of those nine studies was designated ‘high quality’ overall (‘acceptable MVHT’ and ‘reliable evidence’), and is thus currently the only reported RCT that represents best therapeutic practice as well as unbiased evidence in non-individualised homeopathy. As well as minimising risk of bias, new RCTs in this area must aim to maximise MVHT and clarity of reporting.

The use of complementary and alternative medicine (CAM) has become increasingly popular in most Western countries. As a result, safety-related issues associated with these practices have become more apparent, including adverse effects and negative interactions with conventional medical therapies. The potential dangers associated with CAM are further exacerbated by the absence of high-quality clinical research on the subject; a lack of a basic understanding of the principles of CAM among physicians; and a reluctance of patients to disclose their use of CAM, including those modalities being used in parallel with conventional medical treatments. The increase in CAM use by their patients and the increased potential for harmful effects and interactions are central to the increasing interest among physicians and other healthcare professionals in learning more about CAM paradigms and practices of care. In light of this increasing interest in CAM, the majority of medical schools in the U.S. and Canada and a large number in Europe are providing their students with compulsory or elective courses on this subject. A similar process is taking place in Israel, with the Faculty of Medicine at the Hebrew University in Jerusalem having completed its first compulsory course in CAM at the Hadassah University Medical Center, Ein Karem. The increased use of CAM presents a number of challenges to the conventional medical profession. Medical schools can and should provide students with the knowledge and skills which will enable them to discuss CAM use with their patients, providing evidence-based guidance on the safe and effective use of these modalities.

Background and purpose. COVID-19 is a novel viral disease causing worldwide pandemia. The aim of this study was to describe the effect of adjunctive individualized homeopathic treatment delivered to hospitalized patients with confirmed symptomatic SARS-CoV-2 infection. Patient presentation Thirteen patients with COVID-19 were admitted. Mean age was 73.4 ± 15.0 (SD) years. Twelve (92.3%) were speedily discharged without relevant sequelae after 14.4 ± 8.9 days. A single patient admitted in an advanced stage of septic disease died in hospital. A time-dependent improvement of relevant clinical symptoms was observed in the 12 surviving patients. Six (46.2%) were critically ill and treated in the intensive care unit (ICU). Mean stay at the ICU of the 5 surviving patients was 18.8 ± 6.8 days. In six patients (46.2%) gastrointestinal disorders accompanied COVID-19. Conclusion The observations suggest that adjunctive homeopathic treatment may be helpful to treat patients with confirmed COVID-19 even in high – risk patients especially since there is no conventional treatment of COVID-19 available at present.

Postpartum psychosis has long-lasting consequences for mother and child. Beside depression, sleep and eating disturbances, exhaustion, social withdrawal, and anxiety, postpartum depression can also interfere with normal maternal-infant bonding and adversely affect child development. Recent reports show that most affected pregnant women are hesitant about taking antidepressant drugs, with a high percentage discontinuing their use. Some authors suggest that the reluctance of pregnant women to take antidepressant drugs should encourage clinicians to discuss with their patients the use of psychological interventions or alternative forms of treatment. In this article, a case of severe postpartum depression, treated successfully with homeopathic therapy, is presented. Considering the high noncompliance of women suffering from postpartum depression with conventional antidepressant medication, research in safe complementary medical methods is justified. One of these methods should be homeopathy.

This editorial introduces a revised set of publication requirements for papers, submitted to Homeopathy, that involve animal experimentation. Journals that publish studies involving animal experimentation have a major role to play in the maintenance of ethical standards because researchers are reliant upon them for publication of their findings. With an increasing global trend towards greater transparency and accountability in animal experimentation, many academic journals, such as the British Journal of Pharmacology, 1 and 2 are taking action to improve reporting standards. In recognition of this need, members of Homeopathy's Editorial Board have been working together to examine the scientific rationale and the most relevant ethical guidelines for the use of animals in research. In addition, they have examined existing published studies in homeopathy research and current practice within the broad domain of medical research. Each of these aspects has informed the revised publication policy, whose overarching objectives are to maximise the ethical standards and scientific quality of animal research in homeopathy, and thereby ultimately to avoid any unnecessary suffering of animals used in such research. The following description details the background that was considered, the rationale for this development, and the steps that will be taken.

Background: \ud \ud To date, our programme of systematic reviews has assessed randomised controlled trials (RCTs) of individualised homeopathy separately for risk of bias (RoB) and for model validity of homeopathic treatment (MVHT).\ud \ud Objectives: \ud \ud The purpose of the present paper was to bring together our published RoB and MVHT findings and, using an approach based on GRADE methods, to merge the quality appraisals of these same RCTs, examining the impact on meta-analysis results.\ud \ud Design: \ud \ud Systematic review with meta-analysis.\ud \ud Methods: \ud \ud As previously, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were the subject of study.\ud \ud Main outcome measures: \ud \ud For each trial, the separate ratings for RoB and MVHT were merged to obtain a single overall quality designation (‘high’, ‘moderate, “low”, ‘very low’), based on the GRADE principle of ‘downgrading’.\ud \ud Results: \ud \ud Merging the assessment of MVHT and RoB identified three trials of ‘high quality’, eight of ‘moderate quality’, 18 of ‘low quality’ and three of ‘very low quality’. There was no association between a trial’s MVHT and its RoB or its direction of treatment effect (P > 0.05). The three ‘high quality’ trials were those already labelled ‘reliable evidence’ based on RoB, and so no change was found in meta-analysis based on best-quality evidence: a small, statistically significant, effect favouring homeopathy.\ud \ud Conclusion: \ud \ud Accommodating MVHT in overall quality designation of RCTs has not modified our pre-existing conclusion that the medicines prescribed in individualised homeopathy may have small, specific, treatment effects.

Introduction Hormesis is a dose–response relationship characterized by a biphasic dose response to stressors with a low dose stimulation and a high dose inhibition. The first systematic description of hormesis appeared toward the close of the 18th century by the German pharmacology professor Hugo Schulz. The stressor agent can be any agent or factor capable of causing a deleterious effect. The biological systems can be diverse: bacteria, fungi, algae, yeasts, animals, humans, protozoa and plants. The range of endpoints covers longevity, reproduction, cancer, survival, growth, metabolic effects and others. Hormesis is a nonspecific phenomenon, which can occur in any biological system and can be caused by any stressor. It is quantifiable and reproducible. The apparent similarity between the basic principle of hormesis and homeopathy's Similia Principle, together with the homeopathic claim that hormesis validates homeopathy caused its marginalization, and its rejection during the past century by central figures in pharmacology. Recent years have seen a slight renaissance in the conventional scientific attitude towards hormesis. Method We compared hormesis and homeopathy. Result There is no convincing evidence of similarity between these two systems. Moreover, there are several crucial differences between them, which seem to refute any idea that they stem from the same root. This paper discusses these differences. The rejection of hormesis on grounds of its similarity to homeopathy is unjustified. Conclusion The authors suggest exploring the differences between both systems. Such exploration may answer the key question of whether they do indeed share a root or embrace the same principles. Such exploration may also spur research within both systems to answer further open questions.

Background: Though potentially an important limitation in the literature of randomised controlled trials (RCTs) of homeopathy, the model validity of homeopathic treatment (MVHT) has not previously been systematically investigated.Objective: As an integral part of a programme of systematic reviews, to assess MVHT of eligible RCTs of individualised homeopathic treatment.Methods: From 46 previously identified papers in the category, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were thus the subject of the study. For each of six domains of assessment per trial, MVHT was judged independently by three randomly allocated assessors from our group, who reached a final verdict by consensus discussion as necessary.Results: Nineteen trials were judged overall as ‘acceptable’ MVHT, nine as ‘uncertain’ MVHT, and four as ‘inadequate’ MVHT.Conclusions: These results do not support concern that deficient MVHT has frequently undermined the published findings of RCTs of individualised homeopathy. However, the 13 trials with ‘uncertain’ or ‘inadequate’ MVHT will be a focus of attention in supplementary meta-analysis. New RCTs of individualised homeopathy must aim to maximise MVHT and to enable its assessment through clear reporting.

The debate between those who believe homeopathy and hormesis derive from the same root and those who believe the two are different phenomena is as old as hormesis. It is an emotionally loaded discussion, with both sides fielding arguments which are far from scientific. Careful analysis of the basic paradigms of the two systems questions the claim of the homeopaths, who find similarities between them. The authors discuss these paradigms, indicating the differences between the claims of homeopathy and hormesis. It is time for thorough and serious research to lay this question to rest. One possible approach is to compare the activity of a hormetic agent, prepared in the usual way, with that of the same agent in the same concentration prepared homeopathically by serial dilution and succussion.

Background and aims The use of CAM (Complementary and Alternative Medicine) in paediatrics is high, although a variability of usage frequency between countries is reported, depending on data collection methods and type of CAM. The aim of this survey was to look into physicians’ approaches towards paediatric use of natural medicines, by a consistent study approach in a multi-country survey. Methods On-line survey involving 582 general paediatricians and general practioners treating paediatric patients in 6 countries. The study was sponsored by DHU-Arzneimittel GmbH and Co. KG. Results 99% of respondents recommended natural medicines (Phytotherapy or vitamins/minerals/supplements, VSM) in the previous year. Natural medicines were used as a complement to conventional treatment in most of patients. The most frequently treated conditions were: upper respiratory tract infections (51%), allergies (22%), acute abdominal problems (22%), recurrent infections (22%), earache (17%) and infant colic (15%). Here we give summarised data about the trends in natural remedies prescriptions by paediatricians. In the case of a 2 month old infant with recurrent colic 80% of physicians advised dietary changes. Conventional drugs were as frequently recommended as phytotherapy or homeopathy. The therapy of choice was probiotics. For a 2 year old child with teething problems, homeopathy was advised by 30% of physicians, while only 25% recommended conventional drugs. For a 5 year old child with recurrent upper respiratory tract infections the most frequent recommendations were conventional drugs, dietary advice and vitamins. Personal use of natural medicines corresponded to physicians´ predisposition to recommend natural treatments for their paediatric patients. Nearly half of the physicians were extremely interested in phytotherapy for paediatric conditions. Conclusions This survey confirms that physicians have a high interest in using natural medicines in paediatrics. Natural medicines were most often prescribed alongside conventional drugs. There is evidence of a variable level of knowledge about natural medicine options. There were significant country differences showing a cultural influence on physicians’ decisions.

Diabetic foot ulcers (DFU), which can affect up to 15% of individuals with diabetes, remain a major unmet medical need. Left untreated, DFU seriously impact on quality of life and level of function. Conventional treatment is costly and often ineffective. In severe cases, patients with DFU may undergo painful amputations. IZN 6D4 is an impregnated hydrogel containing active pharmaceutical ingredients that have both wound-healing promoting and anti-inflammatory activities This is an observational human clinical trial study involving 15 patients treated with IZN 6D4. Subjects in the study had DFU which were categorized as being at stage 1A or greater using the University of Texas Health Science Center, San Antonio scale (UTHSC) grading system. Treatment lasted 21 days, and during the course of the study, patches were applied every 3-4 days. Response to therapy was measured by extent and depth of the lesion (wound grid and digital photography), qualitative assessment of wound healing (tissue granulation), and the rate of wound closure over the trial period. Results of the study showed that 40% of subjects had 75% closure of the wound and 27% had complete wound closure. Nearly all patients had evidence of active wound healing (e.g., presence of granulation tissue), and percent mean wound reduction for the entire study group was 67.7 ± 26.4%. Photo documentation of wound healing showed impressive differences between pre- and posttreatment appearances of diabetic ulcers in many of the patients studied. Based on the promising data from preclinical studies and the observational clinical trial provide strong justification for initiating a large-scale, longer duration clinical trial evaluating the efficacy of IZN 6D4 hydrogel in the treatment of patients with DFU.

To study non-vitamin, non-mineral (NVNM) supplements use and disclosure of among hospitalized internal medicine patients.A convenience sample of patients completed an interviewer-administered questionnaire examining use of and perceptions regarding NVNM supplements, and disclosure to medical personnel.280 patients were interviewed (54% female), 15.4% reporting NVNM supplement use. This practice was more prevalent among female patients (p=0.045), more educated (p0.001) and patients with more impaired quality-of-life, measured by the SF-12 tool (p0.020). The most common factor influencing NVNM supplement use was a physician's recommendation. Most (74%) patients using NVNM supplements reported having disclosed this practice to community-based physicians, with only 23.7% disclosing to hospital staff. Six patients reported using supplements at the exclusion of conventional medication, with potentially serious implications.While the majority of patients using NVNM supplements are sharing this information with their primary-care physicians, there is little disclosure of this practice to hospital staff. This may be due to a perceived negative attitude of medical professionals to complementary medicine, and a lack of awareness by hospital staff regarding such practices.Hospital-based medical professionals need to be aware of the use of NVNM supplements and the resulting implications by their internal medicine patients.

Summary Objective The purpose of this study was to examine the effect of acupuncture on bone/joint pain, headache and fatigue, as well as quality of life in patients with Gaucher disease (GD), within the framework of an integrated treatment programme. Methods Patients with GD suffering from any of the above symptoms were offered a series of 10–12 weekly acupuncture treatment sessions. Prior to initiation of treatment, participants were asked to score the severity of pain, as well as to complete the Functional Assessment of Chronic Illness Therapy-Fatigue measure (FACIT-F) and the Medical Outcomes Study (MOS) Short-Form (SF) questionnaire. These tools were evaluated again at the end of the treatment period. Results A total of 12 patients were evaluated. While the only pain outcome reduced by acupuncture was knee pain, a significant improvement was observed with respect to nearly all FACIT-Fatigue measures, including the Physical Well Being (PWB) subscales and the SF-12 Physical Composite Score (PCS), though not for the Mental Composite Score (MCS). Patients reported satisfaction with the treatment process, and no significant side effects were reported. Conclusion Acupuncture may play a beneficial role for patients with GD when used in conjunction with conventional therapy, reducing fatigue and improving physical function. The preliminary finding of this observational study should encourage further research.

Prurigo Nodularis (PN) is a chronic pruritic skin condition for which current conventional therapies are of limited benefit and with potentially toxic effects. Acupuncture — the insertion of thin needles at specific points on the skin - has been shown to alleviate itching through a number of itch-associated mediator effects. Hypnosis has been shown to modify and reduce the intensity of itching as well. A 44 year-old woman presented with a 30-year history of a diffuse itchy rash diagnosed as PN. She had tried various antihistamine and corticosteroid medications, to no avail. A treatment regimen using hypnosis and acupuncture (hypnopuncture) was initiated, with significant reduction in the itching, size and number of skin lesions. Hypnopuncture may offer a synergistic and augmented response to treatment, though further research is needed to understand the true benefits of this combined regimen.

The use of complementary and alternative medicine is on the rise, including among patients with epilepsy. Herbal medicine, one of the most popular forms of CAM, is considered to be both safe and effective by most consumers. Yet many herbs may increase the risk for seizures, through intrinsic proconvulsant properties or contamination by heavy metals, as well as via effects on the cytochrome P450 enzymes and P-glycoproteins, altering antiepileptic drug (AED) disposition. Herb-drug interactions may be difficult to predict, especially since the quality and quantity of active ingredients are often unknown. Since most patients do not inform their physicians that they are taking herbal medicines, health care professionals must initiate a dialogue in order to prevent complications with the combined regimen. At the same time, further research is required regarding the effect of herbs on seizure activity and interactions with AED treatment.

Summary Background Despite modern surgical technique and anaesthesia, post-operative pain following ambulatory surgery remains an important cause of delayed hospital discharge, readmission, and post-operative visits to primary care physician. Traumeel S® is a homeopathic complex preparation widely used in German speaking Europe for trauma and orthopaedic pain. Methods We performed an open, quasi-randomized triple-arm clinical trial to evaluate the efficacy of two regimens of Traumeel S® in minimizing post-operative pain and analgesic consumption following elective Hallux valgus surgery. A total of 30 patients were assigned to the single injection, the injection + oral intake (PO) or the control group. Repeated measures of maximal pain at rest during 13 days post-operative were evaluated using a linear mixed effects model. The total consumption of analgesics was also compared between the three groups. Results The single injection and injection + PO groups experienced lower pain scores as compared to the control group (p = 0.02 and 0.05, respectively). There was no significant difference between the single injection group and the injection + PO groups. Similarly, the mean total consumption of analgesics was lower in the single injection and the injection + PO groups than in the control group but the difference was not statistically significant. Conclusion In this pilot study, Traumeel S® demonstrated efficacy in minimizing post-operative pain following repair of H. valgus. These promising results should be validated in a randomized, double-blinded, placebo controlled trial.

In order to better understand the global approach and country differences in physicians’ usage, knowledge, and attitudes towards natural remedies and homeopathy in pediatric practice, an online survey involving 582 general pediatricians and general practitioners treating pediatric diseases was conducted in 6 countries. Overall, 17% of the pediatric prescriptions refer to phytotherapy and 15% refer to homeopathic preparations. Natural remedies and homeopathic preparations are more frequently used in upper respiratory tract infections, infant colic, sleep disturbances, and recurrent infections. In the majority of cases, they are used together with chemical drugs. Both treatment options are typically used if parents are concerned about side effects of conventional drugs or prefer natural remedies for themselves. Physicians express high interest in natural remedies and homeopathy; however, their knowledge is variable. Lack of proven efficacy, knowledge on mechanism of action, and information on indications are main factors that limit their usage.

Gastroparesis is a chronic disorder of abnormal gastric motility causing considerable suffering. We describe two cases of gastroparesis which were treated by methods which were not part of routine conventional therapy, but which, nevertheless, led to significant clinical improvement. In the first case, the patient suffered from gastroparesis following a vagal injury while undergoing a lung transplant. During his illness a mega-bezoar formed, a well-described complication of gastroparesis. After conservative measures failed, and in order to avoid a surgical intervention that carried considerable risk under the circumstances, a successful trial consisting of imbibing large amounts of "Coca Cola" and acupuncture was initiated. The bezoar dissolved completely and considerable improvement of the patient's gastric motility was achieved. In the second case, the patient was a young woman suffering from idiopathic gastroparesis, which responded well to treatment with tricyclic antidepressants. Due to her intention to become pregnant, this treatment was discontinued and she was admitted to receive homeopathic treatment. After two failed attempts in finding the right homeopathic remedy to replace the conventional treatment, the third remedy (Sepia) used brought dramatic improvement in her general condition and her dyspepsia. Today, over two years after her successful homeopathic treatment, she is in the middle of her second pregnancy, without any treatment and free of complaints. These two cases are examples of simple solutions for seemingly complicated and complex conditions alleviated by an integration of conventional and complementary/alternative medicine.

Context The incidence of tendon injuries and tendinopathy has risen substantially in the past decades. Objective To assess the noninferiority of therapy based on the homeopathic preparation Traumeel S ointment (Heel GmbH, Baden-Baden, Germany) compared with treatment based on diclofenac 1% gel in patients with tendinopathies of varying etiology. Design Nonrandomized, observational study. Setting Ninety-five homeopathy and conventional medical practices in Germany. Patients Three hundred fifty-seven patients aged 18 to 93 years with tendinopathy of varying etiology based on excessive tendon load rather than inflammation. Interventions Traumeel S ointment or diclofenac 1% gel for a maximum of 28 days. Main Outcome Measures Efficacy was measured on a four-degree scale on pain-related variables, on variables related to motility, and on overall treatment outcome. Tolerability was monitored as adverse events. Compliance was assessed by practitioner and patient on a four-degree scale. Results The patients groups were comparable at baseline. The changes in summary score of all pain-related variables were −5.3 ± 2.7 (all values means ± SD) in the Traumeel group and −5.0 ± 2.7 in the control group. Changes for all motility-related variables were −4.2 ± 3.8 with Traumeel and −3.7 ± 3.4 with control therapy. The summary scores for all clinical variables were reduced by −9.5 ± 5.7 with Traumeel therapy and by −8.7 ± 5.4 with diclofenac-based treatment. Homeopathic therapy was noninferior to diclofenac therapy on all variables. For motility-related variables, there was a trend toward superiority of Traumeel. Treatments were well tolerated with no treatment-related adverse events. Conclusions The results suggest that Traumeel ointment is an effective alternative to nonsteroidal antiinflammatory drugs therapy for the acute symptomatic treatment of patients with tendinopathy.

To study the effects of the homeopathic preparation Engystol (Biologische Heilmittel HEEL GmbH, Baden-Baden, Germany) on a panel [corrected] of human pathogenic viruses in vitro.The effects of Engystol were studied using plaque-reduction assays and virus titration assays, and by quantification of newly synthesized viral proteins in virus-specific enzyme-linked immunoabsorbent assays (ELISAs).The DNA viruses Adeno 5 and herpes simplex type 1 (HSV-1), the RNA virus respiratory syncytial virus (RSV), and human rhinovirus (HRV).A 73% reduction of Adeno 5 specific proteins and an 80% reduction in HSV-1 specific proteins were observed in ELISAs of virus-infected cells treated with Engystol after infection. The effects appeared to be dose-dependent. With these viruses, similar results were observed in titration assays of viral offspring from cells treated with Engystol. Pretreatment of adenovirus with Engystol did not inhibit the infectivity of the virus suspension and no Engystol-induced stimulation of interferon-alpha could be observed. Plaque-reduction assays with the RNA viruses, RSV and HRV, showed reductions in infectivity by 37% (RSV) and 20% (HRV), respectively.The results indicate antiviral activity of Engystol independent of the activation of the cellular interferon system.

To evaluate the effect of Arnica Montana and Bellis perennis on postpartum blood loss.Double blind, placebo-controlled, randomized, clinical trial.Department of Gynecology, Shaare Zedek Medical Center, Jerusalem.Forty parturients were randomized to one of three groups: Arnica montana C6 and Bellis perennis C6 (n=14), Arnica montana C30 and Bellis perennis C30 (n=14), or double placebo (n=12). After 48 h the Arnica/placebo was halted, and patients continued the Bellis/placebo until cessation of lochia.Hemoglobin levels (Hb) at 48 and 72 h postpartum.At 72 h postpartum, mean Hb levels remained similar after treatment with homeopathic remedies (12.7 versus 12.4) as compared to a significant decrease in Hb levels in the placebo group (12.7 versus 11.6; p0.05), in spite of less favorable initial characteristics of the treatment group. The mean difference in Hb levels at 72 h postpartum was -0.29 (95% CI -1.09; 0.52) in the treatment group and -1.18 (95% CI -1.82; -0.54) in the placebo group (p0.05).Treatment with homeopathic Arnica montana and Bellis perennis may reduce postpartum blood loss, as compared with placebo.

Introduction: The primary objective of treatment of inflammatory diseases of the upper respiratory tract (rhinitis, uncomplicated sinusitis) with local decongestants is to relieve obstruction and t

Objective: To compare the homeopathic remedy Traumeel® S with standard NSAID therapy for effects on symptomatic relief in patients with diagnosed epicondylitis. Methods: An observational, non-randomized study over 2 weeks in 184 patients with diagnosed epicondylitis from 38 primary care centers in Germany. At the start of the study, patients were given initial injections of either Traumeel® S or NSAID (unspecified; mainly diclofenac). Traumeel® S patients might have other Traumeel® S injections and other treatments were allowed, e.g. oral analgesics (in the NSAID group only) or physiotherapy. Treatments were evaluated on clinically relevant variables: three pain variables (local pressure pain, pain with movements, pain at rest) and two mobility variables (change in extensional joint mobility and change in torsional joint mobility). Results: Both treatments significantly improved scores on all five variables with no significant differences in time to onset of action. Traumeel® S was equivalent to NSAIDs on all evaluated variables and was significantly superior to NSAID therapy on the variables pain at rest (p® S group versus 44.2% of patients receiving NSAIDs. Tolerability was good in all groups. Conclusion: Traumeel® S represents an appealing and well-tolerated alternative to NSAIDs for symptomatic treatment of epicondylitis.

Traumeel S (Traumeel), a mixture of highly diluted (10(-1)-10(-9)) extracts from medicinal plants and minerals is widely used in humans to relieve trauma, inflammation and degenerative processes. However, little is known about its possible effects on the behavior of immune cells. The effects of Traumeel were examined in vitro on the ability of resting and PHA-, PMA- or TNF-alpha-activated human T cells, monocytes, and gut epithelial cells to secrete the prototypic pro-inflammatory mediators IL-1beta, TNF-alpha and IL-8 over a period of 24-72 h. Traumeel inhibited the secretion of all three agents in resting, as well as activated immune cells. IL-beta secretion was reduced by up to 70% in both resting and activated cells; TNF-alpha secretion was reduced by up to 65 and 54%, respectively, and IL-8 secretion was reduced by 50% in both resting and activated cells (P0.01 for all cells). Interestingly, the effect appeared to be inversely dose-related; maximal inhibition (usually 30-60% inhibition; P0.01) was seen with dilutions of 10(-3)-10(-6) of the Traumeel stock material. This finding suggests that Traumeel does not inhibit immune cells functions by exerting a toxic effect. Indeed, Traumeel did not affect T cell and monocyte proliferation. Although additional studies are needed to clarify the mode of action of Traumeel and to demonstrate causative relationship between the inhibition of cytokine/chemokine secretion in cell culture and the reported clinical effects of the preparation, our in vitro results offer a mechanism for the anti-inflammatory effects of Traumeel observed in clinical use.

The growing popularity of complementary medicine has been accompanied by a call for controlled clinical studies to examine the efficacy and validity of its various methods. The difficulties encountered in applying the evaluation methods of conventional medicine to complementary medicine are the result of the different paradigms underlying these two methods of medicine, and the differences in the healing process. This paper attempts to bridge the gap between these two approaches and to suggest a possibility to use conventional research methodology in clinical studies of classical homeopathy. Two methods are described. One is the randomization into a placebo or a treatment group after an individual remedy is chosen for each patient. This method requires an experienced homeopath and is reproducible only by the same homeopath in the same population. On the other hand, the expected success rate will be high. Another method is prescribing and treating according to so-called keynotes, a set of symptoms known to respond to a particular remedy that must be present in a patient in order to elicit a reaction from the remedy. This method is more suitable to a conventional design of a clinical study and is reproducible by anyone. Yet the expected success rate is much lower. Some general design issues that may have a particular impact on clinical trials of classical homeopathy are discussed, including the need for sufficiently powered trials to detect relatively small effects, strategies to deal with patient preference and embracing the use of "active-control" pragmatic trial designs.

Following a multiple-casualty construction disaster in Israel, members of The Center of Integrated Complementary Medicine joined in the emergency activity of the Shaare Zedek Medical Center. They administered homeopathic treatment to injured patients to supplement conventional orthopaedic treatment. This was to our knowledge the first time that complementary medicine had been used officially in conjunction with conventional medicine in an emergency situation. Our objective is to report and summarize the rationale, procedures and outcome of the complementary medicine intervention. Fifteen orthopaedic patients were included. They were treated by homeopathy in two phases starting 24 h post-trauma. All patients initially received Arnica montana 200CH in a single dose. Anxiety was treated with Aconite 200CH in nine patients, Opium 200CH in three, Ignatia 200CH in two and Arsenicum album 200CH in one according to type of anxiety. One day later, most patients reported a lessening of pain, 58% felt improvement, 89% had reduced anxiety, and overall, 61% felt that homeopathic treatment was helpful. In the second phase, 48 h post-trauma, specific complaints were addressed with classical homeopathy. At discharge patients rated the homeopathic treatment successful in 67% of the specific complaints. Several issues relating to the use of homeopathy in emergency medicine and its relation to conventional treatment are discussed. These include compliance, the conduct of rounds, shortage of time and staff, and the procurement of medicines.

BACKGROUND Stomatitis is a common consequence of chemotherapy and a condition for which there is little effective treatment. Although the management of patients with other chemotherapy-related toxicities has improved in recent years, the incidence of stomatitis is increasing because of more intensive treatment and is often a dose limiting factor in chemotherapy. The authors assessed the efficacy of a homeopathic remedy, TRAUMEEL S®, in the management of chemotherapy-induced stomatitis in children undergoing bone marrow transplantation. METHODS A randomized, placebo-controlled, double-blind clinical trial was conducted in 32 patients ages 3–25 years who had undergone allogeneic (16 patients) or autologous (16 patients) stem cell transplantation. Of the 30 evaluable patients, 15 were assigned placebo, and 15 were assigned TRAUMEEL S both as a mouth rinse, administered five times daily from 2 days after transplantation for a minimum of 14 days, or until at least 2 days after all signs of stomatitis were absent. Stomatitis scores were evaluated according to the World Health Organization grading system for mucositis. RESULTS A total of five patients (33%) in the TRAUMEEL S treatment group did not develop stomatitis compared with only one patient (7%) in the placebo group. Stomatitis worsened in only 7 patients (47%) in the TRAUMEEL S treatment group compared with 14 patients (93%) in the placebo group. The mean area under the curve stomatitis scores were 10.4 in the TRAUMEEL S treatment group and 24.3 in the placebo group. This difference was statistically significant (P < 0.01). CONCLUSIONS This study indicates that TRAUMEEL S may reduce significantly the severity and duration of chemotherapy-induced stomatitis in children undergoing bone marrow transplantation. Cancer 2001;92:684–90. © 2001 American Cancer Society.

Alternative therapies in general, and homeopathy in particular, lack clear scientific evaluation of efficacy. Controlled clinical trials are urgently needed, especially for conditions that are not helped by conventional methods. The objective of this work was to assess the efficacy of homeopathic treatment in relieving symptoms associated with premenstrual syndrome (PMS). It was a randomised controlled double-blind clinical trial. Two months baseline assessment with post-intervention follow-up for 3 months was conducted at Hadassah Hospital outpatient gynaecology clinic in Jerusalem in Israel 1992–1994. The subjects were 20 women, aged 20–48, suffering from PMS. Homeopathic intervention was chosen individually for each patient, according to a model of symptom clusters. Recruited volunteers with PMS were treated randomly with one oral dose of a homeopathic medication or placebo. The main outcome measure was scores of a daily menstrual distress questionnaire (MDQ) before and after treatment. Psychological tests for suggestibility were used to examine the possible effects of suggestion. Mean MDQ scores fell from 0.44 to 0.13 (P30% was observed in 90% of patients receiving active treatment and 37.5% receiving placebo (P=0.048). Homeopathic treatment was found to be effective in alleviating the symptoms of PMS in comparison to placebo. The use of symptom clusters in this trial may offer a novel approach that will facilitate clinical trials in homeopathy. Further research is in progress.

112 Michael Frass, MD Department of Internal Medicine I, Medical University of Vienna, Institute for Homeopathic Research, Interdisciplinary College Graz Seggau, Austria Ernst Schuster, MD Department of Internal Medicine I, Medical University of Vienna, Institute for Homeopathic Research, Interdisciplinary College Graz Seggau, Austria Ilse Muchitsch, PhD Department of Internal Medicine I, Medical University of Vienna, Institute for Homeopathic Research, Interdisciplinary College Graz Seggau, Austria Beatrix Wulkersdorfer, MD Department of Internal Medicine I, Medical University of Vienna, Institute for Homeopathic Research, Interdisciplinary College Graz Seggau, Austria Helmut Friehs, MD Department of Internal Medicine I, Medical University of Vienna, Institute for Homeopathic Research, Interdisciplinary College Graz Seggau, Austria Michael Muellner Department of Internal Medicine I, Medical University of Vienna, Institute for Homeopathic Research, Interdisciplinary College Graz Seggau, Austria Menachem Oberbaum Department of Internal Medicine I, Medical University of Vienna, Institute for Homeopathic Research, Interdisciplinary College Graz Seggau, Austria Corresponding author. E-mail: michael.frass @meduniwien.ac.at

Objectives: To increase the awareness of intoxication by folk herbal remedies in the pediatric population. Methods: Case report of a 7-day-old baby boy admitted to a pediatric intensive care unit in a university-affiliated hospital. Results: The patient presented with respiratory failure and central nervous system depression. Specific questioning of the parents revealed consumption of folk herbal remedy by the neonate. Mechanical ventilation was used for 24 hours until normal activity level resumed. Conclusions: The possibility of intoxication in a neonate should not be overlooked. Folk herbal remedies, especially if taken in larger than recommended amounts, may be hazardous. Accessible herbal and folk medicine data bank will contribute to a better treatment of patients having side effects of these remedies.