Menachem Oberbaum

A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL s® in the treatment of chemotherapy‐induced stomatitis in children undergoing stem cell transplantation

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(R), 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.

Herbal medicine and epilepsy: proconvulsive effects and interactions with antiepileptic drugs.

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.

INHIBITION OF IL-1BETA AND TNF-ALPHA SECRETION FROM RESTING AND ACTIVATED HUMAN IMMUNOCYTES BY THE HOMEOPATHIC MEDICATION TRAUMEEL S

Abstract 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-α-activated human T cells, monocytes, and gut epithelial cells to secrete the prototypic pro-inflammatory mediators IL-1β, TNF-α 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-β secretion was reduced by up to 70% in both resting and activated cells; TNF-α secretion was reduced by up to 65 and 54%, respectively, and IL-8 secretion was reduced by 50% in both resting and activated cells (P<0.01 for all cells). Interestingly, the effect appeared to be inversely dose-related; maximal inhibition (usually 30-60% inhibition; P<0.01) 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.

Influence of adjunctive classical homeopathy on global health status and subjective wellbeing in cancer patients — A pragmatic randomized controlled trial

OBJECTIVES The use of complementary and alternative medicine has increased over the past decade. The aim of this study was to evaluate whether homeopathy influenced global health status and subjective wellbeing when used as an adjunct to conventional cancer therapy. DESIGN In this pragmatic randomized controlled trial, 410 patients, who were treated by standard anti-neoplastic therapy, were randomized to receive or not receive classical homeopathic adjunctive therapy in addition to standard therapy. The study took place at the Medical University Vienna, Department of Medicine I, Clinical Division of Oncology. MAIN OUTCOME MEASURES The main outcome measures were global health status and subjective wellbeing as assessed by the patients. At each of three visits (one baseline, two follow-up visits), patients filled in two different questionnaires. RESULTS 373 patients yielded at least one of three measurements. The improvement of global health status between visits 1 and 3 was significantly stronger in the homeopathy group by 7.7 (95% CI 2.3-13.0, p=0.005) when compared with the control group. A significant group difference was also observed with respect to subjective wellbeing by 14.7 (95% CI 8.5-21.0, p<0.001) in favor of the homeopathic as compared with the control group. Control patients showed a significant improvement only in subjective wellbeing between their first and third visits. CONCLUSION Results suggest that the global health status and subjective wellbeing of cancer patients improve significantly when adjunct classical homeopathic treatment is administered in addition to conventional therapy.

Use of non-vitamin, non-mineral (NVNM) supplements by hospitalized internal medicine patients and doctor–patient communication

OBJECTIVE To study non-vitamin, non-mineral (NVNM) supplements use and disclosure of among hospitalized internal medicine patients. METHODS A convenience sample of patients completed an interviewer-administered questionnaire examining use of and perceptions regarding NVNM supplements, and disclosure to medical personnel. RESULTS 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 (p<0.001) and patients with more impaired quality-of-life, measured by the SF-12 tool (p<0.020). The most common factor influencing NVNM supplement use was a physicians 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. CONCLUSION 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. PRACTICE IMPLICATIONS Hospital-based medical professionals need to be aware of the use of NVNM supplements and the resulting implications by their internal medicine patients.

Behandlung von Entzündungen im Bereich der oberen Atemwege – Vergleich eines homöopathischen Komplexpräparates mit Xylometazolin

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 to improve associated symptoms. Restoration of unrestricted respiration and drainage of the nasal sinuses reduce the risk of further complications (i.e. chronicity). Objective: To determine whether the therapeutic effects of the homeopathic complex remedy Euphorbium compositum nasal drops SN are comparable to those of xylometazoline with respect to efficacy and tolerability. Methods: Open, multicenter, prospective, active-controlled cohort study in patients with inflammatory processes and diseases of the upper respiratory tract. The primary outcome was to demonstrate non-inferiority of the homeopathic complex remedy to xylometazoline. Results: Clinically relevant reductions in the intensities of disease-specific symptoms were observed with both therapies. Non-inferiority of the homeopathic complex remedy to xylometazoline could be shown for all studied variables and in no case did the lower boundary of the 95% confidence interval cross the threshold of 0.5 score points. Tolerability was good with for both therapies. Conclusions: This cohort study indicates a comparable efficacy and tolerability profile of the homeopathic complex remedy Euphorbium compositum nasal drops SN and the reference substance xylometazoline in patients with inflammatory processes and diseases of the upper respiratory tract.

Use of and attitudes toward complementary and alternative medicine among obstetricians in Israel

To examine attitudes toward and use of complementary and alternative medicine (CAM) by obstetricians during pregnancy and childbirth.

Effect of Traumeel S on Cytokine Profile in a Cecal Ligation and Puncture (CLP) Sepsis Model in Rats

BACKGROUND Sepsis results in significant morbidity and mortality, with current treatment options limited with respect to efficacy as well as safety. The complex homeopathic remedy Traumeel S has been shown to have both anti-inflammatory and immunostimulatory effects in the in vitro setting. OBJECTIVES The objective was to explore the effects of Traumeel S in an in vivo setting, using a cecal ligation and puncture (CLP) sepsis model in rats, evaluating the effects of the medication on cytokine activity. DESIGN Sepsis was induced in 30 rats using accepted CLP methodology. Following the procedure, rats were randomly allocated to receive an intraperitoneal injection of either Traumeel S (n=15) or normal saline (n=15). At 6 hours post-CLP, serum cytokines (interleukin [IL]-1β, tumor necrosis factor-α, IL-6, and IL-10) were evaluated. RESULTS IL-1β levels were significantly higher in the treatment group (p=0.03) with no significant differences found between the groups with respect to the other cytokines tested. CONCLUSIONS In contrast to in vitro studies, Traumeel significantly increased IL-1β levels in an in vivo model, without influencing other cytokines. IL-1β is a proinflammatory cytokine that has been shown to have a protective effect in the CLP rat model. Further research is warranted to examine this finding, as well as its clinical implications.

Traumeel S® for pain relief following hallux valgus surgery: a randomized controlled trial

BackgroundIn spite of recent advances in post-operative pain relief, pain following orthopedic surgery remains an ongoing challenge for clinicians. We examined whether a well known and frequently prescribed homeopathic preparation could mitigate post-operative pain.MethodWe performed a randomized, double blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S® in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus. Eighty consecutive patients were randomized to receive either Traumeel tablets or an indistinguishable placebo, and took primary and rescue oral analgesics as needed. Maximum numerical pain scores at rest and consumption of oral analgesics were recorded on day of surgery and for 13 days following surgery.ResultsTraumeel was not found superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial, however a transient reduction in the daily maximum post-operative pain score favoring the Traumeel arm was observed on the day of surgery, a finding supported by a treatment-time interaction test (p = 0.04).ConclusionsTraumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score on the day of surgery is of questionable clinical importance.Trial RegistrationThis study was registered at ClinicalTrials.gov. # NCT00279513

Homeopathy in emergency medicine.

SummaryBACKGROUND: Use of homeopathy is not frequently reported in critically ill patients. We describe our experience treating such patients homeopathically in the emergency room, on the wards, and in the intensive care unit of conventional hospitals in Austria and Israel. METHODS: We describe a case series of patients treated in the ER for multiple casualty incidents, two case reports of remarkable cures in the ICU, and two RCTs demonstrating the efficacy of homeopathy in septic and intubated patients. RESULTS: A case series documents favorable results in homeopathic treatment of patients in the ER and wards after multiple casualty incidents. Two case reports narrate remarkable homeopathic cures to imminently terminal illnesses. Finally, homeopathy was demonstrated effective as compared with placebo in improving long-term survival in severely ill septic patients and in hastening extubation ICU patients. CONCLUSIONS: Our report suggests that homeopathy may be applicable even for critically ill patients. We discuss the obstacles encountered, including a dearth of tools for successful homeopathic prescription in these situations, suspicion and lack of cooperation by patients and conventional colleagues, and the highly suppressive nature of concomitant conventional therapies. We suggest the development of algorithms and other tools to aid rapid homeopathic prescription in critical care patients and discuss the importance of familiarizing physicians and medical students with homeopathy in order to facilitate communication and cooperation between these complementary branches of medicine.ZusammenfassungGRUNDLAGEN: Die Anwendung der Homöopathie bei kritisch kranken Patienten wird nur selten berichtet. Wir beschreiben unsere Erfahrungen bei der homöopathischen Behandlung solcher Patienten in der Notfallaufnahme, den Bettenstationen und Intensivstationen konventioneller Spitäler in Österreich und Israel. METHODIK: Wir beschreiben eine Serie von Fallberichten von Patienten, die in der Notfallaufnahme wegen Katastrophenfällen behandelt worden sind, zwei Fallberichte bemerkenswerter Heilungen an der Intensivstation, sowie zwei randomisierte klinische Studien, die die Effektivität der Homöopathie bei septischen und intubierten Patienten zeigen. ERGEBNISSE: Eine Fallstudie dokumentiert günstige Ergebnisse bei der homöopathischen Behandlung von Patienten in der Notfallaufnahme- und der Normalstation nach Katastrophenfällen. Weiters beschreiben zwei Fallberichte bemerkenswerte homöopathische Heilungen bei fortgeschrittenen tödlichen Erkrankungen. In zwei randomisierten klinischen Studien zeigte sich die Homöopathie im Vergleich zu Plazebo als effektiver bezüglich der Verbesserung des Langzeitüberlebens von Patienten mit schwerster Sepsis sowie bei der Beschleunigung der Extubation von Intensivpatienten. SCHLUSSFOLGERUNGEN: Unser Bericht lässt vermuten, dass die Homöopathie auch bei kritisch kranken Patienten sinnvoll ist. Wir diskutieren die dabei angetroffenen Hindernisse, einschließlich des Mangels an Werkzeugen für eine erfolgreiche homöopathische Verschreibung bei solchen Situationen, des Misstrauens und der fehlenden Kooperation seitens der Patienten und konventionell tätiger Kollegen sowie der supprimierenden Wirkungsweise begleitender konventioneller Therapien. Wir regen die Entwicklung von Algorithmen und anderer Werkzeuge zur Beschleunigung homöopathischer Verschreibungen bei kritisch kranken Patienten an und diskutieren die Wichtigkeit, Ärzte und Medizinstudenten mit Homöopathie bekannt zu machen, um die Kommunikation und Kooperation zwischen diesen komplementären Zweigen der Medizin zu verbessern.