Mistletoe Therapy Research Articles

Homöopathische Differenzierung der Wirtsbäume der Mistel

In homeopathy mistletoe, viscum album, is a particular remedy showing a broad spectrum of effects. Nevertheless, it is not considered that the remedy picture of mistletoe is dependent on its host tree. The same applies to the mistletoe therapy of cancer. Experiences of the last years show that, depending on the host tree, there are particular remedy pictures being of special importance for cancer therapy and prophylaxis. For homeopathy a new field is opened: the mistletoe tree medicine: visco-dendrology.

Complementary and alternative medicine in patients with chronic lymphocytic leukemia

Despite the widespread use of complementary and alternative medicine (CAM) in the general population for the treatment of chronic diseases, only few data have been published for patients with leukemia. The aim of this survey was to study systematically the use of CAM in patients with chronic lymphocytic leukemia (CLL). A structured questionnaire was sent to 247 CLL patients of all clinical stages and disease durations, treated and untreated. The questionnaire was returned anonymously by 87 patients (35%). Thirty-nine patients (44%) had used alternative treatments. No correlation was seen with educational level, gender, or previous or current chemotherapy. The most common alternative or complementary treatment modality was vitamin supplementation (26%), followed by mineral (18%), homeopathic (14%), and mistletoe therapy (9.2%). Some 21% of patients considered their alternative treatment as being successful. Most patients reported that they decided to use CAM after conducting a personal investigation and based on the information they found, without outside recommendations (59%). The majority of the patients used patient brochures about CLL as an important source of information (54%), followed by specific lectures (34%) or the internet (32%). Our data show that patients with CLL use a wide range of CAM, among them potentially harmful methods. Rational, evidence-based medical information about the effects and risks of CAM use should be made available through patient brochures distributed by patient organizations, through information events with lectures, or via the internet.

Mistletoe therapy in oncology

Mistletoe extracts are commonly used in cancer patients. It is claimed that they improve survival and quality of life (QOL) in cancer patients. To determine the effectiveness, tolerability and safety of mistletoe extracts given either as monotherapy or adjunct therapy for patients with cancer. Search sources included the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, 2007) Cochrane Complementary Medicine Field Registry of randomized clinical trials (RCTs) and controlled clinical trials, MEDLINE, EMBASE, HEALTHSTAR, INT. HEALTH TECHNOLOGY ASSESSMENT, SOMED, AMED, BIOETHICSLINE, BIOSIS, CancerLit, CATLINE, CISCOM (August 2007). For the search the Standard Operating Procedures of the Information System in Health Economics at the German Institute for Medical Documentation and Information (DIMDI) were utilized. Reference lists of relevant articles and authors extensive files were searched for additional studies. Manufacturers of mistletoe preparations were contacted. We included RCTs of adults with cancer of any type. The interventions were mistletoe extracts as sole treatments or given concomitantly with chemo- or radiotherapy. The outcome measures were survival times, tumor response, QOL, psychological distress, adverse effects from antineoplastic treatment and safety of mistletoe extracts. Three review authors independently assessed trials for inclusion in the review. All review authors independently took part in the extraction of data and assessment of study quality and clinical relevance. Disagreements were resolved by consensus. Study authors were contacted where information was unclear. Methodological quality was narratively described and additionally assessed with the Delphi list and the Jadad score. High methodological quality was defined if six out of nine Delphi criteria, or four out of five Jadad criteria were fulfilled. Results were presented qualitatively. Eighty studies were identified. Fifty-eight were excluded for various reasons, usually as there was no prospective trial design with randomised treatment allocation. Of the 21 included studies 13 provided data on survival, 7 on tumour response, 16 on measures of QOL or psychological outcomes, or prevalence of chemotherapy-related adverse effects and 12 on side effects of mistletoe treatment; overall comprising 3484 randomised cancer patients. Interventions evaluated were 5 preparations of mistletoe extracts from 5 manufacturers and one commercially not available preparation. The general reporting of RCTs was poor. Of the 13 trials investigating survival, 6 showed some evidence of a benefit, but none of them was of high methodological quality. The results of two trials in patients with melanoma and head and neck cancer gave some evidence that the used mistletoe extracts are not effective for improving survival. Of the 16 trials investigating the efficacy of mistletoe extracts for either improving QOL, psychological measures, performance index, symptom scales or the reduction of adverse effects of chemotherapy, 14 showed some evidence of a benefit, but only 2 of them including breast cancer patients during chemotherapy were of higher methodological quality. Data on side effects indicated that, depending on the dose, mistletoe extracts were usually well tolerated and had few side effects. The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak. Nevertheless, there is some evidence that mistletoe extracts may offer benefits on measures of QOL during chemotherapy for breast cancer, but these results need replication. Overall, more high quality, independent clinical research is needed to truly assess the safety and effectiveness of mistletoe extracts. Patients receiving mistletoe therapy should be encouraged to take part in future trails.

Individual Patient Data Meta‐Analysis of Survival and Psychosomatic Self‐Regulation from Published Prospective Controlled Cohort Studies for Long‐Term Therapy of Breast Cancer Patients with a Mistletoe Preparation (Iscador)

Mistletoe preparations such as Iscador are in common use as complementary/anthroposophic medications for many cancer indications, particularly for solid cancers. The efficacy is still discussed controversially. This paper presents an individual patient data meta-analysis of all published prospective matched-pair studies with breast cancer patients concerned with long-term application of a complementary/anthroposophic therapy with the mistletoe preparation Iscador. Six sets of data were available for individual patient meta-analysis of breast cancer patients, matched according to prognostic factors into pairs with and without mistletoe (Iscador) therapy. The main outcome measures were overall survival and psychosomatic self-regulation. Overall survival was almost significant in favor of the Iscador group in the combined data set of the randomized studies: estimate of the hazard ratio with 95% confidence interval 0.59 (0.34, 1.02). Overall survival was highly significant in the combined data set of the non-randomized studies: 0.43 (0.34, 0.56). In the combined analysis of the randomized studies, improvement of psychosomatic self-regulation, as a measure of autonomous coping with the disease, was highly significant in favor of the Iscador group: estimate of the median difference 0.45 (0.15, 0.80), P = 0.0051. The analyzed studies show that therapy with Iscador might prolong overall survival and improve psychosomatic self-regulation of breast cancer patients.

Mistletoe Preparation Iscador: Are there Methodological Concerns with Respect to Controlled Clinical Trials?

In Europe many cancer patients use complementary therapies, particularly mistletoe. Only a few controlled clinical trials have been performed with the mistletoe preparation Iscador as a complementary treatment for cancer, many of them with medium to low quality due to methodological shortcomings. Reasons for some quality concerns, particularly discontinuation of treatment and/or participation and premature termination are analyzed. Analysis is based on controlled clinical trials dealing with Iscador. Data stem from the archive of published and ongoing research of the «Verein für Krebsforschung» (Society for Cancer Research) in Arlesheim, Switzerland. Controlled clinical studies with cancer patients that were started after 01.01.1990 or were not completed by then have been evaluated. Fifty-six controlled studies are documented, 24 of them randomized and 32 non-randomized. Nine of the randomized studies were done by matched-pair design, the others by conventional parallel group design; six of the last were terminated prematurely primarily for slow recruitment due to patient preferences and compliance of physicians. Patient and physician preference seem to be important factors limiting recruitment for randomized trials and hence implementation. This adds to the overall unwillingness of participation by patients with serious diseases. A well-balanced mix of designs using different research methods and outcomes is suggested combined with analyses, in countries where mistletoe therapy in general or Iscador in particular is unknown or not available.

The importance of the primary dosis in mistletoe therapy

The importance of the primary dosis in mistletoe therapy

What rank has anthroposophic mistletoe therapy in modern multi-modal oncological therapy concepts? A position assessment under clinical aspects

What rank has anthroposophic mistletoe therapy in modern multi-modal oncological therapy concepts? A position assessment under clinical aspects

Significance of lectin-standardized mistletoe therapy in oncology ¿ a tool for the management of adverse effects

Significance of lectin-standardized mistletoe therapy in oncology ¿ a tool for the management of adverse effects

Treatment with standardized mistletoe extract (Viscum album L.) Iscador® as a part of long-term supportive care in patients with primary non-metastatic colorectal carcinoma

Aims: Mistletoe therapy is a frequently used supportive treatment in cancer patients to improve quality of life and baseline therapy induced adverse events.

Prospective Controlled Cohort Studies on Long-Term Therapy of Cervical Cancer Patients with a Mistletoe Preparation (Iscador®)

Mistletoe preparations such as Iscador are commonlyused in complementary medication for many cancer indications,particularly solid cancers. The efficacy of this complementarytherapy is still controversial. Objective: Does longtermtherapy with Iscador show any effect on survival, tumorprogression and psychosomatic self-regulation of patients withcervical cancer? Patients and Methods: Prospective recruitmentand long-term follow-up was carried out in 3 controlled cohortstudies: In a randomized matched-pair study (19 pairs), cervicalcancer patients with distant metastases and no mistletoe therapywere matched for prognostic factors. By paired random allocation,one of the patients was recommended mistletoe therapyby the attending physician. In 2 non-randomized matched-pairstudies, cervical cancer patients without (102) and with (66)metastases, who already received mistletoe therapy, werematched with control patients without Iscador therapy. Results:For survival, the non-randomized studies showed significanteffects in favor of Iscador therapy: hazard ratio (HR) estimateand 95% confidence interval (CI): 0.23 (0.14-0.39) and 0.37(0.17-0.80), respectively. An effect of long-term Iscador therapyon tumor progression was not seen. Psychosomatic self-regulationin the Iscador group improved significantly within 12months compared with the control group in the randomized aswell as in 1 non-randomized study (cervical cancer withoutmetastases): estimate of the median difference and 95% CI: 0.70(0.15-1.05) and 0.25 (0.15-0.35), respectively. Conclusion: Iscadormay have the effect of prolonging overall survival of cervicalcancer patients. In the short term, psychosomatic self-regulationincreases more markedly under complementary Iscadortherapy than under conventional therapy alone.

Successful Treatment of Metastatic Malignant Melanoma with Viscum album Extract (Iscador® M)

Recent study results demonstrate possible clinical benefit from adjuvant treatment with a standardized mistletoe (Viscum album) extract in patients with malignant melanoma. We present a male patient, currently 68 years of age, with one malignant melanoma at the upper part of the right arm since 1992, and another nodular melanoma at the left shoulder, first diagnosed in 1999. After discovery of the second melanoma and surgical resection, the patient was exclusively treated with standardized mistletoe extract (Iscador, (R)M; Weleda AG, CH-Arlesheim, Switzerland). COURSE OF THERAPY AND RESULTS: In June 1992, histologic analysis confirmed the presence of stage IA superficially spreading malignant melanoma with low infiltration of the papillary dermis in a skin excision sample from the upper part of the right arm. In November 1999, another melanoma was surgically removed at the patient's right shoulder. In this case, the histologic examination revealed nodular melanoma, stage IIA (pT3, pN0, M0). Therapy with mistletoe extract was introduced shortly afterwards as the sole adjuvant treatment. During the course of the mistletoe therapy, axillary removal of 8 lymph nodes became necessary, 3 of which proved to be metastatic. First signs of a defined solitary liver metastasis in an area next to segments IV and V were detected during an abdominal ultrasound examination in September 2001. This finding was confirmed by further sonographic examinations. The solitary liver metastasis was not resected, nor was classical antitumor treatment (chemotherapy or radiotherapy) initiated. The patient continued subcutaneous treatment with Iscador M after dose adaptation to 2 mg twice weekly (0.2 mL of a 10-mg vial); the treatment is still ongoing to the present. By June 2002, complete remission of the liver metastasis was diagnosed by liver ultrasound examination. There has been no local relapse so far, and the patient has been in stable condition ever since. No further metastases were discovered so far (as of May 2006). The use of low-dose Iscador as the sole postoperative modality for the adjuvant treatment of metastatic melanoma was extremely effective and very well tolerated in this patient. It achieved complete response and absence of all complaints.

The Immunological Effect of Mistletoe Extract on Gastric Cancer Patients

Purpose: Mistletoe (Viscum album L.) extract is one of the most widely used agents in alternative cancer therapeutic regimens in Europe. This study was conducted to determine the effect of mistletoe extract on immune function in gastric cancer patients. Materials and Methods: Ten patients that had undergone a curative gastrectomy were enrolled in the prospective study. ABNOBAviscum was injected subcutaneously three times a week from postoperative-day 7 to week 16 with an increasing dose. All of the patients simultaneously received chemotheraphy with mitomycin, oral 5-FU and a cisplatin regimen. The WBC count, differential count, lymphocyte/WBC ratio and the level of cytokines (IL-, IL-2, IL-6, IFN-, TNF-) were checked in the peripheral blood preoperatively, at postoperative week 8 and at postoperative week 16. Results: The WBC and neutrophil counts significantly decreased after treatment on week 8 and week 16 (P=0.001), but the total eosinophil count was slightly increased (P=0.15). The total lymphocyte count also decreased during treatment but the lymphocyte/WBC ratio was slightly increased without statistical significance (P=0.91). The cytokine levels did not significantly change during treatment. Conclusion: It is somewhat difficult to determine the direct effect of mistletoe therapy on immune function as the effect may be compromised by the concurrent chemotherapy. It can be assumed that the slightly increased lymphocyte/WBC ratio and eosinophil count may be a result of the immunomodulatory effect of the mistletoe extract.

Gene expression signatures of pathway alterations in tumor cells caused by plant extracts

Extracts of Viscum album from different host trees (Iscador ® Qu, M, P and A) and isolated mistletoe lectin showed distinct gene-expression profiles using cDNA microarrays. We were able to confirm that genes of apoptosis, the cell cycle and the immune system were affected by mistletoe preparations and we also found that signal transduction, cell communication and cancer related pathways were overregulated in the tested breast cancer (HCC-1937, MCF-7, KPL-1, Mfm-223) and lymphoma cell lines (WSZ-NHL). The effect of a specific mistletoe extract on a particular cell line was individual, so that the distinction between the reaction of the cell type and/or the influence of the mistletoe preparation could be used in targeted mistletoe therapy.

Complementary and alternative medicine in the treatment of prostate cancer

Treatments based on complementary medicine have gained significant ground in oncology. Patients are mainly interested in adequate support, reduction of the side effects of clinical medicine, strengthening their immune system and enhancing quality of life both during and after chemotherapy and irradiation treatments. In the last few years, a number of complementary strategies for the treatment of prostate cancer have been evaluated and published in international journals. These studies allow us to present today, with scientific accuracy, the initial results of complementary treatment methods, describe their contraindications and interactions, and discuss a safe individualized therapy with the patient. In Western Europe and the USA, immunomodulatory, anti-oxidative and herbal therapies, in particular, have been investigated and published. Of these, we discuss mistletoe therapy, enzyme therapy, carotinoids, lycopene, vitamin A, C, E, selenium, phytoestrogens, PC-SPES, physical therapy and relaxation techniques and psychological therapy. Several studies have demonstrated the improvement in quality of life and the value of complementary medicine as an adjunct to chemotherapy or radiotherapy. Based on fruitful communication and cooperation with the treating oncological urologist, internist/oncologist or radiotherapist, complementary therapy might serve as a valuable and useful supportive measure for prostate cancer patients.

CD30+ Lymphoproliferative Disorder/Lymphomatoid Papulosis - A Regression Caused by Mistletoe Therapy.

Lymphomatoid papulosis (LyP) is a CD30+ cutaneous lymphoma according to the WHO classifications and regarded as a condition of uncertain malignant potential. The incidence of LyP in children is relatively low compared to that in adults. It is correlated with malignant lymphomas in 5–20% of adult LyP-patients. In children, an increased risk for the development of a malignant lymphoma is observed. The clinical course is often chronic. Most common treatment for LyP is topical steroids, antibiotics, phototherapy and low-dose methotrexate. Prognosis is excellent with a survival of 100% even for patients with malignant lymphomas. Case-report: An 8-years old boy suffered from reddish nodules (maximum 7 cm in diameter) on his right forearm and his left leg. Immunohistochemical analysis identified a CD30+large-T-cell-type-NHL of the skin. Topic steroids were effective but six months later he showed axillar lymph-node swelling. Immunohistochemically it was classified as anaplastic large cell T-type-lymphoma (ALCL) without signs of systemic involvement. Combination chemotherapy according to the European ALCL-trial (high-risk-group) was given for six months. All nodules (cutaneous and lympoid/axilla) resolved within a few weeks. Two months after cessation of chemotherapy a new skin-nodule on the left forearm appeared. The immunohistochemical diagnosis was now LyP. No specific therapy was given. In the following two months he developed two further solid and painful skin-lesions. In this situation we decided to start a therapeutic approach with subcutaneous mistleote (MT), which was injected close to one of these lesions. The skin-nodules decreased after the first dose and MT injections into all nodules were continued. Within the following two weeks the skin-lesions resolved completely and subcutaneous MT therapy was continued. Two months later, he developed two new nodules responding within a few days to increased dose of MT. While continuation therapy with MT the boy was without clinical signs both of the LvP and ALCL for nearly two years. Subsequently MT therapy was terminated. Three weeks after cessation the cutaneus LyP generally reactivated all over the body with typical nodules (maximum 1 cm in diameter). Subcutaneus MT therapy was restarted and the cutnaneus LyP regressed within 2 weeks completely without additional therapy.

Unkonventionelle Krebstherapien – Vergleich von Einstellungen und Kenntnissen bei Ärzten in Deutschland und Griechenland

Hintergrund und Fragestellung: Unkonventionelle Krebstherapienerfreuen sich besonders in Deutschland grosserBeliebtheit. Im Rahmen dieser Studie sollte geklärtwerden, inwieweit sich subjektive Krankheitsätiologie,Kenntnisstand und Erwartungen an Heilungserfolgedurch unkonventionelle Krebstherapien bei deutschenÄrzten und ihren griechischen Kollegen unterscheiden.Personen und Methodik: Im Jahr 2002 wurde ein Fragebogen,der nach eigenen Vorarbeiten und der Literaturzum genannten Thema entwickelt wurde, an 300 Ärzte inDeutschland versandt und an 494 Ärzte in Griechenlandverteilt. Ergebnisse: Bei Rücklaufraten von 53,0 und47,8% konnten zwischen beiden Ländern deutlicheUnterschiede der subjektiven Krankheitsätiologie, desKenntnisstandes und der Erwartungen an Heilungserfolgegefunden werden. Deutsche Ärzte betrachten sich generellals deutlich besser informiert als ihre griechischenKollegen. Allerdings liegt der Prozentsatz der Ärzte mitgutem bzw. sehr gutem Kenntnisstand nur für Misteltherapieund Antioxidantien über 30%. Griechische Ärztehingegen sind mit unkonventionellen Krebstherapiennicht vertraut, weniger als 10% geben einen guten bzw.sehr guten Kenntnisstand an. Schlussfolgerung: Die Hypothese,dass kulturelle Aspekte bei den Einstellungenzu unkonventionellen Krebstherapien eine wesentlicheRolle spielen, wird durch diese Untersuchung gestützt.Es könnten aber auch demographische Faktoren eineRolle spielen, da das mittlere Alter in der griechischenStichprobe niedriger war. Eine verbesserte Ausbildungvon Ärzten über unkonventionelle Krebstherapienscheint notwendig.

037 Mistletoe therapy as the intermittent symptomatic management in persistent endometriosis patients

037 Mistletoe therapy as the intermittent symptomatic management in persistent endometriosis patients

Retrolective, Comparative, Epidemiological Cohort Study with Parallel Groups Design for Evaluation of Efficacyand Safety of Drugs with ‘Well-Established Use’ Experience with the Long-Term Treatment Using the European Mistletoe Extract (Viscum album L.) in Addition to Conventional Oncological Therapy in Primary, Non-Metastatic Breast Carcinoma

The randomized controlled clinical trial (RCT) is accepted as the ‘golden standard’ for the evaluation of efficacy and safety of new drugs. In contrast, to demonstrate efficacy and safety of drugs with ‘well-established use’ that have been on the European Community market for long time, observational comparative epidemiological studies can be used according to the European drug regulation directive. However, because comparative epidemiological cohort studies can share some risk of bias with other nonrandomized observational study designs, there is a need for an approach that could effectively reduce the bias risk in this type of studies. Study Objectives: The purpose of the study was to evaluate the therapeutic efficacy and safety of a long-term complementary therapy of primary, non-metastatic breast carcinoma patients treated with standardized European mistletoe extract Iscador^TM (‘mistletoe’) in addition to the conventional adjuvant oncologic therapy, and compared to the control group treated with the conventional therapy alone. Methods: The multicenter, comparative, retrolective, pharmaco-epidemiological cohort study with parallel groups design and randomly selected centers that routinely used both treatments was carried out according to Good Epidemiological Practice rules under a standard operating procedure control. The test group patients received the mistletoe extract treatment subcutaneously for at least 3 months, while the control group patients of the same cohort was exclusively treated with the conventional therapy. The patients were followed up for at least 3 years or until death. The primary endpoint of efficacy was the incidence of adverse reactions to the conventional oncologic therapy. Secondary endpoints were change from baseline of the symptoms associated with the disease and treatment as well as overall survival. All endpoints were adjusted to baseline imbalance and confounders. Safety was assessed descriptively by the number of patients with adverse drug reactions (ADRs) attributed to the test treatment. Results: 1442 patients (710 tests and 732 controls) were eligible for the ‘per protocol’ analysis of efficacy and safety. At baseline, the test group had a more advanced disease and worse prognostic factors profile. After a median follow-up of 66 vs. 60 months, and a median mistletoe therapy duration of 52 months, significantly fewer test group patients (16.2%) than control patients (54.0%) developed ADRs attributed to the conventional therapy [adjusted odds ratio, OR (95% confidence interval, CI), OR = 0.47 (0.32–0.67), < 0.001]. In the test group, the majority of the symptoms disappeared more frequently, and overall mortality hazard was significantly lower [adjusted hazard ratio, HR (95% CI), HR = 0.46 (0.22–0.96), p = 0.038] than in the control group. Systemic ADRs attributed to the test treatment developed in 0.8%, and local ADRs in 17.3% of the patients. ADR severity was mild to intermediate. Tumor enhancement was not observed. Conclusions: Complementary therapy of patients with primary, non-metastatic breast carcinoma with the mistletoe extract Iscador was safe and in comparison to the control group within the same study cohort showed con- siderably fewer ADRs attributed to concurrent conventional therapy, reduced disease symptoms, and suggested a significant improvement of survival. Despite some methodical limitations that require careful study planning and conduction as well as critical interpretation, the applied study design seems suitable to evaluate the efficacy and safety of drugs with ‘well-established use’, particularly in oncology.

Anti-inflammatory effect of Viscum album agglutinin-I (VAA-I): induction of apoptosis in activated neutrophils and inhibition of lipopolysaccharide-induced neutrophilic inflammation in vivo.

Viscum album agglutinin-I (VAA-I) is a plant lectin which possesses antitumoral properties. This lectin is also known for its immunostimulatory effects when used at low concentrations (1-100 ng/ml). We have demonstrated recently that VAA-I is a potent inducer of human neutrophil apoptosis in vitro when used at higher concentrations. The role of VAA-I on activated neutrophils has not so far been investigated and its potential proinflammatory properties in vivo are poorly documented. Herein, we demonstrated that VAA-I (1000 ng/ml) induces apoptosis in lipopolysaccharide (LPS)-treated human neutrophils in vitro as well as in murine neutrophils isolated from lipopolysaccharide (LPS)-induced neutrophil influx. Using this model, we found that administration of VAA-I (100 or 1000 ng/ml) did not induce an inflammatory response. However, when used at 1 or 10 ng/ml, VAA-I was found to significantly induce a transitory inflammatory response, based on an increased leucocyte infiltration (>98% neutrophils). Also, we found that VAA-I inhibits LPS-induced neutrophil influx when administered simultaneously with LPS. In such conditions, some characteristic apoptotic neutrophils were observed in the pouch. Unlike LPS, which increased the production of some cytokines, VAA-I (1 or 10 ng/ml) did not increase the production of tumour necrosis factor (TNF)-alpha, interleukin (IL)-1Ra, IL-1alpha, IL-beta, IL-8, IL-10 or IL-12 (p70) in human neutrophils. We conclude that VAA-I possesses the ability to induce apoptosis of preactivated neutrophils at a concentration that does not induce a proinflammatory response. Moreover, we conclude that VAA-I can inhibit a LPS-induced proinflammatory response in vivo. These data may provide new clinical perspectives in future mistletoe therapy and favour its potential utilization based on anti-inflammatory activity that at first appears contradictory with its use as immunostimulant.

Problematik randomisierter Studien in der Komplementärmedizin dargestellt am Beispiel der Misteltherapie bei Patientinnen mit Mammakarzinom

Problems of Randomized Studies in Complementary Medicine Demonstrated in a Study on Mistletoe Treatment of Patients with Breast Cancer Background: Prospective randomized studies on mistletoe therapy repeatedly demonstrated that there is a basic problem in the matter of enrolling the appropriate number of patients within a reasonable amount of time. Most studies have to face this problem. However, recent experience suggests that this problem is more pronounced in the case of mistletoe treatment of cancer patients. Objective: Possibility of recruitment and randomization of breast cancer patients for a mistletoe study. Patients: During a period of 28 months every patient was registered who was admitted to the Gynecological Hospital of the University of Heidelberg because of suspected cancer. Results: Out of 1,922 patients who were operated on for breast tumor, 521 first met the inclusion and exclusion criteria. 154 out of these 521 patients agreed to take part in the study. After availability of the final results on tumor staging and the therapy plan for conventional treatment, 80 out of the 154 women had to be excluded from the study. From the remaining 74 patients (48%), however, only 29 (39%) would have agreed to take part in a randomized mistletoe study. Conclusions: This confirms our suspicion that the difficulties of enrolment and randomization in the case of mistletoe studies exceed those of studies conducted in conventional oncology. The reasons for this dramatic effect and the possibility of alternative study designs are discussed.