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Directory of Clinical Mistletoe Studies

Collection of Clinical Mistletoe Studies 

Introduction

This compilation is an attempt at an organized directory of all the published and available clinically relevant studies on mistletoe use for the treatment of cancer. I have not attempted to dismiss any negative study. I have made comments where the title is not self-explanatory and in some of the more important studies I have quoted from the results or conclusions. I have included case series and case reports. I have not included all bench trials but have included some I felt noteworthy. Several studies have been left out that were not reviews and did not focus on a particular cancer type. 

My database was pubmed and search terms were “viscum album cancer” and “mistletoe cancer”. 

Updated December 23, 2021

Systematic Reviews and Meta-analysis 

A Systematic Review and Meta-Analysis on the Survival of Cancer Patients Treated with a Fermented Viscum album L. Extract (Iscador): An Update of Findings

“Results: Eighty-two controlled studies met the inclusion criteria, of which 32 with 55 strata provided data for extracting HR and CI. The overall HR was 0.59 (95% CI: [0.53; 0.65], p < 0.0001) in favour of Iscador treatment. Heterogeneity of study results was moderate (I2 = 50.9%; p < 0.0001, τ2 = 0.053). Meta-regression did not reveal significant effects of sample size or study design. However, significant differences were found between cancer entities (p < 0.01), with most pronounced effects in cervical (HR = 0.43) and less pronounced effects in lung cancer (HR = 0.84).

Conclusions: We found almost identical effects on cancer survival based on a broader database of higher quality. However, none of the studies was blinded and, therefore, there might be risk of performance bias. Implications for cancer survivors are as follows: findings indicate that adjuvant treatment of cancer patients with Iscador can be associated with a better survival.”

Quality of life in cancer patients treated with mistletoe: a systematic review and meta-analysis

“Results: We included 26 publications with 30 data sets. The studies were heterogeneous. The pooled standardized mean difference (random effects model) for global QoL after treatment with mistletoe extracts vs. control was d = 0.61 (95% CI 0.41-0.81, p < 0,00001). The effect was stronger for younger patients, with longer treatment, in studies with lower risk of bias, in randomized and blinded studies. Sensitivity analyses support the validity of the finding. 50% of the QoL subdomains (e.g. pain, nausea) show a significant improvement after mistletoe treatment. Most studies have a high risk of bias or at least raise some concern.

Conclusion: Mistletoe extracts produce a significant, medium-sized effect on QoL in cancer. Risk of bias in the analyzed studies is likely due to the specific type of treatment, which is difficult to blind; yet this risk is unlikely to affect the outcome.”

[Mistletoe in the treatment of cancer patients]

“Preclinical studies have demonstrated cytotoxic, apoptosis-inducing, and immunomodulatory effects.Many clinical studies indicate a supportive efficacy of mistletoe extracts in tumor patients, even though methodological quality is discussed controversially in many cases. Clinical data regarding effects on survival of patients is inconsistent; effects concerning quality of life as well as the tolerability of antitumoral treatments are evaluated more positively.In view of the high demand on the patient side and increasing scientific evidence, the general conditions for prescriptions should continue as well as the ongoing scientific evaluation.”

Mistletoe and Immunomodulation: Insights and Implications for Anticancer Therapies

“In this review, the impact of VA compounds on different cellular pathways and immunological reactions in the fight against cancerous cells is discussed.”

Mistletoe Extracts (PDQ®): Patient Version

Viscum album (L.) in experimental animal tumors: A meta-analysis.

“The quality of the studies was satisfactory and the majority reported positive outcomes. Nevertheless, there is a great deal of methodological heterogeneity among the studies, which precludes conclusive comparisons. Based on these results, the present authors strongly suggest developing guidelines for reporting in vivo mistletoe cancer treatment experiments.”

Cancer Patients’ Experiences of Using Mistletoe (Viscum album): A Qualitative Systematic Review and Synthesis.

A qualitative review: “Patients reported demonstrable changes to their physical, emotional, and psychosocial well-being following MT, as well as a reduction in chemotherapy side effects” “Given the variation in context of MT delivery across the articles, it is not possible to ascribe changes in patients’ quality of life specifically to MT.”

Cancer therapy with phytochemicals: evidence from clinical studies.

Based our literature search, Allium sativum, camptothecin, curcumin, green tea, Panax ginseng, resveratrol, Rhus verniciflua and Viscum album had satisfactory instances of clinical evidence for supporting their anticancer effects. 

Safety of higher dosages of Viscum album L. in animals and humans–systematic review of immune changes and safety parameters.

Important systematic review of safety of mistletoe therapy. “Application of higher dosages of VAE or ML is not accompanied by immunosuppression; altogether VAE seems to exhibit low risk but should be monitored by clinicians when applied in high dosages.”

Review article: Influence of Viscum album L (European mistletoe) extracts on quality of life in cancer patients: a systematic review of controlled clinical studies.

“VAEs seem to have an impact on QoL and reduction of side effects of conventional therapies (chemotherapy, radiation) in experimental trials as well as in routine daily application. The influence on fatigue especially should be investigated further.”

Survival of cancer patients treated with mistletoe extract (Iscador): a systematic literature review.

“Pooled analysis of clinical studies suggests that adjuvant treatment of cancer patients with the mistletoe extract Iscador is associated with a better survival. Despite obvious limitations, and strong hints for a publication bias which limits the evidence found in this meta-analysis, one can not ignore the fact that studies with positive effects of VA-E on survival of cancer patients are accumulating. “

Efficacy and safety of mistletoe preparations (Viscum album) for patients with cancer diseases. A systematic review.

“Supportive ‘mistletoe therapy’ seems safe and beneficial for QoL in adult patients with solid tumours”

Viscum album L. extracts in breast and gynaecological cancers: a systematic review of clinical and preclinical research.

“19 randomized (RCT), 16 non-randomized (non-RCT) controlled studies, and 11 single-arm cohort studies were identified that investigated VAE treatment of breast or gynaecological cancer. They included 2420, 6399 and 1130 patients respectively. 8 RCTs and 8 non-RCTs were embedded in the same large epidemiological cohort study. 9 RCTs and 13 non-RCTs assessed survival; 12 reported a statistically significant benefit, the others either a trend or no difference. 3 RCTs and 6 non-RCTs assessed tumour behaviour (remission or time to relapse); 3 reported statistically significant benefit, the others either a trend, no difference or mixed results. Quality of life (QoL) and tolerability of chemotherapy, radiotherapy or surgery was assessed in 15 RCTs and 9 non-RCTs. 21 reported a statistically significant positive result, the others either a trend, no difference, or mixed results. Methodological quality of the studies differed substantially; some had major limitations, especially RCTs on survival and tumour behaviour had very small sample sizes. Some recent studies, however, especially on QoL were reasonably well conducted. Single-arm cohort studies investigated tumour behaviour, QoL, pharmacokinetics and safety of VAE. Tumour remission was observed after high dosage and local application. VAE application was well tolerated. 34 animal experiments investigated VAE and isolated or recombinant compounds in various breast and gynaecological cancer models in mice and rats. VAE showed increase of survival and tumour remission especially in mice, while application in rats as well as application of VAE compounds had mixed results. In vitro VAE and its compounds have strong cytotoxic effects on cancer cells.

CONCLUSION:

VAE shows some positive effects in breast and gynaecological cancer. More research into clinical efficacy is warranted.”

Immune modulation using mistletoe (Viscum album L.) extracts Iscador.

Paywall

Preclinical investigations with mistletoe (Viscum album L.) extract Iscador.

Paywall

Mistletoe Extracts (PDQ®)

PDQ US Government Review of Mistletoe

Preclinical and clinical effects of mistletoe against breast cancer.

Retrolective studies on the survival of cancer patients treated with mistletoe extracts: a meta-analysis.

Positive survival noted but difficulty with data/methodology also noted.

Quality of life and related dimensions in cancer patients treated with mistletoe extract (iscador): a meta-analysis.

Positive effect on quality of life.

Mistletoe therapy in oncology.

Cochrane review. “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.”

Mistletoe in cancer – a systematic review on controlled clinical trials.

“Among 23 identified studies evaluated for clinically relevant outcome measures, 12 studies showed one or more statistically significant, positive results, another 7 studies showed at least one positive trend, 3 showed no effect and 1 had a negative trend. All studies, however, suffered from methodological shortcomings to some degree, and many of the studies are not conclusive. As several reasonably well conducted studies indicate beneficial effects, further properly designed trials should be encouraged.”

Questionable Reviews

Mistletoe for cancer? A systematic review of randomised clinical trials.

Written by a biased researcher (Edzard Ernst), this review in my opinion shows how not to do a systemic review more than it shows anything conclusive. There have been numerous critiques of this review. “Rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy.”

Mistletoe in oncological treatment: a systematic review : Part 1: survival and safety

“Conclusions: With respect to survival, a thorough review of the literature does not provide any indication to prescribe mistletoe to patients with cancer.”

Mistletoe in oncological treatment: a systematic review : Part 2: quality of life and toxicity of cancer treatment

“Conclusions: With respect to quality of life or reduction of treatment-associated side effects, a thorough review of the literature does not provide any indication to prescribe mistletoe to patients with cancer.”

Part 1 and 2 appear to contain bias in included studies as well as their conclusions. Please see the appendix containing an extensive quotation from Letter to the editors of the Journal of Cancer Research and Clinical Oncology. The authors note multiple errors in Freuding’s review and “we conclude that the review of Freuding et al. does to a relevant extent not fulfill the criteria for a systematic literature review and therefore should be thoroughly corrected or withdrawn by the authors.”

Safety and Interactions

Adverse Drug Reactions and Expected Effects to Therapy with Subcutaneous Mistletoe Extracts (Viscum album L.) in Cancer Patients.

The results of this study indicate that mistletoe therapy is safe. ADRs were mostly mild to moderate in intensity and appear to be dose-related and explained by the immune-stimulating, pharmacological activity of mistletoe.

Interaction of standardized mistletoe (Viscum album) extracts with chemotherapeutic drugs regarding cytostatic and cytotoxic effects in vitro.

“VAE (mistletoe) did not inhibit chemotherapy induced cytostasis and cytotoxicity in any of our experimental settings. At higher concentrations VAE showed an additive inhibitory effect.”

Anaphylaxis to viscotoxins of mistletoe (Viscum album) extracts.

Anaphylaxis is rare but possible. A case report.

Anaphylactic reactions after therapeutic injection of mistletoe (Viscum album L.).

3 cases of anaphylaxis. Case series. 

Complementary Treatment with Mistletoe Extracts During Chemotherapy: Safety, Neutropenia, Fever, and Quality of Life Assessed in a Randomized Study.

Subcutaneous mistletoe use safe. Significant impact on quality of life and less chemotherapy side effects. No observed impact on recurrence noted- mistletoe again only used during chemotherapy in this trial.

Safety and effects of two mistletoe preparations on production of Interleukin-6 and other immune parameters – a placebo controlled clinical trial in healthy subjects.

No induction of pro inflammatory CRP or IL-6 in healthy volunteers with subcutaneous dosing.

Use and Safety of Viscum album L Applications in Cancer Patients With Preexisting Autoimmune Diseases: Findings From the Network Oncology Study

“Conclusions: Our findings suggest that add-on VA-therapy in cancer patients with preexisting autoimmune diseases as Hashimoto’s thyroiditis, psoriasis, ulcerative colitis, Grave’s disease, and some rheumatic diseases is safe. No higher rates of VA-associated AEs were observed and the overall AE-rates were significantly lowered in VA-therapy periods. However, results should be interpreted with caution in light of the study’s observational character.”

Immunomodulatory effects of Viscum album extracts on natural killer cells: review of clinical trials.

Quality of Life

Impact of Oncological Therapy and Viscum album L Treatment on Cancer-Related Fatigue and Internal Coherence in Nonmetastasized Breast Cancer Patients

“Conclusions: In the present real-world study, add-on VA applications had a supportive effect on cancer-related fatigue, insomnia, physical functioning, and thermo-coherence. Thus, VA applications might be suited to alleviate symptom burden during anticancer therapy in breast cancer patients.”

An exploratory study on the quality of life and individual coping of cancer patients during mistletoe therapy.

“patients experienced an improvement of QoL during MT. This therapy seemed to offer a platform for an integrative coping with the disease, which might be important in reconciling the perceived shock of an existential illness with a good QoL.”

Mistletoe treatment in cancer-related fatigue: a case report.

Mistletoe treatments for minimising side effects of anticancer chemotherapy.

A review noting evidence for increased quality of life with mistletoe in breast cancer. Not conclusive about protection from toxicity.

Development and validation of an instrument to measure the effects of a mistletoe preparation on quality of life of cancer patients: the Life Quality Lectin-53 (LQL-53) Questionnaire.

Impact of complementary mistletoe extract treatment on quality of life in breast, ovarian and non-small cell lung cancer patients. A prospective randomized controlled clinical trial.

Improved quality of life demonstrated.

Brain Cancer

Adjuvant Therapy Using Mistletoe Containing Drugs Boosts the T-Cell-Mediated Killing of Glioma Cells and Prolongs the Survival of Glioma Bearing Mice

Iscador Qu used with conventional treatment extended mouse survival in glioma. 

Fermented mistletoe extract as a multimodal antitumoral agent in gliomas.

An important review of benchside and mouse models of mistletoe and glioma treatment.

Extract from mistletoe, Viscum album L., reduces Hsp27 and 14-3-3 protein expression and induces apoptosis in C6 rat glioma cells.

Rat study showing positive effect of mistletoe in glioma.

Paediatric medulloblastoma cells are susceptible to Viscum album (Mistletoe) preparations.

Bench test

Complete remission of a diffuse pontine glioma.

Young boy used Iscador and Helleborus without conventional treatment and had complete remission of diffuse pontine glioma. Abstract does not mention therapies but paper available at this link:

http://dna2162268.typepad.com/blog/2012/02/complete-remission-of-a-diffuse-pontine-glioma.html

Anthroposophic supportive treatment in children with medulloblastoma receiving first-line therapy.

Appears safe, effectiveness needs more studies.

Survival of glioma patients after complementary treatment with galactoside-specific lectin from mistletoe.

Mistletoe doubled survival in treatment group.

Mistletoe-Based Drugs Work in Synergy with Radio-Chemotherapy in the Treatment of Glioma In Vitro and In Vivo in Glioblastoma Bearing Mice

“Results: In cells, the expression of the ML receptor CD75s, which is also expressed in GBM specimen, but not in normal brain, correlates with the drug-induced cytotoxicity. In GBM cells, the drugs induce cell death in a concentration-dependent manner and reduce cell growth by inducing cell cycle arrest in the G2/M phase. The cell cycle arrest was paralleled by modifications in the expression of cell cycle regulating genes. ML containing drugs, if combined with glioma standard therapy, provide synergistic and additive anticancer effects. Despite not reaching statistical significance, a single intratumoral application of Aviscumine prolonged the median survival of GBM mice longer than tumor irradiation. Moreover, intratumorally applied Aviscumine prolonged the survival of GBM-bearing mice if used in combination with irradiation and TMZ for further 6.5 days compared to the radio-chemotherapy.

Conclusion: Our results suggest that an adjuvant treatment of glioma patients with ML-containing drugs might be beneficial.”

Supportive mistletoe therapy in a patient with metastasised neuroblastoma

“Initial chemotherapy induced regression of neuroblastoma (NB) but also reduction of quality of life.

Significant increase in physical and subjective well-being could be achieved after beginning of mistletoe therapy in a patient with NB.

Quality of life could be preserved for a long time even after recurrence of progression of the disease.

To the best of our knowledge, this is the first documented case of a significant improvement in quality of life induced by supportive mistletoe therapy of a patient suffering from NB.”

Pediatric

Safety of high-dose intravenous mistletoe therapy in pediatric cancer patients: A case series.

A case series for pediatric use of intravenous high dose mistletoe. Paywall

Preclinical Evaluation of Antitumoral and Cytotoxic Properties of Viscum album Fraxini Extract on Pediatric Tumor Cells

“In summary, we can state that these results provide the first preclinical data for cytotoxic activities of abnobaVISCUM Fraxini for a broad panel of pediatric tumor cell lines, in particular, neuroblastoma cells. Thus, it might be a potential remedy for the supportive treatment of neuroblastoma.”

Lung Cancer

Overall survival of stage IV non-small cell lung cancer patients treated with Viscum album L. in addition to chemotherapy, a real-world observational multicenter analysis.

Positive effects on survival in stage 4 Lung cancer in patients using mistletoe. Median survival was 17.0 months in the CTx plus VA group (95%CI: 11.0–40.0) and was 8.0 months (95%CI: 7.0–11.0) in the CTx only group (χ2 = 7.2, p = .007).

Overall Survival of Nonmetastasized NSCLC Patients Treated With Add-On Viscum album L: A Multicenter Real-World Study

Results: A total of 275 patients with stages I to IIIA NSCLC were enrolled (mean age = 67.6 years, 57.2% male patients). No significant difference of OS was observed between both groups. Even though not significant, for a subgroup of unresected patients with stage I NSCLC, adenocarcinoma or squamous cell carcinoma, a medium effect size OS improvement was observed for S+VA compared to S.

Conclusions: Our findings support the importance of surgery as the most effective intervention in nonmetastasized NSCLC patients. Add-on VA therapy shows here no additional effect in resected patients. However, a small subgroup analysis suggests a possible role of add-on VA for nonresected subgroups. Our results complement existing knowledge on the clinical impact of add-on VA therapy in NSCLC patients and may serve as hypothesis-generating data for further examinations in this cohort. Further research could be directed towards the role of combined therapy for nonresected early-stage NSCLC.

Cost-effectiveness of real-world administration of chemotherapy and add-on Viscum album L. therapy compared to chemotherapy in the treatment of stage IV NSCLC patients

“Results: 118 patients (C: n = 86, V: n = 32) were included in the analysis, mean age 63.8 years, the proportion of male patients was 55.1%. Adjusted hospital’s total mean costs for patients from the C and V group were €16,289, 95%CI: 13,834€-18,744€ (over an adjusted mean OS time of 13.4 months) and €17,992, 95%CI: 13,658-22,326 (over an adjusted mean OS time of 19.1 months), respectively. The costs per additional OS year gained (ICER) with the V-therapy compared to C therapy were €3,586.

Conclusion: The findings of the present study suggest that the combined use of chemotherapy and VA was clinically effective and comparably cost-effective to chemotherapy alone in our analysed patient sample from the hospital’s perspective. Further randomized and prospective cost-effectiveness studies are necessary to complement our findings.”

The cost per year of life saved by using mistletoe was estimated to be $4000. Incredibly, the cost/benefit ratio (ICER) for new conventional targeted therapies is accepted at $40,000-400,00 according to this Lancet article.

Mistletoe (Viscum album) extract targets Axl to suppress cell proliferation and overcome cisplatin- and erlotinib-resistance in non-small cell lung cancer cells.

Paywall

Combined cytotoxic action of Viscum album agglutinin-1 and anticancer agents against human A549 lung cancer cells.

Bench trial.

Apparent response of small cell lung cancer to an extract of mistletoe and homoeopathic treatment.

Long 5+ year survival in a patient with small cell lung cancer treated with subcutaneous iscador (no chemotherapy).

Mistletoe as complementary treatment in patients with advanced non-small-cell lung cancer treated with carboplatin-based combinations: a randomised phase II study.

Only effect noted in this trial was that mistletoe group tolerated more chemotherapy.

[Prevention of recurrence of bronchial carcinomas after surgery by means of the mistletoe extract Iscador. Results of a clinical study from 1969-1971].

Positive findings of prolonged survival.

Pleurodesis

 Efficacy and safety of Viscum album extract (Helixor-M) to treat malignant pleural effusion in patients with lung cancer.

Use of mistletoe in pleurodesis. “Results: The median age of patient was 63 years, and 77% of the 52 patients were male. About 85% of pleural effusions were found to be malignant by cytogenetic analysis. Forty-two (81%) patients were evaluable for recurrence of MPE. The 1-month recurrence rate was 48% (20/42). Among the 20 patients who developed recurrent MPE, 6 required therapeutic thoracentesis. Thirteen (25%) patients experienced procedure-related pain requiring medication. Eight (15%) had fever > 38 °C.

Conclusions: Our results suggest that a pleurodesis with Helixor-M was an effective and tolerable procedure for controlling MPE in lung cancer patients.”

Acute pneumonitis consequent on pleurodesis with Viscum album extract: severe chest images but benign clinical course.

Stimulation of antitumour immunity by intrapleural instillation of a Viscum album L. extract.

Pleurodesis Using Mistletoe Extract Delivered via a Spray Catheter during Semirigid Pleuroscopy for Managing Symptomatic Malignant Pleural Effusion.

Mistletoe safe and effective for malignant pleural effusion.

Chemical Pleurodesis Using Mistletoe Extraction (ABNOVAviscum(®) Injection) for Malignant Pleural Effusion.

Mistletoe safe and effective for pleurodesis.

Mistletoe preparation (Viscum Fraxini-2) as palliative treatment for malignant pleural effusion: a feasibility study with comparison to bleomycin.

Mistletoe twice as effective as Bleomycin for malignant pleural effusion.

Targeted Therapy (monoclonal antibodies (mAbs), tyrosine kinase inhibitors (TKIs),and immunotherapy) and Mistletoe

Clinical Safety of Combined Targeted and Viscum album L. Therapy in Oncological Patients.

Addition of mistletoe to targeted therapy studied in a multicenter observational study. . Addition of VA to targeted therapy significantly reduced the probability of oncological treatment discontinuation by 70%.

Safety of Combined Treatment With Monoclonal Antibodies and Viscum album L Preparations.

Monoclonal antibody treatment reactions occurred 1/5th as often in patients concurrently using mistletoe.

Clinical safety of combined therapy of immune checkpoint inhibitors and Viscum album L. therapy in patients with advanced or metastatic cancer.

This study showed no evidence of interaction between mistletoe and immune checkpoint inhibitors.

Interaction of a standardized mistletoe (Viscum album) preparation with antitumor effects of Trastuzumab in vitro.

No interaction found.

Lymphoma and Leukemia

Complete Remission and Long-term Survival of a Patient with a Diffuse Large B-cell Lymphoma Under Viscum album Extracts After Resistance to R-CHOP: A Case Report.

Homeopathic mistletoe adverse reaction mimics nodal involvement in 18F-FDG PET/CT performed for evaluation of response to chemotherapy in lymphoma.

Not clear this should be considered an adverse reaction but is an important consideration in mistletoe use.

A Natural Combination Extract of Viscum album L. Containing Both Triterpene Acids and Lectins Is Highly Effective against AML In Vivo.

Extract from mistletoe, Viscum album L., reduces Hsp27 and 14-3-3 protein expression and induces apoptosis in C6 rat glioma cells.

Bench trial showing positive results.

Comparison of Viscum album QuFrF extract with vincristine in an in vitro model of human B cell lymphoma WSU-1.

Bench Trial

Molecular mechanisms of mistletoe plant extract-induced apoptosis in acute lymphoblastic leukemia in vivo and in vitro.

Bench Trial

The Viscum album extract Iscador P does not cause an autocrine interleukin-6 loop in B-Non-Hodgkin’s Lymphoma cell lines.

Bench Trial

[Favorable long-term outcome with mistletoe therapy in a patient with centroblastic-centrocytic non-Hodgkin lymphoma].

Case report. Paywall.

Durable Regression of Primary Cutaneous B-Cell Lymphoma Following Fever-inducing Mistletoe Treatment: Two Case Reports.

2 patients treated with high dose mistletoe alone with total regression of cutaneous B-Cell Lymphoma.

Nodal anaplastic large-cell lymphoma ALK-1- with CD30+ cutaneous lymphoproliferation treated with mistletoe: spontaneous remission or treatment response?

12 year old girl with remission after mistletoe. 

[Favorable long-term outcome with mistletoe therapy in a patient with centroblastic-centrocytic non hodgkin lymphoma].

Case report. Article not available.

Multiple Myeloma

Investigation of the proliferation, apoptosis/necrosis, and cell cycle phases in several human multiple myeloma cell lines. Comparison of Viscum album QuFrF extract with vincristine in an in vitro model.

Bench test. Mistletoe more effective than conventional chemotherapy.

Intratumoral Mistletoe Therapy

Durable clinical remission of a skull metastasis under intralesional Viscum album extract therapy: Case report.

Use and safety of intratumoral application of European mistletoe (Viscum album L) preparations in Oncology.

“The frequency of ADRs to IT mistletoe injections was 3 times and 5 times higher than has previously been found for subcutaneous and intravenous applications of mistletoe, respectively. Nearly all ADRs were mild to moderate however, and no serious ADRs occurred. Furthermore, it is possible that immune-related ADRs such as pyrexia and local inflammatory reactions might be critical for tumor response.”

Intratumoral application of standardized mistletoe extracts down regulates tumor weight via decreased cell proliferation, increased apoptosis and necrosis in a murine model.

Mouse model demonstrating key concepts of intratumoral mistletoe injection.

Anticancer activity of a lectin-rich mistletoe extract injected intratumorally into human pancreatic cancer xenografts.

[Blood and tissue eosinophilia, mistletoe lectin antibodies and quality of life in a breast cancer patient undergoing intratumoral and subcutaneous mistletoe therapy].

Case report. Abstract only.

Intra-Peritoneal Injection

Reducing malignant ascites accumulation by repeated intraperitoneal administrations of a Viscum album extract.

Phase II study. Patients given mistletoe intra-abdominally needed less frequent removal of fluid than prior. No adverse events.

[Favourable course of persisting malignant ascites].

Case report of woman who received intra-abdominal mistletoe and improvement of malignant ascites.

High Dose Mistletoe

Immune-related and adverse drug reactions to low versus high initial doses of Viscum album L. in cancer patients.

Adverse effects were mild and anticipated. 

Safety of intravenously applied mistletoe extract – results from a phase I dose escalation study in patients with advanced cancer.

Fever Therapy With Intravenously Applied Mistletoe Extracts for Cancer Patients: A Retrospective Study.

Generally safe with fevers reaching >38.5C

Safety of Intravenous Application of Mistletoe (Viscum album L.) Preparations in Oncology: An Observational Study.

Overall, patients were almost two times less likely to experience an ADR to intravenous compared to subcutaneous application of mistletoe. No serious ADR’s occurred.

Merkel Cell Carcinoma

A 21-year course of Merkel cell carcinoma with adjuvant Viscum album extract treatment: A case report.

Rare tumor with poor prognosis held in check with mistletoe.

Breast Cancer

Analysis of Changes in Cancer-Related Fatigue of Breast Cancer Patients Receiving an Integrative Medicine Program

“Results: 231 female breast cancer patients of all tumor stages were evaluated. While chemotherapy exhibited significant severe deterioration, add-on VA Viscum album applications seem to partially mitigate this impairment on CRF. 36 separate multivariable regression analyses for all NPIs showed that in particular significant associations between CFS-D improvements and the interventions nursing compresses (6 point change; P = .0002; R² = 28%) or elaborate consultations and life review (ECLR) (4 point change; P = .0002; R² = 25%) were observed.

Conclusions: Breast cancer patients benefit from a hospital-based integrative medicine program. To alleviate fatigue symptoms during oncological therapy, an expansion of this concept should be developed in the future.”

Implementation of an Integrative Oncological Concept in the Daily Care of a German Certified Breast Cancer Center.

Discusses a large German hospital that has implemented integrative concepts including use of mistletoe in cancer treatment.

Synergistic anticancer effects of lectin and doxorubicin in breast cancer cells.

Chemo plus mistletoe is better.

Five-year follow-up of patients with early stage breast cancer after a randomized study comparing additional treatment with viscum album (L.) extract to chemotherapy alone.

“Six of 28 patients in one of the VaL groups and eight of 29 patients in the control group developed relapse or metastasis within 5 years. Subgroup analysis for hormone- and radiotherapy also showed no difference between groups. Additional VaL therapy during chemotherapy of early stage breast cancer patients appears not to influence the frequency of relapse or metastasis within 5 years.” 

Note that mistletoe group only used for the duration of chemotherapy (most experts would continue subcutaneous injections for a longer sometimes pulsed, duration.) Also, the study may be underpowered to “see” a significant result- there were fewer recurrences in the mistletoe group but this was not statistically significant. 

Quality of life in breast cancer patients during chemotherapy and concurrent therapy with a mistletoe extract.

“the overall results point to a relevant stabilisation of Health Related Quality of Life during various chemotherapy regimes, possibly due to a reduction of chemotherapy caused side effects with an excellent tolerability of the mistletoe therapy.”

Randomised and non-randomised prospective controlled cohort studies in matched-pair design for the long-term therapy of breast cancer patients with a mistletoe preparation (Iscador): a re-analysis.

Consistent positive survival results and positive quality of life results.

Prospective controlled cohort studies on long-term therapy of breast cancer patients with a mistletoe preparation (Iscador).

“Iscador shows a clinically relevant effect on breast tumor progression as measured by overall survival as well as by the time to recurrences, lymphatic or distant metastases.”

Gene expression profiles of different breast cancer cells compared with their responsiveness to fermented mistletoe (Viscum album L.) extracts Iscador from oak (Quercus), pine (Pinus), white fir (Abies) and apple tree (Malus) in vitro.

Paywall

Prevention of surgery-induced suppression of granulocyte function by intravenous application of a fermented extract from Viscum album L. in breast cancer patients.

Presurgical Iscador prevented suppression of immune system as compared to controls.

[Efficacy and safety of long-term complementary treatment with standardized European mistletoe extract (Viscum album L.) in addition to the conventional adjuvant oncologic therapy in patients with primary non-metastasized mammary carcinoma. Results of a multi-center, comparative, epidemiological cohort study in Germany and Switzerland].

“The results of the present study confirmed the safety of the complementary therapy of patients with primary, non-metastatic mammary carcinoma with a standardized mistletoe extract and showed considerably fewer ADRs attributed to concurrent conventional therapy, as well as reduced disease and treatment-associated symptoms, and suggested a prolonged overall survival in the mistletoe extract group as compared with controls.”

Improvement of DNA repair in lymphocytes of breast cancer patients treated with Viscum album extract (Iscador).

Mistletoe protecting the immune system. Only abstract available.

[Postoperative Viscum album therapy after surgery of breast neoplasms].

Abstract only. Iscador significantly improves survival in breast cancer (stage 1+2 studied).

Is Mistletoe Treatment Beneficial in Invasive Breast Cancer? A New Approach to an Unresolved Problem.

Paywall. No difference noted in treatment group.

Additional Therapy with a Mistletoe Product during Adjuvant Chemotherapy of Breast Cancer Patients Improves Quality of Life: An Open Randomized Clinical Pilot Trial.

Mistletoe improves quality of life significantly.

Quality of life and neutropenia in patients with early stage breast cancer: a randomized pilot study comparing additional treatment with mistletoe extract to chemotherapy alone.

Increased quality of life demonstrated.

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).

Increased quality of life in Iscador group.

Impact of complementary treatment of breast cancer patients with standardized mistletoe extract during aftercare: a controlled multicenter comparative epidemiological cohort study.

Positive findings for quality of life with mistletoe.

[Adjuvant simultaneous mistletoe chemotherapy in breast cancer–influence on immunological parameters, quality of life and tolerability].

Paywall. Retention of quality of life with mistletoe.

Quality of life is improved in breast cancer patients by Standardised Mistletoe Extract PS76A2 during chemotherapy and follow-up: a randomised, placebo-controlled, double-blind, multicentre clinical trial.

Improved quality of life with mistletoe.

The standardised mistletoe extract PS76A2 improves QoL in patients with breast cancer receiving adjuvant CMF chemotherapy: a randomised, placebo-controlled, double-blind, multicentre clinical trial.

Influence of postoperative complementary treatment with lectin-standardized mistletoe extract on breast cancer patients. A controlled epidemiological multicentric retrolective cohort study.

Mistletoe improved quality of life and lengthened relapse free intervals.

Ovarian Cancer

Safety of herbal medicine use during chemotherapy in patients with ovarian cancer: a “bedside-to-bench” approach.

Paywall

Prospective controlled cohort studies on long-term therapy of ovarian cancer patients with mistletoe (Viscum album L.) extracts iscador.

Paywall. Positive survival and quality of life with mistletoe in ovarian cancer.

[What prospects of success does Iscador therapy offer in advanced ovarian cancer?].

Abstract only. Iscador improves survival in ovarian cancer.

Recombinant mistletoe lectin (rML) is successful in treating human ovarian cancer cells transplanted into severe combined immunodeficient (SCID) mice.

Mouse study.

Cervical Cancer

Prospective controlled cohort studies on long-term therapy of cervical cancer patients with a mistletoe preparation (Iscador).

Paywall. Positive impact on survival and quality of life.

Intralesional and subcutaneous application of Viscum album L. (European mistletoe) extract in cervical carcinoma in situ: A CARE compliant case report

“This is the first report on complete remission of cervical CIS after intralesional and subcutaneous injection with VAE. Prospective studies should evaluate to what degree the treatment effect is reproducible.”

[Role of immunomodulatory treatment with Iscador QuS and Intron A of women with CIN1 with concurrent HPV infection].

Remission from abnormal cervical pathology CIN1 and CIN2 with mistletoe.

[Iscador QuS and human recombinant interferon alpha (Intron A) in cervical intraepithelial neoplasia (CIN)].

In Polish, abstract in English. CIN changes in cervix impacted favorably by Iscador.

Uterine Cancer

Randomized and non-randomized prospective controlled cohort studies in matched pair design for the long-term therapy of corpus uteri cancer patients with a mistletoe preparation (Iscador).

Increased survival and quality of life with mistletoe.

Mesothelioma

Minor regression and long-time survival (56 months) in a patient with malignant pleural mesothelioma under Viscum album and Helleborus niger extracts-a case report.

Mesothelioma is an aggressive cancer that typically has poor survival even with optimal chemotherapy. This response is remarkable. (I have seen a case with 9+ year survival with mistletoe as well).

Melanoma

Complete remission and long-term survival of a patient with melanoma metastases treated with high-dose fever-inducing Viscum album extract: A case report.

Patient used mistletoe treatment alone and had complete remission.

Mistletoe lectin-I augments antiproliferative effects of the PPARgamma agonist rosiglitazone on human malignant melanoma cells.

Bench trial.

Successful treatment of metastatic malignant melanoma with Viscum album extract (Iscador M).

Low dose iscador associated with complete remission 14+ year survival of metastatic melanoma patient.

Safety and efficacy of the long-term adjuvant treatment of primary intermediate- to high-risk malignant melanoma (UICC/AJCC stage II and III) with a standardized fermented European mistletoe (Viscum album L.) extract. Results from a multicenter, comparative, epidemiological cohort study in Germany and Switzerland.

“The long-term FME treatment in patients with primary intermediate to high-risk MM appears safe. Tumor enhancement was not observed. When compared with an untreated parallel control group from the same cohort, the results of the FME treatment suggested a significant survival benefit in primary stage II-III MM patients.”

Final results of the EORTC 18871/DKG 80-1 randomised phase III trial. rIFN-alpha2b versus rIFN-gamma versus ISCADOR M versus observation after surgery in melanoma patients with either high-risk primary (thickness >3 mm) or regional lymph node metastasis.

Iscador M compared to 2 other investigational drugs, compared to control. No difference in recurrence or survival noted. Paywall.

The Viscum album preparation Isorel inhibits the growth of melanoma B16F10 by influencing the tumour-host relationship.

Bench study.

Neuroendocrine Tumors

Long-term survival of a patient with an inoperable thymic neuroendocrine tumor stage IIIa under sole treatment with Viscum album extract: A CARE compliant clinical case report

“This is an exceptionally good course of disease of an inoperable, large, obstructing, and invasive TNET with a reduced baseline condition (Karnofsky index: 50-60) due to pronounced symptoms. Given the considerable reduction of symptoms and improved QoL following the onset of VAE therapy and other reports describing long disease stability and improvement of the QoL using VAE in different cancer types, we presume that the VAE treatment was supportive in this case. As TNETs are rare and few trials are available, future treatments of TNETs using VAE should be carefully documented and published to help determine whether further investigation of the use of VAE in TNET treatment is worthwhile.”

Osteosarcoma

ViscumTT induces apoptosis and alters IAP expression in osteosarcoma in vitro and has synergistic action when combined with different chemotherapeutic drugs.

Mistletoe induces apoptosis and works synergistically with chemotherapy in this effect in osteosarcoma.

Case reports of sarcoma patients with optimized lectin-oriented mistletoe extract therapy.

Pay wall. Description of 6 patients with response to VAE therapy.

Ewing Sarcoma

Multiple Active Compounds from Viscum album L. Synergistically Converge to Promote Apoptosis in Ewing Sarcoma.

Bladder Cancer

High-Dose Viscum album Extract Treatment in the Prevention of Recurrent Bladder Cancer: A Retrospective Case Series.

High-dose Viscum album treatment may have interrupted frequently recurring tumors in individual patients with recurrent bladder cancer.

Prolonged cytotoxic effect of aqueous extracts from dried viscum album on bladder cancer cells.

Bench Trial with Iscucin

Antiproliferative effects of mistletoe (Viscum album L.) extract in urinary bladder carcinoma cell lines.

Bench Trial

Adjuvant intravesical treatment of superficial bladder cancer with a standardized mistletoe extract.

Pilot study showing similar efficacy to adjuvant BCG.

Evaluation of an unconventional treatment modality with mistletoe lectin to prevent recurrence of superficial bladder cancer: a randomized phase II trial.

No effect seen in treatment group.

Renal Cell Carcinoma

Misteltoe (Iscador) therapy in stage IV renal adenocarcinoma. A phase II study in patients with measurable lung metastases.

A phase II trial with iscador. No difference noted in treatment groups. All patients enrolled as stage 4. Nonrandomized study. 

Colon Cancer

Effect of mistletoe extract on tumor response in neoadjuvant chemoradiotherapy for rectal cancer: a cohort study

“Results: Overall, the study included 52 patients (MG: n = 15; NMG: n = 37). Baseline demographics between the two groups were similar, except carbohydrate antigen 19-9 levels and tumor location from the anal verge. There was no difference in the clinical stage between the two groups. A better tumor response in the MG, relative to the NMG, was observed with respect to tumor regression grade (TRG), T stage, and overall tumor-node-metastasis stage. Tumor response was significantly better in the MG than in the NMG in terms of pathologic complete response rate (53.3% vs. 21.6%, P = 0.044), good TRG response (66.7% vs. 32.4%, P = 0.024), T downstaging (86.7% vs. 43.2%, P = 0.004), and overall downstaging (86.7% vs. 56.8%, P = 0.040). The toxicities during NCRT were minimal in both groups. More apoptotic cells were noted in MG samples than in the NMG samples on TUNEL staining. Cleaved caspase-3 level following treatment with Abnoba Viscum Q® was higher in SNU-503R80Gy cells than in SNU-503 cells.

Conclusion: Patients treated with chemoradiation combined with mistletoe extract showed better outcomes than patients not treated with mistletoe extract in terms of tumor responses. This diversity in treatment may improve the efficacy of NCRT, leading to better oncologic outcomes. Prospective and randomized studies with long-term follow-up are warranted to confirm and extend these results.”

Disappearance of an advanced adenomatous colon polyp after intratumoural injection with Viscum album (European mistletoe) extract: a case report.

Targeting inflammation in cancer-related-fatigue: a rationale for mistletoe therapy as supportive care in colorectal cancer patients.

Iscador helped reduce cancer related fatigue

The influence of isorel on the advanced colorectal cancer.

Isorel (a mistletoe extract) beneficial for advanced colorectal cancer.

Systematic evaluation of the clinical effects of supportive mistletoe treatment within chemo- and/or radiotherapy protocols and long-term mistletoe application in nonmetastatic colorectal carcinoma: multicenter, controlled, observational cohort study.

Positive survival effects noted.

Abnoba-viscum (mistletoe extract) in metastatic colorectal carcinoma resistant to 5-fluorouracil and leucovorin-based chemotherapy.

No effect seen in tumor progression in resistant stage 4 colon cancer.

Gastric Carcinoma

Quality of life, immunomodulation and safety of adjuvant mistletoe treatment in patients with gastric carcinoma – a randomized, controlled pilot study.

Positive impact on quality of life in patients using mistletoe. Concluded to be safe.

Hepatocellular Carcinoma

Phase II study of viscum fraxini-2 in patients with advanced hepatocellular carcinoma.

Abnoba Fraxini showed survival benefit in HCC.

Mistletoe Extract Viscum Fraxini-2 for Treatment of Advanced Hepatocellular Carcinoma: A Case Series

“This case series of advanced HCC indicates that mistletoe extract VF-2 may have potential biological activity against HCC for selected patients. Research is needed to identify the active compound and predictive markers of response.”

Adenoid Cystic Carcinoma

Tumour response following high-dose intratumoural application of Viscum album on a patient with adenoid cystic carcinoma.

Pancreatic Cancer

Cost-Effectiveness of Real-World Administration of Concomitant Viscum album L. Therapy for the Treatment of Stage IV Pancreatic Cancer

“Conclusion: Based on this CEA analysis, from the hospital’s point of view, the costs per mean month of OS and per mean hospital stay were lower for patients under combinational standard of care plus VA compared to patients receiving standard of care alone for the treatment of stage IV pancreatic cancer. Further prospective cost-effectiveness studies are mandatory to reevaluate our findings.”

Intratumoral Mistletoe (Viscum album L) Therapy in Patients With Unresectable Pancreas Carcinoma: A Retrospective Analysis.

Increased survival in mistletoe group.

Viscum album [L.] extract therapy in patients with locally advanced or metastatic pancreatic cancer: a randomised clinical trial on overall survival.

“Median OS (overall survival) was 4.8 for VaL (Mistletoe) and 2.7 months for control patients (prognosis-adjusted hazard ratio, HR=0.49; p<0.0001). Within the ‘good’ prognosis subgroup, median OS was 6.6 versus 3.2 months (HR=0.43; p<0.0001), within the ‘poor’ prognosis subgroup, it was 3.4 versus 2.0 months respectively (HR=0.55; p=0.0031). No VaL-related adverse events were observed.”

Phase III randomized trial. Positive findings. Note that mistletoe was only given subcutaneously in this trial. 

Long-term tumor-free survival in a metastatic pancreatic carcinoma patient with FOLFIRINOX/Mitomycin, high-dose, fever inducing Viscum album extracts and subsequent R0 resection: A case report

“This case demonstrates the favorable outcome of a patient with metastatic pancreatic cancer following treatment with chemotherapy, integrative medicine, and surgical excision. As other positive outcomes in pancreatic cancer patients are related to inflammatory events, we presume the immunologic effects of VAE to have contributed to the favorable outcome here. Based on this case, and the other positive results of VAE use in pancreatic cancer, further investigations seem highly worthwhile.”

Molecular mistletoe therapy: friend or foe in established anti-tumor protocols? A multicenter, controlled, retrospective pharmaco-epidemiological study in pancreas cancer.

Findings of improved quality of life and survival with mistletoe.

Quality of life of patients with advanced pancreatic cancer during treatment with mistletoe: a randomized controlled trial.

Mistletoe improves quality of life in pancreatic cancer.

Sustained partial remission of metastatic pancreatic cancer following systemic chemotherapy with gemcitabine and oxaliplatin plus adjunctive treatment with mistletoe extract.

Case report

Head and Neck

Cytotoxic effects of mistletoe (Viscum album L.) in head and neck squamous cell carcinoma cell lines.

Bench trial. Positive findings.

Influence of complementary Viscum album (Iscador) administration on microcirculation and immune system of ear, nose and throat carcinoma patients treated with radiation and chemotherapy.

“Adverse effects of radiotherapy and chemotherapy on the microcirculation and the immune system were decreased and reconstitution processes were accelerated by complementary administration of a standardized mistletoe extract (Iscador).”

The case for mistletoe in the treatment of laryngeal cancer.

Case report with discussion. Paywall.

[Influence of ML-1 standardized mistletoe extract on the quality of life in head and neck cancer patients].

Paywall. No difference seen in quality of life.

The effect of an adjuvant mistletoe treatment programme in resected head and neck cancer patients: a randomised controlled clinical trial.

No difference noted in treatment group. Paywall.

Cutaneous Squamous Cell Carcinoma

Durable response of cutaneous squamous cell carcinoma following high-dose peri-lesional injections of Viscum album extracts–a case report.

Appendix

Letter to the editors of the Journal of Cancer Research and Clinical Oncology.

Freuding et al. aimed at reviewing the effects of mistletoe extracts in cancer therapy on overall survival and safety and giving an overview about current research (Freuding et al. 2019). Risk of bias was

declared to have been assessed by means of the Cochrane Risk of Bias Tool (Higgins et al. 2017). The authors conclude that “most studies did not show any effect of mistletoe on survival”, and that “with respect to survival, a thorough review of the literature does not provide any indication to

prescribe mistletoe to patients with cancer.” We argue in the following that both these statements of Freuding et al. are not supported by their own analysis. In their analysis, 14 out of the 26 reviewed publications reported on survival time. Mistletoe extracts numerically prolonged survival in 11 of these 14 studies (79%), with five studies (36%) demonstrating statistically significant prolongation of survival.

Freuding et al. did not perform a meta-analysis in their review. The Cochrane Handbook for Systematic Reviews of Interventions states that “Potential advantages of metaanalyses include an increase in power, an improvement in precision, the ability to answer questions not posed by individual studies, and the opportunity to settle controversies arising from conflicting claims” (Deeks et al. 2017). Given

the fact that 5 out of 14 studies yielded significant survival benefits and further 6 out of the 14 studies showed a favorable trend, a meta-analysis seems indicated to increase power to detect any real differences in survival. The meta-analysis conducted by Ostermann et al. in 2009 on the effects of fermented mistletoe extracts correspondingly came to the conclusion “A random effect meta-analysis estimated the overall hazard ratio at HR = 0.59 (CI 0.53 to 0.66, p<0.0001)”. As a scientific community we should be committed to avoiding communication of false-positive as well as false-negative results. Therefore, the statement that “most studies did not show any effect of mistletoe on survival” seems not justified to us, in view of the available data. Furthermore, risk of bias assessment is largely faulty and

was only insufficiently conducted according to the declared methods (Cochrane Risk of Bias Tool (Higgins et al. 2017)).

In the following, we refer mainly to Table 3 of the publication and the corresponding parts of the text. 

Regarding selection bias (“random sequence generation (RSQ)” and “allocation concealment (AC)” in columns 2 and 3 of Table 3), a ‘high risk of bias’ was attributed to all studies of Grossarth-Maticek et al. However, in all these studies the procedure of randomization has been described by “The principal investigator put two slips of paper (each with the name of one of the patients in the pair) in a hat, and

a masked assistant selected one.” This method is explicitly listed also in the Cochrane handbook in Table 8.5.d (“coin tossing, shuffling cards or envelopes, throwing dice, drawing of lots, …”) as one criterion for an assessment of low risk of RSQ bias. Equivalently, AC can also be assigned only as low risk of bias because each single randomization was part of the enlisting process of a new patient and could therefore

not be known beforehand. Thus, following the Cochrane Risk of Bias Tool, the publications of Grossarth-Maticek et al. show a low risk of selection bias. Table 3 should be corrected accordingly.

In terms of attrition bias, Freuding et al. attribute a high risk to a study on pancreatic cancer (Tröger et al. 2013) in Table 4, despite the fact that all patients were included in the analysis of OS. There were only few events of early study termination (2 and 5 of a total of 220 randomized patients in the mistletoe and control group, respectively). Withdrawn patients were included in the analysis as censored cases in

accordance with a proper analysis of survival times and with the Cochrane handbook (Chapter 9, Section 9.2.6). Therefore, a low risk of attrition bias should be stated. Table 4 should be corrected accordingly.

Freuding et al. report on other risks of bias:

1. “Further, in three studies less patients were included than was calculated in power analysis (Bar-Sela et al. 2013; Longhi et al. 2014; Troger et al. 2013). In these studies, there is a risk that no significant results were detected in spite of groups differing in reality”. This statement may be true for the study of Bar-Sela et al. but not for Longhi et al. 2014 and Tröger et al. 2013, since significant results were achieved in both trials.

2. “Apart from that, in 14 studies either no power analysis was conducted or it was not reported.” We see no basis for a risk of bias due to a missing power calculation. This is confirmed by the Cochrane Handbook stating that “review authors should focus on the mechanisms that lead to bias rather than descriptors of studies that refect only quality” (Higgins et al. 2017).

3. A multiple testing problem is attributed to the publication on pancreatic cancer (Tröger et  al. 2013) in

Table 4. Obviously, this is caused by misunderstanding the sequential study design. Overall survival was the only primary endpoint to be evaluated by a pre-planned testing procedure of three tests to be done with sample sizes of 50%, 75% and 100% of the total patient number, respectively. This statistical approach of group sequential testing using properly adjusted stage-wise error levels holds the overall alpha error level and is accepted without reservation by regulatory bodies (E9 Statistical Principles for Clinical Trials 1998). Since the first interim analysis of this study already revealed a statistically significant difference, no reference to further group-sequential alpha level boundaries had to be done. So, a single test on a single primary parameter was performed, annihilating any multiple testing problem.

Table 4 should be corrected accordingly.

4. “In some studies, there was an unclear therapeutic setting.” The authors pretend that the best supportive care that was administered in a pancreatic cancer trial (Tröger et al. 2013) in both mistletoe and control group “was not described at all”. This is wrong, since it has been reported: “During the trial, all patients received best supportive care (BSC), which was delivered by the trial physicians. The nature of BSC was determined in the trial center; it consisted of the symptomatic treatment of pain, nausea, vomiting, and dyspepsia and was individually adapted at each of the patient’s visits (in Months 1,

2, 3, 6, 9, and 12)” (Tröger et al. 2014). Thus the text of the review should be corrected. 

5. “Finally, it is seen as a risk of bias that there are many studies which, respectively, were written by the same group of authors or several studies even refer, respectively, to a one cohort of patients. There is a high probability that results of different studies from the same group of authors are not independently of each other”. The Cochrane Handbook does not list multiple studies from the same group of authors as a possible source of bias. We suggest that the text of the review should be corrected accordingly.

Abreu, P., R. Sánchez, T. Mut, D. Balaguer, I. Latorre, and H. Rodríguez. “Homeopathic Mistletoe Adverse Reaction Mimics Nodal Involvement in 18F-FDG PET/CT Performed for Evaluation of Response to Chemotherapy in Lymphoma.” Revista Espanola De Medicina Nuclear E Imagen Molecular 36, no. 2 (April 2017): 110–12. https://doi.org/10/gd847p.

Augustin, Matthias, Paul R. Bock, Jürgen Hanisch, Marita Karasmann, and Berthold Schneider. “Safety and Efficacy of the Long-Term Adjuvant Treatment of Primary Intermediate- to High-Risk Malignant Melanoma (UICC/AJCC Stage II and III) with a Standardized Fermented European Mistletoe (Viscum Album L.) Extract. Results from a Multicenter, Comparative, Epidemiological Cohort Study in Germany and Switzerland.” Arzneimittel-Forschung 55, no. 1 (2005): 38–49. https://doi.org/10/gd87nj.

Baek, J. H., Jeon, Y., Han, K. W., Jung, D. H., & Kim, K. O. (2021). Effect of mistletoe extract on tumor response in neoadjuvant chemoradiotherapy for rectal cancer: a cohort study. World journal of surgical oncology, 19(1), 178. https://doi.org/10.1186/s12957-021-02293-4

Bar-Sela, Gil, Hadassah Goldberg, Dan Beck, Amnon Amit, and Abraham Kuten. “Reducing Malignant Ascites Accumulation by Repeated Intraperitoneal Administrations of a Viscum Album Extract.” Anticancer Research 26, no. 1B (February 2006): 709–13.

Bar-Sela, Gil, and Nissim Haim. “Abnoba-Viscum (Mistletoe Extract) in Metastatic Colorectal Carcinoma Resistant to 5-Fluorouracil and Leucovorin-Based Chemotherapy.” Medical Oncology (Northwood, London, England) 21, no. 3 (2004): 251–54. https://doi.org/10/cdkc2p.

Bar-Sela, Gil, Mira Wollner, Liat Hammer, Abed Agbarya, Elizabeth Dudnik, and Nissim Haim. “Mistletoe as Complementary Treatment in Patients with Advanced Non-Small-Cell Lung Cancer Treated with Carboplatin-Based Combinations: A Randomised Phase II Study.” European Journal of Cancer (Oxford, England: 1990) 49, no. 5 (March 2013): 1058–64. https://doi.org/10/f2h5wr.

Bauer, Carolyn, Tilmann Oppel, Franziska Ruëff, and Bernhard Przybilla. “Anaphylaxis to Viscotoxins of Mistletoe (Viscum Album) Extracts.” Annals of Allergy, Asthma & Immunology: Official Publication of the American College of Allergy, Asthma, & Immunology 94, no. 1 (January 2005): 86–89. https://doi.org/10/bv4pkq.

Ben-Arye, Eran, Ofer Lavie, Noah Samuels, Hazem Khamaisie, Elad Schiff, Orit Gressel Raz, and Jamal Mahajna. “Safety of Herbal Medicine Use during Chemotherapy in Patients with Ovarian Cancer: A ‘Bedside-to-Bench’ Approach.” Medical Oncology (Northwood, London, England) 34, no. 4 (April 2017): 54. https://doi.org/10/gd8468.

Beuth, J., H. L. Ko, H. Schneider, S. Tawadros, H. U. Kasper, H. Zimst, and J. M. Schierholz. “Intratumoral Application of Standardized Mistletoe Extracts down Regulates Tumor Weight via Decreased Cell Proliferation, Increased Apoptosis and Necrosis in a Murine Model.” Anticancer Research 26, no. 6B (December 2006): 4451–56.

Beuth, J., B. Schneider, and J. M. Schierholz. “Impact of Complementary Treatment of Breast Cancer Patients with Standardized Mistletoe Extract during Aftercare: A Controlled Multicenter Comparative Epidemiological Cohort Study.” Anticancer Research 28, no. 1B (February 2008): 523–27.

Bock, Paul R., Walter E. Friedel, Jürgen Hanisch, Marita Karasmann, and Berthold Schneider. “[Efficacy and safety of long-term complementary treatment with standardized European mistletoe extract (Viscum album L.) in addition to the conventional adjuvant oncologic therapy in patients with primary non-metastasized mammary carcinoma. Results of a multi-center, comparative, epidemiological cohort study in Germany and Switzerland].” Arzneimittel-Forschung 54, no. 8 (2004): 456–66. https://doi.org/10/gd87nk.

Bock, Paul R., Jürgen Hanisch, Harald Matthes, and Kurt S. Zänker. “Targeting Inflammation in Cancer-Related-Fatigue: A Rationale for Mistletoe Therapy as Supportive Care in Colorectal Cancer Patients.” Inflammation & Allergy Drug Targets 13, no. 2 (2014): 105–11.

Bonamin, Leoni Villano, Aloisio Cunha de Carvalho, and Silvia Waisse. “Viscum Album (L.) in Experimental Animal Tumors: A Meta-Analysis.” Experimental and Therapeutic Medicine 13, no. 6 (June 2017): 2723–40. https://doi.org/10/gd8467.

Bradley, G. W., and A. Clover. “Apparent Response of Small Cell Lung Cancer to an Extract of Mistletoe and Homoeopathic Treatment.” Thorax 44, no. 12 (December 1989): 1047–48.

Braedel-Ruoff, Sibylla. “Immunomodulatory Effects of Viscum Album Extracts on Natural Killer Cells: Review of Clinical Trials.” Forschende Komplementarmedizin (2006) 17, no. 2 (April 2010): 63–73. https://doi.org/10/c84gzc.

Büssing, Arndt. “Immune Modulation Using Mistletoe (Viscum Album L.) Extracts Iscador.” Arzneimittel-Forschung 56, no. 6A (June 2006): 508–15. https://doi.org/10/gd87mh.

Büssing, Arndt, Mechtild Bischof, Wolfgang Hatzmann, Felix Bartsch, Danyl Soto-Vera, Eva-Maria Fronk, Martin Gmeindl, and Gerburg M. Stein. “Prevention of Surgery-Induced Suppression of Granulocyte Function by Intravenous Application of a Fermented Extract from Viscum Album L. in Breast Cancer Patients.” Anticancer Research 25, no. 6C (December 2005): 4753–57.

Büssing, Arndt, Christa Raak, and Thomas Ostermann. “Quality of Life and Related Dimensions in Cancer Patients Treated with Mistletoe Extract (Iscador): A Meta-Analysis.” Evidence-Based Complementary and Alternative Medicine: ECAM 2012 (2012): 219402. https://doi.org/10/cmbwzm.

Cazacu, Mircea, Traian Oniu, Cornel Lungoci, Anca Mihailov, Ana Cipak, Rainer Klinger, Thomas Weiss, and Neven Zarkovic. “The Influence of Isorel on the Advanced Colorectal Cancer.” Cancer Biotherapy & Radiopharmaceuticals 18, no. 1 (February 2003): 27–34. https://doi.org/10/btc5p5.

Cho, Jeong Su, Kook Joo Na, Yongjik Lee, Yeong Dae Kim, Hyo Yeong Ahn, Chang Ryul Park, and Young Chul Kim. “Chemical Pleurodesis Using Mistletoe Extraction (ABNOVAviscum(®) Injection) for Malignant Pleural Effusion.” Annals of Thoracic and Cardiovascular Surgery: Official Journal of the Association of Thoracic and Cardiovascular Surgeons of Asia 22, no. 1 (2016): 20–26. https://doi.org/10/f8swjk.

Cho, Suk Ju, Su Wan Kim, and Jee Won Chang. “Acute Pneumonitis Consequent on Pleurodesis with Viscum Album Extract: Severe Chest Images but Benign Clinical Course.” Multidisciplinary Respiratory Medicine 9, no. 1 (2014): 61. https://doi.org/10/gd847w.

Delebinski, Catharina I., Monika Twardziok, Susann Kleinsimon, Florian Hoff, Katharina Mulsow, Jana Rolff, Sebastian Jäger, Angelika Eggert, and Georg Seifert. “A Natural Combination Extract of Viscum Album L. Containing Both Triterpene Acids and Lectins Is Highly Effective against AML In Vivo.” PloS One 10, no. 8 (2015): e0133892. https://doi.org/10/f72zg5.

Eggenschwiler, Jenny, Andrea Patrignani, Ulrich Wagner, Hubert Rehrauer, Ralph Schlapbach, Lukas Rist, Mac H. Ramos, and Angelika Viviani. “Gene Expression Profiles of Different Breast Cancer Cells Compared with Their Responsiveness to Fermented Mistletoe (Viscum Album L.) Extracts Iscador from Oak (Quercus), Pine (Pinus), White Fir (Abies) and Apple Tree (Malus) in Vitro.” Arzneimittel-Forschung 56, no. 6A (June 2006): 483–96. https://doi.org/10/gd87mk.

Eisenbraun, J., R. Scheer, M. Kröz, F. Schad, and R. Huber. “Quality of Life in Breast Cancer Patients during Chemotherapy and Concurrent Therapy with a Mistletoe Extract.” Phytomedicine: International Journal of Phytotherapy and Phytopharmacology 18, no. 2–3 (January 15, 2011): 151–57. https://doi.org/10/dpf96c.

Elsässer-Beile, Ursula, Christian Leiber, Philipp Wolf, Martin Lucht, Ulrich Mengs, and Ulrich Wetterauer. “Adjuvant Intravesical Treatment of Superficial Bladder Cancer with a Standardized Mistletoe Extract.” The Journal of Urology 174, no. 1 (July 2005): 76–79. https://doi.org/10/d2n46v.

Ernst, Eduard, Katja Schmidt, and Miriam Katharina Steuer-Vogt. “Mistletoe for Cancer? A Systematic Review of Randomised Clinical Trials.” International Journal of Cancer 107, no. 2 (November 1, 2003): 262–67. https://doi.org/10/d6prcn.

Evans, Maggie, Susan Bryant, Alyson L. Huntley, and Gene Feder. “Cancer Patients’ Experiences of Using Mistletoe (Viscum Album): A Qualitative Systematic Review and Synthesis.” Journal of Alternative and Complementary Medicine (New York, N.Y.) 22, no. 2 (February 2016): 134–44. https://doi.org/10/f8kzgb.

Freudlsperger, Christian, Anka Dahl, Juergen Hoffmann, Siegmar Reinert, and Udo Schumacher. “Mistletoe Lectin-I Augments Antiproliferative Effects of the PPARgamma Agonist Rosiglitazone on Human Malignant Melanoma Cells.” Phytotherapy Research: PTR 24, no. 9 (September 2010): 1354–58. https://doi.org/10/dbqnmt.

Friedel, Walter E., Harald Matthes, Paul R. Bock, and Kurt S. Zänker. “Systematic Evaluation of the Clinical Effects of Supportive Mistletoe Treatment within Chemo- and/or Radiotherapy Protocols and Long-Term Mistletoe Application in Nonmetastatic Colorectal Carcinoma: Multicenter, Controlled, Observational Cohort Study.” Journal of the Society for Integrative Oncology 7, no. 4 (2009): 137–45.

Fritz, Peter, Jürgen Dippon, Simon Müller, Sven Goletz, Christian Trautmann, Xenophon Pappas, German Ott, et al. “Is Mistletoe Treatment Beneficial in Invasive Breast Cancer? A New Approach to an Unresolved Problem.” Anticancer Research 38, no. 3 (2018): 1585–93. https://doi.org/10/gc97cg.

Freuding, M., Keinki, C., Micke, O., Buentzel, J., & Huebner, J. (2019). Mistletoe in oncological treatment: a systematic review : Part 1: survival and safety. Journal of cancer research and clinical oncology, 145(3), 695–707. https://doi.org/10.1007/s00432-018-02837-4

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Gaafar, Rabab, Abdel Rahman M. Abdel Rahman, Fatma Aboulkasem, and Ahmed El Bastawisy. “Mistletoe Preparation (Viscum Fraxini-2) as Palliative Treatment for Malignant Pleural Effusion: A Feasibility Study with Comparison to Bleomycin.” Ecancermedicalscience 8 (2014): 424. https://doi.org/10/gcpcn3.

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