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
“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
- Mistletoe is a semiparasitic plant that grows on several types of trees such as apple, oak, pine, and elm (see Question 1).
- Mistletoe is one of the most widely studied complementary and alternative medicine therapies in people with cancer. In Europe, mistletoe extracts are among the most prescribed drugs for patients with cancer (see Question 1).
- Mistletoe extracts are usually given by injection under the skin or, less often, into a vein, into the pleural cavity, or into a tumor (see Question 2).
- Few side effects have been reported from the use of mistletoe extracts (see Question 5).
- The U.S. Food and Drug Administration (FDA) has not approved mistletoe as a treatment for cancer or any other medical condition (see Question 6).
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.”
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.
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.”
“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.”
“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. “
“Supportive ‘mistletoe therapy’ seems safe and beneficial for QoL in adult patients with solid tumours”
“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
PDQ US Government Review of Mistletoe
Preclinical and clinical effects of mistletoe against breast cancer.
Positive survival noted but difficulty with data/methodology also noted.
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.”
“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
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.
“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.
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.
No induction of pro inflammatory CRP or IL-6 in healthy volunteers with subcutaneous dosing.
“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.”
Quality of Life
“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.”
“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.
Improved quality of life demonstrated.
Brain Cancer
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.
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.
Mistletoe doubled survival in treatment group.
“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
“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
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).
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.
“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.
Paywall
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).
Only effect noted in this trial was that mistletoe group tolerated more chemotherapy.
Positive findings of prolonged survival.
Pleurodesis
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.”
Stimulation of antitumour immunity by intrapleural instillation of a Viscum album L. extract.
Mistletoe safe and effective for malignant pleural effusion.
Mistletoe safe and effective for pleurodesis.
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.
This study showed no evidence of interaction between mistletoe and immune checkpoint inhibitors.
No interaction found.
Lymphoma and Leukemia
Not clear this should be considered an adverse reaction but is an important consideration in mistletoe use.
Bench trial showing positive results.
Bench Trial
Bench Trial
Bench Trial
Case report. Paywall.
2 patients treated with high dose mistletoe alone with total regression of cutaneous B-Cell Lymphoma.
12 year old girl with remission after mistletoe.
Case report. Article not available.
Multiple Myeloma
Bench test. Mistletoe more effective than conventional chemotherapy.
Intratumoral Mistletoe Therapy
“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.”
Mouse model demonstrating key concepts of intratumoral mistletoe injection.
Case report. Abstract only.
Intra-Peritoneal Injection
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
Adverse effects were mild and anticipated.
Generally safe with fevers reaching >38.5C
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
Rare tumor with poor prognosis held in check with mistletoe.
Breast Cancer
“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.”
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.
“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.
“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.”
Consistent positive survival results and positive quality of life results.
“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.”
Paywall
Presurgical Iscador prevented suppression of immune system as compared to controls.
“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.”
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).
Paywall. No difference noted in treatment group.
Mistletoe improves quality of life significantly.
Increased quality of life demonstrated.
Increased quality of life in Iscador group.
Positive findings for quality of life with mistletoe.
Paywall. Retention of quality of life with mistletoe.
Improved quality of life with mistletoe.
Mistletoe improved quality of life and lengthened relapse free intervals.
Ovarian Cancer
Paywall
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.
Mouse study.
Cervical Cancer
Paywall. Positive impact on survival and quality of life.
“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.”
Remission from abnormal cervical pathology CIN1 and CIN2 with mistletoe.
In Polish, abstract in English. CIN changes in cervix impacted favorably by Iscador.
Uterine Cancer
Increased survival and quality of life with mistletoe.
Mesothelioma
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
Patient used mistletoe treatment alone and had complete remission.
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.
“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.”
Iscador M compared to 2 other investigational drugs, compared to control. No difference in recurrence or survival noted. Paywall.
Bench study.
Neuroendocrine Tumors
“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
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
Bladder Cancer
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
Bench Trial
Adjuvant intravesical treatment of superficial bladder cancer with a standardized mistletoe extract.
Pilot study showing similar efficacy to adjuvant BCG.
No effect seen in treatment group.
Renal Cell Carcinoma
A phase II trial with iscador. No difference noted in treatment groups. All patients enrolled as stage 4. Nonrandomized study.
Colon Cancer
“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.”
Iscador helped reduce cancer related fatigue
The influence of isorel on the advanced colorectal cancer.
Isorel (a mistletoe extract) beneficial for advanced colorectal cancer.
Positive survival effects noted.
No effect seen in tumor progression in resistant stage 4 colon cancer.
Gastric Carcinoma
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
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.”
Increased survival in mistletoe group.
“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.
“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.”
Findings of improved quality of life and survival with mistletoe.
Mistletoe improves quality of life in pancreatic cancer.
Case report
Head and Neck
Bench trial. Positive findings.
“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.
Paywall. No difference seen in quality of life.
No difference noted in treatment group. Paywall.
Cutaneous Squamous Cell Carcinoma
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.
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