Research and clinical studies are important

for developments in mistletoe therapy.

Read about case reports, clinical trials and systematic reviews.

We have a small selection of the most up to date reports, trials and reviews on mistletoe therapy. If you are interested in finding out more about specific cancers, you can also visit the German Mistel Die research website.

Updates


April 2017: Mistletoe & breast cancer pilot randomised controlled trial 
We are very pleased to announce that a pilot randomised controlled trial for mistletoe therapy in the UK has been given the go ahead. Find out more including how to support the research by visiting the campaign page.

Mistletoe Therapy and Cancer - an Overview 2014


Produced by a research team at the University of Witten/Herdecke, this paper summarises all the recent evidence on Mistletoe Therapy with regards to safety, effectiveness and impact on Quality of Life and Life Expectancy.

This is useful reading for those who wish to gain an oversight of mistletoe evidence available.

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Case Studies


The case for mistletoe in the treatment of laryngeal cancer

Shakeel M, Trinidade A, Geider S, Ah-See KW
The Journal of Laryngology & Otology. March 2014; 128: 302–306.

ABSTRACT
Introduction: Complementary and alternative medicine usage, though rising, remains largely devoid of a sound scientific basis; however, there is increasing evidence to support its use in cancer therapy.
Aim: To present the case of a patient with laryngeal carcinoma who made a full recovery following mistletoe therapy, despite failing to respond to chemoradiotherapy and salvage laryngectomy.
Design: Case report with relevant literature review.
Results: The patient developed extensive, unresectable stomal recurrence, and it was deemed appropriate to supply palliative care only. Following treatment with mistletoe extract injections after palliative radiotherapy, he recovered fully and was eventually discharged from care.
Conclusion: The benefit of mistletoe in laryngeal cancer treatment requires further investigation, and might be considered in selected patients, as an adjunct or when other conventional therapies have failed.

Please contact Mistletoe Therapy UK, if you would like a copy of the full paper.

Durable Regression of primary Cutaneous B-Cell Lymphoma Following Fever-inducing Mistletoe treatment: Two Case Reports

Orange M, Lace A, Fonseca MP, von Laue BH, Geider S & Kienle GS.
Global Advances in Health and Medicine. March 2012 1(1): 18-25

ABSTRACT
Background: Mistletoe is a complementary cancer treatment that is widely used, usually in addition to and alongside recommended conventional cancer therapy. However, little is known about its use, effectiveness, and safety in the treatment of cutaneous lymphoma.
Case Report: Two patients with primary cutaneous B-cell lymphoma (pT2bcNxM0 follicle center and pT2ac-NxM0 marginal zone) either declined or postponed recommended conventional treatment and received high-dose, fever-inducing mistletoe treatment; a combination of intratumoral, subcutaneous, and intravenous application was given; and one patient also underwent whole-body hyperthermia. The lymphoma regressed over a period of 12 and 8 months, respectively, and after administration of a cumulative dose of 12.98 g and 4.63 g mistletoe extract, respectively. The patients are in remission to date, 3.5 years after commencement of treatment. Neither patient received conventional cancer treatment during the entire observation period.

Please contact Mistletoe Therapy UK, if you would like a copy of the full paper.

Durable tumour responses following primary high dose induction with mistletoe extracts: Two case reports

Orange M, Fonseca A, Lace A, von Laue HB & Geider S
European Journal of Integrative Medicine, June 2010; 2(2): 63–69

ABSTRACT
Introduction: Viscum album L. extracts (VAEs) are widely used in the complementary treatment of cancer, to improve quality of life of cancer patients, commonly using subcutaneous application of low doses of VAEs.
Case presentations: Two patients were treated with VAE (AbnobaViscum®) alone, using a combination of intratumoural, subcutaneous and in one case intravenous administration. A 75-year-old lady with relapsed Merkel cell cancer – a rare and aggressive neuro-endocrine cancer of the skin – declined radiotherapy, and was treated with VAE alone over 9.8 months, using a total of 5.8G VAE, averaging 592 mg/VAE/month (>300,000 ng mistletoe lectin (ML)/month; >2300 μg viscotoxin (VTX)/month); the 3 cm tumour was impalpable after 4 months and she continues to be in complete remission after 3 years. A 50-year-old postmenopausal woman with asynchronous bilateral breast cancer (right breast: grade 1, hormone sensitive; left breast: grade 3, hormone insensitive and HER2-positive ductal carcinoma), declined all conventional cancer treatment. She was treated with VAE alone for 2.6 years, with a total of 8.9G VAE, averaging 290 mg/month (>150,000 ng ML/month; >1200 μg VTX/month); she had complete responses of both tumours after 31 months of intratumoural and subcutaneous VAE application, and remains in remission after 4 years.
Conclusions: Durable tumour regression occurred in 2 patients following treatment with VAE, used in higher than generally used doses and combining different applications. Both patients had no other established cancer therapies. Further studies are required to define the strategic role of VAE and its different applications, safety and efficacy.

Please contact Mistletoe Therapy UK, if you would like a copy of the full paper.

 

Clinical Trials


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

Tröger W, Galun D, Reif M, Schumann A, Stankovic N, Milicevic M
European Journal of Cancer. Dec 2013; 49(18): 3788-97

ABSTRACT
Background: The unfavourable side-effects of late-stage pancreatic cancer treatments call for non-toxic and effective therapeutic approaches. We compared the overall survival (OS) of patients receiving an extract of Viscum album [L.] (VaL) or no antineoplastic therapy.
Methods: This is a prospective, parallel, open label, monocentre, group-sequential, randomised phase III study. Patients with locally advanced or metastatic cancer of the pancreas were stratified according to a binary prognosis index, composed of tumour stage, age and performance status; and were evenly randomised to subcutaneous injections of VaL extracts or no antineoplastic therapy (control). VaL was applied in a dose-escalating manner from 0.01 mg up to 10mg three times per week. Patients in both groups received best supportive care. The primary end-point was 12-month OS, assessed in a group-sequential analysis.
Findings: We present the first interim analysis, including data from 220 patients. Baseline characteristics were well balanced between the study arms. Median OS was 4.8 for VaL 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.
Conclusion: VaL therapy showed a significant and clinically relevant prolongation of OS. The study findings suggest VaL to be a non-toxic and effective second-line therapy that offers a prolongation of OS as well as less disease-related symptoms for patients with locally advanced or metastatic pancreatic cancer.

Please contact Mistletoe Therapy UK, if you would like a copy of the full paper.

 

 

Systematic Reviews


Mistletoe therapy in oncology

Horneber M, Bueschel G, Huber R, Linde K, Rostock M.
Cochrane Database of Systematic Reviews. April 2008, (2): CD003297

ABSTRACT
Background: Mistletoe extracts are commonly used in cancer patients. It is claimed that they improve survival and quality of life (QOL) in cancer
patients.
Objectives: To determine the effectiveness, tolerability and safety of mistletoe extracts given either as monotherapy or adjunct therapy for patients
with cancer.
Main Results: Eighty studies were identified. Fifty-eight were excluded for various reasons, usually as there was no prospective trial design with randomised treatment allocation. Of the 21 included studies 13 provided data on survival, 7 on tumour response, 16 on measures of QOL or psychological outcomes, or prevalence of chemotherapy-related adverse effects and 12 on side effects of mistletoe treatment; overall comprising 3484 randomised cancer patients. Interventions evaluated were 5 preparations of mistletoe extracts from 5 manufacturers and one commercially not available preparation. The general reporting of RCTs was poor. Of the 13 trials investigating survival, 6 showed some evidence of a benefit, but none of them was of high methodological quality. The results of two trials in patients with melanoma and head and neck cancer gave some evidence that the used mistletoe extracts are not effective for improving survival. Of the 16 trials investigating the efficacy of mistletoe extracts for either improving QOL, psychological measures, performance index, symptom scales or the reduction of adverse effects of chemotherapy, 14 showed some evidence of a benefit, but only 2 of them including breast cancer patients during chemotherapy were of higher methodological quality. Data on side effects indicated that, depending on the dose, mistletoe extracts were usually well tolerated and had few side effects.
Author's Conclusions: The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak. Nevertheless, there is some evidence that mistletoe extracts may offer benefits on measures of QOL during chemotherapy for breast cancer, but these results need replication. Overall, more high quality, independent clinical research is needed to truly assess the safety and effectiveness of mistletoe extracts. Patients receiving mistletoe therapy should be encouraged to take part in future trails.

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

Kienle GS, Kiene H.
Integrative Cancer Therapy. June 2010; 9(2):142-157.

ABSTRACT
Objective: To evaluate controlled clinical studies on the efficacy and effectiveness of Viscum album for quality of life (QoL) in cancer.
Materials & methods: The authors conducted a search of 7 electronic databases and reference lists and had extensive consultations with experts. They carried out a criteria-based assessment of methodological study quality.
Results: The authors identified 26 randomized controlled trials (RCTs) and 10 non-RCTs that investigated the influence of V album extracts (VAEs) on QoL in malignant diseases; 26 studies assessed patient-reported QoL. Questionnaires were mostly well established and validated. Half of the studies investigated VAEs concomitant with chemotherapy, radiotherapy, or surgery. Some studies were well designed, whereas others had minor or major methodological weaknesses. Among the 26 RCTs, 22 reported a QoL benefit, 3 indicated no difference, and 1 did not report any result. All the non-RCTs reported a QoL benefit. Of the studies with higher methodological quality, most reported a benefit, whereas 1 found no difference. Improvements were mainly in regard to coping, fatigue, sleep, exhaustion, energy, nausea, vomiting, appetite, depression, anxiety, ability to work, and emotional and functional well-being in general and, less consistently, in regard to pain, diarrhea, general performance, and side effects of conventional treatments. VAEs were well tolerated.
Conclusions: 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.

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Complementary cancer therapy: a systematic review of prospective clinical trials on anthroposophic mistletoe extracts.

Kienle GS, Kiene H.
European Journal of Medical Research. March 2007; 12(3):103-119.

ABSTRACT
Background: Anthroposophic Mistletoe therapy is a widely used complementary cancer treatment.
Objective: To evaluate prospective clinical trials on the effectiveness of anthroposophic mistletoe therapy for cancer.
Design: Systematic review.
Material & methods: Search of 9 electronic databases, reference lists and extensive expert consultations. Criteria-based assessment of methodological study quality.
Results: 16 randomized (RCT) and 9 non-randomized (N-RCT) controlled trials were identified that investigated mistletoe treatment of malignant diseases. Statistically significant benefit for survival was reported in 8 of 17 trials (in 5 of 10 RCTs), for disease-free survival and tumour recurrence in none of 2 RCTs, for remission of tumour and malignant effusion in 1 RCT and 1 N-RCT of 4 controlled trials, for quality of life (QoL) in 3 of 5 RCTs, and for QoL and reduction of side effects of cytoreductive therapies (chemotherapy, radiation or surgery) in 5 of 7 trials (3 of 5 RCTs). Methodological quality of the controlled trials differed substantially; some had major limitations while others were reasonably well conducted. 12 single-arm cohort studies were identified. 5 of 7 studies found substantial tumour remission in various cancers, one study reported remission of CIN, and 4 studies remission of malignant pleural effusion or ascites. Quality of reporting in cohort studies was mostly reasonably good. Mistletoe application was well tolerated.
Conclusions: Regarding quality of studies and consistency of results, the best evidence for efficacy of mistletoe therapy exists for improvement of QoL and reduction of side effects of cytotoxic therapies (chemotherapy, radiation). Survival benefit has been shown but not beyond critique. Tumour remissions are described in cohort studies that investigate the application of high dose or local mistletoe extracts. As several reasonably well-conducted studies indicate beneficial effects, further properly designed trials should be encouraged to investigate clinical efficacy and its possible dependency on the mode of application.

Please contact Mistletoe Therapy UK, if you would like a copy of the full paper.