List of References
Safety and Risk Aspects of Oncological Mistletoe Therapy
A number of systematic and comprehensive reviews of mistletoe therapy trials focusing on tolerability, adverse effects, hypersensitivity reactions, toxicity studies and discussion concerning potential tumour enhancement have been conducted [20a-23]. Additional systematic reviews include case reports on adverse effects [44, 45] and toxicology [43]. A recent publication compiled various adverse effect reports [40].
Mistletoe therapy has generally proven to be well-tolerated. Localised reactions at the injection site (redness, swelling, itching and pain) occur frequently and influenza-like symptoms may develop occasionally. These reactions mostly appear at the beginning of treatment or after increase in dosage; they are dose-dependent and, as a rule, subside quickly and spontaneously. Occasionally allergic reactions may develop and hypersensitivity to other substances can be enhanced by mistletoe extracts.
In more detail:
Tolerability and safety in clinical studies 
All available prospective and retrospective clinical mistletoe studies (with and without comparison groups, oncological and non-oncological) and specific tolerability studies were examined systematically for data on adverse effects. Case reports were taken into consideration only when specifically related to side effects. While most of the trials focused on subcutaneous administration of mistletoe extracts, there are also trials on intravenous and per infusionem administration, as well as intra-arterial, intratumoural, peritumoural, intrapleural, intraperitoneal and intrapericardial applications and treatment during pregnancy. More than 10,000 patient cases have been documented in these studies, corresponding to several millions of mistletoe injections. Details are given in the overview [21-23]. The findings are summarised as follows:
- Mistletoe therapy was well tolerated in all studies.
- Organ toxicity, liver-, kidney toxicity or biochemical changes (insofar as these were measured) were not observed.
- Frequently seen in a dose-dependent manner (especially at the beginning of therapy) were local reactions at the injection site - redness, swelling, itching, and pain. In rare cases, a minor localised bacterial infection was observed. These local reactions can intensify during a concomitant chemotherapy [48]. Dose-dependent are also flue like symptoms and pyrexia, which frequently occur when mistletoe extracts are administered by infusion. Symptoms are more marked with high-dosage therapy. Generally, these symptoms cause no problems and heal rapidly. Eosinophilia and other changes in immunological parameters are also frequent (see Basic Research). According to the anthroposophical therapeutic concept, these reactions are desirable and are used for adjustment of individual dosage levels. Mistletoe infusions are also used specifically for fever therapy [20].
- In one of four studies of intraperitoneal mistletoe applications, within only a few weeks of commencing treatment an ileus caused by a tumour conglomerate developed in two patients. Therefore caution has been advised with this particular kind of administration [36].
- In the treatment of AIDS with mistletoe extracts, a dose-dependent increase in inflammatory diseases has been documented. (Review [21]).
- Occasionally, allergic or allergoid side effects can develop. Two prospective clinical trials each reported one hypersensitivity reaction during treatment with Eurixor® [10] and one incidence of an angio-oedema and urticaria developing during treatment with Helixor [38]. A comprehensive retrolective trial of Iscador® therapy reported an allergic reaction, a Quincke’s oedema and a pancreatitis relapse, all of which were mild to moderate and subsided spontaneously [2]. A further prospective trial mentioned side effects but did not distinguish between those resulting from Interferon treatment or mistletoe therapy in two comparative groups [24].
- A retrospective study reported systemic adverse reactions on three occasions following intratumoural injection: flushing, wheals, diarrhoea, nausea and vomiting [36]. These symptoms subsided rapidly in all cases.
- No serious side effects were observed in any of the studies specifically testing tolerability (Review [21]).
- It should also be mentioned in this context that several studies show a reduction in side effects of conventional therapies during concomitant mistletoe therapy (see Prospective Comparative Studies).
A detailed Phase-I trial concerning safety and toxicity of mistletoe extracts (Helixor) and possible interactions with standard chemotherapeutics (Gemcitabine) in patients with advanced tumours is currently being conducted by the National Centre for Complementary and Alternative Medicine (National Institute of Health) in the USA [34]. A first interim evaluation found that mistletoe extracts were well tolerated and have no dose-limiting toxicity; they also do not affect the Gemcitabine plasma concentrations [35].
Case reports of allergic reactions or other specific side effects
- Allergic or allergoid reactions have been published in some case reports which, in exceptional cases, were serious, with Quincke’s oedema, dyspnoea and even anaphylactic shock.
- Within a period of twenty years up until the year 2000, eight such cases [1, 10, 13, 31, 37, 39, 41, 45, 49] have been noted, documenting occurrences of anaphylactic reaction, acute asthmatic response, allergic colitis, allergic rhinitis, generalised erythema with necrotic areas, high fever, urticaria and Quincke’s oedema during the course of mistletoe therapy. Two further reports describe the development of sarcoidosis and localised NHL-nodules at the injection site, respectively, as a side effect of mistletoe therapy (see below). Referring to these eight plus two cases, Stein’s systematic evaluation showed the causal relationship to mistletoe therapy as the triggering agent as being unclear in three cases, possible in one case, and probable or very probable in six cases [45].
- Since then a further six case reports of serious allergic or allergoid reactions have been published: five of them describe allergic or allergoid reactions [3, 12, 17]. The sixth case report presents a hypersensitivity reaction to a chemotherapeutic agent (oxaliplatin) which was enhanced after injection of mistletoe extract, in fact after an extreme dose intensification (50 times) [16b]. Such massive increase in dosage is usually disadvised. Nonetheless, mistletoe extracts can enhance the immunological response to co-administered antigens (they possess adjuvant activity and can enhance the activity of vaccines) [20].
- Furthermore, 43 cases of side effects reported during mistletoe treatment with Helixor were subjected to immunological investigation by Stein and Berg in the immunopathology laboratory at Tübingen University. There were sixteen cases of localised reactions (redness, swelling, itching and exanthema) and 27 cases of systemic reactions (generalised urticaria, Quincke’s oedema, rhinitis, conjunctivitis, high fever, serious myalgia and anaphylactic reaction). The side effects were linked to mistletoe therapy in 34 cases; a link was improbable in nine cases. Following reexposition to mistletoe extracts, symptoms reoccurred in some patients whereas in others there were no reoccurrences [44-46].
Further assessments
Another review of adverse events (AEs) occurring with a temporal relationship to mistletoe therapy has been published recently [40]. 25 out of 138 clinical studies were selected according to criteria that were not specified, thirteen of which (prospective comparative studies) gave information about AEs. The review summarised a further fourteen otherwise selected studies of different designs, which also contained information about AEs. (All of these studies have been considered in the above mentioned reviews.) Case reports with AEs were also collected; these are either included in the aforementioned case reports or describe local and systemic reactions or immunological changes (e.g. eosinophilia). Furthermore, the pharmaceutical authorities were contacted. Three of them had been notified of AE. However, as the causal relationship to mistletoe therapy was not investigated in these AEs, it is not possible to distinguish between either adverse reactions to mistletoe therapy or the effects of other therapies and complications or problems caused by the primary disease or other influences. Consequently, these AE reports are not really usable.
For reviews on toxicology, see [21, 43].
Reports without an empirical basis
Several toxicological publications have discussed the striking discrepancy between the traditional image of mistletoe as a dangerous poisonous plant (‘kiss of death’) and the small number of empirical references available to support - or refute - this notion [25]. This old wives’ tale of ill-fortune possibly originates in Nordic mythology where a spear of mistletoe was used to kill the God Baldur. Numerous horror stories about the dangers of taking mistletoe are also to be found in present-day literature; these are not to be listed or analysed here because of missing or misinterpreted data. An editorial about mistletoe therapy in the European Journal of Cancer [9] is a good example of this, quoting: ‘Contrary to what proponents want us to believe, there are several reports of adverse side effects and serious complications after mistletoe therapy.’ This statement is underpinned with a list of 26 side effects and complications of mistletoe therapy, including not only the well-known immunomodulatory effects such as local reactions, mild fever or slight increase in leucocytes, or known effects such as hypotension or allergic reactions, but also a series of serious effects such as cardiac arrest, coma, death, delirium, hallucinations, hepatitis, pancreatic bleeding, seizures, diarrhoea, gastroenteritis, dehydration, etc. [9]. In tracing the cited references back to the original literature, one finds the following:
- Toxicity experiments with isolated viscotoxins and mistletoe lectins carried out on animals in order to determine toxic and lethal dosage levels;
- Cases of accidental consumption of the leaves and berries of Phoradendron [14], the ‘American mistletoe’; in actual fact, this species is not used for mistletoe therapy and, moreover, experts consider American Mistletoe to be harmless if consumed [25];
- A case of a ‘mistletoe hepatitis’ following ingestion of herbal tablets [15]; in the end, however, it emerged that these tablets did not contain mistletoe extracts [7];
- A report dating from 1874 about a boy suffering from loss of consciousness and vomiting; the regurgitations contained, amongst other things, eight mistletoe berries [8]. Considering that much larger quantities of mistletoe berries are often consumed without such adverse effects, this report has not been taken seriously by experts.
For details see [20].
Therefore the dramatic effects claimed in the above-mentioned editorial related to toxicity research on animals and to effects caused by substances other than mistletoe extracts. There was no empirical basis for relating these effects to oncological mistletoe treatment. Recently, the author again published similar statements [9a], which, however, again were not based on valid empiric observations [21a].
Tumour enhancement
Potential tumour enhancement as an effect of mistletoe treatment has often been debated in recent years. The sources of this discussion are as follows:
- Repeatedly Gabius et al have published statements to the effect that mistletoe extracts could stimulate tumour growth. This assertion has been substantiated with speculative conclusions drawn from cytokine experiments conducted in other contexts. However, experiments with single cytokines have hardly any relevance for the in vivo reality, as the results are highly context-dependent and could even support the claim that a cross country run and the consumption of a chocolate biscuit are potentially and dramatically dangerous (review, see [20a]). After many years of speculative debate, three experiments by Gabius and co-authors followed - in vitro [11] and in the animal model [11, 47] - to prove stimulation of carcinogenesis and tumour cell proliferation [28 - 30]. However, reports of methodological and experimental problems in these experiments have subsequently cast into doubt the conclusions of tumour enhancement. Finally, an independent investigation was unable to verify those results but, conversely, showed tumour-inhibiting effects [5, 18a-18c, 20a, 33].
- A few years ago there were repeated reports in the press of a melanoma study which had observed an increase in brain metastases during mistletoe therapy [4, 16a, 42]. These reports had great resonance even though the trial and study details were not yet made available. In the public discussion about these reports, the probability of a detection-bias was pointed out, that can generate the impression of early or frequent occurrences of brain metastases without this actually being the case. When the study was finally published eight years after the first of these intermediate reports, it made no further mention of brain metastases enhancement [24]. Nevertheless, this study gave rise to an elaborate GEP-conform retrolective cohort study involving a large collective of melanoma patients who had been treated with mistletoe extracts. This study, carried out at the Freiburg University Clinic, could not confirm the suspicion of metastases enhancement; on the contrary, it pointed at a reduction in metastatic spread and a lengthening of disease-free periods and survival time [2]. For further particulars see the detailed discussion of the respective studies: Kleeberg et al 2004 and Augustin et al 2005, or see [20a, 22, 23].
- A patient with advanced, therapy-refractive centrocytic Non-Hodgkin lymphoma with blood lymphocytosis, previously treated with conventional therapies on several occasions, developed indurations at the injection site while under treatment with mistletoe injections. Histological investigation confirmed that the indurations contained infiltrations of lymphoma cells. Following discontinuation of mistletoe therapy, the disease - already advanced prior to administration of mistletoe extracts - continued to progress. Six weeks later the patient developed a lung infection and he passed away as a result of this. The indurations on the abdominal wall were interpreted as subcutaneous manifestations of lymphoma activated by the high local concentration of mistletoe extract which had exerted a proliferative stimulus on the lymphoma cells, the latter reaching the abdominal wall during blood lymphocytosis [13]. - This rationale did not, however, remain unchallenged. While the nodules did not grow further following discontinuation of mistletoe therapy (despite systemic progression of the disease), location and time correspondence indicates they were certainly induced by the mistletoe injections. On the other hand, however, this could also have been a case of the usual local reactions associated with subcutaneous mistletoe administration. As this patient had ‘pronounced T-lymphocytopenia’ and advanced disease with blood lymphocytosis, he probably only had lymphoma cells with which to respond to any locals stimulus (unfortunately the report provided no information regarding differentiation of peripheral blood leucocytes), and therefore the indurations were unavoidably infiltrated with this kind of cell [6, 45].
- Shortly after the above-mentioned report appeared, a further case of a patient with centroblastic-centrocytic NH lymphoma was published in the Deutsche Medizinische Wochenschrift (DMW) [German Medical Weekly]. This patient had been treated with mistletoe extracts for over twelve years. The lymphoma frequently went into remission while the patient was receiving mistletoe therapy whereas during the therapy pauses the disease continued to progress [26]. A recent publication also described positive long-term outcomes for patients with follicular NH lymphoma receiving treatment with the mistletoe extract, Iscador® P [27].
- A review of the large number of available in vitro experiments, of approx. 110 animal experiments investigating anti-tumoural effects and the now well-over 100 clinical studies [19, 19a, 20, 32, 38] could not find any evidence of tumour enhancement.
Hence, there is no solid evidence of tumour enhancement up to the present day. (For details regarding the empirical data in this context, see [20a].)
Summary and comments
Overall, the studies show that mistletoe therapy is very well-tolerated. Harmless local reactions are frequent and flue-like symptoms may arise occasionally; both are dose-dependent. Allergic reactions may also develop occasionally. Furthermore, hypersinsitivity reactions to other substances can be enhanced by co-administered mistletoe extracts. Side effects of mistletoe extracts can occur especially after an intense increase of dosage. Treatment with high-dosage or intravenous, intrapleural, intraperitoneal, intrapericardial, intratumoural, intra-arterial applications of mistletoe extracts should only be managed by specialists. With this caveat, these methods of administration can also be considered to be safe. To date there is no solid evidence of tumour enhancement due to mistletoe therapy.
Investigations concerning safety and risks are for the most part systematically and clearly described and thoroughly substantiated. However, some of the reports of side effects contain polemics, making it difficult to distinguish between empirical observations and personal opinion.
Gunver S. Kienle, MD
Last Modified:
March 2009
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