clinical trial
Due to the common adverse effects of motion sickness pharmaceuticals (e.g., drowsiness), medication options to treat the condition are limited. Thus many non-pharmacological therapies are being advocated for it. One of them is osteopathy.
The purpose of this study was to explore the potential utility of a nonpharmaceutical method for motion sickness prevention, specifically an osteopathic manipulative technique (OMT). A novel OMT protocol for the reduction of motion sickness symptoms and severity was evaluated using a sham-controlled, counterbalanced, between-subjects study design. The independent variable was OMT treatment administered prior to the motion sickness-inducing procedure (rotating chair). The primary dependent measures were total and subscale scores from the Motion Sickness Assessment Questionnaire.
The OMT treatment group experienced significantly fewer gastrointestinal (mean scores postprocedure, treatment M = 20.42, sham M = 41.67) and sopite-related (mean scores postprocedure, treatment M = 12.81, sham M = 20.68) symptoms than the sham group while controlling for motion sickness susceptibility. There were no differences between groups with respect to peripheral and central symptoms.
The authors concluded that the results suggest that the treatment may prevent gastrointestinal (nausea) and sopite-related symptoms (sleepiness). These preliminary findings support further exploration of OMT for the prevention of motion sickness. A more precise evaluation of the mechanism of action is needed. Additionally, the duration of the effects needs to be investigated to determine the usefulness of this technique in training and operational settings.
Motion sickness is one of those conditions for which many forms of so-called alternative medicine (SCAM) have been tried and found in dodgy studies to be promissing, e.g.:
And now even OMT!
But before we rush into doing further research on this topic, we should perhaps ask whether the trial really does show OMT to be effective. Unfortunately, the article is behind a paywall, and I can therefore only speculate and ask whether the sham procedure was credible. Was the success of patient-blinding tested? I suspect it wasn’t. If that is so, it could mean that the OMT itself was not the reason for the results but that patient expectation caused the reported outcomes.
In any case, if nothing else, this paper shows yet again that the notion of OMT being an option purely for spinal problems is fantasy. Its advocates try everything to get it accepted as a cure all.
Despite effective vaccines, there is still a need for effective treatments for COVID, especially for people in the community. Dietary supplements have long been used to treat respiratory infections, and preliminary evidence indicates some may be effective in people with COVID-19. This study tested whether a combination of vitamin C, vitamin D3, vitamin K2 and zinc would improve overall health and decrease symptom burden in outpatients diagnosed with COVID-19.
Participants were randomised to receive either vitamin C (6 g), vitamin D3 (1000 units), vitamin K2 (240 μg) and zinc acetate (75 mg) or placebo daily for 21 days and were followed for 12 weeks. An additional loading dose of 50 000 units vitamin D3 (or placebo) was given on day one. The primary outcome was participant-reported overall health using the EuroQol Visual Assessment Scale summed over 21 days. Secondary outcomes included health status, symptom severity, symptom duration, delayed return to usual health, frequency of hospitalisation and mortality.
A total of 90 patients (46 control, 44 treatment) were randomised. The study was stopped prematurely due to insufficient capacity for recruitment. The mean difference (control-treatment) in cumulative overall health was -37.4 (95% CI -157.2 to 82.3), p=0.53 on a scale of 0-2100. No clinically or statistically significant differences were seen in any secondary outcomes.
The authors concluded that, in this double-blind, placebo-controlled, randomised trial of outpatients diagnosed with COVID-19, the dietary supplements vitamin C, vitamin D3, vitamin K2 and zinc acetate showed no clinically or statistically significant effects on the documented measures of health compared with a placebo when given for 21 days. Termination due to feasibility limited our ability to demonstrate the efficacy of these supplements for COVID-19. Further research is needed to determine clinical utility.
In several ways I am puzzled by this study. On the other hand, I should congratulate the naturopathic authors for honestly reporting such a squarely negative result. One could, of course, argue that the study was under-powered and that thus the findings are not conclusive. However, the actual survival curve depicting the results show clearly that there was not even the tiniest trend for the supplement to show any effect. In other words, a larger sample would have most likely yielded the same result.
Participants randomised to the treatment arm received:
- Vitamin D3 50 000 units orally once on day 1 of the study (capsule).
- Vitamin K2/D3 120 μg/500 units orally two times per day for 21 days (liquid).
- Vitamin C/Zinc acetate 2 g/25 mg orally three times daily for 21 days (capsule).
I fail to understand why the researchers might have conceived the hypothesis that such a mixture would be effective. Only 90 of a planned 200 participants were enrolled in this study which ran between September 2021 and April 2022. I fail to understand why recruitment was so poor that the study eventually had to be aborted. My speculation is that the naturopaths in charge of running the trial were too inexperienced in conducting such research to make it a success.
The study was supported by the Ottawa Integrative Cancer Centre Foundation and by Mavis and Martin Sacher. All investigational products for this study were provided in-kind by New Roots Herbal. Perhaps in future these sponsors should think again before they support amateurs pretending to be scientists?
Certain aspects of yoga can be used as a non-pharmacological conservative therapeutic approach to the management of chronic low back pain (CLBP). This overview summarized and evaluated data from current systematic reviews (SRs) on the use of yoga for CLBP.
The researchers searched SRs on the use of yoga for CLBP in nine electronic databases from inception to September 2023. The methodological quality was evaluated using the Assessment of Multiple Systematic Review Scale-2 (AMSTAR-2). The reporting quality of the included SRs was evaluated using the Preferred Reporting Item for Systematic Review and Meta-Analysis-2020 (PRISMA-2020), and the quality of data was graded using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Two independent researchers performed the screening, data extraction, and quality assessment process of SRs.
A total of 13 SRs were included. The results of the AMSTAR-2 indicated that the methodological quality of the included studies was relatively low. The PRISMA-2020 checklist evaluation results indicated that methodological limitations in reporting, especially regarding data processing and presentation, were the main weaknesses. The GRADE assessment indicated that 30 outcomes were rated moderate, 42 were rated low level, and 20 were rated very low level. Downgrading factors were mainly due to the limitations of the included studies.
The authors concluded that yoga appears to be an effective and safe non-pharmacological therapeutic modality for the Management of CLBP. Currently, it may exhibit better efficacy in improving pain and functional disability associated with CLBP. However, the methodological quality and quality of evidence for SRs/MAs in the included studies were generally low, and these results should be interpreted cautiously.
Sorry, but I beg to differ!
- The safety of a therapy cannot be ascertained on the basis of such small sample sizes.
- The effectiveness of yoga has not been demonstrated by these data.
- All that has been shown with this review is that the quality of the research in this area is too poor for drawing conclusions.
I was alerted to a new book entitled “Handbook of Space Pharmaceuticals“. It contains a chapter on “Homeopathy as a Therapeutic Option in Space” (yes, I am not kidding!). Here is its abstract (the numbers were inserted by me and refer to the short comments below):
Homeopathy is one of the largest used unorthodox medicinal systems having a wide number of principles and logic to treat and cure various diseases [1]. Many successful concepts like severe dilution to high agitation have been applied in the homeopathic system [2]. Though many concepts like different treatment for same diseases and many more are contradictory to the allopathic system [3], homeopathy has proved its worth in decreasing drug-related side effects in many arenas [4]. Various treatments and researches are carried out on various diseases; mostly homeopathic treatment is used in joint diseases, respiratory diseases, cancer, and gastrointestinal tract diseases [5]. In this chapter, readers will have a brief idea about many meta-analysis results of most common respiratory diseases, i.e., asthma, incurable hypertension condition, rheumatoid arthritis, and diarrhea and a megareview of all the diseases to see their unwanted effects, uses of drugs, concepts, and issues related to homeopathy [6]. Various limitations of homeopathic treatments are also highlighted which can give a clear idea about the future scope of research [7]. Overall, it can be concluded that placebo and homeopathic treatments give almost the same effect [8], but the less severe side effects of homeopathic drugs in comparison to all other treatment groups catch great attention [9].
Apart from the very poor English of the text and the fact that it has as good as nothing to do with the subject of ‘Homeopathy as a Therapeutic Option in Space’, I have the following brief comments:
- I did not know that homeopathy has ‘a wide number of logic’ and had alwas assumed that there is only one logic.
- Successful concepts? Really?
- So, homeopaths believe that the ‘allopathic system’ treats the same diseases uniformly? In this case, they should perhaps read up what conventional medicine really does.
- I am not aware of good evidence showing that homeopathy reduces drug related adverse effects.
- No, homeopathy is used for all symptoms – Hahnemann did not believe in treating disease entities – and mostly for those that are self-limiting.
- I love the term ‘incurable hypertension condition’; can somebody please explain what it is?
- The main limitation is that homeopathy is nonsense and, as such, does not really require further research.
- Not ‘almost’ but ‘exactly’! But thanks for pointing it out.
- Wishful thinking and not true. Firstly, the author forgot about ‘homeopathic aggravations’ in which homeopaths so strongly believe. Secondly, I know of many non-homeopathic treatments that are free of adverse effects when done properly.
Altogether, I am as disappointed by this article as you must be: we were probably all hoping to hear about the discovery showing that homeopathy works splendidly in space – not least because we have known for a while that homeopaths seem to be from a different planet.
NICE helps practitioners and commissioners get the best care to patients, fast, while ensuring value for the taxpayer. Internationally, NICE has a reputation for being reliable and trustworthy. But is that also true for its recommendations regarding the use of acupuncture? NICE currently recommends that patients consider acupuncture as a treatment option for the following conditions:
- chronic (long-term) pain
- chronic tension-type headaches
- migraines
- prostatitis symptoms
- hiccups
Confusingly, on a different site, NICE also recommends acupuncture for retinal migraine, a very specific type of migraine that affect normally just one eye with symptoms such as vision loss lasting up to one hour, a blind spot in the vision, headache, blurred vision and seeing flashing lights, zigzag patterns or coloured spots or lines, as well as feeling nauseous or being sick.
I think this perplexing situation merits a look at the evidence. Here I quote the conclusions of recent, good quality, and (where possible) independent reviews:
- Chronic pain: Acupuncture is efficacious for reducing pain in patients with LBP… Further research needs to be done to evaluate acupuncture’s efficacy in these conditions, especially for abdominal pain, as many of the current studies have a risk of bias due to lack of blinding and small sample size.
- Chronic tension-type headaches (TTH): Acupuncture may be an effective and safe treatment for TTH patients. Due to low or very low certainty of evidence and high heterogeneity, more rigorous RCTs are needed to verify the effect and safety of acupuncture in the management of TTH.
- Migraines: Many studies suggest that acupuncture is a safe, helpful and available alternative therapy that may be beneficial to certain migraine patients. Nevertheless, further large-scale RCTs are warranted to further consolidate these findings and provide further support for the clinical value of acupuncture. Despite previous studies that have analyzed the effects of acupuncture on migraine, there is still a need for further investigation to ensure that the incorporation of acupuncture into migraine treatment management will have a positive outcome on patients.
- Prostatitis: This meta-analysis indicated that acupuncture has measurable benefits on CP/CPPS, and security has also been ensured. However, this meta-analysis only included 10 RCTs; thus, RCTs with a larger sample size and longer-term observation are required to verify the effectiveness of acupuncture further in the future.
- Hiccups: All of these studies sought to determine the effectiveness of different acupuncture techniques in the treatment of persistent and intractable hiccups. All four studies had a high risk of bias, did not compare the intervention with placebo, and failed to report side effects or adverse events for either the treatment or control groups.
- Retinal migraine: no evidence
So, what do we make of this? I think that, on the basis of the evidence:
- a positive recommendation for all types of chromic pain is not warranted;
- a positive recommendation for the treatment of TTH is questionable;
- a positive recommendation for migraine is questionable;
- a positive recommendation for prostatitis is questionable;
- a positive recommendation for hiccups is not warranted;
- a positive recommendation for retinal migraine is not warranted.
But why did NICE issue positive recommendations despite weak or even non-existent evidence?
SEARCH ME!
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Congratulations to Joseph Prahlow, MD, who is the winner of the Excellence in Homeopathy Award! Here are the conclusions of his winning essay. Special thanks to Hermeet Singh and Boiron for their prize donation.
Despite the many obstacles and challenges which face homeopathy in the 21st century, the homeopathic community should be emboldened and encouraged by the fact that there are also many opportunities for the advancement of homeopathy as an alternative choice in health care.
Proclaim the Truth: Homeopathy Actually Works
Notwithstanding the challenges involved (especially for a student) in arriving at the correct simillimum for a case, let alone the appropriate follow-up and case management, the truth of the matter is that homeopathy does, in fact, work! Those of us who have been the beneficiaries of homeopathic care, or who have seen the benefits in others, know with no doubt whatsoever that homeopathy represents a truly amazing form of alternative medicine that is able to successfully treat patients having a wide range of health concerns, including some very ill individuals. And it’s not just based on “experience” or “perception,” although such evidence should not be discounted. Numerous studies show the effectiveness of homeopathy.6-9 The fact that homeopathy actually works represents one of the biggest and most important opportunities for homeopathy. The corresponding challenge relates to “getting the word out” into the general community as well as the medical community. Instead of homeopathy being the “last resort,” it should increasingly become the “first choice” amongst patients. Only by “spreading the word” of its success can this become a reality.
What intrigued me here was the evidence that an award-winning homeopath believes might justify the claim that
“Numerous studies show the effectiveness of homeopathy”
6. Mathie RT, Lloyd SM, Legg LA, et al. Randomised placebo-controlled trials of individualized homeopathic treatment: systematic review and meta-analysis. Syst Rev. 2014 Dec 6;3:142. doi: 10.1186/2046-4053-3-142.
As we have discussed previously that meta-analysis is phoney and created a false-positive result by omitting at least two negative studies.
7. Taylor JA, Jacobs J. Homeopathic ear drops as an adjunct in reducing antibiotic usage in children with otitis media. Glob Pediatr Health 2014 Nov 21;1:2333794X14559395. doi: 10.1177/2333794X14559395.
This study had the notorious A+B versus B design and thus was unable to test for specific effects of homeopathy. Moreover, the lead author, Dr Jennifer Jacobs, was a paid consultant to Standard Homeopathic Company.
8. Sorrentino L, Piraneo S, Riggio E, et al. Is there a role for homeopathy in breast cancer surgery? A first randomized clinical trial on treatment with Arnica montana to reduce post-operative seroma and bleeding in patients undergoing total mastectomy. J Intercult Ethnopharmacol 2017 Jan 3;6(1):1-8. doi: 10.5455/jice.20161229055245.
This study showed no significant result in the intention to treat analysis. The positive conclusion seems to be based on data dredging only.
9. Frass M, Lechleitner P, Grundling C, et al. Homeopathic treatment as an add-on therapy may improve quality of life and prolong survival in patients with non-small cell lung cancer: a randomized, placebo-controlled, double-blind, three-arm, multic0-e1955enter study. Oncologist 2020 Dec 25(12):e1930-e1955. doi: 10.1002/onco.13548.
This study is since months under investigation for fraud. The reasons for this have been discussed previously.
Perhaps the award winning author should chance the crucial sentence into something like:
Numerous studies have shown how homeopaths try to mislead the public?
In any case, please do not let this stop you from reading the full paper by the award-winning author. I promise you that it will create much hilarity.
What does homeopathy offer our modern ailing world?
NOTHING!
The concept that the outcomes of spinal manipulation therapy (SMT) – the hallmark intervention of chiropractors which they use on practically every patient – are optimized when the treatment is aimed at a clinically relevant joint is commonly assumed and central to teaching and clinical use of chiropractic. But is the assumption true?
This systematic review investigated whether clinical effects are superior when this is the case compared to SMT applied elsewhere. Eligible study designs were randomized controlled trials that investigated the effect of SMT applied to candidate versus non-candidate sites for spinal pain.
The authors obtained studies from four different databases. Risk of bias was assessed using an adjusted Cochrane risk of bias tool, adding four items for study quality. Between-group differences were extracted for any reported outcome or, when not reported, calculated from the within-group changes. Outcomes were compared for SMT applied at a ‘relevant’ site to SMT applied elsewhere. The authors prioritized methodologically robust studies when interpreting results.
Ten studies were included. They reported 33 between-group differences; five compared treatments within the same spinal region and five at different spinal regions.
None of the nine studies with low or moderate risk of bias reported statistically significant between-group differences for any outcome. The tenth study reported a small effect on pain (1.2/10, 95%CI – 1.9 to – 0.5) but had a high risk of bias. None of the nine articles of low or moderate risk of bias and acceptable quality reported that “clinically-relevant” SMT has a superior outcome on any outcome compared to “not clinically-relevant” SMT. This finding contrasts with ideas held in educational programs and clinical practice that emphasize the importance of joint-specific application of SMT.
The authors concluded that the current evidence does not support that SMT applied at a supposedly “clinically relevant” candidate site is superior to SMT applied at a supposedly “not clinically relevant” site for individuals with spinal pain.
I came across this study when I searched for the published work of Prof Stephen Perle, a chiropractor and professor at the School of Chiropractic, College of Health Sciences, University of Bridgeport, US, who recently started trolling me on this blog. Against my expectation, I find his study interesting and worthwhile.
His data quite clearly show that the effects of SMT are non-specific and mainly due to a placebo response. That in itself is not hugely remarkable and has been suspected to some time, e.g.:
- Chiropractic manipulation for migraine is a placebo therapy
- Chiropractic treatments are placebos
- Chiropractic spinal manipulation = placebo!
- Manual therapy (mainly chiropractic and osteopathy) does not have clinically relevant effects on back pain compared with sham treatment
- Manual therapies for back pain: not better than a placebo
- Is spinal manipulation a placebo therapy?
What is remarkable, however, is the fact that Perle and his co-authors offer all sorts of other explanation for their findings without even seriously considering what is stareing in their faces:
SPINAL MANIPULATIONS ARE PLACEBOS
CHIROPRACTIC IS A PLACEBO THERAPY
This might be almost acceptable, if chiropractic would not also be burdened with significant risks (as we have discussed ad nauseam on this blog) – another fact of which chiros like Perle are in denial.
What does all that mean for patients?
The practical implication is fairly straight forward: the risk/benefit balance of chiropractic is negative. And this surely means the only responsible advice to patients is this:
NEVER CONSULT A CHIRO!
Bioenergy therapies are among the popular so-called alternative medicine (SCAM) treatments. They are used for many diseases, including cancer. Many studies deal with the advantages and disadvantages of bioenergy therapies as an addition to established treatments such as chemotherapy, surgery, and radiation in the treatment of cancer. However, a systematic overview of this evidence is thus far lacking. For this reason, the available evidence was reviewed and critically examined in this paper.
A systematic search was conducted searching five electronic databases (Embase, Cochrane, PsychInfo, CINAHL and Medline) to find randomized clinical trials concerning the use, effectiveness and potential harm of bioenergy therapies including Reiki, Therapeutic Touch, Healing Touch and Polarity Therapy on cancer patients.
From all 2477 search results, 21 publications with 1375 patients were included in this systematic review. The patients treated with bioenergy therapies were mainly diagnosed with breast cancer. The main outcomes measured were anxiety, depression, mood, fatigue, quality of life (QoL), comfort, well-being, neurotoxicity, pain, and nausea. The studies were predominantly of moderate quality and for the most part found no effect. In terms of QoL, pain and nausea, there were improved short-term effects of the interventions, but no long-term differences were detectable. The risk of side effects from bioenergy therapies appears to be relatively small. Most studies only had a passive control group. Accordingly, in contrast to the active bioenergy therapies groups, attention effects may strongly affect the results. In the comparisons with an active control group, for example a sham group, no effects were detectable.
The authors concluded that, considering the methodical limitations of the included studies, studies with high study quality could not find any difference between bioenergy therapies and active (placebo, massage, RRT, yoga, meditation, relaxation training, companionship, friendly visit) and passive control groups (usual care, resting, education). Only studies with a low study quality were able to show significant effects.
This conclusion will not surprise anyone who is capable of rational thinking. Energy healing methods are implausible; further research into this area is a pure wast of money and arguably unethical.
This study investigated whether Tongxinluo,a traditional Chinese medicine compound that has shown promise in in vitro, animal, and small human studies for myocardial infarction, could improve clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). The randomized, double-blind, placebo-controlled clinical trial was conducted among patients with STEMI within 24 hours of symptom onset from 124 hospitals in China. Patients were enrolled from May 2019 to December 2020; the last date of follow-up was December 15, 2021.
Patients were randomized 1:1 to receive either Tongxinluo or placebo orally for 12 months. A loading dose of 2.08 g was given after randomization, followed by the maintenance dose of 1.04 g, 3 times a day, in addition to STEMI guideline-directed treatments. The primary end point was 30-day major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke. Follow-up for MACCEs occurred every 3 months to 1 year.
Among 3797 patients who were randomized, 3777 (Tongxinluo: 1889 and placebo: 1888; mean age, 61 years; 76.9% male) were included in the primary analysis. Thirty-day MACCEs occurred in 64 patients (3.4%) in the Tongxinluo group vs 99 patients (5.2%) in the control group. Individual components of 30-day MACCEs, including cardiac death, were also significantly lower in the Tongxinluo group than the placebo group. By 1 year, the Tongxinluo group continued to have lower rates of MACCEs and cardiac death. There were no significant differences in other secondary end points including 30-day stroke; major bleeding at 30 days and 1 year; 1-year all-cause mortality; and in-stent thrombosis. More adverse drug reactions occurred in the Tongxinluo group than the placebo group, mainly driven by gastrointestinal symptoms.
The authors concluded that in patients with STEMI, the Chinese patent medicine Tongxinluo, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly improved both 30-day and 1-year clinical outcomes. Further research is needed to determine the mechanism of action of Tongxinluo in STEMI.
Tongxinluo is mixture of various active ingredients, including
- ginseng,
- leech,
- scorpion,
- Paeonia lactiflora,
- cicada slough,
- woodlouse bug,
- centipede,
- sandalwood.
With chaotic mixtures of this type, it is impossible to name all the potentially active ingredients, list their actions, or identify the ones that are truly relevant. According to the thinking of TCM proponents, this would also be the wrong way to go about it – such mixtures work as a whole, they would insist.
Tongxinluo is by no means a mixture that has not been studied before.
A previous systematic review of 12 studies found that Tongxinluo capsule is superior to conventional treatment in improving clinical overall response rate and hemorheological indexes and is relatively safe. Due to the deficiencies of the existing studies, more high-quality studies with rigorous design are required for further verification.
A 2022 meta-analysis indicated that the mixture had beneficial effects on the prevention of cardiovascular adverse events, especially in TVR or ISR after coronary revascularization and may possibly lower the incidence of first or recurrent MI and HF within 12 months in patients with CHD, while insufficient sample size implied that these results lacked certain stability. And the effects of TXLC on cardiovascular mortality, cerebrovascular events, and unscheduled readmission for CVDs could not be confirmed due to insufficient cases. Clinical trials with large-sample sizes and extended follow-up time are of interest in the future researches.
A further meta-analysis suggested beneficial effects on reducing the adverse cardiovascular events without compromising safety for CHD patients after PCI on the 6-month course.
Finally, a systematic review of 10 studies found that the remedy is an effective and safe therapy for CHD patients after percutaneous coronary interventions.
So, should we believe the new study with its remarkable findings? On the one hand, the trial seems rigorous and is reported in much detail. On the other hand, the study (as all previous trials of this mixture) originates from China. We know how important TCM is for that country as an export item, and we know how notoriously unreliable Chinese research sadly has become. In view of this, I would like to see an independent replication of this study by an established research group outside China before I recommend Tongxinluo to anyone.
Let’s not forget:
if it sound too good to be true, it probably is!
Mistletoe, an anthroposophical medicine, is often recommended as a so-callled alternative medicine (SCAM) for cancer patients. But what type of cancer, what type of mistletoe preparation, what dosage regimen, what form of application?
The aim of this systematic analysis was to assess the concept of mistletoe treatment in published clinical studies with respect to indication, type of mistletoe preparation, treatment schedule, aim of treatment, and assessment of treatment results. The following databases were systematically searched: Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, CINAHL, and “Science Citation Index Expanded” (Web of Science). The researchers assessed all studies for study types, methods, endpoints and mistletoe preparations including their ways of application, host trees and dosage schedules.
The searches revealed 3296 hits. Of these, 102 publications with a total of 19.441 patients were included. The researchers included several study types investigating the application of mistletoe in different groups of participants: cancer patients with any type of cancer were included as well as studies conducted with healthy volunteers and pediatric patients. The most common types of cancer were:
- breast cancer,
- pancreatic cancer,
- colorectal cancer,
- malignant melanoma.
Randomized controlled studies, cohort studies and case reports make up most of the included studies. A huge variety was observed concerning the type and composition of mistletoe extracts (differing pharmaceutical companies and host trees), ways of applications and dosage schedules. Administration varied widely, e. g. between using mistletoe extract as sole treatment and as concomitant therapy to cancer treatment. The researchers found no relationship between the mistletoe preparation used, host tree, dosage, and cancer type.
A variety of different mistletoe preparations was used to treat cancer patients. Due to the heterogeneity of the mistletoe preparations used, no comparability between different studies or within single studies using different types of mistletoe preparations or host trees is possible. Moreover, no relationship between mistletoe preparation and type of cancer can be observed. This results in a severely limited comparability of studies with regard to the different cancer entities and mistletoe therapy in oncology in general. Analyzing the methods sections of all articles, there are no information on how the selection of the respective mistletoe preparation took place. None of the articles provided any argument which type of preparation (homeopathic, anthroposophic, standardized) or which host tree was chosen due to which selection criteria. Considering preparations from different companies, funding may have been the reason of the selection.
Dosage or dosage regimens varied strongly in the studies. Due to the heterogeneity of dosage and dosage regimens within studies and between studies of the endpoints the comparability of the different studies is severely limited. Duration of mistletoe treatment varied strongly in the studies ranging from a single dose given on one day to the application of mistletoe preparations for several years. Moreover, the duration of treatment frequently varied within the studies. Mistletoe preparations were administered by different ways of application. Most frequently, the patients received mistletoe preparations subcutaneously. The second most common way was intravenous administration of mistletoe preparations. According to the respective manufacturers, this type of application is only recommended for Lektinol® and Eurixor®. Other preparations were given as off-label intravenous applications. No dosage recommendations from the respective manufacturers were available. Only in two studies the dose schedules were mentioned: according to the classical phase I 3 + 3 dose escalation schedule or in ratio to the body surface area.
The authors concluded that despite a large number of clinical studies and reports, there is a complete lack of transparently reported, structured procedures considering all fields of mistletoe therapy. This applies to type of mistletoe extract, host tree, preparation, treatment schedules as well as indication with respect of type of cancer and the respective treatment aim. All in all, despite several decades of clinical mistletoe research, no clear concept of usage is discernible and, from an evidence-based point of view, there are serious concerns on the scientific base of this part of anthroposophical treatment.
A long time ago, I worked as a junior doctor in a hospital where we used subcutaneous misteloe injections regularly to treat cancer. I remember being utterly confused: none of my peers was able to explain to me what preparation to use and how to does it. There simply were no rules and the manufacurer’s instructions made little sense. I suspected then that mistletoe therapy was a danerous nonsense. Today, after much research has been published on mistletoe, I do no longer suspect it, I know it.
I would urge every cancer patient to stay well clear of mistletoe and those practitioners who recommend it.
