MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Cancer

A 2020 article that I just came across concluded with this rather remarkable statement:

High-dose enzyme therapy is a natural cancer protocol that has been highly successful in treating this much-feared disease.

Since we can find a plethora of similar claims on social media and elsewhere, it is high time, I think, to dedicate a post to this alleged cancer cure.

Enzyme therapy involves the administration of proteolytic enzymes by mouth. Proteolytic enzymes are large molecules that are nevertheless said to be absorbed in the gut before they are dispersed into different compartments of the body where they can be detected in various concentrations. Proteolytic enzymes (serine endopeptidases such as trypsin or chymotrypsin and cysteine endo-proteinases such as bromelain and papain or combinations of those enzymes) have long been available for diverse medical indications, including cancer. They are claimed to exert anticancer activities by restoring the reduced cytotoxic activity of patients’ sera.

Enzyme therapy has been subjected to experimental investigations and to a few studies in cancer patients. A systematic review claimed that, for plasmacytoma patients, systemic enzyme therapy was shown to increase the response rates, the duration of remissions, and the overall survival times.[1]

This statement is based on just one study. Here is its abstract[2]:

Purpose: To evaluate the impact of an additive therapy with an oral enzyme (OE) preparation given for more than 6 months additionally to standard combination chemotherapy (vincristine/melphalan/cyclophosphamide/prednisone (VMCP)- or methylprednisolone/ vincristine/CCNU/cyclophosphamide/melphalan (MOCCA)-regimen) in the primary treatment of patients with multiple myeloma stages I-III.

Methods: A cohort of 265 patients with multiple myeloma stages I-III was consecutively treated at our institution in two parallel groups (control group (n = 99): chemotherapy +/-OE for less than 6 months; OE-group (n = 166): chemotherapy + OE for more than 6 months). The median follow-up time in the stages I, II, and III for the OE-group was 61, 37, and 46.5 months, respectively; for the control group the respective values were 33, 51.5, and 31.5 months. The primary endpoint of the study was disease-specific survival. Secondary endpoints were response to therapy, duration of first response and side effects. The chosen method for evaluation was the technique of a retrolective cohort analysis with a concurrent control group. Survival analysis was performed by the Kaplan-Meier method and multivariate analysis was done with the Cox proportional hazards model.

Results: Significantly higher overall response rates and longer duration of remissions were observed in the OE-group. Primary responders showed a longer mean survival time than non-responders. Additive therapy with OE given for more than 6 months decreased the hazard of death for patients at all stages of disease by approximately 60%. Observation time was not long enough to estimate the median survival for patients at stages I and II; for stage III patients it was 47 months in the control group versus 83 months for the patients treated with OE (P = 0.0014) which means a 3-year gain of survival time. Significant prognostic factors for survival, in the Cox regression analysis, were stage of disease and therapy with OE. The OE-therapy was generally well tolerated (3.6% of patients with mild to moderate gastrointestinal symptoms).

Conclusion: OEs represent a promising new additive therapy in multiple myeloma which will be further evaluated in a randomized phase III trial in the USA.

My searches located no prospective clinical trials supporting the notion that enzyme therapy is an effective cancer cure for any type of human cancer. So, what about the bold statement quoted above? In my view, it is a dangerous and highly irresponsible claim that endangers the lives of many vulnerable cancer patients desperately looking for alternative cancer cures.

REFERENCES

[1] Beuth J. Proteolytic enzyme therapy in evidence-based complementary oncology: fact or fiction? Integr Cancer Ther. 2008 Dec;7(4):311-6. doi: 10.1177/1534735408327251. PMID: 19116226.

[2] Sakalová A, Bock PR, Dedík L, Hanisch J, Schiess W, Gazová S, Chabronová I, Holomanova D, Mistrík M, Hrubisko M. Retrolective cohort study of an additive therapy with an oral enzyme preparation in patients with multiple myeloma. Cancer Chemother Pharmacol. 2001 Jul;47 Suppl:S38-44. doi: 10.1007/s002800170008. PMID: 11561871.

Black salve is a paste for external use made from a variable mixture of herbal and non-herbal ingredients. It usually contains bloodroot and/or chaparral and/or zinc chloride which are all ingredients that render the products corrosive. This means black salve destroys living cells that come in contact with it.

Black salve is said to originate from native American tribes who used the paste as a treatment for various conditions. It was adopted by conventional medicine during the Victorian era as a treatment for a range of skin problems, including skin cancers. When effective treatments became available, it became obsolete.

Black salve was recently re-discovered by some practitioners of so-called alternative medicine (SCAM) who now recommend it as a natural treatment for various skin conditions, including cancer. Black salve is readily available, for instance, via the Internet. Several national regulators have issued warnings to consumers not to use it. Consumers have little means of telling what is the nature, quality or strength of the black salve they might be purchasing.

No compelling evidence exists that black salve is efficacious for any condition, especially not for any type of skin cancer. Rigorous clinical trials testing its efficacy are not available. A recent review[1] of the published evidence concluded as follows: Black salve is not a natural therapy. It contains significant concentrations of synthetic chemicals. Black salve does not appear to possess tumour specificity with in vitro and in vivo evidence indicating normal cell toxicity. Black salve does appear to cure some skin cancers, although the cure rate for this therapy is currently unknown. The use of black salve should be restricted to clinical research in low risk malignancies located at low risk sites until a better understanding of its efficacy and toxicity is developed. Where a therapy capable of harm is already being used by patients, it is ethically irresponsible not to study and analyse its effects. Although cautionary tales are valuable, black salve research needs to move beyond the case study and into the carefully designed clinical trial arena. Only then can patients be properly informed of its true benefits and hazards.

Due to its erosive nature, black salve burns away the tissue with which it comes into contact. Numerous case reports of the resulting deformations have been published.[2],[3] Many horrendous pictures of patients maimed by their use of black salve are available on the Internet and give a dramatic impression of the harm caused. Black salve is unquestionably a treatment that can cause considerable damage and should be regarded as unsafe. One paper concluded that it is vital that members of the public are aware of the potential effects and toxicity of commercial salve products.[4]

In conclusion, black salve is not of proven efficacy as a treatment of any condition. It is well documented to cause much harm. Its use should be discouraged. Practitioners who employ or recommend it are, in my view, irresponsible to the extreme.

References:

[1] Croaker A, King GJ, Pyne JH, Anoopkumar-Dukie S, Liu L. A Review of Black Salve: Cancer Specificity, Cure, and Cosmesis. Evid Based Complement Alternat Med. 2017;2017:9184034. doi:10.1155/2017/9184034

[2] Ong NC, Sham E, Adams BM. Use of unlicensed black salve for cutaneous malignancy. Med J Aust. 2014;200(6):314. doi:10.5694/mja14.00041

[3] Saltzberg F, Barron G, Fenske N. Deforming self-treatment with herbal “black salve”. Dermatol Surg. 2009;35(7):1152-1154. doi:10.1111/j.1524-4725.2009.01206.x

[4] Lim A. Black salve treatment of skin cancer: a review. J Dermatolog Treat. 2018;29(4):388-392. doi:10.1080/09546634.2017.1395795

Dr Mathias Rath, the German born purveyor of multiple food supplements, and his organisation puzzle me a great deal. As previously reported, the ‘Dr Rath Foundation’ published an article about me. In it, the author got my name right, but not much more. Here is its opening passage [the numbers in square brackets refer to my comments below].

Professor Edzard Ernst: A Career Built On Discrediting Natural Health Science? [1]

Professor Edzard Ernst, a retired German [2] physician and academic, has recently [3] become a prominent advocate of plans that could potentially outlaw [4] the entire profession of naturopathic doctors [5] in Germany. Promoting the nonsensical idea that naturopathic medicine somehow poses a risk to public health, Ernst attacks its practitioners as supposedly having been educated in “nonsense” [6]. Tellingly, however, given that he himself has seemingly not published even so much as one completely original scientific trial of his own [7], Ernst’s apparent attempts to discredit natural healthcare approaches are largely reliant instead on his analysis or review of handpicked negative studies carried out by others [8].

  1. When I was appointed at Exeter to research alternative medicine in 1993, I had already been a full professor at Hannover, Germany and subsequently at Vienna, Austria. If anything, coming to Exeter was a big step down in terms of ‘career’, salary, number of co-workers etc. (full details in my memoir)
  2. I am German-born, became an Austrian citizen in 1990, and since 2000 I am a British national.
  3. I have been critical about the German ‘Heilpraktiker’ for more than 20 years.
  4. This refers to the recent ‘Muensteraner Memorandum’ which is the work of an entire team of multidisciplinary experts and advocates reforming this profession.
  5. ‘Heilpraktiker’ are certainly not doctors; they have no academic or medical background.
  6. This is correct, and I stand by my statement that educating people in vitalism and other long-obsolete concepts is pure nonsense.
  7. Since I am researching alternative medicine, I have conducted and published about 40 ‘scientific trials’, and before that time (1993) I have published about the same number again in various other fields.
  8. This refers to systematic reviews which, by definition, include all the studies available on a defines research question, regardless of their conclusion (their aim is to minimise random and selection biases)  .

Rath states about himself that “Dr. Rath heads a research and development institute in nutritional and Cellular Medicine. His institute is conducting basic research and clinical studies to scientifically document the health benefits of micronutrients in fighting a multitude of diseases.”

But this is equally puzzling.

Firstly, because research does not aim ‘to scientifically document the health benefits of ‘ anything; it is for testing hypotheses; Rath surely must know that. Secondly, on Medline, I find dozens of publications by Rath. These refer mostly to mechanistic in-vitro or animal studies about the mode of action of vitamins and other natural compounds.

But ‘clinical studies‘?

None!

Hold on! My Medline searches did deliver one clinical trial – just one – (Rath himself lists more, but they seem to be meaningless observational studies without a control group). It was published as an abstract on his own website. Here is the abstract:

Healing of bone fractures is a prolonged process that can be affected by nutrition. Our objective was to critically evaluate the effect of supplementation with an essential nutrient complex, containing ascorbic acid, lysine, proline, and vitamin B6 on healing time of tibial fractures.

Design:

Random double-blind placebo-controlled study

Setting:
Dr. Jamdar Hospital, Jabalpur, India

Subjects and Intervention:
113 patients with unilateral displaced closed or grade I open tibial fractures were randomized to receive either standard care with placebo or with supplementation with an essential nutrient complex containing ascorbic acid, lysine, proline, and vitamin B6. Qualifying patients, on admission to the study, were clinically examined, radiographs of the affected limbs taken, fractures reduced under anesthesia, and above knee plaster casts applied. Radiographs were taken at each follow-up visit to confirm reduced alignment of fracture and proper callus formation.

Primary Outcome Measure:
The primary outcome measure was the number of weeks required for fracture to be healed. Healing was defined as absence of abnormal mobility at fracture site clinically, absence of pain elicited by stressing the fracture or by walking, and radiographic confirmation of callus formation.

Results:
Data analysis demonstrated reduced fracture-healing time associated with experimental supplementation. For PP analysis group, fracture healing time in 75% of the supplemented group of patients (N=21) was 17 weeks or less and 19 weeks or less in 75% of the placebo group patients (N=36). The percentage of patients with fractures healing in 10 weeks or less was 33.3% for the supplemented group and 11.1% for the placebo group. However, the difference in healing time between the two groups did not reach statistical significance.

Conclusion:
Results showed encouraging trends that fracture-healing time is reduced by supplementation with an essential nutrient complex containing ascorbic acid, lysine, proline, and vitamin B6. In addition, the nutrient supplemented participants reported improved feeling of well-being with use of the supplement.

This is odd in several ways:

  1. Even though the conclusions hide it quite well, the trial was in fact negative, i. e. it failed to show a significant difference between the verum and the placebo in the primary outcome measure.
  2. The trial was never published as a peer-reviewed full paper. The website refers to its publication as a ‘letter to the editor’ (LTTE) in the notorious JACM (a LTTE is not normally peer-reviewed).
  3. Why was it never properly published?
  4. Could it be because there was no ethics approval [none was mentioned in the LTTE]?
  5. Could it be because there was no informed consent [none was mentioned in the LTTE]?
  6. The LTTE mentions that a larger study with 200 patients is planned. This was 16 years ago, and to date there is no trace of such a trial.

Rath’s latest contribution to the world of science is a paper implying that his supplements could play a role in the fight against the present pandemic; it is entitled ‘Effective and safe global public health strategy to fight the COVID-19 pandemic: Specific micronutrient composition inhibits Coronavirus cell-entry receptor (ACE2) expression’. Here is the abstract which clearly shows that Rath has not a jot of clinical evidence:

Optimum micronutrient intake is the only scientifically proven way to improve general immune resistance against infections, a fact documented in every leading textbook of biology.  This study provides scientific evidence that, in addition, specific micronutrient compositions are powerful tools in the fight against the COVID-19 pandemic.

Both, SARS-CoV-2 – the virus that causes the current pandemic – and other coronaviruses enter body cells via a specific receptor, the Angiotensin-Converting-Enzyme 2 (ACE2). The ACE2 receptor is expressed by many cell types, including lung epithelial cells as well as endothelial cells of the vascular system.

Based on our earlier research that demonstrated that specific micronutrients can block several mechanisms of viral infections, we tested the efficacy of these natural compounds in suppressing the expression of the ACE2 receptor on human endothelial cells and small airway epithelial cells.

Our results show that a micronutrient composition comprising vitamin C as well as certain amino acids, polyphenols, and trace elements is able to suppress this viral ‘entry door’ into the body under both normal and inflammatory conditions, which are associated with infections.

Thus, vitamin-rich nutrition and micronutrient supplementation should be implemented as effective, safe and affordable public health strategies to fight the COVID-19 pandemic and help prevent future outbreaks.  Optimizing the micronutrient status of the entire population should form the basis for any global strategy to help prevent future pandemics across the world, including the developing nations.

The Wiki-page on Rath lists 10 (!) legal cases in which he has been involved. This looks like he easily sues people who disagree with his often bizarre views and sales techniques. Considering this suspicion, I better be careful what I say here. Therefore let me conclude by meekly repeating the title of this post which comes from my friend Ben Goldacre who, together with THE GUARDIAN won a famous and expensive legal battle against Rath:

Rath is an example of the worst excesses of the alternative therapy industry.

 

 

 

PS

What I like best about the many supplements sold by Rath is the footnote in the patient leaflets:

THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE

Acute radiation-induced proctitis (ARP) is a common side effect following radiotherapy for malignant pelvic disease. It occurs in about 75% of patients and often proves difficult to treat thus causing much pain and suffering. Aloe vera has been advocated for the prevention of ARP, but does it work?

This study evaluated the efficacy of Aloe vera ointment in prevention of ARP. Forty-two patients receiving external-beam radiotherapy (RT) for pelvic malignancies were randomized to receive either Aloe vera 3% or placebo topical ointment during radiotherapy for 6 weeks. Participants applied ointments especially manufactured for the study rectally via applicator, from the first day of starting radiotherapy for 6 weeks, 1 g twice daily. They were evaluated based on the severity (grade 0-4) of the following symptoms weekly: rectal bleeding, abdominal/rectal pain, diarrhoea, or faecal urgency. RTOG acute toxicity criteria and psychosocial status of the patients were also recorded weekly. Lifestyle impact of the symptoms, and quantitative measurement of C-reactive protein (CRP), an indicator of systemic inflammation, were also measured.

The results demonstrated a significant preventive effect for Aloe vera in occurrence of symptom index for diarrhoea (p < 0.001), rectal bleeding (p < 0.001), and faecal urgency (p = 0.001). The median lifestyle score improved significantly with Aloe vera during RT (p < 0.001). Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009).

The authors concluded that Aloe vera topical ointment was effective in prevention of symptoms of ARP in patients undergoing RT for pelvic cancers.

This is by no means the first study of its kind. A previous trial had concluded that a substantial number of patients with radiation proctitis seem to benefit from therapy with Aloe vera 3% ointment. And another study has shown that the prophylactic use of Aloe vera reduces the intensity of radiation-induced dermatitis.

The new trial seems to be methodologically the best so far. Yet it is not perfect, for instance, its sample size is small. Therefore, it would probably be wise to insist on more compelling evidence before this approach can be recommended in oncological routine care.

Intravenous (IV) vitamin C seems to be recommended more and more, particularly by practitioners of so-called alternative medicine (SCAM). At least this is what this survey suggests:

We surveyed attendees at annual CAM Conferences in 2006 and 2008, and determined sales of intravenous vitamin C by major U.S. manufacturers/distributors. We also queried practitioners for side effects, compiled published cases, and analyzed FDA’s Adverse Events Database. Of 199 survey respondents (out of 550), 172 practitioners administered IV vitamin C to 11,233 patients in 2006 and 8876 patients in 2008. Average dose was 28 grams every 4 days, with 22 total treatments per patient. Estimated yearly doses used (as 25g/50ml vials) were 318,539 in 2006 and 354,647 in 2008. Manufacturers’ yearly sales were 750,000 and 855,000 vials, respectively. Common reasons for treatment included infection, cancer, and fatigue.

Yet, the potential harm associated with the use of IV vitamin C has not been systematically assessed. An international team of researchers aimed to fill this gap by reviewing the available evidence on harm related to such treatment. They included studies in adult populations that reported harm related to IV high-dose vitamin C which they defined as greater than or equal to 6 g/d, greater than or equal to 75 mg/kg/d, or greater than or equal to 3 g/m/d.

They identified 8,149 reports, of which 650 full text were assessed for eligibility, leaving 74 eligible studies. In these studies, 2,801 participants received high-dose vitamin C at a median (interquartile range) dose of 22.5 g/d (8.25-63.75 g/d), 455 mg/kg/d (260-925 mg/kg/d), or 70 g/m/d (50-90 g/m/d); and 932 or more adverse events were reported. Among nine double-blind randomized controlled trials (2,310 patients), adverse events were reported in three studies with an event rate per patient for high-dose vitamin C identical to placebo group in one study (0.1 [1/10] vs 0.1 [1/10]), numerically lower in one study (0.80 [672/839] vs 0.82 [709/869]), and numerically higher in one study (0.33 [24/73] vs 0.23 [17/74]). Six double-blind randomized controlled trials reported no adverse event in either group. Five cases of oxalate nephropathy, five cases of hypernatremia, three cases of hemolysis in glucose-6-phosphate dehydrogenase deficiency patients, two cases of glucometer error, and one case of kidney stones were also reported overall.

The authors concluded that there is no consistent evidence that IV high-dose vitamin C therapy is more harmful than placebo in double-blind randomized controlled trials. However, reports of oxalate nephropathy, hypernatremia, glucometer error, and hemolysis in glucose-6-phosphate dehydrogenase deficiency patients warrant specific monitoring.

So, is IV vitamin C safe or not?

I would interpret these findings as follows:

  • Clinical trials are often very poor yard-sticks for estimating safety; they are too small and often neglect to mention adverse effects.
  • When it come to evaluating the safety of therapeutic interventions, we must therefore often rely on case-reports, case series and other uncontrolled data.
  • Such data show that IV vitamin C has been associated with adverse effects, some of which are serious.
  • The incidence of such event remains unclear.

Together with a co-worker, Prof Walach conducted a systematic review of mistletoe extracts (Rudolf Steiner’s anti-cancer drug) as a treatment for improving the quality of life (QoL) of cancer patients. They included all prospective controlled trials that compared mistletoe extracts with a control in cancer patients and reported QoL or related dimensions.

Walach 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 supported the validity of the finding. 50% of the QoL subdomains (e.g. pain, nausea) showed a significant improvement after mistletoe treatment. Most studies had a high risk of bias or at least raise some concern.

The authors concluded that 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.

This is a surprising conclusion, not least because – as reported on this blog – only a year ago another German team of researchers conducted a similar review and came to a very different conclusion. Here is their abstract again:

Purpose: One important goal of any cancer therapy is to improve or maintain quality of life. In this context, mistletoe treatment is discussed to be highly controversial. The aim of this systematic review is to give an extensive overview about the current state of evidence concerning mistletoe therapy of oncologic patients regarding quality of life and side effects of cancer treatments.

Methods: In September and October 2017, Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, CINAHL and “Science Citation Index Expanded” (Web of Science) were systematically searched.

Results: The search strategy identified 3647 articles and 28 publications with 2639 patients were finally included in this review. Mistletoe was used in bladder cancer, breast cancer, other gynecological cancers (cervical cancer, corpus uteri cancer, and ovarian cancer), colorectal cancer, other gastrointestinal cancer (gastric cancer and pancreatic cancer), glioma, head and neck cancer, lung cancer, melanoma and osteosarcoma. In nearly all studies, mistletoe was added to a conventional therapy. Regarding quality of life, 17 publications reported results. Studies with better methodological quality show less or no effects on quality of life.

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.

How can this discrepancy be explained? Which of the reviews is drawing the correct conclusion? Here are some relevant details that could help finding an answer to these questions:

  • Walach is a psychologist by training, while the senior author of the 2019 review, Jutta Huebner, is an oncologist.
  • Huebner included only randomised clinical trials (RCTs), whereas Walach included any interventional and non-interventional prospective controlled study.
  • Huebner included 17 RCTs that reported QoL data, while Walach included 26 publications with 30 data sets including 5 non-randomised studies.
  • Several of the primary studies had been published multiple times at different stages of completion. Walach included these as independent data sets, while Huebner included each study only once.
  • Huebner looked at QoL, whereas Walach also considered measurements of self-regulation as outcome measures.
  • Both reviews point out that the methodological quality of the primary studies was often poor; Walach drew a positive conclusion regardless, while Huebner did not and pointed out that studies with better methodology show less or no effects on quality of life or side effects of cancer therapy.
  • Walach’s review was funded by funded by the Förderverein komplementärmedizinische Forschung, Arlesheim, Switzerland, a lobby group for mistletoe therapy, while Huebner’s work was funded by the German Guideline “S3 Leitlinie Komplementärmedizin in der Behandlung von onkologischen PatientInnen (Registernummer 032-055OL)” funded by the German Cancer Aid (Fördernummer 11583) within the German Guideline Program in Oncology and by the working group Prevention and Integrative Oncology of the German Cancer Society.

I am sure there are other important differences, but the ones listed above suffice, I think, to decide which of the two papers is trustworthy and which is not.

This recently published survey aimed to investigate the use of so-called alternative medicine (SCAM) among long-term cancer survivors and its links with healthy behaviour. Data was used from the VICAN survey, conducted in 2015-2016 on a representative sample of French cancer survivors 5 years after diagnosis.

Among the 4174 participants, 21.4% reported using SCAM at the time of the survey, including 8.4% who reported uses not associated with cancer. The most frequently cited reasons for using SCAM were:

  • to improve their physical well-being (83.0%),
  • to strengthen their body (71.2%),
  • to improve their emotional well-being (65.2%),
  • to relieve the side effects of treatment (50.7%).

The SCAM users who reported using SCAM to cure cancer or prevent relapses (8.5% of the participants) also used SCAM for other reasons. They had more often experienced cancer progression, feared a recurrence, and had a poorer quality of life because of sequelae, pain, and fatigue. They also consulted their general practitioners more frequently and had changed their lifestyle by adopting more healthy practices.

The authors concluded that the use of SCAM is not an alternative but a complementary means of coping with impaired health. Further research is now required to determine whether the use of SCAM reflects a lifestyle change or whether it assists survivors rather to make behavioural changes.

The 2012 data from the same survey had previously reported that, among the participants, 16.4% claimed to have used SCAM, and 45.3% of this group had not used SCAM before cancer diagnosis (new SCAM users). Commonly, SCAMs used were:

  • homeopathy (64.0%),
  • acupuncture (22.1%),
  • osteopathy (15.1%),
  • herbal medicine (8.1%),
  • diets (7.3%),
  • energy therapies (5.8%).

SCAM use was found to be significantly associated with younger age, female gender and a higher education level. Previous SCAM use was significantly associated with having a managerial occupation and an expected 5-year survival rate ≥80% at diagnosis; recent SCAM use was associated with cancer progression since diagnosis, impaired quality of life and higher pain reports.

In nearly half of the SCAM users, cancer diagnosis was one of the main factors which incited patients to use SCAM. Opting for SCAM was a pragmatic response to needs which conventional medicine failed to meet during the course of the disease.

These surveys mostly confirm what has been shown over and over again in other countries. What I find remarkable with these results, however, is the increase in SCAM use over time and the extraordinary high use of homeopathy by French cancer patients (more recently, the reimbursement of homeopathy in France has changed, of course). As homeopathy has no effects beyond placebo, this suggests that SCAM use by French cancer patients is far from being driven by evidence.

So, what then does determine it?

My best answer I can give to this question is this: relentless promotion through pharmacies, advertisements and journalists. These have all been very powerful in France in relation to homeopathy (hardly surprising, as the world’s largest homeopathic producer, Boiron, is based in France).

This leads me to the conclusion that SCAM is far more commercially driven than its enthusiasts would ever admit. They think of the pharmaceutical industry as the evil exploiter of the sick. It is now time to realise that the SCAM industry is, to a large extent, part of the pharmaceutical industry and often behaves just as badly or even worse: because what could be more unethical that selling placebos to desperate and vulnerable cancer patients?

When I discuss published articles on this blog, I usually focus on recent papers. Not so today! Today I write about a small study we published 17 years ago. It was conducted in Canada by researchers whom I merely assisted in designing the protocol and interpreting the findings.

They trained 8 helpers to pretend being customers of health food stores. They entered individually into assigned stores; the helpers had been informed to browse in the store until approached by an employee. At this time they would declare that their mother has breast cancer. They disclosed information on their mother’s condition, use of chemotherapy (Tamoxifen) and physician visits, only if asked. The helpers would then ask what the employee recommend for this condition. They followed a structured, memorized, pretested questionnaire that asked about product usage, dosage, cost, employee education and product safety or potential for drug interactions.

The helpers recorded which products were recommended by the health food store employees, along with the recommended dose and price per product as well as price per month. Additionally, they inquired about where the employee had obtained information on the recommended products. They also noted whether the employees referred them on to SCAM practitioners or recommended that they consult a physician. Full notes on the encounters were written immediately after leaving the store.

The findings were impressive. Of the 34 stores that met our inclusion criteria, 27 recommended SCAMs; a total of 33 different products were recommended. Here are some further findings:

  • Essiac was recommended most frequently.
  • The mean cost of the recommended products per month was $58.09 (CAD) (minimum $5.28, median $32.99, maximum $600).
  • Twenty-three employees (68%) did not ask whether the patient took prescription medications.
  • Fifteen (44%) employees recommended visiting a healthcare professional; these included: naturopaths (9), physicians (5) and nutritionists (1).
  • Health food store employees relied on a variety of sources of information. Twelve employees (35%) said they had received their information from books, 5 (15%) from a supplier, 3 (9%) had formal education in SCAM, 2 (6%) had in-store training, and 12 (35%) did not disclose their sources of information.

Since our paper has been published, several other investigations have addressed similar issues. Here are a few excerpts:

But why do I mention all this today?

The answer is that firstly, I think it is important to warn consumers of the often dangerous advice they might receive in HFSs. Secondly, I feel it would worthwhile to do further research, check whether the situation has changed and repeat a similar study today. Ideally, a new investigation should be conducted in different locations comparing several countries. If you have the possibility to plan and conduct such an experiment, please drop me a line.

Glucosamine is currently one of the most popular of all dietary supplements. It is marketed as a treatment for arthritis, and there is some evidence that it is moderately helpful for this indication. But evidence had been accumulating to suggest that glucosamine might have other effects as well. The latest analysis evaluated the associations of regular glucosamine use with all-cause and cause-specific mortality in a large prospective cohort.

This population-based prospective cohort study included 495 077 women and men from the UK Biobank study. Participants were recruited from 2006 to 2010 and were followed up through 2018. The investigators evaluated all-cause mortality and mortality due to cardiovascular disease (CVD), cancer, respiratory and digestive disease. Hazard ratios (HRs) and 95% CIs for all-cause and cause-specific mortality were calculated using Cox proportional hazards models with adjustment for potential confounding variables.

At baseline, 19.1% of the participants reported regular use of glucosamine supplements. During a median follow-up of 8.9 years (IQR 8.3-9.7 years), 19 882 all-cause deaths were recorded, including 3802 CVD deaths, 8090 cancer deaths, 3380 respiratory disease deaths and 1061 digestive disease deaths. In multivariable adjusted analyses, the HRs associated with glucosamine use were 0.85 (95% CI 0.82 to 0.89) for all-cause mortality, 0.82 (95% CI 0.74 to 0.90) for CVD mortality, 0.94 (95% CI 0.88 to 0.99) for cancer mortality, 0.73 (95% CI 0.66 to 0.81) for respiratory mortality and 0.74 (95% CI 0.62 to 0.90) for digestive mortality. The inverse associations of glucosamine use with all-cause mortality seemed to be somewhat stronger among current than non-current smokers (p for interaction=0.00080).

The authors concluded that regular glucosamine supplementation was associated with lower mortality due to all causes, cancer, CVD, respiratory and digestive diseases.

Previous epidemiological investigations indicated that glucosamine use might play a role in prevention of cancer, cardiovascular disease and other diseases. This suggests that the finding is more than the result of a large ‘fishing expedition’ to which epidemiological studies are sadly prone. It we are indeed dealing with a true phenomenon, we should ask by what mechanism these remarkable outcomes might be achieved. It is well documented that glucosamine has powerful anti-inflammatory effects. Therefore it is conceivable that such anti-inflammatory mechanisms are the cause for the observed outcomes.

How do we prove or disprove the hypothesis that glucosamine reduces the mortality of a range of diseases? A reasonable starting point would be to consult the good old Hill criteria of causality:

(1) The strength of association is small to moderate – certainly not strong

(2) The consistency of the findings is quite remarkable; that is unless dozens of epidemiological studies that failed to yield and association were never published.

(3) The specificity of the association with diseases linked to inflammation is also impressive (with the caveat above).

(4) Temporality seems also not a problem, as far as I can see.

(5) Biological gradient needs further testing, I think.

(6) Plausibility is not a problem, since there is a possible mechanism that could explain the findings.

(7) The same applies to coherence.

(8) Experiment is needed, but it is far from easy to conduct clinical trials where mortality is an endpoint.

(9) Analogy is realised through the well-established concept of (cardiovascular) risk factors.

What does all this actually mean?

It means, I think, that glucosamine could well have clinical effects that go far beyond easing the pain of arthritis. However, we cannot be sure. Once again, it boils down to the need of robust clinical trial data. The subject certainly seems important enough to consider this option.

 

On his website, Phillip Hughes – D. Hom (Med), M.A.R.H, describes himself as follows:

In the early 1990’s my life was turned upside-down by a prolapsed disk in my back, putting me in traction in a hospital for 6 weeks! The doctor’s prognosis was poor, leaving me with little hope of full mobility, and no choice but to seek treatment elsewhere.

I decided on Homeopathy, and after treatment I experienced real change in my condition within a month, and was completely well within 3 months. I was so inspired by this I decided to study Homeopathy myself – and in 1994 I enrolled at the Hahnemann College of Homeopathy in London, qualifying in 1998.

After qualifying I set up my first clinic in Waterloo, Liverpool. I also became a senior lecturer at the Hahnemann College of Homeopathy, and founder of the Liverpool branch of the Hahnemann College.

I then moved my clinic to College Road Crosby, when I took up the role of secretary of Homeopathic Medical Association (since resigned). It was during this time that my wife Rosa found a lump in her breast, motivating us again to seek safer and alternative treatments, this time using Thermography. We now run Thermography and Homeopathic clinics side by side.

I had never heard of Mr Hughes until yesterday, when it was reported that he had treated a Sean Walsh, a young musician, for Hodgkin lymphoma that had initially been controlled with chemotherapy, but had later returned. Here is an excerpt from the sad story:

Sean was having scans at a clinic – Medical Thermal Imaging – run by a couple called Philip and Rosa Hughes. Philip Hughes, a homeopath, had previously told Sean’s parents he’d successfully treated Rosa for breast cancer. Dawn [Sean’s girlfriend] went along to Sean’s first appointment. “Phil was just talking all about how damaging chemotherapy is, you know, on the human body… saying, ‘I’ve had lots of people come to my clinic, but by the time I get them, they’re shot with all this chemotherapy, so I can’t help them … And then he was talking all about how you can change your diet, which can reverse cancer. He’d said that Rosa had developed breast cancer. She’d had a lump in her breast, and she decided not to do hospital treatment, and she was going to, you know, reverse the cancer herself. So obviously Sean’s listening to this thinking, ‘Well, if one person’s done it, and then I’m hearing other little stories off them, I can do this’. Sean’s scans did carry a disclaimer, stating that thermography does not see or diagnose cancer and recommending further clinical investigation. But the scan results seemed reassuring – and Sean was convinced his cancer had gone. ‘Medical Thermal Imaging’ describe their scans as “100% safe and radiation-free”.

To find out more about the service the Hughes were offering, a BBC reporter went to the clinic where Sean had his scans, posing as a patient who’d found a lump. They were seen by Rosa Hughes, who had provided scans for Sean. Rosa told our reporter that when she went to the breast clinic to have her lump investigated, she should have an ultrasound rather than a mammogram. This is a transcript of what she said: “Not a mammogram, because you’re going to get radiated, and it’s going to squash… and the amount of women that have had their tumours, the tumour burst, that spreads cancer.”

[The BBC] asked cancer specialist Prof Andrew Wardley, of Manchester’s Christie Hospital, to review the medical claims Rosa Hughes made to our reporter. “That’s preposterous. You don’t burst tumours, they are solid. You do squash the breast down to do a mammogram, it is unpleasant but it’s a short-term thing. You do not spread cancer by doing a mammogram, that’s a complete fallacy.” Rosa and Philip Hughes say they “utterly reject” the allegation that they gave Mr Walsh inappropriate advice. They added they had “consistently made clear” that thermography can only be used alongside other tests, such as MRIs or mammograms.

At first Sean believed he had cured his own cancer. But tragically Sean was wrong. Gradually his health declined, until he was rushed to hospital in Liverpool where medical staff found he had multiple tumours in his stomach and chest. He did eventually receive chemotherapy but it was too late.

Sean died in January 2019.

On Philip Hughes’ website, he advertises his services with the help of several testimonials from happy customers. Here is one of them:

In November 2000, I had an aggressive Sarcoma Tumour removed along with my left lung. Shortly after surgery I was referred to Weston Park Hospital, Sheffield for ‘follow up’ treatments where I was offered both chemotherapy and radiotherapy. At around the same time, I first visited Waterloo Homeopathic Clinic on a friends recommendation. After this initial introduction to Homeopathy I began ti educate myself about my condition and possible treatments. Consequently I considered chemotherapy to be a crude option and decided to refuse it. However, the frightening thought of this aggressive tumour returning encourages me to go ahead with a six week course of radiotherapy as a precaution alongside Homeopathic treatment. Accordingly this holistic approach resulted in my immune system being boosted by Homeopathy and my body prepared for this medical treatment. Leading up to the radiotherapy and during the six weeks of treatments, I took a rang of Homeopathic remedies. Radium Brom, in my opinion, was undoubtedly the input that enabled me to go through an intense course of treatment daily and continue my healthy recovery. I didn’t miss a days work and finished a half marathon only three weeks after completing the radiotherapy. I have since remained in good health and all checks been clear.

I have said it often, but it seems I have to say it again: the homeopathic remedy might be harmless, but the homeopath isn’t!

 

 

 

PS

The BBC documentary provides many more details about Sean and another of Mr Hughes’ patients. It also shows some rare footage from the inside of the Gerson clinic in Mexico where Sean went for a while. Very sad but well worth watching!!!

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