evidence
A study from the US found that belief in conspiracy theories is rife in health care. The investigators presented people with 6 different conspiracy theories, and the one that was most widely believed was the following:
THE FOOD AND DRUG ADMINISTRATION IS DELIBERATELY PREVENTING THE PUBLIC FROM GETTING NATURAL CURES FOR CANCER AND OTHER DISEASES BECAUSE OF PRESSURE FROM DRUG COMPANIES.
A total of 37% agreed with this statement, 31% had no opinion on the matter, and just 32% disagreed. What is more, the belief in this particular conspiracy correlated positively with the usage of alternative medicine.
The current popularity of so-called alternative medicine (SCAM) is at least partly driven by the conviction that there is a sinister plot by the FDA or more generally speaking ‘the establishment’ that prevents people from benefitting from the wonders of SCAM.
But where do those conspiracy theories come from?
How do they evolve?
A new article investigates these questions. Here is its abstract:
Although conspiracy theories are endorsed by about half the population and occasionally turn out to be true, they are more typically false beliefs that, by definition, have a paranoid theme. Consequently, psychological research to date has focused on determining whether there are traits that account for belief in conspiracy theories (BCT) within a deficit model. Alternatively, a two-component, socio-epistemic model of BCT is proposed that seeks to account for the ubiquity of conspiracy theories, their variance along a continuum, and the inconsistency of research findings likening them to psychopathology. Within this model, epistemic mistrust is the core component underlying conspiracist ideation that manifests as the rejection of authoritative information, focuses the specificity of conspiracy theory beliefs, and can sometimes be understood as a sociocultural response to breaches of trust, inequities of power, and existing racial prejudices. Once voices of authority are negated due to mistrust, the resulting epistemic vacuum can send individuals “down the rabbit hole” looking for answers where they are vulnerable to the biased processing of information and misinformation within an increasingly “post-truth” world. The two-component, socio-epistemic model of BCT argues for mitigation strategies that address both mistrust and misinformation processing, with interventions for individuals, institutions of authority, and society as a whole.
This makes a lot of sense to me, and it seems to apply well to the BCT in SCAM.
To mitigate BCT, the authors advocate asking:
- Who do you trust or mistrust and why?
- How do you decide what to believe?
Effective mitigation strategies, they state, may necessitate wholescale approaches that:
- confer resistance against BCT by utilizing inoculation strategies that counter misinformation where it occurs (e.g. online),
- teach analytic thinking within educational systems at an early age,
- restructure or otherwise impose restrictions on the digital architectures that distribute information in order to label or curb misinformation and promote “technocognition”.
These are no small challenges, and I am proud to say that, in the realm of SCAM, I am doing what I can to tackle them.
THE FIRST WORLDWIDE MANIFESTO AGAINST PSEUDOSCIENCE
2750 signatories from 44 countries have signed it [I was number 11] and today is its official launch. I am delighted to present to you the full text of the English version:
Let’s be clear: pseudoscience kills. And they are being used with total impunity thanks to European
laws that protect them.
They kill thousands of people, with names and families. People such as Francesco Bonifaz, a 7-yearold boy whose doctor prescribed homeopathy instead of antibiotics. He died in Italy [1]. People like Mario Rodríguez, who was 21 years old and was told to use vitamins to treat his cancer. He died in Spain [2]. People like Jacqueline Alderslade, a 55-year-old woman whose homeopath told her to stop taking her asthma medication. She died in Ireland [3]. People like Cameron Ayres, a 6-month-old baby, whose parents did not want to give their child “scientific medicine”. He died in England [4]. People like Victoria Waymouth, a 57-year-old woman who was prescribed a homeopathic medication to treat her heart problem. She died in France [5]. People like Sofia Balyaykina, a 25-year-old woman, who had a cancer that was curable with chemotherapy but was recommended an “alternative treatment”, a mosquito bite treatment. She died in Russia [6]. People like Erling Møllehave, a 71-year-old man whose acupuncturist pierced and damaged his lung with a needle. He died in Denmark [7]. People like Michaela Jakubczyk-Eckert, a 40-year-old-woman whose therapist recommended the German NewMedicine to treat her breast cancer. She died in Germany [8]. People like Sylvia Millecam, a 45-year-old woman whose New Age healer promised to cure her cancer. She died in the Netherlands [9].
European directive 2001/83/CE has made –and still makes— possible the daily deception of thousands of hundreds of European citizens [10]. Influential lobbyists have been given the opportunity to redefine what a medicine is, and now they are selling sugar to sick people and making them believe it can cure them or improve their health. This has caused deaths and will continue to do so until Europe admits an undeniable truth: scientific knowledge cannot yield to economic interests, especially when it means deceiving patients and violating their rights.
Europe is facing very serious problems regarding public health. Overmedication, multi-resistant bacteria and the financial issues of the public systems are already grave enough, without the additional problem of gurus, fake doctors or even qualified doctors claiming they can cure any disease by manipulating chakras, making people eat sugar or using “quantic frequencies”. Europe must not only stop the promotion of homeopathy but also actively fight to eradicate public health scams. More than 150 pseudo-therapies have been identified as being in use throughout Europe. Thousands of citizens lives depend on this being prevented. In fact, according to a recent research, 25.9 % of Europeans have used pseudo-therapies last year. In other words, 192 million patients have been deceived [11].
Some believe there is a conflict between freedom of choice for a treatment and the removal of pseudo-therapies, but this is not true. According to article 25 of the Universal Declaration of Human Rights, every person has a right to medical care. Lying to patients in order to sell them useless products that could kill them breaks their right to correct information about their health. This way, even if a citizen has a right to refuse medical treatment when he or she is properly informed, it is also true that nobody has the right to lie to obtain profit at the expense of someone else’s life. Only in a world in which lying to a sick person would be considered ethical, could homeopathy —or any other pseudo-therapy— be allowed to continue to be sold to citizens.
Effective treatments being replaced by false ones is not the only danger of pseudo-therapies. Obvious delays in therapeutic care occur when a person gets false products instead of medication at the early stages of a disease. Many times, it is then too late by the time they get treated with proper medicine. Moreover, several of these practices have serious effects on their own and may cause damage or even death because of their side effects.
Many pseudo-therapists argue that “the other medicine” comes with side effects as well, which is indeed true. However, the difference resides in that pseudo-therapies cannot cure a disease or improve your health, and because of that patients assume risks in exchange of promises that are a scam, according to the full weight of the scientific evidence available. Lying to a sick person is not another type of medicine, it is simply lying to a sick person.
Every country has to face the pseudo-therapies issue in its own ways. Yet it is not acceptable that European laws protect the distortion of scientific facts so that thousands of citizens can be deceived or even lead to their deaths.
We, the signatories of this manifest, therefore declare that:
1. Scientific knowledge is incompatible with what pseudo-therapies postulate, as in the case
of homeopathy.
2. European laws that protect homeopathy are not acceptable in a scientific and technological
society that respects the right of the patients not to be deceived.
3. Homeopathy is the best known pseudo-therapy, but it is not the only one nor the most
dangerous one. Others, such as acupuncture, reiki, German New Medicine, iridology,
biomagnetism, orthomolecular therapy and many more, are gaining ground and causing
victims.
4. Measures must be taken to stop pseudo-therapies, since they are harmful and result in
thousands of people being adversely affected.
5. Europe needs to work towards creating legislation that will help stop this problem.
Europe being concerned about the misinformation phenomena but at the same time protecting one the most dangerous types of it, health misinformation, is just not coherent. This is why the people signing this manifesto urge the governments of European countries to end a problem in which the name of science is being used falsely and which has already cost too many lives.
[1] Homeopathy boy died of encephalitis. Redazione ANSA, 2017.
http://www.ansa.it/english/news/general_news/2017/05/29/homeopathy-boy-died-of-encephalitis-3_13e02493-
4e62-4787-9162-12d831121ef6.html
[2] Grieving dad sues over ‘cure cancer with vitamins’ therapy, The local. Emma Anderson, 2016.
https://www.thelocal.es/20160412/grieving-father-sues-naturopath-over-son-cure-cancer-vitamins-leukaemia
[3] Asthmatic ‘told to give up drugs’. The Irish News, 2001.
https://www.independent.ie/irish-news/asthmatic-told-to-give-up-drugs-26063764.html
[4] Homeopaths warn of further tragèdies. BBC News, 2000.
http://news.bbc.co.uk/2/hi/health/702699.stm
[5] Alternative cure doctor suspended. BBC News, 2007.
http://news.bbc.co.uk/2/hi/uk_news/england/london/6255356.stm
[6] Футболист рассказал трагичную историю жены. Она умерла от рака в 25 лет. Sport24, 2018.
https://sport24.ru/news/football/2018-08-28-futbolist-rasskazal-tragichnuyu-istoriyu-zheny-ona-umerla-ot-raka-v-25-let
[7] Mand døde efter akupunktur – enke vil nu lægge sag an mod behandleren, TV2, 2018.
http://nyheder.tv2.dk/samfund/2018-01-23-mand-doede-efter-akupunktur-enke-vil-nu-laegge-sag-an-modbehandleren [8] The price of refusing science-based medical and surgical therapy in breast càncer, Science Blogs, 2012.
https://scienceblogs.com/insolence/2012/08/30/the-price-of-refusing-science-based-medical-and-surgical-therapy-inbreast-cancer
[9] Psychic ‘misled actress to hopeless cancer death’. Expatica. 2004.
http://web.archive.org/web/20070208144309/http://www.expatica.com/actual/article.asp?subchannel_i
d=19&story_id=4821
[10] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001.
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
[11] Use of complementary and alternative medicine in Europe: Health-related and sociodemographic
determinants. Scandinavian Journal of Public Health. Laura M. Kemppainen et al. 2018.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5989251/
I want to thank our friend ‘OLD BOB’ for alerting me to Patrick Holford’s comment on a recent trial of vitamin C for COVID-19. Here are three short quotes from Holford:
… Overall, 5 out 26 people (19%) died in the vitamin C group while 10 out of 28 (36%) receiving the placebo died. That means that vitamin C almost halved the number of deaths. Those on vitamin C were 60% more likely to survive.
… Of those most critically ill, 4 people (18%) in the vitamin C group died, compared to 10 (50%) in the placebo group. That’s two-thirds less deaths. Statistically this meant that of those most critically ill who were given vitamin C, they were 80% less likely to die…
… now there is another proven treatment – vitamin C…
And here is the abstract of the actual trial Holford refers to:
Background: No specific medication has been proven effective for the treatment of patients with severe coronavirus disease 2019 (COVID-19). Here, we tested whether high-dose vitamin C infusion was effective for severe COVID-19.
Methods: This randomized, controlled, clinical trial was performed at 3 hospitals in Hubei, China. Patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the ICU were randomly assigned in as 1:1 ratio to either the high-dose intravenous vitamin C (HDIVC) or the placebo. HDIVC group received 12 g of vitamin C/50 ml every 12 hours for 7 days at a rate of 12 ml/hour, and the placebo group received bacteriostatic water for injection in the same way. The primary outcome was invasive mechanical ventilation-free days in 28 days(IMVFD28). Secondary outcomes were 28-day mortality, organ failure, and inflammation progression.
Results: Only fifty-six critical COVID-19 patients were ultimately recruited due to the early control of the outbreak. There was no difference in IMVFD28 between two groups. During the 7-day treatment period, patients in the HDIVC group had a steady rise in the PaO2/FiO2 (day 7: 229 vs. 151 mmHg, 95% CI 33 to 122, P=0.01). Patients with SOFA scores ≥3 in the HDIVC group exhibited a trend of reduction in 28-day mortality (P=0.06) in univariate survival analysis. IL-6 in the HDIVC) group was lower than that in the placebo group (19.42 vs. 158.00; 95% CI -301.72 to -29.79; P=0.04) on day 7.
Conclusion: This pilot trial showed that HDIVC might show a potential signal of benefit for critically ill patients with COVID-19, improving oxygenation even though it failed to improve IMVFD28.
The following points are, I think, worth mentioning:
- This was, according to its authors, a PILOT study.
- It was far too small (n=56) to provide reliable results on mortality.
- The trial authors know that and interpret their findings with sufficient caution.
- The primary endpoint, the IMVFD28, showed NO significant difference between the groups.
- The secondary endpoint: HDIVC infusion exhibited a non-significant trend of reduction in 28-day mortality (P=0.06).
- In more severe patients (SOFA score ≥3), univariate survival analysis and Cox regression showed a similar results (P=0.07, HR, 0.32 [95% CI 0.10-1.06]).
And what does all of this mean? It means that, in this pilot study, vitamin C failed to produce a significant result. Only in a subgroup analysis related to a secondary endpoint was there a slight advantage of vitamin C. This effect is, of course, interesting and needs further investigation (I am sure that is happening as we speak). It could have some clinical significance but, just as likely, it could just be due to chance. There is not way of knowing which is which.
In other words, to hype the findings and to even make statements such as ‘now there is another proven treatment, vitamin C’ is not just exaggerated, it is irresponsible.
This begs the question: why does Mr Holford do it? In case you don’t already know about this man, go on the Internet, and you will quickly find possible answers. Here is an excerpt from his Wiki page which might give you a clue:
Patrick Holford is a British author and entrepreneur who endorses a range of controversial vitamin tablets. As an advocate of alternative nutrition and diet methods, he appears regularly on television and radio in the UK and abroad. He has 36 books in print in 29 languages. His business career promotes a wide variety of alternative medical approaches such as orthomolecular medicine, many of which are considered pseudoscientific by mainstream science and medicine.
Holford’s claims about HIV and autism are not in line with modern medical thought, and have been criticised for putting people in danger and damaging public health.
In 2006 Holford was discovered to be using his PR advisor to delete critical content from his Wikipedia page…
Holford has been the subject of criticism for his promotion of medically dubious techniques and products including hair analysis, his support of the now struck off doctor Andrew Wakefield, and advocating the use of “non-drug alternatives for mental health” for which he has been given an award by the Church of Scientology-backed Citizens Commission on Human Rights.
SAY NO MORE!
Research by a reputable independent research company done for Securivita a German insurance company shows that those receiving homeopathic care were much better off. Over 15,700 patients were involved in the study which also used a comparison group.
The study showed that in a wide range of patients with various pathological problems that if they had homeopathic care they faired dramatically better than those just getting conventional medicine.
Children having homeopathy treatment from birth, were particularly healthier and with less problems. Over the three year study period, the number of children needing antibiotics decreased by 16.7 per cent in the homeopathy group, whereby it increased by 73.9 per cent in the conventional medical comparison group!
The number of hospitalizations in the comparison group increased by 32.6 per cent whereby in the homeopathy treatment group it decreased by 9.8 per cent!
Adults and children treated homoeopathically had dramatic improvements in allergies, dermatitis, asthma, just to name a few.
These are just a few examples of the remarkable benefits of homeopathic treatment outlined in the study by by the Leipzig Health Forum , an independent analytical institute specializing in health services conducted for Securvita Krankenkasse Insurer.
“We don’t need fewer, but more homeopathic doctors who will continue on this successful path,” says Götz Hachtmann , director of the health insurance company Securvita.
The study is in German and can be found here.
____________________________
Blessed are those who don’t read German (at least in this instance)!
As I am not amongst the blessed, I ought to tell you a bit about the ‘massive’ study. The OHR, the ‘OFFICIAL HOMEOPATHIC RESOURCE’ (btw what makes the OHR ‘official’?) claims that the study can be found here. The OHR is evidently not well enough resourced for translating the German text into English; if they were, they would know that the link goes not to a ‘study’ but to some kind of a glossy marketing brochure about the ‘study’ (there is no actual published scientific paper on the ‘study’). It provides hardly any relevant information; all we learn is that 15 700 individuals who regularly consulted homeopathic physicians were compared over a three year period to an equally sized control group who did not consult homeopathic doctors… And that’s essentially it! No further relevant details are offered.
By contrast, quite a bit of information is offered about the findings, for instance:
- In the homeopathy group, the hospitalisation rate of depressive patients dropped by 10%, while it increased in controls by 33%.
- The days off work dropped by 17% vs an increase in controls of 17%.
- The use of antibiotics decreased by 17% vs an increase of 74%.
And how do they explain these differences?
Yes, you guessed it:
they are due to homeopathy!
One does not need to have a perfumer’s nose to smell a few badly decomposing rats here, for example:
- We do not learn how many variables were tested in this ‘study’. Therefore, it is likely that the ‘results’ provided are the positive ones, while the not so positive potential effects of homeopathy remained unmentioned. Perhaps the death rate was higher in the homeopathy group? Perhaps they suffered more heart attacks? Perhaps they had a lower quality of life? Perhaps they caused more costs? Perhaps they committed more suicides? etc. etc.
- Even more obvious is the stench of selection bias. The individuals in the homeopathy group were clearly different from the controls to start with. They might have been more health conscious. They clearly were more cautious about antibiotics. They might have been of better general health. They might have been younger. They could have contained more women. They might have been more afraid of going into a hospital. They might have been keener to attend work. In fact, the only variable in which the two groups were comparable is sample size.
Even if we eventually we see this ‘study’ published in a peer-reviewed journal with full methodological details etc., it will not allow even the smartest spin-doctor to establish cause and effect. Its findings would not be more conclusive than those of previously discussed attempts to produce positive evidence for homeopathy. The ‘positive’ findings could have been the result of hundreds of causes, none of which are related to homeopathy.
In a nutshell: this new German ‘study’ is a textbook example for arguing in favour of conducting proper research rather that rampant pseudo-research.
But I must not always be so negative!!!
So, let me try to point out the positive sides of this ‘study’:
The ‘massive independent study’ is a true masterpiece of advertising and marketing for both Securivita and homeopathy.
Well done guys!
I am proud of you!
- That’s exactly the stuff needed for successfully misleading the public.
- That’s precisely the info required to increase your cash flow.
- That’s helpful ‘research’ for convincing politicians.
- That’s definitely the type of baloney to impresses the Ullmanns of this world.
- That’s even the sort of ‘science’ which the ‘OFFICIAL HOMEOPATHIC RESOURCE’ cannot recognise for what it truly is:
invalid junk.
This recent review claimed to evaluate the evidence on the use of human and veterinary homeopathy, evidence level 1a studies were considered. Focusing on the external evidence on the use of homeopathy in infections, some evidence level 1a, 1b, 2c studies, and a case report, are described in more detail.
In conclusion, evidence for the effectiveness of human and veterinary homeopathy in general, and in particular, of homeopathic treatment for infections, is available. Especially, individualized homeopathy demonstrates effects at all quality levels according to Cochrane criteria, even in the methodologically high-quality studies. As in most areas of veterinary medicine and medicine, further good/excellent studies are necessary. In compliance with the principles of homeopathy, further methodologically high-quality trials focusing on the homeopathic treatment of infections are the next logical step. The selection of the simile (individually fitting homeopathic medicinal product) by appropriately trained homeopathic doctors/veterinarians is essential for the effectiveness of homeopathy. Implementation of studies at university facilities is a prerequisite for quality assurance. Consequently, further integration of homeopathy at universities is a necessary requirement for the patients’ best interests.
Who wrote this bizarre paper?
The authors who state to have no conflicts of interest are
Researchers from the Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar, Haryana, India, and the Mother Teresa Saket College of Physiotherapy, Saket, Panchkula, Haryana, India, have just published a systematic review which is remarkable in several ways. Let me therefore present to you the abstract unaltered:
Background: Spinal pain or misalignment is a very common disorder affecting a significant number of populations resulting in substantial disability and economic burden. Various manual therapeutic techniques such as spinal manipulations and mobilizations can be used to treat and manage pain and movement dysfunctions such as spinal mal-alignments and associated complications. These manual therapeutic techniques can affect the cardiovascular parameters.
Objective: The objective of this systematic review and meta-analysis is to assess the effect of spinal manipulation and mobilization on cardiovascular parameters.
Methods: We conducted a systematic review and meta-analysis to assess the effects of spinal mobilization and manipulation on cardiovascular responses. Mean changes in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Heart Rate (HR) were primary outcome measures. RevMan 5.3 software was used for the meta-analyses. Quality of the included studies was assessed by PEDro Rating scale. Risk of bias was assessed by Cochrane collaboration tool of risk of bias.
Results: Results of meta-analysis showed that there was statistically significant decrease in SBP ( MD=-4.56 , 95% CI=-9.20 , 0.08; p≤0.05 ) with moderate heterogeneity ( I2=75% , p<0.0002 ) in experimental group as compared to control group. There was statistically non-significant decrease in DBP ( MD=-1.96 , 95% CI=-4.60 , 0.69; p=0.15 ) with high heterogeneity ( I2=91% , p<0.00001 ), Change HR was statistically non-significant ( MD=-0.24 , 95% CI=-3.59 , 3.11; p=0.89 ) with moderate heterogeneity ( I2=60% , p=0.01 ). Exclusion of short duration studies in sensitivity analysis revealed a statistically significant change in DBP ( MD=-0.94 , 95% CCI=-1.85 , -0.03 ; p=0.04 ). However, the result was statistically non-significant for HR after sensitivity analysis.
Conclusion: Spinal manipulations and mobilizations may result in significant decrease of systolic as well as diastolic Blood Pressure.
After reading the full paper, I was uncertain whether to laugh or to cry. Then I decided for the former option.
Any paper that starts with the statement ‘spinal pain or misalignment is a very common disorder affecting a significant number of populations resulting in substantial disability and economic burden‘ can only be a hoax! In case you are uncertain about the reason of my amusement: spinal pain is not the same as spinal misalignment, and spinal misalignment (in the sense it is used here) is the figment of the imagination of a 18 carat charlatan called DD Palmer.
The rest of the article offers more superb hilarity: the authors write, for instance, that spinal malalignments (such as scoliosis) are mainly caused by body’s abnormal posture, asymmetries in bone growth and abnormalities of neuromuscular system. Scoliosis is an abnormal lateral curvature of the spine, not a spinal malalignment and certainly not one that can be treated with spinal manipulation.
Then the authors state that spinal pain and malalignment mainly occur due to structure deterioration, altered biomechanics and abnormal posture. Workplace physical and psychosocial factors, emotional problems, smoking, poor job satisfaction, awkward posture and poor work environment can be the possible risk factors for spinal pain and malalignment. This leads to various musculoskeletal, psychosomatic, cardiovascular and respiratory dysfunctions which affect the functional capacity of the patient as well as quality of life. Oh really?
So, the findings of the authors’ meta-analysis do suggest a tiny effect on blood pressure.
Compared to what?
In the paper, the review authors repeatedly try to make us believe it is compared to placebo. However, this is not true; mostly it was compared to no treatment.
Was the hypotensive effect verified in hypertensive patients?
No, it was measured mostly in healthy volunteers.
Is the effect clinically relevant?
No, I don’t think so!
Is it comparable to or better than the one achievable with established treatments for hypertension?
No! In fact it is much smaller.
Does that bother the authors?
No, on the contrary, they state that in this meta-analysis, spinal manipulation and mobilization resulted in statistically significant reduction in SBP. Therefore, it can be used as an adjuvant therapy for the management of hypertension.
Were the studies using spinal manipulation as an adjuvant therapy?
No, mostly not.
Is the effect lasting long enough to be relevant for the management of hypertension?
No.
I better stop here because already my whole body hurts from laughing so much. Please, do read the full text, if you are in need of some comic relief.
And, I almost forgot: many thanks to the Indian researchers for this hilarious hoax!
…
…
…
Or did you perhaps mean all that seriously?
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.
Several strands of evidence have indicated that vitamin D supplementation might be helpful for COVID-19 infections. Now we also have a study testing whether it works.
Spanish researchers evaluated the effect of calcifediol treatment on Intensive Care Unit Admission and Mortality rate among patients hospitalized for COVID-19 in a randomized, double blind clinical trial. A total of 76 consecutive patients hospitalized with COVID-19 infection and clinical picture of acute respiratory infection (confirmed by a radiographic pattern of viral pneumonia and by a positive SARS-CoV-2 PCR with CURB65 severity scale) were included. All patients received as best available therapy the same standard care. This consisted of a combination of:
- hydroxychloroquine (400 mg every 12 h on the first day, and 200 mg every 12 h for the following 5 days),
- azithromycin (500 mg orally for 5 days.
Eligible patients were allocated at a 2 calcifediol : 1 no calcifediol ratio through electronic randomization on the day of admission to take oral calcifediol (0.532 mg), or not. Patients in the calcifediol group continued with oral calcifediol (0.266 mg) on day 3 and 7, and then weekly until discharge or ICU admission. Outcomes of effectiveness included rate of ICU admission and deaths.
Of the 50 patients treated with calcifediol, one required admission to the ICU (2%), while of 26 untreated patients, 13 required admission (50 %). Univariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment versus without Calcifediol treatment: 0.02 (95 %CI 0.002-0.17). Multivariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment vs Without Calcifediol treatment ICU (adjusting by Hypertension and T2DM): 0.03 (95 %CI: 0.003-0.25). Of the patients treated with calcifediol, none died, and all were discharged, without complications. The 13 patients not treated with calcifediol, who were not admitted to the ICU, were discharged. Of the 13 patients admitted to the ICU, two died and the remaining 11 were discharged.
The authors concluded as follows:
Our pilot study demonstrated that administration of calcifediol may improve the clinical outcome of subjects requiring hospitalization for COVID-19. Whether that would also apply to patients with an earlier stage of the disease and whether baseline vitamin D status modifies these results is unknown. Therefore, a multicenter randomized controlled trial using calcifediol, properly matched (Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome (COVIDIOL)), in 15 Spanish hospitals, funded by Clinical Research Program at COVID-19 “Progreso y Salud” Foundation and Foundation for Biomedical Research of Córdoba (FIBICO), Spain, (registered as NCT04366908 in NIH Trialnet database) will be carried out with the number of patients recalculated from the data provided by this study.
An interesting perspective of the new COVIDIOL trial with the recently available information, could be to evaluate calcifediol associated to dexamethasone or other corticoid vs. dexamethasone or other corticosteroid, since dexamethasone, which has potent anti-inflammatory actions, has recently been shown to reduce mortality in hospitalized patients on Covid-19 who are on respiratory assistance; so that treatment guidelines have been updated to recommend the use of glucocorticoids (including dexametasone), now proposed as the best available treatment in many hospitals around the world.
It is undeniable that this trial has several important limitations (and its authors are very honest to point them out). However, it is equally undeniable, in my view, that it is an important contribution to our current knowledge.
In my last post, I reported that there are no rigorous studies of homeopathy for diabetes. This was only partly true: there are no such trials to test homeopathy’s effects on the disease itself, but I did find a study of homeopathy for diabetic complications.
It comes from India and seems to be based on proper preliminary ground-work:
A prospective multi-centric clinical observational study was published in 2013 in the journal ‘HOMEOPATHY’. It was carried out from October 2005 to September 2009 by Central Council for Research in Homeopathy (CCRH) at its five institutes/units. Its authors were Patients suffering from diabetes mellitus (DM) and presenting with symptoms of diabetic polyneuropathy (DPN) were screened, investigated and were enrolled in the study after fulfilling the inclusion and exclusion criteria. Patients were evaluated by the diabetic distal symmetric polyneuropathy symptom score (DDSPSS) developed by the Council. A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in 30, 200 and 1 M potency on an individualized basis. Patients were followed up regularly for 12 months.
Of 336 patients (167 males and 169 females) enrolled in the study, 247 patients (123 males and 124 females) were analysed. All patients who attended at least three follow-up appointments and baseline curve conduction studies were included in the analysis.). A statistically significant improvement in DDSPSS total score (p = 0.0001) was found at 12 months from baseline. Most objective measures did not show significant improvement. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the medicines most frequently prescribed. Adverse event of hypoglycaemia was observed in one patient only.
The authors concluded that this study suggests homeopathic medicines may be effective in managing the symptoms of DPN patients. Further studies should be controlled and include the quality of life (QOL) assessment.
As good as their word, they then conducted a more rigorous trial which was published this year:
This study (authored in 2020 by and published in ‘EXPLORE’, an even worse journal than ‘HOMEOPATHY’, in my view) assessed the efficacy of individualized homoeopathic medicines in management of diabetic distal symmetric polyneuropathy (DDSP). It was designed as a multi-centric double-blind, placebo controlled, randomised clinical trial and conducted by the Central Council for Research in Homoeopathy at 6 centres with a sample size of 84. Based on earlier observational studies and repertorial anamnesis of DDSP symptoms 15 homoeopathic medicines were shortlisted and validated scales were used for evaluating the outcomes post-intervention.
The primary outcome measure was change in Neuropathy Total Symptom Score-6 (NTSS-6) from baseline to 12 months. Secondary outcomes included changes in peripheral nerve conduction study (NCS), World Health Organization Quality of Life BREF (WHOQOL-BREF) and Diabetic Neuropathy Examination (DNE) Score at 12 months.
The data of 68 enrolled cases was considered for data analysis. Statistically significant difference (p<0.014) was found in NTSS-6 post intervention in the Verum group. Positive trend was noted for Verum group as per the graph plotted for DNE score and assessment done for NCS. No significant difference was found between the groups for WHOQOL-Bref. Out of 15 pre-identified homoeopathic medicines 11 medicines were prescribed in potencies in ascending order from 6C to 1M.
The authors concluded that further studies must be taken up with larger sample size and defined parameters for NCS to assess the effectiveness of homoeopathy.
This looks to me as though the trial failed to produce a positive result on inter-group comparisons. The abstract is unfortunately not very clear, and I have no access to the full text (in case someone has, please send it to me). Judging from the abstract, the study has several important flaws. For instance, it was small and we don’t know why only 68 of 84 patients were considered for analysis. Normally, an intention to treat analysis would be needed for analysis of all 84 patients.
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So, does homeopathy have anything to offer to patients with diabetes?
As far as I can see, the answer is NO!
I’d be happy to change my mind, provided someone shows me convincing evidence.
Prof. Shailendra Ramchandra Vishampayan is the 1st author of the paper we discussed yesterday. He was kind enough to repeatedly join us in the comments section, and I was therefore keen to learn more about him. On his website, he says about himself that he is a renowned academician and famous homeopath, enriched with decades of ideal experiences and quality services. He is registered medical practitioner (M.D), performs all the duties of registered medical practitioner following the law of land in India. Globally he is considered as homeopath and known as “Dr.V”. He is a registered member of Society of Homeopaths (overseas).
Dr. V, is a practicing homeopath with clinical experience of over 20 years. In course of his years of practice he had successfully helped more than 250 happy families globally, with various kinds of cases like thyroid, immune compromised, epilepsy, endocrine disorders, paediatric, gynaecological disorders addictions, psychiatric disorder, children with special needs, pets and plants.
He is famous for his path breaking concept and novel idea of creating an organization called ‘Folk Homeopathy ‘, which is dedicated to professional enrichment of homeopathic practitioners helping them to improve their clinical acumen with spot on prescription.
His practical approach in solving cases has earned him accolades and fame throughout the globe.
Dr. V is the author of ‘Kinder Garten Materia Medica’ a reference book for beginners widely used by homeopathic students in India. It is a book with unique combination of pictorial and pneumonic.
He is a Professor (PG) at D.Y.Patil Homeopathy Medical College (Pune). He has a teaching experience of over 16 years in teaching UG and PG. He has drawn large number of followers through webinars which is accessible throughout the globe. He has given more than 50 international seminar ,workshops and webinars in countries like USA, Ireland, Malaysia, with presentations on Homeopathic approach to female hormonal imbalance cases at OMICS Conference of Alternative Medicine, presentation on Psychiatric cases at Asian Homeopathic League. And various presentation at University of Cyberjaya, Malaysia, California Homeopathic Medical society, San Diego and also at Corte Madera, 98th FOH Congress, Liverpool and Kinvara Co Galway, Ireland.
And on the same site, we also learn that ‘Dr V’ is particularly adept at treating diabetes:
India is now considered as the diabetes capital of the world. Approximately 8.7 percent of Indians between the age of 20 to 70 years are diabetic. This translates to approximately 62.5 million diabetics living in India, according to estimates by the World Health Organisation (W.H.O.) The economic burden of managing this disease is also substantial since this is a combination of cost of treatment and loss of productivity in such a high number of diabetics. Diabetes can affect multiple organ systems resulting in a wide range of serious issues in patients. Many of these complications in a diabetic do not have any specific treatment with conventional medicines. However, an indication of the popularity of homeopathy amongst diabetics is that the doctors at our clinic treat approximately two hundred cases of diabetes or diabetes related issues every day. We have, in fact, developed specific diabetes management protocols for patients based on the experience of thousands of cases we have seen over four decades.
This is interesting, I thought, and conducted a few Medline searches to see whether there is any evidence to show that homeopathy is an effective therapy for diabetes. I am afraid, I found no papers of ‘Dr V’ to suggest such an effect. But what I did find was certainly fascinating.
Last year, Italian diabetologists published an review entitled ‘Alternative treatment or alternative to treatment? A systematic review of randomized trials on homeopathic preparations for diabetes and obesity‘. Here is what they reported:
The searches failed to retrieve any trial comparing homeopathic remedies with placebo or any active drug for the treatment of either diabetes or obesity.
These authors commented that
… if homeopathy is used as an alternative to available and effective treatments, the consequences can be catastrophic, particularly in some conditions such as insulin-requiring diabetes. In conclusion, there is no scientific evidence on efficacy and no demonstration of safety of homeopathy in diabetes and obesity…
I agree with my Italian colleagues and I have previously expressed this view bluntly; I even entitled one of my posts ‘This is how homeopathy could kill millions‘.
‘Dr V’ will probably point out that he is a fully qualified doctor and uses homeopathy merely as an adjunct to conventional anti-diabetic treatments; thus he kills nobody.
I certainly hope this is so! But, even in this case, I must still ask: WHERE IS THE EVIDENCE THAT HOMEOPATHY IS AN EFFECTIVE ADJUNCT TO CONVENTIONAL MEDICINE?
