evidence
In so-called alternative medicine (SCAM), there are few notions more difficult to argue against than this one:
I KNOW IT WORKS BECAUSE I HAVE EXPERIENCED IT MYSELF!
Yet, it is this notion that we most often encounter when discussing with proponents of SCAM. To argue against it often gets an emotional response, not least because the SCAM proponent feels that we are implying that (s)he is either lying or stupid or both. Therefore, it is important, I feel, to keep on addressing this issue. So, let me once again explain why ineffective treatments often appear to be effective.
To make this less boring, let’s consider a concrete case, one where nobody (well, almost nobody) will get emotionally involved. Let’s consider a patient who has been suffering from recurring pain of an undiagnosed origin and experiences benefit after crystal healing, a form of SCAM for which there truly is not a jot of evidence.
Why then does (s)he experience less pain after consulting her crystal healer?
There is a myriad of reasons, and in this post I will borrow some from the literature of psychology:
- The patient might think his/her pain is less frequent without actual change; recall bias.
- The healer might have provided an explanation for the pain which the patient experiences as a symptomatic improvement.
- The healer could have convinced him/her that his/her pre-treatment pain was worse than it truly was; recall bias.
- The patient might report improvement in accord with what (s)he believes to be the healer’s hope and expectation; social desirability.
- The patient is prone to preferentially remembering improvements as opposed to worsening; recall bias.
- Patients might interpret ambiguous changes in symptoms as indications of improvement.
- Many symptoms disappear or improve on their own; natural history of the disease.
- Many symptoms fluctuate; natural history of the disease.
- Extremes become less extreme on re-testing; the phenomenon of ‘regression towards the mean’.
- Patients employ several therapies simultaneously and later misattribute an improvement to one treatment.
- Patients expect to improve; the placebo-effect.
- Patients are conditioned to improve; the placebo-effect.
- Improvement owing to enthusiasm of receiving a new intervention; the novelty effect.
- Improvement owing to enthusiasm of receiving an exotic therapy.
- Improvement due to the compassionate care and attention received.
- Improvement due to the time spent with the healer.
- Improvement due to the effort and resources invested by the patient.
All these phenomena (and several more, I am sure) work in concert and can generate a clinical outcome that makes ineffective therapies and even slightly harmful treatments appear to be effective. In any single case, it is impossible to decide what precisely brought about the improvement. The only way to make sure that the specific effects of the treatment (in my example the crystal therapy) was involved is to conduct one (better several) controlled clinical trials.
It would be interesting, I thought, to get some information on what type of books on so-called alternative medicine (SCAM) are being most frequently sold and read in different countries. In particular, it would be relevant to see how many of them are books that one might recommend.
But how would one go about researching this?
The simplest solution, I guessed, would be to go on the Amazon sites of various countries and have a look. And that’s precisely what I did a few days ago. I decided to scan the first 100 books that are listed under ‘alternative medicine’ and pick out the ones that are non-promotional, factual or critical. I did this little research in 4 countries: USA, UK, France and Germany.
Here are my findings:
1 USA
Not one of the 100 books seems to offer a critical assessment of SCAM. That means the percentage of what I might call recommendable books (books that do not promote unproven or disproven SCAMs to the unsuspecting public) seems to be precisely zero.
2 UK
On place 6, I was delighted to find my recent book Alternative Medicine: A Critical Assessment of 150 Modalities. On place 14 was You Are the Placebo: Making Your Mind Matter. And on place 70 Trick or Treatment?: Alternative Medicine on Trial.
That makes the percentage 3.
3 FRANCE
Surprisingly, there are hardly any books in French listed in the SCAM category. Place 4 is my SCAM: So-Called Alternative Medicine, place 7 More Harm than Good?: The Moral Maze of Complementary and Alternative Medicine, place 9 Trick or Treatment: The Undeniable Facts about Alternative Medicine, and place 64 Killing Us Softly: The Sense and Nonsense of Alternative Medicine.
The percentage is thus 4.
4 GERMANY
Not a single book met the inclusion criteria which makes the percentage a proud zero.
____________
In 1998, we assessed for the first time books on SCAM ( Int J Risk Safety Med 1998, 11: 209-215. [the article is not Medline-listed]). We chose a random sample of 6 such books published in 1997, and assessed their contents according to pre-defined criteria. The findings showed that the advice given in these volumes was frequently misleading, not based on good evidence and often inaccurate. If followed, it would have caused significant harm to patients.
In 2006, we conducted a similar investigation which we then reported in the first and second editions of our book THE DESKTOP GUIDE TO COMPLEMENTARY AND ALTERNATIVE MEDICINE (now out of print, but the German and French translations are still available, I think). This time, we selected 7 best-sellers in SCAM and scrutinised them in much the same way. Our findings showed that almost every form of SCAM was recommended for almost every condition. There was no agreement between the 7 books which SCAM might be effective for which condition. Some treatments were even named as indications for a certain condition in one book, while, in other books, they were listed as contra-indications for the same problem. A bewildering plethora of treatments was recommended for most conditions, for instance:
- addictions: 120 different SCAMs
- arthritis: 131 different SCAMs
- asthma: 119 different SCAMs
- cancer: 133 different SCAMs
- etc. etc.
Even though, it included a much larger range of SCAM books, I do not consider my new investigation into this area to be a reliable piece of research. There are many reasons why, it can provide merely a very rough impression, e.g.:
- The lists included lots of misclassifications, i. e. books that have nothing to do with SCAM.
- Nobody seems to know by what rank order Amazon lists these books; I had hoped that it would be by sales figures, but I am not sure that this is so.
- Amazon is just one of many book sellers.
- My categorising can be criticised for being highly subjective.
Nonetheless, this little exercise, together with my previous research, might tell us something valuable after all. There are now between 30 000 and 60 000 SCAM books listed on the national Amazon sites, and even the most useless forms of SCAM are thus being promoted as though they were evidence-based forms of healthcare. Consumer demand for SCAM books is evidently substantial. The vast majority of these books are dangerously uncritical.
I believe that consumers deserve better.
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].
- 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)
- I am German-born, became an Austrian citizen in 1990, and since 2000 I am a British national.
- I have been critical about the German ‘Heilpraktiker’ for more than 20 years.
- This refers to the recent ‘Muensteraner Memorandum’ which is the work of an entire team of multidisciplinary experts and advocates reforming this profession.
- ‘Heilpraktiker’ are certainly not doctors; they have no academic or medical background.
- This is correct, and I stand by my statement that educating people in vitalism and other long-obsolete concepts is pure nonsense.
- 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.
- 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:
- 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.
- 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).
- Why was it never properly published?
- Could it be because there was no ethics approval [none was mentioned in the LTTE]?
- Could it be because there was no informed consent [none was mentioned in the LTTE]?
- 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
Much of so-called alternative medicine (SCAM) is used in the management of osteoarthritis pain. Yet few of us ever seem to ask whether SCAMs are more or less effective and safe than conventional treatments.
This review determined how many patients with chronic osteoarthritis pain respond to various non-surgical treatments. Published systematic reviews of randomized controlled trials (RCTs) that included meta-analysis of responder outcomes for at least 1 of the following interventions were included: acetaminophen, oral nonsteroidal anti-inflammatory drugs (NSAIDs), topical NSAIDs, serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, cannabinoids, counselling, exercise, platelet-rich plasma, viscosupplementation (intra-articular injections usually with hyaluronic acid ), glucosamine, chondroitin, intra-articular corticosteroids, rubefacients, or opioids.
In total, 235 systematic reviews were included. Owing to limited reporting of responder meta-analyses, a post hoc decision was made to evaluate individual RCTs with responder analysis within the included systematic reviews. New meta-analyses were performed where possible. A total of 155 RCTs were included. Interventions that led to more patients attaining meaningful pain relief compared with control included:
- exercise (risk ratio [RR] of 2.36; 95% CI 1.79 to 3.12),
- intra-articular corticosteroids (RR = 1.74; 95% CI 1.15 to 2.62),
- SNRIs (RR = 1.53; 95% CI 1.25 to 1.87),
- oral NSAIDs (RR = 1.44; 95% CI 1.36 to 1.52),
- glucosamine (RR = 1.33; 95% CI 1.02 to 1.74),
- topical NSAIDs (RR = 1.27; 95% CI 1.16 to 1.38),
- chondroitin (RR = 1.26; 95% CI 1.13 to 1.41),
- viscosupplementation (RR = 1.22; 95% CI 1.12 to 1.33),
- opioids (RR = 1.16; 95% CI 1.02 to 1.32).
Pre-planned subgroup analysis demonstrated no effect with glucosamine, chondroitin, or viscosupplementation in studies that were only publicly funded. When trials longer than 4 weeks were analysed, the benefits of opioids were not statistically significant.
The authors concluded that interventions that provide meaningful relief for chronic osteoarthritis pain might include exercise, intra-articular corticosteroids, SNRIs, oral and topical NSAIDs, glucosamine, chondroitin, viscosupplementation, and opioids. However, funding of studies and length of treatment are important considerations in interpreting these data.
Exercise clearly is an effective intervention for chronic osteoarthritis pain. It has consistently been recommended by international guideline groups as the first-line treatment in osteoarthritis management. The type of exercise is likely not important.
Pharmacotherapies such as NSAIDs and duloxetine demonstrate smaller but statistically significant benefit that continues beyond 12 weeks. Opioids appear to have short-term benefits that attenuate after 4 weeks, and intra-articular steroids after 12 weeks. Limited data (based on 2 RCTs) suggest that acetaminophen is not helpful. These findings are consistent with recent Osteoarthritis Research Society International guideline recommendations that no longer recommend acetaminophen for osteoarthritis pain management and strongly recommend against the use of opioids.
Limited benefit was observed with other interventions including glucosamine, chondroitin, and viscosupplementation. When only publicly funded trials were examined for these interventions, the results were no longer statistically significant.
Adverse events were inconsistently reported. However, withdrawal due to adverse events was consistently reported and found to be greater in patients using opioids, SNRIs, topical NSAIDs, and viscosupplementation.
Few of the interventions assessed fall under the umbrella of so-called alternative medicine (SCAM):
- some forms of exercise,
- cannabinoids,
- counselling,
- chondroitin,
- glucosamine.
It is unclear why the authors did not include SCAMs such as chiropractic, osteopathy, massage therapy, acupuncture, herbal medicines, neural therapy, etc. in their review. All of these SCAMs are frequently used for osteoarthritis pain. If they had included these treatments, how do you think they would have fared?
Prof Ernst is far too critical about homeopathy!
He is biased against it!
He cherry-picks the evidence!
He does not understand homeopathy!
If you are one of the many who believe such notions, please read on.
The website of the NHS England has a fairly detailed account of homeopathy. Here is the section entitled ‘What can we conclude from the evidence?‘ – but I recommend reading the full text:
There have been several reviews of the scientific evidence on the effectiveness of homeopathy.
The House of Commons Science and Technology Committee said there’s no evidence that homeopathy is effective as a treatment for any health condition.
There’s no evidence behind the idea that substances that cause certain symptoms can also help treat them.
Nor is there any evidence behind the idea that diluting and shaking substances in water can turn those substances into medicines.
The ideas that underpin homeopathy aren’t accepted by mainstream science, and aren’t consistent with long-accepted principles on the way the physical world works.
The Committee’s 2010 report on homeopathy said the “like cures like” principle is “theoretically weak”, and that this is the “settled view of medical science”.
For example, many homeopathic remedies are diluted to such an extent that it’s unlikely there’s a single molecule of the original substance remaining in the final remedy. In cases like these, homeopathic remedies consist of nothing but water.
Some homeopaths believe that, as a result of the succussion process, the original substance leaves an “imprint” of itself on the water. But there’s no known mechanism by which this can occur.
The 2010 report said: “We consider the notion that ultra-dilutions can maintain an imprint of substances previously dissolved in them to be scientifically implausible.”
Some people who use homeopathy may see an improvement in their health condition as the result of a phenomenon known as the placebo effect.
If you choose health treatments that provide only a placebo effect, you may miss out on other treatments that have been proven to be more effective.
__________________________________
Since 1948, homeopathy had been part of the NHS, there were 5 homeopathic NHS hospitals, and the costs for homeopathy were covered. Why would the NHS decision makers suddenly turn against it? They must have loved homeopathy for at least 4 reasons:
-
-
- It is inexpensive.
- It has support in high places.
- It did not cause any direct harm.
- It had many supporters who fought tooth and nail for it.
-
It is therefore hardly reasonable to assume that the NHS is biased against homeopathy. But, why do they now say that it is
- implausible,
- not effective beyond placebo,
- and can cause harm by making people miss out on effective therapies?
The answer is simple: BECAUSE THESE STATEMENTS ARE IN ACCORDANCE WITH THE OVERWHELMING MAJORITY OF THE BEST EVIDENCE AVAILABLE TO DATE.
So, here you are: the NHS now confirms what I (and many other experts) have been saying since years. And we all insist on the fact that this not because we are biased, stupid, uninformed, paid by BIG PHARMA, or want to deprive anyone of anything. We do it for one reason only:
BECAUSE IT’S THE TRUTH!
When chiropractors try to play medical doctors, their patients are in danger. When they try to play epidemiologists, we might all be in danger. Already in April 2020, the Australian ‘Patrons of Chiropractic Science’ issued a press release on COVID 19 stating:
Good function of the body’s joints, particularly within the spine, may improve neurological function, which is important for an effective natural immune system. Treatment by a qualified and experienced chiropractor offers one of the most effective methods to improve and maintain good spinal joint function. The chiropractic profession attends to many patients, and like all other health workers, the profession truly cares for the welfare of every individual.
Now they have gone further. Their press release of 18/8/2020 states amongst other things:
- Approximately 1.5% of those infected with SARS-CoV-2 may die; all people with a compromised immune system, that being the aged or those suffering a co-morbidity;
- 98.5% of those infected with the COVID-19 virus suffer either no symptoms, mild symptoms or treatable symptoms no worse than seasonal influenza;
- COVID-19 positive test numbers are largely irrelevant, as 98.5% of those testing positive will simply develop natural immunity and recover as the virus moves through the population. Recent studies by the UK based Centre for Evidence Based Medicine confirms increased COVID testing is the primary reason for increased case numbers, which have little relationship to mortality. The focus on case numbers is again designed to engender public fear and compliance;
Patrons of Chiropractic Science demands that the Victorian Government and its senior health officials cease distorting facts, stop blaming Victorian non-compliance for the increased positive testing numbers, and assume full responsibility for the aged care deaths and the current economic damage.
Simple facts: it is critical and more effective to isolate and protect the high-risk groups, effectively quarantine return travellers, but cease the illogical isolation of the vast majority of the population who are not at risk as the virus naturally circulates, and allow them to recommence working to save many businesses and initiate economic recovery.
________________________________
Implying that regular chiropractic manipulations improve immunity or protect people from the corona virus is bad enough. But the new press release is worse:
- It is not true that only people with impaired immune systems, of old age, or affected by other diseases die of COVID 19.
- It is not true that all of the 98.5% who do not die have treatable symptoms not worse than a flu; an undefined percentage of the survivors suffer from very severe and sometimes long-lasting conditions.
- It is not true that 98.5% of those testing positive will simply develop natural immunity and recover; many will not recover completely, and the question whether mildly affected individuals develop immunity and for how long is as yet unanswered.
- It is not true that COVID testing results are unrelated to mortality; the figures need, of course, careful interpretation; the percentage of positive tests per number of tests done, for instance, should be independent of the frequency of testing.
- It is not true that the vast majority of the population are not at risk, if the virus were to circulate naturally.
All this looks to me as though the ‘Patrons of Chiropractic Science’ are in urgent need of learning some science. Meanwhile, it would be most helpful, if they could keep quiet.
At present, we see a wave of promotion of Traditional Chinese Medicine (TCM) as a treatment of corona-virus infections. In this context, we should perhaps bear in mind that much of the Chinese data seem to be less than reliable. Moreover, I find it important to alert people to a stern warning recently published by two Australian experts. Here is the crucial passage from their paper:
We wish to highlight significant concerns regarding the association between traditional herbal medicines and severe, non-infective interstitial pneumonitis and other aggressive pulmonary syndromes, such as diffuse alveolar haemorrhage and ARDS which have emerged from Chinese and Japanese studies particularly during the period 2017−2019. Initially the association between traditional herbal therapies and pneumonitis was based on isolated case reports. These included hypersensitivity pneumonitis associated with the use of traditional Chinese or Japanese medicines such as Sai-rei-to, Oren-gedoku-to, Seisin-renshi-in and Otsu-ji-to (9 references in supplemental file). Larger cohorts and greater numbers now support this crucial relationship. In a Japanese cohort of 73 patients, pneumonitis development occurred within 3 months of commencing traditional medicine in the majority of patients [3], while a large report from the Japanese Ministry of Health, Labor and Welfare, described more than 1000 cases of lung injury secondary to traditional medications, the overwhelming majority of which (852 reports) were described as ‘interstitial lung disease [4].
Currently the constituent of traditional herbal medicines which is considered most likely to underlie causation of lung disease is Scutellariae Radix also known as Skullcap or ou-gon, which has been implicated through immunological evidence of hypersensitivity as well as circumstantial evidence, being present in all of those medicines outlined above [3]. Notably, skullcap is a constituent of QPD as used and described in the paper by Ren et al. relating to COVID-19 [1]. Scutellariae Radix-induced ARDS and COVID-19 disease share the same characteristic chest CT changes such as ground-glass opacities and airspace consolidation, therefore distinguishing between lung injury due to SARS-CoV-2 and that secondary to TCM may be very challenging. The potential for iatrogenic lung injury with TCM needs to be acknowledged [5]…
Morbidity and mortality from COVID-19 are almost entirely related to lung pathology [6]. Factors which impose a burden on lung function such as chronic lung disease and smoking are associated with increased risk for a poor outcome. Severe COVID-19 may be associated with a hypersensitivity pneumonitis component responsive to corticosteroid therapy [7]. Against this background the use of agents with little or no evidence of clinical efficacy and which have been significantly implicated in causing interstitial pneumonitis that could complicate SARS-CoV-2 infection, should be considered with extreme caution.
In conclusion, the benefits of TCM in the treatment of COVID-19 remain unproven and may be potentially deleterious. We recognise that there is currently insufficient evidence to prove the role of TCM in the causation of interstitial pneumonitis, however the circumstantial data is powerful and it would seem prudent to avoid these therapies in patients with known or suspected SARS-CoV-2 infection, until the evidence supports their use.
Declaration of Competing Interest: There are no conflicts to declare.
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.
As recently reported, the most thorough review of the subject showed that the evidence for acupuncture as a treatment for chronic pain is very weak. Yesterday, NICE published a draft report that seems to somewhat disagree with this conclusion (and today, this is being reported in most of the UK daily papers). The draft is now open to public consultation until 14 September 2020 and many of my readers might want to comment.
The draft report essentially suggests that people with chronic primary pain (CPP) should not get pain-medication of any type, but be offered supervised group exercise programmes, some types of psychological therapy, or acupuncture. While I understand that chronic pain should not be treated with long-term pain-medications – I did even learn this in medical school all those years ago – one might be puzzled by the mention of acupuncture.
But perhaps we need first ask, WHAT IS CPP? The NICE report informs us that CPP represents chronic pain as a condition in itself and which can’t be accounted for by another diagnosis, or where it is not the symptom of an underlying condition (this is known as chronic secondary pain). I find this definition most unsatisfactory. Pain is usually a symptom and not a disease. In many forms of what we now call CPP, an underlying disease does exist but might not yet be identifiable, I suspect.
The evidence on acupuncture considered for the draft NICE report included conditions like:
- neck pain,
- myofascial pain,
- radicular arm pain,
- shoulder pain,
- prostatitis pain,
- mechanical neck pain,
- vulvodynia.
I find it debatable whether these pain syndromes can be categorised to be without an underlying diagnosis. Moreover, I find it problematic to lump them together as though they were one big entity.
The NICE draft document is huge and far too big to be assessed in a blog like mine. As it is merely a draft, I also see little point in evaluating it or parts of in detail. Therefore, my comments are far from detailed, very brief and merely focussed on pain (the draft NICE report considers several further outcome measures).
There is a separate document for acupuncture, from which I copy what I consider the key evidence:
Acupuncture versus sham acupuncture
Pain reduction
Very low quality evidence from 13 studies with 1230 participants showed a clinically
important benefit of acupuncture compared to sham acupuncture at ≤3 months. Low quality
evidence from 2 studies with 159 participants showed a clinically important benefit of
acupuncture compared to sham acupuncture at ≤3 months.
Low quality evidence from 4 studies with 376 participants showed no clinically important
difference between acupuncture and sham acupuncture at >3 months. Moderate quality
evidence from 2 studies with 159 participants showed a clinically important benefit of
acupuncture compared to sham acupuncture at >3 months. Low quality evidence from 1
study with 61 participants showed no clinically important difference between acupuncture
and sham acupuncture at >3 months.
As acupuncture has all the features that make a perfect placebo (slightly invasive, mildly painful, exotic, involves touch, time and attention), I see little point in evaluating its efficacy through studies that make no attempt to control for placebo effects. This is why the sham-controlled studies are central to the question of acupuncture’s efficacy, no matter for what condition.
Reading the above evidence carefully, I fail to see how NICE can conclude that CPP patients should be offered acupuncture. I am sure that some readers will disagree and am looking forward to reading their comments.
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?
