critical thinking
The amount of different so-called alternative medicines (SCAMs) that are being tried or promoted against COVID-19 is legion. Anything really from vitamins to herbal remedies, homeopathics to chiropractic. In fact, it is hard these days to find a SCAM that is not touted for COVID-19.
This study aimed to evaluate if a dietary supplement of quercetin (a polyphenol contained in many fruit and vegetables), vitamin C and bromelain (a proteolytic enzyme contained in pineapple) could be protective against coronavirus infections.
In the verum group, a supplement containing
- 500mg of quercetin,
- 500mg of vitamin C,
- 50mg of bromelain (QCB)
was administered daily in 2 divided doses for 71 healthcare workers working in areas with high risk of COVID-19, whereas 42 were the control group who received no supplements. The maximum period of follow-up was 120 days. Termination of QCB use prematurely or having a coronavirus infection was the end of a volunteer’s study participation. A rapid diagnostic test was used to detect immunoglobulin positivity.
Graphic demonstrated survival without COVID-19 during follow up time between groups
A total of 113 persons were included. No significant difference were detected between groups at baseline. Mean age of QCB group was 39.0 ± 8.8 years and control group was 32.9 ± 8.7. Average follow-up period for the QCB group was 113 days, and for the control group, 118 days. During the follow-up period, 1 healthcare worker in the QCB group and 9 out in 42 in control group contracted COVID-19. One case was asymptomatic, while others were not. Transmission risk hazard ratio of participants who did not receive QCB was 12.04 (95% Confidence interval= 1.26-115.06, P = 0.031). No significant effect of gender, smoking, antihypertensive medication exposure and having chronic disease on rate of transmission. The authors concluded that this study revealed that QCB was protective for healthcare workers.
The sudy is so poorly written and reported that I had trouble making sense of it. In fact, I first thought it was a fake. Then I saw this note:
Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed.
If the results are for real (because of the small sample size, the lack of a placebo-control, dozens of potential confounders, etc., the findings could easily false-positive), they would merit urgent replication in a larger, more rigorous trial.
And meanwhile?
Meanwhile I would be very sceptical about the validity of the results. The paper (it really is just a submission for publication in the Lancet; I am not even sure that it will be officially published and I don’t quite see why it is being made available to the public in this way) is too flimsy for words. Despite these warnings, it is likely that many consumers will fall for the claim that QCB was protective for healthcare workers.
In these pre-Xmas days, many homes will smell of cinnamon. It’s certainly a wonderful spice for creating an atmosphere. But ther are also other uses for ciannamon.
Current treatments for overactive bladder (OAB) have limited efficacy, low persistence and a high rate of adverse events commonly leading to treatment cessation in clinical practice. Clinicians in Asia commonly use traditional Chinese medicine as an alternative for OAB treatment despite it having uncertain efficacy and safety. To evaluate the efficacy and safety of cinnamon patch (CP) treatment for alleviating symptoms of OAB, this double-blind randomized, placebo-controlled trial was conducted.
The 6-week study was conducted in an outpatient setting; 66 subjects diagnosed as having OAB were enrolled and treated with a placebo (n=33) or CP (n=33). The OAB symptom score (OABSS) was selected as the primary end point, and a patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume were selected as secondary end points.
In total, 66 participants (40 women and 26 men), 60 years of age, were included in the intention-to-treat analyses. Baseline characteristics were comparable between the CP and placebo groups. Treatment with a CP showed statistically significant differences in reductions in OABSS scores, PPBC scores, and USS scores.
The authors concluded that compared to a placebo, treatment with CP might be considered an effective and safe complementary therapy for OAB. Further studies employing a positive control, different dosage forms, larger sample sizes, and longer treatment periods are warranted.
Cinnamon (Cinnamomum zeylanicum and Cinnamon cassia)belongs to the Lauraceae family. It contains manganese, iron, dietary fiber, and calcium as well as cinnamaldehyde, cinnamic acid, cinnamate, and numerous other components such as polyphenols and antioxidant, anti-inflammatory, antidiabetic, antimicrobial, anticancer effects. Several reports have dealt with the numerous properties of cinnamon in the forms of bark, essential oils, bark powder, and phenolic compounds, and each of these properties can play a key role in human health.
The new study is interesting and prompts me to ponder:
- Do the pharmacologically active ingredients of cinnamon pass the skin barrier in sufficient amounts to have any effect at all? Or perhaps it was the scent? In which case, this would have been a study of aromatherapy.
- Considering the typical scent of cinnamon, I find it hard to imagine that this study was truly double blind.
- Cinnamon is alleged to have antimicrobial, antiviral, antifungal, antioxidant, antitumor, antihypertensive, antilipemic, antidiabetic, gastroprotective, and immunomodulatory effects. I do wonder which, if any, of these are responsible for the observed clinical results of this trial.
- Cinnamon is known to sometimes lead to allergic reactions. I wonder whether this could be a problem when it is applied in patches.
So, for the time being, I think, I prefere cinnamon, the spice, to cinnamon, the medicine.
Recent comments on this blog prompted me to look into a very strange therapeutic and diagnostic device used by some practitioners of so-called alternative medicine (SCAM):
The OBERON provides the most unique tool for scanning the various organs and systems of the physical body without having to make a medical or surgical intrusion. Developed by Russian scientists since the early 1990’s, the OBERON is the most revolutionary computer programmed invention available in the world today for analyzing and treating all the body’s organs and functions.
This device scans each organ or tissue on a cellular level. It compares the measurements to a database of thousands of referenced conditions and their diagnosis. OBERON uses a special emitter to modulate the carrier frequency for the cell communication and it uses special sensor trigger readers built into headphones to read the cells own signals.
OBERON finds out how stressed an organ is, and if there are any diseases developing, how much the cells are influenced by a specific disease, and which micro organisms and bacteria are in the area at the time of the scan.
BENEFITS OF THE OBERON:
Rebalances the body so that it can start to heal itself!
Makes intrusive and embarrassing examinations a THING OF THE PAST!!!!
Quick examination (in seconds) with immediate results
Replaces dozens of traditional diagnostic methods.
Finds weaknesses in the skeleton, organs, blood, tissue, etc.
There are no side effects, unpleasantness or injury after treatment
Bio-resonance META-therapy
A print out of the report on findings can be taken at the end of the session…
The method is based on an analysis of the brain stems electromagnetic waves which contain the complete information of the entire organism. This information is read by a sensor. A frequency transmitter aimed at the projection area of the brain stem stimulates this electromagnetic radiation.
Meta- Therapy repairs the organism using a diversity of modulated electromagnetic waves. This treatment stimulates the body’s own functions so that they solve the problem and it stimulates the immune defense and is a very good supplement or alternative to traditional treatment. The patient can follow on the screen how the organ progressively gets better, and afterwards one can take a new measurement showing the improvement…
________________________________________
Sounds fantastic?
Yes, indeed – fantastic as in fantasy!
Almost as much relation to reality as OBERON, king of the fairies in medieval literature.
The modern OBERON device is being used by infamous proponents of integrated medicine like Dr Julian Kenyon who already made an appearance on this blog. On his website, Kenyon published a paper in which he provides details about the OBERON. To a lay person, the sciency text might look like science; however, this impression would be false. The ‘study’ Kenyon mentioned is not on Medline. In fact, Dr Kenyon (former associate of the late George Lewith) has merely 4 Medline-listed papers:
- Physiological and psychological explanations for the mechanism of acupuncture as a treatment for chronic pain. Soc Sci Med. 1984;19(12):1367-78. doi: 10.1016/0277-9536(84)90026-1.PMID: 6085191 Review.
- Is electrodermal testing as effective as skin prick tests for diagnosing allergies? A double blind, randomised block design study. BMJ. 2001 Jan 20;322(7279):131-4. doi: 10.1136/bmj.322.7279.131.PMID: 11159567 Free PMC article. Clinical Trial.
- Randomised double-blind trial on the immediate effects of naloxone on classical Chinese acupuncture therapy for chronic pain. Acupunct Electrother Res. 1983;8(1):17-24. doi: 10.3727/036012983816715064.PMID: 6135300 Clinical Trial.
- Food sensitivity, a search for underlying causes. Case study of 12 patients. Kenyon JN.Acupunct Electrother Res. 1986;11(1):1-13. doi: 10.3727/036012986816359238.PMID: 2872775
And what about other researchers? Aren’t there ANY decent studies of the OBERON?
Not as far as I can see (if anyone does know of peer-reviewed research, please let me know).
So, what is the conclusion?
My conclusion is this:
There is no evidence that the OBERON does anything useful other than putting money in the bank accounts of those charlatans who use or manufacture it.
And what does that make Kenyon and all the other SCAM practitioners using the OBERON or similar devices?
I leave it to you to decide.
The Center for Science in the Public Interest*** (CSPI) announced its agreement with Boiron to improve the labeling on the homeopathic products manufactured by Boiron and sold under the Boiron or other private label brands. The agreement covers the labeling for over 50 homeopathic products.
On Boiron’s Oscillococcinum and two similar products, Boiron will substantially increase the prominence of the words “Homeopathic Medicine” on the front of the box and the disclaimer on the back of the box that says the product’s uses have not been evaluated by the Food and Drug Administration (FDA). These changes will make it easier for consumers to identify that the products are homeopathic products, and are not FDA approved over-the-counter medicines.
For all of the other homeopathic products manufactured by Boiron, consumers will receive much more information on the packages. In addition to increasing the prominence of the words “Homeopathic Medicine,” a new disclaimer in large and contrasting font will be added to the back of the package (endorsed by the American Association of Homeopathic Pharmacists) stating: “Claims based on traditional homeopathic practice, not accepted medical evidence, and not FDA evaluated.”…
“The labeling changes that Boiron has agreed to on all the products covered by the agreement will help consumers more clearly identify that these are homeopathic products and are not FDA approved over-the-counter medicines that have been scientifically proven to be safe and effective,” said CSPI litigation director Lisa Mankofsky. “In addition, the vast majority of the covered homeopathic products will bear a disclaimer clarifying that they are based on traditional homeopathic practice, not accepted medical evidence, and not FDA evaluated. We think that consumers will find this labeling change important when choosing a remedy. We encourage other manufacturers to similarly make their labels more transparent and clear for consumers.”
Bravo!
Clearly a step into the right direction!
But it’s a small step only. It is a long way short of what Dylan Evans suggestied in his book ‘Placebo‘, first published in 2004:
Warning: this product is a placebo. It will work only if you believe in homeopathy, and only for certain conditions such as pain and depression. Even then, it is not likely to be as powerful as orthodox drugs. You may get fewer side-effects from this treatment than from a drug, but you will probably also get less benefit.
***The Center for Science in the Public Interest is perhaps the oldest independent, science-based consumer advocacy organization with an impressive record of accomplishments and a clear and ambitious agenda for improving the food system to support healthy eating.
There is some encouraging evidence regarding the positive influence of vitamin D on COVID-19. But is it convincing? Is it causal? As always, it is worth looking at the totality of the reliable evidence.
In this systematic review and meta-analysis, the researchers analyze the association between vitamin D deficiency and COVID-19 severity. They conducted an analysis of the prevalence of vitamin D deficiency and insufficiency in people with the disease. Five online databases—Embase, PubMed, Scopus, Web of Science, ScienceDirect and pre-print Medrevix were searched. The inclusion criteria were observational studies measuring serum vitamin D in adult and elderly subjects with COVID-19. The main outcome was the prevalence of vitamin D deficiency in severe cases of COVID-19.
The researchers identified 1542 articles and 27 met their inclusion criteria. The results show that
- vitamin D deficiency was not associated with a higher chance of infection by COVID-19,
- severe cases of COVID-19 present 64% more vitamin D deficiency compared with mild cases,
- vitamin D concentration insufficiency increased hospitalization and mortality rates,
- There was a positive association between vitamin D deficiency and the severity of the disease.
The authors concluded that the results of the meta-analysis confirm the high prevalence of vitamin D deficiency in people with COVID-19, especially the elderly. We should add that vitamin D deficiency was not associated with COVID-19 infection. However, we observed a positive association between vitamin D deficiency and the severity of the disease. From this perspective, evaluating blood vitamin D levels could be considered in the clinical practice of health professionals. Moreover, vitamin D supplementation could be considered in patients with vitamin D deficiency and insufficiency, if they have COVID-19. However, there is no support for supplementation among groups with normal blood vitamin D values with the aim of prevention, prophylaxis or reducing the severity of the disease.
These are interesting findings, no doubt. They relate to associations, as the authors repeatedly stress in the text of the paper. They do not, however, signify cause and effect relationships. The principal outcome of this research should be a hypothesis that subsequently needs testing in clinical trials.
So, why on earth did the authors chose that seriously misleading title of their paper? It clearly implies a causal effect; and this can only be verified by conducting clinical trials. One such study has been published (as discussed here) and it concluded that administration of calcifediol may improve the clinical outcome of subjects requiring hospitalization for COVID-19.
My conclusion: it seems well worth conducting more and more rigorous clinical trials.
Many experts doubt that acupuncture generates the many positive health effects that are being claimed by enthusiasts. Yet, few consider that acupuncture might not be merely useless but could even make things worse. Here is a trial that seems to suggest exactly that.
This study evaluated whether combining two so-called alternative medicines (SCAMs), acupuncture and massage, reduce postoperative stress, pain, anxiety, muscle tension, and fatigue more than massage alone.
Patients undergoing autologous tissue breast reconstruction were randomly assigned to one of two postoperative SCAMs for three consecutive days. All participants were observed for up to 3 months. Forty-two participants were recruited from January 29, 2016 to July 11, 2018. Twenty-one participants were randomly assigned to massage alone and 21 to massage and acupuncture. Stress, anxiety, relaxation, nausea, fatigue, pain, and mood (score 0-10) were measured at enrollment before surgery and postoperative days 1, 2, and 3 before and after the intervention. Patient satisfaction was evaluated.
Stress decreased from baseline for both Massage-Only Group and Massage+Acupuncture Group after each treatment intervention. Change in stress score from baseline decreased significantly more in the Massage-Only Group at pretreatment and posttreatment. After adjustment for baseline values, change in fatigue, anxiety, relaxation, nausea, pain, and mood scores did not differ between groups. When patients were asked whether they would recommend the study, 100% (19/19) of Massage-Only Group and 94% (17/18) of Massage+Acupuncture Group responded yes.
The authors concluded tha no additive beneficial effects were observed with addition of acupuncture to massage for pain, anxiety, relaxation, nausea, fatigue, and mood. Combined massage and acupuncture was not as effective in reducing stress as massage alone, although both groups had significant stress reduction. These findings indicate a need for larger studies to explore these therapies further.
I recently went to the supermarket to find out whether combining two bank notes (£10 + £5) can buy more goods than one £10 note alone. What I found was interesting: the former did indeed purchase more than the latter. Because I am a scientist, I did not stop there; I went to a total of 10 shops and my initial finding was confirmed each time: A+B results in more than A alone.
It stands to reason that the same thing happens with clinical trials. We even tested this hypothesis in a systematic review entitled ‘A trial design that generates only ”positive” results‘. Here is our abstract:
In this article, we test the hypothesis that randomized clinical trials of acupuncture for pain with certain design features (A + B versus B) are likely to generate false positive results. Based on electronic searches in six databases, 13 studies were found that met our inclusion criteria. They all suggested that acupuncture is effective (one only showing a positive trend, all others had significant results). We conclude that the ‘A + B versus B’ design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.
But why is this not so with the above-mentioned study?
Why is, in this instance, A even more that A+B?
There are, of course, several possible answers. To use my supermarket example again, the most obvious one is that B is not a £5 note but a negative amount, a dept note, in other words: A + B can only be less than A alone, if B is a minus number. In the context of the clinical trail, this means acupuncture must have caused a negative effect.
But is that possible? Evidently yes! Many patients don’t like needles and experience stress at the idea of a therapist sticking one into their body. Thus acupuncture would cause stress, and stress would have a negative effect on all the other parameters quantified in the study (pain, anxiety, muscle tension, and fatigue).
My conclusion: in certain situations, acupuncture is more than just useless; it makes things worse.
Melatonin is an indolamine hormone which is secreted from the human pineal gland during night-time acting as physiological regulator. In many countries, dietary supplements containing synthetically produced melatonin are available. Melatonin is being promoted as a treatment of a range of conditions, including virtually all types of cancer.
One website, for instance, states that the anti-cancer benefits of melatonin aren’t just indirect; this miracle molecule is also classified as a directly cytotoxic hormone and anti-cancer agent. Studies have referred to melatonin as a “full-service anti-cancer agent” due to its ability to inhibit the initiation of cell mutation and cancer growth, and to halt the progression and metastasis of cancer cell colonies.
Such statements sound far too good to be true. So, let’s have a look and find out what the evidence tells us. Test-tube experiments suggest that melatonin has anti-cancer effects.[1] Its actions include the advancement of apoptosis, the arrest of the cell cycle, inhibition of metastasis, and antioxidant activity.[2]
A review of 21 clinical trials of melatonin for cancer found positive effects for complete response, partial response, and stable disease. In trials combining melatonin with chemotherapy, adjuvant melatonin therapy decreased 1-year mortality and improved outcomes of complete response, partial response, and stable disease. In these studies, melatonin also significantly reduced asthenia, leukopenia, nausea and vomiting, hypotension, and thrombocytopenia. The authors concluded that melatonin may benefit cancer patients who are also receiving chemotherapy, radiotherapy, supportive therapy, or palliative therapy by improving survival and ameliorating the side effects of chemotherapy.[3]
A further systematic review of RCTs of melatonin in solid tumour cancer patients evaluated its effect on one-year survival. Ten trials were included of melatonin as either sole treatment or as adjunct treatment. Melatonin reduced the risk of death at 1 year. Effects were consistent across melatonin dose, and type of cancer. No severe adverse events were reported.[4]
A 2012 systematic review confirmed these findings by concluding that Melatonin as an adjuvant therapy for cancer led to substantial improvements in tumor remission, 1-year survival, and alleviation of radiochemotherapy-related side effects.[5]
Finally, a 2020 review concluded that melatonin in combination with anticancer agents may improve the efficacy of routine medicine and survival rate of patients with cancer. [6] Apart from its direct anticancer potential, melatonin also seems to reduce chemotherapy toxicity, while improving its therapeutic efficacy.[7]
So, is this evidence compelling? While all this does indeed sound encouraging, it is necessary to mention several important caveats:
- The primary studies of melatonin suffer from several methodological shortcomings.
- Their vast majority originate from one single research group.
- In recent years, there have been no further clinical studies trying to replicate the initial findings.
This means that definitive trials are still missing, and it would seem wise to interpret the existing evidence with great caution.
References
[1] Kong X, Gao R, Wang Z, Wang X, Fang Y, Gao J, Reiter RJ, Wang J. Melatonin: A Potential Therapeutic Option for Breast Cancer. Trends Endocrinol Metab. 2020 Sep 3:S1043-2760(20)30155-7. doi: 10.1016/j.tem.2020.08.001. Epub ahead of print. PMID: 32893084.
[2] Samanta S. Melatonin: an endogenous miraculous indolamine, fights against cancer progression. J Cancer Res Clin Oncol. 2020 Aug;146(8):1893-1922. doi: 10.1007/s00432-020-03292-w. Epub 2020 Jun 24. PMID: 32583237.
[3] Seely D, Wu P, Fritz H, Kennedy DA, Tsui T, Seely AJ, Mills E. Melatonin as adjuvant cancer care with and without chemotherapy: a systematic review and meta-analysis of randomized trials. Integr Cancer Ther. 2012 Dec;11(4):293-303. doi: 10.1177/1534735411425484. Epub 2011 Oct 21. PMID: 22019490.
[4] Mills E, Wu P, Seely D, Guyatt G. Melatonin in the treatment of cancer: a systematic review of randomized controlled trials and meta-analysis. J Pineal Res. 2005 Nov;39(4):360-6. doi: 10.1111/j.1600-079X.2005.00258.x. PMID: 16207291.
[5] Wang YM, Jin BZ, Ai F, Duan CH, Lu YZ, Dong TF, Fu QL. The efficacy and safety of melatonin in concurrent chemotherapy or radiotherapy for solid tumors: a meta-analysis of randomized controlled trials. Cancer Chemother Pharmacol. 2012 May;69(5):1213-20. doi: 10.1007/s00280-012-1828-8. Epub 2012 Jan 24. PMID: 22271210.
[6] Pourhanifeh MH, Mehrzadi S, Kamali M, Hosseinzadeh A. Melatonin and gastrointestinal cancers: Current evidence based on underlying signaling pathways. Eur J Pharmacol. 2020 Nov 5;886:173471. doi: 10.1016/j.ejphar.2020.173471. Epub 2020 Aug 30. PMID: 32877658.
[7] Iravani S, Eslami P, Dooghaie Moghadam A, Moazzami B, Mehrvar A, Hashemi MR, Mansour-Ghanaei F, Mansour-Ghanaei A, Majidzadeh-A K. The Role of Melatonin in Colorectal Cancer. J Gastrointest Cancer. 2020 Sep;51(3):748-753. doi: 10.1007/s12029-019-00336-4. PMID: 31792737.
Misinformation by chiropractors is unfortunately nothing new and has been discussed ad nauseam on this blog. It is tempting to ask whether chiropractors have lost (or more likely never had) the ability to ditinguish real information from misinformation or substantiated from unsubstantiated claims. During the pandemic, the phenomenon of chiropractic misinformation has become even more embarrassingly obvious, as this new article highlights.
Chiropractors made statements on social media claiming that chiropractic treatment can prevent or impact COVID-19. The rationale for these claims is that spinal manipulation can impact the nervous system and thus improve immunity. These beliefs often stem from nineteenth-century chiropractic concepts. The authors of the paper are aware of no clinically relevant scientific evidence to support such statements.
The investigators explored the internet and social media to collect examples of misinformation from Europe, North America, Australia and New Zealand regarding the impact of chiropractic treatment on immune function. They discussed the potential harm resulting from these claims and explore the role of chiropractors, teaching institutions, accrediting agencies, and legislative bodies.
The authors conclude as follows: In this search of public media in Europe, North America, New Zealand, and Australia, we discovered many cases of misinformation. Claims of chiropractic treatment improving immunity conflict with the advice from authorities and the scientific consensus. The science referenced by these claims is missing, flawed or has no clinical relevance. Consequently, their claims about clinical effectiveness are spurious at best and misleading at worst. However, our examples cannot be used to make statements about the magnitude of the problem among practitioners as our samples were not intended to be representative. For that reason, we also did not include an analysis of the arguments provided in the various postings. In view of the seriousness of the topic, it would be relevant to conduct a systematic study on a representative sample of public statements, to better understand these issues. Our search illustrates the possible danger to public health of misinformation posted on social media and the internet. This situation provides an opportunity for growth and maturation for the chiropractic profession. We hope that individual chiropractors will reflect on and improve their communication and practices. Further, we hope that the chiropractic teaching institutions, regulators, and professional organisations will always demonstrate responsible leadership in their respective domains by acting to ensure that all chiropractors understand and uphold their fiduciary duties.
Several previous papers have found similar things, e.g.: Twitter activity about SMT and immunity increased during the COVID-19 crisis. Results from this work have the potential to help policy makers and others understand the impact of SMT misinformation and devise strategies to mitigate its impact.
The pandemic has crystallised the embarrassment about chiropractic false claims. Yet, the phenomenon of chiropractors misleading the public has long been known and arguably is even more important when it relates to matters other than COVID-19. Ten years ago, we published this paper:
Background: Some chiropractors and their associations claim that chiropractic is effective for conditions that lack sound supporting evidence or scientific rationale. This study therefore sought to determine the frequency of World Wide Web claims of chiropractors and their associations to treat, asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash (not supported by sound evidence), and lower back pain (supported by some evidence).
Methods: A review of 200 chiropractor websites and 9 chiropractic associations’ World Wide Web claims in Australia, Canada, New Zealand, the United Kingdom, and the United States was conducted between 1 October 2008 and 26 November 2008. The outcome measure was claims (either direct or indirect) regarding the eight reviewed conditions, made in the context of chiropractic treatment.
Results: We found evidence that 190 (95%) chiropractor websites made unsubstantiated claims regarding at least one of the conditions. When colic and infant colic data were collapsed into one heading, there was evidence that 76 (38%) chiropractor websites made unsubstantiated claims about all the conditions not supported by sound evidence. Fifty-six (28%) websites and 4 of the 9 (44%) associations made claims about lower back pain, whereas 179 (90%) websites and all 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were made about asthma, ear infection/earache/otitis media, neck pain,
Conclusions: The majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.
It makes it clear that the misleading information of chiropractors is a serious problem. And I find it disappointing to see that so little has been done about it, and that progress seems so ellusive.
This, of course, begs the question, where does all this misinformation come from? The authors of the new paper stated that beliefs often stem from nineteenth-century chiropractic concepts. This, I believe, is very true and it gives us an important clue. It suggests that, because it is good for business, chiro schools are still steeped in obsolete notions of pseudo- and anti-science. Thus, year after year, they seem to churn out new generations of naively willing victims of the Dunning Kruger effect.
We have often heard it said on this blog and elsewhere that chiropractors are making great strides towards reforming themselves and becoming an evidence-based profession. In view of the data cited above, this does not ring all that true, I am afraid. Is the picture that emerges not one of a profession deeply embroiled in BS with but a few fighting a lost battle to clean up the act?
- the chiro suggests a manipulation of the neck;
- this often involves forcing a spinal joint beyond its physiological range of motion;
- the treatment will be short but needs repeating several times during the coming weeks;
- the expected benefits are a reduction of pain and improvement of motion;
- the total cost of the treatment series will be xy;
- there are many other treatment options for neck pain;
- most of these have a better risk/benefit profile than neck manipulation;
- having no treatment for neck pain at all is likely to lead to full resolution of the problem over time.
Apart from any doubts that chiropractors would actually comply with these requirements, the question remains: is the listed information sufficient? Does it outline a truly a fully informed consent? I think that essential aspects of informed consent are missing.
- The code does not explicidly require an explanation about the possible harms of spinal manipulation (i.e. 50% of all patients will suffer mild to moderate adverse effects lasting 2-3 days, and occasionally patients will have a stroke of which some have died).
- Moreover, the code mentions EXPECTED benefits, but not benefits supported by evidence. Chiros may well EXPECT their treatment to work, but what does the evidence show? As often discussed on this blog, the evidence is negative or very week, depending how you want to interpret it. The code does not require a chiro to inform his patients about this fact.
So, the way I see it, the code does not expressedly demand the chiro to explain his patient that the treatment he is being asked to consent to is
- not supported by sound evidence for effectiveness,
- nor that the treatment is burdened with significant risks.
And what about the other questions listed above? An Australian chiropractor who will remain anonymous gave me the following answers:
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Yet, Australian chiropractors claim that they abide by the ethical imperative of informed consent. Are they taking the Mickey?
Perhaps not. Perhaps they are merely trying to make sure they do not lose the majority of their clientele. As I already pointed out in my previous post, fully informed consent would make most chiropractic patients turn round and run a mile.
Some of us got used to the idea that acupuncture might be effective for pain. But could it work for infections? Unlikely! Well, let’s not rely on gut feelings; let’s have a fair and critical look at the evidence.
This systematic review assessed the evidence for acupuncture for uncomplicated recurrent urinary tract infections (rUTI) women. Five randomised controlled trials (RCTs) evaluating the effects of acupuncture and related therapies for prophylaxis or treatment of uncomplicated rUTI in women were included. The methodological quality of the studies and the strength of the evidence were low to moderate. The chance of achieving a composite cure with acupuncture therapies was greater than that with antibiotics (three studies, 170 participants, RR 1.92, 95% CI 1.31‐2.81, I2 = 38%). The risk of UTI recurrence was lower with acupuncture than with no treatment (two studies, 135 participants, RR 0.39, 95% CI 0.26–0.58, I2 = 0%) and sham acupuncture (one study, 53 participants, RR 0.45, 95% CI 0.22–0.92).
The authors concluded that acupuncture showed promising results compared to no treatment and sham acupuncture in reducing recurrence, based on low to moderate certainty evidence. Low certainty evidence found acupuncture increased the chance of achieving a composite cure compared to antibiotics. Findings from this review should be interpreted with caution, taking into consideration the biases identified and small sample size of the included trials. Included studies suggest acupuncture has a good safety profile for women with UTI, and may be considered as a therapeutic option in the treatment and prevention of rUTI in women, particularly those who are unresponsive to, or intolerant of, antibiotics. Rigorously designed research is needed to inform clinical decisionmaking about the use of acupuncture for women with UTIs.
The authors of this review are affiliated to the Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangdong Provincial Academy of Chinese Medical Sciences and The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China and the China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Melbourne, VIC, Australia. The review was funded by the China-Australia International Research Centre for Chinese Medicine (CAIRCCM) (International Cooperation Project, Grant Number 2012DFA31760), and the National Natural Science Foundation of China (NSFC) (Grant Number 81873261). In view of these facts, it is strange, I think, that the authors declared no conflicts of interest.
The 5 primary studies included in this review are the following:
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- Alraek T, Soedal LI, Fagerheim SU, Digranes A, Baerheim A. Acupuncture treatment in the
prevention of uncomplicated recurrent lower urinary tract infections in adult women. American journal of
public health. 2002;92(10):1609-11. - Aune A, Alraek T, LiHua H, Baerheim A. Acupuncture in the prophylaxis of recurrent lower urinary
tract infection in adult women. Scandinavian journal of primary health care. 1998;16(1):37-9. - Hong JY, Li F, Liang XQ, Hou Z. [Efficacy observation on female chronic pyelonephritis treated with
abdominal cluster-needling therapy]. Zhongguo zhen jiu = Chinese acupuncture & moxibustion.
2013;33(4):303-5. - Yu SM, Guo DD. Moxibustion combined with antibiotics was used to treat 30 cases of chronic
urinary tract infection in adult women. Shandong Journal of Traditional Chinese Medicine.
2010;29(09):621-2. - Liu JL, Luo Q, Liu XH, Lin L. Observation on the clinical effect of external treatment of strong renal
moxibustion on recurrent urinary tract infection. China Modern Doctor. 2018;56(29):116-8.
- Alraek T, Soedal LI, Fagerheim SU, Digranes A, Baerheim A. Acupuncture treatment in the
As always, it is worth checking these studies for reliability.
In the trial by Alraek et al patients were randomised patients to receive either acupuncture or no treatment. Is anyone surprised that the former group fared better than the latter? (I am not!)
The trial by Aune et al is the only study that attempted to control for placebo effects by using a sham control group. This is what they used as a sham treatment: Sham acupuncture was given using six needles superficially inserted in the calves, thighs or abdomen outside known acupuncture points or meridians. Needles were not manipulated in the sham group. Sham controls have the purpose of rendering patients unaware whether they receive the real or the sham treatment. The method used here cannot achieve this aim; patients were easily able to determine that they were in the control group.
The last three trials are all not Medline-listed studies authored by Chinese investigators published in inaccessible journals in Chinese. We know that such studies invariably report positive outcomes which are often fabricated and thus have a reliability close to zero. But even if we ignore these facts for a moment, from what I see in the results table of the review, these studies are invalid. All three are equivalence trials of acupuncture versus antibiotics; with a sample size of merely around 30, they must be woefully underpowered and thus unable to generate a reliable result.
The authors of this review claim that the risk of bias of trials was generally high or unclear. This is an understatement to put it mildly. In fact, the quality of the studies was mostly dismal.
In view of all this, I take the liberty to re-formulate the conclusions drawn by the review authors as follows:
Due to the lack of reliable RCTs, the effectiveness of acupuncture as a treatment or prevention of rUTIs remains unproven. Due to the implausibility of the therapy, its effectiveness seems highly unlikely.
PS
The BJOG should never have published such a deeply misleading paper.
FOUR QUESTIONS TO DC + CRITICAL CHIRO (CC):
1) what does the law say about informed consent for Australian chiros?
2) what info exactly do you have to provide?
3) who monitors it?
4) what published evidence do we have about compliance?
CC then posted this reply:
Here we go again you demand evidence while providing little if any for your own assumptions (poor case studies do not count. The pleural of anecdote does not equal evidence whether it’s from chiro’s or you).
We have been over this many times over many years, I cite research/provide links yet you still find it challenging to take it onboard. It is human nature to feel obligated once making a public statement to defend it no matter how much evidence is sent your way. So not surprising.
“1) what does the law say about informed consent for Australian chiros?”
It is all freely available on the national regulators website (as you know and as I have referenced in the past):
https://www.chiropracticboard.gov.au/Codes-guidelines/Code-of-conduct.aspx
https://www.chiropracticboard.gov.au/Search.aspx?q=Informed+consent
Some research by chiropractors on this topic (cited many times in the past):
Risk Management for Chiropractors and Osteopaths. Informed consent
A Common Law Requirement (2004):
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2051308/
Quick advanced PubMed with filters set to “Chiropractic” AND “Informed consent”.
https://www.ncbi.nlm.nih.gov/pmc/?term=(Chiropractic)+AND+Informed+consent
Not rocket science
Latest paper that you wrote an ill informed blog on and the comments were not going as you expected (So I expected you to double down like Donald Trump with a new blog within days. Your getting predictable).
https://chiromt.biomedcentral.com/articles/10.1186/s12998-020-00342-5
This paper questions the legal implications of vertebral subluxations with high powered legal input and is a broadside by evidence based chiropractors against vitalistic chiropractors. You respond a snide fantasy informed consent dialogue when you should be supporting the authors:
https://edzardernst.com/2020/11/informed-consent-why-chiropractors-dont-like-it/
“2) what info exactly do you have to provide?”
“4) what published evidence do we have about compliance?”
We have discussed this as well. It is a common law requirement for every profession and is checked upon re-registration by AHPRA every year and by the professional indemnity insurers every year. No informed consent, no registration and no professional indemnity insurance.
Checked AHPRA’s panel decisions and went back 5 YEARS and found ONE decision relating to informed consent:
https://www.ahpra.gov.au/Publications/Panel-decisions.aspx
“3) who monitors it?”
Another of your tired old arguments that we have discussed many times over the years.
In the UK there is the “‘Chiropractic Reporting and Learning System’ (CRLS)” but this is set up by the association representing chiropractors and not the registration board that advocates for patients. Right idea and step in the right direction, wrong organization.
Here years ago there was a trial of an adverse event reporting system in a Melbourne emergency department systematically collected relevant AE information on all professions which was sent to the relevant board for investigation.
It was supported by doctors and chiropractors while physio’s were not involved. A doctor involved told me it was killed off by ER doctors who “snivelled” about the extra paperwork.
There is no AE reporting system for physio’s, chiro’s, osteo’s, GP’s in private practice etc.
Over the years you have harped on and on about this topic as if it is a failing purely of the chiropractic profession when we have supported initiatives for its implementation.
You have also kept up with the research even commenting on an chiropractic researcher on AE’s Charlotte Leboeuf-Yde (who you highly regard) yet ignored until you could take issue with two sentences written in a blog then you wrote this hatchet blog:
https://edzardernst.com/2017/04/we-have-an-ethical-legal-and-moral-duty-to-discourage-chiropractic-neck-manipulations/
So you are asking for evidence yet willfully ignore an author who “I have always thought highly of Charlotte’s work”.
Stop the cynical cherry picked blogs and start supporting the researchers and reformers otherwise you are just someone standing on the sidelines blindly throwing grenades. You do not care who you hit or the damage you do to the chiropractors leading the reform you demand yet consistently fail to support.
____________________________________
I thought the tone of this response was oddly aggressive and found that CC had failed to understand some of my questions. Yet the link to the chiro’s code of conduct https://www.chiropracticboard.gov.au/Codes-guidelines/Code-of-conduct.aspx was useful. This is what it says about informed consent: