methodology
When I first saw this press-release, I thought it was a hoax. After all, it came from a most dubious homeopathic source. Then I read it again and was no longer sure.
What do you think?
Here it is in full:
Santa Clara, Cuba, April 3,2020 (Prensa Latina) The homeopathic medicine Prevengho-VIR began to be administered as a measure to confront the Covid-19 in this province of central Cuba.
Dr. Mirtha Rosa Hernandez, head of the Department of the Elderly in Villa Clara, reported that the supply of the preparation began in the Grandparents’ Homes and Elderly Homes of the territory, which has 184,000 people over 60 years old, 23.9 percent of the local universe. The medicine is administered by doctors and nurses of the basic working group where the Grandparents’ Homes and Nursing Homes are located in the 13 municipalities of this province.
This homeopathic medicine comes in a 10-milliliter bottle, and the daily dosage is 5 drops, thrice a day; while on the tenth day a reactivation of the initial dose is performed. It is aimed at preventing the respiratory diseases in this risk group, in addition to other medical conditions, such as dengue.
In the upcoming days it will be extended to the Maternal Homes. It is administered by the doctors and the nurses from the basic work group of the senior homes.
She said, that besides avoiding the new coronavirus the formula is also aimed at preventing respiratory diseases in this risk group, in addition to others such as dengue fever.
This medicine can also be administered to children under 10 years old, pregnant women, nursing mothers, and patients with liver disorders.
Combination Medicine
Anas berberiae 200
Baptisia tinctora 200
Bascilinum 30
Pyrogenum 200
Eupetorium perf 200
Influezinum 200
Arsenicum Album 200
As I said, I was not sure whether this was for real. Is it possible that even officials are so stupid, brainwashed or gullible to go for homeopathy in such a serious situation?
In an attempt to find out, I did a little search and quickly found that the story has been reported by multiple media. This, for instance, is what the Miami Herald reported:
As scientists around the world speed up clinical trials to find a cure or vaccine for the coronavirus, the Cuban government will begin distributing a homeopathic remedy to the elderly and other vulnerable people to “prevent” the spread of the disease, a top health official said.
Dr. Francisco Durán, national director of Epidemiology at the Ministry of Public Health, said in a press conference on Sunday that “sublingual drops” of the compound PrevengHo-Vir “prevent different diseases such as influenza, the common cold, dengue, and emerging viral infections such as this one.”
On Monday, Durán tried to correct his statements and said that the product “does not prevent contagion” but rather “increases resistance, the body’s defenses against a certain virus.”
Several state media outlets reported that PrevengHo-Vir is already being used in various Cuban provinces to treat the elderly and other groups vulnerable to the coronavirus. There is no internet record of PrevengHo-Vir, other than press reports about the announcement of its distribution in Cuba.
So, it’s not a hoax!
In this case, let me try to predict what will happen next:
- When the pandemic is over, the Cubans will publish mortality rates achieved with their homeopathic prevention [A].
- They will compare them to data from a cohort that did not receive the homeopathic treatment [B].
- Neither of the data-sets will be transparent and nobody will be able to check its reliability.
- The comparison will yield a significant difference in favour of homeopathy.
- The Cubans will use this to market their remedy.
- The world of homeopathy will use it as a proof that homeopathy is effective (it wouldn’t be the first time).
Nothing wrong with that, some will say. Others who understand research methodology will, however, point out that these data are less than convincing.
In such case/control studies, one large group of patients [A] is compared to another group [B]. Group A has been treated homeopathically, while group B received no homeopathy. Any difference in outcome between A and B might be due to a range of circumstances that are unrelated to the homeopathic treatment, for instance:
- group A might have been less ill than group B,
- group A might have been better nourished,
- group A might have benefited from better hygiene,
- group A might have received better care,
- group B might have received treatments that made the situation not better but worse,
- the researchers might have prettified the data to make group A look better.
Such concerns are not totally unfounded; after all, Cuba seems to have a long history of making irresponsible claims for their homeopathic products.
Resveratrol is one of the most popular dietary supplements. It is an antioxidant found in red grape skin, Japanese knotweed, blueberries and other berries. Resveratrol is available as dietary supplements from red wine extracts, grape seed extracts, Japanese knotweed extracts and other plants. The amount and purity of resveratrol in supplements varies significantly; absorption in the gut is low.
While, for many supplements, there is no or very little research, this one has a huge amount. So, has reseveratrol any proven health effects demonstrated in clinical trials?
The answer is encouraging.
This abstract provides a useful summary:
Resveratrol is a polyphenolic nutraceutical that exhibits pleiotropic activities in human subjects. The efficacy, safety, and pharmacokinetics of resveratrol have been documented in over 244 clinical trials, with an additional 27 clinical trials currently ongoing. Resveretrol is reported to potentially improve the therapeutic outcome in patients suffering from diabetes mellitus, obesity, colorectal cancer, breast cancer, multiple myeloma, metabolic syndrome, hypertension, Alzheimer’s disease, stroke, cardiovascular diseases, kidney diseases, inflammatory diseases, and rhinopharyngitis. The polyphenol is reported to be safe at doses up to 5 g/d, when used either alone or as a combination therapy. The molecular basis for the pleiotropic activities of resveratrol are based on its ability to modulate multiple cell signaling molecules such as cytokines, caspases, matrix metalloproteinases, Wnt, nuclear factor-κB, Notch, 5′-AMP-activated protein kinase, intercellular adhesion molecule, vascular cell adhesion molecule, sirtuin type 1, peroxisome proliferator-activated receptor-γ coactivator 1α, insulin-like growth factor 1, insulin-like growth factor-binding protein 3, Ras association domain family 1α, pAkt, vascular endothelial growth factor, cyclooxygenase 2, nuclear factor erythroid 2 like 2, and Kelch-like ECH-associated protein 1. Although the clinical utility of resveratrol is well documented, the rapid metabolism and poor bioavailability have limited its therapeutic use. In this regard, the recently produced micronized resveratrol formulation called SRT501, shows promise. This review discusses the currently available clinical data on resveratrol in the prevention, management, and treatment of various diseases and disorders. Based on the current evidence, the potential utility of this molecule in the clinic is discussed.
This is a comprehensive review but it fails to critically assess the quality of the clinical trials. Once we do that, we are likely to get disappointed. Many studies are just not up to the mark.
And if we consult a Cochrane review, our enthusiasm for resveratrol disappears completely: Currently, research is insufficient for review authors to evaluate the safety and efficacy of resveratrol supplementation for treatment of adults with T2DM [type 2 diabetes mellitus]. The limited available research does not provide sufficient evidence to support any effect, beneficial or adverse, of four to five weeks of 10 mg to 1000 mg of resveratrol in adults with T2DM. Adequately powered RCTs reporting patient-relevant outcomes with long-term follow-up periods are needed to further evaluate the efficacy and safety of resveratrol supplementation in the treatment of T2DM.
So, for the time being, I might just continue to obtain my resveratrol in very small but regular doses from red wine, I think.
The objective of this trial, just published in the BMJ, was to assess the efficacy of manual acupuncture as prophylactic treatment for acupuncture naive patients with episodic migraine without aura. The study was designed as a multi-centre, randomised, controlled clinical trial with blinded participants, outcome assessment, and statistician. It was conducted in 7 hospitals in China with 150 acupuncture naive patients with episodic migraine without aura.
They were given the following treatments:
- 20 sessions of manual acupuncture at true acupuncture points plus usual care,
- 20 sessions of non-penetrating sham acupuncture at heterosegmental non-acupuncture points plus usual care,
- usual care alone over 8 weeks.
The main outcome measures were change in migraine days and migraine attacks per 4 weeks during weeks 1-20 after randomisation compared with baseline (4 weeks before randomisation).
A total of 147 were included in the final analyses. Compared with sham acupuncture, manual acupuncture resulted in a significantly greater reduction in migraine days at weeks 13 to 20 and a significantly greater reduction in migraine attacks at weeks 17 to 20. The reduction in mean number of migraine days was 3.5 (SD 2.5) for manual versus 2.4 (3.4) for sham at weeks 13 to 16 and 3.9 (3.0) for manual versus 2.2 (3.2) for sham at weeks 17 to 20. At weeks 17 to 20, the reduction in mean number of attacks was 2.3 (1.7) for manual versus 1.6 (2.5) for sham. No severe adverse events were reported. No significant difference was seen in the proportion of patients perceiving needle penetration between manual acupuncture and sham acupuncture (79% v 75%).
The authors concluded that twenty sessions of manual acupuncture was superior to sham acupuncture and usual care for the prophylaxis of episodic migraine without aura. These results support the use of manual acupuncture in patients who are reluctant to use prophylactic drugs or when prophylactic drugs are ineffective, and it should be considered in future guidelines.
Considering the many flaws in most acupuncture studies discussed ad nauseam on this blog, this is a relatively rigorous trial. Yet, before we accept the conclusions, we ought to evaluate it critically.
The first thing that struck me was the very last sentence of its abstract. I do not think that a single trial can ever be a sufficient reason for changing existing guidelines. The current Cochrance review concludes that the available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Thus, one could perhaps argue that, together with the existing data, this new study might strengthen its conclusion.
In the methods section, the authors state that at the end of the study, we determined the maintenance of blinding of patients by asking them whether they thought the needles had penetrated the skin. And in the results section, they report that they found no significant difference between the manual acupuncture and sham acupuncture groups for patients’ ability to correctly guess their allocation status.
I find this puzzling, since the authors also state that they tried to elicit acupuncture de-qi sensation by the manual manipulation of needles. They fail to report data on this but this attempt is usually successful in the majority of patients. In the control group, where non-penetrating needles were used, no de-qi could be generated. This means that the two groups must have been at least partly de-blinded. Yet, we learn from the paper that patients were not able to guess to which group they were randomised. Which statement is correct?
This may sound like a trivial matter, but I fear it is not.
Like this new study, acupuncture trials frequently originate from China. We and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. If that is so, one does not need to read the paper, one already knows that it is positive before one has even seen it. Neither do the researchers need to conduct the study, one already knows the result before the trial has started.
You don’t believe the findings of my research nor those of others?
Excellent! It’s always good to be sceptical!
But in this case, do you believe Chinese researchers?
In this systematic review, all RCTs of acupuncture published in Chinese journals were identified by a team of Chinese scientists. An impressive total of 840 trials were found. Among them, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.
So, at least three independent reviews have found that Chinese acupuncture trials report virtually nothing but positive findings. Is that enough evidence to distrust Chinese TCM studies?
Perhaps not!
But there are even more compelling reasons for taking evidence from China with a pinch of salt:
A survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations. “Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Chinese research organisations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”
So, am I claiming the new acupuncture study just published in the BMJ is a fake?
No!
Am I saying that it would be wise to be sceptical?
Yes.
Sadly, my scepticism is not shared by the BMJ’s editorial writer who concludes that the new study helps to move acupuncture from having an unproven status in complementary medicine to an acceptable evidence based treatment.
Call me a sceptic, but that statement is, in my view, hard to justify!
[If you do not like black humour or sarcasm, please do NOT read this post!!!]
Donald Trump just announced that, at Easter, he wants to see churches packed, his way of saying the lock-down is over because it is damaging the economy. Many others have put forward similar arguments and have pointed out that caring for the vulnerable, sick, old, etc. creates an economic burden that might eventually kill more people than it saves (see for instance ‘Economic crash could cost more lives than coronavirus, study warns‘).
Many people have also argued that homeopathy is unjustly vilified because it is truly a wholesome and safe medicine that should be used routinely. The notion here is that, alright, the evidence is not brilliant, but 200 years of experience and millions of fans cannot be ignored.
I have been wondering whether these two lines of thinking could not be profitably combined. Here is my suggestion based on the following two axioms.
- The economy is important for all our well-being.
- Homeopaths have a point in that the value of experience must not be ignored.
What follows is surprisingly simple: in view of the over-riding importance of the economy, let’s prioritise it over health. As it would look bad to deny those poor corona victims all forms of healthcare, let’s treat them homeopathically. This would make lots of people happy:
- those who think the economy must take precedent,
- those who fear the huge costs of saving corona patients (homeopathy is very cheap),
- those who argued for decades that we never gave homeopathy a fighting chance to show its worth.
There is a downside, of course. There would be a most lamentable mortality rate. But, to paraphrase Dominic Cummings, if a few oldies have to snuff it, so be it!
Once we get used to this innovative approach – I suggest we call it integrative medicine – we might even consider adopting it for other critical situations. When we realise, for instance, that the pension pots are empty, we could officially declare that homeopathy is the ideal medicine for anybody over 60.
What do you think?
I have often stated jokingly that ‘HOMEOPATHY IS INCURABLE’; well, I was wrong! There seems to be a treatment that works quite reliably.
It’s called humour.
The Brits have been the pioneers in this field. One of the best examples is this classic by Mitchell and Webb.
In my view, it marked a turning point in UK homeopathy. After it’s enormous success, even the NHS re-considered its previously positive stance on homeopathy.
Now, a brilliant French comedian, Jeremy Ferrari, is having a similar success with his homeopathy-show in France. And it too marks the turning point where homeopathy is starting to be phased out from reimbursement in France.
So, are comedians the ones that bring consumers to reason when it comes to absurdities such as homeopathy? Or are comedians gifted at picking up the Zeitgeist and thus merely the ones who hammer the last nail into the coffin of homeopathy?
I think it is probably a bit of both.
But, whatever it is, these guys are brilliant! They achieve more good with their work than others writing clever articles in the Lancet and other medical journals. One good laugh seems to be more efficacious that pages of critical analysis.
If my blog has in the past stimulated some of these comedians to do their ingenious work – and I happen to know it has – I am both delighted and proud.
This ‘Manifesto of the European Committee for Homeopathy (ECH) and the European Federation of Homeopathic Patients Associations (EFHPA)‘ has just been published. It is worth considering in more detail, I think. So, I will first reproduce the document in its entirety and subsequently provide some critical assessment of it.
Homeopathy: a solution for major healthcare problems in the EU
- Helps to reduce the need of antibiotics in human and veterinary health care, thus reducing the problem of antimicrobial resistance [i],[ii]
- Increases quality of life and reduces severity of complaints in patients with chronic disease, when integrated in health care [iii],[iv],[v],[vi],[vii],[viii]
- Can reduce the use of long-term conventional prescription drugs, when integrated in health care [ix]
Homeopathy: safe and cost-effective with a high patient satisfaction
- Can lead to lower health care costs, when integrated in health care, [x],[xi],[xii],
- Is safe, with high patient satisfaction [xiii],[xiv],[xv],[xvi]
- Patients using homeopathy have better outcomes than users of conventional treatment, with similar costs [xvii]
- Quality, safety and correct labelling of homeopathic products is guaranteed by Directive 2001/83 EC
EU consumers expect and demand homeopathy as part of their health care
- Reported as the most used medical complementary medicine in Europe [xviii]
- Three out of four European citizens know about homeopathy and out of them 29% use it for their day-to day health care [xix]
Scientific evidence of the highest calibre confirms the clinical efficacy of homeopathic medicine
- Clinical effects of homeopathic medicines have been confirmed by systematic reviews and meta- analyses [xx],[xxi],[xxii],[xxiii],[xxiv],[xxv],[xxvi]
There is convincing evidence for biological efficacy of homeopathic medicine
- Irrefutable scientific evidence has been published on the positive effects of homeopathic products in laboratory settings [xxvii],[xxviii]
References
[i] Grimaldi-Bensouda L, Bégaud B, Rossignol M, et al. Management of upper respiratory tract infections by different medical practices, including homeopathy, and consumption of antibiotics in primary care: the EPI3 cohort study in France 2007-2008. PLoS One. 2014 Mar 19;9(3):e89990
[ii] Camerlink I, Ellinger L, Bakker EJ, Lantinga EA. Homeopathy as replacement to antibiotics in the case of Escherichia coli diarrhoea in neonatal piglets. Homeopathy. 2010 Jan;99(1):57-62
[iii] Witt CM, Lüdtke R, Baur R, Willich SN. Homeopathic medical practice: long-term results of a cohort study with 3981 patients. BMC Public Health 2005; 5:115
[iv] Spence DS, Thompson EA, Barron SJ. Homeopathic treatment for chronic disease: a 6-year, university-hospital outpatient observational study. J Altern Complement Med 2005; 11:793–798
[v] Mathie RT, Robinson TW. Outcomes from homeopathic prescribing in medical practice: a prospective, research-targeted, pilot study. Homeopathy 2006; 95:199–205
[vi] Thompson EA, Mathie RT, Baitson ES, et al. Towards standard setting for patient-reported outcomes in the NHS homeopathic hospitals. Homeopathy 2008; 97:114–121
[vii] Witt CM, Lüdtke R, Mengler N, Willich SN. How healthy are chronically ill patients after eight years of homeopathic treatment?–Results from a long term observational study BMC Public Health 2008;8:413
[viii] Rossi E, Endrizzi C, Panozzo MA, Bianchi A, Da Frè M. Homeopathy in the public health system: a seven-year observational study at Lucca Hospital (Italy). Homeopathy 2009; 98:142–148
[ix] Grimaldi-Bensouda L, Abenhaim L, Massol J, et al. EPI3-LA-SER group. Homeopathic medical practice for anxiety and depression in primary care: the EPI3 cohort study. BMC Complement Altern Med. 2016 May 4; 16:125
[x] Kooreman P, Baars EW. Patients whose GP knows complementary medicine tend to have lower costs and live longer. Eur J Health Econ. 2012 Dec;13(6):769-76
[xi] Baars EW, Kooreman P. A 6-year comparative economic evaluation of healthcare costs and mortality rates of Dutch patients from conventional and CAM GPs. BMJ Open. 2014 Aug 27;4(8):e005332
[xii] Colas A, Danno K, Tabar C, Ehreth J, Duru G. Economic impact of homeopathic practice in general medicine in France. Health Econ Rev. 2015;5(1):55
[xiii] Van Wassenhoven M, Galen Y. An observational study of patients receiving homeopathic treatment. Homeopathy 2004 Jan;93(1):3-11
[xiv] Marian F, Joost K, Saini KD, von Ammon K, Thurneysen A, Busato A. Patient satisfaction and side effects in primary care: An observational study comparing homeopathy and conventional medicine. BMC Complement Altern Med. 2008 Sep 18; 8:52
[xv] Witt C, Keil T, Selim D, et al. Outcome and costs of homoeopathic and conventional treatment strategies: a comparative cohort study in patients with chronic disorders. Complement Ther Med. 2005;13(2):79-86
[xvi] Marian F, Joost K, Saini KD, von Ammon K, Thurneysen A, Busato A. Patient satisfaction and side effects in primary care: An observational study comparing homeopathy and conventional medicine. BMC Complement Altern Med. 2008 Sep 18; 8:52
[xvii] Bornhöft G, Wolf U, von Ammon K, Righetti M, Maxion-Bergemann S, Baumgartner S, Thurneysen AE, Matthiessen PF. Effectiveness, safety and cost-effectiveness of homeopathy in general practice – summarized health technology assessment.Forsch Komplementmed. 2006;13 Suppl 2:19-29. Epub 2006 Jun 26. Review
[xviii] Eardley S, Bishop FL, Prescott P, Cardini F, Brinkhaus B, Santos K Ͳ Rey, Vas J, von Ammon K, Hegyi G, Dragan S, Uehleke B, Fønnebø V, Lewith G. CAM use in Europe. The patients’ perspective.Part I: A systematic literature review of CAM prevalence in the EU. 2012. Online retrieved 19-11-2019. https://cam-europe.eu/wp-content/uploads/2018/09/CAMbrella-WP4-part_1final.pdf
[xix] Report of the European Commission, 1997. Online retrieved 15-12-2019 via https://www.hri-research.org/resources/essentialevidence/use-of-homeopathy-across-the-world/
[xx] Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet. 1997 Sep 20;350(9081):834-4.
[xxi] Cucherat M, Haugh MC, Gooch M, Boissel JP.Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur J Clin Pharmacol. 2000 Apr;56(1):27-33
[xxii] Hahn RG. Homeopathy: meta-analyses of pooled clinical data. Forsch Komplementmed. 2013;20(5):376-81
[xxiii] Mathie RT, Van Wassenhoven M, Jacobs J et al. Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment. Complement Ther Med. 2016 Apr; 25:120-5
[xxiv] Mathie RT, Lloyd, SM, Legg, LA, Clausen J, Moss S, Davidson JR, Ford: Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis. Syst Rev 2014 Dec 6; 3:142
[xxv] Mathie RT, Clausen J. Veterinary homeopathy: systematic review of medical conditions studied by randomised placebo-controlled trials. Vet Rec. 2014 Oct 18;175(15):373-81.
[xxvi] Mathie RT, Clausen J. Veterinary homeopathy: meta-analysis of randomised placebo-controlled trials. Homeopathy. 2015 Jan;104(1):3-8.
[xxvii] Tournier A, Klein SD, Würtenberger S, Wolf U, Baumgartner S. Physicochemical Investigations of Homeopathic Preparations: A Systematic Review and Bibliometric Analysis-Part 2. J Altern Complement Med. 2019 Jul 10
[xxviii] Witt CM, Bluth M, Albrecht H, Weisshuhn TE, Baumgartner S, Willich SN. The in vitro evidence for an effect of high homeopathic potencies–a systematic review of the literature. Complement. Ther Med. 2007 Jun;15(2):128-38
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Did I state above that the manifesto is worth considering in more detail? I need to retract or modify this statement.
Here are the considerations that are relevant, in my view:
- The statements in the manifesto are based on wishful thinking and do not reflect the reality based on the best evidence available today.
- The manifesto is the result of a mixture of cherry-picking and/or misinterpreting the evidence.
- Most of the cited studies have been discussed on this blog in previous posts which disclose their flaws and/or erroneous conclusions.
So, instead of discussing all the tedious details yet again, I will present here a corrected version of the manifesto:
Homeopathy: no solution for major healthcare problems in the EU
- Does not help to reduce the need of antibiotics in human and veterinary health care, thus reducing the problem of antimicrobial resistance
- does not increases quality of life and reduces severity of complaints in patients with chronic disease, when integrated in health care
- Cannot reduce the use of long-term conventional prescription drugs, when integrated in health care
Homeopathy: neither safe nor cost-effective with a high patient satisfaction
- Cannot lead to lower health care costs, when integrated in health care
- Is unsafe
- Patients using homeopathy have no better outcomes than users of conventional treatment, but cause higher costs
- Quality and correct labelling of homeopathic products is guaranteed by Directive 2001/83 EC
Some EU consumers expect and demand homeopathy as part of their health care
- Reported as a much-used complementary medicine in Europe
- Three out of four European citizens know about homeopathy and out of them many use it for their day-to day health care
Scientific evidence of the highest calibre fails to confirm the clinical efficacy of homeopathic medicine
- Clinical effects of homeopathic medicines have been confirmed by systematic reviews and meta- analyses to be no better than placebo
There is no convincing evidence for biological efficacy of homeopathic medicine
- No irrefutable scientific evidence has been published on the positive effects of homeopathic products in laboratory settings
The objective of this analysis was to evaluate the impact of chiropractic utilization upon use of prescription opioids among patients with spinal pain. The researchers employed a retrospective cohort design for analysis of health claims data from three contiguous US states for the years 2012-2017.
They included adults aged 18-84 years enrolled in a health plan and with office visits to a primary care physician or chiropractor for spinal pain. Two cohorts of subjects were thus identified:
- patients who received both primary care and chiropractic care,
- Patients who received primary care but not chiropractic care.
The total number of subjects was 101,221. Overall, between 1.55 and 2.03 times more nonrecipients of chiropractic care filled an opioid prescription, as compared with recipients.
The authors concluded that patients with spinal pain who saw a chiropractor had half the risk of filling an opioid prescription. Among those who saw a chiropractor within 30 days of diagnosis, the reduction in risk was greater as compared with those with their first visit after the acute phase.
Similar findings have been reported before and we have discussed them on this blog (see here, here and here). As before, one has to ask: WHAT DO THEY ACTUALLY MEAN?
The short answer is NOTHING MUCH! And certainly not what many chiros make of them.
They do not suggest that chiropractic care is a substitute for opioids in the management of spinal pain.
Why?
There are several reasons. Perhaps the most important ones are that such analyses lack any clinical outcome data, and that comparing one mistake (opioid-overuse) whith what might be another (chiropractic care) is a wrong apporoach. Imagine a scenario where half to the patients had received, in addition to their usual care, the services of:
- a paranormal healer,
- a crystal therapist,
- a shaman,
- or a homeopath.
Nobody would be surprised to see a very similar result, particularly if all of these practitioners were in the habit of discouraging their patients from using conventional drugs. Or imagine a scenario where half of all patients suffering from spinal pain are entered into an environment where they receive no treatment at all. Who would not expect that this regimen does not dramatically reduce the risk of filling an opioid prescription? But would that indicate that zero treatment is a good solution for managing spinal pain?
The thing is this:
- If you want to reduce opioid use, you need to prescribe less opioids (for instance, by re-educating doctors to do as they have been told in med school and curb over-prescribing).
- If you discourage patients to use opioids (as many other healthcare professionals would), many will not use opioids.
- If you want to know whether chiropractic is effective in managing spinal pain, you need to conduct a well-designed clinical trial.
Or, to put it simply:
CORRELATION IS NOT CAUSATION!
A new appointment in the realm of so-called alternative medicine (SCAM) has just been announced:
Friends of Science in Medicine (FSM) President, Assoc Professor Ken Harvey MB BS (Melb), FRCPA, AM congratulates Professor Jon Wardle, nurse and naturopath, with postgraduate qualifications in public health, law and health economics, on being appointed to Southern Cross University’s (SCU) Maurice Blackmore Chair of Naturopathic Medicine in Lismore. Professor Wardle has also been appointed as Foundation Director of the National Centre for Naturopathic Medicine (NCNM) funded with $10 Million from the Blackmore Foundation set up to sponsor research into ‘complementary medicine’.
Vice Chancellor, Professor Adam Shoemaker BA (Hons), PhD (ANU), researcher in Indigenous literature and culture, said the benefits of basing the NCNM at Southern Cross were enormous, “Being in a region like the Northern Rivers of New South Wales means we have brilliant local networks in this field. We are also supported by a local community who, like the University, are really receptive to trying new things in order to create a healthier future”.
Professor Harvey comments, “Professor Wardle certainly has challenges ahead. The Northern Rivers region is the anti-vax capital of Australia and some naturopaths advise against vaccination. Degree courses in naturopathy such as the Torrens Bachelor of Health Science (Naturopathy) degree, include studies of homeopathy, iridology and flower essence therapy. None have scientific evidence of efficacy”.
FSM has long argued that health care should be based on scientifically sound research, published in peer-reviewed journals of accepted standing. FSM is equally concerned about medical practitioners offering unproven and often exploitative treatments as it is about complementary medicine practitioners. Professor Harvey said, “some naturopaths practicing in Lismore, associated with SCU, work at clinics that use unverified laboratory tests to make dubious diagnoses and recommend treatment programs that lack evidence of efficacy”.
Professor Harvey (and FSM) conclude that there is an urgent need for evidence-based science to be applied to naturopathy. They trust that Professor Wardle will emulate Professor Edzard Ernst, Foundation Professor of Complementary Medicine at Exeter University, by applying accepted scientific standards to the evaluation of naturopathic interventions.
The March 24 opening of the NCNM in Lismore will feature a panel discussion on the future of health care with guest speakers: Professor Kerryn Phelps AM, former President of the Australasian Integrative Medicine Association, Marcus Blackmore AM, naturopath and Executive Director of Blackmores Ltd, which markets vitamin and herbal products, and Professor Jon Wardle. FSM hopes that the panel will discuss some of the issues raised above.
Sounds exciting, but is Wardle up to the job?
Judging from his publication record, he is certainly a naturopath through and through. He has published lots of papers; as far as I can see most of them are surveys of some sort or another. Many leave me somewhat bewildered. Two examples must suffice:
Objectives: To explore the recommendations of naturopathic medicine for the management of endometriosis, dysmenorrhea, and menorrhagia, drawing on traditional and contemporary sources.
Design: Content analysis.
Setting: Australia, Canada, and the United States of America (USA).
Subjects: Contemporary sources were identified from reviewing naturopathic higher education institutions’ recommended texts, while traditional sources were identified from libraries which hold collections of naturopathic sources. Sources were included if they were published from 1800 to 2016, were in English, published in Australia, Canada, or the USA, and reported on the topic. Included sources were as follows: 37 traditional texts; 47 contemporary texts; and 83 articles from naturopathic periodicals.
Results: Across included sources, the most reported disciplines were herbal medicine, clinical nutrition, mineral medicines, homeopathy, hydrotherapy, and chemical-based medicines. Herbal medicines were extensively reported from all sources for the management of endometriosis, dysmenorrhea, and menorrhagia. Clinical nutrition was only recommended from contemporary sources for all three conditions. Mineral medicines were mentioned in both traditional and contemporary sources, but were only recommended for dysmenorrhea and menorrhagia. There were limited recommendations for homeopathy and hydrotherapy treatments in all conditions across all sources. Chemical-based medicines were only mentioned for dysmenorrhea and menorrhagia, and recommendations ceased after 1922. Recommendations for endometriosis were not present in any of the traditional sources, across all reported disciplines.
Conclusions: The findings of this article provide insights into the documented historical and contemporary treatments within naturopathic medicine for endometriosis, dysmenorrhea, and menorrhagia. While philosophical principles remain the core of naturopathic practice, the therapeutic armamentarium appears to have changed over time, and a number of the original naturopathic treatments appear to have been retained as key elements of treatment for these conditions. Such insights into naturopathic treatments will be of particular interest to clinicians providing care to women, educators designing and delivering naturopathic training, and researchers conducting clinical and health service naturopathic research.
Complementary and alternative medicine (CAM) is an increasingly prevalent part of contemporary health care. Whilst there have been some attempts to understand the dynamics of CAM integration in the health care system from the perspective of conventional care providers and patients, little research has examined the view of CAM practitioners. This study aims to identify the experiences of integration within a conventional healthcare system as perceived by naturopaths. Qualitative semi-structured interviews were conducted using a purposeful sample of 20 practising naturopaths in South East Queensland, Australia to discuss their experiences and perceptions of integrating with conventional medical providers. Analysis of the interviews revealed five broad challenges for the integration of CAM according to naturopaths: competing paradigms between CAM and conventional medicine; co-option of CAM by conventional medical practitioners; the preservation of separate CAM and conventional medical worlds by patients and providers due to lack of formalised relations; negative feedback and biases created through selective or limited experience or information with CAM; and indifferent, reactive and one-sided interaction between CAM and conventional medical providers. Naturopaths support the integration of health services and attempt to provide safe and appropriate care to their patients through collaborative approaches to practice. The challenges identified by naturopaths associated with integration of CAM with conventional providers may impact the quality of care of patients who choose to integrate CAM and conventional approaches to health. Given the significant role of naturopaths in contemporary health-care systems, these challenges require further research and policy attention.
So, is Jon Wardle up to the job?
The answer obviously depends on what the job is.
If it is about publishing 100 more surveys that show nothing of much value and are essentially SCAM-promotion, then he ought to be fine. If it is about rigorously testing which SCAMs generate more good than harm, then ‘Houston, we have a problem’!
My critics regularly display a lot of imagination. For instance, some come up with the claim that I have never done any original research.
Well, I have!
How much?
A lot.
The precise answer depends on how you define original research.
Usually, my detractors then focus on clinical trials. Prof Ernst can only criticise and find fault in studies of so-called alternative medicine (SCAM) published by others, they claim, but he never did a single clinical trial in his life!
Well, I have!
The allegation came up recently in a legal case that I am involved in, and I was asked to prove that it is false. I skimmed through my files and found something that I had almost forgotten about. Until my retirement in 2012, I had kept a record entitled THE EVIDENCE, A DOCUMENTATION OF OUR CLINICALLY RELEVANT RESEARCH. The document is based on 470 of our published articles and 35 of our clinical trials (I do not know many SCAM-researchers who have done more).
For the legal case, I also did a Medline-search to get the links of clinical trials including the ones before the Exeter job. The list is quite incomplete but, for what it’s worth, here it is:
- Placebo-controlled, double-blind study of haemodilution in peripheral arterial disease Ernst E, et al. Lancet 1987 – Clinical Trial. PMID 2885450
- Regular sauna bathing and the incidence of common colds Ernst E, et al. Ann Med 1990 – Clinical Trial. PMID 2248758
- A single blind randomized, controlled trial of hydrotherapy for varicose veins Ernst E, et al. Vasa 1991 – Clinical Trial. PMID 1877335
- Effects of felodipine ER and hydrochlorothiazide on blood rheology in essential hypertension–a randomized, double-blind, crossover study Koenig W, et al. J Intern Med 1991 – Clinical Trial. Among authors: Ernst E. PMID 2045762
- Does pentoxifylline prolong the walking distance in exercised claudicants? A placebo-controlled double-blind trial Ernst E, et al. Angiology 1992 – Clinical Trial. PMID 1536472
- Exercise therapy for osteoporosis: results of a randomised controlled trial Preisinger E, et al. Br J Sports Med 1996 – Clinical Trial. Among authors: Ernst E. PMID 8889112 Free PMC article.
- Randomized trial of acupuncture for nicotine withdrawal symptoms White AR, et al. Arch Intern Med 1998 – Clinical Trial. Among authors: Ernst E. PMID 9818805
- Randomized, double-blind trial of chitosan for body weight reduction Pittler MH, et al. Eur J Clin Nutr 1999 – Clinical Trial. Among authors: Ernst E. PMID 10369493 Free article
- A randomized trial of distant healing for skin warts Harkness EF, et al. Am J Med 2000 – Clinical Trial. Among authors: Ernst E. PMID 10781776
- Can singing exercises reduce snoring? A pilot study Ojay A and Ernst E. Complement Ther Med 2000 – Clinical Trial. PMID 11068344
- A blinded investigation into the accuracy of reflexology charts White AR, et al. Complement Ther Med 2000 – Clinical Trial. Among authors: Ernst E. PMID 11068346
- Acupuncture for episodic tension-type headache: a multicentre randomized controlled trial White AR, et al. Cephalalgia 2000 – Clinical Trial. Among authors: Ernst E. PMID 11128820
- Spiritual healing as a therapy for chronic pain: a randomized, clinical trial Abbot NC, et al. Pain 2001 – Clinical Trial. Among authors: Ernst E. PMID 11240080
- Randomised controlled trial of reflexology for menopausal symptoms Williamson J, et al. BJOG 2002 – Clinical Trial. Among authors: Ernst E. PMID 12269681 Free article.
- Validating a new non-penetrating sham acupuncture device: two randomised controlled trials Park J, et al. Acupunct Med 2002 – Clinical Trial. Among authors: Ernst E. PMID 12512790
- Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery Stevinson C, et al. J R Soc Med 2003 – Clinical Trial. Among authors: Ernst E. PMID 12562974 Free PMC
- Randomized, double-blind, placebo-controlled trial of autologous blood therapy for atopic dermatitis Pittler MH, et al. Br J Dermatol 2003 – Clinical Trial. Among authors: Ernst E. PMID 12588384
- Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial White A, et al. Thorax 2003 – Clinical Trial. Among authors: Ernst E. PMID 12668794 Free PMC article.
- Multiple n = 1 trials in the identification of responders and non-responders to the cognitive effects of Ginkgo biloba Canter PH and Ernst E. Int J Clin Pharmacol Ther 2003 – Clinical Trial. PMID 12940592
- Effectiveness of artichoke extract in preventing alcohol-induced hangovers: a randomized controlled trial Pittler MH, et al. CMAJ 2003 – Clinical Trial. Among authors: Ernst E. PMID 14662662 Free PMC article.
- Autogenic training reduces anxiety after coronary angioplasty: a randomized clinical trial Kanji N, et al. Am Heart J 2004 – Clinical Trial. Among authors: Ernst E. PMID 14999212
- Does aromatherapy massage benefit patients with cancer attending a specialist palliative care day centre? Wilcock A, et al. Palliat Med 2004 – Clinical Trial. Among authors: Ernst E. PMID 15198118
- Randomised controlled trial of magnetic bracelets for relieving pain in osteoarthritis of the hip and knee Harlow T, et al. BMJ 2004 – Clinical Trial. Among authors: Ernst E. PMID 15604181 Free PMC article.
- Acupuncture for subacute stroke rehabilitation: a Sham-controlled, subject- and assessor-blind, randomized trial Park J, et al. Arch Intern Med 2005 – Clinical Trial. Among authors: Ernst E. PMID 16186474
- Autogenic training to reduce anxiety in nursing students: randomized controlled trial Kanji N, et al. J Adv Nurs 2006 – Clinical Trial. Among authors: Ernst E. PMID 16553681
- Autogenic training to manage symptomology in women with chest pain and normal coronary arteries Asbury EA, et al. Menopause 2009 – Clinical Trial. Among authors: Ernst E. PMID 18978640
- The effects of triple therapy (acupuncture, diet and exercise) on body weight: a randomized, clinical trial Nourshahi M, et al. Int J Obes (Lond) 2009 – Clinical Trial. Among authors: Ernst E. PMID 19274056
Five things I like about the list:
- It is long.
- It displays a wide variety of subjects.
- It hardly depicts me as a ‘pharma shill’.
- Most of the trials were published in top journals (suggesting they were of decent quality).
- It reminds me how much fun these studies often were (I wrote a chapter about No13 in my memoir, and I could write [very amusing] short stories about No 20 and [less funny but baffling] about No 17 and 23)
So, the next time they claim ‘Prof Ernst never did any clinical trials’, I will be able to shut them up by simply showing them this post.
I am looking forward to it!
During my almost 30 years of research into so-called alternative medicine (SCAM), I have published many papers which must have been severe disappointments to those who advocate SCAM or earn their living through it. Many SCAM proponents thus reacted with open hostility. Others tried to find flaws in those articles which they found most upsetting with a view of discrediting my work. The 2012 article entitled ‘A Replication of the Study ‘Adverse Effects of Spinal Manipulation: A Systematic Review‘ by the Australian chiropractor, Peter Tuchin, seems to be an example of the latter phenomenon (used recently by Jens Behnke in an attempt to defame me).
Here is the abstract of the Tuchin paper:
Objective: To assess the significance of adverse events after spinal manipulation therapy (SMT) by replicating and critically reviewing a paper commonly cited when reviewing adverse events of SMT as reported by Ernst (J Roy Soc Med 100:330-338, 2007).
Method: Replication of a 2007 Ernst paper to compare the details recorded in this paper to the original source material. Specific items that were assessed included the time lapse between treatment and the adverse event, and the recording of other significant risk factors such as diabetes, hyperhomocysteinemia, use of oral contraceptive pill, any history of hypertension, atherosclerosis and migraine.
Results: The review of the 32 papers discussed by Ernst found numerous errors or inconsistencies from the original case reports and case series. These errors included alteration of the age or sex of the patient, and omission or misrepresentation of the long term response of the patient to the adverse event. Other errors included incorrectly assigning spinal manipulation therapy (SMT) as chiropractic treatment when it had been reported in the original paper as delivered by a non-chiropractic provider (e.g. Physician).The original case reports often omitted to record the time lapse between treatment and the adverse event, and other significant clinical or risk factors. The country of origin of the original paper was also overlooked, which is significant as chiropractic is not legislated in many countries. In 21 of the cases reported by Ernst to be chiropractic treatment, 11 were from countries where chiropractic is not legislated.
Conclusion: The number of errors or omissions in the 2007 Ernst paper, reduce the validity of the study and the reported conclusions. The omissions of potential risk factors and the timeline between the adverse event and SMT could be significant confounding factors. Greater care is also needed to distinguish between chiropractors and other health practitioners when reviewing the application of SMT and related adverse effects.
The author of this ‘replication study’ claims to have identified several errors in my 2007 review of adverse effects of spinal manipulation. Here is the abstract of my article:
Objective: To identify adverse effects of spinal manipulation.
Design: Systematic review of papers published since 2001.
Setting: Six electronic databases.
Main outcome measures: Reports of adverse effects published between January 2001 and June 2006. There were no restrictions according to language of publication or research design of the reports.
Results: The searches identified 32 case reports, four case series, two prospective series, three case-control studies and three surveys. In case reports or case series, more than 200 patients were suspected to have been seriously harmed. The most common serious adverse effects were due to vertebral artery dissections. The two prospective reports suggested that relatively mild adverse effects occur in 30% to 61% of all patients. The case-control studies suggested a causal relationship between spinal manipulation and the adverse effect. The survey data indicated that even serious adverse effects are rarely reported in the medical literature.
Conclusions: Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke. Currently, the incidence of such events is not known. In the interest of patient safety we should reconsider our policy towards the routine use of spinal manipulation.
In my view, there are several things that are strange here:
- Tuchin published his paper 5 years after mine.
- He did not publish it in the same journal as my original, but in an obscure chiro journal that hardly any non-chiropractor would ever read.
- Tuchin never contacted me and never alerted me to his publication.
- The journal that Tuchin chose was not Medline-listed in 2012; consequently, I never got to know about the Tuchin article in a timely fashion. (Therefore, I did never respond to it.)
- A ‘replication study’ is a study that repeats the methodology of a previous study.
- Tuchin’s paper is therefore NOT a replication study. Firstly, mine was a review and not a study. Secondly, and crucially, Tuchin never repeated my methodology but used an entirely different one.
But arguably, these points are trivial. They should not distract from the fact that I might have made mistakes. So, let’s look at the substance of Tuchin’s claim, namely that I made errors or omissions in my review.
As to ‘omissions’, one could argue that a review such as mine will always have to omit some details in order to generate a concise summary. The only way to not omit any details is to re-publish all the primary papers in one large volume. Yet, this can hardly be the purpose of a systematic review.
As to the ‘errors’, it seems that the ages and sex of three patients were wrong (I have not checked this against the primary publications but, for the moment, I believe Tuchin). This is, of course, lamentable and – even though I have no idea whether the errors happened at the data extraction phase, during the typing, the revising, or the publishing of the paper – it is entirely my responsibility. I also seem to have mistaken a non-chiropractor for a chiropractor. This too is regrettable but, as the review was about spinal manipulation and not about chiropractic, the error is perhaps not so grave.
Be that as it may, these errors are unquestionably not good, and I can only apologise for them. If Tuchin had dealt with them in the usual way – by publishing in a timely fashion a ‘letter to the editor’ of the JRSM – I could have easily corrected them for everyone to see.
But I think there is a more important point to be made here:
Tuchin concludes his paper stating that it is unwise to make conclusions regarding causality from any case study or multiple case studies. The number of errors or omissions in the 2007 Ernst paper significantly limit any reported conclusions. I believe that both sentences are unjustified. The safety of any intervention in routine use has to be examined on the basis of published case studies. This is particularly true for chiropractic where no post-marketing surveillance similar to that for drugs exists.
The conclusions based on such evidence can, of course, never be firm, but they provide valuable signals that can prompt more rigorous investigations in the interest of patient safety. In view of such considerations, my own conclusions in my 2007 paper were, I think, correct and are NOT invalidated by my relatively trivial mistakes: spinal manipulation, particularly when performed on the upper spine, has repeatedly been associated with serious adverse events. Currently the incidence of such events is unknown. Adherence to informed consent, which currently seems less than rigorous, should therefore be mandatory to all therapists using this treatment. Considering that spinal manipulation is used mostly for self-limiting conditions and that its effectiveness is not well established, we should adopt a cautious attitude towards using it in routine health care.
And my conclusions in the abstract have now, I believe, become established wisdom. They are thus even less in jeopardy through my calamitous lapsus or Tuchin’s ‘replication study’: Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke. Currently, the incidence of such events is not known. In the interest of patient safety we should reconsider our policy towards the routine use of spinal manipulation.
