evidence
This survey assessed chiropractic (DC) and naturopathic “doctors”‘ (ND) knowledge, attitudes, and behaviour with respect to the pediatric patients in their practice. Cross-sectional surveys were developed in collaboration with DC and ND educators. Surveys were sent to randomly selected DCs and NDs in Ontario, Canada in 2004, and a national online survey was conducted in 2014. Data were analyzed using descriptive statistics, t-tests, non-parametric tests, and linear regression.
Response rates for DCs were n = 172 (34%) in 2004, n = 553 (15.5%) in 2014, and for NDs, n = 171 (36%) in 2004, n = 162 (7%) in 2014. In 2014, 366 (78.4%) of DCs and 83 (61%) of NDs saw one or more paediatric patients per week. Paediatric training was rated as inadequate by most respondents in both 2004 and 2014, with most respondents (n = 643, 89.9%) seeking post-graduate training by 2014. About half of DCs (51.7% in 2004, 49.2% in 2014) and one fifth of NDs (21% in 2004 and 23% in 2014) reported they received no hands-on clinical paediatric training. Only a minority of practitioners felt their hands-on paediatric training was adequate (somewhat or very) for their needs: DCs: 10.6% in 2004, 15.6% in 2014; NDs: 10% in 2004 and 19% in 2014. Respondents’ comfort in treating children and youth is based on experience and post-graduate training. Both DCs and NDs that see children and youth in their practices address a broad array of paediatric health concerns, from well child care and preventative health, to mild and serious illness.
The authors included two ‘case studies’ of conditions frequently treated by DCs and NDs:
Case study 1: colic
DC practitioners’ primary treatment focus (314 respondents) would be to use spinal manipulation (78.3%) if physical assessment suggests utility, diet changes (14.6% for child, 6.1% for mom if breast feeding), and massage (16.9%). ND practitioners (95 respondents) would assess and treat primarily with diet changes (62% for child including prescribing probiotics; 48% for mom if breast feeding), homeopathy (46%), weak herbal or tea preparations (19%), and use topical castor oil (packs or massage) (18%). In 2014, 65.9% of DCs and 59% of NDs believe (somewhat or very much) that concurrent treatment by a medical practitioner would be of benefit; 64.0% of DCs and 60% of NDs would refer the patient to another health care practitioner (practitioner type not specified).
Case study 2: acute otitis media
In 2014, almost all practitioners identified this as otitis media (in 2004, the DCs had a profession-specific question); DCs were more cautious about the value of their care for it relative to the NDs (DCs, 46.2% care will help patient very much, NDs, 95%). For treatment, DCs would primarily use spinal manipulation (98.5%) if indicated after assessment, massage (19.5%), dietary modifications (17.6%), and 3.8% would specifically refer to an MD for an antibiotic prescription. ND-preferred treatments were NHP products (79%), dietary modifications (66%), ear drops (60%), homeopathic remedies (18%), and 10% would prescribe antibiotics right away or after a few days. In 2014, 86.3% of DCs and 75% of NDs believe the patient would benefit (somewhat or very much) from concurrent treatment by a conventional medical practitioner; 81.7% of DCs and 58% of NDs would refer the patient to another health care provider.
The authors concluded that although the response rate in 2014 is low, the concerns identified a decade earlier remain. The majority of responding DCs and NDs see infants, children, and youth for a variety of health conditions and issues, but self-assess their undergraduate paediatric training as inadequate. We encourage augmented paediatric educational content be included as core curriculum for DCs and NDs and suggest collaboration with institutions/organizations with expertise in paediatric education to facilitate curriculum development, especially in areas that affect patient safety.
I find these data positively scary:
- Despite calling themselves ‘doctors’, they are nothing of the sort.
- DCs and NCs are not adequately educated or trained to treat children.
- They nevertheless often do so, presumably because this constitutes a significant part of their income.
- Even if they felt confident to be adequately trained, we need to remember that their therapeutic repertoire is wholly useless for treating sick children effectively and responsibly.
- Therefore, harm to children is almost inevitable.
- To this, we must add the risk of incompetent advice from CDs and NDs – just think of immunisations.
The only conclusion I can draw is this: chiropractors and naturopaths should keep their hands off our kids!
We have discussed the NHMRC report on homeopathy several times – see, for instance, here, here and here. Perhaps understandably, homeopaths have great difficulties accepting its negative findings, and have complained about it ever since it was published. Now, a very detailed and well-researched analysis has become available of both the report and its criticism. Here I take the liberty to copy and (clumsily) translate its conclusions; if you can read German, I highly recommend studying the full document.
START OF MY TRANSLATION
The criticism of the NHMRC review is very voluminous and highlights many different aspects of the background, the methodology, the execution and the unwanted results from a homeopathic perspective. The very engaging discussions in the general public about this document and its flaws are, however, relatively meaningless: the NHMRC arrives at exactly the same conclusions as the employee of the Homeopathic Research Institute (HRI), Mathie, in his reviews of 2014 and 2017.
In both reviews, Mathie evaluated a total of 107 primary studies and found only 2 trials that could be rated as qualitatively good, that is to say constituting reliable evidence. Mathie did upgrade 2 further studies to the category of reliable evidence, however, this was in violation of the procedures proscribed in the study protocol.
The criticism of the NHMRC review was not able to make a single valid rebuttal. No condition could be identified for which homeopathy is clearly superior to placebo. This is all the more important, as Mathie avoided the mistakes that constituted the most prominent alleged criticisms of the NHMRC report.
- Since Mathie and most of his co-authors are affiliated with organisations of homeopathy, an anti-homeopathy bias can be excluded.
- Mathie conducted classic reviews and even differentiated between individualised and non-individualised homeopathy.
- Mathie did not exclude studies below a certain sample size.
Yet, in both reviews, he draws the same conclusion.
In view of the truly independent replications of an employee of the HRI, we can be sure that there are, in fact, no solid proofs for the effectiveness of homeopathy. The claim of a strong efficacy, equivalent to conventional medicines, that is made by homeopathy’s advocates is therefore not true.
END OF MY TRANSLATION
And here is the original German text:
Die Kritik an dem Review des NHMRC ist sehr umfangreich und beleuchtet sehr viele verschiedene Facetten über das Umfeld, die Methodik und die Durchführung sowie das aus Sicht der Homöopathen unerwünschte Ergebnis selbst. Die in der Öffentlichkeit sehr engagierte Diskussion um diese Arbeit und ihre möglichen Unzulänglichkeiten sind jedoch relativ bedeutungslos: Das NHMRC kommt zu genau dem gleichen Ergebnis wie Mathie als Mitarbeiter des HRI in seinen in 2014 und 2017 veröffentlichten systematischen Reviews:
Insgesamt hat Mathie in beiden Reviews 107 Einzelstudien untersucht und fand nur zwei Studien, die als qualitativ gut („low risk of bias“), also als zuverlässige Evidenz betrachtet werden können. Mathie hat zwar vier weitere Studien zur zuverlässigen Evidenz aufgewertet, was allerdings im Widerspruch zu den üblichen Vorgehensweisen steht und im Studienprotokoll nicht vorgesehen war.
Die Kritik am Review des NHMRC hat keinen einzigen Punkt fundiert widerlegen können. Man konnte keine Indikation finden, bei der sich die Homöopathie als klar über Placebo hinaus wirksam erwiesen hätte. Diese Punkte sind umso bedeutsamer, weil Mathie die am NHMRC hauptsächlich kritisierten Fehler nicht gemacht hat:
- Als Mitarbeiter des HRI und mit Autoren, die überwiegend für Homöopathie-affine Organisationen arbeiten, ist eine Voreingenommenheit gegen die Homöopathie auszuschließen.
- Mathie hat klassische Reviews ausgeführt, sogar getrennt zwischen einzelnen Ausprägungen (individualisierte Homöopathie und nicht-individualisierte Homöopathie).
- Mathie hat keine Größenbeschränkung der Studien berücksichtigt.
Er kommt aber dennoch zweimal zum gleichen Ergebnis wie das NHMRC.
Angesichts der wirklich als unabhängig anzusehenden Bestätigung der Ergebnisse des NHMRC durch einen Mitarbeiter des Homeopathy Research Institute kann man sicher davon ausgehen, dass es tatsächlich keine belastbaren Wirkungsnachweise für die Homöopathie gibt und dass die von ihren Anhängern behauptete starke, der konventionellen Medizin gleichwertige oder gar überlegene Wirksamkeit der Homöopathie nicht gegeben ist.
I do apologise for my clumsy translation and once again encourage those who can to study the detailed original in full.
My conclusion of this (and indeed of virtually all criticism of homeopathy) is that homeopaths are just as unable to accept criticism as an evangelic believer is going to accept any rational argument against his belief. In other words, regardless of how convincing the evidence, homeopaths will always dismiss it – or, to put it in a nutshell: HOMEOPATHY IS A CULT.
The title of this post is a statement recently made in an article by Mike Adams in ‘Alternative Medicine News’:
The cancer industry goes to great lengths to deny patients access to any information that they might use to prevent, treat or cure cancer without requiring expensive (and highly toxic) medical interventions. That’s what makes the BMJ documentation of this curcumin cancer cure so astonishing: In years past, the BMJ never would have even tolerated the publishing of such a scientific assessment. So what changed? In truth, the evidence of natural cures for cancer is now so overwhelming that even the BMJ cannot remain in a state of denial without appearing to be hopelessly out of touch with scientific reality.
The story is based on one single patient who apparently was cured of cancer using curcumin (turmeric). The case was also recently (3/1/18) featured on BBC’s ‘YOU AND YOURS’ (http://www.bbc.co.uk/programmes/b09k0ng7) in a similarly uncritical way: no expert was asked to provide an evidence-based assessment and bring some reason into the discussion. Even the DAILY FAIL reported about the story, and predictably, critical assessment had to make way for sensationalism.
So what?
We hear about such nonsense almost every day!
True, but this case is different; it is based on a publication in the highly-respected BMJ (well, actually, it was the ‘BMJ CASE REPORTS’ and not the BMJ, as reported). Here is the article:
START OF QUOTE
A woman aged 57 years was initially diagnosed with monoclonal gammopathy of undetermined significance (MGUS) in 2007 following an incidental finding of M-protein (18 g/L) during investigation for hypertension.
Within 15 months, the patient had rapidly progressed to ISS stage 3 myeloma with M-protein 49 g/L, urinary protein 1.3 g/24-hour, Bence-Jones protein 1.0 g/24-hour, Hb 9.7 g/dL and increasing back pain. She initially declined antimyeloma treatment but 6 months later, following vertebral collapse at T5 and T12, started cyclophosphamide, thalidomide and dexamethasone (CTD) treatment. However, after a week, the patient was admitted with idiosyncratic syndrome including hyponatraemia, a fall in albumin and worsening of blood counts. She received red cell transfusion and her electrolyte abnormalities were carefully corrected.
Although there was evidence of a response to CTD (M-protein 34 g/L), bortezomib and dexamethasone treatment was initiated as an alternative, but this was discontinued after three cycles due to progressive disease (M-protein 49 g/L). The patient was then treated with lenalidomide and dexamethasone with the aim of reducing disease burden prior to high-dose therapy and autologous stem cell transplantation. Treatment was frequently interrupted and dose adjusted to account for neutropenia and despite a minor response after six cycles (starting M-protein 47 g/L, finishing M-protein 34 g/L), in October 2009, she proceeded with stem cell mobilisation. However, neither cyclophosphamide nor plerixafor/GCSF priming were successful. A bone marrow biopsy revealed 50% myeloma cells and a course of CTD was restarted with cautious titration of thalidomide.
The patient achieved a partial response with CTD retreatment over the course of 17 cycles (M-protein 13 g/L) with no further episodes of idiosyncratic syndrome. However, attempts to harvest stem cells in February 2011 and again there months later, both failed. By then, her M-protein had risen to 24 g/L and the patient was too neutropenic to be considered for a clinical trial.
At this point, the patient began a daily regime of oral curcumin complexed with bioperine (to aid absorption), as a single dose of 8 g each evening on an empty stomach. A few months later, she also embarked on a once-weekly course of hyperbaric oxygen therapy (90 min at 2 ATA) which she has maintained ever since. Her paraprotein levels gradually declined to a nadir of 13 g/L, her blood counts steadily improved and there was no evidence of further progressive lytic bone disease.
Outcome and follow-up
The patient continues to take oral curcumin 8 g daily without further antimyeloma treatment. Over the last 60 months, her myeloma has remained stable with minimal fluctuation in paraprotein level, her blood counts lie within the normal range and she has maintained good quality of life throughout this period. Repeat bone imaging in 2014 identified multiple lucencies <1 cm in the right hip and degenerative changes in both hips, but these were attributed to osteoarthritis rather than the myeloma. Recent cytogenetic analysis revealed she had no abnormal cytogenetics by fluorescent in situ hybridisation.
Discussion
A small but significant number of myeloma patients consume dietary supplements in conjunction with conventional treatment primarily to help cope with the side effects of treatment, manage symptoms and enhance general well-being. Few, if any, use dietary supplementation as an alternative to standard antimyeloma therapy. Here, we describe a case in which curcumin has maintained long-term disease control in a multiply-relapsed myeloma patient. To the best of our knowledge, this is the first report in which curcumin has demonstrated an objective response in progressive disease in the absence of conventional treatment.
Curcumin is a polyphenol derived from the perennial herb Curcuma longa (turmeric) and has, for centuries, been used as a traditional Indian medicine. Several reports published over the two decades have claimed various health benefits of curcumin and this has led to its increasing popularity as a dietary supplement to prevent or treat a number of different diseases.
The biological activity of curcumin is indeed remarkable. It is a highly pleiotropic molecule which possesses natural antioxidant, anti-inflammatory, antiseptic and analgesic properties. More recently, it has demonstrated antiproliferative effects in a wide variety of tumour cells including myeloma cells and exerts its antiproliferative effects through multiple cellular targets that regulate cell growth and survival.
In vitro, curcumin prevents myeloma cell proliferation through inhibition of IL-6-induced STAT-3 phosphorylation and through modulation of the expression of NF-kB-associated proteins such as IkB〈,Bcl-2, Bcl-xL, cyclin D1 and IL-6 and apoptosis-related molecules including p53 and Bax. In other studies, curcumin was shown to circumvent resistance to dexamethasone, doxorubicin and melphalan as well as potentiate the effects of bortezomib, thalidomide and lenalidomide. Furthermore, curcumin-induced cell death was not influenced by myeloma molecular heterogeneity.
The antimyeloma effects of curcumin in the clinical setting however are less clear. Only one phase I/II study has evaluated curcumin treatment in myeloma patients. These patients were either asymptomatic, relapsed or had plateau phase disease. Treatment with curcumin downregulated the expression of NFkB, COX-2 and STAT3 in peripheral blood mononuclear cells, but no objective responses were observed in any subgroup of patients. This may be as a result of small sample size in this study, follow-up was limited to 3 months and clinical responses may have been observed with longer follow-up. However, downregulation of NFkB, COX-2 and STAT3 expression may not correlate with the clinical activity of curcumin and there may be further mechanisms of action that remain unclear, possibly through the modulation of another target. We would not be able to identify any patient-specific mechanisms of activity in this case study, as the patient has been taking curcumin for some time now and baseline bone marrow or peripheral blood samples are not available. However, in the setting of a clinical trial, it may be possible to use next-generation sequencing to help identify a mutation that may be a potential target for curcumin.
Another study examined its effects in preventing the progression of MGUS and smouldering myeloma to myeloma. The results showed that curcumin exerted a trace of biological activity with modest decreases in free light chain and paraprotein levels and a reduction in a marker of bone resorption with curcumin treatment, suggesting the therapeutic potential of curcumin in MGUS and smouldering myeloma. However, more studies are needed to address this further.
Whether such effects are observed in patients with active disease remains to be seen. The fact that our patient, who had advanced stage disease and was effectively salvaged while exclusively on curcumin, suggests a potential antimyeloma effect of curcumin. She continues to take daily curcumin and remains in a very satisfactory condition with good quality of life. This case provides further evidence of the potential benefit for curcumin in myeloma. We would recommend further evaluation of curcumin in myeloma patients in the context of a clinical trial.
END OF QUOTE
What should we make of this?
I think that much of the reporting around the story was grossly irresponsible. It is simply not possible to conclude that curcumin was the cause of the remission. It could be due to a whole host of other factors. And a case report is just an anecdote; it never can prove anything and can only be used to stimulate further research.
I fully agree with the authors of the case report: curcumin seems worthy of further investigation. But recommending it to patients for self-medication is vastly premature and quite simply dangerous, unethical and naïve bordering on stupid.
And, of course, the above-cited drivel of Mike Adams is just beyond the pale – the evidence for ‘alternative cancer cures‘ is very, very far from ‘overwhelming’; and the ‘cancer industry’ is doing what they can to determine whether turmeric or any other natural remedy can be used to treat cancer and other diseases.
If they are ever successful, the Adams of this world will shout ‘EXPLOITATION!!!’
If their endeavours are not successful, they will complain ‘CONSPIRACY!!!’
Yesterday, I heard my ‘good friend’ Dr Michael Dixon (see here, here and here, for example) talk on the BBC about the “new thing” in healthcare: social prescribing. He explained, for instance, that social prescribing could mean treating a diabetic not with medication but with auto-hypnosis and other alternative therapies. At that moment, I wasn’t even entirely sure what the term ‘social prescribing’ meant, I have to admit – so I did some reading.
What is social prescribing?
The UK ‘Social Prescribing Network‘ defines it thus:
Social Prescribing is a means of enabling GPs and other frontline healthcare professionals to refer patients to a link worker – to provide them with a face to face conversation during which they can learn about the possibilities and design their own personalised solutions, i.e. ‘co-produce’ their ‘social prescription’- so that people with social, emotional or practical needs are empowered to find solutions which will improve their health and wellbeing, often using services provided by the voluntary and community sector. It is an innovative and growing movement, with the potential to reduce the financial burden on the NHS and particularly on primary care.
Does social prescribing work?
The UK King’s Fund is mildly optimistic:
There is emerging evidence that social prescribing can lead to a range of positive health and well-being outcomes. Studies have pointed to improvements in areas such as quality of life and emotional wellbeing, mental and general wellbeing, and levels of depression and anxiety. For example, a study into a social prescribing project in Bristol found improvements in anxiety levels and in feelings about general health and quality of life. In general, social prescribing schemes appear to result in high levels of satisfaction from participants, primary care professionals and commissioners.
Social prescribing schemes may also lead to a reduction in the use of NHS services. A study of a scheme in Rotherham (a liaison service helping patients access support from more than 20 voluntary and community sector organisations), showed that for more than 8 in 10 patients referred to the scheme who were followed up three to four months later, there were reductions in NHS use in terms of accident and emergency (A&E) attendance, outpatient appointments and inpatient admissions. The Bristol study also showed reductions in general practice attendance rates for most people who had received the social prescription.
However, robust and systematic evidence on the effectiveness of social prescribing is very limited. Many studies are small scale, do not have a control group, focus on progress rather than outcomes, or relate to individual interventions rather than the social prescribing model. Much of the evidence available is qualitative, and relies on self-reported outcomes. Researchers have also highlighted the challenges of measuring the outcomes of complex interventions, or making meaningful comparisons between very different schemes.
Determining the cost, resource implications and cost effectiveness of social prescribing is particularly difficult. The Bristol study found that positive health and wellbeing outcomes came at a higher cost than routine GP care over the period of a year, but other research has highlighted the importance of looking at cost effectiveness over a longer period of time. Exploratory economic analysis of the Rotherham scheme, for example, suggested that the scheme could pay for itself over 18–24 months in terms of reduced NHS use….
END OF QUOTES
Is there no harder evidence at all?
The only Medline-listed controlled study seems to have been omitted by the King’s Fund – I wonder why. Perhaps because it fails to share the optimism? Here is its abstract:
Social prescribing is targeted at isolated and lonely patients. Practitioners and patients jointly develop bespoke well-being plans to promote social integration and or social reactivation. Our aim was to investigate: whether a social prescribing service could be implemented in a general practice (GP) setting and to evaluate its effect on well-being and primary care resource use. We used a mixed method evaluation approach using patient surveys with matched control groups and a qualitative interview study. The study was conducted in a mixed socio-economic, multi-ethnic, inner city London borough with socially isolated patients who frequently visited their GP. The intervention was implemented by ‘social prescribing coordinators’. Outcomes of interest were psychological and social well-being and health care resource use. At 8 months follow-up there were no differences between patients referred to social prescribing and the controls for general health, depression, anxiety and ‘positive and active engagement in life’. Social prescribing patients had high GP consultation rates, which fell in the year following referral. The qualitative study indicated that most patients had a positive experience with social prescribing but the service was not utilised to its full extent. Changes in general health and well-being following referral were very limited and comprehensive implementation was difficult to optimise. Although GP consultation rates fell, these may have reflected regression to the mean rather than changes related to the intervention. Whether social prescribing can contribute to the health of a nation for social and psychological wellbeing is still to be determined.
So, there is a lack of evidence for social prescribing. Yet, this is not why I feel uneasy about the promotion of this “new thing”. The more i think about it, the more I realise that social prescribing is just good care and decent medicine. It is what I was taught at med school 40 years ago. It therefore seems like a fancy name for something that should be obvious.
But why my unease?
The way I see it, it will be (and perhaps already is) used to smuggle bogus alternative therapies into the mainstream. In this way, it could turn out to serve the same purpose as did the boom in integrative/integrated medicine/healthcare: a smokescreen to incorporate treatments into medical routine which otherwise would not pass muster. If advocates of this approach, like Michael Dixon, subscribe to it, the danger of this happening is hard to deny.
The disservice to patients (and medical ethics) would then be obvious: diabetics unquestionably can benefit from a change of life-style (and to encourage them is part of good conventional medicine), but I very much doubt that they should replace their anti-diabetic medications with auto-hypnosis or other alternative therapies.
We should not have to repeat this! But, as it is currently topical and certainly true, let me tell you again:
DETOX IS BUNK!
After the season of gluttony, it seems that half the population has fallen victim to the legion of alternative practitioners and entrepreneurs who claim that their particular form of quackery is ideally suited for detoxifying the body – and, sure enough, rid their clients of money instead of poisons. I have pointed out again and again why detox, as promoted in alternative medicine. is bogus and occasionally even harmful – see for instance here, here and here. And years ago, I published a review of the evidence on ‘alternative detox’ (AD); it concluded that “the principles of AD make no sense from a scientific perspective and there is no clinical evidence to support them. The promotion of AD treatments provides income for some entrepreneurs but has the potential to cause harm to patients and consumers. In alternative medicine, simplistic but incorrect concepts such as AD abound. All therapeutic claims should be scientifically tested before being advertised-and AD cannot be an exception.”
But I have, of course, many readers who do not trust a word I am putting on paper. So, please don’t take it from me, take it from others; read for example this recent article:
Detox diets are popular dieting strategies that claim to facilitate toxin elimination and weight loss, thereby promoting health and well-being. The present review examines whether detox diets are necessary, what they involve, whether they are effective and whether they present any dangers. Although the detox industry is booming, there is very little clinical evidence to support the use of these diets. A handful of clinical studies have shown that commercial detox diets enhance liver detoxification and eliminate persistent organic pollutants from the body, although these studies are hampered by flawed methodologies and small sample sizes. There is preliminary evidence to suggest that certain foods such as coriander, nori and olestra have detoxification properties, although the majority of these studies have been performed in animals. To the best of our knowledge, no randomised controlled trials have been conducted to assess the effectiveness of commercial detox diets in humans. This is an area that deserves attention so that consumers can be informed of the potential benefits and risks of detox programmes.
To the best of our knowledge, no randomised controlled trials have been conducted to assess the effectiveness of commercial detox diets in humans. I think that says enough; and it applies not just to detox diets, it applies to all detox methods promoted in alternative medicine.
DETOX IS BUNK!
Save your hard-earned money for stuff that is proven to work.
In 2017, Medline listed just over 1800 articles on ‘complementary alternative medicine’. If you find this number impressively high, consider that, for ‘surgery’ (a subject that has often been branded as less that active in conducting research), there were almost 18 000 Medline-listed papers.
So, the research activity in CAM is relatively small. Vis a vis the plethora of open questions, this inactivity is perhaps lamentable. What I find much more regrettable, however, is the near total lack of investigations into the ethical issues in CAM. In 2017, there were just 11 articles on Medline on ‘ethics and CAM’ (24393 articles on ‘ethics and surgery’).
One of the 11 papers that tackled the ethics directly and that was (in my opinion) one of the best is this article. Here is its concluding paragraph:
When we encounter patients who use or consider the use of complementary and/or alternative medicine, we should respect their autonomy while also fulfilling our obligations of beneficence and nonmaleficence. Physicians should become more knowledgeable about research on CAM therapies and approach discussions in an open, nonjudgmental manner to enhance patient trust. In situations where there is little risk of harm and the possibility of benefit, supporting a patient in their interest in complementary therapies can strengthen the patient-physician relationship. However, when a patient’s desire to utilize alternative therapies poses a health risk, physicians have the ethical obligation to skillfully counsel the patient toward those therapies that are medically appropriate.
I have had a long-lasting and keen interest in the ethics of CAM which resulted in the publication of many papers. Here is a selection:
‘Complementary & Alternative Medicine’ (CAM): Ethical And Policy Issues.
Pharmacists and homeopathic remedies.
Homeopathy, a “helpful placebo” or an unethical intervention?
Advice offered by practitioners of complementary/ alternative medicine: an important ethical issue.
The ethics of British professional homoeopaths.
Evidence-based practice in British complementary and alternative medicine: double standards?
Ethics of complementary medicine: practical issues.
Reporting of ethical standards: differences between complementary and orthodox medicine journals?
Informed consent: a potential dilemma for complementary medicine.
Ethical problems arising in evidence based complementary and alternative medicine.
Complementary medicine: implications for informed consent in general practice.
Ethics and complementary and alternative medicine.
Research ethics questioned in Qigong study.
Informed consent in complementary and alternative medicine.
The ethics of complementary medicine.
For most of the time conducting this research, I felt that I was almost alone in realising the importance of this topic. And all this time, I was convinced that the subject needed more attention and recognition. Therefore, I teamed up with with the excellent ethicist Kevin Smith from the University of Dundee, and together we spent the best part of 2017 writing about it.
Our book is entitled ‘MORE HARM THAN GOOD? THE MORAL MAZE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE’ and will be published shortly by Springer.
It is an attempt to highlight some of the most important topics in this broad and under-researched area. While working on it, I was continually struck by the fact that most of the issues we have been struggling with on this blog are, in the final analysis, ethical by nature.
My hope is that, in 2018, we will see many more high quality papers filling the almost total void of ethical perspectives on CAM. In my view, it is unquestionably an area that needs to be addressed with some urgency.
How often have we heard the claim from proponents of alternative medicine that one strength of their approach is disease prevention (see for instance my previous post or this, this and this) and that conventional medicine neglects prevention almost completely? Such claims annoy me because they are demonstrably false.
I know, to some readers, this may seem like a bold statement; let me therefore try to justify it.
- So far, I have seen no good evidence that any alternative therapy might be effective in preventing any disease.
- Practically everything we know today about disease prevention originates from conventional medicine and science.
- There are thousands of papers that address prevention and, as far as I can see, they all originate from the realm of conventional medicine. Below is a list of just 7 recent reviews on the subject.
This paper is an update of the evidence for exercise as a prevention of heart failure. It concluded that exercise provides protective benefit in preventing HF (primary prevention). With HF present: exercise improvement with training provides benefits in HF (secondary prevention). The prediction of future in HF patients: exercise impairment, as a leading characteristic of HF, is used as a prognostic factor.
The aim of this review was to update evidence for the US Preventive Services Task Force on the benefits and harms of hormone therapy in reducing risks for chronic conditions. The authors found that hormone therapy for the primary prevention of chronic conditions in menopausal women is associated with some beneficial effects but also with a substantial increase of risks for harms. The available evidence regarding benefits and harms of early initiation of hormone therapy is inconclusive.
This paper reviewed the evidence for Implantable Cardiac Defibrillators (ICDs). The authors stated that individuals with stable ischemic heart disease (no recent myocardial infarction), especially those with inducible arrhythmias, seem to derive the highest mortality benefit from prophylactic ICD use.
These authors investigated whether neuromuscular and proprioceptive training is effective in preventing knee and anterior cruciate ligament (ACL) injuries. They concluded that neuromuscular and proprioceptive training appeared to decrease the incidence of injury to the knee and specifically the AC.
Other researchers summarized current evidence about real-world studies on apixaban for stroke prevention in atrial fibrillation. They concluded that the use of apixaban in real-life is associated with an overall similar effectiveness in reducing stroke and any thromboembolic events when compared with warfarin. A better safety profile was found with apixaban compared with warfarin, dabigatran, and rivaroxaban.
Finally, a review assessed the evidence of blood pressure (BP) lowering treatments as a means of reducing cardiovascular morbidity and mortality. The authors concluded that primary preventive BP lowering is associated with reduced risk for death and CVD if baseline SBP is 140 mm Hg or higher. At lower BP levels, treatment is not associated with any benefit in primary prevention but might offer additional protection in patients with CHD.
Testing preventative treatments is, of course, far from easy. Ideally, one would want to do an RCT, but often this is not possible, for instance, because the sample size would need to be prohibitively huge and the observation period prohibitively long (think of cholesterol-lowering for reducing cardiovascular risks, or smoking cessation for preventing cancer). Thus we rely frequently on other types of investigations such as epidemiological studies. This type of research is, however, rarely undertaken in alternative medicine, and when it does cover subjects related to this area, it is almost never done by proponents of alternative medicine.
The long and short of all this is depressingly simple: the often-heard claim that alternative medicine is strong on prevention is quite simply false. Proponents of alternative medicine like to talk about prevention (presumably because it is good for business), but when it comes to applying prevention and showing that their preventative interventions are effective, all this talk turns out to be little more than hot air.
I am sure – even hope – that some readers will disagree, and I look forward to their evidence proving me wrong.
What better to give to you for the holidays than your very own CHRISTMAS SURVIVAL KIT? This article by Eileen Scullion, Registered Homeopath LicISH ISHom with the Irish Society of Homeopaths explains. Sadly, its recommendations lack sections detailing the evidence for the claims made. Therefore, I have taken the liberty of adding my short scientific assessments (IN BOLD CAPITAL LETTERS):
START OF QUOTE
1. Over indulgence
Nux Vomica – For symptoms that arise after over indulgence and excess in food, alcohol, tobacco and coffee. The person suffers from headaches, indigestion, nausea and irritability and symptoms are worse in the morning or after eating.
Arsenicum – For symptoms of diarrhea, vomiting, cramps where you suspect food poisoning.
ZERO PLAUSIBILITY, NO EVIDENCE FOR EFFECTIVENESS.
2. Stress & Anxiety
Argentum Nitricum – Anxiety from worry that it won’t work out – What if the turkey burns? What if the electric goes out? What if the gifts don’t arrive on time? There is a great sense of urgency, hurriedness and worrying about everything with sleepless nights of tossing and turning.
ZERO PLAUSIBILITY, NO EVIDENCE FOR EFFECTIVENESS.
3. Sleep problems
Coffea – Sleeplessness from excitement. For the kids who just can’t sleep in anticipation of Santa’s arrival.
ZERO PLAUSIBILITY, NO EVIDENCE FOR EFFECTIVENESS.
4. Anger and resentment
Staphysagria – If you are feeling angry and resentful and are suffering in silence, or have difficulty in saying no but feel walked over, then this is an excellent remedy to help verbalise things or process your emotions. Pent up emotions can also be accompanied with urinary tract infections where this remedy fits the symptoms.
ZERO PLAUSIBILITY, NO EVIDENCE FOR EFFECTIVENESS.
5. Colds
Aconite – If caught at the early stage, nip those colds in the bud that come on suddenly after exposure to cold dry winds or getting chilled.
ZERO PLAUSIBILITY, NO EVIDENCE FOR EFFECTIVENESS.
END OF QUOTE
As the ‘survival kit’ turns out to be pure speculation, fantasy and wishful thinking, let’s join into the seasonal fun and add some equally evidence-based homeopathic treatments of our own.
1. World peace
We all live in dangerous times, but the way to world peace could be guaranteed by this homeopathic remedy: Donald Trump C30. It is manufactured by exposing a glass of distilled water to a picture of the US president for about 30 minutes and then potentising the mother tincture 30 times in the time-tested way of homeopathy.
2. Fuzzy head
After all the booze and laziness over the holidays, one is bound to feel oddly fuzzy, incoherent and unfocussed. My homeopathic remedy for this complaint is HRH C200. You can make it yourself: take a vial of distilled water to a public library, find Prince Charles’ book ‘Harmony‘ (do not buy this book! it is expensive and not worth it), put the vial between its pages and shake vigorously. Subsequently return the book to its shelve and potentise your mother tincture 200 times.
3. Poverty
Yes, Christmas is expensive! If your bank account is now empty, don’t worry: homeopathy can help. Take your last fiver, cut a tiny bit off, grind it down in some sugar, put the mixture in distilled water, and your mother tincture is ready. You can then potentise it in the usual way; if you want to become a millionaire use the £ C30 potency; if you prefer to be a billionaire, I recommend the £ C200 dilution.
I must stop myself here, because I hope you, the reader of this post, will now chip in. If you are suffering from any symptom at all, please use your imagination and, based on the ‘like cures like’ principle, design your very own homeopathic cure.
Yes, that’s my Christmas challenge.
Have fun!
On their website, the US Food and Drug Administration (FDA) has recently published a statement on homeopathy which, I think, is important enough to get cited extensively:
… Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices…
The FDA’s proposed approach prioritizes enforcement and regulatory actions involving unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients… The FDA intends to focus its enforcement authorities on the following kinds of products:
- products with reported safety concerns;
- products that contain or claim to contain ingredients associated with potentially significant safety concerns;
- products for routes of administration other than oral and topical;
- products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
- products for vulnerable populations; and
- products that do not meet standards of quality, strength or purity as required under the law.
Examples of products that may be subject to the enforcement priorities in the draft guidance are infant and children’s products labeled to contain ingredients associated with potentially significant safety concerns, such as belladonna and nux vomica; and products marketed for serious conditions, such as cancer and heart disease.
While the FDA considers comments to the draft guidance, the FDA intends to examine how the agency is implementing its current compliance policy. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA will consider taking additional enforcement and/or regulatory actions, consistent with the current enforcement policies, which also align with the risk-based categories described in the draft guidance, in the interest of protecting the public…
Until relatively recently, homeopathy was a small market for specialized products. Over the last decade, the homeopathic drug market has grown exponentially, resulting in a nearly $3 billion industry that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims. During this time, the FDA has seen a corresponding increase in safety concerns, including serious adverse events, associated with drug products labeled as homeopathic. In addition, the agency has also found an increasing number of poorly manufactured products that contain potentially dangerous amounts of active ingredients that can create additional risks.
In September 2016, the FDA warned against the use of homeopathic teething tablets and gels containing belladonna, a toxic substance that has an unpredictable response in children under two years of age, after the products were associated with serious adverse events, including seizures and deaths, in infants and children. An FDA lab analysis later confirmed that certain homeopathic teething tablets contained elevated and inconsistent levels of belladonna. A similar issue occurred in 2010 when Hyland’s Teething Tablets were found to contain varying amounts of belladonna. An FDA inspection of that product’s manufacturing facility indicated substandard control of the product’s manufacturing.
The FDA has issued warnings related to a number of other homeopathic drug products over the past several years. These include certain homeopathic zinc-containing intranasal products that may cause a loss of sense of smell, homeopathic asthma products that have not been shown to be effective in treating asthma and various homeopathic drug products labeled to contain potentially toxic ingredients, like nux vomica, which contains strychnine (a highly toxic, well-studied poison often used to kill rodents).
“Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The draft guidance is an important step forward in the agency’s work to protect patients from unproven and potentially dangerous products.”…
The FDA is not alone in reexamining its approach to homeopathy. In November 2016, the Federal Trade Commission (FTC) announced a new enforcement policy explaining that they will hold efficacy and safety claims for over-the-counter homeopathic drugs to the same standard as other products making similar health claims. Notably, the FTC said that companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions…
END OF QUOTE
US homeopaths were quick to respond, as reported here:
The National Center for Homeopathy’s board of directors stated:
The National Center for Homeopathy supports the FDA’s efforts to ensure safety and good manufacturing practices in the industry. We are committed to working with industry partners to protect consumer access to homeopathic medicines, and we are hopeful that this action will not impede access. Homeopathic medicines are safe, gentle and effective when products are manufactured in accordance with HPUS (Homoeopathic Pharmacopoeia of the United States) guidelines under CGMPs (Current Good Manufacturing Practices). We welcome the opportunity to educate consumers and healthcare professionals about the unique aspects of homeopathic medicine.
Of course, the unique aspect of homeopathic medicines undoubtedly is that they usually contain no active molecules and therefore do not work. But somehow, I doubt that the NCH was thinking of telling consumers the truth.
The NCH statement is tame in comparison with the NCH’s response to the FDA’s actions during the homeopathic teething investigation last year. Prior to the recall, the FDA issued a warning to consumers, which the NCH dubbed as “arbitrary and capricious.” The NCH went on to say that the FDA’s warning led to “exaggerated fear mongering” in the media and a “public scare” that threatened access to homeopathic products. “[G]roups interested in seeing homeopathy destroyed continue to hammer away at the system—making exaggerated claims that create misunderstandings about and limit consumer access,” the NCH wrote [emphasis theirs].
And this response is tame compared to what a prominent US homeopaths claimed at the time:
“It’s time to hold these people accountable. There are laws in every country against officials taking bribes and malfeasance in office. Write to your legislators and demand that they investigate and bring these criminals to justice. Send them the links to hundreds of homeopathy studies, including disease prevention with homeopathy, at the end of this article. Tell them that the regulatory agencies are protecting Pharma profits, not the public.
Meanwhile, let us insist that pharmaceutical drugs be labeled honestly, like this:
“This drug was tested by the same company that profits from it, and which company has been fined millions of dollars in the past for lying about test results. This drug does not cure any medical condition, but only suppresses symptoms which may ultimately make the patient sicker. This drug has already killed or injured X number of people.”
The outrage is understandable for two reasons, I think:
- even homeopaths cannot deny that the days of unchecked claims are counted;
- against rage of this sort homeopathic remedies are obviously not working.
The common cold is a perfect condition for providers of alternative medicine:
- it is prevalent (good money to be earned),
- it is not normally dangerous,
- it nevertheless reduces quality of life and thus patients look for a treatment,
- there probably is not a single alternative therapy that does not claim to be effective for it,
- it is gone after about a week, treated or not.
But is there an alternative therapy that does actually work? An article by the Cochrane Collaboration provides an excellent overview. It includes conventional as well as alternative treatments; here I have merely copied the passages related to the latter:
VITAMIN C
There was great excitement in the 1970s when Linus Pauling, (a Nobel laureate twice over), concluded from placebo-controlled trials that Vitamin C could prevent and alleviate the common cold. Further research followed and a Cochrane review, published in 2013, found 29 clinical trials, involving 11,306 participants. Unfortunately, the review did not confirm Pauling’s findings. Taking regular Vitamin C did not reduce the incidence of colds in the general population, although there was a modest reduction in the duration and severity of symptoms. The only people who appeared to derive some benefit were those who undertook short bursts of extreme exercise, such as marathon runners and skiers. In this group the risk of getting a cold was halved.
Trials looking at taking high dose Vitamin C at the onset of cold symptoms showed no consistent effect on the duration and severity of symptoms and more research is needed to clarify these findings.
ECHINACEA
Echinacea is widely used in Europe and North America for common colds. A Cochrane review (2014) showed that some Echinacea products may be more effective than placebo in treating colds but the overall evidence for clinically relevant effects was weak. There was some evidence of a small preventative effect.
INHALATIONS
Inhaled steam has been used for decades (see earlier reference to my childhood humiliation!) thinking that it helps drain away mucus more effectively and possibly destroys the cold virus. A Cochrane review (2017) of six trials with 387 participants showed no consistent benefit for this intervention.
GARLIC
A single trial with 146 participants showed that taking garlic every day for three months might prevent occurrences of the common cold but the evidence was of low quality and more research is needed to validate this finding. (Cochrane review 2014.)
END OF QUOTE
The article obviously focuses only on such therapies for which Cochrane reviews have been published. What about other treatments? As I already mentioned, if we believe the promoters of alternative medicine, the list is long. But fortunately, we do not believe them and want to see the evidence.
HOMEOPATHY
Unsurprisingly, the evidence is not good. One of my posts even expressed the fear that it might involve scientific misconduct.
CHIROPRACTIC
Yes, some chiropractors claim that their manipulations are effective for the common cold. But, as with almost all of their claims, this cannot be taken seriously; the assumption is bogus.
CHINESE HERBAL MEDICINES
A systematic review concluded that their use for common cold is not supported by robust evidence.
SAUNA
Ages ago, I published a small study with promising results:
Twenty-five volunteers were submitted to sauna bathing, with 25 controls abstaining from this or comparable procedures. In both groups the frequency, duration and severity of common colds were recorded for six months. There were significantly fewer episodes of common cold in the sauna group. This was found particularly during the last three months of the study period when the incidence was roughly halved compared to controls. The mean duration and average severity of common colds did not differ significantly between the groups. It is concluded that regular sauna bathing probably reduces the incidence of common colds, but further studies are needed to prove this.
Sadly, the findings were never replicated.
MY CONCLUSION
Grin and bear it!
(That is the cold as well as the myriad of false claims made by enthusiasts of alternative medicine)
