An article entitled “Homeopathy in the Age of Antimicrobial Resistance: Is It a Viable Treatment for Upper Respiratory Tract Infections?” cannot possibly be ignored on this blog, particularly if published in the amazing journal ‘Homeopathy‘. The title does not bode well, in my view – but let’s see. Below, I copy the abstract of the paper without any changes; all I have done is include a few numbers in brackets; they refer to my comments that follow.
START OF ABSTRACT
Acute upper respiratory tract infections (URTIs) and their complications are the most frequent cause of antibiotic prescribing in primary care. With multi-resistant organisms proliferating, appropriate alternative treatments to these conditions are urgently required. Homeopathy presents one solution (1); however, there are many methods of homeopathic prescribing. This review of the literature considers firstly whether homeopathy offers a viable alternative therapeutic solution for acute URTIs (2) and their complications, and secondly how such homeopathic intervention might take place.
Critical review of post 1994 (3) clinical studies featuring homeopathic treatment of acute URTIs and their complications. Study design, treatment intervention, cohort group, measurement and outcome were considered. Discussion focused on the extent to which homeopathy is used to treat URTIs, rate of improvement and tolerability of the treatment, complications of URTIs, prophylactic and long-term effects, and the use of combination versus single homeopathic remedies.
Multiple peer-reviewed (4) studies were found in which homeopathy had been used to treat URTIs and associated symptoms (cough, pharyngitis, tonsillitis, otitis media, acute sinusitis, etc.). Nine randomised controlled trials (RCTs) and 8 observational/cohort studies were analysed, 7 of which were paediatric studies. Seven RCTs used combination remedies with multiple constituents. Results for homeopathy treatment were positive overall (5), with faster resolution, reduced use of antibiotics and possible prophylactic and longer-term benefits.
Variations in size, location, cohort and outcome measures make comparisons and generalisations concerning homeopathic clinical trials for URTIs problematic (6). Nevertheless, study findings suggest at least equivalence between homeopathy and conventional treatment for uncomplicated URTI cases (7), with fewer adverse events and potentially broader therapeutic outcomes. The use of non-individualised homeopathic compounds tailored for the paediatric population merits further investigation, including through cohort studies (8). In the light of antimicrobial resistance, homeopathy offers alternative strategies for minor infections and possible prevention of recurring URTIs (9).
END OF ABSTRACT
And here are my comments:
- This sounds as though the author already knew the conclusion of her review before she even started.
- Did she not just state that homeopathy is a solution?
- This is most unusual; why were pre-1994 articles not considered?
- This too is unusual; that a study is peer-reviewed is not really possible to affirm, one must take the journal’s word for it. Yet we know that peer-review is farcical in the realm of alternative medicine (see also below). Therefore, this is an odd inclusion criterion to mention in an abstract.
- An overall positive result obtained by including uncontrolled observational and cohort studies lacking a control group is meaningless. There is also no assessment of the quality of the RCTs; after a quick glance, I get the impression that the methodologically sound studies do not show homeopathy to be superior to placebo.
- Reviewers need to disentangle these complicating factors and arrive at a conclusion. This is almost invariably problematic, but it is the reviewer’s job.
- What might be the conventional treatment of uncomplicated URTI?
- Why on earth cohort studies? They tell us nothing about equivalence, efficacy etc.
- To reach that conclusion seems to have been the aim of this review (see my point number 1). If I am not mistaken, antibiotics are not indicated in the vast majority of cases of uncomplicated URTI. This means that the true alternative in the light of antimicrobial resistance is to not prescribe antibiotics and treat the patient symptomatically. No need at all for homeopathic placebos, and no need for wishful thinking reviews!
In the paper, the author explains her liking of uncontrolled studies: Non-RCTs and patient reported surveys are considered by some to be inferior forms of research evidence, but are important adjuncts to RCTs that can measure key markers such as patient satisfaction, quality of life and functional health. Observational studies such as clinical outcome studies and case reports, monitoring the effects of homeopathy in real-life clinical settings, are a helpful adjunct to RCTs and more closely reﬂect real-life experiences of patients and physicians than RCTs, and are therefore considered in this study. I would counter that this is not an issue of inferiority but one that depends on the research question; if the research question relates to efficacy/effectiveness, uncontrolled data are next to useless.
She also makes fairly categorical statements in the conclusion section of the paper about the effectiveness of homeopathy: [the] combined evidence from these and other studies suggests that homeopathic treatment can exert biological effects with fewer adverse events and broader therapeutic opportunities than conventional medicine in the treatment of URTIs. Given the cost implications of treating URTIs and their complications in children, and the relative absence of effective alternatives without potential side effects, the use of non-individualised homeopathic compounds tailored for the paediatric population merits further investigation, including through large-scale cohort studies… the most important evidence still arises from practical clinical experience and from the successful treatment of millions of patients. I would counter that none of these conclusions are warranted by the data presented.
From reading the paper, I get the impression that the author (the paper provides no information about her conflicts of interest, nor funding source) is a novice to conducting reviews (even though the author is a senior lecturer, the paper reads more like a poorly organised essay than a scientific review). I am therefore hesitant to criticise her – but I do nevertheless find the fact deplorable that her article passed the peer-review process of ‘Homeopathy‘ and was published in a seemingly respectable journal. If anything, articles of this nature are counter-productive for everyone concerned; they certainly do not further effective patient care, and they give homeopathy-research a worse name than it already has.
An announcement by the UK Society of Homeopaths caught my attention. Here it is in its full and unabbreviated beauty:
START OF ANNOUNCEMENT
Homeopaths are being urged to contribute to an inquiry exploring ways to tackle a looming public health crisis threatened by ‘superbugs’ – bacteria resistant to antibiotics and other antimicrobial drugs.
The Commons Select Committee on Health and Social Care is inviting evidence for its investigation into the progress made by the government so far in responding to the challenge.
The two angles it is exploring are:
- What results have been delivered by the current UK strategy on antimicrobial resistance (AMR), launched in 2013?
- Key actions and priorities for the government’s next AMR strategy, due to be published at the end of 2018.
The Society of Homeopaths is putting together a submission and is asking members to submit their own evidence to the inquiry of using homeopathic alternatives to antimicrobials.
According to the inquiry background papers, antimicrobial resistance – in which bacteria have evolved into ‘superbugs’, resistant to drugs devised to kill them – is a “significant and increasing threat” to public health in the UK and globally. EU data indicates that it is responsible for 700,000 deaths a year worldwide and at least 50,000 in the US and Europe.
The death toll could reach 10m people a year by 2050 if the rise in resistance is not headed off, it is estimated.
Society Chief Executive Mark Taylor said: “Our members know a great deal about the alternatives to antibiotics through their own practice and knowledge. This is a timely inquiry from the Health and Social Care Committee to assess the success of the existing strategy and an opportunity to make the case again for fresh thinking on this pressing public health challenge.”
END OF ANNOUNCEMENT
Yes, of course!
We have a crisis of antibiotic resistance.
Who is going to offer the solution?
They are going to treat us all with homeopathic remedies when the superbugs strike.
And the result?
No more crisis.
Because they have turned it into a catastrophe!!!
Grace Dasilva-Hill has just published an article entitled “Autism/ADHD and Vaccines – are we walking a tightrope whilst blindfolded?“. Who is Grace Dasilva-Hill, you will ask.
She is a professional registered homeopath, based in Charing – East Kent, UK. She has been in practice since 1997. During this time she has developed a busy practice, alongside teaching, running students’ clinics and tutorials. She was a team member of the Ghana Homeopathy Project soon after it started, and later became their treasurer as well. Grace has published in the Journal Homeopathy in Practice, and HPathy. She also is an ‘Energy EFT Master Practitioner Trainer’ and a ‘qualified CEASE therapist’.
And what is the Ghana Homeopathy Project ? It is an organization whose goal is the establishment of homeopathy as a recognised part of the health care system in Africa and Ghana in particular. Their objective is the relief and prevention of disease. They support the development of homeopathic education and wish to make homeopathy available to deprived communities as a valid and affordable form of treatment.
The lengthy article by Grace Dasilva-Hill re-hashes all the bogus arguments about immunisation that you could ever wish for. I will show you only what she calls her ‘conclusions’:
START OF QUOTE
…at the present time we have only just scratched the surface of the issue of autism and ADHD; my aim in this article is to challenge the reader to pause, reflect and ask: do vaccines do more good than harm, or it is actually the other way round? Just who is considered to be responsible for my health and that of my family – my doctor, my country’s government or myself? Do we need to stand up as a profession, and be more pro-active?
The big question seems to be, are we not only failing our patients but also the greater good of the world’s populations, unless we question and do not just ‘accept’ what science and medicine tells us, especially as ‘vested interests’ seem to have such a strong influence on what we are told?
The health journalist Phillip Day has done just that in his book ‘Health Wars’ – he argues how the multinationals have a vested interest in keeping all of us ill, for this is the only way that they can continue making money. His propositions are supported by Goldman Sacks Bank which recently stated that they would not invest in the alternative health industry because it tends to cure people, so there is little profit to be made from it.
I invite you to become an advocate for those who are unable or who are too young to ask questions, or to stand up for themselves, or whose parents don’t have the knowledge or tenacity to challenge.
Children and young adults suffering with autism, ADHD, ASD, deserve our loyalty, support and action.
In the UK, we recently shared the anguish and pain felt by baby Alfie Evans’ parents and family. It is impossible for anyone who is caring to witness such horror, and not to ask any questions. Hopefully we will learn much from this very sad event. There are questions not only about causative factors (ie. the role that vaccinations may have played), but also the issue of parental rights versus the State’s perceived protectionist rights.
What has been happening in the field of healthcare is fast becoming unsustainable. On the other hand Homeopathy has so much to offer, being a sustainable form of medicine not influenced by market forces.
One could argue that one of the reasons why the denialists want to see the demise of homeopathy and other natural modalities, is that more and more people are choosing these modes of healthcare in place of conventional medicine which is reductionist in approach and only has drugs to offer.
I find myself wondering whether there is a need for something radically different to happen. As a profession, do we need to do something collectively? Do we need to stand up more, do we need to speak up more? How do we go about doing this? I know that I am asking more questions than providing answers, and this is because at the moment I don’t have the answers either. But I have a deep and sincere desire to do my best to make a difference that will be both worthwhile and sustainable.
I would like to believe that others in our community would like to do the same for the bigger benefit of sustainable and effective healthcare for all.
Footnote: I have just carried out an impromptu, unrepresentative survey of homeopathic colleagues on a homeopathic professional group. I asked them if they knew of any health care professionals (doctors, nurses, midwives) who did not vaccinate their children. Most of those who replied, surprisingly said that they do know of at least one doctor, or nurse or midwife who did not vaccinate their children, and they added that these professionals keep this quiet. I certainly know of two medical doctors who do not vaccinate their children, and again they do not talk about it. It was shared with me in confidence.
END OF QUOTE
Of course, these words are not really ‘conclusions’, they are just a continuation of a barmy rant.
And yes, such articles exist in abundance. Many homeopaths are active campaigners against vaccination.
The Society of Homeopaths (SoH), the professional UK organisation for lay homeopaths, has recently stated that … it is unethical for a homeopath to advise a patient against the use of conventional vaccines… This could not be clearer! Yet, I suspect that the homeopaths put out such statements mainly to cover their backs and subsequently they do what they feel like – and they rarely feel like supporting vaccinations.
They obviously try to give the impression that lay homeopaths are not antivaxers. I fear, however, this impression is wrong: as we have discussed repeatedly on this blog, many homeopaths do advise their patients against immunisation. And many claim that homeopathic immunisations are an effective alternative. It takes not long to find even VIP-members of the SoH putting parents off from immunising their kids. And thanks to the Ghana Homeopathy and several similar projects, this is happening not just in the UK but also in Africa and elsewhere.
Is that not irresponsible?
In my view, it is!
Is that not illegal?
Apparently not, because such homeopaths usually add a clever disclaimer; Grace Dasilva-Hill for instance states that Any information obtained here is not to be construed as medical OR legal advice. The decision to vaccinate and how you implement that decision is yours and yours alone.
Remember when an international delegation of homeopaths travelled to Liberia to cure Ebola?
Virologists and other experts thought at the time that this was pure madness. But, from the perspective of dedicated homeopaths who have gone through ‘proper’ homeopathic ‘education’ and have the misfortune to believe all the nonsense they have been told, this is not madness. In fact, the early boom of homeopathy, about 200 years ago, was based not least on the seemingly resounding success homeopaths had during various epidemics.
I fully understand that homeopath adore this type of evidence – it is good for their ego! And therefore, they tend to dwell on it and re-hash it time and again. The most recent evidence for this is a brand-new article entitled ‘Homeopathic Prevention and Management of Epidemic Diseases’. It is such a beauty that I present you the original abstract without change:
START OF QUOTE
Homeopathy has been used to treat epidemic diseases since the time of Hahnemann, who used Belladonna to treat scarlet fever. Since then, several approaches using homeopathy for epidemic diseases have been proposed, including individualization, combination remedies, genus epidemicus, and isopathy.
The homeopathic research literature was searched to find examples of each of these approaches and to evaluate which were effective.
There is good experimental evidence for each of these approaches. While individualization is the gold standard, it is impractical to use on a widespread basis. Combination remedies can be effective but must be based on the symptoms of a given epidemic in a specific location. Treatment with genus epidemicus can also be successful if based on data from many practitioners. Finally, isopathy shows promise and might be more readily accepted by mainstream medicine due to its similarity to vaccination.
Several different homeopathic methods can be used to treat epidemic diseases. The challenge for the future is to refine these approaches and to build on the knowledge base with additional rigorous trials. If and when conventional medicine runs out of options for treating epidemic diseases, homeopathy could be seen as an attractive alternative, but only if there is viable experimental evidence of its success.
END OF QUOTE
I don’t need to stress, I think, that such articles are highly irresponsible and frightfully dangerous: if anyone ever took the message that homeopathy has the answer to epidemic seriously, millions might die.
The reasons why epidemiological evidence of this nature is wrong has been discussed before on this blog; I therefore only need to repeat them:
In the typical epidemiological case/control study, one large group of patients [A] is retrospectively compared to another group [B]. In our case, group A has been treated homeopathically, while group B received the treatments available at the time. It is true that several of such reports seemed to suggest that homeopathy works. But this does by no means prove anything; the result might have been due to a range of circumstances, for instance:
- group A might have been less ill than group B,
- group A might have been richer and therefore better nourished,
- group A might have benefitted from better hygiene in the homeopathic hospital,
- group A might have received better care, e. g. hydration,
- group B might have received treatments that made the situation not better but worse.
Because these are RETROSPECTIVE studies, there is no way to account for these and many other factors that might have influenced the outcome. This means that epidemiological studies of this nature can generate interesting results which, in turn, need testing in properly controlled studies where these confounding factors are adequately controlled for. Without such tests, they are next to worthless for recommendations regarding clinical practice.
In essence, this means that epidemiological evidence of this type can be valuable for generating hypotheses which, in turn, need testing in rigorous clinical trials. Without these tests, the evidence can be dangerously misleading.
But, of course, Jennifer Jacobs, the author of the new article, knows all this – after all, she has been employed for many years by the Department of Epidemiology, School of Public Health and Community Medicine, University of Washington, Seattle, Washington, United States!
In this case, why does she re-hash the old myth of homeopathy being the answer to epidemics?
I do not know the answer to this question, but I do know that she is a convinced homeopath with plenty of papers on the subject.
And what sort of journal would publish such dangerous, deeply unethical rubbish?
It is a journal we have discussed several before; its called HOMEOPATHY.
This journal is, I think, remarkable: not even homeopaths would deny that homeopathy is a most controversial subject. One would therefore expect that the editorial board of the leading journal of homeopathy (Impact Factor = 1.16) has a few members who are critical of homeopathy and its assumptions. Yet, I fail to spot a single such person of the board of HOMEOPATHY. Please have a look yourself and tell me, if you can identify such an individual:
FRCP, FFHom, London, UK
Senior Deputy Editor
Robert T. Mathie
BSc (Hons), PhD, London, UK
Paulista University, São Paulo, Brazil
Shaare Zedek Medical Center, Jerusalem, Israel
University of Central Lancashire, Preston, UK
Editorial Advisory Board
Centre for Integrative Psychiatry, Groningen, The Netherlands
University of Witten-Herdecke, Germany
Iris R. Bell
University of Arizona, USA
Indian Institute of Technology, Mumbai, India
Centre de Recherche et de Documentation Thérapeutique, France
University of Maryland, School of Medicine, USA
Centre for Integrative Care, Amsterdam, The Netherlands
University of California, Santa Rosa, USA
Kusum S. Chand
Pushpanjali Crosslay Hospital, Ghaziabad, India
London South Bank University, UK
University of Uberlândia, Brazil
Faculty of Homeopathy, UK
Duke University, USA
Haguenau Hospital, France
Interuniversity College Graz/Castle of Seggau, Austria
Queen’s University Belfast, UK
Veterinary Dean, Faculty of Homeopathy, UK
University of Baja California, Mexico
Carla Holandino Quaresma
Universidade Federal do Rio de Janeiro, Brazil
University of Washington, USA
Samueli Institute, Alexandria, USA
Faculty of Homeopathy, UK
Glasgow Homoeopathic Hospital, UK
Pretoria, South Africa
Technical University, Munich, Germany
Faculty of Homeopathy, UK
Raj K. Manchanda
Central Council for Research in Homoeopathy, New Delhi, India
University of Westminster, London, UK
Association Française pour la Recherche en Homéopathie, France
Glasgow Homoeopathic Hospital, UK
Integrative Medicine Institute, Portland, USA
Breda, The Netherlands
University of Technology, Sydney, Australia
University of Bristol, UK
Centre de médecines intégrées, Switzerland
Homeopathy Research Institute, UK
Robbert van Haselen
International Institute for Integrated Medicine, Kingston, UK
Michel Van Wassenhoven
Unio Homeopathica Belgica, Belgium
University of Witten-Herdecke, Germany
University of Utrecht, The Netherlands
I rest my case.
I have often criticised papers published by chiropractors.
This article is excellent and I therefore quote extensively from it.
The objective of this systematic review was to investigate, if there is any evidence that spinal manipulations/chiropractic care can be used in primary prevention (PP) and/or early secondary prevention in diseases other than musculoskeletal conditions. The authors conducted extensive literature searches to locate all studies in this area. Of the 13.099 titles scrutinized, 13 articles were included (8 clinical studies and 5 population studies). They dealt with various disorders of public health importance such as diastolic blood pressure, blood test immunological markers, and mortality. Only two clinical studies could be used for data synthesis. None showed any effect of spinal manipulation/chiropractic treatment.
The authors concluded that they found no evidence in the literature of an effect of chiropractic treatment in the scope of PP or early secondary prevention for disease in general. Chiropractors have to assume their role as evidence-based clinicians and the leaders of the profession must accept that it is harmful to the profession to imply a public health importance in relation to the prevention of such diseases through manipulative therapy/chiropractic treatment.
In addition to this courageous conclusion (the paper is authored by a chiropractor and published in a chiro journal), the authors make the following comments:
Beliefs that a spinal subluxation can cause a multitude of diseases and that its removal can prevent them is clearly at odds with present-day concepts, as the aetiology of most diseases today is considered to be multi-causal, rarely mono-causal. It therefore seems naïve when chiropractors attempt to control the combined effects of environmental, social, biological including genetic as well as noxious lifestyle factors through the simple treatment of the spine. In addition, there is presently no obvious emphasis on the spine and the peripheral nervous system as the governing organ in relation to most pathologies of the human body.
The ‘subluxation model’ can be summarized through several concepts, each with its obvious weakness. According to the first three, (i) disturbances in the spine (frequently called ‘subluxations’) exist and (ii) these can cause a multitude of diseases. (iii) These subluxations can be detected in a chiropractic examination, even before symptoms arise. However, to date, the subluxation has been elusive, as there is no proof for its existence. Statements that there is a causal link between subluxations and various diseases should therefore not be made. The fourth and fifth concepts deal with the treatment, namely (iv) that chiropractic adjustments can remove subluxations, (v) resulting in improved health status. However, even if there were an improvement of a condition following treatment, this does not mean that the underlying theory is correct. In other words, any improvement may or may not be caused by the treatment, and even if so, it does not automatically validate the underlying theory that subluxations cause disease…
Although at first look there appears to be a literature on this subject, it is apparent that most authors lack knowledge in research methodology. The two methodologically acceptable studies in our review were found in PubMed, whereas most of the others were identified in the non-indexed literature. We therefore conclude that it may not be worthwhile in the future to search extensively the non-indexed chiropractic literature for high quality research articles.
One misunderstanding requires some explanations; case reports are usually not considered suitable evidence for effect of treatment, even if the cases relate to patients who ‘recovered’ with treatment. The reasons for this are multiple, such as:
- Individual cases, usually picked out on the basis of their uniqueness, do not reflect general patterns.
- Individual successful cases, even if correctly interpreted must be validated in a ‘proper’ research design, which usually means that presumed effect must be tested in a properly powered and designed randomized controlled trial.
- One or two successful cases may reflect a true but very unusual recovery, and such cases are more likely to be written up and published as clinicians do not take the time to marvel over and spend time on writing and publishing all the other unsuccessful treatment attempts.
- Recovery may be co-incidental, caused by some other aspect in the patient’s life or it may simply reflect the natural course of the disease, such as natural remission or the regression towards the mean, which in human physiology means that low values tend to increase and high values decrease over time.
- Cases are usually captured at the end because the results indicate success, meaning that the clinical file has to be reconstructed, because tests were used for clinical reasons and not for research reasons (i.e. recorded by the treating clinician during an ordinary clinical session) and therefore usually not objective and reproducible.
- The presumed results of the treatment of the disease is communicated from the patient to the treating clinician and not to a third, neutral person and obviously this link is not blinded, so the clinician is both biased in favour of his own treatment and aware of which treatment was given, and so is the patient, which may result in overly positive reporting. The patient wants to please the sympathetic clinician and the clinician is proud of his own work and overestimates the results.
- The long-term effects are usually not known.
- Further, and most importantly, there is no control group, so it is impossible to compare the results to an untreated or otherwise treated person or group of persons.
Nevertheless, it is common to see case reports in some research journals and in communities with readers/practitioners without a firmly established research culture it is often considered a good thing to ‘start’ by publishing case reports.
Case reports are useful for other reasons, such as indicating the need for further clinical studies in a specific patient population, describing a clinical presentation or treatment approach, explaining particular procedures, discussing cases, and referring to the evidence behind a clinical process, but they should not be used to make people believe that there is an effect of treatment…
For groups of chiropractors, prevention of disease through chiropractic treatment makes perfect sense, yet the credible literature is void of evidence thereof. Still, the majority of chiropractors practising this way probably believe that there is plenty of evidence in the literature. Clearly, if the chiropractic profession wishes to maintain credibility, it is time seriously to face this issue. Presently, there seems to be no reason why political associations and educational institutions should recommend spinal care to prevent disease in general, unless relevant and acceptable research evidence can be produced to support such activities. In order to be allowed to continue this practice, proper and relevant research is therefore needed…
All chiropractors who want to update their knowledge or to have an evidence-based practice will search new information on the internet. If they are not trained to read the scientific literature, they might trust any article. In this situation, it is logical that the ‘believers’ will choose ‘attractive’ articles and trust the results, without checking the quality of the studies. It is therefore important to educate chiropractors to become relatively competent consumers of research, so they will not assume that every published article is a verity in itself…
END OF QUOTES
YES, YES YES!!!
I am so glad that some experts within the chiropractic community are now publishing statements like these.
This was long overdue.
How was it possible that so many chiropractors so far failed to become competent consumers of research?
Do they and their professional organisations not know that this is deeply unethical?
Actually, I fear they do and did so for a long time.
Why then did they not do anything about it ages ago?
I fear, the answer is as easy as it is disappointing:
If chiropractors systematically trained to become research-competent, the chiropractic profession would cease to exist; they would become a limited version of physiotherapists. There is simply not enough positive evidence to justify chiropractic. In other words, as chiropractic wants to survive, it has little choice other than remaining ignorant of the current best evidence.
Generally speaking, Cochrane reviews provide the best (most rigorous, transparent and independent) evidence on the effectiveness of medical or surgical interventions. It is therefore important to ask what they tell us about homeopathy. In 2010, I did exactly that and published it as an overview of the current best evidence. At the time, there were 6 relevant Cochrane reviews. They covered the following conditions: cancer, attention-deficit hyperactivity disorder, asthma, dementia, influenza and induction of labour. And their results were clear: they did not show that homeopathic medicines have effects beyond placebo.
Now a further Cochrane review has been published.
Does it change this situation?
This systematic review assessed the effectiveness and safety of oral homeopathic medicinal products compared with placebo or conventional therapy to prevent and treat acute respiratory tract infections (ARTIs) in children. The researchers conducted extensive literature searches, checked references, and contacted study authors to identify additional studies. They included all double-blind, randomised controlled trials (RCTs) or double-blind cluster-RCTs comparing oral homeopathy medicinal products with identical placebo or self selected conventional treatments to prevent or treat ARTIs in children aged 0 to 16 years.
Eight RCTs of 1562 children receiving oral homeopathic medicinal products or a control treatment (placebo or conventional treatment) for upper respiratory tract infections (URTIs). Four treatment studies examined the effect on recovery from URTIs, and four studies investigated the effect on preventing URTIs after one to three months of treatment and followed up for the remainder of the year. Two treatment and two prevention studies involved homeopaths individualising treatment for children. The other studies used predetermined, non-individualised treatments. All studies involved highly diluted homeopathic medicinal products.
Several key limitations to the included studies were identified, in particular methodological inconsistencies and high attrition rates, failure to conduct intention-to-treat analysis, selective reporting, and apparent protocol deviations. The authors deemed three studies to be at high risk of bias in at least one domain, and many had additional domains with unclear risk of bias. Three studies received funding from homeopathy manufacturers; one reported support from a non-government organisation; two received government support; one was co-sponsored by a university; and one did not report funding support.
Methodological inconsistencies and significant clinical and statistical heterogeneity precluded robust quantitative meta-analysis. Only four outcomes were common to more than one study and could be combined for analysis. Odds ratios (OR) were generally small with wide confidence intervals (CI), and the contributing studies found conflicting effects, so there was little certainty that the efficacy of the intervention could be ascertained.
All studies assessed as at low risk of bias showed no benefit from oral homeopathic medicinal products; trials at uncertain and high risk of bias reported beneficial effects. The authors found low-quality evidence that non-individualised homeopathic medicinal products confer little preventive effect on ARTIs (OR 1.14, 95% CI 0.83 to 1.57). They also found low-quality evidence from two individualised prevention studies that homeopathy has little impact on the need for antibiotic usage (N = 369) (OR 0.79, 95% CI 0.35 to 1.76).
The authors also assessed adverse events, hospitalisation rates and length of stay, days off school (or work for parents), and quality of life, but were not able to pool data from any of these secondary outcomes. There is insufficient evidence from two pooled individualised treatment studies (N = 155) to determine the effect of homeopathy on short-term cure (OR 1.31, 95% CI 0.09 to 19.54; very low-quality evidence) and long-term cure rates (OR 1.01, 95% CI 0.10 to 9.96; very low-quality evidence). Adverse events were reported inconsistently; however, serious events were not reported. One study found an increase in the occurrence of non-severe adverse events in the treatment group.
The authors concluded that pooling of two prevention and two treatment studies did not show any benefit of homeopathic medicinal products compared to placebo on recurrence of ARTI or cure rates in children. We found no evidence to support the efficacy of homeopathic medicinal products for ARTIs in children. Adverse events were poorly reported, so conclusions about safety could not be drawn.
In their paper, the authors state that “there are no established explanatory models for how highly diluted homeopathic medicinal products might work. For this reason, homeopathy remains highly controversial because the key concepts governing this form of medicine are not consistent with the established laws of conventional therapeutics.” In other words, there is no reason why highly diluted homeopathic remedies should work. Yet, remarkably, when asked what conditions responds best to homeopathy, most homeopaths would probably include ARTI of children.
The authors also point out that “The results of this review are consistent with all previous systematic reviews on homeopathy. Funders and study investigators contemplating any further research in this area need to consider whether further research will advance our knowledge, given the uncertain mechanism of action and debate about how the lack of a measurable dose can make them effective. The studies we identified did not use a uniform approach to choosing and measuring outcomes or assigning appropriate time points for outcome measurement. The use of validated symptom scales would facilitate future meta-analyses. It is unclear if there is any benefit from individualised (classical) homeopathy over the use of commercially available products.”
Even though I agree with the authors on most of their views and comment their excellent work, I would be more outspoken regarding the need of further research. In my view, it would be a foolish, wasteful and therefore unethical activity to fund, plan or conduct further research in this area.
This week, I find it hard to decide where to focus; with all the fuzz about ‘Homeopathy Awareness Week’ it is easy to forget that our friends, the chiros are celebrating Chiropractic Awareness Week (9-15 April). On this occasion, the British Chiropractic Association (BCA), for instance, want people to keep moving to make a positive impact on managing and preventing back and neck pain.
Good advice! In a recent post, I even have concluded that people should “walk (slowly and cautiously) to the office of their preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.” The reason for my advice is based on the fact that there is precious little evidence that the spinal manipulations of chiropractors make much difference plus some worrying indications that they may cause serious damage.
It seems to me that, by focussing their PR away from spinal manipulations and towards the many other things chiropractors sometimes do – they often call this ‘adjunctive therapies’ – there is a tacit admission here that the hallmark intervention of chiros (spinal manipulation) is of dubious value.
A recent article entitled ‘Spinal Manipulative Therapy and Other Conservative Treatments for Low Back Pain: A Guideline From the Canadian Chiropractic Guideline Initiative’ seems to confirm this impression. Its objective was to develop a clinical practice guideline on the management of acute and chronic low back pain (LBP) in adults. The specific aim was to develop a guideline to provide best practice recommendations on the initial assessment and monitoring of people with low back pain and address the use of spinal manipulation therapy (SMT) compared with other commonly used conservative treatments.
The topic areas were chosen based on an Agency for Healthcare Research and Quality comparative effectiveness review, specific to spinal manipulation as a non-pharmacological intervention. The panel updated the search strategies in Medline and assessed admissible systematic reviews and randomized controlled trials. Evidence profiles were used to summarize judgments of the evidence quality and link recommendations to the supporting evidence. Using the Evidence to Decision Framework, the guideline panel determined the certainty of evidence and strength of the recommendations. Consensus was achieved using a modified Delphi technique. The guideline was peer reviewed by an 8-member multidisciplinary external committee.
For patients with acute (0-3 months) back pain, we suggest offering advice (posture, staying active), reassurance, education and self-management strategies in addition to SMT, usual medical care when deemed beneficial, or a combination of SMT and usual medical care to improve pain and disability. For patients with chronic (>3 months) back pain, we suggest offering advice and education, SMT or SMT as part of a multimodal therapy (exercise, myofascial therapy or usual medical care when deemed beneficial). For patients with chronic back-related leg pain, we suggest offering advice and education along with SMT and home exercise (positioning and stabilization exercises).
The authors concluded that a multimodal approach including SMT, other commonly used active interventions, self-management advice, and exercise is an effective treatment strategy for acute and chronic back pain, with or without leg pain.
I find this paper most interesting and revealing. Considering that it originates from the ‘Canadian Chiropractic Guideline Initiative’, it is remarkably shy about recommending SMT – after all their vision is “To enhance the health of Canadians by fostering excellence in chiropractic care.” They are thus not likely to be overly critical of the treatment chiropractors use most, i. e. SMT.
Perhaps this is also the reason why, in their conclusion, they seem to have rather a large blind spot, namely the risks of SMT. I have commented on this issue more often than I care to remember. Most recently, I posted this:
The reason why my stance, as expressed on this blog and elsewhere, is often critical about certain alternative therapies is thus obvious and transparent. For none of them (except for massage) is the risk/benefit balance positive. And for spinal manipulation, it even turns out to be negative. It goes almost without saying that responsible advice must be to avoid treatments for which the benefits do not demonstrably outweigh the risks.
HAPPY CHIROPRACTIC AWARENESS WEEK EVERYONE!
The question whether spinal manipulative therapy (SMT) has any specific therapeutic effects is still open. This fact must irritate ardent chiropractors, and they therefore try everything to dispel our doubts. One way would be to demonstrate a dose-effect relationship between SMT and the clinical outcome. But, for several reasons, this is not an easy task.
This RCT was aimed at identifying the dose-response relationship between visits for SMT and chronic cervicogenic headache (CGH) outcomes; to evaluate the efficacy of SMT by comparison with a light massage control.
The study included 256 adults with chronic CGH. The primary outcome was days with CGH in the prior 4 weeks evaluated at the 12- and 24-week primary endpoints. Secondary outcomes included CGH days at remaining endpoints, pain intensity, disability, perceived improvement, medication use, and patient satisfaction. Participants were randomized to 4 different dose levels of chiropractic SMT: 0, 6, 12, or 18 sessions. They were treated 3 times per week for 6 weeks and received a focused light-massage control at sessions when SMT was not assigned. Linear dose effects and comparisons to the no-manipulation control group were evaluated at 6, 12, 24, 39, and 52 weeks.
A linear dose-response was observed for all follow-ups, a reduction of approximately 1 CGH day/4 weeks per additional 6 SMT visits (p<.05); a maximal effective dose could not be determined. CGH days/4 weeks were reduced from about 16 to 8 for the highest and most effective dose of 18 SMT visits. Mean differences in CGH days/4 weeks between 18 SMT visits and control were -3.3 (p=.004) and -2.9 (p=.017) at the primary endpoints, and similar in magnitude at the remaining endpoints (p<.05). Differences between other SMT doses and control were smaller in magnitude (p > .05). CGH intensity showed no important improvement nor differed by dose. Other secondary outcomes were generally supportive of the primary.
The authors concluded that there was a linear dose-response relationship between SMT visits and days with CGH. For the highest and most effective dose of 18 SMT visits, CGH days were reduced by half, and about 3 more days per month than for the light-massage control.
This trial would make sense, if the effectiveness of SMT for CGH had been a well-documented fact, and if the study had rigorously controlled for placebo-effects.
But guess what?
Neither of these conditions were met.
A recent review concluded that there are few published randomized controlled trials analyzing the effectiveness of spinal manipulation and/or mobilization for TTH, CeH, and M in the last decade. In addition, the methodological quality of these papers is typically low. Clearly, there is a need for high-quality randomized controlled trials assessing the effectiveness of these interventions in these headache disorders. And this is by no means the only article making such statements; similar reviews arrive at similar conclusions. In turn, this means that the effects observed after SMT are not necessarily specific effects due to SMT but could easily be due to placebo or other non-specific effects. In order to avoid confusion, one would need a credible placebo – one that closely mimics SMT – and make sure that patients were ‘blinded’. But ‘light massage’ clearly does not mimic SMT, and patients obviously were aware of which interventions they received.
So, an alternative – and I think at least as plausible – conclusion of the data provided by this new RCT is this:
Chiropractic SMT is associated with a powerful placebo response which, of course, obeys a dose-effect relationship. Thus these findings are in keeping with the notion that SMT is a placebo.
And why would the researchers – who stress that they have no conflicts of interest – mislead us by making this alternative interpretation of their findings not abundantly clear?
I fear, the reason might be simple: they also seem to mislead us about their conflicts of interest: they are mostly chiropractors with a long track record of publishing promotional papers masquerading as research. What, I ask myself, could be a stronger conflict of interest?
(Pity that a high-impact journal like SPINE did not spot these [not so little] flaws)
Many hard-nosed sceptics might claim that there is no herbal treatment for upper respiratory infections that makes the slightest difference difference. But is this assumption really correct?
According to my own research of 2004, it is not. Here is the abstract of our systematic review:
Acute respiratory infections represent a significant cause of over-prescription of antibiotics and are one of the major reasons for absence from work. The leaves of Andrographis paniculata (Burm. f.) Wall ex Nees (Acanthaceae) are used as a medicinal herb in the treatment of infectious diseases. Systematic literature searches were conducted in six computerised databases and the reference lists of all papers located were checked for further relevant publications. Information was also requested from manufacturers, the spontaneous reporting schemes of the World Health Organisation and national drug safety bodies. No language restrictions were imposed. Seven double-blind, controlled trials (n = 896) met the inclusion criteria for evaluation of efficacy. All trials scored at least three, out of a maximum of five, for methodological quality on the Jadad scale. Collectively, the data suggest that A. paniculata is superior to placebo in alleviating the subjective symptoms of uncomplicated upper respiratory tract infection. There is also preliminary evidence of a preventative effect. Adverse events reported following administration of A. paniculata were generally mild and infrequent. There were few spontaneous reports of adverse events. A. paniculata may be a safe and efficacious treatment for the relief of symptoms of uncomplicated upper respiratory tract infection; more research is warranted.
A. Paniculata (Burm.f.) Wall ex Nees (Acanthaceae family), also known as nemone chinensi, Chuān Xīn Lián, has traditionally been used in Indian and Chinese herbal medicine mostly as an antipyretic for relieving and reducing the severity and duration of symptoms of common colds and alleviating fever, cough and sore throats, or as a tonic to aid convalescence after uncomplicated respiratory tract infections. The active constituents of A. paniculata include the diterpene, lactones commonly known as the andrographolides which have shown anti-inflammatory, antiviral, anti-allergic, and immune-stimulatory activities. A. Paniculata has also been shown, in vitro, to be effective against avian influenza A (H9N2 and H5N1) and human influenza A H1N1 viruses, possibly through blocking the binding of viral hemagglutinin to cells, or by inhibiting H1N1 virus-induced cell death.
But our systematic review was published 14 years ago!
We need more up-to-date information!
And I am pleased to report that a recent paper provided exactly that.
This systematic review included published and unpublished RCTs. Quasi-RCTs, crossover trials, controlled before and after studies, interrupted time series (ITS) studies, and non-experimental studies were not included due to their potential high risk of bias.
Thirty-three trials involving 7175 patients with ARTIs were included. Their methodological quality was restricted as randomisation was not well documented; 73% of the trials included were not blinded; where ITT analysis were performed, loss to follow-up data were counted as no effect; and most trials were published without a protocol available.
Findings suggested limited but consistent evidence that A. Paniculata improved cough and sore throat when compared with placebo. A. Paniculata (alone or plus usual care) had a statistically significant effect in improving overall symptoms of ARTIs when compared to placebo, usual care, and other herbal therapies. A. Paniculata in pillule tended to be more effective in improving overall symptoms over A. Paniculata in tablet. Evidence also suggested that A. Paniculata (alone or plus usual care) shortens the duration of cough, sore throat and sick leave/time to resolution when compared versus usual care. Reduction in antibiotic usage was seldom evaluated in the included trials.
The authors concluded that A. Paniculata appears beneficial and safe for relieving ARTI symptoms and shortening time to symptom resolution. However, these findings should be interpreted cautiously owing to poor study quality and heterogeneity. Well-designed trials evaluating the effectiveness and potential to reduce antibiotic use of A. Paniculata are warranted.
In case you wonder about conflicts of interest: there were none with my 2004 paper, and the authors of the new review state that this paper presents independent research funded by the National Institute for Health Research School for Primary Care Research (NIHR SPCR). The views expressed are those of the author(s) and not necessarily those of the NIHR, the NHS or the Department of Health.
Yes, the RCTs are not all of top quality.
And yes, the effect size is not huge.
But maybe – just maybe – we do have here an alternative therapy that does help against a condition for which conventional drugs are fairly useless!?!
If you ask me, the field of alternative medicine is plagued with surveys; too many are published and most are complete, meaningless rubbish which serve merely the purpose of being misinterpreted as a means of popularising bogus treatments. Yet, every now and then, a decent and informative article appears – like this survey from Canada.
It yields a number of fascinating findings:
- More than three-quarters of Canadians (79%) had used at least one from of CAM sometime in their lives in 2016 (74% in 2006 and 73% in 1997). British Columbians were most likely to have used an alternative therapy during their lifetime (89%), followed by Albertans (84%) and Ontarians (81%).
- More than half (56%) of Canadians had used at least one CAM therapy in the year prior to the 2016 survey, compared to 54% in 2006 and 50% in 1997.
- In 2016, massage was the most common type of therapy that Canadians used over their lifetime with 44 percent having tried it, followed by chiropractic care (42%), yoga (27%), relaxation techniques (25%), and acupuncture (22%).
- The most rapidly expanding therapies over the past two decades were massage, yoga, acupuncture, chiropractic care, osteopathy, and naturopathy.
- High dose/mega vitamins, herbal therapies, and folk remedies were in declining use over that same time period.
- The most likely users of CAM over the past 12 months in 2016 were from the 35- to 44-year-old age group (61%). The use of CAM diminished with age, and generally rose with both income and education. These trends are similar to those observed in 2006 and 1997.
- The majority of people choosing to use CAM in the 12 months preceding the 2016 survey did so for “wellness”.
- Canadians spent an estimated $8.8 billion on CAM in the last 12 months ($8.0 billion in 2005/06 and $6.3 billion in 1996/97.
- Of the $8.8 billion spent in 2016, more than $6.5 billion was spent on providers of CAM, while another $2.3 billion was spent on herbs, vitamins, special diet programs, books, classes, and equipment.
- The majority of Canadians believe that CAM should be paid for privately and not by provincial health.
The strengths of this survey are that it is methodologically rigorous, and that it provides longitudinal data (this is in sharp contrast to the plethora of CAM surveys published recently). Many of its findings confirm what has already been known. Yet some results are new and noteworthy.
To many readers of this blog, the high CAM-usage will be disturbing. However, I am mildly encouraged by the results of this survey.
- Firstly, the choice of CAM by Canadians seems rather more reasonable than that by other nations. Canadians seem to avoid the more ridiculous types of CAM, such as homeopathy or para-normal healing.
- Secondly, many Canadians seem to view CAM not as medicine, but as a sort of luxurious pampering that they use to relax and feel well. Consequently, most are not pushing to get it reimbursed which I find more sensible than consumers’ attitudes in many other countries.