MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

prevention

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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

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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.

METHODS:

The homeopathic research literature was searched to find examples of each of these approaches and to evaluate which were effective.

RESULTS:

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.

CONCLUSION:

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

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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:

Editor

Peter Fisher
FRCP, FFHom, London, UK

Senior Deputy Editor

Robert T. Mathie
BSc (Hons), PhD, London, UK

Deputy Editors

Leoni Bonamin
Paulista University, São Paulo, Brazil

Menachem Oberbaum
Shaare Zedek Medical Center, Jerusalem, Israel

Ethics Adviser

Kate Chatfield
University of Central Lancashire, Preston, UK

Editorial Advisory Board

Cees Baas
Centre for Integrative Psychiatry, Groningen, The Netherlands

Stephan Baumgartner
University of Witten-Herdecke, Germany

Iris R. Bell
University of Arizona, USA

Jayesh Bellare
Indian Institute of Technology, Mumbai, India

Philippe Belon
Centre de Recherche et de Documentation Thérapeutique, France

Brian Berman
University of Maryland, School of Medicine, USA

Martien Brands
Centre for Integrative Care, Amsterdam, The Netherlands

Michael Carlston
University of California, Santa Rosa, USA

Kusum S. Chand
Pushpanjali Crosslay Hospital, Ghaziabad, India

Martin Chaplin
London South Bank University, UK

Flávio Dantas
University of Uberlândia, Brazil

Peter Darby
Faculty of Homeopathy, UK

Jonathan Davidson
Duke University, USA

Jean-Louis Demangeat
Haguenau Hospital, France

Christian Endler
Interuniversity College Graz/Castle of Seggau, Austria

Madeleine Ennis
Queen’s University Belfast, UK

Edoardo Felisi
Milan, Italy

Peter Gregory
Veterinary Dean, Faculty of Homeopathy, UK

German Guajardo-Bernal
University of Baja California, Mexico

Carla Holandino Quaresma
Universidade Federal do Rio de Janeiro, Brazil

Jennifer Jacobs
University of Washington, USA

Wayne Jonas
Samueli Institute, Alexandria, USA

Lee Kayne
Faculty of Homeopathy, UK

Steven Kayne
Glasgow Homoeopathic Hospital, UK

David Lilley
Pretoria, South Africa

Klaus Linde
Technical University, Munich, Germany

Russell Malcolm
Faculty of Homeopathy, UK

Raj K. Manchanda
Central Council for Research in Homoeopathy, New Delhi, India

David Peters
University of Westminster, London, UK

Bernard Poitevin
Association Française pour la Recherche en Homéopathie, France

David Reilly
Glasgow Homoeopathic Hospital, UK

David Riley
Integrative Medicine Institute, Portland, USA

ALB Rutten
Breda, The Netherlands

Jürgen Schulte
University of Technology, Sydney, Australia

Trevor Thompson
University of Bristol, UK

André Thurneysen
Centre de médecines intégrées, Switzerland

Alexander Tournier
Homeopathy Research Institute, UK

Francis Treuherz
London, UK

Robbert van Haselen
International Institute for Integrated Medicine, Kingston, UK

Michel Van Wassenhoven
Unio Homeopathica Belgica, Belgium

Harald Walach
University of Witten-Herdecke, Germany

Fred Wiegant
University of Utrecht, The Netherlands

___________________________________________________________________________

I rest my case.

 

I have often criticised papers published by chiropractors.

Not today!

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.

This systematic review aimed to identify and explore published studies on the health, wellbeing and economic impact of retreat experiences. Three electronic databases were searched for residential retreat studies published in English. Studies were included, if they involved an intervention program in a residential setting of one or more nights, and included before-and-after data related to the health of participants.

A total of 23 studies including 8 randomised controlled trials, 6 non-randomised controlled trials and 9 longitudinal cohort studies met the inclusion criteria. These studies included a total of 2592 participants from diverse geographical and demographic populations and a great heterogeneity of outcome measures, with 7 studies examining objective outcomes such as blood pressure or biological makers of disease, and 16 studies examining subjective outcomes that mostly involved self-reported questionnaires on psychological and spiritual measures.

All studies reported post-retreat health benefits ranging from immediately after to five-years post-retreat. Study populations varied widely and most studies had small sample sizes, poorly described methodology and little follow-up data, and no studies reported on health economic outcomes or adverse effects, making it difficult to make definite conclusions about specific conditions, safety or return on investment.

The authors concluded that health retreat experiences appear to have health benefits that include benefits for people with chronic diseases such as multiple sclerosis, various cancers, HIV/AIDS, heart conditions and mental health. Future research with larger numbers of subjects and longer follow-up periods are needed to investigate the health impact of different retreat experiences and the clinical populations most likely to benefit. Further studies are also needed to determine the economic benefits of retreat experiences for individuals, as well as for businesses, health insurers and policy makers.

In the article, the authors also state that the findings from the reviewed studies suggest there are many positive health benefits from retreat experiences that includes improvements in both subjective and objective measures… The results from the most rigorous studies that used randomized controlled designs were consistent with less rigorous studies and suggest that retreat experiences can produce benefits that include positive changes in metabolic and neurological pathways, loss of weight, blood pressure and abdominal girth, reduction in health symptoms and improvements in quality of life and subjective wellbeing.

As it happens, we have discussed one of their ‘most rigorous’ RCTs on this blog. Here is what I wrote about it when it was first published:

The ‘study‘ in question allegedly examined the effects of a comprehensive residential mind–body program on well-being. The authors describe it as “a quasi-randomized trial comparing the effects of participation in a 6-day Ayurvedic system of medicine-based comprehensive residential program with a 6-day residential vacation at the same retreat location.” They included 69 healthy women and men who received the Ayurvedic intervention addressing physical and emotional well-being through group meditation and yoga, massage, diet, adaptogenic herbs, lectures, and journaling. Key components of the program include physical cleansing through ingestion of herbs, fiber, and oils that support the body’s natural detoxification pathways and facilitate healthy elimination; two Ayurvedic meals daily (breakfast and lunch) that provide a light plant-based diet; daily Ayurvedic oil massage treatments; and heating treatments through the use of sauna and/or steam. The program includes lectures on Ayurvedic principles and lifestyle as well as lectures on meditation and yoga philosophy. The study group also participated in twice-daily group meditation and daily yoga and practiced breathing exercises (pranayama) as well as emotional expression through a process of journaling and emotional support. During the program, participants received a 1-hour integrative medical consultation with a physician and follow-up with an Ayurvedic health educator.

The control group simply had a vacation without any of the above therapies in the same resort. They were asked to do what they would normally do on a resort vacation with the additional following restrictions: they were asked not to engage in more exercise than they would in their normal lifestyle and to refrain from using La Costa Resort spa services. They were also asked not to drink ginger tea or take Gingko biloba during the 2 days before and during the study week.

Recruitment was via email announcements on the University of California San Diego faculty and staff and Chopra Center for Wellbeing list-servers. Study flyers stated that the week-long Self-Directed Biological Transformation Initiative (SBTI) study would be conducted at the Chopra Center for Wellbeing, located at the La Costa Resort in Carlsbad, California, in order to learn more about the psychosocial and physiologic effects of the 6-day Perfect Health (PH) Program compared with a 6-day stay at the La Costa Resort. The study participants were not blinded, and site investigators and study personnel knew to which group participants were assigned.

Participants in the Ayurvedic program showed significant and sustained increases in ratings of spirituality and gratitude compared with the vacation group, which showed no change. The Ayurvedic participants also showed increased ratings for self-compassion as well as less anxiety at the 1-month follow-up.

The authors arrived at the following conclusion: Findings suggest that a short-term intensive program providing holistic instruction and experience in mind–body healing practices can lead to significant and sustained increases in perceived well-being and that relaxation alone is not enough to improve certain aspects of well-being.

This ‘study’ had ethical approval from the University of California San Diego and was supported by the Fred Foundation, the MCJ Amelior Foundation, the National Philanthropic Trust, the Walton Family Foundation, and the Chopra Foundation. The paper’s first author is director of research at the Chopra Foundation… Just for the record, let me formulate a short conclusion that actually fits the data from this ‘study’: Lots of TLC, attention and empathy does make some people feel better… 

END OF QUOTE FROM MY OWN POST

The subject of health retreats could be relevant and important. Educating people and teaching them the essentials about healthy life-styles is potentially a good thing. It could well turn out that health retreats benefit many individuals, while saving money for society.

Yet, do we need all sorts of quackery for achieving this aim?

No, we don’t!

A rational programme would need to teach and motivate people about diet, weight control, smoking cessation, regular sleep, relaxation, exercise, etc. It could prevent disease and save funds. This approach has existed in Europe long before the US ‘New Agers’ with their flimflam jumped on this bandwagon. Health education is a good idea, but it does not require the use of alternative therapies or luxury retreats.

As it turns out, the new systematic review is a disappointment. It fails to stress that no firm conclusions can be drawn from flimsy data and degenerates into little more than an embarrassing advertisement for Deepak Chopra’s and similar entrepreneurs’ money-making retreats. It totally ignores the sizable body of Non-English literature on the subject, and is focussed on promoting fashionable retreats and wellness centres in the US and Australia.

To be fair to the authors, they almost admit as much when they state: “Competing interests: MC is a board member of the Global Wellness Summit and has previously been a paid presenter at the Gwinganna Health Retreat. RMIT University has received donations from Danubius Hotel Group, Lapinha, Sunswept Resorts, Sheenjoy and The Golden Door for ongoing retreat research.”

I rest my case.

Can conventional therapy (CT) be combined with herbal therapy (CT + H) in the management of Alzheimer’s disease (AD) to the benefit of patients? This was the question investigated by Chinese researchers in a recent retrospective cohort study funded by grants from China Ministry of Education, National Natural Science Foundation of China, Beijing Municipal Science and Technology Commission, and Beijing Municipal Commission of Health and Family Planning.

In total, 344 outpatients diagnosed as probable dementia due to AD were collected, who had received either CT + H or CT alone. The GRAPE formula was prescribed for AD patients after every visit according to TCM theory. It consisted mainly (what does ‘mainly’ mean as a description of a trial intervention?) of Ren shen (Panax ginseng, 10 g/d), Di huang (Rehmannia glutinosa, 30 g/d), Cang pu (Acorus tatarinowii, 10 g/d), Yuan zhi (Polygala tenuifolia, 10 g/d), Yin yanghuo (Epimedium brevicornu, 10 g/d), Shan zhuyu (Cornus officinalis, 10 g/d), Rou congrong (Cistanche deserticola, 10 g/d), Yu jin (Curcuma aromatica, 10 g/d), Dan shen (Salvia miltiorrhiza, 10 g/d), Dang gui (Angelica sinensis, 10 g/d), Tian ma (Gastrodia elata, 10 g/d), and Huang lian (Coptis chinensis, 10 g/d), supplied by Beijing Tcmages Pharmaceutical Co., LTD. Daily dose was taken twice and dissolved in 150 ml hot water each time. Cognitive function was quantified by the mini-mental state examination (MMSE) every 3 months for 24 months.

The results show that most of the patients were initially diagnosed with mild (MMSE = 21-26, n = 177) and moderate (MMSE = 10-20, n = 137) dementia. At 18 months, CT+ H patients scored on average 1.76 (P = 0.002) better than CT patients, and at 24 months, patients scored on average 2.52 (P < 0.001) better. At 24 months, the patients with improved cognitive function (△MMSE ≥ 0) in CT + H was more than CT alone (33.33% vs 7.69%, P = 0.020). Interestingly, patients with mild AD received the most robust benefit from CT + H therapy. The deterioration of the cognitive function was largely prevented at 24 months (ΔMMSE = -0.06), a significant improvement from CT alone (ΔMMSE = -2.66, P = 0.005).

 

The authors concluded that, compared to CT alone, CT + H significantly benefited AD patients. A symptomatic effect of CT + H was more pronounced with time. Cognitive decline was substantially decelerated in patients with moderate severity, while the cognitive function was largely stabilized in patients with mild severity over two years. These results imply that Chinese herbal medicines may provide an alternative and additive treatment for AD.

Conclusions like these render me speechless – well, almost speechless. This was nothing more than a retrospective chart analysis. It is not possible to draw causal conclusions from such data.

Why?

Because of a whole host of reasons. Most crucially, the CT+H patients were almost certainly a different and therefore non-comparable population to the CT patients. This flaw is so elementary that I need to ask, who are the reviewers letting such utter nonsense pass, and which journal would publish such rubbish? In fact, I can be used for teaching students why randomisation is essential, if we aim to find out about cause and effect.

Ahhh, it’s the ! I think the funders, editors, reviewers, and authors of this paper should all go and hide in shame.

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.

  1. So far, I have seen no good evidence that any alternative therapy might be effective in preventing any disease.
  2. Practically everything we know today about disease prevention originates from conventional medicine and science.
  3. 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.

 

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