MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

conflict of interest

A recent blog-post pointed out that the usefulness of yoga in primary care is doubtful. Now we have new data to shed some light on this issue.

The new paper reports a ‘prospective, longitudinal, quasi-experimental study‘. Yoga group (n= 49) underwent 24-weeks program of one-hour yoga sessions. The control group had no yoga.

Participation was voluntary and the enrolment strategy was based on invitations by health professionals and advertising in the community (e.g., local newspaper, health unit website and posters). Users willing to participate were invited to complete a registration form to verify eligibility criteria.

The endpoints of the study were:

  • quality of life,
  • psychological distress,
  • satisfaction level,
  • adherence rate.

The yoga routine consisted of breathing exercises, progressive articular and myofascial warming-up, followed by surya namascar (sun salutation sequence; adapted to the physical condition of each participant), alignment exercises, and postural awareness. Practice also included soft twists of the spine, reversed and balance postures, as well as concentration exercises. During the sessions, the instructor discussed some ethical guidelines of yoga, as for example, non-violence (ahimsa) and truthfulness (satya), to allow the participant to have a safer and integrated practice. In addition, the participants were encouraged to develop their awareness of the present moment and their body sensations, through a continuous process of self-consciousness, keeping a distance between body sensations and the emotional experience. The instructor emphasized the connection between breathing and movement. Each session ended with a guided deep relaxation (yoga nidra; 5–10 min), followed by a meditation practice (5–10 min).

The results of the study showed that the patients in the yoga group experienced a significant improvement in all domains of quality of life and a reduction of psychological distress. Linear regression analysis showed that yoga significantly improved psychological quality of life.

The authors concluded that yoga in primary care is feasible, safe and has a satisfactory adherence, as well as a positive effect on psychological quality of life of participants.

Are the authors’ conclusions correct?

I think not!

Here are some reasons for my judgement:

  • The study was far to small to justify far-reaching conclusions about the safety and effectiveness of yoga.
  • There were relatively high numbers of drop-outs, as seen in the graph above. Despite this fact, no intention to treat analysis was used.
  • There was no randomisation, and therefore the two groups were probably not comparable.
  • Participants of the experimental group chose to have yoga; their expectations thus influenced the outcomes.
  • There was no attempt to control for placebo effects.
  • The conclusion that yoga is safe would require a sample size that is several dimensions larger than 49.

In conclusion, this study fails to show that yoga has any value in primary care.

PS

Oh, I almost forgot: and yoga is also satanic, of course (just like reading Harry Potter!).

 

As you know, I have repeatedly written about integrative cancer therapy (ICT). Yet, to be honest, I was never entirely sure what it really is; it just did not make sense – not until I saw this announcement. It left little doubt about the nature of ICT.

As it is in German, allow me to translate it for you [the numbers added to the text refer to my comments below]:

ICT is a method of treatment that views humans holistically [1]. The approach is characterised by a synergistic application (integration) of all conventional [the actual term used is a derogatory term coined by Hahnemann to denounce the prevailing medicine of his time], immunological, biological and psychological insights [2]. In this spirit, also personal needs and subjective experiences of disease are accounted for [3]. The aim of this special approach is to offer cancer patients an individualised, interdisciplinary treatment [4].

Besides surgery, chemotherapy and radiotherapy, ICT also includes hormone therapy, hyperthermia, pain management, immunotherapy, normalisation of metabolism, stabilisation of the psyche, physical activity, dietary changes, as well as substitution of vital nutrients [5].

With ICT, the newest discoveries of cancer research are being offered [6], that support the aims of ICT. Therefore, the aims of the ICT doctor include continuous research of the world literature on oncology [7]…

Likewise, one has to start immediately with measures that help prevent metastases and tumour progression [8]. Both the maximization of survival and the optimisation of quality of life ought to be guaranteed [9]. Therefore, the alleviation of the side-effects of the aggressive therapies are one of the most important aims of ICT [10]…

HERE IS THE GERMAN ORIGINAL

Die integrative Krebstherapie ist eine Behandlungsmethode, die den Menschen in seiner Ganzheit sieht und sich dafür einsetzt. Ihre Behandlungsweise ist gekennzeichnet durch die synergetische Anwendung (Integration) aller sinnvollen schulmedizinischen, immunologischen, biologischen und psychologischen Erkenntnisse. In diesem Sinne werden auch die persönlichen Bedürfnisse und die subjektiven Krankheitserlebnisse berücksichtigt. Ziel dieser besonderen Therapie ist es, dass dem Krebspatienten eine individuell eingerichtete und interdisziplinär geplante Behandlung angeboten wird.

Zur integrativen Krebstherapie gehört neben der operativen Tumorbeseitigung, Chemotherapie und Strahlentherapie auch die Hormontherapie, Hyperthermie, Schmerzbeseitigung, Immuntherapie, Normalisierung des Stoffwechsels, Stabilisierung der Psyche, körperliche Aktivierung, Umstellung der Ernährung sowie die Ergänzung fehlender lebensnotwendiger Vitalstoffe.

Mit dieser Behandlungsmethode werden auch die neuesten Entdeckungen der Krebsforschung angeboten, die die Ziele der Integrativen Krebstherapie unterstützen. Deshalb sind die ständigen Recherchen der umfangreichen Ergebnisse der Onkologie-Forschung in der medizinischen Weltliteratur auch Aufgabe der Mediziner in der Integrativen Krebstherapie…

Ebenso sollte auch sofort mit den Maßnahmen begonnen werden, die helfen, dieMetastasen Bildung und Tumorprogredienz zu verhindern. Nicht nur die Maximierung des Überlebens, sondern auch die Optimierung der Lebensqualität sollen gewährleistet werden. Deshalb ist auch die Linderung der Nebenwirkungen der aggressiven Behandlungsmethoden eines der wichtigsten Ziele der Integrativen Krebstherapie….

MY COMMENTS

  1. Actually, this describes conventional oncology!
  2. Actually, this describes conventional oncology!
  3. Actually, this describes conventional oncology!
  4. Actually, this describes conventional oncology!
  5. Actually, this describes conventional oncology!
  6. Actually, this describes conventional oncology!
  7. Actually, this describes conventional oncology!
  8. Actually, this describes conventional oncology!
  9. Actually, this describes conventional oncology!
  10. Actually, this describes conventional oncology!

ICT might sound fine to many consumers. I can imagine that it gives confidence to some patients. But it really is nothing other than the adoption of the principles of good conventional cancer care?

No!

But in this case, ICT is just a confidence trick!

It is a confidence trick that allows the trickster to smuggle no end of SCAM into routine cancer care!

Or did I miss something here?

Am I perhaps mistaken?

Please, do tell me!

Excellent journals always publish excellent science!

If this is what you believe, you might want to read a study of chiropractic just published in the highly respected SCIENTIFIC REPORTS.

The objective of this study was to investigate whether a single session of chiropractic care could increase strength in weak plantar flexor muscles in chronic stroke patients. Maximum voluntary contractions (strength) of the plantar flexors, soleus evoked V-waves (cortical drive), and H-reflexes were recorded in 12 chronic stroke patients, with plantar flexor muscle weakness, using a randomized controlled crossover design. Outcomes were assessed pre and post a chiropractic care intervention and a passive movement control. Repeated measures ANOVA was used to asses within and between group differences. Significance was set at p < 0.05. Following the chiropractic care intervention there was a significant increase in strength (F (1,11) = 14.49, p = 0.002; avg 64.2 ± 77.7%) and V-wave/Mmax ratio (F(1,11) = 9.67, p = 0.009; avg 54.0 ± 65.2%) compared to the control intervention. There was a significant strength decrease of 26.4 ± 15.5% (p = 0.001) after the control intervention. There were no other significant differences. Plantar flexor muscle strength increased in chronic stroke patients after a single session of chiropractic care. An increase in V-wave amplitude combined with no significant changes in H-reflex parameters suggests this increased strength is likely modulated at a supraspinal level. Further research is required to investigate the longer term and potential functional effects of chiropractic care in stroke recovery.

In the article we find the following further statements (quotes in bold, followed by my comments in normal print):

  • Data were collected by a team of researchers from the Centre for Chiropractic Research at the New Zealand College of Chiropractic. These researchers can be assumed to be highly motivated in generating a positive finding.
  • The entire spine and both sacroiliac joints were assessed for vertebral subluxations, and chiropractic adjustments were given where deemed necessary, by a New Zealand registered chiropractor. As there is now near-general agreement that such subluxations are a myth, the researchers treated a non-existing entity.
  • The chiropractor did not contact on a segment deemed to be subluxated during the control set-up and no adjustive thrusts were applied during any control intervention. The patients therefore were clearly able to tell the difference between real and control treatmentsParticipants were not checked for blinding success.
  • Maximum isometric plantarflexion force was measured using an isometric strain gauge. Such measurements crucially depend on the motivation of the patient.
  • The grant proposal for this study was reviewed by the Australian Spinal Research Foundation to support facilitation of funding from the United Chiropractic Association. Does this not mean the researchers had a conflict of interest?
  • The authors declare no competing interests. Really? They were ardent subluxationists supported by the United Chiropractic Association, an organisation stating that chiropractic is concerned with the preservation and restoration of health, and focuses particular attention on the subluxation, and subscribes to to the obsolete concept of vitalism: we ascribe to the idea that all living organisms are sustained by an innate intelligence, which is both different from and greater than physical and chemical forces. Further, we believe innate intelligence is an expression of universal intelligence.

So, in essence, what we have here is an under-powered study sponsored by vitalists and conducted by subluxationists treating a mythical entity with dubious interventions without controlling for patients’ expectation pretending their false-positive findings are meaningful.

I cannot help wondering what possessed the SCIENTIFIC REPORTS to publish such poor science.

Did we not have a flurry of systematic reviews of homeopathy in recent months?

And were they not a great disappointment to homeopaths and their patients?

Just as we thought that this is more than enough evidence to show that homeopathy is not effective, here comes another one.

This new review evaluated RCTs of non-individualised homeopathic treatment (NIHT) in which the control group received treatments other than placebo (OTP). Specifically, its aim was to determine the comparative effectiveness of NIHT on health-related outcomes for any given condition.

For each eligible trial, published in the peer-reviewed literature up to the end of 2016, the authors assessed its risk of bias (internal validity) using the seven-domain Cochrane tool, and its relative pragmatic or explanatory attitude (external validity) using the 10-domain PRECIS tool. The researchers grouped RCTs by whether these examined homeopathy as an alternative treatment (study design 1a), adjunctively with another intervention (design 1b), or compared with no intervention (design 2). RCTs were sub-categorised as superiority trials or equivalence/non-inferiority trials. For each RCT, a single ‘main outcome measure’ was selected to use in meta-analysis.

Seventeen RCTs, representing 15 different medical conditions, were eligible for inclusion. Three of the trials were more pragmatic than explanatory, two were more explanatory than pragmatic, and 12 were equally pragmatic and explanatory. Fourteen trials were rated ‘high risk of bias’ overall; the other three trials were rated ‘uncertain risk of bias’ overall. Ten trials had data that were extractable for meta-analysis. Significant heterogeneity undermined the planned meta-analyses or their meaningful interpretation. For the three equivalence or non-inferiority trials with extractable data, the small, non-significant, pooled effect size was consistent with a conclusion that NIHT did not differ from treatment by a comparator (Ginkgo biloba or betahistine) for vertigo or (cromolyn sodium) for seasonal allergic rhinitis.

The authors concluded that the current data preclude a decisive conclusion about the comparative effectiveness of NIHT. Generalisability of findings is restricted by the limited external validity identified overall. The highest intrinsic quality was observed in the equivalence and non-inferiority trials of NIHT.

I do admire the authors’ tenacity in meta-analysing homeopathy trials and empathise with their sadness of the multitude of negative results they thus have to publish. However, I do disagree with their conclusions. In my view, at least two firm conclusions ARE possible:

  1. This dataset confirms yet again that the methodological quality of homeopathy trials is lousy.
  2. The totality of the trial evidence analysed here fails to show that non-individualised homeopathy is effective.

In case you wonder why the authors are not more outspoken about their own findings, perhaps you need to read their statement of conflicts of interest:

Authors RTM, YYYF, PV and AKLT are (or were) associated with a homeopathy organisation whose significant aim is to clarify and extend an evidence base in homeopathy. RTM holds an independent research consultancy contract with the Deutsche Homöopathie-Union, Karlsruhe, Germany. YYYF and AKLT belong to Living Homeopathy Ltd., which has contributed funding to some (but not this current) HRI project work. RTM and PV have no other relationships or activities that could appear to have influenced the submitted work. JRTD had no support from any organisation for the submitted work; in the last 3 years, and for activities outside the submitted study, he received personal fees, royalties or out-of-pocket expenses for advisory work, invitational lectures, use of rating scales, published book chapters or committee membership; he receives royalties from Springer Publishing Company for his book, A Century of Homeopaths: Their Influence on Medicine and Health. JTRD has no other relationships or activities that could appear to have influenced the submitted study.

If one had wanted to add insult to injury, one could have added that, if, despite such conflicts of interest, the overall result of this new review turned out to be not positive, the evidence must be truly negative.

Simply put, in the realm of SCAM, we seem to have two types of people:

  1. those who don’t care a hoot about evidence;
  2. those who try their best to follow the evidence.

The first group is replete with SCAM enthusiasts who make their decisions based purely on habit, emotion, intuition etc. They are beyond my reach, I fear. It is almost exclusively the second group for whom I write this blog.

And that could be relatively easy, if the evidence were always accessible, understandable, straight forward, conclusive and convincing. But sadly, in SCAM (as in most other areas of healthcare), the evidence is full of apparent and real contradictions. In this situation, it is often difficult even for experts to understand what is going on; for lay people this must be immeasurably more confusing. Yet, it is the lay consumers who often will take the decision to use or not use this or that SCAM. They therefore need our help.

What can consumers do when they are confronted with contradictory evidence?

How can they distinguish right from wrong?

  • Some articles claim that homeopathy works – others say it is just a placebo therapy.
  • Some experts claim that chiropractic is safe – others say it can do serious harm.
  • Some articles claim that SCAM-practitioners are competent – others say this is not true.
  • Some experts claim that SCAM is the future – others stress that it is obsolete.

What can a lay person with no or very little understanding of science do to see through this fog of contradictions?

Let me try to provide consumers with a step by step approach to get closer to the truth by asking a few incisive questions:

  1. WHERE DID YOU READ THE CLAIM? If it was in a newspaper, magazine, website, etc. take it with a pinch of salt (double the dose of salt, if it’s from the Daily Mail).
  2. CAN YOU RETRACE THE CLAIM TO A SCIENTIFIC PAPER? This might challenge you skills as a detective, but it is always well-worth finding the original source of a therapeutic claim in order to judge its credibility. If no good source can be found, I advise caution.
  3. IN WHICH MEDICAL JOURNAL WAS THE CLAIM PUBLISHED? Be aware of the fact that there are dozens of SCAM-journals that would publish virtually any rubbish.
  4. WHO ARE THE AUTHORS OF THE SCIENTIFIC PAPER? It might be difficult for a lay person to evaluate their credibility. But there might be certain pointers; for instance, authors affiliated to a university tend to be more credible than SCAM-practitioners who have no such affiliations or authors working for a lobby-group.
  5. WHAT SORT OF ARTICLE IS THE ORIGINAL SOURCE OF THE CLAIM? Is it a proper experimental study or a mere opinion piece? If possible, try to find a good-quality (perhaps even a Cochrane) review on the subject.
  6. ARE THERE OTHER RESEARCHERS WHO HAVE ARRIVED AT SIMILAR CONCLUSIONS? If the claim is based on just one solitary piece of research or opinion, it clearly weighs less than a consensus of experts.
  7. DO PUBLICATIONS EXIST THAT DISAGREE WITH THE CLAIM? Even if there are several scientific papers from different teams of researchers supporting the claim, it is important to find out whether the claim is shared by all experts in the field.

Eventually, you might get a good impression about the veracity of the claim. But sometimes you also might end up with a bunch of systematic reviews of which several support, while others reject the claim. And all of them could look similarly credible to your untrained eyes. Does that mean your attempt to find the truth of the matter has been frustrated?

Not necessarily!

In this case, you would probably consider the following options:

  1. You could do a simple ‘pea count’; this would tell you whether the majority of reviews is pro or contra the claim. However, this might be your worst bet for arriving at a sound conclusion. The quantity of the evidence usually is far less important than its quality.
  2. If you have no training to judge the quality of a review, you might just go with the most recent and up-to-date review. This, however, would also be fraught with problems, as you can, of course, not be sure that the most recent one is also the least biased assessment.
  3. Perhaps you can somehow get an impression about the respectability of the source. If, for instance, there is a recent Cochrane review, I advise to go with that one.
  4. Look up the profession of the authors of the review. The pope is unlikely to condemn Catholicism; likewise, you will find very few homeopaths who are critical of homeopathy, or chiropractors who are critical of chiropractic, etc. I know this is a very crude ‘last resort’ for replacing an authorative evaluation of the claim. But, if that’s all you have, it is better than nothing. Ask yourself who can normally be trusted more, the SCAM-practitioner or lobbyist who makes a living from the claim or an independent academic who has no such conflict of interest?

If all of this does not help you to decide whether a therapeutic claim is trustworthy or not, my advice has always been to reflect on this: IF IT SOUNDS TOO GOOD TO BE TRUE, IT PROBABLY IS.

 

 

In 2004, my team published a review analysing the diversity of so-called alternative medicine (SCAM) research published in one single year (2002) across 7 European countries (Germany, United Kingdom, Italy, France, Spain, Netherlands, Belgium) and the US. In total 652 abstracts of articles were assessed. Germany and the UK were the only two European countries to publish in excess of 100 articles in that year (Germany: 137, UK: 183). The majority of articles were non-systematic reviews and comments, analytical studies and surveys. The UK carried out more surveys than any of the other countries and also published the largest number of systematic reviews. Germany, the UK and the US covered the widest range of interests across various SCAM modalities and investigated the safety of CAM. We concluded that important national differences exist in terms of the nature of SCAM research. This raises important questions regarding the reasons for such differences.

One striking difference was the fact that, compared to the UK, Germany had published far less research on SCAM that failed to report a positive result (4% versus 14%). Ever since, I have wondered why. Perhaps it has something to do with the biggest sponsor of SCAM research in Germany: THE CARSTENS STIFTUNG?

The Carstens Foundation (CF) was created by the former German President, Prof. Dr. Karl Carstens and his wife, Dr. Veronica Carstens. Karl Carstens (1914-1992) was the 5th President of federal Germany, from 1979 to 1984. Veronica Carstens (1923-2012) was a doctor of Internal Medicine with an interest in natural medicine and homeopathy in particular. She is quoted by the CF stating: „Der Arzt und die Ärztin der Zukunft sollen zwei Sprachen sprechen, die der Schulmedizin und die der Naturheilkunde und Homöopathie. Sie sollen im Einzelfall entscheiden können, welche Methode die besten Heilungschancen für den Patienten bietet.“ (Future doctors should speak two languages, that of ‘school medicine’ [Hahnemann’s derogatory term for conventional medicine] and that of naturopathy and homeopathy. They should be able to decide on a case by case basis which method offers the best chances of a cure for the patient.***)

Together, the two Carstens created the CF with the goal of sponsoring SCAM in Germany. More than 35 million € have so far been spent on more than 100 projects, fellowships, dissertations, an own publishing house, and a patient societyNatur und Medizin” (currently ~23 000 members) with the task of promoting SCAM. Projects the CF proudly list as their ‘milestones’ include: 

  • an outpatient clinic of natural medicine for cancer
  • a project ‘Natural medicine and homeopathy for children and adolescents’.

The primary focus of the CF clearly is homeopathy, and it is in this area where their anti-science bias gets most obvious. I do invite everyone who reads German to have a look at their website and be amazed at the plethora of misleading claims.

Their expert for all things homeopathic is Dr Jens Behnke (‘Referent für Homöopathieforschung bei der Karl und Veronica Carstens-Stiftung: Evidenzbasierte Medizin, CAM, klinische Forschung, Grundlagenforschung’). He is not a medical doctor but has a doctorate from the ‘Kulturwissenschaftlichen Fakultät der Europa-Universität Viadrina’ entitled ‘Wissenschaft und Weltanschauung. Eine epistemologische Analyse des Paradigmenstreits in der Homöopathieforschung’ (Science and world view. An epistemological analysis of the paradigm-quarrel in homeopathy research). His supervisor was Prof Harald Walach who has long been close to the CF.

Behnke claims to be an expert in EBM, clinical research and basic research but, intriguingly, he has not a single Medline-listed publication to his name. So, we only have his dissertation to assess his expertise.

The very 1st sentence of his dissertation is noteworthy, in my view: Die Homöopathie ist eine Therapiemethode, die seit mehr als 200 Jahren praktiziert wird und eine beträchtliche Zahl an Heilungserfolgen vorzuweisen hat (Homeopathy is a therapeutic method, that is being used since more than 200 years and which is supported by a remarkable number of therapeutic successes). In essence, the dissertation dismisses the scientific approach for evaluating homeopathy as well as the current best evidence that shows homeopathy to be ineffective.

Behnke dismisses my own research on homeopathy without even considering it. He first claims to have found an error in one of my systematic reviews and then states: Die Fragwürdigkeit der oben angeführten Methoden rechtfertigt das Übergehen sämtlicher Publikationen dieses Autors im Rahmen dieser Arbeit. Wenn einem Wissenschaftler die aufgezeigte absichtliche Falschdarstellung aufgrund von Voreingenommenheit nachgewiesen werden kann, sind seine Ergebnisse, wenn überhaupt, nur nach vorheriger systematischer Überprüfung sämtlicher Originalpublikationen und Daten, auf die sie sich beziehen, verwertbar. Essentially, he claims that, because he has found one error, the rest cannot be trusted and therefore he is entitled to reject the lot.

In the same dissertation, we read the following: Ernst konstatiert in allen … Arbeiten zur Homöopathie ausnahmslos, dass es keinerlei belastbare Hinweise auf eine Wirksamkeit homöopathischer Arzneimittel über Placeboeffekte hinaus gebe (Ernst states in all publications on homeopathy without exception that no solid suggestions exist at all for an effectiveness of homeopathic remedies). However, it is demonstrably wrong that all of my papers arrive at a negative judgement of homeopathy’s effectiveness; here are three that spring into my mind:

So, applying Behnke’s own logic outlined above, one should argue that, because I have found one error in his research, the rest of what Behnke will (perhaps one day be able to) publish cannot be trusted and therefore I am entitled to reject the lot.

That would, of course, be tantamount to adopting the stupidity of one’s own opponents. So, I will certainly not do that; instead, I will wait patiently for the sound science that Dr Behnke (and indeed the CF) might eventually produce.

 

***phraseology that is strikingly similar to that of Rudolf Hess on the same subject.

The Journal of Experimental Therapeutics and Oncology states that it is devoted to the rapid publication of innovative preclinical investigations on therapeutic agents against cancer and pertinent findings of experimental and clinical oncology. In the journal you will find review articles, original articles, and short communications on all areas of cancer research, including but not limited to preclinical experimental therapeutics; anticancer drug development; cancer biochemistry; biotechnology; carcinogenesis; cancer cytogenetics; clinical oncology; cytokine biology; epidemiology; molecular biology; pathology; pharmacology; tumor cell biology; and experimental oncology.

After reading an article entitled ‘How homeopathic medicine works in cancer treatment: deep insight from clinical to experimental studies’ in its latest issue, I doubt that the journal is devoted to anything.

Here is the abstract:

In the current scenario of medical sciences, homeopathy, the most popular system of therapy, is recognized as one of the components of complementary and alternative medicine (CAM) across the world. Despite, a long debate is continuing whether homeopathy is just a placebo or more than it, homeopathy has been considered to be safe and cost-effectiveness therapeutic modality. A number of human ailments ranging from common to serious have been treated with homeopathy. However, selection of appropriate medicines against a disease is cumbersome task as total spectrum of symptoms of a patient guides this process. Available data suggest that homeopathy has potency not only to treat various types of cancers but also to reduce the side effects caused by standard therapeutic modalities like chemotherapy, radiotherapy or surgery. Although homeopathy has been widely used for management of cancers, its efficacy is still under question. In the present review, the anti-cancer effect of various homeopathic drugs against different kinds of cancers has been discussed and future course of action has also been suggested.

I do wonder what possessed the reviewers of this paper and the editors of the journal to allow such dangerous (and badly written) rubbish to get published. Do they not know that:

  1. homeopathy is a placebo therapy,
  2. homeopathy can not cure any cancer,
  3. cancer patients are highly vulnerable to false hope,
  4. such an article endangers the lives of many cancer patients,
  5. they have an ethical, moral and possibly legal duty to prevent such mistakes?

What makes this paper even more upsetting is the fact that one of its authors is affiliated with the Department of Health Research, Ministry of Health and Family Welfare, Government of India.

Family welfare my foot!

This certainly is one of the worst violations of healthcare and publication ethic that I have come across for a long time.

 

Highly diluted homeopathic remedies are pure placebos! This is what the best evidence clearly shows. Ergo they cannot be shown in a rigorous study to have effects that differ from placebo.  But now there is a study that seems to contradict this widely accepted conclusion.

Can someone please help me to understand what is going on?

In this double-blind, placebo-controlled RCT, 60 patients suffering from insomnia were treated either individualised homeopathy (IH) or placebo for 3 months. Patient-administered sleep diary and Insomnia Severity Index (ISI) were used the primary and secondary outcomes respectively, measured at baseline, and after 3 months.

Five patients dropped out (verum:2,control:3).Intention to treat sample (n=60) was analysed. Trial arms were comparable at baseline. In the verum group, except sleep diary item 3 (P= 0.371), rest of the outcomes improved significantly (all P < 0.01). In the control group, there were significant improvements in diary item 6 and ISI score (P < 0.01) and just significant improvement in item 5 (P= 0.018). Group differences were significant for items 4, 5 and 6(P < 0.01) and just significant (P= 0.014) for ISI score with moderate to large effect sizes; but non-significant (P > 0.01) for rest of the outcomes.

The authors concluded that in this double-blind, randomized, prospective, placebo-controlled, two parallel arms clinical trial conducted on 60 patients suffering from insomnia, there was statistically significant difference measured in sleep efficiency, total sleep time, time in bed, and ISI score in favour of homeopathy over placebo with moderate to large effect sizes. Group differences were non-significant for rest of the outcomes(i.e. latency to fall asleep, minutes awake in middle of night and minutes awake too early). Individualized homeopathy seemed to produce significantly better effect than placebo. Independent replications and adequately powered trials with enhanced methodological rigor are warranted.

I have studied this article in some detail; its methodology is nicely and fully described in the original paper. To my amazement, I cannot find a flaw that is worth mentioning. Sure, the sample was small, the treatment time short, the outcome measure subjective, the paper comes from a dubious journal, the authors have a clear conflict of interest, even though they deny it – but none of these limitations has the potential to conclusively explain the positive result.

In view of what I stated above and considering what the clinical evidence so far tells us, this is most puzzling.

A 2010 systematic review authored by proponents of homeopathy  included 4 RCTs comparing homeopathic medicines to placebo. All involved small patient numbers and were of low methodological quality. None demonstrated a statistically significant difference in outcomes between groups.

My own 2011 not Medline-listed review (Focus on Alternative and Complementary Therapies Volume 16(3) September 2011 195–199) included several additional studies. Here is its abstract:

The aim of this review was the critical evaluation of evidence for the effectiveness of homeopathy for insomnia and sleep-related disorders. A search of MEDLINE, AMED, CINAHL, EMBASE and Cochrane Central Register was conducted to find RCTs using any form of homeopathy for the treatment of insomnia or sleep-related disorders. Data were extracted according to pre-defined criteria; risk of bias was assessed using Cochrane criteria. Six randomised, placebo-controlled trials met the inclusion criteria. Two studies used individualised homeopathy, and four used standardised homeopathic treatment. All studies had significant flaws; small sample size was the most prevalent limitation. The results of one study suggested that homeopathic remedies were superior to placebo; however, five trials found no significant differences between homeopathy and placebo for any of the main outcomes. Evidence from RCTs does not show homeopathy to be an effective treatment for insomnia and sleep-related disorders.

It follows that the new trial contradicts previously published evidence. In addition, it clearly lacks plausibility, as the remedies used were highly diluted and therefore should be pure placebos. So, what could be the explanation of the new, positive result?

As far as I can see, there are the following possibilities:

  • fraud,
  • coincidence,
  • some undetected/undisclosed bias,
  • homeopathy works after all.

I would be most grateful, if someone could help solving this puzzle for me (if needed, I can send you the full text of the new article for assessment).

If so-called alternative medicine (SCAM) ever were to enter the Guinness Book of Records, it would most certainly be because it generates more surveys than any other area of medical inquiry. I have long been rather sceptical about this survey-mania. Therefore, I greet any major new survey with some trepidation.

The aim of this new survey was to obtain up-to-date general population figures for practitioner-led SCAM use in England, and to discover people’s views and experiences regarding access. The researchers commissioned a face-to-face questionnaire survey of a nationally representative adult quota sample (aged ≥15 years). Ten questions were included within Ipsos MORI’s weekly population-based survey. The questions explored 12-month practitioner-led SCAM use, reasons for non-use, views on NHS-provided SCAM, and willingness to pay.

Of 4862 adults surveyed, 766 (16%) had seen a SCAM practitioner. People most commonly visited SCAM practitioners for manual therapies (massage, osteopathy, chiropractic) and acupuncture, as well as yoga, pilates, reflexology, and mindfulness or meditation. Women, people with higher socioeconomic status (SES) and those in south England were more likely to access SCAM. Musculoskeletal conditions (mainly back pain) accounted for 68% of use, and mental health 12%. Most was through self-referral (70%) and self-financing. GPs (17%) or NHS professionals (4%) referred and/or recommended SCAM to users. These SCAM users were more often unemployed, with lower income and social grade, and receiving NHS-funded SCAM. Responders were willing to pay varying amounts for SCAM; 22% would not pay anything. Almost two in five responders felt NHS funding and GP referral and/or endorsement would increase their SCAM use.

The authors concluded that SCAM is commonly used in England, particularly for musculoskeletal and mental health problems, and by affluent groups paying privately. However, less well-off people are also being GP-referred for NHS-funded treatments. For SCAM with evidence of effectiveness (and cost-effectiveness), those of lower SES may be unable to access potentially useful interventions, and access via GPs may be able to address this inequality. Researchers, patients, and commissioners should collaborate to research the effectiveness and cost-effectiveness of SCAM, and consider its availability on the NHS.

I feel that a few critical thoughts are in order:

  1. The authors call their survey an ‘up-date’. The survey ran between 25 September and 18 October 2015. That is more than three years ago. I would not exactly call this an up-date!
  2. Authors (several of whom are known SCAM-enthusiasts) also state that practitioner-led SCAM use was about 5% higher than previous national (UK and England) surveys. This may relate to the authors’ wider SCAM definition, which included 11 more therapies than Hunt et al (a survey from my team), or increased SCAM use since 2005. Despite this uncertainty, the authors write this: Figures from 2005 reported that 12% of the English population used practitioner-led CAM. This 2015 survey has found that 16% of the general population had used practitioner-led CAM in the previous 12 months. Thus, they imply that SCAM-use has been increasing.
  3. The main justification for running yet another survey presumably was to determine whether SCAM-use has increased, decreased or remained the same (virtually everything else found in the new survey had been shown many times before). To not answer this main question conclusively by asking the same questions as a previous survey is just daft, in my view. We have used the same survey methods at two points one decade apart and found little evidence for an increase, on the contrary: overall, GPs were less likely to endorse CAMs than previously shown (38% versus 19%).
  4. The main reason why I have long been critical about such surveys is the manner in which their data get interpreted. The present paper is no exception in this respect. Invariably the data show that SCAM is used by those who can afford it. This points to INEQUALITY that needs to be addressed by allowing much more SCAM on the public purse. In other words, such surveys are little more that very expensive and somewhat under-hand promotion of quackery.
  5. Yes, I know, the present authors are more clever than that; they want the funds limited to SCAM with evidence of effectiveness and cost-effectiveness. So, why do they not list those SCAMs together with the evidence for effectiveness and cost-effectiveness? This would enable us to check the validity of the claim that more public money should fund SCAM. I think I know why: such SCAMs do not exist or, at lest, they are extremely rare.

But otherwise the new survey was excellent.

 

The PGIH (currently chaired by the Tory MP David Tredinnick) was founded in 1992 (in the mid 1990, they once invited me to give a lecture which I did with pleasure). Its overriding aim is to bring about improvements in patient care. The PGIH have conducted a consultation that involved 113 SCAM-organisations and other stakeholders. The new PGIH-report is based on their feedback and makes 14 recommendations. They are all worth studying but, to keep this post concise, I have selected the three that fascinated me most:

Evidence Base and Research

NICE guidelines are too narrow and do not fit well with models of care such as complementary, traditional and natural therapies, and should incorporate qualitative evidence and patient outcomes measures as well as RCT evidence. Complementary, traditional and natural healthcare associations should take steps to educate and advise their members on the use of Measure Yourself Medical Outcome Profiles (MYMOP), and patient outcome measures should be collated by an independent central resource to identify for what conditions patients are seeking treatment, and with what outcomes.

Cancer Care

Every cancer patient and their families should be offered complementary therapies as part of their treatment package to support them in their cancer journey. Cancer centres and hospices providing access to complementary therapies should be encouraged to make wider use of Measure Yourself Concerns and Wellbeing (MYCaW) to evaluate the benefits gained by patients using complementary therapies in cancer support care. Co-ordinated research needs to be carried out, both clinical trials and qualitative studies, on a range of complementary, traditional and natural therapies used in cancer care support.

Cost Savings

The government should run NHS pilot projects which look at non-conventional ways of treating patients with long-term and chronic conditions affected by Effectiveness Gaps, such as stress, arthritis, asthma and musculoskeletal problems, and audit these results against conventional treatment options for these conditions to determine whether cost savings and better patient outcomes could be achieved.

END OF QUOTE

Here are a few brief comments on those three recommendations.

Evidence base and research

NICE guidelines are based on rigorous assessments of efficacy, safety and costs. Such evaluations are possible for all interventions, including SCAM. Qualitative data are useless for this purpose. Outcome measures like the MYMOP are measures that can and are used in clinical trials. To use them outside clinical trials would not provide any relevant information about the specific effects of SCAM because this cannot account for confounding factors like the natural history of the disease, regression towards the mean, etc. The entire paragraph disclosed a remarkable level of naivety and ignorance about research on behalf of the PGIH.

Cancer care

There is already a significant amount of research on SCAM for cancer (see for instance here). It shows that no SCAM is effective in curing any form of cancer, and that only very few SCAMs can effectively improve the quality of life of cancer patients. Considering these facts, the wholesale recommendation of offering SCAM to cancer patients can only be characterised as dangerous quackery.

Cost savings

Such a pilot project has already been conducted at the behest of Price Charles (see here). Its results show that flimsy research will generate flimsy findings. If anything, a rigorous trial would be needed to test whether more SCAM on the NHS saves or costs money. The data currently available suggests that the latter is the case (see also here, here, here, here, etc.).

Altogether, one gets the impression that the PGIH need to brush up on their science and knowledge (if they invite me, I’d be delighted to give them another lecture). As it stands, it seems unlikely that their approach will, in fact, bring about improvements in patient care.

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