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

conflict of interest

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One of the favourite arguments of proponents of so-called alternative medicine (SCAM) is that conventional medicine is amongst the world’s biggest killers. The argument is used cleverly to discredit conventional medicine and promote SCAM. It has been shown to be wrong many times, but it nevertheless is much-loved by SCAM enthusiasts and thus refuses to disappear. Perhaps this new and important review might help instilling some realism into this endless discussion? Here is its abstract:

Objective To systematically quantify the prevalence, severity, and nature of preventable patient harm across a range of medical settings globally.

Design Systematic review and meta-analysis.

Data sources Medline, PubMed, PsycINFO, Cinahl and Embase, WHOLIS, Google Scholar, and SIGLE from January 2000 to January 2019. The reference lists of eligible studies and other relevant systematic reviews were also searched.

Review methods Observational studies reporting preventable patient harm in medical care. The core outcomes were the prevalence, severity, and types of preventable patient harm reported as percentages and their 95% confidence intervals. Data extraction and critical appraisal were undertaken by two reviewers working independently. Random effects meta-analysis was employed followed by univariable and multivariable meta regression. Heterogeneity was quantified by using the I2 statistic, and publication bias was evaluated.

Results Of the 7313 records identified, 70 studies involving 337 025 patients were included in the meta-analysis. The pooled prevalence for preventable patient harm was 6% (95% confidence interval 5% to 7%). A pooled proportion of 12% (9% to 15%) of preventable patient harm was severe or led to death. Incidents related to drugs (25%, 95% confidence interval 16% to 34%) and other treatments (24%, 21% to 30%) accounted for the largest proportion of preventable patient harm. Compared with general hospitals (where most evidence originated), preventable patient harm was more prevalent in advanced specialties (intensive care or surgery; regression coefficient b=0.07, 95% confidence interval 0.04 to 0.10).

Conclusions Around one in 20 patients are exposed to preventable harm in medical care. Although a focus on preventable patient harm has been encouraged by the international patient safety policy agenda, there are limited quality improvement practices specifically targeting incidents of preventable patient harm rather than overall patient harm (preventable and non-preventable). Developing and implementing evidence-based mitigation strategies specifically targeting preventable patient harm could lead to major service quality improvements in medical care which could also be more cost effective.

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One in 20 patients is undoubtedly an unacceptably high proportion, but it is nowhere close to some of the extraordinarily alarming claims by SCAM enthusiasts. And, as I try regularly to remind people, the harm must be viewed in relation to the benefit. For the vast majority of conventional treatments, the benefits outweigh the risks. But, if there is no benefit at all – as with some form of SCAM – a risk/benefit balance can never be positive. Moreover, many experts work hard and do their very best to improve the risk/benefit balance of conventional healthcare by educating clinicians, maximising the benefits, minimising the risks, and filling the gaps in our current knowledge. Do equivalent activities exist in SCAM? The answer is VERY FEW?

I have to admit, I do not often read the ‘Aargauer Zeitung’. But perhaps I should? Certainly this article from yesterday’s issue is most interesting.

It reported that the University of Basel will soon have a new chair. Apparently, the move has created a fiercely controversial debate within the university. But the decision to go ahead with the plan has been made, and Carsten Gründemann has been formally invited to become the new professor for «translationale Komplementärmedizin». (I am sure in Basel they know what «translationale Komplementärmedizin» is, however, I don’t.)

As it turns out, the term seems entirely irrelevant, because the chair will be in anthroposophical medicine. In case you are not familiar with this SCAM, here is a short explanation copied from my new book:

Anthroposophic medicine is a form of healthcare developed in the 1920s by Rudolf Steiner (1861–1925) in collaboration with the physician Ita Wegman (1876–1943). It is based on Steiner’s mystical ideas of anthroposophy. Steiner had developed his ‘philosophy’ of anthroposophy from personal experiences, occult notions and mystical concepts. Ita Wegman studied medicine after having met Steiner in 1902. She pioneered an ‘alternative cancer treatment’ with a fermented mistletoe extract, according to Steiner’s ideas. Together, Wegman and Steiner wrote Steiner’s last book entitled ‘Extending Practical Medicine’ which was meant as a theoretical basis for their anthroposophical medicine. Wegman was also a co-founder of the pharmaceutical firm ‘Weleda’ which became the biggest producer of anthroposophical remedies. Proponents of anthroposophic medicine make several irrational assumptions, for instance, they claim that our past lives influence our present health, or that the course of an illness is determined by our ‘karmic’ destiny. Practitioners of anthroposophic medicine are usually medically trained; they employ a variety of treatments including massage, exercise, counselling, and a range of remedies (more than 1 300 different anthroposophic medicinal products are currently on the market). Most of the remedies are, like homeopathic remedies, highly diluted but they are not normally prescribed according to the ‘like cures like’ principle and are therefore distinct from homeopathy.

The report mentions that the creation of the new chair caused wide-spread anger amongst the science-based faculties at Basel. The head of Pharmacy, Christoph Meier, is quoted stating: «Indem die Professur in den Forschungsbetrieb eingebunden wird, bieten wir keine Hand zur Scharlatanerie.» [As the professorship will be tied into research, we offer no opportunity for quackery.]

Carsten Gründemann studied Biochemistry/Biology at the University of Tübingen and Freiburg (Germany) and received his Ph.D. in Experimental Immunology from the University of Tübingen (Germany). He was awarded the Karl und Veronica Carstens (KVC) Science Award 2018 for his research in the field of complementary medicine for multiple sclerosis (MS). He is currently based at the Center for Complementary Medicine, Institute for Environmental Health Sciences, University Medical Center Freiburg. Much of his past research seems to focus on anthroposophical medicines, including those produced by Weleda, the world’s largest manufacturer of anthroposophical preparations. Here is one of his 32 Medline-listed abstracts:

BACKGROUND:

Preparations from anthroposophical medicine (AM) are clinically used to treat inflammatory disorders. We wanted to investigate effects of a selection of AM medications for parenteral use in cell-based systems in vitro.

METHODS:

Colchicum officinale tuber D3, Mandragora D3, Rosmarinus officinale 5% and Bryophyllum 5% were selected for the experiments. Induction of apoptosis and necrosis (human lymphocytes and dendritic cells [DCs]) and proliferation of lymphocytes as well as maturation (expression of CD14, CD83 and CD86) and cytokine secretion (IL-10, IL12p70) of DCs were analyzed. Furthermore, proliferation of allogeneic human T lymphocytes was investigated in vitro in coculture experiments using mature DCs in comparison to controls.

RESULTS:

The respective preparations did not induce apoptosis or necrosis in lymphocytes or DCs. Lymphocyte proliferation was dose-dependently reduced by Colchicum officinale tuber D3 while the viability was unchanged. Rosmarinus officinale 5%, but not the other preparations, dose-dependently inhibited the maturation of immature DCs, reduced secretion of IL-10 and IL-12p70 and slightly inhibited proliferation of allogeneic CD4(+) T-lymphocytes in coculture experiments with DCs.

CONCLUSION:

The selected preparations from AM for parenteral use are nontoxic to lymphocytes and DCs. Rosmarinus officinale 5% has immunosuppressive properties on key functions of the immune system which propose further investigation.

The new chair is contractually bound to adhere to the ‘anthroposophical model’ (which probably is a synonym for ‘Steiner cult’). It will be financed to the tune of 3 million Swiss Franks, money that comes from the ‘Software AG Stiftung‘, Weleda, Beatrice Oeri, and other anthroposophical institutions.

George Vithoulkas, has been mentioned on this blog repeatedly. He is a lay homeopath – one that has no medical background – and has, over the years, become an undisputed hero within the world of homeopathy. Yet, Vithoulkas’ contribution to homeopathy research is perilously close to zero. Judging from a recent article in which he outlines the rules of rigorous research, his understanding of research methodology is even closer to zero. Here is a crucial excerpt from this paper intercepted by a few comment from me in brackets and bold print.

Which are [the] homoeopathic principles to be respected [in clinical trials and meta-analyses]?

1. Homoeopathy does not treat diseases, but only diseased individuals. Therefore, every case may need a different remedy although the individuals may be suffering from the same pathology. This rule was violated by almost all the trials in most meta-analyses. (This statement is demonstrably false; there even has been a meta-analysis of 32 trials that respect this demand)

2. In the homoeopathic treatment of serious chronic pathology, if the remedy is correct usually a strong initial aggravation takes place []. Such an aggravation may last from a few hours to a few weeks and even then we may have a syndrome-shift and not the therapeutic results expected. If the measurements take place in the aggravation period, the outcome will be classified negative. (Homeopathic aggravations exist only in the mind of homeopaths; our systematic review failed to find proof for their existence.)

This factor was also ignored in most trials []. At least sufficient time should be given in the design of the trial, in order to account for the aggravation period. The contrary happened in a recent study [], where the aggravation period was evaluated as a negative sign and the homoeopathic group was pronounced worse than the placebo []. (There are plenty of trials where the follow-up period is long enough to account for this [non-existing] phenomenon.)

3. In severe chronic conditions, the homoeopath may need to correctly prescribe a series of remedies before the improvement is apparent. Such a second or third prescription should take place only after evaluating the effects of the previous remedies []. Again, this rule has also been ignored in most studies. (Again, this is demonstrably wrong; there are many trials where the homeopath was able to adjust his/her prescription according to the clinical response of the patient.)

4. As the prognosis of a chronic condition and the length of time after which any amelioration set in may differ from one to another case [], the treatment and the study-design respectively should take into consideration the length of time the disease was active and also the severity of the case. (This would mean that conditions that have a short history, like post-operative ileus, bruising after injury, common cold, etc. should respond well after merely a short treatment with homeopathics. As this is not so, Vithoulkas’ argument seems to be invalid.)

5. In our experience, Homeopathy has its best results in the beginning stages of chronic diseases, where it might be possible to prevent the further development of the chronic state and this is its most important contribution. Examples of pathologies to be included in such RCTs trials are ulcerative colitis, sinusitis, asthma, allergic conditions, eczema, gangrene rheumatoid arthritis as long as they are within the first six months of their appearance. (Why then is there a lack of evidence that any of the named conditions respond to homeopathy?)

In conclusion, three points should be taken into consideration relating to trials that attempt to evaluate the effectiveness of homoeopathy.

First, it is imperative that from the point of view of homoeopathy, the above-mentioned principles should be discussed with expert homoeopaths before researchers undertake the design of any homoeopathic protocol. (I am not aware of any trial where this was NOT done!)

Second, it would be helpful if medical journals invited more knowledgeable peer-reviewers who understand the principles of homoeopathy. (I am not aware of any trial where this was NOT done!)

Third, there is a need for at least one standardized protocol for clinical trials that will respect not only the state-of-the-art parameters from conventional medicine but also the homoeopathic principles []. (Any standardised protocol would be severely criticised; a good study protocol must always take account of the specific research question and therefore cannot be standardised.)

Fourth, experience so far has shown that the therapeutic results in homeopathy vary according to the expertise of the practitioner. Therefore, if the objective is to validate the homeopathic therapeutic modality, the organizers of the trial have to pick the best possible prescribers existing in the field. (I am not aware of any trial where this was NOT done!)

Only when these points are transposed and put into practice, the trials will be respected and accepted by both homoeopathic practitioners and conventional medicine and can be eligible for meta-analysis.

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I suspect what the ‘GREAT VITHOULKAS’ really wanted to express are ‘THE TWO ESSENTIAL PRINCIPLES OF HOMEOPATHY RESEARCH’:

  1. A well-designed study of homeopathy can always be recognised by its positive result.
  2. Any trial that fails to yield a positive finding is, by definition, wrongly designed.

In Switzerland, so-called alternative medicine (SCAM) is officially recognised within the healthcare system and mainly practised in conjunction with conventional medicine. So far no research has been published into the attitude towards, training in and offer of SCAM among paediatricians in Switzerland. This survey addresses this gap by investigating these topics with an online survey of paediatricians in Switzerland.

It employed a 19-item, self-reporting questionnaire among all ordinary and junior members of the Swiss Society of Paediatrics (SSP). A comparison of the study sample with the population of all paediatricians registered with the Swiss Medical Association (FMH) allowed an assessment of the survey’s representativeness. The data analysis was performed on the overall group level as well as for predefined subgroups (e.g. sex, age, language, workplace and professional experience).

A total of 1890 paediatricians were approached and 640, from all parts of Switzerland, responded to the survey (response rate 34%). Two thirds of respondents were female, were aged between 35 and 55 years, trained as paediatric generalist and worked in a practice. Apart from young paediatricians in training, the study sample was representative of all Swiss paediatricians.

According to the authors’ statistics, the results suggest that

  • 23% had attended training in SCAM, most frequently in phytotherapy, homeopathy, acupuncture/traditional Chinese medicine (TCM) and anthroposophic medicine
  • 8% had a federal certificate in one or more SCAM methods.
  • 44% did not routinely ask their patients about their use of SCAM.
  • 84% did not offer SCAM.
  • 65% were interested in SCAM courses and training.
  • 16% provided SCAM services to their patients.
  • 97% were asked by patients/parents about SCAM therapies.
  • More than half of the responding paediatricians use SCAM for themselves or their families.
  • 42% were willing to contribute to paediatric SCAM research.

The authors concluded that in a representative sample of paediatricians in Switzerland, the overall attitude towards SCAM was positive, emphasised by great interest in SCAM training, willingness to contribute to SCAM research and, in particular, by the high rate of paediatricians using SCAM for themselves and their families. However, given the strong demand for SCAM for children, the rate of paediatricians offering SCAM is rather low, despite the official recognition of SCAM in Switzerland. Among the various reasons for this, insufficient knowledge and institutional barriers deserve special attention. The paediatricians’ great interest in SCAM training and support for SCAM research offer key elements for the future development of complementary and integrative medicine for children in Switzerland.

SCAM suffers from acute survey mania. I am anxiously waiting for a survey of SCAM use in left-handed, diabetic policemen in retirement from Devon. But every other variation of the theme has been exploited. And why not? It provides the authors with a most welcome addition to their publication list. And, of course, it lends itself very nicely to SCAM-promotion. Sadly, there is not much else that such surveys offer.

Except perhaps for an opportunity to do an alternative evaluation of their results. Here is an assessment the devil’s advocate in me proposes. Based on the reasonable assumption that those 34% of paediatricians who responded did so because they had an interest in SCAM, and the 64% who did not reply couldn’t care less, it is tempting to do an analysis of the entire population of Swiss paediatricians. Here are my findings:

  • Hardly anyone had attended training in SCAM.
  • Hardly anyone had a federal certificate in one or more SCAM methods.
  • Very few did not routinely ask their patients about their use of SCAM.
  • Hardly anyone offered SCAM.
  • Very few were interested in SCAM courses and training.
  • Hardly anyone provided SCAM services to their patients.
  • Quite a few were asked by patients/parents about SCAM therapies.
  • Very few paediatricians use SCAM for themselves or their families.
  • Few were willing to contribute to paediatric SCAM research.

These results might be closer to the truth but they have one very important drawback: they do not lend themselves to drawing the SCAM-promotional conclusions formulated by the authors.

Oh Yes, reality can be a painful thing!

A team from Israel conducted a pragmatic trial to evaluate the impact of So-called Alternative Medicine (SCAM) treatments on postoperative symptoms. Patients ≥ 18 years referred to SCAM treatments by surgical medical staff were allocated to standard of care with SCAM treatment (SCAM group) or without SCAM. Referral criteria were patient preference and practitioner availability. SCAM treatments included Acupuncture, Reflexology, or Guided Imagery. The primary outcome variable was the change from baseline in symptom severity, measured by Visual Analogue Scale (VAS).

A total of 1127 patients were enrolled, 916 undergoing 1214 SCAM treatments and 211 controls. Socio-demographic characteristics were similar in both groups. Patients in the SCAM group had more severe baseline symptoms. Symptom reduction was greater in the SCAM group compared with controls. No significant adverse events were reported with any of the CAM therapies.

The authors concluded that SCAM treatments provide additional relief to Standard Of Care (SOC) for perioperative symptoms. Larger randomized control trial studies with longer follow-ups are needed to confirm these benefits.

Imagine a situation where postoperative patients are being asked “do you want merely our standard care or do you prefer having a lot of extra care, fuss and attention? Few would opt for the former – perhaps just 211 out of a total of 1127, as in the trial above. Now imagine being one of those patients receiving a lot of extra care and attention; would you not feel better, and would your symptoms not improve faster?

I am sure you have long guessed where I am heading. The infamous A+B versus B design has been discussed often enough on this blog. Researchers using it can be certain that they will generate a positive result for their beloved SCAM – even if the SCAM itself is utterly ineffective. The extra care and attention plus the raised expectation will do the trick. If the researchers want to make extra sure that their bogus treatments come out of this study smelling of roses, they can – like our Israeli investigators – omit to randomise patients to the two groups and let them chose according to their preference.

To cut a long story short: this study had zero chance to yield a negative result.

  • As such it was not a test but a promotion of SCAM.
  • As such it was not science but pseudo science.
  • As such it was not ethical but unethical.

WHEN WILL WE FINALLY STOP PUBLISHING SUCH MISLEADING NONSENSE?

Tian Jiu (TJ) therapy is a so-called alternative medicine (SCAM) that has been widely utilized in the management of allergic rhinitis (AR). TJ is also known as “drug moxibustion” or “vesiculating moxibustion.” Herbal patches are applied on the selected acupoints or the diseased body part. In TCM, this treatment is said to regulate the functions of meridians and zang-fu organs, warm the channels, disperse coldness, invigorate qi movement, harmonize nutrient absorption and defence mechanisms, and resolve stagnation in the body and stasis of the blood.

But does it work? This single-blinded, three-arm, randomized controlled study evaluated the efficacy of TJ therapy in AR. A total of 138 AR patients were enrolled. The TJ group and placebo group both received 4-weeks of treatment with either TJ or placebo patches for 2 hours. The patches were applied to Dazhui (GV 14), bilateral Feishu (UB 13), and bilateral Shenshu (UB 23) points. Patients received one session per week and then underwent a 4-week follow-up. The waitlist group received no treatment during the corresponding treatment period, but would be given compensatory TJ treatment in the next 4 weeks.

The primary outcome was the change of the Total Nasal Symptom Score (TNSS) after treatment. The secondary outcomes included the changes of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and rescue medication score (RMS).

After the treatment period, the total TNSS in TJ group was significantly reduced compared with baseline, but showed no statistical difference compared with placebo. Among the four domains of TNSS, the change of nasal obstruction exhibited statistical difference compared with placebo group. The total RQLQ score in TJ group was significantly reduced compared with both placebo and waitlist groups. The needs of rescue medications were not different between the two groups.

There were no serious adverse events. The common adverse events included flush, pruritus, blister, and pigmentation, occurring in 17, 23, 3, and 36 person-times among TJ group, and 3, 7, 1, and 4 person-times among placebo group, respectively. These adverse events were generally tolerated and disappeared quickly after removing the patches.

The authors (from the Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University) concluded that this randomized, single-blinded, controlled trial served primary evidence of the efficacy and safety of TJ therapy on AR in Hong Kong. This pilot study provided a fundamental TJ protocol for future research. Through adjusting treatment timing, frequency, retention time, and even body response settings, it has the potential to develop into an optimal therapeutic method for future application.

The authors of this poorly written paper seem to ignore their own findings by concluding as they do. The fact is that the primary endpoint of this trial failed to show a significant difference between TJ and placebo. Moreover, TJ does have considerable adverse effects. Therefore, this study  fails to demonstrate both the effectiveness and the safety of TJ as a treatment of AR.

PS

I often hesitate whether or not to discuss the plethora such frightfully incompetent research. The reason I sometimes do it is to alert the public to the fact that so much utter rubbish is published by incompetent researchers in trashy (but Medline-listed) journals, passed by incompetent ethics committees, supported by naïve funding agencies, accepted by reviewers and editors who evidently do not do their job properly. Do all these people have forgotten that they have a responsibility towards the public?

It is time to stop this nonsense!

It gives a bad name to science, misleads the public and inhibits progress.

I recently received this unexpected and surprising email:

Dear Friend,

I wanted to point out an article that published last month in the New England Journal of Medicine Catalyst that gets to the root of why we are not solving the nation’s current epidemics of chronic pain, obesity, opioids, suicide, and cardiovascular disease.

My co-authors included Dr. Eric Schoomaker, the former surgeon general of the Army; Dr. Tracy Gaudet, who leads cultural transformation at the Veterans Health Administration; and Dr. James Marzolf, the chief health and data analyst in Dr. Gaudet’s office.

In the article Finding the Cause of the Crises: Opioids, Pain, Suicide, Obesity, and Other “Epidemics”, we show how our nation’s response to our current epidemics are tackling the wrong problems.

For example, take the opioid epidemic. The response has been to restrict opioids and focus on other drugs. This narrow approach is compounding the problem. The root cause is that we don’t manage chronic pain appropriately. We need a major roll out of non-pharmacological approaches for pain.

Instead of treating pain with a pill, we need to pay attention to the whole person in mind, body, and spirit. When we do this, we may find that non-drug approaches to treating the person are more appropriate, and treat not only the pain, but the suffering that often accompanies it.

The article describes how systems like the Military and Veterans Health Administration are doing this with transformative approaches that embrace whole person, integrative health.

The good news is that the answers are out there. The entire nation can do this, and we can start now.

Be well.

Dr. Wayne Jonas

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In case you don’t know who my ‘friend’ Wayne is (I did mention him before here and here, for instance), here is a concise summary of his background. As you doubtlessly do know, the NEJM is a (perhaps even the most) respected medical journal. I therefore tried to find the article there and was amazed not to find it. Then I realised that Wayne said it was published not in the NEJM but in the ‘New England Journal of Medicine Catalyst’, a very different proposition.

The New England Journal of Medicine Catalyst brings health care executives, clinical leaders, and clinicians together to share innovative ideas and practical applications for enhancing the value of health care delivery. From a network of top thought leaders, experts, and advisors, our digital publication, quarterly events, and qualified Insights Council provide real-life examples and actionable solutions to help organizations address urgent challenges affecting health care.

But what about the paper that Wayne so warmly recommends? It turns out to be little more than a promotional stunt for integrative medicine. Here is an excerpt from it:

It is often a surprise to people that two of the largest health care systems in the country are trying to radically redesign what they do to provide more whole-person and integrative care. These two systems are run by the Department of Defense (DoD) and the Veterans Health Administration (VHA) and collectively care for over 20 million people. The nation can learn from their efforts.

The need for reform emerged after the turn of this century when leaders in the DoD and VHA began to hold informal meetings under the title “From Healthcare to Health.” Over the course of those meetings, the participants recognized the failure of their health care systems to get at the underlying causes of chronic disease. In 2009, they secured the support of the Chairman of the Joint Chiefs of Staff to change overall military doctrine and guidance to a radically holistic approach called “Total Force Fitness,” which subsequently led to health and community innovations. An example of these redesign innovations was the Defense and Veterans’ Pain Management Task Force and Report and the resulting strategy that preceded the National Academy of Medicine’s report on pain in America.

Other innovations included the Healthy Base Initiative and the Performance Triad, the latter of which focuses on the importance of asking all patients about their sleep, nutrition, and physical activity. All services — Army, Navy, Air Force, Coast Guard, and Special Forces — continue to shift to whole-person models that seek to implement behavioral and complementary approaches. For example, >6000 providers have been trained in and routinely use Battlefield Acupuncture for pain.

The transformation currently underway in the VHA, which goes under the name “Whole Health,” is also an offshoot of that leadership dialogue from 20 years ago. In the Whole Health approach, the emphasis is to empower and equip people to take charge of their health and well-being. In this approach, trained peers help veterans explore their sense of mission and purpose, and well-being programs focus on skill-building and support for self-care. These elements, in addition to person-centered, holistic clinical care, create the Whole Health delivery system. VHA facilities are shifting from a system designed around points of clinical care (in which the primary focus is on disease management) to one that is based in a partnership across time (in which the primary focus is on whole health). Clinical encounters are essential but not sufficient. This health system is designed to focus not only on treatment, but also on self-empowerment, self-healing, and self-care.

This radical redesign is built on decades of VHA work enhancing its integrative approaches with innovations such as Patient-Aligned Care Teams, Primary Care Mental Health Integration, peer-to-peer support, group access to mental health services, and the increasing use of complementary medicine approaches. These changes laid the groundwork for the kind of radical redesign now underway in the VHA and that is needed in all national health care delivery systems.

In 2011, the VHA established an Office of Patient Centered Care and Cultural Transformation to further redefine health care delivery and to oversee this unique approach. Whole Health has begun rapid deployment across the entire VHA system, starting with 18 VHA medical centers in 2018 and with a planned expansion to all VHA medical centers by the end of 2022. System-wide implementation will require an estimated $556 million over 5 years.

When fully implemented, operating costs for this shift are projected to represent 1% of the VHA annual budget. This implementation will involve hiring almost 6,400 new staff, the majority for positions that did not previously exist in the VHA, including health coaches and peer health partners, nutritionists, acupuncturists, and yoga instructors. Whole Health is building access through group visits, peer-to-peer support, and the development of Personal Health Plans for every veteran — something everyone in the country could use. In addition, new payment codes have been created, allowing providers to capture and cover their time and efforts using relative value units (RVUs) and to track productivity.

Will Whole Health help to cure what ails health care? Current models suggest that it will. With improvement in health outcomes, there will be a reduction in the need for existing clinical and biomedical services. These models predict increased access and more proactive population health management. With the addition of these new Whole Health services, we project a 24.5% increase in access when fully deployed — without the addition of a single hospital bed or medical specialist. In addition, Whole Health exceeds cost neutrality and is conservatively estimated to return $2.19 for every dollar invested over 6 years.

These returns reflect net cost avoidance and are derived from reductions in the need and demand for existing clinical health services — exactly what the nation needs in order to reduce chronic disease crises and contain costs. The per capita savings or cost avoidance is modest, averaging $535 per veteran annually over the 6-year period. Cumulatively, however, this totals over $6.2 billion in cost avoidance. Given that the Whole Health approach will improve the health of veterans, many of whom are dealing with complex issues such as chronic pain, mental health conditions, and opioid use at a cost of about $1 per day per veteran, it is a financially sound, cost-effective change from the current health care paradigm.

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So, does this change my mind about integrative medicine?

I’m afraid not! And Wayne fails to provide the slightest evidence that his concepts amount to more than wishful thinking (note how he first mentions predictions of cost savings and, in the next paragraph, pretends they are a reality). I simply do not believe that adding a few unproven therapies to our routine healthcare and wrapping the mixture into politically correct platitudes will improve anything. This cannot work from a theoretical standpoint and, crucially, there is no empirical evidence that it does improve anything else but the income stream of charlatans.

If healthcare needs reform, then let’s reform it! Adding cow pie to apple pie is not a solution, it merely spoils what we have already. I am saying this now since 17 years when I published my first comment on integrative medicine. It was entitled Integrative medicine: not a carte blanche for untested nonsense. I do still think that it sums up the issue succinctly.

You might remember my post from last October:

On Twitter and elsewhere, homeopaths have been celebrating: FINALLY A PROOF OF HOMEOPATHY HAS BEEN PUBLISHED IN A TOP SCIENCE JOURNAL!!!

Here is just one example:

#homeopathy under threat because of lack of peer reviewed studies in respectable journals? Think again. Study published in the most prestigious journal Nature shows efficacy of rhus tox in pain control in rats.

But what exactly does this study show (btw, it was not published in ‘Nature’)?

The authors of the paper in question evaluated antinociceptive efficacy of Rhus Tox in the neuropathic pain and delineated its underlying mechanism. Initially, in-vitro assay using LPS-mediated ROS-induced U-87 glioblastoma cells was performed to study the effect of Rhus Tox on reactive oxygen species (ROS), anti-oxidant status and cytokine profile. Rhus Tox decreased oxidative stress and cytokine release with restoration of anti-oxidant systems. Chronic treatment with Rhus Tox ultra dilutions for 14 days ameliorated neuropathic pain revealed as inhibition of cold, warm and mechanical allodynia along with improved motor nerve conduction velocity (MNCV) in constricted nerve. Rhus Tox decreased the oxidative and nitrosative stress by reducing malondialdehyde (MDA) and nitric oxide (NO) content, respectively along with up regulated glutathione (GSH), superoxide dismutase (SOD) and catalase activity in sciatic nerve of rats. Notably, Rhus Tox treatment caused significant reductions in the levels of tumor necrosis factor (TNF-α), interleukin-6 (IL-6) and interleukin-1β (IL-1β) as compared with CCI-control group. Protective effect of Rhus Tox against CCI-induced sciatic nerve injury in histopathology study was exhibited through maintenance of normal nerve architecture and inhibition of inflammatory changes. Overall, neuroprotective effect of Rhus Tox in CCI-induced neuropathic pain suggests the involvement of anti-oxidative and anti-inflammatory mechanisms.

END OF QUOTE

I am utterly under-whelmed by in-vitro experiments (which are prone to artefacts) and animal studies (especially those with a sample size of 8!) of homeopathy. I think they have very little relevance to the question whether homeopathy works.

But there is more, much more!

It has been pointed out that there are several oddities in this paper which are highly suspicious of scientific misconduct or fraud. It has been noted that the study used duplicated data figures that claimed to show different experimental results, inconsistently reported data and results for various treatment dilutions in the text and figures, contained suspiciously identical data points throughout a series of figures that were reported to represent different experimental results, and hinged on subjective, non-blinded data from a pain experiment involving just eight rats.

Lastly, others pointed out that even if the data is somehow accurate, the experiment is unconvincing. The fast timing differences of paw withdraw is subjective. It’s also prone to bias because the researchers were not blinded to the rats’ treatments (meaning they could have known which animals were given the control drug or the homeopathic dilution). Moreover, eight animals in each group is not a large enough number from which to draw firm conclusions, they argue.

As one consequence of these suspicions, the journal has recently added the following footnote to the publication:

10/1/2018 Editors’ Note: Readers are alerted that the conclusions of this paper are subject to criticisms that are being considered by the editors. Appropriate editorial action will be taken once this matter is resolved.

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Well, it took a while, but now there is some news about this case:

‘Science Reports’, just published a retraction note:

Retraction of: Scientific Reports https://doi.org/10.1038/s41598-018-31971-9, published online 10 September 2018

Following publication, the journal received criticisms regarding the rationale of this study and the plausibility of its central conclusions. Expert advice was obtained, and the following issues were determined to undermine confidence in the reliability of the study.

The in vitro model does not support the main conclusion of the paper that Rhus Tox reduces pain. The qualitative and quantitative composition of the Rhus Tox extract is unknown. Figures 1G and 1H are duplicates; and figures 1I and 1J are duplicates. The majority of experimental points reported in figure 3 panel A are duplicated in figure 3 panel B. The collection, description, analysis and presentation of the behavioural data in Figure 3 is inadequate and cannot be relied upon.

As a result the editors are retracting the Article. The authors do not agree with the retraction.

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Does that mean the suspect paper has been declared fraudulent?

I think so.

In any case: another victory of reason over unreason!

So-called alternative medicine (SCAM) is a seriously dangerous option for cancer patients who aim at curing their cancer with it. One cannot warn patients often and strongly enough, I believe. But when it comes to supportive cancer treatment (care that does not aim at changing the natural history of the disease), SCAM might have a place. I said ‘might’ because its exact role is far from clear.

The aim of this study was to investigate the effects of a complex, nurse-led, supportive care intervention using SCAM on patients’ quality of life (QoL) and associated patient-reported outcomes. In this prospective, pragmatic, bicentric, randomized controlled trial, women with breast or gynaecologic cancers undergoing a new regimen of chemotherapy (CHT) were randomly assigned to routine supportive care plus intervention (intervention group, IG) or routine care alone (control group, CG). The intervention consisted of SCAM applications and counseling for symptom management, as well as SCAM information material. The primary endpoint was global QoL measured with the EORTC-QLQ-C30 before and after SCAM.

In total, 126 patients were randomly assigned into the IG and 125 patients into the CG. The patients’ medical and socio-demographic characteristics were homogenous at baseline and at follow-up. No group effects on QoL were found upon completion of CHT, but there was a significant group difference in favour of the IG, 6 months later. IG patients did also experience significant better emotional functioning and less fatigue.

The authors concluded that the tested supportive intervention did not improve patients’ QoL outcomes directly after CHT (T3), but was associated with significant QoL improvements when considering the change from baseline to the time point T4, which could be assessed 6 months after patients’ completion of CHT. This delayed effect may have resulted due to a strengthening of patients’ self-management competencies.

A prospective, pragmatic, bicentric, randomized controlled trial! Doesn’t this sound rigorous? In fact, this term merely hides a trial that was destined to generate a positive result. As it followed the infamous A+B versus B design, it hardly had a chance to not come out positive.

The only thing I find amazing is that the short-term results failed to be statistically significant. Far too many SCAM researchers, it seems to me, view science as a tool for promoting their dubious ideas.

The use of SCAM with the aim of improving QoL might be helpful. But this assumption cannot be accepted on the basis of opinion; we need good science to find out which forms of SCAM are worth employing. Sadly, studies like the above are not in this category.

If you ask me, it is high time that this misleading nonsensical and unethical pseudo-research stops!

Many cancer patients use so-called alternative medicine (SCAM) such as Traditional Chinese Medicine (TCM). On this blog, we have repeatedly discussed whether this does more good than harm. This study sheds new light on the question. Specifically, it aims to explore the benefits of TCM therapy in the long-term survival of patients with hepatocellular carcinoma in China.

In total, 3483 patients with HCC admitted to the Beijing Ditan Hospital of Capital Medical University were enrolled. The researchers used 1:1 frequency matching by sex, age, diagnosis time, Barcelona Clinic Liver Cancer staging, and type of treatments to compare the TCM users (n = 526) and non-TCM users (n = 526). A Cox multivariate regression model was employed to evaluate the effects of TCM therapy on the HR value and Kaplan-Meier survival curve for mortality risk in HCC patients. A log-rank test was performed to analyse the effect of TCM therapy on the survival time of HCC patients.

The Cox multivariate analysis indicated that TCM therapy was an independent protective factor for 5-year survival in patients with HCC. The Kaplan-Meier curve also showed that after PS matching, TCM users had a higher overall survival rate and a higher progression-free survival rate than non-TCM users. TCM users, regardless of the classification of etiology, tumor stage, liver function level, or type of treatment, all benefited significantly from TCM therapy. The most commonly used Chinese patent medications used were Fufang Banmao Capsule, Huaier Granule, and Jinlong Capsule.

The authors concluded that using traditional Chinese medications as adjuvant therapy can probably prolong median survival time and improve the overall survival among patients with HCC. Further scientific studies and clinical trials are needed to examine the efficiency and safety.

I was unable to access the full article and therefore am unable to provide a detailed critique of it. From reading the abstract, I should point out, however, that this was not an RCT. To minimise bias, the researchers used a matching technique to generate two comparable groups. Such methods can be successful in matching for the named parameters, but they cannot match for the plethora of variables that might be relevant but were not measured. Therefore, the survival difference between the two groups might be due not to the therapies they received, but to the fact that the groups were not comparable in terms of factors that impact on survival.

Another important point about this paper is the obvious fact that it originates from China. We know from several independent investigations that such studies almost never report negative findings. We also know that TCM is a hugely important export item for China. Adding two and two together should therefore make us sceptical. I for one take the present findings with more than a pinch of salt.

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