Leah Bracknell, started raising funds ~3 years ago for alternative cures of her stage 4 lung cancer. Bracknell who, after her acting career, had become a yoga teacher said at the time that, in the UK, she was given “a fairly brutal and bleak diagnosis, but one I am determined to challenge”. Her partner, Jez Hughes, who helped with the fund-raising said the money would be used for “immunotherapy and integrative medicine, which are seeing previously ‘incurable’ cancers going into complete remission”.
The team thus raised over £50 000 and went to Germany, a country that is well-known for its liberal stance on quackery. In Britain, there are just a few physicians who are devoted to this or that alternative medicine. In Germany, there are thousands of them. In addition, Germany has a healthcare profession called the ‘Heilpraktiker’, a poorly-regulated left-over from the Third Reich. A Heilpraktiker has not studied medicine, yet is legally permitted to make all sorts of unsubstantiated claims and treat many serious diseases, including cancer, with unproven therapies.
It was reported that Leah Bracknell went to the ‘Hallwang Private Oncology Clinic’, an institution which claims that “Healing-oriented and individualised medicine considers all aspects of lifestyle and not only relies on conventional treatments and recent cutting-edge developments in medicine, but also takes into account our experience in natural remedies and is open for alternative treatment options in order to work in synergy with conventional treatment strategies. We always try to be as natural as possible and as conventional as needed to achieve the best results. Integrative Health Concepts are successfully used in many diseases including malignant diseases, neurological disorders as well as in prevention and rehabilitation.” The SCAMs used there include homeopathy, micronutrients, natural supplements, whole body hyperthermia and ozone therapy.
The evidence does not support these or other alternative cancer ‘cures’. In fact, the very notion of an alternative cancer cure is nonsensical: if an alternative cancer therapy showed even the slightest shimmer of promise, it would get investigated and, if shown to work, become part of routine oncology. The suggestion that there are treatments out there that are effective, yet shunned by oncologists because they originate from nature or from some exotic tradition is insulting and utterly barmy.
Yet cancer patients can easily fall for such claims. They are understandably desperate and listen to anyone promissing a cure. Therefore, they all too easily believe in weird conspiracy theories of ‘Big Parma’, the evil ‘establishment’ etc. who allegedly suppress the news of an effective therapy, as it might threaten their profits. If they do fall for such lies, they not only lose pots of money but also their lives.
Last Wednesday, it was reported that Leah Bracknell had died of cancer.
The World Federation of Chiropractic (WFC) claim to have been at the forefront of the global development of chiropractic. Representing the interests of the profession in over 90 countries worldwide, the WFC has advocated, defended and promoted the profession across its 7 world regions. Now, the WFC have formulated 20 principles setting out who they are, what they stand for, and how chiropractic as a global health profession can, in their view, impact on nations so that populations can thrive and reach their full potential. Here are the 20 principles (in italics followed by some brief comments by me in normal print):
1. We envision a world where people of all ages, in all countries, can access the benefits of chiropractic.
That means babies and infants! What about the evidence?
2. We are driven by our mission to advance awareness, utilization and integration of chiropractic internationally.
One could almost suspect that the drive is motivated by misleading the public about the risks and benefits of spinal manipulation for financial gain.
3. We believe that science and research should inform care and policy decisions and support calls for wider access to chiropractic.
If science and research truly did inform care, it would soon be chiropractic-free.
4. We maintain that chiropractic extends beyond the care of patients to the promotion of better health and the wellbeing of our communities.
The best example to show that this statement is a politically correct platitude is the fact that so many chiropractors are (educated to become) convinced that vaccinations are undesirable or harmful.
5. We champion the rights of chiropractors to practice according to their training and expertise.
I am not sure what this means. Could it mean that they must practice according to their training and expertise, even if both fly in the face of the evidence?
6. We promote evidence-based practice: integrating individual clinical expertise, the best available evidence from clinical research, and the values and preferences of patients.
So far, I have seen little to convince me that chiropractors care a hoot about the best available evidence and plenty to fear that they supress it, if it does not enhance their business.
7. We are committed to supporting our member national associations through advocacy and sharing best practices for the benefit of patients and society.
Much more likely for the benefit of chiropractors, I suspect.
8. We acknowledge the role of chiropractic care, including the chiropractic adjustment, to enhance function, improve mobility, relieve pain and optimize wellbeing.
Of course, you have to pretend that chiropractic adjustments (of subluxations) are useful. However, evidence would be better than pretence.
9. We support research that investigates the methods, mechanisms, and outcomes of chiropractic care for the benefit of patients, and the translation of research outcomes into clinical practice.
And if it turns out to be to the detriment of the patient? It seems to me that you seem to know the result of the research before you started it. That does not bode well for its reliability.
10. We believe that chiropractors are important members of a patient’s healthcare team and that interprofessional approaches best facilitate optimum outcomes.
Of course you do believe that. Why don’t you show us some evidence that your belief is true?
11. We believe that chiropractors should be responsible public health advocates to improve the wellbeing of the communities they serve.
Of course you do believe that. But, in fact, many chiropractors are actively undermining the most important public health measure, vaccination.
12. We celebrate individual and professional diversity and equality of opportunity and represent these values throughout our Board and committees.
What you should be celebrating is critical assessment of all chiropractic concepts. This is the only way to make progress and safeguard the interests of the patient.
13. We believe that patients have a fundamental right to ethical, professional care and the protection of enforceable regulation in upholding good conduct and practice.
The truth is that many chiropractors violate medical ethics on a daily basis, for instance, by not obtaining fully informed consent.
14. We serve the global profession by promoting collaboration between and amongst organizations and individuals who support the vision, mission, values and objectives of the WFC.
Yes, those who support your vision, mission, values and objectives are your friends; those who dare criticising them are your enemies. It seems far from you to realise that criticism generates progress, perhaps not for the WFC, but for the patient.
15. We support high standards of chiropractic education that empower graduates to serve their patients and communities as high value, trusted health professionals.
For instance, by educating students to become anti-vaxxers or by teaching them obsolete concepts such as adjustment of subluxation?
16. We believe in nurturing, supporting, mentoring and empowering students and early career chiropractors.
You are surpassing yourself in the formulation of platitudes.
17. We are committed to the delivery of congresses and events that inspire, challenge, educate, inform and grow the profession through respectful discourse and positive professional development.
You are surpassing yourself in the formulation of platitudes.
18. We believe in continuously improving our understanding of the biomechanical, neurophysiological, psychosocial and general health effects of chiropractic care.
Even if there are no health effects?!?
19. We advocate for public statements and claims of effectiveness for chiropractic care that are honest, legal, decent and truthful.
Advocating claims of effectiveness in the absence of proof of effectiveness is neither honest, legal, decent or truthful, in my view.
20. We commit to an EPIC future for chiropractic: evidence-based, people-centered, interprofessional and collaborative.
And what do you propose to do with the increasing mountain of evidence suggesting that your spinal adjustments are not evidence-based as well as harmful to the health and wallets of your patients?
What do I take out of all this? Not a lot!
Perhaps mainly this: the WFC is correct when stating that, in the interests of the profession in over 90 countries worldwide, the WFC has advocated, defended and promoted the profession across its 7 world regions. What is missing here is a small but important addition to the sentence: in the interests of the profession and against the interest of patients, consumers or public health in over 90 countries worldwide, the WFC has advocated, defended and promoted the profession across its 7 world regions.
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?
I recently received this unexpected and surprising email:
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.
Dr. Wayne Jonas
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.
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.
The fact that homeopathy is under siege in France, has been discussed before. Now even the international media have picked up the story. Here are some excerpts from an interesting article in Bloomberg:
… The looming brawl gets to the heart of conflicting visions of the state’s involvement in the country’s health system at a time of eroding quality and services. Jobs are also at stake: France is home to Boiron SA, the leader in a global homeopathy market estimated at more than $30 billion.
Boiron’s pills and tinctures have long coexisted with conventional care in France, prescribed by regular doctors and dispensed in almost every pharmacy. Ending public support for the remedies would discredit homeopathy and “send a shock wave” through the industry worldwide, says Boiron’s chief executive officer, Valerie Poinsot. “We’ve been caught in this storm for the past year,” Poinsot says. “Why the hostility, when we contribute to caring for patients?”
Facing a possible backlash, Boiron, based in Lyon, teamed with rivals Weleda AG of Switzerland and closely held family group Lehning to fund a campaign called MyHomeoMyChoice. The push has garnered just over 1 million signatures in an online petition and placed bright-colored posters framed with the recognizable little white pills at pharmacies across the country. “Homeopathy has treated generations of French patients,” says one slogan. “Why deprive future generations?”
For now, French people can walk into any pharmacy and buy a tube of Arnica granules — recommended for shocks and bruises — or roughly a thousand other similar remedies for 1.6 euros ($1.80) with a prescription, because the state health system shoulders about 30% of its cost. In some cases, private insurers cover the remainder and patients pay nothing. That may all soon change. A science agency is wrapping up a study of the relative benefits of alternative medicine that will inform the government’s position: Keep the funding, trim it or scrap it altogether.
If the government cuts funding, Boiron would instantly feel the pain. Poinsot estimates that sales of reimbursed treatments could plummet by 50% in France, where the company brings in almost half its revenue. The company’s stock price has lost about 13% since May 15, when a French newspaper wrote that the panel reviewing homeopathy funding would probably rule against it…
In France, the controversy first erupted last year when the influential Le Figaro newspaper published a letter from a doctor’s collective called FakeMed lambasting alternative medicines. The authors called for ending support of “irrational and dangerous” therapies with “no scientific foundation.” The ensuing debate prompted Health Minister Agnes Buzyn to place funding under review and ask the country’s High Authority for Health to rule on homeopathy’s scientific merits…
David Beausire, a doctor in palliative care at the hospital in Mont de Marsan, in southwest France, is among those who signed the FakeMed letter. Beausire, who sees many terminally ill patients, said he regularly gets people who consult too late because they first explored alternative medicine paths that include homeopathy. “I am not an extremist,” he says. But homeopathy’s reimbursement by the state health system gives it legitimacy when “there’s no proof that it works.”…
Stung by accusations of quackery, Antoine Demonceaux, a doctor and homeopath in Reims, founded a group called SafeMed last November to relay the message that homeopathy has a role to play alongside standard care. He points to the growing number of cancer centers offering consultations to relieve treatment-related symptoms, such as nausea, with homeopathic medicine. Demonceaux says neither he nor his colleagues would ever use homeopathy as a substitute for treatments intended to, say, shrink tumors. “A general practitioner or a specialist who’d claim to be a homeopath and to cure cancer with homeopathy? Just sack him,” he says. “Let’s get real. We are doctors.”
On the whole, this is a good report which – as far as I can see – describes the situation quite well and provides interesting details. What, however, with this articles and many like it is this: journalists (and others) are too often too lethargic or naïve to check the veracity of the claims that are being made during these disputes. For instance, it would not have been all that difficult to discover that:
- Hahnemann called clinicians who used homeopathy alongside conventional treatments ‘traitors‘! He categorically forbade it and denied that such an approach merits the name ‘HOMEOPATHY’. In other words, let’s get real and let’s not pull wool over the eyes of the public (and let’s be honest, it is not possible to practice homeopathy within the boundaries of medical ethics).
- Many homeopaths do advocate homeopathy as a sole treatment for cancer and other serious conditions (see for instance here, here and here).
The obvious risk of such lack of critical thinking is that homeopathy might be kept refundable on the basis of big, fat lies. And clearly, that would not be in the interest of anyone (with the exception of family Boiron, of course).
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.
A new paper reminds us that so-called alternative medicine (SCAM) has been increasing in the United States and around the world, particularly at medical institutions known for providing rigorous evidence-based care. The use of SCAM may cause harm to patients through interactions with prescribed medications or by patients choosing to forego evidence-based care. SCAM may also put financial strain on patients as most SCAM expenditures are paid out-of-pocket.
Despite these drawbacks, patients continue to use SCAM due to a range of reasons, e.g. media promotion of SCAM therapies, dissatisfaction with conventional healthcare, a desire for more holistic care. Given the increasing demand for SCAM, many medical institutions now offer SCAM services. Several leaders of SCAM centres based at a highly respected academic medical institution have publicly expressed anti-vaccination views, and non-evidence-based philosophies run deep within SCAM.
Although there are financial incentives for institutions to provide SCAM, it is important to recognize that this legitimizes SCAM and may cause harm to patients. The poor regulation of SCAM allows for the continued distribution of products and services that have not been rigorously tested for safety and efficacy.
As I have tried to point out many times, the potential for harm caused by the increasing integration of SCAM can thus be summarised as follows:
- direct harm due to adverse effects such as toxicity of an herbal remedy, stroke after chiropractic manipulation, pneumothorax after acupuncture;
- direct harm through the use of bogus diagnostic techniques;
- direct harm by using materials from endangered species;
- indirect harm through incompetent advice such as recommendation not to immunize or discontinue prescribed medications;
- neglect due to using SCAM instead of an effective therapy for a serious condition;
- harm due to medicalising trivial states of reduced well-being;
- financial harm due to the costs of SCAM;
- harm through making a mockery of evidence-based medicine;
- harm caused by undermining rational thinking in the society at large;
- harm caused by inhibiting medical progress and research.
In case you see other ways in which SCAM can cause harm, please let me know by posting a comment.
One of the most difficult things in so-called alternative medicine (SCAM) can be having a productive discussion with patients about the subject, particularly if they are deeply pro-SCAM. The task can get more tricky, if a patient is suffering from a serious, potentially life-threatening condition. Arguably, the discussion would become even more difficult, if the SCAM in question is relatively harmless but supported only by scarce and flimsy evidence.
An example might be the case of a cancer patient who is fond of mindfulness cognitive therapy (MBCT), a class-based program designed to prevent relapse or recurrence of major depression. To contemplate such a situation, let’s consider the following hypothetical exchange between a patient (P) and her oncologist (O).
P: I often feel quite low, do you think I need some treatment for depression?
O: That depends on whether you are truly depressed or just a bit under the weather.
P: No, I am not clinically depressed; it’s just that I am worried and sometimes see everything in black.
O: I understand, that’s not an unusual thing in your situation.
P: Someone told me about MBCT, and I wonder what you think about it.
O: Yes, I happen to know about this approach, but I’m not sure it would help you.
P: Are you sure? A few years ago, I had some MBCT; it seemed to work and, at least, it cannot do any harm.
O: Yes, that’s true; MBCT is quite safe.
P: So, why are you against it?
O: I am not against it; I just doubt that it is the best treatment for you.
O: Because there is little evidence for it and even less for someone like you.
P: But I have seen some studies that seem to show it works.
O: I know, there have been trials but they are not very reliable.
P: But the therapy has not been shown to be ineffective, has it?
O: No, but the treatment is not really for your condition.
P: So, you admit that there is some positive evidence but you are still against it because of some technicalities with the science?
O: No, I am telling you that this treatment is not supported by good evidence.
P: And therefore you want me to continue to suffer from low mood? I don’t call that very compassionate!
O: I fully understand your situation, but we ought to find the best treatment for you, not just one that you happen to be fond of.
P: I don’t understand why you are against giving MBCT a try; it’s safe, as you say, and there is some evidence for it. And I have already had a good experience with it. Is that not enough?
O: My role as your doctor is to provide you with advice about which treatments are best in your particular situation. There are options that are much better than MBCT.
P: But if I want to try it?
O: If you want to try MBCT, I cannot prevent you from doing so. I am only trying to tell you about the evidence.
P: Fine, in this case, I will give it a go.
Clearly this discussion did not go all that well. It was meant to highlight the tension between the aspirations of a patient and the hope of a responsible clinician to inform his patient about the best available evidence. Often the evidence is not in favour of SCAM. Thus there is a gap that can be difficult to breach. (Instead of using MBCT, I could, of course, have used dozens of other SCAMs like homeopathy, chiropractic, Reiki, etc.)
The pro-SCAM patient thinks that, as she previously has had a good experience with SCAM, it must be fine; at the very minimum, it should be tried again, and she wants her doctor to agree. The responsible clinician thinks that he ought to recommend a therapy that is evidence-based. The patient feels that scientific evidence tells her nothing about her experience. The clinician insists that evidence matters. The patient finds the clinician lacks compassion. The clinician feels that the most compassionate and ethical strategy is to recommend the most effective therapy.
As the discussion goes on, the gap is not closing but seems to be widening.
What can be done about it?
I wish I knew the answer!