Recently, I came across the ‘Clinical Practice Guidelines on the Use of Integrative Therapies as Supportive Care in Patients Treated for Breast Cancer’ published by the ‘Society for Integrative Oncology (SIO) Guidelines Working Group’. The mission of the SIO is to “advance evidence-based, comprehensive, integrative healthcare to improve the lives of people affected by cancer. The SIO has consistently encouraged rigorous scientific evaluation of both pre-clinical and clinical science, while advocating for the transformation of oncology care to integrate evidence-based complementary approaches. The vision of SIO is to have research inform the true integration of complementary modalities into oncology care, so that evidence-based complementary care is accessible and part of standard cancer care for all patients across the cancer continuum. As an interdisciplinary and inter-professional society, SIO is uniquely poised to lead the “bench to bedside” efforts in integrative cancer care.”
The aim of the ‘Clinical Practice Guidelines’ was to “inform clinicians and patients about the evidence supporting or discouraging the use of specific complementary and integrative therapies for defined outcomes during and beyond breast cancer treatment, including symptom management.”
This sounds like a most laudable aim. Therefore I studied the document carefully and was surprised to read their conclusions: “Specific integrative therapies can be recommended as evidence-based supportive care options during breast cancer treatment.”
How can this be? On this blog, we have repeatedly seen evidence to suggest that integrative medicine is little more than the admission of quackery into evidence-based healthcare. This got me wondering how their conclusion had been reached, and I checked the document even closer.
On the surface, it seemed well-made. A team of researchers first defined the treatments they wanted to look at, then they searched for RCTs, evaluated their quality, extracted their results, combined them into an overall verdict and wrote the whole thing up. In a word, they conducted what seems a proper systematic review.
Based on the findings of their review, they then issued recommendations which I thought were baffling in several respects. Let me just focus on three of the SIO’s recommendations dealing with acupuncture:
- “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
- “Acupuncture can be considered for improving depressive symptoms in women suffering from hot flashes…” [RCTs (1 and 2) cited in support]
- “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
The actual RCT (1) cited in support of all three recommendations stated that the authors “randomly assigned 75 patients to usual care and 227 patients to acupuncture plus usual care…” As we have discussed often before on this blog and elsewhere, such a ‘A+B versus B study design’ will never generate a negative result, does not control for placebo-effects and is certainly not a valid test for the effectiveness of the treatment in question. Nevertheless, the authors of this study concluded that: “Acupuncture is an effective intervention for managing the symptom of cancer-related fatigue and improving patients’ quality of life.”
RCT (2) cited in support of recommendation number 2 seems to be a citation error; the study in question is not an acupuncture-trial and does not back the statement in question. I suspect they meant to cite their reference number 87 (instead of 88). This trial is an equivalence study where 50 patients were randomly assigned to receive 12 weeks of acupuncture (n = 25) or venlafaxine (n = 25) treatment for cancer-related hot flushes. Its results indicate that the two treatments generated the similar results. As the two therapies could also have been equally ineffective, it is impossible, in my view, to conclude that acupuncture is effective.
Finally, RCT (1) does in no way support recommendation number two. Yet RCT (1) and RCT (2) were both cited in support of this recommendation.
I have not systematically checked any other claims made in this document, but I get the impression that many other recommendations made here are based on similarly ‘liberal’ interpretations of the evidence. How can the ‘Society for Integrative Oncology’ use such dodgy pseudo-science for formulating potentially far-reaching guidelines?
I know none of the authors (Heather Greenlee, Lynda G. Balneaves, Linda E. Carlson, Misha Cohen, Gary Deng, Dawn Hershman, Matthew Mumber, Jane Perlmutter, Dugald Seely, Ananda Sen, Suzanna M. Zick, Debu Tripathy) of the document personally. They made the following collective statement about their conflicts of interest: “There are no financial conflicts of interest to disclose. We note that some authors have conducted/authored some of the studies included in the review.” I am a little puzzled to hear that they have no financial conflicts of interest (do not most of them earn their living by practising integrative medicine? Yes they do! The article informs us that: “A multidisciplinary panel of experts in oncology and integrative medicine was assembled to prepare these clinical practice guidelines. Panel members have expertise in medical oncology, radiation oncology, nursing, psychology, naturopathic medicine, traditional Chinese medicine, acupuncture, epidemiology, biostatistics, and patient advocacy.”). I also suspect they have other, potentially much stronger conflicts of interest. They belong to a group of people who seem to religiously believe in the largely nonsensical concept of integrative medicine. Integrating unproven treatments into healthcare must affect its quality in much the same way as the integration of cow pie into apple pie would affect the taste of the latter.
After considering all this carefully, I cannot help wondering whether these ‘Clinical Practice Guidelines’ by the ‘Society for Integrative Oncology’ are just full of honest errors or whether they amount to fraud and scientific misconduct.
WHATEVER THE ANSWER, THE GUIDELINES MUST BE RETRACTED, IF THIS SOCIETY WANTS TO AVOID LOSING ALL CREDIBILITY.
Depending on your understanding of ‘fraud’. My understanding is ‘both’.
We all know Minchin’s Law – by definition, alternative medicine either hasn’t been proven to work, or has been proven not to work – and we all know that the suborning of potentially valid complementary therapies under the umbrella of CAM was always a trick designed to impart a “halo effect” on treatments that have no good evidence.
The problem for any proponent of any alternative to medicine has always been:
1. They sincerely believe in the alternative treatment.
2. They know it is alternative precisely due to lack of credible evidence.
3. In order to reduce cognitive dissonance, they therefore have to conclude that there is something wrong with the normal process of evidence gathering.
That’s why they keep trying to invent studies that show what they want them to show, and why they don’t feel the need to follow honest scientific protocols. They believe in the treatment, they know that rigorous research shows it to be bogus, so they conclude that something about the way of excluding bias, also excludes whatever magical factor it is that makes it “work”. Thus they have no problem with crap studies, because they are a necessary evil in order to show the obvious innate [geddit?] value of the things in which they believe.
“Integrative” medicine will always love the A+B vs. B type of study design, for exactly the same reasons that alternative medicine became CAM: adding a valid therapy gives a positive (i.e. “correct”) result, and all positive results will be interpreted as validating the entire house of cards. Positive means it supports the whole thing, negative means the answer must have been wrong.
I don’t know what can be done about this, as membership of the community of “integrative medicine” more or less demands that you drink this Kool-Aid and adopt of the same lax standards of evidence that all SCAM proponents use.
trouble is that SIO is now taken seriously by many.
Prof. Ernst is a bit behind the times in just how far “integrative oncology” has gone in achieving seeming respectability in oncology. It’s been showing up in a JNCI monograph and at the American Society of Clinical Oncology (ASCO):
I hope this is the last hurrah of postmodernist bullshit in medicine. But I fear it isn’t.
The Society for Integrative Oncology has never had any credibility in the first place.
‘IM’ (a mish-mash all known treatment modalities) is what once apon a time, long ago was called ‘medicine’.
Regulated, scientific, modern medicine moved on. The modalities involved in ‘IM’ have been left behind and long lost their credibility.
We are left with a group of practitioners who appear not to understand this and are deluded, or do understand and are quacks and/or do understand and are seeking to defraud. They won’t change, they’re in too deep.
One might say that if patient after acupuncture or whatever is feeling better, then why not? Unfortunately many perceive all health problems, especially all problems associated with one disease as equally significant. Alternative medicine helped (really?) to look at the life from the brighter side? Then it will certainly help against …
If you really believe the way to be happy in life is to lie constantly to yourself – and pay a whole sack of cash to kooks and grifters to lie constantly to you too – perhaps there’s something else in your life you should be fixing instead.
I don’t. And neither I believe in the strategy of shaming sp popular during my Soviet childhood, unfortunately, but cancer brings up a big problem: relatives that feel more helpless than the patient himself, but believe it is their duty to cheer him up although result is quite the opposite.
As an aside, I’ve earned the enmity of SIO for this article in Nature Reviews Cancer:
Particularly hilarious was SIO’s pique at my criticizing it for admitting naturopaths as members. (Indeed, a naturopath was one of the co-authors of the guidelines Prof. Ernst excoriates.) Another criticism was over my discussion of homeopathy in the paper. The SIO responded that there’s no way homeopathy could be a part of integrative oncology because it’s such obvious pseudoscience. My response was to point out that homeopathy is a major part of the training of naturopaths and that the NPLEX (the naturopathic licensing exam) tests naturopaths-to-be on homeopathy. Then I pointed out that Dugald Seely, the naturopath who is a co-author of the SIO guidelines, is the principle investigator of a clinical trial of homeopathy! Seriously, though. the SIO has no clue how much pseudoscience it is embracing. It really does think itself to be evidence- and science-based.
Ernst’s Law: if you are writing about alternative medicine and the quacks don’t hate you, you’re doing it wrong 🙂
see also my article published in the MJA today:
As Ernst rightly calls it, the article must be retracted. But what the hell is going on? Why the article appeared in the Journal of the National Cancer Institute in the first place is the biggest head-slapper. What happened in the peer review process is even more of a mystery, although we can guess what happened; the Editor obviously dropped the ball.
see also this article just out:
You people behave like a pack of hungry hounds, barking up the wrong tree. CAM and therapies like acupuncture are sought after only because conventional medicine too often makes patients suffer progressively, causing deformity, amputations, joint replacements, disability and premature deaths that are completely avoidable.
Instead of learning to improve your knowledge and skill to secure improvement in health and wellbeing, and in the prevention, diagnosis and treatment of illness, and to safeguard life expectancy, your pack waste energy egging one another on to attack everything you choose not to understand.
I do not know how many people die each year from homeopathy, acupuncture and all CAM therapies put together but NHS Information Centre reveals that conventional treatment results in killing 70-75,000 diabetic patients every year, including 24,000 deaths that can be avoided if the NHS provided better information, advice, management or treatment of this condition.
In 2010/11, the NHS spent £9.8bn of taxpayers’ money, about 10% of the NHS’ annual budget, on treatment that killed 24,000 patients needlessly. The NHS then forced social services, employment support and local councils to find a further £13.9bn a year to pay for patients conventional medicine made disabled or unfit for work, until they die prematurely. £23.7bn a year is a lot of money to waste every year.
Millions of Britons are suffering needlessly every day and hundreds of thousands are dying needlessly every year because there are many incurable conditions in conventional medicine.
An incurable condition means that every drug and treatment available in conventional medicine is proved ineffective and harmful. If even one treatment is effective and safe, the condition cannot be said to be incurable.
For example, MS is said to be incurable. Can anyone explain why the NHS subjects MS patients to expensive drugs to weaken their immune system when no effective or safe treatment exists?
You don’t need to be a doctor to know that everyone dies when the immune system is weakened sufficiently. Every doctor knows that people with MS die early even though MS is not fatal. It is not rocket science that patients are killed by drugs and treatment doctors provide or fail to provide. If these drugs are effective and safe (as they all are proven effective and safe in robust clinical trials), no one would suffer progressively or die prematurely.
Every doctor knows from NHS statistics that patients subjected to the same drugs that have always resulted in progressive suffering and in shortening life expectancy will continue to suffer progressively and die prematurely. Subjecting anyone to any treatment, knowing that the treatment has always resulted in shortening life expectancy is murder. Why do you people attack homeopaths and acupuncturists while you let so many doctors get away with murder scot-free? Why do you let people with MS die prematurely and do nothing?
The driver of a train involved in 240 people dying needlessly will never be permitted to drive again, even if he is not prosecuted for murder or manslaughter.
Every doctor knows that 24,000 patients will die needlessly each year yet they carry on subjecting patients to the same treatment that will result in killing another 24,000 patients this year and every year.
This is the kind of madness you mindlessly support. Isn’t it insensitive and hypocritical to tell others what treatment they should have or not have, when you do nothing to prevent 24,000 people from dying needlessly from diabetes alone each year?
it seems to me that you are barking from the tree of logical fallacy.
Edzard and Alan
“it seems to me that you….”
It does not seem so. It is very clear that Mr Alex took off your clothes along with the fig leaf of scientific pretension of the claimed benefits of scientific medicine.
It seems to me you couldn’t spot a logical fallacy if your life depended on it.
How many of your hundreds of thousands of diabetic countrymen you could save from getting killed by doctor’s errors by explaining one epsom death in India? Or will save in the coming years?
That is the intended result of your logical fallacy?
Oops! There you go again.
What is your suggestion to save those countrymen Iqbal? Glucosum 30C and to stay away from doctors?
“…… to stay away from doctors?………”
Keep away from doctors who use physics and chemistry to solve human illness. First mix medication to create diabetic patients and then, glucose control in diabetic patients.
“One thing not yet adequately embraced by evidence-based medicine is what to do for someone with diabetes, hypertension, heart disease, and depression,” explains Kaiser’s Wallace. Doctors now typically try to treat the most pressing problems. “But we fail to pick the right ones consistently, so we have misdirected utilization and a great deal of waste,” he says. Kaiser Permanente’s Dr. Jim Dudl had a counterintuitive suggestion. With diabetics, doctors assume that keeping blood sugar levels low and consistent is the best way to ward off problems such as heart disease. But Dudl wondered what would happen if he flipped it around, aiming treatment at the downstream problems. The idea is to give patients a trio of generic medicines: aspirin, a cholesterol-lowering statin, and drugs called ACE inhibitors.
Using Archimedes and thousands of virtual patients, Eddy and Schlessinger compared the traditional approach with the drug combination. The model took about a half-hour to simulate a 30-year trial, and showed that the three-drug combination was “cost- and life-saving,” says Kaiser’s Wallace. The benefits far surpassed “what can be achieved with aggressive glucose control.” Kaiser Permanente docs switched their standard of care for diabetes, adding these drugs to other interventions. It is too early to declare a victory, but the experience with patients seems to be mimicking Eddy’s computer model. “It goes against our mental picture of the disease,” says Wallace. But it also makes sense, he adds. “Cardiovascular disease is the worst complication of diabetes — and what people die of.”
The next stage will be to find out the outcome for this drug cocktail!
“Keep away from doctors who use physics and chemistry to solve human illness. First mix medication to create diabetic patients and then, glucose control in diabetic patients.”
“The trials found that when other factors were taken into account, those given the drug lived 15 per cent longer than those who were not on it – which could mean an extra three years’ lifespan for the average pensioner.”
Do you care about 15% longer life expectancy? You want people to live 15% less, so that we can reduce the life expectancy Iqbal? Is this your homeopathic medical system?
“Prof Currie, a diabetes expert, said: “If I was borderline type 2, I really would want to be taking this drug.”
Simon O’Neill, Director of Health Intelligence at charity Diabetes UK, said the research demonstrated that metformin should be the first choice drug for all patients with Type 2 diabetes.”
Avoid drug cocktails and die from diabetes, the homeopathic system of Iqbal.
“The study said such advice could save 6,000 lives a year, preventing up to one third of cancers of the bowel, throat and stomach.”
Suggest patients to stay away from doctors, and kill 6,000 lives a year. And let people develop bowel, throat and stomach cancers. This is what Iqbal suggests. This is the homeopathic medicine system.
“The study, which involved 9,340 adults with type 2 diabetes and a high risk of a cardiovascular disease, also showed that participants given Victoza had a 22 percent lower chance of cardiovascular death. This was statistically significant. As an added bonus, those given Victoza lost about 5 pounds more than those who were on a placebo.”
Stay away from doctors that use chemistry and physics, and let 22% of diabetic people die from cardiovascular death. This is first-class homeopathy advice.
Good job Iqbal! Homeopathy advises people to die helpless while you pretend to cure their disease with water.
I see your arguments here in long form are no less fallacious than they are on Twitter.
You have some knowledge where from a number of these stupid diabetics got their disease from?
First prescribe Paroxetine and Pravastatin for imaginary problems that provides an opening to add drug for diabetes control.
Oops. The poor patient just keeled over.
Is this the great medicine you crow about?
It would be helpful to everyone if you could manage to get your comments under the comment you’re trying to respond to, don’t you think?
But thanks for demonstrating yet again your failure to grasp argumentation.
Your argumentation saved even “one” of the over 20000 diabetic patients killed by medical error?
LOL! It’s not my argumentation, Iqbal! But a basic understanding of how to construct arguments and what constitutes a logical fallacy are essential in any discussion about science. You should try it sometime.
“But a basic understanding of how to construct arguments and what constitutes a logical fallacy are essential in any discussion about science.”
I am extremely doubtful you understand medical science.
Edzard seems to value 1 Indian life more than 20000 British lives. UK really has gone to dogs.
Another red herring, Iqbal? But thanks for proving my point (again).
Medical science is a funny phrase to be seen as worded by Iqbal, someone who believes in sympathetic magic.
Iqbal, everyone! The legendary, the majestic, the one and only! Version 2.0 upgraded, includes conspiracy-theory plugin!
Fellow Iqbal, from this point on, whatever point you are trying to make is almost certainly safe to ignore. You imagine things way too much to let reason keep the lead in the fight between delusion and rationality, a fight rationality has probably long lost.
Fresh, renewed, you once again drop by to explicitly express this persistent figment of your imagination, that medicine is a well-designed plan to kill people, and more excrementum vaccinium…mother tincture of course! The plans you expose could only be conceived by a mind as perversive and as malevolent against medicine, as yours.
Of course, doctors weren’t even aware of this effect of the specific drug combination until recently. For anyone around, the link above is a pretty decent read! To set things straight, I will only quote the concluding excerpt of the speaker, that is, what Iqbal didn’t read because he stopped reading after reaching the small subset of the comment that satisfied his delusional beliefs:
This is as reasonable a conclusion, as it gets. Iqbal’s conclusion, on the other hand, is as perversive as it gets.
And… fellow Iqbal’s points can safely be ignored.
It’s always a cocktail of drugs, fellow Iqbal. You will have to find far crazier and more delusional sources to supply credibility to the delusion you are addicted to. Your favorite delusion, homeopathy, does not cure anything, because it does not affect anything… because it contains nothing… but water, of course… shaken… of course!
“….you once again drop by to explicitly express this persistent figment of your imagination, that medicine is a well-designed plan to kill people…..”
If it was a plan designed to kill people, I will have no grudge. This would have been a perfect plan: kill people and make them pay for it. And go Scott free. The prefect murder.
The problem is that the allopathic medical system, promises poor patients suffering from various ailments, relief from these conditions and ends up killing them or making their lives more miserable, and gets them to pay for it.
“The plans you expose could only be conceived by a mind as perversive and as malevolent against medicine, as yours.”
Vioxx was designed by a sane mind? ME? Actos is designed by a sane mind? How many such cases of sane minds would you like me to state here? (What is the difference between sane and perverse when looked through the prism of money?) It does not matter what is the thought as sane or malevolent: the end result is important as that is the real measure.
“…doctors weren’t even aware of this effect of the specific drug combination until recently. For anyone around, the link above is a pretty decent read! To set things straight, I will only quote the concluding excerpt of the speaker…”
This is what homeopaths define as “pure unadulterated allopathic medical system”. The doctor offers patient one tablet for symptom one, second for symptom 2, third for symptom 3 without a thought. Because of the 3 tablets taken together, as the doctor has no knowledge of outcome, the patient develops new symptom for which doctor adds a new tablet. The patient is now primed for an additional tablet.
Do you know the outcome after the patients with cholesterol, hypertension and now diabetes starts the new tablet: cancer from mixing 3 tablets? Cardiac issue requiring bypass?
Doctors creating patients: this is the mess I call “perversive and as malevolent as it can get.”
“…….. sad story. The two drugs actually caused problems. They increased glucose. They could throw somebody into diabetes who would otherwise not be in diabetes, and so you would want to use the two drugs very carefully together, perhaps not together, make different choices when you’re prescribing.”
The doctor stopped short. He could have checked the outcome with patients that added the diabetes tablet: new 3 drug combination. What do you expect him to find? A new disease? Cancer?
“It’s always a cocktail of drugs,..”
I am aware. Are you aware of the outcome? The patient is cured of HIV and dies of drug interaction!!!!!!
“However, there’s a couple of things. We don’t just use pairs of drugs at a time. As I said before, there are patients on three, five, seven, nine drugs. Have they been studied with respect to their nine-way interaction? Yes, we can do pair-wise, A and B, A and C, A and D, but what about A, B, C, D, E, F, G all together, being taken by the same patient, perhaps interacting with each other in ways that either makes them more effective or less effective or causes side effects that are unexpected? We really have no idea. It’s a blue sky, open field for us to use data to try to understand the interaction of drugs.”
Evidence based medicine: who is being conned?
Ban paracetamol, and stop antibiotics…
Ooops… 25000 people died. Not a good end-result.
Maybe you don’t care about stroke patients fellow Iqbal.
Focus on one death from paracetamol overdose and pretend you don’t see 25000 people die. This is your idea of a homeopathic medicine system?
There is no requirement to jump the gun.
“The study, which will involve almost 4,000 patients from around Europe, will test whether offering the relatively low-cost drugs immediately following a stroke would reduce the risk of these complications occurring.
Those receiving preventative care will be offered paracetamol to prevent high fevers and antibiotics to lower the risk of infections.
Professor Malcolm Macleod, from the University of Edinburgh’s Centre for Clinical Brain Sciences, who is leading the study in the UK, said: “We have made great progress in treating stroke, but it still remains a major cause of death and disability.
“This new trial aims to understand how to use existing treatments most effectively and has the potential to reduce risk of death or disability for as many as 25,000 people each year, at very low costs.”
The trial was to start. The outcome is a forgone conclusion: wastage of 4 million pounds. It will show that more patients in the control group will die when followed up over 18 months.
Wow. For the first time in history, Iqbal reads the article to the end. You don’t seem to do that when you cite things from articles Iqbal. You always ignore what you don’t like.
OK! So when it does not support Iqbal’s opinion, it is rigged?
No, fellow Iqbal. The outcome is not a foregone conclusion! The trial will show what you don’t want to believe because your brain is immune to reality. But, of course, you can keep your eyes closed and pretend that it is all a conspiracy. These are the rules in the homeopathic medicine system. Follow or burn in fire together with rationality.
“it is rigged?”
No. Sheer stupidity.
The article appeared in July 2015. Why not check outcome. It is easy to predict outcome.
At 18 month follow up, more patients from the treated group will die. The stupid doctors don’t seem to understand the benefits associated with fever.