The ketogenic diet (KD) is a currently popular high-fat, low-carbohydrate diet; it limits the intake of glucose which results in the production of ketones by the liver and their uptake as an alternative energy source by the brain. KD is an effective treatment for intractable epilepsy. In addition, it is being promoted as a so-called alternative medicine (SCAM) for a wide range of conditions, including:
- weight loss,
- cognitive and memory enhancement,
- type II diabetes,
- neurological and psychiatric disorders.
However, these indications are not supported by good evidence.
A side effect of KD is “keto flu,” a syndrome of transient symptoms generally reported as occurring within the first few weeks of adhering to the diet. These symptoms can feel similar to the flu and are caused by the body adapting to a new diet consisting of very little carbohydrates.
Ketones are by-products of fat breakdown and become the main energy source when following the KD. Normally, fat is reserved as a secondary fuel source to use when glucose is not available. This switch to burning fat for energy is called ketosis. It occurs during specific circumstances, including starvation, fasting … or KD. The KD reduces carbohydrates typically to under 50 grams per day. This drastic reduction may cause withdrawal-like symptoms, similar to those experienced when weaning off an addictive substance.
A recent paper aimed to characterize the pattern of symptoms, severity and time course of keto flu as related by users of online forums. Online forums referring to “keto flu,” “keto-induction,” or “keto-adaptation” in the URL were identified. Passages describing personal experiences of keto flu were categorized with reference to pattern of symptoms, severity, time course, and remedies proposed.
The search criteria identified 75 online forums, 43 met inclusion criteria and contained 448 posts from 300 unique users. Seventy-three made more than one post (mean 3.12, range 2-11). Descriptors of personal experience of keto flu, reported by 101 of 300 users, included 256 symptom descriptions involving 54 discrete symptoms. Commonest symptoms were “flu,” headache, fatigue, nausea, dizziness, “brain fog,” gastrointestinal discomfort, decreased energy, feeling faint and heartbeat alterations.
Symptom reports peaked in the first and dwindled after 4 weeks. Resolution of keto flu symptoms was reported by 8 users between days 3 and 30 (median 4.5 ). Severity of symptoms, reported by 60 users in 40 forums, was categorized as mild (N = 15), moderate (N = 23), or severe (N = 22). Eighteen remedies were proposed by 121 individual users in 225 posts. The following treatments were most frequently recommended (numbers represent the number of times of each recommendation was made):
|Increase sodium intake||58|
|Supplement with electrolytes||38|
|Drink broth (including bone broth, stock cubes)||27|
I find this paper interesting, not least because of the unusual methodological approach. It seems to confirm that, even though the KD is often recommended as safe, it is associated with significant side-effects. One adverse effect remained unmentioned, while leading to more people discontinuing the diet than any other side-effect: the fact that the diet is quite unpalatable on the long-run and soon puts people off eating. This, of course, might be one mechanism by which KD leads to weight loss.
Spermidine is a polyamine which is a natural component of our cells. It has its name from the fact that it was first found in sperm. It can also be found in varying concentrations in different fruits, vegetables, meat and cheese. About one third of the spermidine levels in our body is produced by our own cells, the rest is absorbed through food and certain bacteria found in our digestive tract. A balanced diet can therefore help maintain high levels of spermidine.
There has been a flurry of research into spermidine, not least because epidemiologic evidence supports to the concept that nutrition rich in spermidine is linked to increased survival in humans. Unsurprisingly, many spermidine supplements are now available for sale (at around £50 for one month’s supply). In order to check whether there is any clinical evidence to suggest that they are effective, I ran a quick Medline search for placebo-controlled, double-blind RCTs. I found 4 such studies; here are their abstracts:
Introduction: Nutritional intervention with the natural polyamine spermidine, an autophagy-enhancing agent, can prevent memory loss in aging model organisms. This is the first human study to evaluate the impact of spermidine supplementation on memory performance in older adults at risk for the development of Alzheimer’s disease.
Methods: Cognitively intact participants with subjective cognitive decline (n = 30, 60-80 years of age) were included in this three-months, randomized, placebo-controlled, double-blind Phase IIa pilot trial with a spermidine-rich plant extract supplement. Effects of intervention were assessed using the behavioral mnemonic similarity task, measured at baseline and post-intervention visits. Data analysis was focused on reporting and interpreting effectiveness based on effect sizes.
Results: Memory performance was moderately enhanced in the spermidine group compared with placebo at the end of intervention [contrast mean = .17, 95% confidence interval (CI): -.01, .35, Cohen’s d = .77, 95% CI: 0, 1.53]. Mnemonic discrimination ability improved in the spermidine-treated group with a medium effect size (mean difference = -.11, 95% CI: -.19, -.03, Cohen’s d = .79, 95% CI: .01, 1.55). A similar effect was not found in the placebo-treated group (mean difference = .07, 95% CI: -.13, .27, Cohen’s d = -.20, 95% CI: -.94, .54).
Discussion: In this pilot trial, nutritional spermidine was associated with a positive impact on memory performance in older adults with subject cognitive decline. The beneficial effect might be mediated by stimulation of neuromodulatory actions in the memory system. A follow-up Phase IIb randomized controlled trial will help validate the therapeutic potential of spermidine supplementation and delineate possible neurophysiological mechanisms of action.
Supplementation of spermidine, an autophagy-inducing agent, has been shown to protect against neurodegeneration and cognitive decline in aged animal models. The present translational study aimed to determine safety and tolerability of a wheat germ extract containing enhanced spermidine concentrations. In a preclinical toxicity study, supplementation of spermidine using this extract did not result in morbidities or changes in behavior in BALBc/Rj mice during the 28-days repeated-dose tolerance study. Post mortem examination of the mice organs showed no increase in tumorigenic and fibrotic events. In the human cohort (participants with subjective cognitive decline, n=30, 60 to 80 years of age), a 3-month randomized, placebo-controlled, double-blind Phase II trial was conducted with supplementation of the spermidine-rich plant extract (dosage: 1.2 mg/day). No differences were observed between spermidine and placebo-treated groups in vital signs, weight, clinical chemistry and hematological parameters of safety, as well as in self-reported health status at the end of intervention. Compliance rates above 85% indicated excellent tolerability. The data demonstrate that spermidine supplementation using a spermidine-rich plant extract is safe and well-tolerated in mice and older adults. These findings allow for longer-term intervention studies in humans to investigate the impact of spermidine treatment on cognition and brain integrity.
Recently, it was demonstrated that spermidine-induced autophagy reduces the risk of cardiovascular disease in mice. Intestinal bacteria are a major source of polyamines, including spermidine. We previously reported that the intake of both Bifidobacterium animalis subsp. lactis (Bifal) and arginine (Arg) increases the production of putrescine, a spermidine precursor, in the gut. Here, we investigated the effects of Bifal and Arg consumption on endothelial function in healthy subjects. Healthy individuals with body mass index (BMI) near the maximum value in the “healthy” range (BMI: 25) (n = 44) were provided normal yogurt containing Bifal and Arg (Bifal + Arg YG) or placebo (normal yogurt) for 12 weeks in this randomized, double-blinded, placebo-controlled, parallel-group comparative study. The reactive hyperemia index (RHI), the primary outcome, was measured using endo-peripheral arterial tone (EndoPAT). The change in RHI from week 0 to 12 in the Bifal + Arg YG group was significantly higher than that in the placebo group, indicating that Bifal + Arg YG intake improved endothelial function. At week 12, the concentrations of fecal putrescine and serum putrescine and spermidine in the Bifal + Arg YG group were significantly higher than those in the placebo group. This study suggests that consuming Bifal + Arg YG prevents or reduces the risk of atherosclerosis.
Background: Spermidine has been shown both in vitro and in mice models to have an anagen-prolonging effect on hair follicles (HFs).
Objectives: To evaluate the effects of a spermidine-based nutritional supplement on the anagen phase of HFs in healthy human subjects in a randomized, double-blind, placebo-controlled trial.
Methods: One hundred healthy males and females were randomized to receive a tablet containing a spermidine-based nutritional supplement or a placebo once daily for 90 days. At the beginning and the end of the treatment period, 100 HFs were plucked and subjected to microscopic evaluation to determine the number of anagen V-VI HFs, and immunohistochemical examination was performed to quantify the Ki-67 and c-Kit levels in the hair bulbs. Pull test was performed after three and six months.
Results: The spermidine-based nutritional supplement increased the number of anagen V-VI HFs after three months of treatment, accompanied by increased Ki-67, a marker for cellular proliferation, and decreased c-Kit, a marker for apoptosis, levels. All results were also significantly better when compared to the placebo group. The pull test remained negative after six months in all patients receiving the spermidine supplement, while 68% of the subjects in the placebo group had a positive pull test.
Conclusions: This preliminary study shows that a spermidine-based nutritional supplement can prolong the anagen phase in humans, and therefore might be beneficial for hair loss conditions. Further studies are needed to evaluate its effects in specific different clinical settings.
I could certainly do with a few more hair on my head.
And living longer with less cognitive decline would also be not a bad prospect.
Do I therefore rush to the next health food shop to buy a spermidine supplement?
Yes, the evidence – particularly the pre-clinical one – is fascinating. But it seems to me that a normal diet will provide all the spermidine I need (and for £50 I can buy a lot of good food).
The researchers identified the top 100 best-selling books and assessed for both the claims they make in their summaries and the credentials of the authors. Weight loss was a common theme in the summaries of nutritional best-selling books. In addition to weight loss, 31 of the books promised to cure or prevent a host of diseases, including diabetes, heart disease, cancer, and dementia.
The nutritional advice given to achieve these outcomes varied widely in terms of which types of foods should be consumed or avoided and this information was often contradictory between books. Recommendations regarding the consumption of carbohydrates, dairy, proteins, and fat in particular differed greatly between books.
To determine the qualifications of each author in making nutritional claims, the highest earned degree and listed occupations of each author was researched and analyzed. Out of 83 unique authors, 33 had an M.D. or Ph.D degree. Twenty-eight of the authors were physicians, three were dietitians, and other authors held a wide range of jobs, including personal trainers, bloggers, and actors. Of 20 authors who had or claimed university affiliations, seven had a current university appointment that could be verified online in university directories.
The authors concluded that this study illuminates the range of the incongruous information being dispersed to the public and emphasizes the need for future efforts to improve the dissemination of sound nutritional advice.
The authors also provide a ‘sample of claims that appear disputable and/or unsubstantiated according to our expertize and opinion’:
1. “Carbs are destroying your brain”—Grain Brain
2. “Have high blood pressure? Hibiscus tea can work better than a leading hypertensive drug-and without the side effects. Fighting off liver disease? Drinking coffee can reduce liver inflammation. Battling breast cancer? Consuming soy is associated with prolonged survival.”—How Not to Die
3. “Zero Belly diet attacks fat on a genetic level, placing a bull’s-eye on the fat cells that matter most: visceral fat, the type of fat ensconced in your belly.”—Zero Belly Diet
4. “SKIP THE CRUNCHES: They just build muscle under the fat…LESS (EXERCISE) IS MORE”—This Is Why You’re Fat (And How to Get Thin Forever)
5. “Eating pasta, bread, potato, and pizza will actually make you happier, healthier, and thinner—for good”—The Carb Lovers Diet
6. “Skip breakfast, stop counting calories, eat high levels of healthy saturated fat, work out and sleep less, and add smart supplements”—The Bulletproof Diet
7. “Modern “improvements” to our food supply—including refrigeration, sanitation, and modified grains—have damaged our intestinal health. Dr. Axe offers simple ways to get these needed microbes, from incorporating local honey and bee pollen into your diet to forgoing hand sanitizers and even ingesting a little probiotic-rich soil”—Eat Dirt
8. “Overeating doesn’t make you fat; the process of getting fat makes you overeat.”—Always Hungry?
9. “Do you have an overall sense of not feeling your best, but it has been going on so long it’s actually normal to you? You may have an autoimmune disease, and this book is the “medicine” you need.”—The Immune System Recovery Plan
10. “Shows you how to grow new receptors for your seven metabolic hormones, making you lose weight and feel great fast!”—The Hormone Reset Diet
11. “The world’s foremost expert on the therapeutic use of culinary spices, takes an in-depth look at 50 different spices and their curative qualities, and offers spice “prescriptions”–categorized by health condition–to match the right spice to a specific ailment.”—Healing Spices
12. “The idea that people simply eat too much is no longer supported by science”—The Adrenal Reset Diet
13. “Most of us think God is not concerned with what we eat, but the Bible actually offers great insight and instruction about the effects of food on our bodies”—Let Food Be Your Medicine
14. “Dieters can actually lose weight by eating foods, nutrients, teas, and spices that change the chemical balance of the brain for permanent weight loss—a major factor contributing to how quickly the body ages. In fact, everyone can take years off their age by changing their brain chemistry.”—Younger (Thinner) You Diet
15. “Weight gain is not about the food, but about the body’s environment. Excess weight is a result of the body being in a toxic, inflammatory state. If your body is not prepared or ‘primed’ for weight loss, you will fight an uphill biochemical battle”—The Prime
16. “Throwing ice cubes in your water to make it more “structured”. Skipping breakfast, as it could be making you fat. Eating up to 75 percent of your calories each day in fat for optimal health, reduction of heart disease, and cancer prevention”—Effortless Healing
To call these statements ‘disputable’ must be the understatement of the year!
I have long been concerned about the dangerous rubbish published in so-called ‘self-help books’. In 1998, we assessed for the first time the quality of books on so-called alternative medicine (SCAM) [Int J Risk Safety Med 1998, 11: 209-215. [for some reason, this article is not Medline-listed]. We chose a random sample of 6 such books all published in 1997, and we assessed their contents according to pre-defined criteria. The findings were sobering: the advice given in these volumes was frequently misleading, not based on good evidence and often inaccurate. If followed, it would have caused significant harm to patients.
In 2006, we conducted a similar investigation the results of which we reported in the first and second editions of our book THE DESKTOP GUIDE TO COMPLEMENTARY AND ALTERNATIVE MEDICINE. This time, we selected 7 best-sellers in SCAM and scrutinised them in much the same way. We found that almost every treatment seemed to be recommended for almost every condition. There was no agreement between the different books which therapy might be effective for which condition. Some treatments were even named as indications for a certain condition, while, in other books, they were listed as contra-indications for the same problem. A bewildering plethora of treatments was recommended for most conditions, for instance:
- addictions: 120 different treatments
- arthritis: 131 different treatments
- asthma: 119 different treatments
- cancer: 133 different treatments
This experience, which we published as a chapter in the above-mentioned book entitled AN EPITAPH TO OPINION-BASED MEDICINE, confirmed our suspicion that books on SCAM are a major contributor to the misinformation in this area.
The new paper by Ioannidis et al adds substantially to all this. It shows that the problem is wide-spread and has not gone away. Since such books have a huge readership, they are a danger to public health. Now that the problem has been identified and confirmed, it is high time, I think, that we do something about it … but I wish I knew what.
If you, like many of us, have heavily ‘toxed’, you might now consider ‘detoxing’. What I mean is that we have probably all over-indulged a bit over the holidays. Unless you were the guest of someone, you had to pay dearly for it (Champagne is not cheap!). And now, a whole industry of ‘detox’ entrepreneurs tells you to pay again – this time, for detox.
As you payed ‘through your nose’ for the ‘tox’, you might as well use the same orifice for the ‘detox’. An Indian tradition called Nasiyam (or Nasyam? or Nasya? – I am confused!) makes it possible. This website explains:
Nasal Instillation (Nasyam) is the practice of instilling medicated oils, fresh juices of leaves or flowers in the nostrils … Nasyam is specially directed towards the purification of various parts related to the head…
I don’t know about you, but I always felt that all my parts were related to my head! So, Nasyam is for purification of all my parts? The announcement below – I picked it up on Twitter – is much clearer: detox through the nasal doorway! Who would refuse such an offer after the festivities of late?
This sounds fascinating, I thought. Thus I ran a quick Medline search but only found this abstract:
Ardita (facial paralysis) is a medical condition that disfigures or distorts the facial appearance of the sufferer causing facial asymmetry and malfunction. Ardita patients may benefit from considering alternative treatments such as Ayurveda, including Taila Nasya (nasal instillation of medicated oil).
To synthesize the best available evidence on the effectiveness of different Nasya oils in the treatment of Ardita.
INCLUSION CRITERIA TYPES OF PARTICIPANTS:
Studies conducted on adult sufferers (18-70 years) of Ardita (chronic or acute) in any setting were considered. Studies including participants who were pregnant or suffered allergic rhinitis, fever, intracranial tumor/hemorrhage and bilateral facial palsy were excluded.
Standalone treatment of Nasya (at all dosages and frequencies) compared to Nasya in combination with other Ayurvedic treatments was considered. Comparisons between different interventions including Taila Nasya alone, Taila Nasya in combination with other Ayurvedic interventions and Ayurvedic interventions that did not include Taila Nasya were also considered.
OUTCOMES AND MEASURES:
Changes in Ardita symptoms, including facial distortion, speech disorders and facial pain, were measured.
TYPES OF STUDIES:
All quantitative study designs (experimental, quasi-experimental and observational) were considered.
Relevant studies were identified following a comprehensive literature search. References provided within these key studies identified additional resources. Indian universities were also contacted for results of Ardita studies undertaken in their institutions.A three-step search strategy aimed to find studies of published and unpublished studies was undertaken. Studies published in the English language were considered for inclusion, irrespective of publication date/year. Following an initial limited search of MEDLINE and CINAHL, the text words contained in the title and abstract, and of the index terms used to describe each articles were analyzed. From the identified keywords and index terms, searches were undertaken across all relevant databases such as PubMed, CINHAL, Cochrane (CENTRAL), Scopus, Centre for Review and Dissemination databases, Turning Research into Practice (TRIP), EMBASE, EBM Reviews, DHARA, Google Scholar, MedNar and ProQuest Dissertations. Finally, reference lists of identified theses and articles were searched for additional studies. Universities and website operators related to Ayurvedic research in India were contacted, including the National Institute of Ayurveda for relevant studies. Besides this, the University of Adelaide librarian was contacted to retrieve those studies identified in the reference lists of theses and articles.
Studies were critically assessed by the review author and a secondary reviewer prior to inclusion in the review using the standardized critical appraisal instrument from the Joanna Briggs Institute.
Data was extracted by the primary reviewer using the standardized data extraction tool from the Joanna Briggs Institute.
Different interventions and comparators across studies precluded meta-analysis. Narrative synthesis was performed.
Only two pseudo randomized studies with a small number of participants met inclusion criteria and were included in the review. One study with 20 participants, divided equally into two groups compared the effectiveness of two nasal instillations in alleviating four Ardita symptoms. The second study of 15 participants each in two groups compared the effectiveness of nasal instillation with placement of medicated oil on the head on seven Ardita symptoms. Observational measurements of Ardita symptoms were graded as Mild, Moderate or Marked at baseline and after one month. The study conducted on 30 participants using Nasya intervention showed participants had better relief from the symptoms of facial pain, speech disorder and earache within the range of 78.2% to 90.9%, graded as Marked. Along with statistical data available in the studies, this review found low levels of evidence favoring Taila Nasya intervention. The review did not include any studies examining effectiveness of Nasya compared to conventional treatment for Ardita.
This review presents extremely limited evidence from only two small experimental studies that administration of Nasya oil alone may provide some relief from Ardita symptoms of facial distortion, speech disorder, inability to shut eyelids/upward eye rolling and dribbling of saliva in adult patients. No strong conclusions may be drawn from the evidence included in the review due to the limited number of studies, limited number of participants and poor quality of studies.
IMPLICATIONS FOR PRACTICE:
Practitioners should advice Ardita patients that there is extremely limited evidence suggesting the potential effectiveness of Nasya oils alone or Nasya in conjunction with other Ayurvedic treatments in managing symptoms. However, given the absence of a strong evidence base, practitioners should be guided by clinical wisdom and patient preference.
IMPLICATIONS FOR RESEARCH:
Well controlled clinical trials comparing standalone Nasya therapy to other Ayurvedic treatments and/or conventional medicine for Ardita symptoms need to be conducted to examine the relative effectiveness of different Nasya oils in treating.
I think you agree, that’s nothing to write home about.
So, on second thought I might give Nasya (or whatever it is called) a miss. The same applies, by the way, to any other form of detox.
On Twitter, I recently found this remarkable advertisement:
Naturally, it interested me. The implication seemed to be that we can boost our immune system and thus protect ourselves from colds, the flu and other infections by using this supplement. With the flu season approaching, this might be important. On the other hand, the supplement might be unsafe for many other patients. As I had done a bit of research in this area, I needed to know more.
According to the manufacturer’s information sheet, Viracid
- Provides Support for Immune Challenges
- Strengthens Immune Function
- Maintains Normal Inflammatory Balance
The manufacurer furthermore states the following:
Our body’s immune system is a complex and dynamic defense system that comes to our rescue at the first sign of exposure to an outside invader. The dynamic nature of the immune system means that all factors that affect health need to be addressed in order for it to function at peak performance. The immune system is very sensitive to nutrient deficiencies. While vitamin deficiencies can compromise the immune system, consuming immune enhancing nutrients and botanicals can support and strengthen your body’s immune response. Viracid’s synergistic formula significantly boosts immune cell function including antibody response, natural killer (NK) cell activity, thymus hormone secretions, and T-cell activation. Viracid also helps soothe throat irritations and nasal secretions, and maintains normal inflammatory balance by increasing antioxidant levels throughout the body.
This sounds impressive. Viracid could thus play an important role in keeping us healthy. It could also be contra-indicated to lots of patients who suffer from autoimmune and other conditions. In any case, it is worth having a closer look at this dietary supplement. The ingredients of the product include:
- Vitamin A,
- Vitamin C,
- Vitamin B12,
- Pantothenic Acid,
- L-Lysine Hydrochloride,
- Echinacea purpurea Extract,
- Acerola Fruit,
- Andrographis paniculata,
- European Elder,
- Berry Extract,
- Astragalus membranaceus Root Extract
Next, I conducted several literature searches. Here is what I did NOT find:
- any clinical trial of Viracid,
- any indication that its ingredients work synergistically,
- any proof of Viracid inducing an antibody response,
- or enhancing natural killer (NK) cell activity,
- or thymus hormone secretions,
- or T-cell activation,
- or soothing throat irritations,
- or controlling nasal secretions,
- or maintaining normal inflammatory balance,
- any mention of contra-indications,
- any reliable information about the risks of taking Viracid.
There are, of course, two explanations for this void of information. Either I did not search well enough, or the claims that are being made for Viracid by the manufacturer are unsubstantiated and therefore bogus.
Which of the two explanations apply?
Please, someone – preferably the manufacturer – tell me.
It is hard to deny that many practitioners of so-called alternative medicine (SCAM) advise their patients to avoid ‘dangerous chemicals’. By this they usually mean prescription drugs. If you doubt how strong this sentiment often is, you have not followed the recent posts and the comments that regularly followed. Frequently, SCAM practitioners will suggest to their patients to not take this or that drug and predict that patients would then see for themselves how much better they feel (usually, they also administer their SCAM at this point).
Lo and behold, many patients do indeed feel better after discontinuing their ‘chemical’ medicines. Of course, this experience is subsequently interpreted as a proof that the drugs were dangerous: “I told you so, you are much better off not taking synthetic medicines; best to use the natural treatments I am offering.”
But is this always interpretation correct?
I seriously doubt it.
Let’s look at a common scenario: a middle-aged man on several medications for reducing his cardiovascular risk (no, it’s not me). He has been diagnosed to have multiple cardiovascular risk factors. Initially, his GP told him to change his life-style, nutrition and physical activity – to which he was only moderately compliant. Despite the patient feeling perfectly healthy, his blood pressure and lipids remained elevated. His doctor now strongly recommends drug treatment and our chap soon finds himself on statins, beta-blockers plus ACE-inhibitors.
Our previously healthy man has thus been turned into a patient with all sorts of symptoms. His persistent cough prompts his GP to change the ACE-inhibitor to a Ca-channel blocker. Now the patients cough is gone, but he notices ankle oedema and does not feel in top form. His GP said that this is nothing to worry about and asks him to grin and bear it. But the fact is that a previously healthy man has been turned into a patient with reduced quality of life (QoL).
This fact takes our man to a homeopath in the hope to restore his QoL (you see, it certainly isn’t me). The homeopath proceeds as outlined above: he explains that drugs are dangerous chemicals and should therefore best be dropped. The homeopath also prescribes homeopathics and is confident that they will control the blood pressure adequately. Our man complies. After just a few days, he feels miles better, his QoL is back, and even his sex-life improves. The homeopath is triumphant: “I told you so, homeopathy works and those drugs were really nasty stuff.”
When I was a junior doctor working in a homeopathic hospital, my boss explained to me that much of the often considerable success of our treatments was to get rid of most, if not all prescription drugs that our patients were taking (the full story can be found here). At the time, and for many years to come, this made a profound impression on me and my clinical practice. As a scientist, however, I have to critically evaluate this strategy and ask: is it the correct one?
The answer is YES and NO.
YES, many (bad) doctors over-prescribe. And there is not a shadow of a doubt that unnecessary drugs must be scrapped. But what is unnecessary? Is it every drug that makes a patient less well than he was before?
NO, treatments that are needed should not be scrapped, even if this would make the patient feel better. Where possible, they might be altered such that side-effects disappear or become minimal. Patients’ QoL is important, but it is not the only factor of importance. I am sure this must sound ridiculous to lay people who, at this stage of the discussion, would often quote the ethical imperative of FIRST DO NO HARM.
So, let me use an extreme example to explain this a bit better. Imagine a cancer patient on chemo. She is quite ill with it and QoL is a thing of the past. Her homeopath tells her to scrap the chemo and promises she will almost instantly feel fine again. With some side-effect-free homeopathy see will beat the cancer just as well (please, don’t tell me they don’t do that, because they do!). She follows the advice, feels much improved for several months. Alas, her condition then deteriorates, and a year later she is dead.
I know, this is an extreme example; therefore, let’s return to our cardiovascular patient from above. He too followed the advice of his homeopath and is happy like a lark for several years … until, 5 years after discontinuing the ‘nasty chemicals’, he drops dead with a massive myocardial infarction at the age of 62.
I hope I made my message clear: those SCAM providers who advise discontinuing prescribed drugs are often impressively successful in improving QoL and their patients love them for it. But many of these practitioners haven’t got a clue about real medicine, and are merely playing dirty tricks on their patients. The advise to stop a prescribed drug can be a very wise move. But frequently, it improves the quality, while reducing the quantity of life!
The lesson is simple: find a rational doctor who knows the difference between over-prescribing and evidence-based medicine. And make sure you start running when a SCAM provider tries to meddle with necessary prescribed drugs.
Robert Verkerk, Executive & scientific director, Alliance for Natural Health (ANH), seems to adore me (maybe that’s why I kept this post for Valentine’s Day?). In 2006, he published this article about me (it is lengthy, and I therefore shortened a bit, but feel free to study it in its full beauty):
START OF QUOTE
PROFESSOR EDZARD ERNST, the UK’s first professor of complementary medicine, gets lots of exposure for his often overtly negative views on complementary medicine. He’s become the media’s favourite resource for a view on this controversial subject…
The interesting thing about Prof Ernst is that he seems to have come a long way from his humble beginnings as a recipient of the therapies that he now seems so critical of. Profiled by Geoff Watts in the British Medical Journal, the Prof tells us: ‘Our family doctor in the little village outside Munich where I grew up was a homoeopath. My mother swore by it. As a kid I was treated homoeopathically. So this kind of medicine just came naturally. Even during my studies I pursued other things like massage therapy and acupuncture. As a young doctor I had an appointment in a homeopathic hospital, and I was very impressed with its success rate. My boss told me that much of this success came from discontinuing main stream medication. This made a big impression on me.’ (BMJ Career Focus 2003; 327:166; doi:10.1136/bmj.327.7425.s166)…
After his early support for homeopathy, Professor Ernst has now become, de facto, one of its main opponents. Robin McKie, science editor for The Observer (December 18, 2005) reported Ernst as saying, ‘Homeopathic remedies don’t work. Study after study has shown it is simply the purest form of placebo. You may as well take a glass of water than a homeopathic medicine.’ Ernst, having done the proverbial 180 degree turn, has decided to stand firmly shoulder to shoulder with a number of other leading assailants of non-pharmaceutical therapies, such as Professors Michael Baum and Jonathan Waxman. On 22 May 2006, Baum and twelve other mainly retired surgeons, including Ernst himself, bandied together and co-signed an open letter, published in The Times, which condemned the NHS decision to include increasing numbers of complementary therapies…
As high profile as the Ernsts, Baums and Waxmans of this world might be—their views are not unanimous across the orthodox medical profession. Some of these contrary views were expressed just last Sunday in The Sunday Times (Lost in the cancer maze, 10 December 2006)…
The real loser in open battles between warring factions in healthcare could be the consumer. Imagine how schizophrenic you could become after reading any one of the many newspapers that contains both pro-natural therapy articles and stinging attacks like that found in this week’s Daily Mail. But then again, we may misjudge the consumer who is well known for his or her ability to vote with the feet—regardless. The consumer, just like Robert Sandall, and the millions around the world who continue to indulge in complementary therapies, will ultimately make choices that work for them. ‘Survival of the fittest’ could provide an explanation for why hostile attacks from the orthodox medical community, the media and over-zealous regulators have not dented the steady increase in the popularity of alternative medicine.
Although we live in a technocratic age where we’ve handed so much decision making to the specialists, perhaps this is one area where the might of the individual will reign. Maybe the disillusionment many feel for pharmaceutically-biased healthcare is beginning to kick in. Perhaps the dictates from the white coats will be overruled by the ever-powerful survival instinct and our need to stay in touch with nature, from which we’ve evolved.
END OF QUOTE
Elsewhere, Robert Verkerk even called me the ‘master trickster of evidence-based medicine’ and stated that Prof Ernst and his colleagues appear to be evaluating the ‘wrong’ variable. As Ernst himself admitted, his team are focused on exploring only one of the variables, the ‘specific therapeutic effect’ (Figs 1 and 2). It is apparent, however, that the outcome that is of much greater consequence to healthcare is the combined effect of all variables, referred to by Ernst as the ‘total effect’ (Fig 1). Ernst does not appear to acknowledge that the sum of these effects might differ greatly between experimental and non-experimental situations.
Adding insult to injury, Ernst’s next major apparent faux pas involves his interpretation, or misinterpretation, of results. These fundamental problems exist within a very significant body of Prof Ernst’s work, particularly that which has been most widely publicised because it is so antagonistic towards healing cultures that have in many cases existed and evolved over thousands of years.
By example, a recent ‘systematic review’ of individualised herbal medicine undertaken by Ernst and colleagues started with 1345 peer-reviewed studies. However, all but three (0.2%) of the studies (RCTs) were rejected. These three RCTs in turn each involved very specific types of herbal treatment, targeting patients with IBS, knee osteoarthritis and cancer, the latter also undergoing chemotherapy, respectively. The conclusions of the study, which fuelled negative media worldwide, disconcertingly extended well beyond the remit of the study or its results. An extract follows: “Individualised herbal medicine, as practised in European medical herbalism, Chinese herbal medicine and Ayurvedic herbal medicine, has a very sparse evidence base and there is no convincing evidence that it is effective in any [our emphasis] indication. Because of the high potential for adverse events and negative herb-herb and herb-drug interactions, this lack of evidence for effectiveness means that its use cannot be recommended (Postgrad Med J 2007; 83: 633-637).
Robert Verkerk has recently come to my attention again – as the main author of a lengthy report published in December 2018. Its ‘Executive Summary’ makes the following points relevant in the context of this blog (the numbers in his text were added by me and refer to my comments below):
- This position paper proposes a universal framework, based on ecological and sustainability principles, aimed at allowing qualified health professionals (1), regardless of their respective modalities (disciplines), to work collaboratively and with full participation of the public in efforts to maintain or regenerate health and wellbeing. Accordingly, rather than offering ‘fixes’ for the NHS, the paper offers an approach that may significantly reduce the NHS’s current and growing disease burden that is set to reach crisis point given current levels of demand and funding.
- A major factor driving the relentlessly rising costs of the NHS is its over-reliance on pharmaceuticals (2) to treat a variety of preventable, chronic disorders. These (3) are the result — not of infection or trauma — but rather of our 21st century lifestyles, to which the human body is not well adapted. The failure of pharmaceutically-based approaches to slow down, let alone reverse, the dual burden of obesity and type 2 diabetes means wider roll-out of effective multi-factorial approaches are desperately needed (4).
- The NHS was created at a time when infectious diseases were the biggest killers (5). This is no longer the case, which is why the NHS must become part of a wider system that facilitates health regeneration or maintenance. The paper describes the major mechanisms underlying these chronic metabolic diseases, which are claiming an increasingly large portion of NHS funding. It identifies 12 domains of human health, many of which are routinely thrown out of balance by our contemporary lifestyles. The most effective way of treating lifestyle disorders is with appropriate lifestyle changes that are tailored to individuals, their needs and their circumstances. Such approaches, if appropriately supported and guided, tend to be far more economical and more sustainable as a means of maintaining or restoring people’s health (6).
- A sustainable health system, as proposed in this position paper, is one in which the individual becomes much more responsible for maintaining his or her own health and where more effort is invested earlier in an individual’s life prior to the downstream manifestation of chronic, degenerative and preventable diseases (7). Substantially more education, support and guidance than is typically available in the NHS today will need to be provided by health professionals (1), informed as necessary by a range of markers and diagnostic techniques (8). Healthy dietary and lifestyle choices and behaviours (9) are most effective when imparted early, prior to symptoms of chronic diseases becoming evident and before additional diseases or disorders (comorbidities) have become deeply embedded.
- The timing of the position paper’s release coincides not only with a time when the NHS is in crisis, but also when the UK is deep in negotiations over its extraction from the European Union (EU). The paper includes the identification of EU laws that are incompatible with sustainable health systems, that the UK would do well to reject when the time comes to re-consider the British statute books following the implementation of the Great Repeal Bill (10).
- This paper represents the first comprehensive attempt to apply sustainability principles to the management of human health in the context of our current understanding of human biology and ecology, tailored specifically to the UK’s unique situation. It embodies approaches that work with, rather than against, nature (11). Sustainability principles have already been applied successfully to other sectors such as energy, construction and agriculture.
- It is now imperative that the diverse range of interests and specialisms (12) involved in the management of human health come together. We owe it to future generations to work together urgently, earnestly and cooperatively to develop and thoroughly evaluate new ways of managing and creating health in our society. This blueprint represents a collaborative effort to give this process much needed momentum.
My very short comments:
- I fear that this is meant to include SCAM-practitioners who are neither qualified nor skilled to tackle such tasks.
- Dietary supplements (heavily promoted by the ANH) either have pharmacological effects, in which case they too must be seen as pharmaceuticals, or they are useless, in which case we should not promote them.
- I think ‘some of these’ would be more correct.
- Multifactorial yes, but we must make sure that useless SCAMs are not being pushed in through the back-door. Quackery must not be allowed to become a ‘factor’.
- Only, if we discount cancer and arteriosclerosis, I think.
- SCAM-practitioners have repeatedly demonstrated to be a risk to public health.
- All we know about disease prevention originates from conventional medicine and nothing from SCAM.
- Informed by…??? I would prefer ‘based on evidence’ (evidence being one term that the report does not seem to be fond of).
- All healthy dietary and lifestyle choices and behaviours that are backed by good evidence originate from and are part of conventional medicine, not SCAM.
- Do I detect the nasty whiff a pro-Brexit attitude her? I wonder what the ANH hopes for in a post-Brexit UK.
- The old chestnut of conventional medicine = unnatural and SCAM = natural is being warmed up here, it seems to me. Fallacy galore!
- The ANH would probably like to include a few SCAM-practitioners here.
Call me suspicious, but to me this ANH-initiative seems like a clever smoke-screen behind which they hope to sell their useless dietary supplements and homeopathic remedies to the unsuspecting British public. Am I mistaken?
You probably know what yoga is. But what is FODMAP? It stands for fermentable oligosaccharides, disaccharides, monosaccharides and polyols, more commonly known as carbohydrates. In essence, FODMAPs are carbohydrates found in a wide range of foods including onions, garlic, mushrooms, apples, lentils, rye and milk. These sugars are poorly absorbed, pass through the small intestine and enter the colon . There they are fermented by bacteria a process that produces gas which stretches the sensitive bowel causing bloating, wind and sometimes even pain. This can also cause water to move into and out of the colon, causing diarrhoea, constipation or a combination of both. Irritable bowel syndrome (IBS) makes people more susceptible to such problems.
During a low FODMAP diet these carbohydrates are eliminated usually for six to eight weeks. Subsequently, small amounts of FODMAP foods are gradually re-introduced to find a level of symptom-free tolerance. The question is, does the low FODMAP diet work?
This study examined the effect of a yoga-based intervention vs a low FODMAP diet on patients with irritable bowel syndrome. Fifty-nine patients with IBS undertook a randomised controlled trial involving yoga or a low FODMAP diet for 12 weeks. Patients in the yoga group received two sessions weekly, while patients in the low FODMAP group received a total of three sessions of nutritional counselling. The primary outcome was a change in gastrointestinal symptoms (IBS-SSS). Secondary outcomes explored changes in quality of life (IBS-QOL), health (SF-36), perceived stress (CPSS, PSQ), body awareness (BAQ), body responsiveness (BRS) and safety of the interventions. Outcomes were examined in weeks 12 and 24 by assessors “blinded” to patients’ group allocation.
No statistically significant difference was found between the intervention groups, with regard to IBS-SSS score, at either 12 or 24 weeks. Within-group comparisons showed statistically significant effects for yoga and low FODMAP diet at both 12 and 24 weeks. Comparable within-group effects occurred for the other outcomes. One patient in each intervention group experienced serious adverse events and another, also in each group, experienced nonserious adverse events.
The authors concluded that patients with irritable bowel syndrome might benefit from yoga and a low-FODMAP diet, as both groups showed a reduction in gastrointestinal symptoms. More research on the underlying mechanisms of both interventions is warranted, as well as exploration of potential benefits from their combined use.
Technically, this study is an equivalence study comparing two interventions. Such trials only make sense, if one of the two treatments have been proven to be effective. This is, however, not the case. Moreover, equivalence studies require much larger sample sizes than the 59 patients included here.
What follows is that this trial is pure pseudoscience and the positive conclusion of this study is not warranted. The authors have, in my view, demonstrated a remarkable level of ignorance regarding clinical research. None of this is all that unusual in the realm of alternative medicine; sadly, it seems more the rule than the exception.
What might make this lack of research know-how more noteworthy is something else: starting in January 2019, one of the lead authors of this piece of pseudo-research (Prof. Dr. med. Jost Langhorst) will be the director of the new Stiftungslehrstuhl “Integrative Medizin” am Klinikum Bamberg (clinic and chair of integrative medicine in Bamberg, Germany).
This does not bode well, does it?
Yesterday, I received a ‘LETTER FROM DR JONAS’ (the capital lettering was his) – actually, it was an email, and not a very personal one at that. Therefore I feel it might be permissible to share some of it here (you do remember Jonas, don’t you? I did mention him in a recent post: “Considering the prominence and experience of Wayne Jonas, the 1st author of this paper, such obvious transgression is more than a little disappointing – I would argue that is amounts to overt scientific misconduct.”)
Here we go:
As part of my book tour, I spent last month visiting hospitals and medical schools, talking to the doctors, nurses and students. I tell them to think of a chronically ill patient, and I ask:
“What matters most for this patient? What is the person’s lifestyle like – their nutrition, movement and sleep? How does that patient manage their stress? Does that patient have a good support system at home? What supplements does that patient take? Has your patient seen any CAM practitioners to cope with their condition? Why do they want to get well?”
Most can’t answer these questions. Providers may know the diagnosis and treatments a patient gets, but few know their primary determinants of health. They know ‘what’s the matter’, but not ‘what matters.’ …
END OF QUOTE
Let’s have a closer look at those items of which Jonas thinks they matter:
- What is the person’s lifestyle like – their nutrition, movement and sleep? Depending on the condition of the patient, these issues might indeed matter. And if they do, any good doctor will consider them. There is nothing new about this; it is stuff I learnt in medical school all those years ago.
- How does that patient manage their stress? The question supposes that all patients suffer from stress. I know it is fashionable to ‘have stress’, but not every patient suffers from it. If the patient does suffer, it goes without saying that a good doctor would consider it.
- Does that patient have a good support system at home? Elementary, my dear Watson! If a doctor does not know about this, (s)he has slept through medical school (where did you go to medical school Wayne, and what did you do during these 6 years?).
- What supplements does that patient take? That’s a good one. I suppose Jonas would ask it to see what further nonsense he might recommend. Most rational doctors would ask this question to see what (s)he must advise the patient to discontinue.
- Has your patient seen any CAM practitioners to cope with their condition? As above.
- Why do they want to get well? Most patients would assume we are pulling their leg, if we really asked this. Instead of a response, they might return a question: Why do you ask, do you think being ill is fun?
So, doctor Jonas’ questions might do well during lectures to a self-selected audience, but in reality they turn out to be a mixture of embarrassing re-discoveries from conventional medicine, platitudes and outright nonsense. “My goal is for integrative healthcare to become the standard of care…” says Jonas towards the end of his ‘LETTER’. I suppose, this explains it!
Thus Jonas’ ‘LETTER’ turns out to be yet another indication to suggest that the reality of ‘integrative medicine’ consists of little more than re-discoveries from conventional medicine, platitudes and outright nonsense.
During Voltaire’s time, this famous quote was largely correct. But today, things are very different, and I often think this ‘bon mot’ ought to be re-phrased into ‘The art of alternative medicine consists in amusing the patient, while medics cure the disease’.
To illustrate this point, I shall schematically outline the story of a patient seeking care from a range of clinicians. The story is invented but nevertheless based on many real experiences of a similar nature.
Tom is in his mid 50s, happily married, mildly over-weight and under plenty of stress. In addition to holding a demanding job, he has recently moved home and, as a consequence of lots of heavy lifting, his whole body aches. He had previous episodes of back trouble and re-starts the exercises a physio once taught him. A few days later, the back-pain has improved and most other pains have subsided as well. Yet a dull and nagging pain around his left shoulder and arm persists.
He is tempted to see his GP, but his wife is fiercely alternative. She was also the one who dissuaded Tom from taking Statins for his high cholesterol and put him on Garlic pills instead. Now she gives Tom a bottle of her Rescue Remedy, but after a week of taking it Tom’s condition is unchanged. His wife therefore persuades him to consult alternative practitioners for his ‘shoulder problem’. Thus he sees a succession of her favourite clinicians.
THE CHIROPRACTOR examines Tom’s spine and diagnoses subluxations to be the root cause of his problem. Tom thus receives a series of spinal manipulations and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE ENERGY HEALER diagnoses a problem with Tom’s vital energy as the root cause of his persistent pain. Tom thus receives a series of healing sessions and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE REFLEXOLOGIST examines Tom’s foot and diagnoses knots on the sole of his foot to cause energy blockages which are the root cause of his problem. Tom thus receives a series of most agreeable foot massages and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE ACUPUNCTURIST examines Tom’s pulse and tongue and diagnoses a chi deficiency to be the root cause of his problem. Tom thus receives a series of acupuncture treatments and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE NATUROPATH examines Tom and diagnoses some form of auto-intoxication as the root cause of his problem. Tom thus receives a full program of detox and feels a little improved each time. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore makes another appointment for him.
THE HOMEOPATH takes a long and detailed history and diagnoses a problem with Tom’s vital force to be the root cause of his pain. Tom thus receives a homeopathic remedy tailor-made for his needs and feels a little improved after taking it for a few days. But he is disappointed that the pain in the left shoulder and arm returns. His wife therefore tries to make another appointment for him.
But this time, Tom had enough. His pain has not really improved and he is increasingly feeling unwell.
At the risk of a marital dispute, he consults his GP. The doctor looks up Tom’s history, asks a few questions, conducts a brief physical examination, and arranges for Tom to see a specialist. A cardiologist diagnoses Tom to suffer from coronary heart disease due to a stenosis in one of his coronary arteries. She explains that Tom’s dull pain in the left shoulder and arm is a rather typical symptom of this condition.
Tom has to have a stent put into the affected coronary artery, receives several medications to lower his cholesterol and blood pressure, and is told to take up regular exercise, lose weight and make several other changes to his stressful life-style. Tom’s wife is told in no uncertain terms to stop dissuading her husband from taking his prescribed medicines, and the couple are both sent to see a dietician who offers advice and recommends a course on healthy cooking. Nobody leaves any doubt that not following this complex (holistic!) package of treatments and advice would be a serious risk to Tom’s life.
It has taken a while, but finally Tom is pain-free. More importantly, his prognosis has dramatically improved. The team who now look after him have no doubt that a major heart attack had been imminent, and Tom could easily have died had he continued to listen to the advice of multiple non-medically trained clinicians.
The root cause of his condition was misdiagnosed by all of them. In fact, the root cause was the atherosclerotic degeneration in his arteries. This may not be fully reversible, but even if the atherosclerotic process cannot be halted completely, it can be significantly slowed down such that he can live a full life.
My advice based on this invented and many real stories of a very similar nature is this:
- alternative practitioners are often good at pampering their patients;
- this may contribute to some perceived clinical improvements;
- in turn, this perceived benefit can motivate patients to continue their treatment despite residual symptoms;
- alternative practitioner’s claims about ‘root causes’ and holistic care are usually pure nonsense;
- their pampering may be agreeable, but it can undoubtedly cost lives.