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?
The objective of this ‘real world’ study was to evaluate the effectiveness of integrative medicine (IM) on patients with coronary artery disease (CAD) and investigate the prognostic factors of CAD in a real-world setting.
A total of 1,087 hospitalized patients with CAD from 4 hospitals in Beijing, China were consecutively selected between August 2011 and February 2012. The patients were assigned to two groups:
- Chinese medicine (CM) plus conventional treatment, i.e., IM therapy (IM group). IM therapy meant that the patients accepted the conventional treatment of Western medicine and the treatment of Chinese herbal medicine including herbal-based injection and Chinese patent medicine as well as decoction for at least 7 days in the hospital or 3 months out of the hospital.
- Conventional treatment alone (CT group).
The endpoint was a major cardiac event [MCE; including cardiac death, myocardial infarction (MI), and the need for revascularization].
A total of 1,040 patients finished the 2-year follow-up. Of them, 49.4% received IM therapy. During the 2-year follow-up, the total incidence of MCE was 11.3%. Most of the events involved revascularization (9.3%). Cardiac death/MI occurred in 3.0% of cases. For revascularization, logistic stepwise regression analysis revealed that age ⩾ 65 years [odds ratio (OR), 2.224], MI (OR, 2.561), diabetes mellitus (OR, 1.650), multi-vessel lesions (OR, 2.554), baseline high sensitivity C-reactive protein level ⩾ 3 mg/L (OR, 1.678), and moderate or severe anxiety/depression (OR, 1.849) were negative predictors (P<0.05); while anti-platelet agents (OR, 0.422), β-blockers (OR, 0.626), statins (OR, 0.318), and IM therapy (OR, 0.583) were protective predictors (P<0.05). For cardiac death/MI, age ⩾ 65 years (OR, 6.389) and heart failure (OR, 7.969) were negative predictors (P<0.05), while statin use (OR, 0.323) was a protective predictor (P<0.05) and IM therapy showed a beneficial tendency (OR, 0.587), although the difference was not statistically significant (P=0.218).
The authors concluded that in a real-world setting, for patients with CAD, IM therapy was associated with a decreased incidence of revascularization and showed a potential benefit in reducing the incidence of cardiac death or MI.
What the authors call ‘real world setting’ seems to be a synonym of ‘lousy science’, I fear. I am not aware of good evidence to show that herbal injections and concoctions are effective treatments for CAD, and this study can unfortunately not change this. In the methods section of the paper, we read that the treatment decisions were made by the responsible physicians without restriction. That means the two groups were far from comparable. In their discussion section, the authors state; we found that IM therapy was efficacious in clinical practice. I think that this statement is incorrect. All they have shown is that two groups of patients with similar diagnoses can differ in numerous ways, including clinical outcomes.
The lessons here are simple:
- In clinical trials, lack of randomisation (the only method to create reliably comparable groups) often leads to false results.
- Flawed research is currently being used by many proponents of SCAM (so-called alternative medicine) to mislead us about the value of SCAM.
- The integration of dubious treatments into routine care does not lead to better outcomes.
- Integrative medicine, as currently advocated by SCAM-proponents, is a nonsense.
Ginkgo biloba is a well-researched herbal medicine which has shown promise for a number of indications. But does this include coronary heart disease?
The aim of this systematic review was to provide information about the effectiveness and safety of Ginkgo Leaf Extract and Dipyridamole Injection (GD) as one adjuvant therapy for treating angina pectoris (AP) and to evaluate the relevant randomized controlled trials (RCTs) with meta-analysis. (Ginkgo Leaf Extract and Dipyridamole Injection is a Chinese compound preparation, which consists of ginkgo ﬂavone glycosides (24%), terpene lactones (ginkgolide about 13%, ginkgolide about 2.9%) and dipyridamole.)
RCTs concerning AP treated by GD were searched and the Cochrane Risk Assessment Tool was adopted to assess the methodological quality of the RCTs. A total of 41 RCTs involving 4,462 patients were included in the meta-analysis. The results indicated that the combined use of GD and Western medicine (WM) against AP was associated with a higher total effective rate [risk ratio (RR)=1.25, 95% confidence interval (CI): 1.21–1.29, P<0.01], total effective rate of electrocardiogram (RR=1.29, 95% CI: 1.21–1.36, P<0.01). Additional, GD combined with WM could decrease the level of plasma viscosity [mean difference (MD)=–0.56, 95% CI:–0,81 to–0.30, P<0.01], fibrinogen [MD=–1.02, 95% CI:–1.50 to–0.54, P<0.01], whole blood low shear viscosity [MD=–2.27, 95% CI:–3.04 to–1.49, P<0.01], and whole blood high shear viscosity (MD=–0.90, 95% CI: 1.37 to–0.44, P<0.01).
The authors concluded that comparing with receiving WM only, the combine use of GD and WM was associated with a better curative effect for patients with AP. Nevertheless, limited by the methodological quality of included RCTs more large-sample, multi-center RCTs were needed to confirm our findings and provide further evidence for the clinical utility of GD.
If one reads this conclusion, one might be tempted to use GD to cure AP. I would, however, strongly warn everyone from doing so. There are many reasons for my caution:
- All the 41 RCTs originate from China, and we have repeatedly discussed that Chinese TCM trials are highly unreliable.
- The methodological quality of the primary RCTs was, according to the review authors ‘moderate’. This is not true; it was, in fact, lousy.
- Dipyridamole is not indicated in angina pectoris.
- To the best of my knowledge, there is no good evidence from outside China to suggest that Ginkgo biloba is effective for angina pectoris.
- Angina pectoris is caused by coronary artery disease (a narrowing of one or more coronary arteries due to atherosclerosis), and it seems implausible that this condition can be ‘cured’ with any medication.
So, what we have here is yet another nonsensical paper, published in a dubious journal, employing evidently irresponsible reviewers, run by evidently irresponsible editors, hosted by a seemingly reputable publisher (Springer). This is reminiscent of my previous post (and many posts before). Alarmingly, it is also what I encounter on a daily basis when scanning the new publications in my field.
The effects of this incessant stream of nonsense can only have one of two effects:
- People take this ‘evidence’ seriously. In this case, many patients might pay with their lives for this collective incompetence.
- People conclude that alt med research cannot be taken seriously. In this case, we are unlikely to ever see anything useful emerging from it.
Either way, the result will be profoundly negative!
It is high time to stop this idiocy; but how?
I wish, I knew the answer.
After 25 years of full-time research into alternative medicine, I thought that I have seen it all. But I was wrong! Here is an article that surpasses every irresponsible stupidity I can remember. It is entitled ‘Ginger is the monumentally superior alternative to chemotherapy‘:
Let’s say that your doctor has given you a cancer diagnosis. Let’s revisit animal wisdom. If a squirrel was looking over a tasty morsel of ginger on one side, or a vial full of Mehotrexate, Danorubicin or Tioguanine on the other, what would that intelligent squirrel choose? The answer is obvious. And it’s the right answer, because ginger roots, after being dried and cooked, manifest an ingredient called 6-shogaol.
This naturally occurring element is up to 10,000 times more effective at killing cancer cells than those vials of destructive drugs, reports David Guiterrez from Natural News, who states that “researchers found that 6-shogaol is active against cancer stem cells at concentrations that are harmless to healthy cells. This is dramatically different from conventional chemotherapy, which has serious side effects largely because it kills healthy as well as cancerous cells.”
END OF QUOTE
As David Guiterrez from Natural News might not be the most reliable of sources, I did a bit of searching for evidence. This is what I found:
A study examining the efficacy of ginger, as an adjuvant drug to standard antiemetic therapy, in ameliorating acute and delayed CINV in patients with lung cancer receiving cisplatin-based regimens. It concluded that as an adjuvant drug to standard antiemetic therapy, ginger had no additional efficacy in ameliorating CINV in patients with lung cancer receiving cisplatin-based regimens.
A randomized, double-blind, placebo-controlled, multicenter study in patients planned to receive ≥2 chemotherapy cycles with high dose (>50 mg/m2) cisplatin. Patients received ginger 160 mg/day (with standardized dose of bioactive compounds) or placebo in addition to the standard antiemetic prophylaxis for CINV, starting from the day after cisplatin administration. The authors found that in patients treated with high-dose cisplatin, the daily addition of ginger, even if safe, did not result in a protective effect on CINV.
Yes, there are also a few trials to suggest that ginger is effective for reducing nausea and vomiting after chemotherapy, but by and large they are older and less rigorous. And anyway, this is besides the point. The question here is not whether there is good evidence to show that ginger is helpful against chemo-induced nausea; the question is whether Ginger is clinically effective in ‘killing cancer cells’. And the answer is an emphatic
And this means the above-quoted article irresponsible, unethical, perhaps even criminal to the extreme. I shudder to think how many cancer patients have read it and consequently given up their conventional treatments opting for Ginger instead.
The DAILY MAIL is by no means my favourite paper (see, for instance, here, here and here). This week, the Mail published another article which, I thought, is worth mentioning. The Mail apparently asked several UK doctors which dietary supplements they use for their own health (no mention of the number they had to approach to find any fitting into this category). The results remind me of a statement by the Permanent Secretary, Sir Humphrey Appleby in the famous TV series YES MINISTER: “if nobody knows anything then nobody can accuse anybody else of knowing nothing, and so the one thing we do know is that nobody knows anything, and that’s better than us knowing nothing”.
Below, I present the relevant quotes by the doctors who volunteered to be interviewed and add the most up-to date evidence on each subject.
Professor Christopher Eden, 57, is a consultant urological surgeon at the Royal Surrey County Hospital in Guildford.
“I take a 1g supplement of vitamin C daily. (The recommended daily amount, or RDA, is 40mg, which is equivalent to a large orange.) This amount of vitamin C makes the urine mildly acidic and increases the levels of an antimicrobial protein called siderocalin, found naturally in urine, which makes the environment less favourable to bad bacteria and reduces the risk of infection.”
Louise Newson, 48, is a GP and menopause specialist based in Stratford-upon-Avon.
“Women going through the menopause or perimenopause may get bowel symptoms such as bloating which are due to hormone imbalances affecting the balance of gut bacteria. Probiotic (good bacteria) supplements correct this imbalance and are also linked to levels of the brain chemical serotonin, which can improve mood. This is important during the menopause. I make sure I take a probiotic daily, specifically one with a high bacteria count including Lactobacillus acidophilus. I look for one that has to be kept in the fridge, as this is a sign of a quality product.”
Professor Tony Kochhar, 45, is a consultant orthopaedic surgeon at London Bridge Hospital.
“Having taken statins for a couple of years, I developed tendonitis, inflammation in the foot, which caused pain around the outside of it. My GP told me to stop taking the statins, which helped, and I now control my condition with diet. I also take a supplement of collagen (a natural protein found in the tendons) to build up tendon structure and reduce pain. I take two 1,200mg collagen supplements daily and it has really helped. Within two weeks of starting them, my pain had gone.”
Dr Anne Rigg, 51, is a consultant oncologist at London Bridge Hospital.
“One theory is that vitamin D may help control normal breast cell growth and may even stop breast cancer cells from growing. The body creates vitamin D from sunlight on the skin when we are outdoors, but because of the British weather and the rightful use of sunscreen, it’s easy to become deficient. I take the recommended daily dose of 10mcg. [Fatty fish such as salmon and mackerel are good sources, too, but you’d have to eat them in large amounts to get the recommended daily dosage.] It’s vital not to overdose, as it can increase the risk of kidney stones: the vitamin helps absorb calcium from the diet, which can build up into stones.”
Dr Rob Hogan, 62, is an optometrist at iCare Consulting.
“I’m aware, too, of the increased risk of age-related macular degeneration (AMD), a leading cause of sight loss in people over 60. This is where the small central portion of the retina (the macula) at the back of the eye deteriorates. So I take MacuShield, a supplement which, studies have found, can help improve vision and keep the back of the eye healthy. It contains a mixture of natural compounds — lutein, zeaxanthin and meso-zeaxanthin — which are antioxidants that have been found in studies to improve vision and eye health. I take one a day, usually with a meal.”
In early AMD, macular pigment can be augmented with a variety of supplements, although the inclusion of MZ may confer benefits in terms of panprofile augmentation and in terms of contrast sensitivity enhancement.
Dr Milad Shadrooh, 37, is a dentist in Basingstoke, Hampshire.
“I take a varied supplement daily to maintain good health and, specifically, healthy teeth. It contains calcium (an adult’s RDA is 700mg, which is equivalent to three 200ml cups of milk) as most people, including me, don’t get enough in their diet.”
Dr Joanna Gach, 49, is a consultant dermatologist at University Hospitals Coventry and Warwickshire NHS Trust.
“Every so often, I take a multivitamin capsule containing zinc, selenium and biotin. These are all helpful for sorting out my brittle nails and maintaining healthy hair.”
… no evidence supports the use of vitamin supplementation with vitamin E, vitamin C (ascorbic acid), vitamin A, retinoids, retinol, retinal, silicon, zinc, iron, copper, selenium, or vitamin B12 (Cyanocobalamin) for improving the nail health of well-nourished patients or improving the appearance of nails affected by pathologic disease.
Luke Cascarini, 47, is a consultant maxillofacial surgeon at Guy’s and St Thomas’ Hospital in London.
“I take a daily vitamin drink containing a high-dose vitamin B complex, which is necessary for good oral health.”
The published research reveals only a possible relationship between vitamins and minerals and periodontal disease. Vitamin E, zinc, lycopene and vitamin B complex may have useful adjunct benefits. However, there is inadequate evidence to link the nutritional status of the host to periodontal inflammation. More randomized controlled trials are needed to explore this association.
Dr Jenni Byrom, 44, is a consultant gynaecologist at Birmingham’s Women’s and Children’s Hospital.
“I take evening primrose oil for premenstrual symptoms such as breast pain. I take 1g of evening primrose oil daily and have found it really makes a difference.”
Evening primrose oil has not been shown to improve breast pain, and has had its licence withdrawn for this indication in the UK owing to lack of efficacy (it is still available to purchase without prescription).
Dr Sarah Myhill, 60, is a GP based in Wales.
“I take 10g of vitamin C dissolved in a glass of water every day before I start my shift — and I never get colds. I believe that high doses of vitamin C can kill bad microbes on contact — or, at least, help reduce the severity of infections such as colds and sore throats.”
Jonathan Dearing, 49, is a consultant orthopaedic surgeon specialising in sports injuries at BMI Carrick Glen Hospital in Ayrshire.
“I carry a vitamin D oral spray and use it after exercise, as it helps improve muscle recovery by regulating various processes that help them repair and grow.”
… supraphysiological dosages of vitamin D3 have potential ergogenic effects on the human metabolic system and lead to multiple physiological enhancements. These dosages could increase aerobic capacity, muscle growth, force and power production, and a decreased recovery time from exercise. These dosages could also improve bone density. However, both deficiency (12.5 to 50 nmol/L) and high levels of vitamin D (>125 nmol/L) can have negative side effects, with the potential for an increased mortality. Thus, maintenance of optimal serum levels between 75 to 100 nmol/L and ensuring adequate amounts of other essential nutrients including vitamin K are consumed, is key to health and performance. Coaches, medical practitioners, and athletic personnel should recommend their patients and athletes to have their plasma 25(OH)D measured, in order to determine if supplementation is needed. Based on the research presented on recovery, force and power production, 4000-5000 IU/day of vitamin D3 in conjunction with a mixture of 50 mcg/day to 1000 mcg/day of vitamin K1 and K2 seems to be a safe dose and has the potential to aid athletic performance. Lastly, no study in the athletic population has increased serum 25(OH)D levels past 100 nmol/L, (the optimal range for skeletal muscle function) using doses of 1000 to 5000 IU/day. Thus, future studies should test the physiological effects of higher dosages (5000 IU to 10,000 IU/day or more) of vitamin D3 in combination with varying dosages of vitamin K1 and vitamin K2 in the athletic population to determine optimal dosages needed to maximize performance.
Dr Glyn Thomas, 46, is a cardiologist and cardiac electrophysiologist at the Bristol Heart Institute.
“I take a magnesium supplement as it can help address an extra heartbeat — something I suffered with for 20 years.”
Firstly, let me congratulate those colleagues who actually might have got it right:
- Dr Hogan
- Dr Shadrooh
- Mr Cascarini
- Mr Dearing
I say ‘MIGHT HAVE GOT IT RIGHT’ because, even in their cases, the evidence is far from strong and certainly not convincing.
Secondly, let me commiserate those who spend their money on unproven supplements. I find it sad that this group amounts to two thirds of all the ‘experts’ asked.
Thirdly, let me remind THE DAILY MAIL of what I posted recently: journalists to be conscious of their responsibility not to mislead the public and do more rigorous research before reporting on matters of health. Surely, the Mail did us no favour in publishing this article. It will undoubtedly motivate lots of gullible consumers to buy useless or even harmful supplements.
And lastly, let me remind all healthcare professionals that promoting unproven treatments to the unsuspecting public is not ethical.
I regularly scan the new publications in alternative medicine hoping that I find some good quality research. And sometimes I do! In such happy moments, I write a post and make sure that I stress the high standard of a paper.
Sadly, such events are rare. Usually, my searches locate a multitude of deplorably poor papers. Most of the time, I ignore them. Sometime, I do write about exemplarily bad science, and often I report about articles that are not just bad but dangerous as well. The following paper falls into this category, I fear.
The aim of this systematic review was to assess the efficacy and safety of herbal medicines for the induction of labor (IOL). The researchers considered experimental and non-experimental studies that compared relevant pregnancy outcomes between users and non-user of herbal medicines for IOL.
A total of 1421 papers were identified and 10 studies, including 5 RCTs met the authors’ inclusion criteria. Papers not published in English were not considered. Three trials were conducted in Iran, two in the USA and one each in South Africa, Israel, Thailand, Australia and Italy.
The quality of the included trial, even of the 5 RCTs, was poor. The results suggest, according to the authors of this paper, that users of herbal medicine – raspberry leaf and castor oil – for IOL were significantly more likely to give birth within 24 hours than non-users. No significant difference in the incidence of caesarean section, assisted vaginal delivery, haemorrhage, meconium-stained liquor and admission to nursery was found between users and non-users of herbal medicines for IOL.
The authors concluded that the findings suggest that herbal medicines for IOL are effective, but there is inconclusive evidence of safety due to lack of good quality data. Thus, the use of herbal medicines for IOL should be avoided until safety issues are clarified. More studies are recommended to establish the safety of herbal medicines.
As I stated above, I am not convinced that this review is any good. It included all sorts of study designs and dismissed papers that were not in English. Surely this approach can only generate a distorted or partial picture. The risks of herbal remedies for mother and baby are not well investigated. In view of the fact that even the 5 RCTs were of poor quality, the first sentence of this conclusion seems most inappropriate.
On the basis of the evidence presented, I feel compelled to urge pregnant women NOT to consent to accept herbal remedies for IOL.
And on the basis of the fact that far too many papers on alternative medicine that emerge every day are not just poor quality but also dangerously mislead the public, I urge publishers, editors, peer-reviewers and researchers to pause and remember that they all have a responsibility. This nonsense has been going on for long enough; it is high time to stop it.
Evening primrose oil (EPO) is amongst the best-selling herbal remedies of all times. It is marketed in most countries as a dietary supplement. It is being promoted for eczema, rheumatoid arthritis, premenstrual syndrome, breast pain, menopause symptoms, and many other conditions. EPO seems to be a prime example for the fact that, in alternative medicine, the commercial success of a remedy is not necessarily determined by the strength of the evidence but by the intensity and cleverness of the marketing activities.
Evening primrose oil has been extensively tested in clinical trials for a wide range of conditions, including eczema (atopic dermatitis), postmenopausal symptoms, asthma, psoriasis, cellulite, hyperactivity, multiple sclerosis, schizophrenia, obesity, chronic fatigue syndrome, rheumatoid arthritis, and mastalgia. As I have reported previously, these data were burdened with mischief and scientific misconduct, and it is therefore not easy to differentiate between science, pseudoscience and fraud. The results of the more reliable investigations fail to show that it is effective for any condition. A Cochrane review of 2013, for instance, concluded that supplements of evening primrose oil lack effect on eczema; improvement was similar to respective placebos used in trials.
But now, a new study has emerged that casts doubt on this conclusion. The aim of this double-blinded, placebo-controlled RCT is to evaluate the efficacy and safety of EPO in Korean patients with atopic dermatitis (AD).
Fifty mild AD patients with an Eczema Area Severity Index (EASI) score of 10 or less were randomly divided into two groups. The first group received an oval unmarked capsule containing 450 mg of EPO (40 mg of GLA) per capsule, while placebo capsules identical in appearance and containing 450 mg of soybean oil were given to the other group. Treatment continued for a period of 4 months. EASI scores, transepidermal water loss (TEWL), and skin hydration were evaluated in all the AD patients at the baseline, and in months 1, 2, 3, and 4 of the study.
At the end of month 4, the patients of the EPO group showed a significant improvement in the EASI score, whereas the patients of the placebo group did not. There was a significant difference in the EASI score between the EPO and placebo groups. Although not statistically significant, the TEWL and skin hydration also slightly improved in the EPO patients group. Adverse effect were not found in neither the experimental group nor the control group during the study period.
The authors concluded by suggesting that EPO is a safe and effective medicine for Korean patients with mild AD.
I find this study odd for several reasons:
- One cannot possibly draw conclusions based on such a small sample.
- The authors state that a total of 69 mild AD patients were enrolled and randomized into either the control group (14 males and 17 females) or the EPO group (20 males and 18 females). Six patients in the control group and 13 patients in the EPO group dropped out due to follow up loss. No patient dropped out because the disease worsened. Should this not have necessitated an intention-to-treat analysis? And, if 19 patients were lost to follow-up, how do the authors know that their disease did not worsen?
- The graph shows impressively the lack of a placebo-response. I don’t understand why there was none.
- The authors state that there were no adverse effects at all. I find this implausible; we know that even taking placebos will prompt patients to report adverse effects.
So, what to make out of this?
I am not at all sure, but one thing is certain: this study does not alter my verdict on EPO; as far as I am concerned, the effectiveness of EPO for AD is unproven.
Psoriasis is one of those conditions that is
- not curable,
- irritating to the point where it reduces quality of life.
In other words, it is a disease for which virtually all alternative treatments on the planet are claimed to be effective. But which therapies do demonstrably alleviate the symptoms?
This review (published in JAMA Dermatology) compiled the evidence on the efficacy of the most studied complementary and alternative medicine (CAM) modalities for treatment of patients with plaque psoriasis and discusses those therapies with the most robust available evidence.
PubMed, Embase, and ClinicalTrials.gov searches (1950-2017) were used to identify all documented CAM psoriasis interventions in the literature. The criteria were further refined to focus on those treatments identified in the first step that had the highest level of evidence for plaque psoriasis with more than one randomized clinical trial (RCT) supporting their use. This excluded therapies lacking RCT data or showing consistent inefficacy.
A total of 457 articles were found, of which 107 articles were retrieved for closer examination. Of those articles, 54 were excluded because the CAM therapy did not have more than 1 RCT on the subject or showed consistent lack of efficacy. An additional 7 articles were found using references of the included studies, resulting in a total of 44 RCTs (17 double-blind, 13 single-blind, and 14 nonblind), 10 uncontrolled trials, 2 open-label nonrandomized controlled trials, 1 prospective controlled trial, and 3 meta-analyses.
Compared with placebo, application of topical indigo naturalis, studied in 5 RCTs with 215 participants, showed significant improvements in the treatment of psoriasis. Treatment with curcumin, examined in 3 RCTs (with a total of 118 participants), 1 nonrandomized controlled study, and 1 uncontrolled study, conferred statistically and clinically significant improvements in psoriasis plaques. Fish oil treatment was evaluated in 20 studies (12 RCTs, 1 open-label nonrandomized controlled trial, and 7 uncontrolled studies); most of the RCTs showed no significant improvement in psoriasis, whereas most of the uncontrolled studies showed benefit when fish oil was used daily. Meditation and guided imagery therapies were studied in 3 single-blind RCTs (with a total of 112 patients) and showed modest efficacy in treatment of psoriasis. One meta-analysis of 13 RCTs examined the association of acupuncture with improvement in psoriasis and showed significant improvement with acupuncture compared with placebo.
The authors concluded that CAM therapies with the most robust evidence of efficacy for treatment of psoriasis are indigo naturalis, curcumin, dietary modification, fish oil, meditation, and acupuncture. This review will aid practitioners in advising patients seeking unconventional approaches for treatment of psoriasis.
I am sorry to say so, but this review smells fishy! And not just because of the fish oil. But the fish oil data are a good case in point: the authors found 12 RCTs of fish oil. These details are provided by the review authors in relation to oral fish oil trials: Two double-blind RCTs (one of which evaluated EPA, 1.8g, and DHA, 1.2g, consumed daily for 12 weeks, and the other evaluated EPA, 3.6g, and DHA, 2.4g, consumed daily for 15 weeks) found evidence supporting the use of oral fish oil. One open-label RCT and 1 open-label non-randomized controlled trial also showed statistically significant benefit. Seven other RCTs found lack of efficacy for daily EPA (216mgto5.4g)or DHA (132mgto3.6g) treatment. The remainder of the data supporting efficacy of oral fish oil treatment were based on uncontrolled trials, of which 6 of the 7 studies found significant benefit of oral fish oil. This seems to support their conclusion. However, the authors also state that fish oil was not shown to be effective at several examined doses and duration. Confused? Yes, me too!
Even more confusing is their failure to mention a single trial of Mahonia aquifolium. A 2013 meta-analysis published in the British Journal of Dermatology included 5 RCTs of Mahonia aquifolium which, according to these authors, provided ‘limited support’ for its effectiveness. How could they miss that?
More importantly, how could the reviewers miss to conduct a proper evaluation of the quality of the studies they included in their review (even in their abstract, they twice speak of ‘robust evidence’ – but how can they without assessing its robustness? [quantity is not remotely the same as quality!!!]). Without a transparent evaluation of the rigour of the primary studies, any review is nearly worthless.
Take the 12 acupuncture trials, for instance, which the review authors included based not on an assessment of the studies but on a dodgy review published in a dodgy journal. Had they critically assessed the quality of the primary studies, they could have not stated that CAM therapies with the most robust evidence of efficacy for treatment of psoriasis …[include]… acupuncture. Instead they would have had to admit that these studies are too dubious for any firm conclusion. Had they even bothered to read them, they would have found that many are in Chinese (which would have meant they had to be excluded in their review [as many pseudo-systematic reviewers, the authors only considered English papers]).
There might be a lesson in all this – well, actually I can think of at least two:
- Systematic reviews might well be the ‘Rolls Royce’ of clinical evidence. But even a Rolls Royce needs to be assembled correctly, otherwise it is just a heap of useless material.
- Even top journals do occasionally publish poor-quality and thus misleading reviews.
If you thought that Chinese herbal medicine is just for oral use, you were wrong. This article explains it all in some detail: Injections of traditional Chinese herbal medicines are also referred to as TCM injections. This approach has evolved during the last 70 years as a treatment modality that, according to the authors, parallels injections of pharmaceutical products.
The researchers from China try to provide a descriptive analysis of various aspects of TCM injections. They used the the following data sources: (1) information retrieved from website of drug registration system of China, and (2) regulatory documents, annual reports and ADR Information Bulletins issued by drug regulatory authority.
As of December 31, 2017, 134 generic names for TCM injections from 224 manufacturers were approved for sale. Only 5 of the 134 TCM injections are documented in the present version of Ch.P (2015). Most TCM injections are documented in drug standards other than Ch.P. The formulation, ingredients and routes of administration of TCM injections are more complex than conventional chemical injections. Ten TCM injections are covered by national lists of essential medicine and 58 are covered by China’s basic insurance program of 2017. Adverse drug reactions (ADR) reports related to TCM injections account for over 50% of all ADR reports related to TCMs, and the percentages have been rising annually.
The authors concluded that making traditional medicine injectable might be a promising way to develop traditional medicines. However, many practical challenges need to be overcome by further development before a brighter future for injectable traditional medicines can reasonably be expected.
I have to admit that TCM injections frighten the hell out of me. I feel that before we inject any type of substance into patients, we ought to know as a bare minimum:
- for what conditions, if any, they have been proven to be efficacious,
- what adverse effects each active ingredient can cause,
- with what other drugs they might interact,
- how reliable the quality control for these injections is.
I somehow doubt that these issues have been fully addressed in China. Therefore, I can only hope the Chinese manufacturers are not planning to export their dubious TCM injections.
Bacterial vaginosis is a common condition which is more than a triviality. It can have serious consequences including pelvic inflammatory disease, endometritis, postoperative vaginal cuff infections, preterm labor, premature rupture of membranes, and chorioamnionitis. Therefore, it is important to treat it adequately with antibiotics. But are there other options as well?
This trial was conducted on 127 women with bacterial vaginosis to compare a vaginal suppository of metronidazole with Forzejeh, a vaginal suppository of herbal Persian medicine combination of
- Tribulus terrestris,
- Myrtus commuis,
- Foeniculum vulgare,
- Tamarindus indica.
The patients (63 in metronidazole group and 64 in Forzejeh group) received the medications for 1 week. Their symptoms including the amount and odour of discharge and cervical pain were assessed using a questionnaire. Cervical inflammation and Amsel criteria (pH of vaginal discharge, whiff test, presence of clue cells and Gram staining) were investigated at the beginning of the study and 14 days after treatment.
The amount and odour of discharge, Amsel criteria, pelvic pain and cervical inflammation significantly decreased in Forzejeh and metronidazole groups (p = <.001). There was no statistically significant difference between the metronidazole and Fozejeh groups with respect to any of the clinical symptoms or the laboratory assessments.
The authors concluded that Forzejeh … has a therapeutic effect the same as metronidazole in bacterial vaginosis.
The plants in Fozejeh are assumed to have antimicrobial activities. Forzejeh has been used in folk medicine for many years but was only recently standardised. According to the authors, this study shows that the therapeutic effects of Forzejeh on bacterial vaginosis is similar to metronidazole.
Yet, I am far less convinced than these Iranian researchers. As this trial compared two active treatments, it was an equivalence study. As such, it requires a different statistical approach and a much larger sample size. The absence of a difference between the two groups is most likely due to the fact that the study was too small to show it.
If I am correct, the present investigation only demonstrates yet again that, with flawed study-designs, it is easy to produce false-positive results.