alternative medicine
The title of this post is a statement recently made in an article by Mike Adams in ‘Alternative Medicine News’:
The cancer industry goes to great lengths to deny patients access to any information that they might use to prevent, treat or cure cancer without requiring expensive (and highly toxic) medical interventions. That’s what makes the BMJ documentation of this curcumin cancer cure so astonishing: In years past, the BMJ never would have even tolerated the publishing of such a scientific assessment. So what changed? In truth, the evidence of natural cures for cancer is now so overwhelming that even the BMJ cannot remain in a state of denial without appearing to be hopelessly out of touch with scientific reality.
The story is based on one single patient who apparently was cured of cancer using curcumin (turmeric). The case was also recently (3/1/18) featured on BBC’s ‘YOU AND YOURS’ (http://www.bbc.co.uk/programmes/b09k0ng7) in a similarly uncritical way: no expert was asked to provide an evidence-based assessment and bring some reason into the discussion. Even the DAILY FAIL reported about the story, and predictably, critical assessment had to make way for sensationalism.
So what?
We hear about such nonsense almost every day!
True, but this case is different; it is based on a publication in the highly-respected BMJ (well, actually, it was the ‘BMJ CASE REPORTS’ and not the BMJ, as reported). Here is the article:
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A woman aged 57 years was initially diagnosed with monoclonal gammopathy of undetermined significance (MGUS) in 2007 following an incidental finding of M-protein (18 g/L) during investigation for hypertension.
Within 15 months, the patient had rapidly progressed to ISS stage 3 myeloma with M-protein 49 g/L, urinary protein 1.3 g/24-hour, Bence-Jones protein 1.0 g/24-hour, Hb 9.7 g/dL and increasing back pain. She initially declined antimyeloma treatment but 6 months later, following vertebral collapse at T5 and T12, started cyclophosphamide, thalidomide and dexamethasone (CTD) treatment. However, after a week, the patient was admitted with idiosyncratic syndrome including hyponatraemia, a fall in albumin and worsening of blood counts. She received red cell transfusion and her electrolyte abnormalities were carefully corrected.
Although there was evidence of a response to CTD (M-protein 34 g/L), bortezomib and dexamethasone treatment was initiated as an alternative, but this was discontinued after three cycles due to progressive disease (M-protein 49 g/L). The patient was then treated with lenalidomide and dexamethasone with the aim of reducing disease burden prior to high-dose therapy and autologous stem cell transplantation. Treatment was frequently interrupted and dose adjusted to account for neutropenia and despite a minor response after six cycles (starting M-protein 47 g/L, finishing M-protein 34 g/L), in October 2009, she proceeded with stem cell mobilisation. However, neither cyclophosphamide nor plerixafor/GCSF priming were successful. A bone marrow biopsy revealed 50% myeloma cells and a course of CTD was restarted with cautious titration of thalidomide.
The patient achieved a partial response with CTD retreatment over the course of 17 cycles (M-protein 13 g/L) with no further episodes of idiosyncratic syndrome. However, attempts to harvest stem cells in February 2011 and again there months later, both failed. By then, her M-protein had risen to 24 g/L and the patient was too neutropenic to be considered for a clinical trial.
At this point, the patient began a daily regime of oral curcumin complexed with bioperine (to aid absorption), as a single dose of 8 g each evening on an empty stomach. A few months later, she also embarked on a once-weekly course of hyperbaric oxygen therapy (90 min at 2 ATA) which she has maintained ever since. Her paraprotein levels gradually declined to a nadir of 13 g/L, her blood counts steadily improved and there was no evidence of further progressive lytic bone disease.
Outcome and follow-up
The patient continues to take oral curcumin 8 g daily without further antimyeloma treatment. Over the last 60 months, her myeloma has remained stable with minimal fluctuation in paraprotein level, her blood counts lie within the normal range and she has maintained good quality of life throughout this period. Repeat bone imaging in 2014 identified multiple lucencies <1 cm in the right hip and degenerative changes in both hips, but these were attributed to osteoarthritis rather than the myeloma. Recent cytogenetic analysis revealed she had no abnormal cytogenetics by fluorescent in situ hybridisation.
Discussion
A small but significant number of myeloma patients consume dietary supplements in conjunction with conventional treatment primarily to help cope with the side effects of treatment, manage symptoms and enhance general well-being. Few, if any, use dietary supplementation as an alternative to standard antimyeloma therapy. Here, we describe a case in which curcumin has maintained long-term disease control in a multiply-relapsed myeloma patient. To the best of our knowledge, this is the first report in which curcumin has demonstrated an objective response in progressive disease in the absence of conventional treatment.
Curcumin is a polyphenol derived from the perennial herb Curcuma longa (turmeric) and has, for centuries, been used as a traditional Indian medicine. Several reports published over the two decades have claimed various health benefits of curcumin and this has led to its increasing popularity as a dietary supplement to prevent or treat a number of different diseases.
The biological activity of curcumin is indeed remarkable. It is a highly pleiotropic molecule which possesses natural antioxidant, anti-inflammatory, antiseptic and analgesic properties. More recently, it has demonstrated antiproliferative effects in a wide variety of tumour cells including myeloma cells and exerts its antiproliferative effects through multiple cellular targets that regulate cell growth and survival.
In vitro, curcumin prevents myeloma cell proliferation through inhibition of IL-6-induced STAT-3 phosphorylation and through modulation of the expression of NF-kB-associated proteins such as IkB〈,Bcl-2, Bcl-xL, cyclin D1 and IL-6 and apoptosis-related molecules including p53 and Bax. In other studies, curcumin was shown to circumvent resistance to dexamethasone, doxorubicin and melphalan as well as potentiate the effects of bortezomib, thalidomide and lenalidomide. Furthermore, curcumin-induced cell death was not influenced by myeloma molecular heterogeneity.
The antimyeloma effects of curcumin in the clinical setting however are less clear. Only one phase I/II study has evaluated curcumin treatment in myeloma patients. These patients were either asymptomatic, relapsed or had plateau phase disease. Treatment with curcumin downregulated the expression of NFkB, COX-2 and STAT3 in peripheral blood mononuclear cells, but no objective responses were observed in any subgroup of patients. This may be as a result of small sample size in this study, follow-up was limited to 3 months and clinical responses may have been observed with longer follow-up. However, downregulation of NFkB, COX-2 and STAT3 expression may not correlate with the clinical activity of curcumin and there may be further mechanisms of action that remain unclear, possibly through the modulation of another target. We would not be able to identify any patient-specific mechanisms of activity in this case study, as the patient has been taking curcumin for some time now and baseline bone marrow or peripheral blood samples are not available. However, in the setting of a clinical trial, it may be possible to use next-generation sequencing to help identify a mutation that may be a potential target for curcumin.
Another study examined its effects in preventing the progression of MGUS and smouldering myeloma to myeloma. The results showed that curcumin exerted a trace of biological activity with modest decreases in free light chain and paraprotein levels and a reduction in a marker of bone resorption with curcumin treatment, suggesting the therapeutic potential of curcumin in MGUS and smouldering myeloma. However, more studies are needed to address this further.
Whether such effects are observed in patients with active disease remains to be seen. The fact that our patient, who had advanced stage disease and was effectively salvaged while exclusively on curcumin, suggests a potential antimyeloma effect of curcumin. She continues to take daily curcumin and remains in a very satisfactory condition with good quality of life. This case provides further evidence of the potential benefit for curcumin in myeloma. We would recommend further evaluation of curcumin in myeloma patients in the context of a clinical trial.
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What should we make of this?
I think that much of the reporting around the story was grossly irresponsible. It is simply not possible to conclude that curcumin was the cause of the remission. It could be due to a whole host of other factors. And a case report is just an anecdote; it never can prove anything and can only be used to stimulate further research.
I fully agree with the authors of the case report: curcumin seems worthy of further investigation. But recommending it to patients for self-medication is vastly premature and quite simply dangerous, unethical and naïve bordering on stupid.
And, of course, the above-cited drivel of Mike Adams is just beyond the pale – the evidence for ‘alternative cancer cures‘ is very, very far from ‘overwhelming’; and the ‘cancer industry’ is doing what they can to determine whether turmeric or any other natural remedy can be used to treat cancer and other diseases.
If they are ever successful, the Adams of this world will shout ‘EXPLOITATION!!!’
If their endeavours are not successful, they will complain ‘CONSPIRACY!!!’
Yesterday, I heard my ‘good friend’ Dr Michael Dixon (see here, here and here, for example) talk on the BBC about the “new thing” in healthcare: social prescribing. He explained, for instance, that social prescribing could mean treating a diabetic not with medication but with auto-hypnosis and other alternative therapies. At that moment, I wasn’t even entirely sure what the term ‘social prescribing’ meant, I have to admit – so I did some reading.
What is social prescribing?
The UK ‘Social Prescribing Network‘ defines it thus:
Social Prescribing is a means of enabling GPs and other frontline healthcare professionals to refer patients to a link worker – to provide them with a face to face conversation during which they can learn about the possibilities and design their own personalised solutions, i.e. ‘co-produce’ their ‘social prescription’- so that people with social, emotional or practical needs are empowered to find solutions which will improve their health and wellbeing, often using services provided by the voluntary and community sector. It is an innovative and growing movement, with the potential to reduce the financial burden on the NHS and particularly on primary care.
Does social prescribing work?
The UK King’s Fund is mildly optimistic:
There is emerging evidence that social prescribing can lead to a range of positive health and well-being outcomes. Studies have pointed to improvements in areas such as quality of life and emotional wellbeing, mental and general wellbeing, and levels of depression and anxiety. For example, a study into a social prescribing project in Bristol found improvements in anxiety levels and in feelings about general health and quality of life. In general, social prescribing schemes appear to result in high levels of satisfaction from participants, primary care professionals and commissioners.
Social prescribing schemes may also lead to a reduction in the use of NHS services. A study of a scheme in Rotherham (a liaison service helping patients access support from more than 20 voluntary and community sector organisations), showed that for more than 8 in 10 patients referred to the scheme who were followed up three to four months later, there were reductions in NHS use in terms of accident and emergency (A&E) attendance, outpatient appointments and inpatient admissions. The Bristol study also showed reductions in general practice attendance rates for most people who had received the social prescription.
However, robust and systematic evidence on the effectiveness of social prescribing is very limited. Many studies are small scale, do not have a control group, focus on progress rather than outcomes, or relate to individual interventions rather than the social prescribing model. Much of the evidence available is qualitative, and relies on self-reported outcomes. Researchers have also highlighted the challenges of measuring the outcomes of complex interventions, or making meaningful comparisons between very different schemes.
Determining the cost, resource implications and cost effectiveness of social prescribing is particularly difficult. The Bristol study found that positive health and wellbeing outcomes came at a higher cost than routine GP care over the period of a year, but other research has highlighted the importance of looking at cost effectiveness over a longer period of time. Exploratory economic analysis of the Rotherham scheme, for example, suggested that the scheme could pay for itself over 18–24 months in terms of reduced NHS use….
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Is there no harder evidence at all?
The only Medline-listed controlled study seems to have been omitted by the King’s Fund – I wonder why. Perhaps because it fails to share the optimism? Here is its abstract:
Social prescribing is targeted at isolated and lonely patients. Practitioners and patients jointly develop bespoke well-being plans to promote social integration and or social reactivation. Our aim was to investigate: whether a social prescribing service could be implemented in a general practice (GP) setting and to evaluate its effect on well-being and primary care resource use. We used a mixed method evaluation approach using patient surveys with matched control groups and a qualitative interview study. The study was conducted in a mixed socio-economic, multi-ethnic, inner city London borough with socially isolated patients who frequently visited their GP. The intervention was implemented by ‘social prescribing coordinators’. Outcomes of interest were psychological and social well-being and health care resource use. At 8 months follow-up there were no differences between patients referred to social prescribing and the controls for general health, depression, anxiety and ‘positive and active engagement in life’. Social prescribing patients had high GP consultation rates, which fell in the year following referral. The qualitative study indicated that most patients had a positive experience with social prescribing but the service was not utilised to its full extent. Changes in general health and well-being following referral were very limited and comprehensive implementation was difficult to optimise. Although GP consultation rates fell, these may have reflected regression to the mean rather than changes related to the intervention. Whether social prescribing can contribute to the health of a nation for social and psychological wellbeing is still to be determined.
So, there is a lack of evidence for social prescribing. Yet, this is not why I feel uneasy about the promotion of this “new thing”. The more i think about it, the more I realise that social prescribing is just good care and decent medicine. It is what I was taught at med school 40 years ago. It therefore seems like a fancy name for something that should be obvious.
But why my unease?
The way I see it, it will be (and perhaps already is) used to smuggle bogus alternative therapies into the mainstream. In this way, it could turn out to serve the same purpose as did the boom in integrative/integrated medicine/healthcare: a smokescreen to incorporate treatments into medical routine which otherwise would not pass muster. If advocates of this approach, like Michael Dixon, subscribe to it, the danger of this happening is hard to deny.
The disservice to patients (and medical ethics) would then be obvious: diabetics unquestionably can benefit from a change of life-style (and to encourage them is part of good conventional medicine), but I very much doubt that they should replace their anti-diabetic medications with auto-hypnosis or other alternative therapies.
The question whether chiropractic is a truly valuable option for people suffering from back pain has been addressed repeatedly on this blog. My answer was usually negative, but proponents of chiropractic tended to argue that I am biased. Therefore I find it constructive to see what an organisation that hardly can be accused of bias says on this topic. An article by ‘SHOW ME THE EVIDENCE’ has recently provided a comprehensive overview of treatments for back pain. This is what they wrote about chiropractic:
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Spinal manipulation, the cranking and tweaking on offer when you visit a traditional chiropractor, is among the most popular approaches to back pain. Practitioners lay their hands on the patient and move their joints to or beyond their range of motion — a technique that’s often accompanied by a pop or crack.
There is some evidence the approach can help people with chronic back pain — but not any more than over-the-counter painkillers or exercise, and you need to take precautions when seeking out a chiropractor.
First, a quick look at the evidence. There are two recent Cochrane reviews on spinal manipulation for low back pain: one focused on people with acute (again, episodic/short duration) pain and the other on chronic pain. The 2011 review on chronic low back pain found that spinal manipulation had small, short-term effects on reducing pain and improving the patient’s functional status — but this effect was about the same as other common therapies for chronic low back pain, such as exercise. That review was published in 2011; UpToDate reviewed the randomized trials that have come out since — and also found that spinal manipulation delivered modest, short-term benefits for chronic back pain sufferers.
The Cochrane review on acute pain found that spinal manipulation worked no better than placebo. So people with a short episode of back pain should probably not bother seeing a chiropractor.
“Based on the evidence,” University of Amsterdam assistant professor Sidney Rubinstein, who is the lead author on the Cochrane reviews, told me, “it would appear [spinal manipulation] works as well as other accepted conservative therapies for chronic low back pain, such as non-prescription medication or exercise, but less well for patients with acute low back pain.”
As a chiropractor himself, he had some advice for patients: They should avoid chiropractors who routinely make X-rays or do advanced diagnostics for low back pain because this adds nothing to the clinical picture, particularly in the case of nonspecific low back pain. Patients should also beware chiropractors who put them on extended programs of care.
“Patients who respond to chiropractic care traditionally respond rather quickly,” he said. “My advice is those patients who have not responded to a short course of chiropractic care or manipulation should consider another type of therapy.”
While the risks of serious side effects from spinal manipulation for back pain are rare — about one in 10 million — the risks associated with chiropractic therapy for neck pain tend to be slightly higher: 1.46 strokes for every million neck adjustments.
The issue is the vertebral artery, which travels from the neck down through the vertebrae. Manipulating the neck can put patients at a higher risk of arterial problems, including stroke or vertebral artery dissection, or the tearing of the vertebral artery (though Rubinstein noted that people in the initial stages of stroke or dissection may also seek out care for their symptoms, such as neck pain, which makes it difficult to untangle how many of health emergencies are brought on by the adjustments).
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This all seems fairly reasonable to me – except for the following not entirely unimportant points:
- I am not sure where the evidence about risks of spinal manipulation comes from. In my view, it is not entirely correct: as there is no effective post-marketing surveillance, we cannot possibly name the incidence figures.
- Neck manipulations are clearly more risky than manipulations lower down. But this does not necessarily mean that back patients are safer than those with neck pain. Chiropractors view the spine as a whole organ and will regularly manipulate the neck (if they sense ‘subluxations’ in this area), even if the patient comes with low back pain.
- There are also indirect risks with consulting a chiropractor; for instance, they often give incompetent advice about healthcare. This can include discouraging immunisations or treating serious diseases, such as asthma, colic etc., with chiropractic.
- I think the article should point out that exercise is not just as effective (or as ineffective) as chiropractic, but it is much safer and less expensive.
- What Rubinstein says about responders is debatable, in my view. In particular, most chiropractors will convince their patients to continue treatment, even if they do not ‘respond’. And ‘responding’ might be simply the natural history of the condition and therefore totally unrelated to the therapy.
The bottom line: Chiropractic is not the best treatment for back pain!
US Republican Senator Hatch from Utah (born March 22, 1934) has announced that he is retiring after having been a Senator since 1977. When he leaves, the Senate “will lose its most ardent supporter of alternative medicine“. His decision comes after ‘The Salt Lake Tribune’ published a Christmas Day editorial calling on him to do so. The editorial stated that he has an “utter lack of integrity” that comes from “his unquenchable thirst for power.”
For advocates of alternative medicine, Hatch’s retirement comes as a blow: for decades, the senator has been one of the most powerful defender of quackery. As a young man, Orrin Hatch sold vitamins and supplements. As an old man, he takes them every day—including. “I really believe in them. I use them daily. They make me feel better, as they make millions of Americans feel better. And I hope they give me that little added edge as we work around here”, he was quoted stating.
And his love was returned: Between 1989 and 1994 Herbalife International gave Hatch $49,250; MetaboLife, $31,500; and Rexall Sundown, Nu Skin International, and Starlight International a total of $88,550. In addition, according to his financial disclosures for 2003, Hatch owned 35,621 shares of Pharmics, a Utah-based nutritional supplement company. In the early 1990s, Hatch’s son Scott began working for lobbying groups representing vitamin and supplement makers. Kevin McGuiness, Hatch’s former chief of staff, was also a lobbyist for the industry.
The NYT reported in 2011 that Hatch “was the chief author of a federal law enacted … that allows companies to make general health claims about their products, but exempts them from federal reviews of their safety or effectiveness before they go to market. During the Obama administration, Mr. Hatch has repeatedly intervened with his colleagues in Congress and federal regulators in Washington to fight proposed rules that industry officials consider objectionable…
“Mr. Hatch has been rewarded with hundreds of thousands of dollars in campaign contributions, political loyalty and corporate sponsorship of his favorite causes back home.
“His family and friends have benefited, too, from links to the supplement industry. His son Scott Hatch, is a longtime industry lobbyist in Washington, as are at least five of the senator’s former aides. Mr. Hatch’s grandson and son-in-law increase revenue at their chiropractic clinic near here by selling herbal and nutritional treatments, including $35 “thyroid dysfunction” injections and a weight-loss product, “Slim and Sassy Metabolic Blend.” And Mr. Hatch’s former law partner owns Pharmics, a small nutritional supplement company in Salt Lake City…”
Further information is provided by Wikipedia:
Hatch’s son Scott Hatch is a partner and registered lobbyist at Walker, Martin & Hatch LLC, a Washington lobbying firm. The firm was formed in 2001 with Jack Martin, a staff aide to Hatch for six years, and H. Laird Walker, described as a close associate of the senator. In March 2003, the Los Angeles Times reported that the firm was formed with Hatch’s personal encouragement and that he saw no conflict of interest in working on issues that involved his son’s clients. In 2009, the Washington Times reported that Hatch said “My son, Scott, does not lobby me or anyone in my office”.
In March 2009, the Washington Times reported that the pharmaceutical industry, which has benefited from Hatch’s legislative efforts, had previously unreported connections to Hatch. In 2007, five pharmaceutical companies and the industry’s main trade association, Pharmaceutical Research and Manufacturers of America (PhRMA), donated $172,500 to the Utah Families Foundation—a charitable foundation which Hatch helped start in the 1990s and has continued to support since. Walker, Martin & Hatch LLC was paid $120,000 by PhRMA in 2007 to lobby Congress on pending U.S. Food and Drug Administration legislation.
And finally:
Donald J. TrumpVerified account @realDonaldTrump Jan 2
We should not have to repeat this! But, as it is currently topical and certainly true, let me tell you again:
DETOX IS BUNK!
After the season of gluttony, it seems that half the population has fallen victim to the legion of alternative practitioners and entrepreneurs who claim that their particular form of quackery is ideally suited for detoxifying the body – and, sure enough, rid their clients of money instead of poisons. I have pointed out again and again why detox, as promoted in alternative medicine. is bogus and occasionally even harmful – see for instance here, here and here. And years ago, I published a review of the evidence on ‘alternative detox’ (AD); it concluded that “the principles of AD make no sense from a scientific perspective and there is no clinical evidence to support them. The promotion of AD treatments provides income for some entrepreneurs but has the potential to cause harm to patients and consumers. In alternative medicine, simplistic but incorrect concepts such as AD abound. All therapeutic claims should be scientifically tested before being advertised-and AD cannot be an exception.”
But I have, of course, many readers who do not trust a word I am putting on paper. So, please don’t take it from me, take it from others; read for example this recent article:
Detox diets are popular dieting strategies that claim to facilitate toxin elimination and weight loss, thereby promoting health and well-being. The present review examines whether detox diets are necessary, what they involve, whether they are effective and whether they present any dangers. Although the detox industry is booming, there is very little clinical evidence to support the use of these diets. A handful of clinical studies have shown that commercial detox diets enhance liver detoxification and eliminate persistent organic pollutants from the body, although these studies are hampered by flawed methodologies and small sample sizes. There is preliminary evidence to suggest that certain foods such as coriander, nori and olestra have detoxification properties, although the majority of these studies have been performed in animals. To the best of our knowledge, no randomised controlled trials have been conducted to assess the effectiveness of commercial detox diets in humans. This is an area that deserves attention so that consumers can be informed of the potential benefits and risks of detox programmes.
To the best of our knowledge, no randomised controlled trials have been conducted to assess the effectiveness of commercial detox diets in humans. I think that says enough; and it applies not just to detox diets, it applies to all detox methods promoted in alternative medicine.
DETOX IS BUNK!
Save your hard-earned money for stuff that is proven to work.
In 2017, Medline listed just over 1800 articles on ‘complementary alternative medicine’. If you find this number impressively high, consider that, for ‘surgery’ (a subject that has often been branded as less that active in conducting research), there were almost 18 000 Medline-listed papers.
So, the research activity in CAM is relatively small. Vis a vis the plethora of open questions, this inactivity is perhaps lamentable. What I find much more regrettable, however, is the near total lack of investigations into the ethical issues in CAM. In 2017, there were just 11 articles on Medline on ‘ethics and CAM’ (24393 articles on ‘ethics and surgery’).
One of the 11 papers that tackled the ethics directly and that was (in my opinion) one of the best is this article. Here is its concluding paragraph:
When we encounter patients who use or consider the use of complementary and/or alternative medicine, we should respect their autonomy while also fulfilling our obligations of beneficence and nonmaleficence. Physicians should become more knowledgeable about research on CAM therapies and approach discussions in an open, nonjudgmental manner to enhance patient trust. In situations where there is little risk of harm and the possibility of benefit, supporting a patient in their interest in complementary therapies can strengthen the patient-physician relationship. However, when a patient’s desire to utilize alternative therapies poses a health risk, physicians have the ethical obligation to skillfully counsel the patient toward those therapies that are medically appropriate.
I have had a long-lasting and keen interest in the ethics of CAM which resulted in the publication of many papers. Here is a selection:
‘Complementary & Alternative Medicine’ (CAM): Ethical And Policy Issues.
Pharmacists and homeopathic remedies.
Homeopathy, a “helpful placebo” or an unethical intervention?
Advice offered by practitioners of complementary/ alternative medicine: an important ethical issue.
The ethics of British professional homoeopaths.
Evidence-based practice in British complementary and alternative medicine: double standards?
Ethics of complementary medicine: practical issues.
Reporting of ethical standards: differences between complementary and orthodox medicine journals?
Informed consent: a potential dilemma for complementary medicine.
Ethical problems arising in evidence based complementary and alternative medicine.
Complementary medicine: implications for informed consent in general practice.
Ethics and complementary and alternative medicine.
Research ethics questioned in Qigong study.
Informed consent in complementary and alternative medicine.
The ethics of complementary medicine.
For most of the time conducting this research, I felt that I was almost alone in realising the importance of this topic. And all this time, I was convinced that the subject needed more attention and recognition. Therefore, I teamed up with with the excellent ethicist Kevin Smith from the University of Dundee, and together we spent the best part of 2017 writing about it.
Our book is entitled ‘MORE HARM THAN GOOD? THE MORAL MAZE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE’ and will be published shortly by Springer.
It is an attempt to highlight some of the most important topics in this broad and under-researched area. While working on it, I was continually struck by the fact that most of the issues we have been struggling with on this blog are, in the final analysis, ethical by nature.
My hope is that, in 2018, we will see many more high quality papers filling the almost total void of ethical perspectives on CAM. In my view, it is unquestionably an area that needs to be addressed with some urgency.
At this time of the year it is customary to look back and highlight some remarkable things that occurred during the last 12 months. Here I will try to identify for each month the most important event. My choice is entirely subjective, and I invite everybody to disagree with it and add other happenings.
The U.S. Food and Drug Administration announced today that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.
It has just been reported that the Russian Academy of Sciences (RAS) has labelled homeopathic medicine a health hazard. The organization is now petitioning Russia’s Ministry of Health to abandon the use of homeopathic medicine in the country’s state hospitals, the RBC news outlet reported Monday.
A RAS committee warns that some patients were rejecting standard medicine for serious conditions in favour of homeopathic remedies, a move that almost inevitably puts their lives in danger. The committee also noted that, because of sloppy quality control during the manufacturing processes, some unlicensed homeopathic remedies contain toxic substances which harm patients in a direct fashion.
“The principles of homeopathy contradict known chemical, physical and biological laws and persuasive scientific trials proving its effectiveness are not available,” the committee stated in its report.
George Lewith has died on 17 March, aged 67. He was one of the most productive researchers of alternative medicine in the UK; specifically he was interested in acupuncture. If you search this blog, you find several posts that mention him or are entirely dedicated to his work. Undeniably, my own views and research were often very much at odds with those of Lewith.
A new review of the risks of spinal manipulative therapy (SMT) concluded that it is currently not possible to provide an overall conclusion about the safety of SMT; however, the types of SAEs reported can indeed be significant, sustaining that some risk is present. High quality research and consistent reporting of AEs and SAEs are needed.
My favourite journal has succumbed to BS. A review that is ‘state of the art’ must fulfil certain criteria; foremost it should be informative, unbiased and correct. The paper I am discussing here has, I think, neither of these qualities. It is entitled ‘Management of chronic pain using complementary and integrative medicine’, and here is its abstract:
Complementary and integrative medicine (CIM) encompasses both Western-style medicine and complementary health approaches as a new combined approach to treat a variety of clinical conditions. Chronic pain is the leading indication for use of CIM, and about 33% of adults and 12% of children in the US have used it in this context. Although advances have been made in treatments for chronic pain, it remains inadequately controlled for many people. Adverse effects and complications of analgesic drugs, such as addiction, kidney failure, and gastrointestinal bleeding, also limit their use. CIM offers a multimodality treatment approach that can tackle the multidimensional nature of pain with fewer or no serious adverse effects. This review focuses on the use of CIM in three conditions with a high incidence of chronic pain: back pain, neck pain, and rheumatoid arthritis. It summarizes research on the mechanisms of action and clinical studies on the efficacy of commonly used CIM modalities such as acupuncture, mind-body system, dietary interventions and fasting, and herbal medicine and nutrients.
Scientology seems to have started an aggressive campaign in the UK to promote its cult.
The NHS seems to be edging towards banning homeopathy.
A group of German experts published a document pointing out that the ‘Heilpraktiker’ has introduced two hugely different quality standards into the German healthcare system. In the interest of the patient and of good healthcare, this double standard must be addressed. We are demanding the profession of the Heilpraktiker either is completely abolished, or is reformed such that it no longer poses a threat to public health in Germany. Our document makes concrete suggestions for such reforms.
It has been announced that Susan and Henry Samueli have given US$ 200 million to medical research at the University of California, Irvine (UCI). Surely this is a generous and most laudable gift! How could anyone doubt it?
I feel deeply honoured to have received the Ockham Award. It is a generous appreciation of our small efforts in decreasing the ignorance and stupidity that seems to be all around us today – sadly not just in the realm of alternative medicine (but that would be the subject of another blog). I thank everyone who contributed to our blog’s success and hope you keep the comments coming.
The RCVS publishes a position paper on alternative medicine for animals: “Homeopathy exists without a recognised body of evidence for its use. Furthermore, it is not based on sound scientific principles. In order to protect animal welfare, we regard such treatments as being complementary rather than alternative to treatments for which there is a recognised evidence base or which are based in sound scientific principles. It is vital to protect the welfare of animals committed to the care of the veterinary profession and the public’s confidence in the profession that any treatments not underpinned by a recognised evidence base or sound scientific principles do not delay or replace those that do.”
The US Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices…
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This time of the year is also a good moment for thanking those who made writing this blog an exercise that is fun and hopefully constructive. Happy New Year to all of you.
How often have we heard the claim from proponents of alternative medicine that one strength of their approach is disease prevention (see for instance my previous post or this, this and this) and that conventional medicine neglects prevention almost completely? Such claims annoy me because they are demonstrably false.
I know, to some readers, this may seem like a bold statement; let me therefore try to justify it.
- So far, I have seen no good evidence that any alternative therapy might be effective in preventing any disease.
- Practically everything we know today about disease prevention originates from conventional medicine and science.
- There are thousands of papers that address prevention and, as far as I can see, they all originate from the realm of conventional medicine. Below is a list of just 7 recent reviews on the subject.
This paper is an update of the evidence for exercise as a prevention of heart failure. It concluded that exercise provides protective benefit in preventing HF (primary prevention). With HF present: exercise improvement with training provides benefits in HF (secondary prevention). The prediction of future in HF patients: exercise impairment, as a leading characteristic of HF, is used as a prognostic factor.
The aim of this review was to update evidence for the US Preventive Services Task Force on the benefits and harms of hormone therapy in reducing risks for chronic conditions. The authors found that hormone therapy for the primary prevention of chronic conditions in menopausal women is associated with some beneficial effects but also with a substantial increase of risks for harms. The available evidence regarding benefits and harms of early initiation of hormone therapy is inconclusive.
This paper reviewed the evidence for Implantable Cardiac Defibrillators (ICDs). The authors stated that individuals with stable ischemic heart disease (no recent myocardial infarction), especially those with inducible arrhythmias, seem to derive the highest mortality benefit from prophylactic ICD use.
These authors investigated whether neuromuscular and proprioceptive training is effective in preventing knee and anterior cruciate ligament (ACL) injuries. They concluded that neuromuscular and proprioceptive training appeared to decrease the incidence of injury to the knee and specifically the AC.
Other researchers summarized current evidence about real-world studies on apixaban for stroke prevention in atrial fibrillation. They concluded that the use of apixaban in real-life is associated with an overall similar effectiveness in reducing stroke and any thromboembolic events when compared with warfarin. A better safety profile was found with apixaban compared with warfarin, dabigatran, and rivaroxaban.
Finally, a review assessed the evidence of blood pressure (BP) lowering treatments as a means of reducing cardiovascular morbidity and mortality. The authors concluded that primary preventive BP lowering is associated with reduced risk for death and CVD if baseline SBP is 140 mm Hg or higher. At lower BP levels, treatment is not associated with any benefit in primary prevention but might offer additional protection in patients with CHD.
Testing preventative treatments is, of course, far from easy. Ideally, one would want to do an RCT, but often this is not possible, for instance, because the sample size would need to be prohibitively huge and the observation period prohibitively long (think of cholesterol-lowering for reducing cardiovascular risks, or smoking cessation for preventing cancer). Thus we rely frequently on other types of investigations such as epidemiological studies. This type of research is, however, rarely undertaken in alternative medicine, and when it does cover subjects related to this area, it is almost never done by proponents of alternative medicine.
The long and short of all this is depressingly simple: the often-heard claim that alternative medicine is strong on prevention is quite simply false. Proponents of alternative medicine like to talk about prevention (presumably because it is good for business), but when it comes to applying prevention and showing that their preventative interventions are effective, all this talk turns out to be little more than hot air.
I am sure – even hope – that some readers will disagree, and I look forward to their evidence proving me wrong.
What better to give to you for the holidays than your very own CHRISTMAS SURVIVAL KIT? This article by Eileen Scullion, Registered Homeopath LicISH ISHom with the Irish Society of Homeopaths explains. Sadly, its recommendations lack sections detailing the evidence for the claims made. Therefore, I have taken the liberty of adding my short scientific assessments (IN BOLD CAPITAL LETTERS):
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1. Over indulgence
Nux Vomica – For symptoms that arise after over indulgence and excess in food, alcohol, tobacco and coffee. The person suffers from headaches, indigestion, nausea and irritability and symptoms are worse in the morning or after eating.
Arsenicum – For symptoms of diarrhea, vomiting, cramps where you suspect food poisoning.
ZERO PLAUSIBILITY, NO EVIDENCE FOR EFFECTIVENESS.
2. Stress & Anxiety
Argentum Nitricum – Anxiety from worry that it won’t work out – What if the turkey burns? What if the electric goes out? What if the gifts don’t arrive on time? There is a great sense of urgency, hurriedness and worrying about everything with sleepless nights of tossing and turning.
ZERO PLAUSIBILITY, NO EVIDENCE FOR EFFECTIVENESS.
3. Sleep problems
Coffea – Sleeplessness from excitement. For the kids who just can’t sleep in anticipation of Santa’s arrival.
ZERO PLAUSIBILITY, NO EVIDENCE FOR EFFECTIVENESS.
4. Anger and resentment
Staphysagria – If you are feeling angry and resentful and are suffering in silence, or have difficulty in saying no but feel walked over, then this is an excellent remedy to help verbalise things or process your emotions. Pent up emotions can also be accompanied with urinary tract infections where this remedy fits the symptoms.
ZERO PLAUSIBILITY, NO EVIDENCE FOR EFFECTIVENESS.
5. Colds
Aconite – If caught at the early stage, nip those colds in the bud that come on suddenly after exposure to cold dry winds or getting chilled.
ZERO PLAUSIBILITY, NO EVIDENCE FOR EFFECTIVENESS.
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As the ‘survival kit’ turns out to be pure speculation, fantasy and wishful thinking, let’s join into the seasonal fun and add some equally evidence-based homeopathic treatments of our own.
1. World peace
We all live in dangerous times, but the way to world peace could be guaranteed by this homeopathic remedy: Donald Trump C30. It is manufactured by exposing a glass of distilled water to a picture of the US president for about 30 minutes and then potentising the mother tincture 30 times in the time-tested way of homeopathy.
2. Fuzzy head
After all the booze and laziness over the holidays, one is bound to feel oddly fuzzy, incoherent and unfocussed. My homeopathic remedy for this complaint is HRH C200. You can make it yourself: take a vial of distilled water to a public library, find Prince Charles’ book ‘Harmony‘ (do not buy this book! it is expensive and not worth it), put the vial between its pages and shake vigorously. Subsequently return the book to its shelve and potentise your mother tincture 200 times.
3. Poverty
Yes, Christmas is expensive! If your bank account is now empty, don’t worry: homeopathy can help. Take your last fiver, cut a tiny bit off, grind it down in some sugar, put the mixture in distilled water, and your mother tincture is ready. You can then potentise it in the usual way; if you want to become a millionaire use the £ C30 potency; if you prefer to be a billionaire, I recommend the £ C200 dilution.
I must stop myself here, because I hope you, the reader of this post, will now chip in. If you are suffering from any symptom at all, please use your imagination and, based on the ‘like cures like’ principle, design your very own homeopathic cure.
Yes, that’s my Christmas challenge.
Have fun!
On their website, the US Food and Drug Administration (FDA) has recently published a statement on homeopathy which, I think, is important enough to get cited extensively:
… Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices…
The FDA’s proposed approach prioritizes enforcement and regulatory actions involving unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients… The FDA intends to focus its enforcement authorities on the following kinds of products:
- products with reported safety concerns;
- products that contain or claim to contain ingredients associated with potentially significant safety concerns;
- products for routes of administration other than oral and topical;
- products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
- products for vulnerable populations; and
- products that do not meet standards of quality, strength or purity as required under the law.
Examples of products that may be subject to the enforcement priorities in the draft guidance are infant and children’s products labeled to contain ingredients associated with potentially significant safety concerns, such as belladonna and nux vomica; and products marketed for serious conditions, such as cancer and heart disease.
While the FDA considers comments to the draft guidance, the FDA intends to examine how the agency is implementing its current compliance policy. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA will consider taking additional enforcement and/or regulatory actions, consistent with the current enforcement policies, which also align with the risk-based categories described in the draft guidance, in the interest of protecting the public…
Until relatively recently, homeopathy was a small market for specialized products. Over the last decade, the homeopathic drug market has grown exponentially, resulting in a nearly $3 billion industry that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims. During this time, the FDA has seen a corresponding increase in safety concerns, including serious adverse events, associated with drug products labeled as homeopathic. In addition, the agency has also found an increasing number of poorly manufactured products that contain potentially dangerous amounts of active ingredients that can create additional risks.
In September 2016, the FDA warned against the use of homeopathic teething tablets and gels containing belladonna, a toxic substance that has an unpredictable response in children under two years of age, after the products were associated with serious adverse events, including seizures and deaths, in infants and children. An FDA lab analysis later confirmed that certain homeopathic teething tablets contained elevated and inconsistent levels of belladonna. A similar issue occurred in 2010 when Hyland’s Teething Tablets were found to contain varying amounts of belladonna. An FDA inspection of that product’s manufacturing facility indicated substandard control of the product’s manufacturing.
The FDA has issued warnings related to a number of other homeopathic drug products over the past several years. These include certain homeopathic zinc-containing intranasal products that may cause a loss of sense of smell, homeopathic asthma products that have not been shown to be effective in treating asthma and various homeopathic drug products labeled to contain potentially toxic ingredients, like nux vomica, which contains strychnine (a highly toxic, well-studied poison often used to kill rodents).
“Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The draft guidance is an important step forward in the agency’s work to protect patients from unproven and potentially dangerous products.”…
The FDA is not alone in reexamining its approach to homeopathy. In November 2016, the Federal Trade Commission (FTC) announced a new enforcement policy explaining that they will hold efficacy and safety claims for over-the-counter homeopathic drugs to the same standard as other products making similar health claims. Notably, the FTC said that companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions…
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US homeopaths were quick to respond, as reported here:
The National Center for Homeopathy’s board of directors stated:
The National Center for Homeopathy supports the FDA’s efforts to ensure safety and good manufacturing practices in the industry. We are committed to working with industry partners to protect consumer access to homeopathic medicines, and we are hopeful that this action will not impede access. Homeopathic medicines are safe, gentle and effective when products are manufactured in accordance with HPUS (Homoeopathic Pharmacopoeia of the United States) guidelines under CGMPs (Current Good Manufacturing Practices). We welcome the opportunity to educate consumers and healthcare professionals about the unique aspects of homeopathic medicine.
Of course, the unique aspect of homeopathic medicines undoubtedly is that they usually contain no active molecules and therefore do not work. But somehow, I doubt that the NCH was thinking of telling consumers the truth.
The NCH statement is tame in comparison with the NCH’s response to the FDA’s actions during the homeopathic teething investigation last year. Prior to the recall, the FDA issued a warning to consumers, which the NCH dubbed as “arbitrary and capricious.” The NCH went on to say that the FDA’s warning led to “exaggerated fear mongering” in the media and a “public scare” that threatened access to homeopathic products. “[G]roups interested in seeing homeopathy destroyed continue to hammer away at the system—making exaggerated claims that create misunderstandings about and limit consumer access,” the NCH wrote [emphasis theirs].
And this response is tame compared to what a prominent US homeopaths claimed at the time:
“It’s time to hold these people accountable. There are laws in every country against officials taking bribes and malfeasance in office. Write to your legislators and demand that they investigate and bring these criminals to justice. Send them the links to hundreds of homeopathy studies, including disease prevention with homeopathy, at the end of this article. Tell them that the regulatory agencies are protecting Pharma profits, not the public.
Meanwhile, let us insist that pharmaceutical drugs be labeled honestly, like this:
“This drug was tested by the same company that profits from it, and which company has been fined millions of dollars in the past for lying about test results. This drug does not cure any medical condition, but only suppresses symptoms which may ultimately make the patient sicker. This drug has already killed or injured X number of people.”
The outrage is understandable for two reasons, I think:
- even homeopaths cannot deny that the days of unchecked claims are counted;
- against rage of this sort homeopathic remedies are obviously not working.
