conflict of interest
Drug and alcohol dependencies are notoriously difficult to treat effectively. Patients and their families are often desperate and willing to try anything. This seems like an ideal ground for acupuncturists who are, in my experience, experts in putting up smokescreens hiding the true value of their treatment.
The best way to determine the value of any intervention is probably conducting a systematic review of the evidence from rigorous clinical trials. Today we are in the fortunate position to have not just one of those articles; but do they really tell us the truth?
This brand-new systematic review investigated the effects of acupuncture on alcohol-related symptoms and behaviors in patients with this disorder. The PubMed database was searched until 23 August 2016, and reference lists from review studies were also reviewed. The inclusion criteria were the following: (1) being published in a peer-reviewed English-language journal, (2) use of randomized controlled trials (RCTs), (3) assessing the effects of acupuncture on psychological variables in individuals with a primary alcohol problem, and (4) reporting statistics that could be converted to effect sizes.
Seventeen studies were identified for a full-text inspection, and seven (243 patients) of these met our inclusion criteria. The outcomes assessed at the last post-treatment point and any available follow-up data were extracted from each of the studies. Five studies treated patients by inserting a needle into several acupoints in each ear. Two studies stimulated body points with or without ear stimulation. Four studies treated control patients with a placebo needle or under a completely different type of intervention, such as relaxation or transdermal stimulation, whereas the remaining studies inserted needles into nonspecific points. The patients were treated for 2 weeks to 3 months, and the treatment duration per session was 15–45 min. The results of the meta-analysis demonstrated that an acupuncture intervention had a stronger effect on reducing alcohol-related symptoms and behaviours than did the control intervention. A beneficial but weak effect of acupuncture treatment was also found in the follow-up data.
The authors concluded that although our analysis showed a significant difference between acupuncture and the control intervention in patients with alcohol use disorder, this meta-analysis is limited by the small number of studies included. Thus, a larger cohort study is required to provide a firm conclusion.
I am used to reading poor research papers, but this one is like a new dimension. Here are just the most obvious flaws:
- by searching just one database, the likelihood of missing studies is huge,
- by excluding non-English papers, the review automatically becomes non-systematic,
- the included studies differed vastly in many respects and can therefore not be pooled.
As it happens, a further meta-analysis has just been published. Here is its abstract:
Acupuncture has been widely used as a treatment for alcohol dependence. An updated and rigorously conducted systematic review is needed to establish the extent and quality of the evidence on the effectiveness of acupuncture as an intervention for reducing alcohol dependence. This review aimed to ascertain the effectiveness of acupuncture for reducing alcohol dependence as assessed by changes in either craving or withdrawal symptoms.
In this systematic review, a search strategy was designed to identify randomised controlled trials (RCTs) published in either the English or Chinese literature, with a priori eligibility criteria. The following English language databases were searched from inception until June 2015: AMED, Cochrane Library, EMBASE, MEDLINE, PsycINFO, and PubMed; and the following Chinese language databases were similarly searched: CNKI, Sino-med, VIP, and WanFang. Methodological quality of identified RCTs was assessed using the Jadad Scale and the Cochrane Risk of Bias tool.
Fifteen RCTs were included in this review, comprising 1378 participants. The majority of the RCTs were rated as having poor methodological rigour. A statistically significant effect was found in the two primary analyses: acupuncture reduced alcohol craving compared with all controls (SMD = −1.24, 95% CI = −1.96 to −0.51); and acupuncture reduced alcohol withdrawal symptoms compared with all controls (SMD = −0.50, 95% CI = −0.83 to −0.17). In secondary analyses: acupuncture reduced craving compared with sham acupuncture (SMD = −1.00, 95% CI = −1.79 to −0.21); acupuncture reduced craving compared with controls in RCTs conducted in Western countries (SMD = −1.15, 95% CI = −2.12 to −0.18); and acupuncture reduced craving compared with controls in RCTs with only male participants (SMD = −1.68, 95% CI = −2.62 to −0.75).
This study showed that acupuncture was potentially effective in reducing alcohol craving and withdrawal symptoms and could be considered as an additional treatment choice and/or referral option within national healthcare systems.
This Meta-analysis is only a little better than the first, I am afraid. What its conclusions do not sufficiently reflect, in my view, is the fact that the quality of the primary studies was mostly very poor – too poor to draw conclusions from (other than ‘acupuncture research is usually lousy’; see figure below). Therefore, I fail to see how the authors could draw the relatively firm and positive conclusions cited above. In my view, they should have stated something like this: DUE TO THE RISK OF BIAS IN MANY TRIALS, THE EFFECTIVENESS OF ACUPUNCTURE REMAINS UNPROVEN.
The authors of the first meta-analysis open the discussion by proudly declaring that “the present study is the first meta-analysis to examine the effect of acupuncture treatment on patients with alcohol use disorder and to provide data on the magnitude of this effect on alcohol-related clinical symptoms and behaviours.” They discretely overlook this meta-analysis from 2009 (and several others which even their rudimentary search would have identified):
Nineteen electronic databases, including English, Korean, Japanese, and Chinese databases, were systematically searched for RCTs of acupuncture for alcohol dependence up to June 2008 with no language restrictions. The methodological qualities of eligible studies were assessed using the criteria described in the Cochrane Handbook.
Eleven studies, which comprised a total of 1,110 individual cases, were systematically reviewed. Only 2 of 11 trials reported satisfactorily all quality criteria. Four trials comparing acupuncture treatment and sham treatments reported data for alcohol craving. Three studies reported that there were no significant differences. Among 4 trials comparing acupuncture and no acupuncture with conventional therapies, 3 reported significant reductions. No differences between acupuncture and sham treatments were found for completion rates (Risk Ratio = 1.07, 95% confidence interval, CI = 0.91 to 1.25) or acupuncture and no acupuncture (Risk Ratio = 1.15, 95% CI = 0.79 to 1.67). Only 3 RCTs reported acupuncture-related adverse events, which were mostly minimal.
The results of the included studies were equivocal, and the poor methodological quality and the limited number of the trials do not allow any conclusion about the efficacy of acupuncture for treatment of alcohol dependence. More research and well-designed, rigorous, and large clinical trials are necessary to address these issues.
One does not need to be an expert in interpreting meta-analyses, I think, to see that this paper is more rigorous than the new ones (which incidentally were published in the very dubious journals). And this is why I trust the conclusions of this last-named meta-analysis more than those of the new one: the efficacy of acupuncture remains unproven. And this means that we should not employ or promote it for routine care.
THE TELEGRAPH reported that “homeopathic medicines will escape an NHS prescribing ban even though the Chief Medical Officer Dame Sally Davies has dismissed the treatments as ‘rubbish’ and a waste of taxpayers money.”
This sounds insane!
Sorry, I do not know the answer either, but below I offer 10 possible options – so bear with me, please.
The NHS spends around £4 million a year on homeopathic remedies, the article claimed. Sandra Gidley, chairwoman of the Royal Pharmaceutical Society, said: “We are surprised that homeopathy, which has no scientific evidence of effectiveness, is not on the list for review. We are in agreement with NHS England that products with low or no clinical evidence of effectiveness should be reviewed with urgency.”
The NHS Clinical Commissioners, the body which was asked to review which medications should no longer be prescribed for NHS England, said it had included drugs with ‘little or no clinical value’, yet could not offer an explanation why homeopathic medicines had escaped the cut. Julie Wood, Chief Executive, NHS Clinical Commissioners said: “Clinical commissioners have always had to make difficult choices about prioritising how they spend their budget on services, but the finance and demand challenges we face at the moment are unprecedented. Clinical Commissioning Groups have been looking at their medicines spend, and many are already implementing policies to reduce spending on those prescribeable items that have little or no clinical value for patients, and are therefore not an effective use of the NHS pound.”
Under the new rules, NHS doctors will be banned from routinely prescribing items that are cheaply available in chemists. The list includes heartburn pills, paracetamol, hayfever tablets, sun cream, muscle rubs, Omega 3 fish oils, medicine for coughs and colds and travel vaccinations. Coeliacs will also be forced to buy their own gluten-free food.
So, why are homeopathic remedies excluded from this new cost-saving exercise?
I am puzzled!
Is it because:
- The NHS has recently found out that homeopathy is effective after all?
- The officials have forgotten to put homeopathics on the list?
- In times of Brexit, the government cannot be bothered about reason, science and all that?
- The NHS does not need the money?
- Homeopathic globuli look so pretty?
- Our Health Secretary is in love with homeopathy?
- Experts are no longer needed for decision-making?
- EBM has suddenly gone out of fashion?
- Placebos are now all the rage?
- Some influential person called Charles is against it?
Sorry, no prizes for the winner of this quiz!
Therapeutic Touch is a therapy mostly popular with nurses. We have discussed it before, for instance here, here, here and here. To call it implausible would be an understatement. But what does the clinical evidence tell us? Does it work?
This literature review by Iranian authors was aimed at critically evaluating the data from clinical trials examining the clinical efficacy of therapeutic touch as a supportive care modality in adult patients with cancer.
Four electronic databases were searched from the year 1990 to 2015 to locate potentially relevant peer-reviewed articles using the key words therapeutic touch, touch therapy, neoplasm, cancer, and CAM. Additionally, relevant journals and references of all the located articles were manually searched for other potentially relevant studies.
The number of 334 articles was found on the basis of the key words, of which 17 articles related to the clinical trial were examined in accordance with the objectives of the study. A total of 6 articles were in the final dataset in which several examples of the positive effects of healing touch on pain, nausea, anxiety and fatigue, and life quality and also on biochemical parameters were observed.
The authors concluded that, based on the results of this study, an affirmation can be made regarding the use of TT, as a non-invasive intervention for improving the health status in patients with cancer. Moreover, therapeutic touch was proved to be a useful strategy for adult patients with cancer.
This review is badly designed and poorly reported. Crucially, its conclusions are not credible. Contrary to what the authors stated when formulating their aims, the methods lack any attempt of critically evaluating the primary data.
A systematic review is more than a process of ‘pea counting’. It requires a rigorous assessment of the risk of bias of the included studies. If that crucial step is absent, the article is next to worthless and the review degenerates into a promotional excercise. Sadly, this is the case with the present review.
You may think that this is relatively trivial (“Who cares what a few feeble-minded nurses do?”), but I would disagree: if the medical literature continues to be polluted by such irresponsible trash, many people (nurses, journalists, healthcare decision makers, researchers) who may not be in a position to see the fatal flaws of such pseudo-reviews will arrive at the wrong conclusions and make wrong decisions. This will inevitably contribute to a hindrance of progress and, in certain circumstances, must endanger the well-being or even the life of vulnerable patients.
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.
Wikipedia informs us that Lewith graduated from Trinity College, Cambridge in medicine and biochemistry. He then went on to Westminster Medical School to complete his clinical studies and began working clinically in 1974. In 1977 Lewith became a member of the Royal College of Physicians. Then, in 1980, he became a member of the Royal College of General Practitioners and, later in 1999, was elected a fellow of the Royal College of Physicians.
He was a Professor of Health Research in the Department of Primary Care at the University of Southampton and a director of the International Society for Complementary Medicine Research. Lewith has obtained a significant number of institutional peer reviewed fellowships at doctoral and post-doctoral level and has been principal investigator or collaborator in research grants totally over £5 million during the last decade.
Between 1980 and 2010, Lewith was a partner at the Centre for Complementary and Integrated Medicine, a private practice providing complementary treatments with clinics in London and Southampton.
A tribute by the British Acupuncture Council is poignant, in my view: “George was a friend not only to all of the acupuncture profession, be it traditional, medical or physiotherapist – he was a member of all three professional bodies – but to the whole of complementary medicine. As well as being a research leader he was also politically savvy, working tirelessly up front and behind the scenes to try to bring acupuncture and CAM further into the mainstream. Nobody did more.”
I find it poignant because it hints at the many differences I (and many others) had with Lewith during the last 25 years that I knew him. George was foremost a proponent of acupuncture. His 1985 book – the first of many – advocated treating many internal diseases with acupuncture!
George did not strike me as someone who had the ability or even the ambition to use science for finding the truth and for falsifying hypotheses; in my view, he employed it to confirm his almost evangelic belief. In the pursuit of this all-important aim he did indeed spend a lot of time and energy pulling strings, including on the political level. George was undoubtedly successful but the question has to be asked to what extent this was due to his tireless work ‘behind the scenes’.
In my view, George was a typical example of someone who first and foremost was an advocate and a researcher second. During my time in Exeter, I have met numerous co-workers who had the same problem. Almost without exception, I found that it is impossible to turn such a person into a decent scientist. The advocacy of alternative medicine always got in the way of objectivity and rationality, qualities that are, of course, essential for good science.
George’s very first publication on acupuncture was a ‘letter to the editor’ published in the BMJ. In it, he announced that he is planning to conduct a trial of acupuncture and stated that “acupuncture will be compared to an equally magical placebo”. Yes, George always had the ability to make me laugh; and this is why I will miss him.
On 13 March, the UK Charity Commission published the following announcement:
This consultation is about the Commission’s approach to deciding whether an organisation which uses or promotes CAM therapies is a charity. For an organisation to be charitable, its purposes must be exclusively charitable. Some purposes relate to health and to relieve the needs of the elderly and disabled.
We are seeking views on:
- the level and nature of evidence to support CAM
- conflicting and inconsistent evidence
- alternative therapies and the risk of harm
- palliative alternative therapy
Last year, lawyers wrote to the Charity Commission on behalf of the Good Thinking Society suggesting that, if the commission refused to revoke the charitable status of organisations that promote homeopathy, it could be subject to a judicial review. The commission responded by announcing their review which will be completed by 1 July 2017.
Charities must meet a “public benefit test”. This means that they must be able to provide evidence that the work they do benefits the public as a whole. Therefore the consultation will have to determine what nature of evidence is required to demonstrate that a CAM-promoting charity provides this benefit.
In a press release, the Charity Commission stated that it will consider what to do in the face of “conflicting or inconsistent” evidence of a treatment’s effectiveness, and whether it should approach “complementary” treatments, intended to work alongside conventional medicine, differently from “alternative” treatments intended to replace it. In my view, however, this distinction is problematic and often impossible. Depending on the clinical situation, almost any given alternative therapy can be used both as a complementary and as an alternative treatment. Some advocates seem to cleverly promote their therapy as complementary (because this is seen as more acceptable), but clearly employ it as an alternative. The dividing line is often far too blurred for this distinction to be practical, and I have therefore long given up making it.
John Maton, the commission’s head of charitable status, said “Our consultation is not about whether complementary and alternative therapies and medicines are ‘good’ or ‘bad’, but about what level of evidence we should require when making assessments about an organisation’s charitable status.” Personally, I am not sure what this means. It sounds suspiciously soft and opens all sorts of escape routes for even the most outright quackery, I fear.
Michael Marshall of the Good Thinking Society said “We are pleased to see the Charity Commission making progress on their review. Too often we have seen little effective action to protect the public from charities whose very purpose is the promotion of potentially dangerous quackery. However, the real progress will come when the commission considers the clear evidence that complementary and alternative medicine organisations currently afforded charitable status often offer therapies that are completely ineffective or even potentially harm the public. We hope that this review leads to a policy to remove such misleading charities from the register.”
On this blog, I have occasionally reported about charities promoting quackery (for instance here, here and here) and pointed out that such activities cannot ever benefit the public. On the contrary, they are a danger to public health and bring many good charities into disrepute. I would therefore encourage everyone to use this unique occasion to write to the Charity Commission and make their views felt.
One phenomenon that can be noted more frequently than any other in alternative medicine research is that studies arrive at wrong or misleading conclusions. This is more than a little disappointing, not least because it is the conclusion of a trial that is often picked up by health writers and others who in turn mislead the public. On this blog, we must have seen hundreds of examples of this irritating phenomenon. Here is yet another one. This study, a randomized, parallel, open-label exploratory trial, evaluated and compared the effects of systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture for treating patients with tinnitus. It included patients who suffered from idiopathic tinnitus for more than two weeks were recruited. They were divided into three groups:
- systemic manual acupuncture group (MA),
- periauricular electroacupuncture group (PE),
- distal electroacupuncture group (DE).
Nine acupoints (TE 17, TE21, SI19, GB2, GB8, ST36, ST37, TE3 and TE9), two periauricular acupoints (TE17 and TE21), and four distal acupoints (TE3, TE9, ST36, and ST37) were selected. The treatment sessions were performed twice weekly for a total of 8 sessions over 4 weeks. Outcome measures were the tinnitus handicap inventory (THI) score and the loud and uncomfortable visual analogue scales (VAS). Demographic and clinical characteristics of all participants were compared between the groups upon admission using one-way analysis of variance (ANOVA). One-way ANOVA was used to evaluate the THI, VAS loud, and VAS uncomfortable scores. The least significant difference test was used as a post-hoc test. In total, 39 subjects were eligible for analysis. No differences in THI and VAS loudness scores were observed between groups. The VAS uncomfortable scores decreased significantly in MA and DE compared with those in PE. Within the group, all three treatments showed some effect on THI, VAS loudness scores and VAS uncomfortable scores after treatment except DE in THI. The authors concluded that there was no statistically significant difference between systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture in tinnitus. However, all three treatments had some effect on tinnitus within the group before and after treatment. Systemic manual acupuncture and distal electroacupuncture have some effect on VAS. Neither of the three treatments tested in this study have been previously proven to work. Therefore, it is quite simply nonsensical to compare them. Comparative studies are indicated only with therapies that have a solid evidence-base. They are called ‘superiority trials’ and require a different statistical approach as well as much larger sample sizes. In other words, this study was an unethical waste of resources from the outset. With this in mind, there is only one conclusion that fits the data: there was no statistically significant difference between the three types of acupuncture. The data are therefore in keeping with the notion that all three are placebos. Alternatively one might conclude more clearly for those who are otherwise resistant to learning a lesson: POORLY DESIGNED CLINICAL TRIALS ARE UNETHICAL AND NEVER LEND THEMSELVES TO MEANINGFUL CONCLUSIONS.
In the realm of alternative medicine, the Internet is a double-edged sword. It can be most useful to many, particularly to those who are able to think critically. To those who do not have this ability, it can be outright dangerous. We have researched this area in several way and always arrived at this very conclusion. For instance, we evaluated websites providing advice for cancer patients and concluded that “the most popular websites on complementary and alternative medicine for cancer offer information of extremely variable quality. Many endorse unproven therapies and some are outright dangerous.”
This makes it abundantly clear that, for some, the Internet can become a danger to their health and life. Recently I was reminded of this fact when I saw this website entitled ‘Foods that will naturally cleanse your arteries’. Its message is instantly clear, particularly as it provides this impressive drawing.
The implication here is that we can all clear our arteries of atherosclerotic plaques by eating the right foods. The site also lists the exact foods. Here they are:
START OF QUOTE
Salmon is one of the best heart foods as it is packed with healthy fats which reduce cholesterol, triglycerides, and inflammation. However you must make sure that the fish is organic.
Orange juice is rich in antioxidants which strengthens the blood vessels and lowers blood pressure. Simply drink 2 glasses of fresh orange juice a day and you’re good to go.
According to numerous studies 2-4 cups of coffee a day can significantly reduce the risk of stroke and heart attack by 20%. However don’t drink excessively as it may cause problems with your digestion.
Nuts are packed with omega-3 fatty acids, healthy properties and unsaturated fats which regulate your memory, cholesterol and prevent joint pain.
The persimmon fruit is packed with fiber and sterols which help lower cholesterol. It makes a great addition to salads and cereals
Curcumin, the active ingredient in turmeric provides a large variety of health benefits. It helps reduce tissue inflammation and prevents overactive fat accumulation. Feel free to add it to your meals or to your tasty cup of tea.
Aside from having a soothing effect, green tea helps energize the whole body, boost the metabolism and lower the absorption of cholesterol. Just drink 1-2 cups of green tea a day and you have nothing to worry about.
Cheese can also help lower blood pressure and cholesterol.
Watermelon is the most delicious summer fruit. But aside from its amazing taste, it also improves the production of nitric oxide which enhances the function of the blood vessels.
Whole grains are rich in fiber content which helps lower cholesterol and cholesterol accumulation in the arteries. Consume more whole grain bread, brown rice and oats.
Cranberries have been long known to be the richest source of potassium. Due to this, they can easily lower bad cholesterol and increase the good one. 2 glasses of cranberry juice a day can lower the risk of heart attack by 40%.
Seaweeds are packed with vitamins, proteins, minerals and carotenoids which easily regulate your blood pressure.
Cinnamon prevents buildups in the arteries and lower cholesterol.
It is an exotic fruit that provides a healthy portion of phytochemicals. These improve the production of nitric oxide, and boost circulation. Add pomegranate seeds to your salads.
It is high in folic acid and potassium. You need this to lower your blood pressure, strengthen muscles, and prevent heart attack.
Broccoli is rich in vitamin K, which help lower blood pressure and cholesterol when eaten steam-cooked or raw.
Olive oil helps maintain your health at its peak. Be sure to use cold-pressed oil as it is rich in healthy fats which lower cholesterol and reduce the risk of heart attack by 40%.
Asparagus prevents inflammation, clogging and lowers cholesterols. Implement it to dishes, noodles, soups or potatoes.
Blueberries are high in potassium and as we mentioned above, potassium is the key to reducing bad cholesterol and increasing the good one. Drink 2 glasses of blueberry juice a day.
Avocadoes are without a doubt – one of the healthiest fruits known to man. They’re rich in healthy fat and improve the balance of bad and good cholesterol.
END OF QUOTE
As far as I know, there is no good evidence for the claim that any of these 20 foods will clear arteriosclerotic arteries. There is some evidence for fish oil and some for green tea to reduce the risk of cardiovascular disease. But surely, this is quite a different matter than reversing atherosclerotic plaques.
What’s the harm? I believe the potential for harm is obvious: people at high risk of suffering a major cardiovascular event who read such nonsense and believe it might think they can abandon the treatments, drugs and life-styles they have been advised to follow and take. Instead they might eat a bit more of the 20 ingredients listed above. If they did that, many would die.
I think many of us who know better have become far too tolerant of dangerous nonsense of such nature. We tend to think that either nobody is as stupid as to follow such silly advice, or we assume that taking a bit of daft advice will not do much harm. I fear we are wrong on both accounts.
Yes, I am afraid it is Dana Ullman again!
On the last post, he commented: “If you actually think that homeopathic medicines will KILL people, then, we all must assume that you think that conventional medicines create MASS MURDERS.”
In my view, this is a sad comment indeed. It reveals that a homeopath who has, after all, been in the business for decades has really very little idea about what makes an intervention a potentially good or a bad treatment.
Is it its efficacy?
Is it its safety?
IT IS THE RATIO OF THE TWO!!!
For the Ullmans of this world, I provide two very simple examples:
- One could prevent a common cold effectively with interferon. Why don’t we do this routinely? Because the benefit would not out-weigh its harm.
- We all know that chemotherapy can have terrible adverse effects. Why do we nevertheless use it for cancer? Because the benefits of saving a life out-weigh all the significant harm chemotherapy might do.
The conclusion is simple: to be useful, a therapy must demonstrably generate more good than harm. If there is no effectiveness, the risk/benefit balance can never be positive, even if the risks are relatively small. But risk/benefit balance can still be favourable, even if the therapy causes considerable harm.
This hardly is rocket science, is it? But the Ullmans of this world do refuse to get it, and that is sad, in my view. This ignorance is the basis for the fundamentally misguided advice they issue to their patients day in, day out.
What is more, the Ullmans of this world stubbornly deny that anyone can do significant harm with homeopathic remedies; they evidently think that homeopathy cannot kill patients. Yet they are evidently wrong.
Whenever the simple rules of risk/benefit are ignored, even apparently harmless treatments, like highly diluted homeopathic remedies, can – and sadly will – kill patients.
I suspect that the Ullmans of this world are still in closed-minded denial about this point. Let me therefore quote a few of my own posts where cases of ‘death by homeopathy’ have been mentioned:
- The ‘pernicious practice of homeopathy in Australia’: ‘tolerated by authorities to avoid an inconvenient confrontation’
- The end of a free ride for homeopathy in the US
- Homeopathy cost another life … and homeopaths remain once again silent
- A further strong nail in the coffin of homeopathy
- Time for the legal profession to have a serious look at homeopathy?
I fear that the Ullmans of this world will still not be convinced. Perhaps a look at this website might do the trick? No, probably not – changing one’s mind vis a vis facts requires intelligence. They will carry on claiming that, in comparison, “conventional medicines creates MASS MURDERS”.
And this is where we go full circle and I start again explaining about the balance of risk and benefit…
GIVE ME STRENGTH!!!
Dana Ullman is an indefatigable promotor of bogus claims and an unwitting contributor of hilarity. Therefore he has become a regular feature of this blog (see for instance here, here and here). His latest laughable assertion is that lead and other poisonings can be successfully treated with homeopathy.
Just to make sure: lead poisoning is no joke. The greatest risk is to brain development in babies, where irreversible damage can occur. Higher levels can damage the kidneys and nervous system in both children and adults. Very high lead levels may cause seizures, unconsciousness and death.
In view of this, Ullman’s claim is surprising, to say the least. In order to persuade the unsuspecting public of his notion, Ullman first cites a review of basic research on homeopathy and toxins published in Human and Experimental Toxicology. “Of forty high-quality studies, 27 showed positive results from homeopathic treatment”, Ullman states.
Now, now, now Dana!
Has your mom not taught you that telling porkies is forbidden?
Or did you perhaps miss this line in the article’s abstract? “The quality of evidence in these studies was low with only 43% achieving one half of the maximum possible quality score and only 31% reported in a fashion that permitted re-evaluation of the data. Very few studies were independently replicated using comparable models.”
Hardly ‘high quality studies’, wouldn’t you agree?
But this review was of pre-clinical studies; what about the much more important clinical evidence?
Here Ullman cites one trial where a potentized homeopathic remedy, Arsenicum Album 30C, was administered to 55 people who were entered into a double-blind, placebo-controlled trial. According to Ullman, the homeopathically treated group “experienced higher excretion of arsenic in their urine for the first eleven days, compared to those given a placebo.”
Na, na, na, Dana, this is getting serious!!!
Another porky – and not even a little one.
The authors of this study clearly stated that, at the end of the 11-day RCT, there was no significant difference between the homeopathy and the placebo group: “The differences in the concentration between the two groups (drug versus placebo) were generally a little higher during the first week, but subsequently the differences were not so palpable, particularly at the 11th day.” And for those who are a bit slow on the uptake, they even included a graph that makes it abundantly clear.
The only other clinical study cited by Ullman in support of his surprising claim is a double-blind randomized trial which was conducted with 131 workers who suffered lead poisoning at the Ajax battery plant in Bauru, São Paulo State, Brazil. Subjects were prescribed homeopathic doses of lead (Plumbum metallicum 15C) or placebo which they took orally for 35 days. The results of this RCT show that homeopathy is not better than placebo.
So, we seem to have all of two RCTs on the subject (I did a quick Medline-search and also found no further RCTs), and both are negative.
Anyone who is not given to compulsive porky-telling would, I guess, conclude from this evidence that people suffering from lead poisoning should urgently see conventional experts and avoid homeopaths at all costs – not so Dana Ullman who boldly concludes his article with these words:
“As an adjunct to conventional medical treatment, professional homeopathic care is recommended for people who have been exposed (or think they have been exposed) to toxic substances… Even if you do not have a professional homeopath in your town, many homeopathic practitioners “see” their patients via Skype or do consultations over the telephone. Unlike acupuncturists, who put needles in you, or chiropractors, who adjust your spine, homeopaths are not “hands-on”: they simply need to conduct a detailed interview… If your symptoms are serious or potentially serious, it is important to see a professional homeopath and/or physician. While a homeopath will commonly prescribe a safe homeopathic dose of the toxic substance to which one was exposed, the homeopath may instead decide that a different substance more closely matches the patient’s unique symptoms…”
It takes a lot these days to make me speechless but there, Dana, you almost succeeded!
A new study published in JAMA investigated the long-term effects of acupuncture compared with sham acupuncture and being placed in a waiting-list control group for migraine prophylaxis. The trial was a 24-week randomized clinical trial (4 weeks of treatment followed by 20 weeks of follow-up). Participants were randomly assigned to 1) true acupuncture, 2) sham acupuncture, or 3) a waiting-list control group. The trial was conducted from October 2012 to September 2014 in outpatient settings at three clinical sites in China. Participants 18 to 65 years old were enrolled with migraine without aura based on the criteria of the International Headache Society, with migraine occurring 2 to 8 times per month.
Participants in the true acupuncture and sham acupuncture groups received treatment 5 days per week for 4 weeks for a total of 20 sessions. Participants in the waiting-list group did not receive acupuncture but were informed that 20 sessions of acupuncture would be provided free of charge at the end of the trial. Participants used diaries to record migraine attacks. The primary outcome was the change in the frequency of migraine attacks from baseline to week 16. Secondary outcome measures included the migraine days, average headache severity, and medication intake every 4 weeks within 24 weeks.
A total of 249 participants 18 to 65 years old were enrolled, and 245 were included in the intention-to-treat analyses. Baseline characteristics were comparable across the 3 groups. The mean (SD) change in frequency of migraine attacks differed significantly among the 3 groups at 16 weeks after randomization; the mean (SD) frequency of attacks decreased in the true acupuncture group by 3.2 (2.1), in the sham acupuncture group by 2.1 (2.5), and the waiting-list group by 1.4 (2.5); a greater reduction was observed in the true acupuncture than in the sham acupuncture group (difference of 1.1 attacks; 95% CI, 0.4-1.9; P = .002) and in the true acupuncture vs waiting-list group (difference of 1.8 attacks; 95% CI, 1.1-2.5; P < .001). Sham acupuncture was not statistically different from the waiting-list group (difference of 0.7 attacks; 95% CI, −0.1 to 1.4; P = .07).
The authors concluded that among patients with migraine without aura, true acupuncture may be associated with long-term reduction in migraine recurrence compared with sham acupuncture or assigned to a waiting list.
Note the cautious phraseology: “… acupuncture may be associated with long-term reduction …”
The authors were, of course, well advised to be so atypically cautious:
- Comparisons to the waiting list group are meaningless for informing us about the specific effects of acupuncture, as they fail to control for placebo-effects.
- Comparisons between real and sham acupuncture must be taken with a sizable pinch of salt, as the study was not therapist-blind and the acupuncturists may easily have influenced their patients in various ways to report the desired result (the success of patient-blinding was not reported but would have gone some way to solving this problem).
- The effect size of the benefit is tiny and of doubtful clinical relevance.
My biggest concern, however, is the fact that the study originates from China, a country where virtually 100% of all acupuncture studies produce positive (or should that be ‘false-positive’?) findings and data fabrication has been reported to be rife. These facts do not inspire trustworthiness, in my view.
So, does acupuncture work for migraine? The current Cochrane review included 22 studies and its authors concluded that the available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking.
So, maybe acupuncture is effective. Personally, I am not convinced and certainly do not think that the new JAMA study significantly strengthened the evidence.