Most of the underlying assumptions of alternative medicine (AM) lack plausibility. Whenever this is the case, so the argument put forward by an international team of researchers in a recent paper, there are difficulties involved in obtaining a valid statistical significance in clinical studies.
Using a mostly statistical approach, they argue that, since the prior probability of a research hypothesis is directly related to its scientific plausibility, the commonly used frequentist statistics, which do not account for this probability, are unsuitable for studies exploring matters in various degree disconnected from science. Any statistical significance obtained in this field should be considered with great caution and may be better applied to more plausible hypotheses (like placebo effect) than the specific efficacy of the intervention.
The researchers conclude that, since achieving meaningful statistical significance is an essential step in the validation of medical interventions, AM practices, producing only outcomes inherently resistant to statistical validation, appear not to belong to modern evidence-based medicine.
To emphasize their arguments, the researchers make the following additional points:
- It is often forgotten that frequentist statistics, commonly used in clinical trials, provides only indirect evidence in support of the hypothesis examined.
- The p-value inherently tends to exaggerate the support for the hypothesis tested, especially if the scientific plausibility of the hypothesis is low.
- When the rationale for a clinical intervention is disconnected from the basic principles of science, as in case of complementary alternative medicines, any positive result obtained in clinical studies is more reasonably ascribable to hypotheses (generally to placebo effect) other than the hypothesis on trial, which commonly is the specific efficacy of the intervention.
- Since meaningful statistical significance as a rule is an essential step to validation of a medical intervention, complementary alternative medicine cannot be considered evidence-based.
Further explanations can be found in the discussion of the article where the authors argue that the quality of the hypothesis tested should be consistent with sound logic and science and therefore have a reasonable prior probability of being correct. As a rule of thumb, assuming a “neutral” attitude towards the null hypothesis (odds = 1:1), a p-value of 0.01 or, better, 0.001 should suffice to give a satisfactory posterior probability of 0.035 and 0.005 respectively.
In the area of AM, hypotheses often are entirely inconsistent with logic and frequently fly in the face of science. Four examples can demonstrate this instantly and sufficiently, I think:
- Homeopathic remedies which contain not a single ‘active’ molecule are not likely to generate biological effects.
- Healing ‘energy’ of Reiki masters has no basis in science.
- Meridians of acupuncture are pure imagination.
- Chiropractic subluxation have never been shown to exist.
Positive results from clinical trials of implausible forms of AM are thus either due to chance, bias or must be attributed to more credible causes such as the placebo effect. Since the achievement of meaningful statistical significance is an essential step in the validation of medical interventions, unless some authentic scientific support to AM is provided, one has to conclude that AM cannot be considered as evidence-based.
Such arguments are by no means new; they have been voiced over and over again. Essentially, they amount to the old adage: IF YOU CLAIM THAT YOU HAVE A CAT IN YOUR GARDEN, A SIMPLE PICTURE MAY SUFFICE. IF YOU CLAIM THERE IS A UNICORN IN YOUR GARDEN, YOU NEED SOMETHING MORE CONVINCING. An extraordinary claim requires an extraordinary proof! Put into the context of the current discussion about AM, this means that the usual level of clinical evidence is likely to be very misleading as long as it totally neglects the biological plausibility of the prior hypothesis.
Proponents of AM do not like to hear such arguments. They usually insist on what we might call a ‘level playing field’ and fail to see why their assumptions require not only a higher level of evidence but also a reasonable scientific hypothesis. They forget that the playing field is not even to start with; to understand the situation better, they should read this excellent article. Perhaps its elegant statistical approach will convince them – but I would not hold my breath.
Medical treatments with no direct effect, such as homeopathy, are surprisingly popular. But how does a good reputation of such treatments spread and persist? Researchers from the Centre for the Study of Cultural Evolution in Stockholm believe that they have identified the mechanism.
They argue that most medical treatments result in a range of outcomes: some people improve while others deteriorate. If the people who improve are more inclined to tell others about their experiences than the people who deteriorate, ineffective or even harmful treatments would maintain a good reputation.
They conducted a fascinating study to test the hypothesis that positive outcomes are overrepresented in online medical product reviews, examined if this reputational distortion is large enough to bias people’s decisions, and explored the implications of this bias for the cultural evolution of medical treatments.
The researchers compared outcomes of weight loss treatments and fertility treatments as evidenced in clinical trials to outcomes reported in 1901 reviews on Amazon. Subsequently, in a series of experiments, they evaluated people’s choice of weight loss diet after reading different reviews. Finally, a mathematical model was used to examine if this bias could result in less effective treatments having a better reputation than more effective treatments.
The results of these investigations confirmed the hypothesis that people with better outcomes are more inclined to write reviews. After 6 months on the diet, 93% of online reviewers reported a weight loss of 10 kg or more, while just 27% of clinical trial participants experienced this level of weight change. A similar positive distortion was found in fertility treatment reviews. In a series of experiments, the researchers demonstrated that people are more inclined to begin a diet that was backed by many positive reviews, than a diet with reviews that are representative of the diet’s true effect. A mathematical model of medical cultural evolution suggested that the size of the positive distortion critically depends on the shape of the outcome distribution.
The authors concluded that online reviews overestimate the benefits of medical treatments, probably because people with negative outcomes are less inclined to tell others about their experiences. This bias can enable ineffective medical treatments to maintain a good reputation.
To me, this seems eminently plausible; but there are, of course, other reasons why bogus treatments survive or even thrive – and they may vary in their importance to the overall effect from treatment to treatment. As so often in health care, things are complex and there are multiple factors that contribute to a phenomenon.
Recently, I was invited to give a lecture about homeopathy for a large gathering of general practitioners (GPs). In the coffee break after my talk, I found myself chatting to a very friendly GP who explained: “I entirely agree with you that homeopathic remedies are pure placebos, but I nevertheless prescribe them regularly.” “Why would anyone do that?” I asked him. His answer was as frank as it was revealing.
Some of his patients, he explained, have symptoms for which he has tried every treatment possible without success. They typically have already seen every specialist in the book but none could help either. Alternatively they are patients who have nothing wrong with them but regularly consult him for trivial or self-limiting problems.
In either case, the patients come with the expectation of getting a prescription for some sort of medicine. The GP knows that it would be a hassle and most likely a waste of time to try and dissuade them. His waiting room is full, and he is facing the following choice:
- to spend valuable 15 minutes or so explaining why he should not prescribe any medication at all, or
- to write a prescription for a homeopathic placebo and get the consultation over with in two minutes.
Option number 1 would render the patient unhappy or even angry, and chances are that she would promptly see some irresponsible charlatan who puts her ‘through the mill’ at great expense and considerable risk. Option number 2 would free the GP quickly to help those patients who can be helped, make the patient happy, preserve a good therapeutic relationship between GP and the patient, save the GP’s nerves, let the patient benefit from a potentially powerful placebo-effect, and be furthermore safe as well as cheap.
I was not going to be beaten that easily though. “Basically” I told him “you are using homeopathy to quickly get rid of ‘heart sink’ patients!”
“And you find this alright?”
“No, but do you know a better solution?”
I explained that, by behaving in this way, the GP degrades himself to the level of a charlatan. “No”, he said “I am saving my patients from the many really dangerous charlatans that are out there.”
I explained that some of these patients might suffer from a serious condition which he had been able to diagnose. He countered that this has so far never happened because he is a well-trained and thorough physician.
I explained that his actions are ethically questionable. He laughed and said that, in his view, it was much more ethical to use his time and skills to the best advantage of those who truly need them. In his view, the more important ethical issue over-rides the relatively minor one.
I explained that, by implying that homeopathy is an effective treatment, he is perpetuating a myth which stands in the way of progress. He laughed again and answered that his foremost duty as a GP is not to generate progress on a theoretical level but to provide practical help for the maximum number of patients.
I explained that there cannot be many patients for whom no treatment existed that would be more helpful than a placebo, even if it only worked symptomatically. He looked at me with a pitiful smile and said my remark merely shows how long I am out of clinical medicine.
I explained that doctors as well as patients have to stop that awfully counter-productive culture of relying on prescriptions or ‘magic bullets’ for every ill. We must all learn that, in many cases, it is better to do nothing or rely on life-style changes; and we must get that message across to the public. He agreed, at least partly, but claimed this would require more that the 10 minutes he is allowed for each patient.
I explained….. well, actually, at this point, I had run out of arguments and was quite pleased when someone else started talking to me and this conversation had thus been terminated.
Since that day, I am wondering what other arguments exist. I would be delighted, if my readers could help me out.
General practitioners (GPs) play an important role in advising patients on all sorts of matters related to their health, and this includes, of course, the possible risks of electromagnetic fields (EMF). Their views on EMF are thus relevant and potentially influential.
A team of German and Danish researchers therefore conducted a survey comparing GPs using conventional medicine (COM) with GPs using complementary and alternative medicine (CAM) concerning their perception of EMF risks. A total of 2795 GPs drawn randomly from lists of German GPs were sent an either long or short self-administered postal questionnaire on EMF-related topics. Adjusted logistic regression models were fitted to assess the association of an education in alternative medicine with various aspects of perceiving EMF risks.
Concern about EMF, misconceptions about EMF, and distrust toward scientific organizations are more prevalent in CAM-GPs. CAM-GPs more often falsely believed that mobile phone use can lead to head warming of more than 1°C, more often distrusted the Federal Office for Radiation Protection, were more often concerned about mobile phone base stations, more often attributed own health complaints to EMF, and more often reported at least 1 EMF consultation. GPs using homeopathy perceived EMF as more risky than GPs using acupuncture or naturopathic treatment.
The authors concluded that concern about common EMF sources is highly prevalent among German GPs. CAM-GPs perceive stronger associations between EMF and health problems than COM-GPs. There is a need for evidence-based information about EMF risks for GPs and particularly for CAM-GPs. This is the precondition that GPs can inform patients about EMF and health in line with current scientific knowledge.
True, the evidence is somewhat contradictory but the majority of independent reviews seem to suggest that EMF constitute little or no health risks. In case you don’t believe me, here are a few conclusions from recent reviews:
- At present, there is little, if any, evidence that the use of mobile phones is associated with cancer in adults, including brain tumors, acoustic neuroma, cancer of the salivary glands, leukemia, or malignant melanoma of the eye.
- Mobile phone-like EMF do not seem to induce cognitive and psychomotor effects
- No clinical association has been demonstrated between cell and cordless phone use and vestibular schwannoma.
- The balance of epidemiologic evidence indicates that mobile phone use of less than 10 years does not pose any increased risk of brain tumour or acoustic neuroma.
But even if someone wants to err on the safe side, and seriously considers the possibility that EMF sources might have the potential to harm our health, a general distrust in scientific organizations, and wrong ideas about modern technologies such as mobile phones are hardly very helpful – in fact, I find them pretty worrying. To learn that CAM-GPs are more likely than COM-GPs to hold such overtly anti-scientific views does not inspire me with trust; to see that homeopaths are the worst culprits is perhaps not entirely unexpected. Almost by definition, critical evaluation of the existing evidence is not a skill that is prevalent amongst homeopaths – if it were, there would be no homeopaths!
Twenty years ago, when I started my Exeter job as a full-time researcher of complementary/alternative medicine (CAM), I defined the aim of my unit as applying science to CAM. At the time, this intention upset quite a few CAM-enthusiasts. One of the most prevalent arguments of CAM-proponents against my plan was that the study of CAM with rigorous science was quite simply an impossibility. They claimed that CAM included mind and body practices, holistic therapies, and other complex interventions which cannot not be put into the ‘straight jacket’ of conventional research, e. g. a controlled clinical trial. I spent the next few years showing that this notion was wrong. Gradually and hesitantly CAM researchers seemed to agree with my view – not all, of course, but first a few and then slowly, often reluctantly the majority of them.
What followed was a period during which several research groups started conducting rigorous tests of the hypotheses underlying CAM. All too often, the results turned out to be disappointing, to say the least: not only did most of the therapies in question fail to show efficacy, they were also by no means free of risks. Worst of all, perhaps, much of CAM was disclosed as being biologically implausible. The realization that rigorous scientific scrutiny often generated findings which were not what proponents had hoped for led to a sharp decline in the willingness of CAM-proponents to conduct rigorous tests of their hypotheses. Consequently, many asked whether science was such a good idea after all.
But that, in turn, created a new problem: once they had (at least nominally) committed themselves to science, how could they turn against it? The answer to this dilemma was easier that anticipated: the solution was to appear dedicated to science but, at the same time, to argue that, because CAM is subtle, holistic, complex etc., a different scientific approach was required. At this stage, I felt we had gone ‘full circle’ and had essentially arrived back where we were 20 years ago – except that CAM-proponents no longer rejected the scientific method outright but merely demanded different tools.
A recent article may serve as an example of this new and revised stance of CAM-proponents on science. Here proponents of alternative medicine argue that a challenge for research methodology in CAM/ICH* is the growing recognition that CAM/IHC practice often involves complex combination of novel interventions that include mind and body practices, holistic therapies, and others. Critics argue that the reductionist placebo controlled randomized control trial (RCT) model that works effectively for determining efficacy for most pharmaceutical or placebo trial RCTs may not be the most appropriate for determining effectiveness in clinical practice for either CAM/IHC or many of the interventions used in primary care, including health promotion practices. Therefore the reductionist methodology inherent in efficacy studies, and in particular in RCTs, may not be appropriate to study the outcomes for much of CAM/IHC, such as Traditional Korean Medicine (TKM) or other complex non-CAM/IHC interventions—especially those addressing comorbidities. In fact it can be argued that reductionist methodology may disrupt the very phenomenon, the whole system, that the research is attempting to capture and evaluate (i.e., the whole system in its naturalistic environment). Key issues that surround selection of the most appropriate methodology to evaluate complex interventions are well described in the Kings Fund report on IHC and also in the UK Medical Research Council (MRC) guidelines for evaluating complex interventions—guidelines which have been largely applied to the complexity of conventional primary care and care for patients with substantial comorbidity. These reports offer several potential solutions to the challenges inherent in studying CAM/IHC. [* IHC = integrated health care]
Let’s be clear and disclose what all of this actually means. The sequence of events, as I see it, can be summarized as follows:
- We are foremost ALTERNATIVE! Our treatments are far too unique to be subjected to reductionist research; we therefore reject science and insist on an ALTERNATIVE.
- We (well, some of us) have reconsidered our opposition and are prepared to test our hypotheses scientifically (NOT LEAST BECAUSE WE NEED THE RECOGNITION THAT THIS MIGHT BRING).
- We are dismayed to see that the results are mostly negative; science, it turns out, works against our interests.
- We need to reconsider our position.
- We find it inconceivable that our treatments do not work; all the negative scientific results must therefore be wrong.
- We always said that our treatments are unique; now we realize that they are far too holistic and complex to be submitted to reductionist scientific methods.
- We still believe in science (or at least want people to believe that we do) – but we need a different type of science.
- We insist that RCTs (and all other scientific methods that fail to demonstrate the value of CAM) are not adequate tools for testing complex interventions such as CAM.
- We have determined that reductionist research methods disturb our subtle treatments.
- We need pragmatic trials and similarly ‘soft’ methods that capture ‘real life’ situations, do justice to CAM and rarely produce a negative result.
What all of this really means is that, whenever the findings of research fail to disappoint CAM-proponents, the results are by definition false-negative. The obvious solution to this problem is to employ different (weaker) research methods, preferably those that cannot possibly generate a negative finding. Or, to put it bluntly: in CAM, science is acceptable only as long as it produces the desired results.
Dodgy science abounds in alternative medicine; this is perhaps particularly true for homeopathy. A brand-new trial seems to confirm this view.
The aim of this study was to test the hypothesis that homeopathy (H) enhances the effects of scaling and root planing (SRP) in patients with chronic periodontitis (CP).
The researchers, dentists from Brazil, randomised 50 patients with CP to one of two treatment groups: SRP (C-G) or SRP + H (H-G). Assessments were made at baseline and after 3 and 12 months of treatment. The local and systemic responses to the treatments were evaluated after one year of follow-up. The results showed that both groups displayed significant improvements, however, the H-G group performed significantly better than C-G group.
The authors concluded that homeopathic medicines, as an adjunctive to SRP, can provide significant local and systemic improvements for CP patients.
Really? I am afraid, I disagree!
Homeopathic medicines might have nothing whatsoever to do with this result. Much more likely is the possibility that the findings are caused by other factors such as:
- patients’ expectations,
- improved compliance with other health-related measures,
- the researchers’ expectations,
- the extra attention given to the patients in the H-G group,
- disappointment of the C-G patients for not receiving the additional care,
- a mixture of all or some of the above.
I should stress that it would not have been difficult to plan the study in such a way that these factors were eliminated as sources of bias or confounding. But this study was conducted according to the A+B versus B design which we have discussed repeatedly on this blog. In such trials, A is the experimental treatment (homeopathy) and B is the standard care (scaling and root planning). Unless A is an overtly harmful therapy, it is simply not conceivable that A+B does not generate better results than B alone. The simplest way to comprehend this argument is to imagine A and B are two different amounts of money: it is impossible that A+B is not more that B!
It is unclear to me what relevant research question such a study design actually does answer (if anyone knows, please tell me). It seems obvious, however, that it cannot test the hypothesis that homeopathy (H) enhances the effects of scaling and root planing (SRP). This does not necessarily mean that the design is necessarily useless. But at the very minimum, one would need an adequate research question (one that matches this design) and adequate conclusions based on the findings.
The fact that the conclusions drawn from a dodgy trial are inadequate and misleading could be seen as merely a mild irritation. The facts that, in homeopathy, such poor science and misleading conclusions emerge all too regularly, and that journals continue to publish such rubbish are not just mildly irritating; they are annoying and worrying – annoying because such pseudo-science constitutes an unethical waste of scarce resources; worrying because it almost inevitably leads to wrong decisions in health care.
Readers of this blog will know that few alternative treatments are more controversial and less plausible than homeopathy. Therefore they might be interested to read about the latest attempt of homeopathy-enthusiasts to convince the public that, despite all the clinical evidence to the contrary, homeopathy does work.
The new article was published in German by Swiss urologist and is a case-report describing a patient suffering from paralytic ileus. This condition is a typical complication of ileocystoplasty of the bladder, the operation the patient had undergone. The patient had also been suffering from a spinal cord injury which, due to a pre-existing neurogenic bowel dysfunction, increases the risk of paralytic ileus.
The paraplegic patient developed a massive paralytic ileus after ileocystoplasty and surgical revision. Conventional stimulation of bowel function was unsuccessful. But after adjunctive homeopathic treatment normalization of bowel function was achieved.
The authors conclude that adjunctive homeopathic therapy is a promising treatment option in patients with complex bowel dysfunction after abdominal surgery who do not adequately respond to conventional treatment.
YES, you did read correctly: homeopathic therapy is a promising treatment…
In case anyone doubts that this is more than a trifle too optimistic, let me suggest three much more plausible reasons why the patient’s bowel function finally normalised:
- It could have been a spontaneous recovery (in most cases, even severe ones, this is what happens).
- It could have been all the conventional treatments aimed at stimulating bowel function.
- It could have been a mixture of the two.
The article made me curious, and I checked whether the authors had previously published other material on homeopathy. Thus I found two further articles in a very similar vein:
We present the clinical course of a patient with an epididymal abscess caused by multiresistant bacteria. As the patient declined surgical intervention, a conservative approach was induced with intravenous antibiotic treatment. As the clinical findings did not ameliorate, adjunctive homeopathic treatment was used. Under combined treatment, laboratory parameters returned to normal, and the epididymal abscess was rapidly shrinking. After 1 week, merely a subcutaneous liquid structure was detected. Fine-needle aspiration revealed sterile purulent liquid, which was confirmed by microbiological testing when the subcutaneous abscess was drained. Postoperative course was uneventful.
As the risk for recurrent epididymitis is high in persons with spinal cord injury, an organ-preserving approach is justified even in severe cases. Homeopathic treatment was a valuable adjunctive treatment in the above-mentioned case. Therefore, prospective studies are needed to further elucidate the future opportunities and limitations of classical homeopathy in the treatment of urinary tract infections.
Recurrent urinary tract infections (UTI) in patients with spinal cord injury are a frequent clinical problem. Often, preventive measures are not successful. We present the case reports of five patients with recurrent UTI who received additional homeopathic treatment. Of these patients, three remained free of UTI, whereas UTI frequency was reduced in two patients. Our initial experience with homeopathic prevention of UTI is encouraging. For an evidence-based evaluation of this concept, prospective studies are required.
It seems clear that all of the three more plausible explanations for the patients’ recovery listed above also apply to these two cases.
One might not be far off speculating that J Pannek, the first author of all these three articles, is a fan of homeopathy (this suspicion is confirmed by a link between him and the HOMEOPATHY RESEARCH INSTITUE: Prof Jürgen Pannek on the use of homeopathy for prophylaxis of UTI’s in patients with neurogenic bladder dysfunction). If that is so, I wonder why he does not conduct a controlled trial, rather than publishing case-report after case-report of apparently successful homeopathic treatments. Does he perhaps fear that his effects might dissolve into thin air under controlled conditions?
Case-reports of this nature can, of course, be interesting and some might even deserve to be published. But it would be imperative to draw the correct conclusions. Looking at the three articles above, I get the impression that, as time goes by, the conclusions of Prof Pannek et al (no, I know nobody from this group of authors personally) are growing more and more firm on less and less safe ground.
In my view, responsible authors should have concluded much more cautiously and reasonably. In the case of the paralytic ileus, for instance, they should not have gone further than stating something like this: adjunctive homeopathic therapy might turn out to be a promising treatment option for such patients. Despite the implausibility of homeopathy, this case-report might deserve to be followed up with a controlled clinical trial. Without such evidence, firm conclusions are clearly not possible.
If you believe herbalists, the Daily Mail or similarly reliable sources, you come to the conclusion that herbal medicines are entirely safe – after all they are natural, and everything that is natural must be safe. However, there is plenty of evidence that these assumptions are not necessarily correct. In fact, herbal medicines can cause harm in diverse ways, e. g. because:
- one or more ingredients of a plant are toxic,
- they interact with prescribed drugs,
- they are contaminated, for instance, with heavy metals,
- they are adulterated with prescription drugs.
There is no shortage of evidence for any of these 4 scenarios. Here are some very recent and relevant publications:
German authors reviewed recent case reports and case series that provided evidence for herbal hepatotoxicity caused by Chinese herbal mixtures. The implicated remedies were the TCM products Ban Tu Wan, Chai Hu, Du Huo, Huang Qin, Jia Wei Xia Yao San, Jiguja, Kamishoyosan, Long Dan Xie Gan Tang, Lu Cha, Polygonum multiflorum products, Shan Chi, ‘White flood’ containing the herbal TCM Wu Zhu Yu and Qian Ceng Ta, and Xiao Chai Hu Tang. the authors concluded that stringent evaluation of the risk/benefit ratio is essential to protect traditional Chinese medicines users from health hazards including liver injury.
A recent review of Nigerian anti-diabetic herbal remedies suggested hypoglycemic effect of over 100 plants. One-third of them have been studied for their mechanism of action, while isolation of the bioactive constituent(s) has been accomplished for 23 plants. Several plants showed specific organ toxicity, mostly nephrotoxic or hepatotoxic, with direct effects on the levels of some liver function enzymes. Twenty-eight plants have been identified as in vitro modulators of P-glycoprotein and/or one or more of the cytochrome P450 enzymes, while eleven plants altered the levels of phase 2 metabolic enzymes, chiefly glutathione, with the potential to alter the pharmacokinetics of co-administered drugs
US authors published a case of a 44-year-old female who developed subacute liver injury demonstrated on a CT scan and liver biopsy within a month of using black cohosh to resolve her hot flashes. Since the patient was not taking any other drugs, they concluded that the acute liver injury was caused by the use of black cohosh. The authors concluded: we agree with the United States Pharmacopeia recommendations that a cautionary warning about hepatotoxicity should be labeled on the drug package.
Hong Kong toxicologists recently reported five cases of poisoning occurring as a result of inappropriate use of herbs in recipes or general herbal formulae acquired from books. Aconite poisoning due to overdose or inadequate processing accounted for three cases. The other two cases involved the use of herbs containing Strychnos alkaloids and Sophora alkaloids. These cases demonstrated that inappropriate use of Chinese medicine can result in major morbidity, and herbal formulae and recipes containing herbs available in general publications are not always safe.
Finally, Australian emergency doctors just published this case-report: A woman aged 34 years presented to hospital with a history of progressive shortness of breath, palpitations, decreased exercise tolerance and generalised arthralgia over the previous month. A full blood count revealed normochromic normocytic anaemia and a haemoglobin level of 66 g/L. The blood film showed basophilic stippling, prompting measurement of lead levels. Her blood lead level (BLL) was 105 µg/dL. Mercury and arsenic levels were also detected at very low levels. On further questioning, the patient reported that in the past 6 months she had ingested multiple herbal preparations supplied by an overseas Ayurvedic practitioner for enhancement of fertility. She was taking up to 12 different tablets and various pastes and powders daily. Her case was reported to public health authorities and the herbal preparations were sent for analytical testing. Analysis confirmed high levels of lead (4% w/w), mercury (12% w/w), arsenic and chromium. The lead levels were 4000 times the maximum allowable lead level in medications sold or produced in Australia. Following cessation of the herbal preparations, the patient was commenced on oral chelation therapy, iron supplementation and contraception. A 3-week course of oral DMSA (2,3-dimercaptosuccinic acid) was well tolerated; BLL was reduced to 13 µg/dL and haemoglobin increased to 99 g/L. Her symptoms improved over the subsequent 3 months and she remains hopeful about becoming pregnant.
So, how safe are herbal medicines? Unfortunately, the question is unanswerable. Some herbal medicines are quite safe, others are not. But always remember: whenever you administer a treatment you should ask yourself one absolutely crucial question: do the documented benefits outweigh the risks? There are several thousand different herbal medicines, and for less than a dozen of them can the honest answer to this question be YES.
There must be well over 10 000 clinical trials of acupuncture; Medline lists ~5 000, and many more are hidden in the non-Medline listed literature. That should be good news! Sadly, it isn’t.
It should mean that we now have a pretty good idea for what conditions acupuncture is effective and for which illnesses it does not work. But we don’t! Sceptics say it works for nothing, while acupuncturists claim it is a panacea. The main reason for this continued controversy is that the quality of the vast majority of these 10 000 studies is not just poor, it is lousy.
“Where is the evidence for this outraging statement???” – I hear the acupuncture-enthusiasts shout. Well, how about my own experience as editor-in-chief of FACT? No? Far too anecdotal?
How about looking at Cochrane reviews then; they are considered to be the most independent and reliable evidence in existence? There are many such reviews (most, if not all [co-]authored by acupuncturists) and they all agree that the scientific rigor of the primary studies is fairly awful. Here are the crucial bits of just the last three; feel free to look for more:
Or how about providing an example? Good idea! Here is a new trial which could stand for numerous others:
This study was performed to compare the efficacy of acupuncture versus corticosteroid injection for the treatment of Quervain’s tendosynovitis (no, you do not need to look up what condition this is for understanding this post). Thirty patients were treated in two groups. The acupuncture group received 5 acupuncture sessions of 30 minutes duration. The injection group received one methylprednisolone acetate injection in the first dorsal compartment of the wrist. The degree of disability and pain was evaluated by using the Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) scale and the Visual Analogue Scale (VAS) at baseline and at 2 weeks and 6 weeks after the start of treatment. The baseline means of the Q-DASH and the VAS scores were 62.8 and 6.9, respectively. At the last follow-up, the mean Q-DASH scores were 9.8 versus 6.2 in the acupuncture and injection groups, respectively, and the mean VAS scores were 2 versus 1.2. Thus there were short-term improvements of pain and function in both groups.
The authors drew the following conclusions: Although the success rate was somewhat higher with corticosteroid injection, acupuncture can be considered as an alternative option for treatment of De Quervain’s tenosynovitis.
The flaws of this study are exemplary and numerous:
- This should have been a study that compares two treatments – the technical term is ‘equivalence trial – and such studies need to be much larger to produce a meaningful result. Small sample sizes in equivalent trials will always make the two treatments look similarly effective, even if one is a pure placebo.
- There is no gold standard treatment for this condition. This means that a comparative trial makes no sense at all. In such a situation, one ought to conduct a placebo-controlled trial.
- There was no blinding of patients; therefore their expectation might have distorted the results.
- The acupuncture group received more treatments than the injection group; therefore the additional attention might have distorted the findings.
- Even if the results were entirely correct, one cannot conclude from them that acupuncture was effective; the notion that it was similarly ineffective as the injections is just as warranted.
These are just some of the most fatal flaws of this study. The sad thing is that similar criticisms can be made for most of the 10 000 trials of acupuncture. But the point here is not to nit-pick nor to quack-bust. My point is a different and more serious one: fatally flawed research is not just a ‘poor show’, it is unethical because it is a waste of scarce resources and, even more importantly, an abuse of patients for meaningless pseudo-science. All it does is it misleads the public into believing that acupuncture might be good for this or that condition and consequently make wrong therapeutic decisions.
In acupuncture (and indeed in most alternative medicine) research, the problem is so extremely wide-spread that it is high time to do something about it. Journal editors, peer-reviewers, ethics committees, universities, funding agencies and all others concerned with such research have to work together so that such flagrant abuse is stopped once and for all.
Niacin – also known as vitamin B3 or nicotinic acid – is a natural compound (formula C
2 ) and an essential nutrient for humans. It is water-soluble, which means it is not stored in the body. Excess amounts of the vitamin leave the body through the urine. That means we need a continuous supply of niacin in your diet.
Niacin is found in variety of foods, including liver, chicken, beef, fish, cereal, peanuts and legumes. It can also be synthesized from tryptophan, an essential amino acid found in protein. Niacin has long been an accepted treatment for high cholesterol. It is well-documented to increase the levels of high-density cholesterol (HDL or “good cholesterol”) and to decrease the levels of low-density cholesterol (LDL or “bad cholesterol”).
But what do these effects really mean? Do they translate into true health benefits? A brand-new study casts doubt on the value of niacin therapy:
After a pre-randomization run-in phase to standardize the background statin-based LDL cholesterol-lowering therapy and to establish participants’ ability to take extended-release niacin without clinically significant adverse effects, the researchers randomly assigned 25,673 adults with vascular disease to receive 2 g of extended-release niacin and 40 mg of laropiprant or a matching placebo daily. The primary outcome was the first major vascular event (non-fatal myocardial infarction, death from coronary causes, stroke, or arterial revascularization).
During a median follow-up period of 3.9 years, participants who were assigned to extended-release niacin-laropiprant had an LDL cholesterol level that was 10 mg per deciliter (0.25 mmol/l) lower and an HDL cholesterol level that was 6 mg per deciliter (0.16 mmol/l) higher than the levels in those assigned to placebo. Thus the lipid-effects of previous studies were confirmed.
However, assignment to niacin-laropiprant, as compared with assignment to placebo, had no significant effect on the incidence of major vascular events Niacin-laropiprant was associated with an increased incidence of disturbances in diabetes control that were considered to be serious and with an increased incidence of diabetes diagnoses as well as increases in serious adverse events associated with the gastrointestinal system, the musculoskeletal system, the skin and infections and bleeding.
Based of these data, the authors arrived at the following conclusion: among participants with atherosclerotic vascular disease, the addition of extended-release niacin-laropiprant to statin-based LDL cholesterol-lowering therapy did not significantly reduce the risk of major vascular events but did increase the risk of serious adverse events.
This extremely well-done trial is a poignant reminder of the fact that, in health care, we must never take our assumptions for granted. Here the underlying assumption was that the Niacin-induced lipid changes lead to a reduction of cardiovascular risks. Not only it proved to be erroneous but, through serious adverse effects, Niacin actually decreased patients’ health status.
The lessons from all this are straight forward, I think:
- ‘Natural’ does not necessarily mean safe.
- Long-established does not necessarily mean efficacious.
- Assumptions are merely assumptions, nothing more; if we want to make sure that they hold, we need to test them.
- When we finally do test assumptions, we better do it rigorously.