research methodology
Conventional cough syrups do not have the best of reputations – but the repute of homeopathic cough syrups is certainly not encouraging. So what should one do with such a preparation? Forget about it? No, one conducts a clinical trial, of course! Not just any old trial but one where science, ethics and common sense are absent. Here are the essentials of a truly innovative study that, I think, has all of these remarkable qualities:
The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (−0.52 ± 0.66 in the homeopathic syrup group and −0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020).
Conclusions
Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.
Let us be clear about what has happened here. I think, the events can be summarised as follows:
- the researchers come across a homeopathic syrup (anyone who understands respiratory problems and/or therapeutics would be more than a little suspicious of this product, but this team is exceptional),
- they decide to do a trial with it (a decision which would make some ethicists already quite nervous, but the ethics committee is exceptional too),
- the question raises, what should the researchers give to the control group?
- someone has the idea, why not compare our dodgy syrup against something that is equally dodgy, perhaps even a bit unsafe?
- the researchers are impressed and ask: but what precisely could we use?
- let’s take antibiotics; they are often used for acute coughs, but the best evidence fails to show that they are helpful and they have, of course, risks,
- another member of the team adds: let’s use children, they and their mothers are unlikely to understand what we are up to,
- the team is in agreement,
- Boiron, the world’s largest producer of homeopathic products, accepts to finance the study,
- a protocol is written,
- ethics approval is obtained,
- the trial is conducted and even published by a journal with the help of peer-reviewers who are less than critical.
And the results of the trial? Contrary to the authors’ conclusion copied above, they show that two bogus treatments are worse that one.
BOB’S YOUR UNCLE!
EVERYONE SEEMS HAPPY: THE RESEARCHERS CAN ADD AN ARTICLE TO THEIR PUBLICATION LIST, BOIRON HAS MORE ‘EVIDENCE’ IN FAVOUR OF HOMEOPATHY, AND THE ETHICS COMMITTEE SLEEP JUST AS SOUNDLY AS THE PEER-REVIEWERS.
While my last post was about the risk following some naturopaths’ advice, this one is about the effectiveness of naturopathic treatments. This is a complex subject, not least because naturopaths use a wide range of therapies (as the name implies, they pride themselves of employing all therapeutic means supplied by nature). Some of these interventions are clearly supported by good evidence; for instance, nobody would doubt the effectiveness of a healthy diet or the benefits of regular exercise. But what about all the other treatments naturopaths use? The best approach to find an answer might be to assess not each single therapy but to evaluate the entire package of the naturopathic approach, and not a single study but all such trials.
This is precisely what US researchers have recently done. The purpose of this interesting, new systematic review was to compile and consolidate research that has investigated the whole practice of naturopathic medicine as it is practiced in community settings in order to better assess the quantity and quality of the research, and clinical effect, if any.
In order to get included into the review, studies had to report results from multi-modal treatment delivered by North American naturopathic doctors. The effect size for each study was calculated; no meta-analysis was undertaken.
Fifteen studies met the authors’ inclusion criteria. They covered a wide range of chronic diseases. Most studies had low to medium risks of bias including acknowledged limitations of pragmatic trials. Effect sizes for the primary medical outcomes varied and were statistically significant in 10 out of 13 studies. A quality of life metric was included in all of the RCTs with medium effect size and statistical significance in some subscales.
The authors concluded that previous reports about the lack of evidence or benefit of naturopathic medicine (NM) are inaccurate; a small but compelling body of research exists. Further investigation is warranted into the effectiveness of whole practice NM across a range of health conditions.
This sounds like good news for naturopathy! However, there are several important caveats:
- the authors seem to have only looked at US studies (naturopathy is a European tradition!),
- the searches were done three years ago, and more recent data were thus omitted,
- the authors included all sorts of investigations, even uncontrolled studies; only 6 were RCTs,
- rigorous trials were very scarce; and for each condition, they were even more so,
- the authors mention the PRISMA guidelines for systematic reviews implying that they followed them but, in fact, they did not.
My biggest concern, however, is something else. It relates to the interventions tested in these studies. The authors claim that their results table provides full details on this issue but this is unfortunately not true. All we have by way of an explanation is the authors’ remark that the interventions tested in the studies of their review included diet counseling and nutritional recommendations, specific home exercises and physical activity recommendations, deep breathing techniques or other stress reduction strategies, dietary supplements including vitamins, hydrotherapy, soft-tissue manual techniques, electrical muscle stimulation, and botanical medicines.
Survey data from two US states tell us that the most commonly prescribed naturopathic therapeutics are botanical medicines (51% of visits in Connecticut, 43% in Washington), vitamins (41% and 43%), minerals (35% and 39%), homeopathy (29% and 19%) and allergy treatments (11% and 13%). They also inform us that the mean length of a consultation with an US naturopath is about 40 minutes.
I think, this puts things into perspective. If I advise a patient with diabetes or hypertension or coronary heat disease to follow an appropriate diet, exercise and to adhere to some stress reduction program, if in addition I show empathy and compassion during a 40 minute consultation and make sure that my advise is taken seriously and subsequently adhered to, the outcome is likely to be positive. Naturopaths may elect to call this package of intervention ‘naturopathy’, however, I would call it good conventional medicine.
The problem, I think is clear: good therapeutic advice is effective but it is not naturopathy, and it cannot be used to justify the use of doubtful interventions like homeopathy or all sorts of dodgy supplements. Testing whole treatment packages of this nature can therefore lead to highly misleading results, particularly if the researchers draw unwarranted conclusions about specific schools of health care.
Of all alternative treatments, aromatherapy (i.e. the application of essential oils to the body, usually by gentle massage or simply inhalation) seems to be the most popular. This is perhaps understandable because it certainly is an agreeable form of ‘pampering’ for someone in need of come TLC. But is aromatherapy more than that? Is it truly a ‘THERAPY’?
A recent systematic review was aimed at evaluating the existing data on aromatherapy interventions as a means of improving the quality of sleep. Electronic literature searches were performed to identify relevant studies published between 2000 and August 2013. Randomized controlled and quasi-experimental trials that included aromatherapy for the improvement of sleep quality were considered for inclusion. Of the 245 publications identified, 13 studies met the inclusion criteria, and 12 studies could be used for a meta-analysis.
The meta-analysis of the 12 studies revealed that the use of aromatherapy was effective in improving sleep quality. Subgroup analysis showed that inhalation aromatherapy was more effective than aromatherapy applied via massage.
The authors concluded that readily available aromatherapy treatments appear to be effective and promote sleep. Thus, it is essential to develop specific guidelines for the efficient use of aromatherapy.
Perfect! Let’s all rush out and get some essential oils for inhalation to improve our sleep (remarkably, the results imply that aroma therapists are redundant!).
Not so fast! As I see it, there are several important caveats we might want to consider before spending our money this way:
- Why did this review focus on such a small time-frame? (Systematic reviews should include all the available evidence of a pre-defined quality.)
- The quality of the included studies was often very poor, and therefore the overall conclusion cannot be definitive.
- The effect size of armoatherapy is small. In 2000, we published a similar review and concluded that aromatherapy has a mild, transient anxiolytic effect. Based on a critical assessment of the six studies relating to relaxation, the effects of aromatherapy are probably not strong enough for it to be considered for the treatment of anxiety. The hypothesis that it is effective for any other indication is not supported by the findings of rigorous clinical trials.
- It seems uncertain which essential oil is best suited for this indication.
- Aromatherapy is not always entirely free of risks. Another of our reviews showed that aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.
- There are several effective ways for improving sleep when needed; we need to know how aromatherapy compares to established treatments for that indication.
All in all, I think stronger evidence is required that aromatherapy is more that pampering.
ENOUGH SAID?
When I come across a study with the aim to “examine the effectiveness of acupuncture to relieve symptoms commonly observed in patients in a hospice program” my hopes are high. When I then see that its authors are from the ‘New England School of Acupuncture’, the ‘All Care Hospice and the ‘Tufts University School of Medicine, Boston, my hopes for a good piece of science are even higher. So, let’s see what this new paper has to offer.
A total of 26 patients participated in this acupuncture ‘trial’, receiving a course of weekly treatments that ranged from 1 to 14 weeks. The average number of treatments was five. The Edmonton Symptom Assessment Scale (ESAS) was used to assess the severity of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and dyspnoea. A two-tailed, paired t test was applied to the data to compare symptom scores pre- versus post-acupuncture treatment. Patients enrolled in All Care Hospice’s home care program were given the option to receive acupuncture to supplement usual care offered by the hospice team. Treatment was provided by licensed acupuncturists in the patient’s place of residence.
The results indicated that 7 out of 9 symptoms were significantly improved with acupuncture, the exceptions being drowsiness and appetite. Although the ESAS scale demonstrated a reduction in symptom severity post-treatment for both drowsiness and appetite, this reduction was not found to be significant.
At tis stage, I have lost most of my hopes for good science. This is not a ‘trial’ but a glorified case-series. There is no way that the stated aim can be pursued with this type of methodology. There is no reason whatsoever to assume that the observed outcome can be attributed to acupuncture; the additional attention given to these patients is but one of several factors that are quite sufficient to explain their symptomatic improvements.
This is yet another disappointment then from the plethora of ‘research’ into alternative medicine that, on closer inspection, turns out to be little more than thinly disguised promotion of quackery. These days, I can bear such disappointments quite well – after all, I had many years to get used to them. What I find more difficult to endure is the anger that overcomes me when I read the authors’ conclusion: Acupuncture was found to be effective for the reduction and relief of symptoms that commonly affect patient QOL. Acupuncture effectively reduced symptoms of pain, tiredness, nausea, depression, anxiety, and shortness of breath, and enhanced feelings of well-being. More research is required to assess the long-term benefits and symptom reduction of acupuncture in a palliative care setting.
This is not disappointing; in my view, this is scientific misconduct by
- the authors,
- the institutions employing the authors,
- the ethics committee that has passed the ‘research’,
- the sponsors of the ‘research’,
- the peer-reviewers of the paper,
- the journal and its editors responsible for publishing this paper.
The fact that this sort of thing happens virtually every day in the realm of alternative medicine does not render this case less scandalous, it merely makes it more upsetting.
The notion that the use homeopathy instead of real medicine might save money (heavily promoted by homeopaths and their followers, often to influence health politics) has always struck me as being utterly bizarre: without effectiveness, it is hard to imagine cost-effectiveness. Yet the Smallwood report (in)famously claimed that the NHS would save lots of money, if GPs were to use more homeopathy. At the time, I thought this was such a serious and dangerous error that I decided to do something about it. My objection to the flawed report might have prevented it being taken seriously by anyone with half a brain, but sadly it also cost me my job (the full story can be read here).
Later publications perpetuated the erroneous idea of homeopathy’s cost-effectiveness. For instance, an Italian analysis (published in the journal ‘Homeopathy’) concluded that homeopathic treatment for respiratory diseases (asthma, allergic complaints, Acute Recurrent Respiratory Infections) was associated with a significant reduction in the use and costs of conventional drugs. Costs for homeopathic therapy are significantly lower than those for conventional pharmacological therapy. Again, this paper was so badly flawed that, other than some homeopaths, nobody seemed to have taken the slightest notice of it.
Now a new article has been published on this very subject. The aim of this study was to compare the health care costs for patients using additional homeopathic treatment (homeopathy group) with the costs for those receiving usual care (control group).
Cost data provided by a large German statutory health insurance company were retrospectively analysed from the societal perspective (primary outcome) and from the statutory health insurance perspective. Patients in both groups were matched using a propensity score matching procedure based on socio-demographic variables as well as costs, number of hospital stays and sick leave days in the previous 12 months. Total cumulative costs over 18 months were compared between the groups with an analysis of covariance (adjusted for baseline costs) across diagnoses and for six specific diagnoses (depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache).
Data from 44,550 patients (67.3% females) were available for analysis. From the societal perspective, total costs after 18 months were higher in the homeopathy group (adj. mean: EUR 7,207.72 [95% CI 7,001.14-7,414.29]) than in the control group (EUR 5,857.56 [5,650.98-6,064.13]; p<0.0001) with the largest differences between groups for productivity loss (homeopathy EUR 3,698.00 [3,586.48-3,809.53] vs. control EUR 3,092.84 [2,981.31-3,204.37]) and outpatient care costs (homeopathy EUR 1,088.25 [1,073.90-1,102.59] vs. control EUR 867.87 [853.52-882.21]). Group differences decreased over time. For all diagnoses, costs were higher in the homeopathy group than in the control group, although this difference was not always statistically significant.
The authors of this paper (who have a long track record of being pro-homeopathy) concluded that, compared with usual care, additional homeopathic treatment was associated with significantly higher costs. These analyses did not confirm previously observed cost savings resulting from the use of homeopathy in the health care system.
The next time someone does a (no doubt costly) cost-effectiveness analysis of an ineffective treatment, it would be good (and cost-effective) to remember: WITHOUT EFFECTIVENESS, THERE CAN BE NO COST-EFFECTIVENESS.
“So what? We all know that homeopathy is nonsense,” I hear some people argue, “at the same time, it is surely trivial. Let those nutters do what they want; at least it is not harmful!”
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I THINK I CAN REST MY CASE.
For ‘my’ journal FACT, I review all the new articles that have emerged on the subject of alternative medicine on a monthly basis. Here are a few impressions and concerns that this activity have generated:
- The number of papers on alternative medicine has increased beyond belief: between the year 2000 and 2010, there was a slow, linear increase from 335 to 610 Medline-listed articles; thereafter, the numbers exploded to 1189 (2011), 1674 (2012) and 2236 (2013).
- This fast growing and highly lucrative ‘market’ has been cornered mainly by one journal: ‘EVIDENCE BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE’ (EBCAM), a journal that I mentioned several times before (see here, for instance). In 2010, EBCAM published 76 papers, while these figures increased to 546, 880 and 1327 during the following three years.
- Undeniably, this is big business, as authors have to pay tidy sums each time they get published in EBCAM.
- The peer-review system of EBCAM is farcical: potential authors who send their submissions to EBCAM are invited to suggest their preferred reviewers who subsequently are almost invariably appointed to do the job. It goes without saying that such a system is prone to all sorts of serious failures; in fact, this is not peer-review at all, in my opinion, it is an unethical sham.
- As a result, most (I estimate around 80%) of the articles that currently get published on alternative medicine are useless rubbish. They tend to be either pre-clinical investigations which never get followed up and are thus meaningless, or surveys of no relevance whatsoever, or pilot studies that never are succeeded by more definitive trials, or non-systematic reviews that are wide open to bias and can only mislead the reader.
- Nowadays, very few articles on alternative medicine are good enough to get published in mainstream journals of high standing.
The consequences of these fairly recent developments are serious:
- Conventional scientists and clinicians must get the impression that there is little research activity in alternative medicine (while, in fact, there is lots) and that the little research that does emerge is of poor quality.
- Consequently alternative medicine will be deemed by those who are not directly involved in it as trivial, and the alternative medicine journals will be ignored or even become their laughing stock.
- At the same time, the field of alternative medicine and its proponents (the only ones who might actually be reading the plethora of rubbish published in alternative medicine journals) will get more and more convinced that their field is supported by an ever- abundance of peer-reviewed, robust science.
- Gradually, they will become less and less aware of the standards and requirements that need to be met for evidence to be called reliable (provided they ever had such knowledge in the first place).
- They might thus get increasingly frustrated by the lack of acceptance of their ‘advances’ by proper scientists – an attitude which, from their perspective, must seem unfair, biased and hostile.
- In the end, conventional and alternative medicine, rather than learning from each other, will move further and further apart.
- Substantial amounts of money will continue to be wasted for research into alternative medicine that, whenever assessed critically, turns out to be too poor to advance healthcare in any meaningful way.
- The ones who medicine should be all about, namely the patients who need our help and rely on the progress of research, are not well served by these developments.
In essence this suggests, I think, that alternative medicine is ill-advised and short-sighted to settle for standards that are so clearly below those generally deemed acceptable in medicine. Similarly, conventional medicine does a serious disfavour to progress and to us all, if it ignores or tolerates this process.
I am not at all sure how to reverse this trend. In the long-term, it would require a change of attitude that obviously is far from easy to bring about. In the short-term, it might help, I think, to de-list journals from Medline that are in such obvious conflict with publication ethics.
A new RCT of Reiki healing has been published by US authors from the following institutions: Union Institute & University, Psychology Program, Brattleboro, VT, Coyote Institute, Augusta and Bangor, ME, Eastern Maine Medical Center and Acadia Hospital, Bangor, ME, University of New England College of Osteopathic Medicine, Biddeford, ME, Coyote Institute, Orono, ME. The purpose of this study was to determine if 30 minutes of healing touch could reduce burnout in community mental health clinicians.
The authors utilized a crossover design to explore the efficacy of Reiki versus sham Reiki, a pseudo treatment performed by volunteers who had no experience with Reiki and pretended to be healers vis-à-vis the patients. This sham control intervention was designed to mimic true Reiki.
Subjects were randomized to whether they started with Reiki or sham. The Maslach Burnout Inventory-Human Services Survey (MBI-HSS) and the Measure Your Medical Outcome Profile Version 2 (MYMOP-2) were used as outcome measures. Multilevel modeling was used to represent the relations among variables.
The results showed that real Reiki was significantly better than sham Reiki in reducing burnout among community mental health clinicians. Reiki was significant in reducing depersonalization, but only among single people. Reiki reduced the primary symptom on the MYMOP also only among single people.
The authors concluded that the effects of Reiki were differentiated from sham Reiki. Reiki could be helpful in community mental health settings for the mental health of the practitioners.
My team has published on Reiki (see here and here, for instance), and on this blog I have repeatedly been expressed my doubts that Reiki is more than an elaborate placebo (see here and here, for instance). Do these new results mean that I need to eat my words and henceforth praise the wonders of Reiki? No, I don’t think so!
Having conducted studies on ‘energy healing’ myself, I know only too well of the many pitfalls and possibilities of generating false-positive findings with such research. This new study has many flaws, but we need not look far to find the reason for the surprising and implausible finding. Here is my explanation why this study suggests one placebo to be superior to another placebo.
The researchers had to recruit 16 Reiki healers and several non-Reiki volunteers to perform the interventions on the small group of patients. It goes without saying that the Reiki healers were highly motivated to demonstrate the value of their therapy. This means they (unintentionally?) used verbal and non-verbal communication to maximise the placebo effect of their treatment. The sham healers, of course, lacked such motivation. In my view, this seemingly trivial difference alone is capable of producing the false-positive result above.
There are, of course, ways of minimising the danger of such confounding. In our own study of ‘energy healing’ with sham healers as controls, for instance, we instructed both the healers and the sham healers to abstain from all communication with their patients, we filmed each session to make sure, and we asked each patient to guess which treatment they had received. None of these safeguards were incorporated in the present study – I wonder why!
In the realm of alternative medicine, we encounter many therapeutic claims that beggar belief. This is true for most modalities but perhaps for none more than chiropractic. Many chiropractors still adhere to Palmer’s gospel of the ‘inate’, ‘subluxation’ etc. and thus they believe that their ‘adjustments’ are a cure all. Readers of this blog will know all that, of course, but even they might be surprised by the notion that a chiropractic adjustment improves the voice of a choir singer.
This, however, is precisely the ‘hypothesis’ that was recently submitted to an RCT. To be precise, the study investigated the effect of spinal manipulative therapy (SMT) on the singing voice of male individuals.
Twenty-nine subjects were selected among male members of a local choir. Participants were randomly assigned to two groups: (A) a single session of chiropractic SMT and (B) a single session of non-therapeutic transcutaneous electrical nerve stimulation (TENS). Recordings of the singing voice of each participant were taken immediately before and after the procedures. After a 14-day wash-out period, procedures were switched between groups: participants who underwent SMT on the first occasion were now subjected to TENS and vice versa. Recordings were assessed via perceptual audio and acoustic evaluations. The same recording segment of each participant was selected. Perceptual audio evaluation was performed by a specialist panel (SP). Recordings of each participant were randomly presented thus making the SP blind to intervention type and recording session (before/after intervention). Recordings compiled in a randomized order were also subjected to acoustic evaluation.
No differences in the quality of the singing on perceptual audio evaluation were observed between TENS and SMT.
The authors concluded that no differences in the quality of the singing voice of asymptomatic male singers were observed on perceptual audio evaluation or acoustic evaluation after a single spinal manipulative intervention of the thoracic and cervical spine.
Laughable? Yes!
There is nevertheless an important point to be made here, I feel: some claims are just too silly to waste resources on. Or, to put it in more scientific terms, hypotheses require much more than a vague notion or hunch.
To set up, conduct and eventually publish an RCT as above requires expertise, commitment, time and money. All of this is entirely wasted, if the prior probability of a relevant result approaches zero. In the realm of alternative medicine, this is depressingly often the case. In the final analysis, this suggests that all too often research in this area achieves nothing other than giving science a bad name.
The press officers of journals like to send out press-releases of articles which are deemed to be particularly good and important. Sadly, it is not often that articles on alternative medicine fulfil these criteria. I was therefore excited to receive this press-release which seemed encouraging, to say the least:
Medical evidence supports the potential for acupuncture to be significantly more effective in the treatment of dermatologic conditions such as dermatitis, pruritus, and urticaria than alternative treatment options, “placebo acupuncture,” or no treatment, according to a review of the medical literature published in The Journal of Alternative and Complementary Medicine, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers…
The abstract was equally promising:
Objectives: Acupuncture is a form of Traditional Chinese Medicine that has been used to treat a broad range of medical conditions, including dermatologic disorders. This systematic review aims to synthesize the evidence on the use of acupuncture as a primary treatment modality for dermatologic conditions.
Methods: A systematic search of MEDLINE, EMBASE, and the Cochrane Central Register was performed. Studies were limited to clinical trials, controlled studies, case reports, comparative studies, and systematic reviews published in the English language. Studies involving moxibustion, electroacupuncture, or blood-letting were excluded.
Results: Twenty-four studies met inclusion criteria. Among these, 16 were randomized controlled trials, 6 were prospective observational studies, and 2 were case reports. Acupuncture was used to treat atopic dermatitis, urticaria, pruritus, acne, chloasma, neurodermatitis, dermatitis herpetiformis, hyperhidrosis, human papillomavirus wart, breast inflammation, and facial elasticity. In 17 of 24 studies, acupuncture showed statistically significant improvements in outcome measurements compared with placebo acupuncture, alternative treatment options, and no intervention.
Conclusions: Acupuncture improves outcome measures in the treatment of dermatitis, chloasma, pruritus, urticaria, hyperhidrosis, and facial elasticity. Future studies should ideally be double-blinded and standardize the control intervention.
One has to read the actual full text article to understand that the evidence presented here is dodgy to the extreme. In fact, one has to go into the tedious details of the methods section to find the reasons why: All searches were limited to clinical trials, controlled studies, case reports, comparative studies, and systematic reviews published in the English language.
There are many more weaknesses of this review, but the inclusion of uncontrolled studies and even anecdotes is, in my view, a virtual death sentence to its credibility. It means that no general conclusions about the effectiveness of acupuncture, such as the authors have decided to make, are possible.
Such overt exaggerations are sadly no rarities in the realm of alternative medicine. I think, this begs a number of serious questions:
- Does this cross the line between flawed research and scientific misconduct?
- Why did the reviewers not pick up these flaws?
- Why did the editor pass this article for publication?
- How can the publisher tolerate such dubious behaviour?
- Should this journal (which I have commented on before here and which is one with the highest impact factor of all the alt med journals) be de-listed from Medline?
I don’t think that we will get answers from the people responsible for this disgrace, but I would like to learn my readers’ opinions.
This post is dedicated to all homeopathic character assassins.
Some ardent homeopathy fans have reminded me that, some 25 years ago, I published (OH, WHAT A SCANDAL!!!) a positive trial of homeopathy; I even found a website that proudly announces this fact. Homeopaths seem jubilant about this discovery (not because they now need to revise their allegations that I never did any trials; or the other, equally popular claim, that I have always been squarely against their trade but) because the implication is that even I have to concede that homeopathic remedies are better than placebo. In their view, this seems to beg the following important and embarrassing questions:
- Why did I change my mind?
- Am I not contradicting myself?
- Who has bribed me?
- Am I in the pocket of Big Pharma?
- Does this ‘skeleton in my closet’ discredit me for all times?
I remember the trial in question quite well. We conducted it during my time in Vienna, and I am proud of several innovative ideas that went into it. Here is the abstract in full:
The aim of this study was to test the effectiveness of a combined homeopathic medication in primary varicosity. A well-defined population of 61 patients was randomized into active medication (Poikiven®) or placebo. Both were given for 24 d. At the start of the trial, after 12 d medication and at the end of the study, objective and subjective parameters were recorded: venous filling time, leg volume, calf circumference, haemorheological measurements and patients’ symptoms such as cramps, itching, leg heaviness, pain during standing and the need to elevate the legs. The results show that venous filling time is changed by 44% towards normal in the actively-treated group. The average leg volume fell significantly more in this group, but calf circumferences did not change significantly and blood rheology was not altered in any relevant way. None of the patients reported side-effects. Subjective complaints were relieved significantly more by Poikiven than by placebo. These results suggest that the oral treatment of primary varicosity using Poikiven is feasible.
So, there we have it: a homeopathic remedy (as tested by me) is clearly better than placebo normalising important objective parameters as well as subjective symptoms of varicose veins. Is that not a contradiction of what I keep saying today, namely that homeopathy is a placebo therapy?
YES AND NO! (But much more NO than YES)
Yes, because that was clearly our result, and I never tried to deny it.
No, because our verum was far from being a homeopathic, highly diluted remedy. It contained Aesculus D1 12,5 ml, Arnica D1 2,5 ml, Carduus marianus D1 5 ml, Hamamelis D1 10 ml, Lachesis D6 5 ml, Lycopodium D4 5 ml, Melilotus officinalis D1 10 ml. Take just the first of these ingredients, Aesculus or horse chestnut. This is a herbal medicine that has been well documented (even via a Cochrane review) to be effective for the symptoms of varicose veins, and it contains Aesculus in the D1 potency. This means that it is diluted merely by a factor of 1:10. So, for all intents and purposes, our verum was herbal by nature, and there is no surprise at all that we found it to be effective.
[Here is a little ‘aside’: Aesculus is a proven treatment for varicose veins. Homeopathy must always rely on the ‘like cures like’ principle. Therefore, if Aesculus had been used in the homeopathic way, would it not, according to homeopathic dogma, had to worsen the symptoms of our patients rather than alleviating them?]All of this would be trivial to the extreme, if it did not touch upon an important and confusing point which is often used as an ‘escape route’ by homeopaths when they find themselves between a rock and a hard place. Some trials of homeopathy are positive because they use medications which are homeopathic only by name. This regularly creates considerable confusion. In the recent BMJ debate I tried to address this issue head on by stating at the outset: ” Nobody questions, of course, that some substances used in homeopathy, such as arsenic or strychnine, can be pharmacologically active, but homeopathic medicines are typically far too dilute to have any effect.”
And that’s the point: homeopathic remedies beyond a C12 potency contain nothing, less dilute ones contain little to very little, and D1 potencies are hardy diluted at all and thus contain substantial amounts of active ingredients. Such low potencies are rarely used by homeopaths and should be called PSEUDO-HOMEOPATHIC, in my view. Homeopaths tend to use this confusing complexity to wriggle out of difficult arguments, and often they rely on systematic reviews of homeopathic trials which can generate somewhat confusing overall findings because of such PSEUDO-HOMEOPATHIC remedies.
To make it perfectly clear: the typical homeopathic remedy is far too dilute to have any effect. When scientists or the public at large speak of homeopathic remedies, we don’t mean extracts of Aesculus or potent poisons like Arsenic D1 (has anyone heard of someone claiming to have killed rats with homeopathy?); we refer to the vast majority of remedies which are highly dilute and contain no or very few active molecules – even when we do not explain this somewhat complicated and rather tedious circumstance each and every time. I therefore declare once and for all that, unless I indicate otherwise, I do NOT mean potencies below C6 when I speak of a ‘homeopathic remedy’ (sorry homeopathy fans, perhaps I should have done this when I started this blog).
What if our Vienna study all those years ago had tested not the pseudo-homeopathic ‘Poikiven’ but a highly dilute, real homeopathic remedy and had still come up with a positive finding? Would that make me inconsistent, dishonest, untrustworthy or corrupt? Certainly not!
I have always urged people to not go by the results of single trials. There are numerous reasons why a single study can produce a misleading result. We should therefore, wherever possible, rely on systematic reviews that critically evaluate the totality of the evidence (I would always mistrust even my own trial data, if it contradicted the totality of the reliable evidence) – and such analyses clearly fail to show that homeopathy is more than a placebo.
And even, if none of this had happened, and I had just changed my mind about homeopathy because
- the evidence changed,
- I had become wiser,
- I had learnt how to think like a scientist,
- I had managed to see behind the smokescreen many homeopaths put up to hide the truth?
Would that discredit me? I don’t think so! As someone once said, being able to change one’s mind is a sign of intelligence.
I am sure that the weird world of homeopathic character assassination will soon find something else to discredit me – but for now…
I REST MY CASE.
