“Non-reproducible single occurrences are of no significance to science”, this quote by Karl Popper often seems to get forgotten in medicine, particularly in alternative medicine. It indicates that findings have to be reproducible to be meaningful – if not, we cannot be sure that the outcome in question was caused by the treatment we applied.
This is thus a question of cause and effect.
The statistician Sir Austin Bradford Hill proposed in 1965 a set of 9 criteria to provide evidence of a relationship between a presumed cause and an observed effect while demonstrating the connection between cigarette smoking and lung cancer. One of his criteria is consistency or reproducibility: Consistent findings observed by different persons in different places with different samples strengthens the likelihood of an effect.
By mentioning ‘different persons’, Hill seems to also establish the concept of INDEPENDENT replication.
Let me try to explain this with an example from the world of SCAM.
- A homeopath feels that childhood diarrhoea could perhaps be treated with individualised homeopathic remedies. She conducts a trial, finds a positive result and concludes that the statistically significant decrease in the duration of diarrhea in the treatment group suggests that homeopathic treatment might be useful in acute childhood diarrhea. Further study of this treatment deserves consideration.
- Unsurprisingly, this study is met with disbelieve by many experts. Some go as far as doubting its validity, and several letters to the editor appear expressing criticism. The homeopath is thus motivated to run another trial to prove her point. Its results are consistent with the finding from the previous study that individualized homeopathic treatment decreases the duration of diarrhea and number of stools in children with acute childhood diarrhea.
- We now have a replication of the original finding. Yet, for a range of reasons, sceptics are far from satisfied. The homeopath thus runs a further trial and publishes a meta-analysis of all there studies. The combined analysis shows a duration of diarrhoea of 3.3 days in the homeopathy group compared with 4.1 in the placebo group (P = 0.008). She thus concludes that the results from these studies confirm that individualized homeopathic treatment decreases the duration of acute childhood diarrhea and suggest that larger sample sizes be used in future homeopathic research to ensure adequate statistical power. Homeopathy should be considered for use as an adjunct to oral rehydration for this illness.
To most homeopaths it seems that this body of evidence from three replication is sound and solid. Consequently, they frequently cite these publications as a cast-iron proof of their assumption that individualised homeopathy is effective. Sceptics, however, are still not convinced.
The studies have been replicated alright, but what is missing is an INDEPENDENT replication.
To me this word implies two things:
- The results have to be reproduced by another research group that is unconnected to the one that conducted the three previous studies.
- That group needs to be independent from any bias that might get in the way of conducting a rigorous trial.
And why do I think this latter point is important?
Simply because I know from many years of experience that a researcher, who strongly believes in homeopathy or any other subject in question, will inadvertently introduce all sorts of biases into a study, even if its design is seemingly rigorous. In the end, these flaws will not necessarily show in the published article which means that the public will be mislead. In other words, the paper will report a false-positive finding.
It is possible, even likely, that this has happened with the three trials mentioned above. The fact is that, as far as I know, there is no independent replication of these studies.
In the light of all this, Popper’s axiom as applied to medicine should perhaps be modified: findings without independent replication are of no significance. Or, to put it even more bluntly: independent replication is an essential self-cleansing process of science by which it rids itself from errors, fraud and misunderstandings.
Having yesterday been to a ‘Skeptics in the Pub’ event on MEDITATION in Cambridge (my home town since last year) I had to think about the subject quite a bit. As I have hardly covered this topic on my blog, I am today trying to briefly summarise my view on it.
The first thing that strikes me when looking at the evidence on meditation is that it is highly confusing. There seem to be:
- a lack of clear definitions,
- hundreds of studies, most of which are of poor or even very poor quality,
- lots of people with ’emotional baggage’,
- plenty of strange links to cults and religions,
- dozens of different meditation methods and regimen,
- unbelievable claims by enthusiasts,
- lots of weirdly enthusiastic followers.
What was confirmed yesterday is the fact that, once we look at the reliable medical evidence, we are bound to find that the health claims of various meditation techniques are hugely exaggerated. There is almost no strong evidence to suggest that meditation does affect any condition. The small effects that do emerge from some meta-analyses could easily be due to residual bias and confounding; it is not possible to rigorously control for placebo effects in clinical trials of meditation.
Another thing that came out clearly yesterday is the fact that meditation might not be as risk-free as it is usually presented. Several cases of psychoses after meditation are on record; some of these are both severe and log-lasting. How often do they happen? Nobody knows! Like with most alternative therapies, there is no reporting system in place that could possibly give us anything like a reliable answer.
For me, however, the biggest danger with (certain forms of) meditation is not the risk of psychosis. It is the risk of getting sucked into a cult that then takes over the victim and more or less destroys his or her personality. I have seen this several times, and it is a truly frightening phenomenon.
In our now 10-year-old book THE DESKTOP GUIDE TO COMPLEMENTARY AND ALTERNATIVE MEDICINE, we included a chapter on meditation. It concluded that “meditation appears to be safe for most people and those with sufficient motivation to practise regularly will probably find a relaxing experience. Evidence for effectiveness in any indication is week.” Even today, this is not far off the mark, I think. If I had to re-write it now, I would perhaps mention the potential for harm and also add that, as a therapy, the risk/benefit balance of meditation fails to be convincingly positive.
I highly recommend ‘Skeptics in the Pub’ events to anyone who likes stimulating talks and critical thinking.
On this blog, we constantly discuss the shortcomings of clinical trials of (and other research into) alternative medicine. Yet, there can be no question that research into conventional medicine is often unreliable as well.
What might be the main reasons for this lamentable fact?
A recent BMJ article discussed 5 prominent reasons:
Firstly, much research fails to address questions that matter. For example, new drugs are tested against placebo rather than against usual treatments. Or the question may already have been answered, but the researchers haven’t undertaken a systematic review that would have told them the research was not needed. Or the research may use outcomes, perhaps surrogate measures, that are not useful.
Secondly, the methods of the studies may be inadequate. Many studies are too small, and more than half fail to deal adequately with bias. Studies are not replicated, and when people have tried to replicate studies they find that most do not have reproducible results.
Thirdly, research is not efficiently regulated and managed. Quality assurance systems fail to pick up the flaws in the research proposals. Or the bureaucracy involved in having research funded and approved may encourage researchers to conduct studies that are too small or too short term.
Fourthly, the research that is completed is not made fully accessible. Half of studies are never published at all, and there is a bias in what is published, meaning that treatments may seem to be more effective and safer than they actually are. Then not all outcome measures are reported, again with a bias towards those are positive.
Fifthly, published reports of research are often biased and unusable. In trials about a third of interventions are inadequately described meaning they cannot be implemented. Half of study outcomes are not reported.
END OF QUOTE
Apparently, these 5 issues are the reason why 85% of biomedical research is being wasted.
That is in CONVENTIONAL medicine, of course.
What about alternative medicine?
There is no question in my mind that the percentage figure must be even higher here. But do the same reasons apply? Let’s go through them again:
- Much research fails to address questions that matter. That is certainly true for alternative medicine – just think of the plethora of utterly useless surveys that are being published.
- The methods of the studies may be inadequate. Also true, as we have seen hundreds of time on this blog. Some of the most prevalent flaws include in my experience small sample sizes, lack of adequate controls (e.g. A+B vs B design) and misleading conclusions.
- Research is not efficiently regulated and managed. True, but probably not a specific feature of alternative medicine research.
- Research that is completed is not made fully accessible. most likely true but, due to lack of information and transparency, impossible to judge.
- Published reports of research are often biased and unusable. This is unquestionably a prominent feature of alternative medicine research.
All of this seems to indicate that the problems are very similar – similar but much more profound in the realm of alternative medicine, I’d say based on many years of experience (yes, what follows is opinion and not evidence because the latter is hardly available).
The thing is that, like almost any other job, research needs knowledge, skills, training, experience, integrity and impartiality to do it properly. It simply cannot be done well without such qualities. In alternative medicine, we do not have many individuals who have all or even most of these qualities. Instead, we have people who often are evangelic believers in alternative medicine, want to further their field by doing some research and therefore acquire a thin veneer of scientific expertise.
In my 25 years of experience in this area, I have not often seen researchers who knew that research is for testing hypotheses and not for trying to prove one’s hunches to be correct. In my own team, those who were the most enthusiastic about a particular therapy (and were thus seen as experts in its clinical application), were often the lousiest researchers who had the most difficulties coping with the scientific approach.
For me, this continues to be THE problem in alternative medicine research. The investigators – and some of them are now sufficiently skilled to bluff us to believe they are serious scientists – essentially start on the wrong foot. Because they never were properly trained and educated, they fail to appreciate how research proceeds. They hardly know how to properly establish a hypothesis, and – most crucially – they don’t know that, once that is done, you ought to conduct investigation after investigation to show that your hypothesis is incorrect. Only once all reasonable attempts to disprove it have failed, can your hypothesis be considered correct. These multiple attempts of disproving go entirely against the grain of an enthusiast who has plenty of emotional baggage and therefore cannot bring him/herself to honestly attempt to disprove his/her beloved hypothesis.
The plainly visible result of this situation is the fact that we have dozens of alternative medicine researchers who never publish a negative finding related to their pet therapy (some of them were admitted to what I call my HALL OF FAME on this blog, in case you want to verify this statement). And the lamentable consequence of all this is the fast-growing mountain of dangerously misleading (but often seemingly robust) articles about alternative treatments polluting Medline and other databases.
The two German authors start their article (it is in German but has an English abstract to which I refer here) by claiming that “homeopathy is steadily gaining in sympathy in the population.” This is a very odd statement, considering that the sales figures in Germany and elsewhere have, in fact, been declining. Any homeopathy-paper with such an opening is naturally of interest to me.
As I read on, I find further surprises: “the possible effectiveness and the modes of action are currently not scientifically elucidated.” These are two big assumptions which happen to be both untrue:
- The effectiveness of homeopathy has now been tested in about 500 clinical trials, and the totality of the reliable evidence from these studies fails to show that highly diluted homeopathic remedies are more than placebos.
- The mode of action of homeopathy isn’t “not scientifically elucidated“, but the relevant science tells us that there cannot be a mode of action that is in line with the laws of nature as we understand them today.
And the surprises keep on coming: “there is a whole series of positive evidence for the effects of homeopathic remedies for mental disorders, such as depression, anxiety disorders and addiction.” This statement is not in keeping with the results of a systematic review (which, by the way was authored by ardent homeopaths); here is the abstract:
To systematically review placebo-controlled randomized trials of homeopathy for psychiatric conditions.
Eligible studies were identified using the following databases from database inception to April 2010: PubMed, CINAHL, PsycINFO, Hom-Inform, Cochrane CENTRAL, National Center for Complementary and Alternative Medicine grantee publications database, and ClinicalTrials.gov. Gray literature was also searched using Google, Google Scholar, the European Committee for Homeopathy, inquiries with homeopathic experts and manufacturers, and the bibliographic lists of included published studies and reviews. Search terms were as follows: (homeopath* or homoeopath*) and (placebo or sham) and (anxiety or panic or phobia or post-traumatic stress or PTSD or obsessive-compulsive disorder or fear or depress* or dysthym* or attention deficit hyperactivity or premenstrual syndrome or premenstrual disorder or premenstrual dysphoric disorder or traumatic brain injury or fibromyalgia or chronic fatigue syndrome or myalgic encephalitis or insomnia or sleep disturbance). Searches included only English-language literature that reported randomized controlled trials in humans.
Trials were included if they met 7 criteria and were assessed for possible bias using the Scottish Intercollegiate Guidelines Network (SIGN) 50 guidelines. Overall assessments were made using the Grading of Recommendations Assessment, Development and Evaluation procedure. Identified studies were grouped into anxiety or stress, sleep or circadian rhythm complaints, premenstrual problems, attention-deficit/hyperactivity disorder, mild traumatic brain injury, and functional somatic syndromes.
Twenty-five eligible studies were identified from an initial pool of 1,431. Study quality according to SIGN 50 criteria varied, with 6 assessed as good, 9 as fair, and 10 as poor. Outcome was unrelated to SIGN quality. Effect size could be calculated in 16 studies, and number needed to treat, in 10 studies. Efficacy was found for the functional somatic syndromes group (fibromyalgia and chronic fatigue syndrome), but not for anxiety or stress. For other disorders, homeopathy produced mixed effects. No placebo-controlled studies of depression were identified. Meaningful safety data were lacking in the reports, but the superficial findings suggested good tolerability of homeopathy. A funnel plot in 13 studies did not support publication bias (χ(2)(1) = 1.923, P = .166).
The database on studies of homeopathy and placebo in psychiatry is very limited, but results do not preclude the possibility of some benefit.
And specifically for depression, another review (also by proponents of homeopathy) is available; here is its abstract:
To systematically review the research evidence on the effectiveness of homeopathy for the treatment of depression and depressive disorders.
A comprehensive search of major biomedical databases including MEDLINE, EMBASE, CINAHL, PsycINFO and the Cochrane Library was conducted. Specialist complementary and alternative medicine (CAM) databases including AMED, CISCOM and Hom-Inform were also searched. Additionally, efforts were made to identify unpublished and ongoing research using relevant sources and experts in the field. Relevant research was categorised by study type and appraised according to study design. Clinical commentaries were obtained for studies reporting clinical outcomes.
Only two randomised controlled trials (RCTs) were identified. One of these, a feasibility study, demonstrated problems with recruitment of patients in primary care. Several uncontrolled and observational studies have reported positive results including high levels of patient satisfaction but because of the lack of a control group, it is difficult to assess the extent to which any response is due to specific effects of homeopathy. Single-case reports/studies were the most frequently encountered clinical study type. We also found surveys, but no relevant qualitative research studies were located.: Adverse effects reported appear limited to ‘remedy reactions’ (‘aggravations’) including temporary worsening of symptoms, symptom shifts and reappearance of old symptoms. These remedy reactions were generally transient but in one study, aggravation of symptoms caused withdrawal of the treatment in one patient.
A comprehensive search for published and unpublished studies has demonstrated that the evidence for the effectiveness of homeopathy in depression is limited due to lack of clinical trials of high quality. Further research is required, and should include well-designed controlled studies with sufficient numbers of participants. Qualitative studies aimed at overcoming recruitment and other problems should precede further RCTs. Methodological options include the incorporation of preference arms or uncontrolled observational studies. The highly individualised nature of much homeopathic treatment and the specificity of response may require innovative methods of analysis of individual treatment response.
Back to the new article I started discussing above. Its authors make a vague attempt at being reasonable: “It is clear that homoeopathic remedies can only be used as an add-on and not alone.” I find this statement slightly puzzling. If (as the authors assume) homeopathy is effective for mental disorders, why not on its own? Can a therapy that must not be used as a sole treatment be called effective?
The authors continue with another caveat: “These remedies belong in the hands of physicians experienced in homeopathic and psychiatric psychopharmacology.” That’s actually quite funny! As the average homeopath has no experience in psychiatric psychopharmacology, they must not use homeopathy for mental conditions. I would agree with the conclusion but not with the reason given for it.
And now to the ‘grand finale’, the conclusion: “It would be advisable to at least try out homeopathy for the well-being of the patient not only in the case of very mild disorders but also in severe chronic cases, since due to the generally good tolerability, no avoidable disadvantage should result.” That sort of conclusion makes me almost speechless. The evidence fails to show that it works, yet it is ADVISABLE to use it in severe chronic cases!
Such articles suggest to me that homeopathy is a cult where logic and reason are irrelevant and need to be supressed. They also indicate that something is amiss with medical publishing. How can it be that, in 2018, ‘Der Nervenarzt’ (or any other medical journal for that matter) can be so bar of critical thinking to publish such dangerously misleading nonsense? ‘Der Nervenarzt‘, by the way, claims to be an internationally recognized journal addressing neurologists and psychiatrists working in clinical or practical environments. Essential findings and current information from neurology, psychiatry as well as neuropathology, neurosurgery up to psychotherapy are presented.
Please bear with me and have a look at the three short statements quoted below:
… a Reiki practitioner channels this pure ‘chi’, the ‘ki’ in Reiki, or energy through her hands to the recipient, enhancing and stimulating the individual’s natural ability to restore a sense of wellbeing. It is instrumental in lowering stress levels, and therefore may equip the recipient with increased resources to deal with the physical as well as the emotional, mental and spiritual problems raised by his/her condition. It is completely natural and safe, and can be used alongside conventional medicine as well as other complementary therapies or self-help techniques.
It has been documented that patients receiving chemotherapy have commented on feeling less distress and discomfort when Reiki is part of their care plan. Besides feeling more energy, hope and tranquillity, some patients have felt that the side-effects of chemotherapy were easier to cope with. Reiki has been shown to reduce anxiety and depression, to raise energy levels in tired and apathetic patients. It is of great value in degenerative disease for the very reasons that pain and anxiety can be reduced.
The treatment is gentle, supportive and non-invasive, the patient always remains clothed. Even though the origins of reiki are spiritual in nature, Reiki imposes no set of beliefs. It can be used by people of different cultural backgrounds and faith, or none at all. This makes it particularly suitable in medical settings. Predicting who would or would not like to receive Reiki is impossible.
EMMETT is a gentle soft tissue release technique developed by Australian remedial therapist Ross Emmett. It involves the therapist using light finger pressure at specific locations on the body to elicit a relaxation response within the area of concern.
Cancer impacts people in different ways throughout the journey of diagnosis, treatment and recovery. Many have found the EMMETT Technique to be very beneficial in a number of ways. Although pressure therapy isn’t new (e.g. acupressure and trigger point therapy are already well known), the amount of pressure required with EMMETT is much lighter and the placement of the pressure is unique to EMMETT Therapy.
Many cancer patients undergo surgery and experience post-surgery tightness and tension around the surgery site in the scar tissue and further afield through the connective tissue or fascia as the body heals. They experience restricted range of movement that may be painful too. Mastectomy patients as an example will usually experience pain or tenderness, swelling around the surgery site, limited arm or shoulder movement, and even numbness in the chest or upper arm. Here’s where EMMETT can assist. With gentle pressure to specific points, many women have received relief from the pain, reduced swelling and much improved range of movement. There are multiple EMMETT points that are used to help these women and that give the therapist a range of options depending on the patient’s specific concern.
Many cancer patients also experience fatigue, increased risk of infection, nausea, appetite changes and constipation as common side effects of chemotherapy. These symptoms can also be greatly supported with a designated sequence where the EMMETT Therapist gently stimulates areas all around the body for an overall effect. Patients report reduction in swelling, feelings of lightness, increased energy, more robust emotional well-being, less pain and feeling better generally within themselves.
3 Daoyin Tao
The theory behind this massage lies in traditional Chinese medicine, so covers yin and yang, five elements and Chinese face reading from a health perspective. It enables the emotional elements behind disease to be explored. For example, the Chinese will say that grief is held in the Lung, anger in the liver, and fear in the kidney.
For this half hour massage there is no need for the patient to remove clothes, so it is a lovely way of receiving a massage where body image may be an issue, or where lines and feeds are in place, making removal of clothes difficult. This massage therapy can be given not only in a clinic, but also on the day unit, on hospital wards and even in an intensive care unit.
In working the meridian system the therapist is able to work the whole body, reaching areas other than the contact zone. Patients have commented that this deeply relaxing and soothing massage is; “one of the best massages I have ever had”. It has been proven to be beneficial with problems of; sleep, headaches, anxiety, watery eyes, shoulder and neck tension, sinusitis and panic attacks, jaw tension, fear, emotional trauma/distress.
END OF QUOTES
Where do you think these statements come from?
They sound as though they come from a profoundly uncritical source, such as a commercial organisation trying to persuade customers to use some dodgy treatments, don’t they?
They come from the NHS! To be precise, they come from the NHS NATURAL HEALTH SCHOOL in Harrowgate, a service that offers a range of free complementary therapy treatments to patients and their relatives who are affected by a cancer diagnosis and are either receiving their cancer treatment at Harrogate or live in the Harrogate and Rural District.
This NHS school offers alternative treatments to cancer patients and claim that they know from experience, that when Complementary Therapies are integrated into patient care we are able to deliver safe, high quality care which fulfils the needs of even the most complex of patients.
In addition, they also run courses for alternative practitioners. Their reflexology course, for instance, covers all of the following:
- Explore the history and origins of Reflexology
- Explore the use of various mediums used in treatment including waxes, balms, powders and oils
- Explore the philosophy of holism and its role within western bio medicine
- Reading the feet/hands and mapping the reflex points
- Relevant anatomy, physiology and pathology
- Managing a wide range of conditions
- Legal implications
- Cautions and contraindications
- Assessment and client care
- Practical reflexology skills and routines
- Treatment planning
I imagine that the initiators of the school are full of the very best, altruistic intentions. I therefore have considerable difficulties in criticising them. Yet, I do strongly feel that the NHS should be based on good evidence; and that much of the school’s offerings seems to be the exact opposite. In fact, the NHS-label is being abused for giving undeserved credibility to outright quackery, in my view.
I am sure the people behind this initiative only want to help desperate patients. I also suspect that most patients are very appreciative of their service. But let me put it bluntly: we do not need to make patients believe in mystical life forces, meridians and magical energies; if nothing else, this undermines rational thought (and we could do with a bit more of that at present). There are plenty of evidence-based approaches which, when applied with compassion and empathy, will improve the well-being of these patients without all the nonsense and quackery in which the NHS NATURAL HEALTH SCHOOL seems to specialise.
It is bad enough, I believe, that such nonsense is currently popular and increasingly politically correct, but let’s keep/make the NHS evidence-based, please!
An article entitled “Homeopathy in the Age of Antimicrobial Resistance: Is It a Viable Treatment for Upper Respiratory Tract Infections?” cannot possibly be ignored on this blog, particularly if published in the amazing journal ‘Homeopathy‘. The title does not bode well, in my view – but let’s see. Below, I copy the abstract of the paper without any changes; all I have done is include a few numbers in brackets; they refer to my comments that follow.
START OF ABSTRACT
Acute upper respiratory tract infections (URTIs) and their complications are the most frequent cause of antibiotic prescribing in primary care. With multi-resistant organisms proliferating, appropriate alternative treatments to these conditions are urgently required. Homeopathy presents one solution (1); however, there are many methods of homeopathic prescribing. This review of the literature considers firstly whether homeopathy offers a viable alternative therapeutic solution for acute URTIs (2) and their complications, and secondly how such homeopathic intervention might take place.
Critical review of post 1994 (3) clinical studies featuring homeopathic treatment of acute URTIs and their complications. Study design, treatment intervention, cohort group, measurement and outcome were considered. Discussion focused on the extent to which homeopathy is used to treat URTIs, rate of improvement and tolerability of the treatment, complications of URTIs, prophylactic and long-term effects, and the use of combination versus single homeopathic remedies.
Multiple peer-reviewed (4) studies were found in which homeopathy had been used to treat URTIs and associated symptoms (cough, pharyngitis, tonsillitis, otitis media, acute sinusitis, etc.). Nine randomised controlled trials (RCTs) and 8 observational/cohort studies were analysed, 7 of which were paediatric studies. Seven RCTs used combination remedies with multiple constituents. Results for homeopathy treatment were positive overall (5), with faster resolution, reduced use of antibiotics and possible prophylactic and longer-term benefits.
Variations in size, location, cohort and outcome measures make comparisons and generalisations concerning homeopathic clinical trials for URTIs problematic (6). Nevertheless, study findings suggest at least equivalence between homeopathy and conventional treatment for uncomplicated URTI cases (7), with fewer adverse events and potentially broader therapeutic outcomes. The use of non-individualised homeopathic compounds tailored for the paediatric population merits further investigation, including through cohort studies (8). In the light of antimicrobial resistance, homeopathy offers alternative strategies for minor infections and possible prevention of recurring URTIs (9).
END OF ABSTRACT
And here are my comments:
- This sounds as though the author already knew the conclusion of her review before she even started.
- Did she not just state that homeopathy is a solution?
- This is most unusual; why were pre-1994 articles not considered?
- This too is unusual; that a study is peer-reviewed is not really possible to affirm, one must take the journal’s word for it. Yet we know that peer-review is farcical in the realm of alternative medicine (see also below). Therefore, this is an odd inclusion criterion to mention in an abstract.
- An overall positive result obtained by including uncontrolled observational and cohort studies lacking a control group is meaningless. There is also no assessment of the quality of the RCTs; after a quick glance, I get the impression that the methodologically sound studies do not show homeopathy to be superior to placebo.
- Reviewers need to disentangle these complicating factors and arrive at a conclusion. This is almost invariably problematic, but it is the reviewer’s job.
- What might be the conventional treatment of uncomplicated URTI?
- Why on earth cohort studies? They tell us nothing about equivalence, efficacy etc.
- To reach that conclusion seems to have been the aim of this review (see my point number 1). If I am not mistaken, antibiotics are not indicated in the vast majority of cases of uncomplicated URTI. This means that the true alternative in the light of antimicrobial resistance is to not prescribe antibiotics and treat the patient symptomatically. No need at all for homeopathic placebos, and no need for wishful thinking reviews!
In the paper, the author explains her liking of uncontrolled studies: Non-RCTs and patient reported surveys are considered by some to be inferior forms of research evidence, but are important adjuncts to RCTs that can measure key markers such as patient satisfaction, quality of life and functional health. Observational studies such as clinical outcome studies and case reports, monitoring the effects of homeopathy in real-life clinical settings, are a helpful adjunct to RCTs and more closely reﬂect real-life experiences of patients and physicians than RCTs, and are therefore considered in this study. I would counter that this is not an issue of inferiority but one that depends on the research question; if the research question relates to efficacy/effectiveness, uncontrolled data are next to useless.
She also makes fairly categorical statements in the conclusion section of the paper about the effectiveness of homeopathy: [the] combined evidence from these and other studies suggests that homeopathic treatment can exert biological effects with fewer adverse events and broader therapeutic opportunities than conventional medicine in the treatment of URTIs. Given the cost implications of treating URTIs and their complications in children, and the relative absence of effective alternatives without potential side effects, the use of non-individualised homeopathic compounds tailored for the paediatric population merits further investigation, including through large-scale cohort studies… the most important evidence still arises from practical clinical experience and from the successful treatment of millions of patients. I would counter that none of these conclusions are warranted by the data presented.
From reading the paper, I get the impression that the author (the paper provides no information about her conflicts of interest, nor funding source) is a novice to conducting reviews (even though the author is a senior lecturer, the paper reads more like a poorly organised essay than a scientific review). I am therefore hesitant to criticise her – but I do nevertheless find the fact deplorable that her article passed the peer-review process of ‘Homeopathy‘ and was published in a seemingly respectable journal. If anything, articles of this nature are counter-productive for everyone concerned; they certainly do not further effective patient care, and they give homeopathy-research a worse name than it already has.
The Impact Factor (IF) of a journal is a measure reflecting the yearly average number of citations to recent articles published in that journal. It is frequently used as a measure of the importance of a journal within its field; journals with higher impact factors are often deemed to be more important than those with lower ones. The IF for any given year can be calculated as the number of citations, received in that year, of articles published in that journal during the two preceding years, divided by the total number of articles published in that journal during the two preceding years.
A press-release celebrated the new IF of the journal ‘HOMEOPATHY’ which has featured on this blog before. I am sure that you all want to share in this joy:
START OF QUOTE
For the second year running there has been an increase in the number of times articles published in the Faculty of Homeopathy’s journal Homeopathy have been cited in articles in other peer-reviewed publications. The figure known as the Impact Factor (IF) has risen from 1.16 to 1.524, which represents a 52% increase in the number of citations.
An IF is used to determine the impact a particular journal has in a given field of research and is therefore widely used as a measure of quality. The latest IF assessment for Homeopathy covers citations during 2017 for articles published in the previous two years (2015 and 2016).
Dr Peter Fisher, Homeopathy’s editor-in-chief, said: “Naturally the editorial team is delighted by this news. This success is due to the quality and international nature of research and other content we publish. So I thank all those who have contributed such high quality papers, maintaining the journal’s position as the world’s foremost publication in the scholarly study of homeopathy. I would particularly like to thank our senior deputy editor, Dr Robert Mathie for all his hard work.”
First published in 1911 as the British Homoeopathic Journal, Homeopathy is the only homeopathic journal indexed by Medline, with over 100,000 full-text downloads per year. In January 2018, publishing responsibilities for the quarterly journal moved to Thieme, an award-winning medical and science publisher.
Greg White, Faculty chief executive, said: “Moving to a new publisher can be difficult, but the decision we took last year is certainly paying dividends. I would therefore like to thank everyone at Thieme for the part they are playing in the journal’s continued success.”
END OF QUOTE
While the champagne corks might be popping in homeopathic circles, I want to try and give some perspective to this celebration.
The IP has rightly been criticised so many times for so many reasons, that it is now not generally considered to be a valuable measure for anything. The main reason for this is that it can be (and is being) manipulated in numerous ways. But even if we accept the IP as a meaningful parameter, we must ask what an IP of 1.5 means and how it compares to other medical journals’ IP.
Here are some IFs of general and specialised medical journals readers of this blog might know:
Annals Int Med: 2016/2017 Impact Factor : 17.135,
BMJ: 2016/2017 Impact Factor : 20.785,
Circulation: 2016/2017 Impact Factor : 19.309,
Diabetes Care: 2016/2017 Impact Factor : 11.857,
Gastroenterology: 2016/2017 Impact Factor : 18.392,
Gut: 2016/2017 Impact Factor : 16.658,
J Clin Oncol: 2016/2017 Impact Factor : 24.008,
Lancet: 2016/2017 Impact Factor : 47.831,
Nature Medicine: 2016/2017 Impact Factor : 29.886,
Plos Medicine: 2016/2017 Impact Factor : 11.862,
Trends Pharm Sci: 2016/2017 Impact Factor : 12.797,
This selection seems to indicate that an IF of 1.5 is modest, to say the least. In turn, this means that the above press-release is perhaps just a little bit on the hypertrophic side.
But, of course, it’s all about homeopathy where, as we all know, LESS IS MORE!
Why do most alternative practitioners show such dogged determination not to change their view of the efficacy of their therapy, even if good evidence shows that it is a placebo? This is the question that I have been pondering for some time. I have seen many doctors change their mind about this or that treatment in the light of new evidence. In fact, I have not seen one who has not done so at some stage. Yet I have never seen an alternative therapist change his/her mind about his/her alternative therapy. Why is that?
You might say that the answers are obvious:
- because they have heavily invested in their therapy, both emotionally and financially;
- because their therapy has ‘stood the test of time’;
- because they believe what they were taught;
- because they are deluded, not very bright, etc.;
- because they need to earn a living.
All of these reasons may apply. But do they really tell the whole story? While contemplating about this question, I thought of something that had previously not been entirely clear to me: they simply KNOW that the evidence MUST be wrong.
Let me try to explain.
Consider an acupuncturist (I could have chosen almost any other type of alternative practitioner) who has many years of experience. He has grown to be a well-respected expert in the world of acupuncture. He sits on various committees and has advised important institutions. He knows the literature and has treated thousands of patients.
This experience has taught him one thing for sure: his patients do benefit from his treatment. He has seen it happening too many times; it cannot be a coincidence. Acupuncture works, no question about it.
And this is also what the studies tell him. Even the most sceptical scientist cannot deny the fact that patients do get better after acupuncture. So, what is the problem?
The problem is that sceptics say that this is due to a placebo effect, and many studies seem to confirm this to be true. Yet, our acupuncturist completely dismisses the placebo explanation.
- Because he has heavily invested in their therapy? Perhaps.
- Because acupuncture has ‘stood the test of time’? Perhaps.
- Because he believes what he has been taught? Perhaps.
- Because he is deluded, not very bright, etc.? Perhaps.
- Because he needs to earn a living? Perhaps.
But there is something else.
He has only ever treated his patients with acupuncture. He has therefore no experience of real medicine, or other therapeutic options. He has no perspective. Therefore, he does not know that patients often get better, even if they receive an ineffective treatment, even if they receive no treatment, and even if they receive a harmful treatment. Every improvement he notes in his patients, he relates to his acupuncture. Our acupuncturist never had the opportunity to learn to doubt cause and effect in his clinical routine. He never had to question the benefits of acupuncture. He never had to select from a pool of therapies the optimal one, because he only ever used acupuncture.
It is this lack of experience that never led him to think critically about acupuncture. He is in a similar situation as physicians were 200 years ago; they only (mainly) had blood-letting, and because some patients improved with it, they had no reason to doubt it. He only ever saw his successes (not that all his patients improved, but those who did not, did not return). He simply KNOWS that acupuncture works, because his own, very limited experience never forced him to consider anything else. And because he KNOWS, the evidence that does not agree with his knowledge MUST be wrong.
I am of course exaggerating and simplifying in order to make a point. And please don’t get me wrong.
I am not saying that doctors cannot be stubborn. And I am not saying that all alternative practitioners have such limited experience and are unable to change their mind in the light of new evidence. However, I am trying to say that many alternative practitioners have a limited perspective and therefore find it impossible to be critical about their own practice.
If I am right, there would be an easy (and entirely alternative) cure to remedy this situation. We should sent our acupuncturist to a homeopath (or any other alternative practitioner whose practice he assumes to be entirely bogus) and ask him to watch what kind of therapeutic success the homeopath is generating. The acupuncturist would soon see that it is very similar to his own. He would then have the choice to agree that highly diluted homeopathic remedies are effective in curing illness, or that the homeopath relies on the same phenomenon as his own practice: placebo.
Sadly, this is not going to happen, is it?
Several previous studies have suggested improvements in sperm quality after vitamin supplementation, and several reviews have drawn tentatively positive conclusions:
- The current literature seems to suggest a beneficial effect of antioxidants on male infertility.
- Several studies have reported a significant increase in sperm quality and pregnancy rates when the men were supplemented by specific vitamins and micronutrients
- For those undergoing assisted reproduction, the odds ratio that antioxidant use would improve pregnancy rates was 4.18, with a 4.85-fold improvement in live birth rate also noted.
Most of the primary trials lacked scientific rigour, however. Now a new study has emerged that overcomes many of the flaws of the previous research.
Professor Anne Steiner from the University of North Carolina at Chapel Hill, USA, presented her study yesterday at the 34th Annual Meeting of ESHRE in Barcelona. This clinical trial of 174 couples has found that an antioxidant formulation taken daily by the male partner for a minimum of three months made no difference to sperm concentration, motility or morphology, nor to the rate of DNA fragmentation. The study was performed in eight American fertility centres.
All men in the study had been diagnosed with male factor infertility, reflected in subnormal levels of sperm concentration, motility, or morphology, or higher than normal rates of DNA fragmentation. These parameters were measured at the start of the trial and at three months. In between, the men allocated to the antioxidant intervention were given a daily supplement containing vitamins C, D3 and E, folic acid, zinc, selenium and L-carnitine; the control group received a placebo.
At three months, results showed only a “slight” overall difference in sperm concentration between the two groups, and no significant differences in morphology, motility, or DNA fragmentation measurements. Sub-group analysis (according to different types of sperm abnormality) found no significant differences in sperm concentration (in oligospermic men), motility (in asthenospermic men), and morphology (in teratospermic men).(1) There was also no change seen after three months in men with high rates of DNA fragmentation (28.9% in the antioxidant group and 28.8 in the placebo group).
Natural conception during the initial three month study period did also not differ between the two groups of the entire cohort – a pregnancy rate of 10.5% in the antioxidant group and 9.1% in the placebo. These rates were also comparable at six months (after continued antioxidant or placebo for the male partner and three cycles of clomiphene and intrauterine insemination for the female partner).
The authors concluded that “the results do not support the empiric use of antioxidant therapy for male factor infertility in couples trying to conceive naturally”.
The story about supplements and health claims seems to be strangely repetitive:
- the claim that supplements help for condition xy is heavily promoted, e. g. via the Internet;
- a few flimsy trials seem to support the claim;
- these results are relentlessly hyped;
- the profit of the manufacturers grows;
- eventually a rigorous, independently-funded trial emerges with a negative finding;
- the card house seems to collapse;
- the manufacturers claim that the trial’s methodology was faulty (e. g. wrong does, wrong mixture of ingredients);
- thus another profitable card house is built elsewhere.
In the end, the only supplement-related effects are that 1) the consumers produce expensive urine and 2) the manufacturers have plenty of funds to start a new campaign based on yet another bogus heath claim.
One of the biggest danger of SCAM, in my view, is the fact that SCAM-practitioners all too often advise their patients to forego effective conventional medicine. This probably applies to most medicines, but is best-researched for immunisations. A recent article puts it clearly:
… negative attitudes towards vaccines reflect a broader and deeper set of beliefs about health and wellbeing… this alternative worldview is influenced by ontological confusions (e.g. regarding purity, natural energy), and knowledge based on personal lived experience and trusted peers, rather than the positivist epistemological framework. [This] view is supported by recent social-psychological research, including strong correlations of vaccine scepticism with adherence to complementary and alternative medicine, magical health beliefs, and conspiracy ideation. For certain well-educated and well-resourced individuals, opposition to vaccines represents an expression of personal intuition and agency, in achieving a positive and life-affirming approach to health and wellbeing. These core beliefs are not amenable to change – and especially resistant to communications from orthodox, authoritative sources.
The authors concluded suggesting that a better long-term strategy is to combine with other disciplines in order to address the root causes of vaccine scepticism. Vaccine scepticism is unlikely to thrive in a cultural context that trusts and values the scientific consensus.
If I understand them correctly, the authors believe it is necessary to change the societal attitude to science.
I am sure they are correct.
We live in a time when anyone’s opinion is deemed as valuable as the next person’s. Pseudo-experts who have their knowledge from a couple of google searches are being considered as trustworthy as the true experts who have the background, knowledge and experience to issue responsible advice. Science is viewed by many as just another way of knowing, or even as the new cult or religion that must be viewed with suspicion.
It is clear that these are deplorable developments. But how to stop them?
This is where it gets complex.
One is tempted to lay the blame at the door of our politicians. Why do we tolerate the fact that so many of them have not the slightest inkling about science?
But hold on, WE elected them!
Because large sections of the public are ignorant too.
So, one must start much earlier. We need better science education, and that has to begin in the first year of schooling! We need evening classes in critical thinking. We need adult science courses for politicians.
But this is not going to happen, because our politicians fail to see the importance of such measures (and, of course, they might feel that an uneducated public is easier to govern than an educated one).
How to break this vicious circle?
It is clear from these simple (and simplistic) reflections that a multifactorial approach is required. And it is clear that it ought to be a strategy that prevents standards in the most general terms from slipping ever lower. But how?
I wish I knew!!!