Updated Edition!
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.
I have mentioned lymph drainage before. It is a gentle massage technique applied along the lymph vessels and nodes to stimulate lymph flow. All sorts of extraordinary claims are made for this treatment. In particular, lymphoedema after surgery for breast cancer, which can be a debilitating complication, is claimed to be preventable with this approach. This seems vaguely plausible, but does it really work?
This study tested whether manual lymphatic drainage (MLD) or active exercise (AE) are associated with improvements in shoulder range of motion (ROM), wound complication and changes in the lymphatic parameters after breast cancer (BC) surgery, and whether these parameters have an association with lymphoedema formation in the long run.
The researchers conducted a clinical trial with 106 women undergoing radical BC surgery. Women were matched for staging, age and body mass index and were allocated to AE or MLD, twice weekly during one month after surgery. The wound was evaluated two months after surgery. ROM, upper limb circumference measurement and upper limb lymphoscintigraphy were performed before surgery, and 2 and 30 months after surgery.
The incidence of seroma, dehiscence and infection did not differ between groups. Both groups showed ROM deficit of flexion and abduction in the second month postoperative and partial recovery after 30 months. Cumulative incidence of lymphoedema was 23.8% and did not differ between groups (p = 0.29). Concerning the lymphoscintigraphy parameters, there was a significant convergent trend between baseline degree uptake (p = 0.003) and velocity visualization of axillary lymph nodes (p = 0.001) with lymphoedema formation. A reduced marker uptake before or after surgery predicted lymphedema formation in the long run (>2 years). None of the lymphoscintigraphy parameters were shown to be associated with the study group. Age ≤39 years was the factor with the greatest association with lymphedema (p = 0.009). In women with age ≤39 years, BMI >24Kg/m2 was significantly associated with lymphedema (p = 0.017). In women over 39 years old, women treated with MLD were at a significantly higher risk of developing lymphedema (p = 0.011).
The authors concluded that lymphatic abnormalities precede lymphedema formation in BC patients. In younger women, obesity seems to be the major player in lymphedema development and, in older women, improving muscle strength through AE can prevent lymphedema. In essence, MLD is as safe and effective as AE in rehabilitation after breast cancer surgery.
I am not sure I agree with these conclusions; to me, they seem a bit over-optimistic. The results fail to show that MLD is clinically effective, as both AE and MLD might be equally ineffective. In fact, in the discussion section of the paper the authors state that their study suggests that AE may be more effective than MLD for the prevention of lymphedema in women older than 39 years.
So far, only very few controlled clinical trials tested the MLD effects in the prevention of lymphedema after breast cancer. Some suggested that MLD administered early in the postoperative period can effectively prevent lymphedema, whereas others failed to find positive effects of MLD. Thus the question whether MLD is effective for lymphoedema after breast cancer remains open.
For once, the call for more and better research seems justified.
Doctor Jens Wurster is no stranger to this blog; previously I discussed his claim that he has treated more than 1000 cancer patients homeopathically and we could even cure or considerably ameliorate the quality of life for several years in some, advanced and metastasizing cases. So far, his claims were based not on evidence published in peer-reviewed journals (I cannot find a single Medline-listed paper by this man); but now Wurster has published an article in a German Journal (Wurster J. Zusatznutzen der Homöopathie … Deutsche Zeitschrift für Onkologie 2018; 50: 85–91; not Medline-listed, I am afraid). The paper is in German, but it has an English abstract; here it is:
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All over the world, oncology patients receive homeopathic treatment concomitant to conventional treatments, such as chemotherapy and radiation treatment, in order to reduce the side effects of these therapies. It has been shown that cancer patients, who are receiving homeopathic treatment in addition to conventional therapies, have a higher quality of life and a longer survival rate. Studies in cancer cell research have shown the direct effects of highly potentized homeopathic medicines on tumor cell lines. Tumor inhibiting properties of homeopathic medicines have been proven in vivo as well as in vitro. Research projects into complementary medicine (CAMbrella) and research into personalized immunotherapies as well as additive homeopathy open the door to the future of integrative oncology.
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In the article, Wurster states that he has 20 years of experience in treating cancer with homeopathy as an add-on to conventional care, and that he can confirm homeopathy’s effectiveness. He claims that ‘very many’ patients have thus benefitted by experiencing less side-effects of conventional treatments. And he offers two case-reports to illustrate this.
[Nach 20 Jahren klinischer Erfahrung in der Clinica St. Croce im Tessin mit der Behandlung onkologischer Patienten mithilfe der Homöopathie können wir deutlich den Zusatznutzen der Homöopathie in der Onkologie bestätigen [1]. So gelang es unserem Ärzteteam in den zurückliegenden Jahren bei sehr vielen Patienten, durch gezielten Einsatz homöopathischer Mittel die Nebenwirkungen von Chemotherapien oder Bestrahlungen erfolgreich zu reduzieren [1]. Wie dabei Schulmedizin und Homöopathie in der Praxis zusammenwirken, zeigt folgendes Beispiel. ([1] Wurster J. Die homöopathische Behandlung und Heilung von Krebs und metastasierten Tumoren. Norderstedt: Books on Demand; 2015)]The two case-reports lack detail and are less than convincing, in my view. Both patients have had conventional therapies and Wurster claims that his homeopathic remedies reduced their side-effects. There is no way of verifying this claim, and the improvements might have occurred also without homeopathy.
In the discussion section of his paper, Wurster then elaborates that oncologists throughout Europe are now realising the potential of homeopathy. In support he mentions paediatric oncologists in Klagenfurt who managed to spare pain-killers by giving homeopathics. Similarly, at the Inselspital in Bern, they are offering homeopathic consultations to complement conventional treatments.
[Inzwischen haben auch einige Onkologen erkannt, wie eine gezielt eingesetzte homöopathische Behandlung die Nebenwirkungen von Chemotherapien oder Bestrahlungen reduzieren kann. Wir arbeiten inzwischen mit einigen Onkologen aus ganz Europa zusammen, die den Zusatznutzen der Homöopathie in der Onkologie erlebt haben. In der Kinderonkologie in Klagenfurt beispielsweise konnten mithilfe der Homöopathie Schmerzmittel bei den Kindern eingespart werden. Auch am Inselspital Bern werden zusätzliche homöopathische Konsile in der Kinderonkologie angeboten, um die konventionelle Behandlung begleiten zu können [8].]At this point, Wurster inserts his reference number 8. As several of his references are either books or websites, this reference to an article in a top journal seems interesting. Here is its abstract:
___________________________________________________________________________________
BACKGROUND:
Though complementary and alternative medicine (CAM) are frequently used by children and adolescents with cancer, there is little information on how and why they use it. This study examined prevalence and methods of CAM, the therapists who applied it, reasons for and against using CAM and its perceived effectiveness. Parent-perceived communication was also evaluated. Parents were asked if medical staff provided information on CAM to patients, if parents reported use of CAM to physicians, and what attitude they thought physicians had toward CAM.
STUDY DESIGN:
All childhood cancer patients treated at the University Children‘s Hospital Bern between 2002-2011 were retrospectively surveyed about their use of CAM.
RESULTS:
Data was collected from 133 patients (response rate: 52%). Of those, 53% had used CAM (mostly classical homeopathy) and 25% of patients received information about CAM from medical staff. Those diagnosed more recently were more likely to be informed about CAM options. The most frequent reason for choosing CAM was that parents thought it would improve the patient’s general condition. The most frequent reason for not using CAM was lack of information. Of those who used CAM, 87% perceived positive effects.
CONCLUSIONS:
Since many pediatric oncology patients use CAM, patients’ needs should be addressed by open communication between families, treating oncologists and CAM therapists, which will allow parents to make informed and safe choices about using CAM.
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Any hope that this paper might back up the statements made by Wurster is thus disappointed.
Altogether, this Wurster-paper contains no reliable evidence. The only clinical trial it seems to rely on is the one by Prof Frass which we have discussed previously here and here. The Frass-study is odd in several ways and, before we can take its results seriously, we need to see an independent replication of its findings. In this context, it is noteworthy that my own 2006 systematic review concluded that there is insufficient evidence to support clinical efficacy of homeopathic therapy in cancer care. In view of all this, I feel that the new Wurster-paper provides no reliable evidence and no reason to change my now somewhat dated conclusion of 2006. Moreover, I would insist that those who claim otherwise are unethical and behave irresponsible.
And finally, I need to reiterate what I stated in my previous post: the Wurster-paper indicates that something is amiss with medical publishing. How can it be that, in 2018, the ‘Deutsche Zeitschrift für Onkologie’ (or any other medical journal for that matter) can be so bar of critical thinking to publish such dangerously misleading nonsense? The editors of this journal (Univ.-Prof. Dr. med. Arndt Büssing, Witten/Herdecke; Dr. med. Peter Holzhauer, Bad Trissl und München) and its editorial board members (L. Auerbach, Wien; C. Bahne Bahnson, Kiel; J. Büntzel, Nordhausen; B. Freimüller-Kreutzer, Heidelberg; H.R. Maurer, Berlin; A. Mayr, Starnberg; R. Moss, New York; T. Ostermann, Witten/Herdecke; K. Prasad, Denver; G. Pulverer, Köln; H. Renner, Nürnberg; C.P. Siegers, Lübeck; W. Schmidt, Greifswald; G. Uhlenbruck, Köln; B. Wolf, München; K.S. Zänker, Witten/Herdecke) should ask themselves whether they are taking their moral obligations seriously enough, or whether their behaviour is not a violation of their most fundamental ethical duties.
In our book ‘MORE HARM THAN GOOD‘ we allude to such problems as follows: …Spurious results are frequently paraded by CAM advocates in support of implausible treatments… the more poorly conceived and executed a research project is, the more likely it is to produce false-positive results. These results then may lead to repetitive cycles of unproductive work to explain what was found—often to simply disprove the erroneous results. This is an unfortunate feature of various fields of scientific research, but it has particularly serious implications in medical research. Moreover, researchers who practice and behave as advocates of CAM may unintentionally or deliberately distort or exaggerate weak findings. Invalid CAM research claims tend not to be put to rest; instead they are repeatedly recycled…
And:
…The CAM practitioner who promotes untruths has either failed to enlighten themselves as to the facts—this being a central requirement of professional ethics— or has chosen to deliberately deceive patients. Either of these reasons for promulgating falsehoods amounts to a serious breach in terms of virtue ethics. According to almost all forms of ethical theory, the truth-violating nature of CAM renders it immoral in both theory and practice.
The damage that can result from such violations of medical ethics is not merely a matter for the ‘ivory towers of academia’, it can virtually be a matter of life and death.
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:
_________________________________________________________________________________________
OBJECTIVE:
To systematically review placebo-controlled randomized trials of homeopathy for psychiatric conditions.
DATA SOURCES:
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.
STUDY SELECTION:
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.
RESULTS:
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).
CONCLUSIONS:
The database on studies of homeopathy and placebo in psychiatry is very limited, but results do not preclude the possibility of some benefit.
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And specifically for depression, another review (also by proponents of homeopathy) is available; here is its abstract:
OBJECTIVE:
To systematically review the research evidence on the effectiveness of homeopathy for the treatment of depression and depressive disorders.
METHODS:
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.
RESULTS:
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.
CONCLUSIONS:
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.
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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:
1 Reiki
… 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.
2 Emmett
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
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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?
Wrong!
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.
METHOD:
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.
RESULTS:
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.
CONCLUSIONS:
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.
As this press-release is important and entirely self-explanatory, I will post it here without comment (other than congratulating the CFI for their action and encouraging organisations in other countries to follow suit) :
The Center for Inquiry has filed a lawsuit in the District of Columbia on behalf of the general public against drug retailer CVS for consumer fraud over its sale and marketing of useless homeopathic medicines. CFI, an organization advancing reason and science, accused the country’s largest drug retailer of deceiving consumers through its misrepresentation of homeopathy’s safety and effectiveness, wasting customers’ money and putting their health at risk.
Click here to access the official complaint (PDF).
Homeopathy is an 18th-century pseudoscience premised on the absurd, unscientific notion that a substance that causes a particular symptom is what should be ingested to alleviate it. Dangerous substances are diluted to the point that no trace of the active ingredient remains, but its alleged effectiveness rests on the nonsensical claim that water molecules have “memories” of the original substance. Homeopathic treatments have no effect whatsoever beyond that of a placebo.
“Homeopathy is a total sham, and CVS knows it. Yet the company persists in deceiving its customers about the effectiveness of homeopathic products,” said Nicholas Little, CFI’s Vice President and General Counsel. “Homeopathics are shelved right alongside scientifically-proven medicines, under the same signs for cold and flu, pain relief, sleep aids, and so on.”
“If you search for ‘flu treatment’ on their website, it even suggests homeopathics to you,” said Little. “CVS is making no distinction between those products that have been vetted and tested by science, and those that are nothing but snake oil.”
Apart from being a waste of money, choosing homeopathic treatments to the exclusion of evidence-based medicines can result in worsened or prolonged symptoms, and in some cases, even death. Several products have been found to contain poisonous ingredients which have affected tens of thousands of adults and children in just the last few years.
“CVS is taking cynical advantage of their customers’ confusion and trust in the CVS brand, and putting their health at risk to make a profit,” said Little. “And they can’t claim ignorance. If the people in charge of the country’s largest pharmacy don’t know that homeopathy is bunk, they should be kept as far away from the American healthcare system as possible.”
“We made a number of efforts to discuss this situation with CVS, but the concerns we raised were ignored,” said Robyn Blumner, president and CEO of CFI. “Homeopathy is a multi-billion dollar consumer fraud. If CVS would rather line its pockets than protect Americans’ health, we have no choice but to take this fight to the courts.”
CFI has for many years lobbied for tighter regulation of homeopathic products, and has been invited by the Food and Drug Administration and the Federal Trade Commission to provide expert testimony. As a result, the FTC declared in 2016 that the marketing of homeopathic products for specific diseases and symptoms is only acceptable if consumers are told: “(1) there is no scientific evidence that the product works and (2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.” And last year, the FDA announced a new “risk-based” policy of regulatory action against homeopathic products.
“CVS should be warned, the evidence for our case is extremely strong,” said Blumner. “And if CVS’s endorsement of homeopathy is any indication, evidence will not be their strong suit.”
Currently, there are measles outbreaks almost everywhere. I have often pointed out that SCAM does not seem to be entirely innocent in this development. Now another study examined the relationship between SCAM-use and vaccination scepticism. Specifically, the researchers wanted to know whether a person’s more general health-related worldview might explain this relationship.
A cross-sectional online survey of adult Australians (N = 2697) included demographic, SCAM, and vaccination measures, as well as the holistic and magical health belief scales (HHB, MHB). HHB emphasises links between mind and body health, and the impact of general ‘wellness’ on specific ailments or resistance to disease, whilst MHB specifically taps ontological confusions and cognitive errors about health. SCAM and anti-vaccination were found to be linked primarily at the attitudinal level (r = -0.437). The researchers did not find evidence that this was due to SCAM practitioners influencing their clients. Applying a path-analytic approach, they found that individuals’ health worldview (HHB and MHB) accounted for a significant proportion (43.1%) of the covariance between SCAM and vaccination attitudes. MHB was by far the strongest predictor of both SCAM and vaccination attitudes in regressions including demographic predictors.
The researchers concluded that vaccination scepticism reflects part of a broader health worldview that discounts scientific knowledge in favour of magical or superstitious thinking. Therefore, persuasive messages reflecting this worldview may be more effective than fact-based campaigns in influencing vaccine sceptics.
Parents opposing vaccination of their kids are often fiercely determined. Numerous cases continue to make their way through the courts where parents oppose the vaccination of their children, often inspired by the views of both registered and unregistered health practitioners, including homeopaths and chiropractors. A recent article catalogued decisions by the courts in Australia, New Zealand, the UK and Canada. Most of them ruled in favour of vaccination and dismissed the arguments of those opposed to vaccination as unscientific. The author, an Australian barrister and Professor of Forensic Medicine, concluded that Australia should give serious consideration to emulating the model existing in multiple countries, including the United States, and should create a no-fault vaccination injury compensation scheme.
Such programs are based on the assumption that it is fair and reasonable that a community protected by a vaccination program accepts responsibility for and provides compensation in those rare instances where individuals are injured by it. To Me, this seems a prudent and ethical concept that should be considered everywhere.
Alternative practitioners practise highly diverse therapies. They seem to have nothing in common – except perhaps that ALL of them are allegedly stimulating our self-healing powers (and except that most proponents are latently or openly against vaccinations). And it is through these self-healing powers that the treatments in question cure anything and become a true panacea. When questioned what these incredible powers really are, most practitioners would (somewhat vaguely) name the immune system as the responsible mechanism. With this post, I intend to provide a short summary of the evidence on this issue:
Acupuncture: no good evidence to show stimulation of self-healing powers.
Aromatherapy: no good evidence to show stimulation of self-healing powers.
Bioresonance: no good evidence to show stimulation of self-healing powers.
Chiropractic: no good evidence to show stimulation of self-healing powers.
Detox: no good evidence to show stimulation of self-healing powers.
Energy healing: no good evidence to show stimulation of self-healing powers.
Feldenkrais: no good evidence to show stimulation of self-healing powers.
Gua sha: no good evidence to show stimulation of self-healing powers.
Herbal medicine: no good evidence to show stimulation of self-healing powers.
Homeopathy: no good evidence to show stimulation of self-healing powers.
Macrobiotics: no good evidence to show stimulation of self-healing powers.
Naturopathy: no good evidence to show stimulation of self-healing powers.
Osteopathy: no good evidence to show stimulation of self-healing powers.
Power bands: no good evidence to show stimulation of self-healing powers.
Reiki: no good evidence to show stimulation of self-healing powers.
Reflexology: no good evidence to show stimulation of self-healing powers.
Shiatsu: no good evidence to show stimulation of self-healing powers.
Tai chi: no good evidence to show stimulation of self-healing powers.
TCM: no good evidence to show stimulation of self-healing powers.
Vibrational therapy: no good evidence to show stimulation of self-healing powers.
Vaccinations: very good evidence to show stimulation of self-healing powers.
THE END
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!
