alternative medicine
Yesterday was the 80th anniversary of the Kristallnacht, the infamous start of the Nazi holocaust. For Cristian Becker, a German PR man who is currently spending much of his time promoting homeopathy and attacking critics of homeopathy, it was the occasion to publish this tweet:
I will try to translate it for you:
Today, on 9 November, all fundamentalist GWUP-sceptics such as Natalie Grams and Edzard Ernst reflect on what hate can bring about. First, one hates homeopathy, then advocates of homeopathy, and then it can seem as though one tolerates violence.
I struggle to respond to such vitriolic stupidity.
What makes this even more shocking is the fact that, as far as I see, none of the professional bodies of German homeopathy have distanced themselves for it.
I know Dr Grams a little, and can honestly say that neither of us ‘hates’ homeopathy nor homeopaths. And crucially, we both detest violence.
If such pseudo-arguments are now being used by the defenders of homeopathy, it mainly shows, I think, two things:
- They clearly have run out of real arguments which, in turn, suggests that the end of publicly funded homeopathy is imminent.
- Homeopathic remedies are not an effective therapy against feeble-mindedness.
The Clinic for Complementary Medicine and Diet in Oncology was opened, in collaboration with the oncology department, at the Hospital of Lucca (Italy) in 2013. It uses a range of alternative therapies aimed at reducing the adverse effects of conventional oncology treatments.
Their latest paper presents the results of complementary medicine (CM) treatment targeted toward reducing the adverse effects of anticancer therapy and cancer symptoms, and improving patient quality of life. Dietary advice was aimed at the reduction of foods that promote inflammation in favour of those with antioxidant and anti-inflammatory properties.
This is a retrospective observational study on 357 patients consecutively visited from September 2013 to December 2017. The intensity of symptoms was evaluated according to a grading system from G0 (absent) to G1 (slight), G2 (moderate), and G3 (strong). The severity of radiodermatitis was evaluated with the Radiation Therapy Oncology Group (RTOG) scale. Almost all the patients (91.6%) were receiving or had just finished some form of conventional anticancer therapy.
The main types of cancer were breast (57.1%), colon (7.3%), lung (5.0%), ovary (3.9%), stomach (2.5%), prostate (2.2%), and uterus (2.5%). Comparison of clinical conditions before and after treatment showed a significant amelioration of all symptoms evaluated: nausea, insomnia, depression, anxiety, fatigue, mucositis, hot flashes, joint pain, dysgeusia, neuropathy.
The authors concluded that the integration of evidence-based complementary treatments seems to provide an effective response to cancer patients’ demand for a reduction of the adverse effects of anticancer treatments and the symptoms of cancer itself, thus improving patient’s quality of life and combining safety and equity of access within public healthcare systems. It is, therefore, necessary for physicians (primarily oncologists) and other healthcare professionals in this field to be appropriately informed about the potential benefits of CMs.
Why do I call this ‘wishful thinking’?
I have several reasons:
- A retrospective observational study cannot establish cause and effect. It is likely that the findings were due to a range of factors unrelated to the interventions used, including time, extra attention, placebo, social desirability, etc.
- Some of the treatments in the therapeutic package were not CM, reasonable and evidence-based. Therefore, it is likely that these interventions had positive effects, while CM might have been totally useless.
- To claim that the integration of evidence-based complementary treatments seems to provide an effective response to cancer patients’ is pure fantasy. Firstly, some of the CMs were certainly not evidence-based (the clinic’s prime focus is on homeopathy). Secondly, as already pointed out, the study does not establish cause and effect.
- The notion that it is necessary for physicians (primarily oncologists) and other healthcare professionals in this field to be appropriately informed about the potential benefits of CMs is not what follows from the data. The paper shows, however, that the authors of this study are in need to be appropriately informed about EBM as well as CM.
I stumbled across this paper because a homeopath cited it on Twitter claiming that it proves the effectiveness of homeopathy for cancer patients. This fact highlights why such publications are not just annoyingly useless but acutely dangerous. They mislead many cancer patients to opt for bogus treatments. In turn, this demonstrates why it is important to counterbalance such misinformation, critically evaluate it and minimise the risk of patients getting harmed.
Boiron is the world’s largest manufacturer of homeopathic products. The 2016 sales figures of the company amounted to 614 489 000 Euro. Boiron has recently been very active promoting its products, not least on Twitter where I note about 10 of their promotional tweets every day. I saw the following tweet yesterday:
Acidil temporarily relieves occasional heartburn, acid indigestion, bloating or upset stomach. (link: http://bit.ly/2gCARdu)
This prompted me to look up what this product contains. The ingredients (potencies) are as follows:
- Abies nigra (4C)
- Carbo vegetablilis (4C)
- Nux vomica (4C)
- Robinia pseudoacacia (4C)
Just to remind you, 4C means the substance is diluted at a rate of 1: 100 000 000. Even the most deadly poison would be ineffective at such a dilution.
So, how can they claim that it is effective?
To find the answer, I did a Medline search and found the only listed trial of Acidil (if anyone knows of further studies, please let me know). Here is its abstract:
BACKGROUND:
It is unclear whether the benefits that some patients derive from complementary and integrative medicine (CIM) are related to the therapies recommended or to the consultation process as some CIM provider visits are more involved than conventional medical visits. Many patients with gastrointestinal conditions seek out CIM therapies, and prior work has demonstrated that the quality of the patient-provider interaction can improve health outcomes in irritable bowel syndrome, however, the impact of this interaction on gastroesophageal reflux disease (GERD) is unknown. We aimed to assess the safety and feasibility of conducting a 2 x 2 factorial design study preliminarily exploring the impact of the patient-provider interaction, and the effect of an over-the-counter homeopathic product, Acidil, on symptoms and health-related quality of life in subjects with GERD.
METHODS:
24 subjects with GERD-related symptoms were randomized in a 2 x 2 factorial design to receive 1) either a standard visit based on an empathic conventional primary care evaluation or an expanded visit with questions modeled after a CIM consultation and 2) either Acidil or placebo for two weeks. Subjects completed a daily GERD symptom diary and additional measures of symptom severity and health-related quality of life.
RESULTS:
There was no significant difference in GERD symptom severity between the Acidil and placebo groups from baseline to follow-up (p = 0.41), however, subjects who received the expanded visit were significantly more likely to report a 50% or greater improvement in symptom severity compared to subjects who received the standard visit (p = 0.01). Total consultation length, perceived empathy, and baseline beliefs in CIM were not associated with treatment outcomes.
CONCLUSION:
An expanded patient-provider visit resulted in greater GERD symptom improvement than a standard empathic medical visit. CIM consultations may have enhanced placebo effects, and further studies to assess the active components of this visit-based intervention are warranted.
The question I have is simple: why are they allowed to make false medical claims?
Is there anyone out there who can answer it?
Acupuncture is a branch of alternative medicine where pseudo-science abounds. Here is yet another example of this deplorable phenomenon.
This study was conducted to evaluate the efficacy of acupuncture in the management of primary dysmenorrhea.
Sixty females aged 17-23 years were randomly assigned to either a study group or a control group.
- The study group received acupuncture for the duration of 20 minutes/day, for 15 days/month, for the period of 90 days.
- The control group did not receive acupuncture for the same period.
Both groups were assessed on day 1; day 30 and day 60; and day 90. The results showed a significant reduction in all the variables such as the visual analogue scale score for pain, menstrual cramps, headache, dizziness, diarrhoea, faint, mood changes, tiredness, nausea, and vomiting in the study group compared with those in the control group.
The authors concluded that acupuncture could be considered as an effective treatment modality for the management of primary dysmenorrhea.
These findings contradict those of a recent Cochrane review (authored by known acupuncture-proponents) which included 42 RCTs and concluded that there is insufficient evidence to demonstrate whether or not acupuncture or acupressure are effective in treating primary dysmenorrhoea, and for most comparisons no data were available on adverse events. The quality of the evidence was low or very low for all comparisons. The main limitations were risk of bias, poor reporting, inconsistency and risk of publication bias.
The question that I ask myself is this: why do researchers bother to conduct studies that contribute NOTHING to our knowledge and progress? The new study had a no-treatment control group which means it cannot control for the effects of placebo, the extra attention, social desirability etc. In view of the fact that already 42 poor quality trials exist, it is not just useless to add a 43rd but, in my view, it is scandalous! A 43rd useless trial:
- tells us nothing of value;
- misleads the public;
- pollutes the medical literature;
- is a waste of resources;
- undermines the trust in clinical research;
- is deeply unethical.
It is high time to stop such redundant, foolish, wasteful and unethical pseudo-science.
I regularly scan the new publications in alternative medicine hoping that I find some good quality research. And sometimes I do! In such happy moments, I write a post and make sure that I stress the high standard of a paper.
Sadly, such events are rare. Usually, my searches locate a multitude of deplorably poor papers. Most of the time, I ignore them. Sometime, I do write about exemplarily bad science, and often I report about articles that are not just bad but dangerous as well. The following paper falls into this category, I fear.
The aim of this systematic review was to assess the efficacy and safety of herbal medicines for the induction of labor (IOL). The researchers considered experimental and non-experimental studies that compared relevant pregnancy outcomes between users and non-user of herbal medicines for IOL.
A total of 1421 papers were identified and 10 studies, including 5 RCTs met the authors’ inclusion criteria. Papers not published in English were not considered. Three trials were conducted in Iran, two in the USA and one each in South Africa, Israel, Thailand, Australia and Italy.
The quality of the included trial, even of the 5 RCTs, was poor. The results suggest, according to the authors of this paper, that users of herbal medicine – raspberry leaf and castor oil – for IOL were significantly more likely to give birth within 24 hours than non-users. No significant difference in the incidence of caesarean section, assisted vaginal delivery, haemorrhage, meconium-stained liquor and admission to nursery was found between users and non-users of herbal medicines for IOL.
The authors concluded that the findings suggest that herbal medicines for IOL are effective, but there is inconclusive evidence of safety due to lack of good quality data. Thus, the use of herbal medicines for IOL should be avoided until safety issues are clarified. More studies are recommended to establish the safety of herbal medicines.
As I stated above, I am not convinced that this review is any good. It included all sorts of study designs and dismissed papers that were not in English. Surely this approach can only generate a distorted or partial picture. The risks of herbal remedies for mother and baby are not well investigated. In view of the fact that even the 5 RCTs were of poor quality, the first sentence of this conclusion seems most inappropriate.
On the basis of the evidence presented, I feel compelled to urge pregnant women NOT to consent to accept herbal remedies for IOL.
And on the basis of the fact that far too many papers on alternative medicine that emerge every day are not just poor quality but also dangerously mislead the public, I urge publishers, editors, peer-reviewers and researchers to pause and remember that they all have a responsibility. This nonsense has been going on for long enough; it is high time to stop it.
On this blog, I have repeatedly discussed chiropractic research that, on closer examination, turns out to be some deplorable caricature of science. Today, I have another example of what I would call pseudo-research.
This RCT compared short-term treatment (12 weeks) versus long-term management (36 weeks) of back and neck related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE).
Eligible participants were aged 65 and older with back and neck disability for more than 12 weeks. Co-primary outcomes were changes in Oswestry and Neck Disability Index after 36 weeks. An intention to treat approach used linear mixed-model analysis to detect between group differences. Secondary analyses included other self-reported outcomes, adverse events and objective functional measures.
A total of 182 participants were randomized. The short-term and long-term groups demonstrated significant improvements in back and neck disability after 36 weeks, with no difference between groups. The long-term management group experienced greater improvement in neck pain at week 36, self-efficacy at week 36 and 52, functional ability and balance.
The authors concluded that for older adults with chronic back and neck disability, extending management with SMT and SRE from 12 to 36 weeks did not result in any additional important reduction in disability.
What renders this paper particularly fascinating is the fact that its authors include some of the foremost researchers in (and most prominent proponents of) chiropractic today. I therefore find it interesting to critically consider the hypothesis on which this seemingly rigorous study is based.
As far as I can see, it essentially is this:
36 weeks of chiropractic therapy plus exercise leads to better results than 12 weeks of the same treatment.
I find this a most remarkable hypothesis.
Imagine any other form of treatment that is, like SMT, not solidly based on evidence of efficacy. Let’s use a new drug as an example, more precisely a drug for which there is no solid evidence for efficacy or safety. Now let’s assume that the company marketing this drug publishes a trial based on the hypothesis that:
36 weeks of therapy with the new drug plus exercise leads to better results than 12 weeks of the same treatment.
Now let’s assume the authors affiliated with the drug manufacturer concluded from their findings that for patients with chronic back and neck disability, extending drug therapy plus exercise from 12 to 36 weeks did not result in any additional important reduction in disability.
WHAT DO YOU THINK SUCH A TRIAL CAN TELL US?
My answer is ‘next to nothing’.
I think, it merely tells us that
- daft hypotheses lead to daft research,
- even ‘top’ chiropractors have problems with critical thinking,
- SMT might not be the solution to neck and back related disability.
I REST MY CASE.
Twenty years ago (5 years into my post at Exeter), I published this little article (BJGP, Sept 1998). It was meant as a sort of warning – sadly, as far as I can see, it has not been heeded. Oddly, the article is unavailable on Medline, I therefore take the liberty of re-publishing it here without alterations (if I had to re-write it today, I would not change much) or comment:
Once the omnipotent heroes in white, physicians today are at risk of losing the trust of their patients. Medicine, some would say, is in a deep crisis. Shouldn’t we start to worry?
The patient-doctor relationship, it seems, is at the heart of this argument. Many patients are deeply dissatisfied with this aspect of medicine. A recent survey on patients consulting GPs and complementary practitioners in parallel and for the same problem suggested that most patients are markedly more happy with all facets of the therapeutic encounter as offered by complementary practitioners. This could explain the extraordinary rise of complementary medicine during recent years. The neglect of the doctor-patient relationship might be the gap in which complementary treatments build their nest.
Poor relationships could be due to poor communication. Many books have been written about communications skills with patients. But never mind the theory, the practice of all this may be less optimal than we care to believe. Much of this may simply relate to the usage of language. Common terms such as ‘stomach’, ‘palpitations’, ‘lungs’, for instance, are interpreted in different ways by lay and professional people. Words like ‘anxiety’, ‘depression’, and ‘irritability’ are well defined for doctors, while patients view them as more or less interchangeable. At a deeper level, communication also relates to concepts and meanings of disease and illness. For instance, the belief that a ‘blockage of the bowel’ or an ‘imbalance of life forces’ lead to disease is as prevalent with patients as it is alien to doctors. Even on the most obvious level of interaction with patients, physicians tend to fail. Doctors often express themselves unclearly about the nature, aim or treatment schedule of their prescriptions.
Patients want to be understood as whole persons. Yet modern medicine is often seen as emphazising a reductionistic and mechanistic approach, merely treating a symptom or replacing a faulty part, or treating a ‘case’ rather than an individual. In the view of some, modern medicine has become an industrial behemoth shifted from attending the sick to guarding the economic bottom line, putting itself on a collision course with personal doctoring. This has created a deeply felt need which complementary medicine is all too ready to fill. Those who claim to know the reason for a particular complaint (and therefore its ultimate cure) will succeed in satisfying this need. Modern medicine has identified the causes of many diseases while complementary medicine has promoted simplistic (and often wrong) ideas about the genesis of health and disease. The seductive message usually is as follows: treating an illness allopathically is not enough, the disease will simply re-appear in a different guise at a later stage. One has to tackle the question – why the patient has fallen ill in the first place. Cutting off the dry leaves of a plant dying of desiccation won’t help. Only attending the source of the problem, in the way complementary medicine does, by pouring water on to the suffering plant, will secure a cure. This logic is obviously lop-sided and misleading, but it creates trust because it is seen as holistic, it can be understood by even the simplest of minds, and it generates a meaning for the patient’s otherwise meaningless suffering.
Doctors, it is said, treat diseases but patients suffer from illnesses. Disease is something an organ has; illness is something an individual has. An illness has more dimensions than disease. Modern medicine has developed a clear emphasis on the physical side of disease but tends to underrate aspects like the patient’s personality, beliefs and socioeconomic environment. The body/mind dualism is (often unfairly) seen as a doctrine of mainstream medicine. Trust, it seems, will be given to those who adopt a more ‘holistic’ approach without dissecting the body from the mind and spirit.
Empathy is a much neglected aspect in today’s medicine. While it has become less and less important to doctors, it has grown more and more relevant to patients. The literature on empathy is written predominantly by nurses and psychologists. Is the medical profession about to delegate empathy to others? Does modern, scientific medicine lead us to neglect the empathic attitude towards our patients? Many of us are not even sure what empathy means and confuse empathy with sympathy. Sympathy with the patient can be described as a feeling of ‘I want to help you’. Empathy, on these terms, means ‘I am (or could be) you’; it is therefore some sort of an emotional resonance. Empathy has remained somewhat of a white spot on the map of medical science. We should investigate it properly. Re-integrating empathy into our daily practice can be taught and learned. This might help our patients as well as us.
Lack of time is another important cause for patients’ (and doctors’) dissatisfaction. Most patients think that their doctor does not have enough time for them. They also know from experience that complementary medicine offers more time. Consultations with complementary practitioners are appreciated, not least because they may spend one hour or so with each patient. Obviously, in mainstream medicine, we cannot create more time where there is none. But we could at least give our patients the feeling that, during the little time available, we give them all the attention they require.
Other reasons for patients’ frustration lie in the nature of modern medicine and biomedical research. Patients want certainty but statistics provides probabilities at best. Some patients may be irritated to hear of a 70% chance that a given treatment will work; or they feel uncomfortable with the notion that their cholesterol level is associated with a 60% chance of suffering a heart attack within the next decade. Many patients long for reassurance that they will be helped in their suffering. It may be ‘politically correct’ to present patients with probability frequencies of adverse effects and numbers needed to treat, but anybody who (rightly or wrongly) promises certainty will create trust and have a following.
Many patients have become wary of the fact that ‘therapy’ has become synonymous with ‘pharmacotherapy’ and that many drugs are associated with severe adverse reactions. The hope of being treated with ‘side-effect-free’ remedies is a prime motivator for turning to complementary medicine.
Complementary treatments are by no means devoid of adverse reactions, but this fact is rarely reported and therefore largely unknown to patients. Physicians are regularly attacked for being in league with the pharmaceutical industry and the establishment in general. Power and money are said to be gained at the expense of the patient’s well-being. The system almost seems to invite dishonesty. The ‘conspiracy theory’ goes as far as claiming that ‘scientific medicine is destructive, extremely costly and solves nothing. Beware of the octopus’. Spectacular cases could be cited which apparently support it. Orthodox medicine is described as trying to ‘inhibit the development of unorthodox medicine’, in order to enhance its own ‘power, status and income’. Salvation, it is claimed, comes from the alternative movement which represents ‘… the most effective assault yet on scientific biomedicine’. Whether any of this is true or not, it is perceived as the truth by many patients and amounts to a serious criticism of what is happening in mainstream medicine today.
In view of such criticism, strategies for overcoming problems and rectifying misrepresentations are necessary. Mainstream medicine might consider discovering how patients view the origin, significance, and prognosis of the disease. Furthermore, measures should be considered to improve communication with patients. A diagnosis and its treatment have to make sense to the patient as much as to the doctor – if only to enhance adherence to therapy. Both disease and illness must be understood in their socio-economic context. Important decisions, e.g. about treatments, must be based on a consensus between the patient and the doctor. Scientists must get better in promoting their own messages, which could easily be far more attractive, seductive, and convincing than those of pseudo-science.These goals are by no means easy to reach. But if we don’t try, trust and adherence will inevitably deteriorate further. I submit that today’s unprecedented popularity of complementary medicine reflects a poignant criticism of many aspects of modern medicine. We should take it seriously
Even though illegal and unethical, many remedies used in Traditional Chinese Medicine (TCM) still contain animal parts. This fact has long concerned critics. Not only is there no evidence that these ingredients have any positive health effects, they also endanger the survival of endangered species. In the past, China has paid lip service to conservation and evidence. However, even these half-hearted pronouncements seem to be a thing of the past.
China’s State Council is now replacing its 1993 ban on the trade of tiger bones and rhino horn. Horns of rhinos or bones of tigers that were bred in captivity can hence force be used “for medical research or clinical treatment of critical illnesses” under the new rules. The fact that no critical illness responds to either of these remedies seems to matter little. Grave concern has therefore been voiced by the World Wildlife Fund (WWF) over China’s announcement.
“It is deeply concerning that China has reversed its 25 year old tiger bone and rhino horn ban, allowing a trade that will have devastating consequences globally”, said Margaret Kinnaird, WWF Wildlife Practice Leader. “Trade in tiger bone and rhino horn was banned in 1993. The resumption of a legal market for these products is an enormous setback to efforts to protect tigers and rhinos in the wild. China’s experience with the domestic ivory trade has clearly shown the difficulties of trying to control parallel legal and illegal markets for ivory. Not only could this lead to the risk of legal trade providing cover to illegal trade, this policy will also stimulate demand that had otherwise declined since the ban was put in place.”
Both tiger bone and rhino horn were removed from the TCM pharmacopeia in 1993, and the World Federation of Chinese Medicine Societies released a statement in 2010 urging members not to use tiger bone or any other parts from endangered species. Even if restricted to antiques and use in hospitals, the WWF argue, this trade would increase confusion by consumers and law enforcers as to which products are and are not legal, and would likely expand the markets for other tiger and rhino products. “With wild tiger and rhino populations at such low levels and facing numerous threats, legalized trade in their parts is simply too great a gamble for China to take. This decision seems to contradict the leadership China has shown recently in tackling the illegal wildlife trade, including the closure of their domestic ivory market, a game changer for elephants warmly welcomed by the global community,” Kinnaird added.
WWF calls on China to set a clear plan and timeline to close existing captive tiger breeding facilities used for commercial purposes. Such tiger farms pose a high risk to wild tiger conservation by complicating enforcement and increasing demand in tiger products.
China’s announcement comes at the precise moment when we learnt from the 2018 edition of the Living Planet Report that, between 1970 and 2014, there was 60% decline, on average, among 16,700 wildlife populations around the world. The Living Planet report, issued every two years to track global biodiversity, is based on the Living Planet Index, put out every two years since 1998 in collaboration with the Zoological Society of London and based on international databases of wildlife populations. The two previous reports, in 2014 and 2016, found wildlife population declines of 50% and 58%, respectively, since 1970.
The researcher who proves that highly diluted homeopathics work beyond placebo might be in for a Nobel Prize. The scientist who finds a cure for addictions probably also deserves one. The investigator who does both might get two Nobels. The question is, do these Brazilian homeopaths fulfil these criteria?
Their study investigated the effectiveness and tolerability of homeopathic Q-potencies of opium and E. coca in the integrative treatment of cocaine craving in a community-based psychosocial rehabilitation setting. A randomized, double-blind, placebo-controlled, parallel-group, eight-week pilot trial was performed at the Psychosocial Attention Center for Alcohol and Other Drugs (CAPS-AD), Sao Carlos/SP, Brazil. Eligible subjects included CAPS-AD patients between 18 and 65 years of age, with an International Classification of Diseases-10 diagnosis of cocaine dependence. The patients were randomly assigned to two treatment groups: psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca (homeopathy group), and psychosocial rehabilitation plus indistinguishable placebo (placebo group). The main outcome measure was the percentage of cocaine-using days. Secondary measures were the Minnesota Cocaine Craving Scale and 12-Item Short-Form Health Survey scores. Adverse events were recorded in both groups.
The study population comprised 54 patients who attended at least one post-baseline assessment, out of the 104 subjects initially enrolled. The mean percentage of cocaine-using days in the homeopathy group was 18.1% compared to 29.8% in the placebo group (P < 0.01). Analysis of the Minnesota Cocaine Craving Scale scores showed no between-group differences in the intensity of cravings, but results significantly favored homeopathy over placebo in the proportion of weeks without craving episodes and the patients’ appraisal of treatment efficacy for reduction of cravings. Analysis of 12-Item Short-Form Health Survey scores found no significant differences. Few adverse events were reported: 0.57 adverse events/patient in the homeopathy group compared to 0.69 adverse events/patient in the placebo group.
The authors concluded that a psychosocial rehabilitation setting improved recruitment but was not sufficient to decrease dropout frequency among Brazilian cocaine treatment seekers. Psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca were more effective than psychosocial rehabilitation alone in reducing cocaine cravings. Due to high dropout rate and risk of bias, further research is required to confirm our findings, with specific focus on strategies to increase patient retention.
I am glad that the authors mention the high dropout rate which clearly is a serious limitation of this fascinating trial. Had they analysed the data according to an intention to treat analysis – which, I think, would have been a better statistical approach – the results would almost certainly have been negative.
But there are other puzzling issues about this study:
- The authors say they used homeopathic remedies. I think, however, that this is not the case. Homeopathy is defined as a therapy that follows the ‘like cures like’ principle. If the remedy is based on the causative agent, as in the case of the present study, it follows a different principle (identical cures identical) and is not called homeopathy but isopathy (here an explanation from my book: “Isopathy is the use of potentised remedies which are derived from the causative agent of the disease that is being treated. It thus does not follow the supreme law of homeopathy; instead of ‘like cures like’, instead it postulates that identical cures identical. An example of isopathy is the use of potentised grass pollen to treat patients suffering from hay fever. Some of the methodologically best trials that generated a positive result were done using isopathy; they therefore did not test homeopathy and its principal assumption, the ‘like cures like’ theory. They are nevertheless regularly used by proponents of homeopathy to argue that homeopathy is effective”). This means that the above trial does, in fact, NOT test the defining principle of homeopathy.
- Moreover, I fail to understand why the authors called their trial a PILOT study. It does not explore the feasibility of a more definitive trial, but tests the effectiveness of the intervention. It is thus NOT a pilot study.
- I cannot help being suspicious of authors who, based on an extremely implausible, such as homeopathy, publish one paper after the next with positive or encouraging results.
- I am also puzzled by the fact that, in 2012 and 2013, the authors have published two previous studies along the same lines that produced encouraging results. Surely 6/5 years are a long enough period for INDEPENDENT replications to be carried out and published. And surely, a finding like this would have been replicated several times by now.
- I furthermore find it odd that the authors chose to publish their findings in the JOURNAL OF INTEGRATIVE MEDICINE. This is a 3rd class journal read only by those who promote alternative therapies. The notion that a treatment of addiction has finally be found should appear in journals like SCIENCE, NATURE, NEJM, etc.
- Considering the extremely low prior probability of their hypothesis, the authors should perhaps have not used the conventional 5% probability threshold, but one two dimensions lower.
- I have not found a statement regarding informed consent of the study participants.
So, are these Brazilian homeopaths likely to be on the next list of Nobel laureates?
I have my doubts.
What do you think?
Homeopathy for depression? A previous review concluded that the evidence for the effectiveness of homeopathy in depression is limited due to lack of clinical trials of high quality. But that was 13 years ago. Perhaps the evidence has changed?
A new review aimed to assess the efficacy, effectiveness and safety of homeopathy in depression. Eighteen studies assessing homeopathy in depression were included. Two double-blind placebo-controlled trials of homeopathic medicinal products (HMPs) for depression were assessed.
- The first trial (N = 91) with high risk of bias found HMPs were non-inferior to fluoxetine at 4 and 8 weeks.
- The second trial (N = 133), with low risk of bias, found HMPs was comparable to fluoxetine and superior to placebo at 6 weeks.
The remaining research had unclear/high risk of bias. A non-placebo-controlled RCT found standardised treatment by homeopaths comparable to fluvoxamine; a cohort study of patients receiving treatment provided by GPs practising homeopathy reported significantly lower consumption of psychotropic drugs and improved depression; and patient-reported outcomes showed at least moderate improvement in 10 of 12 uncontrolled studies. Fourteen trials provided safety data. All adverse events were mild or moderate, and transient. No evidence suggested treatment was unsafe.
The authors concluded that limited evidence from two placebo-controlled double-blinded trials suggests HMPs might be comparable to antidepressants and superior to placebo in depression, and patients treated by homeopaths report improvement in depression. Overall, the evidence gives a potentially promising risk benefit ratio. There is a need for additional high quality studies.
I beg to differ!
What these data really show amounts to far less than the authors imply:
- The two ‘double-blind’ trials are next to meaningless. As equivalence studies they were far too small to produce meaningful results. Any decent review should discuss this fact in full detail. Moreover, these studies cannot have been double-blind, because the typical adverse-effects of anti-depressants would have ‘de-blinded’ the trial participants. Therefore, these results are almost certainly false-positive.
- The other studies are even less rigorous and therefore do also not allow positive conclusions.
This review was authored by known proponents of homeopathy. It is, in my view, an exercise in promotion rather than a piece of research. I very much doubt that a decent journal with a responsible peer-review system would have ever published such a biased paper – it had to appear in the infamous EUROPEAN JOURNAL OF INTEGRATIVE MEDICINE.
So what?
Who cares? No harm done!
Again, I beg to differ.
Why?
The conclusion that homeopathy has a ‘promising risk/benefit profile’ is frightfully dangerous and irresponsible. If seriously depressed patients follow it, many lives might be lost.
Yet again, we see that poor research has the potential to kill vulnerable individuals.
