Wet cupping is a therapy traditionally used in several cultures. It involves superficial injuries to the skin and subsequently the application of a vacuum cup over the injured site. This procedure would draw a small amount of blood into the cup, and this visible effect was taken as a sign that the humors or life forces or whatever are being restored.
The treatment is obviously painful and carries the risk of infection. But does it work? There are not many clinical trials of this form of alternative medicine, and I was therefore thrilled to find a new paper with a randomised clinical trial.
The aim of this clinical trial was to evaluate the effectiveness and safety of wet cupping therapy as the sole treatment for persistent nonspecific low back pain (PNSLBP). The investigators recruited 80 with PNSLBP lasting at least 3 months and randomly allocated them to an intervention group (n=40) or to a control group (n=40). The experimental group had 6 wet cupping sessions within 2 weeks, each of which were done at two bladder meridian (BL) acupuncture points. The control group had no such treatments. Acetaminophen was allowed as a rescue treatment in both groups. The Numeric Rating Scale (NRS), McGill Present Pain Intensity (PPI), and Oswestry Disability Questionnaire (ODQ) were used as outcome measures. Numbers of acetaminophen tablets taken were compared at 4 weeks from baseline. Adverse events were recorded.
At the end of the intervention, statistically significant differences in all three outcome measures favouring the wet cupping group compared with the control group were seen. These improvements continued for another two weeks after the end of the intervention. Acetaminophen was used less in the wet cupping group, but this difference was not statistically significant. No adverse events were reported.
The authors concluded that wet cupping is potentially effective in reducing pain and improving disability associated with PNSLBP at least for 2 weeks after the end of the wet cupping period. Placebo-controlled trials are needed.
Every now and then – well, actually in alternative medicine this is not so rare an event – I come across a study that ‘smells to high heaven’. This one certainly does; to be precise, it has the stench of TOO GOOD TO BE TRUE.
Apart from the numerous weaknesses of the study design, there is the fact that the results are do simply not seem plausible. Low back pain has a natural history that is well-studied. We therefore know that the majority of cases do get better fairly quickly regardless of whether we treat them or not. In this study, the control group did not improve at all, as shown on the impressive graph below (the grey line depicts the symptoms in the control group and the black one those of the cupping group).
To me, the improvement of the experimental group looks much like one might expect from the natural history of back pain. If this were true, the effect of wet cupping would by close to zero and the conclusion drawn by the authors of this trial would be false-positive.
But why was there no improvement in the control group?
I do not know the answer to this question. All I know is that it is this unexplained phenomenon which has created the impression of effectiveness of wet cupping.
When it comes to alternative medicine, the public relies heavily on the writings of health journalists. We therefore have to count ourselves lucky to have some that are outstanding in their ability to inform the public honestly, objectively and responsibly. Here is an excerpt of what one particularly gifted and ethical heath journalist (and consultant!!!) just published regarding the treatment of babies and kids on a highly visible, popular website:
Homeopathy, or homeopathic medicine, is based on the principle that “like cures like.” Instead of treating an individual’s illness, homeopathy treats individual symptoms with substances from plants and minerals that are highly diluted and “succussed,” or shaken to release energy, said Sara Chana Silverstein, a homeopath, master herbalist and an international board-certified lactation consultant…Although homeopathy isn’t meant to replace Western medicine, it can be a complementary or alternative approach for ailments like colds, the stomach flu and teething. For example, if your pediatrician has diagnosed your baby with an upper respiratory infection, there’s not much you can do other than offer lots of fluids, rest and possibly acetaminophen or ibuprofen. In this case, a homeopathic remedy might help. Plus, since antibiotic overuse and antimicrobial resistance remain a major concern in the U.S., and antibiotics often have side effects, homeopathy could help heal without the need for a prescription. In fact, a study in the journal Homeopathy found that homeopathy for ear infections was just as effective as conventional treatment but patients in the homeopathic group had a faster improvement in symptoms. Although some studies show promising results, more research is needed to determine who homeopathic remedies work best for and in what situations, said Dr. Hilary McClafferty, chair of the American Academy of Pediatrics’ Section on Complementary and Integrative Medicine…
“In the United, States, the homeopathic products that carry the label, HPUS—
Homeopathic Pharmacopeia of the United States— are prepared with a very standardized, procedural monograph. So there is a map and regulations that ensure what’s on the label is what’s in the bottle,” McClafferty said…The only adverse effect of homeopathy, according to Silverstein, is that if a baby consumed a remedy too frequently, such as every hour for 10 hours, they would “prove” the remedy, or create the symptoms the remedy was trying to heal. “But if you gave it to a child 3 times a day at a low dose, personally I do not believe it could injure a child in anyway whatsoever,” she said…Your best bet is to see a trained homeopath who will target individual symptoms and give you pellets in the size that’s appropriate for your child’s age, Silverstein said. The bottom line when it comes to deciding between homeopathy, a medication or another remedy? “You want to be well educated, conservative and in touch with your pediatrician,” McClafferty said.
Julie Revelant is a health journalist and a consultant who provides content marketing and copywriting services for the healthcare industry. She’s also a mom of two. Learn more about Julie at revelantwriting.com.
As I said: outstanding!
With so much sound information about homeopathy and its merits in the treatment of childhood conditions, we are inclined to forgive the few tiny errors and marginally misleading statements that might require corrections such as:
- homeopathy is very much meant as a replacement of conventional medicine by its inventor Hahnemann who was adamant that it must not be combined with other treatments because it is the only true healing art;
- there is no good evidence that homeopathy is anything else than a placebo for children or, indeed, for anyone else;
- the study in the journal ‘Homeopathy’ was lousy and does not allow any conclusions whatsoever about the effectiveness of homeopathy;
- to state “some studies show promising results” is very misleading; the totality of the reliable evidence is negative;
- more research is not needed to determine who benefits from homeopathy; there is no longer a debate about homeopathy within science;
- the label of a typical homeopathic preparation does not tell you what’s in the bottle, at best it tells you what used to be there;
- the main risk of homeopathy is that diseases are not treated effectively; in this way, homeopathy can kill.
Yes, these are but very minor flaws, I know. They should not distract from this journalist’s great achievement of getting her brilliantly informative article read by the widest possible audience. If Prince Charles offered an award for the best science writer of the year (why has he not yet thought of this publicity stunt?), she would certainly be a candidate.
We used to call it ‘alternative medicine’ (on this blog, I still do so, because I believe it is a term as good or bad as any other and it is the one that is easily recognised); later some opted for ‘complementary medicine’; since about 15 years a new term is en vogue: INTEGRATED MEDICINE (IM).
Supporters of IM are adamant that IM is not synonymous with the other terms. But how is IM actually defined?
One of IM’s most prominent defenders is, of course Prince Charles. In his 2006 address to the WHO, he explained: “We need to harness the best of modern science and technology, but not at the expense of losing the best of what complementary approaches have to offer. That is integrated health – it really is that simple.”
Perhaps a bit too simple?
There are several more academic definitions, and it seems that, over the years, IM-fans have been busy moving the goal post quite a bit. The original principle of ‘THE BEST OF BOTH WORLDS’ has been modified considerably.
- IM is a “comprehensive, primary care system that emphasizes wellness and healing of the whole person…” [Arch Intern Med. 2002;162:133-140]
- IM “views patients as whole people with minds and spirits as well as bodies and includes these dimensions into diagnosis and treatment.” [BMJ. 2001; 322:119-120]
During my preparations for my lecture at the 16th European Sceptics Congress in London last week (which was on the subject of IM), I came across a brand-new (September 2015) definition. It can be found on the website of the COLLEGE OF MEDICINE This Michael Dixon-led organisation can be seen as the successor of Charles’ ill-fated FOUNDATION FOR INTEGRATED HEALTH; it was originally to be called COLLEGE FOR INTEGRATED MEDICINE. We can therefore assume that they know best what IM truly is or aspires to be. The definition goes as follows:
IM is a holistic, evidence-based approach which makes intelligent use of all available therapeutic choices to achieve optimal health and resilience for our patients.
This may sound good to many who are not bothered or unable to think critically. It oozes political correctness and might therefore even impress some politicians. But, on closer scrutiny, it turns out to be little more than offensive nonsense. I feel compelled to publish a short analysis of it. I will do this by highlighting and criticising the important implications of this definition one by one.
1) IM is holistic
Holism has always been at the core of any type of good health care. To state that IM is holistic misleads people into believing that conventional medicine is not holistic. It also pretends that medicine might become more holistic through the addition of some alternative modalities. Yet I cannot imagine anything less holistic than diagnosing patients by merely looking at their iris (iridology) or assuming all disease stems from subluxations of the spine (chiropractic), for example. This argument is a straw-man, if there ever was one.
2) IM is evidence-based
This assumption is simply not true. If we look what is being used under the banner of IM, we find no end of treatments that are not supported by good evidence, as well as several for which the evidence is squarely negative.
3) IM is intelligent
If it were not such a serious matter, one could laugh out loud about this claim. Is the implication here that conventional medicine is not intelligent?
4) IM uses all available therapeutic choices
This is the crucial element of this definition which allows IM-proponents to employ anything they like. Do they seriously believe that patients should have ALL AVAILABLE treatments? I had thought that responsible health care is about applying the most effective therapies for the condition at hand.
5) IM aims at achieving optimal health
Another straw-man; it implies that conventional health care professionals do not want to restore their patients to optimal health.
In my lecture, which was not about this definition but about IM in general, I drew the following six conclusions:
- Proponents of IM mislead us with their very own, nonsensical terminology and definitions.
- They promote two main principles: use of quackery + holism.
- Holism is at the heart of all good medicine; IM is at best an unnecessary distraction.
- Using holism to promote quackery is dishonest and counter-productive.
- The integration of quackery will render healthcare not better but worse.
- IM flies in the face of common sense and medical ethics; it is a disservice to patients.
On a blog about alternative medicine, the issue of ‘pseudoscience’ can never be far. Several posts have already focussed specifically on this topic. Recently, I came across an excellent article on homeopathy (which is well worth reading in full). It concluded by listing the techniques commonly used in pseudoscience.
I think this is important and relevant to much of the discussions about alternative medicine. Therefore I take the liberty to cite it here in full. According to the authors of this article,, the techniques are as follows:
- Ignore settled issues in science: We know a great deal about the behavior of water (and evolution, and other contentious topics), but there are many efforts to introduce new science without ever addressing the existing body of knowledge. As such, many of the basic tenets of topics such as homeopathy appear to be ungrounded in reality as we understand it.
- Misapplication of real science: Quantum mechanics is an undeniably successful description of parts of the natural world, but the limitations of its applicability are widely recognized by the scientific community, if not the general public. Pseudoscientists such as homeopaths appear to cynically target this sort of ignorance by applying scientific principles to inappropriate topics.
- Rejection of scientific standards: Over the centuries, science has established standards of evidence and experiment to ensure that data remains consistent and reproducible. But these strengths are presented as weaknesses that make science impervious to new ideas, a stance that is often accompanied by…
- Claims of suppression: Pseudoscience is rejected because it does not conform to the standards held by the scientific community. That community is depicted as a dangerous hegemony that rejects new ideas in order to perpetuate a stifling orthodoxy. This happens in spite of many examples of radical ideas that have rapidly gained not only acceptance, but major prizes, when they were properly supported by scientific evidence.
- A conclusion/evidence gap: Many areas of pseudoscience do not set out to examine a phenomenon but rather have the stated goal of supporting a preordained conclusion. As such, they often engage in excessive logical leaps when the actual data is insufficient to support the desired conclusion.
- Focusing on the fringes: All areas of science have anomalous data and anecdotal findings that are inconsistent with the existing understanding. But those anomalies should not obscure the fact that the vast majority of current data does support the predominant theories. In the hands of a pseudoscientist, these unconnected edge cases are presented as a coherent body of knowledge that supports the replacement of existing understandings.
Perhaps the clearest theme running through many areas of pseudoscience, however, is the attempt to make a whole that is far, far greater than the sum of its parts. Enlarging a collection of terminally-flawed trivia does not somehow strengthen its scientific significance. This is especially true when many of the components of the argument don’t form a coherent whole. For example, quantum entanglement, structured water, and silica are essentially unrelated explanations, and any support for one of them makes no difference to the others. Yet, somehow, presenting them all at once is supposed to make the case for water’s memory harder to dismiss.
END OF QUOTE
Anthroposophic medicine is based on Rudolf Steiner’s mystical ideas. It is popular in Germany and is slowly also spreading to other countries. Anthroposophic drugs are prepared according to ancient notions of alchemy and are fly in the face of modern pharmacology. Anthroposophic doctors treat all sorts of diseases, and their treatments include anthroposophic medications, and a range of other modalities.
A recent paper reported a secondary analysis from an observational study of 529 children with respiratory or ear infections (RTI/OM) <18 years from Europe and the USA. Their caregivers had chosen to consult physicians offering either anthroposophic (A-) or conventional (C-) treatment for RTI/OM.
During the 28-day follow-up antibiotics were prescribed to 5.5% of A-patients and 25.6% of C-patients (P < 0.001); the unadjusted odds ratio for non-prescription in A- versus C-patients was 6.58 (95%-CI 3.45-12.56); after adjustment for demographics and morbidity it was 6.33 (3.17-12.64). Antibiotic prescription rates in recent observational studies with similar patients in similar settings, ranged from 31.0% to 84.1%. Compared to C-patients, A-patients also had much lower use of analgesics, somewhat quicker symptom resolution, and higher caregiver satisfaction. Adverse drug reactions were infrequent (2.3% in both groups) and not serious.
What can we conclude from these data?
Not a lot, I fear!
The authors of the study are a little more optimistic than I; they conclude that this analysis from a prospective observational study under routine primary care conditions showed a very low use of antibiotics and analgesics/antipyretics in children treated for RTI/OM by physicians offering AM therapy, compared to current practice in conventional therapy settings (antibiotics prescribed to 5% versus 26% of A- and C-patients, respectively, during days 0–28; antipyretics prescribed to 3% versus 26%). The AM treatment entailed no safety problem and was not associated with delayed short-term recovery. These differences could not explained by differences in demographics or baseline morbidity. The low antibiotic use is consistent with findings from other studies of paediatric RTI/OM in AM settings.
They are clearly careful to avoid causal inferences; but are they implying them? I would like to know what you think.
Being constantly on the look-out for new, good quality articles on alternative therapy which suggest that a treatment might actually work, I was excited to find not just one or two but four recent publications on an old favourite of mine: massage therapy.
The first paper described a study aimed to investigate the effect of whole body massage on the vital signs, Glasgow Coma Scale (GCS) scores and arterial blood gases (ABG) in trauma ICU patients.
In a randomized, double-blind trial, 108 trauma ICU patients received whole body massage or routine care only. The patients vital signs; systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), pulse rate (PR), Temperature (T), GCS score and ABG parameters were measured in both groups before the intervention and 1 hour and 3 hours after the intervention. The patient in experimental group received full body massage in 45 minute by a family member.
Significant differences were observed between experimental and control groups in SBP 1 hour and 3 hours after intervention, DBP, RR and PR 1 hour after intervention, and GCS 1 hour and 3 hours after intervention. Significant differences were also observed between experimental and control groups in O2 saturation, PH and pO2. No significant differences between experimental and control groups were noted in Temperature, pCO2 and HCO3.
The authors concluded that massage therapy is a safe and effective treatment in intensive care units to reduce patient’s physical and psychological problems. Therefore the use of massage therapy is recommended to clinical practice as a routine method.
The second paper reported a clinical trial on 66 male and female nurses working in intensive care units of Isfahan University of Medical Sciences, Iran.
Patients were randomly divided into experimental and control groups. The Occupational Stress Inventory (OSI) (Osipow and Spokane, 1987) was completed by participants of the two groups before, immediately after, and 2 weeks after the intervention. Swedish massage was performed on participants of the experimental group for 25 min in each session, twice a week for 4 weeks.
Results showed a significant difference in favour of the massage therapy in overall mean occupation stress scores between experimental and control groups two weeks after the intervention.
The authors concluded that it is recommended that massage, as a valuable noninvasive method, be used for nurses in intensive care units to reduce their stress, promote mental health, and prevent the decrease in quality of nursing work life.
The third paper described a randomized controlled trial evaluating the effects of post-operative massage in patients undergoing abdominal colorectal surgery.
One hundred twenty-seven patients were randomized to receive a 20-min massage or social visit and relaxation session on postoperative days 2 and 3. Vital signs and psychological well-being (pain, tension, anxiety, satisfaction with care, relaxation) were assessed before and after each intervention.
Post-operative massage significantly improved the patients’ perception of pain, tension, and anxiety, but overall satisfaction was unchanged.
The authors concluded that massage may be beneficial during postoperative recovery for patients undergoing abdominal colorectal surgery. Further studies are warranted to optimize timing and duration and to determine other benefits in this clinical setting.
The fourth paper reported a systematic review was to evaluate the effectiveness of massage on the short- and long-term outcomes of pre-term infants.
Literature searches were conducted using the PRISMA framework. Validity of included studies was assessed using criteria defined by the Cochrane Collaboration. Assessments were carried out independently by two reviewers with a third reviewer to resolve differences.
Thirty-four studies met the inclusion criteria, 3 were quasi-experimental, 1 was a pilot study, and the remaining 30 were RCTs. The outcomes that could be used in the meta-analysis and found in more than three studies suggested that massage improved daily weight gain by 0.53 g, and resulted in a significant improvement in mental scores by 7.89 points. There were no significant effects on length of hospital stay, caloric intake, or weight at discharge. Other outcomes were not analyzed either because the units of measurement varied between studies, or because means and standard deviations were not provided by the authors. The quality of the studies was variable with methods of randomization and blinding of assessment unclear in 18 of the 34 trials.
The authors concluded that massage therapy could be a comforting measure for infants in the NICU to improve weight gain and enhance mental development. However, the high heterogeneity, the weak quality in some studies, and the lack of a scientific association between massage and developmental outcomes preclude making definite recommendations and highlight the need for further RCTs to contribute to the existing body of knowledge.
I am not saying that these articles are flawless, nor that I agree with all of their conclusion. What I am trying to indicate is that we finally have here an alternative therapy that is promising.
When I worked in Germany and later in Austria, massage was considered to be entirely mainstream. It was only after I had moved to the UK when I realised that, in English-speaking countries, it is mostly considered to be alternative. Perhaps this classification is wrong?
Perhaps we should differentiate according to what type of massage we are talking about. In the realm of alternative medicine – and not just there, I suppose – this seems good advice indeed.
The above papers are about classical massage therapy, but there are some types pf massage which are less than conventional: aura-massage, Marma massage, Indian head massage, shiatsu etc. etc. the list seems endless. These are alternative in more than one sense, and they have one thing in common: there is, as far as I can see, no good evidence to show that they do anything to human health.
My conclusion therefore is that, even with something as common as massage therapy, we need to be careful not to be roped in by the charlatans.
Medical ethics comprise a set of rules and principles which are essential for all aspects of medicine, including of course research. The main issues are:
- Respect for autonomy – patients must have the right to refuse or choose their treatments.
- Beneficence – researchers and clinicians must act in the best interest of the patient.
- Non-maleficence – the expected benefits of interventions must outweigh their risks.
- Justice – the distribution of health resources must be fair.
- Respect for persons – patients must be treated with dignity.
- Truthfulness and honesty – informed consent is an essential element in research and clinical practice.
While all of this has long been fairly standard in conventional health care, it is often neglected in alternative medicine. It is therefore timely to ask, how much of research in the realm of alternative medicine abides by the rules of medical ethics?
After more than two decades of involvement in this sector, I have serious and growing concerns. The subject is, of course complex, but the way I see it, in alternative medicine there are two main areas where medical ethics are violated with some regularity.
- Nonsensical research projects
- Lack of informed consent
NONSENSICAL RESEARCH PROJECTS
At best, nonsensical research is a waste of precious resources, at worst it violates the beneficence principle. In alternative medicine, nonsensical research seems to happen ad nauseam. Regular readers of this blog will have seen plenty of examples of such abuse – for instance, if researchers conduct a clinical trial of chiropractic spinal manipulation for improving the singing voices of choir singers, or homeopaths test whether their remedies enhance female fertility. Often, nonsensical research happens when naïve enthusiasts decide to dabble a bit in science in order to promote their trade – but without realising that research would require a minimum of education.
But there are other occasions when it seems that the investigators know only too well what they are doing. Take for instance the plethora of ‘pragmatic’ trials which are currently so much ‘en vogue’ in alternative medicine. They can be designed in such a way that their results must produce what the researchers intended to show; the ‘A+B versus B’ study design is a prominent and obvious example of this type of abuse which I have repeatedly written about on this blog.
I use the term ‘abuse’ intentionally, because that is precisely what it is, in my view. Nonsensical research abuses the willingness of patients to participate by misleading them that it is a worthwhile sacrifice. In reality it is an unethical attempt to generate findings that can mislead us all. Moreover, it gives science a bad name and can lead to patients’ unwillingness to take part in research that does need doing. The damage done by nonsensical research projects is therefore immeasurable.
Informed consent is essential in research for protecting the interests of the volunteering patients. When a clinical trial is first conceived, the researchers need to work out all the details, write a protocol and submit it to their ethics committee. Their submission has to give evidence that all the participating patients have given informed consent in writing before they are enrolled into the study. That means, they have to be told the essential details about what might happen to them during the trial.
In a placebo-controlled trial of homeopathy, for instance, they might be told that they will receive either a homeopathic remedy or a placebo during the study period. They might also be informed that there is some encouraging evidence that the former works, and that the trial is designed to define to what extend this is so. Generating this knowledge, they might further be told, will help future patients and will be an important contribution to improving health care. Based on such phraseology, the ethics committee is likely to allow the study to go ahead, and patients are likely to agree to take part.
But, of course, this information is less than truthful. An honest and full information for patients would need to include the following points:
- you will receive either a homeopathic remedy or a placebo,
- the former contains no active molecules and the totality of the most reliable evidence does not show that it works for your condition,
- this means that you will receive either a homeopathic or a conventional placebo,
- neither of these can possibly help your condition,
- the study can therefore not advance our knowledge in any way,
- during the trial your condition will remain untreated which is likely to increase your suffering unnecessarily.
If any research team would truthfully disclose this information, no ethics committee would pass their protocol. If by some weird mistake they did, no patients would volunteer to participate in the study.
I have chosen here the example of homeopathy (because most readers will understand it quite easily), but I could have used almost any other alternative treatment. The issues are identical or very similar: informed consent is usually misinformed consent. If it were fully and truthfully informed, it would neither pass the hurdle of the essential ethics approval nor would it lend itself to recruiting sufficiently large numbers of patients.
There are, I think, very serious concerns about the ethical standards in alternative medicine research. I have been banging on about these issues since many years (for instance here and here and here and here). Predictably, this did not find much resonance in the realm of alternative medicine. Regrettably, very few ethicists have so far taken this subject seriously; they seem to feel that these problems are trivial compared to the important issues medical ethics face in conventional health care. I remain unconvinced that this is true and believe it is high time to systematically address the ethics of alternative medicine.
Conventional cough syrups do not have the best of reputations – but the repute of homeopathic cough syrups is certainly not encouraging. So what should one do with such a preparation? Forget about it? No, one conducts a clinical trial, of course! Not just any old trial but one where science, ethics and common sense are absent. Here are the essentials of a truly innovative study that, I think, has all of these remarkable qualities:
The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (−0.52 ± 0.66 in the homeopathic syrup group and −0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020).
Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.
Let us be clear about what has happened here. I think, the events can be summarised as follows:
- the researchers come across a homeopathic syrup (anyone who understands respiratory problems and/or therapeutics would be more than a little suspicious of this product, but this team is exceptional),
- they decide to do a trial with it (a decision which would make some ethicists already quite nervous, but the ethics committee is exceptional too),
- the question raises, what should the researchers give to the control group?
- someone has the idea, why not compare our dodgy syrup against something that is equally dodgy, perhaps even a bit unsafe?
- the researchers are impressed and ask: but what precisely could we use?
- let’s take antibiotics; they are often used for acute coughs, but the best evidence fails to show that they are helpful and they have, of course, risks,
- another member of the team adds: let’s use children, they and their mothers are unlikely to understand what we are up to,
- the team is in agreement,
- Boiron, the world’s largest producer of homeopathic products, accepts to finance the study,
- a protocol is written,
- ethics approval is obtained,
- the trial is conducted and even published by a journal with the help of peer-reviewers who are less than critical.
And the results of the trial? Contrary to the authors’ conclusion copied above, they show that two bogus treatments are worse that one.
BOB’S YOUR UNCLE!
EVERYONE SEEMS HAPPY: THE RESEARCHERS CAN ADD AN ARTICLE TO THEIR PUBLICATION LIST, BOIRON HAS MORE ‘EVIDENCE’ IN FAVOUR OF HOMEOPATHY, AND THE ETHICS COMMITTEE SLEEP JUST AS SOUNDLY AS THE PEER-REVIEWERS.
While my last post was about the risk following some naturopaths’ advice, this one is about the effectiveness of naturopathic treatments. This is a complex subject, not least because naturopaths use a wide range of therapies (as the name implies, they pride themselves of employing all therapeutic means supplied by nature). Some of these interventions are clearly supported by good evidence; for instance, nobody would doubt the effectiveness of a healthy diet or the benefits of regular exercise. But what about all the other treatments naturopaths use? The best approach to find an answer might be to assess not each single therapy but to evaluate the entire package of the naturopathic approach, and not a single study but all such trials.
This is precisely what US researchers have recently done. The purpose of this interesting, new systematic review was to compile and consolidate research that has investigated the whole practice of naturopathic medicine as it is practiced in community settings in order to better assess the quantity and quality of the research, and clinical effect, if any.
In order to get included into the review, studies had to report results from multi-modal treatment delivered by North American naturopathic doctors. The effect size for each study was calculated; no meta-analysis was undertaken.
Fifteen studies met the authors’ inclusion criteria. They covered a wide range of chronic diseases. Most studies had low to medium risks of bias including acknowledged limitations of pragmatic trials. Effect sizes for the primary medical outcomes varied and were statistically significant in 10 out of 13 studies. A quality of life metric was included in all of the RCTs with medium effect size and statistical significance in some subscales.
The authors concluded that previous reports about the lack of evidence or benefit of naturopathic medicine (NM) are inaccurate; a small but compelling body of research exists. Further investigation is warranted into the effectiveness of whole practice NM across a range of health conditions.
This sounds like good news for naturopathy! However, there are several important caveats:
- the authors seem to have only looked at US studies (naturopathy is a European tradition!),
- the searches were done three years ago, and more recent data were thus omitted,
- the authors included all sorts of investigations, even uncontrolled studies; only 6 were RCTs,
- rigorous trials were very scarce; and for each condition, they were even more so,
- the authors mention the PRISMA guidelines for systematic reviews implying that they followed them but, in fact, they did not.
My biggest concern, however, is something else. It relates to the interventions tested in these studies. The authors claim that their results table provides full details on this issue but this is unfortunately not true. All we have by way of an explanation is the authors’ remark that the interventions tested in the studies of their review included diet counseling and nutritional recommendations, specific home exercises and physical activity recommendations, deep breathing techniques or other stress reduction strategies, dietary supplements including vitamins, hydrotherapy, soft-tissue manual techniques, electrical muscle stimulation, and botanical medicines.
Survey data from two US states tell us that the most commonly prescribed naturopathic therapeutics are botanical medicines (51% of visits in Connecticut, 43% in Washington), vitamins (41% and 43%), minerals (35% and 39%), homeopathy (29% and 19%) and allergy treatments (11% and 13%). They also inform us that the mean length of a consultation with an US naturopath is about 40 minutes.
I think, this puts things into perspective. If I advise a patient with diabetes or hypertension or coronary heat disease to follow an appropriate diet, exercise and to adhere to some stress reduction program, if in addition I show empathy and compassion during a 40 minute consultation and make sure that my advise is taken seriously and subsequently adhered to, the outcome is likely to be positive. Naturopaths may elect to call this package of intervention ‘naturopathy’, however, I would call it good conventional medicine.
The problem, I think is clear: good therapeutic advice is effective but it is not naturopathy, and it cannot be used to justify the use of doubtful interventions like homeopathy or all sorts of dodgy supplements. Testing whole treatment packages of this nature can therefore lead to highly misleading results, particularly if the researchers draw unwarranted conclusions about specific schools of health care.
Of all alternative treatments, aromatherapy (i.e. the application of essential oils to the body, usually by gentle massage or simply inhalation) seems to be the most popular. This is perhaps understandable because it certainly is an agreeable form of ‘pampering’ for someone in need of come TLC. But is aromatherapy more than that? Is it truly a ‘THERAPY’?
A recent systematic review was aimed at evaluating the existing data on aromatherapy interventions as a means of improving the quality of sleep. Electronic literature searches were performed to identify relevant studies published between 2000 and August 2013. Randomized controlled and quasi-experimental trials that included aromatherapy for the improvement of sleep quality were considered for inclusion. Of the 245 publications identified, 13 studies met the inclusion criteria, and 12 studies could be used for a meta-analysis.
The meta-analysis of the 12 studies revealed that the use of aromatherapy was effective in improving sleep quality. Subgroup analysis showed that inhalation aromatherapy was more effective than aromatherapy applied via massage.
The authors concluded that readily available aromatherapy treatments appear to be effective and promote sleep. Thus, it is essential to develop specific guidelines for the efficient use of aromatherapy.
Perfect! Let’s all rush out and get some essential oils for inhalation to improve our sleep (remarkably, the results imply that aroma therapists are redundant!).
Not so fast! As I see it, there are several important caveats we might want to consider before spending our money this way:
- Why did this review focus on such a small time-frame? (Systematic reviews should include all the available evidence of a pre-defined quality.)
- The quality of the included studies was often very poor, and therefore the overall conclusion cannot be definitive.
- The effect size of armoatherapy is small. In 2000, we published a similar review and concluded that aromatherapy has a mild, transient anxiolytic effect. Based on a critical assessment of the six studies relating to relaxation, the effects of aromatherapy are probably not strong enough for it to be considered for the treatment of anxiety. The hypothesis that it is effective for any other indication is not supported by the findings of rigorous clinical trials.
- It seems uncertain which essential oil is best suited for this indication.
- Aromatherapy is not always entirely free of risks. Another of our reviews showed that aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.
- There are several effective ways for improving sleep when needed; we need to know how aromatherapy compares to established treatments for that indication.
All in all, I think stronger evidence is required that aromatherapy is more that pampering.