false positive
Recently an interesting article caught my eye. It was published in the official journal of the ‘Deutscher Zentralverein Homoeopathischer Aerzte’ (the professional body of German doctor homeopath which mostly acts as a lobby group). Unfortunately it is in German – but I will try to take you through what I believe to be the most important issue.
The article seems to have the aim to defame Natalie Grams, the homeopath who had the courage to change her mind about homeopathy and to even write a book about her transformation. This book impressed me so much that I wrote a post about it when it was first published. The book did, however, not impress her ex-colleagues. Consequently the book review by the German lobbyists is full of personal attacks and almost devoid of credible facts.
A central claim of the defamatory piece is that, contrary to what she claims in her book, homeopathy is supported by sound evidence. Here is the crucial quote: Meta-Analysen von Kleijnen (1991), Linde (1997), Cucherat (2000) und Mathie (2014) [liefern] allesamt positive Ergebnisse zur Wirksamkeit der Homöopathie… This translates as follows: meta-analyses of Kleijnen, Linde, Cucherat and Matie all provide positive results regarding the effectiveness of homeopathy. As this is a claim, we hear ad nauseam whenever we discuss the issue with homeopathy (in the UK, most homeopathic bodies and even the Queen’s homeopath, P Fisher, have issued very similar statements), it may be worth addressing it once and for all.
- CUCHERAT
This paper was the result of an EU-funded project in which I was involved as well; I therefore know about it first hand. The meta-analysis itself is quite odd in that it simply averages the p-values of all the included studies and thus provides a new overall p-value across all trials. As far as I know, this is not an accepted meta-analytic method and seems rather a lazy way of doing the job. The man on our EU committee was its senior author, professor Boissel, who did certainly not present it to us as a positive result for homeopathy (even Peter Fisher who also was a panel member should be able to confirm this). What is more, the published conclusions are not nearly as positive as out lobbyists seem to think: ‘There is some evidence that homeopathic treatments are more effective than placebo; however, the strength of this evidence is low because of the low methodological quality of the trials. Studies of high methodological quality were more likely to be negative than the lower quality studies. Further high quality studies are needed to confirm these results.’
- LINDE
The meta-analysis by Linde et al seems to be the flag-ship in the homeopathic fleet. For those who don’t know it, here is its abstract in full:
BACKGROUND: Homeopathy seems scientifically implausible, but has widespread use. We aimed to assess whether the clinical effect reported in randomised controlled trials of homeopathic remedies is equivalent to that reported for placebo.
METHODS: We sought studies from computerised bibliographies and contracts with researchers, institutions, manufacturers, individual collectors, homeopathic conference proceedings, and books. We included all languages. Double-blind and/or randomised placebo-controlled trials of clinical conditions were considered. Our review of 185 trials identified 119 that met the inclusion criteria. 89 had adequate data for meta-analysis, and two sets of trial were used to assess reproducibility. Two reviewers assessed study quality with two scales and extracted data for information on clinical condition, homeopathy type, dilution, “remedy”, population, and outcomes.
FINDINGS: The combined odds ratio for the 89 studies entered into the main meta-analysis was 2.45 (95% CI 2.05, 2.93) in favour of homeopathy. The odds ratio for the 26 good-quality studies was 1.66 (1.33, 2.08), and that corrected for publication bias was 1.78 (1.03, 3.10). Four studies on the effects of a single remedy on seasonal allergies had a pooled odds ratio for ocular symptoms at 4 weeks of 2.03 (1.51, 2.74). Five studies on postoperative ileus had a pooled mean effect-size-difference of -0.22 standard deviations (95% CI -0.36, -0.09) for flatus, and -0.18 SDs (-0.33, -0.03) for stool (both p < 0.05).
INTERPRETATION: The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homeopathy is clearly efficacious for any single clinical condition. Further research on homeopathy is warranted provided it is rigorous and systematic.
Again, the conclusions are not nearly as strongly in favour of homeopaths as the German lobby group assumes. Moreover, this paper has been extensively criticised for a wide range of reasons which I shall not have to repeat here. However, one point is often over-looked: this is not an assessment of RCTs, it is an analysis of studies which were double-blind and/or randomised and placebo-controlled. This means that it includes trials that were not randomised and studies that were not double-blind.
But this is just by the way. What seems much more important is the fact that, in response to the plethora of criticism to their article, the same authors published a re-analysis of exactly the same data-set two years later. Having considered the caveats and limitations more carefully, they now concluded that ‘in the study set investigated, there was clear evidence that studies with better methodological quality tended to yield less positive results.’
It is most intriguing to see how homeopaths cite their ‘flagship’ on virtually every possible occasion, while forgetting that a quasi correction has been published which puts the prior conclusions in a very different light !
- KLEIJNEN
The much-cited article by Kleijnen is now far too old to be truly relevant. It includes not even half of the trials available today. But, for what it’s worth, here are Kleijnen’s conclusions: At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials.
If the homeopathy lobby today proclaims that this paper constitutes proof of efficacy, they are in my view deliberately misleading the public.
- MATHIE
The Mathie meta-analysis has been extensively discussed on this blog (see here and here). It is not an overall meta-analysis but merely evaluates the subset of those trials that employed individualised homeopathy. Crucially, it omits the two most rigorous studies which happen to be negative. Its conclusions are as follows: ‘Medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.’
Again, I would suggest that anyone who interprets this as stating that this provides ‘positive results regarding the effectiveness of homeopathy’ is not telling the truth.
MY CONCLUSIONS FROM ALL THIS:
- Some systematic reviews and meta-analyses do indeed suggest that the trial data are positive. However, they all caution that such a result might be false-positive.
- None of these papers provide anything near a proof for the effectiveness of homeopathy.
- Homeopathy has not been shown to be more than a placebo therapy.
- To issue statements to the contrary is dishonest.
Today the GUARDIAN published an article promoting acupuncture on the NHS. The article is offensively misleading, I think, and therefore deserves a comment. I write these comments with a heavy heart, I should add, because the GUARDIAN is by far my favourite UK daily. In the following, I will cite key passages from the article in question and add my comments in bold.
Every woman needing pain relief while giving birth at University College London hospital (UCLH) is offered acupuncture, with around half of the hospital’s midwives specially trained to give the treatment. UCLH is far from typical in this respect, though: acupuncture is not standard throughout the UK and many health practitioners claim patients are often denied access to it through the NHS because of entrenched scepticism from sections of the medical establishment.
Entrenched scepticism? I would say that it could be perhaps be related to the evidence. The conclusions of the current Cochrane review on acupuncture for labour pain are cautious and do not seem strong enough to issue a general recommendation for general use in childbirth: “acupuncture and acupressure may have a role with reducing pain, increasing satisfaction with pain management and reduced use of pharmacological management. However, there is a need for further research.”
“There are conditions for which acupuncture works and others where it doesn’t. It is not a cure-all, and should be open to scrutiny. But the focus of my work is for acupuncture to become a standard part of midwifery training, and at the same time change perceptions among clinicians about its appropriate use for a whole range of other conditions.”
Open to scrutiny indeed! And if we scrutinise the evidence critically – rather than engaging in uncritical and arguably irresponsible promotion – we find that the evidence is not nearly as convincing as acupuncture fans try to make us believe.
The UK lags behind many other European countries in its support for acupuncture. Just 2,500 medical professionals here are qualified to practice it, compared with 45,000 in Germany. The National Institute for Clinical Excellence (Nice) recommends WMA specifically for the treatment of only two conditions – lower back pain (which costs the NHS £1bn a year) and headaches.
Yes, the UK also lags behind Germany in the use of leeches and other quackery. The ‘ad populum’ fallacy is certainly popular in alternative medicine – but surely, it is still a fallacy!
A growing body of healthcare practitioners believe it should be offered routinely for a variety of conditions, including pain in labour, cancer, musculoskeletal conditions and even irritable bowel syndrome (IBS).
Here we go, belief as a substitute for evidence and fallacies as a replacement of logical arguments. I had thought the GUARDIAN was better than this!
At a time of NHS cuts the use of needles at 8p per unit look attractive. In St Albans, where a group of nurse-led clinics have been using acupuncture since 2008 for patients with knee osteoarthritis, economics have been put under scrutiny. WMA was offered to 114 patients rather than a knee replacement costing £5,000, and 79% accepted. Two years later a third of them had not required a knee transplant, representing an annual saving of £100,000, as estimated by researchers to the St Albans local commissioning group.
This looks a bit like a ‘back of an envelope’ analysis. I would like to see this published in a reputable journal and see it scrutinised by a competent health economist.
So why is acupuncture not being used more widely? The difficulty of proving its efficacy is clearly one of the biggest stumbling blocks. An analysis of 29 studies of almost 18,000 patients found acupuncture effective in treating chronic pain compared with sham acupuncture.
This passage refers to an analysis by Vickers et al. It was severely and repeatedly criticised for being too optimistic and, more importantly, it is not nearly as positive as implied here. Its conclusions are in fact quite cautious: “acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.”
But even treatment proponents question whether a randomised controlled trial – the gold standard of medical research – works, given that faking treatment is nearly impossible.
What do you mean ‘even treatment proponents’? It is only proponents who question these sham needles! The reason: they frequently do not generate the results acupuncture fans had hoped for.
MY CONCLUSIONS
The article is clearly not the GUARDIAN’s finest hour. It lacks even a tinge of critical assessment. This is regrettable, I think, particularly as the truth about acupuncture is not that difficult to transmit to the public:
- Much of the research is of woefully poor quality.
- Its effectiveness is not proven beyond doubt for a single condition.
- Serious adverse effects have been reported.
- Because it requires substantial amounts of therapist time, it also is not cheap.
An Indian chain of homeopathic clinics, Dr Batra’s, has just opened its first branch in London. The new website is impressive. It claims homeopathy is effective for the following conditions:
Hair loss? Are they serious? Have they not seen pictures of Samuel Hahnemann?
I decided to look into the psoriasis claim a little closer. This is what they state regarding the homeopathic treatment of psoriasis:
Research-based evidences speak clear and loud of the success of homeopathy in treating psoriasis.
A study published in the Journal of the European Academy of Dermatology and Venereology, a conventional medical Journal, showed that psoriasis patients experienced significant improvement in their quality of life and reduction in their psoriasis symptoms with homeopathy. And this was without any kind of side-effects whatsoever. Of the 82 patients involved in the study that went on for 2 years, many had suffered psoriasis for as long as 15 years and had previously unsuccessfully tried conventional treatments.
At Dr. Batra’s we have successfully treated more than 25,000 cases of psoriasis with homeopathy over the last 35 years. Our safe and scientific solutions have brought smiles to many suffering patients of psoriasis. In fact, a study conducted by A.C. Nielson showed that as compared to general practitioners, specialists and local homeopaths, a higher than average improvement is seen at Dr. Batra’s in treatment of skin ailments.
To the reader who does not look deeper, this may sound fairly convincing. Sadly, it is not. The first study cited above was an uncontrolled trial. Here is its abstract:
Design Prospective multicentre observational study. Objective To evaluate details and effects of homeopathic treatment in patients with psoriasis in usual medical care. Methods Primary care patients were evaluated over 2 years using standardized questionnaires, recording diagnoses and complaints severity, health-related quality of life (QoL), medical history, consultations, all treatments, and use of other health services. Results Forty-five physicians treated 82 adults, 51.2% women, aged 41.6 +/- 12.2 (mean +/- SD) years. Patients had psoriasis for 14.7 +/- 11.9 years; 96.3% had been treated before. Initial case taking took 127 +/- 47 min. The 7.4 +/- 7.4 subsequent consultations (duration: 19.4 +/- 10.5 min) cumulated to 169.0 +/- 138.8 min. Patients received 6.0 +/- 4.9 homeopathic prescriptions. Diagnoses and complaints severity improved markedly with large effect sizes (Cohen’s d= 1.02-2.09). In addition, QoL improved (SF-36 physical component score d = 0.26, mental component score d = 0.49), while conventional treatment and health service use were considerably reduced. Conclusions Under classical homeopathic treatment, patients with psoriasis improved in symptoms and QoL.
It is clear that, due to the lack of a control group, no causal inference can be made between the treatment and the outcome. To claim that otherwise is in my view bogus.
I should mention that there is not a single controlled clinical trial of homeopathy for psoriasis that would support the claim that it is effective.
The second study is not listed in Medline. In fact, the only publication of an author by the name of ‘A C Nielson’ is entitled ‘Are men more intuitive when it comes to eating and physical activity?’. Until I see the evidence, I very much doubt that the study cited above produced strong evidence that homeopathy is an effective cure for psoriasis.
Dr Batra’s chain of clinics boasts to provide the best quality and the highest standards of services that percolate down to all levels in an organisation. Everyone in the institute and those associated with it strive for excellence in whatever they do. Measuring the degree of customer satisfaction was the fundamental concept on which this homeopathic institute’s commitment to become a patient-driven institution was built.
Nice words! SHAME THAT THEY HAVE DECIDED TO DILUTE THEIR TRUTH HOMEOPATHICALLY!
This study created a media storm when it was first published. Several articles in the lay press seemed to advertise it as though a true breakthrough had been made in the treatment of hypertension. I would not be surprised, if many patients consequently threw their anti-hypertensives over board and queued up at their local acupuncturist.
Good for business, no doubt – but would this be a wise decision?
The aim of this clinical trial was to examine effectiveness of electroacupuncture (EA) for reducing systolic blood pressure (SBP) and diastolic blood pressures (DBP) in hypertensive patients. Sixty-five hypertensive patients not receiving medication were assigned randomly to one of two acupuncture intervention. Patients were assessed with 24-hour ambulatory blood pressure monitoring. They were treated by 4 acupuncturists with 30-minutes of EA at PC 5-6+ST 36-37 or LI 6-7+GB 37-39 (control group) once weekly for 8 weeks. Primary outcomes measuring effectiveness of EA were peak and average SBP and DBP. Secondary outcomes examined underlying mechanisms of acupuncture with plasma norepinephrine, renin, and aldosterone before and after 8 weeks of treatment. Outcomes were obtained by blinded evaluators.
After 8 weeks, 33 patients treated with EA at PC 5-6+ST 36-37 had decreased peak and average SBP and DBP, compared with 32 patients treated with EA at LI 6-7+GB 37-39 control acupoints. Changes in blood pressures significantly differed between the two patient groups. In 14 patients, a long-lasting blood pressure–lowering acupuncture effect was observed for an additional 4 weeks of EA at PC 5-6+ST 36-37. After treatment, the plasma concentration of norepinephrine, which was initially elevated, was decreased by 41%; likewise, renin was decreased by 67% and aldosterone by 22%.
The authors concluded that EA at select acupoints reduces blood pressure. Sympathetic and renin-aldosterone systems were likely related to the long-lasting EA actions.
These results are baffling, to say the least; and they contradict a recent meta-analysis which did not find that acupuncture without antihypertensive medications significantly improves blood pressure in those hypertensive patients.
So, who is right and who is wrong here?
Or shall we just look for alternative explanations of the effects observed in the new study?
There could be dozens of reasons for these findings that are unrelated to the alleged effects of acupuncture. For instance, they could be due to life-style changes suggested to the experimental but not the control group, or they might be caused by some other undisclosed bias or confounding. At the very minimum, we should insist on an independent replication of this trial.
It would be silly, I think, to trust these results and now recommend acupuncture to the millions of hypertensive patients worldwide, particularly as dozens of safe, cheap and very effective treatments for hypertension do already exist.
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.
No, this post is not about the pop duo ‘EURYTHMICS’, it is about ‘EURYTHMY’ which pre-dates the pop duo by a few decades.
Eurythmy is a movement therapy of anthroposophic medicine which, according to its proponents, has positive effects on a person’s physical body, spirit, and soul. It is involves expressive movements developed by Rudolf Steiner in conjunction with Marie von Sivers in the early 20th century. It is used as a performance art, in education, especially in Steiner schools, and – as part of anthroposophic medicine – for therapeutic purposes. Here is what one pro-eurymthy website tells us about it:
Eurythmy is one of Rudolf Steiner’s proudest achievements. To better understand what Steiner says about eurythmy, you should read his self-titled “A Lecture on Eurythmy” Not always one to boast, Steiner says:
EURYTHMY has grown up out of the soil of the Anthroposophical Movement, and the history of its origin makes it almost appear to be a gift of the forces of destiny.
Steiner, Rudolf. A Lecture on Eurythmy, 1923
Clearly, Steiner felt that eurythmy was something very special, and of great importance. As such, eurythmy is a tool of Anthroposophy used to reveal and bring about a certain “spiritual impulse” in our age:
Read
OnlineFor it is the task of the Anthroposophical Movement to reveal to our present age that spiritual impulse which is suited to it.I speak in all humility when I say that within the Anthroposophical Movement there is a firm conviction that a spiritual impulse of this kind must now, at the present time, enter once more into human evolution. And this spiritual impulse must perforce, among its other means of expression, embody itself in a new form of art. It will increasingly be realised that this particular form of art has been given to the world in Eurythmy.
Steiner, Rudolf. A Lecture on Eurythmy
The question is, of course, whether as a therapy eurythmy works. A recent publication might give an answer.
The aim of this systematic review was to update and summarize the relevant literature on the effectiveness of eurythmy in a therapeutic context since 2008. It is thus an up-date of a previously published review. This paper found 8 citations which met the inclusion criterion: 4 publications referring to a prospective cohort study without control group (the AMOS study), and 4 articles referring to 2 explorative pre-post studies without control group, 1 prospective, non-randomized comparative study, and 1 descriptive study with a control group. The methodological quality of studies ranged in from poor to good, and in sample size from 5 to 898 patients. In most studies, EYT was used as an add-on, not as a mono-therapy. The studies described positive treatment effects with clinically relevant effect sizes in most cases.
For the up-date, different databases like PubMed, MEDPILOT, Research Gate, The Cochrane Library, DIMDI, Arthe and also the journal databases Der Merkurstab and the European Journal of Integrative Medicine were searched for prospective and retrospective clinical trials in German or English language. There were no limitations for indication, considered outcome or age of participants. Studies were evaluated with regard to their description of the assembly process and treatment, adequate reporting of follow-ups, and equality of comparison groups in controlled trials.
Eleven studies met the inclusion criteria. These included two single-arm, non-controlled pilot studies, two publications on the same non-randomized controlled trial and one case study; six further studies referred to a prospective cohort study, the Anthroposophic Medicine Outcome Study. Most of these studies described positives treatment effects with varying effect sizes. The studies were heterogynous according to the indications, age groups, study design and measured outcome. The methodological quality of the studies varied considerably.
The authors who all come from the Institute of Integrative Medicine, anthroposophical University of Witten/Herdecke in Germany draw the following conclusions: Eurythmy seems to be a beneficial add-on in a therapeutic context that can improve the health conditions of affected persons. More methodologically sound studies are needed to substantiate this positive impression.
I am puzzled! How on earth could they reach this conclusion? There is not a single trial that would allow to establish cause and effect!!! The way I read the evidence from the therapeutic trials included in this and the previous reviews, the only possible conclusion is that EURYTHMY IS A WEIRD THERAPY FOR WHICH THERE IS NOT GOOD EVIDENCE WHATSOEVER.
While my last post was about the risk following some naturopaths’ advice, this one is about the effectiveness of naturopathic treatments. This is a complex subject, not least because naturopaths use a wide range of therapies (as the name implies, they pride themselves of employing all therapeutic means supplied by nature). Some of these interventions are clearly supported by good evidence; for instance, nobody would doubt the effectiveness of a healthy diet or the benefits of regular exercise. But what about all the other treatments naturopaths use? The best approach to find an answer might be to assess not each single therapy but to evaluate the entire package of the naturopathic approach, and not a single study but all such trials.
This is precisely what US researchers have recently done. The purpose of this interesting, new systematic review was to compile and consolidate research that has investigated the whole practice of naturopathic medicine as it is practiced in community settings in order to better assess the quantity and quality of the research, and clinical effect, if any.
In order to get included into the review, studies had to report results from multi-modal treatment delivered by North American naturopathic doctors. The effect size for each study was calculated; no meta-analysis was undertaken.
Fifteen studies met the authors’ inclusion criteria. They covered a wide range of chronic diseases. Most studies had low to medium risks of bias including acknowledged limitations of pragmatic trials. Effect sizes for the primary medical outcomes varied and were statistically significant in 10 out of 13 studies. A quality of life metric was included in all of the RCTs with medium effect size and statistical significance in some subscales.
The authors concluded that previous reports about the lack of evidence or benefit of naturopathic medicine (NM) are inaccurate; a small but compelling body of research exists. Further investigation is warranted into the effectiveness of whole practice NM across a range of health conditions.
This sounds like good news for naturopathy! However, there are several important caveats:
- the authors seem to have only looked at US studies (naturopathy is a European tradition!),
- the searches were done three years ago, and more recent data were thus omitted,
- the authors included all sorts of investigations, even uncontrolled studies; only 6 were RCTs,
- rigorous trials were very scarce; and for each condition, they were even more so,
- the authors mention the PRISMA guidelines for systematic reviews implying that they followed them but, in fact, they did not.
My biggest concern, however, is something else. It relates to the interventions tested in these studies. The authors claim that their results table provides full details on this issue but this is unfortunately not true. All we have by way of an explanation is the authors’ remark that the interventions tested in the studies of their review included diet counseling and nutritional recommendations, specific home exercises and physical activity recommendations, deep breathing techniques or other stress reduction strategies, dietary supplements including vitamins, hydrotherapy, soft-tissue manual techniques, electrical muscle stimulation, and botanical medicines.
Survey data from two US states tell us that the most commonly prescribed naturopathic therapeutics are botanical medicines (51% of visits in Connecticut, 43% in Washington), vitamins (41% and 43%), minerals (35% and 39%), homeopathy (29% and 19%) and allergy treatments (11% and 13%). They also inform us that the mean length of a consultation with an US naturopath is about 40 minutes.
I think, this puts things into perspective. If I advise a patient with diabetes or hypertension or coronary heat disease to follow an appropriate diet, exercise and to adhere to some stress reduction program, if in addition I show empathy and compassion during a 40 minute consultation and make sure that my advise is taken seriously and subsequently adhered to, the outcome is likely to be positive. Naturopaths may elect to call this package of intervention ‘naturopathy’, however, I would call it good conventional medicine.
The problem, I think is clear: good therapeutic advice is effective but it is not naturopathy, and it cannot be used to justify the use of doubtful interventions like homeopathy or all sorts of dodgy supplements. Testing whole treatment packages of this nature can therefore lead to highly misleading results, particularly if the researchers draw unwarranted conclusions about specific schools of health care.
Of all alternative treatments, aromatherapy (i.e. the application of essential oils to the body, usually by gentle massage or simply inhalation) seems to be the most popular. This is perhaps understandable because it certainly is an agreeable form of ‘pampering’ for someone in need of come TLC. But is aromatherapy more than that? Is it truly a ‘THERAPY’?
A recent systematic review was aimed at evaluating the existing data on aromatherapy interventions as a means of improving the quality of sleep. Electronic literature searches were performed to identify relevant studies published between 2000 and August 2013. Randomized controlled and quasi-experimental trials that included aromatherapy for the improvement of sleep quality were considered for inclusion. Of the 245 publications identified, 13 studies met the inclusion criteria, and 12 studies could be used for a meta-analysis.
The meta-analysis of the 12 studies revealed that the use of aromatherapy was effective in improving sleep quality. Subgroup analysis showed that inhalation aromatherapy was more effective than aromatherapy applied via massage.
The authors concluded that readily available aromatherapy treatments appear to be effective and promote sleep. Thus, it is essential to develop specific guidelines for the efficient use of aromatherapy.
Perfect! Let’s all rush out and get some essential oils for inhalation to improve our sleep (remarkably, the results imply that aroma therapists are redundant!).
Not so fast! As I see it, there are several important caveats we might want to consider before spending our money this way:
- Why did this review focus on such a small time-frame? (Systematic reviews should include all the available evidence of a pre-defined quality.)
- The quality of the included studies was often very poor, and therefore the overall conclusion cannot be definitive.
- The effect size of armoatherapy is small. In 2000, we published a similar review and concluded that aromatherapy has a mild, transient anxiolytic effect. Based on a critical assessment of the six studies relating to relaxation, the effects of aromatherapy are probably not strong enough for it to be considered for the treatment of anxiety. The hypothesis that it is effective for any other indication is not supported by the findings of rigorous clinical trials.
- It seems uncertain which essential oil is best suited for this indication.
- Aromatherapy is not always entirely free of risks. Another of our reviews showed that aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.
- There are several effective ways for improving sleep when needed; we need to know how aromatherapy compares to established treatments for that indication.
All in all, I think stronger evidence is required that aromatherapy is more that pampering.
ENOUGH SAID?
When I come across a study with the aim to “examine the effectiveness of acupuncture to relieve symptoms commonly observed in patients in a hospice program” my hopes are high. When I then see that its authors are from the ‘New England School of Acupuncture’, the ‘All Care Hospice and the ‘Tufts University School of Medicine, Boston, my hopes for a good piece of science are even higher. So, let’s see what this new paper has to offer.
A total of 26 patients participated in this acupuncture ‘trial’, receiving a course of weekly treatments that ranged from 1 to 14 weeks. The average number of treatments was five. The Edmonton Symptom Assessment Scale (ESAS) was used to assess the severity of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and dyspnoea. A two-tailed, paired t test was applied to the data to compare symptom scores pre- versus post-acupuncture treatment. Patients enrolled in All Care Hospice’s home care program were given the option to receive acupuncture to supplement usual care offered by the hospice team. Treatment was provided by licensed acupuncturists in the patient’s place of residence.
The results indicated that 7 out of 9 symptoms were significantly improved with acupuncture, the exceptions being drowsiness and appetite. Although the ESAS scale demonstrated a reduction in symptom severity post-treatment for both drowsiness and appetite, this reduction was not found to be significant.
At tis stage, I have lost most of my hopes for good science. This is not a ‘trial’ but a glorified case-series. There is no way that the stated aim can be pursued with this type of methodology. There is no reason whatsoever to assume that the observed outcome can be attributed to acupuncture; the additional attention given to these patients is but one of several factors that are quite sufficient to explain their symptomatic improvements.
This is yet another disappointment then from the plethora of ‘research’ into alternative medicine that, on closer inspection, turns out to be little more than thinly disguised promotion of quackery. These days, I can bear such disappointments quite well – after all, I had many years to get used to them. What I find more difficult to endure is the anger that overcomes me when I read the authors’ conclusion: Acupuncture was found to be effective for the reduction and relief of symptoms that commonly affect patient QOL. Acupuncture effectively reduced symptoms of pain, tiredness, nausea, depression, anxiety, and shortness of breath, and enhanced feelings of well-being. More research is required to assess the long-term benefits and symptom reduction of acupuncture in a palliative care setting.
This is not disappointing; in my view, this is scientific misconduct by
- the authors,
- the institutions employing the authors,
- the ethics committee that has passed the ‘research’,
- the sponsors of the ‘research’,
- the peer-reviewers of the paper,
- the journal and its editors responsible for publishing this paper.
The fact that this sort of thing happens virtually every day in the realm of alternative medicine does not render this case less scandalous, it merely makes it more upsetting.
