evidence
Alternative medicine (AM) use has become popular among patients with cancer. I find this very easy to understand: faced with such a grave diagnosis, who would not be tempted to try everything that is being promoted as being helpful. And, by Jove, promoted it is! But does it do any good?
The evidence clearly shows that no form of AM is capable of changing the natural history of any form of cancer. This means the millions of websites that imply otherwise are criminally wrong and frightfully dangerous.
But some AMs might still be useful, namely for improving symptoms, well-being and quality of life (QOL) as supportive or palliative therapies. Unfortunately the evidence for this assumption is less sound than AM fans try to make us believe. Before this background, better research is needed and more trials would be welcome. A brand-new paper might tell us more.
The purposes of this study were to compare the QOL in CAM users and non-CAM users and to determine whether AM use influences QOL among breast cancer patients during chemotherapy.
A cross-sectional survey was conducted at two outpatient chemotherapy centers. A total of 546 patients completed the questionnaires on AM use. QOL was evaluated based on the European Organization for Research and Treatment of Cancer (EORTC) core quality of life (QLQ-C30) and breast cancer-specific quality of life (QLQ-BR23) questionnaires.
A total of 70.7% of patients were identified as AM users. There was no significant difference in global health status scores and in all 5 subscales of the QLQ C30 functional scales between AM users and non-AM users. On the QLQ-C30 symptom scales, AM users (44.96±3.89) had significantly (p = 0.01) higher mean scores for financial difficulties than non-AM users (36.29±4.81). On the QLQ-BR23 functional scales, AM users reported significantly higher mean scores for sexual enjoyment (6.01±12.84 vs. 4.64±12.76, p = 0.04) than non-AM users. On the QLQ-BR23 symptom scales, AM users reported higher systemic therapy side effects (41.34±2.01 vs. 37.22±2.48, p = 0.04) and breast symptoms (15.76±2.13 vs. 11.08±2.62, p = 0.02) than non-AM users. Multivariate logistic regression analysis indicated that the use of CAM modality was not significantly associated with higher global health status scores (p = 0.71).
The authors drew the following conclusions: While the findings indicated that there was no significant difference between users and non-users of AM in terms of QOL, AM may be used by health professionals as a surrogate to monitor patients with higher systemic therapy side effects and breast symptoms. Furthermore, given that AM users reported higher financial burdens (which may have contributed to increased distress), patients should be encouraged to discuss the potential benefits and/or disadvantages of using AM with their healthcare providers.
One needs to caution, of course, that this was not an RCT, and therefore cause and effect cannot be taken for granted. Nevertheless, I believe, that these findings should make us think critically about the wide-spread notion that the supportive and palliative use of AM leads to an improvement of QOL in cancer patients.
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.
Regular readers of this blog will be aware of the many bogus claims made by chiropractors. One claim, however, namely the one postulating chiropractors can effectively treat low back pain with spinal manipulation, is rarely viewed as being bogus. Chiropractors are usually able to produce evidence that does suggest the claim to be true, and therefore even most critics of chiropractic back off on this particular issue.
But is the claim really true?
A recent trial might provide the answer.
The purpose of this study was to compare the effectiveness of chiropractic spinal manipulative therapy (cSMT) to a sham intervention on pain (Visual Analogue Scale, SF-36 pain subscale), disability (Oswestry Disability Index), and physical function (SF-36 subscale, Timed Up and Go) by performing a randomized placebo-controlled trial at 2 Veteran Affairs Clinics.
Older veterans (≥ 65 years of age) who were naive to chiropractic were recruited. A total of 136 who suffered from chronic low back pain (LBP) were included in the study – with 69 being randomly assigned to cSMT and 67 to the sham intervention. Patients were treated twice per week for 4 weeks. The outcomes were assessed at baseline, 5, and 12 weeks post baseline.
Both groups demonstrated significant decrease in pain and disability at 5 and 12 weeks. At 12 weeks, there was no significant difference in pain and a statistically significant decline in disability scores in the cSMT group when compared to the control group. There were no significant differences in adverse events between the groups.
The authors concluded that cSMT did not result in greater improvement in pain when compared to our sham intervention; however, cSMT did demonstrate a slightly greater improvement in disability at 12 weeks. The fact that patients in both groups showed improvements suggests the presence of a nonspecific therapeutic effect.
Hold on, I hear you say, this does not mean that cSMT is a placebo in the treatment of LBP! There are other studies that yield positive results. Let’s not cherry-pick our evidence!
Absolutely correct! To avoid cherry-picking, lets see what the current Cochrane review tells us about cSMT and chronic LBP. Here is the conclusion of this review based on 26 RCTs: High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain.
Convinced?
This article is hilarious, I think. It was written by Heike Bishop, a homeopath who works in Australia. Here she tries to advise colleagues how best to defend homeopathy and how to deal effectively with the increasingly outspoken criticism of homeopathy. Below is the decisive passage from her article; I have not changed or omitted a word, not even her grammatical or other mistakes [only the numbers in brackets were inserted by me; they refer to my comments added below]:
Getting up in the morning and hearing that all the television and radio station report that it is dangerous for people to see their homoeopath, is utterly heart breaking. Even more so because I grew up in East Germany where the government suppressed free speech and anything that was off the beaten path [1]. So what can we do in times like these?
First of all, watch out for Government inquiries. History has shown that they are usually not favourable towards homoeopathy [2] unless you live in Switzerland [3]. It is vitally important in times like these to put differences aside amongst our professional peers. Every association should be mobilised to take an active and ONGOING role to educate and advertise the benefits of homoeopathy [4]. If things have gone too far already, talk about freedom of choice [5]. Write articles and join blogs talking about what you can do specifically for certain conditions [6]. Encourage your patients to tell their success stories in blogs and other social media forums [7]. It is in most cases utterly useless to engage in any conversation [8] online with trolls [9].
Try to develop a calloused skin when it comes to criticism. Your patients don’t want to hear how difficult it is to be a homeopath [10], they want you to be in control and to be reassured that their treatment continues [11]. When someone asks you to comment on an attack on homoeopathy, put your best smile on and state how threatened the pharmaceutical industry must be to resort to such tactics [12].
Staphysagria is indeed a good remedy. Hahnemann also knew its benefits and even alternated it with Arsenicum the day his first wife died and he got a letter that the hospital built in his name allowed patients to choose their treatment between allopathy and homoeopathy [13]. That was the only time he took two remedies on the same day! [14]
Find out what you can about your country’s own internet trolls [15]. However, don’t underestimate their effectiveness in swaying popular opinion [16]. There is no denying that their methods are very effective [17]. It doesn’t matter how ludicrous their comments are, don’t go into direct explanation [18]. Learn from the enemy [19] and repeat a positive message over and over again so it can’t be contorted [20].
Our colleges should support post-graduate studies featuring marketing and media courses [21]. I once met a Homoeopath from the UK and she pointed out that part of the training in the UK is for students to hold homoeopathic first aid courses to promote homoeopathy [22]. Everyone is different – some of us are happy to stand in front of an audience others choose the pen as their sword [23]. The main thing is to do something to save the image of our healing art [24].
- Is she implying that facing criticism of homeopathy is akin to living in a totalitarian state? Or that criticism is a violation of free speech?
- I wonder why this is so – nothing to do with the evidence, I presume?
- Does she refer to the famous ‘Swiss Government report’ which was not by the Swiss Government at all?
- ‘Advertise and educate’ seems to be homeopathic speak for ‘MISLEAD’
- Good idea! Freedom of choice is a perfect argument (in this case, my choice would be to have a bottle of champagne at around 6 pm every day – on the NHS, of course).
- Certain conditions??? And I thought homeopaths do not treat conditions, only whole people.
- And forbid them to disclose stories where things did not work out quite so well?
- Very wise! Conversations are fraught with the danger of being found wrong.
- Critics are not critics but ‘trolls’ – makes sense.
- I would have thought that practising as a homeopath is not difficult at all – in most countries, they don’t even check whether you can spell the name correctly.
- Is it not rather the homeopath who wants the treatment to continue – after all, it is her livelihood?
- Ah yes, BIG PHARMA, the last resort of any quack!
- Did she not just praise patient choice as an important virtue?
- Hahnemann was famously cantankerous and argumentative all his life; does that mean that his remedies did not work?
- Homeopaths might need that for your ad hominem attacks.
- Never underestimate the power of truth!!!
- This might show that it is you and not the ‘trolls’ who are ludicrous.
- Particularly as there are no direct explanations for homeopathy.
- First the critics were ‘trolls’, now they have been upgraded to ‘enemy’! Is it really a war?
- You need to repeat it at least regularly so that eventually you believe it yourself.
- Are marketing and media a substitute for evidence?
- Really, first aid? Do homeopaths know what this is? Obviously not!
- But real clinicians, homeopaths call them allopaths, are quite happy simply with effective treatments that help patients to improve.
- And I thought the main thing was to treat patients with the most effective therapies available.
ENOUGH JOKING AND SARCASM!
There is, of course, a very serious message in all of this: when under pressure, homeopaths seem to think of all sorts of things in their (and homeopathy’s) defense – some more rational than others – but the ideas that criticism might be a good way to generate progress, and that a factual debate about the known facts might improve healthcare, do not seem to be amongst them.
The BMJ is my favourite medical journal by far; I think it is full of good science as well as entertaining to read, and I look forward to finding it in my letter box every Friday. It is thus hard for me to criticise the BMJ, and this is not made easier by the fact that I am the author of one of the two pieces in question. However, the current ‘HEAD TO HEAD’ entitled ‘SHOULD DOCTORS RECOMMEND HOMEOPATHY’ does, in my view, not mark the finest hour of this journal. Let me explain why.
The first question that arises is whether homeopathy is a good subject for such a debate. As several commentators have pointed out, it is not – the debate has long been closed; to serious scientists and many doctors, homeopathy tends to be a subject that is nothing more than an odd, obsolete triviality that does not even deserve a mention in the BMJ or any other serious publication. In a way, this notion has almost been proven wrong by the high level of interest the subject quickly generated. So, I will not dwell on this point any longer.
The second issue that arises just from nothing more than merely reading the title of the debate is that the question posed is imprecise. ‘Homeopathy’ is too broad a term for a focussed discussion; it includes amongst other phenomena empathetic encounters, remedies with material doses of highly active ingredients (e.g. Arsenic D1) and remedies that contain absolutely nothing at all (any ‘potency’ beyond C12). In my piece, I tried to make it clear that I speak mostly about ultra-molecular dilutions. This is less obvious in Peter Fisher’s article, and there is doubtlessly a lot of confusion in the debate as well as the comments that follow.
The two articles had to be written without either author knowing the text of the other. Consequently the issues raised by one author were not necessarily addressed by the other. This is somewhat frustrating, as it fails to clarify issues that could easily have been dealt with. In a previous post, I have already explained that the peer-review process of the two articles was seriously flawed. It failed to correct the many misleading statements in Fisher’s piece, as Alan Henness has pointed out in his response both in the BMJ and on this blog. In fact, reading Fisher’s article, I fail to find a single passage that is not factually wrong or highly misleading (the accompanying podcast is even worse, in my view). To me it is obvious that the debate about homeopathy cannot advance, if one side continues to behave in this fashion.
Homeopaths are very adept at recruiting ‘grass roots’ for public relation activities. We know this from various previous experiences. It was therefore predictable that this would swiftly get organised also in this instance. I happen to know from more than one source that there was a highly active campaign by homeopaths trying to persuade their supporters to post responses on the BMJ site and to vote on the BMJ straw poll (scientists, by contrast, know that such polls are silly gadgets and tend to view homeopathy as a triviality that is not worth the effort). In this way, they try to generate the impression that the majority of the public stands firmly behind homeopathy and want doctors to recommend it. It does not need too much to realise that popularity is not a measure of efficacy. Homeopaths, however, tend to relish logical fallacies and therefore will rejoice at such nonsense and celebrate it as their very own victory.
So, was this ‘HEAD TO HEAD’ a mistake? Should I have refused to participate? With hindsight, perhaps. My main reason for accepting was that, had I declined the offer, someone else would have written the piece (there are plenty of excellent scientists who could do an excellent job at this). As sure as hell, that person would subsequently gotten attacked for not ever having researched and/or practiced homeopathy (in the podcast, Fisher even tried to undermine my authority by pointing out that 1) I have not worked as a clinician for decades and 2) I have no NHS contract). I think I may be one of the few critics of homeopathy who cannot possibly be accused of not knowing enough about homeopathy to discuss the subject.
My hope is that, because the BMJ is such an excellent journal, the two articles will survive the current hoo-hah and some people will read them carefully, look up and study the references, analyse all this critically and weigh the arguments responsibly. Then they must be able to discern the fiction from the facts. And in this case, perhaps it was worth it after all.
The ‘Homeopathy Action Trust’ (HAT) is a charity that claims to encourage and support public understanding of homeopathy. They believe that homeopathy is invaluable to many people and plays an important role in maintaining their health and wellbeing. The HAT advocates that patients have a right to choose homeopathic treatments and access to it on the NHS or privately. Many of HAT’s projects are about promoting to use of homeopathy in Africa, for instance, where they advocate homeopathy as a treatment for all sorts of serious diseases.
Recently HAT embarked on another project: a campaign against the current Wiki-page on homeopathy which HAT believes to be biased against homeopathy. Thus they issued a ‘position statement’ on their website. Here is a short paragraph from that statement which I find worthy of a comment (the numbers were inserted by me and refer to my comments below; otherwise the text in bold is by HAT):
We acknowledge that the scientific evidence in support of Homeopathy remains inconclusive (1), but it is by no means definitively negative (2) and there is in fact an active and growing field of research worldwide (3). We acknowledge that the mechanism of action of homeopathic remedies is unknown (4) – as it is for some conventional medicines – but this does not preclude their usage in clinical situations (5). We welcome honest and open-minded debate (6) about Homeopathy and fully support the call for high quality (7), appropriately designed research studies (8) into the effectiveness of homeopathy as it is practised by both medical and professional homeopaths (9).
- The evidence is not ‘inconclusive’ but the most reliable evidence fails to convincingly show efficacy (see here, for instance).
- In healthcare, we do not focus on the question whether the evidence for anything is ‘definitely negative’, but we base our decisions on the question whether or not the evidence is positive. In other words, we use those treatments that are backed up with positive evidence and not those where this is in serious doubt.
- The research activity in homeopathy has been in decline for some time; this can easily be verified by searching Medline.
- No, we know that there cannot be a mechanism of action that is in line with the laws of nature.
- If such therapies are used in conventional healthcare, it is because they are (contrary to homeopathy) supported by sufficiently strong clinical evidence.
- So far, this ‘position statement’ is neither honest nor open-minded, in my view.
- More research seems unnecessary, perhaps even unethical, and most research in this area is not of high quality.
- ‘Appropriately designed’ sounds frightfully suspicious to me, because homeopaths tend to see any trial that fails to confirm their bizarre notions as ‘not appropriately designed’.
- ‘Professional homeopath’ is a term designed to mislead the public; lay homeopaths would be more to the point, I think.
I just came across a website that promised to”cover 5 common misconceptions about alternative medicine that many people have”. As much of this blog is about this very issue, I was fascinated. Here are Dr Cohen’s 5 points in full:
5 Misconceptions about Alternative Medicine Today
1. Alternative Medicine Is Only an Alternative
In fact, many alternative practitioners are also medical doctors, chiropractors, or other trained medical professionals. Others work closely with MDs to coordinate care. Patients should always let all of their health care providers know about treatments that they receive from all the others.
2. Holistic Medicine Isn’t Mainstream
In fact, scientists and doctors do perform studies on all sorts of alternative therapies to determine their effectiveness. These therapies, like acupuncture and an improved diet, pass the test of science and then get integrated into standard medical practices.
3. Natural Doctors Don’t Use Conventional Medicine
No credible natural doctor will ever tell a patient to replace prescribed medication without consulting with his or her original doctor. In many cases, the MD and natural practitioner are the same person. If not, they will coordinate treatment to benefit the health of the patient.
4. Alternative Medicine Doesn’t Work
Actual licensed health providers won’t just suggest natural therapies on a whim. They will consider scientific studies and their own experience to suggest therapies that do work. Countless studies have, for example, confirmed that acupuncture is an effective treatment for many medical conditions. Also, the right dietary changes are known to help improve health and even minimize or cure some diseases. Numerous other alternative therapies have been proven effective using scientific studies.
5. Big Medical Institutions are Against Alternative Medicine
According to a recent survey, about half of big insurers pay for tested alternative therapies like acupuncture. Also, hospitals and doctors do recognize that lifestyle changes, some herbal remedies, and other kinds of alternative medicine may reduce side effects, allow patients to reduce prescription medicine, and even lower medical bills.
This is not to say that every insurer, doctor, or hospital will support a particular treatment. However, patients are beginning to take more control of their health care. If their own providers won’t suggest natural remedies, it might be a good idea to find one who does.
The Best Medicine Combines Conventional and Alternative Medicine
Everyone needs to find the right health care providers to enjoy the safest and most natural care possible. Good natural health providers will have a solid education in their field. Nobody should just abandon their medical treatment to pursue alternative cures. However, seeking alternative therapies may help many people reduce their reliance on harsh medications by following the advice of alternative providers and coordinating their care with all of their health care providers.
END OF COHEN’S TEXT
COMMENT BY MYSELF
Who the Dickens is Dr Cohen and what is his background? I asked myself after reading this. From his website, it seems that he is a chiropractor from North Carolina – not just any old chiro, but one of the best!!! – who also uses several other dubious therapies. He sums up his ‘philosophy’ as follows:
There is an energy or life force that created us (all 70 trillion cells that we are made of) from two cells (sperm and egg cells). This energy or innate intelligence continues to support you throughout life and allows you to grow, develop, heal, and express your every potential. This life force coordinates all cells, tissues, muscles and organs by sending specific, moment by moment communication via the nervous system. If the nervous system is over-stressed or interfered with in any way, then your life force messages will not be properly expressed.
Here he is on the cover of some magazine and here is also his ‘PAIN CLINIC’
Fascinating stuff, I am sure you agree.
As I do not want to risk a libel case, I will abstain from commenting on Dr Cohen and his methods or beliefs. Instead I will try to clear up a few misconceptions that are pertinent to him and the many other practitioners who are promoting pure BS via the Internet.
- Not everyone who uses the title ‘Dr’ is a doctor in the sense of having studied medicine.
- Chiropractors are not ‘trained medical professionals’.
- The concepts of ‘vitalism’, ‘life force’ etc. have been abandoned in real heath care a long time ago, and medicine has improved hugely because of this.
- Hardly any alternative therapy has ‘passed the test of science’.
- Therefore, it is very doubtful whether alternative practitioners actually will ‘consider scientific studies’.
- True, some trials did suggest that acupuncture is an effective treatment for many medical conditions; but their methodological quality is often far too low to draw firm conclusions and many other, often better studies have shown the contrary.
- Numerous other alternative therapies have been proven ineffective using scientific studies.
- Therefore it might be a good idea to find a health care provider who does not offer unproven treatments simply to make a fast buck.
- Seeking alternative therapies may harm many people.
Dear Professor Robinson,
please forgive me for writing to you in a matter that, you might think, is really none of my business. I have been following the news and discussions about the BLACKMORE CHAIR at your university. Having been a professor of complementary medicine at Exeter for ~20 years and having published more papers on this subject than anyone else on the planet, I am naturally interested and would like to express some concerns, if you allow me to.
With my background, I would probably be the last person to argue that a research chair in alternative medicine is not a good and much-needed thing. However, accepting an endowment from a commercially interested source is, as you are well aware, a highly problematic matter.
I am confident that you intend to keep the sponsor at arm’s length and plan to appoint a true scientist to this post who will not engage in the promotional activities which the alternative medicine scene might be expecting. And I am equally sure that the money will be put to good use resulting in good and fully independent science.
But, even if all of this is the case, there are important problems to consider. By accepting Blackmore’s money, you have, perhaps inadvertently, given credit to a commercially driven business empire. As you probably know, Blackmores have a reputation of being ‘a bit on the cavalier side’ when it comes to rules and regulations. This is evidenced, for instance, by the number of complaints that have been upheld against them by the Australian authorities.
For these reasons, the creation of the new chair is not just a step towards generating research, it could (and almost inevitably will) be seen as a boost for quackery. It is foremost this aspect which might endanger the reputation of your university, I am afraid.
My own experience over the last two decades has taught me to be cautious and sceptical regarding the motives of many involved in the multi-billion alternative medicine business. I have recently published my memoir entitled ‘A SCIENTIST IN WONDERLAND. SEARCHING FOR TRUTH AND FINDING TROUBLE’; it might be a helpful read for you and the new professor.
I hope you take my remarks as they were meant: constructive advice from someone who had to learn it all the hard way. If I can be of further assistance, please do not hesitate to ask me.
Sincerely
Edzard Ernst
The purpose of this study was to evaluate the impact of early and guideline adherent physical therapy for low back pain on utilization and costs within the Military Health System (MHS).
Patients presenting to a primary care setting with a new complaint of LBP from January 1, 2007 to December 31, 2009 were identified from the MHS Management Analysis and Reporting Tool. Descriptive statistics, utilization, and costs were examined on the basis of timing of referral to physical therapy and adherence to practice guidelines over a 2-year period. Utilization outcomes (advanced imaging, lumbar injections or surgery, and opioid use) were compared using adjusted odds ratios with 99% confidence intervals. Total LBP-related health care costs over the 2-year follow-up were compared using linear regression models.
753,450 eligible patients with a primary care visit for LBP between 18-60 years of age were considered. Physical therapy was utilized by 16.3% (n = 122,723) of patients, with 24.0% (n = 17,175) of those receiving early physical therapy that was adherent to recommendations for active treatment. Early referral to guideline adherent physical therapy was associated with significantly lower utilization for all outcomes and 60% lower total LBP-related costs.
The authors concluded that the potential for cost savings in the MHS from early guideline adherent physical therapy may be substantial. These results also extend the findings from similar studies in civilian settings by demonstrating an association between early guideline adherent care and utilization and costs in a single payer health system. Future research is necessary to examine which patients with LBP benefit early physical therapy and determine strategies for providing early guideline adherent care.
These are certainly interesting data. Because LBP is such a common condition, it costs us all dearly. Measures to reduce this burden in suffering and expense are urgently needed. The question is whether early referral to a physiotherapist is such a measure. The present data show that this is possible but they do not prove it.
I applaud the authors for realising this point and discussing it at length: The results of this study should be examined in light of the following limitations. Given the favorable natural history of LBP, many patients improve regardless of treatment. Those referred to physical therapy early are also more likely to have a shorter duration of pain, thus the potential for selection bias to have influenced these results. We accounted for a number of co-morbidities available in the data set and excluded patients with prior visits for LBP to mitigate against this possibility. However, the retrospective observational design of this study imposes limitations on extending the associations we observed to causation. Although we attempted to exclude patients with a specific spinal pathology, it is possible that a few patients may have been inadvertently included in the data set, in which case advanced imaging may be indicated. Additionally, although our results support that early physical therapy which adheres to practice guidelines may be less resource intense, we cannot conclude without patient-centered clinical outcomes (i.e., pain, function, disability, satisfaction, etc.) that the care was more cost effective. Further, it may be that the standard we used to judge adherence to practice guidelines (CPT codes) was not sufficiently sensitive to determine whether care is consistent with clinical practice guidelines. We also did not account for indirect or out-of-pocket costs for treatments such as complementary care, which is common for LBP. However, it is likely that the observed effects on total costs would have been even larger had these costs been considered.
I was originally alerted to this paper through a tweet claiming that these results demonstrate that chiropractic has an important role in LBP. However, the study does not even imply such a conclusion. It is, of course, true that many chiropractors use physical therapies. But they do not have the same training as physiotherapists and they tend to use spinal manipulations far more frequently. Virtually every LBP-patient consulting a chiropractor would be treated with spinal manipulations. As this approach is neither based on sound evidence nor free of risks, the conclusion, in my view, cannot be to see chiropractors for LBP; it must be to consult a physiotherapist.
The FDA just made the following significant announcement:
The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.
Date
April 20-21, 2015
Time
9:00 am to 4:00 pm
Location
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (Great Room)
Silver Spring, Maryland 20993
Attendance, Registration, and Oral Presentations
Registration is free and available on a first-come, first-served basis. If you wish to attend or make an oral presentation, please reference section III of the forthcoming Federal Register Notice (Attendance and/or Participation in the Public Hearing) for information on how to register and the deadline for registration.
Webcast Information
If you cannot attend in person, information about how you can access a live Webcast will be located at Homeopathic Product Regulation
Agenda
The agenda will be posted soon
And this is what Reuters reported about the planned event:
The hearing, scheduled for April 20-21, will discuss prescription drugs, biological products, and over-the-counter drugs labeled homeopathic, a market that has expanded to become a multimillion dollar industry in the United States. The agency is set to evaluate its regulatory framework for homeopathic products after a quarter century. (http://1.usa.gov/1Hxwup3) An Australian government study released this month concluded that homeopathy does not work. (http://bit.ly/1BheAmR) The FDA issued a warning earlier this month asking consumers not to rely on asthma products labeled homeopathic that are sold over the counter. (http://1.usa.gov/1EEuKrC) Homeopathic medicines include pellets placed under the tongue, tablets, liquids, ointments, sprays and creams. The basic principles of homeopathy, formulated by German physician Samuel Hahnemann in the late 18th century, are based on a theory that a disease can be treated using small doses of natural substances that in a healthy person would produce symptoms of the disease. The agenda for the hearing will be posted soon, the FDA said on Tuesday.
In my view, this is an important occasion for experts believing in evidence to make their position regarding homeopathy heard. I therefore encourage all my readers who have an evidence-based opinion on homeopathy to submit it to the hearing.
