If we believe homeopaths, we might get the impression that homeopathy is firmly established in mainstream health care. “They would say that, wouldn’t they?” To convince skeptics, we might want to have a bit more than wishful thinking.
We have just published a systematic review in order to instill some evidence into this debate. Our aim was to evaluate all the data from recent surveys of GPs and assess their involvement with and attitudes towards homeopathy. We searched 7 electronic databases to identify all relevant articles. Data extraction was conducted by three independent reviewers. Thirteen surveys met the inclusion criteria. Their findings suggest that less than 10% of GPs treated patients with homeopathy; referral rates varied hugely and ranged from 4.6% to 73%.
Two surveys also assessed GPs’ endorsement of homeopathy; they suggested that less than 15% of GPs were endorsing homeopathy. One survey asked about GPs’ personal usage of homeopathy and reported less than 10% had used this form of therapy on themselves.
Three surveys investigated adverse events (AEs) from homeopathic treatments. One was solely focussed on AEs which were classified as “serious” (either life threatening or likely to cause disability or sever morbidity) or non-serious. In total, 21 “indirect” serious AEs were reported (e.g., stopping medication, refusing immunisation, refusing cancer treatment, delaying diagnosis). Another survey found that 14% of GPs reported AEs following homeopathic treatment within a year. Other authors reported that the discontinuation of conventional asthma treatment in favour of a homeopathic remedy had led to cardiovascular arrest.
These data shed a much more sober light on the use of homeopathy in the UK. They fail to show that homeopathy is well-accepted by British GPs. More importantly perhaps they disclose serious problems with the use of homeopathy.
Whenever we consider alternative medicine, we think of therapeutic interventions and tend to forget that alternative practitioners frequently employ diagnostic methods which are alien to mainstream health care. Acupuncturists, iridologists, spiritual healers, massage therapists, reflexologists, applied kinesiologists, homeopaths, chiropractors, osteopaths and many other types of alternative practitioners all have their very own ways of diagnosing what might be wrong with their patients.
The purpose of a diagnostic test or technique is, of course, to establish the presence or absence of an abnormality, condition or disease. Conventional doctors use all sorts of validated diagnostic methods, from physical examination to laboratory tests, from blood pressure measurements to X-rays. Alternative practitioners use mostly alternative methods for arriving at a diagnosis, and we should ask: how reliable are these techniques?
Anyone trying to answer this question, will be surprised to find how very little reliable information on this topic exists. Scientific tests of the validity of alternative diagnostic tests are a bit like gold dust. And this is why a recently published article is, in my view, of particular importance and value.
The aim of this study was to evaluate the inter-rater reliability of pulse-diagnosis as performed by Traditional Korean Medicine (TKM) clinicians. A total 658 patients with stroke who were admitted into Korean oriental medical university hospitals were included. Each patient was seen by two TKM-experts for an examination of the pulse signs – pulse diagnosis is regularly used by practitioners of TKM and Traditional Chinese Medicine (TCM), and is entirely different from what conventional doctors do when they feel the pulse of a patient. Inter-observer reliability was assessed using three methods: simple percentage agreement, the kappa value, and the AC(1) statistic. The kappa value indicated that the inter-observer reliability in evaluating the pulse signs ranged from poor to moderate, whereas the AC(1) analysis suggested that agreement between the two experts was generally high (with the exception of ‘slippery pulse’). The kappa value indicated that the inter-observer reliability was generally moderate to good (with the exceptions of ‘rough pulse’ and ‘sunken pulse’) and that the AC(1) measure of agreement between the two experts was generally high.
Based on these findings, the authors drew the following conclusion: “Pulse diagnosis is regarded as one of the most important procedures in TKM… This study reveals that the inter-observer reliability in making a pulse diagnosis in stroke patients is not particularly high when objectively quantified. Additional research is needed to help reduce this lack of reliability for various portions of the pulse diagnosis.”
This indicates, I think, that the researchers (who are themselves practitioners of TCM!) are not impressed with the inter-rater reliability of the most commonly used diagnostic tool in TCM/TKM. Imagine this to be true for a commonly used test in conventional medicine; imagine, for instance, that one doctor measuring your blood pressure produces entirely different readings than the next one. Hardly acceptable, don’t you think?
And, of course, inter-rater reliability would be only one of several preconditions for their diagnostic methods to be valid. Other essential preconditions for diagnostic tests to be of value are their specificity and their sensitivity; do they discriminate between healthy and unhealthy, and are they capable of differentiating between severely abnormal findings and those that are just a little out of the normal range?
Until we have answers to all the open questions about each specific alternative diagnostic method, it would be unwise to pretend these tests are valid. Imagine a doctor prescribing a life-long anti-hypertensive therapy on the basis of a blood pressure reading that is little more than guess-work!
Since non-validated diagnostic tests can generate both false positive and false negative results, the danger of using them should not be under-estimated. In a way, invalid diagnostic tests are akin to bogus bomb-detectors (which made headlines recently): both are techniques to identify a problem. If the method generates a false positive result, an alert will be issued in vain, people will get anxious for nothing, time and money will be lost, etc. If the method generates a false negative result, we will assume to be safe while, in fact, we are not. In extreme cases, such an error will cost lives.
It is difficult to call those ‘experts’ who advocate using such tests anything else than irresponsible, I’d say. And it is even more difficult to have any confidence in the treatments that might be administered on the basis of such diagnostic methods, wouldn’t you agree?
I think I must have mentioned this once or twice before: I am constantly on the look-out for new evidence which shows or suggests that some form of alternative medicine works. Today, it seems, I have been lucky.
In this randomised, double-blind, placebo-controlled clinical trial, 200 patients suffering from chronic obstructive pulmonary disease (COPD) were randomly allocated to receive oral therapy with 3 × 30 drops/day of an extract of Pelargonium sidoides (EPs 7630) or placebo. Both treatments were administered in addition to standardised COPD- therapies, and the treatment period lasted 24 weeks. The primary endpoint of this study was the time to the next exacerbation of COPD. Secondary endpoints were the number of such exacerbations, consumption of antibiotics, quality of life, patient satisfaction, inability to work, and the tolerability of the treatment.
The results show that the median time to exacerbation was significantly prolonged with the herbal treatment compared to placebo (57 versus 43 days). The superiority of EPs 7630 over placebo was also confirmed in secondary endpoints, e.g., fewer exacerbations, less patients with antibiotic use, improved quality of life, higher patient satisfaction, and less days of inability to work. The incidence of minor gastrointestinal adverse events was higher in the EPs 7630 group.
The authors of the study conclude that “the results demonstrate a statistically significant and clinically relevant superiority of add-on therapy with EPs 7630 over placebo and a good long-term tolerability in the treatment of moderate to severe COPD. EPs 7630 prolonged time to exacerbations and reduced exacerbation frequency and antibiotic use.”
Chronic obstructive pulmonary disease, is a progressive and serious condition linked to smoking which makes breathing increasingly difficult. The symptoms of COPD typically include a productive cough, wheezing, shortness of breath and chest tightness. Long-term exposure to other lung irritants—such as air pollution, chemical fumes, or dust may contribute to COPD. The condition is a major cause of disability, and currently it is the third leading cause of death, which means that millions of people suffer from COPD.
There is no cure for COPD; the damage to the airways and lungs is not reversible. Various symptomatic treatments exist, for instance, antibiotics, bronchio-dilators, steroids and physiotherapy. Lifestyle changes can further improve the situation, help patients to stay more active, and slow the progress of the disease.
It is clear that COPD is a very serious condition, that the burden of suffering for individual patients can be immense, that therapeutic options are limited and often associated with adverse-effects. In this situation, any new effective and safe therapy would be more than welcome. Pelargonium has previously shown promise in the treatment of asthma, acute bronchitis as well as other respiratory infections. It seems generally safe but is not totally devoid of adverse-effects.
This new study gives hope to COPD-sufferers as it suggests that Pelargonium sidoides might alleviate their symptoms. The trial seems rigorous but the benefit is not huge and the treatment is not a cure of COPD. Moreover, I should point out that any new finding of this nature requires independent confirmations. I do think that the trial is an important step in the right direction, yet I feel that it is too early for issuing general recommendations.
This post has an odd title and addresses an odd subject. I am sure some people reading it will ask themselves “has he finally gone potty; is he a bit xenophobic, chauvinistic, or what?” I can assure you none of the above is the case.
Since many years, I have been asked to peer-review Chinese systematic reviews and meta-analyses of TCM-trials submitted to various journals and to the Cochrane Collaboration for publication, and I estimate that around 300 such articles are available today. Initially, I thought they were a valuable contribution to our knowledge, particularly for the many of us who cannot read Chinese languages. I hoped they might provide reliable information about this huge and potentially important section of the TCM-evidence. After doing this type of work for some time, I became more and more frustrated; now I have decided not to accept this task any longer – not because it is too much trouble, but because I have come to the conclusion that these articles are far less helpful than I had once assumed; in fact, I now fear that they are counter-productive.
In order to better understand what I mean, it might be best to use an example; this recent systematic review seems as good for that purpose as any.
Its Chinese authors “hypothesized that the eligible trials would provide evidence of the effect of Chinese herbs on bone mineral density (BMD) and the therapeutic benefits of Chinese medicine treatment in patients with bone loss“. Randomized controlled trials (RCTs) were thus retrieved for a systematic review from Medline and 8 Chinese databases. The authors identified 12 RCTs involving a total of 1816 patients. The studies compared Chinese herbs with placebo or standard anti-osteoporotic therapy. The pooled data from these RCTs showed that the change of BMD in the spine was more pronounced with Chinese herbs compared to the effects noted with placebo. Also, in the femoral neck, Chinese herbs generated significantly higher increments of BMD compared to placebo. Compared to conventional anti-osteoporotic drugs, Chinese herbs generated greater BMD changes.
In their abstract, the part on the paper that most readers access, the authors reached the following conclusions: “Our results demonstrated that Chinese herb significantly increased lumbar spine BMD as compared to the placebo or other standard anti-osteoporotic drugs.” In the article itself, we find this more detailed conclusion: “We conclude that Chinese herbs substantially increased BMD of the lumbar spine compared to placebo or anti-osteoporotic drugs as indicated in the current clinical reports on osteoporosis treatment. Long term of Chinese herbs over 12 months of treatment duration may increase BMD in the hip more effectively. However, further studies are needed to corroborate the positive effect of increasing the duration of Chinese herbs on outcome as the results in this analysis are based on indirect comparisons. To date there are no studies available that compare Chinese herbs, Chinese herbs plus anti-osteoporotic drugs, and anti-osteoporotic drug versus placebo in a factorial design. Consequently, we are unable to draw any conclusions on the possible superiority of Chinese herbs plus anti-osteoporotic drug versus anti-osteoporotic drug or Chinese herb alone in the context of BMD.“
Most readers will feel that this evidence is quite impressive and amazingly solid; they might therefore advocate routinely using Chinese herbs for the common and difficult to treat problem of osteoporosis. The integration of TCM might avoid lots of human suffering, prolong the life of many elderly patients, and save us all a lot of money. Why then am I not at all convinced?
The first thing to notice is the fact that we do not really know which of the ~7000 different Chinese herbs should be used. The article tells us surprisingly little about this crucial point. And even, if we manage to study this question in more depth, we are bound to get thoroughly confused; there are simply too many herbal mixtures and patent medicines to easily identify the most promising candidates.
The second and more important hurdle to making sense of these data is the fact that most of the primary studies originate from inaccessible Chinese journals and were published in Chinese languages which, of course, few people in the West can understand. This is entirely our fault, some might argue, but it does mean that we have to believe the authors, take their words at face value, and cannot check the original data. You may think this is fine, after all, the paper has gone through a rigorous peer-review process where it has been thoroughly checked by several top experts in the field. This, however, is a fallacy; like you and me, the peer-reviewers might not read Chinese either! (I don’t, and I reviewed quite a few of these papers; in some instances, I even asked for translations of the originals to do the job properly but this request was understandably turned down) In all likelihood, the above paper and most similar articles have not been properly peer-reviewed at all.
The third and perhaps most crucial point can only be fully appreciated, if we were able to access and understand the primary studies; it relates to the quality of the original RCTs summarised in such systematic reviews. The abstract of the present paper tells us nothing at all about this issue. In the paper, however, we do find a formal assessment of the studies’ risk of bias which shows that the quality of the included RCTs was poor to very poor. We also find a short but revealing sentence: “The reports of all trials mentioned randomization, but only seven described the method of randomization.” This remark is much more significant than it may seem: we have shown that such studies use such terminology in a rather adventurous way; reviewing about 2000 of these allegedly randomised trials, we found that many Chinese authors call a trial “randomised” even in the absence of a control group (one cannot randomise patients and have no control group)! They seem to like the term because it is fashionable and makes publication of their work easier. We thus have good reason to fear that some/many/most of the studies were not RCTs at all.
The fourth issue that needs mentioning is the fact that very close to 100% of all Chinese TCM-trials report positive findings. This means that either TCM is effective for every indication it is tested for (most unlikely, not least because there are many negative non-Chinese trials of TCM), or there is something very fundamentally wrong with Chinese research into TCM. Over the years, I have had several Chinese co-workers in my team and was invariably impressed by their ability to work hard and efficiently; we often discussed the possible reasons for the extraordinary phenomenon of 0% negative Chinese trials. The most plausible answer they offered was this: it would be most impolite for a Chinese researcher to produce findings which contradict the opinion of his/her peers.
In view of these concerns, can we trust the conclusions of such systematic reviews? I don’t think so – and this is why I have problems with research of this nature. If there are good reasons to doubt their conclusions, these reviews might misinform us systematically, they might not further but hinder progress, and they might send us up the garden path. This could well be in the commercial interest of the Chinese multi-billion dollar TCM-industry, but it would certainly not be in the interest of patients and good health care.
I happen to be convinced that safety issues related to alternative medicine are important - very important, in fact. Therefore I will continue to report on recent publications addressing them – even at the risk of irritating a few of my readers. And here is such a recent publication:
This review, a sequel to one published 10 years ago, is an evaluation of the number and the severity of adverse events (AEs) reported after acupuncture, moxibustion, and cupping between 2000 and 2011. Relevant English-language reports in 6 databases were identified and assessed by two reviewers; no Asian databases were searched and no articles were included which were in languages other than English. 117 reports of 308 AEs from 25 countries and regions were associated with acupuncture (294 cases), moxibustion (4 cases), or cupping (10 cases). Three patients died after receiving acupuncture.
A total of 239 of infections associated with acupuncture were reported in 17 countries and regions. Korea reported 162 cases, Canada 33, Hong Kong 7, Australia 8, Japan 5, Taiwan 5, UK 4, USA 6, Spain 1, Ireland 1, France 1, Malaysia 1, Croatia 1, Scotland 1, Venezuela 1, Brazil 1, and Thailand 1. Of 38 organ or tissue injuries, 13 were pneumothoraxes; 9 were central nerve system injuries; 4 were peripheral nerve injuries; 5 were heart injuries; 7 were other injuries. These cases originated from 10 countries: 10 from South Korea, 6 from the USA, 6 from Taiwan, 5 from Japan, 3 from the UK, 2 from Germany, 2 from Hong Kong, 1 from Austria, 1 from Iran, 1 from Singapore, and 1 from New Zealand.
The authors concluded “although serious AEs associated with acupuncture are rare, acupuncture practice is not risk-free. Adequate regulation can even further minimize any risk. We recommend that not only adequate training in biomedical knowledge, such as anatomy and microbiology, but also safe and clean practice guidelines are necessary requirements and should continue to be enforced in countries such as the United States where they exist, and that countries without such guidelines should consider developing them in order to minimize acupuncture AEs.”
When I last wrote about the risks of acupuncture, I discussed a Chinese paper reporting 1038 cases of serious adverse events, including 35 fatalities. I was keen to point out that, due to under-reporting, this might just be the tip of a much bigger iceberg. Subsequently, my inbox was full with hate-mail, and comments such as this one appeared on the blog: “This is tiresome old stuff, and we have to wonder what’s wrong with Ernst that he still peddles his dubious arguments.”
I suspect that I will see similar reactions to this post. It probably does not avert the anger to point out that the authors of the new article are, in fact, proponents of acupuncture. Neither will it cool the temper of acupuncture-fans to stress that the new paper completely ignored the Chinese literature as well as articles not published in English; this means that the 1038 Chinese cases (and an unknown amount published in other languages; after all, there might be a lot of published material in Japanese, Korean or other Asian languages) would need adding to the published 308 cases summarised in the new article; and this, in turn, means that the numbers provided here are not even nearly complete. And finally, my re-publishing the conclusions from my previous post is unlikely to apease many acupuncture-enthusiasts either:
True, these are almost certainly rare events – but we have no good idea how rare they are. There is no adverse event reporting scheme in acupuncture, and the published cases are surely only the tip of the ice-berg. True, most other medical treatments carry much greater risks! And true, we need to have the right perspective in all of this!
So let’s put this in a reasonable perspective: with most other treatments, we know how effective they are. We can thus estimate whether the risks outweigh the benefit, and if we find that they do, we should (and usually do) stop using them. I am not at all sure that we can perform similar assessments in the case of acupuncture.
Having previously criticised the abundance of mostly rather meaningless surveys in alternative medicine, I now should perhaps admit to having published my fair share of such investigations. The most recent one was only just published.
The aim of this survey was to conduct a follow-up of a previous, identical investigation and to thus ascertain changes in usage, referral rate, beliefs and attitudes towards alternative medicine during the last decade. A questionnaire was posted in 2009 to all GPs registered with the Liverpool Primary Care Trust asking them whether they treat, refer, endorse or discuss eight common alternative therapies and about their views on National Health Service (NHS) funding, effectiveness, training needs and theoretical validity of each therapy. Comparisons were made between these results and those collected 10 years ago.
The response rate was unfortunately low (32%) compared with the 1999 survey (52%). The main findings were similar as 10 years before: the most popular therapies were still acupuncture, hypnotherapy and chiropractic and the least popular were aromatherapy, reflexology and medical herbalism. GPs felt most comfortable with acupuncture and had greater belief in its theoretical validity, a stronger desire for training in acupuncture and more support for acupuncture to receive NHS funding than for the other alternative therapies. Opinions about homeopathy had become less supportive during the last 10 years. Overall, GPs were less likely to endorse alternative treatments than previously shown (38% versus 19%).
I think these findings speak for themselves. They suggest that British GPs have become more skeptical about alternative medicine in general and about homeopathy in particular. It would, of course, be interesting to know why this is so. Unfortunately we are merely able to speculate here: might it be the increasingly obvious lack of evidence and biological plausibility that matter? As a rationalist, I would hope this to be true but our data do not allow any firm conclusion.
Speaking about the data, I have to admit that they are rather soft. This was just a very small survey in one specific part of the UK. More importantly, the flaws in our investigation are fairly obvious. The most important limitation probably is the low response rate. It may be caused by a general ‘survey-fatigue’ that many GPs suffer from. Whatever the reason, it severely limits the usefulness of our paper.
So why publish the survey at all then? The answer is simple: we certainly do already have an abundance of surveys, but we have a dearth of longitudinal data. Because we employed the same methodology as 10 years ago, this investigation does provide a unique insight into what might have been happening over time – albeit with more than just a pinch of salt.
Some national and international guidelines advise physicians to use spinal manipulation for patients suffering from acute (and chronic) low back pain. Many experts have been concerned about the validity of this advice. Now an up-date of the Cochrane review on this subject seems to provide clarity on this rather important matter.
Its aim was to assess the effectiveness of spinal manipulative therapy (SMT) as a treatment of acute low back pain. Randomized controlled trials (RCTs) testing manipulation/mobilization in adults with low back pain of less than 6-weeks duration were included. The primary outcome measures were pain, functional status and perceived recovery. Secondary endpoints were return-to-work and quality of life. Two authors independently conducted the study selection, risk of bias assessment and data extraction. The effects were examined for SMT versus inert interventions, sham SMT, other interventions, and for SMT as an adjunct to other forms of treatment.
The researchers identified 20 RCTs with a total number of 2674 participants, 12 (60%) RCTs had not been included in the previous version of this review. Only 6 of the 20 studies had a low risk of bias. For pain and functional status, there was low- to very low-quality evidence suggesting no difference in effectiveness of SMT compared with inert interventions, sham SMT or as adjunct therapy. There was varying quality of evidence suggesting no difference in effectiveness of SMT compared with other interventions. Data were sparse for recovery, return-to-work, quality of life, and costs of care.
The authors draw the following conclusion: “SMT is no more effective for acute low back pain than inert interventions, sham SMT or as adjunct therapy. SMT also seems to be no better than other recommended therapies. Our evaluation is limited by the few numbers of studies; therefore, future research is likely to have an important impact on these estimates. Future RCTs should examine specific subgroups and include an economic evaluation.”
In other words, guidelines that recommend SMT for acute low back pain are not based on the current best evidence. But perhaps the situation is different for chronic low back pain? The current Cochrane review of 26 RCTs is equally negative: “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. Determining cost-effectiveness of care has high priority. Further research is likely to have an important impact on our confidence in the estimate of effect in relation to inert interventions and sham SMT, and data related to recovery.”
This clearly begs the question why many of the current guidelines seem to mislead us. I am not sure I know the answer to this one; however I suspect that the panels writing the guidelines might have been dominated by chiropractors and osteopaths or their supporters who have not exactly made a name for themselves for being impartial. Whatever the reason, I think it is time for a re-think and for up-dating guidelines which are out of date and misleading.
Similarly, it might be time to question for what conditions chiropractors and osteopaths, the two professions who use spinal manipulation/mobilisation most, do actually offer anything of real value at all. Back pain and SMT are clearly their domains; if it turns out that SMT is not evidence-based for back pain, what is left? There is no good evidence for anything else, as far as I can see. To make matters worse, there are quite undeniable risks associated with SMT. The conclusion of such considerations is, I fear, obvious: the value of and need for these two professions should be re-assessed.
Evidence-based medicine (EBM) is a tool which enables health care professionals to optimize the chances for patients to be treated according to ethically, legally and medically accepted standards. Many proponents of alternative medicine used to reject the principles of EBM, not least because there is precious little good evidence from reliable clinical trials to support their treatments. In recent years, however, some alternative practitioners have stopped trying to swim against the tide.
They have discreetly changed their tune claiming that they do, in fact, practice EBM. Their argument usually holds that EBM represents much more than just data from clinical trials and that they actually do abide by the rules of EBM when treating their patients. The former claim is correct but the latter is not.
In order to explain why, we ought to first define our terminology. During recent years, several descriptions of EBM have become available. According to David Sackett, who was part of the McMaster group that coined the term, EBM is “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical experience with the best available external clinical evidence from systematic research”. As proposed by Sackett, the practice of EBM rests on the following three pillars:
- External Evidence- clinically relevant and reliable research mostly from clinical investigations into the efficacy and safety of therapeutic interventions – in other words clinical trials and systematic reviews. In a previous blog-post, I have elaborated on the question what evidence means.
- Clinical Expertise- the ability to use clinical skills to identify each patient’s unique health state, diagnosis and risks as well as his/her chances to benefit from the available therapeutic options.
- Patient Values- the individual preferences, concerns and expectations of the patient which are important in order to meet the patient’s needs.
So, how can a homeopath treating a patient with migraine, a chiropractor manipulating a child with asthma, or an acupuncturist needling a consumer for smoking cessation claim to practice EBM? The best available external evidence shows that neither of these therapies is effective. In fact, it even suggests that these options are ineffective for the above-named indications.
Using the first example of the homeopath, the scenario goes something like this: a homeopath believes in the ability of homeopathy and has the clinical expertise in it (he probably has clinical expertise in nothing else but homeopathy). His patient’s preference is very clearly with homeopathy (otherwise, she would not have consulted him). It follows that the homeopath does embrace two pillars of EBM. As to the third pillar – external evidence – he is adamant that clinical trials cannot do justice to something as holistic, subtle, individualized etc. Therefore he refuses to recognize the trial data as conclusive and rather trusts his experience which might be substantial.
I am sure that this line of arguing can convince some people; it certainly seems to appear compelling to those alternative practitioners who claim to practice EBM. However, I cannot agree with them.
The reason is simple: the practice of EBM must rest on three pillars, and each one of those three pillars is essential; we cannot just pick the ones we happen to like and drop the ones which we find award, we need them all.
We might be generous and grant that the homeopath’s pseudo-EBM argument outlined above suggests that his practice rests on two of the three pillars. However, the third one is absent and has been replaced by a bizarre imitation. To pretend that external evidence can be substituted by something else is erroneous and introduces double standards which are not acceptable – not because this would be against some bloodless principles of nit-picking academics, but because it would not be in the best interest of the patient. And, after all, the primary concern of EBM has to be the patient.
Many cancer patients will suffer from severe, debilitating fatigue during the course of their illness. The exact cause of this common symptom is not entirely clear. Most likely it is due to a combination of the cancer and the treatments used to cure it. Managing cancer-related fatigue (CRF) is thus an important part of the palliative and supportive care of cancer patients. Acupuncture is often advocated for this purpose and many centres use it routinely. The question therefore is, does it work?
The most recent trial on this subject was aimed at assessing the effectiveness of maintenance acupuncture in the management of CRF; acupuncture or self-acupuncture/self-needling was compared with no such treatment. Breast cancer patients who previously had received acupuncture were randomized to have 4 acupuncturist-delivered weekly sessions, 4 self-administered weekly acupuncture sessions (self-needling); or no acupuncture at all. The primary outcome-measure was general fatigue, while mood, quality of life and safety served as secondary endpoints. In total, 197 patients were randomized: 65 to therapist-delivered sessions, 67 to self-acupuncture/self-needling and 65 to no further acupuncture. The results failed to demonstrate significant inter-group differences in any of the parameters evaluated. The authors concluded that “maintenance acupuncture did not yield important improvements beyond those observed after an initial clinic-based course of acupuncture“.
But this is just one single of several available studies. Acupuncture-fans might suspect me of cherry-picking a largely negative study. If we want a fair verdict, we must consider the totality of the evidence. The aim of our systematic review was therefore to critically evaluate the effectiveness of acupuncture (AT) for CRF based on all the trial data available to us.
Fourteen databases were searched from their respective inception to November 2012. Randomized clinical trials (RCTs) of AT for the treatment of CRF were considered for inclusion. The risk of bias/methodological quality was assessed using the method suggested by the Cochrane Collaboration. Seven RCTs met the eligibility criteria. Most were small pilot studies with serious methodological flaws. Four of them showed effectiveness of AT or AT in addition to usual care (UC) over sham AT, UC, enhanced UC, or no intervention for alleviating CRF. Three RCTs failed to demonstrate an effect of AT over sham treatment.
Our conclusion had to be cautious: “Overall, the quantity and quality of RCTs included in the analysis were too low to draw meaningful conclusions. Even in the positive trials, it remained unclear whether the observed outcome was due to specific effects of AT or nonspecific effects of care. Further research is required to investigate whether AT demonstrates specific effects on CRF”
There will, of course, be those who claim that no trial evidence is needed in this case; if a cancer-patient benefits from the treatment, she should have it regardless of whether it works as a placebo or has effects beyond that. I do sympathize with this attitude but should point out that there are a number of points to consider when making it:
2) There are other treatments against CRF; if we blindly advocate acupuncture, we might not offer the best option to our patients.
3) If we spend our limited resources on acupuncture, we might not afford treatments which are more effective.
4) If we are happy using acupuncture because it conveys a sizable placebo-effect, how will we make progress in finding treatments that are more effective?
It is therefore difficult to decide whether or not to recommend acupuncture for CRF. There are some arguments for both sides. Skeptics or critical thinkers or clinicians adhering to the principles of evidence-based medicine are unlikely to condone it, and some people might accuse them for cruelly and heartlessly denying severely ill patients help which they so badly need. Personally, I fail to see what is cruel or heartless in insisting that these patients receive the treatment which demonstrably works best – and that does not seem to be acupuncture.
Many cancer patients use some form of complementary and alternative medicine (CAM), mostly as an adjunct to conventional cancer therapies to improve the symptoms of the disease or to alleviate the side-effects of the often harsh cancer-therapy. The hope is that this approach leads to less suffering and perhaps even longer survival – but is this really so?
In a recently published study, Korean researchers evaluated whether CAM-use influenced the survival and health-related quality of life (HRQOL) of terminal cancer patients. From July 2005 to October 2006, they prospectively studied a cohort study of 481 cancer patients. During a follow-up of 163.8 person-years, they identified 466 deceased patients. Their multivariate analyses of these data showed that, compared with non-users, CAM-users did not have better survival. Using mind-body interventions or prayer was even associated with significantly worse survival. CAM users reported significantly worse cognitive functioning and more fatigue than nonusers. In sub-group analyses, users of alternative medical treatments, prayer, vitamin supplements, mushrooms, or rice and cereal reported significantly worse HRQOL. The authors conclude that “CAM did not provide any definite survival benefit, CAM users reported clinically significant worse HRQOLs.”
Most proponents of CAM would find this result counter-intuitive and might think it is a one-off coincidental result or a fluke. But, in fact, it is not; similar data have been reported before. For instance, a Norwegian study from 2003 examined the association between CAM-use and cancer survival. Survival data were obtained with a follow-up of 8 years for 515 cancer patients. A total of 112 patients used CAM. During the follow-up period, 350 patients died. Death rates were higher in CAM-users (79%) than in those who did not use CAM (65%). The hazard ratio of death for CAM-use compared with no use was 1.30. The authors of this paper concluded that “use of CAM seems to predict a shorter survival from cancer.”
I imagine that, had the results been the opposite (i.e. showing that CAM-users live longer and have a better quality of life), most CAM-enthusiasts would not have hesitated in claiming a cause effect relationship (i.e. that the result was due to the use of alternative medicine). Critical thinkers, however, are more careful, after all, correlation is not causation! So, how can these findings be explained?
There are, of course, several possibilities, for example:
1) Some patients might use ineffective alternative therapies instead of effective cancer treatments thus shortening their life and reducing their quality of life.
2) Other patients might employ alternative treatments which cause direct harm; for this, there are numerous options; for instance, if they self-medicate St John’s Wort, they would decrease the effectiveness of many mainstream medications, including some cancer drugs.
3) Patients who elect to use alternative medicine as an adjunct to their conventional cancer treatment might, on average, be more sick than those who stay clear of alternative medicine.
The available data do not allow us to say which explanation applies. But things are rarely black or white, and I would not be surprised, if a complex combination of all three possibilities came closest to the truth.