Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated as a treatment of chronic low back pain. According to its authors, this RCT was aimed at evaluating “the effectiveness for chronic low back pain of MBSR vs cognitive behavioural therapy (CBT) or usual care.”
The investigators randomly assigned patients to receive MBSR (n = 116), CBT (n = 113), or usual care (n = 113). CBT meant training to change pain-related thoughts and behaviours and MBSR meant training in mindfulness meditation and yoga. Both were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received.
Coprimary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks.
There were 342 randomized participants with a mean duration of back pain of 7.3 years. They attended 6 or more of the 8 sessions, 294 patients completed the study at 26 weeks, and 290 completed it at 52 weeks. In intent-to-treat analyses at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received MBSR (60.5%) and CBT (57.7%) than for usual care (44.1%), and RR for CBT vs usual care, 1.31 [95% CI, 1.01-1.69]). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group and 44.9% in the CBT group, vs 26.6% in the usual care group, and RR for CBT vs usual care was 1.69 [95% CI, 1.18-2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes.
The authors concluded that among adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.
At first glance, this seems like a well-conducted study. It was conducted by one of the leading back pain research team and was published in a top-journal. It will therefore have considerable impact. However, on closer examination, I have serious doubts about certain aspects of this trial. In my view, both the aims and the conclusions of this RCT are quite simply wrong.
The authors state that they aimed at evaluating “the effectiveness for chronic low back pain of MBSR vs cognitive behavioural therapy (CBT) or usual care.” This is not just misleading, it is wrong! The correct aim should have been to evaluate “the effectiveness for chronic low back pain of MBSR plus usual care vs cognitive behavioural therapy plus usual care or usual care alone.” One has to go into the method section to find the crucial statement: “All participants received any medical care they would normally receive.”
Consequently, the conclusions are equally wrong. They should have read as follows: Among adults with chronic low back pain, treatment with MBSR plus usual care or CBT plus usual care, compared with usual care alone, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT.
In other words, this is yet another trial with the dreaded ‘A+B vs B’ design. Because A+B is always more than B (even if A is just a placebo), such a study will never generate a negative result (even if A is just a placebo). The results are therefore entirely compatible with the notion that the two tested treatments are pure placebos. Add to this the disappointment many patients in the ‘usual care group’ might have felt for not receiving an additional therapy for their pain, and you have a most plausible explanation for the observed outcomes.
I am totally puzzled why the authors failed to discuss these possibilities and limitations in full, and I am equally bewildered that JAMA published such questionable research.
In recent blogs, I have written much about acupuncture and particularly about the unscientific notions of traditional acupuncturists. I was therefore surprised to see that a UK charity is teaming up with traditional acupuncturists in an exercise that looks as though it is designed to mislead the public.
The website of ‘Anxiety UK’ informs us that this charity and the British Acupuncture Council (BAcC) have launched a ‘pilot project’ which will see members of Anxiety UK being able to access traditional acupuncture through this new partnership. Throughout the pilot project, they proudly proclaim, data will be collected to “determine the effectiveness of traditional acupuncture for treating those living with anxiety and anxiety based depression.”
This, they believe, will enable both parties to continue to build a body of evidence to measure the success rate of this type of treatment. Anxiety UK’s Chief Executive Nicky Lidbetter said: “This is an exciting project and will provide us with valuable data and outcomes for those members who take part in the pilot and allow us to assess the benefits of extending the pilot to a regular service for those living with anxiety. “We know anecdotally that many people find complementary therapies used to support conventional care can provide enormous benefit, although it should be remembered they are used in addition to and not instead of seeking medical advice from a doctor or taking prescribed medication. This supports our strategic aim to ensure that we continue to make therapies and services that are of benefit to those with anxiety and anxiety based depression, accessible.”
And what is wrong with that, you might ask.
What is NOT wrong with it, would be my response.
To start with, traditional acupuncture relies of obsolete assumptions like yin and yang, meridians, energy flow, acupuncture points etc. They have one thing in common: they fly in the face of science and evidence. But this might just be a triviality. More important is, I believe, the fact that a pilot project cannot determine the effectiveness of a therapy. Therefore the whole exercise smells very much like a promotional activity for pure quackery.
And what about the hint in the direction of anecdotal evidence in support of the study? Are they not able to do a simple Medline search? Because, if they had done one, they would have found a plethora of articles on the subject. Most of them show that there are plenty of studies but their majority is too flawed to draw firm conclusions.
A review by someone who certainly cannot be accused of being biased against alternative medicine, for instance, informs us that “trials in depression, anxiety disorders and short-term acute anxiety have been conducted but acupuncture interventions employed in trials vary as do the controls against which these are compared. Many trials also suffer from small sample sizes. Consequently, it has not proved possible to accurately assess the effectiveness of acupuncture for these conditions or the relative effectiveness of different treatment regimens. The results of studies showing similar effects of needling at specific and non-specific points have further complicated the interpretation of results. In addition to measuring clinical response, several clinical studies have assessed changes in levels of neurotransmitters and other biological response modifiers in an attempt to elucidate the specific biological actions of acupuncture. The findings offer some preliminary data requiring further investigation.”
Elsewhere, the same author, together with other pro-acupuncture researchers, wrote this: “Positive findings are reported for acupuncture in the treatment of generalised anxiety disorder or anxiety neurosis but there is currently insufficient research evidence for firm conclusions to be drawn. No trials of acupuncture for other anxiety disorders were located. There is some limited evidence in favour of auricular acupuncture in perioperative anxiety. Overall, the promising findings indicate that further research is warranted in the form of well designed, adequately powered studies.”
What does this mean in the context of the charity’s project?
I think, it tells us that acupuncture for anxiety is not exactly the most promising approach to further investigate. Even in the realm of alternative medicine, there are several interventions which are supported by more encouraging evidence. And even if one disagrees with this statement, one cannot possibly disagree with the fact that more flimsy research is not required. If we do need more studies, they must be rigorous and not promotion thinly disguised as science.
I guess the ultimate question here is one of ethics. Do charities not have an ethical and moral duty to spend our donations wisely and productively? When does such ill-conceived pseudo-research cross the line to become offensive or even fraudulent?
As it is ‘ACUPUNCTURE AWARENESS WEEK’, I thought I make a constructive contribution to this field by assessing what is currently being published on the subject. For this purpose, I looked at the first 100 Medline-listed articles of 2016. This has the advantage, of course, that all the numbers thus generated can be seen as absolute and as percentage figures at the same time. I categorised the articles according to where they were published and what their subject was.
My results show that, of the first 100 articles,
- 33 were published in CAM journals,
- 67 were published in mainstream medical journals,
- 6 were RCTs,
- 6 were other clinical studies,
- 30 were pre-clinical investigations,
- 27 were systematic reviews,
- 8 were surveys,
- 23 were other types of papers.
I have to admit, these results are not as bad as I had feared. What seems impressive is foremost the notion that acupuncture research has entered the mainstream journals. But there are issues that might be of concern; in my view these results suggest that:
- Too little research is focussed on the two big questions: efficacy and safety.
- In relation to the meagre output in RCTs, there are too many systematic reviews.
- As long as we cannot be sure that acupuncture is more than a placebo, all these pre-clinical studies seem a bit out of place.
- The vast majority of the articles were in low or very low impact journals.
- There was only one paper that I would consider outstanding (my next post will discuss it).
So, what conclusions can one draw from these data?
Not many, I fear.
My little exploration does not lend itself to grand, generalizable or far-reaching conclusions. Acupuncture fans might proudly say: LOOK HOW FAR WE HAVE COME! Less enthusiastic experts, however, might think: LOOK HOW FAR YOU HAVE TO GO!
Cancer-related fatigue (CRF) is one of the most common symptoms reported by cancer patients, and it is a symptom that is often difficult to treat. As always in such a situation, there are lots of alternative therapies on offer. Yet the evidence for most is flimsy, to put it mildly.
But perhaps there is hope? The very first RCT with a 2016 date to be reviewed on this blog investigated the efficacy of the amino acid jelly Inner Power(®) (IP), a semi-solid, orally administrable dietary supplement containing coenzyme Q10 and L-carnitine, in controlling CRF in breast cancer patients in Japan.
Breast cancer patients with CRF undergoing chemotherapy were randomly assigned to receive IP once daily or regular care for 21 days. The primary endpoint was the change in the worst level of fatigue during the past 24 h (Brief Fatigue Inventory [BFI] item 3 score) from day 1 (baseline) to day 22. Secondary endpoints were change in global fatigue score (GFS; the average of all BFI items), anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Breast Cancer-Specific QLQ (EORTC QLQ-BR23), and adverse events.
Fifty-nine patients were enrolled in the study, of whom 57 were included in the efficacy analysis. Changes in the worst level of fatigue, GFS, and current feeling of fatigue were significantly different between the intervention and control groups, whereas the change in the average feeling of fatigue was not significantly different between groups. HADS, EORTC QLQ-C30, and EORTC QLQ-BR23 scores were not significantly different between the two groups. No severe adverse events were observed.
The authors concluded that ‘IP may control moderate-severe CRF in breast cancer patients.’
The website of the manufacturer provides the following information on IP:
Inner Power is a functional food that provides various nutrients, such as zinc and copper. Zinc is a nutrient that your body needs to maintain your sense of taste. Zinc is also vital in keeping the skin and mucous membranes healthy and in regulating metabolism of proteins and nucleic acids. Copper helps the body form red blood cells and bones and regulates many enzymes that are found in the body. One pouch of Inner Power each day is the recommended daily serving.
- Consuming a large amount of the product will not cure any underlying disease or improve your health condition.
- Do not consume too much of the product because excessive zinc intake may inhibit the absorption of copper.
- Observe the recommended daily serving of the product. This product should not be given to infants or children.
The recommended daily serving of the product (1 pouch/day) contains 43% of the reference daily intake of zinc and 50% of the reference daily intake of copper. Inner Power is neither categorized as a food for special dietary use nor approved individually by the Ministry of Health, Labour, and Welfare. You should eat well-balanced meals consisting of staple foods, including a main dish and side dishes.
I cannot say that this inspires me with confidence.
What about the trial itself?
To be honest, I am not impressed. The most obvious flaw is, I think, that there was not the slightest attempt to control for placebo effects. As I pointed out so many times before: with the ‘A+B versus B’ design, one can make any old placebo appear to be effective.
The randomized, placebo-controlled, double-blind trial is usually the methodology to test the efficacy of a therapy that carries the least risk of bias. This fact is an obvious annoyance to some alt med enthusiasts, because such trials far too often fail to produce the results they were hoping for.
But there is no need to despair. Here I provide a few simple tips on how to mislead the public with seemingly rigorous trials.
The most brutal method for misleading people is simply to cheat. The Germans have a saying, ‘Papier ist geduldig’ (paper is patient), implying that anyone can put anything on paper. Fortunately we currently have plenty of alt med journals which publish any rubbish anyone might dream up. The process of ‘peer-review’ is one of several mechanisms supposed to minimise the risk of scientific fraud. Yet alt med journals are more clever than that! They tend to have a peer-review that rarely involves independent and critical scientists, more often than not you can even ask that you best friend is invited to do the peer-review, and the alt med journal will follow your wish. Consequently the door is wide open to cheating. Once your fraudulent paper has been published, it is almost impossible to tell that something is fundamentally wrong.
But cheating is not confined to original research. You can also apply the method to other types of research, of course. For instance, the authors of the infamous ‘Swiss report’ on homeopathy generated a false positive picture using published systematic reviews of mine by simply changing their conclusions from negative to positive. Simple!
Obviously, outright cheating is not always as simple as that. Even in alt med, you cannot easily claim to have conducted a clinical trial without a complex infrastructure which invariably involves other people. And they are likely to want to have some control over what is happening. This means that complete fabrication of an entire data set may not always be possible. What might still be feasible, however, is the ‘prettification’ of the results. By just ‘re-adjusting’ a few data points that failed to live up to your expectations, you might be able to turn a negative into a positive trial. Proper governance is aimed at preventing his type of ‘mini-fraud’ but fortunately you work in alt med where such mechanisms are rarely adequately implemented.
Another very handy method is the omission of aspects of your trial which regrettably turned out to be in disagreement with the desired overall result. In most studies, one has a myriad of endpoints. Once the statistics of your trial have been calculated, it is likely that some of them yield the wanted positive results, while others do not. By simply omitting any mention of the embarrassingly negative results, you can easily turn a largely negative study into a seemingly positive one. Normally, researchers have to rely on a pre-specified protocol which defines a primary outcome measure. Thankfully, in the absence of proper governance, it usually is possible to publish a report which obscures such detail and thus mislead the public (I even think there has been an example of such an omission on this very blog).
Yes – lies, dam lies, and statistics! A gifted statistician can easily find ways to ‘torture the data until they confess’. One only has to run statistical test after statistical test, and BINGO one will eventually yield something that can be marketed as the longed-for positive result. Normally, researchers must have a protocol that pre-specifies all the methodologies used in a trial, including the statistical analyses. But, in alt med, we certainly do not want things to function normally, do we?
5 TRIAL DESIGNS THAT CANNOT GENERATE A NEGATIVE RESULT
All the above tricks are a bit fraudulent, of course. Unfortunately, fraud is not well-seen by everyone. Therefore, a more legitimate means of misleading the public would be highly desirable for those aspiring alt med researchers who do not want to tarnish their record to their disadvantage. No worries guys, help is on the way!
The fool-proof trial design is obviously the often-mentioned ‘A+B versus B’ design. In such a study, patients are randomized to receive an alt med treatment (A) together with usual care (B) or usual care (B) alone. This looks rigorous, can be sold as a ‘pragmatic’ trial addressing a real-fife problem, and has the enormous advantage of never failing to produce a positive result: A+B is always more than B alone, even if A is a pure placebo. Such trials are akin to going into a hamburger joint for measuring the calories of a Big Mac without chips and comparing them to the calories of a Big Mac with chips. We know the result before the research has started; in alt med, that’s how it should be!
I have been banging on about the ‘A+B versus B’ design often enough, but recently I came across a new study design used in alt med which is just as elegantly misleading. The trial in question has a promising title: Quality-of-life outcomes in patients with gynecologic cancer referred to integrative oncology treatment during chemotherapy. Here is the unabbreviated abstract:
Integrative oncology incorporates complementary medicine (CM) therapies in patients with cancer. We explored the impact of an integrative oncology therapeutic regimen on quality-of-life (QOL) outcomes in women with gynecological cancer undergoing chemotherapy.
PATIENTS AND METHODS:
A prospective preference study examined patients referred by oncology health care practitioners (HCPs) to an integrative physician (IP) consultation and CM treatments. QOL and chemotherapy-related toxicities were evaluated using the Edmonton Symptom Assessment Scale (ESAS) and Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire, at baseline and at a 6-12-week follow-up assessment. Adherence to the integrative care (AIC) program was defined as ≥4 CM treatments, with ≤30 days between each session.
Of 128 patients referred by their HCP, 102 underwent IP consultation and subsequent CM treatments. The main concerns expressed by patients were fatigue (79.8 %), gastrointestinal symptoms (64.6 %), pain and neuropathy (54.5 %), and emotional distress (45.5 %). Patients in both AIC (n = 68) and non-AIC (n = 28) groups shared similar demographic, treatment, and cancer-related characteristics. ESAS fatigue scores improved by a mean of 1.97 points in the AIC group on a scale of 0-10 and worsened by a mean of 0.27 points in the non-AIC group (p = 0.033). In the AIC group, MYCAW scores improved significantly (p < 0.0001) for each of the leading concerns as well as for well-being, a finding which was not apparent in the non-AIC group.
An IP-guided CM treatment regimen provided to patients with gynecological cancer during chemotherapy may reduce cancer-related fatigue and improve other QOL outcomes.
A ‘prospective preference study’ – this is the design the world of alt med has been yearning for! Its principle is beautiful in its simplicity. One merely administers a treatment or treatment package to a group of patients; inevitably some patients take it, while others don’t. The reasons for not taking it could range from lack of perceived effectiveness to experience of side-effects. But never mind, the fact that some do not want your treatment provides you with two groups of patients: those who comply and those who do not comply. With a bit of skill, you can now make the non-compliers appear like a proper control group. Now you only need to compare the outcomes and BOB IS YOUR UNCLE!
Brilliant! Absolutely brilliant!
I cannot think of a more deceptive trial-design than this one; it will make any treatment look good, even one that is a mere placebo. Alright, it is not randomized, and it does not even have a proper control group. But it sure looks rigorous and meaningful, this ‘prospective preference study’!
The authors of a recent paper inform us that Reiki is a Japanese system of energy healing that has been used for over 2 500 years. It involves the transfer of energy from the practitioner to the receiver, which promotes healing, and can be done by either contact or non-contact methods. Both the receiver and the practitioner may feel the energy in various forms (warmth, cold, tingling, vibration, pulsations and/or floating sensations). Reiki can also be self-administered if one is a Reiki practitioner. Reiki is mainly used to address stress, anxiety, and pain reduction while also promoting a sense of well-being and improving quality of life.
Such statements should make us weary: what is presented here as fact is nothing more than conjecture – and very, very implausible conjecture too. Anyone who writes stuff like this in the introduction of a scientific paper is, in my view, unlikely to be objective and could be well on the way to present some nasty piece of pseudo-science.
But I am, of course, pre-judging the issue; let’s have a quick look at the article itself.
The purpose of this study was to determine the effects of a 20-week structured self-Reiki program on stress reduction and relaxation in college students. Students were recruited from Stockton University and sessions were conducted in the privacy of their residence. Twenty students completed the entire study consisting of 20 weeks of self-Reiki done twice weekly. Each participant completed a Reiki Baseline Credibility Scale, a Reiki Expectancy Scale, and a Perceived Stress Scale (PSS) after acceptance into the study. The PSS was completed every four weeks once the interventions were initiated. A global assessment questionnaire was completed at the end of the study. Logs summarizing the outcome of each session were submitted at the end of the study.
With the exception of three participants, participants believed that Reiki is a credible technique for reducing stress levels. Except for two participants, participants agreed that Reiki would be effective in reducing stress levels. All participants experienced stress within the month prior to completing the initial PSS. There was a significant reduction in stress levels from pre-study to post-study. There was a correlation between self-rating of improvement and final PSS scores. With one exception, stress levels at 20 weeks did not return to pre-study stress levels.
The authors concluded that this study supports the hypothesis that the calming effect of Reiki may be achieved through the use of self-Reiki.
QED – my suspicions were fully confirmed. This study shows precisely nothing, and it certainly does not support any hypothesis regarding Reiki.
If we recruited 20 volunteers who were sufficiently gullible to believe that watching an ice-cube slowly melting in the kitchen sink, or anything else that we can think of, has profound effects on their vital energy, or chi, or karma, or anything else, we would almost certaily generate similar results.
My conclusion is therefore very different from those of the original authors: THIS STUDY SUPPORTS THE HYPOTHESIS THAT GULLIBLE PEOPLE CAN BE EASILY MISLEAD ABOUT BOGUS THERAPIES WITH PSEUDO-SCIENTIFIC STUDIES BY IRRESPONSIBLE WOULD-BE SCIENTISTS.
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:
For 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.
Conventional cough syrups do not have the best of reputations – but the repute of homeopathic cough syrups is certainly not encouraging. So what should one do with such a preparation? Forget about it? No, one conducts a clinical trial, of course! Not just any old trial but one where science, ethics and common sense are absent. Here are the essentials of a truly innovative study that, I think, has all of these remarkable qualities:
The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (−0.52 ± 0.66 in the homeopathic syrup group and −0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020).
Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.
Let us be clear about what has happened here. I think, the events can be summarised as follows:
- the researchers come across a homeopathic syrup (anyone who understands respiratory problems and/or therapeutics would be more than a little suspicious of this product, but this team is exceptional),
- they decide to do a trial with it (a decision which would make some ethicists already quite nervous, but the ethics committee is exceptional too),
- the question raises, what should the researchers give to the control group?
- someone has the idea, why not compare our dodgy syrup against something that is equally dodgy, perhaps even a bit unsafe?
- the researchers are impressed and ask: but what precisely could we use?
- let’s take antibiotics; they are often used for acute coughs, but the best evidence fails to show that they are helpful and they have, of course, risks,
- another member of the team adds: let’s use children, they and their mothers are unlikely to understand what we are up to,
- the team is in agreement,
- Boiron, the world’s largest producer of homeopathic products, accepts to finance the study,
- a protocol is written,
- ethics approval is obtained,
- the trial is conducted and even published by a journal with the help of peer-reviewers who are less than critical.
And the results of the trial? Contrary to the authors’ conclusion copied above, they show that two bogus treatments are worse that one.
BOB’S YOUR UNCLE!
EVERYONE SEEMS HAPPY: THE RESEARCHERS CAN ADD AN ARTICLE TO THEIR PUBLICATION LIST, BOIRON HAS MORE ‘EVIDENCE’ IN FAVOUR OF HOMEOPATHY, AND THE ETHICS COMMITTEE SLEEP JUST AS SOUNDLY AS THE PEER-REVIEWERS.
In my last post, I claimed that researchers of alternative medicine tend to be less than rigorous. I did not link this statement to any evidence at all. Perhaps I should have at least provided an example!? As it happens, I just came across a brand new paper which nicely demonstrates what I meant.
According to its authors, this non-interventional study was performed to generate data on safety and treatment effects of a complex homeopathic drug. They treated 1050 outpatients suffering from common cold with a commercially available homeopathic remedy for 8 days. The study was conducted in 64 German outpatient practices of medical doctors trained in CAM. Tolerability, compliance and the treatment effects were assessed by the physicians and by patient diaries. Adverse events were collected and assessed with specific attention to homeopathic aggravation and proving symptoms. Each adverse effect was additionally evaluated by an advisory board of experts.
The physicians detected 60 adverse events from 46 patients (4.4%). Adverse drug reactions occurred in 14 patients (1.3%). Six patients showed proving symptoms (0.57%) and only one homeopathic aggravation (0.1%) appeared. The rate of compliance was 84% for all groups. The global assessment of the treatment effects resulted in the verdict “good” and “very good” in 84.9% of all patients.
The authors concluded that the homeopathic complex drug was shown to be safe and effective for children and adults likewise. Adverse reactions specifically related to homeopathic principles are very rare. All observed events recovered quickly and were of mild to moderate intensity.
So why do I think this is ‘positively barmy’?
The study had no control group. This means that there is no way anyone can attribute the observed ‘treatment effects’ to the homeopathic remedy. There are many other phenomena that may have caused or contributed to it, e. g.:
- a placebo effect
- the natural history of the condition
- regression to the mean
- other treatments which the patients took but did not declare
- the empathic encounter with the physician
- social desirability
To plan a study with the aim as stated above and to draw the conclusion as cited above is naïve and unprofessional (to say the least) on the part of the researchers (I often wonder where, in such cases, the boundary between incompetence and research misconduct might lie). To pass such a paper through the peer review process is negligent on the part of the reviewers. To publish the article is irresponsible on the part of the editor.
In a nut-shell: COLLECTIVELY, THIS IS ‘POSITIVELY BARMY’!!!
Twenty years ago, I published a short article in the British Journal of Rheumatology. Its title was ALTERNATIVE MEDICINE, THE BABY AND THE BATH WATER. Reading it again today – especially in the light of the recent debate (with over 700 comments) on acupuncture – indicates to me that very little has since changed in the discussions about alternative medicine (AM). Does that mean we are going around in circles? Here is the (slightly abbreviated) article from 1995 for you to judge for yourself:
“Proponents of alternative medicine (AM) criticize the attempt of conducting RCTs because they view this is in analogy to ‘throwing out the baby with the bath water’. The argument usually goes as follows: the growing popularity of AM shows that individuals like it and, in some way, they benefit through using it. Therefore it is best to let them have it regardless of its objective effectiveness. Attempts to prove or disprove effectiveness may even be counterproductive. Should RCTs prove that a given intervention is not superior to a placebo, one might stop using it. This, in turn, would be to the disadvantage of the patient who, previous to rigorous research, has unquestionably been helped by the very remedy. Similar criticism merely states that AM is ‘so different, so subjective, so sensitive that it cannot be investigated in the same way as mainstream medicine’. Others see reasons to change the scientific (‘reductionist’) research paradigm into a broad ‘philosophical’ approach. Yet others reject the RCTs because they think that ‘this method assumes that every person has the same problems and there are similar causative factors’.
The example of acupuncture as a (popular) treatment for osteoarthritis, demonstrates the validity of such arguments and counter-arguments. A search of the world literature identified only two RCTs on the subject. When acupuncture was tested against no treatment, the experimental group of osteoarthritis sufferers reported a 23% decrease of pain, while the controls suffered a 12% increase. On the basis of this result, it might seem highly unethical to withhold acupuncture from pain-stricken patients—’if a patient feels better for whatever reason and there are no toxic side effects, then the patient should have the right to get help’.
But what about the placebo effect? It is notoriously difficult to find a placebo indistinguishable to acupuncture which would allow patient-blinded studies. Needling non-acupuncture points may be as close as one can get to an acceptable placebo. When patients with osteoarthritis were randomized into receiving either ‘real acupuncture or this type of sham acupuncture both sub-groups showed the same pain relief.
These findings (similar results have been published for other AMs) are compatible only with two explanations. Firstly acupuncture might be a powerful placebo. If this were true, we need to establish how safe acupuncture is (clearly it is not without potential harm); if the risk/benefit ratio is favourable and no specific, effective form of therapy exists one might still consider employing this form as a ‘placebo therapy’ for easing the pain of osteoarthritis sufferers. One would also feel motivated to research this powerful placebo and identify its characteristics or modalities with the aim of using the knowledge thus generated to help future patients.
Secondly, it could be the needling, regardless of acupuncture points and philosophy, that decreases pain. If this were true, we could henceforward use needling for pain relief—no special training in or equipment for acupuncture would be required, and costs would therefore be markedly reduced. In addition, this knowledge would lead us to further our understanding of basic mechanisms of pain reduction which, one day, might evolve into more effective analgesia. In any case the published research data, confusing as they often are, do not call for a change of paradigm; they only require more RCTs to solve the unanswered problems.
Conducting rigorous research is therefore by no means likely to ‘throw out the baby with the bath water’. The concept that such research could harm the patient is wrong and anti-scientific. To follow its implications would mean neglecting the ‘baby in the bath water’ until it suffers serious damage. To conduct proper research means attending the ‘baby’ and making sure that it is safe and well.