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Recently published!
The ‘Healing Revolution’ began, according to BIO KING’s website, more than 25 years ago with the establishment of King Bio. Its founder, Dr. Frank King, was inspired to find the root causes of illness and empower the whole person. He cultivated an interest in developing pure water-based homeopathic medicines – a type of natural product that was not, to his knowledge, being produced anywhere else. Committed to researching and developing this new homeopathic medicine, Dr. King moved to Asheville, North Carolina, and opened King Bio in 1989. For more than 25 years, King Bio’s mission has remained true to the empowerment of whole person health, most recently including breakthroughs in whole food dietary supplements. Dr. King’s vision for the company has always centered around three core guiding principles: health, wholeness, and innovation.
On their website, BIO KING also explains: Homeopathy … is energy medicine. Rather than going through digestion, homeopathic remedies deliver their messages almost instantly along the body’s nerve pathways. Like acupuncture, it works bioenergetically (“bio” means “life,” so “bioenergetic” means “life energy”). If the biochemical aspects of the body are like the building blocks of a home, bioenergy is like the invisible electricity that powers it. (A deceased person may have the same biochemical constituents as a living person, but the bioenergy is missing.)
BIO KING is on a mission! To be precise, the mission, as stated on the website, is this:
- To provide safe, all-natural medicines without harmful side effects.
- To offer affordable natural medicines that help people overcome common health challenges.
- To achieve the trust and respect of our customers and uphold the best product quality.
- To empower people with the most effective ways to achieve abundant health.
Safe medicines?
Without side-effects?
Trust and respect?
Best product quality?
Dr King has been reported to be voluntarily recalling 32 different infant and kids medicines after they tested positive for a microbial contamination. Use of these products could, it is feared, cause life-threatening infections.
Quite a ‘Healing Revolution’!
On this blog, I have ad nauseam discussed the fact that many SCAM-practitioners are advising their patients against vaccinations, e. g.:
- Andrew Wakefield, Donald Trump, SCAM, and the anti-vaccination cult
- More on vaccination scepticism, and the plea for a no-fault vaccination injury compensation scheme
- Naturopaths’ counselling against vaccinations could be criminally negligent
- HOMEOPATHS AGAINST VACCINATION: “The decision to vaccinate and how you implement that decision is yours and yours alone”
- Governments take action to prevent vaccination-rates from falling
- Use of alternative medicine is associated with low vaccination rates
- Integrative medicine physicians tend to harbour anti-vaccination views
- Vaccination: chiropractors “espouse views which aren’t evidence based”
- Faith-healing as an alternative to vaccination?
- Recommending homeoprophylaxis is unethical, irresponsible and possibly even criminal
- Chiropractors are undermining public health
- CAM use is risk factor for the failure to immunise children
- Let’s be blunt: homeopathy is bogus – but homeoprophylaxis is worse, much worse!
- Are mothers being taught by homeopaths to become anti-vaxers?
- Some naturopaths are clearly a danger to public health
The reason why I mention this subject yet again is the alarming news reported in numerous places (for instance in this article) that measles outbreaks are now being reported from most parts of the world.
The number of cases in Europe is at a record high of more than 41,000, the World Health Organization (WHO) warned. Halfway through the year, 2018 is already the worst year on record for measles in Europe in a decade. So far, at least 37 patients have died of the infection in 2018.
“Following the decade’s lowest number of cases in 2016, we are seeing a dramatic increase in infections and extended outbreaks,” Dr. Zsuzsanna Jakab, WHO Regional Director for Europe, said in a statement. “Seven countries in the region have seen over 1,000 infections in children and adults this year (France, Georgia, Greece, Italy, the Russian Federation, Serbia and Ukraine).”
In the U.S., where measles were thought to be eradicated, the Centers for Disease Control and Prevention has reported 107 measles cases as of the middle of July this year. “This partial setback demonstrates that every person who is not immune remains vulnerable no matter where they live, and every country must keep pushing to increase coverage and close immunity gaps,” WHO’s Dr. Nedret Emiroglu said. 95 percent of the population must have received at least two doses of measles vaccine to achive herd immunity and prevent outbreaks. Some parts of Europe have reached that target, while others are even below 70 percent.
And why are many parts below the 95% threshold?
Ask your local SCAM-provider, I suggest.
In one of his many comments, our friend Iqbal just linked to an article that unquestionably is interesting. Here is its abstract (the link also provides the full paper):
Objective: The objective was to assess the usefulness of homoeopathic genus epidemicus (Bryonia alba 30C) for the prevention of chikungunya during its epidemic outbreak in the state of Kerala, India.
Materials and Methods: A cluster- randomised, double- blind, placebo -controlled trial was conducted in Kerala for prevention of chikungunya during the epidemic outbreak in August-September 2007 in three panchayats of two districts. Bryonia alba 30C/placebo was randomly administered to 167 clusters (Bryonia alba 30C = 84 clusters; placebo = 83 clusters) out of which data of 158 clusters was analyzed (Bryonia alba 30C = 82 clusters; placebo = 76 clusters) . Healthy participants (absence of fever and arthralgia) were eligible for the study (Bryonia alba 30 C n = 19750; placebo n = 18479). Weekly follow-up was done for 35 days. Infection rate in the study groups was analysed and compared by use of cluster analysis.
Results: The findings showed that 2525 out of 19750 persons of Bryonia alba 30 C group suffered from chikungunya, compared to 2919 out of 18479 in placebo group. Cluster analysis showed significant difference between the two groups [rate ratio = 0.76 (95% CI 0.14 – 5.57), P value = 0.03]. The result reflects a 19.76% relative risk reduction by Bryonia alba 30C as compared to placebo.
Conclusion: Bryonia alba 30C as genus epidemicus was better than placebo in decreasing the incidence of chikungunya in Kerala. The efficacy of genus epidemicus needs to be replicated in different epidemic settings.
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I have often said the notion that homeopathy might prevent epidemics is purely based on observational data. Here I stand corrected. This is an RCT! What is more, it suggests that homeopathy might be effective. As this is an important claim, let me quickly post just 10 comments on this study. I will try to make this short (I only looked at it briefly), hoping that others complete my criticism where I missed important issues:
- The paper was published in THE INDIAN JOURNAL OF RESEARCH IN HOMEOPATHY. This is not a publication that could be called a top journal. If this study really shows something as revolutionarily new as its conclusions imply, one must wonder why it was published in an obscure and inaccessible journal.
- Several of its authors are homeopaths who unquestionably have an axe to grind, yet they do not declare any conflicts of interest.
- The abstract states that the trial was aimed at assessing the usefulness of Bryonia C30, while the paper itself states that it assessed its efficacy. The two are not the same, I think.
- The trial was conducted in 2007 and published only 7 years later; why the delay?
- The criteria for the main outcome measure were less than clear and had plenty of room for interpretation (“Any participant who suffered from fever and arthralgia (characteristic symptoms of chikungunya) during the follow-up period was considered as a case of chikungunya”).
- I fail to follow the logic of the sample size calculation provided by the authors and therefore believe that the trial was woefully underpowered.
- As a cluster RCT, its unit of assessment is the cluster. Yet the significant results seem to have been obtained by using single patients as the unit of assessment (“At the end of follow-ups it was observed that 12.78% (2525 out of 19750) healthy individuals, administered with Bryonia alba 30 C, were presented diagnosed as probable case of chikungunya, whereas it was 15.79% (2919 out of 18749) in the placebo group”).
- The p-value was set at 0.05. As we have often explained, this is far too low considering that the verum was a C30 dilution with zero prior probability.
- Nine clusters were not included in the analysis because of ‘non-compliance’. I doubt whether this was the correct way of dealing with this issue and think that an intention to treat analysis would have been better.
- This RCT was published 4 years ago. If true, its findings are nothing short of a sensation. Therefore, one would have expected that, by now, we would see several independent replications. The fact that this is not the case might mean that such RCTs were done but failed to confirm the findings above.
As I said, I would welcome others to have a look and tell us what they think about this potentially important study.
A few days ago, I published an article in the ‘Sueddeutsche Zeitung’ (a truly rare event, as I have never done this before) where I argued that German pharmacists should consider stopping the sale of homeopathic remedies. It violates their ethical code, I suggested.
While this discussion has been going on for a while in the UK (British pharmacists have stopped inviting me to their gatherings because I get on their nerves with banging on about this!), it is relatively novel in Germany.
After I had submitted my copy to the SZ, an article was published which is highly relevant to this subject. Here I first copy an extract of the German original, and below I try to briefly explain its content to those who do not read German.
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In vielen Apotheken werden Kunden nicht hinreichend gut zu Homöopathika beraten. Zu diesem Ergebnis kommt Professor Tilmann Betsch, an der Universität Erfurt Leiter der Professur für Sozial-, Organisations- und Wirtschaftspsychologie, der mit seinem Team 100 zufällig ausgewählte Apotheken in Stuttgart, Erfurt, Leipzig und Frankfurt auf Herz und Nieren geprüft hat. Im Mittelpunkt der Kundengespräche stand eine Beratung zu einem erkälteten Familienmitglied.
“Zum einen zeigen unsere Ergebnisse, dass im Falle eines grippalen Infektes die überwiegende Mehrzahl von ihnen zu schulmedizinischen Präparaten rät, die mit hoher Wahrscheinlichkeit zu einer Linderung der Symptome führen”, erläutert Betsch. Was die Wirkung von Homöopathika betreffe, so zeichne das Untersuchungsergebnis ein eher düsteres Bild, ergänzt er. Denn in nur fünf Prozent aller Beratungsgespräche sei gesagt worden, dass es für die Wirkung von Homöopathie keine wissenschaftlichen Belege gäbe. In 30 Prozent sei dagegen behauptet worden, die Wirkung von Homöopathie sei entweder in Studien nachgewiesen oder ergebe sich aus dem Erfahrungswissen.
“Nach den Leitlinien der Bundesapothekenkammer soll jedoch die Beurteilung der Wirksamkeit von Präparaten nach pharmakologisch-toxikologischen Kriterien erfolgen. Zumindest was die Begründung ihrer Empfehlungen betrifft, folgte die überwiegende Mehrheit der von uns befragten Apotheker diesen Leitlinien nicht”, so Betschs Fazit. Während die Empfehlungen der Apotheker in der Regel nachweislich wirksame Medikamente enthalten hätten, habe sich ihr Wissen über die Wirkung von Homöopathie mehrheitlich nicht von Laien-Meinungen unterschieden.
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Professor Tilmann Betsch has conducted a study showing that German pharmacists fail their customers when advising them on homeopathy. His team went under cover as patients with flue-like symptoms to 100 randomly selected pharmacists. Only 5% of the pharmacists admitted that homeopathics have no proven efficacy, while 30% claimed homeopathics have been proven to work in studies and through experience. This behaviour, Betsch explains, violates the current guidelines for pharmacists.
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I am delighted with these findings; they confirm my arguments perfectly.
Since, in Germany, homeopathics are sold only in pharmacies, German pharmacists have a pivotal role here. They are ethically bound to inform their customers based on the current best evidence. So, in my day-dreams, I imagine a dialogue between a customer and an ethical pharmacist:
CUSTOMER: I have a flu, is there a homeopathic remedy against it?
PHARMACIST: Yes, there is.
CUSTOMER: Can I have it please?
PHARMACIST: If you insist; but I must warn you: it has been shown not to work, and there is absolutely nothing in it that could possibly work.
CUSTOMER: What? Why do you sell it then?
PHARMACIST: Because some people like it.
CUSTOMER: Even though it does not work?
PHARMACIST: Yes.
CUSTOMER: Is it expensive?
PHARMACIST: Yes.
CUSTOMER: And some people still buy it?
PHARMACIST: Yes.
CUSTOMER: Well, not I! I am not a fool. But thank you for your honest information. Can I have something else that alleviates my symptoms?
PHARMACIST: With pleasure!
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The fate of homeopathy in Germany is largely in the hands of pharmacists, it seems.
But, is it in good, ethical hands? Is there hope that progress can be made?
We will see – so far, I have heard of just one!!! pharmacy that has stopped displaying homeopathics on its shelves.
The aim of palliative care is to improve quality of life for patients with serious illnesses by treating their symptoms, often in situations where all the possible causative therapeutic options have been exhausted. In many palliative care settings, complementary and alternative medicine (CAM) is used for this purpose. In fact, this is putting it mildly; my impression is that CAM seems to have flooded palliative care. The question is therefore whether this approach is based on sufficiently good evidence.
This review was aimed at evaluating the available evidence on the use of CAM in hospice and palliative care and to summarize their potential benefits. The researchers conducted thorough literature searches and located 4682 studies of which 17 were identified for further evaluation. The therapies considered included:
- acupressure,
- acupuncture,
- aromatherapy massage,
- breathing,
- hypnotherapy,
- massage,
- meditation,
- music therapy,
- reflexology,
- reiki.
Many studies demonstrated a short-term benefit in symptom improvement from baseline with CAM, although a significant benefit was not found between groups.
The authors concluded that CAM may provide a limited short-term benefit in patients with symptom burden. Additional studies are needed to clarify the potential value of CAM in the hospice or palliative setting.
When reading research articles in CAM, I often have to ask myself: ARE THEY TAKING THE MIKEY?
??? “Many studies demonstrated a short-term benefit in symptom improvement from baseline with CAM, although a significant benefit was not found between groups.” ???
Really?!?!?
Controlled clinical trials are only about comparing the outcomes between the experimental and the control groups (and not about assessing improvements from baseline which can be [and often is] unrelated to any effect caused by the treatment per se). Therefore, within-group changes are irrelevant and should not even deserve a mention in the abstract. Thus the only finding worth reporting in the abstract is this:
No significant benefit was found.
It follows that the above conclusions are totally out of line with the data.
They should, according to what the researchers report in their abstract, read something like this:
CAM HAS NO PROVEN BENEFIT IN PALLIATIVE CARE. ITS USE IN THIS AREA IS THEREFORE HIGHLY PROBLEMATIC.
Music therapy is the use of music for therapeutic purposes. Several forms of music therapy exist. They can consist of a patient listening to live or recorded music, or of patients participating in performing music. Music therapy is usually employed to complement other treatments; it is never a curative or causal approach and mostly aimed at inducing relaxation and enhancing physical and emotional well-being, or at promoting motor and communication skills.
There is a paucity of rigorous studies assessing the effectiveness of music therapy for specific condition, not least due to methodological obstacles and funding issues. Several systematic reviews of clinical studies have nevertheless emerged and results are generally encouraging. As for hypertension, the evidence is contradictory whether passive listening to music works. One review concluded that Music may improve systolic blood pressure and should be considered as a component of care of hypertensive patients. And another review revealed a trend towards a decrease in blood pressure in hypertensive patients who received music interventions, but failed to establish a cause-effect relationship between music interventions and blood pressure reduction.
A new study might bring more clarity:
Its authors evaluated the effect of musical auditory stimulus associated with anti-hypertensive medication on heart rate (HR) autonomic control in hypertensive subjects. They included in this trial 37 well-controlled hypertensive patients designated for anti-hypertensive medication. Heart rate variability (HRV) was calculated from the HR monitor recordings of two different, randomly sorted protocols (control and music) on two separate days. Patients were examined in a resting condition 10 minutes before medication and 20 minutes, 40 minutes and 60 minutes after oral anti-hypertensive medications. Music was played throughout the 60 minutes after medication with the same intensity for all subjects in the music protocol.
The results showed analogous response of systolic and diastolic arterial pressure in both protocols. HR decreased 60 minutes after medication in the music protocol, while it remained unchanged in the control protocol. The effects of anti-hypertensive medication on SDNN (Standard deviation of all normal RR intervals), LF (low frequency, nu), HF (high frequency, nu) and alpha-1 scale were more intense in the music protocol. Blood pressure readings showed no significant differences between the two groups.
The authors concluded that musical auditory stimulus increased HR autonomic responses to anti-hypertensive medication in well-controlled hypertensive subjects.
So, there were some acute effects on HRV. But what is the clinical relevance of this effect? I am not sure, and the authors tell us little about this.
Crucially, there was no effect on blood pressure. But the study design might have been ill-suited for detecting one. I think that a much simpler trial with two parallel groups of untreated hypertensives would have been more efficient for this purpose.
As a music-lover, I would like to believe that music can be used therapeutically. Yet, for hypertensives, I find it difficult to see how this could work. Even if passive listening to music had an anti-hypertensive effect, could it be employed in clinical routine? I somehow doubt it; we can hear music for a while, but our daily activities would largely prohibit doing it for prolonged periods (and most likely it would become a nuisance after a while and would put our pressure up rather than down – think of the background music that bothers us in some shops, for instance). And how would it work when we sleep, a time during which blood pressure control can be vital?
As a music-lover, I would also argue that listening to music can be pleasantly relaxing – presumably, the anti-hypertensive effect observed in some trials relies on this effect. But surely, it can also have the opposite effect. If I strongly dislike a piece of music, I might increase my blood pressure. If a piece moves me deeply, it could easily do the same. It is probably only a certain type of music that induces relaxation; and, to make it even more complex, this type might differ from person to person.
So, is music therapy potentially a usable anti-hypertensive?
Somehow, I don’t think so!
About 7 months ago, I contacted a German journalist who I knew and trusted to tell her about the incredible quackery-promotion performed by Germany’s institutes of adult education, the ‘Volkshochschulen‘ (VHSs). After I had been invited to give a few lectures for the VHSs, I had conducted some preliminary research and realised that, nationwide, they run hundreds of courses promoting the worst types of quackery.
My journalist friend, Veronika Hackenbroch, who works for DER SPIEGEL liked the idea of conducting an in-depth investigation into the matter. What it revealed became the centre-piece of a theme issue published today. Here is its title page:
In a nutshell, the key finding is that every 5th course offered by the VHSs in the area of healthcare is steeped in woo. Considering that their funding comes mainly from the public purse, this is intolerable. When asked why they offer so much quackery, some heads of local VHSs said that they are not competent to evaluate the science; they simply assume that, if doctors in Germany use these treatments – specifically homeopathy – and if the public wants to learn about them, they have to offer them.
When I first heard this argument, it made me speechless. It has some undeniable logic behind it. The heads of VHSs are not medical experts. Thus, they cannot do their own research or evaluations. To just follow what the doctors must therefore seem reasonable to them.
So, where is the crux of the problem?
I think, it lies in the vicious circle that inevitable unfolds such a situation:
- some people like homeopathy (or other bogus treatments),
- therefore, they ask their doctors to provide it,
- therefore, some doctors offer it,
- therefore, the VHSs feel they can promote if,
- therefore, people like homeopathy (or other bogus treatments).
This circle has no beginning and no end; it just turns and turns. And it is difficult to stop, not least because it is driven by the relentless promotion of interested parties, such as the manufacturers of woo. Yet, if we want to make progress and are serious about improving healthcare, we have to try stopping it!
But how?
Through providing information and fighting misinformation (of course, some rules and regulations would help as well).
That’s exactly what we tried to do – thank you Veronika Hackenbroch!
I am truly saddened and shocked to hear that Peter Fisher has died. Apparently, he was cycling to work on 15 August, when, at 9.30 am, he was hit and fatally injured by a lorry. The Faculty of Homeopathy published the following statement:
The Faculty of Homeopathy has to announce with great sadness, news of the death of the Faculty President, Dr Peter Fisher in a road accident near the Royal London Hospital for Integrated Medicine (RLHIM), London, UK, on the morning of 15th August 2018.
Dr Fisher was Director of Research at the hospital, Europe’s largest centre for integrative medicine. He was also Physician to Her Majesty Queen Elizabeth II. He was previously Honorary Consultant Rheumatologist at King’s College Hospital. He was also one of the world leaders in homeopathic research, and will be sorely missed not only by his family and UK friends and colleagues but around the whole world.
A graduate of Cambridge University and a Fellow of the Royal College of Physicians and the Faculty of Homeopathy, he was a widely published expert in rheumatology and forms of complementary and alternative medicine. Dr Fisher chaired the World Health Organisation’s working group on homeopathy and was a member of WHO’s Expert Advisory Panel on Traditional and Complementary Medicine. He was awarded the Albert Schweitzer Gold Medal of the Polish Academy of Medicine in 2007.
Further detail will appear on the website in due course.
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This is how Peter described himself on the Bupa website:
I specialise in homeopathy and other forms of complementary medicine, integrated with conventional treatment, for rheumatological complaints including osteoarthritis, rheumatoid arthritis and soft tissue syndromes such as Fibromyalgia. Also for skin conditions including eczema and psoriasis and a range of general medical problems. I accept both NHS and Private referrals.
I am Associate Clinical Director and Director of Research at the Royal London Hospital for Integrated Medicine, Europe’s largest centre for integrative medicine.
I am also Physician to Her Majesty The Queen.
I was previously Honorary Consultant Rheumatologist at King’s College Hospital. I am a graduate of Cambridge University and a Fellow of the Royal College of Physicians and of the Faculty of Homeopathy. I am accredited as a specialist in both homeopathy and rheumatology.
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I knew Peter well. We first met when we both served on a EU committee on homeopathy in Brussels for several years. I do not think that I exaggerate, if I say that we became friends. I did respect him for his relatively prudent stance on many things related to homeopathy. For instance, he was an outspoken critic of the anti-vaxx attitude of many of his fellow homeopaths. We even have two publications together:
Complementary medicine must be research led and evidence based.
He was also a contributor of my book ‘HOMEOPATHY, A CRITICAL APPRAISAL‘ where he co-authored a chapter on homeopathic pathogenetic trials which contained the sentence, ” It is not possible to reach a definitive conclusion regarding the true effects of homeopathic medicines in healthy volunteers...”
And, in 2015, we published a BMJ ‘head to head’ together where we outlined our differences regarding homeopathy:
Should doctors recommend homeopathy?
It is no secret to regular readers of this blog that, lately, we disagreed on many things. In the course of these differences, our friendship regrettably fell apart.
I am nevertheless deeply saddened to hear of this tragic accident.
I know, I have reported about the risks of chiropractic manipulations many times before. But I will continue to do so, because the subject is important and mentioning it might save lives.
The purpose of this study from the US was to determine the frequency of patients seen at a single institution who were diagnosed with a cervical vessel dissection related to chiropractic neck manipulation. The researchers identified cases through a retrospective chart review of patients seen between April 2008 and March 2012 who had a diagnosis of cervical artery dissection following a recent chiropractic manipulation. Relevant imaging studies were reviewed by a board-certified neuroradiologist to confirm the findings of a cervical artery dissection and stroke. The investigators also conducted telephone interviews to ascertain the presence of residual symptoms in the affected patients.
Of the 141 patients with cervical artery dissection, 12 had documented chiropractic neck manipulation prior to the onset of the symptoms that led to medical presentation. The 12 patients had a total of 16 cervical artery dissections. All 12 patients developed symptoms of acute stroke. All strokes were confirmed with magnetic resonance imaging or computerized tomography. The researchers obtained follow-up information on 9 patients, 8 of whom had residual symptoms and one of whom died as a result of his injury.
The authors concluded that, in this case series, 12 patients with newly diagnosed cervical artery dissection(s) had recent chiropractic neck manipulation. Patients who are considering chiropractic cervical manipulation should be informed of the potential risk and be advised to seek immediate medical attention should they develop symptoms.
Cerebellar and spinal cord injuries related to cervical chiropractic manipulation were first reported in 1947. By 1974, there were 12 reported cases. Non-invasive imaging has since greatly improved the diagnosis of cervical artery dissection and of stroke, and cervical artery dissection is now recognized as pathogenic of strokes occurring in association with chiropractic manipulation.
The authors also point out that another institution had previously described 13 stroke cases after chiropractic manipulation. The patients at both institutions were relatively young and incurred substantial residual morbidity. A single patient at each institution died. If these findings are representative of other institutions across the United States, the incidence of stroke secondary to chiropractic manipulation may be higher than supposed. To assess this problem further, a randomized prospective cohort study could establish the relative risk of chiropractic manipulation of the cervical spine resulting in a cervical artery dissection. But such a study may be methodologically prohibitive. More feasible would be a case-control study in which patients who had experienced cervical artery dissection were matched with subjects who had not incurred such injuries. Comparing the groups’ odds of having received chiropractic manipulation demonstrated that spinal manipulative therapy is an independent risk factor for vertebral artery dissection and is highly suggestive of a causal association.
I very much agree with the authors when they sate that until the actual level of risk from chiropractic manipulation is known, patients with neck pain may be better served by equally effective passive physical therapy exercises.
In other words: there is very little reason to recommend chiropractic care for neck pain (or any other condition).
Kinesiology tape KT is fashionable, it seems. Gullible consumers proudly wear it as decorative ornaments to attract attention and show how very cool they are.
Am I too cynical?
Perhaps.
But does KT really do anything more?
A new trial might tell us.
The aim of this study was to investigate whether adding kinesiology tape (KT) to spinal manipulation (SM) can provide any extra effect in athletes with chronic non-specific low back pain (CNLBP).
Forty-two athletes (21males, 21females) with CNLBP were randomized into two groups of SM (n = 21) and SM plus KT (n = 21). Pain intensity, functional disability level and trunk flexor-extensor muscles endurance were assessed by Numerical Rating Scale (NRS), Oswestry pain and disability index (ODI), McQuade test, and unsupported trunk holding test, respectively. The tests were done before and immediately, one day, one week, and one month after the interventions and compared between the two groups.
After treatments, pain intensity and disability level decreased and endurance of trunk flexor-extensor muscles increased significantly in both groups. Repeated measures analysis, however, showed that there was no significant difference between the groups in any of the evaluations.
The authors, physiotherapists from Iran, concluded that the findings of the present study showed that adding KT to SM does not appear to have a significant extra effect on pain, disability and muscle endurance in athletes with CNLBP. However, more studies are needed to examine the therapeutic effects of KT in treating these patients.
Regular readers of my blog will be able to predict what I have to say about this study design: A+B versus B is not a meaningful test of anything. I used to claim that it cannot possibly produce a negative result – and yet, here it seems to have done exactly that!
How come?
The way I see it, there are two possibilities to explain this:
- the KT has a mildly negative effect on CNLBP; thus the expected positive placebo-effect was neutralised to result in a null-effect overall;
- the study was under-powered such that the true inter-group difference could not manifest itself.
I think the second possibility is more likely, but it does really not matter at all. Because the only lesson we can learn from this trial is this: inadequate study designs will hardly ever generate anything worthwhile.
And this is, I think, a lesson that would be valuable for many researchers.
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Reference
Comparing spinal manipulation with and without Kinesio Taping® in the treatment of chronic low back pain.
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