A recent comment to a post of mine (by a well-known and experienced German alt med researcher) made the following bold statement aimed directly at me and at my apparent lack of understanding research methodology:
C´mon , as researcher you should know the difference between efficacy and effectiveness. This is pharmacological basic knowledge. Specific (efficacy) + nonspecific effects = effectiveness. And, in fact, everything can be effective – because of non-specific or placebo-like effects. That does not mean that efficacy is existent.
The point he wanted to make is that outcome studies – studies without a control group where the researcher simply observe the outcome of a particular treatment in a ‘real life’ situation – suffice to demonstrate the effectiveness of therapeutic interventions. This belief is very wide-spread in alternative medicine and tends to mislead all concerned. It is therefore worth re-visiting this issue here in an attempt to create some clarity.
When a patient’s condition improves after receiving a therapy, it is very tempting to feel that this improvement reflects the effectiveness of the intervention (as the researcher mentioned above obviously does). Tempting but wrong: there are many other factors involved as well, for instance:
- the placebo effect (mainly based on conditioning and expectation),
- the therapeutic relationship with the clinician (empathy, compassion etc.),
- the regression towards the mean (outliers tend to return to the mean value),
- the natural history of the patient’s condition (most conditions get better even without treatment),
- social desirability (patients tend to say they are better to please their friendly clinician),
- concomitant treatments (patients often use treatments other than the prescribed one without telling their clinician).
So, how does this fit into the statement above ‘Specific (efficacy) + nonspecific effects = effectiveness’? Even if this formula were correct, it would not mean that outcome studies of the nature described demonstrate the effectiveness of a therapy. It all depends, of course, on what we call ‘non-specific’ effects. We all agree that placebo-effects belong to this category. Probably, most experts also would include the therapeutic relationship and the regression towards the mean under this umbrella. But the last three points from my list are clearly not non-specific effects of the therapy; they are therapy-independent determinants of the clinical outcome.
The most important factor here is usually the natural history of the disease. Some people find it hard to imagine what this term actually means. Here is a little joke which, I hope, will make its meaning clear and memorable.
CONVERATION BETWEEN TWO HOSPITAL DOCTORS:
Doc A: The patient from room 12 is much better today.
Doc B: Yes, we stared his treatment just in time; a day later and he would have been cured without it!
I am sure that most of my readers now understand (and never forget) that clinical improvement cannot be equated with the effectiveness of the treatment administered (they might thus be immune to the misleading messages they are constantly exposed to). Yet, I am not at all sure that all ‘alternativists’ have got it.
Reflexology is the treatment of reflex zones, usually on the sole of the feet, with manual massage and pressure. Reflexologists assume that certain zones correspond to certain organs, and that their treatment can influence the function of these organs. Thus reflexology is advocated for all sorts of conditions. Proponents are keen to point out that their approach has many advantages: it is pleasant (the patient feels well with the treatment and the therapist feels even better with the money), safe and cheap, particularly if the patient does the treatment herself.
Self-administered foot reflexology could be practical because it is easy to learn and not difficult to apply. But is it also effective? A recent systematic review evaluated the effectiveness of self-foot reflexology for symptom management.
Participants were healthy persons not diagnosed with a specific disease. The intervention was foot reflexology administered by participants, not by practitioners or healthcare providers. Studies with either between groups or within group comparison were included. The electronic literature searches utilized core databases (MEDLINE, EMBASE, Cochrane, and CINAHL Chinese (CNKI), Japanese (J-STAGE), and Korean databases (KoreaMed, KMbase, KISS, NDSL, KISTI, and OASIS)).
Three non-randomized trials and three before-and-after studies met the inclusion criteria. No RCTs were located. The results of these studies showed that self-administered foot reflexology resulted in significant improvement in subjective outcomes such as perceived stress, fatigue, and depression. However, there was no significant improvement in objective outcomes such as cortisol levels, blood pressure, and pulse rate. We did not find any randomized controlled trial.
The authors concluded that this study presents the effectiveness of self-administered foot reflexology for healthy persons’ psychological and physiological symptoms. While objective outcomes showed limited results, significant improvements were found in subjective outcomes. However, owing to the small number of studies and methodological flaws, there was insufficient evidence supporting the use of self-performed foot reflexology. Well-designed randomized controlled trials are needed to assess the effect of self-administered foot reflexology in healthy people.
I find this review quite interesting, but I would draw very different conclusions from its findings.
The studies that are available turned out to be of very poor methodological quality: they lack randomisation or rely on before/after comparisons. This means they are wide open to bias and false-positive results, particularly in regards to subjective outcome measures. Predictably, the findings of this review confirm that no effects are seen on objective endpoints. This is in perfect agreement with the hypothesis that reflexology is a pure placebo. Considering the biological implausibility of the underlying assumptions of reflexology, this makes sense.
My conclusions of this review would therefore be as follows: THE RESULTS ARE IN KEEPING WITH REFLEXOLOGY BEING A PURE PLACEBO.
Iyengar Yoga, named after and developed by B. K. S. Iyengar, is a form of Hatha Yoga that has an emphasis on detail, precision and alignment in the performance of posture (asana) and breath control (pranayama). The development of strength, mobility and stability is gained through the asanas.
B.K.S. Iyengar has systematised over 200 classical yoga poses and 14 different types of Pranayama (with variations of many of them) ranging from the basic to advanced. This helps ensure that students progress gradually by moving from simple poses to more complex ones and develop their mind, body and spirit step by step.
Iyengar Yoga often makes use of props, such as belts, blocks, and blankets, as aids in performing asanas (postures). The props enable students to perform the asanas correctly, minimising the risk of injury or strain, and making the postures accessible to both young and old.
Sounds interesting? But does it work?
The objective of this recent systematic review was to conduct a systematic review of the existing research on Iyengar yoga for relieving back and neck pain. The authors conducted extensive literature searches and found 6 RCTs that met the inclusion criteria.
The difference between the groups on the post-intervention pain or functional disability intensity assessment was, in all 6 studies, favouring the yoga group, which projected a decrease in back and neck pain.
The authors concluded that Iyengar yoga is an effective means for both back and neck pain in comparison to control groups. This systematic review found strong evidence for short-term effectiveness, but little evidence for long-term effectiveness of yoga for chronic spine pain in the patient-centered outcomes.
So, if we can trust this evidence (I would not call the evidence ‘strong), we have yet another treatment that might be effective for acute back and neck pain. The trouble, I fear, is not that we have too few such treatments, the trouble seems to be that we have too many of them. They all seem similarly effective, and I cannot help but wonder whether, in fact, they are all similarly ineffective.
Regardless of the answer to this troubling question, I feel the need to re-state what I have written many times before: FOR A CONDITION WITH A MULTITUDE OF ALLEGEDLY EFFECTIVE THERAPIES, IT MIGHT BE BEST TO CHOSE THE ONE THAT IS SAFEST AND CHEAPEST.
Homeopathy has many critics who claim that there is no good evidence for this type of therapy. Homeopaths invariably find this most unfair and point to a plethora of studies that show an effect. They are, of course, correct! There are plenty of trials that suggest that homeopathic remedies do work. The question, however, is HOW RELIABLE ARE THESE STUDIES?
Here is a brand new one which might stand for dozens of others.
In this study, homeopaths treated 50 multimorbid patients with homeopathic remedies identifies by a method called ‘polarity analysis’ (PA) and prospectively followed them over one year (PA enables homeopaths to calculate a relative healing probability, based on Boenninghausen’s grading of polar symptoms).
The 43 patients (86%) who completed the observation period experienced an average improvement of 91% in their initial symptoms. Six patients dropped out, and one did not achieve an improvement of 80%, and was therefore also counted as a treatment failure. The cost of homeopathic treatment was 41% of projected equivalent conventional treatment.
Good news then for enthusiasts of homeopathy? 91% improvement!
Yet, I am afraid that critics might not be bowled over. They might smell a whiff of selection bias, lament the lack of a control group or regret the absence of objective outcome measures. But I was prepared to go as far as stating that such results might be quite interesting… until I read the authors’ conclusions that is:
Polarity Analysis is an effective method for treating multimorbidity. The multitude of symptoms does not prevent the method from achieving good results. Homeopathy may be capable of taking over a considerable proportion of the treatment of multimorbid patients, at lower costs than conventional medicine.
Virtually nothing in these conclusions is based on the data provided. They are pure extrapolation and wild assumptions. Two questions seem to emerge from this:
- How on earth can we take this and so many other articles on homeopathy seriously?
- When does this sort of article cross the line between wishful thinking and scientific misconduct?
Reiki is a form of energy healing that evidently has been getting so popular that, according to the ‘Shropshire Star’, even stressed hedgehogs are now being treated with this therapy. In case you argue that this publication is not cutting edge when it comes to reporting of scientific advances, you may have a point. So, let us see what evidence we find on this amazing intervention.
A recent systematic review of the therapeutic effects of Reiki concludes that the serious methodological and reporting limitations of limited existing Reiki studies preclude a definitive conclusion on its effectiveness. High-quality randomized controlled trials are needed to address the effectiveness of Reiki over placebo. Considering that this article was published in the JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE, this is a fairly damming verdict. The notion that Reiki is but a theatrical placebo recently received more support from a new clinical trial.
This pilot study examined the effects of Reiki therapy and companionship on improvements in quality of life, mood, and symptom distress during chemotherapy. Thirty-six breast cancer patients received usual care, Reiki, or a companion during chemotherapy. Data were collected from patients while they were receiving usual care. Subsequently, patients were randomized to either receive Reiki or a companion during chemotherapy. Questionnaires assessing quality of life, mood, symptom distress, and Reiki acceptability were completed at baseline and chemotherapy sessions 1, 2, and 4. Reiki was rated relaxing and caused no side effects. Both Reiki and companion groups reported improvements in quality of life and mood that were greater than those seen in the usual care group.
The authors of this study conclude that interventions during chemotherapy, such as Reiki or companionship, are feasible, acceptable, and may reduce side effects.
This is an odd conclusion, if there ever was one. Clearly the ‘companionship’ group was included to see whether Reiki has effects beyond simply providing sympathetic attention. The results show that this is not the case. It follows, I think, that Reiki is a placebo; its perceived relaxing effects are the result of non-specific phenomena which have nothing to do with Reiki per se. The fact that the authors fail to spell this out more clearly makes me wonder whether they are researchers or promoters of Reiki.
Some people will feel that it does not matter how Reiki works, the main thing is that it does work. I beg to differ!
If its effects are due to nothing else than attention and companionship, we do not need ‘trained’ Reiki masters to do the treatment; anyone who has time, compassion and sympathy can do it. More importantly, if Reiki is a placebo, we should not mislead people that some super-natural energy is at work. This only promotes irrationality – and, as Voltaire once said: those who make you believe in absurdities can make you commit atrocities.
The Alexander Technique is a method aimed at re-educating people to do everyday tasks with less muscular and mental tension. According to the ‘Complete Guide to the Alexander Technique’, this method can help you if:
- You suffer from repetitive strain injury or carpal tunnel syndrome.
- You have a backache or stiff neck and shoulders.
- You become uncomfortable when sitting at your computer for long periods of time.
- You are a singer, musician, actor, dancer or athlete and feel you are not performing at your full potential.
Sounds good!? But which of these claims are actually supported by sound evidence.
Our own systematic review from 2003 of the Alexander Technique (AT) found just 4 clinical studies. Only two of these trials were methodologically sound and clinically relevant. Their results were promising and implied that AT is effective in reducing the disability of patients suffering from Parkinson’s disease and in improving pain behaviour and disability in patients with back pain. A more recent review concluded as follows: Strong evidence exists for the effectiveness of Alexander Technique lessons for chronic back pain and moderate evidence in Parkinson’s-associated disability. Preliminary evidence suggests that Alexander Technique lessons may lead to improvements in balance skills in the elderly, in general chronic pain, posture, respiratory function and stuttering, but there is insufficient evidence to support recommendations in these areas.
This suggests that the ‘Complete Guide’ is based more on wishful thinking than on evidence. But what about the value of AT for performers – after all, it is for this purpose that Alexander developed his method?
A recent systematic review aimed to evaluate the evidence for the effectiveness of AT sessions on musicians’ performance, anxiety, respiratory function and posture. The following electronic databases were searched up to February 2014 for relevant publications: PUBMED, Google Scholar, CINAHL, EMBASE, AMED, PsycINFO and RILM. The search criteria were “Alexander Technique” AND “music*”. References were searched, and experts and societies of AT or musicians’ medicine contacted for further publications.
In total, 237 citations were assessed. 12 studies were included for further analysis, 5 of which were randomised controlled trials (RCTs), 5 controlled but not randomised (CTs), and 2 mixed methods studies. Main outcome measures in RCTs and CTs were music performance, respiratory function, performance anxiety, body use and posture. Music performance was judged by external experts and found to be improved by AT in 1 of 3 RCTs; in 1 RCT comparing neurofeedback (NF) to AT, only NF caused improvements. Respiratory function was investigated in 2 RCTs, but not improved by AT training. Performance anxiety was mostly assessed by questionnaires and decreased by AT in 2 of 2 RCTs and in 2 of 2 CTs.
From this evidence, the authors drew the following conclusion: A variety of outcome measures have been used to investigate the effectiveness of AT sessions in musicians. Evidence from RCTs and CTs suggests that AT sessions may improve performance anxiety in musicians. Effects on music performance, respiratory function and posture yet remain inconclusive. Future trials with well-established study designs are warranted to further and more reliably explore the potential of AT in the interest of musicians.
So, there you are: if you are a performing artist, AT seems to be useful for you. If you have health problems (other than perhaps back pain), I would look elsewhere for help.
I just came across this hilarious yet revealing article by Italian authors defending homeopathy. It is far too remarkable to keep it for myself, and I therefore decided to quote its abstract here in full:
Throughout its over 200-year history, homeopathy has been proven effective in treating diseases for which conventional medicine has little to offer. However, given its low cost, homeopathy has always represented a serious challenge and a constant threat to the profits of drug companies. Moreover, since drug companies represent the most relevant source of funding for biomedical research worldwide, they are in a privileged position to finance detractive campaigns against homeopathy by manipulating the media as well as academic institutions and the medical establishment. The basic argument against homeopathy is that in some controlled clinical trials (CCTs), comparison with conventional treatments shows that its effects are not superior to those of placebo. Against this thesis we argue that a) CCT methodology cannot be applied to homeopathy, b) misconduct and fraud are common in CCTs, c) adverse drug reactions and side effects show that CCT methodology is deeply flawed, d) an accurate testing of homeopathic remedies requires more sophisticated techniques, e) the placebo effect is no more “plausible” than homeopathy, and its real nature is still unexplained, and f) the placebo effect is nevertheless a “cure” and, as such, worthy of further investigation and analysis. It is concluded that no arguments presently exist against homeopathy and that the recurrent campaigns against it represent the specific interests of the pharmaceutical industry which, in this way, strives to protect its profits from the “threat” of a safer, more effective, and much less expensive treatment modality.
Despite (or is it because?) of such nonsense, homeopathy seems to be very popular, especially in the treatment of small children, and particularly for conditions where conventional medicine has no effective treatment. Teething problems are thus an ideal target for the homeopathic industry.
A survey of British GPs found that the most frequently prescribed homeopathic remedies were for common self-limiting infantile conditions such as colic, cuts and bruises, and teething. Similarly, the Avon-study suggested that homeopathic Chamomillia is popular to alleviate the pain of teething. And prominent homeopaths recommend that “teething often responds to Chamomilla.“
One website also recommends Chamomilla as well as several other homeopathic remedies leaving little doubt about their efficacy:
Chamomilla 6c: When teething is very painful and the child becomes quite cranky, satisfied with nothing and pacified only by being carried, then Chamomilla may help. Sometimes, the child seeking some relief from the discomfort will demand one thing after another, rejecting each one when it does not give relief. Children who could benefit from this remedy are very irritable, with a cry that sounds as if they are in pain. Chamomilla 6c can be taken every thirty minutes, up to six times per day, while symptoms persist.
Mercurius sol 6c: This remedy may be of help in cases where teething is accompanied by excessive salivation and drooling. In addition, the gums are likely to be red and sore, and the child may have diarrhea with a foul smell to it. Mercurius sol 6c can be taken four to six times per day for two to three days; its use should be discontinued when the symptoms diminish.
>Belladonna 30c: For children who tend to develop a fever with a flushed, red face when they are cutting teeth, Belladonna may be a good choice. Often the eyes have a glassy look due to the dilation of the pupils. The child may be irritable and crying as if angry. Belladonna 30c can be taken every thirty minutes up to four times per day, while symptoms continue.
Aconite napellus 30c: When the symptoms come on quickly and include physical and mental restlessness, this remedy may be useful. The affected gums will be hot, swollen, and inflamed and there may also be an earache with aversion to loud noises. The condition may come on following exposure to cold, dry winds. Try Aconite napellus 30c every hour for up to six times per day.
Calcarea carbonica 6c: When children are finally cutting teeth that have been late in erupting, Calcarea carbonica could be helpful. This remedy is often helpful with “late bloomers,” babies who develop a little more slowly, crawling, walking, and cutting teeth on their own schedule, weeks or months later than some other babies or toddlers. Children likely to benefit from Calcarea carbonica often have sweaty heads and feet and may have a tendency to develop cradle cap or yeast infections. With teething, they often do not show the extreme irritability that calls for Chamomilla, or the fever that indicates Belladonna, but they may have teeth that seem permanently on the verge of breaking through the surface. Calcarea carbonica 6c can be taken three times per day, for up to ten days; its use should be discontinued when symptoms improve.
Given this level of assurance, it not really surprising that manufacturers of homeopathic remedies want to profit from all this. Anxious mothers must seem like sitting ducks to the homeopathic industry.
Camilia, a homeopathic teething remedy that contains Chamomillia in the 9c potency from Boiron, the world’s largest producer of homeopathic products, will be launched shortly in the UK. The PR-agency in charge of the UK campaign to promote camilia announced that they will focus on a “national awareness drive through earned and paid-for media along with influencer engagement.” The agency is also responsible for re-building the brand’s website and implementing a strategy to drive discovery online. Amanda Meyrick of Clarion Communications, said: “Launching a product into a new market gives us the opportunity to work in partnership from the beginning to establish Camilia in the UK, and we are looking forward to seeing the results of our planning and creativity.” Remarkably, nobody seems to mention efficacy as a factor in the promotion of camilia.
However, the product is already available in the US, and from the US website we learn that this remedy “temporarily relieves symptoms of teething, including painful gums and irritability.” So, there are clear claims of efficacy after all!
Boiron is not the only firm who aim to profit from the vast market of teething problems. Nelson’s Teetha, for instance, is already available in the UK. Each 300mg sachet of TEETHA contains “the active ingredient of Chamomilla 6c.” Even Boots, the UK’s ‘trusted’ high street pharmacy, sell a product called ‘TEETHING PAIN RELIEF’ which also contains Chamomilla 6c, its only ‘active’ ingredient. Even the name of their product carries a therapeutic claim for efficacy, in my view.
But hold on! A 6c dilution equals one ml of plant extract diluted in 1 000 000 000 litres of water (add 6 zeros to that figure for the Boiron product)!!! Is that really going to alleviate teething problems?
Of course not!, you will say. Dilutions of this nature will do nothing whatsoever.
But they are not just dilutions, they are potentiations! would the homeopaths counter; they have been succussed at each dilution step, and this process transfers a vital force from the Chamomilla extract to the remedy. Yes, of course, how could I forget – it’s homeopathy where LIKE CURES LIKE and people believe in the tooth fairy.
But this does not make any sense either!
Chamomillia is nothing other than chamomile, a plant known to sooth through its anti-inflammatory actions. So, in highly diluted homeopathic products, the actions of this plant should be reversed according to the ‘like cures like’ principle. That means that these teething products, according to homeopathic ‘logic’, is not for treating inflamed gums but for treating the absence of inflammation.
My mind boggles because nothing seems to make sense any more:
- according to real science (or just common sense), the dilutions are far to high to have any effect at all,
- according to homeopathic ‘logic’, these products should, if anything, produce inflammation and not alleviate it,
- according to the best clinical evidence, homeopathic remedies are not effective for teething; I am not aware of a single rigorous trial that would show its efficacy, and current reviews do not recommend homeopathy for teething problems,
- regardless of all this and despite of regulations prohibiting it, therapeutic claims are being made for these over-priced placebos.
IT’S HOMEOPATHY STUPID!
Most pharmacies worldwide sell any bogus treatment to their unsuspecting customers, it seems – as long as it makes a profit, anything goes! Not in New Zealand!
The New Zealand’s Pharmacy Council’s Safe Effective Pharmacy Practice Code of Ethics 2011 section 6.9 requires of pharmacists that:
“YOU MUST… Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.”
This instruction was the basis for a complaint against a New Zealand pharmacy selling a homeopathic remedy against jet lag called “No-Jet-Lag”. The New Zealand Advertising Standards Authority (ASA) considered the complaint and decided to uphold it. The complaint, which was lodged with the ASA by the Society for Science Based Healthcare in July 2014, alleged that the advertisement’s claims about the product that “It Really Works” for “Homeopathic Jet Lag Prevention” were unsubstantiated and misleading.
In defence of their advertising, the manufacturer of the product, Miers Laboratories, submitted a study they had conducted with their product. However, the Advertising Standards Complaints Board ruled that: “the trial population in the pilot study was small, the methodology was not robust and the results had not been published or peer reviewed. The Complaints Board also noted the study was an in-house trial conducted by the Advertiser rather than independent research…Given the weaknesses in the study, the majority of the Complaints Board said the Advertiser had not satisfactorily substantiated the claim the product “really works” and, as such, the Complaints Board said the advertisement had the potential to mislead consumers. Consequently, the Complaints Board said the advertisement did not observe a high standard of social responsibility required of advertisements of this type.”
However, today I found the following text still on the website of the company: Jet lag is the curse of modern jet travel, but it doesn´t have to spoil your trip. The unique homeopathic remedy No-Jet-Lag helps ensure holiday enjoyment and working efficiency even after long airline flights. No-Jet-Lag is raved about by satisfied travellers globally, including business executives, sports teams, tour operators, and flight crews. It is safe, easy to take, and proven effective in tests.
Are the days of “No-Jet-Lag” counted?
Why do not all countries’ pharmacists have such codes of ethics?
On this blog, I have often pointed out how dismally poor most of the trials of alternative therapies frequently are, particularly those in the realm of chiropractic. A brand-new study seems to prove my point.
The aim of this trial was to determine whether spinal manipulative therapy (SMT) plus home exercise and advice (HEA) compared with HEA alone reduces leg pain in the short and long term in adults with sub-acute and chronic back-related leg-pain (BRLP).
Patients aged 21 years or older with BRLP for least 4 weeks were randomised to receive 12 weeks of SMT plus HEA or HEA alone. Eleven chiropractors with a minimum of 5 years of practice experience delivered SMT in the SMT plus HEA group. The primary outcome was subjective BRLP at 12 and 52 weeks. Secondary outcomes were self-reported low back pain, disability, global improvement, satisfaction, medication use, and general health status at 12 and 52 weeks.
Of the 192 enrolled patients, 191 (99%) provided follow-up data at 12 weeks and 179 (93%) at 52 weeks. For leg pain, SMT plus HEA had a clinically important advantage over HEA (difference, 10 percentage points [95% CI, 2 to 19]; P = 0.008) at 12 weeks but not at 52 weeks (difference, 7 percentage points [CI, -2 to 15]; P = 0.146). Nearly all secondary outcomes improved more with SMT plus HEA at 12 weeks, but only global improvement, satisfaction, and medication use had sustained improvements at 52 weeks. No serious treatment-related adverse events or deaths occurred.
The authors conclude that, for patients with BRLP, SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks.
This is yet another pragmatic trial following the notorious and increasingly popular A+B versus B design. As pointed out repeatedly on this blog, this study design can hardly ever generate a negative result (A+B is always more than B, unless A has a negative value [which even placebos don’t have]). Thus it is not a true test of the experimental treatment but all an exercise to create a positive finding for a potentially useless treatment. Had the investigators used any mildly pleasant placebo with SMT, the result would have been the same. In this way, they could create results showing that getting a £10 cheque or meeting with pleasant company every other day, together with HEA, is more effective than HEA alone. The conclusion that the SMT, the cheque or the company have specific effects is as implicit in this article as it is potentially wrong.
The authors claim that their study was limited because patient-blinding was not possible. This is not entirely true, I think; it was limited mostly because it failed to point out that the observed outcomes could be and most likely are due to a whole range of factors which are not directly related to SMT and, most crucially, because its write-up, particularly the conclusions, wrongly implied cause and effect between SMT and the outcome. A more accurate conclusion could have been as follows: SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks. Because the trial design did not control for non-specific effects, the observed outcomes are consistent with SMT being an impressive placebo.
No such critical thought can be found in the article; on the contrary, the authors claim in their discussion section that the current trial adds to the much-needed evidence base about SMT for subacute and chronic BRLP. Such phraseology is designed to mislead decision makers and get SMT accepted as a treatment of conditions for which it is not necessarily useful.
Research where the result is known before the study has even started (studies with a A+B versus B design) is not just useless, it is, in my view, unethical: it fails to answer a real question and is merely a waste of resources as well as an abuse of patients willingness to participate in clinical trials. But the authors of this new trial are in good and numerous company: in the realm of alternative medicine, such pseudo-research is currently being published almost on a daily basis. What is relatively new, however, that even some of the top journals are beginning to fall victim to this incessant stream of nonsense.
For every condition which is not curable by conventional medicine there are dozens of alternative treatments that offer a cure or at least symptomatic relief. Multiple sclerosis (MS) is such a disease. It is hard to find an alternative therapy that is not being promoted for MS.
Acupuncture is, of course, no exception. It is widely promoted for treating MS symptoms and many MS patients spend lots of money hoping that it does. The US ‘National MS Society’, For instance claim that acupuncture may provide relief for some MS-related symptoms, including pain, spasticity, numbness and tingling, bladder problems, and depression. There is no evidence, however, that acupuncture can reduce the frequency of MS exacerbations or slow the progression of disability. And the ‘British Acupuncture Council’ state that acupuncture may provide relief for some MS-related symptoms, including pain, spasticity, numbness and tingling, bladder problems, and depression.
Such claims seem a little over-optimistic; let’s have a look what the evidence really tells us.
The purpose of this brand-new review was to assess the literature on the effectiveness of acupuncture for treating MS. A literature search resulted in 12 peer-reviewed articles on the subject that examined the use of acupuncture to treat MS related quality of life, fatigue, spasticity, and pain. The majority of the studies were poorly designed-without control, randomization, or blinding. Description of the subjects, interventions, and outcome measures as well as statistical analysis were often lacking or minimal.
The authors concluded that although many of the studies suggested that acupuncture was successful in improving MS related symptoms, lack of statistical rigor and poor study design make it difficult to draw any conclusions about the true effectiveness of this intervention in the MS population. Further studies with more rigorous designs and analysis are needed before accurate claims can be made as to the effectiveness of acupuncture in this population.
And what about other alternative therapies? Our own systematic review of the subject included 12 randomized controlled trials: nutritional therapy (4), massage (1), Feldenkrais bodywork (1), reflexology (1), magnetic field therapy (2), neural therapy (1) and psychological counselling (2). But the evidence was not compelling for any of these therapies, with many trials suffering from significant methodological flaws. There is evidence to suggest some benefit of nutritional therapy for the physical symptoms of MS. Magnetic field therapy and neural therapy appear to have a short-term beneficial effect on the physical symptoms of MS. Massage/bodywork and psychological counselling seem to improve depression, anxiety and self-esteem.
That was some time ago, and it is therefore reasonable to ask: has the evidence changed? Thankfully, the ‘American Academy of Neurology’ has just published the following guidelines entitles complementary and alternative medicine in multiple sclerosis:
Clinicians might offer oral cannabis extract for spasticity symptoms and pain (excluding central neuropathic pain) (Level A). Clinicians might offer tetrahydrocannabinol for spasticity symptoms and pain (excluding central neuropathic pain) (Level B). Clinicians should counsel patients that these agents are probably ineffective for objective spasticity (short-term)/tremor (Level B) and possibly effective for spasticity and pain (long-term) (Level C). Clinicians might offer Sativex oromucosal cannabinoid spray (nabiximols) for spasticity symptoms, pain, and urinary frequency (Level B). Clinicians should counsel patients that these agents are probably ineffective for objective spasticity/urinary incontinence (Level B). Clinicians might choose not to offer these agents for tremor (Level C). Clinicians might counsel patients that magnetic therapy is probably effective for fatigue and probably ineffective for depression (Level B); fish oil is probably ineffective for relapses, disability, fatigue, MRI lesions, and quality of life (QOL) (Level B); ginkgo biloba is ineffective for cognition (Level A) and possibly effective for fatigue (Level C); reflexology is possibly effective for paresthesia (Level C); Cari Loder regimen is possibly ineffective for disability, symptoms, depression, and fatigue (Level C); and bee sting therapy is possibly ineffective for relapses, disability, fatigue, lesion burden/volume, and health-related QOL (Level C). Cannabinoids may cause adverse effects. Clinicians should exercise caution regarding standardized vs nonstandardized cannabis extracts and overall CAM quality control/nonregulation. Safety/efficacy of other CAM/CAM interaction with MS disease-modifying therapies is unknown.
Interestingly, on yesterday it was announced that the NHS in Wales has just made available a cannabis-based spray for MS-sufferers (I should mention that most cannabis-based preparations are not full plant extracts and thus by definition not herbal but conventional medicines).
It would be wonderful, if other alternative therapies were of proven benefit to MS-sufferers. But sadly, this does not seem to be the case. I think it is better to be truthful about this than to raise false hopes of desperate patients.