According to Bloomberg Markets, A Nelson & Co Ltd. manufactures and markets natural healthcare products. The company offers arnica creams that provide natural first aid for bruises; plant and flower based remedies that help in managing the emotional demands of everyday life; and over-the-counter homeopathic medicines for everyday ailments, such as relief from travel sickness and relief for the symptoms of hay fever. It also provides hemorrhoid relief creams and soothing hygienic wipes; anti-blemish range products for various skin types and age groups; multi-purpose cream that helps to soothe and restore skin; iron supplements; teething granules that provide relief from the symptoms and discomfort of teething; a range of creams, ointments, and sprays for a range of common skin conditions/complaints; and a range of commonly used herbal remedies. The company offers products for ailments, including aches and pains, mild anxiety, babies and children, colds and minor infections, digestion, emotional health, energy, everyday stresses, first aid, getting older, pets, quit smoking, skin, sleep, travel, and women’s health. It also operates a clinic; and a pharmacy that offers homeopathy and complementary healthcare products. The company offers its products through its pharmacy in the United Kingdom; and distributors in Europe, Latin America, and internationally. It also serves customers online. The company was formerly known as Armbrecht, Nelson & Co. The company was founded in 1860 and is based in London, United Kingdom with subsidiary offices in Boston, Massachusetts; and Hamburg, Germany. A Nelson & Co Ltd. operates as a subsidiary of Nelson and Russell Holdings Ltd.
In the journal ‘Chemist and Druggist’ we find an article informing us that, in 1930, Nelsons Homeopathic Pharmacy was approached by Dr Edward Bach who wanted help making and selling his products. He had created 38 flower remedies to rebalance emotions and later created an emergency remedy, a combination of five flower remedies that became Rescue. The relationship between Nelsons and the Dr Edward Bach Centre, based at Dr Bach’s former home at Mount Vernon in Oxfordshire, continues to this day and both the Bach Original Flower Remedies and Rescue are key ranges for Nelsons.
Nelson’s homeopathic pharmacy has a proud history:
Ernst Louis Armbrecht, a German pharmacist and disciple of Samuel Hahnemann, came to London and founded Nelsonsin 1860. Since then, Nelsons has been supplying homeopathic medicines. “Our wish today” they state “is the same as 152 years ago: to make homeopathy accessible and to provide the highest standards of medicine and advice.”
The highest standards of medicine and advice? It seems that the Advertising Standards Authority (ASA) disagrees. A recent ASA Adjudication on A Nelson & Co Ltd deals with an advertisement by Nelsons for ‘Bach Rescue Night’ which stated “I CAN’T SWITCH OFF…The RESCUE NIGHT range helps your mind switch off, so you can enjoy a natural night’s sleep”
A freelance health writer had challenged whether the claims “I can’t switch off … Rescue Night range helps your mind switch off, so you can enjoy a natural night’s sleep” was an authorised health claim in the EU Register of Nutrition and Health Claims for Foods (the EU Register).
The ASA noted that, according to EC Regulation 1924/2006 on Nutrition and Health Claims made on Foods (the Regulation), which was reflected in the CAP Code, only health claims which appeared on the list of authorised health claims (the Register) could be made in ads promoting foods, including food supplements. Health claims were defined as those that stated, suggested or implied that a relationship existed between a food category, a food or one of its constituents and health.
The ASA furthermore stated: We acknowledged Rescue Remedy’s assertion that their ad had not made specific claims to aid sleep or that it improved sleep. However, we considered that the use of visuals such as a crescent moon and stars on a dark background, that the letter ‘O’ in the word “OFF” resembled a simple on/ off light switch image, the text “… you can enjoy a natural night’s sleep” and the name of the product “Rescue Night” was likely to give the impression to consumers that it was a product that would aid sleep or that it would help consumers fall asleep easily. We understood that ‘unwanted thoughts’ was one reason why consumers might find it difficult to get to sleep and, again, considered this added to the impression that the product would contribute positively to sleep. We therefore considered that the ad made a health claim related to sleep involving a food item.
We understood that some Bach Flower Remedies contained levels of alcohol which would preclude them from bearing health claims altogether, however, we noted that Bach Rescue Night was alcohol free. We acknowledged Rescue Remedy’s points regarding EFSA and ‘on hold’ claims for botanicals. We understood that ‘on hold’ claims for such botanicals could be used in marketing, provided such use had the same meaning as the proposed claim and they were used in compliance with applicable existing national provisions (in this case the CAP Code). However, Rescue Remedy did not provide evidence that relevant proposed claims for white chestnut, or any of the other product ingredients were ‘on hold’. Nevertheless, we understood that there were no ‘on hold’ claims entered onto the Register for white chestnut or the other product ingredients. Furthermore, ‘on hold’ claims should also be supported with adequate substantiation which we did not receive.
Because the ad made health claims relating to Bach Rescue Night as a sleep aid and we had not seen evidence that relevant claims for the botanical ingredients contained in the product were ‘on hold’, we concluded that the ad breached the Code.
The ad breached CAP Code (Edition 12) rules 15.1, 15.1.1 and 15.7 (Food, food supplements and associated health or nutritional claims).
The ASA ruled that the ad must not appear again in its current form. We told A Nelson & Co Ltd t/a rescueremedy.co.uk not to make health claims for botanical ingredients if they did not comply with the requirements of the Regulation.
I am afraid that such a ruling will have very little effect on the sale of Bach Flower Remedies. In case you have any doubt, I should mention that these inventions of Dr Bach are not supported by good evidence. Here is the abstract of my systematic review on the subject:
Bach flower remedies continue to be popular and its proponents make a range of medicinal claims for them. The aim of this systematic review was to critically evaluate the evidence for these claims. Five electronic databases were searched without restrictions on time or language. All randomised clinical trials of flower remedies were included. Seven such studies were located. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. It is concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.
Bach Flower Remedies have no effect whatsoever!
Come to think of it, this is not entirely true: they obviously keep the ASA busy, they exploit the gullible public, and they are clearly good for the cash flow at Nelson’s.
I reported previously on this blog that the Australian National Health and Medical Research Council (NH&MRC) has made the most thorough and independent assessment of homeopathy in the history of this form of alternative therapy. The report published at the time was preliminary, and further evidence from parties that were critical of it needed to be taken into account.
Today (11/3/2015), the NH&MRC has released its final report on homeopathy. In essence, it concluded that there is no scientific basis for homeopathy and no quality evidence of its efficacy.
The report is similar in its conclusions to the UK Government Science and Technology 2010 Report on Homeopathy.
The summary of the report sates the following:
Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
Professor Warwick Anderson, CEO of the Council, commented: “All medical treatments and interventions should be underpinned by reliable evidence. NH&MRC’s review shows that there is no good quality evidence to support the claim that homeopathy works better than a placebo.”
The report confirms what many scientific and public health experts have maintained since about 200 years, that not only does homeopathy not work, if it did, chemistry, physics and physiology could not.
“In short, the continued promotion of homeopathy would represent a commercial scam preying on the gullible,” said Professor John Dwyer AO, President of Friends of Science in Medicine (FSM), a non-industry aligned advocacy group for quality evidence in health. “Worse still, as a placebo therapy, harm may occur when it replaces effective therapies, as those given homeopathic treatments may wrongly think that they and their children are protected from serious infections,” he added.
The report emphasises that ‘People who choose homeopathy may put their health at risk, if they reject or delay treatments for which there is good evidence for safety and effectiveness’.
“With so many pressures on the Australian health dollar the Government must stop subsidising unproven alternative therapies such as homeopathy through student loans for homeopathy and similar courses,” said Professor Rob Morrison OAM, Co-Vice President of FSM, “The government should also not subsidise health funds offering cover for pseudoscientific electives of this kind,” said Professor Morrison. “The government should at least mandate that health funds offer a cheaper option that does not include ‘belief based’ therapies,” he said.
“It is completely unprofessional and unethical now for pharmacies to sell homeopathic products,” said Emeritus Professor Alastair MacLennan AO, Co-Vice President of FSM, “These products should now be removed from pharmacies and retail outlets”.
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.
The discussion whether acupuncture is more than a placebo is as long as it is heated. Crucially, it is also quite tedious, tiresome and unproductive, not least because no resolution seems to be in sight. Whenever researchers develop an apparently credible placebo and the results of clinical trials are not what acupuncturists had hoped for, the therapists claim that the placebo is, after all, not inert and the negative findings must be due to the fact that both placebo and real acupuncture are effective.
Laser acupuncture (acupoint stimulation not with needle-insertion but with laser light) offers a possible way out of this dilemma. It is relatively easy to make a placebo laser that looks convincing to all parties concerned but is a pure and inert placebo. Many trials have been conducted following this concept, and it is therefore highly relevant to ask what the totality of this evidence suggests.
A recent systematic review did just that; specifically, it aimed to evaluate the effects of laser acupuncture on pain and functional outcomes when it is used to treat musculoskeletal disorders.
Extensive literature searches were used to identify all RCTs employing laser acupuncture. A meta-analysis was performed by calculating the standardized mean differences and 95% confidence intervals, to evaluate the effect of laser acupuncture on pain and functional outcomes. Included studies were assessed in terms of their methodological quality and appropriateness of laser parameters.
Forty-nine RCTs met the inclusion criteria. Two-thirds (31/49) of these studies reported positive effects. All of them were rated as being of high methodological quality and all of them included sufficient details about the lasers used. Negative or inconclusive studies mostly failed to demonstrate these features. For all diagnostic subgroups, positive effects for both pain and functional outcomes were more consistently seen at long-term follow-up rather than immediately after treatment.
The authors concluded that moderate-quality evidence supports the effectiveness of laser acupuncture in managing musculoskeletal pain when applied in an appropriate treatment dosage; however, the positive effects are seen only at long-term follow-up and not immediately after the cessation of treatment.
Surprised? Well, I am!
This is a meta-analysis I always wanted to conduct and never came round to doing. Using the ‘trick’ of laser acupuncture, it is possible to fully blind patients, clinicians and data evaluators. This eliminates the most obvious sources of bias in such studies. Those who are convinced that acupuncture is a pure placebo would therefore expect a negative overall result.
But the result is quite clearly positive! How can this be? I can see three options:
- The meta-analysis could be biased and the result might therefore be false-positive. I looked hard but could not find any significant flaws.
- The primary studies might be wrong, fraudulent etc. I did not see any obvious signs for this to be so.
- Acupuncture might be more than a placebo after all. This notion might be unacceptable to sceptics.
I invite anyone who sufficiently understands clinical trial methodology to scrutinise the data closely and tell us which of the three possibilities is the correct one.
Chinese proprietary herbal medicines (CPHMs) are a well-established and a hugely profitable part of Traditional Chinese Medicine (TCM) with a long history in China and elsewhere; they are used for all sorts of conditions, not least for the treatment of common cold. Many CPHMs have been listed in the ‘China national essential drug list’ (CNEDL), the official reference published by the Chinese Ministry of Health. One would hope that such a document to be based on reliable evidence – but is it?
The aim of a recent review was to provide an assessment on the potential benefits and harms of CPHMs for common cold listed in the CNEDL.
The authors of this assessment were experts from the Chinese ‘Centre for Evidence-Based Medicine’ and one well-known researcher of alternative medicine from the UK. They searched CENTRAL, MEDLINE, EMBASE, SinoMed, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites from their inception to 31 March 2013 for clinical studies of CPHMs listed in the CNEDL for common cold.
Of the 33 CPHMs listed in the 2012 CNEDL for the treatment of common cold, only 7 had any type of clinical trial evidence at all. A total of 6 randomised controlled trials (RCTs) and 7 case series (CSs) could be included in the assessments.
All these studies had been conducted in China and published in Chinese. All of them were burdened with poor study design and low methodological quality, and all had to be graded as being associated with a very high risk of bias.
The authors concluded that the use of CPHMs for common cold is not supported by robust evidence. Further rigorous well designed placebo-controlled, randomized trials are needed to substantiate the clinical claims made for CPHMs.
I should state that it is, in my view, most laudable that the authors draw such a relatively clear, negative conclusion. This does certainly not happen often with papers originating from China, and George Lewith, the UK collaborator in this article, is also not known for his critical attitude towards alternative medicine. But there are other, less encouraging issues here to mention.
In the discussion section of their paper, the authors mention that the CNEDL has been approved by the Chinese Ministry of Public Health and is currently regarded as the accepted reference point for the medicines used in China. They also explain that the CNEDL was officially launched and implemented in August 2009. The CNEDL is now up-dated every 3 years, and its 2012 edition contains 520 medicines, including 203 CPHMs. The CPHMs listed in CNEDL cover 137 herbal remedies for internal medicine, 11 for surgery, 20 for gynaecology, 7 for ophthalmology, 13 for otorhinolaryngology and 15 for orthopaedics and traumatology.
Moreover, the authors inform us that about 3,100 medical and clinical experts had been recruited to evaluate the safety, effectiveness and costs of CPHMs. The selection process of medicines into CNEDL was strictly in accordance with the principle that they ‘must be preventive and curative, safe and effective, affordable, easy to use, think highly of both Chinese and Western medicine’. A detailed procedure for evaluation is, however, not available because the files are confidential.
The authors finally state that their paper demonstrates that the selection of CPHMs into the CNEDL is less likely to be ‘evidence-based’ and revealed the sharp contrast between the policy and priority given to by the Chinese government to Traditional Chinese Medicine(TCM).
This surely must be a benign judgement, if there ever was one! I would say that the facts disclosed in this review show that TCM seems to exist in a strange universe where commercial interests are officially allowed to reign supreme over patients’ interests and public health.
Neck pain is a common problem which often causes significant disability. Chiropractic manipulation has become one of the most popular forms of alternative treatment for such symptoms. This seems surprising considering that neck manipulations are neither convincingly effective nor free of adverse effects.
The current Cochrane review on this subject could not be clearer: “Done alone, manipulation and/or mobilization were not beneficial; when compared to one another, neither was superior.” In the absence of compelling evidence for efficacy, any risk of neck manipulation would tilt the risk/benefit balance into the negative.
Adverse effects of neck manipulations range from mild symptoms, such as local neck tenderness or stiffness, to more severe injuries involving the spinal cord, peripheral nerve roots, and arteries within the neck. A recent paper reminds us that another serious complication has to be added to this already long list: phrenic nerve injury.
The phrenic nerve is responsible for controlling the contractions of the diaphragm, which allows the lungs to take in and release air and make us breathe properly. The phrenic nerve is formed from C3, C4, and C5 nerve fibres and descends along the anterior surface of the scalenus anterior muscle before entering the thorax to supply motor and sensory input to the diaphragm. Its anatomic location in the neck leaves it vulnerable to traumatic injury. Phrenic nerve injury can result in paralysis of the diaphragm and often leads to deteriorating function of the diaphragm, which can lead to partial or complete paralysis of the muscle and, as a result, serious breathing problems.
Patients who experience such problems may require emergency medical treatment or surgery. Sudden, severe damage to the phrenic nerve can make it impossible for the diaphragm to contract on its own. In order to make sure that the patient can breathe, a breathing tube needs to be inserted, a process called intubation. Artificial respiration would then be required.
American neurologists published a case report of a healthy man who consulted a chiropractor for his neck pain. Predictably, the chiropractor employed cervical manipulation to treat this condition. The result was bilateral diaphragmatic paralysis.
Similar cases have been reported previously, for instance, here and here and here and here. Damage to other nerves has also been documented to be a possible complication of spinal manipulation, for instance, here and here.
The authors of this new case report conclude that physicians must be aware of this complication and should be cautious when recommending spinal manipulation for the treatment of neck pain, especially in the presence of preexisting degenerative disease of the cervical spine.
I know what my chiropractic friends will respond to this post:
- I am alarmist,
- I cherry-pick articles that are negative for their profession,
- these cases are extreme rarities,
- conventional medicine is much more dangerous.
To this I reply: Imagine a conventional therapy about which the current Cochrane review says that it has no proven effect for the condition in question. Imagine further that this therapy causes mild to moderate adverse effects in about 50% of all patients in addition to very dramatic complications which are probably rare but, as no monitoring system exists, of unknown frequency. Imagine now that the professionals using this treatment more regularly than any other clinicians steadfastly deny that the risk/benefit balance is way out of kilter.
Would you call someone who repeatedly tries to warn the public of this situation ‘alarmist’?
Would you not consider the professionals who continue to practice the therapy in question to be irresponsible?
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.
If we go on the internet, we find no end of positive claims for TM. The official TM website, for instance, claims that more than 350 peer-reviewed research studies on the TM technique have been published in over 160 scientific journals. These studies were conducted at many US and international universities and research centers, including Harvard Medical School, Stanford Medical School, Yale Medical School, and UCLA Medical School.
This may well be true – but do those studies amount to more than a heap of beans? Let’s find out.
The objective of our Cochrane review was to determine the effectiveness of TM for the primary prevention of cardiovascular disease (CVD). We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 10); MEDLINE (Ovid) (1946 to week three November 2013); EMBASE Classic and EMBASE (Ovid) (1947 to week 48 2013); ISI Web of Science (1970 to 28 November 2013); and Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment Database and Health Economics Evaluations Database (November 2013). We also searched the Allied and complementary Medicine Database (AMED) (inception to January 2014) and IndMed (inception to January 2014). We hand searched trial registers and reference lists of reviews and articles and contacted experts in the field. We applied no language restrictions.
We included randomised controlled trials (RCTs) of at least three months’ duration involving healthy adults or adults at high risk of CVD. Trials examined TM only and the comparison group was no intervention or minimal intervention. We excluded trials that involved multi-factorial interventions. Outcomes of interest were clinical CVD events (cardiovascular mortality, all-cause mortality and non-fatal events) and major CVD risk factors (e.g. blood pressure and blood lipids, occurrence of type 2 diabetes, quality of life, adverse events and costs). Two authors independently selected trials for inclusion, extracted data and assessed the risk of bias.
We identified 4 RCTs with a total of 430 participants for inclusion in this review. The included trials were small, short term (three months) and at risk of bias. In all studies, TM was practised for 15 to 20 minutes twice a day. None of the included studies reported all-cause mortality, cardiovascular mortality or non-fatal endpoints as trials were short term, but one study reported survival rate three years after the trial was completed. In view of the considerable statistical heterogeneity between the results of the studies for the only outcomes reported, systolic blood pressure (I2 = 72%) and diastolic blood pressure (I2 = 66%), we decided not to undertake a meta-analysis. None of the four trials reported blood lipids, occurrence of type 2 diabetes, adverse events, costs or quality of life.
We concluded that there are few trials with limited outcomes examining the effectiveness of TM for the primary prevention of CVD. Due to the limited evidence to date, we could draw no conclusions as to the effectiveness of TM for the primary prevention of CVD. There was considerable heterogeneity between trials and the included studies were small, short term and at overall serious risk of bias. More and larger long-term, high-quality trials are needed.
Even though I am a co-author of this review, I am not entirely sure that the last sentence of our conclusion is totally correct. The TM movement has, in my view, all the characteristics of a cult with all its the dangers that cults entail. This means, I think, we ought to be cautious about TM and sceptical about their research and results. At the risk of provoking harsh criticism, I would even say we should be distrustful of their aims and methods.
- Chronic low back pain (CLBP) is a condition which affects so many people that it represents a huge burden to individual patients’ suffering as well as to society in terms of loss of work time and increased economic cost. The number of therapies that have been claimed to be effective for CLBP can hardly be counted. Two of the most common treatments are spinal manipulation and exercise.
The purpose of this systematic review was to determine the effectiveness of spinal manipulation vs prescribed exercise for patients diagnosed with CLBP. Only RCTs that compared head-to-head spinal manipulation to an exercise group were included in this review.
A search of the current literature was conducted using a keyword process in CINAHL, Cochrane Register of Controlled Trials Database, Medline, and Embase. The searches included studies available up to August 2014. Studies were included based on PICOS criteria 1) individuals with CLBP defined as lasting 12 weeks or longer; 2) spinal manipulation performed by a health care practitioner; 3) prescribed exercise for the treatment of CLBP and monitored by a health care practitioner; 4) measurable clinical outcomes for reducing pain, disability or improving function; 5) randomized controlled trials. The methodological quality of all included articles was determined using the criteria developed and used by the Physiotherapy Evidence Database (PEDro).
Only three RCTs met the inclusion criteria of this systematic review. The outcomes used in these studies included Disability Indexes, Pain Scales and function improvement scales. One RCT found spinal manipulation to be more effective than exercise, and the results of another RCT indicated the reverse. The third RCT found both interventions offering equal effects in the long term.
The author concluded that there is no conclusive evidence that clearly favours spinal manipulation or exercise as more effective in treatment of CLBP. More studies are needed to further explore which intervention is more effective.
Whenever there are uncounted treatments for a given condition, one has to ask oneself whether they are all similarly effective or equally ineffective. The present review does unfortunately not answer this question, but I fear the latter might be more true than the former.
Considering how much money we spend on treating CLBP, it is truly surprising to see that just three RCTs are available comparing two of the most commonly used treatments for this condition. Equally surprising is the fact that we simply cannot tell, on the basis of these data, which of the two therapies is more effective.
What consequences should we draw from this information. Obviously we need more high quality trials. But what should we do in the meantime?
Whenever two treatments are equally effective (or, in this case, perhaps equally ineffective?), we must consider other important criteria such as safety and cost. Regular chiropractic care (chiropractors use spinal manipulation on almost every patient, while osteopaths and physiotherapists employ it less frequently) is neither cheap nor free of serious adverse effects such as strokes; regular exercise has none of these disadvantages. In view of these undeniable facts, it is hard not to come up with anything other than the following recommendation: until new and compelling evidence becomes available, exercise ought to be preferred over spinal manipulation as a treatment of CLBP – and consequently consulting a chiropractor should not be the first choice for CLBP patients.
Moxibustion is an ancient variation of acupuncture using moxa made from dried mugwort (Artemisia argyi). It has long played an important role in the traditional heath care systems of China and other Asian countries. More recently, it has become popular also in the West. Practitioners use moxa sticks indirectly to warm acupuncture needles, or burn it close to the patient’s skin. Essentially, moxibustion is a treatment where acupuncture points are stimulated mainly or exclusively by the heat of burning moxa.
Because of moxibustion’s long history of usage and the fact that it is employed in many countries for a very wide range of conditions, some might argue that it has stood the ‘test of time’ and should be considered to be a well-established therapy. More critical thinkers would, however, point out that this is not an argument but a classical fallacy.
My team at Exeter regularly had research fellows from Korea and other Asian countries, and we managed to develop a truly productive cooperation. It enabled us to conduct systematic reviews including the Asian literature – and this is how we got involved in an unusual amount of research into moxibustion which, after all, is a fairly exotic alternative therapy. In 2010, we began a series of systematic reviews of moxibustion.
One of the first such articles included 9 RCTs testing the effectiveness of this treatment for stroke rehabilitation. Three RCTs reported favorable effects of moxibustion plus standard care on motor function versus standard care alone Three randomized clinical trials compared the effects of moxibustion on activities of daily living alone but failed to show favorable effects of moxibustion.
Also in 2010, our systematic review of RCTs of moxibustion as a treatment of ulcerative colitis (UC) concluded that current evidence is insufficient to show that moxibustion is an effective treatment of UC. Most of included trials had high risk of bias. More rigorous studies seem warranted.
Our (2010) systematic review od RCTs of moxibustion as a therapy in cancer care found that the evidence was limited to suggest moxibustion is an effective supportive cancer care in nausea and vomiting. However, all studies had a high risk of bias so effectively there was not enough evidence to draw any conclusion.
Our (2010) systematic review of RCTs of moxibustion for treating hypertension concluded that there was insufficient evidence to suggest that moxibustion is an effective treatment for hypertension.
Our (2010) systematic review of RCTs of moxibustion for constipation concluded as follows: Given that the methodological quality of all RCTs was poor, the results from the present review are insufficient to suggest that moxibustion is an effective treatment for constipation. More rigorous studies are warranted.
Our (2010) systematic review found few RCTs were available that test the effectiveness of moxibustion in the management of pain, and most of the existing trials had a high risk of bias. Therefore, more rigorous studies are required before the effectiveness of moxibustion for the treatment of pain can be determined.
Our (2011) systematic review of 14 RCTs of moxibustion for rheumatic conditions failed to provide conclusive evidence for the effectiveness of moxibustion compared with drug therapy in rheumatic conditions.
The, so far, last article in this series has only just been published. The purpose of this systematic review was to assess the efficacy of moxibustion as a treatment of chemotherapy-induced leukopenia. Twelve databases were searched from their inception through June 2014, without a language restriction. Randomized clinical trials (RCTs) were included, if moxibustion was used as the sole treatment or as a part of a combination therapy with conventional drugs for leukopenia induced by chemotherapy. Cochrane criteria were used to assess the risk of bias.
Six RCTs with a total of 681 patients met our inclusion criteria. All of the included RCTs were associated with a high risk of bias. The trials included patients with various types of cancer receiving ongoing chemotherapy or after chemotherapy. The results of two RCTs suggested the effectiveness of moxibustion combined with chemotherapy vs. chemotherapy alone. In four RCTs, moxibustion was more effective than conventional drug therapy. Six RCTs showed that moxibustion was more effective than various types of control interventions in increasing white blood cell counts.
Our conclusion: there is low level of evidence based on these six trials that demonstrates the superiority of moxibustion over drug therapies in the treatment of chemotherapy-induced leukopenia. However, the number of trials, the total sample size, and the methodological quality are too low to draw firm conclusions. Future RCTs appear to be warranted.
Was all this research for nothing?
I know many people who would think so. However, I disagree. If nothing else, these articles demonstrated several facts quite clearly:
- There is quite a bit of research even on the most exotic alternative therapy; sometimes one needs to look hard and include languages other than English.
- Studies from China and other Asian counties very rarely report negative results; this fact casts a dark shadow on the credibility of such data.
- The poor quality of trials in most areas of alternative medicine is lamentable and must be stimulus for researchers in this field to improve their act.
- Authors of systematic reviews must resist the temptation to draw positive conclusions based on flawed primary data.
- Moxibustion is a perfect example for demonstrating that the ‘test of time’ is no substitute for evidence.
- As for moxibustion, it cannot currently be considered an evidence-based treatment for any condition.