MD, PhD, FMedSci, FSB, FRCP, FRCPEd

systematic review

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One could define alternative medicine by the fact that it is used almost exclusively for conditions for which conventional medicine does not have an effective and reasonably safe cure. Once such a treatment has been found, few patients would look for an alternative.

Alzheimer’s disease (AD) is certainly one such condition. Despite intensive research, we are still far from being able to cure it. It is thus not really surprising that AD patients and their carers are bombarded with the promotion of all sorts of alternative treatments. They must feel bewildered by the choice and all too often they fall victim to irresponsible quacks.

Acupuncture is certainly an alternative therapy that is frequently claimed to help AD patients. One of the first websites that I came across, for instance, stated boldly: acupuncture improves memory and prevents degradation of brain tissue.

But is there good evidence to support such claims? To answer this question, we need a systematic review of the trial data. Fortunately, such a paper has just been published.

The objective of this review was to assess the effectiveness and safety of acupuncture for treating AD. Eight electronic databases were searched from their inception to June 2014. Randomized clinical trials (RCTs) with AD treated by acupuncture or by acupuncture combined with drugs were included. Two authors extracted data independently.

Ten RCTs with a total of 585 participants were included in a meta-analysis. The combined results of 6 trials showed that acupuncture was better than drugs at improving scores on the Mini Mental State Examination (MMSE) scale. Evidence from the pooled results of 3 trials showed that acupuncture plus donepezil was more effective than donepezil alone at improving the MMSE scale score. Only 2 trials reported the incidence of adverse reactions related to acupuncture. Seven patients had adverse reactions related to acupuncture during or after treatment; the reactions were described as tolerable and not severe.

The Chinese authors of this review concluded that acupuncture may be more effective than drugs and may enhance the effect of drugs for treating AD in terms of improving cognitive function. Acupuncture may also be more effective than drugs at improving AD patients’ ability to carry out their daily lives. Moreover, acupuncture is safe for treating people with AD.

Anyone reading this and having a friend or family member who is affected by AD will think that acupuncture is the solution and warmly recommend trying this highly promising option. I would, however, caution to remain realistic. Like so very many systematic reviews of acupuncture or other forms of TCM that are currently flooding the medical literature, this assessment of the evidence has to be taken with more than just a pinch of salt:

  • As far as I can see, there is no biological plausibility or mechanism for the assumption that acupuncture can do anything for AD patients.
  • The abstract fails to mention that the trials were of poor methodological quality and that such studies tend to generate false-positive findings.
  • The trials had small sample sizes.
  • They were mostly not blinded.
  • They were mostly conducted in China, and we know that almost 100% of all acupuncture studies from that country draw positive conclusions.
  • Only two trials reported about adverse effects which is, in my view, a sign of violation of research ethics.

As I already mentioned, we are currently being flooded with such dangerously misleading reviews of Chinese primary studies which are of such dubious quality that one could do probably nothing better than to ignore them completely.

Isn’t that a bit harsh? Perhaps, but I am seriously worried that such papers cause real harm:

  • They might motivate some to try acupuncture and give up conventional treatments which can be helpful symptomatically.
  • They might prompt some families to spend sizable amounts of money for no real benefit.
  • They might initiate further research into this area, thus drawing money away from research into much more promising avenues.

IT IS HIGH TIME THAT RESEARCHERS START THINKING CRITICALLY, PEER-REVIEWERS DO THEIR JOB PROPERLY, AND JOURNAL EDITORS STOP PUBLISHING SUCH MISLEADING ARTICLES.

On this blog, we have discussed many different alternative treatments. As it turns out, hardly any of them fulfil the criteria for being used routinely in clinical practice. But here I present one that might be the exception.

The Feldenkrais Method (FM) aims to reduce pain or limitations in movement, to improve physical function, and to promote general wellbeing by increasing the patient’s awareness of herself and by expanding her movement repertoire. The FM is an educational method similar to the Alexander Technique.

The practitioner directs his attention to the patient’s habitual movement patterns which are inefficient or strained, and teaches new patterns using gentle, slow, repeated movements. Slow repetition is believed to be necessary to impart a new habit and allow it to begin to feel normal. These movements may be passive (performed by the practitioner on the recipient’s body) or active (performed by the patient).

At this point, we should ask: but does FM really and demonstrably work?

Ten years ago, we published a systematic review of all RCTs available at the time testing the effectiveness of FM. Six studies met our inclusion criteria. They were all burdened with significant methodological weaknesses. The indications included multiple sclerosis, neck/shoulder problems and chronic back pain. All but one trial reported positive results.  We concluded that the evidence for the FM is encouraging but, due to the paucity and low quality of studies, by no means compelling.

Since then, more research has become available, and an update of our research seemed necessary. This new review aimed to update the evidence for the benefits of FM. Included studies were appraised using the Cochrane risk of bias approach and trial findings analysed individually and collectively where possible. Twenty RCTs were included (an additional 14 to our earlier systematic review). The population, outcome, and findings were highly heterogeneous. Meta-analyses were performed with 7 studies, finding in favour of the FM for improving balance in ageing populations. Single studies reported significant positive effects for reduced perceived effort and increased comfort, body image perception, and dexterity. Risk of bias was high in all studies, thus tempering some results. The effects seemed to be generic, supporting the proposal that FM works on a learning paradigm rather than disease-based mechanisms.

The authors concluded that further research is required; however, in the meantime, clinicians and professionals may promote the use of FM in populations interested in efficient physical performance and self-efficacy.

One might discuss whether or not FM is truly an alternative therapy; it has many characteristics of a physiotherapy, and physiotherapists often employ FM. On the other hand, it is considered to be alternative by some practitioners. So, for the purpose of this article, I will call it alternative.

The evidence for FM has become substantially more promising since we last looked at it systematically. The indication for which the evidence is most convincing is the improvement of elderly people’s balance. Considering that FM is virtually risk-free and inexpensive, I feel that it is one of the rare alternative therapy that could be integrated into clinical routine (for this particular indication).

Nonspecific neck pain is extremely common, often disabling, and very costly for us all. If we believe those who earn their money with them, effective treatments for the condition abound. One of these therapies is osteopathy. But does osteopathic manipulation/mobilisation really work?

The objective of a recent review (the link I originally put in here does not work, I will supply a new one as soon as the article becomes available on Medline) was to find out. Specifically, the authors wanted to assess the effectiveness of osteopathic manipulative treatment (OMT) in the management of chronic nonspecific neck pain regarding pain, functional status, and adverse events.

Electronic literature searches unrestricted by language were performed in March 2014. A manual search of reference lists and personal communication with experts identified additional studies. Only randomized clinical trials (RCTs) were included, and studies of specific neck pain or single treatment techniques were excluded. Primary outcomes were pain and functional status, and secondary outcome was adverse events.

Studies were independently reviewed using a standardized data extraction form. Mean difference (MD) or standard mean difference (SMD) with 95% confidence intervals (CIs) and overall effect size were calculated for primary outcomes. GRADE was used to assess quality of the evidence.

Of 299 identified articles, 18 were evaluated and 15 excluded. The three included RCTs had low risk of bias. The results show that moderate-quality evidence suggested OMT had a significant and clinically relevant effect on pain relief (MD: -13.04, 95% CI: -20.64 to -5.44) in chronic nonspecific neck pain, and moderate-quality evidence suggested a non-significant difference in favour of OMT for functional status (SMD: -0.38, 95% CI: -0.88 to -0.11). No serious adverse events were reported.

The authors concluded that, based on the three included studies, the review suggested clinically relevant effects of OMT for reducing pain in patients with chronic nonspecific neck pain. Given the small sample sizes, different comparison groups, and lack of long-term measurements in the few available studies, larger, high-quality randomized controlled trials with robust comparison groups are recommended.

Yet again I am taken aback by several things simultaneously:

  • the extreme paucity of RCTs, particularly considering that neck pain is one of the main indication for osteopaths,
  • the rather uncritical text by the authors,
  • the nonsensical conclusions.

Let me offer my own conclusions which are, I hope, a little more realistic:

GIVEN THE PAUCITY OF THE RCTs AND THEIR SMALL SAMPLE SIZES, IT IS NOT POSSIBLE TO CLAIM THAT OMT FOR NONSPECIFIC NECK PAIN IS AN EVIDENCE-BASED APPROACH

Lots of alternative therapies are advocated for migraine. Few of them are supported by good evidence. An exception could be the herbal remedy FEVERFEW.

This review is an update of a previously published review in the Cochrane Database of Systematic Reviews on ‘Feverfew for preventing migraine’. Feverfew (Tanacetum parthenium L.) extract is a herbal remedy, which has been used for preventing attacks of migraine. Our aim was to systematically review the evidence from double-blind, randomised, clinical trials (RCTs) assessing the clinical efficacy and safety of feverfew monopreparations versus placebo for preventing migraine.

For this updated version of the review we searched CENTRAL, MEDLINE, EMBASE and AMED to January 2015. We contacted manufacturers of feverfew and checked the bibliographies of identified articles for further trials.

We included randomised, placebo-controlled, double-blind trials assessing the efficacy of feverfew monopreparations for preventing migraine in migraine sufferers of any age. We included trials using clinical outcome measures, while we excluded trials focusing exclusively on physiological parameters. There were no restrictions regarding the language of publication.

We systematically extracted data on patients, interventions, methods, outcome measures, results and adverse events. We assessed risk of bias using the Cochrane ‘Risk of bias’ tool and evaluated methodological quality using the Oxford Quality Scale developed by Jadad and colleagues. Two review authors independently selected studies, assessed methodological quality and extracted data. We resolved disagreements concerning evaluation of individual trials through discussion.

We identified one new study for this update, resulting in a total of 6 trials (561 patients) meeting the inclusion criteria. Five of the 6 trials reported on the main outcome measure which was migraine frequency. Although 5 of the trials were generally of good methodological quality, all studies were either of unclear or high risk of bias with regards to sample size. Pooled analysis of the results was not possible due to the lack of common outcome measures and heterogeneity between studies in terms of participants, interventions and designs. The most recent trial added to this update was rigorous and larger (n = 218) than previous studies. It used a stable feverfew extract at a dose determined by a previous dose-finding trial. It reported that feverfew reduced migraine frequency by 1.9 attacks from 4.8 to 2.9 and placebo by 1.3 from to 4.8 to 3.5 per month. This difference in effect between feverfew and placebo was thus 0.6 attacks per month. For the secondary outcome measures such as intensity and duration of migraine attacks, incidence and severity of nausea and vomiting, and global assessment no statistically significant differences between feverfew and placebo were reported.

The results of previous trials were not convincing: three trials reporting positive effects of feverfew were all of small sample size (17 to 60 participants), while two rigorous trials (n = 50, 147) did not find significant differences between feverfew and placebo.

Only mild and transient adverse events of feverfew, most commonly gastrointestinal complaints and mouth ulcers, were reported in the included trials.

We concluded that, since the last version of this review, one larger rigorous study has been included, reporting a difference in effect between feverfew and placebo of 0.6 attacks per month. This adds some positive evidence to the mixed and inconclusive findings of the previous review. However, this constitutes low quality evidence, which needs to be confirmed in larger rigorous trials with stable feverfew extracts and clearly defined migraine populations before firm conclusions can be drawn. It appears from the data reviewed that feverfew is not associated with any major safety concerns.

So, good or bad news for migraine sufferers? I suppose it depends on whether you are an optimist or a pessimist. I would say that, considering the mostly bad news about alternative medicine for migraine, it is relative good news: patients who want to try something ‘natural’ could do so, particularly in view of the lack of serious risks.

Many people suffering from depression or anxiety are tempted to try alternative therapies. One of those is Reiki, a 2500 year old treatment described as a vibrational or subtle energy therapy, and is most commonly facilitated by light touch on or above the body. On this blog, we have repeatedly discussed Reiki and the fact that there is no good evidence for this utterly implausible approach (e.g. here, here and here). Yet, there have been reports of Reiki alleviating anxiety and depression – but what does the totality of the available evidence show when it is submitted to an impartial assessment?

This Cochrane review was aimed at evaluating the effectiveness of Reiki for treating anxiety and depression in people aged 16 and over.

Literature searches were conducted in the Cochrane Register of Controlled Trials (CENTRAL – all years), the Cochrane Depression, Anxiety and Neurosis Review Group’s Specialised Register (CCDANCTR – all years), EMBASE, (1974 to November 2014), MEDLINE (1950 to November 2014), PsycINFO (1967 to November 2014) and AMED (1985 to November 2014). Additional searches were carried out on the World Health Organization Trials Portal (ICTRP) together with ClinicalTrials.gov to identify any ongoing or unpublished studies. All searches were up to date as of 4 November 2014.

Randomised trials were considered in adults with anxiety or depression or both, with at least one arm treated with Reiki delivered by a trained Reiki practitioner. The two authors independently decided on inclusion/exclusion of studies and extracted data. A prior analysis plan had been specified.

The researchers found three studies for inclusion in the review. One recruited males with a biopsy-proven diagnosis of non-metastatic prostate cancer who were not receiving chemotherapy and had elected to receive external-beam radiation therapy; the second study recruited community-living participants who were aged 55 years and older; the third study recruited university students.These studies included subgroups with anxiety and depression as defined by symptom scores and provided data separately for those subgroups. As this included only 25 people with anxiety and 17 with depression and 20 more with either anxiety or depression, but which was not specified, the results could only be reported narratively.

The findings did not show any evidence that Reiki is either beneficial or harmful in this population. The risk of bias for the included studies was generally rated as unclear or high for most domains, which reduced the certainty of the evidence.

The authors of this Cochrane review concluded that there is insufficient evidence to say whether or not Reiki is useful for people over 16 years of age with anxiety or depression or both.

This is a very diplomatic way of expressing the truth, I think. A more forceful conclusion might have been that THERE IS NO GOOD EVIDENCE THAT REIKI IS EFFECTIVE. GIVEN THE TOTAL LACK OF BIOLOGICAL PLAUSIBILITY, THIS FINDING IS NOT SURPRISING. FUTURE RESEARCH INTO THIS AREA DOES NOT SEEM WARRANTED.

As I grew up in Germany, it was considered entirely normal that I was given homeopathic remedies when ill. I often wondered whether, with the advent of EBM, this has changed. A recent paper provides an answer to this question.

In this nationwide German survey, data were collected from 3013 children on their utilization of medicinal products, including homeopathic and other alternative remedies.

In all, 26% of the reported 2489 drugs were from the realm of alternative medicine. The 4-week prevalence for homeopathy was 7.5%. Of the drugs identified as alternative, 53.7% were homeopathic remedies, and 30.8% were herbal drugs. Factors associated with higher medicinal use of alternative remedies were female gender, residing in Munich, and higher maternal education. A homeopathy user utilized on average homeopathic remedies worth EUR 15.28. The corresponding figure for herbal drug users was EUR 16.02, and EUR 18.72 for overall medicinal CAM users. Compared with data from 4 years before, the prevalence of homeopathy use had declined by 52%.

The authors concluded that CAM use among 15-year-old children in the GINIplus cohort is popular, but decreased noticeably compared with children from the same cohort at the age of 10 years. This is possibly mainly because German health legislation normally covers CAM for children younger than 12 years only.

The survey shows that homeopathy is still a major player in the health care of German children. From the point of view of a homeopath, this makes a lot of sense: children are supposed to respond particularly well to homeopathy. But is that really true? The short answer is NO.

Our systematic review of all relevant studies tells it straight: The evidence from rigorous clinical trials of any type of therapeutic or preventive intervention testing homeopathy for childhood and adolescence ailments is not convincing enough for recommendations in any condition.

In other words, the evidence is very much at odds with the practice. This begs the question, I think, HOW SHOULD WE INTERPRET THIS DISCREPANCY?

A few possibilities come into mind, and I would be grateful to hear from my readers which they think might be correct:

  • Homeopathy is used as a ‘benign placebo’ [clinicians know that most paediatric conditions are self-limiting and thus prefer to give placebos rather than drugs that can cause adverse effects].
  • Doctors prescribe homeopathy mainly because the kids’ parents insist on them.
  • Doctors believe that homeopathic remedies are more than just placebos [in which case they are clearly ill-informed].
  • German doctors do not believe in scientific evidence and prefer to rely on their intuition.
  • This high level of homeopathy usage misleads the next generation into believing in quackery.
  • It amounts to child abuse and should be stopped.

Distant healing is one of the most bizarre yet popular forms of alternative medicine. Healers claim they can transmit ‘healing energy’ towards patients to enable them to heal themselves. There have been many trials testing the effectiveness of the method, and the general consensus amongst critical thinkers is that all variations of ‘energy healing’ rely entirely on a placebo response. A recent and widely publicised paper seems to challenge this view.

This article has, according to its authors, two aims. Firstly it reviews healing studies that involved biological systems other than ‘whole’ humans (e.g., studies of plants or cell cultures) that were less susceptible to placebo-like effects. Secondly, it presents a systematic review of clinical trials on human patients receiving distant healing.

All the included studies examined the effects upon a biological system of the explicit intention to improve the wellbeing of that target; 49 non-whole human studies and 57 whole human studies were included.

The combined weighted effect size for non-whole human studies yielded a highly significant (r = 0.258) result in favour of distant healing. However, outcomes were heterogeneous and correlated with blind ratings of study quality; 22 studies that met minimum quality thresholds gave a reduced but still significant weighted r of 0.115.

Whole human studies yielded a small but significant effect size of r = .203. Outcomes were again heterogeneous, and correlated with methodological quality ratings; 27 studies that met threshold quality levels gave an r = .224.

From these findings, the authors drew the following conclusions: Results suggest that subjects in the active condition exhibit a significant improvement in wellbeing relative to control subjects under circumstances that do not seem to be susceptible to placebo and expectancy effects. Findings with the whole human database suggests that the effect is not dependent upon the previous inclusion of suspect studies and is robust enough to accommodate some high profile failures to replicate. Both databases show problems with heterogeneity and with study quality and recommendations are made for necessary standards for future replication attempts.

In a press release, the authors warned: the data need to be treated with some caution in view of the poor quality of many studies and the negative publishing bias; however, our results do show a significant effect of healing intention on both human and non-human living systems (where expectation and placebo effects cannot be the cause), indicating that healing intention can be of value.

My thoughts on this article are not very complimentary, I am afraid. The problems are, it seems to me, too numerous to discuss in detail:

  • The article is written such that it is exceedingly difficult to make sense of it.
  • It was published in a journal which is not exactly known for its cutting edge science; this may seem a petty point but I think it is nevertheless important: if distant healing works, we are confronted with a revolution in the understanding of nature – and surely such a finding should not be buried in a journal that hardly anyone reads.
  • The authors seem embarrassingly inexperienced in conducting and publishing systematic reviews.
  • There is very little (self-) critical input in the write-up.
  • A critical attitude is necessary, as the primary studies tend to be by evangelic believers in and amateur enthusiasts of healing.
  • The article has no data table where the reader might learn the details about the primary studies included in the review.
  • It also has no table to inform us in sufficient detail about the quality assessment of the included trials.
  • It seems to me that some published studies of distant healing are missing.
  • The authors ignored all studies that were not published in English.
  • The method section lacks detail, and it would therefore be impossible to conduct an independent replication.
  • Even if one ignored all the above problems, the effect sizes are small and would not be clinically important.
  • The research was sponsored by the ‘Confederation of Healing Organisations’ and some of the comments look as though the sponsor had a strong influence on the phraseology of the article.

Given these reservations, my conclusion from an analysis of the primary studies of distant healing would be dramatically different from the one published by the authors: DESPITE A SIZABLE AMOUNT OF PRIMARY STUDIES ON THE SUBJECT, THE EFFECTIVENESS OF DISTANT HEALING REMAINS UNPROVEN. AS THIS THERAPY IS BAR OF ANY BIOLOGICAL PLAUSIBILITY, FURTHER RESEARCH IN THIS AREA SEEMS NOT WARRANTED.

Twenty years ago, I published a short article in the British Journal of Rheumatology. Its title was ALTERNATIVE MEDICINE, THE BABY AND THE BATH WATER. Reading it again today – especially in the light of the recent debate (with over 700 comments) on acupuncture – indicates to me that very little has since changed in the discussions about alternative medicine (AM). Does that mean we are going around in circles? Here is the (slightly abbreviated) article from 1995 for you to judge for yourself:

“Proponents of alternative medicine (AM) criticize the attempt of conducting RCTs because they view this is in analogy to ‘throwing out the baby with the bath water’. The argument usually goes as follows: the growing popularity of AM shows that individuals like it and, in some way, they benefit through using it. Therefore it is best to let them have it regardless of its objective effectiveness. Attempts to prove or disprove effectiveness may even be counterproductive. Should RCTs prove that a given intervention is not superior to a placebo, one might stop using it. This, in turn, would be to the disadvantage of the patient who, previous to rigorous research, has unquestionably been helped by the very remedy. Similar criticism merely states that AM is ‘so different, so subjective, so sensitive that it cannot be investigated in the same way as mainstream medicine’. Others see reasons to change the scientific (‘reductionist’) research paradigm into a broad ‘philosophical’ approach. Yet others reject the RCTs because they think that ‘this method assumes that every person has the same problems and there are similar causative factors’.

The example of acupuncture as a (popular) treatment for osteoarthritis, demonstrates the validity of such arguments and counter-arguments. A search of the world literature identified only two RCTs on the subject. When acupuncture was tested against no treatment, the experimental group of osteoarthritis sufferers reported a 23% decrease of pain, while the controls suffered a 12% increase. On the basis of this result, it might seem highly unethical to withhold acupuncture from pain-stricken patients—’if a patient feels better for whatever reason and there are no toxic side effects, then the patient should have the right to get help’.

But what about the placebo effect? It is notoriously difficult to find a placebo indistinguishable to acupuncture which would allow patient-blinded studies. Needling non-acupuncture points may be as close as one can get to an acceptable placebo. When patients with osteoarthritis were randomized into receiving either ‘real acupuncture or this type of sham acupuncture both sub-groups showed the same pain relief.

These findings (similar results have been published for other AMs) are compatible only with two explanations. Firstly acupuncture might be a powerful placebo. If this were true, we need to establish how safe acupuncture is (clearly it is not without potential harm); if the risk/benefit ratio is favourable and no specific, effective form of therapy exists one might still consider employing this form as a ‘placebo therapy’ for easing the pain of osteoarthritis sufferers. One would also feel motivated to research this powerful placebo and identify its characteristics or modalities with the aim of using the knowledge thus generated to help future patients.

Secondly, it could be the needling, regardless of acupuncture points and philosophy, that decreases pain. If this were true, we could henceforward use needling for pain relief—no special training in or equipment for acupuncture would be required, and costs would therefore be markedly reduced. In addition, this knowledge would lead us to further our understanding of basic mechanisms of pain reduction which, one day, might evolve into more effective analgesia. In any case the published research data, confusing as they often are, do not call for a change of paradigm; they only require more RCTs to solve the unanswered problems.

Conducting rigorous research is therefore by no means likely to ‘throw out the baby with the bath water’. The concept that such research could harm the patient is wrong and anti-scientific. To follow its implications would mean neglecting the ‘baby in the bath water’ until it suffers serious damage. To conduct proper research means attending the ‘baby’ and making sure that it is safe and well.

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”.

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