It has been reported that ‘Boots the Chemist’ have filed several legal complaints against The Guardian in relation to articles published by the paper in relation to its April 2016 investigation. The Guardian articles in question alleged that Boots, the UK’s largest pharmacy chain, had placed undue pressure on its pharmacists to perform medicines use reviews so that it could claim the maximum payments possible from the NHS. In other words, The Guardian implied that Boots was trying to get more money from our NHS than might have been due.
Personally, I am always uneasy when I hear that someone takes legal action on such matters. I think that legal complaints of such a nature can turn out to be counter-productive, both in general and in this particular instance.
There could be several reasons. For instance, such actions might give someone the idea of filing complaints against Boots. I am sure it is not difficult to find reasons for that.
In the realm of alternative medicine, for example, someone might question whether selling homeopathic remedies in Boot’s section ‘pharmacy and health’ is not misleading. These remedies might be seen by a naïve customer as masquerading as medicines. As readers of this blog know all too well, they do not, in fact, contain anything (other than lactose) that has any pharmacological activity. Therefore Boots should best market them in the category of ‘confectionary’.
One might even suspect that Boots are fully aware of all this. After all, a spokesperson for the company stated years ago during a parliamentary inquiry: “I have no evidence to suggest that they [homeopathic remedies sold by Boots] are efficacious …”
And it is also not the first time that Boots have been challenged for selling products they know to be placebos. This is what The Guardian reported in 2008 about the issue: “Ernst accuses the company [Boots] of breaching ethical guidelines drawn up by the Royal Pharmaceutical Society of Great Britain, by failing to tell customers that its homeopathic medicines contain no active ingredients and are ineffective in clinical trials.”
A similar void of evidence also applies to Boot’s wide range of Bach Flower Remedies and aromatherapy oils.
Or am I wrong?
Perhaps Boots want to post links to the evidence in the comment section below?
I am always keen to learn and only too happy to change my mind in view of new, compelling evidence!
Boots also sell a very wide range of herbal medicines, and here the situation is quite different: herbal medicines actually contain molecules that might have pharmacological effects, i. e. they might heal or might harm you. And many of these products imply indications for which they should be taken. I will pick just one example to explain: HERBAL SLIM AID.
Yes, you are absolutely correct – this product is (according to its name) not for gaining weight, it’s for reducing it. Each coated tablet contains 45 mg of extract (as dry extract) from Bladderwrack thallus (Fucus vesiculosus L.) (5:1) (equivalent to 225 mg of Fucus) Extraction solvent: water, ,30 mg Dandelion Root (Taraxacum officinale Weber ex Wigg), 27 mg of extract (as dry extract) from Boldo leaf (Peumus boldus Molina) (4-6:1) (equivalent to 108-162 mg of Boldo leaf) Extraction solvent: Methanol 70% v/v, 10 mg Butternut Bark (Juglans cinerea L.).
Now, I thought I know quite a bit about herbal slimming aids, after all, we had a research focus on this topic for several years and have published about a dozen papers on the subject. But oddly, I cannot remember that this mixture of herbs has been shown to reduce body weight.
Perhaps Boots want to post evidence for the efficacy and safety of this product as well?
I certainly hope so, and I would instantly withdraw any hint of a suspicion that Boots are selling unproven or disproven medicines.
Where is all this going?
I have to admit that am not entirely sure myself.
I suppose all I wanted to express was that it might be unwise to throw stones when one is sitting in a glass-house – a cliché, I know, but it’s true nevertheless.
CONFLICTS OF INTEREST:
None [except I don’t like those who easily take legal action against others]
Alternative medicine has no shortage of research that suggests it to be effective. Almost invariably, however, one finds – when looking a bit more carefully at such investigations – that the positive conclusions are not warranted by the data. Here is an excellent, recent example:
This new study, authored by two Turkish nurses, was an RCT where the patients were randomly assigned to either an aromatherapy massage (n = 17), reflexology (n = 17) or the control group (n = 17). Aromatherapy massage was applied to both knees of subjects in group 1 for 30 minutes. Reflexology was administered to both feet of subjects in group 2 for 40 minutes during weekly home visits. The subjects of group 3, the control group, received no intervention.
Fifty-one subjects with rheumatoid arthritis were recruited from a university hospital rheumatology clinic in Turkey between July 2014 and January 2015 for this trial. Data were collected by personal information form, DAS28 index, Visual Analog Scale and Fatigue Severity Scale. Pain and fatigue scores were measured at baseline and within an hour after each intervention for 6 weeks.
Pain and fatigue scores significantly decreased in the aromatherapy massage and reflexology groups compared with the control group (p < .05). The reflexology intervention started to decrease pain and fatigue scores earlier than aromatherapy massage (week 1 vs week 2 for pain, week 1 vs week 4 for fatigue) (p < .05).
The authors concluded that aromatherapy massage and reflexology are simple and effective non-pharmacologic nursing interventions that can be used to help manage pain and fatigue in patients with rheumatoid arthritis.
I am sure that most readers have spotted the snag: the two interventions generated better outcomes than no therapy. It is quite simply wrong to assume that this outcome is specifically related to the two treatments. Both of these treatments are fairly agreeable and generate expectations, involve touch, attention and care. In my view, it is these latter factors which together have caused the better outcomes. And this is, of course, entirely unrelated to any specific effects of the two therapies.
This might well be trivial, but if such sloppy conclusions pollute the literature to the extend that they currently do in the realm of alternative medicine, it becomes important.
AROMATHERAPY is one of the most popular alternative therapies. The experience is usually pleasant enough, but what are the risks? None!!! At least this is what the therapists would claim. But is this true? Perhaps not. According to a recent press-release, the risks might be considerable.
Officials with the Tennessee Poison Control Center (TPC) are warning that they are seeing an increasing number of toxic exposures, mostly involving children, to essential oils used in aromatherapy. The TPC says the number of essential oil exposures doubled between 2011 and 2015, and 80 percent of those cases involved children. The primary route of poisoning is by ingestion, but also occurs with excessive or inappropriate application to the skin. Children are at risk because their skin easily absorbs oils and because they may try to ingest essential oils from the container.
“Tea tree oil is commonly cited, and most of those cases are accidental ingestions by children.” said Justin Loden, PharmD, certified specialist in Poison Information (CSPI) at TPC. Most essential oils have a pleasant smell but bitter taste, so children easily choke on them and aspirate the oil to their lungs, Loden said.
Several essential oils such as camphor, clove, lavender, eucalyptus, thyme, tea tree, and wintergreen oils are highly toxic. All of the oils produce oral and throat irritation, nausea, and vomiting when ingested. Most essential oils either produce central nervous system (CNS) stimulation, which results in agitation, hallucinations, delirium, and seizures or CNS depression, which results in lethargy and coma. Other toxic effects include painless chemical burns, hypotension, acute respiratory distress syndrome, acute liver failure, severe metabolic acidosis, and cerebral edema depending on which essential oil is in question.
Tennessee Poison Center Tips for using essential oils
- Safely using and storing essential oils is extremely important
- Use essential oil products ONLY for their intended purpose.
- Use only the amount stated on the label/guide.
- Do not swallow an essential oil unless the label says to do so.
- Do not use a product on the skin unless the label says to do so.
- Do not leave the product out (i.e. as a pesticide) unless the label says to do so.
- If you have bottles of essential oils at home, keep them locked up, out of sight and reach of children and pet at all times. Children act fast, so do poisons.
Many will think that this is alarmist – but I don’t. In fact, in 2012, I published a systematic review aimed at critically evaluating the evidence regarding the adverse effects associated with aromatherapy. No, it was not funded by ‘BIG PHARMA’ but by THE ROYAL COLLEGE OF PHYSICIANS, LONDON.
Five electronic databases were searched to identify all relevant case reports and case series. Forty two primary reports met our inclusion criteria. In total, 71 patients experienced adverse effects of aromatherapy. Adverse effects ranged from mild to severe and included one fatality. The most common adverse effect was dermatitis. Lavender, peppermint, tea tree oil and ylang-ylang were the most common essential oils responsible for adverse effects.
At the time, we concluded that aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.
I might add – before the therapists start making comments – that, yes, aromatherapy is still dimensions safer than many conventional treatments. But remember: the value of a therapy is not determined by its safety but by the risk/benefit balance! And what are the proven benefits of aromatherapy, I ask you.
Of all alternative treatments, aromatherapy (i.e. the application of essential oils to the body, usually by gentle massage or simply inhalation) seems to be the most popular. This is perhaps understandable because it certainly is an agreeable form of ‘pampering’ for someone in need of come TLC. But is aromatherapy more than that? Is it truly a ‘THERAPY’?
A recent systematic review was aimed at evaluating the existing data on aromatherapy interventions as a means of improving the quality of sleep. Electronic literature searches were performed to identify relevant studies published between 2000 and August 2013. Randomized controlled and quasi-experimental trials that included aromatherapy for the improvement of sleep quality were considered for inclusion. Of the 245 publications identified, 13 studies met the inclusion criteria, and 12 studies could be used for a meta-analysis.
The meta-analysis of the 12 studies revealed that the use of aromatherapy was effective in improving sleep quality. Subgroup analysis showed that inhalation aromatherapy was more effective than aromatherapy applied via massage.
The authors concluded that readily available aromatherapy treatments appear to be effective and promote sleep. Thus, it is essential to develop specific guidelines for the efficient use of aromatherapy.
Perfect! Let’s all rush out and get some essential oils for inhalation to improve our sleep (remarkably, the results imply that aroma therapists are redundant!).
Not so fast! As I see it, there are several important caveats we might want to consider before spending our money this way:
- Why did this review focus on such a small time-frame? (Systematic reviews should include all the available evidence of a pre-defined quality.)
- The quality of the included studies was often very poor, and therefore the overall conclusion cannot be definitive.
- The effect size of armoatherapy is small. In 2000, we published a similar review and concluded that aromatherapy has a mild, transient anxiolytic effect. Based on a critical assessment of the six studies relating to relaxation, the effects of aromatherapy are probably not strong enough for it to be considered for the treatment of anxiety. The hypothesis that it is effective for any other indication is not supported by the findings of rigorous clinical trials.
- It seems uncertain which essential oil is best suited for this indication.
- Aromatherapy is not always entirely free of risks. Another of our reviews showed that aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.
- There are several effective ways for improving sleep when needed; we need to know how aromatherapy compares to established treatments for that indication.
All in all, I think stronger evidence is required that aromatherapy is more that pampering.
Aromatherapy is one of the most popular of all alternative therapies. It is most certainly a very agreeable experience. But is it more that a bit of pampering? Does it cure any diseases?
If you believe aromatherapists, their treatment is effective for almost everything. And, of course, there are studies to suggest that, indeed, it works for several conditions. But regular readers of this blog will by now know that it is a bad idea to go by just one single trial; we always must rely on the totality of the most reliable evidence. In other words, we must look for systematic reviews. Recently, such an article has been published.
The aim of this review was to systematically assess the effectiveness of aromatherapy for stress management. Seven databases were searched from their inception through April 2014. RCTs testing aromatherapy against any type of control intervention in healthy but stressed persons assessing stress and cortisol levels were considered. Two reviewers independently performed the selection of the studies, data abstraction and validations. The risk of bias was assessed using Cochrane criteria.
Five RCTs met the authors’ inclusion criteria. Most of the RCTs had high risk of bias. Four RCTs tested the effects of aroma inhalation compared with no treatment, no aroma, and no odour oil. The meta-analysis of these data suggested that aroma inhalation had favourable effects on stress management. Three RCTs tested aroma inhalation on saliva or serum cortisol level compared to controls, and the meta-analysis of these data failed to show significant difference between two groups
The authors concluded that there is limited evidence suggesting that aroma inhalation may be effective in controlling stress. However, the number, size and quality of the RCTs are too low to draw firm conclusions.
This is by no means the only systematic review of this area. In fact, there are so many that, in 2012, we decided to do an overview of systematic reviews evaluating the effectiveness of aromatherapy. We searched 12 electronic databases and our departmental files without restrictions of time or language. The methodological quality of all systematic reviews was evaluated independently by two authors. Of 201 potentially relevant publications, 10 met our inclusion criteria. Most of the systematic reviews were of poor methodological quality. The clinical subject areas were hypertension, depression, anxiety, pain relief, and dementia. For none of the conditions was the evidence convincing. Our conclusion: due to a number of caveats, the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.
So, what does all of this mean? I think it indicates that most of the claims made by aromatherapists are not evidence-based. Or, to express it differently: aromatherapy is hardly more than a bit of old-fashioned pampering – nothing wrong with that, of course, as long as you don’t fall for the hype of those who promote it.
‘THE HINKLEY TIMES’ is not a paper that I read often, I have to admit – but maybe I should! It was there that I found the following remarkable article:
Bosworth MP David Tredinnick has asked questions in the House of Commons about the growing problem of antibiotic resistance within hospitals, suggesting herbal remedies could be answer.
The Tory MP, who has a keen interest in alternative medicine particularly herbal curatives, asked Jeremy Hunt, Secretary of State for Health, whether the problem was being discussed at the very top level.
He said: “Does my right honourable friend agree that a critical problem that A and E units will face in the future is antibiotic resistance? Is he aware that the science and technology committee, of which I am a member, has been looking at this issue and it also interests the health committee, of which I am also a member? Can he assure me that he is talking to the Prime Minister about how to stimulate new antibiotic research, and will he also remember that nature has its own remedies, such as tea tree oil?”
In reply Mr Hunt said: “My honourable friend is right about the seriousness of the issue of antimicrobial resistance. Some 25,000 people die in Europe every year as a result of the failure of antibiotics – more than die in road traffic accidents. I raised the issue at the World Health Assembly and I have discussed it closely with the Prime Minister.”
David Tredinnick is no stranger to strange ideas. Wikipedia (yes I know, many people do not like it as a source) sums it up quite succinctly:
He is a supporter of complementary and alternative medicine (CAM). He has made supportive comments in Parliament on homeopathy, despite continued lack of evidence of its effectiveness. He has supported chiropractic and mentioned the influence of the Moon on blood clotting. In this same debate he characterised scientists as “racially prejudiced”. He has tabled several early day motions in support of homeopathy’s continued funding on the National Health Service.Tredinnick’s views continue to cause amused disbelief in some quarters and a spokesman for the Royal College of Surgeons of England said they would “laugh their heads off” at the suggestion they could not operate at the full moon.
At the 2010 general election, in addition to candidates from the two main parties, Tredinnick was opposed by New Scientist journalist Dr. Michael Brooks who objected to “Tredinnick’s outspoken promotion of complementary and alternative medicine.”During a hustings debate called by Brooks to “highlight the scientific literacy of the UK’s elected representatives” Brooks claimed that Tredinnick regarded homeopathy as a suitable treatment for Malaria and HIV, which Tredinnick did not deny. Tredinnick in turn argued that “alternative treatments are incredibly good value for money” and stated his belief that randomised controlled trials are not effective at evaluating very dilute preparations.
In March 2013 Tredinnick was ridiculed as “nonsensical” by the government’s outgoing chief scientist, Sir John Beddington, who said the MP had fallen for the “Galileo fallacy” (Galileo was laughed at but was right, therefore since I am laughed at I must be right).
In July 2013 Tredinnick sponsored an EDM congratulating a farmer on his decision to use homeopathy with what were claimed to be positive results.The motion was supported by one other MP but the British veterinary association says there is no evidence of any benefit.
Tredinnick is a supporter of astrology especially the use of it in medical practice.In November 2009, he spoke at a meeting organised by the Astrological Association of Great Britain, where he related his personal experience of astrology and illness, advocating that astrology be integrated into the NHS.
Tredinnick’s appointment to the Health committee in June 2010 was criticised in two science reports in the Guardian. Martin Robbins said his appointment was “an extremely disturbing development” even though “Tredinnick is a figure unlikely to be taken seriously by policymakers” whilst Nature‘s Adam Rutherford described Tredinnick as “misinformed about a great many things” and said that “giving [him] influence on medical policy ..is a bad move.”The Telegraph writer Ian Douglas also described it as “a problem.”
His appointment to the Science and technology committee also drew criticism. Andy McSmith in the Independent, cited his views that homeopathy could cure HIV, TB, malaria, urinary infections, diarrhoea, skin eruptions, diabetes, epilepsy, eye infections, intestinal parasites, cancer, and gangrene amongst others and quoted Imran Khan, head of the Campaign for Science and Engineering, as saying that “someone with such incredibly odd views is not helpful”. Tom Whipple in the Times said his appointment caused despair,whilst Elizabeth Gibney in the Times Higher Education quoted the Skeptical Voter website as saying that Tredinnick is “perhaps the worst example of scientific illiteracy in government”…
In 2009 Tredinnick attempted to claim the £125 cost of attending a course on “intimate relationships” through his Parliamentary expenses. He was also found to have used expenses to purchase astrology software, claiming it was for a debate on alternative medicine.
Compared to some of theses bizarre activities, the notion that herbal remedies might provide the solution for antibiotic resistance seems almost reasonable and clever.
Tredinnick does not seem to know that:
- many antibiotics originate from plants or other natural substances,
- several large pharmaceutical companies are feverishly looking for more such substances from plants,
- most plants do actually contain substances which have antibiotic activity,
- however, most cannot be used as medicines, for instance, because they are far too toxic (tea tree oil is a good example for this),
- once a pure compound has been isolated from a plant and is used therapeutically, it ceases to be herbal medicine (which is defined as the use of full plant extracts),
- it is thus unlikely that full plant extracts, i. e. herbal medicine, will ever provide a solution to antibiotic resistance.
I have little doubt that Tredinnick will continue to mislead parliament and the public with his nonsensical views about alternative medicine. And even if it might have no effect whatsoever, I will continue to point out just how nonsensical they are.
HRH, The Prince of Wales has supported quackery on uncounted occasions. Several years ago, Charles even began selling his very own line of snake-oil. Now he surprises the British public with a brand new product: the ‘Baby Organic Hamper’. It is being sold for £195 under Prince Charles’ Highgrove-label and advertised with the following words:
A limited edition, hand-numbered hamper box packed with our new gentle organic bath and body products and a Highgrove Baby Bear. An ideal gift for new babies and parents. The blend of organic Roman chamomile and mandarin has been developed to be calm and gentle on delicate skin.
Roman chamomile has been known for centuries for its calming and relaxing benefits and also acts as an anti-inflammatory. Mandarin, known as ‘happy-oil’, has been chosen for its antiseptic properties and ability to boost immunity. Combined, this blend of ingredients produces a calming, protective barrier helping babies to relax. The exclusive, fully jointed Highgrove Baby Bear in antique mohair is made by Merrythought.
Provenance The unique bath and body collection has been created with Daniel Galvin Jr. in collaboration with Alexandra Soveral. Daniel Galvin Jr. has pioneered and developed organic products for hair and beauty over the last decade and Alexandra Soveral is a renowned and highly respected aromatherapist and facialist.
This new collection has been formulated in accordance with The Soil Association’s standards for health and beauty products, ensuring the purity of the range. Hamper Contents Body Lotion 100ml. Bath and Massage Oil 100ml. Flower Water 100ml. Bath and Body Wash 100ml. Balm 50ml. Highgrove Baby Bear.
Terms like relaxing benefits … anti-inflammatory … antiseptic properties … ability to boost immunity … protective barrier … helping babies to relax do undoubtedly amount to medical/therapeutic claims which, by definition (and by English law), need to be supported by evidence. I fail to see any sound evidence that either chamomile or mandarin oil or their combination have any of these effects on babies when applied as a body lotion, bath oil, massage oil, flower water, body wash.
The only RCT for mandarin-oil I could find concluded that results do not support a benefit of ‘M’ technique massage with or without mandarin oil in these young postoperative patients. Several reasons may account for this: massage given too soon after general anaesthesia, young patients’ fear of strangers touching them, patients not used to massage. For Roman Chamomile, I also identified just one relevant study; its results do not seem to suggest that the oil is the decisive factor in producing relaxation: Massage with or without essential oils appears to reduce levels of anxiety. Neither of these trials were done with babies, and crucially, no clinical trial at all seems to exist of the combination of the two oils as used in the Charles’ products.
As Charles and his team are clearly not scientists or health care experts, they took advice from people who might know about such matters: Daniel Galvin Jr. in collaboration with Alexandra Soveral. Daniel Galvin Jr. has pioneered and developed organic products for hair and beauty over the last decade and Alexandra Soveral is a renowned and highly respected aromatherapist and facialist.
This might look responsible at first glance; at closer scrutiny, Daniel Galvin turns out to be more an expert in cosmetics than in medicine; his own website explains: Born into the country’s most influential hairdressing dynasty, Daniel Galvin Jr, has been instrumental in the growth of the organic beauty market for the past 12 years and has been in the industry for 27 years. As a salon owner and creator of natural, organic professional haircare, he is at the forefront of colour expertise, with a client list including a ‘who’s who’ of TV personalities, British actors, royalty and London’s most beautiful socialites.
Alexandra Soveral might have once worked as an aromatherapist, but today she is the co-owner of a firm marketing natural beauty products; her website explains: We use rare & organic ingredients of the highest quality to create products that work in synergy with nature. We work towards a synthetic chemical free world. The scents from our essential oils evoke mind, body and soul reactions that promote well-being. We aim to continue our journey by always ensuring we source out new ways to improve our products and be kind to the planet.
At this point, two questions emerge in my mind: 1) is this just foolish nonsense or is it more sinister than that? 2) Why on earth does Charles venture into this sort of thing?
I would be inclined to file Charles’ baby-hamper under the category of ‘foolish nonsense’. Ok, it exploits the love of parents for their new-borns – £195 per item is not exactly cheap (even considering that it is HAND-NUMBERED!) – but the type of customer who might buy this product is probably not on the brink of financial hardship. The ‘foolish nonsense’ does, however, acquire a more sinister significance through the fact that the heir to the throne, who arguably should be an example to us all, yet again is responsible for unsubstantiated therapeutic claims. So, on balance, I think this is more than just foolish nonsense; in fact, it is yet another example of Charles misguiding the public through his passion for quackery.
Why does he do it? Does Charles need the money? No, unlike other quacks, he is not motivated by commercial interests. Is it for boosting his public image? Charles has certainly had an alternative bee under his royal bonnet for a very long time; in his quest to spread his abstruse notions of integrated health care, he has aquired an image to live up to. This new foray into quackery seems nevertheless baffling, in my view, because it is so obviously and cynically disregarding the law, regulations and evidence.
The way I see it, there are only two explanations for all this: either Charles is less aware of reality than one might have hoped, or he delegates trivial matters of this nature to one of his many sycophants without caring about the embarrassing details. Both of these possibilities are neither flattering for him nor reassuring for us…GOD SAVE THE QUEEN!
Where I live, some of the old-fashioned, privately-owned shops that used to dominate our high streets have survived the onslaught of the supermarkets. Our bakery is such a quaint remnant from the past. Surprisingly, it also is more holistic and more therapeutic than any alternative health centre I have come across.
The first thing that strikes anyone who enters the premises is the irresistible smell. Customers’ well being hits the ceiling, and the local aromatherapists are in danger of going out of business. The intense stimulation of the customers’ olfactory system relaxes their mind and puts them into a meditative state as they patiently wait to be served. Everyone in the queue has a little word with the baker’s wife, and progress is therefore slow – but we don’t mind: the chat is holistic counselling at its best, and our slow movements towards the counter are healthier than tai chi.
“You are looking well today,” says the baker’s wife, thereby gently arousing me from my aroma-induced meditation and indicating that she is about to focus her shaman healing-energy on me. Her diagnosis is spot on; the alternative therapies I enjoyed while waiting have re-balanced my chakras and got my qi flowing nicely – no wonder I am looking well!
The whole-wheat scones are finely balanced and nutritious; so I order three—one for the walk home and two for tea later. Prices have gone up a bit but, as with all holistic therapies, the more you pay, the more it’s worth. “Here you are,” she says, handing me her dietary delights. As I pay, our hands touch ever so briefly, just long enough for me to experience the instant transfer of healing energy that is so characteristic of Therapeutic Touch.
“Take care now, and God bless”, she says. As I walk out of her aura, I contemplate her words full of empathetic spiritual guidance and ancient wisdom. “That was expensive”, my wife mutters back home. I beg to differ: not only did I get the most wholesome food for my physical body, but I received holistic and patient-centred aromatherapy, counselling, meditation, tai chi and energy healing for my emotional, psychological and spiritual needs.
If only our Health Secretary knew about this traditional, yet integrated and therefore cutting-edge approach to cost-effective health and holistic well-being. We could all have it for free, and it might even save the NHS from its current crisis!
My aim with this blog is to eventually cover most of the 400 or so different alternative therapies and diagnostic techniques. So far, I have focused on some of the most popular modalities; and this means, I have neglected many others. Today, it is time, I think, to discuss aromatherapy, after all, it is one of the most popular forms of alternative medicine in the UK.
Aromatherapists use essential oils, and this is where the confusion starts. They are called “essential” not because humans cannot do without them, like essential nutrients, for instance; they are called “essential” because they are made of flower ESSENCES. The man who ‘discovered’ aromatherapy was a chemist who accidentally had burnt his hand and put some lavender essence on the burn. It healed very quickly, and he thus concluded that essential oils can be useful therapeutics.
Today’s aromatherapists would rarely use the pure essential oil; they dilute it in an inert carrier oil and usually apply it via a very gentle massage to the skin. They believe that specific oils have specific effects for specific conditions. As these oils contain pharmacologically active ingredients, some of these assumptions might even be correct. The question, however, is one of concentration. Do these ingredients reach the target organ in sufficient quantities? Are they absorbed through the skin at all? Does smelling them have a sufficiently large effect to produce the claimed benefit?
The ‘acid test’ for any therapeutic claim is, as always, the clinical trial. As it happens a new paper has just become available. The aim of this randomised study was to determine the effects of inhalation aromatherapy on pregnant women. Essential oils with high linalool and linalyl acetate content were selected and among these the one preferred by the participant was used. Thirteen pregnant women in week 28 of a single pregnancy were randomly assigned into an aromatherapy and a control group. The main outcome measures were several validated scores to assess mood and the heart-rate variability. The results showed significant differences in the Tension-Anxiety score and the Anger-Hostility score after aromatherapy. Heart rate variability changes indicated that the parasympathetic nerve activity increased significantly in the verum group. The authors concluded that aromatherapy inhalation was effective and suggest that more research is warranted.
I have several reasons for mentioning this study here.
1st research into aromatherapy is rare and therefore any new trial of this popular treatment might be important.
2nd aromatherapy is mostly (but not in this study) used in conjunction with a gentle, soothing massage; any outcome of such an intervention is difficult to interpret: we cannot then know whether it was the massage or the oil that produced the observed effect. The present trial is different and might allow conclusions specifically about the effects of the essential oils.
3rd the study displays several classic methodological mistakes which are common in trials of alternative medicine. By exposing them, I hope that they might become less frequent in future.
The most obvious flaw is its tiny sample size. What is an adequate size, people often ask. This question is unfortunately unanswerable. To determine the adequate sample size, it is best to conduct a pilot study or use published data to calculate the required number of patients needed for the specific trial you are planning. Any statistician will be able to help you with this.
The second equally obvious flaw relates to the fact that the results and the conclusions of this study were based on comparing the outcome measures before with those after the interventions within one intervention group. The main reason for taking the trouble of running a control group in a clinical trial is that the findings from the experimental group are compared to those of the control group. Only such inter-group comparisons can tell us whether the results were actually caused by the intervention and not by other factors such as the passage of time, a placebo-effect etc.
In the present study, the authors seem to be aware of their mistake and mention that there were no significant differences in outcomes when the two groups were compared. Yet they fail to draw the right conclusion from this fact. It means that their study demonstrated that aromatherapy inhalation had no effect on the outcomes studied.
So, what does the reliable trial evidence on aromatherapy tell us?
A clinical trial in which I was involved failed to show that it improves the mood or quality of life of cancer patients. But one swallow does not make a summer; what do systematic reviews of all available trials indicate?
The first systematic review was probably the one we published in 2000. We then located 12 randomised clinical trials: six of them had no independent replication; six related to the relaxing effects of aromatherapy combined with massage. These 6 studies collectively suggested that aromatherapy massage has a mild but short-lasting anxiolytic effect. These effects of aromatherapy are probably not strong enough for it to be considered for the treatment of anxiety. We concluded that the hypothesis that it is effective for any other indication is not supported by the findings of rigorous clinical trials.
Since then several other systematic reviews have emerged. We therefore decided to summarise their findings in an overview of all available reviews. We searched 12 electronic databases and our departmental files without restrictions of time or language. The methodological quality of all systematic reviews was evaluated independently by two authors. Of 201 potentially relevant publications, 10 met our inclusion criteria. Most of the systematic reviews were of poor methodological quality. The clinical subject areas were hypertension, depression, anxiety, pain relief, and dementia. For none of the conditions was the evidence convincing. Our conclusions therefore had to be cautious: due to a number of caveats, the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.
Finally, we also investigated the safety of aromatherapy by assessing all published data regarding adverse effects. Forty two primary reports met our inclusion criteria. In total, 71 patients had experienced adverse effects after aromatherapy which ranged from mild to severe and included one fatality. The most common adverse effect was dermatitis. Lavender, peppermint, tea tree oil and ylang-ylang were the most common essential oils responsible for adverse effects. We concluded that aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown.
And what is the conclusion of all this? To me, it seems fairly straight forward: Aromatherapy is not demonstrably effective for any condition. It also is not entirely free of risks. Its risk/benefit profile is thus not positive which can only mean that it is not a useful or recommendable treatment for anybody who is ill.