After a previous post about aromatherapy, someone recently commented:
I love essential oils and use them daily. Essential oils became a part of my life! I do feel better with it! Why I need clinical trials so?
The answer is probably: you don’t need clinical trials for a little pampering that makes you feel good.
But, if someone claims that aromatherapy (or indeed any other treatment) is effective for this or that medical condition, we need proof in the form of a clinical trial. By proof, we usually mean a clinical trial.
One like this new study, perhaps?
The aim of this study was to evaluate the use of a lavender aromatherapy skin patch on anxiety and vital sign variability during the preoperative period in female patients scheduled for breast surgery. Participants received an aromatherapy patch in addition to standard preoperative care. Anxiety levels were assessed with a 10-cm visual analogue scale (VAS) at baseline and then every 15 minutes after patch placement. Vital sign measurements were recorded at the same interval. There was a statistically significant decrease (P = .03) in the anxiety VAS measurements from baseline to final scores.
The authors concluded that the findings from this study suggest the use of aromatherapy is beneficial in reducing anxiety experienced by females undergoing breast surgery. Further research is needed to address the experience of preoperative anxiety, aromatherapy use, and the challenges of managing preoperative anxiety.
No, not one like this study!
This study – its called it a ‘pilot study’ – tells us nothing of value.
- It was not a pilot study because it did not pilot anything; its aim was to evaluate aromatherapy.
- But it could not evaluate aromatherapy because it had no control group. This means the reduction in anxiety was almost certainly not a specific effect of the therapy, but a non-specific effect due to the extra attention, expectation, etc.
- This means that the conclusion (the use of aromatherapy is beneficial) is not justified.
- In turn, this means that the paper is not helpful in any way. All it can possibly do is to mislead the public.
In summary: another fine example of pseudo-research that, I believe, is worse than no research at all.
This randomized controlled trial was aimed to investigate the effect of aromatherapy massage on anxiety, depression, and physiologic parameters in older patients with acute coronary syndrome. It was conducted on 90 older women with acute coronary syndrome. The participants were randomly assigned into the intervention and control groups. The intervention group received reflexology with lavender essential oil plus routine care and the control group only received routine care. Physiologic parameters, the levels of anxiety and depression in the hospital were evaluated using a checklist and the Hospital’s Anxiety and Depression Scale, respectively, before and immediately after the intervention.
Significant differences in the levels of anxiety and depression were reported between the groups after the intervention. The analysis of physiological parameters revealed a statistically significant reduction in systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate. However, no significant difference was observed in the respiratory rate.
The authors concluded that aromatherapy massage can be considered by clinical nurses an efficient therapy for alleviating psychological and physiological responses among older women suffering from acute coronary syndrome.
This trial does not show remotely what the authors think. It demonstrates that A+B is always more than B. We have discussed this phenomenon so often that I hesitate to mention it again. Any study with the ‘A+B versus B’ design can only produce a positive result. The danger that this result is false-positive is so high that it is best to forget about such investigations altogether.
Ethics committees should not accept such protocols.
Researchers should stop running such studies.
Reviewers should not pass them for publication.
Editors should not publish such trials.
THEY MISLEAD ALL OF US AND GIVE CLINICAL RESEARCH A BAD NAME.
Therapeutic Touch is a therapy mostly popular with nurses. We have discussed it before, for instance here, here, here and here. To call it implausible would be an understatement. But what does the clinical evidence tell us? Does it work?
This literature review by Iranian authors was aimed at critically evaluating the data from clinical trials examining the clinical efficacy of therapeutic touch as a supportive care modality in adult patients with cancer.
Four electronic databases were searched from the year 1990 to 2015 to locate potentially relevant peer-reviewed articles using the key words therapeutic touch, touch therapy, neoplasm, cancer, and CAM. Additionally, relevant journals and references of all the located articles were manually searched for other potentially relevant studies.
The number of 334 articles was found on the basis of the key words, of which 17 articles related to the clinical trial were examined in accordance with the objectives of the study. A total of 6 articles were in the final dataset in which several examples of the positive effects of healing touch on pain, nausea, anxiety and fatigue, and life quality and also on biochemical parameters were observed.
The authors concluded that, based on the results of this study, an affirmation can be made regarding the use of TT, as a non-invasive intervention for improving the health status in patients with cancer. Moreover, therapeutic touch was proved to be a useful strategy for adult patients with cancer.
This review is badly designed and poorly reported. Crucially, its conclusions are not credible. Contrary to what the authors stated when formulating their aims, the methods lack any attempt of critically evaluating the primary data.
A systematic review is more than a process of ‘pea counting’. It requires a rigorous assessment of the risk of bias of the included studies. If that crucial step is absent, the article is next to worthless and the review degenerates into a promotional excercise. Sadly, this is the case with the present review.
You may think that this is relatively trivial (“Who cares what a few feeble-minded nurses do?”), but I would disagree: if the medical literature continues to be polluted by such irresponsible trash, many people (nurses, journalists, healthcare decision makers, researchers) who may not be in a position to see the fatal flaws of such pseudo-reviews will arrive at the wrong conclusions and make wrong decisions. This will inevitably contribute to a hindrance of progress and, in certain circumstances, must endanger the well-being or even the life of vulnerable patients.
The love-affair of many nurses with complementary medicine is well-known. We have discussed it many times on this blog – see for instance here, here and here. Yet the reasons for it remain somewhat mysterious, I find. Therefore I was interested to see a new paper on the subject.
The aim of this ‘meta-synthesis‘ was to review, critically, appraise and synthesize the existing qualitative research to develop a new, more substantial interpretation of nurses’ attitudes regarding the, use of complementary therapies by patients. Fifteen articles were included in the review.
Five themes emerged from the data relating to nurses’ attitude towards complementary therapies:
- the strengths and weaknesses of conventional medicine;
- complementary therapies as a way to enhance nursing practice;
- patient empowerment and patient-centeredness;
- cultural barriers and enablers to integration;
- structural barriers and enablers to integration.
Nurses’ support for complementary therapies, the authors of this article claim, is not an attempt to challenge mainstream medicine but rather an endeavour to improve the quality of care available to patients. There are, however, a number of barriers to nurses’ support including institutional culture and clinical context, as well as time and knowledge limitations.
The authors concluded that some nurses promote complementary therapies as an opportunity to personalise care and practice in a humanistic way. Yet, nurses have very limited education in this field and a lack of professional frameworks to assist them. The nursing profession needs to consider how to address current deficiencies in meeting the growing use of complementary therapies by patients.
In my view, there are two most remarkable misunderstandings here:
- While it is undoubtedly laudable that nurses “endeavour to improve the quality of care available to patients”, it has to be said that such an endeavour does not require complementary medicine. Are they implying that with conventional medicine the quality of care cannot be improved?
- I fail to understand why the lack of good evidential support for most complementary therapies did not emerge as a prominent theme. Are nurses not concerned about the (lack of) evidence that underpins their actions?
In a recent Editorial, I wrote: “Complementary and alternative medicine (CAM) is popular, and many nurses seem to be embracing it in the hope of helping their patients…But despite its popularity, CAM has remained a highly controversial area: the evidence-base is often unconvincing or non-existent. For most forms of CAM, we thus know too little to claim with confidence that they generate more good than harm. In the interest of our patients, it might, therefore, be wise to exercise caution and be aware of some of the fallacies which can easily mislead us.”
Yet, my calls for caution seem to fall on nurses’ deaf ears. This is at least what a new article on this subject implies.
This paper investigated how frequently nurses include CAM in their clinical practice. In so doing, its authors investigated nurses’ knowledge of and attitudes towards CAM as well as their ability to communicate the risks and benefits of these therapies with patients. For this purpose, a review was conducted in five stages: (1) identification of research question(s), (2) locate studies, (3) selection of studies, (4) charting of data, and (5) collating, summarising, and reporting of results.
Fifteen papers met the inclusion criteria for the review, among which 53·7% referenced how frequently nurses include CAM in their practice. The researchers found that 66·4% of nurses had positive attitudes towards CAM; however, 77·4% did not possess a comprehensive understanding of the associated risks and benefits. In addition, nearly half of the respondents (47·3-67·7%) reported feeling uncomfortable discussing CAM therapies with their patients.
The authors concluded that the lack of knowledge about complementary and alternative medicine among nurses is a cause for concern, particularly in light of its widespread application. Findings from this study suggest that health care professionals need to promote evidence informed decision-making in complementary and alternative medicine practice and be knowledgeable enough to discuss complementary and alternative medicine therapies. Without involvement of complementary and alternative medicine communication on the part of our profession, we may put our patients at risk of uninformed and without medical guidance.
I think I understand why many nurses feel attracted by CAM; if nothing else, it offers the opportunity to exercise compassion and empathy in patient care – and these are qualities that are often badly needed in routine practice. But it would be important (not just for nurses but for all health care professionals) to realise that compassion is best when it is paired with evidence-based care and effective treatments rather than with quackery and unproven therapies.
Therapeutic Touch is an alternative therapy which is based on the notion of ‘energy healing’; it is thus akin to Reiki and other forms of spiritual healing. A recent survey from Canada suggested that such treatments are incredibly popular: over 50% of the families that were asked admitted using them for kids suffering from cancer.
The therapists using Therapeutic Touch, mostly nurses, believe to be able to channel ‘healing energy’ into the body of the patient which, in turn, is thought to stimulate the patient’s self-healing potential. Proponents of Therapeutic Touch claim that it is effective for a very wide range of conditions. Here is what one typical website by advocates states: As a healing modality Therapeutic Touch has been shown to be very effective in decreasing anxiety, decreasing stress, evoking the relaxation response, decreasing pain, and promoting wound healing. Therapeutic Touch as a method of healing is used by both professionals in the health field and laymen in the community.
There is a surprising amount of research on Therapeutic Touch. Unfortunately most of it is fatally flawed. It is therefore refreshing to see a new clinical study with a rigorous and straight forward design.
The objective of this trial was to determine whether Therapeutic Touch is efficacious in decreasing pain in preterm neonates. Fifty-five infants < 30 weeks’ gestational age participated in a randomized control trial in two neonatal intensive care units. Immediately before and after a painful heel lance procedure, the therapist performed non-tactile Therapeutic Touch with the infant behind curtains. In the sham condition, the therapist stood by the incubator without performing Therapeutic Touch. The Premature Infant Pain Profile was used for measuring pain and time for heart rate to return to baseline during recovery. Heart rate variability and stress response were secondary outcomes.
The results showed no group differences in any of the outcome measures. Mean Premature Infant Pain Profile scores across 2 minutes of heel lance procedure in 30-second blocks ranged from 7.92 to 8.98 in the Therapeutic Touch group and 7.64 to 8.46 in the sham group. The authors concluded that Therapeutic Touch given immediately before and after heel lance has no comforting effect in preterm neonates. Other effective strategies involving actual touch should be considered.
These findings are hardly surprising considering the implausibility of the ‘principles’ that underlie Therapeutic Touch. Nobody has so far been able to measure the mystical ‘energy’ that is the basis of this treatment. The only Cochrane review failed to show that Therapeutic touch works beyond placebo: There is no robust evidence that TT promotes healing of acute wounds.
Why then is Therapeutic Touch so popular? Part of the answer to this question might lie here: New Age spiritualism has co-opted some of the language of physics, including the language of quantum mechanics, in its quest to make ancient metaphysics sound like respectable science. The New Age preaches enhancing your vital energy, tapping into the subtle energy of the universe,or manipulating your biofield so that you can be happy, fulfilled, successful, and lovable, and so life can be meaningful, significant, and endless. The New Age promises you the power to heal the sick and create reality according to your will, as if you were a god.
To include conventional health care professionals amongst those who significantly contribute to the ‘sea of misinformation’ on alternative medicine might come as a surprise. But sadly, they do deserve quite a prominent place in the list of contributors. In fact, I could write one entire book about each of the various professions’ ways to mislead patients about alternative medicine.
There are, of course, considerable national differences and other peculiarities which render each specific profession quite complex to evaluate. The material is huge – far to big to fit in a short comment. All I will therefore try to do with this post is to throw a quick spotlight on some of the mainstream professions mentioning just one or two relevant aspects in each instant.
Particularly in North America, many nurses seem to be besotted with ‘Therapeutic Touch’, an implausible and unproven ‘energy-therapy’. For instance, the College of Nurses of Ontario includes Therapeutic Touch as a therapy permitted for its members. In other regions, other alternative treatments might be more popular with nurses but, in general, many seem to have a weakness for this sector. Researchers from Aberdeen recently conducted a survey to establish the use of alternative medicine by registered nurses, as well as their knowledge-base and attitudes towards it. They sent a questionnaire to 621 nurses and achieved a remarkable response rate of 86%. Eighty per cent of the responders admitted to employ alternative medicine and 41% were using it currently. Only five nurses believed that alternative medicine was not effective and 74% would recommend it to others. In other words, there is a strong likelihood of patients being misinformed by nurses.
A recent article in the UK journal THE PRACTISING MIDWIFE (Sept 2013) by Valerie Smith (not Medline-listed) claimed that the Royal College of Midwives supports the use of homeopathic remedies during childbirth. This does come to no surprise to those who know that several surveys have suggested that midwives are particularly fond of un- or dis-proven therapies and that they employ them often without the knowledge of obstetricians. We investigated this question by conducting a systematic review of all surveys of alternative medicine use by midwives. In total,19 surveys met our inclusion criteria. Most were recent and many originated from the US. Prevalence data varied but were usually high, often close to 100%. Much of this practice was not supported by sound evidence for efficacy and some of the treatments employed had the potential to put patients at risk. It seems obvious that, in order to employ unproven treatment, midwives first need to misinform their patients.
Some physiotherapists promote and practise a range of unproven treatments, e.g. craniosacral therapy. I am not aware of statistics on this, but it is not difficult to find evidence on the Internet: One website boldly states that Physiotherapy & Craniosacral Therapy available with Charetred Physiotherapist with 20 years of experience in the NHS. Another one proudly announces: Our main methods of treatment are through Physiotherapy and Craniosacral Therapy. A third site claims that Craniosacral Therapy is attracting increasing interest for its gentle yet effective approach, working directly with the body’s natural capacity for self-repair to treat a wide range of conditions. And a final example: Catherine is a registered Cranio-Sacral Therapist, a Physiotherapist, and is a tutor at the London College of Cranio-Sacral Therapy. She is also qualified in acupuncture for pain relief and a member of the Craniosacral Therapy Association, the Chartered Society of Physiotherapy and Acupuncture Association for Chartered Physiotherapists.
If you go into any pharmacy in the UK, you do not need to search for long to find shelves full of homeopathic remedies, Bach flower remedies, aromatherapy-oils or useless herbal slimming aids, to mention just 4 of the many different bogus treatments on offer. If you do the same in Germany, France, Switzerland or other countries, the amount of bogus remedies and devices for sale might even be greater. Pharmacists, it seems to me, have long settled to be shopkeepers who have few scruples misleading their customers into believing that these useless products are worth buying. Their code of ethics invariably forbids them such promotion and trade, but most pharmacists seem to pay no or very little attention. The concern for profit has clearly won over the concern for customers or patients.
I have left my own profession for last – not because they are the least contributors to the ‘sea of misinformation, but because, in some respects, they are the most important ones. The general attitude amongst doctors today seems to be ‘I don’t care how it works, as long as it helps my patients’. I have dedicated a previous post on explaining that this is misleading nonsense; therefore there is no reason to not repeat myself. Instead, I might just mention how many doctors practice homeopathy thus misleading patients into believing that it is an effective therapy. Alternatively, I could refer to those charlatans with a medical degree who promote bogus cancer cures. In my view, misinformation by doctors is the most serious form of misinformation of them all: physicians involved in such activities violate their ethical code and betray patients who frequently trust doctors almost blindly.
It would be a misunderstanding to assume that, with this post, I am accusing all conventional health care professionals of misinforming us about alternative medicine. But some clearly do; and when they do abuse their positions of trust in this way, they do a serious disservice to us all. I hope that exposing this problem will contribute to conventional health care professionals behaving more responsibly in future.