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.
WRONG!
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.
7 Responses to Aromatherapy: an ‘efficient’ therapy? It’s time to stop such nonsensical pseudoresearch
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Could you provide a link or two for further reading? i would like to know more about this fallacy and as a fairly new follower, haven’t seen previous discussion that you refer to
To begin with, Dr. Ernst provides a brief account here. Apart from that, testing two simultaneous treatments against only one of them cannot lead to any safe conclusions with respect to the additional treatment. The only conclusion that might be drawn with the least reservations is that the additional treatment probably elicits nonspecific effects in general (cf. the nature of placebo).
When studying a treatment using a design that cannot distinuish specific effects, it is fallacious to explicitly conclude anything implying the effect-specificity of the treatment. The obvious mistake of the study above boils down to the fact that a number of people will distil a take-home message reading along the lines:
Aromatherapy massage can be used by clinical nurses to manage physiological responses in patients with acute coronary syndrome.
What is wrong with that? Well… It would be dangerous to rely solely on aromatherapy massage to manage your blood pressure and heart function in general when suffering from acute coronary syndrome (or anything else for that matter). So, an ineffective treatment can be shown to be effective using this study design and dozens will be misled.
Still, I am amazed that such stuff keeps getting published all around. I thought some types of obvious placebo treatment would have ceased being touted as having significant clinical effects after all these years…
One author in Norway, one in the USA, and 3 from Iran. And the funding organization? Shahed University, Tehran, Iran of course!
This study provides further evidence that aromatherapy massage is a placebo and placebos can elicit physiological responses. Actually, I think it would be fair to say that the study design “A+B vs. B” can only be interpreted as evidence that A elicits placebo effects, of course with a disclaimer reading:
“For further efficacy considerations, test A in isolation“.
Design A+B vs. B had better be called the placebo test (or design). A positive result means that A elicits placebo effects. A negative result means that A elicits nocebo effects. A lack of difference usually means the patients weren’t paying attention.
The full ‘placebo test’ is: “Design A+B vs B means, if positive, A elicits placebo effects only – until proved otherwise by A vs control. (Or nocebo effects only, if negative results.)”
Love it! That has to be the standard.
Dr Ernst’s excellent article referred to by James, and the scientific comments by James are the central crux of the theme of this blog.
I notice that it is recognised that alternative treatments do produce improvements in patient’s health and well-being via placebo effect. If alternative treatments produce no harm has beneficial effects for the patient’s wellbeing, is this not a case for inclusion of placebo into physical and psychological domains of medicine?
Of course Edzard, will come back with the usual story about alternative practitioners lack of medical training diagnostic skills and therefore the high risk of harm due to failure to act but if practitioners are working interactively then this problem should not occur.
In case of MUS (medically unknown symptoms and syndromes), is ‘placebo therapy’ as possibility?
(Excluded from discussion in this comment: I believe homeopathic remedies do have non placebo effects)
The effects of feeling pleased are very well documented, and very well nonspecific. The placebo effect being referred to as a specific treatment is mistaken.
The inclusion of placebo in medicine is not much of a struggle in and of itself. The ethical consideration of informing the patients about it being a nonspecific effect is the burden. When informing a patient that their treatment is just palliative effectively ruins the purpose of placebo. Apart from that, every medical treatment, provided it is administered along with plenty of empathy, understanding and gentleness, is bound to elicit full-blown nonspecific placebo effects.
Another misunderstanding is that alternative treatments do not have beneficial effects for patients. For example, making someone relax may cause their systolic blood pressure to drop down a(n even clinically significant) bit, which is good, but it does not “dispel” a potential coronary artery obstruction. So, while nonspecific effects may manifest as somewhat beneficial to the patient’s well-being-in-spite-of-illness, the underlying cause of disease reigns undisturbed, probably aggravating the condition. Weighed together, the facts of this example lean towards the negative side… there is no actual benefit as a sum total. As has been repeated millions of times, of course, if alternative treatments are shown to have significant benefits, they lose the alternative status, they become efficacious treatment options.
Finally, an end has to be put to this obsession with alternative treatments causing no harm and having beneficial effects, thus being useful. What they mostly equate with is plain pep talk.
Suppose 60 male patients with whichever type of, potentially serious, pathology, are randomly assigned to two groups, 30 for the control arm and 30 for the intervention arm. The control arm is left alone most of the day for one week. The patients of the intervention arm daily receive three sessions of a 15-minute full-fledged nurse-cosplay striptease show from experienced professional strippers, for one week. If blood pressure, heart and respiratory rates are measured, by the end of one week, the results will make those of the referenced aromatherapy massage trial look like a hoax gone wrong! If moderated contact is also included in the intervention arm, the disease might even become totally masked for the whole week…
The point is, placebo effects are very easy to elicit. Caressing, bringing good news (even fake ones), pep talk, experiencing a sexually loaded atmosphere (sure thing!), praying, prescribing shaken water… Just as the sound of runnign water at times elicits a need to pee, saying good and happy stuff elicits pleasure, with all its nonspecific side-effects. This is not a prerogative of alternative treatments! Alternative treatments are, simply, really complicated cover stories for eliciting a placebo effect in return for money. Placebo should not cost (
at all) much and should, definitely, not necessitate a doctor’s prescription (a homeopathic one’s for example).In cases of medically unexplained physical symptoms, placebo therapy might be a palliative option but that, along with its ethical considerations, is a different discussion in and of itself…
Illustrative and informative. I had to think about A+B >A or B. But of course it makes sense