This Cochrane review assessed the efficacy and safety of aromatherapy for people with dementia. The researchers included randomised controlled trials which compared fragrance from plants in an intervention defined as aromatherapy for people with dementia with placebo aromatherapy or with treatment as usual. All doses, frequencies and fragrances of aromatherapy were considered. Participants in the included studies had a diagnosis of dementia of any subtype and severity.
The investigators included 13 studies with 708 participants. All participants had dementia and in the 12 trials which described the setting, all were resident in institutional care facilities. Nine trials recruited participants because they had significant agitation or other behavioural and psychological symptoms in dementia (BPSD) at baseline. The fragrances used were:
- lavender (eight studies);
- lemon balm (four studies);
- lavender and lemon balm,
- lavender and orange,
- cedar extracts (one study each).
For six trials, assessment of risk of bias and extraction of results was hampered by poor reporting. Four of the other seven trials were at low risk of bias in all domains, but all were small (range 18 to 186 participants; median 66). The primary outcomes were:
- overall behavioural,
- psychological symptoms,
- adverse effects.
Ten trials assessed agitation using various scales. Among the 5 trials for which the confidence in the results was moderate or low, 4 trials reported no significant effect on agitation and one trial reported a significant benefit of aromatherapy. The other 5 trials either reported no useable data or the confidence in the results was very low. Eight trials assessed overall BPSD using the Neuropsychiatric Inventory and there was moderate or low confidence in the results of 5 of them. Of these, 4 reported significant benefit from aromatherapy and one reported no significant effect.
Adverse events were poorly reported or not reported at all in most trials. No more than two trials assessed each of our secondary outcomes of quality of life, mood, sleep, activities of daily living, caregiver burden. There was no evidence of benefit on these outcomes. Three trials assessed cognition: one did not report any data and the other two trials reported no significant effect of aromatherapy on cognition. The confidence in the results of these studies was low.
The authors reached the following conclusions: We have not found any convincing evidence that aromatherapy (or exposure to fragrant plant oils) is beneficial for people with dementia although there are many limitations to the data. Conduct or reporting problems in half of the included studies meant that they could not contribute to the conclusions. Results from the other studies were inconsistent. Harms were very poorly reported in the included studies. In order for clear conclusions to be drawn, better design and reporting and consistency of outcome measurement in future trials would be needed.
This is a thorough review. It makes many of the points that I so often make regarding SCAM research:
- too many of the primary studies are badly designed;
- too many of the primary studies are too small;
- too many of the primary studies are poorly reported;
- too many of the primary studies fail to mention adverse effects thus violating research ethics;
- too many of the primary studies are done by pseudo-scientists who use research for promotion rather than testing hypotheses.
It is time that SCAM researchers, ethic review boards, funders, editors and journal reviewers take these points into serious consideration – if only to avoid clinical research getting a bad reputation and losing the support of patients without which it cannot exist.
My new book has just been published. Allow me to try and whet your appetite by showing you the book’s introduction:
“There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking.” These words of Fontanarosa and Lundberg were published 22 years ago. Today, they are as relevant as ever, particularly to the type of healthcare I often call ‘so-called alternative medicine’ (SCAM), and they certainly are relevant to chiropractic.
Invented more than 120 years ago by the magnetic healer DD Palmer, chiropractic has had a colourful history. It has now grown into one of the most popular of all SCAMs. Its general acceptance might give the impression that chiropractic, the art of adjusting by hand all subluxations of the three hundred articulations of the human skeletal frame, is solidly based on evidence. It is therefore easy to forget that a plethora of fundamental questions about chiropractic remain unanswered.
I wrote this book because I feel that the amount of misinformation on chiropractic is scandalous and demands a critical evaluation of the evidence. The book deals with many questions that consumers often ask:
- How well-established is chiropractic?
- What treatments do chiropractors use?
- What conditions do they treat?
- What claims do they make?
- Are their assumptions reasonable?
- Are chiropractic spinal manipulations effective?
- Are these manipulations safe?
- Do chiropractors behave professionally and ethically?
Am I up to this task, and can you trust my assessments? These are justified questions; let me try to answer them by giving you a brief summary of my professional background.
I grew up in Germany where SCAM is hugely popular. I studied medicine and, as a young doctor, was enthusiastic about SCAM. After several years in basic research, I returned to clinical medicine, became professor of rehabilitation medicine first in Hanover, Germany, and then in Vienna, Austria. In 1993, I was appointed as Chair in Complementary Medicine at the University of Exeter. In this capacity, I built up a multidisciplinary team of scientists conducting research into all sorts of SCAM with one focus on chiropractic. I retired in 2012 and am now an emeritus professor. I have published many peer-reviewed articles on the subject, and I have no conflicts of interest. If my long career has taught me anything, it is this: in the best interest of consumers and patients, we must insist on sound evidence; not opinion, not wishful thinking; evidence.
In critically assessing the issues related to chiropractic, I am guided by the most reliable and up-to-date scientific evidence. The conclusions I reach often suggest that chiropractic is not what it is often cracked up to be. Hundreds of books have been published that disagree. If you are in doubt who to trust, the promoter or the critic of chiropractic, I suggest you ask yourself a simple question: who is more likely to provide impartial information, the chiropractor who makes a living by his trade, or the academic who has researched the subject for the last 30 years?
This book offers an easy to understand, concise and dependable evaluation of chiropractic. It enables you to make up your own mind. I want you to take therapeutic decisions that are reasonable and based on solid evidence. My book should empower you to do just that.
In my never-ending search for novel so-called alternative medicines (SCAMs) I came across WATSU. If you had never heard of WATSU, you are in good company (for instance mine). WATSU (water and shiatsu) is a form of passive hydrotherapy in chest-deep thermoneutral water. It was created in the early 1980s by the California-based Shiatsu teacher Harold Dull and combines elements of myofascial stretching, joint mobilization, massage, and shiatsu and is used to address physical and mental issues.
To me, this sounds as though an old physiotherapeutic approach has been re-vamped in order to seem more attractive to the affluent sections of the SCAM brigade. My suspicion seems to be confirmed by SCAM ueber-guru Dr Andrew Weil’s comments:
Dr. Weil has received the therapy many times and often recommends it.
While other bodywork modalities are based on touch in a stationary, two-dimensional world, Watsu offers a different experience. A three-dimensional environment, nearly free from gravity, within a warm and comforting fluid-space and the opportunity to connect with another person all have obvious therapeutic potential.
Achieving states of deep relaxation combined with the therapeutic benefits of good massage therapy can be of great benefit in controlling pain, relieving stress, and recovering from emotional and physical trauma.
But never mind the one-dimensional Dr Weil. The question is: does WATSU work? According to a recent paper, it is effective for a wide range of conditions.
The objective of this systematic review and meta-analyses was to assess the applications, indications, and the effects of WATSU to form a basis for further studies.
Literature searches for “WATSU OR watershiatsu OR (water AND shiatsu)” were conducted without any restrictions in 32 databases. Peer reviewed original articles addressing WATSU as a stand-alone hydrotherapy were assessed for risk of bias. Quantitative data of effects on pain, physical function, and mental issues were processed in random model meta-analyses with subgroup analyses by study design.
Of 1,906 unique citations, 27 articles regardless of study design were assessed for risk of bias. WATSU has been applied to individuals of all ages. Indications covered acute (e.g. pregnancy related low back pain) and chronic conditions (e.g. cerebral palsy) with beneficial effects of WATSU regarding e.g. relaxation or sleep quality. Meta-analyses suggest beneficial effect sizes of WATSU on pain, physical function, and mental issues.
The authors concluded that various applications, indications and beneficial effects of WATSU were identified. The grade of this evidence is estimated to be low to moderate at the best. To strengthen the findings of this study, high-quality RCTs are needed.
Of the 27 studies included in this review, most were case-reports or case series, and only 5 were RCTs. Of these RCTs, none was robust. Some, for instance compared WATSU against no treatment at all, thus not controlling for placebo effects. All of these RCTs had small sample sizes, and all had been published in odd journals of dubious repute.
So, is it justified to categorically conclude that beneficial effects of WATSU were identified?
No, I don’t think so.
That physiotherapy in water can have positive effects on some symptoms would hardly be surprising. But, to convince people who think more critically than Dr Weil, better evidence would be needed.
Spinal epidural haematoma (SEH) is an uncommon but serious emergency condition. A team of emergency physicians reported the case of a SEH associated with traditional massage initially presenting with delayed lower paraplegia.
A 20-year-old man was seen with bilateral lower extremity weakness and numbness, symptoms that had started three hours prior to presentation. He had received a Thai massage by a friend three days before. Magnetic resonance imaging revealed a spinal epidural lesion suspicious for haematoma extending from C6 to T2 levels. Emergent surgical intervention for cord decompression was performed. An epidural haematoma with cord compression at C6-T2 levels was identified intra-operatively. No evidence of abnormal vascular flow or AV malformations was identified. The authors concluded that, similar to chiropractic manipulation, massage may be associated with spinal trauma. Emergency physicians must maintain a high index of suspicion for spinal epidural haematomas in patients with a history of massage or chiropractic manipulation with neurologic complaints, because delays in diagnosis may worsen clinical outcome.
Thai massage therapists typically use no lubricants. The patient remains clothed during a treatment. There is constant body contact between the therapist – who, in the above case, was a lay person – and the patient.
The authors of this case report rightly stress that such adverse events are rare – but they are by no means unknown. In 2003, I reviewed the risks and found 16 reports of adverse effects as well as 4 case series on the subject (like for all other manual therapies, there is no reporting system of adverse effects). The majority of adverse effects were – like the above case – associated with exotic types of manual massage or massage delivered by laymen. Professionally trained massage therapists were rarely implicated. The reported adverse events include cerebrovascular accidents, displacement of a ureteral stent, embolization of a kidney, haematoma, leg ulcers, nerve damage, posterior interosseous syndrome, pseudoaneurism, pulmonary embolism, ruptured uterus, strangulation of neck, thyrotoxicosis and various pain syndromes. In the majority of these instances, there was little doubt about a cause-effect relationship. Serious adverse effects were associated mostly with massage techniques other than ‘Swedish’ massage.
For patients, this means that massage is still amongst the safest form of manual therapy (best to employ qualified therapists and avoid the exotic versions of massage because they are not supported by evidence and carry the highest risks). For doctors, it means to be vigilant, if patients present with neurological problems after having enjoyed a massage.
Back pain is a huge problem: it affects many people, causes much suffering and leads to extraordinary high cost for all of us. Considering these facts, it would be excellent to identify a treatment that truly works. However, at present, we do not have found the ideal therapy; instead we have dozens of different approaches that are similarly effective/ineffective. Two of these therapies are massage and acupuncture.
Is one better than the other?
This study compared the efficacy of classical massage (KMT, n = 66) with acupuncture therapy (AKU, n = 66) in patients with chronic back pain. The primary endpoint was the non-inferiority of classical massage compared with the acupuncture treatment in respect of the impairment in everyday life, with the help of the Hannover function questionnaire (HFAQ) and the reduction in pain (“Von Korff”-Questionnaire) at the follow-up after one month.
In the per-protocol analysis during the period between enrollment in the study and follow-up, the responder rate of the KMT was 56.5% and thus tended to be inferior to the responder rate of the AKU with 62.5% (Δ = - 6%; KIΔ: - 23.5 to + 11.4%).
The authors concluded that classical massage therapy is not significantly inferior to acupuncture therapy in the period from admission to follow-up. Thus, the non-inferiority of the KMT to the AKU cannot be proven in the context of the defined irrelevance area.
I find such studies oddly useless.
To conduct a controlled trial, one needs an experimental treatment (the therapy that is not understood) and compare it with an intervention that is understood (such as a placebo that has no specific effects, or a treatment that has been shown to work). In comparative studies like the one above, one compares one unknown with another unknown. I do not see how such a comparison can ever produce a meaningful result.
In a way, it is like an equation with two unknowns: x + 5 = y. It is simply not possible to define either x nor y, and the equation is unsolvable.
For comparative studies of two back-pain treatments to make sense, we would need one of which the effect size is well-established. I do not think that we currently have identified such a therapy. Certainly, we cannot say that we know it for massage or acupuncture.
In other words, comparative studies like the one above are a waste of resources that cannot possibly make a meaningful contribution to our knowledge.
To put it even more bluntly: we ought to stop such pseudo-research.
In this RCT tested the effectiveness of foot reflexology and slow stroke back massage on the severity of fatigue in 52 patients treated with hemodialysis. Foot massage and slow stroke back massage were performed during three weeks, two sessions each week, 5 sessions in total. At the end of intervention, data of two groups were collected and compared.
The results show that the fatigue in the group receiving foot reflexology massage decreased significantly more compared to slow stroke back massage group.
The authors concluded that reflexology massage is a safe and economical nursing intervention for decreasing fatigue in hemodialysis patients.
At first glance, this might be a fairly straight forward study comparing two different interventions. One treatment yields better results than the other one, and therefore, this therapy is deemed to be the more effective one.
So far, so good.
The problem is, however, that the authors did not draw the conclusion. Instead they stated that:
- Reflexology is safe.
- Reflexology is economical.
The first point is perhaps true but cannot be concluded from the data presented. Adverse effects were not mentioned; and even if they had been noted, 52 patients is a wholly inadequate size to say anything about safety.
The second point might also be correct, but cannot be named as a conclusion, because the study was not a cost evaluation.
All of this would be hardly worth mentioning – except for the fact that such sloppy errors and illogical conclusions happen with such embarrassing regularity in the realm of alternative medicine. I feel strongly that the ‘Journal of Complementary and Integrative Medicine‘ and all similar publications must get their act together. Publishing articles such as the one discussed here only makes them the laughing stock of real scientists.
The authors of this paper wanted to establish and compare the effectiveness of Healing Touch (HT) and Oncology Massage (OM) therapies on cancer patients’ pain. They conducted pre-test/post-test, observational, retrospective study. A total of 572 outpatient oncology were recruited and asked to report pain before and after receiving a single session of either HT or OM from a certified practitioner.
Both HT and OM significantly reduced pain. Unadjusted rates of clinically significant pain improvement (defined as ≥2-point reduction in pain score) were 0.68 HT and 0.71 OM. Adjusted for pre-therapy pain, OM was associated with increased odds of pain improvement. For patients with severe pre-therapy pain, OM was not more effective in yielding clinically significant pain reduction when adjusting for pre-therapy pain score.
The authors concluded that both HT and OM provided immediate pain relief. Future research should explore the duration of pain relief, patient attitudes about HT compared with OM, and how this may differ among patients with varied pretherapy pain levels.
This paper made me laugh out loud; no, not because of the ‘certified’ practitioners (in the UK, we use this term to indicate that someone is not quite sane), but because of the admission that the authors aimed at establishing the effectiveness of their therapies. Most researchers of alternative medicine have exactly this motivation, but few make the mistake to write it into the abstract of their papers. Little do they know that this admission discloses a fatal amount of bias. Science is supposed to test hypotheses, and researchers who aim at establishing the effectiveness of their pet-therapy oust themselves as pseudo-researchers.
It comes therefore as no surprise that the study turns out to be a pseudo-study. As there was no adequate control group, these outcomes cannot be attributed to the interventions administered. The results could therefore be due to:
- the time that has passed;
- regression to the mean;
- the attention provided by the therapists;
- the expectation of the patient;
- social desirability;
- all of the above.
It follows that – just as with the study discussed in the previous post – the conclusion is wholly misleading. In fact, the data are consistent with the hypothesis that HT and OM both aggravated the pain (the results might have been better without HT and OM). The devils advocate concludes that both HT and OM provided an immediate increase in pain.
Aromatherapy usually involves the application of diluted essential (volatile) oils via a gentle massage of the body surface. The chemist Rene-Maurice Gattefosse (1881-1950) coined the term ‘aromatherapy’ after experiencing that lavender oil helped to cure a severe burn of his hand. In 1937, he published a book on the subject: Aromathérapie: Les Huiles Essentielles, Hormones Végétales. Later, the French surgeon Jean Valnet used essential oils to help heal soldiers’ wounds in World War II.
Aromatherapy is currently one of the most popular of all alternative therapies. The reason for its popularity seems simple: it is an agreeable, luxurious form of pampering. Whether it truly merits to be called a therapy is debatable.
The authors of this systematic review stated that they wanted to critically assess the effect of aromatherapy on the psychological symptoms as noted in the postmenopausal and elderly women. They conducted electronic literature searches and fount 4 trials that met their inclusion criteria. The findings demonstrated that aromatherapy massage significantly improves psychological symptoms in menopausal, elderly women as compared to controls. In one trial, aromatherapy massage was no more effective than the untreated group regarding their experience of symptoms such as nervousness.
The authors concluded that aromatherapy may be beneficial in attenuating the psychological symptoms that these women may experience, such as anxiety and depression, but it is not considered as an effective treatment to manage nervousness symptom among menopausal women. This finding should be observed in light of study limitations.
In the discussion section, the authors state that to the best of our knowledge, this is the first meta-analysis evaluating the effect of aromatherapy on the psychological symptoms. I believe that they might be mistaken. Here are two of my own papers (other researchers have published further reviews) on the subject:
- Aromatherapy is the therapeutic use of essential oil from herbs, flowers, and other plants. The aim of this overview was to provide 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. Several SRs of aromatherapy have recently been published. Due to a number of caveats, the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.
- Aromatherapy is becoming increasingly popular; however there are few clear indications for its use. To systematically review the literature on aromatherapy in order to discover whether any clinical indication may be recommended for its use, computerised literature searches were performed to retrieve all randomised controlled trials of aromatherapy from the following databases: MEDLINE, EMBASE, British Nursing Index, CISCOM, and AMED. The methodological quality of the trials was assessed using the Jadad score. All trials were evaluated independently by both authors and data were extracted in a pre-defined, standardised fashion. Twelve trials were located: six of them had no independent replication; six related to the relaxing effects of aromatherapy combined with massage. These studies suggest that aromatherapy massage 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.
Omitting previous research may be odd, but it is not a fatal flaw. What makes this review truly dismal is the fact that the authors fail to discuss the poor quality of the primary studies. They are of such deplorable rigor that one can really not draw any conclusion at all from them. I therefore find the conclusions of this new paper unacceptable and think that our statement (even though a few years old) is much more accurate: the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.
It is no secret to regular readers of this blog that chiropractic’s effectiveness is unproven for every condition it is currently being promoted for – perhaps with two exceptions: neck pain and back pain. Here we have some encouraging data, but also lots of negative evidence. A new US study falls into the latter category; I am sure chiropractors will not like it, but it does deserve a mention.
This study evaluated the comparative effectiveness of usual care with or without chiropractic care for patients with chronic recurrent musculoskeletal back and neck pain. It was designed as a prospective cohort study using propensity score-matched controls.
Using retrospective electronic health record data, the researchers developed a propensity score model predicting likelihood of chiropractic referral. Eligible patients with back or neck pain were then contacted upon referral for chiropractic care and enrolled in a prospective study. For each referred patient, two propensity score-matched non-referred patients were contacted and enrolled. We followed the participants prospectively for 6 months. The main outcomes included pain severity, interference, and symptom bothersomeness. Secondary outcomes included expenditures for pain-related health care.
Both groups’ (N = 70 referred, 139 non-referred) pain scores improved significantly over the first 3 months, with less change between months 3 and 6. No significant between-group difference was observed. After controlling for variances in baseline costs, total costs during the 6-month post-enrollment follow-up were significantly higher on average in the non-referred versus referred group. Adjusting for differences in age, gender, and Charlson comorbidity index attenuated this finding, which was no longer statistically significant (p = .072).
The authors concluded by stating this: we found no statistically significant difference between the two groups in either patient-reported or economic outcomes. As clinical outcomes were similar, and the provision of chiropractic care did not increase costs, making chiropractic services available provided an additional viable option for patients who prefer this type of care, at no additional expense.
This comes from some of the most-renowned experts in back pain research, and it is certainly an elaborate piece of investigation. Yet, I find the conclusions unreasonable.
Essentially, the authors found that chiropractic has no clinical or economical advantage over other approaches currently used for neck and back pain. So, they say that it a ‘viable option’.
I find this odd and cannot quite follow the logic. In my view, it lacks critical thinking and an attempt to produce progress. If it is true that all treatments were similarly (in)effective – which I can well believe – we still should identify those that have the least potential for harm. That could be exercise, massage therapy or some other modality – but I don’t think it would be chiropractic care.
Elder C, DeBar L, Ritenbaugh C, Dickerson J, Vollmer WM, Deyo RA, Johnson ES, Haas M.
J Gen Intern Med. 2018 Jun 25. doi: 10.1007/s11606-018-4539-y. [Epub ahead of print]
Shiatsu is an alternative therapy that is popular, but has so far attracted almost no research. Therefore, I was excited when I saw a new paper on the subject. Sadly, my excitement waned quickly when I stared reading the abstract.
This single-blind randomized controlled study was aimed to evaluate shiatsu on mood, cognition, and functional independence in patients undergoing physical activity. Alzheimer disease (AD) patients with depression were randomly assigned to the “active group” (Shiatsu + physical activity) or the “control group” (physical activity alone).
Shiatsu was performed by the same therapist once a week for ten months. Global cognitive functioning (Mini Mental State Examination – MMSE), depressive symptoms (Geriatric Depression Scale – GDS), and functional status (Activity of Daily Living – ADL, Instrumental ADL – IADL) were assessed before and after the intervention.
The researchers found a within-group improvement of MMSE, ADL, and GDS in the Shiatsu group. However, the analysis of differences before and after the interventions showed a statistically significant decrease of GDS score only in the Shiatsu group.
The authors concluded that the combination of Shiatsu and physical activity improved depression in AD patients compared to physical activity alone. The pathomechanism might involve neuroendocrine-mediated effects of Shiatsu on neural circuits implicated in mood and affect regulation.
- We first evaluated the effect of Shiatsu in depressed patients with Alzheimer’s disease (AD).
- Shiatsu significantly reduced depression in a sample of mild-to-moderate AD patients.
- Neuroendocrine-mediated effect of Shiatsu may modulate mood and affect neural circuits.
Where to begin?
1 The study is called a ‘pilot’. As such it should not draw conclusions about the effectiveness of Shiatsu.
2 The design of the study was such that there was no accounting for the placebo effect (the often-discussed ‘A+B vs B’ design); therefore, it is impossible to attribute the observed outcome to Shiatsu. The ‘highlight’ – Shiatsu significantly reduced depression in a sample of mild-to-moderate AD patients – therefore turns out to be a low-light.
3 As this was a study with a control group, within-group changes are irrelevant and do not even deserve a mention.
4 The last point about the mode of action is pure speculation, and not borne out of the data presented.
5 Accumulating so much nonsense in one research paper is, in my view, unethical.