Aromatherapy is popular and pleasant – but does it have real health effects? The last time I tried to find an answer to this question was in 2012. At that time, our systematic review concluded that “the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.” But 5 years can be a long time in research, and more up-to-date information would perhaps be helpful.
This systematic review of 2017 aimed to provide an analysis of the clinical evidence on the efficacy of aromatherapy specifically for depressive symptoms on any type of patients. The authors searched 5 databases for relevant studies Outcome measures included scales measuring depressive symptoms levels. Twelve randomized controlled trials (RCTs) were included. Aromatherapy was administered by inhalation (5 studies) or massage (7 studies). Seven RCTs showed improvement in depressive symptoms. The quality of half of the studies was low, and the administration protocols varied considerably among the studies. Different assessment tools were employed in the studies. In 6 of the RCTs, aromatherapy was compared to no intervention.
Despite these caveats, the authors concluded that aromatherapy showed potential to be used as an effective therapeutic option for the relief of depressive symptoms in a wide variety of subjects. Particularly, aromatherapy massage showed to have more beneficial effects than inhalation aromatherapy.
Apart from the poor English, this paper is irritating because of the almost total lack of critical input. Given that half of the trials were of poor quality (only one was given the full points on the quality scale) and many totally failed to control for placebo-effects, I think that calling aromatherapy an effective therapeutic option for the relief of depressive symptoms is simply not warranted. In fact, it is highly misleading and, given the fact that depression is a life-threatening condition, it seems unethical and dangerous.
Considering these facts, my conclusion remains that “the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition, including depression.”
WARNING: THIS MIGHT MAKE YOU LAUGH OUT LOUDLY AND UNCONTROLLABLY.
Deepak Chopra rarely publishes in medical journals (I suppose, he has better things to do). I was therefore intrigued when I saw a recent article of which he is a co-author.
The ‘study‘ in question allegedly examined the effects of a comprehensive residential mind–body program on well-being. The authors describe it as “a quasi-randomized trial comparing the effects of participation in a 6-day Ayurvedic system of medicine-based comprehensive residential program with a 6-day residential vacation at the same retreat location.” They included 69 healthy women and men who received the Ayurvedic intervention addressing physical and emotional well-being through group meditation and yoga, massage, diet, adaptogenic herbs, lectures, and journaling. Key components of the program include physical cleansing through ingestion of herbs, fiber, and oils that support the body’s natural detoxification pathways and facilitate healthy elimination; two Ayurvedic meals daily (breakfast and lunch) that provide a light plant-based diet; daily Ayurvedic oil massage treatments; and heating treatments through the use of sauna and/or steam. The program includes lectures on Ayurvedic principles and lifestyle as well as lectures on meditation and yoga philosophy. The study group also participated in twice-daily group meditation and daily yoga and practiced breathing exercises (pranayama) as well as emotional expression through a process of journaling and emotional support. During the program, participants received a 1-hour integrative medical consultation with a physician and follow-up with an Ayurvedic health educator.
The control group simply had a vacation without any of the above therapies in the same resort. They were asked to do what they would normally do on a resort vacation with the additional following restrictions: they were asked not to engage in more exercise than they would in their normal lifestyle and to refrain from using La Costa Resort spa services. They were also asked not to drink ginger tea or take Gingko biloba during the 2 days before and during the study week.
Recruitment was via email announcements on the University of California San Diego faculty and staff and Chopra Center for Wellbeing list-servers. Study flyers stated that the week-long Self-Directed Biological Transformation Initiative (SBTI) study would be conducted at the Chopra Center for Wellbeing, located at the La Costa Resort in Carlsbad, California, in order to learn more about the psychosocial and physiologic effects of the 6-day Perfect Health (PH) Program compared with a 6-day stay at the La Costa Resort. The study participants were not blinded, and site investigators and study personnel knew to which group participants were assigned.
Participants in the Ayurvedic program showed significant and sustained increases in ratings of spirituality and gratitude compared with the vacation group, which showed no change. The Ayurvedic participants also showed increased ratings for self-compassion as well as less anxiety at the 1-month follow-up.
The authors arrived at the following conclusion: Findings suggest that a short-term intensive program providing holistic instruction and experience in mind–body healing practices can lead to significant and sustained increases in perceived well-being and that relaxation alone is not enough to improve certain aspects of well-being.
This ‘study’ had ethical approval from the University of California San Diego and was supported by the Fred Foundation, the MCJ Amelior Foundation, the National Philanthropic Trust, the Walton Family Foundation, and the Chopra Foundation. The paper’s first author is director of research at the Chopra Foundation. Deepak Chopra is the co-founder of The Chopra Center for Wellbeing.
Did I promise too much?
Isn’t this paper hilarious?
Just for the record, let me formulate a short conclusion that actually fits the data from this ‘study’: Lots of TLC, attention and empathy does make some people feel better.
This is hardly something one needs to write home about; and certainly nothing to do a study on!
But which journal would publish such unadulterated advertising?
On this blog, I have mentioned the JACM several times before. Recently, I wrote about the new man in charge of it. I concluded stating WATCH THIS SPACE.
I think the wait is now over – this paper is from the latest issue of the JACM, and I am sure we all agree that the new editor has just shown us of what he is made and where he wants to take his journal.
Just as I thought that this cannot get any better, it did! It did so in the form of a second paper which is evidently reporting from the same ‘study’. Here is its abstract unaltered in its full beauty:
The effects of integrative medicine practices such as meditation and Ayurveda on human physiology are not fully understood. The aim of this study was to identify altered metabolomic profiles following an Ayurveda-based intervention. In the experimental group, 65 healthy male and female subjects participated in a 6-day Panchakarma-based Ayurvedic intervention which included herbs, vegetarian diet, meditation, yoga, and massage. A set of 12 plasma phosphatidylcholines decreased (adjusted p < 0.01) post-intervention in the experimental (n = 65) compared to control group (n = 54) after Bonferroni correction for multiple testing; within these compounds, the phosphatidylcholine with the greatest decrease in abundance was PC ae C36:4 (delta = -0.34). Application of a 10% FDR revealed an additional 57 metabolites that were differentially abundant between groups. Pathway analysis suggests that the intervention results in changes in metabolites across many pathways such as phospholipid biosynthesis, choline metabolism, and lipoprotein metabolism. The observed plasma metabolomic alterations may reflect a Panchakarma-induced modulation of metabotypes. Panchakarma promoted statistically significant changes in plasma levels of phosphatidylcholines, sphingomyelins and others in just 6 days. Forthcoming studies that integrate metabolomics with genomic, microbiome and physiological parameters may facilitate a broader systems-level understanding and mechanistic insights into these integrative practices that are employed to promote health and well-being.
Now that I managed to stop laughing about the first paper, I am not just amused but also puzzled by the amount of contradictions the second article seems to cause. Were there 65 or 69 individuals in the experimental group? Was the study randomised, quasi-randomised or not randomised? All of these versions are implied at different parts of the articles. It turns out that they randomised some patients, while allocating others without randomisation – and this clearly means the study was NOT randomised. Was the aim of the study ‘to identify altered metabolomic profiles following an Ayurveda-based intervention’ or ‘to examine the effects of a comprehensive residential mind–body program on well-being’?
I am sure that others will find further contradictions and implausibilites, if they look hard enough.
The funniest inconsistency, in my opinion, is that Deepak Chopra does not even seem to be sure to which university department he belongs. Is it the ‘Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA.’ as indicated in the 1st paper or is it the ‘Department of Family and Preventive Medicine, University of California San Diego, La Jolla, California, USA’ as listed in the 2nd article?
Does he know from which planet he is?
In alternative medicine, good evidence is like gold dust and good evidence showing that alternative therapies are efficacious is even rarer. Therefore, I was delighted to come across a brand-new article from an institution that should stand for reliable information: the NIH, no less.
According to its authors, this new article “examines the clinical trial evidence for the efficacy and safety of several specific approaches—acupuncture, manipulation, massage therapy, relaxation techniques including meditation, selected natural product supplements (chondroitin, glucosamine, methylsulfonylmethane, S-adenosylmethionine), tai chi, and yoga—as used to manage chronic pain and related disability associated with back pain, fibromyalgia, osteoarthritis, neck pain, and severe headaches or migraines.”
The results of this huge undertaking are complex, of course, but in a nutshell they are at least partly positive for alternative medicine. Specifically, the authors state that “based on a preponderance of positive trials vs negative trials, current evidence suggests that the following complementary approaches may help some patients manage their painful health conditions: acupuncture and yoga for back pain; acupuncture and tai chi for OA of the knee; massage therapy for neck pain with adequate doses and for short-term benefit; and relaxation techniques for severe headaches and migraine. Weaker evidence suggests that massage therapy, SM, and osteopathic manipulation might also be of some benefit to those with back pain, and relaxation approaches and tai chi might help those with fibromyalgia.”
This is excellent news! Finally, we have data from an authoritative source showing that some alternative treatments can be recommended for common pain conditions.
Hold on, not so fast! Yes, the NIH is a most respectable organisation, but we must not blindly accept anything of importance just because it appears to come form a reputable source. Let’s look a bit closer at the actual evidence provided by the authors of this paper.
Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:
- the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
- the authors talk about efficacy but seem to mean effectiveness;
- the authors only included RCTs from the US which must result in a skewed and incomplete picture;
- the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
- not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
- the discussion of the paper totally lacks any critical thinking;
- there is no assessment of the quality of the trials included in this review.
My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.
Personally, I find it lamentable that such a potentially worthy exercise ended up employing such lousy methodology. Perhaps even more lamentable is the fact that the NIH (or one of its Centers) can descend that low; to mislead the public in this way borders on scientific misconduct and is, in my view, unethical and unacceptable.
Yes, I know, lately I have been neglecting my ‘ALT MED HALL OF FAME’. This is entirely my fault; there are so many candidates waiting to be admitted that, I have been hesitant as to who should be next. Today, I came across an article about Deepak Chopra and his latest book, Super Genes. It tells “how lifestyle shifts can help you reboot your health at a genetic level.” If it were just for this single sentence, he would deserve to be admitted – no, not into what you just thought, into the ‘ALT MED HALL OF FAME’, of course’.
I will save you the expense of buying his book (don’t worry, Deepak is already a multi-millionaire) by repeating what the article said about his ‘6 pillars of wellbeing’ (another cracker!!!):
• A typical modern diet is very likely to cause inflammation, which research has linked to many chronic diseases and obesity.
• To reduce inflammation, add prebiotics – substances that buffer the body from inflammation – such as oatmeal, pulpy orange juice, bran cereal and bananas to your breakfast.
• Consume probiotics – foods that contain active bacteria – once a day for gut health. These foods include active yoghurt, pickles and sauerkraut.
• Eat mindfully – eat only when you’re genuinely hungry and stop when you are full.
• Reduce snacking by eating only one measured portion in a bowl; never eat straight from a bag or packet.
• Three factors generally lie behind the problem of chronic stress: repetition, unpredictability and a lack of control. Think of a dog barking outside your window; you don’t know when it will end and you have no way of stopping it.
• Decrease background noise and distractions at work. Also, avoid multitasking by dealing with one thing at a time.
• Leave work on time at least three times a week and don’t bring work home. Leave the office at the office.
• Avoid people who are sources of pressure and conflict. Even normal office behaviour, such as forming cliques and gossiping, is a source of stress that has the potential to be emotionally devastating.
• If you struggle to deal with negative emotions, ask your doctor about cognitive behaviour therapy.
• The secret to exercise is this: keep going and don’t stop. It’s better to be active all your life at a lower level, rather than to be at a near professional-level in high school, say, and then stop completely.
• At work get up and move around once an hour and devote half your lunch break to movement, even if it’s walking around the block.
• Be in nature more: go outside for five to 10 minutes three times a day.
• Acquire more active friends and join them in their activities. Plan a shared exercise activity with your spouse or friends twice a week.
• Make leisure time more creative – think beyond TV or internet.
• Volunteer to help the needy with housecleaning, painting and repairs.
This will serve as both exercise and a morale boost.
• Meditate every day for 10 minutes.
Sit with your eyes closed in a quiet place, put your attention on the tip of your nose and focus on the sensation of your breath coming in and out of your nostrils.
• Don’t look at meditation as an aid for the bad days you experience (“I’m feeling good today, so I don’t need to meditate”). It should be a lifelong practice.
• Take 10 minutes out of your lunch break to sit alone with eyes closed, preferably outside in nature.
• Notice what a relief it is to take big deep breaths when you are upset or nervous, and how ragged your breath becomes when you are anxious or stressed.
• Join an organised meditation course in your area. Search for meetup.com to find local groups that meet all around the country.
• Make your bedroom as dark as possible. If total darkness is impossible, wear a sleep mask.
• Drink a glass of warm almond milk, which is rich in calcium and promotes melatonin, a hormone that helps to regulate the sleep-wake cycle.
• Experiment with herbal teas associated with good sleep such as chamomile, valerian, passionflower, lavender and kava kava.
• Explore abhyanga, a self-massage technique that uses warmed sesame oil, lightly massaged into arms, legs, neck and torso (go to YouTube to see tutorials).
• Don’t ignore insomnia. In some studies sleep disorders have been associated with triggering Alzheimer’s disease and are also associated with high blood pressure.
• Take responsibility for your feelings. Wellbeing depends upon happiness, yet most people don’t really make that connection.
• Write down five specific things that make you happy and, on a daily basis, do at least one of them.
• Set a “good news policy” at meal times, whether it’s the radio station you choose to listen to or the topic of conversation around the table.
• Explore a time in your past when you were happy and learn from it, whether that means re-embracing an old hobby or getting in touch with an old friend.
• Become comfortable with delayed gratification – consider how your choices will make you feel in the future as well as today.
END OF QUOTE
My favourite website about Deepak Chopra is the one by Tom Williamson. It states that “it has been said by some that the thoughts and tweets of Deepak Chopra are indistinguishable from a set of profound sounding words put together in a random order, particularly the tweets tagged with “#cosmisconciousness”. This site aims to test that claim! Each “quote” is generated from a list of words that can be found in Deepak Chopra’s Twitter stream randomly stuck together in a sentence.” It seems to me that Deepak himself might have made ample use of this site for writing his latest book, and if you should ever run out of platitudes or empty phrases, this site will serve you well.
Deepak has published plenty of best-sellers, but he has as good as nothing to show for himself in the peer-reviewed medical literature. (When you are that famous, you obviously don’t need to bother anymore with trivia such as evidence, science and all that jazz.) This means that I had to deviate from my usual admission criteria for the “prophet of alternative medicine”, as Deepak likes to be called. But he is well worth making an exception, I am sure you agree, he is the absolute super-star!
Super-star of what?
I let you decide!
On this blog, I have repeatedly pleaded for a change of the 2010 NICE guidelines for low back pain (LBP). My reason was that it had become quite clear that their recommendation to use spinal manipulation and acupuncture for recurrent LBP was no longer supported by sound evidence.
Two years ago, a systematic review (authored by a chiropractor and published in a chiro-journal) concluded that “there is no conclusive evidence that clearly favours spinal manipulation or exercise as more effective in treatment of CLBP.” A the time, I wrote a blog explaining that “whenever two treatments are equally effective (or, in this case, perhaps equally ineffective?), we must consider other important criteria such as safety and cost. Regular chiropractic care (chiropractors use spinal manipulation on almost every patient, while osteopaths and physiotherapists employ it less frequently) is neither cheap nor free of serious adverse effects such as strokes; regular exercise has none of these disadvantages. In view of these undeniable facts, it is hard not to come up with anything other than the following recommendation: until new and compelling evidence becomes available, exercise ought to be preferred over spinal manipulation as a treatment of chronic LBP – and consequently consulting a chiropractor should not be the first choice for chronic LBP patients.”
Three years ago, a systematic review of acupuncture for LBP (published in a TCM-journal) concluded that the effect of acupuncture “is likely to be produced by the nonspecific effects of manipulation.” At that time I concluded my blog-post with this question: Should NICE be recommending placebo-treatments and have the tax payer foot the bill? Now NICE have provided an answer.
The new draft guideline by NICE recommends various forms of exercise as the first step in managing low back pain. Massage and manipulation by a physiotherapist should only be used alongside exercise; there is not enough evidence to show they are of benefit when used alone. Moreover, patients should be encouraged to continue with normal activities as far as possible. Crucially, the draft guideline no longer recommends acupuncture for treating low back pain.
NICE concluded that the evidence shows that acupuncture is not better than sham treatment. Paracetamol on its own is no longer recommended either, instead non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or aspirin should be tried first. Talking therapies are recommended in combination with physical therapies for patients who had no improvement on previous treatments or who have significant psychological and social barriers to recovery.
Professor Mark Baker, clinical practice director for NICE, was quoted stating “Regrettably there is a lack of convincing evidence of effectiveness for some widely used treatments. For example acupuncture is no longer recommended for managing low back pain with or without sciatica. This is because there is not enough evidence to show that it is more effective than sham treatment.”
Good news for us all, I would say:
- good news for patients who now hear from an accepted authority what to do when they suffer from LBP,
- good news for society who does no longer need to spend vast amounts of money on questionable therapies,
- good news for responsible clinicians who now have clear guidance which they can show and explain to their patients.
Not so good news, I admit, for acupuncturists, chiropractors and osteopaths who just had a major source of their income scrapped. I have tried to find some first reactions from these groups but, for the moment, they seemed to be stunned into silence – nobody seems to have yet objected to the new guideline. Instead, I found a very recent website where chiropractic is not just recommended for LBP therapy but where patients are instructed that, even in the absence of pain, they need to see their chiropractor regularly: “Maintenance chiropractic care is well supported in studies for controlling chronic LBP.”
NEVER LET THE TRUTH GET IN THE WAY OF YOUR CASH-FLOW…they seem to conclude.
Chronic pain is a common and serious problem for many patients. Treatment often includes non-pharmacological approaches despite the mostly flimsy evidence to support them. The objective of this study was to measure the feasibility and efficacy of hypnosis (including self-hypnosis) in the management of chronic pain in older hospitalized patients.
A single center randomized controlled trial using a two arm parallel group design (hypnosis versus massage). Inclusion criteria were chronic pain for more than 3 months with impact on daily life activities, intensity of > 4; adapted analgesic treatment; no cognitive impairment. Fifty-three patients were included. Pain intensity decreased significantly in both groups after each session. Average pain measured by the brief pain index sustained a greater decrease in the hypnosis group compared to the massage group during the hospitalization. This was confirmed by the measure of intensity of the pain before each session that decreased only in the hypnosis group over time. Depression scores improved significantly over the time only in the hypnosis group. There was no effect in either group 3 months post hospitals discharge.
The authors concluded that hypnosis represents a safe and valuable tool in chronic pain management of hospitalized older patients. In hospital interventions did not provide long-term post discharge relief.
So, hypnotherapy is better than massage therapy when administered as an adjunct to conventional pain management. As it is difficult to control for placebo effects, which might be substantial in this case, we cannot be sure whether hypnotherapy per se was effective or not.
Who cares? The main thing is to make life easier for these poor patients!
There are situations where I tend to agree with this slightly unscientific but compassionate point of view. Yes, the evidence is flimsy, but we need to help these patients. Hypnotherapy has very few risks, is relatively inexpensive and might help badly suffering individuals. In this case, does it really matter whether the benefit was mediated by a specific or a non-specific mechanism?
Being constantly on the look-out for new, good quality articles on alternative therapy which suggest that a treatment might actually work, I was excited to find not just one or two but four recent publications on an old favourite of mine: massage therapy.
The first paper described a study aimed to investigate the effect of whole body massage on the vital signs, Glasgow Coma Scale (GCS) scores and arterial blood gases (ABG) in trauma ICU patients.
In a randomized, double-blind trial, 108 trauma ICU patients received whole body massage or routine care only. The patients vital signs; systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), pulse rate (PR), Temperature (T), GCS score and ABG parameters were measured in both groups before the intervention and 1 hour and 3 hours after the intervention. The patient in experimental group received full body massage in 45 minute by a family member.
Significant differences were observed between experimental and control groups in SBP 1 hour and 3 hours after intervention, DBP, RR and PR 1 hour after intervention, and GCS 1 hour and 3 hours after intervention. Significant differences were also observed between experimental and control groups in O2 saturation, PH and pO2. No significant differences between experimental and control groups were noted in Temperature, pCO2 and HCO3.
The authors concluded that massage therapy is a safe and effective treatment in intensive care units to reduce patient’s physical and psychological problems. Therefore the use of massage therapy is recommended to clinical practice as a routine method.
The second paper reported a clinical trial on 66 male and female nurses working in intensive care units of Isfahan University of Medical Sciences, Iran.
Patients were randomly divided into experimental and control groups. The Occupational Stress Inventory (OSI) (Osipow and Spokane, 1987) was completed by participants of the two groups before, immediately after, and 2 weeks after the intervention. Swedish massage was performed on participants of the experimental group for 25 min in each session, twice a week for 4 weeks.
Results showed a significant difference in favour of the massage therapy in overall mean occupation stress scores between experimental and control groups two weeks after the intervention.
The authors concluded that it is recommended that massage, as a valuable noninvasive method, be used for nurses in intensive care units to reduce their stress, promote mental health, and prevent the decrease in quality of nursing work life.
The third paper described a randomized controlled trial evaluating the effects of post-operative massage in patients undergoing abdominal colorectal surgery.
One hundred twenty-seven patients were randomized to receive a 20-min massage or social visit and relaxation session on postoperative days 2 and 3. Vital signs and psychological well-being (pain, tension, anxiety, satisfaction with care, relaxation) were assessed before and after each intervention.
Post-operative massage significantly improved the patients’ perception of pain, tension, and anxiety, but overall satisfaction was unchanged.
The authors concluded that massage may be beneficial during postoperative recovery for patients undergoing abdominal colorectal surgery. Further studies are warranted to optimize timing and duration and to determine other benefits in this clinical setting.
The fourth paper reported a systematic review was to evaluate the effectiveness of massage on the short- and long-term outcomes of pre-term infants.
Literature searches were conducted using the PRISMA framework. Validity of included studies was assessed using criteria defined by the Cochrane Collaboration. Assessments were carried out independently by two reviewers with a third reviewer to resolve differences.
Thirty-four studies met the inclusion criteria, 3 were quasi-experimental, 1 was a pilot study, and the remaining 30 were RCTs. The outcomes that could be used in the meta-analysis and found in more than three studies suggested that massage improved daily weight gain by 0.53 g, and resulted in a significant improvement in mental scores by 7.89 points. There were no significant effects on length of hospital stay, caloric intake, or weight at discharge. Other outcomes were not analyzed either because the units of measurement varied between studies, or because means and standard deviations were not provided by the authors. The quality of the studies was variable with methods of randomization and blinding of assessment unclear in 18 of the 34 trials.
The authors concluded that massage therapy could be a comforting measure for infants in the NICU to improve weight gain and enhance mental development. However, the high heterogeneity, the weak quality in some studies, and the lack of a scientific association between massage and developmental outcomes preclude making definite recommendations and highlight the need for further RCTs to contribute to the existing body of knowledge.
I am not saying that these articles are flawless, nor that I agree with all of their conclusion. What I am trying to indicate is that we finally have here an alternative therapy that is promising.
When I worked in Germany and later in Austria, massage was considered to be entirely mainstream. It was only after I had moved to the UK when I realised that, in English-speaking countries, it is mostly considered to be alternative. Perhaps this classification is wrong?
Perhaps we should differentiate according to what type of massage we are talking about. In the realm of alternative medicine – and not just there, I suppose – this seems good advice indeed.
The above papers are about classical massage therapy, but there are some types pf massage which are less than conventional: aura-massage, Marma massage, Indian head massage, shiatsu etc. etc. the list seems endless. These are alternative in more than one sense, and they have one thing in common: there is, as far as I can see, no good evidence to show that they do anything to human health.
My conclusion therefore is that, even with something as common as massage therapy, we need to be careful not to be roped in by the charlatans.
A reader of this blog recently sent me the following message: “Looks like this group followed you recent post about how to perform a CAM RCT!” A link directed me to a new trial of ear-acupressure. Today is ‘national acupuncture and oriental medicine day’ in the US, a good occasion perhaps to have a critical look at it.
The aim of this study was to assess the effectiveness of ear acupressure and massage vs. control in the improvement of pain, anxiety and depression in persons diagnosed with dementia.
For this purpose, the researchers recruited a total of 120 elderly dementia patients institutionalized in residential homes. The participants were randomly allocated, to three groups:
- Control group – they continued with their routine activities;
- Ear acupressure intervention group – they received ear acupressure treatment (pressure was applied to acupressure points on the ear);
- Massage therapy intervention group – they received relaxing massage therapy.
Pain, anxiety and depression were assessed with the Doloplus2, Cornell and Campbell scales. The study was carried out during 5 months; three months of experimental treatment and two months with no treatment. The assessments were done at baseline, each month during the treatment and at one and two months of follow-up.
A total of 111 participants completed the study. The ear acupressure intervention group showed better improvements than the two other groups in relation to pain and depression during the treatment period and at one month of follow-up. The best improvement in pain was achieved in the last (3rd) month of ear acupressure treatment. The best results regarding anxiety were also observed in the last month of treatment.
The authors concluded that ear acupressure and massage therapy showed better results than the control group in relation to pain, anxiety and depression. However, ear acupressure achieved more improvements.
The question is: IS THIS A RIGOROUS TRIAL?
My answer would be NO.
Now I better explain why, don’t I?
If we look at them critically, the results of this trial might merely prove that spending some time with a patient, being nice to her, administering a treatment that involves time and touch, etc. yields positive changes in subjective experiences of pain, anxiety and depression. Thus the results of this study might have nothing to do with the therapies per se.
And why would acupressure be more successful than massage therapy? Massage therapy is an ‘old hat’ for many patients; by contrast, acupressure is exotic and relates to mystical life forces etc. Features like that have the potential to maximise the placebo-response. Therefore it is conceivable that they have contributed to the superiority of acupressure over massage.
What I am saying is that the results of this trial can be interpreted in not just one but several ways. The main reason for that is the fact that the control group were not given an acceptable placebo, one that was indistinguishable from the real treatment. Patients were fully aware of what type of intervention they were getting. Therefore their expectations, possibly heightened by the therapists, determined the outcomes. Consequently there were factors at work which were totally beyond the control of the researchers and a clear causal link between the therapy and the outcome cannot be established.
An RCT that is aimed to test the effectiveness of a therapy but fails to establish such a causal link beyond reasonable doubt cannot be characterised as a rigorous study, I am afraid.
Sorry! Did I spoil your ‘national acupuncture and oriental medicine day’?
What is the best treatment for the millions of people who suffer from chronic low back pain (CLBP)? If we are honest, no therapy has yet been proven to be overwhelmingly effective. Whenever something like that happens in medicine, we have a proliferation of interventions which all are promoted as effective but which, in fact, work just marginally. And sure enough, in the case of CLBP, we have a constantly growing list of treatments none of which is really convincing.
One of the latest additions to this list is PILATES.
Pilates? What is this ? One practitioner describes it as follows: In Pilates, we pay a lot of attention to how our body parts are lined up in relation to each other, which is our alignment. We usually think of our alignment as our posture, but good posture is a dynamic process, dependent on the body’s ability to align its parts to respond to varying demands effectively. When alignment is off, uneven stresses on the skeleton, especially the spine, are the result. Pilates exercises, done with attention to alignment, create uniform muscle use and development, allowing movement to flow through the body in a natural way.
For example, one of the most common postural imbalances that people have is the tendency to either tuck or tilt the pelvis. Both positions create weaknesses on one side of the body and overly tight areas on the other. They deny the spine the support of its natural curves and create a domino effect of aches and pains all the way up the spine and into the neck. Doing Pilates increases the awareness of the proper placement of the spine and pelvis, and creates the inner strength to support the natural curves of the spine. This is called having a neutral spine and it has been the key to better backs for many people.
Mumbo-jumbo? Perhaps; in any case, we need evidence! Is there any at all? Surprisingly, the answer is yes. Recently, someone even published a proper systematic review.
This systematic review was aimed at evaluating the effectiveness of Pilates exercise in people with chronic low back pain (CLBP).
A search for RCTs was undertaken in 10 electronic. Two independent reviewers did the selection of evidence and evaluated the quality of the primary studies. To be included, relevant RCTs needed to be published in the English language. From 152 studies, 14 RCTs could be included.
The methodological quality of RCTs ranged from “poor” to “excellent”. A meta-analysis of RCTs was not undertaken due to the heterogeneity of RCTs. Pilates exercise provided statistically significant improvements in pain and functional ability compared to usual care and physical activity between 4 and 15 weeks, but not at 24 weeks. There were no consistent statistically significant differences in improvements in pain and functional ability with Pilates exercise, massage therapy, or other forms of exercise at any time period.
The authors drew the following conclusions: Pilates exercise offers greater improvements in pain and functional ability compared to usual care and physical activity in the short term. Pilates exercise offers equivalent improvements to massage therapy and other forms of exercise. Future research should explore optimal Pilates exercise designs, and whether some people with CLBP may benefit from Pilates exercise more than others.
So, Pilates can be added to the long list of treatments that work for CLBP, albeit not convincingly better than most other therapies on offer. Does that mean these options are all as good or as bad as the next? I don’t think so.
Let’s assume chiropractic/osteopathic manipulations, massage and various forms of exercise are all equally effective. How do we decide which is more commendable than the next? We clearly need to take other important factors into account:
- acceptability for patients
If we use these criteria, it becomes instantly clear that chiropractic and osteopathy are not favourites in this race for the most commendable CLBP-treatment. They are neither cheap nor free of risks. Massage is virtually risk-free but not cheap. This leaves us with various forms of exercise, including Pilates. But which exercise is better than the next? At present, we do not know, and therefore the last two factors are crucial: if people love doing Pilates and if they easily stick with it, then Pilates is fine.
I am sure chiropractors will (yet again) disagree with me but, to me, this logic could hardly be more straight forward.
Chronic neck pain is common and makes the life of many sufferers a misery. Pain-killers are helpful, of course, but who wants to take such medications on the long-term? Is there anything else these patients can do?
Massage therapy has been shown to work but how often for how long? This trial was designed to evaluate the optimal dose of massage for individuals with chronic neck pain. 228 individuals with chronic non-specific neck pain were recruited and randomized them to 5 groups receiving various doses of massage:
- 30-minute treatments 2 or 3 times weekly
- 60-minute treatments once weekly
- 60-minutte treatments twice weekly
- 60-minute treatments thrice weekly
- a 4-week period on a wait list
Neck-related dysfunction was assessed with the Neck Disability Index (range, 0-50 points) and pain intensity with a numerical rating scale (range, 0-10 points) at baseline and at 5 weeks.
The results suggested that 30-minute treatments were not significantly better than the waiting list control condition in terms of achieving a clinically meaningful improvement in neck dysfunction or pain, regardless of the frequency of treatments. In contrast, 60-minute treatments 2 and 3 times weekly significantly increased the likelihood of such improvement compared with the control condition in terms of both neck dysfunction and pain intensity.
The authors conclude that after 4 weeks of treatment, we found multiple 60-minute massages per week more effective than fewer or shorter sessions for individuals with chronic neck pain. Clinicians recommending massage and researchers studying this therapy should ensure that patients receive a likely effective dose of treatment.
So two or three hours of massage therapy seems to be optimal as a treatment for chronic neck pain. This would cost ~£ 200-300 per week! Who can or wants to afford this? And are there other options that might be less expensive and equally or more effective? For instance, is physiotherapeutic exercise an option?
I am not sure I know the answers to these questions but, before we recommend massage therapy to the many who chronically suffer from neck pain, we should find out.