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.
Fibromyalgia (FM) is a chronic condition which ruins the quality of life of many patients. It is also a domain of alternative medicine: dozens of different treatments are on offer – this is clearly a paradise for charlatans and bogus claims. So is there a treatment that is demonstrably effective? The purpose of this systematic review is to evaluate the evidence of massage therapy FM.
Electronic databases were searched to identify relevant studies. The main outcome measures were pain, anxiety, depression, and sleep disturbance. Two reviewers independently abstracted data and appraised risk of bias. The risk of bias of eligible studies was assessed based on Cochrane tools.
Nine randomized controlled trials involving 404 patients met the inclusion criteria. A meta-analyses showed that massage therapy with a duration of at least 5 weeks significantly improved pain , anxiety, and depression. Sleep disturbance was not improved by massage therapy.
The authors conclude that massage therapy with duration ≥5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with FM. Massage therapy should be one of the viable complementary and alternative treatments for FM. However, given fewer eligible studies in subgroup meta-analyses and no evidence on follow-up effects, large-scale randomized controlled trials with long follow-up are warrant to confirm the current findings.
To put these results into context, we need to consider the often poor methodological quality of the primary studies. It is, of course, not easy to test massage therapy in rigorous trials. For instance, there is no obvious placebo, and we can therefore not be sure whether the treatment benefits patients through a specific effect or whether non-specific effects are the cause of the improvement.
We also should be aware of the facts that for most other alternative therapies the evidence is not encouraging, and that massage therapy is relatively safe. Therefore the conclusion for those who suffer from FM might well be that massage therapy is worth a try.
Researchers from the ‘International Centre for Allied Health Evidence’, University of South Australia in Adelaide wanted to determine whether massage therapy is an effective intervention for back pain. They carried out extensive literature searches to identify all systematic reviews on the subject, analysed them critically and evaluated their methodological quality. Nine systematic reviews were found. Their methodological quality varied from poor to excellent. The primary research informing these systematic reviews was generally considered to be weak quality. The findings indicated that massage may be an effective treatment option when compared to placebo or active treatment options such as relaxation, especially in the short term. There were conflicting and contradictory findings for the effectiveness of massage therapy as a treatment of non-specific low back pain when compared against other manual therapies such as mobilization, standard medical care, and acupuncture.
The authors concluded that there is an emerging body of evidence, albeit small, that supports the effectiveness of massage therapy for the treatment of non-specific low back pain in the short term. Due to common methodological flaws in the primary research, which informed the systematic reviews recommendations arising from this evidence base should be interpreted with caution.
My own systematic review from 1999 (which the authors of this systematic review of systematic reviews seem to have missed) concluded that massage seems to have some potential as a therapy for low back pain. Indeed, there seems to be unanimous agreement that massage therapy is a promising treatment. Why then do massage therapists not finally get their act together and conduct a few more high quality primary studies? Currently, we have about as many reviews as trials! Doing even more reviews will not answer the question about effectiveness!!!
And it is a damn important question. Back pain is extremely common and extremely expensive for us all. At present, we have no optimal treatment. Chiropractors and osteopaths are claiming to have found a good solution, but many experts are not convinced by their evidence and argue that the risks of spinal manipulation might not outweigh its benefits. Massage, by contrast, is almost risk-free. Considering all this, I believe we need more trials with some urgency.
So, why are such trials not forthcoming? I realise that multiple hurdles have to be taken:
- Clinical studies of that nature are expensive, and there is no obvious funding source.
- Massage therapists usually do not have enough research expertise to pull off a sound study.
- There are multiple methodological problems in conduction a definitive massage trial that might convince us all.
However, none of these obstacles are insurmountable. I suggest massage therapists team up with experts who know how to run clinical trials, hammer out a reasonable study design and approach government or other official funders for support. We need a definitive answers and we need them soon: is massage effective? which type of massage? for which patients? at which stage of non-specific low back pain?
Massage is an agreeable and pleasant treatment. It comes in various guises and, according to many patients’ experience, it relaxes both the mind and the body. But does it have therapeutic effects which go beyond such alleged benefits?
There is a considerable amount of research to test whether massage is effective for some conditions, including depression. In most instances, the evidence fails to be entirely convincing. Our own systematic review of massage for depression, for instance, concluded that there is currently a lack of evidence.
This was ~5 years ago – but now a new trial has emerged. It was aimed at determining whether massage therapy reduces symptoms of depression in subjects with human immunodeficiency virus (HIV) disease. Subjects were randomized into one of three groups to receive either Swedish massage (the type that is best researched amongst the many massage-variations that exist), or touch, or no such interventions. The treatment period lasted for eight weeks. Patients had to be at least 16 years of age, HIV-positive, suffering from a major depressive disorder, and on a stable neuropsychiatric, analgesic, and antiretroviral regimen for > 30 days with no plans to modify therapy for the duration of the study. Approximately 40% of the subjects were taking antidepressants, and all subjects were judged to be medically stable.
Patients in the Swedish massage and touch groups visited the massage therapist for one hour twice per week. In the touch group, a massage therapist placed both hands on the subject with slight pressure, but no massage, in a uniform distribution in the same pattern used for the massage subjects.
The primary and secondary outcome measures were the Hamilton Rating Scale for Depression score and the Beck Depression Inventory. The results showed that, compared to no intervention and/or touch, massage significantly reduced the severity of depression at week 4, 6 and 8.
The authors’ conclusion is clear: The results indicate that massage therapy can reduce symptoms of depression in subjects with HIV disease. The durability of the response, optimal “dose” of massage, and mechanisms by which massage exerts its antidepressant effects remain to be determined.
Clinical trials of massage therapy encounter formidable problems. No obvious funding source exists, and the expertise to conduct research is minimal within the realm of massage therapy. More importantly, it is difficult to find solutions to the many methodological issues involved in designing rigorous trials of massage therapy.
One such issue is the question of an adequate control intervention which might enable to blind patients and thus account for the effects of placebo, compassion, attention etc. The authors of the present trial have elegantly solved it by creating a type of sham treatment which consisted of mere touch. However, this will only work well, if patients can be made to believe that the sham-intervention was a real treatment, and if somehow the massage therapist is prevented to influence the patients through verbal or non-verbal communications. In the current trial, patients were not blinded, and therefore patients’ expectations may have played a role in influencing the results.
Despite this drawback, the study is one of the more rigorous investigations of massage therapy to date. Its findings offer hope to those patients who suffer from depression and who are desperate for an effective and foremost safe treatment to ease their symptoms.
My conclusion: the question whether massage alleviates depression is intriguing and well worth further study.
Lymph oedema in the arms or legs is a frequent complication after lymph-node dissections for cancer. Treatment or prevention can be difficult, and the results are often unsatisfactory. Consequently, the burden of suffering of cancer patients affected by this problem is immense.
Amongst several options, a little-known massage technique, called lymph-drainage (or lymphatic drainage, LD), is sometimes recommended. It consists of gentle manual movements which lightly push the lymph fluid through the lymphatic vessels that eventually enter into the blood circulation. During a session of lymph-drainage, a specially trained massage therapist lightly moves his or her hands along the lymph vessels to facilitate the lymph flow. The treatment is agreeable and relaxing, but does it really reduce the oedema?
A recent systematic review and meta-analysis of RCTs evaluated the effectiveness of LD in the prevention and treatment of breast-cancer related lymph-oedema. The primary outcome for prevention was the incidence of postoperative lymph-oedema. The outcome for management of was a reduction in oedema volume.
In total, 10 RCTs with altogether 566 patients were identified. Two studies evaluating the preventive outcome of LD found no significant difference in the incidence of lymph-oedema between the LD and standard treatments. Seven studies assessed the reduction in arm volume, and found no significant difference between the LD and standard treatments.
The authors conclusion was negative about the value of LD: The current evidence from RCTs does not support the use of LD in preventing or treating lymph-oedema. However, clinical and statistical inconsistencies between the various studies confounded our evaluation of the effect of LD on breast-cancer-related lymph-oedema.
Perhaps a brand-new clinical trial which had not been included in the above assessment would have persuaded the authors to be a little more optimistic. This study evaluated the effectiveness of LD in the prevention of lymph-oedema after treatment of breast cancer. The study-population consisted of 67 women, who had undergone surgery for breast cancer. From the second day of surgery, 33 randomly chosen women were given LD. The control group consisted of 34 women who did not receive LD. Measurements of the volumes of both arms were taken before surgery and on days 2, 7, 14, and at 3 and 6 months after surgery.
Among the women who did not have LD, a significant increase in the arm volume on the operated side was observed after 6 month. There was no statistically significant increase in the volume of the upper limb on the operated side in women who underwent LD.
The authors conclude that regardless of the surgery type and the number of the lymph nodes removed, LD effectively prevented lymph-oedema of the arm on the operated side. Even in high risk breast cancer treatments (operation plus irradiation), LD was demonstrated to be effective against arm volume increase. Even though confirmatory studies are needed, this study demonstrates that LD administered early after operation for breast cancer should be considered for the prevention of lymph-oedema.
So, does LD reduce oedema or not? This does not seem to be such a difficult question that it should take decades to resolve! And who would doubt that it is an important one? Lymph-oedema has the potential to seriously impede the quality of life of many patients, and it can even contribute to unnecessary mortality. The fact that the few available studies are too small and too weak to generate reliable results is disappointing and shines a dim light on the supposedly patient-centred research in oncology, in my view.
The concept of LD is plausible, at least some of the findings from clinical trials are encouraging, and the problem of lymph-oedema is both prevalent and relevant. So what is stopping us from funding a large, well-designed and definitive study?
As I have mentioned before, I like positive news as much as the next person. Therefore, I am constantly on the look-out for recently published, sound evidence suggesting that some form of alternative medicine is effective and safe for this or that condition. This new systematic review fits that description, I am pleased to report.
Its authors evaluated the effectiveness of massage therapy (MT) for neck and shoulder pain. Their extensive literature searches identified 12 high-quality studies. The meta-analyses showed significant effects of MT for neck pain and shoulder pain compared to inactive therapies. MT did not yield better effects for neck pain or shoulder pain than other active therapies administered to the control groups. Shoulder function was not significantly affected by MT. The authors concluded that “MT may provide immediate effects for neck and shoulder pain. However, MT does not show better effects on pain than other active therapies. No evidence suggests that MT is effective in functional status”.
Massage therapy is thus a promising treatment, particularly as this systematic review is by no means the only piece of encouraging evidence. It is not better than other effective treatments, but it is not associated with frequent or serious adverse effects. This means that the demonstrable benefits are likely to outweigh its risks; in other words, the risk benefit balance is positive. Regular readers of this blog will appreciate the importance of this point.
Massage is practiced by several professions: mostly, of course, by massage therapists, but occasionally also by nurses, osteopath, chiropractors etc. Chiropractors, in particular, have recently tried to make much – I think too much – of this fact. They tend to claim that, as they use treatments which are evidence-based, such as massage, chiropractic is an evidence-based profession. I think this is akin to surgeons claiming that all of surgery is evidence-based because surgeons use medications which effectively reduce post-operative pain. Chiropractors foremost employ spinal manipulation and surgeons foremost use surgery; if they want us to believe that their practice is evidence-based, they need to show us the evidence for their hall-mark interventions. In the case of surgery, the evidence is mostly established; in the case of chiropractic, it is mostly not.
Massage is backed by reasonably sound evidence not just for neck and shoulder pain but for a range of other conditions as well. WHAT DO WE CALL AN ALTERNATIVE MEDICINE THAT WORKS? WE CALL IT MEDICINE!
So why is massage not a mainstream therapy? The answer is simple: in many countries, massage therapy has long been considered to be entirely conventional. Twenty years ago, I was chair of rehabilitation medicine at the university of Vienna. Amongst my staff, there always were about 5-8 full time massage therapists and nobody thought this to be unusual in any way. Similarly, in Germany, massage is entirely conventional.
Perhaps it is time that the English-speaking countries catch up with Europe when it comes to massage therapy and the evidence that supports it?
Since weeks I have been searching for new (2013) studies which actually report POSITIVE results. I like good news as much as the next man but, in my line of business, it seems awfully hard to come by. Therefore I am all the more delighted to present these two new articles to my readers.
The first study is a randomized trial with patients suffering from metastatic cancer who received one of three interventions: massage therapy, no-touch intervention or usual care. Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. The mean number of massage therapy sessions per patient was 2.8.
The results show significant improvement in the quality of life of the patients who received massage therapy after 1-week follow-up which was not observed in either of the other groups. Unfortunately, the difference was not sustained at 1 month. There were also trends towards improvement in pain and sleep of the patients after massage. No serious adverse events were noted.
The authors conclude that “providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings“.
The second study examined the effectiveness of a back massage for improving sleep quality in 60 postpartum women suffering from poor sleep. They were randomized to either the intervention or the control group. Participants in both groups received the same care except for the back massages. The intervention group received one 20-minutes back massage at the same time each evening for 5 consecutive days by a certified massage therapist. The outcome measure was the Pittsburgh Sleep Quality Index (PSQI). The results showed that the changes in mean PSQI were significantly lower in the intervention group than in controls indicating a positive effect of massage on sleep quality.
The authors’ conclusions were clear: “an intervention involving back massage in the postnatal period significantly improved the quality of sleep.”
Where I was trained (Germany), massage is not deemed to be an alternative but an entirely mainstream treatment. Despite this fact, there is precious little evidence to demonstrate that it is effective. Our own research has found encouraging evidence for a range of conditions, including autism, cancer palliation, constipation, DOMS and back pain. In addition, we have shown that massage is not entirely free of risks but that its potential for harm is very low (some might say that this was never in question but it is good to have a bit more solid evidence).
The new studies are, of course, not without flaws; this can hardly be expected in an area where logistical, financial and methodological problems abound. The fact that there are many different approaches to massage does not make things easier either. The new evidence is nevertheless encouraging and seems to suggest that massage has relaxing effects which are clinically relevant. In my view, massage is a therapy worth considering for more rigorous research.