MD, PhD, FMedSci, FSB, FRCP, FRCPEd

systematic review

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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.

Alternative?

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.

Regular readers of this blog will be aware of the many bogus claims made by chiropractors. One claim, however, namely the one postulating chiropractors can effectively treat low back pain with spinal manipulation, is rarely viewed as being bogus. Chiropractors are usually able to produce evidence that does suggest the claim to be true, and therefore even most critics of chiropractic back off on this particular issue.

But is the claim really true?

A recent trial might provide the answer.

The purpose of this study was to compare the effectiveness of chiropractic spinal manipulative therapy (cSMT) to a sham intervention on pain (Visual Analogue Scale, SF-36 pain subscale), disability (Oswestry Disability Index), and physical function (SF-36 subscale, Timed Up and Go) by performing a randomized placebo-controlled trial at 2 Veteran Affairs Clinics.

Older veterans (≥ 65 years of age) who were naive to chiropractic were recruited. A total of 136 who suffered from chronic low back pain (LBP) were included in the study – with 69 being randomly assigned to cSMT and 67 to the sham intervention. Patients were treated twice per week for 4 weeks. The outcomes were assessed at baseline, 5, and 12 weeks post baseline.

Both groups demonstrated significant decrease in pain and disability at 5 and 12 weeks. At 12 weeks, there was no significant difference in pain and a statistically significant decline in disability scores in the cSMT group when compared to the control group. There were no significant differences in adverse events between the groups.

The authors concluded that cSMT did not result in greater improvement in pain when compared to our sham intervention; however, cSMT did demonstrate a slightly greater improvement in disability at 12 weeks. The fact that patients in both groups showed improvements suggests the presence of a nonspecific therapeutic effect.

Hold on, I hear you say, this does not mean that cSMT is a placebo in the treatment of LBP! There are other studies that yield positive results. Let’s not cherry-pick our evidence!

Absolutely correct! To avoid cherry-picking, lets see what the current Cochrane review tells us about cSMT and chronic LBP. Here is the conclusion of this review based on 26 RCTs: High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain.

Convinced?

While my last post was about the risk following some naturopaths’ advice, this one is about the effectiveness of naturopathic treatments. This is a complex subject, not least because naturopaths use a wide range of therapies (as the name implies, they pride themselves of employing all therapeutic means supplied by nature). Some of these interventions are clearly supported by good evidence; for instance, nobody would doubt the effectiveness of a healthy diet or the benefits of regular exercise. But what about all the other treatments naturopaths use? The best approach to find an answer might be to assess not each single therapy but to evaluate the entire package of the naturopathic approach, and not a single study but all such trials.

This is precisely what US researchers have recently done. The purpose of this interesting, new systematic review was to compile and consolidate research that has investigated the whole practice of naturopathic medicine as it is practiced in community settings in order to better assess the quantity and quality of the research, and clinical effect, if any.

In order to get included into the review, studies had to report results from multi-modal treatment delivered by North American naturopathic doctors. The effect size for each study was calculated; no meta-analysis was undertaken.

Fifteen studies met the authors’ inclusion criteria. They covered a wide range of chronic diseases. Most studies had low to medium risks of bias including acknowledged limitations of pragmatic trials. Effect sizes for the primary medical outcomes varied and were statistically significant in 10 out of 13 studies. A quality of life metric was included in all of the RCTs with medium effect size and statistical significance in some subscales.

The authors concluded that previous reports about the lack of evidence or benefit of naturopathic medicine (NM) are inaccurate; a small but compelling body of research exists. Further investigation is warranted into the effectiveness of whole practice NM across a range of health conditions.

This sounds like good news for naturopathy! However, there are several important caveats:

  • the authors seem to have only looked at US studies (naturopathy is a European tradition!),
  • the searches were done three years ago, and more recent data were thus omitted,
  • the authors included all sorts of investigations, even uncontrolled studies; only 6 were RCTs,
  • rigorous trials were very scarce; and for each condition, they were even more so,
  • the authors mention the PRISMA guidelines for systematic reviews implying that they followed them but, in fact, they did not.

My biggest concern, however, is something else. It relates to the interventions tested in these studies. The authors claim that their results table provides full details on this issue but this is unfortunately not true. All we have by way of an explanation is the authors’ remark that the interventions tested in the studies of their review included diet counseling and nutritional recommendations, specific home exercises and physical activity recommendations, deep breathing techniques or other stress reduction strategies, dietary supplements including vitamins, hydrotherapy, soft-tissue manual techniques, electrical muscle stimulation, and botanical medicines.

Survey data from two US states tell us that the most commonly prescribed naturopathic therapeutics are botanical medicines (51% of visits in Connecticut, 43% in Washington), vitamins (41% and 43%), minerals (35% and 39%), homeopathy (29% and 19%) and allergy treatments (11% and 13%). They also inform us that the mean length of a consultation with an US naturopath is about 40 minutes.

I think, this puts things into perspective. If I advise a patient with diabetes or hypertension or coronary heat disease to follow an appropriate diet, exercise and to adhere to some stress reduction program, if in addition I show empathy and compassion during a 40 minute consultation and make sure that my advise is taken seriously and subsequently adhered to, the outcome is likely to be positive. Naturopaths may elect to call this package of intervention ‘naturopathy’, however, I would call it good conventional medicine.

The problem, I think is clear: good therapeutic advice is effective but it is not naturopathy, and it cannot be used to justify the use of doubtful interventions like homeopathy or all sorts of dodgy supplements. Testing whole treatment packages of this nature can therefore lead to highly misleading results, particularly if the researchers draw unwarranted conclusions about specific schools of health care.

Of all alternative treatments, aromatherapy (i.e. the application of essential oils to the body, usually by gentle massage or simply inhalation) seems to be the most popular. This is perhaps understandable because it certainly is an agreeable form of ‘pampering’ for someone in need of come TLC. But is aromatherapy more than that? Is it truly a ‘THERAPY’?

A recent systematic review was aimed at evaluating the existing data on aromatherapy interventions as a means of improving the quality of sleep. Electronic literature searches were performed to identify relevant studies published between 2000 and August 2013. Randomized controlled and quasi-experimental trials that included aromatherapy for the improvement of sleep quality were considered for inclusion. Of the 245 publications identified, 13 studies met the inclusion criteria, and 12 studies could be used for a meta-analysis.

The meta-analysis of the 12 studies revealed that the use of aromatherapy was effective in improving sleep quality. Subgroup analysis showed that inhalation aromatherapy was more effective than aromatherapy applied via massage.

The authors concluded that readily available aromatherapy treatments appear to be effective and promote sleep. Thus, it is essential to develop specific guidelines for the efficient use of aromatherapy.

Perfect! Let’s all rush out and get some essential oils for inhalation to improve our sleep (remarkably, the results imply that aroma therapists are redundant!).

Not so fast! As I see it, there are several important caveats we might want to consider before spending our money this way:

  1. Why did this review focus on such a small time-frame? (Systematic reviews should include all the available evidence of a pre-defined quality.)
  2. The quality of the included studies was often very poor, and therefore the overall conclusion cannot be definitive.
  3. The effect size of armoatherapy is small. In 2000, we published a similar review and concluded that aromatherapy 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.
  4. It seems uncertain which essential oil is best suited for this indication.
  5. Aromatherapy is not always entirely free of risks. Another of our reviews showed that aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.
  6. There are several effective ways for improving sleep when needed; we need to know how aromatherapy compares to established treatments for that indication.

All in all, I think stronger evidence is required that aromatherapy is more that pampering.

ENOUGH SAID?

The press officers of journals like to send out press-releases of articles which are deemed to be particularly good and important. Sadly, it is not often that articles on alternative medicine fulfil these criteria. I was therefore excited to receive this press-release which seemed encouraging, to say the least:

Medical evidence supports the potential for acupuncture to be significantly more effective in the treatment of dermatologic conditions such as dermatitis, pruritus, and urticaria than alternative treatment options, “placebo acupuncture,” or no treatment, according to a review of the medical literature published in The Journal of Alternative and Complementary Medicine, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers

The abstract was equally promising:

Objectives: Acupuncture is a form of Traditional Chinese Medicine that has been used to treat a broad range of medical conditions, including dermatologic disorders. This systematic review aims to synthesize the evidence on the use of acupuncture as a primary treatment modality for dermatologic conditions.

Methods: A systematic search of MEDLINE, EMBASE, and the Cochrane Central Register was performed. Studies were limited to clinical trials, controlled studies, case reports, comparative studies, and systematic reviews published in the English language. Studies involving moxibustion, electroacupuncture, or blood-letting were excluded.

Results: Twenty-four studies met inclusion criteria. Among these, 16 were randomized controlled trials, 6 were prospective observational studies, and 2 were case reports. Acupuncture was used to treat atopic dermatitis, urticaria, pruritus, acne, chloasma, neurodermatitis, dermatitis herpetiformis, hyperhidrosis, human papillomavirus wart, breast inflammation, and facial elasticity. In 17 of 24 studies, acupuncture showed statistically significant improvements in outcome measurements compared with placebo acupuncture, alternative treatment options, and no intervention.

Conclusions: Acupuncture improves outcome measures in the treatment of dermatitis, chloasma, pruritus, urticaria, hyperhidrosis, and facial elasticity. Future studies should ideally be double-blinded and standardize the control intervention.

One has to read the actual full text article to understand that the evidence presented here is dodgy to the extreme. In fact, one has to go into the tedious details of the methods section to find the reasons why:  All searches were limited to clinical trials, controlled studies, case reports, comparative studies, and systematic reviews published in the English language.

There are many more weaknesses of this review, but the inclusion of uncontrolled studies and even anecdotes is, in my view, a virtual death sentence to its credibility. It means that no general conclusions about the effectiveness of acupuncture, such as the authors have decided to make, are possible.

Such overt exaggerations are sadly no rarities in the realm of alternative medicine.  I think, this begs a number of serious questions:

  1. Does this cross the line between flawed research and scientific misconduct?
  2. Why did the reviewers not pick up these flaws?
  3. Why did the editor pass this article for publication?
  4. How can the publisher tolerate such dubious behaviour?
  5. Should this journal (which I have commented on before here and which is one with the highest impact factor of all the alt med journals) be de-listed from Medline?

I don’t think that we will get answers from the people responsible for this disgrace, but I would like to learn my readers’ opinions.

This post is dedicated to all homeopathic character assassins.

Some ardent homeopathy fans have reminded me that, some 25  years ago, I published (OH, WHAT A SCANDAL!!!) a positive trial of homeopathy; I even found a website that proudly announces this fact. Homeopaths seem jubilant about this discovery (not because they now need to revise their allegations that I never did any trials; or the other, equally popular claim, that I have always been squarely against their trade but) because the implication is that even I have to concede that homeopathic remedies are better than placebo. In their view, this seems to beg the following important and embarrassing questions:

  • Why did I change my mind?
  • Am I not contradicting myself?
  • Who has bribed me?
  • Am I in the pocket of Big Pharma?
  • Does this ‘skeleton in my closet’ discredit me for all times?

I remember the trial in question quite well. We conducted it during my time in Vienna, and I am proud of several innovative ideas that went into it. Here is the abstract in full:

The aim of this study was to test the effectiveness of a combined homeopathic medication in primary varicosity. A well-defined population of 61 patients was randomized into active medication (Poikiven®) or placebo. Both were given for 24 d. At the start of the trial, after 12 d medication and at the end of the study, objective and subjective parameters were recorded: venous filling time, leg volume, calf circumference, haemorheological measurements and patients’ symptoms such as cramps, itching, leg heaviness, pain during standing and the need to elevate the legs. The results show that venous filling time is changed by 44% towards normal in the actively-treated group. The average leg volume fell significantly more in this group, but calf circumferences did not change significantly and blood rheology was not altered in any relevant way. None of the patients reported side-effects. Subjective complaints were relieved significantly more by Poikiven than by placebo. These results suggest that the oral treatment of primary varicosity using Poikiven is feasible.

So, there we have it: a homeopathic remedy (as tested by me) is clearly better than placebo normalising important objective parameters as well as subjective symptoms of varicose veins. Is that not a contradiction of what I keep saying today, namely that homeopathy is a placebo therapy?

YES AND NO! (But much more NO than YES)

Yes, because that was clearly our result, and I never tried to deny it.

No, because our verum was far from being a homeopathic, highly diluted remedy. It contained Aesculus D1 12,5 ml, Arnica D1 2,5 ml, Carduus marianus D1 5 ml, Hamamelis D1 10 ml, Lachesis D6 5 ml, Lycopodium D4 5 ml, Melilotus officinalis D1 10 ml. Take just the first of these ingredients, Aesculus or horse chestnut. This is a herbal medicine that has been well documented (even via a Cochrane review) to be effective for the symptoms of varicose veins, and it contains Aesculus in the D1 potency. This means that it is diluted merely by a factor of 1:10. So, for all intents and purposes, our verum was herbal by nature, and there is no surprise at all that we found it to be effective.

[Here is a little ‘aside’: Aesculus is a proven treatment for varicose veins. Homeopathy must always rely on the ‘like cures like’ principle. Therefore, if Aesculus had been used in the homeopathic way, would it not, according to homeopathic dogma, had to worsen the symptoms of our patients rather than alleviating them?]

All of this would be trivial to the extreme, if it did not touch upon an important and confusing point which is often used as an ‘escape route’ by homeopaths when they find themselves between a rock and a hard place. Some trials of homeopathy are positive because they use medications which are homeopathic only by name. This regularly creates considerable confusion. In the recent BMJ debate I tried to address this issue head on by stating at the outset: ” Nobody questions, of course, that some substances used in homeopathy, such as arsenic or strychnine, can be pharmacologically active, but homeopathic medicines are typically far too dilute to have any effect.”

And that’s the point: homeopathic remedies beyond a C12 potency contain nothing, less dilute ones contain little to very little, and D1 potencies are hardy diluted at all and thus contain substantial amounts of active ingredients. Such low potencies are rarely used by homeopaths and should be called PSEUDO-HOMEOPATHIC, in my view. Homeopaths tend to use this confusing complexity to wriggle out of difficult arguments, and often they rely on systematic reviews of homeopathic trials which can generate somewhat confusing overall findings because of such PSEUDO-HOMEOPATHIC remedies.

To make it perfectly clear: the typical homeopathic remedy is far too dilute to have any effect. When scientists or the public at large speak of homeopathic remedies, we don’t mean extracts of Aesculus or potent poisons like Arsenic D1 (has anyone heard of someone claiming to have killed rats with homeopathy?); we refer to the vast majority of remedies which are highly dilute and contain no or very few active molecules – even when we do not explain this somewhat complicated and rather tedious circumstance each and every time. I therefore declare once and for all that, unless I indicate otherwise, I do NOT mean potencies below C6 when I speak of a ‘homeopathic remedy’ (sorry homeopathy fans, perhaps I should have done this when I started this blog).

What if our Vienna study all those years ago had tested not the pseudo-homeopathic ‘Poikiven’ but a highly dilute, real homeopathic remedy and had still come up with a positive finding? Would that make me inconsistent, dishonest, untrustworthy or corrupt? Certainly not!

I have always urged people to not go by the results of single trials. There are numerous reasons why a single study can produce a misleading result. We should therefore, wherever possible, rely on systematic reviews that critically evaluate the totality of the evidence (I would always mistrust even my own trial data, if it contradicted the totality of the reliable evidence) – and such analyses clearly fail to show that homeopathy is more than a placebo.

And even, if none of this had happened, and I had just changed my mind about homeopathy because

  • the evidence changed,
  • I had become wiser,
  • I had learnt how to think like a scientist,
  • I had managed to see behind the smokescreen many homeopaths put up to hide the truth?

Would that discredit me? I don’t think so! As someone once said, being able to change one’s mind is a sign of intelligence.

I am sure that the weird world of homeopathic character assassination will soon find something else to discredit me – but for now…

I REST MY CASE.

Chiropractors are back pain specialists, they say. They do not pretend to treat non-spinal conditions, they claim.

If such notions were true, why are so many of them still misleading the public? Why do many chiropractors pretend to be primary care physicians who can take care of most illnesses regardless of any connection with the spine? Why do they continue to happily promote bogus treatments? Why do chiropractors, for instance, claim they can treat gastrointestinal diseases?

This recent narrative review of the literature, for example, was aimed at summarising studies describing the management of disorders of the gastrointestinal (GI) tract using ‘chiropractic therapy’ broadly defined here as spinal manipulation therapy, mobilizations, soft tissue therapy, modalities and stretches.

Twenty-one articles were found through searching the published literature to meet the authors’ inclusion criteria. The retrieved articles included case reports to clinical trials to review articles. The majority of articles chronicling patient experiences under chiropractic care reported that they experienced mild to moderate improvements in GI symptoms. No adverse effects were reported.

From this, the authors concluded that chiropractic care can be considered as an adjunctive therapy for patients with various GI conditions providing there are no co-morbidities.

I think, we would need to look for a long time to find an article with conclusions that are more ridiculous, false and unethical than these.

The old adage applies: rubbish in, rubbish out. If we include unreliable reports such as anecdotes, our finding will be unreliable as well. If we do not make this mistake and conduct a proper systematic review, we will arrive at very different conclusions. My own systematic review, for instance, of controlled clinical trials drew the following conclusion: There is no supportive evidence that chiropractic is an effective treatment for gastrointestinal disorders.

That probably says it all. I only want to add a short question: SHOULD THIS LATEST CHIROPRACTIC ATTEMPT TO MISLEAD THE PUBLIC BE CONSIDERED ‘SCIENTIFIC MISCONDUCT’ OR ‘FRAUD’?

Osteopathy is a difficult subject. In the US, osteopaths are (almost) identical with doctors who have studied conventional medicine and hardly practice any manipulative techniques at all. Elsewhere, osteopaths are alternative healthcare providers specialising in what they like to call ‘osteopathic manipulative therapy’ (OMT). As though this is not confusing enough, osteopaths are doing similar things as chiropractors but are adamant that they are a distinct profession. Despite these assertions, I have seen little to clearly differentiate the two – with one exception perhaps: osteopaths tend to use techniques that are less frequently associated with severe harm.

Despite this confusion, or maybe because of it, we need to ask: DOES OMT WORK?

A recent study was aimed at assessing the effectiveness of OMT on chronic migraineurs using HIT-6 questionnaire, drug consumption, days of migraine, pain intensity and functional disability. All patients admitted to the Department of Neurology of Ancona’s United Hospitals, Italy, with a diagnosis of migraine and without chronic illness, were considered eligible for this 3-armed RCT.

Patients were randomly divided into three (1) OMT+medication therapy, (2) sham+medication therapy and (3) medication therapy only and received 8 treatments during 6 months. Changes in the HIT-6 score were considered as the main outcome measure.

A total of 105 subjects were included. At the end of the study, OMT significantly reduced HIT-6 score, drug consumption, days of migraine, pain intensity and functional disability.

The investigators concluded that these findings suggest that OMT may be considered a valid procedure for the management of migraineurs.

Similar results have been reported elsewhere:

One trial, for instance, concluded: “This study affirms the effects of OMT on migraine headache in regard to decreased pain intensity and the reduction of number of days with migraine as well as working disability, and partly on improvement of HRQoL. Future studies with a larger sample size should reproduce the results with a control group receiving placebo treatment in a long-term follow-up.”

Convinced? No, I am not.

Why? Because the studies that do exist seem a little too good to be true; because they are few and far between, because the few studies tend to be flimsy and have been published in dodgy journals, because they lack independent replications, and because critical reviews seem to conclude that OMT is nowhere near as promising as some osteopaths would like us to believe: “Further studies of improved quality are necessary to more firmly establish the place of physical modalities in the treatment of primary headache disorders. With the exception of high velocity chiropractic manipulation of the neck, the treatments are unlikely to be physically dangerous, although the financial costs and lost treatment opportunity by prescribing potentially ineffective treatment may not be insignificant. In the absence of clear evidence regarding their role in treatment, physicians and patients are advised to make cautious and individualized judgments about the utility of physical treatments for headache management; in most cases, the use of these modalities should complement rather than supplant better-validated forms of therapy.”

One could define alternative medicine by the fact that it is used almost exclusively for conditions for which conventional medicine does not have an effective and reasonably safe cure. Once such a treatment has been found, few patients would look for an alternative.

Alzheimer’s disease (AD) is certainly one such condition. Despite intensive research, we are still far from being able to cure it. It is thus not really surprising that AD patients and their carers are bombarded with the promotion of all sorts of alternative treatments. They must feel bewildered by the choice and all too often they fall victim to irresponsible quacks.

Acupuncture is certainly an alternative therapy that is frequently claimed to help AD patients. One of the first websites that I came across, for instance, stated boldly: acupuncture improves memory and prevents degradation of brain tissue.

But is there good evidence to support such claims? To answer this question, we need a systematic review of the trial data. Fortunately, such a paper has just been published.

The objective of this review was to assess the effectiveness and safety of acupuncture for treating AD. Eight electronic databases were searched from their inception to June 2014. Randomized clinical trials (RCTs) with AD treated by acupuncture or by acupuncture combined with drugs were included. Two authors extracted data independently.

Ten RCTs with a total of 585 participants were included in a meta-analysis. The combined results of 6 trials showed that acupuncture was better than drugs at improving scores on the Mini Mental State Examination (MMSE) scale. Evidence from the pooled results of 3 trials showed that acupuncture plus donepezil was more effective than donepezil alone at improving the MMSE scale score. Only 2 trials reported the incidence of adverse reactions related to acupuncture. Seven patients had adverse reactions related to acupuncture during or after treatment; the reactions were described as tolerable and not severe.

The Chinese authors of this review concluded that acupuncture may be more effective than drugs and may enhance the effect of drugs for treating AD in terms of improving cognitive function. Acupuncture may also be more effective than drugs at improving AD patients’ ability to carry out their daily lives. Moreover, acupuncture is safe for treating people with AD.

Anyone reading this and having a friend or family member who is affected by AD will think that acupuncture is the solution and warmly recommend trying this highly promising option. I would, however, caution to remain realistic. Like so very many systematic reviews of acupuncture or other forms of TCM that are currently flooding the medical literature, this assessment of the evidence has to be taken with more than just a pinch of salt:

  • As far as I can see, there is no biological plausibility or mechanism for the assumption that acupuncture can do anything for AD patients.
  • The abstract fails to mention that the trials were of poor methodological quality and that such studies tend to generate false-positive findings.
  • The trials had small sample sizes.
  • They were mostly not blinded.
  • They were mostly conducted in China, and we know that almost 100% of all acupuncture studies from that country draw positive conclusions.
  • Only two trials reported about adverse effects which is, in my view, a sign of violation of research ethics.

As I already mentioned, we are currently being flooded with such dangerously misleading reviews of Chinese primary studies which are of such dubious quality that one could do probably nothing better than to ignore them completely.

Isn’t that a bit harsh? Perhaps, but I am seriously worried that such papers cause real harm:

  • They might motivate some to try acupuncture and give up conventional treatments which can be helpful symptomatically.
  • They might prompt some families to spend sizable amounts of money for no real benefit.
  • They might initiate further research into this area, thus drawing money away from research into much more promising avenues.

IT IS HIGH TIME THAT RESEARCHERS START THINKING CRITICALLY, PEER-REVIEWERS DO THEIR JOB PROPERLY, AND JOURNAL EDITORS STOP PUBLISHING SUCH MISLEADING ARTICLES.

On this blog, we have discussed many different alternative treatments. As it turns out, hardly any of them fulfil the criteria for being used routinely in clinical practice. But here I present one that might be the exception.

The Feldenkrais Method (FM) aims to reduce pain or limitations in movement, to improve physical function, and to promote general wellbeing by increasing the patient’s awareness of herself and by expanding her movement repertoire. The FM is an educational method similar to the Alexander Technique.

The practitioner directs his attention to the patient’s habitual movement patterns which are inefficient or strained, and teaches new patterns using gentle, slow, repeated movements. Slow repetition is believed to be necessary to impart a new habit and allow it to begin to feel normal. These movements may be passive (performed by the practitioner on the recipient’s body) or active (performed by the patient).

At this point, we should ask: but does FM really and demonstrably work?

Ten years ago, we published a systematic review of all RCTs available at the time testing the effectiveness of FM. Six studies met our inclusion criteria. They were all burdened with significant methodological weaknesses. The indications included multiple sclerosis, neck/shoulder problems and chronic back pain. All but one trial reported positive results.  We concluded that the evidence for the FM is encouraging but, due to the paucity and low quality of studies, by no means compelling.

Since then, more research has become available, and an update of our research seemed necessary. This new review aimed to update the evidence for the benefits of FM. Included studies were appraised using the Cochrane risk of bias approach and trial findings analysed individually and collectively where possible. Twenty RCTs were included (an additional 14 to our earlier systematic review). The population, outcome, and findings were highly heterogeneous. Meta-analyses were performed with 7 studies, finding in favour of the FM for improving balance in ageing populations. Single studies reported significant positive effects for reduced perceived effort and increased comfort, body image perception, and dexterity. Risk of bias was high in all studies, thus tempering some results. The effects seemed to be generic, supporting the proposal that FM works on a learning paradigm rather than disease-based mechanisms.

The authors concluded that further research is required; however, in the meantime, clinicians and professionals may promote the use of FM in populations interested in efficient physical performance and self-efficacy.

One might discuss whether or not FM is truly an alternative therapy; it has many characteristics of a physiotherapy, and physiotherapists often employ FM. On the other hand, it is considered to be alternative by some practitioners. So, for the purpose of this article, I will call it alternative.

The evidence for FM has become substantially more promising since we last looked at it systematically. The indication for which the evidence is most convincing is the improvement of elderly people’s balance. Considering that FM is virtually risk-free and inexpensive, I feel that it is one of the rare alternative therapy that could be integrated into clinical routine (for this particular indication).

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