MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

pain

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Kinesiology tape KT is fashionable, it seems. Gullible consumers proudly wear it as decorative ornaments to attract attention and show how very cool they are.

Am I too cynical?

Perhaps.

But does KT really do anything more?

A new trial might tell us.

The aim of this study was to investigate whether adding kinesiology tape (KT) to spinal manipulation (SM) can provide any extra effect in athletes with chronic non-specific low back pain (CNLBP).

Forty-two athletes (21males, 21females) with CNLBP were randomized into two groups of SM (n = 21) and SM plus KT (n = 21). Pain intensity, functional disability level and trunk flexor-extensor muscles endurance were assessed by Numerical Rating Scale (NRS), Oswestry pain and disability index (ODI), McQuade test, and unsupported trunk holding test, respectively. The tests were done before and immediately, one day, one week, and one month after the interventions and compared between the two groups.

After treatments, pain intensity and disability level decreased and endurance of trunk flexor-extensor muscles increased significantly in both groups. Repeated measures analysis, however, showed that there was no significant difference between the groups in any of the evaluations.

The authors, physiotherapists from Iran, concluded that the findings of the present study showed that adding KT to SM does not appear to have a significant extra effect on pain, disability and muscle endurance in athletes with CNLBP. However, more studies are needed to examine the therapeutic effects of KT in treating these patients.

Regular readers of my blog will be able to predict what I have to say about this study design: A+B versus B is not a meaningful test of anything. I used to claim that it cannot possibly produce a negative result – and yet, here it seems to have done exactly that!

How come?

The way I see it, there are two possibilities to explain this:

  • the KT has a mildly negative effect on CNLBP; thus the expected positive placebo-effect was neutralised to result in a null-effect overall;
  • the study was under-powered such that the true inter-group difference could not manifest itself.

I think the second possibility is more likely, but it does really not matter at all. Because the only lesson we can learn from this trial is this: inadequate study designs will  hardly ever generate anything worthwhile.

And this is, I think, a lesson that would be valuable for many researchers.

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Reference

2018 Apr;22(2):540-545. doi: 10.1016/j.jbmt.2017.07.008. Epub 2017 Jul 26.

Comparing spinal manipulation with and without Kinesio Taping® in the treatment of chronic low back pain.

 

Can I tempt you to run a little (hopefully instructive) thought-experiment with you? It is quite simple: I will tell you about the design of a clinical trial, and you will tell me what the likely outcome of this study would be.

Are you game?

Here we go:

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Imagine we conduct a trial of acupuncture for persistent pain (any type of pain really). We want to find out whether acupuncture is more than a placebo when it comes to pain-control. Of course, we want our trial to look as rigorous as possible. So, we design it as a randomised, sham-controlled, partially-blinded study. To be really ‘cutting edge’, our study will not have two but three parallel groups:

1. Standard needle acupuncture administered according to a protocol recommended by a team of expert acupuncturists.

2. Minimally invasive sham-acupuncture employing shallow needle insertion using short needles at non-acupuncture points. Patients in groups 1 and 2 are blinded, i. e. they are not supposed to know whether they receive the sham or real acupuncture.

3. No treatment at all.

We apply the treatments for a sufficiently long time, say 12 weeks. Before we start, after 6 and 12 weeks, we measure our patients’ pain with a validated method. We use sound statistical methods to compare the outcomes between the three groups.

WHAT DO YOU THINK THE RESULT WOULD BE?

You are not sure?

Well, let me give you some hints:

Group 3 is not going to do very well; not only do they receive no therapy at all, but they are also disappointed to have ended up in this group as they joined the study in the hope to get acupuncture. Therefore, they will (claim to) feel a lot of pain.

Group 2 will be pleased to receive some treatment. However, during the course of the 6 weeks, they will get more and more suspicious. As they were told during the process of obtaining informed consent that the trial entails treating some patients with a sham/placebo, they are bound to ask themselves whether they ended up in this group. They will see the short needles and the shallow needling, and a percentage of patients from this group will doubtlessly suspect that they are getting the sham treatment. The doubters will not show a powerful placebo response. Therefore, the average pain scores in this group will decrease – but only a little.

Group 1 will also be pleased to receive some treatment. As the therapists cannot be blinded, they will do their best to meet the high expectations of their patients. Consequently, they will benefit fully from the placebo effect of the intervention and the pain score of this group will decrease significantly.

So, now we can surely predict the most likely result of this trial without even conducting it. Assuming that acupuncture is a placebo-therapy, as many people do, we now see that group 3 will suffer the most pain. In comparison, groups 1 and 2 will show better outcomes.

Of course, the main question is, how do groups 1 and 2 compare to each other? After all, we designed our sham-controlled trial in order to answer exactly this issue: is acupuncture more than a placebo? As pointed out above, some patients in group 2 would have become suspicious and therefore would not have experienced the full placebo-response. This means that, provided the sample sizes are sufficiently large, there should be a significant difference between these two groups favouring real acupuncture over sham. In other words, our trial will conclude that acupuncture is better than placebo, even if acupuncture is a placebo.

THANK YOU FOR DOING THIS THOUGHT EXPERIMENT WITH ME.

Now I can tell you that it has a very real basis. The leading medical journal, JAMA, just published such a study and, to make matters worse, the trial was even sponsored by one of the most prestigious funding agencies: the NIH.

Here is the abstract:

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Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors and often result in therapy discontinuation. Small studies suggest that acupuncture may decrease aromatase inhibitor-related joint symptoms.

Objective:

To determine the effect of acupuncture in reducing aromatase inhibitor-related joint pain.

Design, Setting, and Patients:

Randomized clinical trial conducted at 11 academic centers and clinical sites in the United States from March 2012 to February 2017 (final date of follow-up, September 5, 2017). Eligible patients were postmenopausal women with early-stage breast cancer who were taking an aromatase inhibitor and scored at least 3 on the Brief Pain Inventory Worst Pain (BPI-WP) item (score range, 0-10; higher scores indicate greater pain).

Interventions:

Patients were randomized 2:1:1 to the true acupuncture (n = 110), sham acupuncture (n = 59), or waitlist control (n = 57) group. True acupuncture and sham acupuncture protocols consisted of 12 acupuncture sessions over 6 weeks (2 sessions per week), followed by 1 session per week for 6 weeks. The waitlist control group did not receive any intervention. All participants were offered 10 acupuncture sessions to be used between weeks 24 and 52.

Main Outcomes and Measures:

The primary end point was the 6-week BPI-WP score. Mean 6-week BPI-WP scores were compared by study group using linear regression, adjusted for baseline pain and stratification factors (clinically meaningful difference specified as 2 points).

Results:

Among 226 randomized patients (mean [SD] age, 60.7 [8.6] years; 88% white; mean [SD] baseline BPI-WP score, 6.6 [1.5]), 206 (91.1%) completed the trial. From baseline to 6 weeks, the mean observed BPI-WP score decreased by 2.05 points (reduced pain) in the true acupuncture group, by 1.07 points in the sham acupuncture group, and by 0.99 points in the waitlist control group. The adjusted difference for true acupuncture vs sham acupuncture was 0.92 points (95% CI, 0.20-1.65; P = .01) and for true acupuncture vs waitlist control was 0.96 points (95% CI, 0.24-1.67; P = .01). Patients in the true acupuncture group experienced more grade 1 bruising compared with patients in the sham acupuncture group (47% vs 25%; P = .01).

Conclusions and Relevance:

Among postmenopausal women with early-stage breast cancer and aromatase inhibitor-related arthralgias, true acupuncture compared with sham acupuncture or with waitlist control resulted in a statistically significant reduction in joint pain at 6 weeks, although the observed improvement was of uncertain clinical importance.

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Do you see how easy it is to deceive (almost) everyone with a trial that looks rigorous to (almost) everyone?

My lesson from all this is as follows: whether consciously or unconsciously, SCAM-researchers often build into their trials more or less well-hidden little loopholes that ensure they generate a positive outcome. Thus even a placebo can appear to be effective. They are true masters of producing false-positive findings which later become part of a meta-analysis which is, of course, equally false-positive. It is a great shame, in my view, that even top journals (in the above case JAMA) and prestigious funders (in the above case the NIH) cannot (or want not to?) see behind this type of trickery.

The only time we discussed gua sha, it led to one of the most prolonged discussions we ever had on this blog (536 comments so far). It seems to be a topic that excites many. But what precisely is it?

Gua sha, sometimes referred to as “scraping”, “spooning” or “coining”, is a traditional Chinese treatment that has spread to several other Asian countries. It has long been popular in Vietnam and is now also becoming well-known in the West. The treatment consists of scraping the skin with a smooth edge placed against the pre-oiled skin surface, pressed down firmly, and then moved downwards along muscles or meridians. According to its proponents, gua sha stimulates the flow of the vital energy ‘chi’ and releases unhealthy bodily matter from blood stasis within sore, tired, stiff or injured muscle areas.

The technique is practised by TCM practitioners, acupuncturists, massage therapists, physical therapists, physicians and nurses. Practitioners claim that it stimulates blood flow to the treated areas, thus promoting cell metabolism, regeneration and healing. They also assume that it has anti-inflammatory effects and stimulates the immune system.

These effects are said to last for days or weeks after a single treatment. The treatment causes microvascular injuries which are visible as subcutaneous bleeding and redness. Gua sha practitioners make far-reaching therapeutic claims, including that the therapy alleviates pain, prevents infections, treats asthma, detoxifies the body, cures liver problems, reduces stress, and contributes to overall health.

Gua sha is mildly painful, almost invariably leads to unsightly blemishes on the skin which occasionally can become infected and might even be mistaken for physical abuse.

There is little research of gua sha, and the few trials that exist tend to be published in Chinese. But recently, a new paper has emerged that is written in English. The goal of this systematic review was to evaluate the available evidence from randomized controlled trials (RCTs) of gua sha for the treatment of patients with perimenopausal syndrome.

A total of 6 RCTs met the inclusion criteria. Most were of low methodological quality. When compared with Western medicine therapy alone, meta-analysis of 5 RCTs indicated favorable statistically significant effects of gua sha plus Western medicine. Moreover, study participants who received Gua Sha therapy plus Western medicine therapy showed significantly greater improvements in serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH) compared to participants in the Western medicine therapy group.

The authors concluded that preliminary evidence supported the hypothesis that Gua Sha therapy effectively improved the treatment efficacy in patients with perimenopausal syndrome. Additional studies will be required to elucidate optimal frequency and dosage of Gua Sha.

This sounds as though gua sha is a reasonable therapy.

Yet, I think this notion is worth being critically analysed. Here are some caveats that spring into my mind:

  • Gua sha lacks biological plausibility.
  • The reviewed trials are too flawed to allow any firm conclusions.
  • As most are published in Chinese, non-Chinese speakers have no possibility to evaluate them.
  • The studies originate from China where close to 100% of TCM trials report positive results.
  • In my view, this means they are less than trustworthy.
  • The authors of the above-cited review are all from China and might not be willing, able or allowed to publish a critical paper on this subject.
  • The review was published in , a journal not known for its high scientific standards or critical stance towards TCM.

So, is gua sha a reasonable therapy?

I let you make this judgement.

THE CONVERSATION recently carried an article shamelessly promoting osteopathy. It seems to originate from the University of Swansea, UK, and is full of bizarre notions. Here is an excerpt:

To find out more about how osteopathy could potentially affect mental health, at our university health and well-being academy, we have recently conducted one of the first studies on the psychological impact of OMT – with positive results.

For the last five years, therapists at the academy have been using OMT to treat members of the public who suffer from a variety of musculoskeletal disorders which have led to chronic pain. To find out more about the mental health impacts of the treatment, we looked at three points in time – before OMT treatment, after the first week of treatment, and after the second week of treatment – and asked patients how they felt using mental health questionnaires.

This data has shown that OMT is effective for reducing anxiety and psychological distress, as well as improving patient self-care. But it may not be suitable for all mental illnesses associated with chronic pain. For instance, we found that OMT was less effective for depression and fear avoidance.

All is not lost, though. Our results also suggested that the positive psychological effects of OMT could be further optimised by combining it with therapy approaches like acceptance and commitment therapy (ACT). Some research indicates that psychological problems such as anxiety and depression are associated with inflexibility, and lead to experiential avoidance. ACT has a positive effect at reducing experiential avoidance, so may be useful with reducing the fear avoidance and depression (which OMT did not significantly reduce).

Other researchers have also suggested that this combined approach may be useful for some subgroups receiving OMT where they may accept this treatment. And, further backing this idea up, there has already been at least one pilot clinical trial and a feasibility study which have used ACT and OMT with some success.

Looking to build on our positive results, we have now begun to develop our ACT treatment in the academy, to be combined with the osteopathic therapy already on offer. Though there will be a different range of options, one of these ACT therapies is psychoeducational in nature. It does not require an active therapist to work with the patient, and can be delivered through internet instruction videos and homework exercises, for example.

Looking to the future, this kind of low cost, broad healthcare could not only save the health service money if rolled out nationwide but would also mean that patients only have to undergo one treatment.

END OF QUOTE

So, they recruited a few patients who had come to receive osteopathic treatments (a self-selected population full of expectation and in favour of osteopathy), let them fill a few questionnaires and found some positive changes. From that, they conclude that OMT (osteopathic manipulative therapy) is effective. Not only that, they advocate that OMT is rolled out nationwide to save NHS funds.

Vis a vis so much nonsense, I am (almost) speechless!

As this comes not from some commercial enterprise but from a UK university, the nonsense is intolerable, I find.

Do I even need to point out what is wrong with it?

Not really, it’s too obvious.

But, just in case some readers struggle to find the fatal flaws of this ‘study’, let me mention just the most obvious one. There was no control group! That means the observed outcome could be due to many factors that are totally unrelated to OMT – such as placebo-effect, regression towards the mean, natural history of the condition, concomitant treatments, etc. In turn, this also means that the nationwide rolling out of their approach would most likely be a costly mistake.

The general adoption of OMT would of course please osteopaths a lot; it could even reduce anxiety – but only that of the osteopaths and their bank-managers, I am afraid.

As you know, my ambition is to cover all (or at least most) alternative methods on this blog _ by no means an easy task because there is a sheer endless list of treatments and a sizable one of diagnostic techniques. One intervention that we have not yet discussed is ZERO BALANCING.

What is it?

This website explains it fairly well:

Developed by Fritz Smith, MD in the early 1970s, Zero Balancing is a powerful body-mind therapy that uses skilled touch to address the relationship between energy and structures of the body. Following a protocol that typically lasts 30 to 45 minutes,  the practitioner uses finger pressure and gentle traction on areas of tension in the bones, joints and soft tissue to create fulcrums, or points of balance, around which the body can relax and reorganize. Zero Balancing focuses primarily on key joints of our skeleton that conduct and balance forces of gravity, posture and movement. By addressing the deepest and densest tissues of the body along with soft tissue and energy fields, Zero Balancing helps to clear blocks in the body’s energy flow, amplify vitality and contribute to better postural alignment. A Zero Balancing session leaves you with a wonderful feeling of inner harmony and organization.

Did I just say ‘fairly well’? I retract this statement. Zero Balancing turns out to be one of the more nebulous alternative treatments.

The therapy might be defined by lots of nonsensical terminology, but that does not necessarily mean it is rubbish. Judging from the claims made for Zero Balancing, it might even be a most useful therapy. Here are just some of the claims frequently made for zero balancing:

  • Increases feelings of health and well-being
  • Releases stress and improves the flow of energy in our bodies
  • Reduces pain and discomfort
  • Enhances stability, balance and freedom
  • Amplifies the sense of connection, peace and happiness
  • Releases mental, emotional and physical tension
  • Supports us through transitions and transformations
  • Improves quality of life and increases capacity for enjoyment

These claims are testable, and we must, of course, ask by what evidence they are being supported. I did a quick Medline-search to find out.

And the result?

Zero!

… now the rather odd name of the treatment begins to make sense: ZERO BALANCING, ZERO EVIDENCE.

We recently discussed the deplorable case of Larry Nassar and the fact that the ‘American Osteopathic Association’ stated that intravaginal manipulations are indeed an approved osteopathic treatment. At the time, I thought this was a shocking claim. So, imagine my surprise when I was alerted to a German trial of osteopathic intravaginal manipulations.

Here is the full and unaltered abstract of the study:

Introduction: 50 to 80% of pregnant women suffer from low back pain (LBP) or pelvic pain (Sabino und Grauer, 2008). There is evidence for the effectiveness of manual therapy like osteopathy, chiropractic and physiotherapy in pregnant women with LBP or pelvic pain (Liccardione et al., 2010). Anatomical, functional and neural connections support the relationship between intrapelvic dysfunctions and lumbar and pelvic pain (Kanakaris et al., 2011). Strain, pressure and stretch of visceral and parietal peritoneum, bladder, urethra, rectum and fascial tissue can result in pain and secondary in muscle spasm. Visceral mobility, especially of the uterus and rectum, can induce tension on the inferior hypogastric plexus, which may influence its function. Thus, stretching the broad ligament of the uterus and the intrapelvic fascia tissue during pregnancy can reinforce the influence of the inferior hypogastric plexus. Based on above facts an additional intravaginal treatment seems to be a considerable approach in the treatment of low back pain in pregnant women.
Objective: The purpose of this study was to compare the effect of osteopathic treatment including intravaginal techniques versus osteopathic treatment only in females with pregnancy-related low back pain.
Methods: Design: The study was performed as a randomized controlled trial. The participants were randomized by drawing lots, either into the intervention group including osteopathic and additional intravaginal treatment (IV) or a control group with osteopathic treatment only (OI). Setting: Medical practice in south of Germany.
Participants 46 patients were recruited between the 30th and 36th week of pregnancy suffering from low back pain.
Intervention Both groups received three treatments within a period of three weeks. Both groups were treated with visceral, mobilization, and myofascial techniques in the cervical, thoracic and lumbar spine, the pelvic and the abdominal region (American Osteopathic Association Guidelines, 2010). The IV group received an additional treatment with intravaginal techniques in supine position. This included myofascial techniques of the M. levator ani and the internal obturator muscles, the vaginal tissue, the pubovesical and uterosacral ligaments as well as the inferior hypogastric plexus.
Main outcome measures As primary outcome the back pain intensity was measured by Visual Analogue Scale (VAS). Secondary outcome was the disability index assessed by Oswestry-Low-Back-Pain-Disability-Index (ODI), and Pregnancy-Mobility-Index (PMI).
Results: 46 participants were randomly assigned into the intervention group (IV; n = 23; age: 29.0 ±4.8 years; height: 170.1 ±5.8 cm; weight: 64.2 ±10.3 kg; BMI: 21.9 ±2.6 kg/m2) and the control group (OI; n = 23; age: 32.0 ±3.9 years; height: 168.1 ±3.5 cm; weight: 62.3 ±7.9 kg; BMI: 22.1 ±3.2 kg/m2). Data from 42 patients were included in the final analyses (IV: n=20; OI: n=22), whereas four patients dropped out due to general pregnancy complications. Back pain intensity (VAS) changed significantly in both groups: in the intervention group (IV) from 59.8 ±14.8 to 19.6 ±8.4 (p<0.05) and in the control group (OI) from 57.4 ±11.3 to 24.7 ±12.8. The difference between groups of 7.5 (95%CI: -16.3 to 1.3) failed to demonstrate statistical significance (p=0.93). Pregnancy-Mobility-Index (PMI) changed significantly in both groups, too. IV group: from 33.4 ±8.9 to 29.6 ±6.6 (p<0.05), control group (OI): from 36.3 ±5.2 to 29.7 ±6.8. The difference between groups of 2.6 (95%CI: -5.9 to 0.6) was not statistically significant (p=0.109). Oswestry-Low-Back-Pain-Disability-Index (ODI) changed significantly in the intervention group (IV) from 15.1 ±7.8 to 9.2 ±3.6 (p<0.05) and also significantly in the control group (OI) from 13.8 ±4.9 to 9.2 ±3.0. Between-groups difference of 1.3 (95%CI: -1.5 to 4.1) was not statistically significant (p=0.357).
Conclusions: In this sample a series of osteopathic treatments showed significant effects in reducing pain and increasing the lumbar range of motion in pregnant women with low back pain. Both groups attained clinically significant improvement in functional disability, activity and quality of life. Furthermore, no benefit of additional intravaginal treatment was observed.

END OF QUOTE

My first thoughts after reading this were: how on earth did the investigators get this past an ethics committee? It cannot be ethical, in my view, to allow osteopaths (in Germany, they have no relevant training to speak of) to manipulate women intravaginally. How deluded must an osteopath be to plan and conduct such a trial? What were the patients told before giving informed consent? Surely not the truth!

My second thoughts were about the scientific validity of this study: the hypothesis which this trial claims to be testing is a far-fetched extrapolation, to put it mildly; in fact, it is not a hypothesis, it’s a very daft idea. The control-intervention is inadequate in that it cannot control for the (probably large) placebo effects of intravaginal manipulations. The observed outcomes are based on within-group comparisons and are therefore most likely unrelated to the treatments applied. The conclusion is as barmy as it gets; a proper conclusion should clearly and openly state that the results did not show any effects of the intravaginal manipulations.

In summary, this is a breathtakingly idiotic trial, and everyone involved in it (ethics committee, funding body, investigators, statistician, reviewers, journal editor) should be deeply ashamed and apologise to the poor women who were abused in a most deplorable fashion.

Reflexology is an alternative therapy that is subjectively pleasant and objectively popular; it has been the subject on this blog before (see also here and here). Reflexologists assume that certain zones on the sole of our feet correspond to certain organs, and that their manual treatment can influence the function of these organs. Thus reflexology is advocated for all sorts of conditions, including infant colic.

The aim of this new study was to explore the effect of reflexology on infantile colic.

A total of 64 babies with colic were included in this study. Following a paediatrician’s diagnosis, two groups (study and control) were created. Socio-demographic data (including mother’s age, educational status, and smoking habits of parents) and medical history of the baby (including gender, birth weight, mode of delivery, time of the onset breastfeeding after birth, and nutrition style) were collected. The Infant Colic Scale (ICS) was used to estimate the colic severity in the infants. Reflexology was applied to the study group by the researcher and their mother 2 days a week for 3 weeks. The babies in the control group did not receive reflexology. Assessments were performed before and after the intervention in both groups.

The results show that the two groups were similar regarding socio-demographic background and medical history. While there was no difference between the groups in ICS scores before application of reflexology, the mean ICS score of the study group was significantly lower than that of control group at the end of the intervention.

The authors concluded that reflexology application for babies suffering from infantile colic may be a promising method to alleviate colic severity.

The authors seem to attribute the outcome to specific effects of reflexology.

However, they are mistaken!

Why?

Because their study does not control for the non-specific effects of the intervention.

Reflexology has not been shown to work for anything (“the best clinical evidence does not demonstrate convincingly reflexology to be an effective treatment for any medical condition“), and there is plenty of evidence to show that holding the baby, massaging it, cuddling it, rocking it or doing just about anything with it will have an effect, e. g.:

This trial of massage treatment for infantile colic showed statistically significant or clinically relevant effect in comparison with the rocking group.

The majority of the included trials appeared to indicate that the parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not…

…kangaroo care for infants with colic is a promising intervention…

I think, in a way, this is rather good news; we do not need to believe in the hocus-pocus of reflexology in order to help our crying infants.

Amongst all the implausible treatments to be found under the umbrella of ‘alternative medicine’, Reiki might be one of the worst, i. e. least plausible and outright bizarre (see for instance here, here and here). But this has never stopped enthusiasts from playing scientists and conducting some more pseudo-science.

This new study examined the immediate symptom relief from a single reiki or massage session in a hospitalized population at a rural academic medical centre. It was designed as a retrospective analysis of prospectively collected data on demographic, clinical, process, and quality of life for hospitalized patients receiving massage therapy or reiki. Hospitalized patients requesting or referred to the healing arts team received either a massage or reiki session and completed pre- and post-therapy symptom questionnaires. Differences between pre- and post-sessions in pain, nausea, fatigue, anxiety, depression, and overall well-being were recorded using an 11-point Likert scale.

Patients reported symptom relief with both reiki and massage therapy. Reiki improved fatigue and anxiety  more than massage. Pain, nausea, depression, and well being changes were not different between reiki and massage encounters. Immediate symptom relief was similar for cancer and non-cancer patients for both reiki and massage therapy and did not vary based on age, gender, length of session, and baseline symptoms.

The authors concluded that reiki and massage clinically provide similar improvements in pain, nausea, fatigue, anxiety, depression, and overall well-being while reiki improved fatigue and anxiety more than massage therapy in a heterogeneous hospitalized patient population. Controlled trials should be considered to validate the data.

Don’t I just adore this little addendum to the conclusions, “controlled trials should be considered to validate the data” ?

The thing is, there is nothing to validate here!

The outcomes are not due to the specific effects of Reiki or massage; they are almost certainly caused by:

  • the extra attention,
  • the expectation of patients,
  • the verbal or non-verbal suggestions of the therapists,
  • the regression towards the mean,
  • the natural history of the condition,
  • the concomitant therapies administered in parallel,
  • the placebo effect,
  • social desirability.

Such pseudo-research only can only serve one purpose: to mislead (some of) us into thinking that treatments such as Reiki might work.

What journal would be so utterly devoid of critical analysis to publish such unethical nonsense?

Ahh … it’s our old friend the Journal of Alternative and Complementary Medicine

Say no more!

Reiki is a Japanese technique administered by “laying on hands” and is based on the idea that an unseen “life force energy” flows through us and is what causes us to be alive. If one’s “life force energy” is low, then we are more likely to get sick or feel stress, and if it is high, we are more capable of being happy and healthy (because it is such a clear-cut case of nonsense, we have discussed Reiki regularly; see for instance here, here, here, here, here, here, and here).

But nonsense does not stop researchers from conducting trials. In this new clinical trial, conducted in Physiotherapy Clinic of Khatam Al-Anbia Hospital in Iran, 60 patients with pain due to inter-vertebral disc herniation (IVDH) were randomly assigned to one of three groups.

  1. The Reiki group received three 15-minute Reiki sessions on consecutive days by a master of Reiki plus Indomethacin and Methocarbamol (as in group 3).
  2. The physiotherapy group underwent 7 to 10 sessions of physiotherapy of 60 to 90 minutes (heat therapy, TENS, pelvic traction, and physical exercises) plus Indomethacin and Methocarbamol (as in group 3).
  3. The drug group received Indomethacin capsules 75 mg and Methocarbamol tablets 500 mg every 8 hours daily for one week.

The severity of pain and the activities of daily living (ADL) were measured using visual analogue scales (VAS) and ADL-Instrumental ADL questionnaire before and after the intervention. A significant difference was found in pain intensity and ADL improvement between Reiki and the drug therapy. No significant difference between the Reiki and physiotherapy groups were noted.

The authors concluded that Reiki and physiotherapy are effective methods in managing pain and improving ADL in patients with IVDH; however, Reiki is more cost-effective and faster treatment method than physiotherapy.

This RCT seems fairly well-panned and conducted, and its results are straight forward. My only problem with it is how the findings are interpreted.

The study design was such that there was no blinding or control for placebo effects. Therefore, the observed outcomes can be interpreted in more than one way. In my view, by far the most plausible explanation is that Reiki (being an exotic, impressive intervention that generates plenty of expectation) produced a powerful placebo effect. Physiotherapy (being entirely normal and routine), on the other hand, was only marginally successful. It is regrettable that the authors do not even consider this interpretation of their results. They should have remembered that a clinical trial test the null-hypothesis (the experimental treatment is not better that the comparator) which can be rejected only, if there is no other reasonable explanation for the results produced.

If I am correct, the conclusions should be re-written as follows:

The addition of Reiki to drug treatment generated better outcomes than drug therapy alone. Physiotherapy was only marginally effective. The effects of Reiki are most likely not due to the treatment per se but to a classical placebo response.

An article in yesterday’ Times makes the surprising claim that ‘doctors turn to herbal cures when the drugs don’t work’. As the subject is undoubtedly relevant to this blog and as the Times is a highly respected newspaper, I think this might be important and will therefore comment (in normal print) on the full text of the article (in bold print):

GPs are increasingly dissatisfied with doling out pills that do not work for illnesses with social and emotional roots, and a surprising number of them end up turning to alternative medicine.

What a sentence! I would have thought that GPs have always been ‘dissatisfied’ with treatments that are ineffective. But who says they turn to alternative medicine in ‘surprising numbers’ (our own survey does not confirm the notion)? And what is a ‘surprising number’ anyway (zero would be surprising, in my view)?

Charlotte Mendes da Costa is unusual in being both an NHS GP and a registered homeopath. Her frustration with the conventional approach of matching a medicine to a symptom is growing as doctors increasingly see the limits, and the risks, of such a tactic.

Do we get the impression that THE TIMES does not know that homeopathy is not herbal medicine? Do they know that ‘matching a medicine to a symptom’ is what homeopaths believe they are doing? Real doctors try to find the cause of a symptom and, whenever possible, treat it.

She asks patients with sore throats questions that few other GPs pose: “What side is it? Is it easier to swallow solids or liquids? What time of day is it worst?” Dr Mendes da Costa is trying to find out which homeopathic remedy to prescribe. But when NHS guidance for sore throats aims mainly to convince patients that they will get better on their own, her questions are just as important as her prescription.

This section makes no sense. Sore throats do get better on their own, that’s a fact. And empathy is not a monopoly of homeopaths. But Dr Mendes Da Costa might be somewhat detached from reality; she once promoted the nonsensical notion that “up to the end of 2010, 156 randomised controlled trials (RCTs) in homeopathy had been carried out with 41% reporting positive effects, whereas only 7% have been negative. The remainder were non-conclusive.” (see more on this particular issue here)

“It’s very difficult to disentangle the effect of listening to someone properly, in a non-judgmental way, and taking a real rather than a superficial interest,” she says. “With a sore throat [I was trained] really only to be interested in, ‘Do they need antibiotics or not?’ ”

In this case, she should ask her money back; her medical school seems to have been rubbish in training her adequately.

This week a Lancet series on back pain said that millions of patients were getting treatments that did them no good. A government review is looking into how one in 11 people has come to be on potentially addictive drugs such as tranquillisers, opioid painkillers and antidepressants.

Yes, and how is that an argument for homeopathy? It isn’t! It seems to come from the textbook of fallacies.

And this week a BMJ Open study found that GPs with alternative training prescribed a fifth fewer antibiotics.

That study was akin to showing that butchers sell less vegetables than green-grocers. It provided no argument at all for implying that homeopathy is a valuable therapy.

Doctors seem receptive to alternative approaches: in a poll on its website 70 per cent agreed that doctors should recommend acupuncture to patients in pain. The Faculty of Homeopathy now counts 400 doctors among its 700 healthcare professional members.

Wow! Does the Times journalist know that the ‘Faculty of Homeopathy’ is primarily an organisation for doctor homeopaths? If so, why are these figures anything to write home about? And does the author appreciate that the pole was open not just to doctors but to to anyone (particularly those who were motivated, like acupuncturists)?

This horrifies many academics, who say that there is almost no evidence that complementary therapies work.

It horrifies nobody, I’d say. It puzzles some people, and not just academics. And their claim of a lack of sound evidence is evidence-based.

“It’s a false battle”, says Michael Dixon, a GP who chairs the College of Medicine, which is trying to broaden the focus on treatment to patients’ whole lives. “GPs are practical. If a patient gets better that’s all that matters.”

Here comes the inevitable Dr Dixon (the ‘pyromaniac in a field of straw-men’) with the oldest chestnut in town. But repeating a nonsense endlessly does not render it sensible.

Dr Dixon says there are enormous areas of illness ranging from chronic pain to irritable bowels where few conventional treatments have been shown to be particularly effective, so why not try alternatives with fewer side effects?

Unable to diagnose and treat adequately, let’s all do the next worst thing and apply some outright quackery?!? Logic does not seem to be Dixon’s strong point, does it?

He recommends herbal remedies such as pelargonium — “like a geranium, quite a pretty little flower” — acupressure, and techniques such as self-hypnosis. To those who say these are placebos he replies: so what?

So what indeed! There are over 200 species of pelargonium; only 2 or 3 of them are used in herbal medicine. I don’t suppose Dr Dixon wants to poison us?

“Aromatherapy does work, but only if you believe in it, that’s the way you have to look at it, like a mother kissing knees better.” He continues: “We are healers. That’s what we do as doctors. You can call it theatrical or you can call it a relationship. A lot of patients come in with a metaphor — a headache is actually unhappiness — and the treatment is symbolic.”

It frightens me to know that there are doctors out there who think like this!

What if a patient is seriously ill?

A cancer is a metaphor for what exactly?

As doctors, we have the ethical duty to apply BOTH the science and the art of medicine, BOTH efficacious, evidence-based therapies AND compassion. Can I be so bold as to recommend our book about the ethics of alternative medicine to Dixon?

Such talk makes conventional doctors very nervous. Yet acupuncture illustrates their dilemma. It used to be recommended by the NHS for back pain because patients did improve. Now it is not, after further evidence suggested that patients given placebo “sham acupuncture” did just as well.

No, acupuncture used to be recommended by NICE because there was some evidence; when subsequently more rigorous trials emerged showing that it does NOT work, NICE stopped recommending it. Real medicine develops – it’s only alternative medicine and its proponents that seem to be stuck in the past and resist progress.

Martin Underwood, of the University of Warwick, asks: “So are you going to say, ‘Well, patients get better than they would do otherwise’? Or say it’s all theatrical placebo because it shows no benefit over sham treatment? That’s the question for society.”

Society has long answered it! The answer is called evidence-based medicine. We are not content using quackery for its placebo response; we know that effective treatments do that too, and we want to make progress and improve healthcare of tomorrow.

Although many doctors agree that they need to look at patients more broadly, they insist they do not need to turn to unproven treatments. The magic ingredient, they say, is not an alternative remedy, but time. Helen Stokes-Lampard, chairwoman of the Royal College of GPs, said: “Practices which offer alternative therapies tend to spend longer with patients . . . allowing for more in-depth conversations.”


I am sorry, if this post turned into a bit of a lengthy rant. But it was needed, I think: if there ever was a poorly written, ill focussed, badly researched and badly argued article on alternative medicine, it must be this one.

Did I call the Times a highly respected paper?

I take it back.

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