MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

causation

Chiropractors and osteopaths have long tried to convince us that spinal manipulation and mobilisation are the best we can do when suffering from neck pain. But is this claim based on good evidence?

This recent update of a Cochrane review was aimed at assessing the effects of manipulation or mobilisation alone compared with those of an inactive control or another active treatment on pain, function, disability, patient satisfaction, quality of life and global perceived effect in adults experiencing neck pain with or without radicular symptoms and cervicogenic headache (CGH) at immediate- to long-term follow-up, and when appropriate, to assess the influence of treatment characteristics (i.e. technique, dosage), methodological quality, symptom duration and subtypes of neck disorder on treatment outcomes.

Review authors searched the following computerised databases to November 2014 to identify additional studies: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). They also searched ClinicalTrials.gov, checked references, searched citations and contacted study authors to find relevant studies.

Randomised controlled trials (RCTs) undertaken to assess whether manipulation or mobilisation improves clinical outcomes for adults with acute/subacute/chronic neck pain were included in this assessment.

Two review authors independently selected studies, abstracted data, assessed risk of bias and applied Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methods (very low, low, moderate, high quality). The authors calculated pooled risk ratios (RRs) and standardised mean differences (SMDs).

Fifty-one trials with a total of 2920 participants could be included. The findings are diverse. Cervical manipulation versus inactive control: For subacute and chronic neck pain, a single manipulation (three trials, no meta-analysis, 154 participants, ranged from very low to low quality) relieved pain at immediate- but not short-term follow-up. Cervical manipulation versus another active treatment: For acute and chronic neck pain, multiple sessions of cervical manipulation (two trials, 446 participants, ranged from moderate to high quality) produced similar changes in pain, function, quality of life (QoL), global perceived effect (GPE) and patient satisfaction when compared with multiple sessions of cervical mobilisation at immediate-, short- and intermediate-term follow-up. For acute and subacute neck pain, multiple sessions of cervical manipulation were more effective than certain medications in improving pain and function at immediate- (one trial, 182 participants, moderate quality) and long-term follow-up (one trial, 181 participants, moderate quality). These findings are consistent for function at intermediate-term follow-up (one trial, 182 participants, moderate quality). For chronic CGH, multiple sessions of cervical manipulation (two trials, 125 participants, low quality) may be more effective than massage in improving pain and function at short/intermediate-term follow-up. Multiple sessions of cervical manipulation (one trial, 65 participants, very low quality) may be favoured over transcutaneous electrical nerve stimulation (TENS) for pain reduction at short-term follow-up. For acute neck pain, multiple sessions of cervical manipulation (one trial, 20 participants, very low quality) may be more effective than thoracic manipulation in improving pain and function at short/intermediate-term follow-up. Thoracic manipulation versus inactive control: Three trials (150 participants) using a single session were assessed at immediate-, short- and intermediate-term follow-up. At short-term follow-up, manipulation improved pain in participants with acute and subacute neck pain (five trials, 346 participants, moderate quality, pooled SMD -1.26, 95% confidence interval (CI) -1.86 to -0.66) and improved function (four trials, 258 participants, moderate quality, pooled SMD -1.40, 95% CI -2.24 to -0.55) in participants with acute and chronic neck pain. A funnel plot of these data suggests publication bias. These findings were consistent at intermediate follow-up for pain/function/quality of life (one trial, 111 participants, low quality). Thoracic manipulation versus another active treatment: No studies provided sufficient data for statistical analyses. A single session of thoracic manipulation (one trial, 100 participants, moderate quality) was comparable with thoracic mobilisation for pain relief at immediate-term follow-up for chronic neck pain. Mobilisation versus inactive control: Mobilisation as a stand-alone intervention (two trials, 57 participants, ranged from very low to low quality) may not reduce pain more than an inactive control. Mobilisation versus another active treatment: For acute and subacute neck pain, anterior-posterior mobilisation (one trial, 95 participants, very low quality) may favour pain reduction over rotatory or transverse mobilisations at immediate-term follow-up. For chronic CGH with temporomandibular joint (TMJ) dysfunction, multiple sessions of TMJ manual therapy (one trial, 38 participants, very low quality) may be more effective than cervical mobilisation in improving pain/function at immediate- and intermediate-term follow-up. For subacute and chronic neck pain, cervical mobilisation alone (four trials, 165 participants, ranged from low to very low quality) may not be different from ultrasound, TENS, acupuncture and massage in improving pain, function, QoL and participant satisfaction at immediate- and intermediate-term follow-up. Additionally, combining laser with manipulation may be superior to using manipulation or laser alone (one trial, 56 participants, very low quality).

Confused? So am I!

In my view, these analyses show that the quality of most studies is wanting and the evidence is weak – much weaker than chiropractors and osteopaths try to make us believe. It seems to me that no truly effective treatments for neck pain have been discovered and that therefore manipulation/mobilisation techniques are as good or as bad as most other options.

In such a situation, it might be prudent to first investigate the causes of neck pain in greater detail  and subsequently determine the optimal therapies for each of them. Neck pain is a SYMPTOM, not a disease! And it is always best to treat the cause of a symptom rather than pretending we know the cause as chiropractors and osteopaths often do.

The authors of the Cochrane review seem to agree with this view at least to some extent. They conclude that although support can be found for use of thoracic manipulation versus control for neck pain, function and QoL, results for cervical manipulation and mobilisation versus control are few and diverse. Publication bias cannot be ruled out. Research designed to protect against various biases is needed. Findings suggest that manipulation and mobilisation present similar results for every outcome at immediate/short/intermediate-term follow-up. Multiple cervical manipulation sessions may provide better pain relief and functional improvement than certain medications at immediate/intermediate/long-term follow-up. Since the risk of rare but serious adverse events for manipulation exists, further high-quality research focusing on mobilisation and comparing mobilisation or manipulation versus other treatment options is needed to guide clinicians in their optimal treatment choices.

The call for further research is, of course, of no help for patients who are suffering from neck pain today. What would I recommend to them?

My advice is to be cautious:

  • Consult your doctor and try to get a detailed diagnosis.
  • See a physiotherapist and ask to be shown exercises aimed at reducing the pain and preventing future episodes.
  • Do these exercises regularly, even when you have no pain.
  • Make sure you do whatever else might be needed in terms of life-style changes (ergonomic work place, correct sleeping arrangements, etc.).
  • If you are keen on seeing an alternative practitioner for manual therapy, consult a osteopath rather than a chiropractor; the former tend to employ techniques which are less risky than the latter.
  • Avoid both chiropractors and long-term medication for neck pain.

The authors of a recent paper inform us that Reiki is a Japanese system of energy healing that has been used for over 2 500 years. It involves the transfer of energy from the practitioner to the receiver, which promotes healing, and can be done by either contact or non-contact methods. Both the receiver and the practitioner may feel the energy in various forms (warmth, cold, tingling, vibration, pulsations and/or floating sensations). Reiki can also be self-administered if one is a Reiki practitioner. Reiki is mainly used to address stress, anxiety, and pain reduction while also promoting a sense of well-being and improving quality of life.

Such statements should make us weary: what is presented here as fact is nothing more than conjecture – and very, very implausible conjecture too. Anyone who writes stuff like this in the introduction of a scientific paper is, in my view, unlikely to be objective and could be well on the way to present some nasty piece of pseudo-science.

But I am, of course, pre-judging the issue; let’s have a quick look at the article itself.

The purpose of this study was to determine the effects of a 20-week structured self-Reiki program on stress reduction and relaxation in college students. Students were recruited from Stockton University and sessions were conducted in the privacy of their residence. Twenty students completed the entire study consisting of 20 weeks of self-Reiki done twice weekly. Each participant completed a Reiki Baseline Credibility Scale, a Reiki Expectancy Scale, and a Perceived Stress Scale (PSS) after acceptance into the study. The PSS was completed every four weeks once the interventions were initiated. A global assessment questionnaire was completed at the end of the study. Logs summarizing the outcome of each session were submitted at the end of the study.

With the exception of three participants, participants believed that Reiki is a credible technique for reducing stress levels. Except for two participants, participants agreed that Reiki would be effective in reducing stress levels. All participants experienced stress within the month prior to completing the initial PSS. There was a significant reduction in stress levels from pre-study to post-study. There was a correlation between self-rating of improvement and final PSS scores. With one exception, stress levels at 20 weeks did not return to pre-study stress levels.

The authors concluded that this study supports the hypothesis that the calming effect of Reiki may be achieved through the use of self-Reiki.

QED – my suspicions were fully confirmed. This study shows precisely nothing, and it certainly does not support any hypothesis regarding Reiki.

If we recruited 20 volunteers who were sufficiently gullible to believe that watching an ice-cube slowly melting in the kitchen sink, or anything else that we can think of, has profound effects on their vital energy, or chi, or karma, or anything else, we would almost certaily generate similar results.

My conclusion is therefore very different from those of the original authors: THIS STUDY SUPPORTS THE HYPOTHESIS THAT GULLIBLE PEOPLE CAN BE EASILY MISLEAD ABOUT BOGUS THERAPIES WITH PSEUDO-SCIENTIFIC STUDIES BY IRRESPONSIBLE WOULD-BE SCIENTISTS.

One of the most common claims of alternative practitioners is that they take a holistic approach to health care. And it is this claim which attracts many consumers. It also makes conventional medicine look bad, reductionist and inhuman, as it implies that mainstream medicine is non-holistic.

The claim can be easily disclosed to be a straw man, because all good medicine was, is and always will be holistic. Moreover, the claim amounts to a falsehood, because much of alternative medicine is everything but holistic. I will try to explain what I mean using the recent example of acupuncture for neck pain, but I could have used almost any other alternative treatment and any other human complaint/condition/disease:

  • chiropractic for back pain;
  • homeopathy for asthma;
  • energy healing for depression;
  • aromatherapy for jet lag;
  • etc. etc.

The recent trial found that adding acupuncture to usual care yields a slightly better outcome than usual care alone. This is hardly a big deal; adding a good cup of tea and a compassionate chat to usual care might have done a similar thing. Acupuncturists, however, will say that their holistic approach is successful.

How holistic is acupuncture?

A ‘Western’ acupuncturist would normally ask what is wrong with the patient; in the case of neck pain, he would probably ask several further questions about the history of the condition, when the pain occurs, what aggravates it etc. Then he might conduct a physical examination of his patient. Eventually, he would get out his needles and start the treatment.

A ‘traditional’ acupuncturist would ask similar questions, feel the pulse, look at the tongue and make a diagnosis in terms of yin and yang imbalance. Eventually, he too would get out his needles and start the treatment.

Is that holistic?

Certainly not! If we look at alternative practitioners in general, we cannot fail to notice that they tend to be the very opposite of holistic. They usually attribute a patients illness to one single cause such as yin/yang imbalance (acupuncture), subluxation (chiropractic), impediment of the life force (homeopathy), etc.

Holistic means that the patient is understood as a whole person. Our neck pain patient might have physical problems such as muscular tension; the acupuncturists might well have realised this and placed their needles accordingly. But neck pain, like most other symptoms, can have many other dimensions:

  • there could be stress;
  • there could be an ergonomically disadvantageous work place;
  • there could be a history of injury;
  • there could be a malformation of the spine;
  • there could be a tumour;
  • there could be an inflammation;
  • there could be many other specific diseases;
  • there could be relationship problems, et. etc.

Of course, the acupuncturists will claim that, during an acupuncture session, they will pick up on all of these. However, in my experience, this is little more than wishful thinking. And even if they did pick up other dimensions of the patient’s complaint, what can they do about it? They can (and often do) give rather amateur advice. This may be meant most kindly but it is rarely optimal.

And what about conventional practitioners, aren’t they even worse?

True, there often is far too much room for improvement. But at least the concept of multifactorial conditions and treatments is deeply ingrained in everyone who has been to medical school. We learn that symptoms/complaints/conditions/diseases are almost invariably multifactorial; they have many causes and contributing factors which can interact in complex ways. Therefore, responsible physicians always consider to treat patients in multifactorial ways; in the case of our neck pain patient:

  • the stress might need a relaxation programme,
  • the work place might need the input of an occupational therapist;
  • in case of an old injury, a physio might be needed;
  • specific conditions might need to be seen by a range of medical specialists;
  • muscular tension could be reduced by a massage therapist;
  • relationship problems might require the help of a psychologist; etc. etc.

I am NOT saying that all of this is necessary in each and every case. But I am saying that, in conventional medicine, both the awareness and the possibility for a professional multidisciplinary approach is well established. You don’t believe me? Ask a physiotherapist or an occupational therapist who refers more patients to them, an acupuncturist or a GP!

Alternative practitioners claim to be holistic and some might even be aware of the complexity of their patients’ symptoms. But, at best, they have an amateur approach to this complexity by dabbling themselves in issuing more or less suited advice. They are not adequately trained to do this job, and they refer very rarely.

My conclusion: professional multidiscipinarity is an approach deeply engrained in conventional medicine (we don’t often call it holism, perhaps because many doctors associate this term with charlatans), and it beats the mostly amateurish pseudo-holism of alternative practitioners any time.

The aim of this study was to evaluate clinical effectiveness of Alexander Technique lessons or acupuncture versus usual care for persons with chronic, nonspecific neck pain.

Patients with neck pain lasting at least 3 months, a score of at least 28% on the Northwick Park Questionnaire (NPQ) for neck pain and associated disability, and no serious underlying pathology were randomised to receive 12 acupuncture sessions or 20 one-to-one Alexander lessons (both 600 minutes total) plus usual care versus usual care alone. The NPQ score at 0, 3, 6, and 12 months (primary end point) and Chronic Pain Self-Efficacy Scale score, quality of life, and adverse events (secondary outcomes) served as outcome measures. 517 patients were recruited. Their median duration of neck pain was 6 years. Mean attendance was 10 acupuncture sessions and 14 Alexander lessons. Between-group reductions in NPQ score at 12 months versus usual care were 3.92 percentage points for acupuncture (95% CI, 0.97 to 6.87 percentage points) (P = 0.009) and 3.79 percentage points for Alexander lessons (CI, 0.91 to 6.66 percentage points) (P = 0.010). The 12-month reductions in NPQ score from baseline were 32% for acupuncture and 31% for Alexander lessons. Participant self-efficacy improved for both interventions versus usual care at 6 months (P < 0.001) and was significantly associated (P < 0.001) with 12-month NPQ score reductions (acupuncture, 3.34 percentage points [CI, 2.31 to 4.38 percentage points]; Alexander lessons, 3.33 percentage points [CI, 2.22 to 4.44 percentage points]). No reported serious adverse events were considered probably or definitely related to either intervention.

The authors drew the following conclusions: acupuncture sessions and Alexander Technique lessons both led to significant reductions in neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained.

Where to begin? There is much to be criticised about this study!

For starters, the conclusions are factually wrong. They should read “acupuncture sessions plus usual care and Alexander Technique lessons plus usual care both led to significant reductions in neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained.

On this blog, we have repeatedly discussed the ‘A+B versus B’ study design and the fact that it cannot provide information about cause and effect because it fails to control for placebo effects and the extra attention, time and empathy (for instance here and here). I suspect that this is the reason why it is so very popular in alternative medicine. It can make ineffective therapies appear to be effective.

Another point is a more clinical concern. Neck pain is not a disease, it is a symptom. In medicine we should, whenever possible, try to treat the cause of the underlying condition and not the symptom. Acupuncture is at best a symptomatic treatment. Usual care is often not very effective because we normally fail to see the cause of neck pain. In my view, alternative treatments should either be tested against placebo or sham interventions or against optimal care.

What is optimal care for nonspecific neck pain? As its causes are often unclear and usually multifactorial, the optimal treatment needs to be multifactorial (one could also call it holistic) as well. The causes often range from poor ergometric conditions at work to muscular tension, stress, psychological problems etc. Thus optimal care would be a team work tailor-made for each patient possibly including physiotherapists, pain specialists, clinical psychologists, orthopaedic surgeons etc.

My points here are:

  • neither acupuncture nor Alexander technique take account of this complexity,
  • they claim to be holistic but, in fact, this turns out to be merely a good sales-slogan,
  • usual care is usually no good,
  • if pragmatic trials using the ‘A+B versus B’ design make any sense at all, they should employ not usual care but optimal care for the control group.

In the end, we are left with a study that looks fairly rigorous at first sight, but that really tells us next to nothing (except that dedicating 600 minutes to patients in pain is not without effect). I am truly surprised that a top journal like the Annals of Internal Medicine decided to publish it.

Alternative medicine (AM) use has become popular among patients with cancer. I find this very easy to understand: faced with such a grave diagnosis, who would not be tempted to try everything that is being promoted as being helpful. And, by Jove, promoted it is! But does it do any good?

The evidence clearly shows that no form of AM is capable of changing the natural history of any form of cancer. This means the millions of websites that imply otherwise are criminally wrong and frightfully dangerous.

But some AMs might still be useful, namely for improving symptoms, well-being and quality of life (QOL) as supportive or palliative therapies. Unfortunately the evidence for this assumption is less sound than AM fans try to make us believe. Before this background, better research is needed and more trials would be welcome. A brand-new paper might tell us more.

The purposes of this study were to compare the QOL in CAM users and non-CAM users and to determine whether AM use influences QOL among breast cancer patients during chemotherapy.

A cross-sectional survey was conducted at two outpatient chemotherapy centers. A total of 546 patients completed the questionnaires on AM use. QOL was evaluated based on the European Organization for Research and Treatment of Cancer (EORTC) core quality of life (QLQ-C30) and breast cancer-specific quality of life (QLQ-BR23) questionnaires.

A total of 70.7% of patients were identified as AM users. There was no significant difference in global health status scores and in all 5 subscales of the QLQ C30 functional scales between AM users and non-AM users. On the QLQ-C30 symptom scales, AM users (44.96±3.89) had significantly (p = 0.01) higher mean scores for financial difficulties than non-AM users (36.29±4.81). On the QLQ-BR23 functional scales, AM users reported significantly higher mean scores for sexual enjoyment (6.01±12.84 vs. 4.64±12.76, p = 0.04) than non-AM users. On the QLQ-BR23 symptom scales, AM users reported higher systemic therapy side effects (41.34±2.01 vs. 37.22±2.48, p = 0.04) and breast symptoms (15.76±2.13 vs. 11.08±2.62, p = 0.02) than non-AM users. Multivariate logistic regression analysis indicated that the use of CAM modality was not significantly associated with higher global health status scores (p = 0.71).

The authors drew the following conclusions: While the findings indicated that there was no significant difference between users and non-users of AM in terms of QOL, AM may be used by health professionals as a surrogate to monitor patients with higher systemic therapy side effects and breast symptoms. Furthermore, given that AM users reported higher financial burdens (which may have contributed to increased distress), patients should be encouraged to discuss the potential benefits and/or disadvantages of using AM with their healthcare providers.

One needs to caution, of course, that this was not an RCT, and therefore cause and effect cannot be taken for granted. Nevertheless, I believe, that these findings should make us think critically about the wide-spread notion that the supportive and palliative use of AM leads to an improvement of QOL in cancer patients.

An Indian chain of homeopathic clinics, Dr Batra’s, has just opened its first branch in London. The new website is impressive. It claims homeopathy is effective for the following conditions:

Hair loss? Are they serious? Have they not seen pictures of Samuel Hahnemann?

I decided to look into the psoriasis claim a little closer. This is what they state regarding the homeopathic treatment of psoriasis:

Research-based evidences speak clear and loud of the success of homeopathy in treating psoriasis.

A study published in the Journal of the European Academy of Dermatology and Venereology, a conventional medical Journal, showed that psoriasis patients experienced significant improvement in their quality of life and reduction in their psoriasis symptoms with homeopathy. And this was without any kind of side-effects whatsoever. Of the 82 patients involved in the study that went on for 2 years, many had suffered psoriasis for as long as 15 years and had previously unsuccessfully tried conventional treatments.

At Dr. Batra’s we have successfully treated more than 25,000 cases of psoriasis with homeopathy over the last 35 years. Our safe and scientific solutions have brought smiles to many suffering patients of psoriasis. In fact, a study conducted by A.C. Nielson showed that as compared to general practitioners, specialists and local homeopaths, a higher than average improvement is seen at Dr. Batra’s in treatment of skin ailments.

To the reader who does not look deeper, this may sound fairly convincing. Sadly, it is not. The first study cited above was an uncontrolled trial. Here is its abstract:

Design Prospective multicentre observational study. Objective To evaluate details and effects of homeopathic treatment in patients with psoriasis in usual medical care. Methods Primary care patients were evaluated over 2 years using standardized questionnaires, recording diagnoses and complaints severity, health-related quality of life (QoL), medical history, consultations, all treatments, and use of other health services. Results Forty-five physicians treated 82 adults, 51.2% women, aged 41.6 +/- 12.2 (mean +/- SD) years. Patients had psoriasis for 14.7 +/- 11.9 years; 96.3% had been treated before. Initial case taking took 127 +/- 47 min. The 7.4 +/- 7.4 subsequent consultations (duration: 19.4 +/- 10.5 min) cumulated to 169.0 +/- 138.8 min. Patients received 6.0 +/- 4.9 homeopathic prescriptions. Diagnoses and complaints severity improved markedly with large effect sizes (Cohen’s d= 1.02-2.09). In addition, QoL improved (SF-36 physical component score d = 0.26, mental component score d = 0.49), while conventional treatment and health service use were considerably reduced. Conclusions Under classical homeopathic treatment, patients with psoriasis improved in symptoms and QoL.

It is clear that, due to the lack of a control group, no causal inference can be made between the treatment and the outcome. To claim that otherwise is in my view bogus.

I should mention that there is not a single controlled clinical trial of homeopathy for psoriasis that would support the claim that it is effective.

The second study is not listed in Medline. In fact, the only publication of an author by the name of ‘A C Nielson’ is entitled ‘Are men more intuitive when it comes to eating and physical activity?’. Until I see the evidence, I very much doubt that the study cited above produced strong evidence that homeopathy is an effective cure for psoriasis.

Dr Batra’s chain of clinics boasts to provide the best quality and the highest standards of services that percolate down to all levels in an organisation. Everyone in the institute and those associated with it strive for excellence in whatever they do. Measuring the degree of customer satisfaction was the fundamental concept on which this homeopathic institute’s commitment to become a patient-driven institution was built. 

Nice words! SHAME THAT THEY HAVE DECIDED TO DILUTE THEIR TRUTH HOMEOPATHICALLY!

Anthroposophic medicine is based on Rudolf Steiner’s mystical ideas. It is popular in Germany and is slowly also spreading to other countries.  Anthroposophic drugs are prepared according to ancient notions of alchemy and are fly in the face of modern pharmacology. Anthroposophic doctors treat all sorts of diseases, and their treatments  include anthroposophic medications, and a range of other modalities.

A recent paper reported a secondary analysis from an observational study of 529 children with respiratory or ear infections (RTI/OM) <18 years from Europe and the USA. Their caregivers had chosen to consult physicians offering either anthroposophic (A-) or conventional (C-) treatment for RTI/OM.

During the 28-day follow-up antibiotics were prescribed to 5.5% of A-patients and 25.6% of C-patients (P < 0.001); the unadjusted odds ratio for non-prescription in A- versus C-patients was 6.58 (95%-CI 3.45-12.56); after adjustment for demographics and morbidity it was 6.33 (3.17-12.64). Antibiotic prescription rates in recent observational studies with similar patients in similar settings, ranged from 31.0% to 84.1%. Compared to C-patients, A-patients also had much lower use of analgesics, somewhat quicker symptom resolution, and higher caregiver satisfaction. Adverse drug reactions were infrequent (2.3% in both groups) and not serious.

What can we conclude from these data?

Not a lot, I fear!

The authors of the study are a little more optimistic than I; they conclude that this analysis from a prospective observational study under routine primary care conditions showed a very low use of antibiotics and analgesics/antipyretics in children treated for RTI/OM by physicians offering AM therapy, compared to current practice in conventional therapy settings (antibiotics prescribed to 5% versus 26% of A- and C-patients, respectively, during days 0–28; antipyretics prescribed to 3% versus 26%). The AM treatment entailed no safety problem and was not associated with delayed short-term recovery. These differences could not explained by differences in demographics or baseline morbidity. The low antibiotic use is consistent with findings from other studies of paediatric RTI/OM in AM settings.

They are clearly careful to avoid causal inferences; but are they implying them? I would like to know what you think.

 

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.

When I come across a study with the aim to “examine the effectiveness of acupuncture to relieve symptoms commonly observed in patients in a hospice program” my hopes are high. When I then see that its authors are from the ‘New England School of Acupuncture’, the ‘All Care Hospice and the ‘Tufts University School of Medicine, Boston, my hopes for a good piece of science are even higher. So, let’s see what this new paper has to offer.

A total of 26 patients participated in this acupuncture ‘trial’, receiving a course of weekly treatments that ranged from 1 to 14 weeks. The average number of treatments was five. The Edmonton Symptom Assessment Scale (ESAS) was used to assess the severity of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and dyspnoea. A two-tailed, paired t test was applied to the data to compare symptom scores pre- versus post-acupuncture treatment. Patients enrolled in All Care Hospice’s home care program were given the option to receive acupuncture to supplement usual care offered by the hospice team. Treatment was provided by licensed acupuncturists in the patient’s place of residence.

The results indicated that 7 out of 9 symptoms were significantly improved with acupuncture, the exceptions being drowsiness and appetite. Although the ESAS scale demonstrated a reduction in symptom severity post-treatment for both drowsiness and appetite, this reduction was not found to be significant.

At tis stage, I have lost most of my hopes for good science. This is not a ‘trial’ but a glorified case-series. There is no way that the stated aim can be pursued with this type of methodology. There is no reason whatsoever to assume that the observed outcome can be attributed to acupuncture; the additional attention given to these patients is but one of several factors that are quite sufficient to explain their symptomatic improvements.

This is yet another disappointment then from the plethora of ‘research’ into alternative medicine that, on closer inspection, turns out to be little more than thinly disguised promotion of quackery. These days, I can bear such disappointments quite well – after all, I had many years to get used to them. What I find more difficult to endure is the anger that overcomes me when I read the authors’ conclusion: Acupuncture was found to be effective for the reduction and relief of symptoms that commonly affect patient QOL. Acupuncture effectively reduced symptoms of pain, tiredness, nausea, depression, anxiety, and shortness of breath, and enhanced feelings of well-being. More research is required to assess the long-term benefits and symptom reduction of acupuncture in a palliative care setting.

This is not disappointing; in my view, this is scientific misconduct by

  • the authors,
  • the institutions employing the authors,
  • the ethics committee that has passed the ‘research’,
  • the sponsors of the ‘research’,
  • the peer-reviewers of the paper,
  • the journal and its editors responsible for publishing this paper.

The fact that this sort of thing happens virtually every day in the realm of alternative medicine does not render this case less scandalous, it merely makes it more upsetting.

A new RCT of Reiki healing has been published by US authors from the following institutions: Union Institute & University, Psychology Program, Brattleboro, VT, Coyote Institute, Augusta and Bangor, ME, Eastern Maine Medical Center and Acadia Hospital, Bangor, ME, University of New England College of Osteopathic Medicine, Biddeford, ME, Coyote Institute, Orono, ME. The purpose of this study was to determine if 30 minutes of healing touch could reduce burnout in community mental health clinicians.

The authors utilized a crossover design to explore the efficacy of Reiki versus sham Reiki, a pseudo treatment performed by volunteers who had no experience with Reiki and pretended to be healers vis-à-vis the patients. This sham control intervention was designed to mimic true Reiki.

Subjects were randomized to whether they started with Reiki or sham. The Maslach Burnout Inventory-Human Services Survey (MBI-HSS) and the Measure Your Medical Outcome Profile Version 2 (MYMOP-2) were used as outcome measures. Multilevel modeling was used to represent the relations among variables.

The results showed that real Reiki was significantly better than sham Reiki in reducing burnout among community mental health clinicians. Reiki was significant in reducing depersonalization, but only among single people. Reiki reduced the primary symptom on the MYMOP also only among single people.

The authors concluded that the effects of Reiki were differentiated from sham Reiki. Reiki could be helpful in community mental health settings for the mental health of the practitioners.

My team has published on Reiki (see here and here, for instance), and on this blog I have repeatedly been expressed my doubts that Reiki is more than an elaborate placebo (see here and here, for instance). Do these new results mean that I need to eat my words and henceforth praise the wonders of Reiki? No, I don’t think so!

Having conducted studies on ‘energy healing’ myself, I know only too well of the many pitfalls and possibilities of generating false-positive findings with such research. This new study has many flaws, but we need not look far to find the reason for the surprising and implausible finding. Here is my explanation why this study suggests one placebo to be superior to another placebo.

The researchers had to recruit 16 Reiki healers and several non-Reiki volunteers to perform the interventions on the small group of patients. It goes without saying that the Reiki healers were highly motivated to demonstrate the value of their therapy. This means they (unintentionally?) used verbal and non-verbal communication to maximise the placebo effect of their treatment. The sham healers, of course, lacked such motivation. In my view, this seemingly trivial difference alone is capable of producing the false-positive result above.

There are, of course, ways of minimising the danger of such confounding. In our own study of ‘energy healing’ with sham healers as controls, for instance, we instructed both the healers and the sham healers to abstain from all communication with their patients, we filmed each session to make sure, and we asked each patient to guess which treatment they had received. None of these safeguards were incorporated in the present study – I wonder why!

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