MD, PhD, FMedSci, FSB, FRCP, FRCPEd

causation

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This double-blind RCT aimed to test the efficacy of self-administered acupressure for pain and physical function in adults with knee osteoarthritis (KOA).

150 patients with symptomatic KOA participated and were randomized to

  1. verum acupressure,
  2. sham acupressure,
  3. or usual care.

Verum and sham, but not usual care, participants were taught to self-apply acupressure once daily, five days/week for eight weeks. Assessments were collected at baseline, 4 and 8 weeks. The numeric rating scale (NRS) for pain was administered during weekly phone calls. Outcomes included the WOMAC pain subscale (primary), the NRS and physical function measures (secondary). Linear mixed regression was conducted to test between group differences in mean changes from baseline for the outcomes at eight weeks.

Compared with usual care, both verum and sham participants experienced significant improvements in WOMAC pain, NRS pain and WOMAC function at 8 weeks. There were no significant differences between verum and sham acupressure groups in any of the outcomes.

The authors concluded that self-administered acupressure is superior to usual care in pain and physical function improvement for older people with KOA. The reason for the benefits is unclear and placebo effects may have played a role.

Another very odd conclusion!

The authors’ stated aim was to TEST THE EFFICACY OF ACUPRESSURE. To achieve this aim, they rightly compared it to a placebo (sham) intervention. This comparison did not show any differences between the two. Ergo, the only correct conclusion is that acupressure is a placebo.

I know, the authors (sort of) try to say this in their conclusions: placebo effects may have played a role. But surely, this is more than a little confusing. Placebo effects were quite evidently the sole cause of the observed outcomes. Is it ethical to confuse the public in this way, I wonder.

 

 

On this blog, we have had (mostly unproductive) discussions with homeopath so often that sometimes they sound like a broken disk. I don’t want to add to this kerfuffle; what I hope to do today is to summarise  a certain line of argument which, from the homeopaths’ point of view, seems entirely logical. I do this in the form of a fictitious conversation between a scientist (S) and a classical homeopath (H). My aim is to make the reader understand homeopaths better so that, future debates might be better informed.

HERE WE GO:

S: I have studied the evidence from studies of homeopathy in some detail, and I have to tell you, it fails to show that homeopathy works.

H: This is not true! We have plenty of evidence to prove that patients get better after seeing a homeopath.

S: Yes, but this is not because of the remedy; it is due to non-specific effect like the empathetic consultation with a homeopath. If one controls for these factors in adequately designed trials, the result usually is negative.

I will re-phrase my claim: the evidence fails to show that highly diluted homeopathic remedies are more effective than placebos.

H: I disagree, there are positive studies as well.

S: Let’s not cherry pick. We must always consider the totality of the reliable evidence. We now have a meta-analysis published by homeopaths that demonstrates the ineffectiveness of homeopathy quite clearly.

H: This is because homeopathy was not used correctly in the primary trials. Homeopathy must be individualised for each unique patient; no two cases are alike! Remember: homeopathy is based on the principle that like cures like!!!

S: Are you saying that all other forms of using homeopathy are wrong?

H: They are certainly not adhering to what Hahnemann told us to do; therefore you cannot take their ineffectiveness as proof that homeopathy does not work.

S: This means that much, if not most of homeopathy as it is used today is to be condemned as fake.

H: I would not go that far, but it is definitely not the real thing; it does not obey the law of similars.

S: Let’s leave this to one side for the moment. If you insist on individualised homeopathy, I must tell you that this approach can also be tested in clinical trials.

H: I know; and there is a meta-analysis which proves that it is effective.

S: Not quite; it concluded that medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

If you call this a proof of efficacy, I would have to disagree with you. The effect was tiny and at least two of the best studies relevant to the subject were left out. If anything, this paper is yet another proof that homeopathy is useless!

H: You simply don’t understand homeopathy enough to say that. I tried to tell you that the remedy must be carefully chosen to fit each unique patient. This is a very difficult task, and sometimes it is not successful – mainly because the homeopaths employed in clinical trials are not skilled enough to find it. This means that, in these studies, we will always have a certain failure rate which, in turn, is responsible for the small average effect size.

S: But these studies are always conducted by experienced homeopaths, and only the very best, most experienced homeopaths were chosen to cooperate in them. Your argument that the trials are negative because of the ineffectiveness of the homeopaths – rather than the ineffectiveness of homeopathy – is therefore nonsense.

H: This is what you say because you don’t understand homeopathy!

S: No, it is what you say because you don’t understand science. How else would you prove that your hypothesis is correct?

H: Simple! Just look at individual cases from the primary studies within this meta-analysis . You will see that there are always patients who did improve. These cases are the proof we need. The method of the RCT is only good for defining average effects; this is not what we should be looking at, and it is certainly not what homeopaths are interested in.

S: Are you saying that the method of the RCT is wrong?

H: It is not always wrong. Some RCTs of homeopathy are positive and do very clearly prove that homeopathy works. These are obviously the studies where homeopathy has been applied correctly. We have to make a meta-analysis of such trials, and you will see that the result turns out to be positive.

S: So, you claim that all the positive studies have used the correct method, while all the negative ones have used homeopathy incorrectly.

H: If you insist to put it like that, yes.

S: I see, you define a trial to have used homeopathy correctly by its result. Essentially you accept science only if it generates the outcome you like.

H: Yes, that sounds odd to you – because you don’t understand enough of homeopathy.

S: No, what you seem to insist on is nothing short of double standards. Or would you accept a drug company claiming: some patients did feel better after taking our new drug, and this is proof that it works?

H: You see, not understanding homeopathy leads to serious errors.

S: I give up.

The question whether spinal manipulative therapy (SMT) is effective for acute low back pain is still discussed controversially. Chiropractors (they use SMT more regularly than other professionals) try everything to make us believe it does work, while the evidence is far less certain. Therefore, it is worth considering the best and most up-to-date data.

The  aim of this paper was to systematically review studies of the effectiveness and harms of SMT for acute (≤6 weeks) low back pain. The research question was straight forward: Is the use of SMT in the management of acute (≤6 weeks) low back pain associated with improvements in pain or function?

A through literature search was conducted to locate all relevant papers. Study quality was assessed using the Cochrane Back and Neck (CBN) Risk of Bias tool. The evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. The main outcome measures were pain (measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale), function (measured by the 24-point Roland Morris Disability Questionnaire or Oswestry Disability Index [range, 0-100]), or any harms measured within 6 weeks.

Of 26 eligible RCTs identified, 15 RCTs (1711 patients) provided moderate-quality evidence that SMT has a statistically significant association with improvements in pain (pooled mean improvement in the 100-mm visual analog pain scale, −9.95 [95% CI, −15.6 to −4.3]). Twelve RCTs (1381 patients) produced moderate-quality evidence that SMT has a statistically significant association with improvements in function (pooled mean effect size, −0.39 [95% CI, −0.71 to −0.07]). Heterogeneity was not explained by type of clinician performing SMT, type of manipulation, study quality, or whether SMT was given alone or as part of a package of therapies. No RCT reported any serious adverse event. Minor transient adverse events such as increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT.

The authors concluded that among patients with acute low back pain, spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks, with transient minor musculoskeletal harms. However, heterogeneity in study results was large.

This meta-analysis has been celebrated by chiropractors around the world as a triumph for their hallmark therapy, SMT. But there have also been more cautionary voices – not least from the lead author of the paper. Patients undergoing spinal manipulation experienced a decline of 1 point in their pain rating, says Dr. Paul Shekelle, an internist with the West Los Angeles Veterans Affairs Medical Center and the Rand Corporation who headed the study. That’s about the same amount of pain relief as from NSAIDs, over-the-counter nonsteroidal anti-inflammatory medication, such as ibuprofen. The study also found spinal manipulation modestly improved function. On average, patients reported greater ease and comfort engaging in two day-to-day activities — such as finding they could walk more quickly, were having less difficulty turning over in bed or were sleeping more soundly.

It’s not clear exactly how spinal manipulation relieves back pain. But it may reposition the small joints in the spine in a way that causes less pain, according to Dr. Richard Deyo, an internist and professor of evidence-based medicine at the Oregon Health and Science University. Deyo wrote an editorial published along with the study. Another possibility, Deyo says, is that spinal manipulation may restore some material in the disk between the vertebrae, or it may simply relax muscles, which could be important. There may also be mind-body interaction that comes from the “laying of hands” or a trusting relationship between patients and their health care provider, he says.

Deyo notes that there are many possible treatments for lower back pain, including oral medicine, injected medicine, corsets, traction, surgery, acupuncture and massage therapy. But of about 200 treatment options, “no single treatment is clearly superior,” he says.

In another comment by Paul Ingraham the critical tone was much clearer: “Claiming it as a victory is one of the best examples I’ve ever seen of making lemonade out of science lemons! But I can understand the mistake, because the review itself does seem positive at first glance: the benefits of SMT are disingenuously summarized as “statistically significant” in the abstract, with no mention of clinical significance (effect size; see Statistical Significance Abuse). So the abstract sounds like good news to anyone but the most wary readers, while deep in the main text the same results are eventually conceded to be “clinically modest.” But even even that seems excessively generous: personally, I need at least a 2-point improvement in pain on a scale of 10 to consider it a “modest” improvement! This is not a clearly positive review: it shows weak evidence of minor efficacy, based on “significant unexplained heterogeneity” in the results. That is, the results were all over the place — but without any impressive benefits reported by any study — and the mixture can’t be explained by any obvious, measurable factor. This probably means there’s just a lot of noise in the data, too many things that are at least as influential as the treatment itself. Or — more optimistically — it could mean that SMT is “just” disappointingly mediocre on average, but might have more potent benefits in a minority of cases (that no one seems to be able to reliably identify). Far from being good news, this review continues a strong trend (eg Rubinstein 2012) of damning SMT with faint praise, and also adds evidence of backfiring to mix. Although fortunately “no RCT reported any serious adverse event,” it seems that minor harms were legion: “increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT.” That’s a lot of undesirable outcomes. So the average patient has a roughly fifty-fifty chance of up to roughly maybe a 20% improvement… or feeling worse to some unknown degree! That does not sound like a good deal to me. It certainly doesn’t sound like good medicine.”

END OF QUOTE

As I have made clear in many previous posts, I do fully agree with these latter statements and would add just three points:

  1. We know that many of the SMT studies completely neglect reporting adverse effects. Therefore it is hardly surprising that no serious complications were on record. Yet, we know that they do occur with sad regularity.
  2. None of the studies controlled for placebo effects. It is therefore possible – I would say even likely – that a large chunk of the observed benefit is not due to SMT per se but to a placebo response.
  3. It seems more than questionable whether the benefits of SMT outweigh its risks.

The aim of this pragmatic study was “to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone.”

Patients with allergic asthma were included in a controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months plus routine care, or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1–7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0–100). Outcome parameters were assessed at baseline and at 3 and 6 months.

A total of 1,445 patients were randomized and included in the analysis (184 patients randomized to acupuncture plus routine care and 173 to routine care alone, and 1,088 in the nonrandomized acupuncture plus routine care group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5–1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0–4.0]; mental 4.0 [2.1–6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group.

The authors concluded that in patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.

We have been over this so many times (see for instance here, here and here) that I am almost a little embarrassed to explain it again: it is fairly easy to design an RCT such that it can only produce a positive result. The currently most popular way to achieve this aim in alternative medicine research is to do a ‘A+B versus B’ study, where A = the experimental treatment, and B = routine care. As A always amounts to more than nothing – in the above trial acupuncture would have placebo effects and the extra attention would also amount to something – A+B must always be more than B alone. The easiest way of thinking of this is to imagine that A and B are both finite amounts of money; everyone can understand that A+B must always be more than B!

Why then do acupuncture researchers not get the point? Are they that stupid? I happen to know some of the authors of the above paper personally, and I can assure you, they are not stupid!

So, why?

I am afraid there is only one reason I can think of: they know perfectly well that such an RCT can only produce a positive finding, and precisely that is their reason for conducting such a study. In other words, they are not using science to test a hypothesis, they deliberately abuse it to promote their pet therapy or hypothesis.

As I stated above, it is fairly easy to design an RCT such that it can only produce a positive result. Yet, it is arguably also unethical, perhaps even fraudulent, to do this. In my view, such RCTs amount to pseudoscience and scientific misconduct.

Charlotte Leboeuf-Yde, DC,MPH,PhD, is professor in Clinical Biomechanics at the University of Southern Denmark and works at the French-European Institute of Chiropractic in Paris. She is a chiropractor with extensive research experience, for example, she was one of the first chiropractors to have studied adverse reactions of spinal manipulation.

Charlotte certainly knows a thing or two about adverse effects of spinal manipulation, and I have always found her work interesting. Therefore, I was delighted to find a recent blog post where she discussed the Cassidy study of 2008 and two opposed views on the validity of this much-discussed paper.

One team (Paulus &Thaler) argued, Charlotte explained, that the Cassidy case-control study is faulty, because vertebro-basilar stroke in general was not separated from stroke specifically caused by vertebral artery dissections, the presumed culprit in cervical spinal manipulation. According to Paulus & Thaler, this would potentially result in a dilution of ‘real’ manipulative-related strokes among all other causes of stroke that are much more common. They argue that the Cassidy-analyses therefore were polluted by this misclassification, whereas the other team (Murphy et al) vehemently disagrees.

The final word is clearly not yet pronounced on this issue, Charlotte concluded, and both teams agree that research has to address various methodological challenges to obtain a trustable answer. Nevertheless, without an international collaboration involving prospective cases this seems an almost impossible task, particularly in view of the rarity of the condition; problems in capturing all cases (going from the reversible to the permanent injuries); the likely large anatomical and physiological variations between individuals; and the daunting task of obtaining relevant and precise descriptions of treatments from a multitude of practitioners.

In the meantime, Charlotte concluded, “practitioners and patients have to make a decision, similarly to judging risk in other walks of life, such as, should I take the plane or stay at home?”

I have always thought highly of Charlotte’s work, however, her conclusion made me doubt whether my high opinion of her reasoning was justified.

Should I take the plane or stay at home?

This question is not remotely similar to the question “should I have chiropractic upper neck manipulation or not?”

Here are a the two main reasons why:

  • Taking the plane of demonstrably effective in transporting you from A to B, while neck manipulation is not demonstrably effective for anything.
  • If you want to go from A to B [assuming B is far way], you need to fly. If you have neck pain or other symptoms, you can employ plenty of therapies other than neck manipulations.

Charlotte Leboeuf-Yde, DC,MPH,PhD, may be a professor in Clinical Biomechanics etc., etc., however, logical and critical thinking do not seem to be her forte.

So, how should we deal with the risks of chiropractic neck manipulations? I think, we should deal with them as responsible healthcare professionals deal with any other suspected therapeutic risks: we must ask whether the known risks of the treatment outweigh the known benefits (as they do with spinal manipulation). If that is so, we have an ethical, legal and moral duty not to employ the therapy in question in routine care. At the same time, we must focus or research efforts on producing full clarity about the open questions. It’s called the precautionary principle!

D D Palmer was born on March 7, 1845; so, why do chiros celebrate the ‘CHIROPRACTIC AWARENESS WEEK’ from 10 – 16 of April? Perhaps out of sympathy with the homeopaths (many US chiros also use homeopathy) who had their ‘big week’ during the same period? Please tell me, I want to know!

Anyway, the HAW almost ‘drowned’ the CAW – but only almost.

The British Chiropractic Association did its best to make sure we don’t forget the CAW. On their website, we find an article that alerts us to their newest bit of research. Here are some excerpts:

The consumer survey by the British Chiropractic Association (BCA) of more than 2,000 UK adults who currently suffer from back or neck pain, or have done so in the past, found that almost three in five (56%) people experienced pain after using some form of technological device. Despite this, only 27% of people surveyed had limited or stopped using their devices due to concerns for their back or neck health and posture. The research showed people were most likely to experience back or neck pain after using the following technological devices:

•    Laptop computer (35%)
•    Desktop computer (35%)
•    Smart phone (22%)
•    Tablet (20%)
•    Games console (17%)

The age group most likely to experience back or neck pain when using their smart phone were 16-24 year olds, while nearly half (45%) of young adults 25-34 year olds) admitted to experiencing back or neck pain after using a laptop. One in seven (14%) 16-24 year olds attributed their back or neck pain to virtual reality headsets.

As part of Chiropractic Awareness Week (10-16 April) the BCA is calling for technology companies to design devices with posture in mind, to help tech proof our back health. BCA chiropractor Rishi Loatey comments: “We all know how easy it is to remain glued to our smart phone or tablet, messaging friends or scrolling through social media. However, this addiction to technology could be causing changes to posture, which can lead to increased pressure on the muscles, joints and discs in the spine. Technology companies are now starting to issue older phone models which hark back to a time before smart phones enabled people to do everything from check emails and take pictures, to internet banking. Returning to a time of basic functionality, which may see people look to limit the time spent on their phone, can only be good news for our backs. Yet, in an age where people can now track their health and wellbeing using their phone, technology companies should also start looking at ways to make their devices posture friendly from the outset, encouraging us to take time away from our desks and breaks from our scrolling, gaming and messaging.”

END OF QUOTE

So, here we have it: another piece of compelling, cutting edge research by the BCA. They have made us giggle before but rarely have I laughed so heartily about a ‘professional’ organisation confusing so unprofessionally correlation with causation.

Considering the amount of highly public blunders they managed to inflict on the profession in recent years, I have come to the conclusion that the BCA is a cover organisation of BIG PHARMA with the aim of giving chiropractic a bad name!

 

Is spinal manipulative therapy (SMT) dangerous? This question has kept us on this blog busy for quite some time now. To me, there is little doubt that SMT can cause adverse effects some of which are serious. But many chiropractors seem totally unconvinced. Perhaps this new overview of reviews might help to clarify the issue. Its aim was to elucidate and quantify the risk of serious adverse events (SAEs) associated with SMT.

The authors searched five electronic databases from inception to December 8, 2015 and included reviews on any type of studies, patients, and SMT technique. The primary outcome was SAEs. The quality of the included reviews was assessed using a measurement tool to assess systematic reviews (AMSTAR). Since there were insufficient data for calculating incidence rates of SAEs, they used an alternative approach; the conclusions regarding safety of SMT were extracted for each review, and the communicated opinion were judged by two reviewers independently as safe, harmful, or neutral/unclear. Risk ratios (RRs) of a review communicating that SMT is safe and meeting the requirements for each AMSTAR item, were calculated.

A total of 283 eligible reviews were identified, but only 118 provided data for synthesis. The most frequently described adverse events (AEs) were stroke, headache, and vertebral artery dissection. Fifty-four reviews (46%) expressed that SMT is safe, 15 (13%) expressed that SMT is harmful, and 49 reviews (42%) were neutral or unclear. Thirteen reviews reported incidence estimates for SAEs, roughly ranging from 1 in 20,000 to 1 in 250,000,000 manipulations. Low methodological quality was present, with a median of 4 of 11 AMSTAR items met (interquartile range, 3 to 6). Reviews meeting the requirements for each of the AMSTAR items (i.e. good internal validity) had a higher chance of expressing that SMT is safe.

The authors concluded that it is currently not possible to provide an overall conclusion about the safety of SMT; however, the types of SAEs reported can indeed be significant, sustaining that some risk is present. High quality research and consistent reporting of AEs and SAEs are needed.

This article is valuable, if only for the wealth of information one can extract from it. There are, however, numerous problems. One is that the overview included mostly reviews of the effectiveness of SMT for various conditions. We know that studies of SMT often do not even mention AEs. If such studies are then pooled in a review, they inevitably generate an impression of safety. But this would, of course, be a false-positive result!

The authors of the overview are aware of this problem and address it in the following paragraph: “When only considering the subset of reviews, where the objective was to investigate AEs (37 reviews), then 8 reviews (22%) expressed that SMT is safe, 13 reviews (35%) expressed that SMT is harmful and 16 reviews (43%) were neutral or unclear regarding the safety of SMT. Hence, there is a tendency that a bigger proportion of these reviews are expressing that SMT is harmful compared to the full sample of reviews…”

To my surprise, I found several of my own reviews in the ‘neutral or unclear’ category. Here are the verbatim conclusions of three of them:

  1. It is concluded that serious cerebrovascular complications of spinal manipulation continue to be reported.
  2. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome.
  3. These data indicate that mild and transient adverse events seem to be frequent. Serious adverse events are probably rare but their incidence can only be estimated at present.

I find it puzzling how this could be classified as neutral or unclear. The solution of the puzzle might lie in the methodology used: “we appraised the communicated opinions of each review concerning the safety of SMT based on their conclusions regarding the AEs and SAEs. This was done by two reviewers independently (SMN, LK), who judged the communicated opinions as either ‘safe’, ‘neutral/unclear’ or ‘harmful’, based on the qualitative impression the reviewers had when reading the conclusions. The reviewers had no opinion about the safety/harmfulness of SMT before commencing the judgements. Cohen’s weighted Kappa was calculated for the agreement between the reviewers, with a value of 0.40–0.59 indicating ‘fair agreement’, 0.60–0.74 indicating ‘good agreement’ and ≥0.75 indicating ‘excellent agreement’. Disagreements were resolved by a third reviewer (MH).”

In other words, the categorisation was done on the basis of subjective judgements of two researchers. It seems obvious that, if their attitude was favourable towards SMT, their judgements would be influenced. The three examples from my own work cited above indicates to me that their verdicts were indeed far from objective.

So what is the main message here? In my view, it can be summarized in the following quote from the overview: “a bigger proportion of these reviews are expressing that SMT is harmful …”

Yes, yes, yes – I know that, if you are a chiropractor (or other practitioner using mostly SMT), you are unlikely to agree with this!

Perhaps you can agree with this statement then:

As long as there is reasonable doubt about the safety of SMT, and as long as we cannot be sure that SMT generates more good than harm, we should be very cautious using it for routine healthcare and do rigorous research to determine the truth (it’s called the precautionary principle and applies to all types of healthcare).

The title of the press-release was impressive: ‘Columbia and Harvard Researchers Find Yoga and Controlled Breathing Reduce Depressive Symptoms’. It certainly awoke my interest and I looked up the original article. Sadly, it also awoke the interest of many journalists, and the study was reported widely – and, as we shall see, mostly wrongly.

According to its authors, the aims of this study were “to assess the effects of an intervention of Iyengar yoga and coherent breathing at five breaths per minute on depressive symptoms and to determine optimal intervention yoga dosing for future studies in individuals with major depressive disorder (MDD)”.

Thirty two subjects were randomized to either the high-dose group (HDG) or low-dose group (LDG) for a 12-week intervention of three or two intervention classes per week, respectively. Eligible subjects were 18–64 years old with MDD, had baseline Beck Depression Inventory-II (BDI-II) scores ≥14, and were either on no antidepressant medications or on a stable dose of antidepressants for ≥3 months. The intervention included 90-min classes plus homework. Outcome measures were BDI-II scores and intervention compliance.

Fifteen HDG and 15 LDG subjects completed the intervention. BDI-II scores at screening and compliance did not differ between groups. BDI-II scores declined significantly from screening (24.6 ± 1.7) to week 12 (6.0 ± 3.8) for the HDG (–18.6 ± 6.6; p < 0.001), and from screening (27.7 ± 2.1) to week 12 (10.1 ± 7.9) in the LDG. There were no significant differences between groups, based on response (i.e., >50% decrease in BDI-II scores; p = 0.65) for the HDG (13/15 subjects) and LDG (11/15 subjects) or remission (i.e., number of subjects with BDI-II scores <14; p = 1.00) for the HDG (14/15 subjects) and LDG (13/15 subjects) after the 12-week intervention, although a greater number of subjects in the HDG had 12-week BDI-II scores ≤10 (p = 0.04).

The authors concluded that this dosing study provides evidence that participation in an intervention composed of Iyengar yoga and coherent breathing is associated with a significant reduction in depressive symptoms for individuals with MDD, both on and off antidepressant medications. The HDG and LDG showed no significant differences in compliance or in rates of response or remission. Although the HDG had significantly more subjects with BDI-II scores ≤10 at week 12, twice weekly classes (plus home practice) may rates of response or remission. Although the HDG, thrice weekly classes (plus home practice) had significantly more subjects with BDI-II scores ≤10 at week 12, the LDG, twice weekly classes (plus home practice) may constitute a less burdensome but still effective way to gain the mood benefits from the intervention. This study supports the use of an Iyengar yoga and coherent breathing intervention as a treatment to alleviate depressive symptoms in MDD.

The authors also warn that this study must be interpreted with caution and point out several limitations:

  • the small sample size,
  • the lack of an active non-yoga control (both groups received Iyengar yoga plus coherent breathing),
  • the supportive group environment and multiple subject interactions with research staff each week could have contributed to the reduction in depressive symptoms,
  • the results cannot be generalized to MDD with more acute suicidality or more severe symptoms.

In the press-release, we are told that “The practical findings for this integrative health intervention are that it worked for participants who were both on and off antidepressant medications, and for those time-pressed, the two times per week dose also performed well,” says The Journal of Alternative and Complementary Medicine Editor-in-Chief John Weeks

At the end of the paper, we learn that the authors, Dr. Brown and Dr. Gerbarg, teach and have published Breath∼Body∼Mind©, a technique that uses coherent breathing. Dr. Streeter is certified to teach Breath∼Body∼Mind©. No competing financial interests exist for the remaining authors.

Taking all of these issues into account, my take on this study is different and a little more critical:

  • The observed effects might have nothing at all to do with the specific intervention tested.
  • The trial was poorly designed.
  • The aims of the study are not within reach of its methodology.
  • The trial lacked a proper control group.
  • It was published in a journal that has no credibility.
  • The limitations outlined by the authors are merely the tip of an entire iceberg of fatal flaws.
  • The press-release is irresponsibly exaggerated.
  • The authors have little incentive to truly test their therapy and seem to use research as a means of promoting their business.

The British Chiropractic Association (BCA) has lost all credibility after suing Simon Singh for drawing the public’s attention to the fact that they were ‘happily promoting bogus treatments’. Now, it seems, they are trying to re-establish themselves with regular, often bogus or dubious pronouncements about back pain. It looks as though they have learnt nothing. A recent article in THE INDEPENDENT is a good example of this ambition, I think:

START OF QUOTE

Skinny jeans and coats with big fluffy hoods can contribute to painful back problems, chiropractors have warned.

Nearly three-quarters of women have experienced back pain, according to a survey by the British Chiropractic Association (BCA), who said fashionable clothing including backless shoes, oversized bags and heavy statement jewellery were partly to blame.

Wearing very tight jeans can restrict mobility and force other muscles to strain as they try to compensate for the resulting change in posture, chiropractor Rishi Loatey told The Independent.

“If they’re incredibly tight, you won’t be able to walk as you normally would,” he said.

“You’ve got a natural gait, or stride, that you would take, and the knee, hip and lower back all move to minimise the pressure coming up through the joints.

“However, if one of those areas isn’t moving as it should be, it’s going to cause more pressure elsewhere.”

While 73 per cent of women from a sample of more than 2,000 said they have had back pain, more than a quarter – 28 per cent – said they were aware their clothing affects their posture and back and neck pain, but did not take this into account when choosing what to wear.

Lower back pain is the most common cause of disability worldwide, with 9.4 per cent of people suffering from it, according to a previous study.

High heels, which cause muscles in the back of the leg and the calf to tighten and pull on the pelvis differently, have long been culprits of back pain.

A number of high-profile campaigns against “sexist” dress codes requiring women to wear high heels at work have made reference to this fact.

But backless shoes, flimsy ballet pumps and some soft boots can also damage your back if they are worn too often, said Mr Loatey.

“If you imagine the back of a shoe, the bit that goes round the back is supposed to be quite firm, so it grips the rear foot,” he said. “If you don’t have that, then your foot is more mobile in the shoe.”

“If they’re not the right size, they’re a bit loose or they don’t have the bit at the back, you’re almost gripping the shoe as you walk, which again changes the way you walk,” said Mr Loatey, adding that ideally shoes should be laced up at the front to make sure the foot is held firmly.

A third of women surveyed by the BCA were unaware that their clothing choices could harm their backs and necks.

Mr Loatey said people should try and wear clothes that allow them to move more freely. Heavy hoods and over-shoulder bags can both restrict movement.

They should also consider limiting the amount of time they spent wearing high heels or backless shoes and consider travelling to work or social events in trainers or other well-supported shoes instead, he said.

END OF QUOTE

This piece strikes me as pure promotion of chiropractic – health journalism at its worse, I’d say. What is more objectionable than the promotion, it is full of half truths, ‘alternative facts’ and pure invention. Let me list a few statements that I find particularly doggy:

  1. “Skinny jeans and coats with big fluffy hoods can contribute to painful back problems.” Do they have any evidence for this? I don’t know of any!
  2. “…fashionable clothing including backless shoes, oversized bags and heavy statement jewellery were partly to blame [for back problems].” Idem!
  3. “Wearing very tight jeans can restrict mobility and force other muscles to strain…” Idem!
  4. “…it’s going to cause more pressure elsewhere.” Idem!
  5. 28% of women said “they were aware their clothing affects their posture and back and neck pain, but did not take this into account when choosing what to wear.” To make the findings from a survey look like scientific evidence for cause and effect is at best misleading, at worst dishonest.
  6. “…according to a previous study“. It turns out that this previous study was of occupational back pain which has nothing to do with tight jeans etc.
  7. “High heels, which cause muscles in the back of the leg and the calf to tighten and pull on the pelvis differently, have long been culprits of back pain.” A link to the evidence would be nice – if there is any.
  8. “But backless shoes, flimsy ballet pumps and some soft boots can also damage your back – if they are worn too often…” Evidence needed – if there is any.
  9. “Mr Loatey said people should try and wear clothes that allow them to move more freely. Heavy hoods and over-shoulder bags can both restrict movement.” Concrete recommendations require concrete evidence or a link to it.
  10. Women “should also consider limiting the amount of time they spent wearing high heels or backless shoes and consider travelling to work or social events in trainers or other well-supported shoes instead.” Idem.

At this point congratulations are in order, I feel.

Firstly to THE INDEPENDENT for publishing one of the most inadequate health-related article which I have seen in recent months.

Secondly to the BCA for their stubborn determination to ‘happily promoting bogus’ notions. Instead of getting their act together when found out to advertise quackery in 2008, they sued Simon Singh (unsuccessfully, I hasten to add). Instead of cutting out the nonsense once and for all, they now promote populist ‘alternative facts’ about the causes of back pain. Instead of behaving like a professional organisation that promotes high standards and solid evidence, they continue to do the opposite.

One cannot but be impressed with so much intransigence.

Prof Walach has featured on this blog before, for instance here, and here. He is a psychologist by training and a vocal and prominent advocate of several bogus treatments, including homeopathy. He also is the editor in chief of the journal ‘Complementary Medicine Research’ and regularly uses this position to sing the praise of homeopathy. There is a degree of mystery about his affiliation: he informed me about 10 months ago that he has left his post at the Europa Universität Viadrina, Frankfurt/Oder (“Dass ich als “ehemaliger Professor” geführt werde liegt daran, dass ich  Ende Januar aufgehört habe. Meine Stelle ist ausgelaufen und ich habe
sie nicht mehr verlängert.”). Yet all, even his recent papers still carry this address.

His latest article is entitled ‘The future of homeopathy’ is no exception. It is remarkable not just because of the mysterious affiliation but also – and mostly – because of its content. Here is my translation of a brief passage from this paper [I added some numbers in square brackets which refer to footnotes below].

START OF MY TRANSLATION

It is entirely undisputed that homeopathy with its therapeutic principles runs against the mainstream of science; and in this, Weymayr [1] is correct. However, to build on this fact a veritable research prohibition, such as the ‘scientability-concept’ suggests, is not just wrong from a science theoretical perspective, but… also discloses a dogmatic and unscientific stance.

If we see things soberly, homeopathy is – from a science theory point of view – an anomaly: empiric data prove that effects appear regularly and more and more frequently [2].  This is being demonstrated with meta-analyses of placebo-controlled clinical trials. And this also shows with our own provings, which conform well with the newly developed standards as well as with the newer provings. Effects are furthermore noted with such frequency in animal and plant-based studies. Contrary to often voiced statements, there are also models which produce replicated effects – for instance the model of children with ADHD which is currently being replicated. Repeatedly high quality pilot studies emerge, such as the one by Gassmann et al., which show that unexpected effects also appear with higher potencies, documented with objective methods. Homeopathy proves itself as useful in large pragmatic trials of which we, however, have far too few. And let’s not forget: homeopathy is pragmatically useful. Even though aggravations do occur occasionally during homeopathic treatments, the claim that homeopathy is dangerous is a careless interpretation of the data. [3]

In what way is homeopathy an anomaly? I have already years ago argued that the signature of the data does not suggest that we are dealing with a classical local effect. This would be an effect which would conform with the usual criterion of causality and would thus be stable, regular and more and more evident with improved experimentation. It is unnecessary to repeat this argument [4] for the purpose of this editorial. But precisely the question of the classic causal effect is the controversy. And exactly this is the issue used by the new wave of critic of homeopathy which is openly aimed at the demise of homeopathy. This situation occurs because also the homeopaths are victims of the misapprehension  that homeopathy is based on a classic causal process. But this assumption is most likely wrong, and homeopaths would be well-advised on the one side to point to the empiric evidence, and on the other side to practice theoretical chastity making clear that, for the time being, we have not a clue how homeopathy functions. This is the typical situation when a scientific anomaly occurs…

My prognosis would be: if we stop to misunderstand homeopathy as a classic causal phenomenon and instead view and research it as a non-classical phenomenon, homeopathy would have a chance and science would get richer by a new category of phenomena. This approach will prompt criticism, because it renders the world more complex rather than simpler. But this cannot be changed. Perhaps a new era of therapeutics might even emerge which does not abolish the molecular paradigm but makes it appear as one of several possibilities. [5]

END OF MY TRANSLATION

For those of you who can read German, here is the original text with references:

Dass die Homöopathie mit ihren therapeutischen Prinzipien dem Hauptstrom der Wissenschaft immer schon zuwiderlief, ist völlig unbestritten, und darin hat Weymayr recht. Aber auf dieser Tatsache ein regelrechtes «Forschungsverbot» aufbauen zu wollen, wie es das Szientabilitätskonzept vorsieht, das ist nicht nur wissenschaftstheoretisch absolut falsch, wie wir in einer Replik gezeigt haben [2], sondern offenbart auch eine dogmatische und unwissenschaftliche Einstellung.

Wenn man die Sache nüchtern sieht, ist die Homöopathie – wissenschaftstheoretisch betrachtet – eine Anomalie [3]: Empirische Daten belegen, dass immer wieder und insgesamt häufiger als zufällig erwartet Effekte auftreten. Das zeigen Meta-Analysen placebokontrollierter klinischer Studien [4,5,6]. Und das zeigt sich sowohl in unseren eigenen Arzneimittel-Prüfungen [7], die im Übrigen den erst neuerdings entwickelten Standards gut entsprechen [8], als auch in neueren Prüfungen [9]. Auch in Tierexperimenten [10,11,12,13] und in Pflanzenstudien [14,15,16] treten Effekte in solcher Häufigkeit auf. Entgegen oft gehörten Äußerungen gibt es durchaus auch Modelle, die replizierte Effekte ergeben – etwa das Modell homöopathischer Behandlung von Kindern mit Aufmerksamkeitsdefizit-/Hyperaktivitätssyndrom [17,18], das gerade repliziert wird [19]. Immer wieder gibt es qualitativ hochwertige Pilotstudien, wie die unlängst publizierte von Gassmann et al. [20], die zeigen, dass unerwartete Effekte auch unter höheren Potenzen und dokumentiert mit objektiven Methoden zu beobachten sind. Homöopathie erweist sich in großen pragmatischen Studien, von denen es allerdings viel zu wenige gibt, als nützlich [21,22,23]. Und nicht zu vergessen: Homöopathie ist pragmatisch hilfreich [24,25,26,27]. Zwar kommt es bei homöopathischer Behandlung gelegentlich zu einer Erstverschlimmerung [28,29], aber die Behauptung, Homöopathie sei gefährlich [30], ist eine fahrlässige Interpretation der Daten [31].

Inwiefern ist die Homöopathie dann eine Anomalie? Ich habe schon vor Jahren argumentiert, dass die Signatur der Daten in der Homöopathie nicht dafür spricht, dass wir es mit einem klassischen, lokalen Effekt zu tun haben [32]. Das wäre ein Effekt, der dem gewöhnlichen Kriterium der Kausalität entspräche und somit stabil, regelmäßig und bei immer besserer Experimentierkunst immer deutlicher hervorträte. Dieses Argument jetzt wieder aufzurollen, ist im Rahmen eines Editorials müßig. Aber genau die Frage nach einem klassisch-kausalen Effekt ist letztlich der Stein des Anstoßes. Und genau diesen Anstoß nimmt nun die neue Welle der Homöopathiekritik, die erklärtermaßen auf die Abschaffung der Homöopathie abzielt, zu ihrem Anlass. Diese Situation ergibt sich, weil auch die Homöopathen dem Selbstmissverständnis aufsitzen, Homöopathie sei ein klassisch-kausaler Prozess. Das ist höchstwahrscheinlich falsch, und die Homöopathie wäre gut beraten, einerseits auf die empirischen Befunde hinzuweisen und auf der anderen Seite theoretische Enthaltsamkeit zu üben und klarzulegen, dass wir vorläufig keinerlei Ahnung haben, wie Homöopathie funktioniert. Das ist die typische Situation, wenn eine wissenschaftliche Anomalie vorliegt…

Meine Prognose wäre: Wenn wir aufhören, die Homöopathie als klassisches Phänomen misszuverstehen, und sie stattdessen als ein mögliches nichtklassisches Phänomen betrachten und beforschen, dann hat die Homöopathie eine Chance und die Wissenschaft wird um eine neue Kategorie von Phänomenen reicher. Dieser Ansatz wird Kritik hervorrufen, denn er macht die Welt eher komplexer als einfacher. Aber das lässt sich nicht ändern. Vielleicht kann sogar eine neue Ära der Therapie beginnen, die das molekulare Paradigma nicht abschafft, aber als eine von mehreren Möglichkeiten erscheinen lässt.


Rather than commenting on this text in full detail, I simply want to provide a few explanations [they refer to the numbers in square brackets inserted by me into my translation] in order to facilitate understanding. I hope, however, that my readers will comment as much as they feel like.

1) Weymayr argued that certain fields lack plausibility to a degree that they do not merit being investigated. Here is an abstract of an article by him:

Evidence-based medicine (EbM) has proved to be very useful in healthcare; thanks to its methodology the reliability of our knowledge of the benefits and harms of interventions can be assessed. This at least applies to interventions which are based on a plausible concept for their mechanism of action and which have already achieved positive effects in experiments and simple studies. However, for interventions whose concepts contradict scientific findings EbM has proved to be unsuitable; it has not been able to prevent that they are still regarded as effective amongst wide parts of the population and medical experts. Particularly homeopathy has managed to even present itself as scientifically justified by using EbM. With the aim of highlighting the speculative character of homeopathy and other procedures and of preventing EbM from getting damaged, the concept of scientability is introduced in this article. This concept only approves of clinical studies if the intervention that is to be tested does not contradict definite scientific findings.

2) A scientific anomaly is “something which cannot be explained by currently accepted scientific theories. Sometimes the new phenomenon leads to new rules or theories, e.g., the discovery of x-rays and radiation.

3) Even a minimal amount of critical thinking leads to the conclusion that the claims made about homeopathy in this paragraph are mostly not true or exaggerated. On this blog, there is plenty of evidence to contradict Walach on all the points he made here.

4) Walach’s argument is detailed in this article:

Among homeopaths the common idea about a working hypothesis for homeopathic effects seems to be that, during the potentization process, ‘information’ or ‘energy’ is being preserved or even enhanced in homeopathic remedies. The organism is said to be able to pick up this information, which in turn will stimulate the organism into a self-healing response. According to this view the decisive element of homeopathic therapy is the remedy which locally contains and conveys this information. I question this view for empirical and theoretical reasons. Empirical research has shown a repetitive pattern, in fundamental and clinical research alike: there are many anomalies in high-dilution research and clinical homeopathic trials which will set any observing researcher thinking. But no single paradigm has proved stable enough in order to produce repeatable results independent of the researcher. I conclude that the database is too weak and contradictory to substantiate a local interpretation of homeopathy, in which the remedy is endowed with causal-informational content irrespective of the circumstances. I propose a non-local interpretation to understand the anomalies along the lines of Jung’s notion of synchronicity and make some predictions following this analysis.

5) In a nutshell, Walach seems to be saying:

  • the empirical evidence for homeopathy is strong;
  • nobody understands the mechanisms by which the effects of homeopathy are brought about;
  • if we all claim that homeopathy is a ‘scientific anomaly’ which operates according to Jung’s notion of synchronicity, the discrepancy between strong evidence and lack of plausible explanation disappears and everyone can be happy.

This is wrong for the following reasons, in my view:

  • the evidence is not strong but negative or extremely weak;
  • we understand very well that the effects of homeopathy are due to non-specific effects;
  • therefore there is no need for a new paradigm;
  • Jung’s notion of synchronicity is pure speculation and not applicable to therapeutics.

In summary, Prof Walach would do well to stop philosophising about homeopathy, read up about critical analysis, fine-tune his BS-detector and familiarise himself with Occam’s razor.

 

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