MD, PhD, FMedSci, FSB, FRCP, FRCPEd

causation

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A paper entitled ‘Real world research: a complementary method to establish the effectiveness of acupuncture’ caught my attention recently. I find it quite remarkable and think it might stimulate some discussion on this blog.  Here is its abstract:

Acupuncture has been widely used in the management of a variety of diseases for thousands of years, and many relevant randomized controlled trials have been published. In recent years, many randomized controlled trials have provided controversial or less-than-convincing evidence that supports the efficacy of acupuncture. The clinical effectiveness of acupuncture in Western countries remains controversial.

Acupuncture is a complex intervention involving needling components, specific non-needling components, and generic components. Common problems that have contributed to the equivocal findings in acupuncture randomized controlled trials were imperfections regarding acupuncture treatment and inappropriate placebo/sham controls. In addition, some inherent limitations were also present in the design and implementation of current acupuncture randomized controlled trials such as weak external validity. The current designs of randomized controlled trials of acupuncture need to be further developed. In contrast to examining efficacy and adverse reaction in a “sterilized” environment in a narrowly defined population, real world research assesses the effectiveness and safety of an intervention in a much wider population in real world practice. For this reason, real world research might be a feasible and meaningful method for acupuncture assessment. Randomized controlled trials are important in verifying the efficacy of acupuncture treatment, but the authors believe that real world research, if designed and conducted appropriately, can complement randomized controlled trials to establish the effectiveness of acupuncture. Furthermore, the integrative model that can incorporate randomized controlled trial and real world research which can complement each other and potentially provide more objective and persuasive evidence.

In the article itself, the authors list seven criteria for what they consider good research into acupuncture:

  1. Acupuncture should be regarded as complex and individualized treatment;
  2. The study aim (whether to assess the efficacy of acupuncture needling or the effectiveness of acupuncture treatment) should be clearly defined and differentiated;
  3. Pattern identification should be clearly specified, and non-needling components should also be considered;
  4. The treatment protocol should have some degree of flexibility to allow for individualization;
  5. The placebo or sham acupuncture should be appropriate: knowing “what to avoid” and “what to mimic” in placebos/shams;
  6. In addition to “hard evidence”, one should consider patient-reported outcomes, economic evaluations, patient preferences and the effect of expectancy;
  7. The use of qualitative research (e.g., interview) to explore some missing areas (e.g., experience of practitioners and patient-practitioner relationship) in acupuncture research.

Furthermore, the authors list the advantages of their RWR-concept:

  1. In RWR, interventions are tailored to the patients’ specific conditions, in contrast to standardized treatment. As a result, conclusions based on RWR consider all aspects of acupuncture that affect the effectiveness.
  2. At an operational level, patients’ choice of the treatment(s) decreases the difficulties in recruiting and retaining patients during the data collection period.
  3. The study sample in RWR is much more representative of the real world situation (similar to the section of the population that receives the treatment). The study, therefore, has higher external validity.
  4. RWR tends to have a larger sample size and longer follow-up period than RCT, and thus is more appropriate for assessing the safety of acupuncture.

The authors make much of their notion that acupuncture is a COMPLEX INTERVENTION; specifically they claim the following: Acupuncture treatment includes three aspects: needling, specific non-needling components drove by acupuncture theory, and generic components not unique to acupuncture treatment. In addition, acupuncture treatment should be performed on the basis of the patient condition and traditional Chinese medicine (TCM) theory.

There is so much BS here that it is hard to decide where to begin refuting. As the assumption of acupuncture or other alternative therapies being COMPLEX INTERVENTIONS (and therefore exempt from rigorous tests) is highly prevalent in this field, let me try to just briefly tackle this one.

The last time I saw a patient and prescribed a drug treatment I did all of the following:

  • I greeted her, asked her to sit down and tried to make her feel relaxed.
  • I first had a quick chat about something trivial.
  • I then asked why she had come to see me.
  • I started to take notes.
  • I inquired about the exact nature and the history of her problem.
  • I then asked her about her general medical history, family history and her life-style.
  • I also asked about any psychological problems that might relate to her symptoms.
  • I then conducted a physical examination.
  • Subsequently we discussed what her diagnosis might be.
  • I told her what my working diagnosis was.
  • I ordered a few tests to either confirm or refute it and explained them to her.
  • We decided that she should come back and see me in a few days when her tests had come back.
  • In order to ease her symptoms in the meanwhile, I gave her a prescription for a drug.
  • We discussed this treatment, how and when she should take it, adverse effects etc.
  • We also discussed other therapeutic options, in case the prescribed treatment was in any way unsatisfactory.
  • I reassured her by telling her that her condition did not seem to be serious and stressed that I was confident to be able to help her.
  • She left my office.

The point I am trying to make is: prescribing an entirely straight forward drug treatment is also a COMPLEX INTERVENTION. In fact, I know of no treatment that is NOT complex.

Does that mean that drugs and all other interventions are exempt from being tested in rigorous RCTs? Should we allow drug companies to adopt the RWR too? Any old placebo would pass that test and could be made to look effective using RWR. In the example above, my compassion, care and reassurance would alleviate my patient’s symptoms, even if the prescription I gave her was complete rubbish.

So why should acupuncture (or any other alternative therapy) not be tested in proper RCTs? I fear, the reason is that RCTs might show that it is not as effective as its proponents had hoped. The conclusion about the RWR is thus embarrassingly simple: proponents of alternative medicine want double standards because single standards would risk to disclose the truth.

If you talk to advocates of homeopathy, you are bound to hear claims that are false or misleading; in fact, you hear them so regularly that you might begin to doubt the truth. For those who have such doubts or are in need of some correct counter-arguments, I have listed here those 12 bogus claims which, in my experience, are most common together with short, suitable, and factual rebuttals.

1) THERE IS NOTHING MYSTERIOUS ABOUT HOMEOPATHY’S MODE OF ACTION, IT WORKS LIKE VACCINATIONS

This argument is used by enthusiasts in response the fact that most homeopathic remedies are too highly diluted to have pharmacological effects. Vaccines are also highly diluted and they are, of course, very effective; therefore, so the bogus notion, there is nothing odd about homeopathy.

The argument is wrong on several levels; the easiest way to refute, I think, it is to point out that vaccines contain measurable amounts of material and lead to measurable changes in the immune system. By contrast, the typical homeopathic remedy (beyond the C12 potency) contains not a single molecule of an active substance and leads to no measurable changes in any system.

2) SIGNIFICANTLY MORE CONTROLLED CLINICAL TRIALS OF HOMEOPATHY ARE POSITIVE THAN NEGATIVE

Several websites of homeopathic organisations make this claim and even provide simple statistics to back it up. Consequently, many homeopathy fans have adopted it.

The statistics they present show that x % of studies are positive, y % are negative and z % are neutral; the whole point is that x is larger than y. The percentage figures may even be correct but they rely on the spurious definitions used: positive = superior to placebo, negative = placebo superior to homeopathy, neutral = no difference between homeopathy and placebo. The latter category was created so that homeopathy comes out trumps.

For all intents and purposes, a study where the experimental treatment is no better than placebo is not a study neutral but a negative result. Thus the negative category in such statistics must be y + z which is, of course, larger than x. In other words, the majority of trials is, in truth, negative.

3) HOMEOPATHY IS SUPPORTED BY NOBEL PRIZE WINNERS

I don’t know of a single Nobel Prize winner who has stated or implied that homeopathy works better than a placebo. Some have tried to find a mechanism of action for homeopathy by doing some basic research and have published theories about it. None of those has been accepted by science.

And if there ever should be a Nobel Prize winner or similarly brilliant person who supports homeopathy, this would merely show that even bright individuals can make mistakes!

4) HOMEOPATHY IS SAFE

Tell that to the child that has just been reported to have died because her parents used homeopathy for an ear infection which (could have been easily treated with antibiotics but) degenerated into a brain abscess with homeopathic therapy. There are many more such tragic cases than I care to remember.

The risks of homeopathy are, of course, minor compared to many conventional treatments, but the risk/benefit balance of homeopathy can never be positive because, unlike those high risk conventional treatments, it has no benefit.

5) HOMEOPATHY DOES NOT LEND ITSELF TO BEING TESTED IN CLINICAL TRIALS

The best way to disprove this argument is to point out that ~ 250 controlled clinical trials are currently available. Every homeopath on the planet boasts about clinical trials – provided they are positive.

6) HOMEOPATHY WORKS VIA QUANTUM ENTANGLEMENT

I do not understand quantum mechanics and, I suspect, neither do the homeopaths who use this argument. But physicists who do understand this subject well are keen to stress that homeopathy cannot be explained in this way.

7) THERE IS NO PROOF THAT HOMEOPATHY DOES NOT WORK

The absence of evidence is not the same as evidence of absence, homeopaths like to exclaim. And they are, of course, correct! However, they forget that, science cannot prove a negative and that, in routine health care, we do not even look for a proof of ineffectiveness. We use those treatments that have a positive proof of effectiveness – everything else is irresponsible.

8) EVEN IF HOMEOPATHY WERE JUST A PLACEBO, IT STILL HELPS PATIENTS AND IS THEREFORE A USEFUL TREATMENT

It is true, of course, that placebo effects can help patients. But it is not true that, for generating a placebo response, we need a placebo. If a clinician administers an effective treatment with compassion, the patient will benefit from a placebo response plus from the specific effects of the treatment. Only giving placebos is therefore tantamount to cheating the patient.

9) THERE IS A WORLDWIDE CONSPIRACY AGAINST HOMEOPATHY

In a way, this argument merely suggests that homeopathic remedies are ineffective in treating paranoia. I have not ever seen a jot of evidence for it – and neither can anyone who uses this claim produce any.

10) YOU NEED TO BE A HOMEOPATH TO BE ABLE TO UNDERSTAND AND ADEQUATELY JUDGE THE VALUE OF HOMEOPATHY

With this notion, homeopaths want to claim that the critics of homeopathy are incompetent. It is like saying that only people who believe in god are allowed to criticise religion. By definition, homeopaths are believers, and therefore they are unlikely to be free of bias when judging the value of homeopathy. Homeopathy is a health technology that must be evaluated like all other health technologies: by independent scientists who know their job.

11) HOMEOPATHY HAS BEEN PROVEN TO WORK FOR LITTLE CHILDREN AND ANIMALS

The argument here is that animals and children cannot possibly respond to placebo. Therefore homeopathy must be more than a placebo.

This notion is twice wrong. Firstly, both animals and children can respond to placebo, if only ‘by proxy’, i.e. via their carers. Secondly, if we consider the totality of the reliable data, we find that neither for children nor for animals is the evidence convincingly positive.

12) HOMEOPATHY HAS BEEN USED VERY SUCCESSFULLY IN MAJOR EPIDEMICS, AND THAT FACT IS PROOF ENOUGH FOR ITS EFFICACY

Yes, there are some rather fascinating historical accounts which homeopaths interpret in this fashion. But if we look a little closer, we invariably find explanations which are much more plausible than the assumption of homeopathy’s effectiveness. Epidemiological observations of this nature can almost never establish cause and effect, and the clinical outcome could have been due to a myriad of confounders unrelated to homeopathy.

Necessity, they say, is the mother of invention. The meaning of this proverb is fairly clear:

  • In the Oxford Dictionary the proverb has been defined as– when the need for something becomes imperative, you are forced to find ways of getting or achieving it.
  • According to the Cambridge Dictionary, this is “an expression that means that if you really need to do something, you will think of a way of doing it.”
  • Finally, the Longman dictionary has defined the proverb as– “if someone really needs to do something, they will find a way of doing it.”

In the world of chiropractic the proverb acquires a special meaning: chiropractic relies almost entirely on inventions. A few examples have to suffice:

  • first, instead of pathophysiology, they invented subluxations,
  • this required the invention of adjustments which were needed for their imagined subluxation,
  • then they invented the ‘inate’,
  • then they invented the idea that all sorts of conditions are caused by subluxations and therefore require adjustments,
  • finally, they invented the notion that regular adjustments are needed for a healthy person to stay healthy.

I was reminded of the unique inventive capacity of chiropractic when I came across the website of the Foundation for Chiropractic Progress (F4CP). The F4CP is, according to their own statements, a not-for-profit organization dedicated to raising awareness about the value of chiropractic care (which is, of course, another invention).

Experts at the F4CP point out that a growing number of professional athletic teams utilize chiropractic care to maximize overall health and maintain peak performance. “Repetitive motion injuries, including shoulder tendinitis, elbow, lower back pain and muscle spasms, are common conditions and injuries among professional baseball players that can be successfully prevented, managed and treated with chiropractic care,” says Hirad N. Bagy, DC. “Chiropractic adjustments, in conjunction with soft tissue mobilization, provide athletes with proper structure, function and balance to reduce the risk of injury, accelerate recovery time and improve overall performance,” he continues – and he must know, because he has received specialized training and certifications specific to sports medicine, which include the Graston Technique®, Active Release Technique®, Myofascial Release Technique, Impact Concussion Testing and Functional Dry Needling. Dr. Bagy continues: “A number of athletes that I treat regularly understand the importance of chiropractic maintenance care, and also seek treatment when an injury arises. Through the restoration of proper bio-mechanics, doctors of chiropractic are now positioned as key health care providers throughout all of the sports teams that I work with.”

BRAVO! We are impressed! So much so, that we almost forgot to ask: “Is there any evidence for all of these therapeutic claims?”

Just as well! Because had we asked and perhaps even did a bit of research, we would have found that almost none of these far-reaching claims are evidence-based.

But who would be so petty? Instead of criticising the incessant flow of bogus claims made by chiropractors worldwide, we should really admire their remarkable skill of invention:

  • When the need for profit becomes imperative, CHIROPRACTORS are forced to find ways of getting or achieving it.
  • If CHIROPRACTORS really need to do something, they will think of a way of doing it.
  • If a CHIROPRACTOR really needs money, he will advocate ‘maintenance care’.

AND THAT’S WHAT IS CALLED ‘CHIROPRACTIC PROGRESS’!

If you ask a chiropractor, you will probably be told that chiropractic spinal manipulation is a safe treatment. Unfortunately this is not quite true, as regular readers of this blog will appreciate. About half of all patients suffer mild to moderate adverse effects after chiropractic treatments and, in addition, many instances of much more serious complications have been documented, including rare cases of Horner syndrome. It results from an interruption of the sympathetic nerve supply to the eye and is characterized by the classic triad of miosis (ie, constricted pupil), partial ptosis, and loss of hemifacial sweating (ie, anhidrosis).

Danish neurologists recently reported the case of a 60-year-old man with no relevant medical history who was admitted to the Department of Neurology with drooping of his right upper eyelid and an ipsilateral contracted pupil, combined with pain, weakness, and numbness in his upper right limb.

The patient had experienced thoracic back pain of moderate intensity with radiating right-sided belt-like chest pain for 7 days. When the discomfort suddenly intensified, he sought chiropractic treatment. Following manipulations of the thoracic and cervical spine, the pain intensity initially lessened. Approximately one hour after chiropractic treatment, the patient experienced the eye and upper limb symptoms described above, for which he sought medical assistance three days later.

A detailed neurologic examination revealed moderate right-sided ptosis and miosis, no facial anhidrosis, decreased strength of the intrinsic and opponens muscles of the right hand, and reduced cutaneous sensation corresponding to the T1 dermatome, with inability to discriminate pain and light touch. The remaining clinical examination, routine blood tests, and vital parameters were unremarkable.

Brain CT scan and CT angiography including the aortic arch and neck vessels were performed and ruled out cerebral stroke and carotid artery dissection, respectively. As clinical signs of Horner syndrome and a concomitant radiating pain to the medial arm were considered suggestive of either a lower brachial plexopathy, i.e., due to a Pancoast tumor, or a radiculopathy, chest X-ray and electroneurography (ENG) were performed. No apical pulmonary pathology was detected. ENG of the right medial cutaneous antebrachial nerve demonstrated a normal sensory action potential (SAP), consistent with the lesion being located proximally to the dorsal spinal root ganglion, thus suggestive of a spinal nerve root lesion. A subsequent MRI of the thoracic spine showed a para-median herniation of the T1-T2 intervertebral disc compressing the right T1 spinal nerve root.

The patient received no surgery, and follow-up examination 6 months later revealed near-complete recovery, with only mild paraesthesia in the T1 segment of his right arm and a subtle ptosis remaining.

Horner syndrome due to a herniated thoracic disc has only been reported 6 times in the English language literature, though never preceded by chiropractic manipulation.

One of the most frequent causes of Horner syndrome is carotid artery dissection, which may occur spontaneously or due to local trauma to the neck region. Chiropractic manipulation as an independent risk factor for neck artery dissection and a consequent stroke is a controversial topic, though multiple cases of Horner syndrome due to ICA dissections subsequent to chiropractic manipulation have been reported. In the patient described here, an ICA dissection was considered unlikely due to the concomitant prominent radiating medial brachialgia and was furthermore ruled out by a CT angiogram of the neck vessels.

This patient experienced the onset of a Horner syndrome and ipsilateral upper limb symptoms shortly after chiropractic treatment, suggesting the cervico-thoracic manipulation as the cause of or at least worsening factor in the T1-T2 disc herniation. Several cases of disc herniations following chiropractic treatment have been reported.

While the definite pathophysiologic mechanism to explain this patient’s Horner syndrome remains unclear, it seems, according to the authors of this case-report, evident that manipulations as a minimum altered the configuration of an already existing disc protrusion.

You may feel that homeopaths are bizarre, irrational, perhaps even stupid – but you cannot deny their tenacity. Since 200 years, they are trying to convince us that their treatments are effective beyond placebo. And they seem to get more and more bold with their claims: while they used to suggest that homeopathy was effective for trivial conditions like a common cold, they now have their eyes on much more ambitious things. Two recent studies, for instance, claim that homeopathic remedies can help cancer patients.

The aim of the first study was to evaluate whether homeopathy influenced global health status and subjective wellbeing when used as an adjunct to conventional cancer therapy.

In this pragmatic randomized controlled trial, 410 patients, who were treated by standard anti-neoplastic therapy, were randomized to receive or not receive classical homeopathic adjunctive therapy in addition to standard therapy. The main outcome measures were global health status and subjective wellbeing as assessed by the patients. At each of three visits (one baseline, two follow-up visits), patients filled in two questionnaires for quantification of these endpoints.

The results show that 373 patients yielded at least one of three measurements. The improvement of global health status between visits 1 and 3 was significantly stronger in the homeopathy group by 7.7 (95% CI 2.3-13.0, p=0.005) when compared with the control group. A significant group difference was also observed with respect to subjective wellbeing by 14.7 (95% CI 8.5-21.0, p<0.001) in favor of the homeopathic as compared with the control group. Control patients showed a significant improvement only in subjective wellbeing between their first and third visits.

Our homeopaths concluded that the results suggest that the global health status and subjective wellbeing of cancer patients improve significantly when adjunct classical homeopathic treatment is administered in addition to conventional therapy.

The second study is a little more modest; it had the aim to explore the benefits of a three-month course of individualised homeopathy (IH) for survivors of cancer.

Fifteen survivors of any type of cancer were recruited by a walk-in cancer support centre. Conventional treatment had to have taken place within the last three years. Patients scored their total, physical and emotional wellbeing using the Functional Assessment of Chronic Illness Therapy for Cancer (FACIT-G) before and after receiving four IH sessions.

The results showed that 11 women had statistically positive results for emotional, physical and total wellbeing based on FACIT-G scores.

And the conclusion: Findings support previous research, suggesting CAM or individualised homeopathy could be beneficial for survivors of cancer.

As I said: one has to admire their tenacity, perhaps also their chutzpa – but not their understanding of science or their intelligence. If they were able to think critically, they could only arrive at one conclusion: STUDY DESIGNS THAT ARE WIDE OPEN TO BIAS ARE LIKELY TO DELIVER BIASED RESULTS.

The second study is a mere observation without a control group. The reported outcomes could be due to placebo, expectation, extra attention or social desirability. We obviously need an RCT! But the first study was an RCT!!! Its results are therefore more convincing, aren’t they?

No, not at all. I can repeat my sentence from above: The reported outcomes could be due to placebo, expectation, extra attention or social desirability. And if you don’t believe it, please read what I have posted about the infamous ‘A+B versus B’ trial design (here and here and here and here and here for instance).

My point is that such a study, while looking rigorous to the naïve reader (after all, it’s an RCT!!!), is just as inconclusive when it comes to establishing cause and effect as a simple case series which (almost) everyone knows by now to be utterly useless for that purpose. The fact that the A+B versus B design is nevertheless being used over and over again in alternative medicine for drawing causal conclusions amounts to deceit – and deceit is unethical, as we all know.

My overall conclusion about all this:

QUACKS LOVE THIS STUDY DESIGN BECAUSE IT NEVER FAILS TO PRODUCE FALSE POSITIVE RESULTS.

A recent comment to a post of mine (by a well-known and experienced German alt med researcher) made the following bold statement aimed directly at me and at my apparent lack of understanding research methodology:

C´mon , as researcher you should know the difference between efficacy and effectiveness. This is pharmacological basic knowledge. Specific (efficacy) + nonspecific effects = effectiveness. And, in fact, everything can be effective – because of non-specific or placebo-like effects. That does not mean that efficacy is existent.

The point he wanted to make is that outcome studies – studies without a control group where the researcher simply observe the outcome of a particular treatment in a ‘real life’ situation – suffice to demonstrate the effectiveness of therapeutic interventions. This belief is very wide-spread in alternative medicine and tends to mislead all concerned. It is therefore worth re-visiting this issue here in an attempt to create some clarity.

When a patient’s condition improves after receiving a therapy, it is very tempting to feel that this improvement reflects the effectiveness of the intervention (as the researcher mentioned above obviously does). Tempting but wrong: there are many other factors involved as well, for instance:

  • the placebo effect (mainly based on conditioning and expectation),
  • the therapeutic relationship with the clinician (empathy, compassion etc.),
  • the regression towards the mean (outliers tend to return to the mean value),
  • the natural history of the patient’s condition (most conditions get better even without treatment),
  • social desirability (patients tend to say they are better to please their friendly clinician),
  • concomitant treatments (patients often use treatments other than the prescribed one without telling their clinician).

So, how does this fit into the statement above ‘Specific (efficacy) + nonspecific effects = effectiveness’? Even if this formula were correct, it would not mean that outcome studies of the nature described demonstrate the effectiveness of a therapy. It all depends, of course, on what we call ‘non-specific’ effects. We all agree that placebo-effects belong to this category. Probably, most experts also would include the therapeutic relationship and the regression towards the mean under this umbrella. But the last three points from my list are clearly not non-specific effects of the therapy; they are therapy-independent determinants of the clinical outcome.

The most important factor here is usually the natural history of the disease. Some people find it hard to imagine what this term actually means. Here is a little joke which, I hope, will make its meaning clear and memorable.

CONVERATION BETWEEN TWO HOSPITAL DOCTORS:

Doc A: The patient from room 12 is much better today.

Doc B: Yes, we stared his treatment just in time; a day later and he would have been cured without it!

I am sure that most of my readers now understand (and never forget) that clinical improvement cannot be equated with the effectiveness of the treatment administered (they might thus be immune to the misleading messages they are constantly exposed to). Yet, I am not at all sure that all ‘alternativists’ have got it.

In my last post, I claimed that researchers of alternative medicine tend to be less than rigorous. I did not link this statement to any evidence at all. Perhaps I should have at least provided an example!? As it happens, I just came across a brand new paper which nicely demonstrates what I meant.

According to its authors, this non-interventional study was performed to generate data on safety and treatment effects of a complex homeopathic drug. They treated 1050 outpatients suffering from common cold with a commercially available homeopathic remedy for 8 days. The study was conducted in 64 German outpatient practices of medical doctors trained in CAM. Tolerability, compliance and the treatment effects were assessed by the physicians and by patient diaries. Adverse events were collected and assessed with specific attention to homeopathic aggravation and proving symptoms. Each adverse effect was additionally evaluated by an advisory board of experts.

The physicians detected 60 adverse events from 46 patients (4.4%). Adverse drug reactions occurred in 14 patients (1.3%). Six patients showed proving symptoms (0.57%) and only one homeopathic aggravation (0.1%) appeared. The rate of compliance was 84% for all groups. The global assessment of the treatment effects resulted in the verdict “good” and “very good” in 84.9% of all patients.

The authors concluded that the homeopathic complex drug was shown to be safe and effective for children and adults likewise. Adverse reactions specifically related to homeopathic principles are very rare. All observed events recovered quickly and were of mild to moderate intensity.

So why do I think this is ‘positively barmy’?

The study had no control group. This means that there is no way anyone can attribute the observed ‘treatment effects’ to the homeopathic remedy. There are many other phenomena that may have caused or contributed to it, e. g.:

  • a placebo effect
  • the natural history of the condition
  • regression to the mean
  • other treatments which the patients took but did not declare
  • the empathic encounter with the physician
  • social desirability

To plan a study with the aim as stated above and to draw the conclusion as cited above is naïve and unprofessional (to say the least) on the part of the researchers (I often wonder where, in such cases, the boundary between incompetence and research misconduct might lie). To pass such a paper through the peer review process is negligent on the part of the reviewers. To publish the article is irresponsible on the part of the editor.

In a nut-shell: COLLECTIVELY, THIS IS ‘POSITIVELY BARMY’!!!

Yoga is a popular form of alternative medicine. Evidence for its effectiveness is scarce and generally far from convincing. But at least it is safe! At least this is what yoga enthusiasts would claim. Unfortunately, this is not entirely true; adverse events have also been reported with some regularity. Their frequency is, however, not known.

A new study was aimed at filling this gap. It was conducted to elucidate the frequencies and characteristics of adverse events of yoga performed in classes and the risk factors of such events.

The subjects were 2508 people taking yoga classes and 271 yoga therapists conducting the classes. A survey for yoga class attendees was performed on adverse events that occurred during a yoga class on the survey day. A survey for yoga therapists was performed on adverse events that the therapists had observed in their students to date. Adverse events were defined as “undesirable symptoms or responses that occurred during a yoga class”.

Among 2508 yoga class attendees, 1343 (53.5%) had chronic diseases and 1063 (42.3%) were receiving medication at hospitals. There were 687 class attendees (27.8%) who reported some type of undesirable symptoms after taking a yoga class. Musculoskeletal symptoms such as myalgia were the most common symptoms, involving 297 cases, followed by neurological symptoms and respiratory symptoms. Most adverse events (63.8%) were mild and did not interfere with class participation. The risk factors for adverse events were examined, and the odds ratios for adverse events were significantly higher in attendees with chronic disease, poor physical condition on the survey day, or a feeling that the class was physically and mentally stressful. In particular, the occurrence of severe adverse events that interfered with subsequent yoga practice was high among elderly participants (70 years or older) and those with chronic musculoskeletal diseases.

The authors concluded that the results of this large-scale survey demonstrated that approximately 30% of yoga class attendees had experienced some type of adverse event. Although the majority had mild symptoms, the survey results indicated that attendees with chronic diseases were more likely to experience adverse events associated with their disease. Therefore, special attention is necessary when yoga is introduced to patients with stress-related, chronic diseases.

I find these findings interesting and thought-provoking. The main question that they raise is, I think, the flowing: ARE THERE ANY CONDITIONS FOR WHICH YOGA DEMONSTRABLY GENERATES MORE GOOD THAN HARM?

Distant healing is one of the most bizarre yet popular forms of alternative medicine. Healers claim they can transmit ‘healing energy’ towards patients to enable them to heal themselves. There have been many trials testing the effectiveness of the method, and the general consensus amongst critical thinkers is that all variations of ‘energy healing’ rely entirely on a placebo response. A recent and widely publicised paper seems to challenge this view.

This article has, according to its authors, two aims. Firstly it reviews healing studies that involved biological systems other than ‘whole’ humans (e.g., studies of plants or cell cultures) that were less susceptible to placebo-like effects. Secondly, it presents a systematic review of clinical trials on human patients receiving distant healing.

All the included studies examined the effects upon a biological system of the explicit intention to improve the wellbeing of that target; 49 non-whole human studies and 57 whole human studies were included.

The combined weighted effect size for non-whole human studies yielded a highly significant (r = 0.258) result in favour of distant healing. However, outcomes were heterogeneous and correlated with blind ratings of study quality; 22 studies that met minimum quality thresholds gave a reduced but still significant weighted r of 0.115.

Whole human studies yielded a small but significant effect size of r = .203. Outcomes were again heterogeneous, and correlated with methodological quality ratings; 27 studies that met threshold quality levels gave an r = .224.

From these findings, the authors drew the following conclusions: Results suggest that subjects in the active condition exhibit a significant improvement in wellbeing relative to control subjects under circumstances that do not seem to be susceptible to placebo and expectancy effects. Findings with the whole human database suggests that the effect is not dependent upon the previous inclusion of suspect studies and is robust enough to accommodate some high profile failures to replicate. Both databases show problems with heterogeneity and with study quality and recommendations are made for necessary standards for future replication attempts.

In a press release, the authors warned: the data need to be treated with some caution in view of the poor quality of many studies and the negative publishing bias; however, our results do show a significant effect of healing intention on both human and non-human living systems (where expectation and placebo effects cannot be the cause), indicating that healing intention can be of value.

My thoughts on this article are not very complimentary, I am afraid. The problems are, it seems to me, too numerous to discuss in detail:

  • The article is written such that it is exceedingly difficult to make sense of it.
  • It was published in a journal which is not exactly known for its cutting edge science; this may seem a petty point but I think it is nevertheless important: if distant healing works, we are confronted with a revolution in the understanding of nature – and surely such a finding should not be buried in a journal that hardly anyone reads.
  • The authors seem embarrassingly inexperienced in conducting and publishing systematic reviews.
  • There is very little (self-) critical input in the write-up.
  • A critical attitude is necessary, as the primary studies tend to be by evangelic believers in and amateur enthusiasts of healing.
  • The article has no data table where the reader might learn the details about the primary studies included in the review.
  • It also has no table to inform us in sufficient detail about the quality assessment of the included trials.
  • It seems to me that some published studies of distant healing are missing.
  • The authors ignored all studies that were not published in English.
  • The method section lacks detail, and it would therefore be impossible to conduct an independent replication.
  • Even if one ignored all the above problems, the effect sizes are small and would not be clinically important.
  • The research was sponsored by the ‘Confederation of Healing Organisations’ and some of the comments look as though the sponsor had a strong influence on the phraseology of the article.

Given these reservations, my conclusion from an analysis of the primary studies of distant healing would be dramatically different from the one published by the authors: DESPITE A SIZABLE AMOUNT OF PRIMARY STUDIES ON THE SUBJECT, THE EFFECTIVENESS OF DISTANT HEALING REMAINS UNPROVEN. AS THIS THERAPY IS BAR OF ANY BIOLOGICAL PLAUSIBILITY, FURTHER RESEARCH IN THIS AREA SEEMS NOT WARRANTED.

Twenty years ago, I published a short article in the British Journal of Rheumatology. Its title was ALTERNATIVE MEDICINE, THE BABY AND THE BATH WATER. Reading it again today – especially in the light of the recent debate (with over 700 comments) on acupuncture – indicates to me that very little has since changed in the discussions about alternative medicine (AM). Does that mean we are going around in circles? Here is the (slightly abbreviated) article from 1995 for you to judge for yourself:

“Proponents of alternative medicine (AM) criticize the attempt of conducting RCTs because they view this is in analogy to ‘throwing out the baby with the bath water’. The argument usually goes as follows: the growing popularity of AM shows that individuals like it and, in some way, they benefit through using it. Therefore it is best to let them have it regardless of its objective effectiveness. Attempts to prove or disprove effectiveness may even be counterproductive. Should RCTs prove that a given intervention is not superior to a placebo, one might stop using it. This, in turn, would be to the disadvantage of the patient who, previous to rigorous research, has unquestionably been helped by the very remedy. Similar criticism merely states that AM is ‘so different, so subjective, so sensitive that it cannot be investigated in the same way as mainstream medicine’. Others see reasons to change the scientific (‘reductionist’) research paradigm into a broad ‘philosophical’ approach. Yet others reject the RCTs because they think that ‘this method assumes that every person has the same problems and there are similar causative factors’.

The example of acupuncture as a (popular) treatment for osteoarthritis, demonstrates the validity of such arguments and counter-arguments. A search of the world literature identified only two RCTs on the subject. When acupuncture was tested against no treatment, the experimental group of osteoarthritis sufferers reported a 23% decrease of pain, while the controls suffered a 12% increase. On the basis of this result, it might seem highly unethical to withhold acupuncture from pain-stricken patients—’if a patient feels better for whatever reason and there are no toxic side effects, then the patient should have the right to get help’.

But what about the placebo effect? It is notoriously difficult to find a placebo indistinguishable to acupuncture which would allow patient-blinded studies. Needling non-acupuncture points may be as close as one can get to an acceptable placebo. When patients with osteoarthritis were randomized into receiving either ‘real acupuncture or this type of sham acupuncture both sub-groups showed the same pain relief.

These findings (similar results have been published for other AMs) are compatible only with two explanations. Firstly acupuncture might be a powerful placebo. If this were true, we need to establish how safe acupuncture is (clearly it is not without potential harm); if the risk/benefit ratio is favourable and no specific, effective form of therapy exists one might still consider employing this form as a ‘placebo therapy’ for easing the pain of osteoarthritis sufferers. One would also feel motivated to research this powerful placebo and identify its characteristics or modalities with the aim of using the knowledge thus generated to help future patients.

Secondly, it could be the needling, regardless of acupuncture points and philosophy, that decreases pain. If this were true, we could henceforward use needling for pain relief—no special training in or equipment for acupuncture would be required, and costs would therefore be markedly reduced. In addition, this knowledge would lead us to further our understanding of basic mechanisms of pain reduction which, one day, might evolve into more effective analgesia. In any case the published research data, confusing as they often are, do not call for a change of paradigm; they only require more RCTs to solve the unanswered problems.

Conducting rigorous research is therefore by no means likely to ‘throw out the baby with the bath water’. The concept that such research could harm the patient is wrong and anti-scientific. To follow its implications would mean neglecting the ‘baby in the bath water’ until it suffers serious damage. To conduct proper research means attending the ‘baby’ and making sure that it is safe and well.

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