MD, PhD, FMedSci, FSB, FRCP, FRCPEd

pain

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Low back pain (LBP) is a ‘minor complaint’ in the sense that it does not cost patients’ lives. At the same time, LBP is amongst the leading causes of disability and one of the most common reasons for patients to seek primary care. Chiropractors, osteopaths, physical therapists and general practitioners are among those treating LBP patients, but there is only limited evidence regarding the effectiveness offered by these provider groups.

The aim of this systematic review was to estimate the clinical effectiveness and to systematically review economic evaluations of chiropractic care compared to other commonly used approaches among adult patients with non-specific LBP.

A comprehensive search strategy was conducted to identify 1) pragmatic randomized clinical trials (RCTs) and/or 2) full economic evaluations of chiropractic care for low back pain compared to standard care delivered by other healthcare providers. Studies published between 1990 and 4th June 2015 were considered. The primary outcomes included pain, functional status and global improvement. Study selection, critical quality appraisal and data extraction were conducted by two independent reviewers. Data from RCTs with low risk of bias were included in a meta-analysis to determine estimates of effect sizes. Cost estimates of full economic evaluations were converted to 2015 USD and results summarized.

Six RCTs and three full economic evaluations were included. Five RCTs with low risk of bias compared chiropractic care to exercise therapy (n = 1), physical therapy (n = 3) and medical care (n = 1). The authors found similar effects for chiropractic care and the other types of care. Three low to high quality full economic evaluations studies (one cost-effectiveness, one cost-minimization and one cost-benefit) compared chiropractic to medical care. Highly divergent conclusions (favours chiropractic, favours medical care, equivalent options) were noted for economic evaluations of chiropractic care compared to medical care.

The authors drew the following conclusions: moderate evidence suggests that chiropractic care for LBP appears to be equally effective as physical therapy. Limited evidence suggests the same conclusion when chiropractic care is compared to exercise therapy and medical care although no firm conclusion can be reached at this time. No serious adverse events were reported for any type of care. Our review was also unable to clarify whether chiropractic or medical care is more cost-effective. Given the limited available evidence, the decision to seek or to refer patients for chiropractic care should be based on patient preference and values. Future studies are likely to have an important impact on our estimates as these were based on only a few admissible studies.

This is a thorough and timely review. Its results are transparent and clear, however, its conclusions are, in my view, more than a little odd.

Let me try to re-formulate them such that they are better supported by the actual data: There is no good evidence to suggest that chiropractic care is better or worse that conventional therapeutic approaches currently used for LBP. The pooled sample size dimensions too small to allow any statements about the risks of the various approaches. The data are also too weak for any pronouncements on the relative cost-effectiveness of the various options. Given these limitations, the decision which approach to use should be based on a more comprehensive analysis of the therapeutic risks.

The point I am trying to make is quite simple:

  • The fact that RCTs fail to show adverse effects could be due to the small collective sample size and/or to the well-known phenomenon that, in well-controlled trials, adverse effects tend to be significantly rarer than in routine care.
  • Hundreds of serious adverse events have been reported after chiropractic spinal manipulations; to these we have to add the fact that ~50% of all chiropractic patients suffer from transient, mild to moderate adverse effects after spinal manipulations.
  • If we want to generate a realistic picture of the safety of a therapy, we need to include case-reports, case-series and other non-RCT evidence.
  • Conventional treatments of LBP may not be free of adverse effects, but some are relatively safe.
  • It seems reasonable, necessary and ethical to consider a realistic picture of the relative risks when deciding which therapy amongst equally (in)effective treatments might be best.

To me, all this seems almost painfully obvious, and I ask myself why the authors of this otherwise sound review failed to consider such thoughts. As one normally is obliged to, the authors included a section about the limitations of their review:

Our review has limitations. First, we did not search the grey literature for clinical effectiveness studies. McAuley et al. showed that the inclusion of results from the grey literature tend to decrease effectiveness estimates in meta-analyses because the unpublished studies tend to report smaller treatment effects. Second, critical appraisal requires scientific judgment that may vary among reviewers. This potential bias was minimized by training reviewers to use a standardized critical appraisal tool and using a consensus process among reviewers to reach decisions regarding scientific admissibility. Most of the original between-group differences and pooled estimates in our meta-analysis did not favour a specific provider group, and we believe it is unlikely that the inclusion of unpublished grey literature would change our conclusions. Third, the low number of clinical trials prevents us from conducting a meaningful investigation for publication bias. Fourth, the majority of the included clinical effectiveness studies (three out of five) and all three economic evaluations were conducted in the United States. Caution should therefore be used when generalizing our findings to other settings or jurisdictions. With respect to economic evaluations in particular, local healthcare systems and insurance plans may have a higher impact on cost than the type of healthcare provider.

Remarkably, this section does not mention their useless assessment of the risks with one word. Why? One answer might be found in the small-print of the paper:

The authors … have the following competing interests: MAB: Personal fees from Ordre des chiropraticiens du Québec for one teaching presentation, outside the submitted work. MJS: Position at the Nordic Institute of Chiropractic and Clinical Biomechanics is funded by the Danish Chiropractic Research Foundation. The Foundation had no role in the study design; in the design and conduct of the study, in the collection, management, analysis, and interpretation of data; in the preparation, review or approval of the manuscript; or in the decision to submit the article for publication. RBDS: Nothing to disclose. JB: Nothing to disclose. PH: Nothing to disclose. AB: Position at the School of Physical and Occupational Therapy at McGill University is funded by the Canadian Chiropractic Research Foundation. The Foundation had no role in the study design; in the design and conduct of the study, in the collection, management, analysis, and interpretation of data; in the preparation, review or approval of the manuscript; or in the decision to submit the article for publication.

In alternative medicine, good evidence is like gold dust and good evidence showing that alternative therapies are efficacious is even rarer. Therefore, I was delighted to come across a brand-new article from an institution that should stand for reliable information: the NIH, no less.

According to its authors, this new article “examines the clinical trial evidence for the efficacy and safety of several specific approaches—acupuncture, manipulation, massage therapy, relaxation techniques including meditation, selected natural product supplements (chondroitin, glucosamine, methylsulfonylmethane, S-adenosylmethionine), tai chi, and yoga—as used to manage chronic pain and related disability associated with back pain, fibromyalgia, osteoarthritis, neck pain, and severe headaches or migraines.”

The results of this huge undertaking are complex, of course, but in a nutshell they are at least partly positive for alternative medicine. Specifically, the authors state that “based on a preponderance of positive trials vs negative trials, current evidence suggests that the following complementary approaches may help some patients manage their painful health conditions: acupuncture and yoga for back pain; acupuncture and tai chi for OA of the knee; massage therapy for neck pain with adequate doses and for short-term benefit; and relaxation techniques for severe headaches and migraine. Weaker evidence suggests that massage therapy, SM, and osteopathic manipulation might also be of some benefit to those with back pain, and relaxation approaches and tai chi might help those with fibromyalgia.”

This is excellent news! Finally, we have data from an authoritative source showing that some alternative treatments can be recommended for common pain conditions.

Hold on, not so fast! Yes, the NIH is a most respectable organisation, but we must not blindly accept anything of importance just because it appears to come form a reputable source. Let’s look a bit closer at the actual evidence provided by the authors of this paper.

Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:

  • the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
  • the authors talk about efficacy but seem to mean effectiveness;
  • the authors only included RCTs from the US which must result in a skewed and incomplete picture;
  • the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
  • not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
  • the discussion of the paper totally lacks any critical thinking;
  • there is no assessment of the quality of the trials included in this review.

My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.

Personally, I find it lamentable that such a potentially worthy exercise ended up employing such lousy methodology. Perhaps even more lamentable is the fact that the NIH (or one of its Centers) can descend that low; to mislead the public in this way borders on scientific misconduct and is, in my view, unethical and unacceptable.

Cranio-sacral therapy has been a subject on this blog before, for instance here, here and here. The authors of this single-blind, randomized trial explain in the introduction of their paper that “cranio-sacral therapy is an alternative and complementary therapy based on the theory that restricted movement at the cranial sutures of the skull negatively affect rhythmic impulses conveyed through the cerebral spinal fluid from the cranium to the sacrum. Restriction within the cranio-sacral system can affect its components: the brain, spinal cord, and protective membranes. The brain is said to produce involuntary, rhythmic movements within the skull. This movement involves dilation and contraction of the ventricles of the brain,  which produce the circulation of the cerebral spinal fluid. The theory states that this fluctuation mechanism causes reciprocal tension within the membranes, transmitting motion to the cranial bones and the sacrum. Cranio-sacral therapy and cranial osteopathic manual therapy originate from the observations made by William G. Sutherland, who said that the bones of the human skeleton have mobility. These techniques are based mainly on the study of anatomic and physiologic mechanisms in the skull and their relation to the body as a whole, which includes a system of diagnostic and therapeutic techniques aimed at treatment and prevention of diseases. These techniques are  based on the so-called primary respiratory movement, which is manifested in the mobility of the cranial bones, sacrum,  dura, central nervous system, and cerebrospinal fluid. The main difference between the two therapies is that cranial osteopathy, in addition to a phase that works in the direction of the lesion (called the functional phase), also uses a phase that worsens the injury, which is called structural phase.”

With this study, the researchers wanted to evaluate the effects of cranio-sacral therapy on disability, pain intensity, quality of life, and mobility in patients with low back pain. Sixty-four patients with chronic non-specific low back pain were assigned to an experimental group receiving 10 sessions of craniosacral therapy, or to the control group receiving 10 sessions of classic massage. Craniosacral therapy took 50 minutes and was conducted as follows: With pelvic diaphragm release, palms are placed in transverse position on the superior aspect of the pubic bone, under  the L5–S1 sacrum, and finger pads are placed on spinal processes.  With respiratory diaphragm release, palms are placed transverse under T12/L1 so that the spine lies along the start of fingers and the border of palm, and the anterior hand is placed on the breastbone. For thoracic inlet release, the thumb and index finger are placed on the opposite sides of the clavicle, with the posterior hand/palm of the hand cupping C7/T1. For the hyoid release, the thumb and index finger are placed on the hyoid, with the index finger on the occiput and the cupping finger pads on the cervical vertebrae. With the sacral technique for stabilizing L5/sacrum, the fingers contact the sulcus and the palm of the hand is in contact with the distal part of the sacral bone. The non-dominant hand of the therapist rested over the pelvis, with one hand on one iliac crest and the elbow/forearm of the other side over the other iliac crest. For CV-4 still point induction, thenar pads are placed under the occipital protuberance, avoiding mastoid sutures.  Classic massage protocol was compounded by the following sequence techniques of soft tissue massage on the  low back: effleurage, petrissage, friction, and kneading. The maneuvers are performed with surface pressure, followed by deep pressure and ending with surface pressure again. The techniques took 30 minutes.

Disability (Roland Morris Disability Questionnaire RMQ, and Oswestry Disability Index) was the primary endpoint. Other outcome measures included the pain intensity (10-point numeric pain rating scale), kinesiophobia (Tampa Scale of Kinesiophobia), isometric endurance of trunk flexor muscles (McQuade test), lumbar mobility in flexion, hemoglobin oxygen saturation, systolic blood pressure, diastolic blood pressure, hemodynamic measures (cardiac index), and biochemical analyses of interstitial fluid. All outcomes were measured at baseline, after treatment, and one-month follow-up.

No statistically significant differences were seen between groups for the main outcome of the study, the RMQ. However, patients receiving craniosacral therapy experienced greater improvement in pain intensity (p ≤ 0.008), hemoglobin oxygen saturation (p ≤ 0.028), and systolic blood pressure (p ≤ 0.029) at immediate- and medium-term and serum potassium (p = 0.023) level and magnesium (p = 0.012) at short-term than those receiving classic massage.

The authors concluded that 10 sessions of cranio-sacral therapy resulted in a statistically greater improvement in pain intensity, hemoglobin oxygen saturation, systolic blood pressure, serum potassium, and magnesium level than did 10 sessions of classic massage in patients with low back pain.

Given the results of this study, the conclusion is surprising. The primary outcome measure failed to show an inter-group difference; in other words, the results of this RCT were essentially negative. To use secondary endpoints – most of which are irrelevant for the study’s aim – in order to draw a positive conclusion seems odd, if not misleading. These positive findings are most likely due to the lack of patient-blinding or to the 200 min longer attention received by the verum patients. They are thus next to meaningless.

In my view, this publication is yet another example of an attempt to turn a negative into a positive result. This phenomenon seems embarrassingly frequent in alternative medicine. It goes without saying that it is not just misleading but also dishonest and unethical.

Acupuncture Today is a much-read online publication for people interested in acupuncture. It informs us that Chinese medicine is quite complex and can be difficult for some people to comprehend. This is because TCM is based, at least in part, on the Daoist belief that we live in a universe in which everything is interconnected. What happens to one part of the body affects every other part of the body. The mind and body are not viewed separately, but as part of an energetic system. Similarly, organs and organ systems are viewed as interconnected structures that work together to keep the body functioning.

To me, this sounds suspiciously woolly. Do they think that conventional healthcare professionals view the various body-parts as separate entities? Do they feel that conventional practitioners see the mind entirely separate from the body? Do they believe others fail to realize that what affects the brain does not affect the rest of the body? These common preconceptions have always puzzled me. Intrigued, I read on.

Elsewhere we learn that Acupuncture Today and acupuncturetoday.com are the only complete news sources in the profession and we don’t take this honor lightly. The acupuncture and Oriental medicine profession is a blend of ancient traditions, healing styles and modern therapies. We provide content that is comprehensive enough to appeal to each of the profession’s diverse groups. In addition, we provide a complete suite of additional products including newsletters, calendars and classifieds that provide our advertisers with the contextual platform they need to communicate with our readers, their customers.

Acupuncture Today seems to reflect a lot of what many acupuncturists want to hear – and thus it might provide us with an important insight into the mind-set of acupuncturists. On their website, I found an article which fascinated me:

START OF QUOTE

A more efficient method for diagnosis and treatment by remote medical dowsing has been found and used in acupuncture with great success. The procedure involves a pendulum, a picture of the patient, an anatomy book, a steel pointer, and a very thin bamboo pointer.

Being a dentist, orthodontist, acupuncturist and dowser, I like to take the liberty of treating a person affected with lockjaw or temporal-mandibular joint ailments via remote dowsing…

…When the mandible cannot open due to a spasm, the chief symptom is pain. Until energy is restored, the muscle cannot lengthen and pain cannot be eliminated. Acupuncture is a good way to correct this condition without the use of a dental appliance. Dentists specializing in treating TMJ use a computerized equipment scan (electrosonography), surface electromyography and the myomonitor to relax the muscles.

Another procedure to treat TMJ is using dowsing. At this point, I will talk about dowsing procedures and information needed to successfully carry out the procedures. Remote dowsing requires the use of the pendulum, a slender bamboo pointer, an anatomy book, a picture of the patient and a steel pointer.

To treat a TMJ patient, the picture of the patient is dowsed holding a pendulum in the right hand while the left hand uses a bamboo pointer to touch the closing and opening muscles individually in the anatomy book. The closing muscles will have good energy (as evidenced by the circular movement of the pendulum) while the lower head of the lateral pterygoid will have no energy (as evidenced by little or no movement of the pendulum). Having advance information on TMJ acupuncture points helps, but these points will have to be tested if needling will supply energy. Master Tong has suggested a point between Liver 2 and Liver 3. I find Spleen 2, a distal point related to the lower head of the lateral pterygoid, to be more effective. This can be checked by having the patient hold the point of the steel pointer so it touches Spleen 2 on the large toe.

To treat a TMJ patient, the picture of the patient is dowsed holding a pendulum in the right hand while the left hand uses a bamboo pointer to touch the closing and opening muscles individually in the anatomy book. The closing muscles will have good energy (as evidenced by the circular movement of the pendulum) while the lower head of the lateral pterygoid will have no energy (as evidenced by little or no movement of the pendulum). Having advance information on TMJ acupuncture points helps, but these points will have to be tested if needling will supply energy. Master Tong has suggested a point between Liver 2 and Liver 3. I find Spleen 2, a distal point related to the lower head of the lateral pterygoid, to be more effective. This can be checked by having the patient hold the point of the steel pointer so it touches Spleen 2 on the large toe.

By dowsing the picture of the patient with the right hand and using a bamboo pointer to touch the lower head of the pterygoid muscle in the anatomy book with the left hand, it will be evident by the circular movement of the pendulum that these muscles now have good energy. This is done before the needle is inserted. In this manner all points can be checked for ailments such as TMJ, stroke, backaches, and neck and shoulder problems before needling. When the needles are placed and after the needling procedure, energy can be checked using the pendulum. By being very accurate on the location of acupuncture points, less treatments will be needed to obtain results. Another point is Small Intestine 19, a local point which is also very effective. Good results are obtained by careful and accurate needling. Therefore, the number of visits are few…

Dowsing is a diagnostic aid that has been used for other situations and can be very helpful to acupuncturists. In conclusion, I feel that remote dowsing is a great approach to diagnosis and treatment.

END OF QUOTE

If I had not seen alternative practitioners doing this procedure with my own eyes, I might have thought the article is a hoax. Sadly, this is the ‘real world’ of alternative medicine.

I tried to find some acupuncturists who had objected to this intense nonsense, but I was not successful in this endeavour. The article was published 6 years ago (no, not on 1 April!), yet so far, nobody has objected.

I have also tried to see whether articles promoting quackery of this nature are rare exceptions in the realm of acupuncture, or whether they are regular occurrences. My impression is that the latter is the case.

What can be concluded from all this?

In a previous post about quackery in chiropractic, I have argued that the tolerance of quackery must be one of the most important hallmarks of a quack profession. As I still believe this to be true, I have to ask to which extend THE TOLERANCE OF SUCH EXTREME QUACKERY MAKES ACUPUNCTURISTS QUACKS?

[I would be most interested to have my readers’ views on this question]

Yesterday, a press-release reached me announcing that a Chinese herbal medicine, ‘Phynova Joint and Muscle Relief Tablets’, containing the active ingredient Sigesbeckia, is now on sale in the UK for the first time in Boots The Chemist: 

Sigesbeckia is the first traditional Chinese treatment granted a traditional herbal registration (THR) under the traditional herbal medicines product directive in the UK, by drug safety watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA).  Oxford based Phynova which manufactures the product was granted the UK licence last year. 

Containing 500mg of the active ingredient, Phynova Joint and Muscle Relief Tablets are specially formulated for the relief of backache, arthritis, minor sports injuries, rheumatic or muscular pains and general aches and pains in muscles or joints.  Two tablets are taken each day, one in the morning and one in the evening. They have no known side effects and are non-addictive. .. 

The product, which retails at £19.99 for one month’s supply of 60 tablets, is available in 950 UK Boots outlets and online via Click and Collect from all stores.  It will be sold both Over the Counter (OTC) by pharmacist staff and off the shelf as part of Boots’ pain relief fixture… 

END OF QUOTE

What on earth is a ‘joint and muscle relief’? Personally I do not want to be relieved of my joints and muscles!!!

Yes, I know, they probably mean ‘joint and muscle pain relief’ but were not allowed to say so because this is a medical indication.

And what about the claim of ‘no side-effects’; is it possible that a pharmacological treatment has positive effects without any risks at all? This is not what they told me during my pharmacology course, if I remember correctly. And anyway, even placebos have side-effects!

I admit, I was puzzled.

The covering letter of the press-release provided more amazement: it informed me that “Phynova joint and muscle relief contains the active ingredient Sigesbeckia which has been through clinical trials and has been used for pain relief in China for hundreds of years…” It was the remark about clinical trials (PLURAL!!!) that caught my interest most.

So, I looked up ‘Sigesbeckia’ on Medline and found as good as nothing. This is mainly because the plant is spelled correctly ‘Siegesbeckia’ in honour of the famous botanist Siegesbeck.

Looking up ‘Siegesbeckia’, I found many pre-clinical studies but no clinical trials.

Next I searched for a comment from the MHRA and discovered that their account makes it very clear that a licence has been granted to this product “exclusively upon long standing use… and not upon data from clinical trials.”

So, who is right?

Are there clinical trials of this product or not? And, if there are any, where are they?

Perhaps someone from Phynova can enlighten us?

 

Chronic pain is a common and serious problem for many patients. Treatment often includes non-pharmacological approaches despite the mostly flimsy evidence to support them. The objective of this study was to measure the feasibility and efficacy of hypnosis (including self-hypnosis) in the management of chronic pain in older hospitalized patients.

A single center randomized controlled trial using a two arm parallel group design (hypnosis versus massage). Inclusion criteria were chronic pain for more than 3 months with impact on daily life activities, intensity of > 4; adapted analgesic treatment; no cognitive impairment. Fifty-three patients were included. Pain intensity decreased significantly in both groups after each session. Average pain measured by the brief pain index sustained a greater decrease in the hypnosis group compared to the massage group during the hospitalization. This was confirmed by the measure of intensity of the pain before each session that decreased only in the hypnosis group over time. Depression scores improved significantly over the time only in the hypnosis group. There was no effect in either group 3 months post hospitals discharge.

The authors concluded that hypnosis represents a safe and valuable tool in chronic pain management of hospitalized older patients. In hospital interventions did not provide long-term post discharge relief.

So, hypnotherapy is better than massage therapy when administered as an adjunct to conventional pain management. As it is difficult to control for placebo effects, which might be substantial in this case, we cannot be sure whether hypnotherapy per se was effective or not.

Who cares? The main thing is to make life easier for these poor patients!

There are situations where I tend to agree with this slightly unscientific but compassionate point of view. Yes, the evidence is flimsy, but we need to help these patients. Hypnotherapy has very few risks, is relatively inexpensive and might help badly suffering individuals. In this case, does it really matter whether the benefit was mediated by a specific or a non-specific mechanism?

The following short passage originates from the abstract of an article that I published in 1998; it is entitled TOWARDS A RISK BENEFIT EVALUATION OF PLACEBOS: the benefits of placebos are often not clearly defined. Generally speaking, the potential for benefit is considerable. The risks are similarly ill defined. Both direct and indirect risks are conceivable. On balance, the risk-benefit relation for placebo could be favourable. Under certain conditions, the clinical use of placebos might therefore be a realistic option. In the final analysis, however, our knowledge for a conclusive risk-benefit evaluation of placebo is incomplete.

Today, I would phrase my conclusion differently: the benefits of placebo therapy are uncertain, while its risks can be considerable. Therefore the use of placebos in clinical routine is rarely justified.

What brought about this change in my attitude?

Lots of things, is the answer; 18 years are a long time in research, and today we know much more about placebo. In my field of inquiry, alternative medicine, we know for instance that, because the mechanisms by which placebos operate are now better understood, some alt med enthusiasts are claiming that placebo effects are real and therefore justify the use of all sorts of placebo treatments, from homeopathy to faith healing. They say that these ineffective (i.e. no better than placebo) therapies are not really ineffective because they help many patients via the well-documented placebo response.

If you are of this opinion, please read the excellent article David Gorski recently published on this issue. Here I want to re-visit my question from above: WHAT DO WE KNOW ABOUT THE RISKS BENEFIT BALANCE OF PLACEBO?

The benefits of placebo can seem impressive on first glance: after receiving placebos, patients can feel better, have less symptoms, need less medication and improve their quality of life. Who would be against any of these outcomes, particularly considering that placebos are usually inexpensive and readily available everywhere?

However, before we get too enthusiastic about the benefits of placebos, we need to consider that they are unreliable. Nobody can predict who will respond to placebo and who won’t. Despite intensive research, it has not been possible to identify placebo-responders as a distinct group of individuals from non-responders. The usefulness of placebos in clinical routine is therefore quite limited. Furthermore, placebo effects are normally only of short duration. Therefore they are not suited for any long-term therapy.

Crucially, placebos almost never effect a cure. They may improve subjective symptoms, but they do not normally cure the disease or remove its causes. A placebo therapy will reduce pain, for instance, and thus it can ease the suffering. If a back pain is caused by a tumour, however, a placebo will not diminish its size or improve the prognosis.

The notion that placebos might cause harm seems paradoxical at first glance. A placebo pill contains no active ingredient – how can it then be harmful? As I have stressed so often before, ANY INEFFECTIVE TREATMENT BECOMES LIFE-THREATENING, IF IT IS USED AS A REPLACEMENT FOR AN EFFECTIVE THERAPY OF A SERIOUS DISEASE. And this warning also applies to placebos, of course.

Seen from this perspective, the much-praised symptomatic relief brought about by a placebo therapy can become a very mixed blessing indeed.

Let’s take the above example of the patient who has back pain. He receives a placebo and subsequently his agony becomes more bearable. Because this approach seems to work, he sticks with it for several month. Eventually the analgesic effect of the placebo wears off and the pain gets too strong to bear. Our patient finally consults a responsible doctor who diagnoses a bone cancer as the cause of his pain. The oncologist who is subsequently consulted regrets that the patient’s prolonged placebo therapy has seriously diminished his chances to cure the cancer.

This may look like an extreme example, but I don’t think it is. Exchange the term ‘placebo’ with almost any alternative treatment, or replace ‘back pain’ and ‘cancer’ with virtually any other conditions, and you will see that such events cannot be rare.

In most instances, placebos may seem helpful but, in fact, they offer little more than the illusion of a cure. They very rarely alter the natural history of a disease and usually achieve little more than a slight, short-term improvement of symptoms. In any case, they are an almost inevitable companion to any well-administered effective treatment. Prescribing pure placebos in clinical routine is therefore not responsible; in most instances, it amounts to fraud.

The two dietary supplements chondroitin and glucosamine have been around for some time. They are being promoted mostly for osteoarthritis; some claim that they reduce pain, others even believe that they restore the damaged cartilage and thus reverse the disease process. But neither for a symptomatic nor causal therapy has the evidence so far been truly convincing. A new trial might change this situation.

This study compared the efficacy and safety of chondroitin sulfate plus glucosamine hydrochloride (CS+GH) versus celecoxib in patients with knee osteoarthritis and severe pain.

 TheDouble-blind Multicentre Osteoarthritis interVEntion trial with SYSADOA’ (MOVES) was conducted in France, Germany, Poland and Spain and evaluated treatment with CS+GH versus celecoxib in 606 patients with Kellgren and Lawrence grades 2–3 knee osteoarthritis and moderate-to-severe pain (Western Ontario and McMaster osteoarthritis index (WOMAC) score ≥301; 0–500 scale). Patients were randomised to receive 400 mg CS plus 500 mg GH three times a day or 200 mg celecoxib every day for 6 months. The primary outcome was the mean decrease in WOMAC pain from baseline to 6 months. Secondary outcomes included WOMAC function and stiffness, visual analogue scale for pain, presence of joint swelling/effusion, rescue medication consumption, Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria and EuroQoL-5D.

The results show that the adjusted mean change (95% CI) in WOMAC pain was −185.7 (−200.3 to −171.1) (50.1% decrease) with CS+GH and −186.8 (−201.7 to −171.9) (50.2% decrease) with celecoxib, meeting the non-inferiority margin of −40: −1.11 (−22.0 to 19.8; p=0.92). All sensitivity analyses were consistent with that result. At 6 months, 79.7% of patients in the combination group and 79.2% in the celecoxib group fulfilled OMERACT-OARSI criteria. Both groups elicited a reduction >50% in the presence of joint swelling; a similar reduction was seen for effusion. No differences were observed for the other secondary outcomes. Adverse events were rare and similarly distributed between groups.

The authors concluded that CS+GH has comparable efficacy to celecoxib in reducing pain, stiffness, functional limitation and joint swelling/effusion after 6 months in patients with painful knee osteoarthritis, with a good safety profile.

This is a rigorous trial, and I do trust its findings. However, I am not entirely sure what they actually mean: is CS+GH as effective or as ineffective as the COX-2-inhibitor celecoxib? The most recent meta-analysis on the subject found that diclofenac (150 mg/day) was likely to be more effective in alleviating pain than celecoxib (200 mg/day). But that does, of course, not necessarily imply that celecoxib is ineffective.

The other big issue here is safety. COX-2-inhibitors had a bad press because of the risk of cardiovascular side-effects. In comparison, the CS+GH supplement is an almost risk-free alternative. Bearing in mind that we are dealing with long-term treatments here, I think the results of this study might persuade me, had I to choose between these two treatments, to opt for the dietary supplement.

No, I kid you not!

This abstract was actually published in the leading chiro-journal. The authors include three professors from the Canadian Memorial Chiropractic College, Research, Toronto, Canada. Its title is impressive but made my alarm bells ring a bit:

A Randomized Pragmatic Clinical Trial of Chiropractic Care for Headaches With and Without a Self-Acupressure Pillow.

And the actual texts does not disappoint those looking for of pure pseudo-science:

The purpose of this study was to determine if the addition of a self-acupressure pillow (SAP) to typical chiropractic treatment results in significantly greater improvement in tension-type and cervicogenic headache sufferers.

METHODS:

A pragmatic randomized clinical trial was conducted in a chiropractic college teaching clinic. Thirty-four subjects, including tension-type and cervicogenic headache sufferers, 21 to 60 years of age, male or female, completed the study. Group A (n = 15) received typical chiropractic care only (manual therapy and exercises), and group B (n = 19) received typical chiropractic care with daily home use of the SAP. The intervention period was 4 weeks. The main outcome measure was headache frequency. Satisfaction and relief scores were obtained from subjects in the SAP group. Analysis of variance was used to analyze the intergroup comparisons.

RESULTS:

Owing to failure of randomization to produce group equivalence on weekly headache frequency, analysis of covariance was performed showing a trend (P = .07) favoring the chiropractic-only group; however, this was not statistically significant. Group A obtained a 46% reduction of weekly headache frequency (t = 3.1, P = .002; d = 1.22). The number of subjects in group A achieving a reduction in headaches greater than 40% was 71%, while for group B, this was 28%. The mean benefit score (0-3) in group B of the use of the SAP was 1.2 (.86). The mean satisfaction rating of users of the SAP was 10.4 (2.7) out of 15 (63%).

CONCLUSION:

This study suggests that chiropractic care may reduce frequency of headaches in patients with chronic tension-type and cervicogenic headache. The use of a self-acupressure pillow (Dr Zaxx device) may help those with headache and headache pain relief as well as producing moderately high satisfaction with use.

Where to begin?

Perhaps it is best, if I simply concentrated on the bizarre research question: is chiropractic care plus the largely uncontrolled use of an ‘acupressure cushion’ better than chiropractic care alone? To savour the lunacy of it, we need to consider that:

  • chiropractic is not plausible;
  • chiropractic care is not proven to be effective for headaches;
  • acupressure is not plausible;
  • acupressure is not proven to be effective;
  • a self-administered acupressure cushion is also unproven and even less plausible;

This, I fear, renders the study one of the most nonsensical trials I have seen for a very long time. To make the bonanza in pseudo-science complete, the article is supplemented with a most bizarre conclusion about the effectiveness of chiropractic (which, of cause, cannot be examined in a trial of chiro vs chiro).

All this leads me to fear that:

  • the best journal of chiropractic is rubbish;
  • a professorship in a chiro school may not mean that the professor has the slightest idea about research methodology;
  • chiropractors will try to squeeze a conclusion that is favourable for their trade even out of a dead horse.

Bach flower remedies (BFR) are amazingly popular. They have been the subject of posts on this blog before (see here and here, for instance). They are as dilute as most homeopathic remedies and just as implausible. All the rigorous trials that have tested BFR have so far been squarely negative. Here is a truly surprising new study where BFR was administered externally which would seem to make an effect not more but less likely.

A randomized, placebo-controlled clinical trial was conducted with the aim of evaluating the effectiveness of a cream based on BFR for symptoms of carpal tunnel syndrome. Forty-three patients with mild to moderate carpal tunnel syndrome during their “waiting” time for surgical option were randomized into 3 parallel groups: Placebo (n = 14), blinded BFR (n = 16), and non-blinded BFR (n = 13). These groups were treated during 21 days with topical placebo or a cream based on BFR.

Significant improvements were observed on self-reported symptom severity and pain intensity favorable to BFR groups with large effect sizes. In addition, all signs observed during the clinical exam showed significant improvements among the groups as well as symptoms of pain, night pain, and tingling, also with large effect sizes (φ > 0.5). Finally, there were significant differences between the blinded and non-blinded BFR groups for signs and pain registered in clinical exam but not in self-reports.

The Cuban authors of this study concluded that the proposed BFR cream could be an effective intervention in the management of mild and moderate carpal tunnel syndrome, reducing the severity symptoms and providing pain relief.

This is truly amazing, not least because there is not much that we can offer such patients except for surgery which usually is very successful. The current Cochrane review of non-surgical interventions for carpal tunnel syndrome shows significant short-term benefit from oral steroids, splinting, ultrasound, yoga and carpal bone mobilisation. Other non-surgical treatments do not produce significant benefit. More trials are needed to compare treatments and ascertain the duration of benefit.

What then should we make of the new study?

I have to admit, I am not sure. It was published in one of the worst journals I know which has attracted our attention on this blog before. It was published by authors from Cuba who I know nothing about. More importantly, its findings sound far too good to be true.

If I had been the editor in charge, I would have asked for the original data and had them re-analysed by an independent statistician. As we cannot do that, our only option is to apply common sense and wait for an independent replication before conceding that BFR are effective.

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