The present trial evaluated the efficacy of homeopathic medicines of Melissa officinalis (MO), Phytolacca decandra (PD), and the combination of both in the treatment of possible sleep bruxism (SB) in children (grinding teeth during sleep).
Patients (n = 52) (6.62 ± 1.79 years old) were selected based on the parents report of SB. The study comprised a crossover design that included 4 phases of 30-day treatments (Placebo; MO 12c; PD 12c; and MO 12c + PD 12c), with a wash-out period of 15 days between treatments.
At baseline and after each phase, the Visual Analogic Scale (VAS) was used as the primary outcome measure to evaluate the influence of treatments on the reduction of SB. The following additional outcome measures were used: a children’s sleep diary with parent’s/guardian’s perceptions of their children’s sleep quality, the trait of anxiety scale (TAS) to identify changes in children’s anxiety profile, and side effects reports. Data were analyzed by ANOVA with repeated measures followed by Post Hoc LSD test.
Significant reduction of SB was observed in VAS after the use of Placebo (-1.72 ± 0.29), MO (-2.36 ± 0.36), PD (-1.44 ± 0.28) and MO + PD (-2.21 ± 0.30) compared to baseline (4.91 ± 1.87). MO showed better results compared to PD (p = 0.018) and Placebo (p = 0.050), and similar result compared to MO+PD (p = 0.724). The sleep diary results and TAS results were not influenced by any of the treatments. No side effects were observed after treatments.
The authors concluded that MO showed promising results in the treatment of possible sleep bruxism in children, while the association of PD did not improve MO results.
Even if one fully subscribed to the principles of homeopathy, this trial raises several questions:
- Why was it submitted and then published in the journal ‘Phytotherapy’. All the remedies were given as C12 potencies. This has nothing to do with phytomedicine.
- Why was a cross-over design chosen? According to homeopathic theory, a homeopathic treatment has fundamental, long-term effects which last much longer than the wash-out periods between treatment phases. This effectively rules out such a design as a means of testing homeopathy.
- MO is used in phytomedicine to induce sleep and reduce anxiety. According to the homeopathic ‘like cures like’ assumption, this would mean it ought to be used homeopathically to treat sleepiness or for keeping patients awake or for making them anxious. How can it be used for sleep bruxism?
Considering all this, I ask myself: should we trust this study and its findings?
What do you think?
I am being told to educate myself and rethink the subject of NAPRAPATHY by the US naprapath Dr Charles Greer. Even though he is not very polite, he just might have a point:
Edzard, enough foolish so-called scientific, educated assesments from a trained Allopathic Physician. When asked, everything that involves Alternative Medicine in your eyesight is quackery. Fortunately, every Medically trained Allopathic Physician does not have your points of view. I have partnered with Orthopaedic Surgeons, Medical Pain Specialists, General practitioners, Thoracic Surgeons, Forensic Pathologists and Others during the course, whom appreciate the Services that Naprapaths provide. Many of my current patients are Medical Physicians. Educate yourself. Visit a Naprapath to learn first hand. I expect your outlook will certainly change.
I have to say, I am not normally bowled over by anyone who calls me an ‘allopath’ (does Greer not know that Hahnemann coined this term to denigrate his opponents? Is he perhaps also in favour of homeopathy?). But, never mind, perhaps I was indeed too harsh on naprapathy in my previous post on this subject.
So, let’s try again.
Just to remind you, naprapathy was developed by the chiropractor Oakley Smith who had graduated under D D Palmer in 1899. Smith was a former Iowa medical student who also had investigated Andrew Still’s osteopathy in Kirksville, before going to Palmer in Davenport. Eventually, Smith came to reject Palmer’s concept of vertebral subluxation and developed his own concept of “the connective tissue doctrine” or naprapathy.
Dr Geer published a short article explaining the nature of naprapathy:
Naprapathy- A scientific, Evidence based, integrative, Alternative form of Pain management and nutritional assessment that involves evaluation and treatment of Connective tissue abnormalities manifested in the entire human structure. This form of Therapeutic Regimen is unique specifically to the Naprapathic Profession. Doctors of Naprapathy, pronounced ( nuh-prop-a-thee) also referred to as Naprapaths or Neuromyologists, focus on the study of connective tissue and the negative factors affecting normal tissue. These factors may begin from external sources and latently produce cellular changes that in turn manifest themselves into structural impairments, such as irregular nerve function and muscular contractures, pulling its’ bony attachments out of proper alignment producing nerve irritability and impaired lymphatic drainage. These abnormalities will certainly produce a pain response as well as swelling and tissue congestion. Naprapaths, using their hands, are trained to evaluate tissue tension findings and formulate a very specific treatment regimen which produces positive results as may be evidenced in the patients we serve. Naprapaths also rely on information obtained from observation, hands on physical examination, soft tissue Palpatory assessment, orthopedic evaluation, neurological assessment linked with specific bony directional findings, blood and urinalysis laboratory findings, diet/ Nutritional assessment, Radiology test findings, and other pertinent clinical data whose information is scrutinized and developed into a individualized and specific treatment plan. The diagnostic findings and results produced reveal consistent facts and are totally irrefutable. The deductions that formulated these concepts of theory of Naprapathic Medicine are rationally believable, and have never suffered scientific contradiction. Discover Naprapathic Medicine, it works.
What interests me most here is that naprapathy is evidence-based. Did I perhaps miss something? As I cannot totally exclude this possibility, I did another Medline search. I found several trials:
1st study (2007)
Four hundred and nine patients with pain and disability in the back or neck lasting for at least 2 weeks, recruited at 2 large public companies in Sweden in 2005, were included in this randomized controlled trial. The 2 interventions were naprapathy, including spinal manipulation/mobilization, massage, and stretching (Index Group) and support and advice to stay active and how to cope with pain, according to the best scientific evidence available, provided by a physician (Control Group). Pain, disability, and perceived recovery were measured by questionnaires at baseline and after 3, 7, and 12 weeks.
At 7-week and 12-week follow-ups, statistically significant differences between the groups were found in all outcomes favoring the Index Group. At 12-week follow-up, a higher proportion in the naprapathy group had improved regarding pain [risk difference (RD)=27%, 95% confidence interval (CI): 17-37], disability (RD=18%, 95% CI: 7-28), and perceived recovery (RD=44%, 95% CI: 35-53). Separate analysis of neck pain and back pain patients showed similar results.
This trial suggests that combined manual therapy, like naprapathy, might be an alternative to consider for back and neck pain patients.
2nd study (2010)
Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409), recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (Index Group), and advice to stay active and on how to cope with pain, provided by a physician (Control Group). Pain intensity, disability and health status were measured by questionnaires.
89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD) = 21%, 95% CI: 10-30) and disability (RD = 11%, 95% CI: 4-22) at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, 95% CI: 7-27 and disability: RD = 17%, 95% CI: 5-28). The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p < or = 0.005). There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status) favoring the Index Group.
Combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck pain.
3rd study (2016)
Participants were recruited among patients, ages 18-65, seeking care at the educational clinic of Naprapathögskolan – the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 1057) were randomized to one of three treatment arms a) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage), b) manual therapy excluding spinal manipulation and c) manual therapy excluding stretching. The primary outcomes were minimal clinically important improvement in pain intensity and pain related disability. Treatments were provided by naprapath students in the seventh semester of eight total semesters. Generalized estimating equations and logistic regression were used to examine the association between the treatments and the outcomes.
At 12 weeks follow-up, 64% had a minimal clinically important improvement in pain intensity and 42% in pain related disability. The corresponding chances to be improved at the 52 weeks follow-up were 58% and 40% respectively. No systematic differences in effect when excluding spinal manipulation and stretching respectively from the treatment were found over 1 year follow-up, concerning minimal clinically important improvement in pain intensity (p = 0.41) and pain related disability (p = 0.85) and perceived recovery (p = 0.98). Neither were there disparities in effect when male and female patients were analyzed separately.
The effect of manual therapy for male and female patients seeking care for neck and/or back pain at an educational clinic is similar regardless if spinal manipulation or if stretching is excluded from the treatment option.
I don’t know about you, but I don’t call this ‘evidence-based’ – especially as all the three trials come from the same research group (no, not Greer; he seems to have not published at all on naprapathy). Dr Greer does clearly not agree with my assessment; on his website, he advertises treating the following conditions:
Chronic Neck Pain
Hip Muscle Strain
Knee Ligament Injuries
Lower Back Injuries
Lumbar Herniated Disc
Lumbar Spinal Stenosis
Sciatica (Not Due to Disc Displacement)
Sciatica (Not Due to Disc Displacement)
Sports Injuries of the Knee
Tennis Elbow (Lateral Epicondylitis)
Thoracic Disc Disorders
Thoracic Outlet Syndrome
Odd, I’d say! Did all this change my mind about naprapathy? Not really.
But nobody – except perhaps Dr Greer – can say I did not try.
And what light does this throw on Dr Greer and his professionalism? Since he seems to be already quite mad at me, I better let you answer this question.
My friend Roger, the homeopath, alerted me to the ‘Self-Controlled Energo Neuro Adaptive Regulation‘ (SCENAR). He uses it in his practice and explains:
The scenar uses biofeedback; by stimulating the nervous system, it is able to teach the body to heal itself. The device sends out a series of signals through the skin and measures the response. Each signal is only sent out when a change, in response to the previous signal, is recorded in the electrical properties of the skin. Visible responses include reddening of the skin, numbness, stickiness (the device will have the feeling of being magnetically dragged), a change in the numerical readout and an increase in the electronic clattering of the device.
The C-fibres, which comprise 85% of all nerves in the body, react most readily to the electro-stimulation and are responsible for the production of neuropeptides and other regulatory peptides. A TENS unit will only stimulate the A & B-fibres for temporary relief.
The body can get accustomed to a stable pathological state, which may have been caused by injury, disease or toxicity. The Scenar catalyses the process to produce regulatory peptides for the body to use where necessary, by stimulation of C-fibres . It is these neuropeptides that in turn reestablish the body’s natural physiological state and are responsible for the healing process. As these peptides last up to several hours, the healing process will continue long after the treatment is over. The large quantity of neuropeptides and C-fibres in the Central Nervous System can also result in the treatment on one area aiding with other general regulatory processes, like chemical imbalances, correcting sleeplessness, appetite and behavioral problems.
Sounds like science fiction?
Or perhaps more like BS?
But, as always, the proof of the pudding is in the eating. Roger explains:
What conditions can Scenar treat?
In the UK, the devices are licensed by the British Standards Institute for pain relief only. Likewise the FDA has approved the Scenar for pain relief. However, because of the nature of the device, viz., stimulating the nervous system, the Russian experience is that Scenar affects all the body systems in a curative manner.
The Russian experience suggests that it can be effective for a very broad range of diseases, including diseases of the digestive, cardio-vascular, respiratory, musculo-skeletal, urinary, reproductive and nervous systems. It is also useful for managing ENT diseases, eye diseases, skin conditions and dental problems. It has also been found beneficial in burns, fractures, insect bites, allergic reactions, diseases of the blood and disorders involving immune mechanisms; endocrine, nutritional and metabolic disorders; stress and mental depression, etc.
It is known to give real relief from many types of pain. It does so because it stimulates the body to heal the underlying disease causing the pain!
Another SCENAR therapist is much more specific. He tells us that SCENAR is effective for:
- Sports and other injuries
- Musculoskeletal problems
- Issues with circulation
- Respiratory diseases
- Digestive disorders
- Certain infections
- Immune dysfunctions
Perhaps I was a bit hasty; perhaps the SCENAR does work after all. It is certainly offered by many therapists like Roger. They cannot all be charlatans, or can they?
Time to do a proper Medline search and find out about the clinical trials that have been done with the SCENAR. Disappointingly, I only found three relevant papers; here they are:
A new technique of low-frequency modulated electric current therapy, SCENAR therapy, was used in treatment of 103 patients with duodenal ulcer (DU). The influence of SCENAR therapy on the main clinical and functional indices of a DU relapse was studied. It was shown that SCENAR therapy, which influences disturbed mechanisms of adaptive regulation and self-regulation, led to positive changes in most of the parameters under study. Addition of SCENAR therapy to the complex conventional pharmacotherapy fastened ulcer healing, increased the effectiveness of Helicobacter pylori eradication, and improved the condition of the gastroduodenal mucosa.
Administration of artrofoon in combination with SCENAR therapy to patients with localized suppurative peritonitis in the postoperative period considerably reduced plasma MDA level, stabilized ceruloplasmin activity, and increased catalase activity in erythrocytes compared to the corresponding parameters in patients receiving standard treatment in combination with SCENAR therapy.
The author recommends a self-control energoneuroadaptive regulator (SCENAR) as effective in the treatment of neurogenic dysfunction of the bladder in children with nocturnal enuresis. This regulator operates according to the principles of Chinese medicine and may be used in sanatoria and at home by the children’s parents specially trained by physiotherapist.
While the quantity of the ‘studies’ is lamentable, their quality seems quite simply unacceptable.
We are thus left with two possibilities: either the SCENAR is more or less what its proponents promise and the science has for some strange reason not caught up with this reality; or the reality is that SCENAR is a bogus treatment used by charlatans who exploit the gullible public.
I know which possibility I favour – how about you?
A new update of the current Cochrane review assessed the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain. The authors included all randomised controlled trials (RCTs) examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded.
The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months.
Forty-seven RCTs including a total of 9211 participants were identified. Most trials compared SMT with recommended therapies. In 16 RCTs, the therapists were chiropractors, in 14 they were physiotherapists, and in 5 they were osteopaths. They used high velocity manipulations in 18 RCTs, low velocity manipulations in 12 studies and a combination of the two in 20 trials.
Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief and a small, clinically better improvement in function. High quality evidence suggested that, compared with non-recommended therapies, SMT results in small, not clinically better effects for short term pain relief and small to moderate clinically better improvement in function.
In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy.
Low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at six and 12 months. Low quality evidence suggested that SMT results in a moderate to strong statistically significant and clinically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically significant better effect than sham SMT at six and 12 months.
(Mean difference in reduction of pain at 1, 3, 6, and 12 months (0-100; 0=no pain, 100 maximum pain) for spinal manipulative therapy (SMT) versus recommended therapies in review of the effects of SMT for chronic low back pain. Pooled mean differences calculated by DerSimonian-Laird random effects model.)
About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event or duration of the event compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT.
The authors concluded that SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.
This paper is currently being celebrated (mostly) by chiropractors who think that it vindicates their treatments as being both effective and safe. However, I am not sure that this is entirely true. Here are a few reasons for my scepticism:
- SMT is as good as other recommended treatments for back problems – this may be so but, as no good treatment for back pain has yet been found, this really means is that SMT is as BAD as other recommended therapies.
- If we have a handful of equally good/bad treatments, it stand to reason that we must use other criteria to identify the one that is best suited – criteria like safety and cost. If we do that, it becomes very clear that SMT cannot be named as the treatment of choice.
- Less than half the RCTs reported adverse effects. This means that these studies were violating ethical standards of publication. I do not see how we can trust such deeply flawed trials.
- Any adverse effects of SMT were minor, restricted to the short term and mainly centred on musculoskeletal effects such as soreness and stiffness – this is how some naïve chiro-promoters already comment on the findings of this review. In view of the fact that more than half the studies ‘forgot’ to report adverse events and that two serious adverse events did occur, this is a misleading and potentially dangerous statement and a good example how, in the world of chiropractic, research is often mistaken for marketing.
- Less than half of the studies (45% (n=21/47)) used both an adequate sequence generation and an adequate allocation procedure.
- Only 5 studies (10% (n=5/47)) attempted to blind patients to the assigned intervention by providing a sham treatment, while in one study it was unclear.
- Only about half of the studies (57% (n=27/47)) provided an adequate overview of withdrawals or drop-outs and kept these to a minimum.
- Crucially, this review produced no good evidence to show that SMT has effects beyond placebo. This means the modest effects emerging from some trials can be explained by being due to placebo.
- The lead author of this review (SMR), a chiropractor, does not seem to be free of important conflicts of interest: SMR received personal grants from the European Chiropractors’ Union (ECU), the European Centre for Chiropractic Research Excellence (ECCRE), the Belgian Chiropractic Association (BVC) and the Netherlands Chiropractic Association (NCA) for his position at the Vrije Universiteit Amsterdam. He also received funding for a research project on chiropractic care for the elderly from the European Centre for Chiropractic Research and Excellence (ECCRE).
- The second author (AdeZ) who also is a chiropractor received a grant from the European Chiropractors’ Union (ECU), for an independent study on the effects of SMT.
After carefully considering the new review, my conclusion is the same as stated often before: SMT is not supported by convincing evidence for back (or other) problems and does not qualify as the treatment of choice.
Osteopathy is a tricky subject:
- Osteopathic manipulations/mobilisations are advocated mainly for spinal complaints.
- Yet many osteopaths use them also for a myriad of non-spinal conditions.
- Osteopathy comprises two entirely different professions; in the US, osteopaths are very similar to medically trained doctors, and many hardly ever employ osteopathic manual techniques; outside the US, osteopaths are alternative practitioners who use mainly osteopathic techniques and believe in the obsolete gospel of their guru Andrew Taylor Still (this post relates to the latter type of osteopathy).
- The question whether osteopathic manual therapies are effective is still open – even for the indication that osteopaths treat most, spinal complaints.
- Like chiropractors, osteopaths now insist that osteopathy is not a treatment but a profession; the transparent reason for this argument is to gain more wriggle-room when faced with negative evidence regarding they hallmark treatment of osteopathic manipulation/mobilisation.
A new paper authored by osteopaths is an attempt to shed more light on the effectiveness of osteopathy. The aim of this systematic review evaluated the impact of osteopathic care for spinal complaints. Only randomized controlled trials conducted in high-income Western countries were considered. Two authors independently screened the titles and abstracts. Primary outcomes included ‘pain’ and ‘functional status’, while secondary outcomes included ‘medication use’ and ‘health status’.
Nineteen studies were included and qualitatively synthesized. Nine studies were from the US, followed by Germany with 7 studies. The majority of studies (n = 13) focused on low back pain.
In general, mixed findings related to the impact of osteopathic care on primary and secondary outcomes were observed. For the primary outcomes, a clear distinction between US and European studies was found, where the latter RCTs reported positive results more frequently. Studies were characterized by substantial methodological differences in sample sizes, number of treatments, control groups, and follow-up.
The authors concluded that “the findings of the current literature review suggested that osteopathic care may improve pain and functional status in patients suffering from spinal complaints. A clear distinction was observed between studies conducted in the US and those in Europe, in favor of the latter. Today, no clear conclusions of the impact of osteopathic care for spinal complaints can be drawn. Further studies with larger study samples also assessing the long-term impact of osteopathic care for spinal complaints are required to further strengthen the body of evidence.”
Some of the most obvious weaknesses of this review include the following:
- In none of the studies employed blinding of patients, care provider or outcome assessor occurred, or it was unclear. Blinding of outcome assessors is easily implemented and should be standard in any RCT.
- In three studies, the study groups differed to some extent at baseline indicating that randomisation was not successful..
- Five studies were derived from the ‘grey literature’ and were therefore not peer-reviewed.
- One study (the UK BEAM trial) employed not just osteopaths but also chiropractors and physiotherapists for administering the spinal manipulations. It is therefore hardly an adequate test of osteopathy.
- The study was funded by an unrestricted grant from the GNRPO, the umbrella organization of the ‘Belgian Professional Associations for Osteopaths’.
Considering this last point, the authors’ honesty in admitting that no clear conclusions of the impact of osteopathic care for spinal complaints can be drawn is remarkable and deserves praise.
Considering that the evidence for osteopathy is even far worse for non-spinal conditions (numerous trials exist for all sorts of other conditions, but they tend to be flimsy and usually lack independent replications), it is fair to conclude that osteopathy is NOT an evidence-based therapy.
Crohn’s disease (CD) is an inflammatory bowel disease characterized by recurring flares altered by periods of inactive disease and remission, affecting physical and psychological aspects and quality of life (QoL). The aim of this study was to determine the therapeutic benefits of soft non-manipulative osteopathic techniques in patients with CD.
A randomized controlled trial was performed. It included 30 individuals with CD who were divided into 2 groups: 16 in the experimental group (EG) and 14 in the control group (CG). The EG was treated with the 6 manual techniques depicted below. All patients were advised to continue their prescribed medications and diets. The intervention period lasted 30 days (1 session every 10 days). Pain, global quality of life (GQoL) and QoL specific for CD (QoLCD) were assessed before and after the intervention. Anxiety and depression levels were measured at the beginning of the study.
A significant effect was observed of the treatment in both the physical and task subscales of the GQoL and also in the QoLCD but not in pain score. When the intensity of pain was taken into consideration in the analysis of the EG, there was a significantly greater increment in the QoLCD after treatment in people without pain than in those with pain. The improvements in GQoL were independent from the disease status.
The authors concluded that soft, non-manipulative osteopathic treatment is effective in improving overall and physical-related QoL in CD patients, regardless of the phase of the disease. Pain is an important factor that inversely correlates with the improvements in QoL.
Where to begin?
Here are some of the most obvious flaws of this study:
- It was far too small for drawing any far-reaching conclusions.
- Because the sample size was so small, randomisation failed to create two comparable groups.
- Sub-group analyses are based on even smaller samples and thus even less meaningful.
- The authors call their trial a ‘single-blind’ study but, in fact, neither the patients nor the therapists (physiotherapists) were blind.
- The researchers were physiotherapists, their treatments were mostly physiotherapy. It is therefore puzzling why they repeatedly call them ‘osteopathic’.
- It also seems unclear why these and not some other soft tissue techniques were employed.
- The CG did not receive additional treatment at all; no attempt was thus made to control for placebo effects.
- The stated aim to determine the therapeutic benefits… seems to be a clue that this study was never aimed at rigorously testing the effectiveness of the treatments.
My conclusion therefore is (yet again) that poor science has the potential to mislead and thus harm us all.
Chronic back pain is often a difficult condition to treat. Which option is best suited?
A review by the US ‘Agency for Healthcare Research and Quality’ (AHRQ) focused on non-invasive nonpharmacological treatments for chronic pain. The following therapies were considered:
- mind-body practices,
- psychological therapies,
- multidisciplinary rehabilitation,
- mindfulness practices,
- manual therapies,
- physical modalities,
Here, I want to share with you the essence of the assessment of spinal manipulation:
- Spinal manipulation was associated with slightly greater effects than sham manipulation, usual care, an attention control, or a placebo intervention in short-term function (3 trials, pooled SMD -0.34, 95% CI -0.63 to -0.05, I2=61%) and intermediate-term function (3 trials, pooled SMD -0.40, 95% CI -0.69 to -0.11, I2=76%) (strength of evidence was low)
- There was no evidence of differences between spinal manipulation versus sham manipulation, usual care, an attention control or a placebo intervention in short-term pain (3 trials, pooled difference -0.20 on a 0 to 10 scale, 95% CI -0.66 to 0.26, I2=58%), but manipulation was associated with slightly greater effects than controls on intermediate-term pain (3 trials, pooled difference -0.64, 95% CI -0.92 to -0.36, I2=0%) (strength of evidence was low for short term, moderate for intermediate term).
This seems to confirm what I have been saying for a long time: the benefit of spinal manipulation for chronic back pain is close to zero. This means that the hallmark therapy of chiropractors for the one condition they treat more often than any other is next to useless.
But which other treatments should patients suffering from this frequent and often agonising problem employ? Perhaps the most interesting point of the AHRQ review is that none of the assessed nonpharmacological treatments are supported by much better evidence for efficacy than spinal manipulation. The only two therapies that seem to be even worse are traction and ultrasound (both are often used by chiropractors). It follows, I think, that for chronic low back pain, we simply do not have a truly effective nonpharmacological therapy and consulting a chiropractor for it does make little sense.
What else can we conclude from these depressing data? I believe, the most rational, ethical and progressive conclusion is to go for those treatments that are associated with the least risks and the lowest costs. This would make exercise the prime contender. But it would definitely exclude spinal manipulation, I am afraid.
And this beautifully concurs with the advice I recently derived from the recent Lancet papers: walk (slowly and cautiously) to the office of your preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.
In 1995, Dabbs and Lauretti reviewed the risks of cervical manipulation and compared them to those of non-steroidal, anti-inflammatory drugs (NSAIDs). They concluded that the best evidence indicates that cervical manipulation for neck pain is much safer than the use of NSAIDs, by as much as a factor of several hundred times. This article must be amongst the most-quoted paper by chiropractors, and its conclusion has become somewhat of a chiropractic mantra which is being repeated ad nauseam. For instance, the American Chiropractic Association states that the risks associated with some of the most common treatments for musculoskeletal pain—over-the-counter or prescription nonsteroidal anti-inflammatory drugs (NSAIDS) and prescription painkillers—are significantly greater than those of chiropractic manipulation.
As far as I can see, no further comparative safety-analyses between cervical manipulation and NSAIDs have become available since this 1995 article. It would therefore be time, I think, to conduct new comparative safety and risk/benefit analyses aimed at updating our knowledge in this important area.
Meanwhile, I will attempt a quick assessment of the much-quoted paper by Dabbs and Lauretti with a view of checking how reliable its conclusions truly are.
The most obvious criticism of this article has already been mentioned: it is now 23 years old, and today we know much more about the risks and benefits of these two therapeutic approaches. This point alone should make responsible healthcare professionals think twice before promoting its conclusions.
Equally important is the fact that we still have no surveillance system to monitor the adverse events of spinal manipulation. Consequently, our data on this issue are woefully incomplete, and we have to rely mostly on case reports. Yet, most adverse events remain unpublished and under-reporting is therefore huge. We have shown that, in our UK survey, it amounted to exactly 100%.
To make matters worse, case reports were excluded from the analysis of Dabbs and Lauretti. In fact, they included only articles providing numerical estimates of risk (even reports that reported no adverse effects at all), the opinion of exerts, and a 1993 statistic from a malpractice insurer. None of these sources would lead to reliable incidence figures; they are thus no adequate basis for a comparative analysis.
In contrast, NSAIDs have long been subject to proper post-marketing surveillance systems generating realistic incidence figures of adverse effects which Dabbs and Lauretti were able to use. It is, however, important to note that the figures they did employ were not from patients using NSAIDs for neck pain. Instead they were from patients using NSAIDs for arthritis. Equally important is the fact that they refer to long-term use of NSAIDs, while cervical manipulation is rarely applied long-term. Therefore, the comparison of risks of these two approaches seems not valid.
Moreover, when comparing the risks between cervical manipulation and NSAIDs, Dabbs and Lauretti seemed to have used incidence per manipulation, while for NSAIDs the incidence figures were bases on events per patient using these drugs (the paper is not well-constructed and does not have a methods section; thus, it is often unclear what exactly the authors did investigate and how). Similarly, it remains unclear whether the NSAID-risk refers only to patients who had used the prescribed dose, or whether over-dosing (a phenomenon that surely is not uncommon with patients suffering from chronic arthritis pain) was included in the incidence figures.
It is worth mentioning that the article by Dabbs and Lauretti refers to neck pain only. Many chiropractors have in the past broadened its conclusions to mean that spinal manipulations or chiropractic care are safer than drugs. This is clearly not permissible without sound data to support such claims. As far as I can see, such data do not exist (if anyone knows of such evidence, I would be most thankful to let me see it).
To obtain a fair picture of the risks in a real life situation, one should perhaps also mention that chiropractors often fail to warn patients of the possibility of adverse effects. With NSAIDs, by contrast, patients have, at the very minimum, the drug information leaflets that do warn them of potential harm in full detail.
Finally, one could argue that the effectiveness and costs of the two therapies need careful consideration. The costs for most NSAIDs per day are certainly much lower than those for repeated sessions of manipulations. As to the effectiveness of the treatments, it is clear that NSAIDs do effectively alleviate pain, while the evidence seems far from being conclusively positive in the case of cervical manipulation.
In conclusion, the much-cited paper by Dabbs and Lauretti is out-dated, poor quality, and heavily biased. It provides no sound basis for an evidence-based judgement on the relative risks of cervical manipulation and NSAIDs. The notion that cervical manipulations are safer than NSAIDs is therefore not based on reliable data. Thus, it is misleading and irresponsible to repeat this claim.
Most chiropractors claim they can effectively treat a wide range of conditions. I have looked far and wide but I fail to see sound evidence to show that this assumption is true. On a good day, I might agree that chiropractic works for back pain (but this would need to be a very good day and I would need to close at least one eye) – and that’s basically it! Unsurprisingly, chiropractors vehemently disagree with me. Yet, they have an all too obvious conflict of interest in that question and, therefore, they are unlikely to be objective.
One regular commentator of this blog recently reminded me that the UK ‘ADVERTISING STANDARDS AUTHORITY’ (ASA) state on their website that based on all evidence submitted and reviewed to date, the ASA and CAP accept that chiropractors may claim to treat the following conditions:
- Ankle sprain (short term management)
- Elbow pain and tennis elbow (lateral epicondylitis) arising from associated musculoskeletal conditions of the back and neck, but not isolated occurrences
- Headache arising from the neck (cervicogenic
- Joint pains
- Joint pains including hip and knee pain from osteoarthritis as an adjunct to core OA treatments and exercise
- General, acute & chronic backache, back pain (not arising from injury or accident)
- Generalised aches and pains
- Mechanical neck pain (as opposed to neck pain following injury i.e. whiplash)
- Migraine prevention
- Minor sports injuries
- Muscle spasms
- Plantar fasciitis (short term management)
- Rotator cuff injuries, disease or disorders
- Shoulder complaints (dysfunction, disorders and pain)
- Soft tissue disorders of the shoulder
- Tension and inability to relax
This is an impressive yet very odd list:
- Why is ‘joint pain’ listed twice?
- Can lateral epicondylitis arise from musculoskeletal conditions of the back and neck?
- What exactly are ‘generalised aches and pains’?
- Isn’t lumbago and backache the same?
- Are ‘minor sports injuries’ (including a cut, bruise or haematoma?) a category that is well-defined?
- What is a ‘soft tissue disorders of the shoulder’
But let’s not be pedantic. Let’s assume these are all defined conditions that need to be treated. The problem still remains that there is hardly any good evidence that they can be effectively treated by chiropractic spinal manipulation (in case you disagree, please post the evidence in the comments section).
And here we come to the crux of the matter, I think.
Chiropractors would say that they use so much more than spinal manipulations.
- For a sport injury, they might apply an ice-pack.
- For the inability to relax, they might give a massage.
- For rotator cuff problems, they might administer exercises.
- For tennis elbow, they might recommend immobilizing the joint.
- Etc., etc.
But that’s not chiropractic!
Yes, it is what we do, insist the chiropractors.
I do not doubt it, but survey after survey shows that chiropractors treat almost all their patients with spinal manipulation. And the history of chiropractic is purely based on spinal manipulation. Yes, today they also use treatments borrowed from other disciplines, yet spinal manipulation is the treatment that defines them.
Let me try an example to make my point clear. Imagine a surgeon who specialises in an obsolete type of operation (e.g. ligation of the mammary artery as a treatment of coronary artery disease). Following the chiro-logic, he could claim that:
- my approach is not ineffective because I do so much more than just operate,
- I also prescribe medications,
- I give dietary advice,
- I give nutritional advice,
- I recommend relaxation,
- I suggest regular exercise.
And the results would, of course, show that many of his patients benefit from all this.
Does that mean our surgeon provides effective care for his patients?
Similarly, crystal healing could be seen as being effective, because some crystal healers tell their obese patients to eat less and exercise more?
So, the above-cited list of claims that the ASA now allows UK chiropractors to make is either way too long or much too short – in any case, it is nonsense. If we base it on the proven effectiveness of spinal manipulation, it must be very short indeed. If we base it on everything chiropractors might do in addition, it is far too short; in this case, it should include everything in the medical textbooks from AIDS to ZOSTER (I cannot imagine many conditions for which life-style advice, exercise or cryotherapy [for pain-control] etc. would not be helpful).
My conclusions from all this are as follows:
- Chiropractors have tried to reinvent themselves by borrowing some treatments from other healthcare professions.
- They have done this, I suspect, to avoid being judged by their largely ineffective hallmark intervention, spinal manipulation. The move may be commercially clever, but it is nevertheless transparently nonsensical and wholly unconvincing.
- Chiropractors must be judged not by the treatments they borrowed and might use occasionally, but by the only therapy that is inherent to chiropractic: spinal manipulation.
- And spinal manipulation is certainly not effective for a wide range of conditions.
Lumbar spinal stenosis (LSS) is a common reason for spine surgery. Several non-surgical LSS treatment options are also available, but their effectiveness remains unproven. The objective of this study was to explore the comparative clinical effectiveness of three non-surgical interventions for patients with LSS:
- medical care,
- group exercise,
- individualised exercise plus manual therapy.
All interventions were delivered during 6 weeks with follow-up at 2 months and 6 months at an outpatient research clinic. Patients older than 60 years with LSS were recruited from the general public. Eligibility required anatomical evidence of central canal and/or lateral recess stenosis (magnetic resonance imaging/computed tomography) and clinical symptoms associated with LSS (neurogenic claudication; less symptoms with flexion). Analysis was intention to treat.
Medical care consisted of medications and/or epidural injections provided by a physiatrist. Group exercise classes were supervised by fitness instructors. Manual therapy/individualized exercise consisted of spinal mobilization, stretches, and strength training provided by chiropractors and physical therapists. The primary outcomes were between-group differences at 2 months in self-reported symptoms and physical function measured by the Swiss Spinal Stenosis questionnaire (score range, 12-55) and a measure of walking capacity using the self-paced walking test (meters walked for 0 to 30 minutes).
A total of 259 participants were allocated to medical care (n = 88), group exercise (n = 84), or manual therapy/individualized exercise (n = 87). Adjusted between-group analyses at 2 months showed manual therapy/individualized exercise had greater improvement of symptoms and physical function compared with medical care or group exercise. Manual therapy/individualized exercise had a greater proportion of responders (≥30% improvement) in symptoms and physical function (20%) and walking capacity (65.3%) at 2 months compared with medical care (7.6% and 48.7%, respectively) or group exercise (3.0% and 46.2%, respectively). At 6 months, there were no between-group differences in mean outcome scores or responder rates.
The authors concluded that a combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity.
In many ways, this is a fairly rigorous study; in one important way, however, it is odd. One can easily see why one group received the usual standard care (except perhaps for the fact that standard medical care should also include exercise). I also understand why one group attended group exercise. Yet, I fail to see the logic in the third intervention, individualised exercise plus manual therapy.
Individualised exercise is likely to be superior to group exercise. If the researchers wanted to test this hypothesis, they should not have added the manual therapy. If they wanted to find out whether manual therapy is better that the other two treatments, they should not have added individualised exercise. As it stands, they cannot claim that either manual therapy or individualised exercise are effective (yet, I am sure that the chiropractic fraternity will claim that this study shows their treatment to be indicated for LSS [three of the authors are chiropractors and the 1st author seems to have a commercial interest in the matter!]).
Manual therapy procedures used in this trial included:
- lumbar distraction mobilization,
- hip joint mobilization,
- side posture lumbar/sacroiliac joint mobilization,
- and neural mobilization.
Is there any good reason to assume that these interventions work for LSS? I doubt it!
And this is what makes the new study odd, in my view. Assuming I am correct in speculating that individualised exercise is better than group exercise, the trial would have yielded a similarly positive result, if the researchers had offered, instead of the manual therapy, a packet of cigarettes, a cup of tea, a chocolate bar, or swinging a dead cat. In other words, if someone had wanted to make a useless therapy appear to be effective, they could not have chosen a better trial design.
And why do I find such studies objectionable?
Mainly because they deliberately mislead many of us. In the present case, many non-critical observers might conclude that manual therapy is effective for LSS. Yet, the truth could well be that it is useless or even harmful (assuming that the effect size of individualised exercise is large, adding a harmful therapy would still render the combination effective). To put it bluntly, such trials
- could harm patients,
- might waste money,
- and hinder progress.