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.
The ‘Double-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.
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.
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%).
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.
Today the GUARDIAN published an article promoting acupuncture on the NHS. The article is offensively misleading, I think, and therefore deserves a comment. I write these comments with a heavy heart, I should add, because the GUARDIAN is by far my favourite UK daily. In the following, I will cite key passages from the article in question and add my comments in bold.
Every woman needing pain relief while giving birth at University College London hospital (UCLH) is offered acupuncture, with around half of the hospital’s midwives specially trained to give the treatment. UCLH is far from typical in this respect, though: acupuncture is not standard throughout the UK and many health practitioners claim patients are often denied access to it through the NHS because of entrenched scepticism from sections of the medical establishment.
Entrenched scepticism? I would say that it could be perhaps be related to the evidence. The conclusions of the current Cochrane review on acupuncture for labour pain are cautious and do not seem strong enough to issue a general recommendation for general use in childbirth: “acupuncture and acupressure may have a role with reducing pain, increasing satisfaction with pain management and reduced use of pharmacological management. However, there is a need for further research.”
“There are conditions for which acupuncture works and others where it doesn’t. It is not a cure-all, and should be open to scrutiny. But the focus of my work is for acupuncture to become a standard part of midwifery training, and at the same time change perceptions among clinicians about its appropriate use for a whole range of other conditions.”
Open to scrutiny indeed! And if we scrutinise the evidence critically – rather than engaging in uncritical and arguably irresponsible promotion – we find that the evidence is not nearly as convincing as acupuncture fans try to make us believe.
The UK lags behind many other European countries in its support for acupuncture. Just 2,500 medical professionals here are qualified to practice it, compared with 45,000 in Germany. The National Institute for Clinical Excellence (Nice) recommends WMA specifically for the treatment of only two conditions – lower back pain (which costs the NHS £1bn a year) and headaches.
Yes, the UK also lags behind Germany in the use of leeches and other quackery. The ‘ad populum’ fallacy is certainly popular in alternative medicine – but surely, it is still a fallacy!
A growing body of healthcare practitioners believe it should be offered routinely for a variety of conditions, including pain in labour, cancer, musculoskeletal conditions and even irritable bowel syndrome (IBS).
Here we go, belief as a substitute for evidence and fallacies as a replacement of logical arguments. I had thought the GUARDIAN was better than this!
At a time of NHS cuts the use of needles at 8p per unit look attractive. In St Albans, where a group of nurse-led clinics have been using acupuncture since 2008 for patients with knee osteoarthritis, economics have been put under scrutiny. WMA was offered to 114 patients rather than a knee replacement costing £5,000, and 79% accepted. Two years later a third of them had not required a knee transplant, representing an annual saving of £100,000, as estimated by researchers to the St Albans local commissioning group.
This looks a bit like a ‘back of an envelope’ analysis. I would like to see this published in a reputable journal and see it scrutinised by a competent health economist.
So why is acupuncture not being used more widely? The difficulty of proving its efficacy is clearly one of the biggest stumbling blocks. An analysis of 29 studies of almost 18,000 patients found acupuncture effective in treating chronic pain compared with sham acupuncture.
This passage refers to an analysis by Vickers et al. It was severely and repeatedly criticised for being too optimistic and, more importantly, it is not nearly as positive as implied here. Its conclusions are in fact quite cautious: “acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.”
But even treatment proponents question whether a randomised controlled trial – the gold standard of medical research – works, given that faking treatment is nearly impossible.
What do you mean ‘even treatment proponents’? It is only proponents who question these sham needles! The reason: they frequently do not generate the results acupuncture fans had hoped for.
The article is clearly not the GUARDIAN’s finest hour. It lacks even a tinge of critical assessment. This is regrettable, I think, particularly as the truth about acupuncture is not that difficult to transmit to the public:
- Much of the research is of woefully poor quality.
- Its effectiveness is not proven beyond doubt for a single condition.
- Serious adverse effects have been reported.
- Because it requires substantial amounts of therapist time, it also is not cheap.
Wet cupping is a therapy traditionally used in several cultures. It involves superficial injuries to the skin and subsequently the application of a vacuum cup over the injured site. This procedure would draw a small amount of blood into the cup, and this visible effect was taken as a sign that the humors or life forces or whatever are being restored.
The treatment is obviously painful and carries the risk of infection. But does it work? There are not many clinical trials of this form of alternative medicine, and I was therefore thrilled to find a new paper with a randomised clinical trial.
The aim of this clinical trial was to evaluate the effectiveness and safety of wet cupping therapy as the sole treatment for persistent nonspecific low back pain (PNSLBP). The investigators recruited 80 with PNSLBP lasting at least 3 months and randomly allocated them to an intervention group (n=40) or to a control group (n=40). The experimental group had 6 wet cupping sessions within 2 weeks, each of which were done at two bladder meridian (BL) acupuncture points. The control group had no such treatments. Acetaminophen was allowed as a rescue treatment in both groups. The Numeric Rating Scale (NRS), McGill Present Pain Intensity (PPI), and Oswestry Disability Questionnaire (ODQ) were used as outcome measures. Numbers of acetaminophen tablets taken were compared at 4 weeks from baseline. Adverse events were recorded.
At the end of the intervention, statistically significant differences in all three outcome measures favouring the wet cupping group compared with the control group were seen. These improvements continued for another two weeks after the end of the intervention. Acetaminophen was used less in the wet cupping group, but this difference was not statistically significant. No adverse events were reported.
The authors concluded that wet cupping is potentially effective in reducing pain and improving disability associated with PNSLBP at least for 2 weeks after the end of the wet cupping period. Placebo-controlled trials are needed.
Every now and then – well, actually in alternative medicine this is not so rare an event – I come across a study that ‘smells to high heaven’. This one certainly does; to be precise, it has the stench of TOO GOOD TO BE TRUE.
Apart from the numerous weaknesses of the study design, there is the fact that the results are do simply not seem plausible. Low back pain has a natural history that is well-studied. We therefore know that the majority of cases do get better fairly quickly regardless of whether we treat them or not. In this study, the control group did not improve at all, as shown on the impressive graph below (the grey line depicts the symptoms in the control group and the black one those of the cupping group).
To me, the improvement of the experimental group looks much like one might expect from the natural history of back pain. If this were true, the effect of wet cupping would by close to zero and the conclusion drawn by the authors of this trial would be false-positive.
But why was there no improvement in the control group?
I do not know the answer to this question. All I know is that it is this unexplained phenomenon which has created the impression of effectiveness of wet cupping.
Much has been written on this blog and elsewhere about the risks of spinal manipulation. It relates almost exclusively to the risks of manipulating patients’ necks. There is far less on the safety of thrust joint manipulation (TJM) when applied to the thoracic spine. A new paper focusses on this specific topic.
The purpose of this review was to retrospectively analyse documented case reports in the literature describing patients who had experienced severe adverse events (AE) after receiving TJM to their thoracic spine.
Case reports published in peer reviewed journals were searched in Medline (using Ovid Technologies, Inc.), Science Direct, Web of Science, PEDro (Physiotherapy Evidence Database), Index of Chiropractic literature, AMED (Allied and Alternative Medicine Database), PubMed and the Cumulative Index to Nursing and Allied Health (CINHAL) from January 1950 to February 2015.
Case reports were included if they: (1) were peer-reviewed; (2) were published between 1950 and 2015; (3) provided case reports or case series; and (4) had TJM as an intervention. The authors only looked at serious complications, not at the much more frequent transient AEs after spinal manipulations. Articles were excluded if: (1) the AE occurred without TJM (e.g. spontaneous); (2) the article was a systematic or literature review; or (3) it was written in a language other than English or Spanish. Data extracted from each case report included: gender; age; who performed the TJM and why; presence of contraindications; the number of manipulation interventions performed; initial symptoms experienced after the TJM; as well as type of severe AE that resulted.
Ten cases, reported in 7 articles, were reviewed. Cases involved females (8) more than males (2), with mean age being 43.5 years. The most frequent AE reported was injury (mechanical or vascular) to the spinal cord (7/10); pneumothorax and hematothorax (2/10) and CSF leak secondary to dural sleeve injury (1/10) were also reported.
The authors point out that there were only a small number of case reports published in the literature and there may have been discrepancies between what was reported and what actually occurred, since physicians dealing with the effects of the AE, rather than the clinician performing the TJM, published the cases.
The authors concluded that serious AE do occur in the thoracic spine, most commonly, trauma to the spinal cord, followed by pneumothorax. This suggests that excessive peak forces may have been applied to thoracic spine, and it should serve as a cautionary note for clinicians to decrease these peak forces.
These are odd conclusions, in my view, and I think I ought to add a few points:
- As I stated above, the actual rate of experiencing AEs after having chiropractic spinal manipulations is much larger; it is around 50%.
- Most complications on record occur with chiropractors, while other professions are far less frequently implicated.
- The authors’ statement about ‘excessive peak force’ is purely speculative and is therefore not a legitimate conclusion.
- As the authors mention, it is hardly ever the chiropractor who reports a serious complication when it occurs.
- In fact, there is no functioning reporting scheme where the public might inform themselves about such complications.
- Therefore their true rate is anyone’s guess.
- As there is no good evidence that thoracic spinal manipulations are effective for any condition, the risk/benefit balance for this intervention fails to be positive.
- Many consumers believe that a chiropractor will only manipulate in the region where they feel pain; this is not necessarily true – they will manipulate where they believe to diagnose ‘SUBLUXATIONS’, and that can be anywhere.
- Finally, I would not call a review that excludes all languages other than English and Spanish ‘systematic’.
And my conclusion from all this? THORACIC SPINAL MANIPULATIONS CAN CAUSE CONSIDERABLE HARM AND SHOULD BE AVOIDED.
Regular readers of this blog will be aware of the many bogus claims made by chiropractors. One claim, however, namely the one postulating chiropractors can effectively treat low back pain with spinal manipulation, is rarely viewed as being bogus. Chiropractors are usually able to produce evidence that does suggest the claim to be true, and therefore even most critics of chiropractic back off on this particular issue.
But is the claim really true?
A recent trial might provide the answer.
The purpose of this study was to compare the effectiveness of chiropractic spinal manipulative therapy (cSMT) to a sham intervention on pain (Visual Analogue Scale, SF-36 pain subscale), disability (Oswestry Disability Index), and physical function (SF-36 subscale, Timed Up and Go) by performing a randomized placebo-controlled trial at 2 Veteran Affairs Clinics.
Older veterans (≥ 65 years of age) who were naive to chiropractic were recruited. A total of 136 who suffered from chronic low back pain (LBP) were included in the study – with 69 being randomly assigned to cSMT and 67 to the sham intervention. Patients were treated twice per week for 4 weeks. The outcomes were assessed at baseline, 5, and 12 weeks post baseline.
Both groups demonstrated significant decrease in pain and disability at 5 and 12 weeks. At 12 weeks, there was no significant difference in pain and a statistically significant decline in disability scores in the cSMT group when compared to the control group. There were no significant differences in adverse events between the groups.
The authors concluded that cSMT did not result in greater improvement in pain when compared to our sham intervention; however, cSMT did demonstrate a slightly greater improvement in disability at 12 weeks. The fact that patients in both groups showed improvements suggests the presence of a nonspecific therapeutic effect.
Hold on, I hear you say, this does not mean that cSMT is a placebo in the treatment of LBP! There are other studies that yield positive results. Let’s not cherry-pick our evidence!
Absolutely correct! To avoid cherry-picking, lets see what the current Cochrane review tells us about cSMT and chronic LBP. Here is the conclusion of this review based on 26 RCTs: High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain.
Nonspecific neck pain is extremely common, often disabling, and very costly for us all. If we believe those who earn their money with them, effective treatments for the condition abound. One of these therapies is osteopathy. But does osteopathic manipulation/mobilisation really work?
The objective of a recent review (the link I originally put in here does not work, I will supply a new one as soon as the article becomes available on Medline) was to find out. Specifically, the authors wanted to assess the effectiveness of osteopathic manipulative treatment (OMT) in the management of chronic nonspecific neck pain regarding pain, functional status, and adverse events.
Electronic literature searches unrestricted by language were performed in March 2014. A manual search of reference lists and personal communication with experts identified additional studies. Only randomized clinical trials (RCTs) were included, and studies of specific neck pain or single treatment techniques were excluded. Primary outcomes were pain and functional status, and secondary outcome was adverse events.
Studies were independently reviewed using a standardized data extraction form. Mean difference (MD) or standard mean difference (SMD) with 95% confidence intervals (CIs) and overall effect size were calculated for primary outcomes. GRADE was used to assess quality of the evidence.
Of 299 identified articles, 18 were evaluated and 15 excluded. The three included RCTs had low risk of bias. The results show that moderate-quality evidence suggested OMT had a significant and clinically relevant effect on pain relief (MD: -13.04, 95% CI: -20.64 to -5.44) in chronic nonspecific neck pain, and moderate-quality evidence suggested a non-significant difference in favour of OMT for functional status (SMD: -0.38, 95% CI: -0.88 to -0.11). No serious adverse events were reported.
The authors concluded that, based on the three included studies, the review suggested clinically relevant effects of OMT for reducing pain in patients with chronic nonspecific neck pain. Given the small sample sizes, different comparison groups, and lack of long-term measurements in the few available studies, larger, high-quality randomized controlled trials with robust comparison groups are recommended.
Yet again I am taken aback by several things simultaneously:
- the extreme paucity of RCTs, particularly considering that neck pain is one of the main indication for osteopaths,
- the rather uncritical text by the authors,
- the nonsensical conclusions.
Let me offer my own conclusions which are, I hope, a little more realistic:
GIVEN THE PAUCITY OF THE RCTs AND THEIR SMALL SAMPLE SIZES, IT IS NOT POSSIBLE TO CLAIM THAT OMT FOR NONSPECIFIC NECK PAIN IS AN EVIDENCE-BASED APPROACH
The purpose of this study was to evaluate the impact of early and guideline adherent physical therapy for low back pain on utilization and costs within the Military Health System (MHS).
Patients presenting to a primary care setting with a new complaint of LBP from January 1, 2007 to December 31, 2009 were identified from the MHS Management Analysis and Reporting Tool. Descriptive statistics, utilization, and costs were examined on the basis of timing of referral to physical therapy and adherence to practice guidelines over a 2-year period. Utilization outcomes (advanced imaging, lumbar injections or surgery, and opioid use) were compared using adjusted odds ratios with 99% confidence intervals. Total LBP-related health care costs over the 2-year follow-up were compared using linear regression models.
753,450 eligible patients with a primary care visit for LBP between 18-60 years of age were considered. Physical therapy was utilized by 16.3% (n = 122,723) of patients, with 24.0% (n = 17,175) of those receiving early physical therapy that was adherent to recommendations for active treatment. Early referral to guideline adherent physical therapy was associated with significantly lower utilization for all outcomes and 60% lower total LBP-related costs.
The authors concluded that the potential for cost savings in the MHS from early guideline adherent physical therapy may be substantial. These results also extend the findings from similar studies in civilian settings by demonstrating an association between early guideline adherent care and utilization and costs in a single payer health system. Future research is necessary to examine which patients with LBP benefit early physical therapy and determine strategies for providing early guideline adherent care.
These are certainly interesting data. Because LBP is such a common condition, it costs us all dearly. Measures to reduce this burden in suffering and expense are urgently needed. The question is whether early referral to a physiotherapist is such a measure. The present data show that this is possible but they do not prove it.
I applaud the authors for realising this point and discussing it at length: The results of this study should be examined in light of the following limitations. Given the favorable natural history of LBP, many patients improve regardless of treatment. Those referred to physical therapy early are also more likely to have a shorter duration of pain, thus the potential for selection bias to have influenced these results. We accounted for a number of co-morbidities available in the data set and excluded patients with prior visits for LBP to mitigate against this possibility. However, the retrospective observational design of this study imposes limitations on extending the associations we observed to causation. Although we attempted to exclude patients with a specific spinal pathology, it is possible that a few patients may have been inadvertently included in the data set, in which case advanced imaging may be indicated. Additionally, although our results support that early physical therapy which adheres to practice guidelines may be less resource intense, we cannot conclude without patient-centered clinical outcomes (i.e., pain, function, disability, satisfaction, etc.) that the care was more cost effective. Further, it may be that the standard we used to judge adherence to practice guidelines (CPT codes) was not sufficiently sensitive to determine whether care is consistent with clinical practice guidelines. We also did not account for indirect or out-of-pocket costs for treatments such as complementary care, which is common for LBP. However, it is likely that the observed effects on total costs would have been even larger had these costs been considered.
I was originally alerted to this paper through a tweet claiming that these results demonstrate that chiropractic has an important role in LBP. However, the study does not even imply such a conclusion. It is, of course, true that many chiropractors use physical therapies. But they do not have the same training as physiotherapists and they tend to use spinal manipulations far more frequently. Virtually every LBP-patient consulting a chiropractor would be treated with spinal manipulations. As this approach is neither based on sound evidence nor free of risks, the conclusion, in my view, cannot be to see chiropractors for LBP; it must be to consult a physiotherapist.