pain
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and can lead to serious complications. Therapeutic strategies for pain control are available but there are few approaches that influence neurological deficits such as numbness.
This study investigated the effectiveness of acupuncture on improving neurological deficits in patients suffering from type 2 DPN.
The acupuncture in DPN (ACUDPN) study was a two-armed, randomized, controlled, parallel group, open, multicenter clinical trial. Patients were randomized in a 1:1 ratio into two groups: The acupuncture group received 12 acupuncture treatments over 8 wk, and the control group was on a waiting list during the first 16 wk, before it received the same treatment as the other group. Both groups received routine care.
Outcome parameters were evaluated after 8, 16 and 24 wk. They included:
- neurological scores, such as an 11-point numeric rating scale (NRS) for hypesthesia,
- neuropathic pain symptom inventory (NPSI),
- neuropathy deficit score (NDS),
- neuropathy symptom score (NSS);
- nerve conduction studies (NCS) as assessed with a handheld point-of-care device.
Sixty-two participants were included. The NRS for numbness showed a difference of 2.3 (P < 0.001) in favor of the acupuncture group, the effect persisted until week 16 with a difference of 2.2 (P < 0.001) between groups and 1.8 points at week 24 compared to baseline. The NPSI was improved in the acupuncture group by 12.6 points (P < 0.001) at week 8, the NSS score at week 8 with a difference of 1.3 (P < 0.001); the NDS and the TNSc score improved for the acupuncture group in week 8, with a difference of 2.0 points (P < 0.001) compared to the control group. Effects were persistent in week 16 with a difference of 1.8 points (P < 0.05). The NCS showed no meaningful changes. In both groups only minor side effects were reported.
The authors concluded that acupuncture may be beneficial in type 2 diabetic DPN and seems to lead to a reduction in neurological deficits. No serious adverse events were recorded and the adherence to treatment was high. Confirmatory randomized sham-controlled clinical studies with adequate patient numbers are needed to confirm the results.
That “acupuncture may be beneficial” has been known before and presumably was the starting point of the present study. So, why conduct an open, under-powered trial with non-blind assessors and without defining a primary outcome measure?
Could the motivation be to add yet another false-positive study to the literature of acupuncture?
False-positive, you ask?
Yes, let me explain by having a look at the outcome measures:
- NRS = a subjective endpoint.
- NPSI = a subjective endpoint.
- NDS = a subjective endpoint.
- NSS = a subjective endpoint.
- NCS = the only objective endpoint.
And what is remarkable about that?
- Subjective endpoints are likely to respond to placebo effects.
- Objective endpoints are not likely to respond to placebo effects.
In other words, what the authors of this study have, in fact, confirmed with their study is this:
acupuncture is a theatrical placebo!
Since the introduction of their new Education Standards in March 2023, the General Chiropractic Council (GCC) has been working with chiropractic education providers to support them in implementing the changes to their curricula. Recently, the GCC have stated this:
We expect students to be taught evidence-based practice: integrating individual clinical expertise, the best available evidence from current and credible clinical research, and the values and preferences of patients. Chiropractors are important members of a patient’s healthcare team, and interprofessional approaches enable the best outcomes. Programmes that meet these Standards will teach ethical, professional care and produce competent healthcare professionals who can serve the needs of patients.
These are indeed most encouraging words!
Basically, they are saying that chiropractic education will now have to be solidly based on the principles of evidence-based medicine (EBM) as well as sound medical ethics. Let me spell out what this really means. Chiropractic courses must teach that:
- The current and credible clinical evidence suggesting that spinal manipulations, the hallmark intervention of chiropractors, are effective is weak for back pain and negative or absent for all other conditions.
- The current and credible clinical evidence suggests that spinal manipulations, the hallmark intervention of chiropractors, can cause harm which in many instances is serious.
- The current and credible clinical evidence thus suggests that the risk/benefit balance for spinal manipulations, the hallmark intervention of chiropractors, is not positive.
- Medical ethics require that competent healthcare professionals inform their patients that spinal manipulations, the hallmark intervention of chiropractors, may not generate more good than harm which is the reason why they cannot employ these therapies.
So, the end of chiropractic in the UK is looming!
Unless, of course, the GCC’s words are not really meant to be translated into action. They could be just window dressing and politically correct bullshit. But that’ s really far too far fetched – after all they come from the GENERAL CHIROPRACTIC COUNCIL, known for its excellent track record, e.g.:
- The GCC “seems to be a little self-regulatory chiropractic bubble where chiropractors regulate chiropractors.”
- A 5-year strategy for UK chiropractors: not fit for purpose
- Chiro behaving badly… is the GCC fit for purpose?
- The UK General Chiropractic Council: fit for purpose?
- Farcical Chiropractic Council: Chiropractic Patient Satisfaction and Experience
- The General Chiropractic Council “regulates chiropractors to ensure the safety of patients” … well, you could have fooled me!
- Death of a chiropractic patient prompts a reaction by the UK General Chiropractic Council
The WHO has just released guidelines for non-surgical management of chronic primary low back pain (CPLBP). The guideline considers 37 types of interventions across five intervention classes. With the guidelines, WHO recommends non-surgical interventions to help people experiencing CPLBP. These interventions include:
- education programs that support knowledge and self-care strategies;
- exercise programs;
- some physical therapies, such as spinal manipulative therapy (SMT) and massage;
- psychological therapies, such as cognitive behavioural therapy; and
- medicines, such as non-steroidal anti-inflammatory medicines.
The guidelines also outline 14 interventions that are not recommended for most people in most contexts. These interventions should not be routinely offered, as WHO evaluation of the available evidence indicate that potential harms likely outweigh the benefits. WHO advises against interventions such as:
- lumbar braces, belts and/or supports;
- some physical therapies, such as traction;
- and some medicines, such as opioid pain killers, which can be associated with overdose and dependence.
As you probably guessed, I am particularly intrigued by the WHO’s positive recommendation for SMT. Here is what the guideline tells us about this specific topic:
Considering all adults, the guideline development group (GDG) judged overall net benefits [of spinal manipulation] across outcomes to range from trivial to moderate while, for older people the benefit was judged to be largely uncertain given the few trials and uncertainty of evidence in this group. Overall, harms were judged to be trivial to small for all adults and uncertain for older people due to lack of evidence.
The GDG commented that while rare, serious adverse events might occur with SMT, particularly in older people (e.g. fragility fracture in people with bone loss), and highlighted that appropriate training and clinical vigilance concerning potential harms are important. The GDG also acknowledged that rare serious adverse events were unlikely to be detected in trials. Some GDG members considered that the balance of benefits to harms favoured SMT due to small to moderate benefits while others felt the balance did not favour SMT, mainly due to the very low certainty evidence for some of the observed benefits.
The GDG judged the overall certainty of evidence to be very low for all adults, and very low for older people, consistent with the systematic review team’s assessment. The GDG judged that there was likely to be important uncertainty or variability among people with CPLBP with respect to their values and preferences, with GDG members noting that some people might prefer manual
therapies such as SMT, due to its “hands-on” nature, while others might not prefer such an approach.
Based on their experience and the evidence presented from the included trials which offered an average of eight treatment sessions, the GDG judged that SMT was likely to be associated with moderate costs, while acknowledging that such costs and the equity impacts from out-of-pocket costs would vary by setting.
The GDG noted that the cost-effectiveness of SMT might not be favourable when patients do not experience symptom improvements early in the treatment course. The GDG judged that in most settings, delivery of SMT would be feasible, although its acceptability was likely to vary across
health workers and people with CPLBP.
The GDG reached a consensus conditional recommendation in favour of SMT on the basis of small to moderate benefits for critical outcomes, predominantly pain and function, and the likelihood of rare adverse events.
The GDG concluded by consensus that the likely short-term benefits outweighed potential harms, and that delivery was feasible in most settings. The conditional nature of the recommendation was informed by variability in acceptability, possible moderate costs, and concerns that equity might be negatively impacted in a user-pays model of financing.
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This clearly is not a glowing endorsement or recommendation of SMT. Yet, in my view, it is still too positive. In particular, the assessment of harm is woefully deficient. Looking into the finer details, we find how the GDG assessed harms:
WHO commissioned quantitative systematic evidence syntheses of randomized controlled
trials (RCTs) to evaluate the benefits and harms (as reported in included trials) of each of the
prioritized interventions compared with no care (including trials where the effect of an
intervention could be isolated), placebo or usual care for each of the critical outcomes (refer to Table 2 for the PICO criteria for selecting evidence). Research designs other than RCTs
were not considered.
That explains a lot!
It is not possible to establish the harms of SMT (or any other therapy) on the basis of just a few RCTs, particularly because the RCTs in question often fail to report adverse events. I can be sure of this phenomenon because we investigated it via a systematic review:
Objective: To systematically review the reporting of adverse effects in clinical trials of chiropractic manipulation.
Data sources: Six databases were searched from 2000 to July 2011. Randomised clinical trials (RCTs) were considered, if they tested chiropractic manipulations against any control intervention in human patients suffering from any type of clinical condition. The selection of studies, data extraction, and validation were performed independently by two reviewers.
Results: Sixty RCTs had been published. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors.
Conclusions: Adverse effects are poorly reported in recent RCTs of chiropractic manipulations.
The GDG did not cite our review (or any other of our articles on the subject) but, as it was published in a very well-known journal, they must have been aware of it. I am afraid that this wilfull ignorance caused the WHO guideline to underestimate the level of harm of SMT. As there is no post-marketing surveillance system for SMT, a realistic assessment of the harm is far from easy and needs to include a carefully weighted summary of all the published reports (such as this one).
The GDG seems to have been aware of (some of) these problems, yet they ignored them and simply assumed (based on wishful thinking?) that the harms were small or trivial.
Why?
Even the most cursory look at the composition of the GDG, begs the question: could it be that the GDG was highjacked by chiropractors and other experts biased towards SMT?
The more I think of it, the more I feel that this might actually be the case. One committee even listed an expert, Scott Haldeman, as a ‘neurologist’ without disclosing that he foremost is a chiropractor who, for most of his professional life, has promoted SMT in one form or another.
Altogether, the WHO guideline is, in my view, a shameful example of pro-chiropractic bias and an unethical disservice to evidence-based medicine.
The purpose of this systematic review was to assess the effectiveness and safety of conservative interventions compared with other interventions, placebo/sham interventions, or no intervention on disability, pain, function, quality of life, and psychological impact in adults with cervical radiculopathy (CR), a painful condition caused by the compression or irritation of the nerves that supply the shoulders, arms and hands.
A multidisciplinary team autors searched MEDLINE, CENTRAL, CINAHL, Embase, and PsycINFO from inception to June 15, 2022 to identify studies that were:
- randomized trials,
- had at least one conservative treatment arm,
- diagnosed participants with CR through confirmatory clinical examination and/or diagnostic tests.
Studies were appraised using the Cochrane Risk of Bias 2 tool and the quality of the evidence was rated using the Grades of Recommendations, Assessment, Development, and Evaluation approach.
Of the 2561 records identified, 59 trials met the inclusion criteria (n = 4108 participants). Due to clinical and statistical heterogeneity, the findings were synthesized narratively.
There is very-low certainty evidence supporting the use of:
- acupuncture,
- prednisolone,
- cervical manipulation,
- low-level laser therapy
for pain and disability in the immediate to short-term, and
- thoracic manipulation,
- low-level laser therapy
for improvements in cervical range of motion in the immediate term.
There is low to very-low certainty evidence for multimodal interventions, providing inconclusive evidence for pain, disability, and range of motion.
There is inconclusive evidence for pain reduction after conservative management compared with surgery, rated as very-low certainty.
The authors concluded that there is a lack of high-quality evidence, limiting our ability to make any meaningful conclusions. As the number of people with CR is expected to increase, there is an urgent need for future research to help address these gaps.
I agree!
Yet, to patients suffering from CR, this is hardly constructive advice. What should they do vis a vis such disappointing evidence?
They might speak to a orthopedic surgeon; but often there is no indication for an operation. What then?
Patients are bound to try some of the conservative options – but which one?
- Acupuncture?
- Prednisolone?
- Cervical manipulation,?
- Low-level laser therapy?
My advice is this: be patient – the vast majority of cases resolves spontaneously regardless of therapy – and, if you are desperate, try any of them except cervical manipulation which is burdened with the risk of serious complications and often makes things worse.
Certain aspects of yoga can be used as a non-pharmacological conservative therapeutic approach to the management of chronic low back pain (CLBP). This overview summarized and evaluated data from current systematic reviews (SRs) on the use of yoga for CLBP.
The researchers searched SRs on the use of yoga for CLBP in nine electronic databases from inception to September 2023. The methodological quality was evaluated using the Assessment of Multiple Systematic Review Scale-2 (AMSTAR-2). The reporting quality of the included SRs was evaluated using the Preferred Reporting Item for Systematic Review and Meta-Analysis-2020 (PRISMA-2020), and the quality of data was graded using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Two independent researchers performed the screening, data extraction, and quality assessment process of SRs.
A total of 13 SRs were included. The results of the AMSTAR-2 indicated that the methodological quality of the included studies was relatively low. The PRISMA-2020 checklist evaluation results indicated that methodological limitations in reporting, especially regarding data processing and presentation, were the main weaknesses. The GRADE assessment indicated that 30 outcomes were rated moderate, 42 were rated low level, and 20 were rated very low level. Downgrading factors were mainly due to the limitations of the included studies.
The authors concluded that yoga appears to be an effective and safe non-pharmacological therapeutic modality for the Management of CLBP. Currently, it may exhibit better efficacy in improving pain and functional disability associated with CLBP. However, the methodological quality and quality of evidence for SRs/MAs in the included studies were generally low, and these results should be interpreted cautiously.
Sorry, but I beg to differ!
- The safety of a therapy cannot be ascertained on the basis of such small sample sizes.
- The effectiveness of yoga has not been demonstrated by these data.
- All that has been shown with this review is that the quality of the research in this area is too poor for drawing conclusions.
This study was aimed at evaluating the effectiveness of osteopathic visceral manipulation (OVM) combined with physical therapy in pain, depression, and functional impairment in patients with chronic mechanical low back pain (LBP).
A total of 118 patients with chronic mechanical LBP were assessed, and 86 who met the inclusion criteria were included in the randomized clinical trial (RCT). The patients were randomized to either:
- Group 1 (n=43), who underwent physical therapy (5 days/week, for a total of 15 sessions) combined with OVM (2 days/week with three-day intervals),
- or Group 2 (n=43), which underwent physical therapy (5 days/week, for a total of 15 sessions) combined with sham OVM (2 days/week with three-day intervals).
Both groups were assessed before and after treatment and at the fourth week post-treatment.
Seven patients were lost to follow-up, and the study was completed with 79 patients. Pain, depression, and functional impairment scores were all improved in both groups (p=0.001 for all). This improvement was sustained at week four after the end of treatment. However, improvement in the pain, depression, and functional impairment scores was significantly higher in Group 1 than in Group 2 (p=0.001 for all).
The authors concluded that the results suggest that OVM combined with physical therapy is useful to improve pain, depression, and functional impairment in patients with chronic mechanical low back pain. We believe that OVM techniques should be combined with other physical therapy modalities in this patient population.
OVM was invented by the French osteopath, Jean-Piere Barral. In the 1980s, he stated that through his clinical work with thousands of patients, he discovered that many health issues were caused by our inner organs being entrapped and immobile. According to its proponents, OVM is based on the specific placement of soft manual forces that encourage the normal mobility, tone and function of our inner organs and their surrounding tissues. In this way, the structural integrity of the entire body is allegedly restored.
I am not aware of good evidence to show that OVM is effective – and this, sadly, includes the study above.
In my view, the most plausible explanation for its findings have little to do with OVM itself: sham OVM was applied “by performing light pressure and touches with the palm of the hand on the selected points for OVM without the intention of treating the patient”. This means that most likely patients were able to tell OVM from sham OVM and thus de-blinded. In other words, their expectation of receiving an effective therapy (and not the OVM per se) determined the outcome.
NICE helps practitioners and commissioners get the best care to patients, fast, while ensuring value for the taxpayer. Internationally, NICE has a reputation for being reliable and trustworthy. But is that also true for its recommendations regarding the use of acupuncture? NICE currently recommends that patients consider acupuncture as a treatment option for the following conditions:
- chronic (long-term) pain
- chronic tension-type headaches
- migraines
- prostatitis symptoms
- hiccups
Confusingly, on a different site, NICE also recommends acupuncture for retinal migraine, a very specific type of migraine that affect normally just one eye with symptoms such as vision loss lasting up to one hour, a blind spot in the vision, headache, blurred vision and seeing flashing lights, zigzag patterns or coloured spots or lines, as well as feeling nauseous or being sick.
I think this perplexing situation merits a look at the evidence. Here I quote the conclusions of recent, good quality, and (where possible) independent reviews:
- Chronic pain: Acupuncture is efficacious for reducing pain in patients with LBP… Further research needs to be done to evaluate acupuncture’s efficacy in these conditions, especially for abdominal pain, as many of the current studies have a risk of bias due to lack of blinding and small sample size.
- Chronic tension-type headaches (TTH): Acupuncture may be an effective and safe treatment for TTH patients. Due to low or very low certainty of evidence and high heterogeneity, more rigorous RCTs are needed to verify the effect and safety of acupuncture in the management of TTH.
- Migraines: Many studies suggest that acupuncture is a safe, helpful and available alternative therapy that may be beneficial to certain migraine patients. Nevertheless, further large-scale RCTs are warranted to further consolidate these findings and provide further support for the clinical value of acupuncture. Despite previous studies that have analyzed the effects of acupuncture on migraine, there is still a need for further investigation to ensure that the incorporation of acupuncture into migraine treatment management will have a positive outcome on patients.
- Prostatitis: This meta-analysis indicated that acupuncture has measurable benefits on CP/CPPS, and security has also been ensured. However, this meta-analysis only included 10 RCTs; thus, RCTs with a larger sample size and longer-term observation are required to verify the effectiveness of acupuncture further in the future.
- Hiccups: All of these studies sought to determine the effectiveness of different acupuncture techniques in the treatment of persistent and intractable hiccups. All four studies had a high risk of bias, did not compare the intervention with placebo, and failed to report side effects or adverse events for either the treatment or control groups.
- Retinal migraine: no evidence
So, what do we make of this? I think that, on the basis of the evidence:
- a positive recommendation for all types of chromic pain is not warranted;
- a positive recommendation for the treatment of TTH is questionable;
- a positive recommendation for migraine is questionable;
- a positive recommendation for prostatitis is questionable;
- a positive recommendation for hiccups is not warranted;
- a positive recommendation for retinal migraine is not warranted.
But why did NICE issue positive recommendations despite weak or even non-existent evidence?
SEARCH ME!
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We have often discussed cupping on this blog, e.g.:
- The ‘WORST PAPER OF 2022 COMPETITION’ entry No 6: “The efficacy and safety of dry cupping in cervical spondylosis with optimization of cup application time – A randomized clinical trial”
- Cupping therapy for non-specific chronic low back pain
- Cupping for Olympic swimmers. Or: why breaking your shoulder is not necessarily good for writing a successful book
- Infant receiving cupping treatment prompts outrage
Yes, generally speaking I have been critical about cupping – not because I don’t like it (I even used the treatment as a young clinician many years ago) but because the evidence tells me to. I was glad to see that the authors of a recent article entitled “Utility of Cupping Therapy in Substance Use Disorder: A Novel Approach or a Bizarre Treatment?” offer even more outspoken words about the therapy. Here are their conclusions:
Established treatment modalities for substance use disorder and its withdrawal symptoms include pharmacotherapy and psychotherapy, but their utilization by the general population remains unsatisfactory. Taboos regarding mental health services and concerns about confidentiality are massive obstacles for patients seeking psychiatric help, and alternative forms of medicine may seem more approachable, even with the associated risks. As displayed in this case, cupping therapy is a traditional therapy with no role in treating polyaddiction and withdrawal symptoms, but it unnecessarily exposes individuals to really uncomfortable and often concealed complications such as bruising, and skin and blood infections, especially when carried out by untrained, incompetent individuals. While one can explore these options in addition to seeking professional mental health care, it is imperative to spread awareness about the roles, scientific soundness, and adverse effects of these alternative health practices. The health promotion and education sectors need reforms to educate the general population, especially the rural population in India, about the dangers of iatrogenesis caused by non-evidence-backed treatments. There needs to be an extensive advertisement of only the most effective and scientific treatment options provided by medical professionals, and the risks of overlooking them in favor of traditional cures propagated by unqualified individuals. With all the scientific advancements in the 21st century ranging from artificial intelligence in healthcare, and robotic surgeries, to extensive clinical trials for novel anti-cancer drugs, we cannot allow the propagation of ancient, scientifically unsound techniques that may cause more harm than benefit to patients.
Why, I am sure you ask yourself, are they so critical? The reason lies in the case they report in the same paper:
A 30-year-old man presented to the psychiatric outpatient department with complaints of nervousness, anxiety, a sense of impending doom, irritability, anger outbursts, headache, and reduced sleep and appetite for the last five days. The patient had a history of daily consumption of 5-10 mg of alprazolam tablets, 200-250 mg of codeine syrup, and about five packets of chewable tobacco over the last seven years; this was a pattern of polyaddiction to a benzodiazepine, opiate, and nicotine. The patient had no history of fever, confusion, or hallucinations. On eliciting the past history, the patient revealed that he went to an alternative medicine practitioner after his family persuaded him to seek help for his substance use disorder. After ceasing the consumption of all three substances for three days, he started developing the symptoms with which he presented to our hospital. He was hesitant to talk about his substance use disorder to medical professionals and concerned about confidentiality, and, hence, went to an alternative medicine practitioner whom he deemed approachable. There he was given wet cupping therapy on the head for four days, which involved the use of rubber pumps to create a suction inside the cups placed on his head. After three to five minutes, the cups were removed and small incisions were made on the cupping sites, following which a second suction caused the oozing out of blood from the incision sites on the scalp (Figure 1). But, this did not improve his symptoms, and hence, he stopped going there two days before coming to our tertiary care hospital.
Figure 1: Wet cupping therapy on the head with blood oozing from incision sites<
On examination, the patient had a pulse rate of 76 beats per minute, blood pressure of 128/78 mm Hg, and respiratory rate of 22 per minute. He was well-oriented to time, place, and person. Systemic examination of the cardiovascular system was unremarkable. He denied any other substance use. The skin over his head had distinct cupping marks but no signs of infection or active bleeding, which are some common complications after cupping therapy (Figure 2). On assessment, the patient had a Clinical Opiate Withdrawal Scale (COWS) score of 13 and a Clinical Institute Withdrawal Assessment (CIWA) scale score of 26.
Figure 2: Cupping marks on the head
Later, the patient was admitted to the psychiatric ward to manage the withdrawal symptoms, where we initiated pharmacotherapy. Tablet diazepam (20 mg/day), sodium valproate (800 mg/day), tramadol (200 mg/day), thiamine (300 mg/day), paracetamol (500 mg/day) and intravenous fluids were given to the patient. We counseled the patient regarding substance abuse, its harmful effects, and de-addiction. The patient’s symptoms started to improve, and we continued the treatment for four days and discharged him with a COWS score of 4 and a CIWA score of 2. We intended to reassess him after 14 days, but we lost him to follow-up.
This review evaluated the magnitude of the placebo response of sham acupuncture in trials of acupuncture for nonspecific LBP, and assessed whether different types of sham acupuncture are associated with different responses. Four databases including PubMed, EMBASE, MEDLINE, and the Cochrane Library were searched through April 15, 2023, and randomized controlled trials (RCTs) were included if they randomized patients with LBP to receive acupuncture or sham acupuncture intervention. The main outcomes included the placebo response in pain intensity, back-specific function and quality of life. Placebo response was defined as the change in these outcome measures from baseline to the end of treatment. Random-effects models were used to synthesize the results, standardized mean differences (SMDs, Hedges’g) were applied to estimate the effect size.
A total of 18 RCTs with 3,321 patients were included. Sham acupuncture showed a noteworthy pooled placebo response in pain intensity in patients with LBP [SMD −1.43, 95% confidence interval (CI) −1.95 to −0.91, I2=89%]. A significant placebo response was also shown in back-specific functional status (SMD −0.49, 95% CI −0.70 to −0.29, I2=73%), but not in quality of life (SMD 0.34, 95% CI −0.20 to 0.88, I2=84%). Trials in which the sham acupuncture penetrated the skin or performed with regular needles had a significantly higher placebo response in pain intensity reduction, but other factors such as the location of sham acupuncture did not have a significant impact on the placebo response.
The authors concluded that sham acupuncture is associated with a large placebo response in pain intensity among patients with LBP. Researchers should also be aware that the types of sham acupuncture applied may potentially impact the evaluation of the efficacy of acupuncture. Nonetheless, considering the nature of placebo response, the effect of other contextual factors cannot be ruled out in this study.
As the authors stated in their conclusion: the effect of other contextual factors cannot be ruled out. I would go much further and say that the outcomes noted here are mostly due to effects other than placebo. Obvious candidates are:
- regression towards the mean;
- natural history of the condition;
- success of patient blinding;
- social desirability.
To define the placebo effect in acupuncture trials as the change in the outcome measures from baseline to the end of treatment – as the authors of the review do – is not just naive, it is plainly wrong. I would not be surprised, if different sham acupuncture treatments have different effects. To me this would be an expected, plausible finding. But such differences just cannot be estimated in the way the authors suggest. For that, we would need an RCT in which patients are randomized to be treated in the same setting with a range of different types of sham acupuncture. The results of such a study might be revealing but I doubt that many ethics committees would be happy to grant their approval for it.
In the absence of such data, the best we can do is to design trials such that the verum is tested against a credible placebo which, for patients, is indistinguishable from the verum, while demonstrating that blinding is successful.
The ‘University College of Osteopathy’ announced a proposal to merge with the AECC University College (AECC UC). Both institutions will seek to bring together the two specialist providers to offer a “unique inter-disciplinary environment for education, clinical practice and research in osteopathy, chiropractic, and across a wide range of allied health and related disciplines”.
The partnership is allegedly set to unlock significant opportunities for growth and development by bringing together the two specialist institutions’ expertise and resources across two locations – in Dorset and central London.
As a joint statement, Chair of the Board of Governors at AECC UC, Jeni Bremner and Chair of the Board of Governors at UCO, Professor Jo Price commented:
“We believe the proposed merger would further the institutional ambitions for both of our organisations and the related professional groups, by allowing us to expand our educational offering, grow student numbers and provide a unique inter-disciplinary training environment, providing students the opportunity to be immersed in multi-professional practice and research, with exposure to and participation in multi-disciplinary teams.
“There is also an exciting and compelling opportunity to expedite the development of a nationally unique, and internationally-leading MSK Centre of Excellence for Education and Research, developed and delivered across our two sites.”
The announcement is accompanied by further uncritical and promotional language:
Established as the first chiropractic training provider in Europe, AECC UC has been at the forefront of evidence-based chiropractic education, practice and research for more than 50 years. The institution is on an exciting journey of growth and development, having expanded and diversified its academic portfolio and activity beyond its traditional core offering of chiropractic across a broad range of allied health courses and apprenticeships, working closely with NHS, local authority and other system partners across Dorset and the south-west. The proposed merger with UCO would allow AECC UC to enhance the breadth and depth of its offer to support the expansion and development of the health and care workforce across a wider range of partners.
Now in its 106th year, UCO is one of the UK’s leading providers of osteopathic education and research with an established reputation for creating highly-skilled, evidence-informed graduates. UCO research is recognised as world-leading, delivering value to the osteopathic and wider health care community.
Sharon Potter, Acting Vice-Chancellor of UCO, said:
“As an institution that has long been at the forefront of osteopathic education and research, we are committed to ensuring further growth and development of the osteopathic profession.
“UCO has been proactively considering options to future-proof the institution. Following a review of strategic options, UCO is delighted by the proposed merger, working closely with AECC UC to ensure that UCO and osteopathy thrives as part of the inter-professional health sciences landscape, both academically and clinically. There is significant congruence between UCO and AECC UC in our strong aligned values, commitment to and delivery of excellent osteopathic education, clinical care and research, and opinion leadership.
“AECC UC has a strong track record of respecting the differences in professions, evidenced by the autonomy across the 10 different professional groups supported by the institution. The merger will not only mean we are protecting UCO through preserving its osteopathic heritage and creating a sustainable future, but that our staff and students can collaborate with other professional groups such as physiotherapy, chiropractic, sport rehabilitation, podiatry and diagnostic imaging, in a multidisciplinary MSK and rehabilitation environment unlike anywhere else in the UK.”
Professor Lesley Haig, Vice-Chancellor of AECC UC, commented:
“Preserving the heritage of UCO and safeguarding its future status as the flagship osteopathy training provider in the UK will be critical, just as it has been to protect the chiropractic heritage of the AECC brand. UCO is seen as synonymous with, and reflective of, the success of the osteopathy profession and we fully recognise and respect the important role that UCO plays not only as a sector-leading provider of osteopathic education, research and clinical care, but as the UK’s flagship osteopathy educational provider.
“Overall it is clear that UCO and AECC UC already have a common values base, similar understanding of approaches to academic and clinical delivery, and positive relationships upon which a future organisational structure and opportunities can be developed. It’s an exciting time for both institutions as we move forward in partnership to create something unique and become recognised nationally and internationally as a centre of excellence.”
The proposed merger would continue the already founded positive relations between the institutions, where regular visits, sharing of good practice, and collaborative research work are already taking place. Heads of terms for the potential merger have now been agreed and both institutions are entering into the next phase of discussions, which will include wide consultation with staff, students and other stakeholders to produce a comprehensive implementation plan.
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In case this bonanza of platitudes and half-truths has not yet overwhelmed you, I might be so bold as to ask 10 critical questions:
- What is an “evidence-based chiropractic education”? Does it include the messages that 1) subluxation is nonsense, 2) chiropractic manipulations can cause harm, 3) there is little evidence that they do more good than harm?
- How an an “expansion and development of the health and care workforce” be anticipated on the basis of the 3 points I just made?
- What does the term “evidence-informed graduates” mean? Does it mean they are informed that you teach them nonsense but instruct them to practice this nonsense anyway?
- Do “options to future-proof the institution” include the continuation of misleading the public about the value of chiropractic/osteopathy?
- Does the”delivery of excellent osteopathic education, clinical care and research, and opinion leadership” account for the fact that the evidence for osteopathy is weak at best and for most conditions negative?
- By “preserving its osteopathic heritage”, do you intend to preserve also the reputation of your founding father, Andrew Taylor Still, who did many dubious things. In 1874, for instance, he was excommunicated by the Methodist Church because of his “laying on of hands”; specifically, he was accused of trying to emulate Jesus Christ, labelled an agent of the Devil, and condemned as practicing voodoo. Or do you prefer to white-wash the osteopathic heritage?
- You also want “to protect the chiropractic heritage”; does that mean you aim at white-washing the juicy biography of the charlatan who created chiropractic, DD Palmer, as well?
- “UCO and AECC UC already have a common values base” – what are they? As far as I can see, they mainly consist in hiding the truth about the uselessness of your activities from the public.
- How do you want to “recognised nationally and internationally as a centre of excellence”? Might it be a good idea to begin by critically assessing your interventions and ask whether they do more good than harm?
- Crucially, what is really behing the merger that you are trying to sell us with such concentrated BS?
