The objective of this trial, just published in the BMJ, was to assess the efficacy of manual acupuncture as prophylactic treatment for acupuncture naive patients with episodic migraine without aura. The study was designed as a multi-centre, randomised, controlled clinical trial with blinded participants, outcome assessment, and statistician. It was conducted in 7 hospitals in China with 150 acupuncture naive patients with episodic migraine without aura.
They were given the following treatments:
- 20 sessions of manual acupuncture at true acupuncture points plus usual care,
- 20 sessions of non-penetrating sham acupuncture at heterosegmental non-acupuncture points plus usual care,
- usual care alone over 8 weeks.
The main outcome measures were change in migraine days and migraine attacks per 4 weeks during weeks 1-20 after randomisation compared with baseline (4 weeks before randomisation).
A total of 147 were included in the final analyses. Compared with sham acupuncture, manual acupuncture resulted in a significantly greater reduction in migraine days at weeks 13 to 20 and a significantly greater reduction in migraine attacks at weeks 17 to 20. The reduction in mean number of migraine days was 3.5 (SD 2.5) for manual versus 2.4 (3.4) for sham at weeks 13 to 16 and 3.9 (3.0) for manual versus 2.2 (3.2) for sham at weeks 17 to 20. At weeks 17 to 20, the reduction in mean number of attacks was 2.3 (1.7) for manual versus 1.6 (2.5) for sham. No severe adverse events were reported. No significant difference was seen in the proportion of patients perceiving needle penetration between manual acupuncture and sham acupuncture (79% v 75%).
The authors concluded that twenty sessions of manual acupuncture was superior to sham acupuncture and usual care for the prophylaxis of episodic migraine without aura. These results support the use of manual acupuncture in patients who are reluctant to use prophylactic drugs or when prophylactic drugs are ineffective, and it should be considered in future guidelines.
Considering the many flaws in most acupuncture studies discussed ad nauseam on this blog, this is a relatively rigorous trial. Yet, before we accept the conclusions, we ought to evaluate it critically.
The first thing that struck me was the very last sentence of its abstract. I do not think that a single trial can ever be a sufficient reason for changing existing guidelines. The current Cochrance review concludes that the available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Thus, one could perhaps argue that, together with the existing data, this new study might strengthen its conclusion.
In the methods section, the authors state that at the end of the study, we determined the maintenance of blinding of patients by asking them whether they thought the needles had penetrated the skin. And in the results section, they report that they found no significant difference between the manual acupuncture and sham acupuncture groups for patients’ ability to correctly guess their allocation status.
I find this puzzling, since the authors also state that they tried to elicit acupuncture de-qi sensation by the manual manipulation of needles. They fail to report data on this but this attempt is usually successful in the majority of patients. In the control group, where non-penetrating needles were used, no de-qi could be generated. This means that the two groups must have been at least partly de-blinded. Yet, we learn from the paper that patients were not able to guess to which group they were randomised. Which statement is correct?
This may sound like a trivial matter, but I fear it is not.
Like this new study, acupuncture trials frequently originate from China. We and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. If that is so, one does not need to read the paper, one already knows that it is positive before one has even seen it. Neither do the researchers need to conduct the study, one already knows the result before the trial has started.
You don’t believe the findings of my research nor those of others?
Excellent! It’s always good to be sceptical!
But in this case, do you believe Chinese researchers?
In this systematic review, all RCTs of acupuncture published in Chinese journals were identified by a team of Chinese scientists. An impressive total of 840 trials were found. Among them, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.
So, at least three independent reviews have found that Chinese acupuncture trials report virtually nothing but positive findings. Is that enough evidence to distrust Chinese TCM studies?
But there are even more compelling reasons for taking evidence from China with a pinch of salt:
A survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations. “Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Chinese research organisations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”
So, am I claiming the new acupuncture study just published in the BMJ is a fake?
Am I saying that it would be wise to be sceptical?
Sadly, my scepticism is not shared by the BMJ’s editorial writer who concludes that the new study helps to move acupuncture from having an unproven status in complementary medicine to an acceptable evidence based treatment.
Call me a sceptic, but that statement is, in my view, hard to justify!
Dry needling (DN), also known as myofascial trigger point dry needling, is a SCAM similar to acupuncture. It involves the use of solid filiform needles or hollow-core hypodermic needles and is usually employed for treating muscle pain. Instead of sticking them into acupuncture points, like with acupuncture, they are inserted into myofascial trigger points usually identified by palpation. There are some theories how DN might work, but whether it is clinically effective remains unclear.
This single-blind RCT determined, if the addition of upper quarter DN to a rehabilitation protocol is more effective in improving ROM, pain, and functional outcome scores when compared to a rehabilitation protocol alone after shoulder stabilization surgery. Thirty-nine post-operative shoulder patients were randomly allocated into two groups: (1) standard of care rehabilitation (control group) (2) standard of care rehabilitation plus dry needling (experimental group). Patient’s pain, ROM, and functional outcome scores were assessed at baseline (4 weeks post-operative), and at 8 weeks, 12 weeks, and 6 months post-operative.
Of 39 enrolled patients, 20 were allocated to the control group and 19 to the experimental group. At six-month follow up, there was a statistically significant improvement in shoulder flexion ROM in the control group. Aside from this, there were no significant differences in outcomes between the two treatment groups. Both groups showed improvement over time. No adverse events were reported.
The authors concluded that dry needling of the shoulder girdle in addition to standard of care rehabilitation after shoulder stabilization surgery did not significantly improve shoulder ROM, pain, or functional outcome scores when compared with standard of care rehabilitation alone. Both group’s improvement was largely equal over time. The significant difference in flexion at the six-month follow up may be explained by additional time spent receiving passive range of motion (PROM) in the control group. These results provide preliminary evidence that dry needling in a post-surgical population is safe and without significant risk of iatrogenic infection or other adverse events.
This trial followed the infamous A+B versus B design. As [A+B] is more than [B] alone, one would have expected that the experimental group has a better outcome than the control group.
But this was not the case!
Theoretically it can mean one of two things:
- DN did not even convey a placebo effect.
- DN had a negative effect on the outcome.
Many chiropractors claim that spinal manipulation (SM) has an effect on the pain threshold even in asymptomatic subjects, but SM has never been compared in studies to a validated sham procedure. Now a chiropractic research team has published a study investigating the effect of SM on the pressure pain threshold (PPT) when measured in
ii) an area remote from the intervention.
In addition, the researchers measured the size and duration of the effect.
In this randomized cross-over trial, 50 asymptomatic chiropractic students had their PPT measured at baseline, immediately after and every 12 min after intervention, over a period of 45 min, comparing values after SM and a previously validated sham. The trial was conducted during two sessions, separated by 48 h. PPT was measured both regionally and remotely from the ‘treated’ thoracic segment. Blinding of study subjects was tested with a post-intervention questionnaire.
The results show that the study subjects had been successfully blinded. No statistically significant differences were found between SM and sham estimates, at any time or anatomical location.
The authors concluded that, when compared to a valid sham procedure and with successfully blinded subjects, there is no regional or remote effect of spinal manipulation of the thoracic spine on the pressure pain threshold in a young pain-free population.
Reduced pain sensitivity following SM (often also called ‘manipulation-induced hypoalgesia’ (MIH)) turns out to be little more than a myth promoted by chiropractors for the obvious reason of boosting their business (6 further myths are summarised in the over-optimistic chiropractic advertisement above).
A recent review of the evidence found that systemic MIH (for pressure pain threshold) does occur in musculoskeletal pain populations, though there was low quality evidence of no significant difference compared to sham manipulation. Future research should focus on the clinical relevance of MIH, and different types of quantitative sensory tests.
The University College London Hospitals (UCLH) include the ‘Royal London Hospital for Integrated Medicine’ (RLHIM). The RLHIM offers a range of so-called alternative medicines (SCAMs), including acupuncture.
This is how they advertise traditional acupuncture to the unsuspecting public:
Acupuncture is a part of Traditional Chinese Medicine (TCM). This is a system of healing which has been practised in China and other Eastern countries for thousands of years.
Although often used as a means of pain relief, it can treat people with other illnesses. The focus is on improving the overall well-being of the patient, rather than the isolated treatment of specific symptoms.
You will be seen individually and assessed by an acupuncturist trained in TCM. They will use traditional Chinese techniques including pulse, tongue and abdominal diagnosis. They will also ask you about your medical history and lifestyle.
The TCM trained acupuncturist can stimulate the body’s own healing response and help to restore its natural balance.
The principal aim of acupuncture in treating the whole person is to create balance between your physical, emotional and spiritual needs. It can help to relax, improve mood and sleep, relieve tension and improve your sense of well-being, as well as improving symptoms.
We will assess your individual needs and discuss a treatment plan with you during your initial consultation.
The treatment may include the use of the following:
- The use of fine acupuncture needles
- Moxibustion (burning of the herb mugwort close to the surface of the skin)
- Cupping therapy (to create local suction on the skin)
- Acupressure (pressure applied to acu-points to stimulate energy flow)
- Electro-acupuncture (a low voltage current is passed between 2 needles)
How reliable is this information? I will try to answer this question by discussing the 6 statements that, in my view, are most questionable.
Although often used as a means of pain relief, it can treat people with other illnesses
Whether acupuncture is effective for pain relief is debatable. A recent analysis cast considerable doubt on the assumption. The notion that acupuncture ‘can treat people with other illnesses’ seems like a ‘carte blanche’ for treating virtually any condition regardless of evidence.
Improving the overall well-being of the patient
I am not aware of sound evidence that acupuncture is an effective treatment for improving overall well-being.
Traditional Chinese techniques including pulse, tongue and abdominal diagnosis
These diagnostic techniques have not been adequately validated and have no place in evidence-based healthcare.
The TCM trained acupuncturist can stimulate the body’s own healing response and help to restore its natural balance
I am not aware of sound evidence to show that acupuncture stimulates healing. The statement seems like another ‘carte blanche’ for treating anything the therapist feels like, regardless of evidence.
The principal aim of acupuncture in treating the whole person is to create balance between your physical, emotional and spiritual needs
The claim that acupuncture is a holistic treatment is based on little more than wishful thinking by acupuncturists.
It can help to relax, improve mood and sleep, relieve tension and improve your sense of well-being, as well as improving symptoms
I am not aware of sound evidence that acupuncture is effective in treating any of the named conditions. The end of the sentence (‘as well as improving symptoms’) is another ‘carte blanche’ for doing anything the acupuncturists feels like.
The UCLH are firmly committed to EBM. The RLHIM claims to be ‘a centre for evidence-based practice’. This claim is not supported by the above advertisement of acupuncture which is clearly not based on good evidence. Moreover, it has the potential to mislead vulnerable patients and thus cause considerable harm. In my view, it is high time that the UCLH address this problem.
The aim of this study was to determine the short-term effectiveness of thoracic manipulation when compared to sham manipulation for individuals with low back pain (LBP).
Patients with LBP were stratified based on symptom duration and randomly assigned to a thoracic manipulation or sham manipulation treatment group. Groups received 3 visits that included manipulation or sham manipulation, core stabilization exercises, and patient education. Three physical therapists with an average of 6 years’ experience administered the treatments according to a standardised protocol. Factorial repeated-measures analysis of variance and multiple regression were performed for pain, disability, and fear avoidance.
Ninety participants completed the study. The overall group-by-time interaction was not significant for the Modified Oswestry Disability Questionnaire, numeric pain-rating scale, and Fear-Avoidance Beliefs Questionnaire outcomes. The global rating of change scale was not significantly different between groups.
The authors concluded that three sessions of thoracic manipulation, education, and exercise did not result in improved outcomes when compared to a sham manipulation, education, and exercise in individuals with chronic LBP. Future studies are needed to identify the most effective management strategies for the treatment of LBP.
This study has many features that are praiseworthy. However, others are of concern. Lumping together chronic and acute back problems might be not ideal. And why study only short-term effects?
But foremost I do wonder why manipulations were carried out on the thoracic and not the lumbar spine, the region where the pain was located. The physiotherapist authors state that the effects of thoracic manipulation on adjacent regions have been widely studied, and the majority of authors cite regional interdependence as an explanation for its success. To some degree, this might make sense. Yet, most chiropractors and osteopaths will dismiss the trial and its findings arguing that they would manipulate at the site of subluxations.
In the Republic of Ireland, chiropractors are not regulated and there is no legislation governing the profession. That means anyone who feels like it can call him/herself a chiropractor and start treating or advising patients regardless of what condition they may be suffering from. The ‘CHIROPRACTIC ASSOCIATION OF IRELAND‘ (CAI) is the professional organisation that represents chiropractors in the country. The purpose of the CAI is to maintain professional standards, liaise with various government and health bodies, and to be a professional voice for Chiropractic.
Recently, the CAI has warned that a proposed law banning practitioners of so-called alternative medicine (SCAM) from claiming they can treat cancer without any medical evidence could have “unintended and unforeseen” consequences for its members. The CAI wrote to health minister Simon Harris claiming that a lack of “clarity” in the bill could have serious implications for chiropractic patients and chiropractors.
I am inclined to agree: the bill would reduce the cash-flow of many charlatans trying to make a fast buck on the desperation of cancer patients. But most probably, Tony Accardi, the president of the CAI, did not have this in mind when he said that, if patients with cancer inform a medical practitioner they are seeing a chiropractor, it may be construed that the chiropractor is “attempting to treat the cancer even though [it] may be for neck/back pain or overall wellbeing”.
As the evidence is hardly convincing that chiropractic is effective for neck/back pain or wellbeing (see numerous previous posts on this blog), we might well ask what else chiropractors have to offer for cancer patients. This website, for instance, is one of many that makes concrete claims:
Chiropractic treatment can benefit cancer patients in many ways. It can reduce stress, increase mobility, and optimize function, and generally improve quality of life.
By easing headaches and nausea, and relieving muscle tightness and neuropathy pain, chiropractic can help patients follow through with their treatment plans, which may even help extend their lives.
Chiropractors treating cancer patients approach patient care in much the same way as other primary care providers by:
- Gathering a comprehensive health history
- Conducting a thorough physical exam
- Ordering necessary diagnostic tests
- Deciding on an appropriate treatment plan
The chiropractic course of treatment often includes spinal manipulation and adjustments that provide patients with pain relief as well as overall improvement in function.
Chiropractic care can also be a viable alternative to pain medication for cancer patients. Although the use of medication is common in the management of a patient’s pain, it’s estimated that at least half of all cancer patients do not receive tolerable relief from their pain. Chiropractic care can address this issue, potentially even decreasing a cancer patient’s dependence on pain medication.
Cancer treatment has historically been focused on treating the disease itself. While doctors of chiropractic don’t treat cancer directly, they function very effectively as part of an integrated care plan to help the patient obtain the best treatment results possible.
The CHIROPRACTIC CANCER FOUNDATION FOR CHILDREN go even further:
Dr. Garvey has a strong belief in the human body’s innate ability to combat cancer cells and other diseases. He has first-hand experience with cancer since Dr. Garvey, himself, was diagnosed with Leukemia at the age of eleven. Stress and poor circulation can undermine the body’s natural healing powers and interfere with the central nervous systems’s ability to communicate effectively. At the foundation, we believe that chiropractic adjustments and other natural healing techniques can mitigate or reverse stresses that lead to poor health and even life threatening diseases such as cancer.
The claims can thus be summarised as follows:
- reduce the stress suffered by cancer patients,
- increase their mobility,
- optimize their function,
- improve their quality of life,
- alleviate cancer pain,
- serve as an alternative to pain medication,
- decrease cancer patients’ dependence on pain medication,
- the ‘innate’ (vital force which, according to DD Palmer is stimulated by chiropractic adjustments of spinal subluxations) can combat cancer.
Considering the above-mentioned dispute, it is only fair to ask: where is the evidence that chiropractic achieves the above (or indeed anything else)? I have to admit, I don’t find any sound evidence for any of these claims. But, of course, I might be biased or blind.
So, if anybody knows of compelling evidence to support the above claims, it would be helpful to let me have it. Meanwhile, it might be an excellent idea for the Irish government to go ahead with their plan of banning practitioners of so-called alternative medicine (SCAM) from claiming they can treat cancer without any medical evidence, don’t you think?
The systematic review assessed the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain. Randomized clinical trials (RCTs) assessing the effects of CST in chronic pain patients were eligible. Pain intensity and functional disability were the primary outcomes. Risk of bias was assessed using the Cochrane tool.
Ten RCTs with a total of 681 patients suffering from neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain were included.
Compared to treatment as usual, CST showed greater post intervention effects on:
- pain intensity (SMD=-0.32, 95%CI=[−0.61,-0.02])
- disability (SMD=-0.58, 95%CI=[−0.92,-0.24]).
Compared to manual/non-manual sham, CST showed greater post intervention effects on:
- pain intensity (SMD=-0.63, 95%CI=[−0.90,-0.37])
- disability (SMD=-0.54, 95%CI=[−0.81,-0.28]) ;
Compared to active manual treatments, CST showed greater post intervention effects on:
- pain intensity (SMD=-0.53, 95%CI=[−0.89,-0.16])
- disability (SMD=-0.58, 95%CI=[−0.95,-0.21]) .
At six months, CST showed greater effects on pain intensity (SMD=-0.59, 95%CI=[−0.99,-0.19]) and disability (SMD=-0.53, 95%CI=[−0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. Sensitivity analyses revealed robust effects of CST against most risk of bias domains. Five of the 10 RCTs reported safety data. No serious adverse events occurred. Minor adverse events were equally distributed between the groups.
The authors concluded that, in patients with chronic pain, this meta-analysis suggests significant and robust effects of CST on pain and function lasting up to six months. More RCTs strictly following CONSORT are needed to further corroborate the effects and safety of CST on chronic pain.
Robust effects! This looks almost convincing, particularly to an uncritical proponent of so-called alternative medicine (SCAM). However, a bit of critical thinking quickly discloses numerous problems, not with this (technically well-made) review, but with the interpretation of its results and the conclusions. Let me mention a few that spring into my mind:
- The literature searches were concluded in August 2018; why publish the paper only in 2020? Meanwhile, there might have been further studies which would render the review outdated even on the day it was published. (I know that there are many reasons for such a delay, but a responsible journal editor must insist on an update of the searches before publication.)
- Comparisons to ‘treatment as usual’ do not control for the potentially important placebo effects of CST and thus tell us nothing about the effectiveness of CST per se.
- The same applies to comparisons to ‘active’ manual treatments and ‘non-manual’ sham (the purpose of a sham is to blind patients; a non-manual sham defies this purpose).
- This leaves us with exactly two trials employing a sham that might have been sufficiently credible to be able to fool patients into believing that they were receiving the verum.
- One of these trials (ref 44) is far too flimsy to be taken seriously: it was tiny (n=23), did not adequately blind patients, and failed to mention adverse effects (thus violating research ethics [I cannot take such trials seriously]).
- The other trial (ref 41) is by the same research group as the review, and the authors award themselves a higher quality score than any other of the primary studies (perhaps even correctly, because the other trials are even worse). Yet, their study has considerable weaknesses which they fail to discuss: it was small (n=54), there was no check to see whether patient-blinding was successful, and – as with all the CST studies – the therapist was, of course, no blind. The latter point is crucial, I think, because patients can easily be influenced by the therapists via verbal or non-verbal communication to report the findings favoured by the therapist. This means that the small effects seen in such studies are likely to be due to this residual bias and thus have nothing to do with the intervention per se.
- Despite the fact that the review findings depend critically on their own primary study, the authors of the review declared that they have no conflict of interest.
Considering all this plus the rather important fact that CST completely lacks biological plausibility, I do not think that the conclusions of the review are warranted. I much prefer the ones from my own systematic review of 2012. It included 6 RCTs (all of which were burdened with a high risk of bias) and concluded that the notion that CST is associated with more than non‐specific effects is not based on evidence from rigorous RCTs.
So, why do the review authors first go to the trouble of conducting a technically sound systematic review and meta-analysis and then fail utterly to interpret its findings critically? I might have an answer to this question. Back in 2016, I included the head of this research group, Gustav Dobos, into my ‘hall of fame’ because he is one of the many SCAM researchers who never seem to publish a negative result. This is what I then wrote about him:
Dobos seems to be an ‘all-rounder’ whose research tackles a wide range of alternative treatments. That is perhaps unremarkable – but what I do find remarkable is the impression that, whatever he researches, the results turn out to be pretty positive. This might imply one of two things, in my view:
- all alternative therapies are effective,
- the ‘Trustworthiness Index’ of Prof Dobos is unusual.
I let my readers chose which possibility they deem to be more likely.
The aim of this review is to synthesise systematic reviews (SRs) of randomised clinical trials (RCTs) evaluating the efficacy of acupuncture to alleviate chronic pain. A total of 177 reviews of acupuncture from 1989 to 2019 met the eligibility criteria. The majority of SRs found that RCTs of acupuncture had methodological shortcomings, including inadequate statistical power with a high risk of bias. Heterogeneity between RCTs was such that meta-analysis was often inappropriate.
Having (co-) authored 13 of these SRs myself, I am impressed with the amount of work that went into this synthesis. The authors should be congratulated for doing it – and for doing it well! The paper itself differentiates the findings according to various types of pain. Here I reproduce the authors’ conclusion regarding different pain entities:
- Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for chronic pain associated with various medical conditions. There is no specific NICE guidance about the use of acupuncture for chronic pain conditions irrespective of aetiology or pathophysiology, although some guidance exists for specific pain conditions (see respective sections below). Guidance by NICE on chronic pain assessment and management is currently being developed (GIDNG10069) with publication expected in August 2020.
- Evidence from the SRs suggests that acupuncture prevents episodic or chronic tension‐type headaches and episodic migraine, although long‐term studies and studies comparing acupuncture with other treatment options are still required. The current NICE guidance (clinical guideline CG150) is that a course of up to 10 sessions of acupuncture over 5–8 weeks is recommended for tension‐type headache and migraine.
- The most recent evidence from a Cochrane review of 16 RCTs suggests that acupuncture is not superior to sham acupuncture for OA of the hip, although in contrast, evidence from nonCochrane reviews suggests that there is moderate‐quality evidence that acupuncture may be effective in the symptomatic relief of pain from OA of the knee. Why there should be a difference in evidence between the knee and the hip is not known. Interestingly, guidance from NICE (CG177) states: “Do not offer acupuncture for the management of osteoarthritis”.
- Evidence suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for low back pain. In 2009, NICE published guidance for the management of nonspecific low back pain that recommended a course of acupuncture as part of first line treatment. This guidance produced much debate. Subsequently, NICE have updated guidance for the management of low back pain and sciatica in people over 16 (NG59) and currently recommend in Section 1.2.8 “Do not offer acupuncture for managing low back pain with or without sciatica”, even though the evidence had not significantly changed.
- Evidence from SRs suggests that dry needling acupuncture might be effective in alleviating pain associated with myofascial trigger points, at least in the short‐term, although there are insufficient high‐quality RCTs to judge the efficacy with any degree of certainty. There is no guidance from NICE on the management of myofascial pain syndrome.
- Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for cancer‐related pain and more high‐quality, appropriately designed and adequately powered studies are needed. The most recent guidance from NICE (CSG4) recognises that patients who are receiving palliative care often seek complementary therapies, but it does not specifically recommend acupuncture. It recognises that “Many studies have a considerable number of methodological limitations, making it difficult to draw definitive conclusions”.
- Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for fibromyalgia pain. There is no NICE guidance on the treatment of fibromyalgia.
- Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for primary dysmenorrhea or chronic pelvic pain. There is NICE guidance on endometriosis (NG73)  but this does not recommend any form of Chinese medicine for this type of pelvic pain, although acupuncture is not specifically mentioned.
- Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for pain in inflammatory arthritis. There is a NICE guideline (NG100)  for the treatment of rheumatoid arthritis but this does not recommend acupuncture.
- Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for neuropathic pain or neuralgia. There is NICE guidance (CG173) on the management of neuropathic pain, but acupuncture is not included in the list of recommended/not recommended treatments.
- Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for a variety of other painful conditions, including lateral elbow pain, shoulder pain and labour pain. There is no guidance available from NICE on the treatment of any of these conditions.
So, what should we make of all this?
Maybe I just point out two things:
- This is a most valuable addition to the literature about acupuncture. It can serve as a reference for all who are interested in an honest account of the (lack of) value of acupuncture in the management of chronic pain.
- If a therapy has been tested in hundreds of (sadly often flawed) trials and the conclusions fail to come out clearly in favour of it, it is most likely not a very effective treatment.
Until we have data to the contrary, acupuncture should not be considered to be an effective therapy for chronic pain management.
The current Cochrane review of clinical trials testing the effectiveness of manipulation/mobilisation for neck pain concluded as follows:
Although support can be found for use of thoracic manipulation versus control for neck pain, function and QoL, results for cervical manipulation and mobilisation versus control are few and diverse. Publication bias cannot be ruled out. Research designed to protect against various biases is needed. Findings suggest that manipulation and mobilisation present similar results for every outcome at immediate/short/intermediate-term follow-up. Multiple cervical manipulation sessions may provide better pain relief and functional improvement than certain medications at immediate/intermediate/long-term follow-up. Since the risk of rare but serious adverse events for manipulation exists, further high-quality research focusing on mobilisation and comparing mobilisation or manipulation versus other treatment options is needed to guide clinicians in their optimal treatment choices.
Such a critical assessment must be tough for chiropractors who gain a substantial part of their income from treating such patients. What is the solution? Simple, convene a panel of chiros and issue recommendations that are more prone to stimulate their cash flow!
Exactly that seems to have just happened.
The purpose of the researchers was to develop best-practice recommendations for chiropractic management of adults with neck pain.
A steering committee of experts in chiropractic practice, education, and research drafted a set of recommendations based on the most current relevant clinical practice guidelines. Additional supportive literature was identified through targeted searches conducted by a health sciences librarian. A national panel of chiropractors representing expertise in practice, research, and teaching rated the recommendations using a modified Delphi process. The consensus process was conducted from August to November 2018. Fifty-six panelists rated the 50 statements and concepts and reached consensus on all statements within 3 rounds.
The statements and concepts covered aspects of the clinical encounter, ranging from informed consent through diagnosis, assessment, treatment planning and implementation, and concurrent management and referral for patients presenting with neck pain.
The authors concluded that these best-practice recommendations for chiropractic management of adults with neck pain are based on the best available scientific evidence. For uncomplicated neck pain, including neck pain with headache or radicular symptoms, chiropractic manipulation and multimodal care are recommended.
Let’s be clear what this amounts to: a panel of highly selected chiropractors (sponsored by a chiropractic organisation) has reached a consensus (and published it in a chiropractic) which allows them to continue to treat patients with neck pain.
Isn’t that just great?
Now let’s think ahead – what next?
I suggest the following:
- A panel of homeopaths recommending homeopathy.
- A panel of faith healers recommending faith healing.
- A panel of crystal healers recommending crystal healing.
- A panel of colon therapists recommending colonic irrigation.
- A panel of supplement manufacturers recommending to buy supplements.
I am sure you get the gist.
I have to admit, I only read the DAILY MAIL, if I have to (and certainly not today). This is probably why I missed this article announcing the 1st traditional Chinese medicine to be licensed in the UK.
The plant Sigesbeckia, which has an unpleasant smell, is renowned for its ability to treat aches and pains – including those caused by arthritis. It is the active ingredient in Phynova Joint and Muscle Relief Tablets, which have just been licensed by drug safety watchdog the Medicines and Healthcare Products Regulatory Agency.
The directive also made it more difficult for medicines to get a licence as it demanded they had to have been in use for 30 years, of which at least 15 years had to be in the EU. Some Western herbal medicines have managed to gain licences in a process costing thousands of pounds to verify their ingredients. But the Phynova tablets are the first traditional Chinese medicine to be approved.
Robert Miller, chief executive of Oxford-based Phynova, said he was ‘extremely proud’, adding: ‘This has come from years of working with our Chinese colleagues. ‘Britain can now benefit from having access to high quality, regulated Chinese medicines.’ He also said that the company is planning to apply for a licence for a second traditional Chinese medicine, a cold and flu remedy.
Dr Chris Etheridge, a medical herbalist and adviser to Potter’s Herbals, celebrated the ‘good news’, adding that Sigesbeckia, which is not commonly used in the West, ‘offers an alternative to those who prefer not to take non-steroidal anti-inflammatory drugs for muscle and joint pain’.
But Michael McIntyre, chairman of the European Herbal and Traditional Medicine Practitioners Association, warned that the new product demonstrates the difficulties the EU rules created for supplying herbal products safely to the public. He said it is ‘almost impossible to satisfy the licensing conditions’. He added that some people have therefore turned to the internet to buy unlicensed products, but this means they have ‘no idea whether they are safe or effective’.
Exciting enough to do a quick search for the evidence. Are there any clinical trials to show or suggest that this herbal remedy does anything other than filling the bank account of the manufacturer? Sadly, the answer seems to be NO! At least, I could not find a single such study (if anyone knows more, I’d be pleased to stand corrected).
Frustrated I looked at the website of the manufacturer. Here I found this:
Exclusively containing Sigesbeckia extract, Phynova Joint and Muscle Relief Tablets is a traditional herbal medicinal product used for the relief of backache, rheumatic, joint and muscle pain as well as minor sports injuries. Sigesbeckia has been used for thousands of years around the world to relieve painful joints and muscles.
– Relief from joint & muscle pain
– Gentle on the stomach
– No known side effects
– No known drug indications or contraindications
– Can be taken with or without food
What can Sigesbeckia be used to treat?
Traditionally used for arthritic pain, rheumatic pain, back pain and sciatica. Today, Sigesbeckia can be used for;
Back pain can occur through a sprain or strain, spasms, nerve compression, herniated discs and other problems in your lower, middle and upper back.
Poor posture, lifting and stretching, sudden movements placing strain on your lower back and sports injuries, are amongst the main culprits for causing back pain.
Minor sports injuries
Minor sports injuries can be caused by an accident such as a fall or blow, not warming up properly before exercise, pushing yourself too hard and not using the appropriate equipment or perhaps poor technique.
Rheumatic and muscular pain
Common causes of rheumatic and muscle pain can be due to; tension and stress, lack of minerals, certain medication, dehydration, sprains and strains, sleep deficiency, too much physical activity and sometimes other underlying health conditions and diseases.
General aches and pains in muscles and joints
Overexertion due to a new exercise routine or from a sprain or strain can cause general aches and pains in muscles and joints. But so too can modern day busy life. The impact on our bodies can trigger aches and pains in your muscles and joints and lower your resistance to illness and disease.
The Benefit of Sigesbeckia extract
One of the benefits of Sigesbeckia extract, as used in approved licensed products, is that it has no known side effects or interactions with other medications according to the Summary of Product Characteristics (SmPC). Always check that the product you purchase is an approved Traditional Herbal Medicine Product in the UK.
In summary: Look after your joints and muscles with Sigesbeckia
Our bodies are all different, and our approach and tolerances will vary. Used for over a thousand years and known for its anti-inflammatory and mobility benefits alongside being used for joint and muscle pain; Sigesbeckia is a herbal medicine that works best when used over time.
Looking for a traditional remedy for joint and muscle relief? Why not try Sigesbeckia?
But again no sign of a clinical trial to back up this plethora of therapeutic claims. How can this be? The answer lies in the directive mentioned in the Mail article. To obtain a licence that enables the manufacturer to make therapeutic claims, a herbal remedy merely needs to demonstrate that it has been in use for 30 years, of which at least 15 years had to be in the EU.
I think I understand the intention of the directive. But I would nevertheless have thought that, 4 years after obtaining a license, the manufacturer could have conducted a study to test whether the product works. In my view this should be a moral and ethical, if not legal obligation. The ‘test of time’ is woefully insufficient and unreliable and no basis for generating progress or securing the best interests of patients.
Considering the total lack of efficacy and safety data, do you agree that the above comment by Michael McIntyre are ironic to the extreme? And do you agree that manufacturers who manage to obtain such a license should be obliged to deliver a proof of efficacy within a reasonable period of time?