guideline
The objective of this paper, as stated by its authors, was to develop an evidence-based clinical practice guideline (CPG) through a broad-based consensus process on best practices for chiropractic management of patients with chronic musculoskeletal (MSK) pain.
Using systematic reviews identified in an initial literature search, a steering committee of experts in research and management of patients with chronic MSK pain drafted a set of recommendations. Additional supportive literature was identified to supplement gaps in the evidence base. A multidisciplinary panel of experienced practitioners and educators rated the recommendations through a formal Delphi consensus process using the RAND Corporation/University of California, Los Angeles, methodology.
The Delphi process was conducted January–February 2020. The 62-member Delphi panel reached consensus on chiropractic management of five common chronic MSK pain conditions:
- low-back pain (LBP),
- neck pain,
- tension headache,
- osteoarthritis (knee and hip),
- fibromyalgia.
Recommendations were made for non-pharmacological treatments, including:
- acupuncture,
- spinal manipulation/mobilization,
- other manual therapy;
- low-level laser (LLL);
- interferential current;
- exercise, including yoga;
- mind–body interventions, including mindfulness meditation and cognitive behavior therapy (CBT);
- lifestyle modifications such as diet and tobacco cessation.
Recommendations covered many aspects of the clinical encounter, from informed consent through diagnosis, assessment, treatment planning and implementation, and concurrent management and referral. Appropriate referral and comanagement were emphasized.
Therapeutic recommendations for low back pain:
- Consider multiple approaches. Both active and passive, and both physical and mind–body interventions should be considered in the management plan. The following are recommended, based on current evidence.
- Exercise
- Yoga/qigong (which may also be considered “mind–body” interventions)
- Lifestyle advice to stay active; avoid sitting; manage weight if obese; and quit smoking
- Spinal manipulation/mobilization
- Massage
- Acupuncture
- LLL therapy
- Transcutaneous electrical nerve stimulation (TENS) or interferential current may be beneficial as part of a multimodal approach, at the beginning of treatment to assist the patient in becoming or remaining active.
- Combined active and passive: multidisciplinary rehabilitation
- CBT
- Mindfulness-based stress reduction
Therapeutic recommendations for neck pain:
- Consider multiple approaches. Both active and passive, and both physical and mind–body interventions should be considered in the management plan for maximum therapeutic effect. The following are recommended, based on current evidence.
- Exercise (range of motion and strengthening).
- Exercise combined with manipulation/mobilization.
- Spinal manipulation and mobilization
- Massage
- Low-level laser
- Acupuncture
- These modalities may be added as part of a multimodal treatment plan, especially at the beginning, to assist the patient in becoming or remaining active:
- Transcutaneous nerve stimulation (TENS), traction, ultrasound, and interferential current.
- Yoga
- Qigong
Therapeutic recommendations for tension headache:
- Consider multiple approaches. Both active and passive, and both physical and mind–body interventions should be considered in the management plan for maximum therapeutic effect. The following are recommended, based on current evidence:
- Reassurance that TTH does not indicate presence of a disease.
- Advice to avoid triggers.
- Exercise (aerobic).
- Spinal manipulation
- Acupuncture
- Cold packs or menthol gels
- Combined active and passive
- CBT
- Relaxation therapy
- Biofeedback
- Mindfulness Meditation
Therapeutic recommendations for knee osteoarthritis:
- Consider multiple approaches. Both active and passive, and both physical and mind–body interventions should be considered in the management plan. The following are recommended, based on current evidence:
- Exercise
- Manual therapy
- Ultrasound
- Acupuncture, using “high dose” (greater treatment frequency, at least 3 × week)
- LLL therapy
Therapeutic recommendations for hip osteoarthritis:
- Consider multiple approaches. Both active and passive, and both physical and mind–body interventions should be considered in the management plan. The following are recommended, based on current evidence6
- Exercise
- Manual therapy
Therapeutic recommendations for fibromyagia:
- Consider multiple approaches. Both active and passive, and both physical and mind–body interventions should be considered in the management plan. The following are recommended, based on current evidence:
- Exercise (aerobic and strengthening)
- Advice on healthy lifestyle
- Education on the condition
- Spinal manipulation
- Myofascial release
- Acupuncture
- LLL therapy
- multidisciplinary rehabilitation
- CBT
- mindfulness meditation
- yoga
- Tai chi,
- Qigong
The authors concluded that these evidence-based recommendations for a variety of conservative treatment approaches to the management of common chronic MSK pain conditions may advance consistency of care, foster collaboration between provider groups, and thereby improve patient outcomes.
This paper is an excellent example of a pseudo-scientific process resulting in unreliable outcomes.
- The Delphi process was conducted some 4 years ago
- Because of the truly weird inclusion criteria, the findings are based essentially on just 3 systematic reviews.
- Anyone who has ever tried to conduct a consensus excercise knows that the outcome will almost entirely depend on who is chosen to sit on the panel. So, all you have to do to obtain pro-chiro recommendations is to select a few pro-chiro ‘experts’ who then write the recommendations!
- A “best practices for chiropractic management” may sound reasonable but, looking at the therapeutic recommendation, one easily realizes that the authors cast their nets so wide that the result has little to do with what differentiates chiropractic from Physiotherapists or osteopaths.
It is therefore not surprising that the recommendations are laughably unreliable: can, for instance, anyone explain to me why “advice on healthy lifestyle and education on the condition” are recommended for fibromyalgia but not for any other condition?
This paper is, in my view, chiropractic pseudo-science at its most ridiculous!
All it really does is it tries to legitimise all sorts of therapies as part of the chiropractic toolbox. My advice to patients is to:
- consult a physio if you need exercise therapy or LLL or manual therapy or ultrasound or interferential current or TENS or cold packs or massage;
- consult a clinical psychologist if you need CBT, or mindfulness, biofeedback;
- consult a doctor if you want rehab or education or lifestyle advice or reassurance;
- etc. etc.
And please avoid chiropractors who pretend they can do all of the above, while merely wanting to manipulate your neck.
The American Society of Clinical Oncology (ASCO) and the Society for Integrative Oncology have collaborated to develop guidelines for the application of integrative approaches in the management of:
- anxiety,
- depression,
- fatigue,
- use of cannabinoids and cannabis in patients with cancer.
These guidelines provide evidence-based recommendations to improve outcomes and quality of life by enhancing conventional cancer treatment with integrative modalities.
All studies that informed the guideline recommendations were reviewed by an Expert Panel which was made up of a patient advocate, an ASCO methodologist, oncology providers, and integrative medicine experts. Panel members reviewed each trial for quality of evidence, determined a grade quality assessment label, and concluded strength of recommendations.
The findings show:
- Strong recommendations for management of cancer fatigue during treatment were given to both in-person or web-based mindfulness-based stress reduction, mindfulness-based cognitive therapy, and tai chi or qigong.
- Strong recommendations for management of cancer fatigue after cancer treatment were given to mindfulness-based programs.
- Clinicians should recommend against using cannabis or cannabinoids as a cancer-directed treatment unless within the context of a clinical trial.
- The recommended modalities for managing anxiety included Mindfulness-Based Interventions (MBIs), yoga, hypnosis, relaxation therapies, music therapy, reflexology, acupuncture, tai chi, and lavender essential oils.
- The strongest recommendation in the guideline is that MBIs should be offered to people with cancer, both during active treatment and post-treatment, to address depression.
The authors concluded that the evidence for integrative interventions in cancer care is growing, with research now supporting benefits of integrative interventions across the cancer care continuum.
I am sorry, but I find these guidelines of poor quality and totally inadequate for the purpose of providing responsible guidance to cancer patients and carers. Here are some of my reasons:
- I know that this is a petty point, particularly for me as a non-native English speaker, but what on earth is an INTEGRATIVE THERAPY? I know integrative care or integrative medicine, but what could possibly be integrative with a therapy?
- I can vouch for the fact that the assertion “all studies that informed the guideline recommendations were reviewed” is NOT true. The authors seem to have selected the studies they wanted. Crucially, they do not reveal their selection criteria. I have the impression that they selected positive studies and omitted those that were negative.
- The panel of experts conducting the research should be mentioned; one can put together a panel to show just about anything simply by choosing the right individuals.
- The authors claim that they assessed the quality of the evidence, yet they fail to tell us what it was. I know that many of the trials are of low quality and their results therefore less than reliable. And guidance based on poor-quality studies is misguidance.
- The guidelines say nothing about the risks of the various treatments. In my view, this would be essential for any decent guideline. I know that some of the mentioned therapies are not free of adverse effects.
- They also say nothing about the absolute and relative effect sizes of the treatments they recommend. Such information would ne necessary for making informed decisions about the optimal therapeutic choices.
- The entire guideline is bar any critical thinking.
Overall, these guidelines provide more an exercise in promotion of dubious therapies than a reliable guide for cancer patients and their carers. The ASCO and the Society for Integrative Oncology should be ashamed to have given their names to such a poor-quality document.
Yesterday, I stumbled across this remarkable notice. As it is in German, I took the libery of translating it for you:
Am 6. April 2024 war es wieder soweit: Die ÖGHM und die Schwabe Austria GmbH luden zur Verleihung des mit 4.000,- Euro dotierten Dr. Peithner Preises ein.
Dieses Mal wurde der Forschungspreis für die zwei eingereichte Arbeiten „Recommendations in the design and conduction of randomized controlled trials in human and veterinary homoeopathic medicine“ und „Recommendations for Designing, Conducting and Reporting Clinical Observational Studies in Homeopathic Veterinary Medicine“ an Katharina Gaertner, Klaus von Ammon, Philippa Fibert, Michael Frass, Martin Frei-Erb, Christien Klein-Laansma, Susanne Ulbrich-Zuerni und Petra Weiermayer vergeben.
Wir freuen uns sehr und gratulieren den Preisträger:innen zum verdienten Erfolg. Ein herzliches Dankeschön geht auch an die ÖGHM und die Schwabe Austria, die nicht nur mit diesem traditionellen Forschungspreis die Wissenschaft unterstützt.
Here is my translation:
On 6 April 2024, the time had come again: the ‘Austrian Society for Homeopathic Medicine’ (ÖGHM) and Schwabe Austria GmbH hosted the award ceremony for the Dr Peithner Prize, which is endowed with 4,000 euros.
This time, the research prize was awarded to Katharina Gaertner, Klaus von Ammon, Philippa Fibert, Michael Frass, Martin Frei-Erb, Christien Klein-Laansma, Susanne Ulbrich-Zuerni and Petra Weiermayer for the two submitted papers “Recommendations in the design and conduction of randomised controlled trials in human and veterinary homoeopathic medicine” and “Recommendations for Designing, Conducting and Reporting Clinical Observational Studies in Homeopathic Veterinary Medicine”.
We are delighted and congratulate the prizewinners on their well-deserved success. A big thank you also goes to the ÖGHM and Schwabe Austria, who support science with this traditional research prize.
______________________________
And where is the irony?
Firstly, homeopaths are not exactly the experts on how to conduct research.
Secondly, there are recommendations and guidelines for conducting clinical research (e.g. here), and there is no reason for homeopathy to not to adopt those.
Thirdly, and most importantly, to award a prize to Michael Frass for telling us how to do research is more than a little ironic. If anything, Frass could teach us a thing or two about how to falsify, fabricate and manipulate research results!
On 8 March 2019, the Council of Australian Governments (COAG) Health Council (CHC) noted community concerns about spinal manipulation on children performed by chiropractors and agreed that there was a need to consider whether public safety was at risk.
On behalf of the CHC, the Victorian Minister for Health, the Hon. Jenny Mikakos MP, instructed Safer Care Victoria (SCV) to undertake an independent review of the practice of chiropractic spinal manipulation on children under 12 years. The findings of this review are to be provided to the Minister for reporting to the CHC. To provide expert guidance and advice to inform the review, SCV established an independent advisory panel. The panel included expertise in chiropractic care, academic allied health, health practitioner regulation, healthcare evidence, governance, paediatrics and paediatric surgery, and musculoskeletal care, and had consumer representation.
The main conclusions were as follows:
- … spinal manipulation in children is not wholly without risk. Any risk associated
with care, no matter how uncommon or minor, must be considered in light of any potential or likely
benefits. This is particularly important in younger children, especially those under the age of 2 years in
whom minor adverse events may be more common. - … the evidence base for spinal manipulation in children is very poor. In particular, no studies have been performed in Australia … The possible, but unlikely, benefits of spinal manipulation in the management of colic or enuresis should be balanced by the possibility, albeit rare, of minor harm.
The main recommendation was straight forward: “Spinal manipulation, as defined in Section 123 of National Law, should not be provided to children under 12 years of age, by any practitioner, for general wellness or for the management of the following conditions: developmental and behavioural disorders, hyperactivity disorders, autism spectrum disorders, asthma, infantile colic, bedwetting, ear infections, digestive problems, headache, cerebral palsy and torticollis.”
The Chiropractic Board of Australia nevertheless decided they would re-start manipulationg babies. On 11/6/2024 The Sydney Morning Harald reported:
Chiropractors have given themselves the green light to resume manipulating the spines of babies following a four-year interim ban supported by the country’s health ministers. In a move slammed by doctors as irresponsible, the Chiropractic Board of Australia has quietly released new guidelines permitting the controversial treatment for children under two. The Royal Australian College of General Practitioners (RACGP) hit out at the decision, saying there was no evidence supporting the spinal manipulation of babies and children and that the practice should be outlawed. ‘‘There is no way in the world I would let anyone manipulate a child’s spine,’’ said Dr James Best, the college’s Specific Interests Child and Young Person’s Health chair. ‘‘The fact that it hasn’t been ruled out by this organisation is very disappointing and concerning. It’s irresponsible.’’ …
Subsequently, it was reported that the federal health minister has intervened in the Chiropractic Board of Australia’s controversial decision to allow practitioners to resume spinal manipulation of children under two and is seeking an urgent explanation.
As pressure mounts on chiropractors to ditch the treatment, federal Health Minister Mark Butler confirmed on Thursday that he would also raise the issue with his state and territory colleagues at a meeting of health ministers in South Australia on Friday.
“The Health Minister is writing to the Chiropractic Board seeking an urgent explanation on its decision to allow a resumption of spinal manipulation of infants under two, in spite of two reviews concluding there was no evidence to support that practice,” a spokeswoman said.
___________________________
This course of events can only be surprising to those who are not familiar with the chiropractors’ general attitude. Chiropractors have always put income before ethics and safety. This, I fear, is not a phenomenon confined to Australia or to the care of children but one that beleagues this profession worldwide from the days of DD Palmer to the present.
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.
___________________________
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.
If you assumed that the best management of a child by chiropractors is not to treat this patient and refer to a proper doctor, think again. This paper was aimed at building upon existing recommendations on best practices for chiropractic management of children by conducting a formal consensus process and best evidence synthesis. Its authors composed a best practice guide based on recommendations from current best available evidence and formal consensus of a panel of experienced practitioners, consumers, and experts for chiropractic management of pediatric patients. They thus syntheized results of a literature search to inform the development of recommendations from a multidisciplinary steering committee, including experts in pediatrics, followed by a formal Delphi panel consensus process.
The consensus process was conducted June to August 2022. All 60 panelists completed the process and reached at least 80% consensus on all recommendations after three Delphi rounds. Recommendations for best practices for chiropractic care for children addressed the following aspects of the clinical encounter:
- patient communication, including informed consent;
- appropriate clinical history, including health habits;
- appropriate physical examination procedures;
- red flags/contraindications to chiropractic care and/or spinal manipulation;
- aspects of chiropractic management of pediatric patients, including infants;
- modifications of spinal manipulation and other manual procedures for pediatric patients;
- appropriate referral and comanagement;
- appropriate health promotion and disease prevention practices.
The authors concluded that this set of recommendations represents a general framework for an evidence-informed and reasonable approach to the management of pediatric patients by chiropractors.
Whenever I read the term ‘evidence-informed’ I need to giggle. Why not evidence-based? Evidence-informed might mean that chiros are informed that their treatments are useless or even dangerous for children … but, on reflection and taking their own need for earning a living, they subsequently ignore these facts. And sure enough, the authors of the present paper do mention that a Cochrane review concluded that spinal manipulation is not recommended for children under 12, for a number of conditions, or for general wellness … only to then go on and ignore the very fact.
In doing so, the authors issue a string of self-evident platitudes which occasionally border on the irresponsible. For instance, under the heading of ‘primary prevention’, vaccinations are mentioned as the very last item with the following words:
If parents ask for advice or information about childhood vaccinations, explain that they have the right to make their own health decisions. They should be adequately informed about the benefits and risks to both their child and the broader community associated with these decisions. Consider referral to a health professional whose scope of practice includes vaccinations to address patient questions or concerns.
What that really means in practice, I fear, might be summarized like this: If parents ask for advice or information about childhood vaccinations, explain that they are dangerous, and that even D. D. Palmer recognized as early as 1894 that vaccination is ‘…the monstrous delusion … fastened on us by the medical profession, enforced by the state boards, and supported by the mass of unthinking people …’
Altogether, the ‘Clinical Practice Guideline for Best Practice Management of Pediatric Patients by Chiropractors’ is a thoroughly disreputable document. It was constructed in the way all charlatans tend to construct their consensus documents:
- convene a few people who are all in favour of a certain motion,
- discuss the motion,
- agree with it,
- write up the process
- publish your paper in a third class journal,
- boast that there is a consensus,
- stress that the motion must thereefore be ethical, correct and valuable.
Do chiropractors know that, using this methodology, the ‘flat earth society’ can easily pass a consensus that the earth is indeed flat?
I am sure they do!
Practitioners of so-called alternative medicine (SCAM) often argue against treating back problems with drugs. They also frequently defend their own therapy by claiming it is backed by published guidelines. So, what should we think about guidelines for the management of back pain?
This systematic review was aimed at:
- systematically evaluating the literature for clinical practice guidelines (CPGs) that included the pharmaceutical management of non-specific LBP;
- appraising the methodological quality of the CPGs;
- qualitatively synthesizing the recommendations with the intent to inform non-prescribing providers who manage LBP.
The authors searched PubMed, Cochrane Database of Systematic Review, Index to Chiropractic Literature, AMED, CINAHL, and PEDro to identify CPGs that described the management of mechanical LBP in the prior five years. Two investigators independently screened titles and abstracts and potentially relevant full text were considered for eligibility. Four investigators independently applied the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument for critical appraisal. Data were extracted for pharmaceutical intervention, the strength of recommendation, and appropriateness for the duration of LBP.
Only nine guidelines with global representation met the eligibility criteria. These CPGs addressed pharmacological treatments with or without non-pharmacological treatments. All CPGs focused on the management of acute, chronic, or unspecified duration of LBP. The mean overall AGREE II score was 89.3% (SD 3.5%). The lowest domain mean score was for applicability, 80.4% (SD 5.2%), and the highest was Scope and Purpose, 94.0% (SD 2.4%). There were ten classifications of medications described in the included CPGs: acetaminophen, antibiotics, anticonvulsants, antidepressants, benzodiazepines, non-steroidal anti-inflammatory drugs (NSAIDs), opioids, oral corticosteroids, skeletal muscle relaxants (SMRs), and atypical opioids.
The authors concluded that nine CPGs, included ten medication classes for the management of LBP. NSAIDs were the most frequently recommended medication for the treatment of both acute and chronic LBP as a first line pharmacological therapy. Acetaminophen and SMRs were inconsistently recommended for acute LBP. Meanwhile, with less consensus among CPGs, acetaminophen and antidepressants were proposed as second-choice therapies for chronic LBP. There was significant heterogeneity of recommendations within many medication classes, although oral corticosteroids, benzodiazepines, anticonvulsants, and antibiotics were not recommended by any CPGs for acute or chronic LBP.
Oddly, this review was published by chiros in a chiro journal. The authors mention that nearly all guidelines the included CPGs recommended non-pharmacological treatments for non-specific LBP, however it was not always delineated as to precede or be used in conjunction with pharmacological intervention.
I find the review interesting because I think it suggests that:
- CPGs are not the most reliable form of evidence. Their guidance depends on how up-to-date they are and on the identity and purpose of the authors.
- Guidelines are therefore often contradictory.
- Back pain is a symptom for which currently no optimal treatment exists.
- The most reliable evidence will rarely come from CPGs but from rigorous, up-to-date, independent systematic reviews such as those from the Cochrane Collaboration.
So, the next time chiropractors osteopaths, acupuncturists, etc. tell you “BUT MY THERAPY IS RECOMMENDED IN THE GUIDELINES”, please take it with a pinch of salt.
Acupuncture is a veritable panacea; it cures everything! At least this is what many of its advocates want us to believe. Does it also have a role in supportive cancer care?
Let’s find out.
This systematic review evaluated the effects of acupuncture in women with breast cancer (BC), focusing on patient-reported outcomes (PROs).
A comprehensive literature search was carried out for randomized controlled trials (RCTs) reporting PROs in BC patients with treatment-related symptoms after undergoing acupuncture for at least four weeks. Literature screening, data extraction, and risk bias assessment were independently carried out by two researchers. The authors stated that they followed the ‘Preferred Reporting Items for Systematic Review and Meta-Analyses’ (PRISMA) guidelines.
Out of the 2, 524 identified studies, 29 studies representing 33 articles were included in this meta-analysis. The RCTs employed various acupuncture techniques with a needle, such as hand-acupuncture and electroacupuncture. Sham/placebo acupuncture, pharmacotherapy, no intervention, or usual care were the control interventions. About half of the studies lacked adequate blinding.
At the end of treatment (EOT), the acupuncture patients’ quality of life (QoL) was measured by the QLQ-C30 QoL subscale, the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES), the Functional Assessment of Cancer Therapy–General/Breast (FACT-G/B), and the Menopause-Specific Quality of Life Questionnaire (MENQOL), which depicted a significant improvement. The use of acupuncture in BC patients lead to a considerable reduction in the scores of all subscales of the Brief Pain Inventory-Short Form (BPI-SF) and Visual Analog Scale (VAS) measuring pain. Moreover, patients treated with acupuncture were more likely to experience improvements in hot flashes scores, fatigue, sleep disturbance, and anxiety compared to those in the control group, while the improvements in depression were comparable across both groups. Long-term follow-up results were similar to the EOT results. Eleven RCTs did not report any information on adverse effects.
The authors concluded that current evidence suggests that acupuncture might improve BC treatment-related symptoms measured with PROs including QoL, pain, fatigue, hot flashes, sleep disturbance and anxiety. However, a number of included studies report limited amounts of certain subgroup settings, thus more rigorous, well-designed and larger RCTs are needed to confirm our results.
This review looks rigorous on the surface but has many weaknesses if one digs only a little deeper. To start with, it has no precise research question: is any type of acupuncture better than any type of control? This is not a research question that anyone can answer with just a few studies of mostly poor quality. The authors claim to follow the PRISMA guidelines, yet (as a co-author of these guidelines) I can assure you that this is not true. Many of the included studies are small and lacked blinding. The results are confusing, contradictory and not clearly reported. Many trials fail to mention adverse effects and thus violate research ethics, etc., etc.
The conclusion that acupuncture might improve BC treatment-related symptoms could be true. But does this paper convince me that acupuncture DOES improve these symptoms?
No!
The new NICE draft guideline on acupuncture for chronic pain has been published several months ago, and we discussed it here. Now the final document entitled ‘Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain‘ has been published on 7/4/2021. Like the draft, it includes quite a bit about acupuncture. Let me just quote three essential sections:
Recommendations: Acupuncture for chronic primary pain
Consider a single course of acupuncture or dry needling, within a traditional Chinese or Western acupuncture system, for people aged 16 years and over to manage chronic primary pain, but only if the course:
- is delivered in a community setting and
- is delivered by a band 7 (equivalent or lower) healthcare professional with appropriate training and
- is made up of no more than 5 hours of healthcare professional time (the number and length of sessions can be adapted within these boundaries) or
- is delivered by another healthcare professional with appropriate training and/or in another setting for equivalent or lower cost.
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Many studies (27 in total) showed that acupuncture reduced pain and improved quality of life in the short term (up to 3 months) compared with usual care or sham acupuncture. There was not enough evidence to determine longer-term benefits. The committee acknowledged the difficulty in blinding for sham procedures, but agreed that the benefit compared with a sham procedure indicated a specific treatment effect of acupuncture. There was a wide variation among the studies in the type and intensity of the intervention used, and the studies were from many different countries. The committee agreed that the type of acupuncture or dry needling should depend on the individual needs of the person with pain.
Two economic evaluations (1 in the UK) showed that acupuncture offered a good balance of benefits and costs for people with chronic neck pain. However, both studies had limitations; a notable limitation being that the costs of acupuncture seemed low. Threshold analysis based on these studies indicated the maximum number of hours of a band 6 and 7 healthcare professional’s time that would make the intervention cost effective.
An original economic model was developed for this guideline, which compared acupuncture with no acupuncture. The model used data from studies with usual care comparisons, not comparisons with sham acupuncture, because the committee agreed that a usual care comparison in an economic model better reflects the real world benefit of the intervention. The model showed that acupuncture was likely to be cost effective. The committee considered the results to be robust, and agreed that the studies used in the model were representative of the whole evidence review. Acupuncture remained cost effective when the assumed benefits and costs were varied (sensitivity analysis).
Overall, the committee agreed that there was a large evidence base showing acupuncture to be clinically effective in the short term (3 months); the original economic modelling also showed it is likely to be cost effective. However, they were uncertain whether the beneficial effects would be sustained long term and were aware of the high resource impact of implementation. Taking these factors into account, the committee made a recommendation to consider acupuncture or dry needling for chronic primary pain, caveated by the factors likely to make the intervention cost effective. These were: only if delivered in the community, and with a maximum of 5 treatment hours (based on the average resource use in the trials in the model and on the threshold analysis), and from a band 7 (equivalent cost or lower) healthcare professional (based on the threshold analysis). It was agreed there may be different ways of delivering the service that enable acupuncture to be delivered for the same costs, which would equally be appropriate. The committee agreed that discontinuing before this total amount of course time would be an option if the person finds that the first few sessions are not effective.
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Acupuncture versus sham acupuncture
Pain reduction
Very low quality evidence from 13 studies with 1230 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months. Low quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months.
Low quality evidence from 4 studies with 376 participants showed no clinically important difference between acupuncture and sham acupuncture at >3 months. Moderate quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at >3 months. Low quality evidence from 1 study with 61 participants showed no clinically important difference between acupuncture
and sham acupuncture at >3 months.
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I will leave this here without a comment for the moment and look forward to reading what you think about this.
As recently reported, the most thorough review of the subject showed that the evidence for acupuncture as a treatment for chronic pain is very weak. Yesterday, NICE published a draft report that seems to somewhat disagree with this conclusion (and today, this is being reported in most of the UK daily papers). The draft is now open to public consultation until 14 September 2020 and many of my readers might want to comment.
The draft report essentially suggests that people with chronic primary pain (CPP) should not get pain-medication of any type, but be offered supervised group exercise programmes, some types of psychological therapy, or acupuncture. While I understand that chronic pain should not be treated with long-term pain-medications – I did even learn this in medical school all those years ago – one might be puzzled by the mention of acupuncture.
But perhaps we need first ask, WHAT IS CPP? The NICE report informs us that CPP represents chronic pain as a condition in itself and which can’t be accounted for by another diagnosis, or where it is not the symptom of an underlying condition (this is known as chronic secondary pain). I find this definition most unsatisfactory. Pain is usually a symptom and not a disease. In many forms of what we now call CPP, an underlying disease does exist but might not yet be identifiable, I suspect.
The evidence on acupuncture considered for the draft NICE report included conditions like:
- neck pain,
- myofascial pain,
- radicular arm pain,
- shoulder pain,
- prostatitis pain,
- mechanical neck pain,
- vulvodynia.
I find it debatable whether these pain syndromes can be categorised to be without an underlying diagnosis. Moreover, I find it problematic to lump them together as though they were one big entity.
The NICE draft document is huge and far too big to be assessed in a blog like mine. As it is merely a draft, I also see little point in evaluating it or parts of in detail. Therefore, my comments are far from detailed, very brief and merely focussed on pain (the draft NICE report considers several further outcome measures).
There is a separate document for acupuncture, from which I copy what I consider the key evidence:
Acupuncture versus sham acupuncture
Pain reduction
Very low quality evidence from 13 studies with 1230 participants showed a clinically
important benefit of acupuncture compared to sham acupuncture at ≤3 months. Low quality
evidence from 2 studies with 159 participants showed a clinically important benefit of
acupuncture compared to sham acupuncture at ≤3 months.
Low quality evidence from 4 studies with 376 participants showed no clinically important
difference between acupuncture and sham acupuncture at >3 months. Moderate quality
evidence from 2 studies with 159 participants showed a clinically important benefit of
acupuncture compared to sham acupuncture at >3 months. Low quality evidence from 1
study with 61 participants showed no clinically important difference between acupuncture
and sham acupuncture at >3 months.
As acupuncture has all the features that make a perfect placebo (slightly invasive, mildly painful, exotic, involves touch, time and attention), I see little point in evaluating its efficacy through studies that make no attempt to control for placebo effects. This is why the sham-controlled studies are central to the question of acupuncture’s efficacy, no matter for what condition.
Reading the above evidence carefully, I fail to see how NICE can conclude that CPP patients should be offered acupuncture. I am sure that some readers will disagree and am looking forward to reading their comments.
