Management of chronic pain using complementary and integrative medicine
BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j1284 (Published 24 April 2017) Cite this as: BMJ 2017;357:j1284
All rapid responses
The first rule of practising evidence-based Medicine is: read the evidence. The respondent below seems to have read a different article in declaiming all these treatments to be useless and dangerous, while under the impression that harms from western Medicine are axiomatically fewer. The lack of discrimination in criticism between any of the different modalities of treatments while branding them all a dangerous threat is also not very convincing.
The article describes a significant body of clinically meaningful RCT evidence - including inflammatory markers - finding that acupuncture may be as effective as DMARDS and may add benefit to DMARD treatment in patients with Rheumatoid Arthritis.
The article also describes a body of relevant evidence of benefit of acupuncture for chronic low back pain. As a USA Orthopaedic surgeon, Steven Zeitzew would know that; "The clinical practice guideline provided by the American College of Physicians and the American Pain Society recommends acupuncture as a non-drug therapy for CLBP patients.".
The harms of acupuncture suggested by the evidence are of the order 0.13%-0.14% for minor adverse events, with no serious adverse events in trials of 31,000 and 35,000 patients. Rather safer than NSAIDs, then.
As a family doctor who practises osteopathy free of charge in the NHS, I was disappointed not to see any mention in the article of the high quality RCTs showing significant clinical benefits of osteopathy, over and above exercise/physio. I have the advantage of continuity of care to know that these patients really do benefit substantially directly from osteopathic treatment, in all of the measures - pain, function, use of analgesics, employment/disability, referrals and reduction in surgery - which one would consider as important outcomes. The positive cost-effectiveness analysis of the UK BEAM trial has been published, so it is a shame to see that the recommendations for manual therapy have been weakened in the revised NICE guideline for back pain. Osteopathy is also safer than NSAIDs.
Where evidence is weak or conflicted, it is sensible to adopt equipoise and learn to tolerate uncertainty while further, better-targeted research evidence is allowed to emerge. Thanks to BMJ for publishing this interesting evidence review, I would recommend contributors read it.
Competing interests: As a medical practitioner of structural osteopathy, I use mechanical, predictable techniques to treat patients' musculoskeletal pain and dysfunction. I believe the evidence base is sufficient for osteopathy to be considered as a first-line treatment alongside or in place of conventional treatments such as physiotherapy.
It is disappointing to see your recommendations for medical practices that are not supported by sufficient evidence of efficacy to justify their documented risks. The alternative medicine treatments recommended here are ineffective or of unproved efficacy and are potentially harmful with significant known risks. Although popular the larger and better designed the double blind controlled clinical trials of acupuncture have been the less likely they have been to show an effect of acupuncture above placebo. Patients will be harmed when unproved unscientific treatment is integrated with or used instead of effective science based medical therapies.
I believe it is time for this and other medical journals to be vocal advocates for the truth, and to begin discouraging unscientific practices. Patients must have the freedom to make up their own mind about the treatments they seek. Their decisions must not be based on misleading unscientific recommendations or by a desire to take a shortcut to making some of them happy with their care by catering to demands from some for alternative medicine that may not be in their best interest.
An ethical physician should only endorse the practice of medicine based on the best available science, with sufficient scientific evidence about safety and efficacy to justify recommendation. Every patient deserves a truthful discussion in order to choose the offered treatment that is the best match for their set of goals and values. Right now the BMJ loses credibility because it endorses treatment that is well known to not be supported by the best available scientific evidence, under the guise of Integrative Medicine.
There are many popular “alternative” medicine methods, complementary remedies and alternative practices, which lack sufficient evidence to justify your endorsement. Unfortunately, because there are political and economic reasons to offer these treatments, they have made inroads into the medical treatment system under the guise of Integrative Medicine, being excused because of claims they improve the patient experience. There is so much vocal support for unscientific methods and wishful thinking that the non-vocal patient hoping for the best science based treatment is discouraged by the perception that physicians and academic centers will promote anything that sounds good. The vocal advocates can mislead the observer into believing that unscientific methods have widespread support. BMJ will continue to lose credibility by endorsing methods of care that lack sufficient evidence to support their use. The costs and consequences of lost credibility are gradual and hard to measure, misleading the observer into complacency.
There is so much political and economic support, and so many vocal advocates, that offering unscientific complementary methods becomes appealing. Individual academic physicians lack authority or incentive to speak up. Those patients fed up by the lack of credibility leave, or never arrive, leaving a slowly increasing population of those who are not sufficiently upset to leave or speak out, leading to the erroneous impression of increasing support for this nonsense. This further inhibits others from speaking out. As the BMJ loses credibility it will be increasingly difficult to retain readers with a passion for seeking and advocating only the truth. Over time quality and credibility will continue to erode unless the BMJ acts to stop unjustified endorsement of unscientific methods of care.
The BMJ ought to stop confusing and misleading patients and to recommit to the truth and to putting the patient at the center of its advocacy. Your priority should be promoting high scientific standards to justify medical treatment recommendations. Some patients may be pleased by the promotion of Integrative Medicine, but they won't be well-served. In the long run the promotion of Integrative Medicine is a form of self-sabotage that will ostracize rational physicians who expect the truth, expect academic integrity, and expect recommendations for providing the best science-based medicine.
The most prominent medical schools and medical journals are no longer standing up for the truth and the best quality scientific evidence.
Perhaps publishing a set of unbiased systematic reviews would create a resource that will enhance the quality of care offered and recommended by physician readers of the journal. Only the best scientific evidence based care can stand up to close scrutiny by advocates for a high quality patient healthcare experience. Educated physicians, patient advocates, and patients will note that the BMJ will become one of the journals willing to stand up for the truth, one of the few that will promote the patient centered experience of receiving only truthful advice based on the best unbiased evaluation of scientific evidence. The BMJ could become an opponent of misleading recommendations for popular but unscientific methods that lack sufficient evidence of efficacy and safety to justify an endorsement. Readers will be able to rely on systematic reviews of the best available evidence. Students will be taught to value and emphasize the truth in their future practice. They will become more ethical physicians less tempted to offer unscientific treatments. Readers will waste less of their patients’ time and money on treatments that lack sufficient evidence for efficacy to justify their risks. The patients will therefore experience better results with lower costs.
Deaths and serious injuries from herbal drugs, acupuncture, and chiropractic manipulation can be prevented by screening out those whose medical condition puts them at high risk for these complications. Evidence shows that patients with high risk illness who choose alternative medicine treatments incur higher costs, and have greater morbidity and mortality rates. Relying on patient satisfaction to guide medical care instead of relying on quality care to improve patient satisfaction has also increased morbidity and mortality, and therefore medical costs, including complications.
Competing interests: No competing interests
There is an interesting paper in Nature on the effects of electroacupuncture on serum TNF concentrations..........cutting edge and controversial and a route to developing new medication for the effective treatment of sepsis, for which there appears not to be a current conventional therapy, let alone possibilities in chronic inflammatory diseases?
Reading some responses 'baby and bathwater' come to mind, as well as examples of a curious prevailing tendency to a closed minded approach to methods which work in clinical settings? It is encouraging the BMJ is prepared to explore treatment modalities which safely enhance patients' experience and their therapeutic pathway.
"Previous anti-inflammatory strategies against sepsis, a leading cause of death in hospitals, had limited efficacy in clinical trials, in part because they targeted single cytokines and the experimental models failed to mimic clinical settings1, 2, 3. Neuronal networks represent physiological mechanisms, selected by evolution to control inflammation, that can be exploited for the treatment of inflammatory and infectious disorders3. Here, we report that sciatic nerve activation with electroacupuncture controls systemic inflammation and rescues mice from polymicrobial peritonitis. Electroacupuncture at the sciatic nerve controls systemic inflammation by inducing vagal activation of aromatic L-amino acid decarboxylase, leading to the production of dopamine in the adrenal medulla. Experimental models with adrenolectomized mice mimic clinical adrenal insufficiency4, increase the susceptibility to sepsis and prevent the anti-inflammatory effects of electroacupuncture. Dopamine inhibits cytokine production via dopamine type 1 (D1) receptors. D1 receptor agonists suppress systemic inflammation and rescue mice with adrenal insufficiency from polymicrobial peritonitis. Our results suggest a new anti-inflammatory mechanism mediated by the sciatic and vagus nerves that modulates the production of catecholamines in the adrenal glands. From a pharmacological perspective, the effects of selective dopamine agonists mimic the anti-inflammatory effects of electroacupuncture and can provide therapeutic advantages to control inflammation in infectious and inflammatory disorders."
Competing interests: No competing interests
Responses to the paper by Chen and Michalsen have not mentioned the dangerously ambivalent role of conventional medications, in the management of chronic pain.
In the USA, “ Prescription painkillers’ overuse has become a silent epidemic....46 Americans die from prescription painkiller overdoses daily,” said the NIH and the CDC in 2015. (1)
In the UK, NHS Digital figures released last week show prescriptions of opioids doubled in the decade to 2016. Prescriptions for oxycodene rose by 385%.
Harry Shapiro of the DrugWise information service said the increasing prescription of painkillers is leading to “a public health disaster.” He added, “ It’s a problem hidden in plain sight, a problem in every GP surgery and pain specialist clinic .“
Shapiro’s concern was reinforced by comments from the Dean of the UK Faculty of Pain Medicine, from the clinical lead for chronic pain at the RCGP, and from a consultant pain specialist in Oxford. (2)
Against this background of widespread alarm at analgesic overuse and abuse, the possibility of other, safer options being explored, for the control of chronic pain, is one that reasonable people might wish to examine.
One must never forget that this grim scenario is fuelled by doctors’ prescribing, and that pharmaceutical companies enjoy large profits from the resulting human misery and addiction.
All the more important that those who take part in the debate are forthcoming about their competing interests and personal agendas.
Chen and Michalsen have barely opened the door to shine a crack of light on other options , and to encourage a wider debate.
Their initiative, if not extinguished by the power of Pharma and the narrow interests of our profession, may prompt the occasional open minded doctor to think beyond another quick fix prescription.
A doctor decorator, finding a crack in his kitchen wall, may apply successive coats of paint, or layers of wall paper, but still the crack reappears. Much as his chronic pain patients receive simple analgesics, NSAIDs, amitriptylene, gabapentin, perhaps an SSRI, then tramadol, before starting on the steep slope of opioid use.
A builder would explain, too late, that the cracked wall problem could be due to a leaking roof, poor foundations, or any one of twenty problems, in between.
A complementary therapist knows that chronic pain, and the sufferer, need to be understood in terms of their life narrative and myriad experiences, before any treatment is offered.
It is important that the response from May, Ernst and Ross does not go unremarked.
Their response illustrates those faults that they identify in the paper by Chen and Michalsen.
They begin by ridiculing those who create their own terminology.
May, Ernst and Ross created their own terminology when they signed a letter in the BMJ containing abusive unprofessional terminology, directed at bona fide colleagues. (3) Five years later, the leading signatory to that letter also complained of poor terminology in the BMJ. Have they all moved on, or forgotten ? (4)
May, Ernst and Ross bemoan the lack of post marketing surveillance and the lack of information on adverse events, while omitting to cite any reference for their own allegation of “ ..the many fatalities “ caused by complementary and integrative medicine.
One of the most unbiased sources of post marketing surveillance is the professional indemnity insurance market. A full time GP in the UK can expect to pay £ 7000 pa, or more, for professional cover. A full time complementary therapist can expect to pay a few hundred pounds, and the well established firms who insure complementary therapists regard them as very low risk.
May, Ernst and Ross have much to say about the pretence of objectivity, thoroughness and the use of broad generalisations, which they identify in Chen and Michalsen’s paper.
Are May, Ernst and Ross being too judgemental in these respects ?
One of them, Emeritus Professor Ernst, has written in his memoirs, that “ The Nazi policy of deliberately amalgamating alternative and conventional medicine bears many similarities to what is today known as ‘ integrative medicine ‘ “. Ernst goes on to point out that “ the most important link between my research into alternative medicine and that related to the Third Reich was that of medical ethics.”
Ernst concluded that “ the principles of medical ethics are routinely ignored and frequently violated by promoters of alternative medicine (5)
He provided no evidence to support this important claim.
Ernst is free to hold controversial opinions, to write books, blogs and opinion pieces, and to accept speaking engagements, to promote his negative views on complementary therapies and integrative medicine. Paid or voluntary, should these activities be included, as competing interests, in the interests of thoroughness, for your readers ?
1 The Guardian, 16 January 2015
https://www.theguardian.com/us-news/2015/jan/16/prescription-painkillers...
2 The Guardian, 6 May 2017
https://www.theguardian.com/science/2017/may/05/unnecessary-opioid-paink...
3 http://www.bmj.com/rapid-response/2011/11/03/evidence-homeopathy-not-pos...
4 http://www.bmj.com/content/356/bmj.j1485/rr-2
5 Edzard Ernst, A Scientist in Wonderland, Imprint Academic 2015. pp 167-169
Competing interests: NHS homeopathy, no private practice
Alternative facts are fashionable in politics these days, so why not also in healthcare? The article by Chen and Michalsen on thebmj.com provides a handy set of five instructions for smuggling alternative facts into medicine. 1
1. Create your own terminology: the term ‘complementary and integrated medicine’ (CIM) is nonsensical. Integrated medicine (a hotly disputed field) already covers complementary and conventional medicine.
2. Pretend to be objective: Chen and Michalsen elaborate on the systematic searches they conducted. But they omit hundreds of sources which do not support their message, which cherry-picks only evidence for the efficacy of the treatments they promote.
3. Avoid negativity: they bypass any material that might challenge what they include. For instance, when discussing therapeutic risks, they omit the disturbing lack of post-marketing surveillance: the reason we lack information on adverse events. They even omit to mention the many fatalities caused by their ‘CIM’.
4. Create an impression of thoroughness: Chen and Michalsen cite a total of 225 references. This apparent scholarly attention to detail masks their misuse of many of they list. Reference 82, for example, is employed to back up the claim that “satisfaction was lowest among complementary medicine users with rheumatoid arthritis, vasculitis, or connective tissue diseases”. In fact, it shows nothing of the sort.
5. Back up your message with broad generalisations: Chen and Michalsen conclude that “Taken together, CIM has an increasing role in the management of chronic pain, but high quality research is needed”. The implication is that all the CIMs mentioned in their figure 1 are candidates for pain control – even discredited treatments such as homeopathy.
In our view, these authors render us a service: they demonstrate to the novice how to alternative facts may be used in medicine.
1 Chen L, Michalsen A. Management of chronic pain using complementary and integrative medicine. BMJ 2017;357:j128
Competing interests: JM, EE and NR are, respectively, chairman, member and president of HealthWatch, a UK charity that promotes science and integrity in healthcare. These are entirely voluntary associations and no income is associated.
This article will provide a good basis for teaching healthcare students about inappropriately conducted reviews which distort the available evidence and, in an apparent show of erudition, manage to point to unsustainable conclusions. I am surprised the internal BMJ refereeing system did not identify the glaring errors in the process and conclusions of the paper.
Competing interests: No competing interests
We read with great interest the review by Chen and Michalsen [1] on the use of complementary and integrative medicine (CIM) in back pain, neck pain, and rheumatoid arthritis with a high incidence of chronic pain. The authors conclude that CIM has an increasing role in the management of chronic pain, but high quality research is warranted.
We would like to respond to their conclusions about acupuncture. Probably due to the timing of the authors, they have missed three highly important articles on assessing acupuncture. The clinical practice guideline from the National Institute for Health and Care Excellence (NICE), in the United Kingdom recommended against the use of acupuncture on osteoarthritis and this decision triggered three papers with remarks on this decision, but also on acupuncture research in general [2-4] and on the bias that may occur if the guidelines for recommendation are not broad enough or not stated well. When the authors remark, that it is too premature to conclude anything on rheumatoid arthritis, they base this conclusion on meta-analyses that do not include all the points mentioned in these articles, especially in the article by Birch et al. [3], for instance, the authors do not describe what would be necessary to make the statement that acupuncture would be an effective treatment? Since they do not seem to work according to a SMART (Specific, Measurable, Achievable, Responsible, Time-related) system [5], their conclusion seems subjective. If they would describe a hypothesis and would tell the readers when it would or would not be confirmed, it would be more scientific and it would be understandable why they draw a conclusion. It is unclear whether the low adverse effects that are generally found and known for acupuncture counted at all in their evaluation, neither was this the fact for cost-effectiveness data. Moreover, there was a lack of comparison between the interventions that they describe. Besides, the effect size, which is important in deciding whether a treatment should be used or not, is highly dependable on the methods of the study. If someone uses enough patients and a low intensity control group, the effect size is likely to be higher than in the case of a high intensity control, like the sham conditions that have been used for a long time [6]. The authors report the article that describes this, but do not seem to implement its consequences in their review. In their abstract, the authors claim to summarize research on CIM in the treatment of chronic pain. In light of our remarks, the authors not only summarize, but draw conclusions without describing the necessary scientific hypotheses and basis to do so; their conclusions are therefore likely to be the subject of bias.
1 Chen L, Michalsen A. Management of chronic pain using complementary and integrative medicine. BMJ 2017;357:j1284. doi:10.1136/bmj.j1284 pmid:28438745.
2 Macpherson H. NICE for some interventions, but not so NICE for others: questionable guidance on acupuncture for osteoarthritis and low-back pain. J Altern Complement Med 2017;23:247-8. doi:10.1089/acm.2017.0029 pmid:28304178.
3 Birch S, Lee MS, Robinson N, Alraek T. The U.K. NICE 2014 guidelines for osteoarthritis of the knee: lessons learned in a narrative review addressing inadvertent limitations and bias. J Altern Complement Med 2017;23:242-6. doi:10.1089/acm.2016.0385 pmid:28394671.
4 Woods B, Manca A, Weatherly H, et al. Cost-effectiveness of adjunct non-pharmacological interventions for osteoarthritis of the knee. PLoS One 2017;12:e0172749. doi:10.1371/journal.pone.0172749 pmid:28267751.
5 Doran GT. There’s a S.M.A.R.T. way to write management’s goals and objectives. Manage Rev 1981;70:35-6.
6 MacPherson H, Vertosick E, Lewith G, et al. Influence of control group on effect size in trials of acupuncture for chronic pain: a secondary analysis of an individual patient data meta-analysis. PLoS One 2014;9:e93739. doi:10.1371/journal.pone.0093739 pmid:24705624.
Competing interests: No competing interests
We read the paper by Chen & Michalsen (1) with interest. The subject of Chronic Pain generates observable attention from professionals and the public alike. We were disappointed that the paper, importantly, lacked working definitions of what the authors considered to be Complementary and Integrative Medicine. This may have affected the validity of their research.
Also, we were disappointed that this paper omitted the treatment, Hypnosis from its review. There is insufficient information to judge whether this is what they called “relaxation” (1) or has been lumped under “Mind-body interventions”. In practice, patients with Chronic Pain often enquire about Hypnosis and high level evidence exists of its value in Chronic Pain (2), such that to totally omit or ignore this treatment does a disservice to patients experiencing a lot of suffering and affects the applicability of this paper.
We recognise that hypnosis does suffer from classification issues. Some regard it as psychological therapy and some as Complementary, Alternative and Integrative Medicine (3). But to totally omit or not comment on any exclusion leaves one bereft.
References:
1. Chen L, Michalsen A. Management of Chronic Pain using Complementary and Integrative Medicine. BMJ 2017;357:j1284. doi: 10.1136/bmj.j1284.
2. Adachi T, Fujino H, Nakae A, Mashimo T, Sasaki J (2014) A Meta-Analysis of Hypnosis for Chronic Pain Problems: A Comparison Between Hypnosis, Standard Care, and Other Psychological Interventions. International Journal of Clinical and Experimental Hypnosis 2014;62:1, 1-28. doi: 10.1080/00207144.2013.841471.
3. National Center for Complementary and Integrative Health. Hypnosis. 2015.
Competing interests: No competing interests
When I see a patient interested in complementary medicine I immediately remember that it is not included in the British National Formulary (BNF) and I have to use another reliable source for information. This article particularly shows that demand for complementary medicine approaches in the treatment of chronic pain is high, and its use is increasing. In a country like the USA [1} the use of complementary medicine therapies has increased steadily since the 1950s.
I do not see good evidence that acupuncture is beneficial in the management of low back pain and NICE no longer recommends offering acupuncture for managing low back pain with or without sciatica [2]. However, patient expectation of benefit seems to affect the outcome [3].
Other approaches considered in complementary medicine might have an increasing role in the management of chronic back pain but as the article stresses high quality research is needed.
Amr Gohar FRCP Glasg UK
Royal College Clinical Educator
References
1. Kessler RC et al. Long-term trends in the use of complementary and alternative medical therapies in the United States. Ann Intern Med 2001; 135: 262–268.
2. NICE. Low back pain and sciatica in over 16s: assessment and management—full guideline (issued November 2016).
3 Chou R, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med 2007; 147: 478–91. Correction. 2008; 148: 247–8.
Competing interests: No competing interests
Re: Management of chronic pain using complementary and integrative medicine
Intercessory prayer.
In this Clinical Review, the Authors list various Hinduistic (meditation, yoga) and Buddhistic (energy meridian manipulation, Tai Chi) practices used against chronic pain.
Their list of effective therapeutic interventions did not include altruistic prayer, practiced in all Monotheistic Abrahamic religions for Millennia.
Systematic reviews and randomized trials, Level I scientific evidence, proved prayer effective against pain. [1][2][3][4][5][6]
References
[1] http://annals.org/aim/article/713514/efficacy-distant-healing-systematic...
[2] https://www.ncbi.nlm.nih.gov/pubmed/10836918
[3] http://www.bmj.com/content/323/7327/1450
[4] https://www.ncbi.nlm.nih.gov/pubmed/27452045
[5] http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-31802017005...
[6] https://www.ncbi.nlm.nih.gov/pubmed/28338863
Competing interests: No competing interests